Search the source libraries

Effectiveness of social prescribing for chronic disease prevention in adults: a systematic review and meta-analysis of randomised controlled trials.

Background: Social prescribing (SP) enables healthcare professionals to link patients with non-medical interventions available in the community to address underlying socioeconomic and behavioural determinants. We synthesised the evidence to understand the effectiveness of SP for chronic disease prevention. Methods: A systematic literature search was conducted using five databases and two registries. Eligible studies included randomised controlled trials of SP among community-dwelling adults recruited from primary care or community setting, investigating any chronic disease risk factors defined by the WHO (behavioural factors: smoking, physical inactivity, unhealthy diet and excessive alcohol consumption; metabolic factors: raised blood pressure, overweight/obesity, hyperlipidaemia and hyperglycaemia). Random effect meta-analyses were performed at two time points: completion of intervention and follow-up after trial. Results: We identified nine reports from eight trials totalling 4621 participants. All studies evaluated SP exercise interventions which were highly heterogeneous regarding the content, duration, frequency and length of follow-up. Majority of studies had some concerns for risk of bias. Meta-analysis revealed that SP likely increased physical activity (completion: mean difference (MD) 21 min/week, 95% CI 3 to 39, I2=0%; follow-up ≤12 months: MD 19 min/week, 95% CI 8 to 29, I2=0%). However, SP may not improve markers of adiposity, blood pressure, glucose and serum lipid. There were no eligible studies that primarily target unhealthy diet, smoking and excessive alcohol drinking behaviours. Conclusions: SP exercise interventions probably increased physical activity slightly; however, no benefits were observed for metabolic factors. Determining whether SP is effective in modifying the determinants of chronic diseases and promotes sustainable healthy behaviours is limited by the current evidence of quantification and uncertainty, warranting further rigorous studies. Prospero registration number: CRD42022346687.

Journal of epidemiology and community health · meta-analysis · 33 citationsread the source →

An online healthy relationship tool and safety decision aid for women experiencing intimate partner violence (I-DECIDE): a randomised controlled trial.

Background: Evidence for online interventions to help women experiencing intimate partner violence is scarce. We assessed whether an online interactive healthy relationship tool and safety decision aid (I-DECIDE) would increase women's self-efficacy and improve depressive symptoms compared with an intimate partner violence information website. Methods: In this two-group pragmatic randomised controlled trial, we enrolled women who had screened positive for any form of intimate partner violence or fear of a partner in the 6 months before recruitment. Women aged 16-50 years currently residing in Australia, who had safe access to a computer and an internet connection, and who answered positively to one of the screening questions in English were eligible for inclusion. Participants were randomly assigned (1:1) by computer to receive either the intervention or control website. The intervention website consisted of modules on healthy relationships, abuse and safety, and relationship priority setting, and a tailored action plan. The control website was a static intimate partner violence information website. As the initial portion of the website containing the baseline questions was identical for both groups, there was no way for women to tell which group they had been allocated to, and the research team were also masked to participant allocation until after analysis of the 12-month data. Data were collected at baseline, immediately after completion of the website, at 6 months, and 12 months. Primary outcomes were mean general self-efficacy score (immediately after website completion, and at 6 months and 12 months) and mean depression score (at 6 months and 12 months). Data analyses were done according to intention-to-treat principles, accounting for missing data, and adjusted for outcome baseline scores. This trial was registered with the Australian New Zealand Clinical Trials Registry, ACTRN 12614001306606. Findings: Between Jan 16, and Aug 28, 2015, 584 patients registered for the study and were assessed for eligibility. 422 eligible participants were randomly allocated to the intervention group (227 patients) or control group (195 patients). 179 (79%) participants in the intervention group and 156 (80%) participants in the control group completed 12-month follow-up. Mean self-efficacy at 6 months and 12 months was lower for participants in the intervention group than for participants in the control group, although this did not meet the prespecified mean difference (6 months: 27·5 [SD 5·1] vs 28·1 [4·4], imputed mean difference 1·3 [95% CI 0·3 to 2·3]; 12 months: 27·8 [SD 5·4] vs 29·0 [5·0], imputed mean difference 1·6 [95% CI 0·5 to 2·7]). We found no difference between groups in depressive symptoms at 6 months or 12 months (6 months: 22·5 [SD 17·1] vs 24·2 [17·2], imputed mean difference -0·3 [95% CI -3·5 to 3·0]; 12 months: 21·9 [SD 19·3] vs 21·5 [19·3], imputed mean difference -1·9 [95% CI -5·6 to 1·7]). Qualitative findings indicated that participants found the intervention supportive and a motivation for action. Interpretation: Our findings highlight the need for further research, development, and refinement of online interventions for women experiencing intimate partner violence, particularly into the duration needed for interventions. Although we detected no meaningful differences between groups, our qualitative results indicated that some women find an online tool a helpful source of motivation and support. Funding: Australian Research Council.

The Lancet. Public health · randomised controlled trial · 43 citationsread the source →

The effectiveness of case-based learning in health professional education. A BEME systematic review: BEME Guide No. 23.

Background: Case-based learning (CBL) is a long established pedagogical method, which is defined in a number of ways depending on the discipline and type of 'case' employed. In health professional education, learning activities are commonly based on patient cases. Basic, social and clinical sciences are studied in relation to the case, are integrated with clinical presentations and conditions (including health and ill-health) and student learning is, therefore, associated with real-life situations. Although many claims are made for CBL as an effective learning and teaching method, very little evidence is quoted or generated to support these claims. We frame this review from the perspective of CBL as a type of inquiry-based learning. Aim: To explore, analyse and synthesise the evidence relating to the effectiveness of CBL as a means of achieving defined learning outcomes in health professional prequalification training programmes. Method: Selection criteria: We focused the review on CBL for prequalification health professional programmes including medicine, dentistry, veterinary science, nursing and midwifery, social care and the allied health professions (physiotherapy, occupational therapy, etc.). Papers were required to have outcome data on effectiveness. Search strategies: The search covered the period from 1965 to week 4 September 2010 and the following databases: ASSIA, CINAHL, EMBASE, Education Research, Medline and Web of Knowledge (WoK). Two members of the topic review group (TRG) independently reviewed the 173 abstracts retrieved from Medline and compared findings. As there was good agreement on inclusion, one went onto review the WoK and ASSIA EndNote databases and the other the Embase, CINAHL and Education Research databases to decide on papers to submit for coding. Coding and data analysis: The TRG modified the standard best evidence medical education coding sheet to fit our research questions and assessed each paper for quality. After a preliminary reliability exercise, each full paper was read and graded by one reviewer with the papers scoring 3-5 (of 5) for strength of findings being read by a second reviewer. A summary of each completed coding form was entered into an Excel spread sheet. The type of data in the papers was not amenable to traditional meta-analysis because of the variability in interventions, information given, student numbers (and lack of) and timings. We, therefore, adopted a narrative synthesis method to compare, contrast, synthesise and interpret the data, working within a framework of inquiry-based learning. Results: The final number of coded papers for inclusion was 104. The TRG agreed that 23 papers would be classified as of higher quality and significance (22%). There was a wide diversity in the type, timing, number and length of exposure to cases and how cases were defined. Medicine was the most commonly included profession. Numbers of students taking part in CBL varied from below 50 to over 1000. The shortest interventions were two hours, and one case, whereas the longest was CBL through a whole year. Group sizes ranged from students working alone to over 30, with the majority between 2 and 15 students per group. The majority of studies involved single cohorts of students (61%), with 29% comparing multiple groups, 8% involving different year groups and 2% with historical controls. The outcomes evaluation was either carried out postintervention only (78 papers; 75%), preintervention and postintervention (23 papers; 22%) or during and postintervention (3 papers; <3%). Our analysis provided the basis for discussion of definitions of CBL, methods used and advocated, topics and learning outcomes and whether CBL is effective based on the evaluation data. Conclusion: Overwhelmingly, students enjoy CBL and think that it enhances their learning. The empirical data taken as a whole are inconclusive as to the effects on learning compared with other types of activity. Teachers enjoy CBL, partly because it engages, and is perceived to motivate, students. CBL seems to foster learning in small groups though whether this is the case delivery or the group learning effect is unclear.

Medical teacher · systematic review · 534 citationsread the source →

To circ or not to circ: clinical and pharmacoeconomic outcomes of a prospective trial of topical steroid versus primary circumcision.

Purpose: To compare the efficacy and costs of circumcision versus topical treatment using a prospective pharmacoeconomic protocol. Materials and methods: We treated 59 patients (3-10 years of age) randomized into two groups: 29 underwent an 8-week course of topical treatment with 0.2% betamethasone-hyaluronidase cream twice a day; and 30 underwent circumcision. Topical treatment success was defined as complete exposure of the glans. In cases of treatment failure, circumcision was performed and its cost imputed to that of the initial treatment. The pharmacoeconomic aspects were defined according to the Brazilian National Public Health System database and the Brazilian Community Pharmacies Index. Results: The two groups were statistically similar for all clinical parameters evaluated. Topical treatment resulted in complete exposure of the glans in 52% of the patients. Topical treatment was associated with preputial pain and hyperemia. However, treatment suspension was unnecessary. Minor complications were observed in 16.6% of the surgical group patients. The mean cost per patient was US$ 53.70 and US$ 125.20, respectively, for topical steroid treatment (including the costs related to treatment failure) and circumcision. The total costs were US$ 2,825.32 and US$ 3,885.73 for topical treatment and circumcision, respectively. Conclusions: Topical treatment of phimosis can reduce costs by 27.3% in comparison with circumcision. Therefore, topical treatment of phimosis should be considered prior to the decision to perform surgery.

International braz j urol : official journal of the Brazilian Society of Urology · randomised controlled trial · 8 citationsread the source →

Five-year follow-up of harms and benefits of behavioral infant sleep intervention: randomized trial.

Background and objectives: Randomized trials have demonstrated the short- to medium-term effectiveness of behavioral infant sleep interventions. However, concerns persist that they may harm children's emotional development and subsequent mental health. This study aimed to determine long-term harms and/or benefits of an infant behavioral sleep program at age 6 years on (1) child, (2) child-parent, and (3) maternal outcomes. Methods: Three hundred twenty-six children (173 intervention) with parent-reported sleep problems at age 7 months were selected from a population sample of 692 infants recruited from well-child centers. The study was a 5-year follow-up of a population-based cluster-randomized trial. Allocation was concealed and researchers (but not parents) were blinded to group allocation. Behavioral techniques were delivered over 1 to 3 individual nurse consultations at infant age 8 to 10 months, versus usual care. The main outcomes measured were (1) child mental health, sleep, psychosocial functioning, stress regulation; (2) child-parent relationship; and (3) maternal mental health and parenting styles. Results: Two hundred twenty-five families (69%) participated. There was no evidence of differences between intervention and control families for any outcome, including (1) children's emotional (P = .8) and conduct behavior scores (P = .6), sleep problems (9% vs 7%, P = .2), sleep habits score (P = .4), parent- (P = .7) and child-reported (P = .8) psychosocial functioning, chronic stress (29% vs 22%, P = .4); (2) child-parent closeness (P = .1) and conflict (P = .4), global relationship (P = .9), disinhibited attachment (P = .3); and (3) parent depression, anxiety, and stress scores (P = .9) or authoritative parenting (63% vs 59%, P = .5). Conclusions: Behavioral sleep techniques have no marked long-lasting effects (positive or negative). Parents and health professionals can confidently use these techniques to reduce the short- to medium-term burden of infant sleep problems and maternal depression.

Pediatrics · randomised controlled trial · 69 citationsread the source →

Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure.

Aims: In chronic heart failure (CHF), reduced vagal activity correlates with increased mortality and acute decompensation. Experimentally, chronic vagus nerve stimulation (VNS) improved left ventricular (LV) function and survival; clinically, it is used for the treatment of drug-refractory epilepsy. We assessed safety and tolerability of chronic VNS in symptomatic CHF patients, using a novel implantable nerve stimulation system. The secondary goal was to obtain preliminary data on clinical efficacy. Methods and results: This multi-centre, open-label phase II, two-staged study (8-patient feasibility phase plus 24-patient safety and tolerability phase) enrolled 32 New York Heart Association (NYHA) class II-IV patients [age 56 ± 11 years, LV ejection fraction (LVEF) 23 ± 8%]. Right cervical VNS with CardioFit (BioControl Medical) implantable system started 2-4 weeks after implant, slowly raising intensity; patients were followed 3 and 6 months thereafter with optional 1-year follow-up. Overall, 26 serious adverse events (SAEs) occurred in 13 of 32 patients (40.6%), including three deaths and two clearly device-related AEs (post-operative pulmonary oedema, need of surgical revision). Expected non-serious device-related AEs (cough, dysphonia, and stimulation-related pain) occurred early but were reduced and disappeared after stimulation intensity adjustment. There were significant improvements (P < 0.001) in NYHA class quality of life, 6-minute walk test (from 411 ± 76 to 471 ± 111 m), LVEF (from 22 ± 7 to 29 ± 8%), and LV systolic volumes (P = 0.02). These improvements were maintained at 1 year. Conclusions: This open-label study shows that chronic VNS in CHF patients with severe systolic dysfunction may be safe and tolerable and may improve quality of life and LV function. A controlled clinical trial appears warranted.

European heart journal · clinical trial · 373 citationsread the source →

Social support following diagnosis and treatment for colorectal cancer and associations with health-related quality of life: Results from the UK ColoREctal Wellbeing (CREW) cohort study.

Objective: Social support is acknowledged as important in cancer survivorship, but little is known about change in support after cancer diagnosis and factors associated with this, particularly in colorectal cancer. The CREW cohort study investigated social support up to 2 years following curative intent surgery for colorectal cancer. Methods: A total of 871 adults recruited pre-treatment from 29 UK centres 2010 to 2012 consented to follow-up. Questionnaires at baseline, 3, 9, 15, and 24 months post-surgery included assessments of social support (Medical Outcomes Study-Social Support Survey, MOS-SSS) and health-related quality of life (HRQoL). Socio-demographic, clinical and treatment details were collected. Longitudinal analyses assessed social support over follow-up, associations with participant characteristics, and HRQoL. Results: Around 20% were living alone and 30% without a partner. Perceived social support declined in around 29% of participants, with 8% of these reporting very low levels overall from baseline to 2 years (mean MOS-SSS overall score < 40 on a scale from 0 to 100). Older age, female gender, greater neighbourhood deprivation, presence of co-morbidities, and rectal cancer site were significantly associated with reductions in perceived support. Poorer HRQoL outcomes (generic health/QoL, reduced wellbeing, anxiety, and depression) were significantly associated with lower levels of social support. Conclusions: Levels of social support decline following colorectal cancer diagnosis and treatment in nearly a third of patients and are an important risk factor for recovery of HRQoL. Assessment of support early on and throughout follow-up would enable targeted interventions to improve recovery, particularly in the more vulnerable patient groups at risk of poorer social support.

Psycho-oncology · cohort or longitudinal · 61 citationsread the source →

Cultivating mindfulness: effects on well‐being

There has been great interest in determining if mindfulness can be cultivated and if this cultivation leads to well-being. The current study offers preliminary evidence that at least one aspect of mindfulness, measured by the Mindful Attention and Awareness Scale (MAAS; K. W. Brown & R. M. Ryan, 2003), can be cultivated and does mediate positive outcomes. Further, adherence to the practices taught during the meditation-based interventions predicted positive outcomes. College undergraduates were randomly allocated between training in two distinct meditation-based interventions, Mindfulness Based Stress Reduction (MBSR; J. Kabat-Zinn, 1990; n=15) and E. Easwaran's (1978/1991) Eight Point Program (EPP; n=14), or a waitlist control (n=15). Pretest, posttest, and 8-week follow-up data were gathered on self-report outcome measures. Compared to controls, participants in both treatment groups (n=29) demonstrated increases in mindfulness at 8-week follow-up. Further, increases in mindfulness mediated reductions in perceived stress and rumination. These results suggest that distinct meditation-based practices can increase mindfulness as measured by the MAAS, which may partly mediate benefits. Implications and future directions are discussed.

Journal of Clinical Psychology · randomised controlled trial · 695 citationsread the source →

Investigating the efficacy of digital cognitive behavioural therapy in comparison to a sleep-monitoring application via integrated diary and actigraphy: A randomised-controlled trial.

Dissemination of digital cognitive behavioural therapy is a promising approach for treating insomnia in the broad population. Current evidence supports the effectiveness of the digital format, but clinical findings are often limited by the choice of control group and lack of in-depth therapeutic measures. This study was designed to investigate the specific effects of digital cognitive behavioural therapy in comparison to a self-monitoring application. Participants meeting criteria for insomnia were randomly allocated (1:1) to 8 weeks of digital cognitive behavioural therapy or 8 weeks of digital sleep monitoring (control application). The primary outcome, insomnia severity, was assessed at baseline, 8- and 16-weeks post-randomisation. Secondary outcomes included the assessment of sleep via application-integrated sleep diaries and actigraphy. Linear-mixed models were fitted to assess between-group differences. Fifty-six participants (48 females, mean age: M = 45.55 ± 13.70 years) were randomised to either digital cognitive behavioural therapy (n = 29) or digital sleep monitoring (n = 27). At 8- and 16-weeks post-randomisation, large treatment effects (d = 0.87-1.08) indicated robust reductions (-3.70 and -2.97, respectively; p ≤ 0.003) in insomnia severity in the digital cognitive behavioural therapy arm, relative to digital sleep monitoring. Treatment effects in favour of digital cognitive behavioural therapy were also found for self-reported and actigraphy-derived sleep continuity variables, indicating that sleep improved throughout the 8-week intervention period. Our study reinforces the role of digital cognitive behavioural therapy in achieving clinical improvements for patients with insomnia, affirming previous findings and supporting the specific effects of cognitive behavioural therapy.

