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المكتبة البحثية60 results
Peer-reviewed works with DOI and abstract, discovered from MEDLINE-indexed literature. Candidates: no tier, no stated finding, not yet read.
Akingbuwa WA, Hammerschlag AR, Jami ES, Allegrini AG, Karhunen V, Sallis H, Ask H, Askeland RB, Baselmans B, Diemer E, Hagenbeek FA, Havdahl A, Hottenga JJ, Mbarek H, Rivadeneira F, Tesli M, van Beijsterveldt C, Breen G, Lewis CM, Thapar A, Boomsma DI, Kuja-Halkola R, Reichborn-Kjennerud T, Magnus P, Rimfeld K, Ystrom E, Jarvelin MR, Lichtenstein P, Lundstrom S, Munafò MR, Plomin R, Tiemeier H, Nivard MG, Bartels M, Middeldorp CM, Bipolar Disorder and Major Depressive Disorder Working Groups of the Psychiatric Genomics Consortium. (2020)MEDLINE-indexed journal, not yet read by usJAMA psychiatry · meta-analysis Genetic Associations Between Childhood Psychopathology and Adult Depression and Associated Traits in 42 998 Individuals: A Meta-analysis.
Importance: Adult mood disorders are often preceded by behavioral and emotional problems in childhood. It is yet unclear what explains the associations between childhood psychopathology and adult traits.
Objective: To investigate whether genetic risk for adult mood disorders and associated traits is associated with childhood disorders.
Design, setting, and participants: This meta-analysis examined data from 7 ongoing longitudinal birth and childhood cohorts from the UK, the Netherlands, Sweden, Norway, and Finland. Starting points of data collection ranged from July 1985 to April 2002. Participants were repeatedly assessed for childhood psychopathology from ages 6 to 17 years. Data analysis occurred from September 2017 to May 2019.
Exposures: Individual polygenic scores (PGS) were constructed in children based on genome-wide association studies of adult major depression, bipolar disorder, subjective well-being, neuroticism, insomnia, educational attainment, and body mass index (BMI).
Main outcomes and measures: Regression meta-analyses were used to test associations between PGS and attention-deficit/hyperactivity disorder (ADHD) symptoms and internalizing and social problems measured repeatedly across childhood and adolescence and whether these associations depended on childhood phenotype, age, and rater.
Results: The sample included 42 998 participants aged 6 to 17 years. Male participants varied from 43.0% (1040 of 2417 participants) to 53.1% (2434 of 4583 participants) by age and across all cohorts. The PGS of adult major depression, neuroticism, BMI, and insomnia were positively associated with childhood psychopathology (β estimate range, 0.023-0.042 [95% CI, 0.017-0.049]), while associations with PGS of subjective well-being and educational attainment were negative (β, -0.026 to -0.046 [95% CI, -0.020 to -0.057]). There was no moderation of age, type of childhood phenotype, or rater with the associations. The exceptions were stronger associations between educational attainment PGS and ADHD compared with internalizing problems (Δβ, 0.0561 [Δ95% CI, 0.0318-0.0804]; ΔSE, 0.0124) and social problems (Δβ, 0.0528 [Δ95% CI, 0.0282-0.0775]; ΔSE, 0.0126), and between BMI PGS and ADHD and social problems (Δβ, -0.0001 [Δ95% CI, -0.0102 to 0.0100]; ΔSE, 0.0052), compared with internalizing problems (Δβ, -0.0310 [Δ95% CI, -0.0456 to -0.0164]; ΔSE, 0.0074). Furthermore, the association between educational attainment PGS and ADHD increased with age (Δβ, -0.0032 [Δ 95% CI, -0.0048 to -0.0017]; ΔSE, 0.0008).
Conclusions and relevance: Results from this study suggest the existence of a set of genetic factors influencing a range of traits across the life span with stable associations present throughout childhood. Knowledge of underlying mechanisms may affect treatment and long-term outcomes of individuals with psychopathology.
JAMA psychiatry · meta-analysis · 62 citationsread the source →
An evaluation of the cardiovascular safety profile of duloxetine: findings from 42 placebo-controlled studies.
Background and objective: In recent years, new classes of medication, such as the serotonin-noradrenaline reuptake inhibitors (SNRIs), have been developed for use in the treatment of major depressive disorder (MDD). For many years, treatment options were largely limited to the use of monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs). However, there have been published reports of orthostatic hypotension, arrhythmias and corrected QT (QTc) interval changes in patients treated with TCAs. As new medications become available, it is important to understand how their cardiovascular safety profile compares with that of more established agents to aid clinicians and patients in choosing the best treatment options. This study was designed to evaluate the cardiovascular safety profile of the SNRI duloxetine through evaluation of cardiovascular-related parameters and adverse events (AEs).
Methods: The cardiovascular safety of duloxetine was assessed using all placebo-controlled duloxetine clinical trial data as of December 2005. This consisted of data from 42 placebo-controlled clinical trials of 8504 patients who were treated with duloxetine. Additional information from a high-dose clinical pharmacology study and postmarketing safety surveillance are also presented. Of the placebo-controlled trials included in this analysis, clinical indications under investigation included MDD (15 studies), diabetic peripheral neuropathic pain (3 studies), fibromyalgia (2 studies), generalised anxiety disorder (3 studies) and lower urinary tract disorders (19 studies, all related to incontinence). Cardiovascular safety was evaluated based on vital signs, ECGs and the incidence of treatment-emergent AEs potentially related to cardiovascular safety. These safety parameters were analysed across all indications. To identify both serious and non-serious cardiovascular-related AEs, as well as AEs reported as the reason for discontinuation, a comprehensive list of terms derived from the Medical Dictionary for Regulatory Activities (version 8.0) was generated and used to search the duloxetine databases for cardiovascular-related events.
Results: Calculation of change from baseline to maximum in ECG parameters showed significant differences between treatment groups for all parameters, with decreases from baseline in RR, QRS and QT intervals for patients receiving duloxetine and increases from baseline for patients treated with placebo. These shifts were related to small heart rate changes, but the mean differences were not considered clinically relevant. Categorical analyses of shifts from normal to abnormal (or abnormal to normal) for heart rate and QT corrected for heart rate using Fridericia's formula (QTcF) values showed that most patients did not shift from their baseline category. Patients with MDD who were treated for up to 1 year with duloxetine had blood pressure changes early in treatment that then stabilised. Even in patients with elevated blood pressure at baseline in these clinical trials, no increased risk of sustained blood pressure elevation with duloxetine treatment was found.
Conclusion: Overall, the findings presented here support our conclusions that use of duloxetine does not appear to be associated with significant cardiovascular risks in patients with conditions for which the drug has been approved or studied.
Drug safety · meta-analysis · 84 citationsread the source →
Purgato M, Gross AL, Betancourt T, Bolton P, Bonetto C, Gastaldon C, Gordon J, O'Callaghan P, Papola D, Peltonen K, Punamaki RL, Richards J, Staples JK, Unterhitzenberger J, van Ommeren M, de Jong J, Jordans MJD, Tol WA, Barbui C. (2018)MEDLINE-indexed journal, not yet read by usThe Lancet. Global health · meta-analysis Focused psychosocial interventions for children in low-resource humanitarian settings: a systematic review and individual participant data meta-analysis.
Background: Results from studies evaluating the effectiveness of focused psychosocial support interventions in children exposed to traumatic events in humanitarian settings in low-income and middle-income countries have been inconsistent, showing varying results by setting and subgroup (eg, age or gender). We aimed to assess the effectiveness of these interventions, and to explore which children are likely to benefit most.
Methods: We did a systematic review and meta-analysis of individual participant data (IPD) from 3143 children recruited to 11 randomised controlled trials of focused psychosocial support interventions versus waiting list. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, PubMed, PsycArticles, Web of Science, and the main local low-income and middle-income countries (LMICs) databases according to the list of databases relevant to LMIC developed collaboratively by Cochrane and WHO Library, up to November, 2016. We included randomised controlled trials that assessed the effectiveness of focused psychosocial support interventions in children exposed to traumatic events in LMICs, compared with waiting lists (eg, inactive controls). We excluded quasi-randomised trials, studies that did not focus on psychosocial support interventions, and studies that compared two active interventions without control conditions. We requested anonymised data from each trial for each of the prespecified variables for each child who was randomly assigned. The main outcomes considered were continuous scores in post-traumatic stress disorder (PTSD) symptoms, depressive symptoms, and anxiety symptoms assessed with rating scales administered immediately (0-4 weeks) after the intervention. We harmonised all individual items from rating scales using item response theory methods. This study is registered with PROSPERO, number CRD42013006960.
Findings: We identified a beneficial effect of focused psychosocial support interventions on PTSD symptoms (standardised mean difference [SMD] -0·33, 95% CI -0·52 to -0·14) that was maintained at follow-up (-0·21, -0·42 to -0·01). We also identified benefits at the endpoint for functional impairment (-0·29, -0·43 to -0·15) and for strengths: coping (-0·22, -0·43 to -0·02), hope (-0·29, -0·48 to -0·09), and social support (-0·27, -0·52 to -0·02). In IPD meta-analyses focused on age, gender, displacement status, region, and household size we found a stronger improvement in PTSD symptoms in children aged 15-18 years (-0·43, -0·63 to -0·23), in non-displaced children (-0·40, -0·52 to -0·27), and in children living in smaller households (<6 members; -0·27, -0·42 to -0·11).
Interpretation: Overall, focused psychosocial interventions are effective in reducing PTSD and functional impairment, and in increasing hope, coping, and social support. Future studies should focus on strengthening interventions for younger children, displaced children, and children living in larger households.
Funding: European Commission FP7th Framework Programme for Research (Marie Curie International Outgoing Fellowship) and the National Institute on Aging.
The Lancet. Global health · meta-analysis · 99 citationsread the source →
Psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the COVID-19 pandemic.
Background: Before the COVID-19 pandemic, coronaviruses caused two noteworthy outbreaks: severe acute respiratory syndrome (SARS), starting in 2002, and Middle East respiratory syndrome (MERS), starting in 2012. We aimed to assess the psychiatric and neuropsychiatric presentations of SARS, MERS, and COVID-19.
Methods: In this systematic review and meta-analysis, MEDLINE, Embase, PsycINFO, and the Cumulative Index to Nursing and Allied Health Literature databases (from their inception until March 18, 2020), and medRxiv, bioRxiv, and PsyArXiv (between Jan 1, 2020, and April 10, 2020) were searched by two independent researchers for all English-language studies or preprints reporting data on the psychiatric and neuropsychiatric presentations of individuals with suspected or laboratory-confirmed coronavirus infection (SARS coronavirus, MERS coronavirus, or SARS coronavirus 2). We excluded studies limited to neurological complications without specified neuropsychiatric presentations and those investigating the indirect effects of coronavirus infections on the mental health of people who are not infected, such as those mediated through physical distancing measures such as self-isolation or quarantine. Outcomes were psychiatric signs or symptoms; symptom severity; diagnoses based on ICD-10, DSM-IV, or the Chinese Classification of Mental Disorders (third edition) or psychometric scales; quality of life; and employment. Both the systematic review and the meta-analysis stratified outcomes across illness stages (acute vs post-illness) for SARS and MERS. We used a random-effects model for the meta-analysis, and the meta-analytical effect size was prevalence for relevant outcomes, I2 statistics, and assessment of study quality.
Findings: 1963 studies and 87 preprints were identified by the systematic search, of which 65 peer-reviewed studies and seven preprints met inclusion criteria. The number of coronavirus cases of the included studies was 3559, ranging from 1 to 997, and the mean age of participants in studies ranged from 12·2 years (SD 4·1) to 68·0 years (single case report). Studies were from China, Hong Kong, South Korea, Canada, Saudi Arabia, France, Japan, Singapore, the UK, and the USA. Follow-up time for the post-illness studies varied between 60 days and 12 years. The systematic review revealed that during the acute illness, common symptoms among patients admitted to hospital for SARS or MERS included confusion (36 [27·9%; 95% CI 20·5-36·0] of 129 patients), depressed mood (42 [32·6%; 24·7-40·9] of 129), anxiety (46 [35·7%; 27·6-44·2] of 129), impaired memory (44 [34·1%; 26·2-42·5] of 129), and insomnia (54 [41·9%; 22·5-50·5] of 129). Steroid-induced mania and psychosis were reported in 13 (0·7%) of 1744 patients with SARS in the acute stage in one study. In the post-illness stage, depressed mood (35 [10·5%; 95% CI 7·5-14·1] of 332 patients), insomnia (34 [12·1%; 8·6-16·3] of 280), anxiety (21 [12·3%; 7·7-17·7] of 171), irritability (28 [12·8%; 8·7-17·6] of 218), memory impairment (44 [18·9%; 14·1-24·2] of 233), fatigue (61 [19·3%; 15·1-23·9] of 316), and in one study traumatic memories (55 [30·4%; 23·9-37·3] of 181) and sleep disorder (14 [100·0%; 88·0-100·0] of 14) were frequently reported. The meta-analysis indicated that in the post-illness stage the point prevalence of post-traumatic stress disorder was 32·2% (95% CI 23·7-42·0; 121 of 402 cases from four studies), that of depression was 14·9% (12·1-18·2; 77 of 517 cases from five studies), and that of anxiety disorders was 14·8% (11·1-19·4; 42 of 284 cases from three studies). 446 (76·9%; 95% CI 68·1-84·6) of 580 patients from six studies had returned to work at a mean follow-up time of 35·3 months (SD 40·1). When data for patients with COVID-19 were examined (including preprint data), there was evidence for delirium (confusion in 26 [65%] of 40 intensive care unit patients and agitation in 40 [69%] of 58 intensive care unit patients in one study, and altered consciousness in 17 [21%] of 82 patients who subsequently died in another study). At discharge, 15 (33%) of 45 patients with COVID-19 who were assessed had a dysexecutive syndrome in one study. At the time of writing, there were two reports of hypoxic encephalopathy and one report of encephalitis. 68 (94%) of the 72 studies were of either low or medium quality.
Interpretation: If infection with SARS-CoV-2 follows a similar course to that with SARS-CoV or MERS-CoV, most patients should recover without experiencing mental illness. SARS-CoV-2 might cause delirium in a significant proportion of patients in the acute stage. Clinicians should be aware of the possibility of depression, anxiety, fatigue, post-traumatic stress disorder, and rarer neuropsychiatric syndromes in the longer term.
Funding: Wellcome Trust, UK National Institute for Health Research (NIHR), UK Medical Research Council, NIHR Biomedical Research Centre at University College London Hospitals NHS Foundation Trust and University College London.
The lancet. Psychiatry · meta-analysis · 1531 citationsread the source →
Shared care across the interface between primary and specialty care in management of long term conditions.
Background: Shared care has been used in the management of many chronic conditions with the assumption that it delivers better care than primary or specialty care alone; however, little is known about the effectiveness of shared care.
Objectives: To determine the effectiveness of shared care health service interventions designed to improve the management of chronic disease across the primary/specialty care interface. This is an update of a previously published review. Secondary questions include the following:1. Which shared care interventions or portions of shared care interventions are most effective?2. What do the most effective systems have in common?
Search methods: We searched MEDLINE, Embase and the Cochrane Library to 12 October 2015.
Selection criteria: One review author performed the initial abstract screen; then two review authors independently screened and selected studies for inclusion. We considered randomised controlled trials (RCTs), non-randomised controlled trials (NRCTs), controlled before-after studies (CBAs) and interrupted time series analyses (ITS) evaluating the effectiveness of shared care interventions for people with chronic conditions in primary care and community settings. The intervention was compared with usual care in that setting.
Data collection and analysis: Two review authors independently extracted data from the included studies, evaluated study quality and judged the certainty of the evidence using the GRADE approach. We conducted a meta-analysis of results when possible and carried out a narrative synthesis of the remainder of the results. We presented the results in a 'Summary of findings' table, using a tabular format to show effect sizes for all outcome types.
Main results: We identified 42 studies of shared care interventions for chronic disease management (N = 18,859), 39 of which were RCTs, two CBAs and one an NRCT. Of these 42 studies, 41 examined complex multi-faceted interventions and lasted from six to 24 months. Overall, our confidence in results regarding the effectiveness of interventions ranged from moderate to high certainty. Results showed probably few or no differences in clinical outcomes overall with a tendency towards improved blood pressure management in the small number of studies on shared care for hypertension, chronic kidney disease and stroke (mean difference (MD) 3.47, 95% confidence interval (CI) 1.68 to 5.25)(based on moderate-certainty evidence). Mental health outcomes improved, particularly in response to depression treatment (risk ratio (RR) 1.40, 95% confidence interval (CI) 1.22 to 1.62; six studies, N = 1708) and recovery from depression (RR 2.59, 95% CI 1.57 to 4.26; 10 studies, N = 4482) in studies examining the 'stepped care' design of shared care interventions (based on high-certainty evidence). Investigators noted modest effects on mean depression scores (standardised mean difference (SMD) -0.29, 95% CI -0.37 to -0.20; six studies, N = 3250). Differences in patient-reported outcome measures (PROMs), processes of care and participation and default rates in shared care services were probably limited (based on moderate-certainty evidence). Studies probably showed little or no difference in hospital admissions, service utilisation and patient health behaviours (with evidence of moderate certainty).
Authors' conclusions: This review suggests that shared care improves depression outcomes and probably has mixed or limited effects on other outcomes. Methodological shortcomings, particularly inadequate length of follow-up, may account in part for these limited effects. Review findings support the growing evidence base for shared care in the management of depression, particularly stepped care models of shared care. Shared care interventions for other conditions should be developed within research settings, with account taken of the complexity of such interventions and awareness of the need to carry out longer studies to test effectiveness and sustainability over time.
The Cochrane database of systematic reviews · meta-analysis · 56 citationsread the source →
Aymerich C, Pedruzo B, Pérez JL, Laborda M, Herrero J, Blanco J, Mancebo G, Andrés L, Estévez O, Fernandez M, Salazar de Pablo G, Catalan A, González-Torres MÁ. (2022)MEDLINE-indexed journal, not yet read by usEuropean psychiatry : the journal of the Association of European Psychiatrists · meta-analysis COVID-19 pandemic effects on health worker's mental health: Systematic review and meta-analysis.
Background: Healthcare workers (HCWs) exposed to coronavirus 19 (COVID-19) are at high risk of developing mental health concerns across several domains. The aim of this study is to determine the updated, global frequency of these outcomes.
Methods: A multistep literature search was performed from database inception until March 1, 2021. PRISMA/MOOSE-compliant systematic review and PROSPERO protocol were used to identify studies reporting on depression, anxiety, acute stress, post-traumatic symptoms, insomnia, and burnout in HCWs exposed to COVID-19. A quantitative meta-analysis with random effects was conducted to analyze the proportion rate of the mental health disorders. Sensitivity analyses were performed to investigate the effect of the different continents and scales. Meta-regression analyses were conducted to examine the effect of gender, age, and work position.
Results: 239 articles were included (n = 271,319 HCWs, mean age = 36.08 ± 8.33 (66.99% female). 33% HCWs exposed to COVID-19 reported depressive symptoms (95% confidence intervals [CI] = 28-38%), 42% anxiety features (95% CI = 35-48), 40% acute stress (95% CI = 32-47), 32% post-traumatic symptoms (95% CI = 26-37%), 42% insomnia (95% CI = 36-48), 37% burnout (95% CI = 31-42). Sensitivity analyses did not show statistically significant differences. Meta-regressions found a statistically significant lower prevalence of post-traumatic symptoms in Asia.
Conclusions: HCWs exposed to COVID-19 were found to have a significant prevalence of mental health concerns in all domains analyzed. The effects of COVID-19 on HCWs' mental health could be underestimated and the future consequences dismissed.
European psychiatry : the journal of the Association of European Psychiatrists · meta-analysis · 170 citationsread the source →
Engagement Strategies to Improve Adherence and Retention in Web-Based Mindfulness Programs: Systematic Review.
Background: Web-based mindfulness programs may be beneficial in improving the well-being outcomes of those living with chronic illnesses. Adherence to programs is a key indicator in improving outcomes; however, with the digitization of programs, it is necessary to enhance engagement and encourage people to return to digital health platforms. More information is needed on how engagement strategies have been used in web-based mindfulness programs to encourage adherence.
Objective: The aim of this study is to develop a list of engagement strategies for web-based mindfulness programs and evaluate the impact of engagement strategies on adherence.
Methods: A narrative systematic review was conducted across the MEDLINE Complete, CINAHL Complete, APA PsycINFO, and Embase databases and followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines. Articles were screened using the population, intervention, comparator, and outcome framework. Adults aged >18 years with chronic health conditions were included in the study. Mindfulness interventions, including those in combination with mindfulness-based cognitive therapy, delivered on the web through the internet or smartphone technology were included. Interventions lasted at least 2 weeks. Studies with a randomized controlled trial design or a pilot randomized controlled trial design were included. Engagement strategies, including web-based program features and facilitator-led strategies, adherence, and retention, were included.
Results: A total of 1265 articles were screened, of which 19 were relevant and were included in the review. On average, 70.98% (2258/3181) of the study participants were women with a mean age of 46 (SD 13) years. Most commonly, mindfulness programs were delivered to people living with mental health conditions (8/19, 42%). Of the 19 studies, 8 (42%) used only program features to encourage adherence, 5 (26%) used facilitator-led strategies, and 6 (32%) used a combination of the two. Encouraging program adherence was the most common engagement strategy used, which was used in 77% (10/13) of the facilitator-led studies and 57% (8/14) of the program feature studies. Nearly two-thirds (63%) of the studies provided a definition of adherence, which varied between 50% and 100% completion across studies. The overall mean participant compliance to the mindfulness programs was 56% (SD 15%). Most studies (10/19, 53%) had a long-term follow-up, with the most common follow-up period being 12 weeks after intervention (3/10, 30%). After the intervention, the mean retention was 78% (SD 15%).
Conclusions: Engagement strategies in web-based mindfulness programs comprise reminders to use the program. Other features may be suitable for encouraging adherence to interventions, and a facilitator-led component may result in higher retention. There is variance in the way adherence is measured, and intervention lengths and follow-up periods are inconsistent. More thorough reporting and a standardized framework for measuring adherence are needed to more accurately assess adherence and engagement strategies.
Journal of medical Internet research · systematic review · 45 citationsread the source →
O'Brien K, Robson K, Bracht M, Cruz M, Lui K, Alvaro R, da Silva O, Monterrosa L, Narvey M, Ng E, Soraisham A, Ye XY, Mirea L, Tarnow-Mordi W, Lee SK, FICare Study Group and FICare Parent Advisory Board. (2018)MEDLINE-indexed journal, not yet read by usThe Lancet. Child & adolescent health · randomised controlled trial Effectiveness of Family Integrated Care in neonatal intensive care units on infant and parent outcomes: a multicentre, multinational, cluster-randomised controlled trial.