Journal of sleep research · randomised controlled trial · 11 citationsread the source →

Exploring Proof of Concept for a Novel Web-Based Self-Management Support Intervention for Polycystic Ovary Syndrome: Multimethod Study.

Background: Polycystic ovary syndrome (PCOS) is a common chronic hormonal condition affecting 8%-13% of women and individuals assigned female at birth. Symptoms may include subfertility, menstrual, skin, and metabolic problems, with long-term health risks including diabetes and cardiovascular disease. PCOS has a significant negative impact on mental health, quality of life, and well-being. We explored proof of concept for a web-based self-management support intervention, "Hope PCOS," designed to reduce anxiety and depression and increase positive well-being for women living with PCOS. Objective: We aim to pilot the intervention to test feasibility for web-based recruitment and delivery, acceptability, and potential to reduce anxiety and depression and increase positive well-being. Methods: Women with PCOS were recruited via social media with support from a patient advocacy charity and offered places on a 6-session cohort of the intervention. In a pre-post design, participants reported depression (Patient Health Questionnaire 9-Items), anxiety (Generalized Anxiety Disorder 7-Items), well-being (Warwick-Edinburgh Mental Wellbeing Scale), hope (SHS [State Hope Scale]), and gratitude (GQ-6 [Gratitude Questionnaire]) at baseline and 6 weeks. All participants who accessed 3 or more sessions were invited to a follow-up qualitative interview to explore user experience. Data from 8 interviews were thematically analyzed, and pre-post data were explored with descriptive statistics. Results: A total of 63 eligible women responded and were given access to the intervention. Three withdrew, leaving a baseline sample of 60, aged 20-58 (median 30, IQR 25-36) years. Further, 48 of the 60 started, of whom 46% (22/48) completed at least 3 sessions, and 29% (14/48) completed all 6. Additionally, 8 women (aged 25-38, median 29, IQR 26-35) years who completed between 3 and 6 sessions reported acceptability and experiences in exit interviews, including prioritizing self-care, developing a self-management mindset, setting motivating goals, improved mental health, self-compassion, reduced shame, openness about PCOS, preparedness for future health concerns, and continuing practice to consolidate behavior change. Furthermore, 11 women aged 25-43 (median 31, IQR 27-37) years, who completed 1-6 sessions (median 6, IQR 6-6), completed pre- and postintervention outcomes. Descriptive quantitative analysis indicated decreases in anxiety and depression and increases in hope agency, hope pathways, and gratitude. There was a meaningful (≥3 points) increase in well-being. Among patients with baseline and follow-up data, 73% (8/11) met clinical caseness for depression at baseline and 36% (4/11) post intervention. Conclusions: We explored proof of concept. Web-based recruitment and delivery online were feasible. We detected early signs of acceptability and potential benefits for anxiety, depression, and positive well-being that warrant testing in a controlled trial. Future research should assess the feasibility of a randomized controlled trial to evaluate effectiveness, acceptability, and cost-effectiveness.

JMIR formative researchread the source →

Complex Moral Injury: Shattered Moral Assumptions.

An infographic model of moral injury (MI) is introduced in this conceptual paper that distinguishes the development of a worldview discrepancy-induced genus of MI, called complex moral injury (C-MI), from a standard expression of moral injury (S-MI), clearly delineated as perpetration-focused and a violation of moral belief in the contemporary view. It builds upon a previous essay that examined the potential of paradoxical circumstance (e.g., clashes of value, competing moral expectations, and moral paradox) to inflict MI among military personnel during wartime (Fleming in J Relig Health 60(5):3012-3033, 2021). Accordingly, it heeds Litz et al.'s recommendation to expand the research of MI beyond the effects of perpetration and investigate the impact of morally injurious events that shake one's core moral beliefs about the world and self (Litz et al. in Clin Psychol Rev 29(8):695-706, 2009). A review of definitional, scale, and qualitative studies shows evidence of a nuanced and complex form of MI that presents as moral disorientation and is a response to a disruption and subsequent failure of foundational moral beliefs to adequately appraise ethical problems and inform moral identity. Interrelations between MI, assumptive world, and meaning theories suggest the mechanism of C-MI and potential therapies. Case studies from a Veterans Administration hospital in the United States and a walk through the diagram will help illustrate the model. Clinical implications of a definition that includes morally injurious events that shatter fundamental moral assumptions are discussed. The role of chaplains in facilitating acceptance and meaning-making processes is recommended for C-MI recovery. Acknowledging the model's need for empirical support, a plausible scale is discussed for future research.

Journal of religion and health · review · 19 citationsread the source →

mHealth Interventions To Support Self-Management In HIV: A Systematic Review.

Background: Self-management is an important aspect of long-term HIV treatment. Mobile technologies offer the potential to efficiently deliver interventions to facilitate HIV self-management. The last comprehensive review of such mHealth interventions was conducted in 2011. Given the rapidly evolving field, a need was identified for an updated review of the literature. Objective: The study aimed to describe and evaluate current evidence-based mHealth interventions to support self-management in HIV. Method: Eight online databases (Medline, Scopus, Embase, PsycINFO, Cochrane, Global Health CAB, IEEE explore, Web of Science) were systematically searched for papers describing and evaluating mHealth HIV self-management interventions. Reference lists of relevant papers were also searched. Data on intervention content and evaluation methodology were extracted and appraised by two researchers. Results: 41 papers were identified evaluating 28 interventions. The majority of these interventions (n=20, 71%) had a single focus of either improving adherence (n=16), increasing engagement in care (n=3) or supporting smoking cessation (n=1), while just 8 (29%) were more complex self-management interventions, targeting a range of health-related behaviours. Interventions were predominantly delivered through SMS messaging. They significantly impacted on a range of outcomes including adherence, viral load, mental health and social support. Conclusion: Since the last major review of mHealth interventions in HIV, there has been a shift from exploratory acceptability/feasibility studies to impact evaluations. While overall the interventions impacted on a range of outcomes, they were generally limited in scope, failing to encompass many functions identified as desirable by people living with HIV. Participant incentives may limit the generalizability of findings.

The open AIDS journal · review · 97 citationsread the source →

Acute and long-term safety and tolerability of risperidone in children with autism.

Treatment-emergent adverse events (AEs) were monitored during an 8-week, double-blind, placebo-controlled trial of risperidone (0.5-3.5 mg/day) in 101 children and adolescents with a lifetime diagnosis of autistic disorder. In addition, 37 placebo nonresponders received open-label risperidone for another 8 weeks. Of all the risperidone responders (n=65), 63 entered an open extension of another 16 weeks (6 months total risperidone exposure), and 32 of them were rerandomized to either continued risperidone therapy (n=16) or gradual replacement with placebo (n=16) over 8 weeks. We collected the following measures of safety and tolerability: (1) laboratory blood assessments (CBC with differential, electrolytes, and liver function tests) and urinalyses, (2) vital signs, (3) Side Effects Review of AEs thought to be associated with risperidone, (4) sleep records, (5) Simpson Angus Neurological Rating Scale (SARS), (6) Abnormal Involuntary Movement Scale (AIMS), and (7) height and weight. No clinically significant changes were found on the lab tests. During the 8-week acute trial, the most common AEs on the Side Effects Review, scored as moderate or higher, were as follows (placebo and risperidone, respectively): Somnolence (12% and 37%), enuresis (29% and 33%), excessive appetite (10% and 33%), rhinitis (8% and 16%), difficulty waking (8% and 12%), and constipation (12% and 10%). "Difficulty falling asleep" and anxiety actually favored the risperidone condition at statistically significant levels. The same AEs tended to recur through 6 months of treatment, although often at reduced levels. Using Centers for Disease Control (CDC) standardized scores, both weight and body mass index (BMI) increased with risperidone during the acute trial (0.5 and 0.6 SDs, respectively, for risperidone; 0.0 and 0.1 SDs, respectively, for placebo) and into open-label extension (0.19 and 0.16 SDs, respectively), although the amount of gain decelerated with time. Extrapyramidal symptoms, as assessed by the SARS, were no more common for drug than placebo, although drooling was reported more often in the risperidone group. There were no differences between groups on the AIMS. Two subjects had seizures (one taking placebo), but these were considered unrelated to active drug. Most AEs were mild to moderate and failed to interfere with therapeutic changes; there were no unanticipated AEs. The side effects of most concern were somnolence and weight gain.

Journal of child and adolescent psychopharmacology · randomised controlled trial · 92 citationsread the source →

Vagus nerve stimulation: from pre-clinical to clinical application: challenges and future directions.

Vagus nerve stimulation was performed experimentally for the first time more than 150 years ago. In the 1980s and 1990s, vagus nerve stimulation was shown, both in the anesthetized and in the conscious animal, to exert marked antiarrhythmic effects, particularly during acute myocardial ischemia. There is a strong rationale for a beneficial effect of augmented vagal activity in the setting of chronic heart failure. Studies in experimental models of heart failure showed that chronic vagus nerve stimulation exerts beneficial effects on left ventricular function and on survival. Vagus nerve stimulation is approved in man for refractory epilepsy and depression. The first-in-man study performed in 32 patients with chronic heart failure suggests that vagus nerve stimulation was safe and well tolerated. Six months of open-label treatment was associated with significant improvements (P < 0.001) in NYHA class, quality of life, 6-min walk test, LV ejection fraction (from 22 ± 7 to 29 ± 8%), and LV systolic volumes (P = 0.02). These improvements were maintained at 1 year. Mechanisms of action may include the following: heart rate, anti-adrenergic, anti-apoptotic, and anti-inflammatory effects as well as an increase in nitric oxide. Controlled clinical trials will start soon to assess whether vagus nerve stimulation can indeed represent a new non-pharmacological approach for the treatment of symptomatic heart failure.

Heart failure reviews · review · 123 citationsread the source →

Mental health of migrants with pre-migration exposure to armed conflict: a systematic review and meta-analysis.

Background: Exposure to armed conflict has been associated with negative mental health consequences. We aimed to estimate the prevalence of generalised anxiety disorder, major depressive disorder, and post-traumatic stress disorder among migrants exposed to armed conflict. Methods: In this systematic review and meta-analysis, we searched online databases (Cochrane Library, Embase, LILACS, PsycInfo [via Ovid], PubMed, and Web of Science Core Collection) for relevant observational studies published between Jan 1, 1994, and June 28, 2021. We included studies that used standardised psychiatric interviews to assess generalised anxiety disorder, major depressive disorder, or post-traumatic stress disorder among migrants (refugees or internally displaced persons; aged ≥18 years) with pre-migration exposure to armed conflict. We excluded studies in which exposure to armed conflict could not be ascertained, studies that included a clinical population or people with chronic diseases that can trigger the onset of mental disease, and studies published before 1994. We used a random effects model to estimate each mental health disorder's pooled prevalence and random effects meta-regression to assess sources of heterogeneity. Two independent reviewers assessed the risk of bias for each study using the Joanna Briggs Institute Checklist for Prevalence Studies. The protocol was registered with PROSPERO, CRD42020209251. Findings: Of the 13 935 studies identified, 34 met our inclusion criteria; these studies accounted for 15 549 migrants. We estimated a prevalence of current post-traumatic stress disorder of 31% (95% CI 23-40); prevalence of current major depressive disorder of 25% (17-34); and prevalence of generalised anxiety disorder of 14% (5-35). Younger age was associated with a higher prevalence of current post-traumatic stress disorder (odds ratio 0·95 [95% CI 0·90-0·99]), lifetime post-traumatic stress disorder (0·88 [0·83-0·92]), and current generalised anxiety disorder (0·87 [0·78-0·97]). A longer time since displacement was associated with a lower lifetime prevalence of post-traumatic stress disorder (0·88 [0·81-0·95]) and major depressive disorder (0·81 [0·77-0·86]). Migrating to a middle-income (8·09 [3·06-21·40]) or low-income (39·29 [11·96-129·70]) country was associated with increased prevalence of generalised anxiety disorder. Interpretation: Migrants who are exposed to armed conflict are at high risk of mental health disorders. The mental health-care needs of migrants should be assessed soon after resettlement, and adequate care should be provided, with particular attention paid to young adults. Funding: Marie Skłodowska-Curie Actions (Horizon 2020-COFUND), MinCiencias (Colombia), and Swiss National Science Foundation.

The Lancet. Public health · meta-analysis · 111 citationsread the source →

Neuropsychiatric phenotypes in children with Noonan syndrome.

Aim: We investigated neuropsychiatric outcomes in children with Noonan syndrome and addressed limitations in previous research with a focus on prepubertal children, comparison to typically developing children, comprehensive neuropsychiatric evaluation, and controlling for overall cognitive abilities. Method: Forty-five children with Noonan syndrome (mean = 8 years 6 months, SD = 2 years 2 months; 29 females) and 40 typically developing children (mean = 8 years 9 months, SD = 2 years; 22 females) were evaluated with objective, parent-report, and psychiatric interview measures. Results: Children with Noonan syndrome demonstrated elevated symptoms across attention-deficit/hyperactivity disorder (ADHD) (attention, hyperactivity, and inhibition), autism spectrum disorder (ASD) (maintaining social relationships, behavioral rigidity, and sensory sensitivity), and oppositional defiant disorder (ODD) (aggression) symptom clusters relative to typically developing children (all p < 0.05). Group differences in nearly all parent-report measures were significant after accounting for variations in intellectual functioning, suggesting that increased neurodevelopmental symptoms are not simply driven by overall intelligence. Twenty out of 42 children with Noonan syndrome met criteria for ADHD, eight out of 42 for ODD, and 11 out of 43 demonstrated clinically significant symptoms seen in children with ASD. Interpretation: Children with Noonan syndrome are at increased risk for a range of ADHD, ASD, and ODD associated symptoms. A dimensional approach reveals significant ASD symptoms in Noonan syndrome that do not emerge when using the currently accepted categorical diagnostic approach. What this paper adds: Neuropsychiatric disorders occur in more than half of children with Noonan syndrome. Children with Noonan syndrome demonstrate highly variable neurodevelopmental symptom profiles. Children with Noonan syndrome display variable impairments in attention, hyperactivity, and inhibition. Specific social concerns include behavioral rigidity, transitions, and difficulties maintaining social relationships. Children with Noonan syndrome display variably elevated levels of aggression and emotional dysregulation.

Developmental medicine and child neurology · 34 citationsread the source →

Educating religious leaders to promote uptake of male circumcision in Tanzania: a cluster randomised trial.

Background: Male circumcision is being widely deployed as an HIV prevention strategy in countries with high HIV incidence, but its uptake in sub-Saharan Africa has been below targets. We did a study to establish whether educating religious leaders about male circumcision would increase uptake in their village. Methods: In this cluster randomised trial in northwest Tanzania, eligible villages were paired by proximity (<60 km) and the time that a free male circumcision outreach campaign from the Tanzanian Ministry of Health became available in their village. All villages received the standard male circumcision outreach activities provided by the Ministry of Health. Within the village pairs, villages were randomly assigned by coin toss to receive either additional education for Christian church leaders on scientific, religious, and cultural aspects of male circumcision (intervention group), or standard outreach only (control group). Church leaders or their congregations were not masked to random assignment. The educational intervention consisted of a 1-day seminar co-taught by a Tanzanian pastor and a Tanzanian clinician who worked with the Ministry of Health, and meetings with the study team every 2 weeks thereafter, for the duration of the circumcision campaign. The primary outcome was the proportion of male individuals in a village who were circumcised during the campaign, using an intention-to-treat analysis that included all men in the village. This trial is registered with ClinicalTrials.gov, number NCT 02167776. Findings: Between June 15, 2014, and Dec 10, 2015, we provided education for church leaders in eight intervention villages and compared the outcomes with those in eight control villages. In the intervention villages, 52·8% (30 889 of 58 536) of men were circumcised compared with 29·5% (25 484 of 86 492) of men in the eight control villages (odds ratio 3·2 [95% CI, 1·4-7·3]; p=0·006). Interpretation: Education of religious leaders had a substantial effect on uptake of male circumcision, and should be considered as part of male circumcision programmes in other sub-Saharan African countries. This study was conducted in one region in Tanzania; however, we believe that our intervention is generalisable. We equipped church leaders with knowledge and tools, and ultimately each leader established the most culturally-appropriate way to promote male circumcision. Therefore, we think that the process of working through religious leaders can serve as an innovative model to promote healthy behaviour, leading to HIV prevention and other clinically relevant outcomes, in a variety of settings. Funding: Bill & Melinda Gates Foundation, National Institutes of Health, and the Mulago Foundation.

Lancet (London, England) · randomised controlled trial · 31 citationsread the source →

Ethnoracial and social trends in breast cancer staging at diagnosis in Brazil, 2001-14: a case only analysis.

Background: Policies for early detection of breast cancer, including clinical breast examinations and mammographic screening, were introduced in Brazil in 2004, but their effect on disease stage at diagnosis is unclear. We aimed to assess whether these policies have led to a decrease in the prevalence of late-stage breast cancer at diagnosis. Methods: In this case only analysis, using an anonymised nationwide hospital based-cancer registry network, we identified women aged 18-89 years who had been diagnosed with an invasive breast cancer in Brazil during 2001-14. We extracted individual patient-level data on patient demographics, tumour variables, and health-care provider variables for the centre where the patient was diagnosed. Our objectives were to estimate the prevalence of late-stage breast cancer (TNM stage III or IV) at diagnosis overall, across age groups, and by ethnoracial and social strata (ie, self-reported ethnoracial group, as white, black, brown, Asian, or Indigenous, and educational level, marital status, and region of residence) across the study period, and compare these estimates with international data from high-income countries (Norway and the USA). We used logistic regression to estimate odds ratios (ORs) for late-stage versus early-stage (TNM stage I or II) breast cancer at diagnosis in relation to relevant exposures, either minimally adjusted (for age, year of diagnosis, and region of residence) or fully adjusted (for all patient, tumour, and health-care provider variables). Findings: We identified 247 719 women who were diagnosed with invasive breast cancer between Jan 1, 2001, and Dec 31, 2014, with a mean age at diagnosis of 55·4 years (SD 13·3), of whom 36·2% (n=89 550) identified as white, 29·8% (n=73 826) as black or brown, and 0·7% (n=1639) as Asian or Indigenous. Prevalence of late-stage breast cancer at diagnosis remained high throughout 2001-14, at approximately 40%, was inversely associated with educational level (p value for linear trend <0·0001), and was higher for women who identified as black (minimally adjusted OR 1·61, 95% CI 1·53-1·70; fully adjusted OR 1·45, 95% CI 1·38-1·54) and brown (minimally adjusted OR 1·26, 95% CI 1·22-1·30; fully adjusted OR 1·18, 1·14-1·23) than those who identified as white. The predicted prevalence of late-stage cancer at diagnosis was highest for women who were black or brown with little or no formal education (48·8%, 95% CI 48·2-49·5) and lowest for women who were white with university education (29·4%, 28·2-30·6), but both these prevalences were higher than that of all women diagnosed with breast cancer in Norway before the introduction of mammography screening (ie, 16·3%, 95% CI 15·4%-17·2% in 1970-74). Similar ethnoracial and social patterns emerged in analyses restricted to the age group targeted by screening (50-69 years). Interpretation: The persistently high prevalence of late-stage breast cancer at diagnosis across all ethnoracial and social strata in Brazil, although more substantially among the most disadvantaged populations, implies that early detection policies might have had little effect on breast cancer mortality so far, and highlights the need to focus primarily on timely diagnosis of symptomatic breast cancer rather than on screening for asymptomatic disease. Funding: Newton Fund, Research Councils UK, and Conselho Nacional das Fundações Estaduais de Amparo à Pesquisa.

The Lancet. Global health · 56 citationsread the source →

Barriers and facilitators influencing the sustainment of health behaviour interventions in schools and childcare services: a systematic review.

Background: Sustainment has been defined as the sustained use or delivery of an intervention in practice following cessation of external implementation support. This review aimed to identify and synthesise factors (barriers and facilitators) that influence the sustainment of interventions (policies, practices, or programmes) in schools and childcare services that address the leading risk factors of chronic disease. Methods: Seven electronic databases and relevant reference lists were searched for articles, of any design, published in English, from inception to March 2020. Articles were included if they qualitatively and/or quantitatively reported on school or childcare stakeholders' (including teachers, principals, administrators, or managers) perceived barriers or facilitators to the sustainment of interventions addressing poor diet/nutrition, physical inactivity, obesity, tobacco smoking, or harmful alcohol use. Two independent reviewers screened texts, and extracted and coded data guided by the Integrated Sustainability Framework, an existing multi-level sustainability-specific framework that assesses factors of sustainment. Results: Of the 13,158 articles identified, 31 articles met the inclusion criteria (8 quantitative, 12 qualitative, 10 mixed-methods, and 1 summary article). Overall, 29 articles were undertaken in schools (elementary n=17, middle n=3, secondary n=4, or a combination n=5) and two in childcare settings. The main health behaviours targeted included physical activity (n=9), diet (n=3), both diet and physical activity (n=15), and smoking (n=4), either independently (n=1) or combined with other health behaviours (n=3). Findings suggest that the majority of the 59 barriers and 74 facilitators identified to impact on intervention sustainment were similar across school and childcare settings. Factors predominantly relating to the 'inner contextual factors' of the organisation including: availability of facilities or equipment, continued executive or leadership support present, and team cohesion, support, or teamwork were perceived by stakeholders as influential to intervention sustainment. Conclusions: Identifying strategies to improve the sustainment of health behaviour interventions in these settings requires a comprehensive understanding of factors that may impede or promote their ongoing delivery. This review identified multi-level factors that can be addressed by strategies to improve the sustainment of such interventions, and suggests how future research might address gaps in the evidence base. Trial registration: This review was prospectively registered on PROSPERO: CRD42020127869 , Jan. 2020.

Implementation science : IS · systematic review · 126 citationsread the source →

What do older people think that others think of them, and does it matter? The role of meta-perceptions and social norms in the prediction of perceived age discrimination.

Psychological theories of aging highlight the importance of social context. However, very little research has distinguished empirically between older people's perception of how others in their social context perceive them (personal meta-perceptions) and the shared perceptions in society (societal meta-perceptions). Drawing on theories of intergroup relations and stereotyping and using a multilevel perspective, this article examines how well older people's perceptions of age discrimination (PAD) are predicted by (a) older people's personal meta-perceptions, (b) societal meta-perceptions, and (c) social norms of intolerance toward age prejudice. Aging meta-perceptions are differentiated into the cognitive and affective components of ageism. Multilevel analyses of data from the European Social Survey (Nover 70 years of age = 8,123, 29 countries; European Social Survey (ESS) Round 4 Data, 2008) confirmed that older people's personal meta-perceptions of negative age stereotypes and specific intergroup emotions (pity, envy, contempt) are associated with higher PAD. However, at the societal-level, only paternalistic meta-perceptions were consistently associated with greater PAD. The results show that a few meta-perceptions operate only as a psychological phenomenon in explaining PAD, some carry consonant, and others carry contrasting effects at the societal-level of analysis. This evidence extends previous research on aging meta-perceptions by showing that both the content of meta-perceptions and the level of analysis at which they are assessed make distinct contributions to PAD. Moreover, social norms of intolerance of age prejudice have a larger statistical effect than societal meta-perceptions. Social interventions would benefit from considering these differential findings. (PsycINFO Database Record

Psychology and aging · 20 citationsread the source →

[Global health of unaccompanied refugee minors in Gironde (France) between 2011 and 2013].

Unlabelled: The lack of clinical practice recommendations for the care of the Unaccompanied Refugee Minors (URM) causes significant disparities depending on which department they arrive. By studying their global health we're willing to promote a standard of care for them. Methods: Data descriptive study from a systematic medical procedure proposed to URM who came in Gironde between January, 2011 and December, 2013. Results: 235 URM were included, from Africa (71%), Asia (21%) and from Eastern Europe (8%). Among them, 143 medical files were complete. The most frenquently diagnosed diseases, and/or the most serious, were digestive parasitoses (50%), schistosomiasis (7%), filariasis (6%), hepatitis B (chronic 6%, seroprevalence 28%), iron deficiency (26%, 4 % with anaemia), G6PD deficiency (8%) and tooth decays (29%). About mental disorders, 45% of the URM had a clinical presentation compatible with post-traumatic stress disorder, 4% had suicidal thoughts. Conclusion: URM accumulate the health risks of teenagers and those of illegal immigrants. Consequently they require an oriented and particular care.

Bulletin de la Societe de pathologie exotique (1990) · 10 citationsread the source →

Psychological responses, mental health, and sense of agency for the dual challenges of climate change and the COVID-19 pandemic in young people in the UK: an online survey study.

Background: The COVID-19 pandemic and climate change are both significant and pressing global challenges, posing threats to public health and wellbeing. Young people are particularly vulnerable to the distress both crises can cause, but understanding of the varied psychological responses to both issues is poor. We aimed to investigate these responses and their links with mental health conditions and feelings of agency. Methods: We conducted an online survey between Aug 5 and Oct 26, 2020, targeting a diverse sample of young people (aged 16-24 years, n=530) in the UK. The survey was distributed using a combination of a survey panel (panel sample) and direct approaches to youth groups and schools who shared the survey with young people in their networks (community sample). We collected data on respondents' psychological responses to both climate change and the COVID-19 pandemic, their sense of agency to respond to each crisis, and the range of impacts on their lives. We also collected demographics data and screened for mental health and wellbeing indicators. We used non-parametric tests for most statistical comparisons. For paired samples, we used Wilcoxon's signed-rank test, and used Mann-Whitney U-tests or Kruskal-Wallis tests for two or more independent samples. Summed scale scores were considered as interval-level data and analysed with Student's t tests and ANOVAs. Effect sizes are reported as Cohen's d and partial eta-squared (η·2p), respectively. Findings: After excluding 18 suspected bots and 94 incomplete responses, 530 responses were retained for analysis. Of the 518 respondents who provided demographic data, 63% were female, 71·4% were White, and the mean family affluence score was 8·22 (SD 2·29). Most participants (n=343; 70%) did not report a history of diagnosis or treatment for a mental health disorder, but mental health scores indicated a common experience of (relatively mild) symptoms of anxiety, depression, and stress. Although UK youth reported more life disruption and concern for their future due to the COVID-19 pandemic, climate change was associated with significantly greater distress overall, particularly for individuals with low levels of generalised anxiety. The COVID-19 pandemic was more associated with feelings of anxiety, isolation, disconnection, and frustration; distress around loss and grief; and effects on quality of life. Climate change was more likely to evoke emotions such as interest and engagement, guilt, shame, anger, and disgust. The greater distress attributed to climate change overall was due, in particular, to higher levels of guilt, sense of personal responsibility, and greater distress triggered by upsetting media coverage. Agency to address climate change was associated with greater climate distress, but pandemic-related distress and agency were unrelated. Interpretation: The COVID-19 pandemic and climate change are affecting the wellbeing of UK young people in distinct ways, with implications for health service, policy, and research responses. There is a need for mental health practitioners, policy makers, and other societal actors to account for the complex relationship between climate agency, distress, and mental wellbeing in young people. Funding: Imperial College London.

The Lancet. Planetary health · 47 citationsread the source →

Parental limited English proficiency and health outcomes for children with special health care needs: a systematic review.

Background: One in 10 US adults of childbearing age has limited English proficiency (LEP). Parental LEP is associated with worse health outcomes among healthy children. The relationship of parental LEP to health outcomes for children with special health care needs (CSHCN) has not been systematically reviewed. Objective: To conduct a systematic review of peer-reviewed literature examining relationships between parental LEP and health outcomes for CSHCN. Data sources: PubMed, Scopus, Cochrane Library, Social Science Abstracts, bibliographies of included studies. Key search term categories: language, child, special health care needs, and health outcomes. Eligibility criteria: US studies published between 1964 and 2012 were included if: 1) subjects were CSHCN; 2) studies included some measure of parental LEP; 3) at least 1 outcome measure of child health status, access, utilization, costs, or quality; and 4) primary or secondary data analysis. Methods: Three trained reviewers independently screened studies and extracted data. Two separate reviewers appraised studies for methodological rigor and quality. Results: From 2765 titles and abstracts, 31 studies met eligibility criteria. Five studies assessed child health status, 12 assessed access, 8 assessed utilization, 2 assessed costs, and 14 assessed quality. Nearly all (29 of 31) studies used only parent- or child-reported outcome measures, rather than objective measures. LEP parents were substantially more likely than English-proficient parents to report that their CSHCN were uninsured and had no usual source of care or medical home. LEP parents were also less likely to report family-centered care and satisfaction with care. Disparities persisted for children with LEP parents after adjustment for ethnicity and socioeconomic status. Conclusions and implications: Parental LEP is independently associated with worse health care access and quality for CSHCN. Health care providers should recognize LEP as an independent risk factor for poor health outcomes among CSHCN. Emerging models of chronic disease care should integrate and evaluate interventions that target access and quality disparities for LEP families.

Academic pediatrics · systematic review · 129 citationsread the source →

Loneliness and social isolation as risk factors for coronary heart disease and stroke: systematic review and meta-analysis of longitudinal observational studies.

Background: The influence of social relationships on morbidity is widely accepted, but the size of the risk to cardiovascular health is unclear. Objective: We undertook a systematic review and meta-analysis to investigate the association between loneliness or social isolation and incident coronary heart disease (CHD) and stroke. Methods: Sixteen electronic databases were systematically searched for longitudinal studies set in high-income countries and published up until May 2015. Two independent reviewers screened studies for inclusion and extracted data. We assessed quality using a component approach and pooled data for analysis using random effects models. Results: Of the 35 925 records retrieved, 23 papers met inclusion criteria for the narrative review. They reported data from 16 longitudinal datasets, for a total of 4628 CHD and 3002 stroke events recorded over follow-up periods ranging from 3 to 21 years. Reports of 11 CHD studies and 8 stroke studies provided data suitable for meta-analysis. Poor social relationships were associated with a 29% increase in risk of incident CHD (pooled relative risk: 1.29, 95% CI 1.04 to 1.59) and a 32% increase in risk of stroke (pooled relative risk: 1.32, 95% CI 1.04 to 1.68). Subgroup analyses did not identify any differences by gender. Conclusions: Our findings suggest that deficiencies in social relationships are associated with an increased risk of developing CHD and stroke. Future studies are needed to investigate whether interventions targeting loneliness and social isolation can help to prevent two of the leading causes of death and disability in high-income countries. Study registration number: CRD42014010225.

Heart (British Cardiac Society) · meta-analysis · 1198 citationsread the source →

Prevalence of Anterior Pituitary Dysfunction Twelve Months or More following Traumatic Brain Injury in Adults: A Systematic Review and Meta-Analysis.

The objective of this study is to systematically review clinical studies that have reported on the prevalence of chronic post-traumatic brain injury anterior pituitary dysfunction (PTPD) 12 months or more following traumatic brain injury (TBI). We searched Medline, Embase, and PubMed up to April 2017 and consulted bibliographies of narrative reviews. We included cohort, case-control, and cross-sectional studies enrolling at least five adults with primary TBI in whom at least one anterior pituitary axis was assessed at least 12 months following TBI. We excluded studies in which other brain injuries were indistinguishable from TBI. Study quality was assessed using the Newcastle-Ottawa Scale (NOS) score. We also considered studies that determined growth hormone deficiency and adrenocorticotrophic hormone reserve using provocation test to be at low risk of bias. Data were extracted by four independent reviewers and assessed for risk of bias using a data extraction form. We performed meta-analyses using random effect models and assessed heterogeneity using the I2 index. We identified 58 publications, of which 29 (2756 participants) were selected for meta-analysis. Twelve of these were deemed to be at low risk of bias and therefore "high-quality," as they had NOS scores greater than 8 and had used provocation tests. The overall prevalence of at least one anterior pituitary hormone dysfunction for all 29 studies was 32% (95% confidence interval [CI] 25-38%). The overall prevalence in the 12 high-quality studies was 34% (95% CI 27-42%). We observed significant heterogeneity that was not solely explained by the risk of bias. Studies with a higher proportion of participants with mild TBI had a lower prevalence of PTPD. Our results show that approximately one-third of TBI sufferers have persistent anterior pituitary dysfunction 12 months or more following trauma. Future research on PTPD should differentiate between mild and moderate/severe TBI.

Journal of neurotrauma · meta-analysis · 37 citationsread the source →

Psychological treatments for depression and anxiety in dementia and mild cognitive impairment.

Background: Experiencing anxiety and depression is very common in people living with dementia and mild cognitive impairment (MCI). There is uncertainty about the best treatment approach. Drug treatments may be ineffective and associated with adverse effects. Guidelines recommend psychological treatments. In this updated systematic review, we investigated the effectiveness of different psychological treatment approaches. Objectives: Primary objective To assess the clinical effectiveness of psychological interventions in reducing depression and anxiety in people with dementia or MCI. Secondary objectives To determine whether psychological interventions improve individuals' quality of life, cognition, activities of daily living (ADL), and reduce behavioural and psychological symptoms of dementia, and whether they improve caregiver quality of life or reduce caregiver burden. Search methods: We searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE, Embase, four other databases, and three trials registers on 18 February 2021. Selection criteria: We included randomised controlled trials (RCTs) that compared a psychological intervention for depression or anxiety with treatment as usual (TAU) or another control intervention in people with dementia or MCI. Data collection and analysis: A minimum of two authors worked independently to select trials, extract data, and assess studies for risk of bias. We classified the included psychological interventions as cognitive behavioural therapies (cognitive behavioural therapy (CBT), behavioural activation (BA), problem-solving therapy (PST)); 'third-wave' therapies (such as mindfulness-based cognitive therapy (MBCT)); supportive and counselling therapies; and interpersonal therapies. We compared each class of intervention with control. We expressed treatment effects as standardised mean differences or risk ratios. Where possible, we pooled data using a fixed-effects model. We used GRADE methods to assess the certainty of the evidence behind each result. Main results: We included 29 studies with 2599 participants. They were all published between 1997 and 2020. There were 15 trials of cognitive behavioural therapies (4 CBT, 8 BA, 3 PST), 11 trials of supportive and counselling therapies, three trials of MBCT, and one of interpersonal therapy. The comparison groups received either usual care, attention-control education, or enhanced usual care incorporating an active control condition that was not a specific psychological treatment. There were 24 trials of people with a diagnosis of dementia, and five trials of people with MCI. Most studies were conducted in community settings. We considered none of the studies to be at low risk of bias in all domains.  Cognitive behavioural therapies (CBT, BA, PST) Cognitive behavioural therapies are probably slightly better than treatment as usual or active control conditions for reducing depressive symptoms (standardised mean difference (SMD) -0.23, 95% CI -0.37 to -0.10; 13 trials, 893 participants; moderate-certainty evidence). They may also increase rates of depression remission at the end of treatment (risk ratio (RR) 1.84, 95% CI 1.18 to 2.88; 2 studies, with one study contributing 2 independent comparisons, 146 participants; low-certainty evidence). We were very uncertain about the effect of cognitive behavioural therapies on anxiety at the end of treatment (SMD -0.03, 95% CI -0.36 to 0.30; 3 trials, 143 participants; very low-certainty evidence). Cognitive behavioural therapies probably improve patient quality of life (SMD 0.31, 95% CI 0.13 to 0.50; 7 trials, 459 participants; moderate-certainty evidence) and activities of daily living at end of treatment compared to treatment as usual or active control (SMD -0.25, 95% CI -0.40 to -0.09; 7 trials, 680 participants; moderate-certainty evidence). Supportive and counselling interventions Meta-analysis showed that supportive and counselling interventions may have little or no effect on depressive symptoms in people with dementia compared to usual care at end of treatment (SMD -0.05, 95% CI -0.18 to 0.07; 9 trials, 994 participants; low-certainty evidence). We were very uncertain about the effects of these treatments on anxiety, which was assessed only in one small pilot study. Other interventions There were very few data and very low-certainty evidence on MBCT and interpersonal therapy, so we were unable to draw any conclusions about the effectiveness of these interventions. Authors' conclusions: CBT-based treatments added to usual care probably slightly reduce symptoms of depression for people with dementia and MCI and may increase rates of remission of depression. There may be important effect modifiers (degree of baseline depression, cognitive diagnosis, or content of the intervention). CBT-based treatments probably also have a small positive effect on quality of life and activities of daily living. Supportive and counselling interventions may not improve symptoms of depression in people with dementia. Effects of both types of treatment on anxiety symptoms are very uncertain. We are also uncertain about the effects of other types of psychological treatments, and about persistence of effects over time. To inform clinical guidelines, future studies should assess detailed components of these interventions and their implementation in different patient populations and in different settings.