Background: Despite evidence suggesting that parent involvement was beneficial for infant and parent outcomes, the Family Integrated Care (FICare) programme was one of the first pragmatic approaches to enable parents to become primary caregivers in the neonatal intensive care unit (NICU). We aimed to analyse the effect of FICare on infant and parent outcomes, safety, and resource use.
Methods: In this multicentre, cluster-randomised controlled trial, we stratified 26 tertiary NICUs from Canada, Australia, and New Zealand by country and size, and assigned them, using a computer-generated random allocation sequence, to provide FICare or standard NICU care. Eligible infants were born at 33 weeks' gestation or earlier, and had no or low-level respiratory support; parents gave written informed consent for enrolment. To be eligible, parents in the FICare group had to commit to be present for at least 6 h a day, attend educational sessions, and actively care for their infant. The primary outcome, analysed at the individual level, was infant weight gain at day 21 after enrolment. Secondary outcomes were weight gain velocity, high frequency breastfeeding (≥6 times a day) at hospital discharge, parental stress and anxiety at enrolment and day 21, NICU mortality and major neonatal morbidities, safety, and resource use (including duration of oxygen therapy and hospital stay). This trial is registered with ClinicalTrials.gov, number NCT01852695.
Findings: From Oct 1, 2012, 26 sites were randomly assigned to provide FICare (n=14) or standard care (n=12). One site assigned to FICare discontinued because of poor site enrolment. Parents and infants were enrolled between April 1, 2013, and Aug 31, 2015, with 895 infants being eligible in the FICare group and 891 in the standard care group. At day 21, weight gain was greater in the FICare group than in the standard care group (mean change in Z scores -0·071 [SD 0·42] vs -0·155 [0·42]; p<0·0002). Average daily weight gain was significantly higher in infants receiving FICare than those receiving standard care (mean daily weight gain 26·7 g [SD 9·4] vs 24·8 g [9·5]; p<0·0001). The high-frequency exclusive breastmilk feeding rate at discharge was higher for infants in the FICare group (279 [70%] of 396) than those in the standard care group (394 [63%] of 624; p=0·016). At day 21, parents in the FICare group had lower mean stress scores than did parents in the standard care group (2·3 [SD 0·8] vs 2·5 [0·8]; p<0·00043), and lower mean anxiety scores (70·8 [20·1] vs 74·2 [19·9]; p=0·0045). There were no significant differences between groups in the rates of the secondary outcomes of mortality, major morbidity, duration of oxygen therapy, and duration of hospital stay. Although the safety assessment was not completed, there were no adverse events.
Interpretation: FICare improved infant weight gain, decreased parent stress and anxiety, and increased high-frequency exclusive breastmilk feeding at discharge, which together suggest that FICare is an important advancement in neonatal care. Further research is required to examine if these results translate into better long-term outcomes for families.
Funding: Canadian Institutes of Health Research Partnerships for Health System Improvement, and Ontario Ministry of Health and Long-Term Care.
The Lancet. Child & adolescent health · randomised controlled trial · 374 citationsread the source →
Kleijkers SH, Mantikou E, Slappendel E, Consten D, van Echten-Arends J, Wetzels AM, van Wely M, Smits LJ, van Montfoort AP, Repping S, Dumoulin JC, Mastenbroek S. (2016)MEDLINE-indexed journal, not yet read by usHuman reproduction (Oxford, England) · randomised controlled trial Influence of embryo culture medium (G5 and HTF) on pregnancy and perinatal outcome after IVF: a multicenter RCT.
Study question: Does embryo culture medium influence pregnancy and perinatal outcome in IVF?
Summary answer: Embryo culture media used in IVF affect treatment efficacy and the birthweight of newborns.
What is known already: A wide variety of culture media for human preimplantation embryos in IVF/ICSI treatments currently exists. It is unknown which medium is best in terms of clinical outcomes. Furthermore, it has been suggested that the culture medium used for the in vitro culture of embryos affects birthweight, but this has never been demonstrated by large randomized trials.
Study design, size, duration: We conducted a multicenter, double-blind RCT comparing the use of HTF and G5 embryo culture media in IVF. Between July 2010 and May 2012, 836 couples (419 in the HTF group and 417 in the G5 group) were included. The allocated medium (1:1 allocation) was used in all treatment cycles a couple received within 1 year after randomization, including possible transfers with frozen-thawed embryos. The primary outcome was live birth rate.
Participants/materials, setting, methods: Couples that were scheduled for an IVF or an ICSI treatment at one of the six participating centers in the Netherlands or their affiliated clinics.
Main results and the role of chance: The live birth rate was higher, albeit nonsignificantly, in couples assigned to G5 than in couples assigned to HTF (44.1% (184/417) versus 37.9% (159/419); RR: 1.2; 95% confidence interval (CI): 0.99-1.37; P = 0.08). Number of utilizable embryos per cycle (2.8 ± 2.3 versus 2.3 ± 1.8; P < 0.001), implantation rate after fresh embryo transfer (20.2 versus 15.3%; P < 0.001) and clinical pregnancy rate (47.7 versus 40.1%; RR: 1.2; 95% CI: 1.02-1.39; P = 0.03) were significantly higher for couples assigned to G5 compared with those assigned to HTF. Of the 383 live born children in this trial, birthweight data from 380 children (300 singletons (G5: 163, HTF: 137) and 80 twin children (G5: 38, HTF: 42)) were retrieved. Birthweight was significantly lower in the G5 group compared with the HTF group, with a mean difference of 158 g (95% CI: 42-275 g; P = 0.008). More singletons were born preterm in the G5 group (8.6% (14/163) versus 2.2% (3/137), but singleton birthweight adjusted for gestational age and gender (z-score) was also lower in the G5 than in the HTF group (-0.13 ± 0.08 versus 0.17 ± 0.08; P = 0.008).
Limitations, reasons for caution: This study was powered to detect a 10% difference in live births while a smaller difference could still be clinically relevant. The effect of other culture media on perinatal outcome remains to be determined.
Wider implications of the findings: Embryo culture media used in IVF affect not only treatment efficacy but also perinatal outcome. This suggests that the millions of human embryos that are cultured in vitro each year are sensitive to their environment. These findings should lead to increased awareness, mechanistic studies and legislative adaptations to protect IVF offspring during the first few days of their existence.
Study funding/competing interests: This project was partly funded by The NutsOhra foundation (Grant 1203-061) and March of Dimes (Grant 6-FY13-153). The authors declare no conflict of interest.
Trial registration number: NTR1979 (Netherlands Trial Registry).
Trial registration date: 1 September 2009.
Date of first patient's enrolment: 18 July 2010.
Human reproduction (Oxford, England) · randomised controlled trial · 104 citationsread the source →
Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, Thurston RC, English M, Franklin C, Lee M, Neal-Perry G. (2023)MEDLINE-indexed journal, not yet read by usLancet (London, England) · randomised controlled trial Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study.
Background: Neurokinin 3 receptor antagonists are potential non-hormonal therapies for the treatment of vasomotor symptoms in menopausal women as options are scarce for those who cannot or do not want to take hormone therapy. Fezolinetant is one of the first non-hormonal neurokinin 3 receptor antagonists in development for the treatment of vasomotor symptoms due to menopause. This study investigated the safety and efficacy of fezolinetant for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.
Methods: SKYLIGHT 1 is a randomised, double-blind, placebo-controlled, 12-week, phase 3 trial with a 40-week active treatment extension. This trial was done at 97 facilities across the USA, Canada, Czech Republic, Hungary, Poland, Spain, and the UK. Women aged 40-65 years with an average of seven or more moderate-to-severe hot flashes per day were randomly assigned (1:1:1) to once-daily exact-matched placebo, fezolinetant 30 mg, or fezolinetant 45 mg. Randomisation was done using a web-based interactive response system and investigators, project team members, clinical staff, and participants were masked to treatment assignment. Coprimary endpoints were mean change in frequency and severity of vasomotor symptoms from baseline to weeks 4 and 12. The efficacy and safety analyses comprised all randomly assigned participants who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov (NCT04003155) and is completed.
Findings: Between July 11, 2019, and Aug 11, 2021, 2205 women were recruited of whom 175 were assigned to placebo, 176 to fezolinetant 30 mg, and 176 to fezolinetant 45 mg (175 in the placebo group, 174 in the fezolinetant 30 mg group, and 173 in the fezolinetant 45 mg received at least one dose [safety analysis set]). One participant randomly assigned to fezolinetant 45 mg received fezolinetant 30 mg in error, so the efficacy analysis set (full analysis set) consisted of 173 in the fezolinetant 30 mg group and 174 in the fezolinetant 45 mg group. 23 participants in the placebo group, 31 in the fezolinetant 30 mg group, and 13 in the fezolinetant 45 mg group discontinued treatment before week 12, mostly due to adverse events or participant withdrawal. Compared with placebo, fezolinetant 30 mg and fezolinetant 45 mg significantly reduced the frequency of vasomotor symptoms at week 4 (difference in change in least squares mean -1·87 [SE 0·42; p<0·001], -2·07 [SE 0·42; p<0·001]) and week 12 (-2·39 [SE 0·44; p<0·001], -2·55 [SE 0·43; p<0·001]). Compared with placebo, fezolinetant 30 mg and 45 mg significantly reduced the severity of vasomotor symptoms at week 4 (-0·15 [0·06; p=0·012], -0·19 [0·06; p=0·002]) and week 12 (-0·24 [0·08; p=0·002], -0·20 [0·08; p=0·007]). Improvements in frequency and severity of vasomotor symptoms were observed after 1 week and maintained over 52 weeks. During the first 12 weeks, treatment-emergent adverse events occurred in 65 (37%) of 174 women in the fezolinetant 30 mg group, 75 (43%) of 173 in the fezolinetant 45 mg group, and 78 (45%) of 175 in the placebo group. The incidence of liver enzyme elevations was low (placebo n=1; fezolinetant 30 mg n=2; fezolinetant 45 mg n=0) and these events were generally asymptomatic, transient, and resolved while on treatment or after treatment discontinuation.
Interpretation: Data support the clinical use of fezolinetant as a non-hormonal treatment for vasomotor symptoms associated with menopause. The study was placebo-controlled for 12 weeks followed by a 40-week blinded extension to assess the maintenance of effect. Furthermore, the population studied was diverse and representative of the potential target population for fezolinetant therapy. Further characterisation of the benefit of fezolinetant on quality of life, including on symptoms of mood and sexual wellbeing, merits investigation.
Funding: Astellas Pharma.
Lancet (London, England) · randomised controlled trial · 172 citationsread the source →
A randomized trial of brief dialectical behaviour therapy skills training in suicidal patients suffering from borderline disorder.
Objective: Evidence-based therapies for borderline personality disorder (BPD) are lengthy and scarce. Data on brief interventions are limited, and their role in the treatment of BPD is unclear. Our aim was therefore to evaluate the clinical effectiveness of brief dialectical behaviour therapy (DBT) skills training as an adjunctive intervention for high suicide risk in patients with BPD.
Method: Eighty-four out-patients were randomized to 20 weeks of DBT skills (n = 42) or a waitlist (WL; n = 42). The primary outcome was frequency of suicidal or non-suicidal self-injurious (NSSI) episodes. Assessments were conducted at baseline 10, 20 and 32 weeks.
Results: DBT participants showed greater reductions than the WL participants on suicidal and NSSI behaviours between baseline and 32 weeks (P < 0.0001). DBT participants showed greater improvements than controls on measures of anger, distress tolerance and emotion regulation at 32 weeks.
Conclusions: This abbreviated intervention is a viable option that may be a useful adjunctive intervention for the treatment of high-risk behaviour associated with the acute phase of BPD.
Acta psychiatrica Scandinavica · randomised controlled trial · 80 citationsread the source →
Field JK, Duffy SW, Baldwin DR, Brain KE, Devaraj A, Eisen T, Green BA, Holemans JA, Kavanagh T, Kerr KM, Ledson M, Lifford KJ, McRonald FE, Nair A, Page RD, Parmar MK, Rintoul RC, Screaton N, Wald NJ, Weller D, Whynes DK, Williamson PR, Yadegarfar G, Hansell DM. (2016)MEDLINE-indexed journal, not yet read by usHealth technology assessment (Winchester, England) · randomised controlled trial The UK Lung Cancer Screening Trial: a pilot randomised controlled trial of low-dose computed tomography screening for the early detection of lung cancer.
Background: Lung cancer kills more people than any other cancer in the UK (5-year survival < 13%). Early diagnosis can save lives. The USA-based National Lung Cancer Screening Trial reported a 20% relative reduction in lung cancer mortality and 6.7% all-cause mortality in low-dose computed tomography (LDCT)-screened subjects.
Objectives: To (1) analyse LDCT lung cancer screening in a high-risk UK population, determine optimum recruitment, screening, reading and care pathway strategies; and (2) assess the psychological consequences and the health-economic implications of screening.
Design: A pilot randomised controlled trial comparing intervention with usual care. A population-based risk questionnaire identified individuals who were at high risk of developing lung cancer (≥ 5% over 5 years).
Setting: Thoracic centres with expertise in lung cancer imaging, respiratory medicine, pathology and surgery: Liverpool Heart & Chest Hospital, Merseyside, and Papworth Hospital, Cambridgeshire.
Participants: Individuals aged 50-75 years, at high risk of lung cancer, in the primary care trusts adjacent to the centres.
Interventions: A thoracic LDCT scan. Follow-up computed tomography (CT) scans as per protocol. Referral to multidisciplinary team clinics was determined by nodule size criteria.
Main outcome measures: Population-based recruitment based on risk stratification; management of the trial through web-based database; optimal characteristics of CT scan readers (radiologists vs. radiographers); characterisation of CT-detected nodules utilising volumetric analysis; prevalence of lung cancer at baseline; sociodemographic factors affecting participation; psychosocial measures (cancer distress, anxiety, depression, decision satisfaction); and cost-effectiveness modelling.
Results: A total of 247,354 individuals were approached to take part in the trial; 30.7% responded positively to the screening invitation. Recruitment of participants resulted in 2028 in the CT arm and 2027 in the control arm. A total of 1994 participants underwent CT scanning: 42 participants (2.1%) were diagnosed with lung cancer; 36 out of 42 (85.7%) of the screen-detected cancers were identified as stage 1 or 2, and 35 (83.3%) underwent surgical resection as their primary treatment. Lung cancer was more common in the lowest socioeconomic group. Short-term adverse psychosocial consequences were observed in participants who were randomised to the intervention arm and in those who had a major lung abnormality detected, but these differences were modest and temporary. Rollout of screening as a service or design of a full trial would need to address issues of outreach. The health-economic analysis suggests that the intervention could be cost-effective but this needs to be confirmed using data on actual lung cancer mortality.
Conclusions: The UK Lung Cancer Screening (UKLS) pilot was successfully undertaken with 4055 randomised individuals. The data from the UKLS provide evidence that adds to existing data to suggest that lung cancer screening in the UK could potentially be implemented in the 60-75 years age group, selected via the Liverpool Lung Project risk model version 2 and using CT volumetry-based management protocols.
Future work: The UKLS data will be pooled with the NELSON (Nederlands Leuvens Longkanker Screenings Onderzoek: Dutch-Belgian Randomised Lung Cancer Screening Trial) and other European Union trials in 2017 which will provide European mortality and cost-effectiveness data. For now, there is a clear need for mortality results from other trials and further research to identify optimal methods of implementation and delivery. Strategies for increasing uptake and providing support for underserved groups will be key to implementation.
Trial registration: Current Controlled Trials ISRCTN78513845.
Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 40. See the NIHR Journals Library website for further project information.
Health technology assessment (Winchester, England) · randomised controlled trial · 206 citationsread the source →
Two-month breathing-based walking improves anxiety, depression, dyspnoea and quality of life in chronic obstructive pulmonary disease: A randomised controlled study.
Aims and objectives: To examine the effects of the two-month breathing-based walking intervention and its follow-up on anxiety, depression, dyspnoea and quality of life in patients with chronic obstructive pulmonary disease.
Background: Mind-body-related exercises improve bio-psychological symptoms and quality of life in chronic diseases, but these improvements are not proven for chronic obstructive pulmonary disease.
Design: This was a randomised controlled study and applied the Consolidated Standards of Reporting Trials (CONSORT) statement.
Methods: Outpatients diagnosed with chronic obstructive pulmonary disease were recruited from a medical centre in Taiwan and randomly assigned to two groups. The walking group (n = 42) received breathing, meditation and walking for two months, and the control group (n = 42) did not. Data from the outcomes of anxiety, depression, dyspnoea and quality of life were collected at baseline and in Month 1, Month 2 and Month 3. Clinical trial registration was done (ClinicalTrials.gov.: NCT03388489).
Findings: The results showed significant changes in anxiety, depression, dyspnoea and quality of life in the walking group across three months, compared to those in the control group and at baseline.
Conclusion: This breathing-based walking intervention is promising to achieve bio-psychological well-being for patients with chronic obstructive pulmonary disease.
Relevance to clinical practice: This breathing-based walking, as a mind-body exercise, could serve as an evidence-based nursing care that contributes to improving anxiety, depression, dyspnoea and quality of life in stable chronic obstructive pulmonary disease outpatients. The feasibility and acceptability of the breathing-based walking were met the requirement of the chronic obstructive pulmonary disease outpatients, which could be considered as home-based exercise.
Journal of clinical nursing · randomised controlled trial · 41 citationsread the source →
Gumley AI, Bradstreet S, Ainsworth J, Allan S, Alvarez-Jimenez M, Aucott L, Birchwood M, Briggs A, Bucci S, Cotton SM, Engel L, French P, Lederman R, Lewis S, Machin M, MacLennan G, McLeod H, McMeekin N, Mihalopoulos C, Morton E, Norrie J, Schwannauer M, Singh SP, Sundram S, Thompson A, Williams C, Yung AR, Farhall J, Gleeson J. (2022)MEDLINE-indexed journal, not yet read by usThe lancet. Psychiatry · randomised controlled trial The EMPOWER blended digital intervention for relapse prevention in schizophrenia: a feasibility cluster randomised controlled trial in Scotland and Australia.
Background: Early warning signs monitoring by service users with schizophrenia has shown promise in preventing relapse but the quality of evidence is low. We aimed to establish the feasibility of undertaking a definitive randomised controlled trial to determine the effectiveness of a blended digital intervention for relapse prevention in schizophrenia.
Methods: This multicentre, feasibility, cluster randomised controlled trial aimed to compare Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) with treatment as usual in community mental health services (CMHS) in Glasgow and Melbourne. CMHS were the unit of randomisation, selected on the basis of those that probably had five or more care coordinators willing to participate. Participants were eligible if they were older than 16 years, had a schizophrenia or related diagnosis confirmed via case records, were able to provide informed consent, had contact with CMHS, and had had a relapse within the previous 2 years. Participants were randomised within stratified clusters to EMPOWER or to continue their usual approach to care. EMPOWER blended a smartphone for active monitoring of early warning signs with peer support to promote self-management and clinical triage to promote access to relapse prevention. Main outcomes were feasibility, acceptability, usability, and safety, which was assessed through face-to-face interviews. App usage was assessed via the smartphone and self-report. Primary end point was 12 months. Participants, research assistants and other team members involved in delivering the intervention were not masked to treatment conditions. Assessment of relapse was done by an independent adjudication panel masked to randomisation group. The study is registered at ISRCTN (99559262).
Findings: We identified and randomised eight CMHS (six in Glasgow and two in Melbourne) comprising 47 care coordinators. We recruited 86 service users between Jan 19 and Aug 8, 2018; 73 were randomised (42 [58%] to EMPOWER and 31 [42%] to treatment as usual). There were 37 (51%) men and 36 (49%) women. At 12 months, main outcomes were collected for 32 (76%) of service users in the EMPOWER group and 30 (97%) of service users in the treatment as usual group. Of those randomised to EMPOWER, 30 (71%) met our a priori criterion of more than 33% adherence to daily monitoring that assumed feasibility. Median time to discontinuation of these participants was 31·5 weeks (SD 14·5). There were 29 adverse events in the EMPOWER group and 25 adverse events in the treatment as usual group. There were 13 app-related adverse events, affecting 11 people, one of which was serious. Fear of relapse was lower in the EMPOWER group than in the treatment as usual group at 12 months (mean difference -7·53 (95% CI -14·45 to 0·60; Cohen's d -0·53).
Interpretation: A trial of digital technology to monitor early warning signs blended with peer support and clinical triage to detect and prevent relapse appears to be feasible, safe, and acceptable. A further main trial is merited.
Funding: UK National Institute for Health Research Health Technology Assessment programme and the Australian National Health and Medical Research Council.
The lancet. Psychiatry · randomised controlled trial · 50 citationsread the source →
Fall rates in hospital rehabilitation units after individualised patient and staff education programmes: a pragmatic, stepped-wedge, cluster-randomised controlled trial.
Background: Falls are the most frequent adverse events that are reported in hospitals. We examined the effectiveness of individualised falls-prevention education for patients, supported by training and feedback for staff, delivered as a ward-level programme.
Methods: Eight rehabilitation units in general hospitals in Australia participated in this stepped-wedge, cluster-randomised study, undertaken during a 50 week period. Units were randomly assigned to intervention or control groups by use of computer-generated, random allocation sequences. We included patients admitted to the unit during the study with a Mini-Mental State Examination (MMSE) score of more than 23/30 to receive individualised education that was based on principles of changes in health behaviour from a trained health professional, in addition to usual care. We provided information about patients' goals, feedback about the ward environment, and perceived barriers to engagement in falls-prevention strategies to staff who were trained to support the uptake of strategies by patients. The coprimary outcome measures were patient rate of falls per 1000 patient-days and the proportion of patients who were fallers. All analyses were by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials registry, number ACTRN12612000877886).
Findings: Between Jan 13, and Dec 27, 2013, 3606 patients were admitted to the eight units (n=1983 control period; n=1623 intervention period). There were fewer falls (n=196, 7·80/1000 patient-days vs n=380, 13·78/1000 patient-days, adjusted rate ratio 0·60 [robust 95% CI 0·42-0·94], p=0·003), injurious falls (n=66, 2·63/1000 patient-days vs 131, 4·75/1000 patient-days, 0·65 [robust 95% CI 0·42-0·88], p=0·006), and fallers (n=136 [8·38%] vs n=248 [12·51%] adjusted odds ratio 0·55 [robust 95% CI 0·38 to 0·81], p=0·003) in the intervention compared with the control group. There was no significant difference in length of stay (intervention median 11 days [IQR 7-19], control 10 days [6-18]).
Interpretation: Individualised patient education programmes combined with training and feedback to staff added to usual care reduces the rates of falls and injurious falls in older patients in rehabilitation hospital-units.