The Cochrane database of systematic reviews · meta-analysis · 57 citationsread the source →

Parental education and inequalities in child mortality: a global systematic review and meta-analysis.

Background: The educational attainment of parents, particularly mothers, has been associated with lower levels of child mortality, yet there is no consensus on the magnitude of this relationship globally. We aimed to estimate the total reductions in under-5 mortality that are associated with increased maternal and paternal education, during distinct age intervals. Methods: This study is a comprehensive global systematic review and meta-analysis of all existing studies of the effects of parental education on neonatal, infant, and under-5 child mortality, combined with primary analyses of Demographic and Health Survey (DHS) data. The literature search of seven databases (CINAHL, Embase, MEDLINE, PsycINFO, PubMed, Scopus, and Web of Science) was done between Jan 23 and Feb 8, 2019, and updated on Jan 7, 2021, with no language or publication date restrictions. Teams of independent reviewers assessed each record for its inclusion of individual-level data on parental education and child mortality and excluded articles on the basis of study design and availability of relevant statistics. Full-text screening was done in 15 languages. Data extracted from these studies were combined with primary microdata from the DHS for meta-analyses relating maternal or paternal education with mortality at six age intervals: 0-27 days, 1-11 months, 1-4 years, 0-4 years, 0-11 months, and 1 month to 4 years. Novel mixed-effects meta-regression models were implemented to address heterogeneity in referent and exposure measures among the studies and to adjust for study-level covariates (wealth or income, partner's years of schooling, and sex of the child). This study was registered with PROSPERO (CRD42020141731). Findings: The systematic review returned 5339 unique records, yielding 186 included studies after exclusions. DHS data were compiled from 114 unique surveys, capturing 3 112 474 livebirths. Data extracted from the systematic review were synthesized together with primary DHS data, for meta-analysis on a total of 300 studies from 92 countries. Both increased maternal and paternal education showed a dose-response relationship linked to reduced under-5 mortality, with maternal education emerging as a stronger predictor. We observed a reduction in under-5 mortality of 31·0% (95% CI 29·0-32·6) for children born to mothers with 12 years of education (ie, completed secondary education) and 17·3% (15·0-18·8) for children born to fathers with 12 years of education, compared with those born to a parent with no education. We also showed that a single additional year of schooling was, on average, associated with a reduction in under-5 mortality of 3·04% (2·82-3·23) for maternal education and 1·57% (1·35-1·72) for paternal education. The association between higher parental education and lower child mortality was significant for both parents at all ages studied and was largest after the first month of life. The meta-analysis framework incorporated uncertainty associated with each individual effect size into the model fitting process, in an effort to decrease the risk of bias introduced by study design and quality. Interpretation: To our knowledge, this study is the first effort to systematically quantify the transgenerational importance of education for child survival at the global level. The results showed that lower maternal and paternal education are both risk factors for child mortality, even after controlling for other markers of family socioeconomic status. This study provides robust evidence for universal quality education as a mechanism to achieve the Sustainable Development Goal target 3.2 of reducing neonatal and child mortality. Funding: Research Council of Norway, Bill & Melinda Gates Foundation, and Rockefeller Foundation-Boston University Commission on Social Determinants, Data, and Decision Making (3-D Commission).

Lancet (London, England) · meta-analysis · 132 citationsread the source →

Psychosocial Interventions and Immune System Function: A Systematic Review and Meta-analysis of Randomized Clinical Trials.

Importance: Recent estimates suggest that more than 50% of all deaths worldwide are currently attributable to inflammation-related diseases. Psychosocial interventions may represent a potentially useful strategy for addressing this global public health problem, but which types of interventions reliably improve immune system function, under what conditions, and for whom are unknown. Objective: To address this issue, we conducted a systematic review and meta-analysis of randomized clinical trials (RCTs) in which we estimated associations between 8 different psychosocial interventions and 7 markers of immune system function, and examined 9 potential moderating factors. Data sources: PubMed, Scopus, PsycInfo, and ClinicalTrials.gov databases were systematically searched from February 1, 2017, to December 31, 2018, for all relevant RCTs published through December 31, 2018. Study selection: Eligible RCTs included a psychosocial intervention, immune outcome, and preintervention and postintervention immunologic assessments. Studies were independently examined by 2 investigators. Of 4621 studies identified, 62 were eligible and 56 included. Data extraction and synthesis: Data were extracted and analyzed from January 1, 2019, to July 29, 2019. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline was followed. Data were extracted by 2 investigators who were blind to study hypotheses and analyses, and were then analyzed using robust variance estimation. Analysis included 8 psychosocial interventions (behavior therapy, cognitive therapy, cognitive behavior therapy [CBT], CBT plus additive treatment or mode of delivery that augmented the CBT, bereavement or supportive therapy, multiple or combined interventions, other psychotherapy, and psychoeducation), 7 immune outcomes (proinflammatory cytokine or marker levels, anti-inflammatory cytokine levels, antibody levels, immune cell counts, natural killer cell activity, viral load, and other immune outcomes), and 9 moderating factors (intervention type, intervention format, intervention length, immune marker type, basal vs stimulated markers, immune marker measurement timing, disease state or reason for treatment, age, and sex). Main outcomes and measures: The primary a priori outcomes were pretest-posttest-control (ppc) group effect sizes (ppc g) for the 7 immunologic outcomes investigated. Results: Across 56 RCTs and 4060 participants, psychosocial interventions were associated with enhanced immune system function (ppc g = 0.30, 95% CI, 0.21-0.40; t50.9 = 6.22; P < .001). Overall, being randomly assigned to a psychosocial intervention condition vs a control condition was associated with a 14.7% (95% CI, 5.7%-23.8%) improvement in beneficial immune system function and an 18.0% (95% CI, 7.2%-28.8%) decrease in harmful immune system function over time. These associations persisted for at least 6 months following treatment and were robust across age, sex, and intervention duration. These associations were most reliable for CBT (ppc g = 0.33, 95% CI, 0.19-0.47; t27.2 = 4.82; P < .001) and multiple or combined interventions (ppc g = 0.52, 95% CI, 0.17-0.88; t5.7 = 3.63; P = .01), and for studies that assessed proinflammatory cytokines or markers (ppc g = 0.33, 95% CI, 0.19-0.48; t25.6 = 4.70; P < .001). Conclusions and relevance: These findings suggest that psychosocial interventions are reliably associated with enhanced immune system function and may therefore represent a viable strategy for improving immune-related health.

JAMA psychiatry · meta-analysis · 187 citationsread the source →

Educational and psychological interventions for managing atopic dermatitis (eczema).

Background: Atopic dermatitis (eczema), can have a significant impact on well-being and quality of life for affected people and their families. Standard treatment is avoidance of triggers or irritants and regular application of emollients and topical steroids or calcineurin inhibitors. Thorough physical and psychological assessment is central to good-quality treatment. Overcoming barriers to provision of holistic treatment in dermatological practice is dependent on evaluation of the efficacy and economics of both psychological and educational interventions in this participant group. This review is based on a previous Cochrane review published in 2014, and now includes adults as well as children. Objectives: To assess the clinical outcomes of educational and psychological interventions in children and adults with atopic dermatitis (eczema) and to summarise the availability and principal findings of relevant economic evaluations. Search methods: We searched the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, APA PsycINFO and two trials registers up to March 2023. We checked the reference lists of included studies and related systematic reviews for further references to relevant randomised controlled trials (RCTs) and contacted experts in the field to identify additional studies. We searched NHS Economic Evaluation Database, MEDLINE and Embase for economic evaluations on 8 June 2022. Selection criteria: Randomised, cluster-randomised and cross-over RCTs that assess educational and psychological interventions for treating eczema in children and adults. Data collection and analysis: We used standard Cochrane methods, with GRADE to assess the certainty of the evidence for each outcome. Primary outcomes were reduction in disease severity, as measured by clinical signs, patient-reported symptoms and improvement in health-related quality-of-life (HRQoL) measures. Secondary outcomes were improvement in long-term control of symptoms, improvement in psychological well-being, improvement in standard treatment concordance and adverse events. We assessed short- (up to 16 weeks after treatment) and long-term time points (more than 16 weeks). Main results: We included 37 trials (6170 participants). Most trials were conducted in high-income countries (34/37), in outpatient settings (25/37). We judged three trials to be low risk of bias across all domains. Fifteen trials had a high risk of bias in at least one domain, mostly due to bias in measurement of the outcome. Trials assessed interventions compared to standard care. Individual educational interventions may reduce short-term clinical signs (measured by SCORing Atopic Dermatitis (SCORAD); mean difference (MD) -5.70, 95% confidence interval (CI) -9.39 to -2.01; 1 trial, 30 participants; low-certainty evidence) but patient-reported symptoms, HRQoL, long-term eczema control and psychological well-being were not reported. Group education interventions probably reduce clinical signs (SCORAD) both in the short term (MD -9.66, 95% CI -19.04 to -0.29; 3 studies, 731 participants; moderate-certainty evidence) and the long term (MD -7.22, 95% CI -11.01 to -3.43; 3 studies, 1424 participants; moderate-certainty evidence) and probably reduce long-term patient-reported symptoms (SMD -0.47 95% CI -0.60 to -0.33; 2 studies, 908 participants; moderate-certainty evidence). They may slightly improve short-term HRQoL (SMD -0.19, 95% CI -0.36 to -0.01; 4 studies, 746 participants; low-certainty evidence), but may make little or no difference to short-term psychological well-being (Perceived Stress Scale (PSS); MD -2.47, 95% CI -5.16 to 0.22; 1 study, 80 participants; low-certainty evidence). Long-term eczema control was not reported. We don't know whether technology-mediated educational interventions could improve short-term clinical signs (SCORAD; 1 study; 29 participants; very low-certainty evidence). They may have little or no effect on short-term patient-reported symptoms (Patient Oriented Eczema Measure (POEM); MD -0.76, 95% CI -1.84 to 0.33; 2 studies; 195 participants; low-certainty evidence) and probably have little or no effect on short-term HRQoL (MD 0, 95% CI -0.03 to 0.03; 2 studies, 430 participants; moderate-certainty evidence). Technology-mediated education interventions probably slightly improve long-term eczema control (Recap of atopic eczema (RECAP); MD -1.5, 95% CI -3.13 to 0.13; 1 study, 232 participants; moderate-certainty evidence), and may improve short-term psychological well-being (MD -1.78, 95% CI -2.13 to -1.43; 1 study, 24 participants; low-certainty evidence). Habit reversal treatment may reduce short-term clinical signs (SCORAD; MD -6.57, 95% CI -13.04 to -0.1; 1 study, 33 participants; low-certainty evidence) but we are uncertain about any effects on short-term HRQoL (Children's Dermatology Life Quality Index (CDLQI); 1 study, 30 participants; very low-certainty evidence). Patient-reported symptoms, long-term eczema control and psychological well-being were not reported. We are uncertain whether arousal reduction therapy interventions could improve short-term clinical signs (Eczema Area and Severity Index (EASI); 1 study, 24 participants; very low-certainty evidence) or patient-reported symptoms (visual analogue scale (VAS); 1 study, 18 participants; very low-certainty evidence). Arousal reduction therapy may improve short-term HRQoL (Dermatitis Family Impact (DFI); MD -2.1, 95% CI -4.41 to 0.21; 1 study, 91 participants; low-certainty evidence) and psychological well-being (PSS; MD -1.2, 95% CI -3.38 to 0.98; 1 study, 91 participants; low-certainty evidence). Long-term eczema control was not reported. No studies reported standard care compared with self-help psychological interventions, psychological therapies or printed education; or adverse events. We identified two health economic studies. One found that a 12-week, technology-mediated, educational-support programme may be cost neutral. The other found that a nurse practitioner group-education intervention may have lower costs than standard care provided by a dermatologist, with comparable effectiveness. Authors' conclusions: In-person, individual education, as an adjunct to conventional topical therapy, may reduce short-term eczema signs compared to standard care, but there is no information on eczema symptoms, quality of life or long-term outcomes. Group education probably reduces eczema signs and symptoms in the long term and may also improve quality of life in the short term. Favourable effects were also reported for technology-mediated education, habit reversal treatment and arousal reduction therapy. All favourable effects are of uncertain clinical significance, since they may not exceed the minimal clinically important difference (MCID) for the outcome measures used (MCID 8.7 points for SCORAD, 3.4 points for POEM). We found no trials of self-help psychological interventions, psychological therapies or printed education. Future trials should include more diverse populations, address shared priorities, evaluate long-term outcomes and ensure patients are involved in trial design.

The Cochrane database of systematic reviews · meta-analysis · 14 citationsread the source →

Nicotine receptor partial agonists for smoking cessation.

Background: Nicotine receptor partial agonists may help people to stop smoking by a combination of maintaining moderate levels of dopamine to counteract withdrawal symptoms (acting as an agonist) and reducing smoking satisfaction (acting as an antagonist). Objectives: To review the efficacy of nicotine receptor partial agonists, including varenicline and cytisine, for smoking cessation. Search methods: We searched the Cochrane Tobacco Addiction Group's specialised register for trials, using the terms ('cytisine' or 'Tabex' or 'dianicline' or 'varenicline' or 'nicotine receptor partial agonist') in the title or abstract, or as keywords. The register is compiled from searches of MEDLINE, EMBASE, and PsycINFO using MeSH terms and free text to identify controlled trials of interventions for smoking cessation and prevention. We contacted authors of trial reports for additional information where necessary. The latest update of the specialised register was in May 2015, although we have included a few key trials published after this date. We also searched online clinical trials registers. Selection criteria: We included randomised controlled trials which compared the treatment drug with placebo. We also included comparisons with bupropion and nicotine patches where available. We excluded trials which did not report a minimum follow-up period of six months from start of treatment. Data collection and analysis: We extracted data on the type of participants, the dose and duration of treatment, the outcome measures, the randomisation procedure, concealment of allocation, and completeness of follow-up. The main outcome measured was abstinence from smoking at longest follow-up. We used the most rigorous definition of abstinence, and preferred biochemically validated rates where they were reported. Where appropriate we pooled risk ratios (RRs), using the Mantel-Haenszel fixed-effect model. Main results: Two trials of cytisine (937 people) found that more participants taking cytisine stopped smoking compared with placebo at longest follow-up, with a pooled risk ratio (RR) of 3.98 (95% confidence interval (CI) 2.01 to 7.87; low-quality evidence). One recent trial comparing cytisine with NRT in 1310 people found a benefit for cytisine at six months (RR 1.43, 95% CI 1.13 to 1.80).One trial of dianicline (602 people) failed to find evidence that it was effective (RR 1.20, 95% CI 0.82 to 1.75). This drug is no longer in development. We identified 39 trials that tested varenicline, 27 of which contributed to the primary analysis (varenicline versus placebo). Five of these trials also included a bupropion treatment arm. Eight trials compared varenicline with nicotine replacement therapy (NRT). Nine studies tested variations in varenicline dosage, and 13 tested usage in disease-specific subgroups of patients. The included studies covered 25,290 participants, 11,801 of whom used varenicline. The pooled RR for continuous or sustained abstinence at six months or longer for varenicline at standard dosage versus placebo was 2.24 (95% CI 2.06 to 2.43; 27 trials, 12,625 people; high-quality evidence). Varenicline at lower or variable doses was also shown to be effective, with an RR of 2.08 (95% CI 1.56 to 2.78; 4 trials, 1266 people). The pooled RR for varenicline versus bupropion at six months was 1.39 (95% CI 1.25 to 1.54; 5 trials, 5877 people; high-quality evidence). The RR for varenicline versus NRT for abstinence at 24 weeks was 1.25 (95% CI 1.14 to 1.37; 8 trials, 6264 people; moderate-quality evidence). Four trials which tested the use of varenicline beyond the 12-week standard regimen found the drug to be well-tolerated during long-term use. The number needed to treat with varenicline for an additional beneficial outcome, based on the weighted mean control rate, is 11 (95% CI 9 to 13). The most commonly reported adverse effect of varenicline was nausea, which was mostly at mild to moderate levels and usually subsided over time. Our analysis of reported serious adverse events occurring during or after active treatment suggests there may be a 25% increase in the chance of SAEs among people using varenicline (RR 1.25; 95% CI 1.04 to 1.49; 29 trials, 15,370 people; high-quality evidence). These events include comorbidities such as infections, cancers and injuries, and most were considered by the trialists to be unrelated to the treatments. There is also evidence of higher losses to follow-up in the control groups compared with the intervention groups, leading to a likely underascertainment of the true rate of SAEs among the controls. Early concerns about a possible association between varenicline and depressed mood, agitation, and suicidal behaviour or ideation led to the addition of a boxed warning to the labelling in 2008. However, subsequent observational cohort studies and meta-analyses have not confirmed these fears, and the findings of the EAGLES trial do not support a causal link between varenicline and neuropsychiatric disorders, including suicidal ideation and suicidal behaviour. The evidence is not conclusive, however, in people with past or current psychiatric disorders. Concerns have also been raised that varenicline may slightly increase cardiovascular events in people already at increased risk of those illnesses. Current evidence neither supports nor refutes such an association, but we await the findings of the CATS trial, which should establish whether or not this is a valid concern. Authors' conclusions: Cytisine increases the chances of quitting, although absolute quit rates were modest in two recent trials. Varenicline at standard dose increased the chances of successful long-term smoking cessation between two- and three-fold compared with pharmacologically unassisted quit attempts. Lower dose regimens also conferred benefits for cessation, while reducing the incidence of adverse events. More participants quit successfully with varenicline than with bupropion or with NRT. Limited evidence suggests that varenicline may have a role to play in relapse prevention. The most frequently recorded adverse effect of varenicline is nausea, but mostly at mild to moderate levels and tending to subside over time. Early reports of possible links to suicidal ideation and behaviour have not been confirmed by current research. Future trials of cytisine may test extended regimens and more intensive behavioural support.

The Cochrane database of systematic reviews · meta-analysis · 234 citationsread the source →

Accuracy of Wristband Fitbit Models in Assessing Sleep: Systematic Review and Meta-Analysis.

Background: Wearable sleep monitors are of high interest to consumers and researchers because of their ability to provide estimation of sleep patterns in free-living conditions in a cost-efficient way. Objective: We conducted a systematic review of publications reporting on the performance of wristband Fitbit models in assessing sleep parameters and stages. Methods: In adherence with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement, we comprehensively searched the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane, Embase, MEDLINE, PubMed, PsycINFO, and Web of Science databases using the keyword Fitbit to identify relevant publications meeting predefined inclusion and exclusion criteria. Results: The search yielded 3085 candidate articles. After eliminating duplicates and in compliance with inclusion and exclusion criteria, 22 articles qualified for systematic review, with 8 providing quantitative data for meta-analysis. In reference to polysomnography (PSG), nonsleep-staging Fitbit models tended to overestimate total sleep time (TST; range from approximately 7 to 67 mins; effect size=-0.51, P<.001; heterogenicity: I2=8.8%, P=.36) and sleep efficiency (SE; range from approximately 2% to 15%; effect size=-0.74, P<.001; heterogenicity: I2=24.0%, P=.25), and underestimate wake after sleep onset (WASO; range from approximately 6 to 44 mins; effect size=0.60, P<.001; heterogenicity: I2=0%, P=.92) and there was no significant difference in sleep onset latency (SOL; P=.37; heterogenicity: I2=0%, P=.92). In reference to PSG, nonsleep-staging Fitbit models correctly identified sleep epochs with accuracy values between 0.81 and 0.91, sensitivity values between 0.87 and 0.99, and specificity values between 0.10 and 0.52. Recent-generation Fitbit models that collectively utilize heart rate variability and body movement to assess sleep stages performed better than early-generation nonsleep-staging ones that utilize only body movement. Sleep-staging Fitbit models, in comparison to PSG, showed no significant difference in measured values of WASO (P=.25; heterogenicity: I2=0%, P=.92), TST (P=.29; heterogenicity: I2=0%, P=.98), and SE (P=.19) but they underestimated SOL (P=.03; heterogenicity: I2=0%, P=.66). Sleep-staging Fitbit models showed higher sensitivity (0.95-0.96) and specificity (0.58-0.69) values in detecting sleep epochs than nonsleep-staging models and those reported in the literature for regular wrist actigraphy. Conclusions: Sleep-staging Fitbit models showed promising performance, especially in differentiating wake from sleep. However, although these models are a convenient and economical means for consumers to obtain gross estimates of sleep parameters and time spent in sleep stages, they are of limited specificity and are not a substitute for PSG.

Journal of medical Internet research · meta-analysis · 310 citationsread the source →

Prevalence of Perinatal Depression and Anxiety in Both Parents: A Systematic Review and Meta-analysis.

Importance: New and expectant parents experience perinatal mood disorders, with consequences to parenting ability, bonding with the neonate, interpersonal relationships, and health and well-being of parents. Research shows that maternal and paternal perinatal mood disorders are associated, but no recent systematic review has addressed the prevalence of perinatal mood disorders in both mothers and fathers (parental dyad). Objective: To examine the prevalence of perinatal mood disorders in parental dyads and identify factors associated with perinatal mood disorders in parental dyads. Data sources: Ovid (MEDLINE, Embase, and PsycINFO) and Web of Science were searched from January 1, 1990, to June 8, 2021, for observational studies reporting on the prevalence of perinatal depression or anxiety in a parental dyad. Study selection: Studies reporting the prevalence of anxiety or depression in both members of a parental dyad were included, with diagnosis according to established criteria (Diagnostic and Statistical Manual of Mental Disorders [Fifth Edition], International Classification of Diseases, 11th Revision) or use of validated screening tools. Data extraction and synthesis: Prevalence data were extracted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Data were analyzed in subgroups: antenatal depression, early postnatal depression (0-12 weeks), late postnatal depression (3-12 months), and perinatal anxiety. Pooled prevalence was calculated using a random-effects meta-analysis model. Quality assessment was performed using Joanna Briggs Institute Appraisal Checklist for Studies Reporting Prevalence Data. Data were analyzed in June 2021. Main outcomes and measures: Prevalence of perinatal anxiety and perinatal depression in parental dyads. Results: Twenty-three studies were included, with data from 29 286 couples. The pooled prevalence of antenatal depression in both parents was 1.72% (95% CI, 0.96%-2.48%; P < .001). The prevalence of early postnatal depression (up to 12 weeks post partum) was 2.37% (95% CI, 1.66%-3.08%; P < .001) and the prevalence of late postnatal depression (3-12 months post partum) was 3.18% (95% CI, 2.3-4.05; P < .001). Only 3 studies reported on perinatal anxiety in both parents, precluding a quantitative analysis. Conclusions and relevance: In up to 3.18% of couples, both parents may concurrently experience perinatal depression. Perinatal health care must consider the mental health needs of parents, both as individuals and as a parental dyad. Further research is needed to examine outcomes in families where both parents experience perinatal mood disorders.

JAMA network open · meta-analysis · 88 citationsread the source →

Health system and community level interventions for improving antenatal care coverage and health outcomes.

Background: The World Health Organization (WHO) recommends at least four antenatal care (ANC) visits for all pregnant women. Almost half of pregnant women worldwide, and especially in developing countries do not receive this amount of care. Poor attendance of ANC is associated with delivery of low birthweight babies and more neonatal deaths. ANC may include education on nutrition, potential problems with pregnancy or childbirth, child care and prevention or detection of disease during pregnancy. This review focused on community-based interventions and health systems-related interventions. Objectives: To assess the effects of health system and community interventions for improving coverage of antenatal care and other perinatal health outcomes. Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (7 June 2015) and reference lists of retrieved studies. Selection criteria: We included randomised controlled trials (RCTs), quasi-randomised trials and cluster-randomised trials. Trials of any interventions to improve ANC coverage were eligible for inclusion. Trials were also eligible if they targeted specific and related outcomes, such as maternal or perinatal death, but also reported ANC coverage. Data collection and analysis: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Main results: We included 34 trials involving approximately 400,000 women. Some trials tested community-based interventions to improve uptake of antenatal care (media campaigns, education or financial incentives for pregnant women), while other trials looked at health systems interventions (home visits for pregnant women or equipment for clinics). Most trials took place in low- and middle-income countries, and 29 of the 34 trials used a cluster-randomised design. We assessed 30 of the 34 trials as of low or unclear overall risk of bias. Comparison 1: One intervention versus no interventionWe found marginal improvements in ANC coverage of at least four visits (average odds ratio (OR) 1.11, 95% confidence interval (CI) 1.01 to 1.22; participants = 45,022; studies = 10; Heterogeneity: Tau² = 0.01; I² = 52%; high quality evidence). Sensitivity analysis with a more conservative intra-cluster correlation co-efficient (ICC) gave similar marginal results. Excluding one study at high risk of bias shifted the marginal pooled estimate towards no effect. There was no effect on pregnancy-related deaths (average OR 0.69, 95% CI 0.45 to 1.08; participants = 114,930; studies = 10; Heterogeneity: Tau² = 0.00; I² = 0%; low quality evidence), perinatal mortality (average OR 0.98, 95% CI 0.90 to 1.07; studies = 15; Heterogeneity: Tau² = 0.01; I² = 58%; moderate quality evidence) or low birthweight (average OR 0.94, 95% CI 0.82 to 1.06; studies = five; Heterogeneity: Tau² = 0.00; I² = 5%; high quality evidence). Single interventions led to marginal improvements in the number of women who delivered in health facilities (average OR 1.08, 95% CI 1.02 to 1.15; studies = 10; Heterogeneity: Tau² = 0.00; I² = 0%; high quality evidence), and in the proportion of women who had at least one ANC visit (average OR 1.68, 95% CI 1.02 to 2.79; studies = six; Heterogeneity: Tau² = 0.24; I² = 76%; moderate quality evidence). Results for ANC coverage (at least four and at least one visit) and for perinatal mortality had substantial statistical heterogeneity. Single interventions did not improve the proportion of women receiving tetanus protection (average OR 1.03, 95% CI 0.92 to 1.15; studies = 8; Heterogeneity: Tau² = 0.01; I² = 57%). No study reported onintermittent prophylactic treatment for malaria. Comparison 2: Two or more interventions versus no interventionWe found no improvements in ANC coverage of four or more visits (average OR 1.48, 95% CI 0.99 to 2.21; participants = 7840; studies = six; Heterogeneity: Tau² = 0.10; I² = 48%; low quality evidence) or pregnancy-related deaths (average OR 0.70, 95% CI 0.39 to 1.26; participants = 13,756; studies = three; Heterogeneity: Tau² = 0.00; I² = 0%; moderate quality evidence). However, combined interventions led to improvements in ANC coverage of at least one visit (average OR 1.79, 95% CI 1.47 to 2.17; studies = five; Heterogeneity: Tau² = 0.00; I² = 0%; moderate quality evidence), perinatal mortality (average OR 0.74, 95% CI 0.57 to 0.95; studies = five; Heterogeneity: Tau² = 0.06; I² = 83%; moderate quality evidence) and low birthweight (average OR 0.61, 95% CI 0.46 to 0.80; studies = two; Heterogeneity: Tau² = 0.00; I² = 0%; moderate quality evidence). Meta-analyses for both ANC coverage four or more visits and perinatal mortality had substantial statistical heterogeneity. Combined interventions improved the proportion of women who had tetanus protection (average OR 1.48, 95% CI 1.18 to 1.87; studies = 3; Heterogeneity: Tau² = 0.01; I² = 33%). No trial in this comparison reported on intermittent prophylactic treatment for malaria. Comparison 3: Two interventions compared head to head. No trials found. Comparison 4: One intervention versus a combination of interventionsThere was no difference in ANC coverage (four or more visits and at least one visit), pregnancy-related deaths, deliveries in a health facility or perinatal mortality. No trials in this comparison reported on low birthweight orintermittent prophylactic treatment of malaria. Authors' conclusions: Implications for practice - Single interventions may improve ANC coverage (at least one visit and four or more visits) and deliveries in health facilities. Combined interventions may improve ANC coverage (at least one visit), reduce perinatal mortality and reduce the occurrence of low birthweight. The effects of the interventions are unrelated to whether they are community or health system interventions. Implications for research - More details should be provided in reporting numbers of events, group totals and the ICCs used to adjust for cluster effects. Outcomes should be reported uniformly so that they are comparable to commonly-used population indicators. We recommend further cluster-RCTs of pregnant women and women in their reproductive years, using combinations of interventions and looking at outcomes that are important to pregnant women, such as maternal and perinatal morbidity and mortality, alongside the explanatory outcomes along the pathway of care: ANC coverage, the services provided during ANC and deliveries in health facilities.

The Cochrane database of systematic reviews · meta-analysis · 117 citationsread the source →

Interventions for the treatment of metastatic extradural spinal cord compression in adults.

Background: Metastatic extradural spinal cord compression (MESCC) is treated with radiotherapy, corticosteroids, and surgery, but there is uncertainty regarding their comparative effects. This is an updated version of the original Cochrane review published in theCochrane Database of Systematic Reviews (Issue 4, 2008). Objectives: To determine the efficacy and safety of radiotherapy, surgery and corticosteroids in MESCC. Search methods: In March 2015, we updated previous searches (July 2008 and December 2013) of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, LILACS, CANCERLIT, clinical trials registries, conference proceedings, and references, without language restrictions. We also contacted experts for relevant published, unpublished and ongoing trials. Selection criteria: Randomised controlled trials (RCTs) of radiotherapy, surgery and corticosteroids in adults with MESCC. Data collection and analysis: Three authors independently screened and selected trials, assessed risk of bias, and extracted data. We sought clarifications from trial authors. Where possible, we pooled relative risks with their 95% confidence intervals, using a random effects model if heterogeneity was significant. We assessed overall evidence-quality using the GRADE approach. Main results: This update includes seven trials involving 876 (723 evaluable) adult participants (19 to 87 years) in high-income countries. Most were free of the risk of bias. Different radiotherapy doses and schedulesTwo equivalence trials in people with MESCC and a poor prognosis evaluated different radiotherapy doses and schedules. In one, a single dose (8 Gray (Gy)) of radiotherapy (RT) was as effective as short-course RT (16 Gy in two fractions over one week) in enhancing ambulation in the short term (65% versus 69%; risk ratio (RR) was 0.93, (95% confidence interval (CI) 0.82 to 1.04); 303 participants; moderate quality evidence). The regimens were also equally effective in reducing analgesic and narcotic use (34% versus 40%; RR 0.85, 95% CI 0.62 to 1.16; 271 participants), and in maintaining urinary continence (90% versus 87%; RR 1.03, 95% CI 0.96 to 1.1; 303 participants) in the short term (moderate quality evidence). In the other trial, split-course RT (30 Gy in eight fractions over two weeks) was no different from short-course RT in enhancing ambulation (70% versus 68%; RR 1.02, 95% CI 0.9 to 1.15; 276 participants); reducing analgesic and narcotic use (49% versus 38%; RR 1.27, 95% CI 0.96 to 1.67; 262 participants); and in maintaining urinary continence (87% versus 90%; RR 0.97, 0.93 to 1.02; 275 participants) in the short term (moderate quality evidence). Median survival was similar with the three RT regimens (four months). Local tumour recurrence may be more common with single-dose compared to short-course RT (6% versus 3%; RR 2.21, 95% CI 0.69 to 7.01; 303 participants) and with short-course compared to split-course RT (4% versus 0%; RR 0.1, 95% CI 0.01 to 1.72; 276 participants), but these differences were not statistically significant (low quality evidence). Gastrointestinal adverse effects were infrequent with the three RT regimens (moderate quality evidence), and serious adverse events or post-radiotherapy myelopathy were not noted. We did not find trials comparing radiotherapy schedules in people with MESCC and a good prognosis. Surgery plus radiotherapy compared to radiotherapyLaminectomy plus RT offered no advantage over RT in one small trial with 29 participants (very low quality evidence). In another trial that was stopped early for apparent benefit, decompressive surgery plus RT resulted in better ambulatory rates (84% versus 57%; RR 1.48, 95% CI 1.16 to 1.90; 101 participants, low quality evidence). Narcotic use may also be lower, and bladder control may also be maintained longer than with than RT in selected patients (low quality evidence). Median survival was longer after surgery (126 days versus 100 days), but the proportions surviving at one month (94% versus 86%; RR 1.09, 95% CI 0.96 to 1.24; 101 participants) did not differ significantly (low quality evidence). Serious adverse events were not noted. Significant benefits with surgery occurred only in people younger than 65 years. High dose corticosteroids compared to moderate dose or no corticosteroidsData from three small trials suggest that high-dose steroids may not differ from moderate-dose or no corticosteroids in enhancing ambulation (60% versus 55%; RR 1.08, 95% CI 0.81 to 1.45; 3 RCTs, 105 participants); survival over two years (11% versus 10%; RR 1.11, 95% CI 0.24 to 5.05; 1 RCT, 57 participants); pain reduction (78% versus 91%; RR 0.86, 95% CI 0.62 to 1.20; 1 RCT, 25 participants); or urinary continence (63% versus 53%; RR 1.18, 95% CI 0.66 to 2.13; 1 RCT, 34 participants; low quality evidence). Serious adverse effects were more frequent with high-dose corticosteroids (17% versus 0%; RR 8.02, 95% CI 1.03 to 62.37; 2 RCTs, 77 participants; moderate quality evidence).None of the trials reported satisfaction with care or quality of life in participants. Authors' conclusions: Based on current evidence, ambulant adults with MESCC with stable spines and predicted survival of less than six months will probably benefit as much from one dose of radiation (8 Gy) as from two doses (16 Gy) or eight doses (30 Gy). We are unsure if a single dose is as effective as two or more doses in preventing local tumour recurrence. Laminectomy preceding radiotherapy may offer no benefits over radiotherapy alone. Decompressive surgery followed by radiotherapy may benefit ambulant and non-ambulant adults younger than 65 years of age, with poor prognostic factors for radiotherapy, a single area of compression, paraplegia for less than 48 hours, and a predicted survival of more than six months. We are uncertain whether high doses of corticosteroids offer any benefits over moderate doses or indeed no corticosteroids; but high-dose steroids probably significantly increases the risk of serious adverse effects. Early detection; and treatment based on neurological status, age and estimated survival, are crucial with all treatment modalities. Most of the evidence was of low quality. High-quality evidence from more trials is needed to clarify current uncertainties, and some studies are in progress.