Funding: State Health Research Advisory Council, Department of Health, Government of Western Australia.
Lancet (London, England) · randomised controlled trial · 143 citationsread the source →
Shame, guilt, and depressive symptoms: a meta-analytic review.
Recent theoretical and empirical work has facilitated the drawing of sharp conceptual distinctions between shame and guilt. A clear view of these distinctions has permitted development of a research literature aimed at evaluating the differential associations of shame and guilt with depressive symptoms. This study quantitatively summarized the magnitude of associations of shame and guilt with depressive symptoms. Two hundred forty-two effect sizes were obtained from 108 studies employing 22,411 participants. Shame showed significantly stronger associations with depressive symptoms (r = .43) than guilt (r = .28). However, the association of shame and depressive symptoms was statistically indistinguishable from the associations of 2 maladaptive variants of guilt and depressive symptoms (contextual-maladaptive guilt, involving exaggerated responsibility for uncontrollable events, r = .39; generalized guilt, involving "free-floating" guilt divorced from specific contexts, r = .42). Other factors also moderated the effects. External shame, which involves negative views of self as seen through the eyes of others, was associated with larger effect sizes (r = .56) than internal shame (r = .42), which involves negative views of self as seen through one's own eyes. Depressive symptom measures that invoked the term guilt yielded stronger associations between guilt and depressive symptoms (r = .33) than depressive symptom measures that did not (r = .21). Age, sex, and ethnicity (proportion of Whites to Asians) did not moderate the effects. Although these correlational data are ambiguous with respect to their causal interpretation, results suggest that shame should figure more prominently in understandings of the emotional underpinnings of depressive symptoms.
Psychological bulletin · meta-analysis · 355 citationsread the source →
Present-centered therapy (PCT) for post-traumatic stress disorder (PTSD) in adults.
Background: Present-centered therapy (PCT) is a non-trauma, manualized psychotherapy for adults with post-traumatic stress disorder (PTSD). PCT was originally designed as a treatment comparator in trials evaluating the effectiveness of trauma-focused cognitive-behavioral therapy (TF-CBT). Recent trials have indicated that PCT may be an effective treatment option for PTSD and that patients may drop out of PCT at lower rates relative to TF-CBT.
Objectives: To assess the effects of PCT for adults with PTSD. Specifically, we sought to determine whether (1) PCT is more effective in alleviating symptoms relative to control conditions, (2) PCT results in similar alleviation of symptoms compared to TF-CBT, based on an a priori minimally important differences on a semi-structured interview of PTSD symptoms, and (3) PCT is associated with lower treatment dropout as compared to TF-CBT.
Search methods: We searched the Cochrane Common Mental Disorders Controlled Trials Register, the Cochrane Library, Ovid MEDLINE, Embase, PsycINFO, PubMed, and PTSDpubs (previously called the Published International Literature on Traumatic Stress (PILOTS) database) (all years to 15 February 2019 search). We also searched the World Health Organization (WHO) trials portal (ICTRP) and ClinicalTrials.gov to identify unpublished and ongoing trials. Reference lists of included studies and relevant systematic reviews were checked. Grey literature searches were also conducted to identify dissertations and theses, clinical guidelines, and regulatory agency reports.
Selection criteria: We selected all randomized clinical trials (RCTs) that recruited adults diagnosed with PTSD to evaluate PCT compared to TF-CBT or a control condition. Both individual and group PCT modalities were included. The primary outcomes of interest included reduced PTSD severity as determined by a clinician-administered measure and treatment dropout rates.
Data collection and analysis: We complied with the Cochrane recommended standards for data screening and collection. Two review authors independently screened articles for inclusion and extracted relevant data from eligible studies, including the assessment of trial quality. Random-effects meta-analyses, subgroup analyses, and sensitivity analyses were conducted using mean differences (MD) and standardized mean differences (SMD) for continuous data or risk ratios (RR) and risk differences (RD) for dichotomous data. To conclude that PCT resulted in similar reductions in PTSD symptoms relative to TF-CBT, we required a MD of less than 10 points (to include the 95% confidence interval) on the Clinician-Administered PTSD Scale (CAPS). Five members of the review team convened to rate the quality of evidence across the primary outcomes. Any disagreements were resolved through discussion. Review authors who were investigators on any of the included trials were not involved in the qualitative or quantitative syntheses.
Main results: We included 12 studies (n = 1837), of which, three compared PCT to a wait-list/minimal attention (WL/MA) group and 11 compared PCT to TF-CBT. PCT was more effective than WL/MA in reducing PTSD symptom severity (SMD -0.84, 95% CI -1.10 to -0.59; participants = 290; studies = 3; I² = 0%). We assessed the quality of this evidence as moderate. The results of the non-inferiority analysis comparing PCT to TF-CBT did not support PCT non-inferiority, with the 95% confidence interval surpassing the clinically meaningful cut-off (MD 6.83, 95% CI 1.90 to 11.76; 6 studies, n = 607; I² = 42%). We assessed this quality of evidence as low. CAPS differences between PCT and TF-CBT attenuated at 6-month (MD 1.59, 95% CI -0.46 to 3.63; participants = 906; studies = 6; I² = 0%) and 12-month (MD 1.22, 95% CI -2.17 to 4.61; participants = 485; studies = 3; I² = 0%) follow-up periods. To confirm the direction of the treatment effect using all eligible trials, we also evaluated PTSD SMD differences. These results were consistent with the primary MD outcomes, with meaningful effect size differences between PCT and TF-CBT at post-treatment (SMD 0.32, 95% CI 0.08 to 0.56; participants = 1129; studies = 9), but smaller effect size differences at six months (SMD 0.17, 95% CI 0.05 to 0.29; participants = 1339; studies = 9) and 12 months (SMD 0.17, 95% CI 0.03 to 0.31; participants = 728; studies = 5). PCT had approximately 14% lower treatment dropout rates compared to TF-CBT (RD -0.14, 95% CI -0.18 to -0.10; participants = 1542; studies = 10). We assessed the quality of this evidence as moderate. There was no evidence of meaningful differences on self-reported PTSD (MD 4.50, 95% CI 3.09 to 5.90; participants = 983; studies = 7) or depression symptoms (MD 1.78, 95% CI -0.23 to 3.78; participants = 705; studies = 5) post-treatment.
Authors' conclusions: Moderate-quality evidence indicates that PCT is more effective in reducing PTSD severity compared to control conditions. Low quality of evidence did not support PCT as a non-inferior treatment compared to TF-CBT on clinician-rated post-treatment PTSD severity. The treatment effect differences between PCT and TF-CBT may attenuate over time. PCT participants drop out of treatment at lower rates relative to TF-CBT participants. Of note, all of the included studies were primarily designed to test the effectiveness of TF-CBT which may bias results away from PCT non-inferiority. The current systematic review provides the most rigorous evaluation to date to determine whether PCT is comparably as effective as TF-CBT. Findings are generally consistent with current clinical practice guidelines that suggest that PCT may be offered as a treatment for PTSD when TF-CBT is not available.
The Cochrane database of systematic reviews · meta-analysis · 36 citationsread the source →
Walsh K, Eggins E, Hine L, Mathews B, Kenny MC, Howard S, Ayling N, Dallaston E, Pink E, Vagenas D. (2022)MEDLINE-indexed journal, not yet read by usThe Cochrane database of systematic reviews · meta-analysis Child protection training for professionals to improve reporting of child abuse and neglect.
Background: Many nations require child-serving professionals to report known or suspected cases of significant child abuse and neglect to statutory child protection or safeguarding authorities. Considered globally, there are millions of professionals who fulfil these roles, and many more who will do so in future. Ensuring they are trained in reporting child abuse and neglect is a key priority for nations and organisations if efforts to address violence against children are to succeed.
Objectives: To assess the effectiveness of training aimed at improving reporting of child abuse and neglect by professionals and to investigate possible components of effective training interventions.
Search methods: We searched CENTRAL, MEDLINE, Embase, 18 other databases, and one trials register up to 4 June 2021. We also handsearched reference lists, selected journals, and websites, and circulated a request for studies to researchers via an email discussion list.
Selection criteria: All randomised controlled trials (RCTs), quasi-RCTs, and controlled before-and-after studies examining the effects of training interventions for qualified professionals (e.g. teachers, childcare professionals, doctors, nurses, and mental health professionals) to improve reporting of child abuse and neglect, compared with no training, waitlist control, or alternative training (not related to child abuse and neglect).
Data collection and analysis: We used methodological procedures described in the Cochrane Handbook for Systematic Reviews of Interventions. We synthesised training effects in meta-analysis where possible and summarised findings for primary outcomes (number of reported cases of child abuse and neglect, quality of reported cases, adverse events) and secondary outcomes (knowledge, skills, and attitudes towards the reporting duty). We used the GRADE approach to rate the certainty of the evidence.
Main results: We included 11 trials (1484 participants), using data from 9 of the 11 trials in quantitative synthesis. Trials took place in high-income countries, including the USA, Canada, and the Netherlands, with qualified professionals. In 8 of the 11 trials, interventions were delivered in face-to-face workshops or seminars, and in 3 trials interventions were delivered as self-paced e-learning modules. Interventions were developed by experts and delivered by specialist facilitators, content area experts, or interdisciplinary teams. Only 3 of the 11 included studies were conducted in the past 10 years.
Primary outcomes
Three studies measured the number of cases of child abuse and neglect via participants' self-report of actual cases reported, three months after training. The results of one study (42 participants) favoured the intervention over waitlist, but the evidence is very uncertain (standardised mean difference (SMD) 0.81, 95% confidence interval (CI) 0.18 to 1.43; very low-certainty evidence).
Three studies measured the number of cases of child abuse and neglect via participants' responses to hypothetical case vignettes immediately after training. A meta-analysis of two studies (87 participants) favoured training over no training or waitlist for training, but the evidence is very uncertain (SMD 1.81, 95% CI 1.30 to 2.32; very low-certainty evidence).
We identified no studies that measured the number of cases of child abuse and neglect via official records of reports made to child protection authorities, or adverse effects of training.
Secondary outcomes
Four studies measured professionals' knowledge of reporting duty, processes, and procedures postintervention. The results of one study (744 participants) may favour the intervention over waitlist for training (SMD 1.06, 95% CI 0.90 to 1.21; low-certainty evidence).
Four studies measured professionals' knowledge of core concepts in all forms of child abuse and neglect postintervention. A meta-analysis of two studies (154 participants) favoured training over no training, but the evidence is very uncertain (SMD 0.68, 95% CI 0.35 to 1.01; very low-certainty evidence).
Three studies measured professionals' knowledge of core concepts in child sexual abuse postintervention. A meta-analysis of these three studies (238 participants) favoured training over no training or waitlist for training, but the evidence is very uncertain (SMD 1.44, 95% CI 0.43 to 2.45; very low-certainty evidence).
One study (25 participants) measured professionals' skill in distinguishing reportable and non-reportable cases postintervention. The results favoured the intervention over no training, but the evidence is very uncertain (SMD 0.94, 95% CI 0.11 to 1.77; very low-certainty evidence).
Two studies measured professionals' attitudes towards the duty to report child abuse and neglect postintervention. The results of one study (741 participants) favoured the intervention over waitlist, but the evidence is very uncertain (SMD 0.61, 95% CI 0.47 to 0.76; very low-certainty evidence).
Authors' conclusions: The studies included in this review suggest there may be evidence of improvements in training outcomes for professionals exposed to training compared with those who are not exposed. However, the evidence is very uncertain. We rated the certainty of evidence as low to very low, downgrading due to study design and reporting limitations. Our findings rest on a small number of largely older studies, confined to single professional groups. Whether similar effects would be seen for a wider range of professionals remains unknown. Considering the many professional groups with reporting duties, we strongly recommend further research to assess the effectiveness of training interventions, with a wider range of child-serving professionals. There is a need for larger trials that use appropriate methods for group allocation, and statistical methods to account for the delivery of training to professionals in workplace groups.
The Cochrane database of systematic reviews · meta-analysis · 25 citationsread the source →
Associations between perfectionism and symptoms of anxiety, obsessive-compulsive disorder and depression in young people: a meta-analysis.
Perfectionism is a transdiagnostic process contributing to the onset and maintenance of anxiety, obsessive-compulsive disorder (OCD) and depression. The aim of this systematic review and meta-analysis was to examine the association between perfectionism, and symptoms of anxiety, OCD and depression among young people aged 6-24 years. A systematic literature search retrieved a total of 4,927 articles, with 121 studies included (Mpooled age = ~17.70 years). Perfectionistic concerns demonstrated significant moderate pooled correlations with symptoms of anxiety (r = .37-.41), OCD (r = .42), and depression (r = .40). Perfectionistic strivings demonstrated significant, small correlations with symptoms of anxiety (r = .05) and OCD (r = .19). The findings highlight the substantial link between perfectionistic concerns and psychopathology in young people, and to a smaller extent perfectionistic strivings, anxiety, and OCD. The results indicate the importance of further research on early intervention for perfectionism to improve youth mental health.
Cognitive behaviour therapy · meta-analysis · 22 citationsread the source →
The effectiveness of group and home-based exercise on psychological status in people with ankylosing spondylitis: A systematic review and meta-analysis.
Introduction: Ankylosing spondylitis (AS) is an inflammatory rheumatic disease in which the physical impact has been evaluated; however, the psychological consequences are less well explored. The primary aim of this review was to determine the effectiveness of group versus home-based exercises on psychological status of patients with AS.
Methods: Six databases were searched until January 2020. Eligible studies were randomised controlled trials including group or home-based exercise interventions. Risk of bias (RoB) was evaluated using the Cochrane RoB 2.0 tool. Relative percentage difference (RPD) between groups and effect sizes were presented as standardised mean differences (SMDs) with 95% confidence intervals (CI).
Results: Five studies met the inclusion criteria (n = 240), outcomes of interest were depression, anxiety and mental health. Three studies were low-risk RoB, one study was high-risk RoB and one study there was 'some concerns' of bias. Group-based exercise was more effective than home-based exercise for improving depression at 6-week (RPD 18%) and 3-month (RPD 42%), anxiety (RPD 17%) and mental health (RPD 20%). Home-based exercise was more effective than control interventions for improving depression (RPD 33%). A meta-analysis demonstrated group-based exercises compared to home exercises, improved depression (SMD: -0.54; 95% CI: [-0.89; -0.18]; p = 0.003) and physical function (SMD: -0.49; 95% CI: [-0.84; -0.14]; p = 0.006).
Conclusion: Supervised group-based demonstrated improvements in depression, anxiety and mental health compared to home-based exercise. Individualised home-based exercise is more effective than no intervention for improving depression in people with AS.
Musculoskeletal care · meta-analysis · 9 citationsread the source →
Supporting smoking cessation and preventing relapse following a stay in a smoke-free setting: a meta-analysis and investigation of effective behaviour change techniques.
Background and aims: Admission to a smoke-free setting presents a unique opportunity to encourage smokers to quit. However, risk of relapse post-discharge is high, and little is known about effective strategies to support smoking cessation following discharge. We aimed to identify interventions that maintain abstinence following a smoke-free stay and determine their effectiveness, as well as the probable effectiveness of behaviour change techniques (BCTs) used in these interventions.
Methods: Systematic review and meta-analyses of studies of adult smokers aged ≥ 18 years who were temporarily or fully abstinent from smoking to comply with institutional smoke-free policies. Institutions included prison, inpatient mental health, substance misuse or acute hospital settings. A Mantel-Haenszel random-effects meta-analysis of randomized controlled trials (RCTs) was conducted using biochemically verified abstinence (7-day point prevalence or continuous abstinence). BCTs were defined as 'promising' in terms of probable effectiveness (if BCT was present in two or more long-term effective interventions) and feasibility (if BCT was also delivered in ≥ 25% of all interventions).
Results: Thirty-seven studies (intervention n = 9041, control n = 6195) were included: 23 RCTs (intervention n = 6593, control n = 5801); three non-randomized trials (intervention n = 845, control n = 394) and 11 cohort studies (n = 1603). Meta-analysis of biochemically verified abstinence at longest follow-up (4 weeks-18 months) found an overall effect in favour of intervention [risk ratio (RR) = 1.27, 95% confidence interval (CI) = 1.08-1.49, I2 = 42%]. Nine BCTs (including 'pharmacological support', 'goal-setting (behaviour)' and 'social support') were characterized as 'promising' in terms of probable effectiveness and feasibility.
Conclusions: A systematic review and meta-analyses indicate that behavioural and pharmacological support is effective in maintaining smoking abstinence following a stay in a smoke-free institution. Several behaviour change techniques may help to maintain smoking abstinence up to 18 months post-discharge.
Addiction (Abingdon, England) · meta-analysis · 29 citationsread the source →
Palliative Care Interventions for Patients with Heart Failure: A Systematic Review and Meta-Analysis.
Objective: To systematically characterize interventions and effectiveness of palliative care for advanced heart failure (HF) patients.
Background: Patients with advanced heart failure experience a high burden of distressing symptoms and diminished quality of life. Palliative care expertise with symptom management and healthcare decision-making benefits HF patients.
Methods: A systematic PubMed search was conducted from inception to June 2016 for studies of palliative care interventions for HF patients. Studies of humans with a HF diagnosis who underwent a palliative care intervention were included. Data were extracted on study design, participant characteristics, intervention components, and in three groups of outcomes: patient-centered outcomes, quality-of-death outcomes, and resource utilization. Study characteristics were examined to determine if meta-analysis was possible.
Results: The fifteen identified studies varied in design (prospective, n = 10; retrospective, n = 5). Studies enrolled older patients, but greater variability was found for race, sex, and marital status. A majority of studies measuring patient-centered outcomes demonstrated improvements including quality of life and satisfaction. Quality-of-death outcomes were mixed with a majority of studies reporting clarification of care preferences, but less improvement in death at home and hospice enrollment. A meta-analysis in three studies found that home-based palliative care consults in HF patients lower the risk of rehospitalization by 42% (RR = 0.58; 95% Confidence Interval 0.44, 0.77).
Discussion: Available evidence suggests that home and team-based palliative interventions for HF patients improve patient-centered outcomes, documentation of preferences, and utilization. Increased high quality studies will aid the determination of the most effective palliative care approaches for the HF population.
Journal of palliative medicine · meta-analysis · 160 citationsread the source →
Exercise therapy for chronic fatigue syndrome.
Background: Chronic fatigue syndrome (CFS) is characterised by persistent, medically unexplained fatigue, as well as symptoms such as musculoskeletal pain, sleep disturbance, headaches and impaired concentration and short-term memory. CFS presents as a common, debilitating and serious health problem. Treatment may include physical interventions, such as exercise therapy, which was last reviewed in 2004.
Objectives: The objective of this review was to determine the effects of exercise therapy (ET) for patients with CFS as compared with any other intervention or control.• Exercise therapy versus 'passive control' (e.g. treatment as usual, waiting-list control, relaxation, flexibility).• Exercise therapy versus other active treatment (e.g. cognitive-behavioural therapy (CBT), cognitive treatment, supportive therapy, pacing, pharmacological therapy such as antidepressants).• Exercise therapy in combination with other specified treatment strategies versus other specified treatment strategies (e.g. exercise combined with pharmacological treatment vs pharmacological treatment alone).
Search methods: We searched The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR), the Cochrane Central Register of Controlled Trials (CENTRAL) and SPORTDiscus up to May 2014 using a comprehensive list of free-text terms for CFS and exercise. We located unpublished or ongoing trials through the World Health Organization (WHO) International Clinical Trials Registry Platform (to May 2014). We screened reference lists of retrieved articles and contacted experts in the field for additional studies SELECTION CRITERIA: Randomised controlled trials involving adults with a primary diagnosis of CFS who were able to participate in exercise therapy. Studies had to compare exercise therapy with passive control, psychological therapies, adaptive pacing therapy or pharmacological therapy.
Data collection and analysis: Two review authors independently performed study selection, risk of bias assessments and data extraction. We combined continuous measures of outcomes using mean differences (MDs) and standardised mean differences (SMDs). We combined serious adverse reactions and drop-outs using risk ratios (RRs). We calculated an overall effect size with 95% confidence intervals (CIs) for each outcome.
Main results: We have included eight randomised controlled studies and have reported data from 1518 participants in this review. Three studies diagnosed individuals with CFS using the 1994 criteria of the Centers for Disease Control and Prevention (CDC); five used the Oxford criteria. Exercise therapy lasted from 12 to 26 weeks. Seven studies used variations of aerobic exercise therapy such as walking, swimming, cycling or dancing provided at mixed levels in terms of intensity of the aerobic exercise from very low to quite rigorous, whilst one study used anaerobic exercise. Control groups consisted of passive control (eight studies; e.g. treatment as usual, relaxation, flexibility) or CBT (two studies), cognitive therapy (one study), supportive listening (one study), pacing (one study), pharmacological treatment (one study) and combination treatment (one study). Risk of bias varied across studies, but within each study, little variation was found in the risk of bias across our primary and secondary outcome measures. Investigators compared exercise therapy with 'passive' control in eight trials, which enrolled 971 participants. Seven studies consistently showed a reduction in fatigue following exercise therapy at end of treatment, even though the fatigue scales used different scoring systems: an 11-item scale with a scoring system of 0 to 11 points (MD -6.06, 95% CI -6.95 to -5.17; one study, 148 participants; low-quality evidence); the same 11-item scale with a scoring system of 0 to 33 points (MD -2.82, 95% CI -4.07 to -1.57; three studies, 540 participants; moderate-quality evidence); and a 14-item scale with a scoring system of 0 to 42 points (MD -6.80, 95% CI -10.31 to -3.28; three studies, 152 participants; moderate-quality evidence). Serious adverse reactions were rare in both groups (RR 0.99, 95% CI 0.14 to 6.97; one study, 319 participants; moderate-quality evidence), but sparse data made it impossible for review authors to draw conclusions. Study authors reported a positive effect of exercise therapy at end of treatment with respect to sleep (MD -1.49, 95% CI -2.95 to -0.02; two studies, 323 participants), physical functioning (MD 13.10, 95% CI 1.98 to 24.22; five studies, 725 participants) and self-perceived changes in overall health (RR 1.83, 95% CI 1.39 to 2.40; four studies, 489 participants). It was not possible for review authors to draw conclusions regarding the remaining outcomes. Investigators compared exercise therapy with CBT in two trials (351 participants). One trial (298 participants) reported little or no difference in fatigue at end of treatment between the two groups using an 11-item scale with a scoring system of 0 to 33 points (MD 0.20, 95% CI -1.49 to 1.89). Both studies measured differences in fatigue at follow-up, but neither found differences between the two groups using an 11-item fatigue scale with a scoring system of 0 to 33 points (MD 0.30, 95% CI -1.45 to 2.05) and a nine-item Fatigue Severity Scale with a scoring system of 1 to 7 points (MD 0.40, 95% CI -0.34 to 1.14). Serious adverse reactions were rare in both groups (RR 0.67, 95% CI 0.11 to 3.96). We observed little or no difference in physical functioning, depression, anxiety and sleep, and we were not able to draw any conclusions with regard to pain, self-perceived changes in overall health, use of health service resources and drop-out rate. With regard to other comparisons, one study (320 participants) suggested a general benefit of exercise over adaptive pacing, and another study (183 participants) a benefit of exercise over supportive listening. The available evidence was too sparse to draw conclusions about the effect of pharmaceutical interventions.
Authors' conclusions: Patients with CFS may generally benefit and feel less fatigued following exercise therapy, and no evidence suggests that exercise therapy may worsen outcomes. A positive effect with respect to sleep, physical function and self-perceived general health has been observed, but no conclusions for the outcomes of pain, quality of life, anxiety, depression, drop-out rate and health service resources were possible. The effectiveness of exercise therapy seems greater than that of pacing but similar to that of CBT. Randomised trials with low risk of bias are needed to investigate the type, duration and intensity of the most beneficial exercise intervention.
The Cochrane database of systematic reviews · meta-analysis · 80 citationsread the source →
Omega-3 fatty acid addition during pregnancy.
Background: Higher intakes of foods containing omega-3 long-chain polyunsaturated fatty acids (LCPUFA), such as fish, during pregnancy have been associated with longer gestations and improved perinatal outcomes. This is an update of a review that was first published in 2006.
Objectives: To assess the effects of omega-3 LCPUFA, as supplements or as dietary additions, during pregnancy on maternal, perinatal, and neonatal outcomes and longer-term outcomes for mother and child.
Search methods: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (16 August 2018), and reference lists of retrieved studies.
Selection criteria: Randomised controlled trials (RCTs) comparing omega-3 fatty acids (as supplements or as foods, stand-alone interventions, or with a co-intervention) during pregnancy with placebo or no omega-3, and studies or study arms directly comparing omega-3 LCPUFA doses or types. Trials published in abstract form were eligible for inclusion.
Data collection and analysis: Two review authors independently assessed study eligibility, extracted data, assessed risk of bias in trials and assessed quality of evidence for prespecified birth/infant, maternal, child/adult and health service outcomes using the GRADE approach.
Main results: In this update, we included 70 RCTs (involving 19,927 women at low, mixed or high risk of poor pregnancy outcomes) which compared omega-3 LCPUFA interventions (supplements and food) compared with placebo or no omega-3. Overall study-level risk of bias was mixed, with selection and performance bias mostly at low risk, but there was high risk of attrition bias in some trials. Most trials were conducted in upper-middle or high-income countries; and nearly half the trials included women at increased/high risk for factors which might increase the risk of adverse maternal and birth outcomes. Preterm birth < 37 weeks (13.4% versus 11.9%; risk ratio (RR) 0.89, 95% confidence interval (CI) 0.81 to 0.97; 26 RCTs, 10,304 participants; high-quality evidence) and early preterm birth < 34 weeks (4.6% versus 2.7%; RR 0.58, 95% CI 0.44 to 0.77; 9 RCTs, 5204 participants; high-quality evidence) were both lower in women who received omega-3 LCPUFA compared with no omega-3. Prolonged gestation > 42 weeks was probably increased from 1.6% to 2.6% in women who received omega-3 LCPUFA compared with no omega-3 (RR 1.61 95% CI 1.11 to 2.33; 5141 participants; 6 RCTs; moderate-quality evidence).For infants, there was a possibly reduced risk of perinatal death (RR 0.75, 95% CI 0.54 to 1.03; 10 RCTs, 7416 participants; moderate-quality evidence: 62/3715 versus 83/3701 infants) and possibly fewer neonatal care admissions (RR 0.92, 95% CI 0.83 to 1.03; 9 RCTs, 6920 participants; moderate-quality evidence - 483/3475 infants versus 519/3445 infants). There was a reduced risk of low birthweight (LBW) babies (15.6% versus 14%; RR 0.90, 95% CI 0.82 to 0.99; 15 trials, 8449 participants; high-quality evidence); but a possible small increase in large-for-gestational age (LGA) babies (RR 1.15, 95% CI 0.97 to 1.36; 6 RCTs, 3722 participants; moderate-quality evidence, for omega-3 LCPUFA compared with no omega-3. Little or no difference in small-for-gestational age or intrauterine growth restriction (RR 1.01, 95% CI 0.90 to 1.13; 8 RCTs, 6907 participants; moderate-quality evidence) was seen. For the maternal outcomes, there is insufficient evidence to determine the effects of omega-3 on induction post-term (average RR 0.82, 95% CI 0.22 to 2.98; 3 trials, 2900 participants; low-quality evidence), maternal serious adverse events (RR 1.04, 95% CI 0.40 to 2.72; 2 trials, 2690 participants; low-quality evidence), maternal admission to intensive care (RR 0.56, 95% CI 0.12 to 2.63; 2 trials, 2458 participants; low-quality evidence), or postnatal depression (average RR 0.99, 95% CI 0.56 to 1.77; 2 trials, 2431 participants; low-quality evidence). Mean gestational length was greater in women who received omega-3 LCPUFA (mean difference (MD) 1.67 days, 95% CI 0.95 to 2.39; 41 trials, 12,517 participants; moderate-quality evidence), and pre-eclampsia may possibly be reduced with omega-3 LCPUFA (RR 0.84, 95% CI 0.69 to 1.01; 20 trials, 8306 participants; low-quality evidence).For the child/adult outcomes, very few differences between antenatal omega-3 LCPUFA supplementation and no omega-3 were observed in cognition, IQ, vision, other neurodevelopment and growth outcomes, language and behaviour (mostly low-quality to very low-quality evidence). The effect of omega-3 LCPUFA on body mass index at 19 years (MD 0, 95% CI -0.83 to 0.83; 1 trial, 243 participants; very low-quality evidence) was uncertain. No data were reported for development of diabetes in the children of study participants.
Authors' conclusions: In the overall analysis, preterm birth < 37 weeks and early preterm birth < 34 weeks were reduced in women receiving omega-3 LCPUFA compared with no omega-3. There was a possibly reduced risk of perinatal death and of neonatal care admission, a reduced risk of LBW babies; and possibly a small increased risk of LGA babies with omega-3 LCPUFA.For our GRADE quality assessments, we assessed most of the important perinatal outcomes as high-quality (e.g. preterm birth) or moderate-quality evidence (e.g. perinatal death). For the other outcome domains (maternal, child/adult and health service outcomes) GRADE ratings ranged from moderate to very low, with over half rated as low. Reasons for downgrading across the domain were mostly due to design limitations and imprecision. Omega-3 LCPUFA supplementation during pregnancy is an effective strategy for reducing the incidence of preterm birth, although it probably increases the incidence of post-term pregnancies. More studies comparing omega-3 LCPUFA and placebo (to establish causality in relation to preterm birth) are not needed at this stage. A further 23 ongoing trials are still to report on over 5000 women, so no more RCTs are needed that compare omega-3 LCPUFA against placebo or no intervention. However, further follow-up of completed trials is needed to assess longer-term outcomes for mother and child, to improve understanding of metabolic, growth and neurodevelopment pathways in particular, and to establish if, and how, outcomes vary by different types of omega-3 LCPUFA, timing and doses; or by characteristics of women.
The Cochrane database of systematic reviews · meta-analysis · 254 citationsread the source →
Mind over Malignancy: A Systematic Review and Meta-Analysis of Psychological Distress, Coping, and Therapeutic Interventions in Oncology.
Background and Objectives: Psychological distress is a pervasive yet often undertreated aspect of the cancer experience, contributing to reduced quality of life, poorer treatment adherence, and worse health outcomes. This systematic review and meta-analysis evaluated the efficacy of non-pharmacological, evidence-based psychological interventions on distress, depression, anxiety, coping capacity, and quality of life in adult cancer patients. Interventions were grouped into three domains: structured psychotherapeutic therapies (e.g., Cognitive Behavioral Therapy [CBT], Acceptance and Commitment Therapy [ACT], Meaning-Centered Psychotherapy [MCP]); mindfulness and stress reduction programs (e.g., Mindfulness-Based Stress Reduction [MBSR], Mindfulness-Based Cognitive Therapy [MBCT]); and coping and resilience-enhancing modalities (e.g., Promoting Resilience in Stress Management [PRISM], expressive writing). Materials and Methods: Following PRISMA guidelines, 42 randomized controlled trials published between 2015 and 2025 were included. A stratified meta-analytic approach calculated pooled standardized mean differences for each intervention class and outcome. Heterogeneity, subgroup, and moderator analyses explored drivers of effect variability. Results: Structured psychotherapeutic interventions yielded the largest effects, especially for depression. Mindfulness-based interventions produced moderate but significant improvements in distress and emotional regulation. Coping and resilience programs provided smaller yet statistically significant gains in adaptive coping. Between-study heterogeneity was moderate, partly explained by intervention type, delivery modality, and cancer subtype. Conclusions: These findings support integrating psychosocial care into standard oncology protocols and endorse its routine implementation as a core component of comprehensive cancer treatment.
Medicina (Kaunas, Lithuania) · meta-analysis · 5 citationsread the source →
Systematic review and meta-analysis of the relationship between the heartbeat-evoked potential and interoception.
The Heartbeat Evoked Potential (HEP) has been proposed as a neurophysiological marker of interoceptive processing. Despite its use to validate interoceptive measures and to assess interoceptive functioning in clinical groups, the empirical evidence for a relationship between HEP amplitude and interoceptive processing, including measures of such processing, is scattered across several studies with varied designs. The aim of this systematic review and meta-analysis was to examine the body of HEP-interoception research, and consider the associations the HEP shows with various direct and indirect measures of interoception, and how it is affected by manipulations of interoceptive processing. Specifically, we assessed the effect on HEP amplitude of manipulating attention to the heartbeat; manipulating participants' arousal; the association between the HEP and behavioural measures of cardiac interoception; and comparisons between healthy and clinical groups. Following database searches and screening, 45 studies were included in the systematic review and 42 in the meta-analyses. We noted variations in the ways individual studies have attempted to address key confounds, particularly the cardiac field artefact. Meta-analytic summaries indicated there were moderate to large effects of attention, arousal, and clinical status on the HEP, and a moderate association between HEP amplitude and behavioural measures of interoception. Problematically, the reliability of the meta-analytic effects documented here remain unknown, given the lack of standardised protocols for measuring the HEP. Thus, it is possible effects are driven by confounds such as cardiac factors or somatosensory effects.
Neuroscience and biobehavioral reviews · meta-analysis · 159 citationsread the source →
Efficacy of treatments for anxiety disorders: a meta-analysis.
To our knowledge, no previous meta-analysis has attempted to compare the efficacy of pharmacological, psychological and combined treatments for the three main anxiety disorders (panic disorder, generalized anxiety disorder and social phobia). Pre-post and treated versus control effect sizes (ES) were calculated for all evaluable randomized-controlled studies (n = 234), involving 37,333 patients. Medications were associated with a significantly higher average pre-post ES [Cohen's d = 2.02 (1.90-2.15); 28,051 patients] than psychotherapies [1.22 (1.14-1.30); 6992 patients; P < 0.0001]. ES were 2.25 for serotonin-noradrenaline reuptake inhibitors (n = 23 study arms), 2.15 for benzodiazepines (n = 42), 2.09 for selective serotonin reuptake inhibitors (n = 62) and 1.83 for tricyclic antidepressants (n = 15). ES for psychotherapies were mindfulness therapies, 1.56 (n = 4); relaxation, 1.36 (n = 17); individual cognitive behavioural/exposure therapy (CBT), 1.30 (n = 93); group CBT, 1.22 (n = 18); psychodynamic therapy 1.17 (n = 5); therapies without face-to-face contact (e.g. Internet therapies), 1.11 (n = 34); eye movement desensitization reprocessing, 1.03 (n = 3); and interpersonal therapy 0.78 (n = 4). The ES was 2.12 (n = 16) for CBT/drug combinations. Exercise had an ES of 1.23 (n = 3). For control groups, ES were 1.29 for placebo pills (n = 111), 0.83 for psychological placebos (n = 16) and 0.20 for waitlists (n = 50). In direct comparisons with control groups, all investigated drugs, except for citalopram, opipramol and moclobemide, were significantly more effective than placebo. Individual CBT was more effective than waiting list, psychological placebo and pill placebo. When looking at the average pre-post ES, medications were more effective than psychotherapies. Pre-post ES for psychotherapies did not differ from pill placebos; this finding cannot be explained by heterogeneity, publication bias or allegiance effects. However, the decision on whether to choose psychotherapy, medications or a combination of the two should be left to the patient as drugs may have side effects, interactions and contraindications.
International clinical psychopharmacology · meta-analysis · 298 citationsread the source →
A meta-analysis of disordered eating and its association with self-criticism and self-compassion.
Objective: Future treatments for eating disorders (ED) need to be enhanced by targeting maintaining mechanisms. Literature suggests self-criticism and self-critical perfectionism act as key mechanisms exacerbating ED, and self-compassion protects against self-criticism. This meta-analysis examines associations between self-criticism and self-critical perfectionism on disordered eating (DE), and reviews how self-compassion and self-criticism relate to each other with respect to DE.
Method: Searches across three databases yielded 135 studies across 42,952 participants. Heterogeneity, publication bias, and quality assessments were analyzed. Moderation analyses between self-criticism measures, self-compassion measures, between clinical and nonclinical samples, and between cross-sectional and experimental studies were also conducted.
Results: Random-effects models showed a medium positive link between self-criticism and DE (r = .37), and 10 subgroups pertaining to various measures of self-criticism utilized in literature showed small to large positive links with DE (r = .20-.52). Preliminary evidence also suggests negative relationships between self-compassion and DE (r = -.40 to -.43) and negative relationships between self-compassion and self-criticism (r = -.04 to -.88).
Discussion: Greater levels of self-criticism is linked with greater levels of DE and reduced levels of self-compassion, suggesting a need to tackle self-criticism and nurture self-compassion in standard treatments for ED. Understanding these interactions better in conjunction with dismantling intervention studies can help develop more effective and efficient interventions targeting self-criticism and self-compassion for people with DE.
Public significance statement: Higher levels of self-criticism are linked with higher levels of DE and lower self-compassion. Self-compassion interventions could be more effective and efficient in reducing ED symptoms if self-criticism is tackled early in such treatments.
The International journal of eating disorders · meta-analysis · 22 citationsread the source →
Transcutaneous electrical nerve stimulation (TENS) for fibromyalgia in adults.
Background: Fibromyalgia is characterised by persistent, widespread pain; sleep problems; and fatigue. Transcutaneous electrical nerve stimulation (TENS) is the delivery of pulsed electrical currents across the intact surface of the skin to stimulate peripheral nerves and is used extensively to manage painful conditions. TENS is inexpensive, safe, and can be self-administered. TENS reduces pain during movement in some people so it may be a useful adjunct to assist participation in exercise and activities of daily living. To date, there has been only one systematic review in 2012 which included TENS, amongst other treatments, for fibromyalgia, and the authors concluded that TENS was not effective.
Objectives: To assess the analgesic efficacy and adverse events of TENS alone or added to usual care (including exercise) compared with placebo (sham) TENS; no treatment; exercise alone; or other treatment including medication, electroacupuncture, warmth therapy, or hydrotherapy for fibromyalgia in adults.
Search methods: We searched the following electronic databases up to 18 January 2017: CENTRAL (CRSO); MEDLINE (Ovid); Embase (Ovid); CINAHL (EBSCO); PsycINFO (Ovid); LILACS; PEDRO; Web of Science (ISI); AMED (Ovid); and SPORTDiscus (EBSCO). We also searched three trial registries. There were no language restrictions.
Selection criteria: We included randomised controlled trials (RCTs) or quasi-randomised trials of TENS treatment for pain associated with fibromyalgia in adults. We included cross-over and parallel-group trial designs. We included studies that evaluated TENS administered using non-invasive techniques at intensities that produced perceptible TENS sensations during stimulation at either the site of pain or over nerve bundles proximal (or near) to the site of pain. We included TENS administered as a sole treatment or TENS in combination with other treatments, and TENS given as a single treatment or as a course of treatments.
Data collection and analysis: Two review authors independently determined study eligibility by assessing each record and reaching agreement by discussion. A third review author acted as arbiter. We did not anonymise the records of studies before assessment. Two review authors independently extracted data and assessed risk of bias of included studies before entering information into a 'Characteristics of included studies' table. Primary outcomes were participant-reported pain relief from baseline of 30% or greater or 50% or greater, and Patient Global Impression of Change (PGIC). We assessed the evidence using GRADE and added 'Summary of findings' tables.
Main results: We included eight studies (seven RCTs, one quasi-RCT, 315 adults (299 women), aged 18 to 75 years): six used a parallel-group design and two used a cross-over design. Sample sizes of intervention arms were five to 43 participants. Two studies, one of which was a cross-over design, compared TENS with placebo TENS (82 participants), one study compared TENS with no treatment (43 participants), and four studies compared TENS with other treatments (medication (two studies, 74 participants), electroacupuncture (one study, 44 participants), superficial warmth (one cross-over study, 32 participants), and hydrotherapy (one study, 10 participants)). Two studies compared TENS plus exercise with exercise alone (98 participants, 49 per treatment arm). None of the studies measured participant-reported pain relief of 50% or greater or PGIC. Overall, the studies were at unclear or high risk of bias, and in particular all were at high risk of bias for sample size. Only one study (14 participants) measured the primary outcome participant-reported pain relief of 30% or greater. Thirty percent achieved 30% or greater reduction in pain with TENS and exercise compared with 13% with exercise alone. One study found 10/28 participants reported pain relief of 25% or greater with TENS compared with 10/24 participants using superficial warmth (42 °C). We judged that statistical pooling was not possible because there were insufficient data and outcomes were not homogeneous. There were no data for the primary outcomes participant-reported pain relief from baseline of 50% or greater and PGIC.There was a paucity of data for secondary outcomes. One pilot cross-over study of 43 participants found that the mean (95% confidence intervals (CI)) decrease in pain intensity on movement (100-mm visual analogue scale (VAS)) during one 30-minute treatment was 11.1 mm (95% CI 5.9 to 16.3) for TENS and 2.3 mm (95% CI 2.4 to 7.7) for placebo TENS. There were no significant differences between TENS and placebo for pain at rest. One parallel group study of 39 participants found that mean ± standard deviation (SD) pain intensity (100-mm VAS) decreased from 85 ± 20 mm at baseline to 43 ± 20 mm after one week of dual-site TENS; decreased from 85 ± 10 mm at baseline to 60 ± 10 mm after single-site TENS; and decreased from 82 ± 20 mm at baseline to 80 ± 20 mm after one week of placebo TENS. The authors of seven studies concluded that TENS relieved pain but the findings of single small studies are unlikely to be correct. One study found clinically important improvements in Fibromyalgia Impact Questionnaire (FIQ) subscales for work performance, fatigue, stiffness, anxiety, and depression for TENS with exercise compared with exercise alone. One study found no additional improvements in FIQ scores when TENS was added to the first three weeks of a 12-week supervised exercise programme. No serious adverse events were reported in any of the studies although there were reports of TENS causing minor discomfort in a total of 3 participants. The quality of evidence was very low. We downgraded the GRADE rating mostly due to a lack of data; therefore, we have little confidence in the effect estimates where available.
Authors' conclusions: There was insufficient high-quality evidence to support or refute the use of TENS for fibromyalgia. We found a small number of inadequately powered studies with incomplete reporting of methodologies and treatment interventions.
The Cochrane database of systematic reviews · meta-analysis · 48 citationsread the source →
Schultze-Lutter F, Michel C, Schmidt SJ, Schimmelmann BG, Maric NP, Salokangas RK, Riecher-Rössler A, van der Gaag M, Nordentoft M, Raballo A, Meneghelli A, Marshall M, Morrison A, Ruhrmann S, Klosterkötter J. (2015)MEDLINE-indexed journal, not yet read by usEuropean psychiatry : the journal of the Association of European Psychiatrists · meta-analysis EPA guidance on the early detection of clinical high risk states of psychoses.
The aim of this guidance paper of the European Psychiatric Association is to provide evidence-based recommendations on the early detection of a clinical high risk (CHR) for psychosis in patients with mental problems. To this aim, we conducted a meta-analysis of studies reporting on conversion rates to psychosis in non-overlapping samples meeting any at least any one of the main CHR criteria: ultra-high risk (UHR) and/or basic symptoms criteria. Further, effects of potential moderators (different UHR criteria definitions, single UHR criteria and age) on conversion rates were examined. Conversion rates in the identified 42 samples with altogether more than 4000 CHR patients who had mainly been identified by UHR criteria and/or the basic symptom criterion 'cognitive disturbances' (COGDIS) showed considerable heterogeneity. While UHR criteria and COGDIS were related to similar conversion rates until 2-year follow-up, conversion rates of COGDIS were significantly higher thereafter. Differences in onset and frequency requirements of symptomatic UHR criteria or in their different consideration of functional decline, substance use and co-morbidity did not seem to impact on conversion rates. The 'genetic risk and functional decline' UHR criterion was rarely met and only showed an insignificant pooled sample effect. However, age significantly affected UHR conversion rates with lower rates in children and adolescents. Although more research into potential sources of heterogeneity in conversion rates is needed to facilitate improvement of CHR criteria, six evidence-based recommendations for an early detection of psychosis were developed as a basis for the EPA guidance on early intervention in CHR states.
European psychiatry : the journal of the Association of European Psychiatrists · meta-analysis · 267 citationsread the source →
Mindfulness-based interventions for weight loss: a systematic review and meta-analysis.
Background: An increasing number of studies are investigating the efficacy of mindfulness-based interventions (MBIs) for weight loss and obesity-related eating behaviours. However, the results of past reviews are inconsistent.
Objective: To clarify these inconsistencies, we conducted a comprehensive effect-size analysis to evaluate the efficacy of MBIs on weight loss and eating behaviours.
Data source: Data sources were identified through a systematic review of studies published in journals or as dissertations in PsychINFO, PubMed, CINAHL, Web of Science, Medline and Scopus, ProQuest or OATD from the first available date to March 10, 2017.
Review methods: A total of 18 publications (19 studies, n = 1,160) were included.
Results: Mean weight loss for MBIs at post-treatment was 6.8 and 7.5 lb at follow-up. In pre-post comparisons, effect-size estimates suggest that MBIs are moderately effective for weight loss (n = 16; Hedge's g = .42; 95% CI [.26, .59], p < .000001) and largely effective in reducing obesity-related eating behaviours (n = 10; Hedge's g = .70; CI 95% [.36, 1.04], p < .00005). Larger effects on weight loss were found in studies that used a combination of informal and formal meditation practice (n = 6; Hedge's g = .55; CI 95% [.32, .77], p < .00001) compared with formal meditation practice alone (n = 4; Hedge's g = .46; CI [.10, .83], p < .05).