The Cochrane database of systematic reviews · meta-analysis · 39 citationsread the source →

Adverse childhood experiences and related outcomes among adults experiencing homelessness: a systematic review and meta-analysis.

Background: Adverse childhood experiences (ACEs) are strong risk factors for homelessness and poor health and functioning. We aimed to evaluate the lifetime prevalence of ACEs and their associations with health-related and functioning-related outcomes among homeless adults. Methods: In this systematic review and meta-analysis, we searched from database inception to Nov 11, 2020, for original and peer-reviewed studies in English that documented lifetime prevalence of ACEs or associations between ACEs and health-related or functioning-related outcomes. We selected studies if they included a definable group of homeless adults and measured at least four ACE categories. We calculated pooled estimates of lifetime prevalence of one or more ACEs and four or more ACEs with random-effects models. We used the leave-one-out method in sensitivity analyses and studied meta-regressions to explore potential moderators of ACE prevalence. We also did a narrative summary of associations between ACEs and health-related and functioning-related outcomes, as there were too few studies on each outcome for quantitative meta-analysis. This study is registered with PROSPERO, CRD42020218741. Findings: We identified 2129 studies through systematic search, of which 29 studies (16 942 individuals) were included in the systematic review, 20 studies (10 034 individuals) were included in the meta-analysis for one or more ACEs, and 15 studies (5693 individuals) were included in the meta-analysis for four or more ACEs. Studies included samples of adults experiencing homelessness in the USA, Canada, and the UK; participants in the included studies were predominantly male (65·2%) and mean ages ranged between 18·3 and 58·1 years, but many studies did not report race, ethnicity, and sexual and gender minority data. Lifetime prevalence of one or more ACEs among homeless adults was 89·8% (95% CI 83·7-93·7) and the lifetime prevalence of four or more ACEs was 53·9% (45·9-61·7). Considerable heterogeneity was identified in both meta-analyses (I2>95%). Of the potential moderators analysed, the ACE measurement tool significantly moderated the estimated lifetime prevalence of one or more ACEs and four or more ACEs, and age also significantly moderated the estimated lifetime prevalence of four or more ACEs. In the narrative synthesis, ACEs were consistently positively associated with high suicidality (two studies), suicide attempt (three studies), major depressive disorder (two studies), substance misuse (two studies), and adult victimisation (two studies). Interpretation: The lifetime prevalence of ACEs is substantially higher among homeless adults than among the general population, and ACE exposure might be associated with prevalence of mental illness, substance misuse, and victimisation. Policy efforts and evidence-based interventions are urgently needed to prevent ACEs and address associated poor outcomes among this population. Funding: Rhodes Trust and Canadian Institutes of Health Research.

The Lancet. Public health · meta-analysis · 70 citationsread the source →

Brain-derived neurotrophic factor (BDNF) gene polymorphisms shape cortical plasticity in humans.

Background: The brain-derived neurotrophic factor (BDNF) gene is involved in mechanisms of synaptic plasticity in the adult brain. It has been demonstrated that BDNF also plays a significant role in shaping externally induced human brain plasticity. Plasticity induced in the human motor cortex by intermittent theta-burst stimulation (iTBS) was impaired in individuals expressing the Val66Met polymorphism. Methods: To explore whether this polymorphism is also important for other neuroplasticity-inducing tools in humans with modes of action differing from that of iTBS, namely, transcranial direct current (tDCS) and random noise stimulation (tRNS), we retrospectively analyzed the data of 64 subjects studied in our laboratory with regard to BDNF genotype. Results: Fifteen subjects with the Val66Met allele, 46 subjects with the Val66Val allele, and 3 Met66Met carriers were identified. The response of the Val66Met allele carriers to stimulation differed in two protocols compared with the response of Val66Val individuals. For iTBS (15 subjects, 5 heterozygotes), plasticity could be only induced in the Val66Val allele carriers. However, for facilitatory tDCS (24 subjects, 10 heterozygotes), as well as for inhibitory tDCS, (19 subjects, 8 heterozygotes), carriers of the Val66Met allele displayed enhanced plasticity, whereas for transcranial random noise stimulation (29 subjects, 8 heterozygotes), the difference between groups was not so pronounced. Conclusions: BDNF polymorphism has a definite impact on plasticity in humans, which might differ according to the mechanism of plasticity induction. This impact of BDNF on plasticity should be taken into account for future studies, as well as having wider ranging implications for the treatment of neuropsychiatric disorders with transcranial stimulation tools, as it may predetermine their efficacy for the treatment of disease and rehabilitation.

Brain stimulation · 193 citationsread the source →

A Systematic Review on TeleMental Health in Youth Mental Health: Focus on Anxiety, Depression and Obsessive-Compulsive Disorder.

Background and Objectives: The Internet is widely used and disseminated amongst youngsters and many web-based applications may serve to improve mental health care access, particularly in remote and distant sites or in settings where there is a shortage of mental health practitioners. However, in recent years, specific digital psychiatry interventions have been developed and implemented for special populations such as children and adolescents. Materials and Methods: Hereby, we describe the current state-of-the-art in the field of TMH application for young mental health, focusing on recent studies concerning anxiety, obsessive-compulsive disorder and affective disorders. Results: After screening and selection process, a total of 56 studies focusing on TMH applied to youth depression (n = 29), to only youth anxiety (n = 12) or mixed youth anxiety/depression (n = 7) and youth OCD (n = 8) were selected and retrieved. Conclusions: Telemental Health (TMH; i.e., the use of telecommunications and information technology to provide access to mental health assessment, diagnosis, intervention, consultation, supervision across distance) may offer an effective and efficacious tool to overcome many of the barriers encountering in the delivery of young mental health care.

Medicina (Kaunas, Lithuania) · systematic review · 48 citationsread the source →

Life Review in Critical Care: Possibilities at the End of Life

The therapeutic use of life review provides nurses with a framework for clinical interactions. It was a short but memorable clinical encounter, initiated with the eldest of 3 living sons. The men’s mother, an 87-year-old frail, Chinese-born woman, had just been terminally extubated. A palliative care nurse was facilitating the woman’s life review with the sons, who were recounting harrowing tales of their mother’s life in Hong Kong during World War II: how people commonly ate animals off the street and weeds growing in the cracks of buildings to survive. Prompted to share their “gifts of the heart”—what their mother taught them about life and living that would resonate in their hearts—the sons spent the next hour in soft-spoken reflection at the bedside. As time progressed, a healing space was created, echoing the words of Curtis and Eldridge2(pp38–40):Using the palliative care consultation service of Lakeland Regional Medical Center, Lakeland, Florida, as a model, we offer clinical nurses an opportunity to extend practice beyond the physical care of patients at the end of life. When a patient’s goals of care clearly shift from cure to comfort, life review provides an evidence-based approach for interaction with the patient’s family. Using the theory and techniques we describe, practitioners can alleviate suffering, for the concern of nursing is “broader than the organ system that is affected, as we turn our attention to the emotional, physical and spiritual health of the whole patient.”3(p17)In her book Kitchen Table Wisdom: Stories That Heal, 4(ppxxvi–xxvii) Remen speaks of being deeply moved by her patients’ stories, “by the people and the meaning they found in their problems, by the unsuspected strengths, the depths of love and devotion. . . . Everybody is a story. . . . Everyone’s story matters.”Referring to a progressive return of the memories of past experience in search of meaning and in striving for emotional resolution, life review is a formal concept that has its roots in life-span developmental psychology.5 As defined by the theories of Butler5 and Erikson,6 development is shaped by countless factors throughout the entire life span: the historical time in which one lives, the economics and culture, and the positive and negative life circumstances.5–9 In his 1963 article,5(p66) Butler theorized that life review was aLife review has applications in varied situations, such as cultural transmission, anthropological field work, and career planning and vocational guidance.8 However, its therapeutic use provides nurses a framework for clinical interactions. Life review has been described as a recasting of the past in the context of the present10: the chance to reexamine one’s life and solve old problems, the chance to make amends and restore harmony,11 and the chance to “find new meaning in the face of impending death.”12(p120) Widely practiced in gerontology,6,11,12 life review is thought to be a useful method for understanding both self and others.13 In gerontology, multiple and consecutive weekly sessions are used to analyze, evaluate, and synthesize life events.14,15 Investigators16,17 have addressed adaptations of life review with terminally ill patients, situations in which time with patients and patients’ families was often limited because of the severity of the illness. Additionally, we (M.J., P.A.) have had countless single clinical encounters in which the therapeutic use of life review has been used, supporting the counsel of Byock18 to “create a space where healing can happen” and to “use a few moments to go deep—even when time is really short.”When any form of life review is undertaken, a life is examined, and questions such as the following19 are asked: Who am I? How did I do? How did I live my life? Thus, an important difference between reminiscence and review must be addressed. Life review is “not a random sharing of pleasurable past events, but rather a structured process containing a component of self-evaluation.”14(p9) Life review can be used with both patients and patients’ families; the outcomes include increased life satisfaction and accomplishment, promotion of peaceful feelings, and a state of integrity.20 Furthermore, Garland and Garland8 contend that life review has a distinct purpose in end-of-life care by upholding the unique value of each person’s life. These themes are consistent with Erikson’s theories of development6: the final task is ego integrity versus ego despair. Ego integrity6 involves acceptance of the course of one’s life, acceptance of one’s place in history, absence of death-anxiety, and satisfaction with life. In contrast, ego despair echoes in the words of the poet Robert Frost21: “. . . nothing to look backward to with pride, and nothing to look forward to with hope, so now and never any different.”Each health care provider can be inspired by the Institute of Medicine report Approaching Death: Improving Care at the End of Life22:Byock23(p36) builds on this vision, contending that a solely physiological approach with the terminally ill is “two-dimensional, and without the color, tone, or texture of life.” Additionally, Volker and Limerick24 explored the concept of dignified dying. In their interviews with advanced practice nurses in oncology, the theme of “going in peace” emerged, which referred to “the importance of connecting with loved ones; conveying final messages; dying in a quiet, nonchaotic environment; not suffering from physical or existential distress; and meeting spiritual needs.”24(p244)Irrespective of the clinical setting, the grief that is expressed at any bedside represents a “developmental crisis that becomes interwoven with family history.”25(p17) Although Butler’s concept of life review5 traditionally involves a patient and a health care practitioner, life review in critical care usually involves a patient’s family members, who become survivors if the patient dies. Compared with those who do not engage in life review, survivors who purposefully recount the events of their loved one’s life and death maintain a higher level of emotional function, such as moving appropriately through the grieving process and retaining the ability to perform activities of daily living. In support of this approach, many authors8,26–28 have articulated that the physical effects of internal stress are reduced by the outward expression of emotion. According to Pennebaker,27 the continuous inhibition of traumatic memory is a physical stressor that adversely affects the immune system. The death of a loved one is clearly a major life stressor. Despite that loss, survivors who participate in life review have the following desired outcome: they retain or regain hope for the future and a passion for life. The 3 interconnected components of life review are recontextualizing, forgiving, and reclaiming unlived life.29Recontextualizing is using an expanded vision of maturity, referring to the wisdom that comes with age and experience. Recontextualizing is used to reframe self-defined mistakes and failures. First, past negative life events and situations must be reexamined or reframed in such a way that they can be perceived as positive. A person must be willing to view the past differently, even when reliving unpleasant or painful experiences. In contrast to viewing oneself as the “victim” of past negative events and experiences, recontextualizing offers the realization that one is often in control of life experiences and has the opportunity to change memories based on perception of the experiences. Recontextualizing allows a reflection on the past, thus repairing relationships and events. Changing the perception changes the memory, from one of failure to one of success.5,8,10,29 Recontextualizing involves the “search for the deeper, sometimes more elusive, patterns that may be operating beneath the surface of everyday events.”29(p117)Present during the life review of a man who was dying were the man’s wife of 59 years, 2 adult daughters, and 1 granddaughter. Between numerous tears, the younger daughter reluctantly and slowly spoke of childhood memories: when her father was always adamant that she fulfill her academic duties. Deeply resentful as a child and adolescent, she was able to trace her current value of responsibility, as well as her national stature in her field, to her father’s expectations when she was a child. Without this purposeful revisiting of past events, the daughter’s memory might have focused on that resentment. Remen26(p29) remarks:Offering forgiveness to another and oneself often has an important result for patients facing the end of life. Anger and resentment, previously concentrated in a negative effort, can now be redirected toward positive thoughts and attitudes.29 Byock30 recounts numerous clinical cases involving forgiveness and cautions about a frequent misconception. Forgiveness is not about absolving someone else’s responsibility. Yet, when a relationship is completed, the story of the fractured relationship is totally reframed: everything that happened before is a prologue to the healing.18 The repair of life review never eliminates the pain, but forgiveness work helps in coming to terms with the painful feelings.29These thoughts are duplicated by Archbishop Desmond Tutu, who won the Nobel Peace Prize in 1984 for his healing work in South Africa after apartheid. Tutu asserts as follows31(pp270–271,279):The following highlights the concept of forgiveness. A 72-year-old man was unresponsive and had been intubated after an extensive myocardial infarction and unknown down-time before resuscitation. His family assembled to spend time with him, but this gathering was no simple feat; the family did not regard their father as a model parent. As a result, the 5 middle-aged adult children were living separate and rather chaotic lives. Some lived in other states, those who lived in the local area rarely talked, and none knew the whereabouts of their mother. Because of the exceptional and harsh nature of the stories (marked by family chaos and alcohol abuse by both parents), it was critical for the facilitators who were listening to maintain a nonjudgmental and therapeutic stance, to build trust and rapport. When talking about their childhood experiences, the adult siblings began to relate the stories that they had heard, as well as those they had experienced. Life review became an opportunity to place their own stories beside the stories of their father’s life. Painful moments, which could not be denied, could at least be placed in the context of the patient’s troubled life. The entire family was willing to reflect on and laugh about the joys that had been a part of their life together, especially holiday memories. More importantly, they found parts of their lives that they could treasure beyond the earlier pain and the current grief. When life support was discontinued, the many years of separation softened as the siblings began to find a sense of forgiveness for their father and each other. The family discovered that their shared stories were allowing them to reconnect, for they had lived through challenging childhoods. Because of the chaotic nature of this family’s life, the reconnection might not be sustainable, but for one moment, the grieving siblings found a sense of grace, appreciation, and gratitude in their shared life review. Reclaiming an unlived life involves reflecting on an opportunity earlier in life that was never used.29 Regret is a common theme in such reflections and is a topic of growing interest to cognitive researchers. Common life regrets involve education (how misgivings about attending school affected other life decisions), career (lack of success or choice of career), romance (long-lost loves and unsuccessful relationships), family (doubts over parenting or estrangements from parents/siblings), and the self (disappointments in abilities, attitudes, and behaviors).32 In expanding on the classic poem of Robert Frost, Beazley33(p9) addresses the concept of The Road Not Taken asSuch reflection transpired during the extensive life review of a dying patient by his adult daughter. Years ago, an irreparable breach had been created between the patient and his sister; the 2 of them took the specific details of the rift to their graves. However, the patient’s daughter had the courage to examine the lost opportunity of a life with her cousins. Deciding to end the division, she contacted her cousins and invited them to join her at her father’s deathbed. One local cousin responded to her invitation. Among many tears and hugs, the cousins pledged to reunite the family, thus reclaiming a lost heritage. Schachter-Shalomi and Miller29(p93) relate the 3 components of life review to the concept of time:Not every critical situation is a terminal one. Yet, life review is an important tool in placing the trauma of critical illness and associated aggressive medical treatment into the broader context of one’s entire life. The following the of an with of and was that a had and a was to be in hope of the from the The patient and her had moved to the after they so none of their 3 children lived in the Because other of support were not the on responded the patient was to The of the patient’s was so her was to reflect on her memories of time together, and the family that they had that this life review would be the of the The was to be because was of a the life review was part of the value of the patient’s life and a context for more and The life review was expanded as the patient’s children as they to questions about meaning and The patient and was to a nursing for but the family positive emotional from the of care unique for dying patients and the patients’ loved because of after may have been a and to by a painful to by and often spiritual In the to and for and of more than of patients who spent at least in a critical care and 3 of and that in the of critical care is and sometimes than dying in other the on adult patients in critical that positive outcomes for end-of-life care addressed and support as well as in this that palliative such as life review and emotional resolution, are part of When life review is in critical multiple and consecutive weekly sessions are not always However, the approach can be for the time of critical As previously life review offers a framework to and alleviate Although many critical care patients do and critical care is a time in a family’s story. experience the emotional trauma of a to the the family regard to emotional resolution, and of nurses of suffering or spiritual of suffering that can and be and through and that patient . . echoes that “the healing nurse for to to the patient an of am in this with that nursing that and be in the and in review was used in the following history, which the wife of a trauma patient with and The was from of state and without their of emotional In the review of her life, the wife had a where I would have been or I would have been if I had not Using this the explored the of the the that would the wife to living. The patient after the wife However, during the critical care she expressed the of the therapeutic review is for any family willing and able to engage in the emotional work of the Because of the nature of critical care life review encounters are However, for nurses who are more with the of life review offers a structured framework for a patient’s must always to the and emotional of critical care patients and the patients’ life review is must be to a patient’s pain and the patient is attention can be to the many factors with life review facilitators be of the family’s or spiritual for life review is in the of the therapeutic Using questions is always thus the of and for the must when not to care not to a thought or the from those new to life review, the in Table 1 might be a useful are to both the positive and the negative of life. can use any to no single way to a life review Although a life review has no a the when the family or to the In situations, life review might be Some patients and patients’ families have no to the never to participate in a life be to both I just talking are or That is a and or practitioners for a more or relationship than a family can or of the therapeutic relationship are beyond the of this but a life review on the understanding of the of such a as in Table be perceived as a nurse must that facilitating a life review involves a sense of and an that place the patient as the of his or her own life an nonjudgmental approach is to this approach can be a even for One with the daughter of a dying The daughter to the family meeting in a backward and a As the life review it was that this had been her father’s for more than she would her she had had his on her and his on her so she would always have his and in her life. The therapeutic relationship must the and to the work of who on the of suffering and 3 of which the is in the suffering of which the helps by listening to stories and the experience into and of one’s own which the is by both the suffering and the to that is the framework of the therapeutic of a life review is with a sense of responsibility. As by the of for nurses of the in the medical must be of and Although it is important for the health care to be about a patient’s of life review often and that do not to be in a family encounters might include on and of situations reflect patient has rather than patient’s is in the state for The therapeutic of life review be in the and the relationship always be must oneself before to Garland and this in Table 3 are for one’s own life As in her the without healing of the of time families for and the of their situations may chaos in critical care such as at the time of because of family more than a single therapeutic is often These are to involve the of the especially an man who was dying in a life The man’s wife and his adult each other. on time with the patient without the of the other. a was supporting the at the patient’s a palliative care nurse was supporting the wife in the The 2 allowing both the wife and the time with the 2 clinical life review could with each grieving family without of the other family review may result in such as with the past, and and despair. In the following the wife of a patient who had just been do not to be . . . my children have each other. . . . I do not to be In the of the wife had expressed so she was but about her to an by the health outcomes such as be because of a family’s but the and appropriately are regrets during life review involve spiritual In to clinical practice that is and facilitators of review activities be of the or spiritual of a patient and the patient’s family. for her work with in that is “the of and is “the that people through stress and challenging found in and our how people relate to each other. as that part of people that is to is both in negative of and for and and in positive and a of between and is often associated with an and on shared and is more and the meaning of life and rather than a of and involves a relationship to the self and to and may or may not involve a relationship with a higher and their families their and with the for people is meaning and purpose even in the of and this with a of are through the previously components of life recontextualizing, and reclaiming the unlived life. and life review are with common themes of forgiveness and and the of and the search for the purpose and meaning of life. the of an man could not be Because a was a life review was and a harrowing was for the the patient’s in World War a of over a the of The a man with with a the use of recontextualizing, the patient was to his emotional to his family. In the the patient’s family forgiveness on of the men’s and the spiritual was life review, patients can and those past life situations that now be or have a distinct opportunity to make a According to is to be at the end of life and to and life Furthermore, has that this we do not the spiritual . . we for the person as a and that in life, are more than is for dying patients in critical care who have lost the ability to fulfill the and of life. listening work offers the chance to a patient’s this the stories of loved for as meaning through care have a opportunity to a to the of final developmental is the of life their continuous we medical and medical and Lakeland Regional Medical