Conclusion: Results suggest that MBIs are effective in reducing weight and improving obesity-related eating behaviours among individuals with overweight and obesity. Further research is needed to examine their efficacy for weight loss maintenance.
Obesity reviews : an official journal of the International Association for the Study of Obesity · meta-analysis · 118 citationsread the source →
Kaner EF, Beyer FR, Garnett C, Crane D, Brown J, Muirhead C, Redmore J, O'Donnell A, Newham JJ, de Vocht F, Hickman M, Brown H, Maniatopoulos G, Michie S. (2017)MEDLINE-indexed journal, not yet read by usThe Cochrane database of systematic reviews · meta-analysis Personalised digital interventions for reducing hazardous and harmful alcohol consumption in community-dwelling populations.
Background: Excessive alcohol use contributes significantly to physical and psychological illness, injury and death, and a wide array of social harm in all age groups. A proven strategy for reducing excessive alcohol consumption levels is to offer a brief conversation-based intervention in primary care settings, but more recent technological innovations have enabled people to interact directly via computer, mobile device or smartphone with digital interventions designed to address problem alcohol consumption.
Objectives: To assess the effectiveness and cost-effectiveness of digital interventions for reducing hazardous and harmful alcohol consumption, alcohol-related problems, or both, in people living in the community, specifically: (i) Are digital interventions more effective and cost-effective than no intervention (or minimal input) controls? (ii) Are digital interventions at least equally effective as face-to-face brief alcohol interventions? (iii) What are the effective component behaviour change techniques (BCTs) of such interventions and their mechanisms of action? (iv) What theories or models have been used in the development and/or evaluation of the intervention? Secondary objectives were (i) to assess whether outcomes differ between trials where the digital intervention targets participants attending health, social care, education or other community-based settings and those where it is offered remotely via the internet or mobile phone platforms; (ii) to specify interventions according to their mode of delivery (e.g. functionality features) and assess the impact of mode of delivery on outcomes.
Search methods: We searched CENTRAL, MEDLINE, PsycINFO, CINAHL, ERIC, HTA and Web of Knowledge databases; ClinicalTrials.com and WHO ICTRP trials registers and relevant websites to April 2017. We also checked the reference lists of included trials and relevant systematic reviews.
Selection criteria: We included randomised controlled trials (RCTs) that evaluated the effectiveness of digital interventions compared with no intervention or with face-to-face interventions for reducing hazardous or harmful alcohol consumption in people living in the community and reported a measure of alcohol consumption.
Data collection and analysis: We used standard methodological procedures expected by The Cochrane Collaboration.
Main results: We included 57 studies which randomised a total of 34,390 participants. The main sources of bias were from attrition and participant blinding (36% and 21% of studies respectively, high risk of bias). Forty one studies (42 comparisons, 19,241 participants) provided data for the primary meta-analysis, which demonstrated that participants using a digital intervention drank approximately 23 g alcohol weekly (95% CI 15 to 30) (about 3 UK units) less than participants who received no or minimal interventions at end of follow up (moderate-quality evidence).Fifteen studies (16 comparisons, 10,862 participants) demonstrated that participants who engaged with digital interventions had less than one drinking day per month fewer than no intervention controls (moderate-quality evidence), 15 studies (3587 participants) showed about one binge drinking session less per month in the intervention group compared to no intervention controls (moderate-quality evidence), and in 15 studies (9791 participants) intervention participants drank one unit per occasion less than no intervention control participants (moderate-quality evidence).Only five small studies (390 participants) compared digital and face-to-face interventions. There was no difference in alcohol consumption at end of follow up (MD 0.52 g/week, 95% CI -24.59 to 25.63; low-quality evidence). Thus, digital alcohol interventions produced broadly similar outcomes in these studies. No studies reported whether any adverse effects resulted from the interventions.A median of nine BCTs were used in experimental arms (range = 1 to 22). 'B' is an estimate of effect (MD in quantity of drinking, expressed in g/week) per unit increase in the BCT, and is a way to report whether individual BCTs are linked to the effect of the intervention. The BCTs of goal setting (B -43.94, 95% CI -78.59 to -9.30), problem solving (B -48.03, 95% CI -77.79 to -18.27), information about antecedents (B -74.20, 95% CI -117.72 to -30.68), behaviour substitution (B -123.71, 95% CI -184.63 to -62.80) and credible source (B -39.89, 95% CI -72.66 to -7.11) were significantly associated with reduced alcohol consumption in unadjusted models. In a multivariable model that included BCTs with B > 23 in the unadjusted model, the BCTs of behaviour substitution (B -95.12, 95% CI -162.90 to -27.34), problem solving (B -45.92, 95% CI -90.97 to -0.87), and credible source (B -32.09, 95% CI -60.64 to -3.55) were associated with reduced alcohol consumption. The most frequently mentioned theories or models in the included studies were Motivational Interviewing Theory (7/20), Transtheoretical Model (6/20) and Social Norms Theory (6/20). Over half of the interventions (n = 21, 51%) made no mention of theory. Only two studies used theory to select participants or tailor the intervention. There was no evidence of an association between reporting theory use and intervention effectiveness.
Authors' conclusions: There is moderate-quality evidence that digital interventions may lower alcohol consumption, with an average reduction of up to three (UK) standard drinks per week compared to control participants. Substantial heterogeneity and risk of performance and publication bias may mean the reduction was lower. Low-quality evidence from fewer studies suggested there may be little or no difference in impact on alcohol consumption between digital and face-to-face interventions. The BCTs of behaviour substitution, problem solving and credible source were associated with the effectiveness of digital interventions to reduce alcohol consumption and warrant further investigation in an experimental context. Reporting of theory use was very limited and often unclear when present. Over half of the interventions made no reference to any theories. Limited reporting of theory use was unrelated to heterogeneity in intervention effectiveness.
The Cochrane database of systematic reviews · meta-analysis · 210 citationsread the source →
Psychological therapies for the management of chronic pain (excluding headache) in adults.
Background: Chronic non-cancer pain, a disabling and distressing condition, is common in adults. It is a global public health problem and economic burden on health and social care systems and on people with chronic pain. Psychological treatments aim to reduce pain, disability and distress. This review updates and extends its previous version, published in 2012.
Objectives: To determine the clinical efficacy and safety of psychological interventions for chronic pain in adults (age > 18 years) compared with active controls, or waiting list/treatment as usual (TAU).
Search methods: We identified randomised controlled trials (RCTs) of psychological therapies by searching CENTRAL, MEDLINE, Embase and PsycINFO to 16 April 2020. We also examined reference lists and trial registries, and searched for studies citing retrieved trials.
Selection criteria: RCTs of psychological treatments compared with active control or TAU of face-to-face therapies for adults with chronic pain. We excluded studies of headache or malignant disease, and those with fewer than 20 participants in any arm at treatment end.
Data collection and analysis: Two or more authors rated risk of bias, extracted data, and judged quality of evidence (GRADE). We compared cognitive behavioural therapy (CBT), behavioural therapy (BT), and acceptance and commitment therapy (ACT) with active control or TAU at treatment end, and at six month to 12 month follow-up. We did not analyse the few trials of other psychological treatments. We assessed treatment effectiveness for pain intensity, disability, and distress. We extracted data on adverse events (AEs) associated with treatment.
Main results: We added 41 studies (6255 participants) to 34 of the previous review's 42 studies, and now have 75 studies in total (9401 participants at treatment end). Most participants had fibromyalgia, chronic low back pain, rheumatoid arthritis, or mixed chronic pain. Most risk of bias domains were at high or unclear risk of bias, with selective reporting and treatment expectations mostly at unclear risk of bias. AEs were inadequately recorded and/or reported across studies. CBT The largest evidence base was for CBT (59 studies). CBT versus active control showed very small benefit at treatment end for pain (standardised mean difference (SMD) -0.09, 95% confidence interval (CI) -0.17 to -0.01; 3235 participants; 23 studies; moderate-quality evidence), disability (SMD -0.12, 95% CI -0.20 to -0.04; 2543 participants; 19 studies; moderate-quality evidence), and distress (SMD -0.09, 95% CI -0.18 to -0.00; 3297 participants; 24 studies; moderate-quality evidence). We found small benefits for CBT over TAU at treatment end for pain (SMD -0.22, 95% CI -0.33 to -0.10; 2572 participants; 29 studies; moderate-quality evidence), disability (SMD -0.32, 95% CI -0.45 to -0.19; 2524 participants; 28 studies; low-quality evidence), and distress (SMD -0.34, 95% CI -0.44 to -0.24; 2559 participants; 27 studies; moderate-quality evidence). Effects were largely maintained at follow-up for CBT versus TAU, but not for CBT versus active control. Evidence quality for CBT outcomes ranged from moderate to low. We rated evidence for AEs as very low quality for both comparisons. BT We analysed eight studies (647 participants). We found no evidence of difference between BT and active control at treatment end (pain SMD -0.67, 95% CI -2.54 to 1.20, very low-quality evidence; disability SMD -0.65, 95% CI -1.85 to 0.54, very low-quality evidence; or distress SMD -0.73, 95% CI -1.47 to 0.01, very low-quality evidence). At follow-up, effects were similar. We found no evidence of difference between BT and TAU (pain SMD -0.08, 95% CI -0.33 to 0.17, low-quality evidence; disability SMD -0.02, 95% CI -0.24 to 0.19, moderate-quality evidence; distress SMD 0.22, 95% CI -0.10 to 0.54, low-quality evidence) at treatment end. At follow-up, we found one to three studies with no evidence of difference between BT and TAU. We rated evidence for all BT versus active control outcomes as very low quality; for BT versus TAU. Evidence quality ranged from moderate to very low. We rated evidence for AEs as very low quality for BT versus active control. No studies of BT versus TAU reported AEs. ACT We analysed five studies (443 participants). There was no evidence of difference between ACT and active control for pain (SMD -0.54, 95% CI -1.20 to 0.11, very low-quality evidence), disability (SMD -1.51, 95% CI -3.05 to 0.03, very low-quality evidence) or distress (SMD -0.61, 95% CI -1.30 to 0.07, very low-quality evidence) at treatment end. At follow-up, there was no evidence of effect for pain or distress (both very low-quality evidence), but two studies showed a large benefit for reducing disability (SMD -2.56, 95% CI -4.22 to -0.89, very low-quality evidence). Two studies compared ACT to TAU at treatment end. Results should be interpreted with caution. We found large benefits of ACT for pain (SMD -0.83, 95% CI -1.57 to -0.09, very low-quality evidence), but none for disability (SMD -1.39, 95% CI -3.20 to 0.41, very low-quality evidence), or distress (SMD -1.16, 95% CI -2.51 to 0.20, very low-quality evidence). Lack of data precluded analysis at follow-up. We rated evidence quality for AEs to be very low. We encourage caution when interpreting very low-quality evidence because the estimates are uncertain and could be easily overturned.
Authors' conclusions: We found sufficient evidence across a large evidence base (59 studies, over 5000 participants) that CBT has small or very small beneficial effects for reducing pain, disability, and distress in chronic pain, but we found insufficient evidence to assess AEs. Quality of evidence for CBT was mostly moderate, except for disability, which we rated as low quality. Further trials may provide more precise estimates of treatment effects, but to inform improvements, research should explore sources of variation in treatment effects. Evidence from trials of BT and ACT was of moderate to very low quality, so we are very uncertain about benefits or lack of benefits of these treatments for adults with chronic pain; other treatments were not analysed. These conclusions are similar to our 2012 review, apart from the separate analysis of ACT.
The Cochrane database of systematic reviews · meta-analysis · 349 citationsread the source →
Cognitive behavioural therapy for tinnitus.
Background: Tinnitus affects up to 21% of the adult population with an estimated 1% to 3% experiencing severe problems. Cognitive behavioural therapy (CBT) is a collection of psychological treatments based on the cognitive and behavioural traditions in psychology and often used to treat people suffering from tinnitus.
Objectives: To assess the effects and safety of CBT for tinnitus in adults.
Search methods: The Cochrane ENT Information Specialist searched the ENT Trials Register; CENTRAL (2019, Issue 11); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 25 November 2019.
Selection criteria: Randomised controlled trials (RCTs) of CBT versus no intervention, audiological care, tinnitus retraining therapy or any other active treatment in adult participants with tinnitus.
Data collection and analysis: We used the standard methodological procedures expected by Cochrane. Our primary outcomes were the impact of tinnitus on disease-specific quality of life and serious adverse effects. Our secondary outcomes were: depression, anxiety, general health-related quality of life, negatively biased interpretations of tinnitus and other adverse effects. We used GRADE to assess the certainty of evidence for each outcome.
Main results: We included 28 studies (mostly from Europe) with a total of 2733 participants. All participants had had tinnitus for at least three months and their average age ranged from 43 to 70 years. The duration of the CBT ranged from 3 to 22 weeks and it was mostly conducted in hospitals or online. There were four comparisons and we were interested in outcomes at end of treatment, and 6 and 12 months follow-up. The results below only refer to outcomes at end of treatment due to an absence of evidence at the other follow-up time points. CBT versus no intervention/wait list control Fourteen studies compared CBT with no intervention/wait list control. For the primary outcome, CBT may reduce the impact of tinnitus on quality of life at treatment end (standardised mean difference (SMD) -0.56, 95% confidence interval (CI) -0.83 to -0.30; 10 studies; 537 participants; low certainty). Re-expressed as a score on the Tinnitus Handicap Inventory (THI; range 0 to 100) this is equivalent to a score 10.91 points lower in the CBT group, with an estimated minimal clinically important difference (MCID) for this scale being 7 points. Seven studies, rated as moderate certainty, either reported or informed us via personal communication about serious adverse effects. CBT probably results in little or no difference in adverse effects: six studies reported none and in one study one participant in the CBT condition worsened (risk ratio (RR) 3.00, 95% CI 0.13 to 69.87). For the secondary outcomes, CBT may result in a slight reduction in depression (SMD -0.34, 95% CI-0.60 to -0.08; 8 studies; 502 participants; low certainty). However, we are uncertain whether CBT reduces anxiety, improves health-related quality of life or reduces negatively biased interpretations of tinnitus (all very low certainty). From seven studies, no other adverse effects were reported (moderate certainty). CBT versus audiological care Three studies compared CBT with audiological care. CBT probably reduces the impact of tinnitus on quality of life when compared with audiological care as measured by the THI (range 0 to 100; mean difference (MD) -5.65, 95% CI -9.79 to -1.50; 3 studies; 444 participants) (moderate certainty; MCID = 7 points). No serious adverse effects occurred in the two included studies reporting these, thus risk ratios were not calculated (moderate certainty). The evidence suggests that CBT may slightly reduce depression but may result in little or no difference in anxiety or health-related quality of life (all low certainty) when compared with audiological care. CBT may reduce negatively biased interpretations of tinnitus when compared with audiological care (low certainty). No other adverse effects were reported for either group (moderate certainty). CBT versus tinnitus retraining therapy (TRT) One study compared CBT with TRT (including bilateral sound generators as per TRT protocol). CBT may reduce the impact of tinnitus on quality of life as measured by the THI when compared with TRT (range 0 to 100) (MD -15.79, 95% CI -27.91 to -3.67; 1 study; 42 participants; low certainty). For serious adverse effects three participants deteriorated during the study: one in the CBT (n = 22) and two in the TRT group (n = 20) (RR 0.45, 95% CI 0.04 to 4.64; low certainty). We are uncertain whether CBT reduces depression and anxiety or improves health-related quality of life (low certainty). CBT may reduce negatively biased interpretations of tinnitus. No data were available for other adverse effects. CBT versus other active control Sixteen studies compared CBT with another active control (e.g. relaxation, information, Internet-based discussion forums). CBT may reduce the impact of tinnitus on quality of life when compared with other active treatments (SMD -0.30, 95% CI -0.55 to -0.05; 12 studies; 966 participants; low certainty). Re-expressed as a THI score this is equivalent to 5.84 points lower in the CBT group than the other active control group (MCID = 7 points). One study reported that three participants deteriorated: one in the CBT and two in the information only group (RR 1.70, 95% CI 0.16 to 18.36; low certainty). CBT may reduce depression and anxiety (both low certainty). We are uncertain whether CBT improves health-related quality of life compared with other control. CBT probably reduces negatively biased interpretations of tinnitus compared with other treatments. No data were available for other adverse effects.
Authors' conclusions: CBT may be effective in reducing the negative impact that tinnitus can have on quality of life. There is, however, an absence of evidence at 6 or 12 months follow-up. There is also some evidence that adverse effects may be rare in adults with tinnitus receiving CBT, but this could be further investigated. CBT for tinnitus may have small additional benefit in reducing symptoms of depression although uncertainty remains due to concerns about the quality of the evidence. Overall, there is limited evidence for CBT for tinnitus improving anxiety, health-related quality of life or negatively biased interpretations of tinnitus.
The Cochrane database of systematic reviews · meta-analysis · 131 citationsread the source →
Gobbi G, Atkin T, Zytynski T, Wang S, Askari S, Boruff J, Ware M, Marmorstein N, Cipriani A, Dendukuri N, Mayo N. (2019)MEDLINE-indexed journal, not yet read by usJAMA psychiatry · meta-analysis Association of Cannabis Use in Adolescence and Risk of Depression, Anxiety, and Suicidality in Young Adulthood: A Systematic Review and Meta-analysis.
Importance: Cannabis is the most commonly used drug of abuse by adolescents in the world. While the impact of adolescent cannabis use on the development of psychosis has been investigated in depth, little is known about the impact of cannabis use on mood and suicidality in young adulthood.
Objective: To provide a summary estimate of the extent to which cannabis use during adolescence is associated with the risk of developing subsequent major depression, anxiety, and suicidal behavior.
Data sources: Medline, Embase, CINAHL, PsycInfo, and Proquest Dissertations and Theses were searched from inception to January 2017.
Study selection: Longitudinal and prospective studies, assessing cannabis use in adolescents younger than 18 years (at least 1 assessment point) and then ascertaining development of depression in young adulthood (age 18 to 32 years) were selected, and odds ratios (OR) adjusted for the presence of baseline depression and/or anxiety and/or suicidality were extracted.
Data extraction and synthesis: Study quality was assessed using the Research Triangle Institute item bank on risk of bias and precision of observational studies. Two reviewers conducted all review stages independently. Selected data were pooled using random-effects meta-analysis.
Main outcomes and measures: The studies assessing cannabis use and depression at different points from adolescence to young adulthood and reporting the corresponding OR were included. In the studies selected, depression was diagnosed according to the third or fourth editions of Diagnostic and Statistical Manual of Mental Disorders or by using scales with predetermined cutoff points.
Results: After screening 3142 articles, 269 articles were selected for full-text review, 35 were selected for further review, and 11 studies comprising 23 317 individuals were included in the quantitative analysis. The OR of developing depression for cannabis users in young adulthood compared with nonusers was 1.37 (95% CI, 1.16-1.62; I2 = 0%). The pooled OR for anxiety was not statistically significant: 1.18 (95% CI, 0.84-1.67; I2 = 42%). The pooled OR for suicidal ideation was 1.50 (95% CI, 1.11-2.03; I2 = 0%), and for suicidal attempt was 3.46 (95% CI, 1.53-7.84, I2 = 61.3%).
Conclusions and relevance: Although individual-level risk remains moderate to low and results from this study should be confirmed in future adequately powered prospective studies, the high prevalence of adolescents consuming cannabis generates a large number of young people who could develop depression and suicidality attributable to cannabis. This is an important public health problem and concern, which should be properly addressed by health care policy.
JAMA psychiatry · meta-analysis · 585 citationsread the source →
The relevance of cognitive emotion regulation to psychotic symptoms - A systematic review and meta-analysis.
Numerous studies emphasise the pivotal role of negative affect in the formation and maintenance of positive symptoms, which moves emotion regulation (ER) as a contributing factor into focus. We systematically reviewed and meta-analysed case-control studies reporting cross-sectional, correlative and experimental data of ER strategies in patients with psychotic disorders. In total, 42 studies were eligible, providing data for 2498 subjects and 3381 healthy controls. Questionnaire-based cross-sectional data (k=39) indicated strongest effects for rumination (g=-0,67 [-0,85 to -0,48]), self-blaming (g=-0,56; [-0,76 to -0,37]) and distraction (g=0,55 [0,11 to 0,98]). Suppression was more frequently (g=-0,36 [-0,56 to -0,16]) and cognitive reappraisal less frequently used (g=0,41 [0,28 to 0,55]), but heterogeneity was high. Correlative data (k=6) supported the assumption of an association between maladaptive strategies and positive symptoms (r=0,34 [0,22 to 0,44]). Less evidence of group differences was found in the experimental studies (k=3). The findings support the notion that ER is markedly impaired in patients with psychotic disorders. However, future research will need to further clarify the extent to which difficulties continue to exist after controlling for context and emotion intensity. The large effects for rumination and self-blaming point to promising treatment targets but also raise questions concerning the specifity of findings.
Clinical psychology review · meta-analysis · 81 citationsread the source →
Depression and telomere length: A meta-analysis.
Background: Several recent studies have investigated the relationship between telomere length and depression with inconsistent results. This meta-analysis examined whether telomere length and depression are associated and explored factors that might affect this association.
Methods: Studies measuring telomere length in subjects with clinically significant unipolar depression were included. A comprehensive search strategy identified studies in PubMed, MEDLINE, PsycINFO, Global Health, The Cochrane Library, and Web of Science. A structured data abstraction form was used and studies were appraised for inclusion or exclusion using a priori conditions. Analyses were conducted using standardized mean differences in a continuous random effects model.
Results: Thirty-eight studies (N=34,347) met the inclusion criteria. The association between depression and telomere length was significant, with a Cohen's d effect size of -0.205 (p<0.0001, I(2)=42%). Depression severity significantly associated with telomere length (p=0.03). Trim and fill analysis indicated the presence of publication bias (p=0.003), but that the association remained highly significant after accounting for the bias. Subgroup analysis revealed depression assessment tools, telomere measurement techniques, source tissue and comorbid medical conditions significantly affected the relationship.
Limitations: Other potentially important sub-groups, including antidepressant use, have not been investigated in sufficient detail or number yet and thus were not addressed in this meta-analysis.
Conclusions: There is a negative association between depression and telomere length. Further studies are needed to clarify potential causality underlying this association and to elucidate the biology linking depression and this cellular marker of stress exposure and aging.
Journal of affective disorders · meta-analysis · 211 citationsread the source →
Exercise training for bronchiectasis.
Background: Bronchiectasis is characterised by excessive sputum production, chronic cough, and acute exacerbations and is associated with symptoms of dyspnoea and fatigue, which reduce exercise tolerance and impair quality of life. Exercise training in isolation or in conjunction with other interventions is beneficial for people with other respiratory diseases, but its effects in bronchiectasis have not been well established.
Objectives: To determine effects of exercise training compared to usual care on exercise tolerance (primary outcome), quality of life (primary outcome), incidence of acute exacerbation and hospitalisation, respiratory and mental health symptoms, physical function, mortality, and adverse events in people with stable or acute exacerbation of bronchiectasis.
Search methods: We identified trials from the Cochrane Airways Specialised Register, ClinicalTrials.gov, and the World Health Organization trials portal, from their inception to October 2020. We reviewed respiratory conference abstracts and reference lists of all primary studies and review articles for additional references.
Selection criteria: We included randomised controlled trials in which exercise training of at least four weeks' duration (or eight sessions) was compared to usual care for people with stable bronchiectasis or experiencing an acute exacerbation. Co-interventions with exercise training including education, respiratory muscle training, and airway clearance therapy were permitted if also applied as part of usual care.
Data collection and analysis: Two review authors independently screened and selected trials for inclusion, extracted outcome data, and assessed risk of bias. We contacted study authors for missing data. We calculated mean differences (MDs) using a random-effects model. We used the GRADE approach to assess the certainty of evidence.
Main results: We included six studies, two of which were published as abstracts, with a total of 275 participants. Five studies were undertaken with people with clinically stable bronchiectasis, and one pilot study was undertaken post acute exacerbation. All studies included co-interventions such as instructions for airway clearance therapy and/or breathing strategies, provision of an educational booklet, and delivery of educational sessions. The duration of training ranged from six to eight weeks, with a mix of supervised and unsupervised sessions conducted in the outpatient or home setting. No studies of children were included in the review; however we identified two studies as currently ongoing. No data were available regarding physical activity levels or adverse events. For people with stable bronchiectasis, evidence suggests that exercise training compared to usual care improves functional exercise tolerance as measured by the incremental shuttle walk distance, with a mean difference (MD) between groups of 87 metres (95% confidence interval (CI) 43 to 132 metres; 4 studies, 161 participants; low-certainty evidence). Evidence also suggests that exercise training improves six-minute walk distance (6MWD) (MD between groups of 42 metres, 95% CI 22 to 62; 1 study, 76 participants; low-certainty evidence). The magnitude of these observed mean changes appears clinically relevant as they exceed minimal clinically important difference (MCID) thresholds for people with chronic lung disease. Evidence suggests that quality of life improves following exercise training according to St George's Respiratory Questionnaire (SGRQ) total score (MD -9.62 points, 95% CI -15.67 to -3.56 points; 3 studies, 160 participants; low-certainty evidence), which exceeds the MCID of 4 points for this outcome. A reduction in dyspnoea (MD 1.0 points, 95% CI 0.47 to 1.53; 1 study, 76 participants) and fatigue (MD 1.51 points, 95% CI 0.80 to 2.22 points; 1 study, 76 participants) was observed following exercise training according to these domains of the Chronic Respiratory Disease Questionnaire. However, there was no change in cough-related quality of life as measured by the Leicester Cough Questionnaire (LCQ) (MD -0.09 points, 95% CI -0.98 to 0.80 points; 2 studies, 103 participants; moderate-certainty evidence), nor in anxiety or depression. Two studies reported longer-term outcomes up to 12 months after intervention completion; however exercise training did not appear to improve exercise capacity or quality of life more than usual care. Exercise training reduced the number of acute exacerbations of bronchiectasis over 12 months in people with stable bronchiectasis (odds ratio 0.26, 95% CI 0.08 to 0.81; 1 study, 55 participants). After an acute exacerbation of bronchiectasis, data from a single study (N = 27) suggest that exercise training compared to usual care confers little to no effect on exercise capacity (MD 11 metres, 95% CI -27 to 49 metres; low-certainty evidence), SGRQ total score (MD 6.34 points, 95%CI -17.08 to 29.76 points), or LCQ score (MD -0.08 points, 95% CI -0.94 to 0.78 points; low-certainty evidence) and does not reduce the time to first exacerbation (hazard ratio 0.83, 95% CI 0.31 to 2.22).
Authors' conclusions: This review provides low-certainty evidence suggesting improvement in functional exercise capacity and quality of life immediately following exercise training in people with stable bronchiectasis; however the effects of exercise training on cough-related quality of life and psychological symptoms appear to be minimal. Due to inadequate reporting of methods, small study numbers, and variation between study findings, evidence is of very low to moderate certainty. Limited evidence is available to show longer-term effects of exercise training on these outcomes.
The Cochrane database of systematic reviews · meta-analysis · 29 citationsread the source →
Leach CW, Cidam A. (2015)MEDLINE-indexed journal, not yet read by usJournal of personality and social psychology · meta-analysis When is shame linked to constructive approach orientation? A meta-analysis.
Despite recent evidence that episodic shame can be linked to the constructive approach of failure (i.e., prosociality, self-improvement), the prevailing view is that shame is neither constructive nor approach-oriented. To integrate these opposing views, we conducted a theory-driven meta-analysis of 90 samples from the published literature (N = 12,364). As expected, shame had a positive link to constructive approach when failure (g = .47, 95% confidence interval [CI] [.37, .55]) or social image (g = .37, 95% CI [.06, .68]) was more reparable. In contrast, shame had a negative link to constructive approach when failure was less reparable (g = -.34, 95% CI [-.53, -.14]). A supplemental meta-analysis of 42 samples showed shame and guilt to have a similar positive link to constructive approach orientation when failure was more reparable (g = .44 and .43), but not when it was less reparable (g = -.08 and .27).
Journal of personality and social psychology · meta-analysis · 49 citationsread the source →
Cannabinoids for the treatment of mental disorders and symptoms of mental disorders: a systematic review and meta-analysis.
Background: Medicinal cannabinoids, including medicinal cannabis and pharmaceutical cannabinoids and their synthetic derivatives, such as tetrahydrocannabinol (THC) and cannabidiol (CBD), have been suggested to have a therapeutic role in certain mental disorders. We analysed the available evidence to ascertain the effectiveness and safety of all types of medicinal cannabinoids in treating symptoms of various mental disorders.
Methods: For this systematic review and meta-analysis we searched MEDLINE, Embase, PsycINFO, the Cochrane Central Register of Controlled Clinical Trials, and the Cochrane Database of Systematic Reviews for studies published between Jan 1, 1980, and April 30, 2018. We also searched for unpublished or ongoing studies on ClinicalTrials.gov, the EU Clinical Trials Register, and the Australian and New Zealand Clinical Trials Registry. We considered all studies examining any type and formulation of a medicinal cannabinoid in adults (≥18 years) for treating depression, anxiety, attention-deficit hyperactivity disorder (ADHD), Tourette syndrome, post-traumatic stress disorder, or psychosis, either as the primary condition or secondary to other medical conditions. We placed no restrictions on language, publication status, or study type (ie, both experimental and observational study designs were included). Primary outcomes were remission from and changes in symptoms of these mental disorders. The safety of medicinal cannabinoids for these mental disorders was also examined. Evidence from randomised controlled trials was synthesised as odds ratios (ORs) for disorder remission, adverse events, and withdrawals and as standardised mean differences (SMDs) for change in symptoms, via random-effects meta-analyses. The quality of the evidence was assessed with the Cochrane risk of bias tool and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. This study is registered with PROSPERO (CRD42017059372, CRD42017059373, CRD42017059376, CRD42017064996, and CRD42018102977).
Findings: 83 eligible studies (40 randomised controlled trials, n=3067) were included: 42 for depression (23 randomised controlled trials; n=2551), 31 for anxiety (17 randomised controlled trials; n=605), eight for Tourette syndrome (two randomised controlled trials; n=36), three for ADHD (one randomised controlled trial; n=30), 12 for post-traumatic stress disorder (one randomised controlled trial; n=10), and 11 for psychosis (six randomised controlled trials; n=281). Pharmaceutical THC (with or without CBD) improved anxiety symptoms among individuals with other medical conditions (primarily chronic non-cancer pain and multiple sclerosis; SMD -0·25 [95% CI -0·49 to -0·01]; seven studies; n=252), although the evidence GRADE was very low. Pharmaceutical THC (with or without CBD) worsened negative symptoms of psychosis in a single study (SMD 0·36 [95% CI 0·10 to 0·62]; n=24). Pharmaceutical THC (with or without CBD) did not significantly affect any other primary outcomes for the mental disorders examined but did increase the number of people who had adverse events (OR 1·99 [95% CI 1·20 to 3·29]; ten studies; n=1495) and withdrawals due to adverse events (2·78 [1·59 to 4·86]; 11 studies; n=1621) compared with placebo across all mental disorders examined. Few randomised controlled trials examined the role of pharmaceutical CBD or medicinal cannabis.
Interpretation: There is scarce evidence to suggest that cannabinoids improve depressive disorders and symptoms, anxiety disorders, attention-deficit hyperactivity disorder, Tourette syndrome, post-traumatic stress disorder, or psychosis. There is very low quality evidence that pharmaceutical THC (with or without CBD) leads to a small improvement in symptoms of anxiety among individuals with other medical conditions. There remains insufficient evidence to provide guidance on the use of cannabinoids for treating mental disorders within a regulatory framework. Further high-quality studies directly examining the effect of cannabinoids on treating mental disorders are needed.
Funding: Therapeutic Goods Administration, Australia; Commonwealth Department of Health, Australia; Australian National Health and Medical Research Council; and US National Institutes of Health.
The lancet. Psychiatry · meta-analysis · 309 citationsread the source →
Bajwah S, Oluyase AO, Yi D, Gao W, Evans CJ, Grande G, Todd C, Costantini M, Murtagh FE, Higginson IJ. (2020)MEDLINE-indexed journal, not yet read by usThe Cochrane database of systematic reviews · meta-analysis The effectiveness and cost-effectiveness of hospital-based specialist palliative care for adults with advanced illness and their caregivers.
Background: Serious illness is often characterised by physical/psychological problems, family support needs, and high healthcare resource use. Hospital-based specialist palliative care (HSPC) has developed to assist in better meeting the needs of patients and their families and potentially reducing hospital care expenditure. There is a need for clarity on the effectiveness and optimal models of HSPC, given that most people still die in hospital and also to allocate scarce resources judiciously.
Objectives: To assess the effectiveness and cost-effectiveness of HSPC compared to usual care for adults with advanced illness (hereafter patients) and their unpaid caregivers/families.
Search methods: We searched CENTRAL, CDSR, DARE and HTA database via the Cochrane Library; MEDLINE; Embase; CINAHL; PsycINFO; CareSearch; National Health Service Economic Evaluation Database (NHS EED) and two trial registers to August 2019, together with checking of reference lists and relevant systematic reviews, citation searching and contact with experts to identify additional studies.
Selection criteria: We included randomised controlled trials (RCTs) evaluating the impact of HSPC on outcomes for patients or their unpaid caregivers/families, or both. HSPC was defined as specialist palliative care delivered by a palliative care team that is based in a hospital providing holistic care, co-ordination by a multidisciplinary team, and collaboration between HSPC providers and generalists. HSPC was provided to patients while they were admitted as inpatients to acute care hospitals, outpatients or patients receiving care from hospital outreach teams at home. The comparator was usual care, defined as inpatient or outpatient hospital care without specialist palliative care input at the point of entry into the study, community care or hospice care provided outside of the hospital setting.
Data collection and analysis: We used standard methodological procedures expected by Cochrane. We assessed risk of bias and extracted data. To account for use of different scales across studies, we calculated standardised mean differences (SMDs) with 95% confidence intervals (CIs) for continuous data. We used an inverse variance random-effects model. For binary data, we calculated odds ratio (ORs) with 95% CIs. We assessed the evidence using GRADE and created a 'Summary of findings' table. Our primary outcomes were patient health-related quality of life (HRQoL) and symptom burden (a collection of two or more symptoms). Key secondary outcomes were pain, depression, satisfaction with care, achieving preferred place of death, mortality/survival, unpaid caregiver burden, and cost-effectiveness. Qualitative data was analysed where available.
Main results: We identified 42 RCTs involving 7779 participants (6678 patients and 1101 caregivers/family members). Twenty-one studies were with cancer populations, 14 were with non-cancer populations (of which six were with heart failure patients), and seven with mixed cancer and non-cancer populations (mixed diagnoses). HSPC was offered in different ways and included the following models: ward-based, inpatient consult, outpatient, hospital-at-home or hospital outreach, and service provision across multiple settings which included hospital. For our main analyses, we pooled data from studies reporting adjusted endpoint values. Forty studies had a high risk of bias in at least one domain. Compared with usual care, HSPC improved patient HRQoL with a small effect size of 0.26 SMD over usual care (95% CI 0.15 to 0.37; I2 = 3%, 10 studies, 1344 participants, low-quality evidence, higher scores indicate better patient HRQoL). HSPC also improved other person-centred outcomes. It reduced patient symptom burden with a small effect size of -0.26 SMD over usual care (95% CI -0.41 to -0.12; I2 = 0%, 6 studies, 761 participants, very low-quality evidence, lower scores indicate lower symptom burden). HSPC improved patient satisfaction with care with a small effect size of 0.36 SMD over usual care (95% CI 0.41 to 0.57; I2 = 0%, 2 studies, 337 participants, low-quality evidence, higher scores indicate better patient satisfaction with care). Using home death as a proxy measure for achieving patient's preferred place of death, patients were more likely to die at home with HSPC compared to usual care (OR 1.63, 95% CI 1.23 to 2.16; I2 = 0%, 7 studies, 861 participants, low-quality evidence). Data on pain (4 studies, 525 participants) showed no evidence of a difference between HSPC and usual care (SMD -0.16, 95% CI -0.33 to 0.01; I2 = 0%, very low-quality evidence). Eight studies (N = 1252 participants) reported on adverse events and very low-quality evidence did not demonstrate an effect of HSPC on serious harms. Two studies (170 participants) presented data on caregiver burden and both found no evidence of effect of HSPC (very low-quality evidence). We included 13 economic studies (2103 participants). Overall, the evidence on cost-effectiveness of HSPC compared to usual care was inconsistent among the four full economic studies. Other studies that used only partial economic analysis and those that presented more limited resource use and cost information also had inconsistent results (very low-quality evidence). Quality of the evidence The quality of the evidence assessed using GRADE was very low to low, downgraded due to a high risk of bias, inconsistency and imprecision.
Authors' conclusions: Very low- to low-quality evidence suggests that when compared to usual care, HSPC may offer small benefits for several person-centred outcomes including patient HRQoL, symptom burden and patient satisfaction with care, while also increasing the chances of patients dying in their preferred place (measured by home death). While we found no evidence that HSPC causes serious harms, the evidence was insufficient to draw strong conclusions. Although these are only small effect sizes, they may be clinically relevant at an advanced stage of disease with limited prognosis, and are person-centred outcomes important to many patients and families. More well conducted studies are needed to study populations with non-malignant diseases and mixed diagnoses, ward-based models of HSPC, 24 hours access (out-of-hours care) as part of HSPC, pain, achieving patient preferred place of care, patient satisfaction with care, caregiver outcomes (satisfaction with care, burden, depression, anxiety, grief, quality of life), and cost-effectiveness of HSPC. In addition, research is needed to provide validated person-centred outcomes to be used across studies and populations.
The Cochrane database of systematic reviews · meta-analysis · 138 citationsread the source →
Interactive telemedicine: effects on professional practice and health care outcomes.
Background: Telemedicine (TM) is the use of telecommunication systems to deliver health care at a distance. It has the potential to improve patient health outcomes, access to health care and reduce healthcare costs. As TM applications continue to evolve it is important to understand the impact TM might have on patients, healthcare professionals and the organisation of care.
Objectives: To assess the effectiveness, acceptability and costs of interactive TM as an alternative to, or in addition to, usual care (i.e. face-to-face care, or telephone consultation).
Search methods: We searched the Effective Practice and Organisation of Care (EPOC) Group's specialised register, CENTRAL, MEDLINE, EMBASE, five other databases and two trials registers to June 2013, together with reference checking, citation searching, handsearching and contact with study authors to identify additional studies.
Selection criteria: We considered randomised controlled trials of interactive TM that involved direct patient-provider interaction and was delivered in addition to, or substituting for, usual care compared with usual care alone, to participants with any clinical condition. We excluded telephone only interventions and wholly automatic self-management TM interventions.
Data collection and analysis: For each condition, we pooled outcome data that were sufficiently homogenous using fixed effect meta-analysis. We reported risk ratios (RR) and 95% confidence intervals (CI) for dichotomous outcomes, and mean differences (MD) for continuous outcomes.
Main results: We included 93 eligible trials (N = 22,047 participants), which evaluated the effectiveness of interactive TM delivered in addition to (32% of studies), as an alternative to (57% of studies), or partly substituted for usual care (11%) as compared to usual care alone. The included studies recruited patients with the following clinical conditions: cardiovascular disease (36), diabetes (21), respiratory conditions (9), mental health or substance abuse conditions (7), conditions requiring a specialist consultation (6), co morbidities (3), urogenital conditions (3), neurological injuries and conditions (2), gastrointestinal conditions (2), neonatal conditions requiring specialist care (2), solid organ transplantation (1), and cancer (1).Telemedicine provided remote monitoring (55 studies), or real-time video-conferencing (38 studies), which was used either alone or in combination. The main TM function varied depending on clinical condition, but fell typically into one of the following six categories, with some overlap: i) monitoring of a chronic condition to detect early signs of deterioration and prompt treatment and advice, (41); ii) provision of treatment or rehabilitation (12), for example the delivery of cognitive behavioural therapy, or incontinence training; iii) education and advice for self-management (23), for example nurses delivering education to patients with diabetes or providing support to parents of very low birth weight infants or to patients with home parenteral nutrition; iv) specialist consultations for diagnosis and treatment decisions (8), v) real-time assessment of clinical status, for example post-operative assessment after minor operation or follow-up after solid organ transplantation (8) vi), screening, for angina (1).The type of data transmitted by the patient, the frequency of data transfer, (e.g. telephone, e-mail, SMS) and frequency of interactions between patient and healthcare provider varied across studies, as did the type of healthcare provider/s and healthcare system involved in delivering the intervention. We found no difference between groups for all-cause mortality for patients with heart failure (16 studies; N = 5239; RR:0.89, 95% CI 0.76 to 1.03, P = 0.12; I(2) = 44%) (moderate to high certainty of evidence) at a median of six months follow-up. Admissions to hospital (11 studies; N = 4529) ranged from a decrease of 64% to an increase of 60% at median eight months follow-up (moderate certainty of evidence). We found some evidence of improved quality of life (five studies; N = 482; MD:-4.39, 95% CI -7.94 to -0.83; P < 0.02; I(2) = 0%) (moderate certainty of evidence) for those allocated to TM as compared with usual care at a median three months follow-up. In studies recruiting participants with diabetes (16 studies; N = 2768) we found lower glycated haemoglobin (HbA1c %) levels in those allocated to TM than in controls (MD -0.31, 95% CI -0.37 to -0.24; P < 0.00001; I(2)= 42%, P = 0.04) (high certainty of evidence) at a median of nine months follow-up. We found some evidence for a decrease in LDL (four studies, N = 1692; MD -12.45, 95% CI -14.23 to -10.68; P < 0.00001; I(2 =) 0%) (moderate certainty of evidence), and blood pressure (four studies, N = 1770: MD: SBP:-4.33, 95% CI -5.30 to -3.35, P < 0.00001; I(2) = 17%; DBP: -2.75 95% CI -3.28 to -2.22, P < 0.00001; I(2) = 45% (moderate certainty evidence), in TM as compared with usual care. Seven studies that recruited participants with different mental health and substance abuse problems, reported no differences in the effect of therapy delivered over video-conferencing, as compared to face-to-face delivery. Findings from the other studies were inconsistent; there was some evidence that monitoring via TM improved blood pressure control in participants with hypertension, and a few studies reported improved symptom scores for those with a respiratory condition. Studies recruiting participants requiring mental health services and those requiring specialist consultation for a dermatological condition reported no differences between groups.
Authors' conclusions: The findings in our review indicate that the use of TM in the management of heart failure appears to lead to similar health outcomes as face-to-face or telephone delivery of care; there is evidence that TM can improve the control of blood glucose in those with diabetes. The cost to a health service, and acceptability by patients and healthcare professionals, is not clear due to limited data reported for these outcomes. The effectiveness of TM may depend on a number of different factors, including those related to the study population e.g. the severity of the condition and the disease trajectory of the participants, the function of the intervention e.g., if it is used for monitoring a chronic condition, or to provide access to diagnostic services, as well as the healthcare provider and healthcare system involved in delivering the intervention.
The Cochrane database of systematic reviews · meta-analysis · 456 citationsread the source →
Effectiveness of brief alcohol interventions in primary care populations.
Background: Excessive drinking is a significant cause of mortality, morbidity and social problems in many countries. Brief interventions aim to reduce alcohol consumption and related harm in hazardous and harmful drinkers who are not actively seeking help for alcohol problems. Interventions usually take the form of a conversation with a primary care provider and may include feedback on the person's alcohol use, information about potential harms and benefits of reducing intake, and advice on how to reduce consumption. Discussion informs the development of a personal plan to help reduce consumption. Brief interventions can also include behaviour change or motivationally-focused counselling. This is an update of a Cochrane Review published in 2007.
Objectives: To assess the effectiveness of screening and brief alcohol intervention to reduce excessive alcohol consumption in hazardous or harmful drinkers in general practice or emergency care settings.
Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and 12 other bibliographic databases to September 2017. We searched Alcohol and Alcohol Problems Science Database (to December 2003, after which the database was discontinued), trials registries, and websites. We carried out handsearching and checked reference lists of included studies and relevant reviews.
Selection criteria: We included randomised controlled trials (RCTs) of brief interventions to reduce hazardous or harmful alcohol consumption in people attending general practice, emergency care or other primary care settings for reasons other than alcohol treatment. The comparison group was no or minimal intervention, where a measure of alcohol consumption was reported. 'Brief intervention' was defined as a conversation comprising five or fewer sessions of brief advice or brief lifestyle counselling and a total duration of less than 60 minutes. Any more was considered an extended intervention. Digital interventions were not included in this review.
Data collection and analysis: We used standard methodological procedures expected by Cochrane. We carried out subgroup analyses where possible to investigate the impact of factors such as gender, age, setting (general practice versus emergency care), treatment exposure and baseline consumption.