Critical Care Nurse · 16 citationsread the source →

Print versus a culturally-relevant Facebook and text message delivered intervention to promote physical activity in African American women: a randomized pilot trial.

Background: African American women report insufficient physical activity and are disproportionally burdened by associated disease conditions; indicating the need for innovative approaches to promote physical activity in this underserved population. Social media platforms (i.e. Facebook) and text messaging represent potential mediums to promote physical activity. This paper reports the results of a randomized pilot trial evaluating a theory-based (Social Cognitive Theory) multi-component intervention using Facebook and text-messages to promote physical activity among African American women. Methods: Participants (N = 29) were randomly assigned to receive one of two multi-component physical activity interventions over 8 weeks: a culturally-relevant, Social Cognitive Theory-based, intervention delivered by Facebook and text message (FI) (n = 14), or a non-culturally tailored print-based intervention (PI) (n = 15) consisting of promotion brochures mailed to their home. The primary outcome of physical activity was assessed by ActiGraph GT3X+ accelerometers. Secondary outcomes included self-reported physical activity, physical activity-related psychosocial variables, and participant satisfaction. Results: All randomized participants (N = 29) completed the study. Accelerometer measured physical activity showed that FI participants decreased sedentary time (FI = -74 minutes/week vs. PI = +118 minute/week) and increased light intensity (FI = +95 minutes/week vs. PI = +59 minutes/week) and moderate-lifestyle intensity physical activity (FI = + 27 minutes/week vs. PI = -34 minutes/week) in comparison to PI participants (all P's < .05). No between group differences for accelerometer measured moderate-to-vigorous intensity physical activity were observed (P > .05). Results of secondary outcomes showed that in comparison to the PI, FI participants self-reported greater increases in moderate-to-vigorous physical activity (FI = +62 minutes/week vs. PI = +6 minutes/week; P = .015) and had greater enhancements in self-regulation for physical activity (P < .001) and social support from family for physical activity (P = .044). Satisfaction with the FI was also high: 100% reported physical activity-related knowledge gains and 100% would recommend the program to a friend. Conclusions: A culturally-relevant Facebook and text message delivered physical activity program was associated with several positive outcomes, including decreased sedentary behavior, increased light- and moderate-lifestyle intensity physical activity, enhanced psychosocial outcomes, and high participant satisfaction. Future studies with larger samples are warranted to further explore the efficacy of technology-based approaches to promote physical activity among African American women. Trial registration: ClinicalTrials.gov NCT02372565 . Registered 25 February 2015.

BMC women's health · randomised controlled trial · 105 citationsread the source →

Critical care staff wellbeing: A new paradigm for understanding burnout.

Background: The wellbeing of paediatric intensive care unit (PICU) staff members influences their engagement with work and the quality of care they provide to patients. Baseline burnout measures in research provide inconclusive evidence of the determinants of burnout and how to target interventions to promote staff wellbeing. Objectives: The objectives of this study were to determine the prevalence of burnout using the Maslach Burnout Inventory (MBI) burnout-engagement workplace profiles in a sample of Australian PICU staff and investigate associations between demographic characteristics, meaningful work, satisfaction with life, and psychological distress on burnout. Methods: A cross-sectional survey was administered to a multidisciplinary sample of PICU staff (target n = 464) from three tertiary paediatric hospitals in Australia. The survey tool was comprised of the MBI, Work and Meaning Inventory, Satisfaction with Life Scale, Kessler Psychological Distress Scale, and demographic questions. Hierarchical multiple regressions examined the relationships between burnout and these variables of interest. Results: A sample of 258 participants (56%) completed the survey. For most respondents, burnout was scored as a low to moderate risk, with over half the participants scoring low risk for emotional exhaustion (EE) (56%) and depersonalisation (DP) (54%). Personal accomplishment (PA) was more evenly distributed (range of burnout risk: low, 32%; moderate, 32%; high, 36%). MBI scores were classified using the burnout-engaged workplace profile system, identifying low levels of burnout (8% burnout, 3% disengaged, 21% overextended, 29% ineffective, and 39% engaged). Psychological distress significantly increased burnout risk across all three dimensions EE (β = 0.253, p < 0.001), DP (β = 0.145, p < 0.05), and PA (β = -0.13, p < 0.05), and being aged between 41 and 55 years was protective of depersonalisation (β = -0.214, p < 0.05). Conclusion: Utilising MBI workplace profiles, this study has built upon the demand for a more comprehensive assessment of burnout. Research that helps improve our understanding of contributory factors to burnout and wellbeing will inform the development of effective interventions that promote wellbeing of staff.

Australian critical care : official journal of the Confederation of Australian Critical Care Nurses · 2 citationsread the source →

Multifactorial and multiple component interventions for preventing falls in older people living in the community.

Background: Falls and fall-related injuries are common, particularly in those aged over 65, with around one-third of older people living in the community falling at least once a year. Falls prevention interventions may comprise single component interventions (e.g. exercise), or involve combinations of two or more different types of intervention (e.g. exercise and medication review). Their delivery can broadly be divided into two main groups: 1) multifactorial interventions where component interventions differ based on individual assessment of risk; or 2) multiple component interventions where the same component interventions are provided to all people. Objectives: To assess the effects (benefits and harms) of multifactorial interventions and multiple component interventions for preventing falls in older people living in the community. Search methods: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature, trial registers and reference lists. Date of search: 12 June 2017. Selection criteria: Randomised controlled trials, individual or cluster, that evaluated the effects of multifactorial and multiple component interventions on falls in older people living in the community, compared with control (i.e. usual care (no change in usual activities) or attention control (social visits)) or exercise as a single intervention. Data collection and analysis: Two review authors independently selected studies, assessed risks of bias and extracted data. We calculated the rate ratio (RaR) with 95% confidence intervals (CIs) for rate of falls. For dichotomous outcomes we used risk ratios (RRs) and 95% CIs. For continuous outcomes, we used the standardised mean difference (SMD) with 95% CIs. We pooled data using the random-effects model. We used the GRADE approach to assess the quality of the evidence. Main results: We included 62 trials involving 19,935 older people living in the community. The median trial size was 248 participants. Most trials included more women than men. The mean ages in trials ranged from 62 to 85 years (median 77 years). Most trials (43 trials) reported follow-up of 12 months or over. We assessed most trials at unclear or high risk of bias in one or more domains. Forty-four trials assessed multifactorial interventions and 18 assessed multiple component interventions. (I2 not reported if = 0%).Multifactorial interventions versus usual care or attention controlThis comparison was made in 43 trials. Commonly-applied or recommended interventions after assessment of each participant's risk profile were exercise, environment or assistive technologies, medication review and psychological interventions. Multifactorial interventions may reduce the rate of falls compared with control: rate ratio (RaR) 0.77, 95% CI 0.67 to 0.87; 19 trials; 5853 participants; I2 = 88%; low-quality evidence. Thus if 1000 people were followed over one year, the number of falls may be 1784 (95% CI 1553 to 2016) after multifactorial intervention versus 2317 after usual care or attention control. There was low-quality evidence of little or no difference in the risks of: falling (i.e. people sustaining one or more fall) (RR 0.96, 95% CI 0.90 to 1.03; 29 trials; 9637 participants; I2 = 60%); recurrent falls (RR 0.87, 95% CI 0.74 to 1.03; 12 trials; 3368 participants; I2 = 53%); fall-related hospital admission (RR 1.00, 95% CI 0.92 to 1.07; 15 trials; 5227 participants); requiring medical attention (RR 0.91, 95% CI 0.75 to 1.10; 8 trials; 3078 participants). There is low-quality evidence that multifactorial interventions may reduce the risk of fall-related fractures (RR 0.73, 95% CI 0.53 to 1.01; 9 trials; 2850 participants) and may slightly improve health-related quality of life but not noticeably (SMD 0.19, 95% CI 0.03 to 0.35; 9 trials; 2373 participants; I2 = 70%). Of three trials reporting on adverse events, one found none, and two reported 12 participants with self-limiting musculoskeletal symptoms in total. Multifactorial interventions versus exerciseVery low-quality evidence from one small trial of 51 recently-discharged orthopaedic patients means that we are uncertain of the effects on rate of falls or risk of falling of multifactorial interventions versus exercise alone. Other fall-related outcomes were not assessed. Multiple component interventions versus usual care or attention controlThe 17 trials that make this comparison usually included exercise and another component, commonly education or home-hazard assessment. There is moderate-quality evidence that multiple interventions probably reduce the rate of falls (RaR 0.74, 95% CI 0.60 to 0.91; 6 trials; 1085 participants; I2 = 45%) and risk of falls (RR 0.82, 95% CI 0.74 to 0.90; 11 trials; 1980 participants). There is low-quality evidence that multiple interventions may reduce the risk of recurrent falls, although a small increase cannot be ruled out (RR 0.81, 95% CI 0.63 to 1.05; 4 trials; 662 participants). Very low-quality evidence means that we are uncertain of the effects of multiple component interventions on the risk of fall-related fractures (2 trials) or fall-related hospital admission (1 trial). There is low-quality evidence that multiple interventions may have little or no effect on the risk of requiring medical attention (RR 0.95, 95% CI 0.67 to 1.35; 1 trial; 291 participants); conversely they may slightly improve health-related quality of life (SMD 0.77, 95% CI 0.16 to 1.39; 4 trials; 391 participants; I2 = 88%). Of seven trials reporting on adverse events, five found none, and six minor adverse events were reported in two. Multiple component interventions versus exerciseThis comparison was tested in five trials. There is low-quality evidence of little or no difference between the two interventions in rate of falls (1 trial) and risk of falling (RR 0.93, 95% CI 0.78 to 1.10; 3 trials; 863 participants) and very low-quality evidence, meaning we are uncertain of the effects on hospital admission (1 trial). One trial reported two cases of minor joint pain. Other falls outcomes were not reported. Authors' conclusions: Multifactorial interventions may reduce the rate of falls compared with usual care or attention control. However, there may be little or no effect on other fall-related outcomes. Multiple component interventions, usually including exercise, may reduce the rate of falls and risk of falling compared with usual care or attention control.

The Cochrane database of systematic reviews · systematic review · 293 citationsread the source →

Acculturation and biological stress markers: A systematic review.

Background: The association of acculturation with health among immigrant populations is believed to be mediated, in part, by acculturation-related stress and stress biology. Objectives: To review and qualitatively synthesize empirical findings on the relationship of acculturation with stress-related inflammatory and endocrine biomarkers and composite allostatic load (AL) scores. Methods: A literature search was performed in the PubMed and PsycInfo databases. Article titles, abstracts or full-texts were screened and checked for match with the search criteria. Studies were eligible if they empirically tested the relationship between acculturation and inflammatory/endocrine stress biomarkers or composite AL scores, and were published in the English language. Results: Among the 41 articles identified as relevant and included in this review, the majority were published after 2010, included adult Hispanic U.S.-based populations, used cross-sectional study designs, operationalized acculturation as a unidimensional construct, and varied considerably in the selection of covariates in the analyses. Acculturation was significantly associated with stress biomarkers in 29 studies, but the direction of effects varied across studies. Specifically, acculturation, operationalized as a higher orientation towards the host culture, was associated with inflammatory biomarkers in 10 of 14 studies, with endocrine stress biomarkers in 12 of 20 studies, and with composite AL scores in 7 of 8 studies. Overall, language-based proxy measures of acculturation were related to higher levels of stress-related inflammatory and endocrine biomarkers and to lower levels of AL scores, whereas nativity-, generation status- and length of stay-based proxy measures of acculturation were related to higher levels of inflammatory biomarkers and AL score. Discussion: The majority of studies reported associations between measures of acculturation and stress biomarkers, however the directions of effects varied across studies. We suggest this heterogeneity may, in part, be a function of limitations imposed by cross-sectional research designs and unidimensional measures of acculturation measures, and we highlight the need for longitudinal studies and use of multidimensional measures of acculturation to better uncover the biobehavioral mechanisms and pathways linking acculturation with health outcomes.

Psychoneuroendocrinology · systematic review · 26 citationsread the source →

Global, regional, and national incidence and mortality burden of non-COVID-19 lower respiratory infections and aetiologies, 1990-2021: a systematic analysis from the Global Burden of Disease Study 2021.