Main results: We included 69 studies that randomised a total of 33,642 participants. Of these, 42 studies were added for this update (24,057 participants). Most interventions were delivered in general practice (38 studies, 55%) or emergency care (27 studies, 39%) settings. Most studies (61 studies, 88%) compared brief intervention to minimal or no intervention. Extended interventions were compared with brief (4 studies, 6%), minimal or no intervention (7 studies, 10%). Few studies targeted particular age groups: adolescents or young adults (6 studies, 9%) and older adults (4 studies, 6%). Mean baseline alcohol consumption was 244 g/week (30.5 standard UK units) among the studies that reported these data. Main sources of bias were attrition and lack of provider or participant blinding. The primary meta-analysis included 34 studies (15,197 participants) and provided moderate-quality evidence that participants who received brief intervention consumed less alcohol than minimal or no intervention participants after one year (mean difference (MD) -20 g/week, 95% confidence interval (CI) -28 to -12). There was substantial heterogeneity among studies (I² = 73%). A subgroup analysis by gender demonstrated that both men and women reduced alcohol consumption after receiving a brief intervention. We found moderate-quality evidence that brief alcohol interventions have little impact on frequency of binges per week (MD -0.08, 95% CI -0.14 to -0.02; 15 studies, 6946 participants); drinking days per week (MD -0.13, 95% CI -0.23 to -0.04; 11 studies, 5469 participants); or drinking intensity (-0.2 g/drinking day, 95% CI -3.1 to 2.7; 10 studies, 3128 participants).We found moderate-quality evidence of little difference in quantity of alcohol consumed when extended and no or minimal interventions were compared (-14 g/week, 95% CI -37 to 9; 6 studies, 1296 participants). There was little difference in binges per week (-0.08, 95% CI -0.28 to 0.12; 2 studies, 456 participants; moderate-quality evidence) or difference in days drinking per week (-0.45, 95% CI -0.81 to -0.09; 2 studies, 319 participants; moderate-quality evidence). Extended versus no or minimal intervention provided little impact on drinking intensity (9 g/drinking day, 95% CI -26 to 9; 1 study, 158 participants; low-quality evidence).Extended intervention had no greater impact than brief intervention on alcohol consumption, although findings were imprecise (MD 2 g/week, 95% CI -42 to 45; 3 studies, 552 participants; low-quality evidence). Numbers of binges were not reported for this comparison, but one trial suggested a possible drop in days drinking per week (-0.5, 95% CI -1.2 to 0.2; 147 participants; low-quality evidence). Results from this trial also suggested very little impact on drinking intensity (-1.7 g/drinking day, 95% CI -18.9 to 15.5; 147 participants; very low-quality evidence).Only five studies reported adverse effects (very low-quality evidence). No participants experienced any adverse effects in two studies; one study reported that the intervention increased binge drinking for women and two studies reported adverse events related to driving outcomes but concluded they were equivalent in both study arms. Sources of funding were reported by 67 studies (87%). With two exceptions, studies were funded by government institutes, research bodies or charitable foundations. One study was partly funded by a pharmaceutical company and a brewers association, another by a company developing diagnostic testing equipment.
Authors' conclusions: We found moderate-quality evidence that brief interventions can reduce alcohol consumption in hazardous and harmful drinkers compared to minimal or no intervention. Longer counselling duration probably has little additional effect. Future studies should focus on identifying the components of interventions which are most closely associated with effectiveness.
The Cochrane database of systematic reviews · meta-analysis · 409 citationsread the source →
Madigan S, Korczak DJ, Vaillancourt T, Racine N, Hopkins WG, Pador P, Hewitt JMA, AlMousawi B, McDonald S, Neville RD. (2023)MEDLINE-indexed journal, not yet read by usThe lancet. Psychiatry · meta-analysis Comparison of paediatric emergency department visits for attempted suicide, self-harm, and suicidal ideation before and during the COVID-19 pandemic: a systematic review and meta-analysis.
Background: There is a lack of consensus about the effect of the COVID-19 pandemic on the mental health of children and adolescents. We aimed to compare rates of paediatric emergency department visits for attempted suicide, self-harm, and suicidal ideation during the pandemic with those before the pandemic.
Methods: For this systematic review and meta-analysis, we searched MEDLINE, Embase, and PsycINFO for studies published between Jan 1, 2020, and Dec 19, 2022. Studies published in English with data on paediatric (ie, those aged <19 years) emergency department visits before and during the COVID-19 pandemic were included. Case studies and qualitative analyses were excluded. Changes in attempted suicide, self-harm, suicidal ideation, and other mental-illness indicators (eg, anxiety, depression, and psychosis) were expressed as ratios of the rates of emergency department visits during the pandemic compared with those before the pandemic, and we analysed these with a random-effects meta-analysis. This study was registered with PROSPERO, CRD42022341897.
Findings: 10 360 non-duplicate records were retrieved, which yielded 42 relevant studies (with 130 sample-estimates) representing 11·1 million emergency department visits for all indications of children and adolescents across 18 countries. The mean age of the samples of children and adolescents across studies was 11·7 years (SD 3·1, range 5·5-16·3), and there were on average 57·6% girls and 43·4% boys as a proportion of emergency department visits for any health reasons (ie, physical and mental). Only one study had data related to race or ethnicity. There was good evidence of an increase in emergency department visits for attempted suicide during the pandemic (rate ratio 1·22, 90% CI 1·08-1·37), modest evidence of an increase in emergency department visits for suicidal ideation (1·08, 0·93-1·25), and good evidence for only a slight change in self-harm (0·96, 0·89-1·04). Rates of emergency department visits for other mental-illness indications showed very good evidence of a decline (0·81, 0·74-0·89), and paediatric visits for all health indications showed strong evidence of a reduction (0·68, 0·62-0·75). When rates for attempted suicide and suicidal ideation were combined as a single measure, there was good evidence of an increase in emergency department visits among girls (1·39, 1·04-1·88) and only modest evidence of an increase among boys (1·06, 0·92-1·24). Self-harm among older children (mean age 16·3 years, range 13·0-16·3) showed good evidence of an increase (1·18, 1·00-1·39), but among younger children (mean age 9·0 years, range 5·5-12·0) there was modest evidence of a decrease (0·85, 0·70-1·05).
Interpretation: The integration of mental health support within community health and the education system-including promotion, prevention, early intervention, and treatment-is urgently needed to increase the reach of mental health support that can mitigate child and adolescent mental distress. In future pandemics, increased resourcing in some emergency department settings would help to address their expected increase in visits for acute mental distress among children and adolescents.
Funding: None.
The lancet. Psychiatry · meta-analysis · 164 citationsread the source →
The effectiveness of non-pharmacological sleep interventions for people with chronic pain: a systematic review and meta-analysis.
Objective: About two thirds of people with chronic pain report problems sleeping. We aimed to evaluate the effectiveness of non-pharmacological sleep interventions for improving sleep in people with chronic pain.
Design: We conducted a systematic review of non-pharmacological and non-invasive interventions to improve sleep quality or duration for adults with chronic non-cancer pain evaluated in a randomised controlled trial. Our primary outcome of interest was sleep; secondary outcomes included pain, health-related quality of life, and psychological wellbeing. We searched the Cochrane Library, MEDLINE, Embase, PsycINFO and CINAHL from inception to April 2020. After screening, two reviewers evaluated articles and extracted data. Meta-analysis was conducted using a random effects model. Risk of bias was assessed with the Cochrane tool.
Results: We included 42 trials involving 3346 people randomised to 94 groups, of which 56 received an intervention targeting sleep. 10 studies were of fair and 32 of good methodological quality. Overall risk of bias was judged to be low in 11, high in 10 and unclear in 21 studies. In 9 studies with 385 people randomised, cognitive behavioural therapy for insomnia showed benefit post-treatment compared with controls for improved sleep quality, standardised mean difference - 1.23 (95%CI -1.76, - 0.70; p < 0.00001). The effect size was only slightly reduced in meta-analysis of 3 studies at low risk of bias. The difference between groups was lower at 3 and 6 months after treatment but still favoured cognitive behavioural therapy for insomnia. Pain, anxiety and depression were reduced post-treatment, but evidence of longer term benefit was lacking. There was no evidence that sleep hygiene interventions were effective in improving sleep and there was some evidence in comparative studies to suggest that cognitive behavioural therapy for insomnia was more effective than sleep hygiene. Numerous other interventions were evaluated in small numbers of studies, but evidence was insufficient to draw conclusions about effectiveness.
Conclusions: Cognitive behavioural therapy for insomnia is an effective treatment to improve sleep for people with chronic pain, but further high-quality primary research is required to explore combined CBT content that will ensure additional improvements to pain, quality of life and psychological health and longer-term maintenance of benefits. Primary research is also needed to evaluate the effectiveness of interventions for which insufficient evidence exists.
Trial registration: PROSPERO registration number: CRD42019093799 .
BMC musculoskeletal disorders · meta-analysis · 30 citationsread the source →
Effect of psychological therapy on disease activity, psychological comorbidity, and quality of life in inflammatory bowel disease: a systematic review and meta-analysis.
Background: Inflammatory bowel disease is associated with psychological comorbidity and impaired quality of life. Psychological comorbidity could affect the natural history of inflammatory bowel disease. Psychological therapies might therefore have beneficial effects on disease activity, mood, and quality of life in patients with inflammatory bowel disease. We did a systematic review and meta-analysis examining these issues.
Methods: In this systematic review and meta-analysis, we searched MEDLINE, Embase, Embase Classic, PsychINFO, and the Cochrane Central Register of Controlled Trials for articles published between 1947 and Sept 22, 2016. Randomised controlled trials (RCTs) recruiting patients with inflammatory bowel disease aged at least 16 years that compared psychological therapy with a control intervention or usual treatment were eligible. We pooled dichotomous data to obtain relative risks of induction of remission in active disease or prevention of relapse of quiescent disease, with 95% CIs. We pooled continuous data to estimate standardised mean differences in disease activity indices, anxiety, depression, perceived stress, and quality-of-life scores in patients dichotomised into those with clinically active or quiescent disease, with 95% CIs. We extracted data from published reports and contacted the original investigators of studies for which the required data were not available. We pooled all data using a random-effects model.
Findings: The search identified 1824 studies, with 14 RCTs of 1196 patients eligible for inclusion. The relative risk of relapse of quiescent inflammatory bowel disease with psychological therapy versus control was 0·98 (95% CI 0·77-1·24; p=0·87; I2=50%; six trials; 518 patients). We observed a significant difference in depression scores (standardised mean difference -0·17 [-0·33 to -0·01]; p=0·04; I2=0%; seven trials; 605 patients) and quality of life (0·30 [0·07-0·52]; p=0·01; I2=42%; nine trials; 578 patients) with psychological therapy versus control at the end of therapy for patients with quiescent disease. However, these beneficial effects were lost at final point of follow-up (depression scores -0·11 [-0·27 to 0·05], p=0·17, I2=0%, eight trials, 593 patients; quality of life 0·15 [-0·05 to 0·34], p=0·14, I2=22%, ten trials, 577 patients). When we assessed the effect of individual physiological therapies on quality of life, only cognitive behavioural therapy had any significant beneficial effect (0·37 [0·02-0·72]). We noted no effect on disease activity indices or other psychological wellbeing scores when compared with control in patients with quiescent disease. Dichotomous data for induction of remission and continuous data for change in clinical disease activity indices, depression, anxiety, and perceived stress scores were only reported in one RCT of patients with active disease. Quality of life was assessed in two RCTs of patients with active disease, but was not significantly different between intervention and control groups (0·27 [-0·05 to 0·59]).
Interpretation: Psychological therapies, and cognitive behavioural therapy in particular, might have small short-term beneficial effects on depression scores and quality of life in patients with inflammatory bowel disease. Further RCTs of these interventions in patients with coexistent psychological distress are required.
Funding: None.
The lancet. Gastroenterology & hepatology · meta-analysis · 163 citationsread the source →
State care in childhood and adult mortality: a systematic review and meta-analysis of prospective cohort studies.
Background: Removal from family of origin to state care can be a highly challenging childhood experience and is itself linked to an array of unfavourable outcomes in adult life. We aim to synthetise evidence on the risk of adult mortality in people with a history of state care in early life, and assess the association according to different contexts.
Methods: In this systematic review and meta-analysis, we focused on four health outcomes hypothesised to be associated with exposure to early state care: total mortality, cardiovascular disease, cancer, and suicide. We searched the electronic databases PubMed and Embase from inception to Jan 21, 2022, for studies fulfilling the following criteria: it was a prospective study in which the assessment of care was made up to 18 years of age; it included an unexposed comparator group; the focus of the study was temporary out-of-home care and not adoption; mortality surveillance was extended into adulthood; standard estimates of association (eg, relative risk, odds ratios, or hazard ratios) and variance (eg, CIs and SE) were provided; the study appeared in a peer-reviewed journal; and the study was published in English. An adapted Cochrane Risk of Bias Tool was used to assess study quality. We extracted estimates of association and variance from qualifying studies and augmented these findings with analyses of unpublished data from individual participants in two UK birth cohorts-ie, the 1958 and 1970 studies (total n=21 936). We computed hazard ratios with accompanying 95% CIs for care and each health outcome separately for each study, and then pooled the results using a random-effects meta-analysis. This review is registered at PROSPERO, CRD42021254665.
Findings: We identified 210 potentially eligible published articles, of which 14 met our inclusion criteria (two studies were unpublished). Of 3 223 580 individuals drawn from 13 studies, those who were exposed to care in childhood had twice the risk of total mortality in adulthood relative to those without a history of care in childhood (summary risk ratio 2·21 [95% CI 1·62-3·02]), with study-specific estimates varying between 1·04 and 5·77 (I2 =98%). Despite some attenuation, this association remained following adjustment for other measures of early-life adversity; extended into middle and older age; was stronger in higher-quality studies; and was of equal magnitude according to sex, geographical region, and birth year. There was some suggestion of sensitive periods of exposure to care, whereby individuals who entered state care for the first time in adolescence (2·47 [0·98-6·52]) had greater rates of mortality than those doing so early in the life course (1·75 [1·25-2·45]). In four studies including 534 890 people, children in care had more than three times the risk of completed suicide in adulthood relative to their unexposed peers (3·35 [2·41-4·68]), with study-specific estimates ranging between 2·42 and 5·85 (I2=72%). The magnitude of this association was weaker after adjustment for multiple covariates; in men than in women; and in lower-quality studies.
Interpretation: Our results for adult mortality suggest child protection systems, social policy, and health services following care graduation are insufficient to mitigate the adverse experiences that might have preceded placement into care and those that might accompany it.
Funding: None.
The Lancet. Public health · meta-analysis · 25 citationsread the source →
Psychological therapies for women who experience intimate partner violence.
Background: Intimate partner violence (IPV) against women is prevalent and strongly associated with mental health problems. Women experiencing IPV attend health services frequently for mental health problems. The World Health Organization recommends that women who have experienced IPV and have a mental health diagnosis should receive evidence-based mental health treatments. However, it is not known if psychological therapies work for women in the context of IPV and whether they cause harm.
Objectives: To assess the effectiveness of psychological therapies for women who experience IPV on the primary outcomes of depression, self-efficacy and an indicator of harm (dropouts) at six- to 12-months' follow-up, and on secondary outcomes of other mental health symptoms, anxiety, quality of life, re-exposure to IPV, safety planning and behaviours, use of healthcare and IPV services, and social support.
Search methods: We searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR), CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, and three other databases, to the end of October 2019. We also searched international trials registries to identify unpublished or ongoing trials and handsearched selected journals, reference lists of included trials and grey literature.
Selection criteria: We included randomised controlled trials (RCTs), quasi-RCTs, cluster-RCTs and cross-over trials of psychological therapies with women aged 16 years and older who self-reported recent or lifetime experience of IPV. We included trials if women also experienced co-existing mental health diagnoses or substance abuse issues, or both. Psychological therapies included a wide range of interventions that targeted cognition, motivation and behaviour compared with usual care, no treatment, delayed or minimal interventions. We classified psychological therapies according to Cochrane Common Mental Disorders's psychological therapies list.
Data collection and analysis: Two review authors extracted data and undertook 'Risk of Bias' assessment. Treatment effects were compared between experimental and comparator interventions at short-term (up to six months post-baseline), medium-term (six to under 12 months, primary outcome time point), and long-term follow-up (12 months and above). We used standardised mean difference (SMD) for continuous and odds ratio (OR) for dichotomous outcomes, and used random-effects meta-analysis, due to high heterogeneity across trials.
Main results: We included 33 psychological trials involving 5517 women randomly assigned to experimental (2798 women, 51%) and comparator interventions (2719 women, 49%). Psychological therapies included 11 integrative therapies, nine humanistic therapies, six cognitive behavioural therapy, four third-wave cognitive behavioural therapies and three other psychologically-orientated interventions. There were no trials classified as psychodynamic therapies. Most trials were from high-income countries (19 in USA, three in Iran, two each in Australia and Greece, and one trial each in China, India, Kenya, Nigeria, Pakistan, Spain and UK), among women recruited from healthcare, community, shelter or refuge settings, or a combination of any or all of these. Psychological therapies were mostly delivered face-to-face (28 trials), but varied by length of treatment (two to 50 sessions) and staff delivering therapies (social workers, nurses, psychologists, community health workers, family doctors, researchers). The average sample size was 82 women (14 to 479), aged 37 years on average, and 66% were unemployed. Half of the women were married or living with a partner and just over half of the participants had experienced IPV in the last 12 months (17 trials), 6% in the past two years (two trials) and 42% during their lifetime (14 trials). Whilst 20 trials (61%) described reliable low-risk random-sampling strategies, only 12 trials (36%) described reliable procedures to conceal the allocation of participant status. While 19 trials measured women's depression, only four trials measured depression as a continuous outcome at medium-term follow-up. These showed a probable beneficial effect of psychological therapies in reducing depression (SMD -0.24, 95% CI -0.47 to -0.01; four trials, 600 women; moderate-certainty evidence). However, for self-efficacy, there may be no evidence of a difference between groups (SMD -0.12, 95% CI -0.33 to 0.09; one trial with medium-term follow-up data, 346 women; low-certainty evidence). Further, there may be no difference between the number of women who dropped out from the experimental or comparator intervention groups, an indicator of no harm (OR 1.04, 95% CI 0.75 to 1.44; five trials with medium-term follow-up data, 840 women; low-certainty evidence). Although no trials reported adverse events from psychological therapies or participation in the trial, only one trial measured harm outcomes using a validated scale. For secondary outcomes, trials measured anxiety only at short-term follow-up, showing that psychological therapies may reduce anxiety symptoms (SMD -0.96, 95% CI -1.29 to -0.63; four trials, 158 women; low-certainty evidence). However, within medium-term follow-up, low-certainty evidence revealed that there may be no evidence between groups for the outcomes safety planning (SMD 0.04, 95% CI -0.18 to 0.25; one trial, 337 women), post-traumatic stress disorder (SMD -0.24, 95% CI -0.54 to 0.06; four trials, 484 women) or re-exposure to any form of IPV (SMD 0.03, 95% CI -0.14 to 0.2; two trials, 547 women).
Authors' conclusions: There is evidence that for women who experience IPV, psychological therapies probably reduce depression and may reduce anxiety. However, we are uncertain whether psychological therapies improve other outcomes (self-efficacy, post-traumatic stress disorder, re-exposure to IPV, safety planning) and there are limited data on harm. Thus, while psychological therapies probably improve emotional health, it is unclear if women's ongoing needs for safety, support and holistic healing from complex trauma are addressed by this approach. There is a need for more interventions focused on trauma approaches and more rigorous trials (with consistent outcomes at similar follow-up time points), as we were unable to synthesise much of the research.
The Cochrane database of systematic reviews · meta-analysis · 78 citationsread the source →
The relationship between perfectionism and self-esteem in adults: a systematic review and meta-analysis.
Background: Perfectionism dimensions, including perfectionistic strivings and perfectionistic concerns, have a significant positive association with psychopathology. Clinical perfectionism is defined as when an individual's self-esteem is excessively reliant on meeting high standards despite negative consequences. Numerous studies have found that higher perfectionistic concerns correlate with lower self-esteem; however, evidence for the association with perfectionistic strivings has been mixed.
Aims: The focus of this systematic review and meta-analysis was to inform theoretical understanding of the relationships between perfectionism dimensions and self-esteem in adults.
Method: A systematic literature search was conducted in Medline, PsycINFO, PsychARTICLES, ProQuest Central, and Scopus on 31 May 2023.
Results: There were 83 articles included, with 32,304 participants (Mage=∼24.66 years). There was a significant negative moderate pooled association between self-esteem and perfectionistic concerns, r=-.42, 95% CI [-0.47 to -0.38]. A significant negligible positive pooled association was found between self-esteem and perfectionistic strivings, r=.06, 95% CI [0.01 to 0.11]. Results indicate higher perfectionistic concerns is associated with lower self-esteem, providing indirect support for the cognitive-behavioural model of clinical perfectionism.
Conclusions: Future research should compare cognitive behaviour therapy for perfectionism to treatments for low self-esteem on outcomes of perfectionistic concerns and psychopathology.
Behavioural and cognitive psychotherapy · meta-analysis · 5 citationsread the source →
Jones RA, Lawlor ER, Birch JM, Patel MI, Werneck AO, Hoare E, Griffin SJ, van Sluijs EMF, Sharp SJ, Ahern AL. (2021)MEDLINE-indexed journal, not yet read by usObesity reviews : an official journal of the International Association for the Study of Obesity · meta-analysis The impact of adult behavioural weight management interventions on mental health: A systematic review and meta-analysis.
There is good evidence that behavioural weight management interventions improve physical health; however, the impact on mental health remains unclear. We evaluated the impact of behavioural weight management interventions on mental health-related outcomes in adults with overweight or obesity at intervention-end and 12 months from baseline. Eligible studies were randomized controlled trials (RCTs) or cluster RCTs of adult behavioural weight loss interventions reporting affect, anxiety, binge eating, body image, depression, emotional eating, quality of life, self-esteem and stress. We searched seven databases from inception to 7 May 2019 and included 43 articles reporting 42 RCTs. Eighteen studies were deemed to be at high risk of bias. We conducted random-effects meta-analyses, stratified analyses and meta-regression using Stata. Interventions generated greater improvements than comparators for depression, mental health-related quality of life and self-efficacy at intervention-end and 12 months from baseline. There was no difference between groups for anxiety, overall quality of life, self-esteem or stress at intervention-end. There was insufficient evidence to assess the impact on anxiety, binge eating, body image, emotional eating, affect, life satisfaction, self-esteem or stress at intervention-end and/or 12 months from baseline. Although evidence suggests that interventions benefit some aspects of mental health, high-quality, transparently reported RCTs measuring a range of mental health outcomes over longer durations are required to strengthen the evidence base.
Obesity reviews : an official journal of the International Association for the Study of Obesity · meta-analysis · 62 citationsread the source →
Association of Early-Life Antibiotic Use and Protective Effects of Breastfeeding: Role of the Intestinal Microbiota.
Importance: Long duration of breastfeeding is known to reduce the frequency of infections and the risk of overweight, both of which are prevalent health problems among children, but the mechanisms are unclear.
Objectives: To test whether early-life antibiotic use in children prevents the beneficial long-term effects of breastfeeding on weight development and lifetime antibiotic use, and to investigate whether the duration of breastfeeding is associated with long-term microbiota development.
Design, setting, and participants: Retrospective cohort study, conducted from June 2015 to December 2015, of the association between the duration of breastfeeding and lifetime antibiotic use by children as well as body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) z score in a cohort of 226 healthy children aged 2 to 6 years attending day care at the study area in northern Finland and participating in a probiotic trial from October 1, 2009, through April 30, 2010. Fecal microbiota composition analysis was performed in a subcohort of 42 of these children.
Exposures: Duration of breastfeeding and the number of different antibiotic courses purchased for the child.
Main outcomes and measures: The BMI z score, lifetime antibiotic use after weaning, and fecal microbiota composition.
Results: A total of 226 children (mean [SD] age, 55 [1.4] months; 54% male) were included in the study. Among the 113 children with no antibiotics before weaning, each month of breastfeeding decreased the mean number of postweaning antibiotic courses by 5% (95% CI, 2% to 8%; P = .001) and mean BMI z scores by 0.08 unit (95% CI, 0.04 to 0.11; P < .001). Among the 113 early-life antibiotic users, the effect of breastfeeding on postweaning antibiotic use was borderline significant (estimated 4% decrease per month; 95% CI, 0% to 7%; P = .04) and the effect on BMI z score disappeared (estimated 1% increase; 95% CI, -3% to 5%; P = .50). In the subcohort of 42 children with fecal microbiota composition analysis, the children with short breastfeeding duration (0-6 months) and no early-life antibiotic use or with long breastfeeding duration (8-16 months) and early-life use of antibiotics had a significantly lower abundance of Bifidobacterium (by 55%; 95% CI, 43% to 87%; P = .006; and 39%, 95% CI, 30% to 68%; P < .001, respectively) and Akkermansia (by 71%; 95% CI, 28% to 87%; P = .008; and 69%; 95% CI, 22% to 90%; P = .02, respectively) compared with those with long duration of breastfeeding and no early-life antibiotics.
Conclusions and relevance: Antibiotic use in a child during breastfeeding may weaken the beneficial effects of long breastfeeding duration. The results suggest that particularly the long-term metabolic benefits of breastfeeding are conveyed by the intestinal microbiota.
JAMA pediatrics · clinical trial · 75 citationsread the source →
Digital Mental Health Interventions for Depression, Anxiety, and Enhancement of Psychological Well-Being Among College Students: Systematic Review.
Background: College students are increasingly reporting common mental health problems, such as depression and anxiety, and they frequently encounter barriers to seeking traditional mental health treatments. Digital mental health interventions, such as those delivered via the Web and apps, offer the potential to improve access to mental health treatment.
Objective: This study aimed to review the literature on digital mental health interventions focused on depression, anxiety, and enhancement of psychological well-being among samples of college students to identify the effectiveness, usability, acceptability, uptake, and adoption of such programs.
Methods: We conducted a systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (registration number CRD42018092800), and the search strategy was conducted by a medical research librarian in the following databases: MEDLINE (Ovid), EMBASE (Elsevier), PsycINFO (EbscoHost), the Cochrane Library (Wiley), and Web of Science (Thomson Reuters) from the date of inception to April 2019. Data were synthesized using a systematic narrative synthesis framework, and formal quality assessments were conducted to address the risk of bias.
Results: A total of 89 studies met the inclusion criteria. The majority of interventions (71/89, 80%) were delivered via a website, and the most common intervention was internet-based cognitive behavioral therapy (28, 31%). Many programs (33, 37%) featured human support in the form of coaching. The majority of programs were either effective (42, 47%) or partially effective (30, 34%) in producing beneficial changes in the main psychological outcome variables. Approximately half of the studies (45, 51%) did not present any usability or acceptability outcomes, and few studies (4, 4%) examined a broad implementation of digital mental health interventions on college campuses. Quality assessments revealed a moderate-to-severe risk of bias in many of the studies.
Conclusions: Results suggest that digital mental health interventions can be effective for improving depression, anxiety, and psychological well-being among college students, but more rigorous studies are needed to ascertain the effective elements of these interventions. Continued research on improving the user experience of, and thus user engagement with, these programs appears vital for the sustainable implementation of digital mental health interventions on college campuses.
Journal of medical Internet research · systematic review · 426 citationsread the source →
Fusar-Poli P, Salazar de Pablo G, Correll CU, Meyer-Lindenberg A, Millan MJ, Borgwardt S, Galderisi S, Bechdolf A, Pfennig A, Kessing LV, van Amelsvoort T, Nieman DH, Domschke K, Krebs MO, Koutsouleris N, McGuire P, Do KQ, Arango C. (2020)MEDLINE-indexed journal, not yet read by usJAMA psychiatry · systematic review Prevention of Psychosis: Advances in Detection, Prognosis, and Intervention.
Importance: Detection, prognosis, and indicated interventions in individuals at clinical high risk for psychosis (CHR-P) are key components of preventive psychiatry.
Objective: To provide a comprehensive, evidence-based systematic appraisal of the advancements and limitations of detection, prognosis, and interventions for CHR-P individuals and to formulate updated recommendations.
Evidence review: Web of Science, Cochrane Central Register of Reviews, and Ovid/PsychINFO were searched for articles published from January 1, 2013, to June 30, 2019, to identify meta-analyses conducted in CHR-P individuals. MEDLINE was used to search the reference lists of retrieved articles. Data obtained from each article included first author, year of publication, topic investigated, type of publication, study design and number, sample size of CHR-P population and comparison group, type of comparison group, age and sex of CHR-P individuals, type of prognostic assessment, interventions, quality assessment (using AMSTAR [Assessing the Methodological Quality of Systematic Reviews]), and key findings with their effect sizes.
Findings: In total, 42 meta-analyses published in the past 6 years and encompassing 81 outcomes were included. For the detection component, CHR-P individuals were young (mean [SD] age, 20.6 [3.2] years), were more frequently male (58%), and predominantly presented with attenuated psychotic symptoms lasting for more than 1 year before their presentation at specialized services. CHR-P individuals accumulated several sociodemographic risk factors compared with control participants. Substance use (33% tobacco use and 27% cannabis use), comorbid mental disorders (41% with depressive disorders and 15% with anxiety disorders), suicidal ideation (66%), and self-harm (49%) were also frequently seen in CHR-P individuals. CHR-P individuals showed impairments in work (Cohen d = 0.57) or educational functioning (Cohen d = 0.21), social functioning (Cohen d = 1.25), and quality of life (Cohen d = 1.75). Several neurobiological and neurocognitive alterations were confirmed in this study. For the prognosis component, the prognostic accuracy of CHR-P instruments was good, provided they were used in clinical samples. Overall, risk of psychosis was 22% at 3 years, and the risk was the highest in the brief and limited intermittent psychotic symptoms subgroup (38%). Baseline severity of attenuated psychotic (Cohen d = 0.35) and negative symptoms (Cohen d = 0.39) as well as low functioning (Cohen d = 0.29) were associated with an increased risk of psychosis. Controlling risk enrichment and implementing sequential risk assessments can optimize prognostic accuracy. For the intervention component, no robust evidence yet exists to favor any indicated intervention over another (including needs-based interventions and control conditions) for preventing psychosis or ameliorating any other outcome in CHR-P individuals. However, because the uncertainty of this evidence is high, needs-based and psychological interventions should still be offered.
Conclusions and relevance: This review confirmed recent substantial advancements in the detection and prognosis of CHR-P individuals while suggesting that effective indicated interventions need to be identified. This evidence suggests a need for specialized services to detect CHR-P individuals in primary and secondary care settings, to formulate a prognosis with validated psychometric instruments, and to offer needs-based and psychological interventions.
JAMA psychiatry · systematic review · 369 citationsread the source →
A systematic review of psychoneuroimmunology-based interventions.
Psychoneuroimmunology-based interventions are used to attenuated disease progression and/or side effects of pharmacological treatment. This systematic review evaluates the different therapeutic and/or clinical psychoneuroimmunology-based interventions associated to both psychological, neuroendocrine and immunological variables. The review was conducted for all English, Portuguese and Spanish language articles published between 2005 and 2015. Independent investigators analyzed 42 studies concerning human psychoneuroimmunology-based interventions. Decreased levels of cortisol, epinephrine and norepinephrine (stress-related hormones) were associated to interventions like yoga, meditation, tai chi, acupuncture, mindfulness, religious/spiritual practices, cognitive behavior therapy, coping and physical exercises. Moreover, those interventions were also associated to reductions in inflammatory processes and levels of pro-inflammatory cytokines in cancer, HIV, depression, anxiety, wound healing, sleep disorder, cardiovascular diseases and fibromyalgia. Despite the associations between PNI variables and clinical/therapeutic interventions, only one study evidenced significant effects on a disease progression.
Psychology, health & medicine · systematic review · 50 citationsread the source →
Houle SA, Ein N, Gervasio J, Plouffe RA, Litz BT, Carleton RN, Hansen KT, Liu JJW, Ashbaugh AR, Callaghan W, Thompson MM, Easterbrook B, Smith-MacDonald L, Rodrigues S, Bélanger SAH, Bright K, Lanius RA, Baker C, Younger W, Bremault-Phillips S, Hosseiny F, Richardson JD, Nazarov A, Atlas Institute Moral Injury Research Community of Practice. (2024)MEDLINE-indexed journal, not yet read by usClinical psychology review · systematic review Measuring moral distress and moral injury: A systematic review and content analysis of existing scales.
Background: Moral distress (MD) and moral injury (MI) are related constructs describing the negative consequences of morally challenging stressors. Despite growing support for the clinical relevance of these constructs, ongoing challenges regarding measurement quality risk limiting research and clinical advances. This study summarizes the nature, quality, and utility of existing MD and MI scales, and provides recommendations for future use.
Method: We identified psychometric studies describing the development or validation of MD or MI scales and extracted information on methodological and psychometric qualities. Content analyses identified specific outcomes measured by each scale.
Results: We reviewed 77 studies representing 42 unique scales. The quality of psychometric approaches varied greatly across studies, and most failed to examine convergent and divergent validity. Content analyses indicated most scales measure exposures to potential moral stressors and outcomes together, with relatively few measuring only exposures (n = 3) or outcomes (n = 7). Scales using the term MD typically assess general distress. Scales using the term MI typically assess several specific outcomes.
Conclusions: Results show how the terms MD and MI are applied in research. Several scales were identified as appropriate for research and clinical use. Recommendations for the application, development, and validation of MD and MI scales are provided.
Clinical psychology review · systematic review · 32 citationsread the source →
Successful behavior change in obesity interventions in adults: a systematic review of self-regulation mediators.
Background: Relapse is high in lifestyle obesity interventions involving behavior and weight change. Identifying mediators of successful outcomes in these interventions is critical to improve effectiveness and to guide approaches to obesity treatment, including resource allocation. This article reviews the most consistent self-regulation mediators of medium- and long-term weight control, physical activity, and dietary intake in clinical and community behavior change interventions targeting overweight/obese adults.
Methods: A comprehensive search of peer-reviewed articles, published since 2000, was conducted on electronic databases (for example, MEDLINE) and journal reference lists. Experimental studies were eligible if they reported intervention effects on hypothesized mediators (self-regulatory and psychological mechanisms) and the association between these and the outcomes of interest (weight change, physical activity, and dietary intake). Quality and content of selected studies were analyzed and findings summarized. Studies with formal mediation analyses were reported separately.
Results: Thirty-five studies were included testing 42 putative mediators. Ten studies used formal mediation analyses. Twenty-eight studies were randomized controlled trials, mainly aiming at weight loss or maintenance (n = 21). Targeted participants were obese (n = 26) or overweight individuals, aged between 25 to 44 years (n = 23), and 13 studies targeted women only. In terms of study quality, 13 trials were rated as "strong", 15 as "moderate", and 7 studies as "weak". In addition, methodological quality of formal mediation analyses was "medium". Identified mediators for medium-/long-term weight control were higher levels of autonomous motivation, self-efficacy/barriers, self-regulation skills (such as self-monitoring), flexible eating restraint, and positive body image. For physical activity, significant putative mediators were high autonomous motivation, self-efficacy, and use of self-regulation skills. For dietary intake, the evidence was much less clear, and no consistent mediators were identified.
Conclusions: This is the first systematic review of mediational psychological mechanisms of successful outcomes in obesity-related lifestyle change interventions. Despite limited evidence, higher autonomous motivation, self-efficacy, and self-regulation skills emerged as the best predictors of beneficial weight and physical activity outcomes; for weight control, positive body image and flexible eating restraint may additionally improve outcomes. These variables represent possible targets for future lifestyle interventions in overweight/obese populations.
BMC medicine · systematic review · 376 citationsread the source →
Ibrahim N, Thompson D, Nixdorf R, Kalha J, Mpango R, Moran G, Mueller-Stierlin A, Ryan G, Mahlke C, Shamba D, Puschner B, Repper J, Slade M. (2020)MEDLINE-indexed journal, not yet read by usSocial psychiatry and psychiatric epidemiology · systematic review A systematic review of influences on implementation of peer support work for adults with mental health problems.
Purpose: The evidence base for peer support work in mental health is established, yet implementation remains a challenge. The aim of this systematic review was to identify influences which facilitate or are barriers to implementation of mental health peer support work.
Methods: Data sources comprised online databases (n = 11), journal table of contents (n = 2), conference proceedings (n = 18), peer support websites (n = 2), expert consultation (n = 38) and forward and backward citation tracking. Publications were included if they reported on implementation facilitators or barriers for formal face-to-face peer support work with adults with a mental health problem, and were available in English, French, German, Hebrew, Luganda, Spanish or Swahili. Data were analysed using narrative synthesis. A six-site international survey [Germany (2 sites), India, Israel, Tanzania, Uganda] using a measure based on the strongest influences was conducted. The review protocol was pre-registered (Prospero: CRD42018094838).
Results: The search strategy identified 5813 publications, of which 53 were included. Fourteen implementation influences were identified, notably organisational culture (reported by 53% of papers), training (42%) and role definition (40%). Ratings on a measure using these influences demonstrated preliminary evidence for the convergent and discriminant validity of the identified influences.
Conclusion: The identified influences provide a guide to implementation of peer support. For services developing a peer support service, organisational culture including role support (training, role clarity, resourcing and access to a peer network) and staff attitudes need to be considered. The identified influences provide a theory base to prepare research sites for implementing peer support worker interventions.
Social psychiatry and psychiatric epidemiology · systematic review · 139 citationsread the source →
Novak I, Honan I. (2019)MEDLINE-indexed journal, not yet read by usAustralian occupational therapy journal · systematic review Effectiveness of paediatric occupational therapy for children with disabilities: A systematic review.
Introduction: Paediatric occupational therapy seeks to improve children's engagement and participation in life roles. A wide variety of intervention approaches exist. Our aim was to summarise the best-available intervention evidence for children with disabilities, to assist families and therapists choose effective care.
Methods: We conducted a systematic review (SR) using the Cochrane methodology, and reported findings according to PRISMA. CINAHL, Cochrane Library, MEDLINE, OTSeeker, PEDro, PsycINFO were searched. Two independent reviewers: (i) determined whether studies met inclusion: SR or randomised controlled trial (RCT); an occupational therapy intervention for children with a disability; (ii) categorised interventions based on name, core components and diagnostic population; (iii) rated quality of evidence and determined the strength of recommendation using GRADE criteria; and (iv) made recommendations using the Evidence Alert Traffic Light System.
Results: 129 articles met inclusion (n = 75 (58%) SRs; n = 54 (42%)) RCTs, measuring the effectiveness of 52 interventions, across 22 diagnoses, enabling analysis of 135 intervention indications. Thirty percent of the indications assessed (n = 40/135) were graded 'do it' (Green Go); 56% (75/135) 'probably do it' (Yellow Measure); 10% (n = 14/135) 'probably don't do it' (Yellow Measure); and 4% (n = 6/135) 'don't do it' (Red Stop). Green lights were: Behavioural Interventions; Bimanual; Coaching; Cognitive Cog-Fun & CAPS; CO-OP; CIMT; CIMT plus Bimanual; Context-Focused; Ditto; Early Intervention (ABA, Developmental Care); Family Centred Care; Feeding interventions; Goal Directed Training; Handwriting Task-Specific Practice; Home Programs; Joint Attention; Mental Health Interventions; occupational therapy after toxin; Kinesiotape; Pain Management; Parent Education; PECS; Positioning; Pressure Care; Social Skills Training; Treadmill Training and Weight Loss 'Mighty Moves'.
Conclusion: Evidence supports 40 intervention indications, with the greatest number at the activities-level of the International Classification of Function. Yellow light interventions should be accompanied by a sensitive outcome measure to monitor progress and red light interventions could be discontinued because effective alternatives existed.
Australian occupational therapy journal · systematic review · 163 citationsread the source →
The effectiveness of social marketing in global health: a systematic review.
Social marketing is a commonly used strategy in global health. Social marketing programmes may sell subsidized products through commercial sector outlets, distribute appropriately priced products, deliver health services through social franchises and promote behaviours not dependent upon a product or service. We aimed to review evidence of the effectiveness of social marketing in low- and middle-income countries, focusing on major areas of investment in global health: HIV, reproductive health, child survival, malaria and tuberculosis. We searched PubMed, PsycInfo and ProQuest, using search terms linking social marketing and health outcomes for studies published from 1995 to 2013. Eligible studies used experimental or quasi-experimental designs to measure outcomes of behavioural factors, health behaviours and/or health outcomes in each health area. Studies were analysed by effect estimates and for application of social marketing benchmark criteria. After reviewing 18 974 records, 125 studies met inclusion criteria. Across health areas, 81 studies reported on changes in behavioural factors, 97 studies reported on changes in behaviour and 42 studies reported on health outcomes. The greatest number of studies focused on HIV outcomes (n = 45) and took place in sub-Saharan Africa (n = 67). Most studies used quasi-experimental designs and reported mixed results. Child survival had proportionately the greatest number of studies using experimental designs, reporting health outcomes, and reporting positive, statistically significant results. Most programmes used a range of methods to promote behaviour change. Programmes with positive, statistically significant findings were more likely to apply audience insights and cost-benefit analyses to motivate behaviour change. Key evidence gaps were found in voluntary medical male circumcision and childhood pneumonia. Social marketing can influence health behaviours and health outcomes in global health; however evaluations assessing health outcomes remain comparatively limited. Global health investments are needed to (i) fill evidence gaps, (ii) strengthen evaluation rigour and (iii) expand effective social marketing approaches.
Health policy and planning · systematic review · 51 citationsread the source →
Furukawa TA, Suganuma A, Ostinelli EG, Andersson G, Beevers CG, Shumake J, Berger T, Boele FW, Buntrock C, Carlbring P, Choi I, Christensen H, Mackinnon A, Dahne J, Huibers MJH, Ebert DD, Farrer L, Forand NR, Strunk DR, Ezawa ID, Forsell E, Kaldo V, Geraedts A, Gilbody S, Littlewood E, Brabyn S, Hadjistavropoulos HD, Schneider LH, Johansson R, Kenter R, Kivi M, Björkelund C, Kleiboer A, Riper H, Klein JP, Klein JP, Schröder J, Meyer B, Moritz S, Bücker L, Lintvedt O, Johansson P, Lundgren J, Milgrom J, Gemmill AW, Mohr DC, Montero-Marin J, Garcia-Campayo J, Nobis S, Zarski AC, O'Moore K, Williams AD, Newby JM, Perini S, Phillips R, Schneider J, Pots W, Pugh NE, Richards D, Rosso IM, Rauch SL, Sheeber LB, Smith J, Spek V, Pop VJ, Ünlü B, van Bastelaar KMP, van Luenen S, Garnefski N, Kraaij V, Vernmark K, Warmerdam L, van Straten A, Zagorscak P, Knaevelsrud C, Heinrich M, Miguel C, Cipriani A, Efthimiou O, Karyotaki E, Cuijpers P. (2021)MEDLINE-indexed journal, not yet read by usThe lancet. Psychiatry · systematic review Dismantling, optimising, and personalising internet cognitive behavioural therapy for depression: a systematic review and component network meta-analysis using individual participant data.
Background: Internet cognitive behavioural therapy (iCBT) is a viable delivery format of CBT for depression. However, iCBT programmes include training in a wide array of cognitive and behavioural skills via different delivery methods, and it remains unclear which of these components are more efficacious and for whom.
Methods: We did a systematic review and individual participant data component network meta-analysis (cNMA) of iCBT trials for depression. We searched PubMed, PsycINFO, Embase, and the Cochrane Library for randomised controlled trials (RCTs) published from database inception to Jan 1, 2019, that compared any form of iCBT against another or a control condition in the acute treatment of adults (aged ≥18 years) with depression. Studies with inpatients or patients with bipolar depression were excluded. We sought individual participant data from the original authors. When these data were unavailable, we used aggregate data. Two independent researchers identified the included components. The primary outcome was depression severity, expressed as incremental mean difference (iMD) in the Patient Health Questionnaire-9 (PHQ-9) scores when a component is added to a treatment. We developed a web app that estimates relative efficacies between any two combinations of components, given baseline patient characteristics. This study is registered in PROSPERO, CRD42018104683.
Findings: We identified 76 RCTs, including 48 trials contributing individual participant data (11 704 participants) and 28 trials with aggregate data (6474 participants). The participants' weighted mean age was 42·0 years and 12 406 (71%) of 17 521 reported were women. There was suggestive evidence that behavioural activation might be beneficial (iMD -1·83 [95% credible interval (CrI) -2·90 to -0·80]) and that relaxation might be harmful (1·20 [95% CrI 0·17 to 2·27]). Baseline severity emerged as the strongest prognostic factor for endpoint depression. Combining human and automated encouragement reduced dropouts from treatment (incremental odds ratio, 0·32 [95% CrI 0·13 to 0·93]). The risk of bias was low for the randomisation process, missing outcome data, or selection of reported results in most of the included studies, uncertain for deviation from intended interventions, and high for measurement of outcomes. There was moderate to high heterogeneity among the studies and their components.
Interpretation: The individual patient data cNMA revealed potentially helpful, less helpful, or harmful components and delivery formats for iCBT packages. iCBT packages aiming to be effective and efficient might choose to include beneficial components and exclude ones that are potentially detrimental. Our web app can facilitate shared decision making by therapist and patient in choosing their preferred iCBT package.
Funding: Japan Society for the Promotion of Science.
The lancet. Psychiatry · systematic review · 158 citationsread the source →