Background: Lower respiratory infections (LRIs) are a major global contributor to morbidity and mortality. In 2020-21, non-pharmaceutical interventions associated with the COVID-19 pandemic reduced not only the transmission of SARS-CoV-2, but also the transmission of other LRI pathogens. Tracking LRI incidence and mortality, as well as the pathogens responsible, can guide health-system responses and funding priorities to reduce future burden. We present estimates from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2021 of the burden of non-COVID-19 LRIs and corresponding aetiologies from 1990 to 2021, inclusive of pandemic effects on the incidence and mortality of select respiratory viruses, globally, regionally, and for 204 countries and territories. Methods: We estimated mortality, incidence, and aetiology attribution for LRI, defined by the GBD as pneumonia or bronchiolitis, not inclusive of COVID-19. We analysed 26 259 site-years of mortality data using the Cause of Death Ensemble model to estimate LRI mortality rates. We analysed all available age-specific and sex-specific data sources, including published literature identified by a systematic review, as well as household surveys, hospital admissions, health insurance claims, and LRI mortality estimates, to generate internally consistent estimates of incidence and prevalence using DisMod-MR 2.1. For aetiology estimation, we analysed multiple causes of death, vital registration, hospital discharge, microbial laboratory, and literature data using a network analysis model to produce the proportion of LRI deaths and episodes attributable to the following pathogens: Acinetobacter baumannii, Chlamydia spp, Enterobacter spp, Escherichia coli, fungi, group B streptococcus, Haemophilus influenzae, influenza viruses, Klebsiella pneumoniae, Legionella spp, Mycoplasma spp, polymicrobial infections, Pseudomonas aeruginosa, respiratory syncytial virus (RSV), Staphylococcus aureus, Streptococcus pneumoniae, and other viruses (ie, the aggregate of all viruses studied except influenza and RSV), as well as a residual category of other bacterial pathogens. Findings: Globally, in 2021, we estimated 344 million (95% uncertainty interval [UI] 325-364) incident episodes of LRI, or 4350 episodes (4120-4610) per 100 000 population, and 2·18 million deaths (1·98-2·36), or 27·7 deaths (25·1-29·9) per 100 000. 502 000 deaths (406 000-611 000) were in children younger than 5 years, among which 254 000 deaths (197 000-320 000) occurred in countries with a low Socio-demographic Index. Of the 18 modelled pathogen categories in 2021, S pneumoniae was responsible for the highest proportions of LRI episodes and deaths, with an estimated 97·9 million (92·1-104·0) episodes and 505 000 deaths (454 000-555 000) globally. The pathogens responsible for the second and third highest episode counts globally were other viral aetiologies (46·4 million [43·6-49·3] episodes) and Mycoplasma spp (25·3 million [23·5-27·2]), while those responsible for the second and third highest death counts were S aureus (424 000 [380 000-459 000]) and K pneumoniae (176 000 [158 000-194 000]). From 1990 to 2019, the global all-age non-COVID-19 LRI mortality rate declined by 41·7% (35·9-46·9), from 56·5 deaths (51·3-61·9) to 32·9 deaths (29·9-35·4) per 100 000. From 2019 to 2021, during the COVID-19 pandemic and implementation of associated non-pharmaceutical interventions, we estimated a 16·0% (13·1-18·6) decline in the global all-age non-COVID-19 LRI mortality rate, largely accounted for by a 71·8% (63·8-78·9) decline in the number of influenza deaths and a 66·7% (56·6-75·3) decline in the number of RSV deaths. Interpretation: Substantial progress has been made in reducing LRI mortality, but the burden remains high, especially in low-income and middle-income countries. During the COVID-19 pandemic, with its associated non-pharmaceutical interventions, global incident LRI cases and mortality attributable to influenza and RSV declined substantially. Expanding access to health-care services and vaccines, including S pneumoniae, H influenzae type B, and novel RSV vaccines, along with new low-cost interventions against S aureus, could mitigate the LRI burden and prevent transmission of LRI-causing pathogens. Funding: Bill & Melinda Gates Foundation, Wellcome Trust, and Department of Health and Social Care (UK).

The Lancet. Infectious diseases · systematic review · 388 citationsread the source →

Music interventions for improving psychological and physical outcomes in people with cancer.

Background: This is an update of the review published on the Cochrane Library in 2016, Issue 8. Having cancer may result in extensive emotional, physical and social suffering. Music interventions have been used to alleviate symptoms and treatment side effects in people with cancer. This review includes music interventions defined as music therapy offered by trained music therapists, as well as music medicine, which was defined as listening to pre-recorded music offered by medical staff. Objectives: To assess and compare the effects of music therapy and music medicine interventions for psychological and physical outcomes in people with cancer. Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 3) in the Cochrane Library, MEDLINE via Ovid, Embase via Ovid, CINAHL, PsycINFO, LILACS, Science Citation Index, CancerLit, CAIRSS, Proquest Digital Dissertations, ClinicalTrials.gov, Current Controlled Trials, the RILM Abstracts of Music Literature, http://www.wfmt.info/Musictherapyworld/ and the National Research Register. We searched all databases, except for the last two, from their inception to April 2020; the other two are no longer functional, so we searched them until their termination date. We handsearched music therapy journals, reviewed reference lists and contacted experts. There was no language restriction. Selection criteria: We included all randomized and quasi-randomized controlled trials of music interventions for improving psychological and physical outcomes in adults and pediatric patients with cancer. We excluded patients undergoing biopsy and aspiration for diagnostic purposes. Data collection and analysis: Two review authors independently extracted the data and assessed the risk of bias. Where possible, we presented results in meta-analyses using mean differences and standardized mean differences. We used post-test scores. In cases of significant baseline difference, we used change scores. We conducted separate meta-analyses for studies with adult participants and those with pediatric participants. Primary outcomes of interest included psychological outcomes and physical symptoms and secondary outcomes included physiological responses, physical functioning, anesthetic and analgesic intake, length of hospitalization, social and spiritual support, communication, and quality of life (QoL) . We used GRADE to assess the certainty of the evidence. Main results: We identified 29 new trials for inclusion in this update. In total, the evidence of this review rests on 81 trials with a total of 5576 participants. Of the 81 trials, 74 trials included adult (N = 5306) and seven trials included pediatric (N = 270) oncology patients. We categorized 38 trials as music therapy trials and 43 as music medicine trials. The interventions were compared to standard care. Psychological outcomes The results suggest that music interventions may have a large anxiety-reducing effect in adults with cancer, with a reported average anxiety reduction of 7.73 units (17 studies, 1381 participants; 95% confidence interval (CI) -10.02 to -5.44; very low-certainty evidence) on the Spielberger State Anxiety Inventory scale (range 20 to 80; lower values reflect lower anxiety). Results also suggested a moderately strong, positive impact of music interventions on depression in adults (12 studies, 1021 participants; standardized mean difference (SMD): -0.41, 95% CI -0.67 to -0.15; very low-certainty evidence). We found no support for an effect of music interventions on mood (SMD 0.47, 95% CI -0.02 to 0.97; 5 studies, 236 participants; very low-certainty evidence). Music interventions may increase hope in adults with cancer, with a reported average increase of 3.19 units (95% CI 0.12 to 6.25) on the Herth Hope Index (range 12 to 48; higher scores reflect greater hope), but this finding was based on only two studies (N = 53 participants; very low-certainty evidence). Physical outcomes We found a moderate pain-reducing effect of music interventions (SMD -0.67, 95% CI -1.07 to -0.26; 12 studies, 632 adult participants; very low-certainty evidence). In addition, music interventions had a small treatment effect on fatigue (SMD -0.28, 95% CI -0.46 to -0.10; 10 studies, 498 adult participants; low-certainty evidence). The results suggest a large effect of music interventions on adult participants' QoL, but the results were highly inconsistent across studies, and the pooled effect size was accompanied by a large confidence interval (SMD 0.88, 95% CI -0.31 to 2.08; 7 studies, 573 participants; evidence is very uncertain). Removal of studies that used improper randomization methods resulted in a moderate effect size that was less heterogeneous (SMD 0.47, 95% CI 0.06 to 0.88, P = 0.02, I2 = 56%). A small number of trials included pediatric oncology participants. The findings suggest that music interventions may reduce anxiety but this finding was based on only two studies (SMD -0.94, 95% CI -1.9 to 0.03; very low-certainty evidence). Due to the small number of studies, we could not draw conclusions regarding the effects of music interventions on mood, depression, QoL, fatigue or pain in pediatric participants with cancer. The majority of studies included in this review update presented a high risk of bias, and therefore the overall certainty of the evidence is low. For several outcomes (i.e. anxiety, depression, pain, fatigue, and QoL) the beneficial treatment effects were consistent across studies for music therapy interventions delivered by music therapists. In contrast, music medicine interventions resulted in inconsistent treatment effects across studies for these outcomes. Authors' conclusions: This systematic review indicates that music interventions compared to standard care may have beneficial effects on anxiety, depression, hope, pain, and fatigue in adults with cancer. The results of two trials suggest that music interventions may have a beneficial effect on anxiety in children with cancer. Too few trials with pediatric participants were included to draw conclusions about the treatment benefits of music for other outcomes. For several outcomes, music therapy interventions delivered by a trained music therapist led to consistent results across studies and this was not the case for music medicine interventions. Moreover, evidence of effect was found for music therapy interventions for QoL and fatigue but not for music medicine interventions. Most trials were at high risk of bias and low or very low certainty of evidence; therefore, these results need to be interpreted with caution.

The Cochrane database of systematic reviews · systematic review · 144 citationsread the source →

Interventions for the management of long covid (post-covid condition): living systematic review.

Objective: To compare the effectiveness of interventions for the management of long covid (post-covid condition). Design: Living systematic review. Data sources: Medline, Embase, CINAHL, PsycInfo, Allied and Complementary Medicine Database, and Cochrane Central Register of Controlled Trials from inception to December 2023. Eligibility criteria: Trials that randomised adults (≥18 years) with long covid to drug or non-drug interventions, placebo or sham, or usual care. Results: 24 trials with 3695 patients were eligible. Four trials (n=708 patients) investigated drug interventions, eight (n=985) physical activity or rehabilitation, three (n=314) behavioural, four (n=794) dietary, four (n=309) medical devices and technologies, and one (n=585) a combination of physical exercise and mental health rehabilitation. Moderate certainty evidence suggested that, compared with usual care, an online programme of cognitive behavioural therapy (CBT) probably reduces fatigue (mean difference -8.4, 95% confidence interval (CI) -13.11 to -3.69; Checklist for Individual Strength fatigue subscale; range 8-56, higher scores indicate greater impairment) and probably improves concentration (mean difference -5.2, -7.97 to -2.43; Checklist for Individual Strength concentration problems subscale; range 4-28; higher scores indicate greater impairment). Moderate certainty evidence suggested that, compared with usual care, an online, supervised, combined physical and mental health rehabilitation programme probably leads to improvement in overall health, with an estimated 161 more patients per 1000 (95% CI 61 more to 292 more) experiencing meaningful improvement or recovery, probably reduces symptoms of depression (mean difference -1.50, -2.41 to -0.59; Hospital Anxiety and Depression Scale depression subscale; range 0-21; higher scores indicate greater impairment), and probably improves quality of life (0.04, 95% CI 0.00 to 0.08; Patient-Reported Outcomes Measurement Information System 29+2 Profile; range -0.022-1; higher scores indicate less impairment). Moderate certainty evidence suggested that intermittent aerobic exercise 3-5 times weekly for 4-6 weeks probably improves physical function compared with continuous exercise (mean difference 3.8, 1.12 to 6.48; SF-36 physical component summary score; range 0-100; higher scores indicate less impairment). No compelling evidence was found to support the effectiveness of other interventions, including, among others, vortioxetine, leronlimab, combined probiotics-prebiotics, coenzyme Q10, amygdala and insula retraining, combined L-arginine and vitamin C, inspiratory muscle training, transcranial direct current stimulation, hyperbaric oxygen, a mobile application providing education on long covid. Conclusion: Moderate certainty evidence suggests that CBT and physical and mental health rehabilitation probably improve symptoms of long covid. Systematic review registration: Open Science Framework https://osf.io/9h7zm/. Readers' note: This article is a living systematic review that will be updated to reflect emerging evidence. Updates may occur for up to two years from the date of original publication.

BMJ (Clinical research ed.) · systematic review · 69 citationsread the source →

Additional behavioural support as an adjunct to pharmacotherapy for smoking cessation.

Background: Pharmacotherapies for smoking cessation increase the likelihood of achieving abstinence in a quit attempt. It is plausible that providing support, or, if support is offered, offering more intensive support or support including particular components may increase abstinence further. Objectives: To evaluate the effect of adding or increasing the intensity of behavioural support for people using smoking cessation medications, and to assess whether there are different effects depending on the type of pharmacotherapy, or the amount of support in each condition. We also looked at studies which directly compare behavioural interventions matched for contact time, where pharmacotherapy is provided to both groups (e.g. tests of different components or approaches to behavioural support as an adjunct to pharmacotherapy). Search methods: We searched the Cochrane Tobacco Addiction Group Specialised Register, clinicaltrials.gov, and the ICTRP in June 2018 for records with any mention of pharmacotherapy, including any type of nicotine replacement therapy (NRT), bupropion, nortriptyline or varenicline, that evaluated the addition of personal support or compared two or more intensities of behavioural support. Selection criteria: Randomised or quasi-randomised controlled trials in which all participants received pharmacotherapy for smoking cessation and conditions differed by the amount or type of behavioural support. The intervention condition had to involve person-to-person contact (defined as face-to-face or telephone). The control condition could receive less intensive personal contact, a different type of personal contact, written information, or no behavioural support at all. We excluded trials recruiting only pregnant women and trials which did not set out to assess smoking cessation at six months or longer. Data collection and analysis: For this update, screening and data extraction followed standard Cochrane methods. The main outcome measure was abstinence from smoking after at least six months of follow-up. We used the most rigorous definition of abstinence for each trial, and biochemically-validated rates, if available. We calculated the risk ratio (RR) and 95% confidence interval (CI) for each study. Where appropriate, we performed meta-analysis using a random-effects model. Main results: Eighty-three studies, 36 of which were new to this update, met the inclusion criteria, representing 29,536 participants. Overall, we judged 16 studies to be at low risk of bias and 21 studies to be at high risk of bias. All other studies were judged to be at unclear risk of bias. Results were not sensitive to the exclusion of studies at high risk of bias. We pooled all studies comparing more versus less support in the main analysis. Findings demonstrated a benefit of behavioural support in addition to pharmacotherapy. When all studies of additional behavioural therapy were pooled, there was evidence of a statistically significant benefit from additional support (RR 1.15, 95% CI 1.08 to 1.22, I² = 8%, 65 studies, n = 23,331) for abstinence at longest follow-up, and this effect was not different when we compared subgroups by type of pharmacotherapy or intensity of contact. This effect was similar in the subgroup of eight studies in which the control group received no behavioural support (RR 1.20, 95% CI 1.02 to 1.43, I² = 20%, n = 4,018). Seventeen studies compared interventions matched for contact time but that differed in terms of the behavioural components or approaches employed. Of the 15 comparisons, all had small numbers of participants and events. Only one detected a statistically significant effect, favouring a health education approach (which the authors described as standard counselling containing information and advice) over motivational interviewing approach (RR 0.56, 95% CI 0.33 to 0.94, n = 378). Authors' conclusions: There is high-certainty evidence that providing behavioural support in person or via telephone for people using pharmacotherapy to stop smoking increases quit rates. Increasing the amount of behavioural support is likely to increase the chance of success by about 10% to 20%, based on a pooled estimate from 65 trials. Subgroup analysis suggests that the incremental benefit from more support is similar over a range of levels of baseline support. More research is needed to assess the effectiveness of specific components that comprise behavioural support.

The Cochrane database of systematic reviews · systematic review · 110 citationsread the source →

Pharmacological and electronic cigarette interventions for smoking cessation in adults: component network meta-analyses.

Background: Tobacco smoking is the leading preventable cause of death and disease worldwide. Stopping smoking can reduce this harm and many people would like to stop. There are a number of medicines licenced to help people quit globally, and e-cigarettes are used for this purpose in many countries. Typically treatments work by reducing cravings to smoke, thus aiding initial abstinence and preventing relapse. More information on comparative effects of these treatments is needed to inform treatment decisions and policies. Objectives: To investigate the comparative benefits, harms and tolerability of different smoking cessation pharmacotherapies and e-cigarettes, when used to help people stop smoking tobacco. Search methods: We identified studies from recent updates of Cochrane Reviews investigating our interventions of interest. We updated the searches for each review using the Cochrane Tobacco Addiction Group (TAG) specialised register to 29 April 2022. Selection criteria: We included randomised controlled trials (RCTs), cluster-RCTs and factorial RCTs, which measured smoking cessation at six months or longer, recruited adults who smoked combustible cigarettes at enrolment (excluding pregnant people) and randomised them to approved pharmacotherapies and technologies used for smoking cessation worldwide (varenicline, cytisine, nortriptyline, bupropion, nicotine replacement therapy (NRT) and e-cigarettes) versus no pharmacological intervention, placebo (control) or another approved pharmacotherapy. Studies providing co-interventions (e.g. behavioural support) were eligible if the co-intervention was provided equally to study arms. Data collection and analysis: We followed standard Cochrane methods for screening, data extraction and risk of bias (RoB) assessment (using the RoB 1 tool). Primary outcome measures were smoking cessation at six months or longer, and the number of people reporting serious adverse events (SAEs). We also measured withdrawals due to treatment. We used Bayesian component network meta-analyses (cNMA) to examine intervention type, delivery mode, dose, duration, timing in relation to quit day and tapering of nicotine dose, using odds ratios (OR) and 95% credibility intervals (CrIs). We calculated an effect estimate for combination NRT using an additive model. We evaluated the influence of population and study characteristics, provision of behavioural support and control arm rates using meta-regression. We evaluated certainty using GRADE. Main results: Of our 332 eligible RCTs, 319 (835 study arms, 157,179 participants) provided sufficient data to be included in our cNMA. Of these, we judged 51 to be at low risk of bias overall, 104 at high risk and 164 at unclear risk, and 118 reported pharmaceutical or e-cigarette/tobacco industry funding. Removing studies at high risk of bias did not change our interpretation of the results. Benefits We found high-certainty evidence that nicotine e-cigarettes (OR 2.37, 95% CrI 1.73 to 3.24; 16 RCTs, 3828 participants), varenicline (OR 2.33, 95% CrI 2.02 to 2.68; 67 RCTs, 16,430 participants) and cytisine (OR 2.21, 95% CrI 1.66 to 2.97; 7 RCTs, 3848 participants) were associated with higher quit rates than control. In absolute terms, this might lead to an additional eight (95% CrI 4 to 13), eight (95% CrI 6 to 10) and seven additional quitters per 100 (95% CrI 4 to 12), respectively. These interventions appeared to be more effective than the other interventions apart from combination NRT (patch and a fast-acting form of NRT), which had a lower point estimate (calculated additive effect) but overlapping 95% CrIs (OR 1.93, 95% CrI 1.61 to 2.34). There was also high-certainty evidence that nicotine patch alone (OR 1.37, 95% CrI 1.20 to 1.56; 105 RCTs, 37,319 participants), fast-acting NRT alone (OR 1.41, 95% CrI 1.29 to 1.55; 120 RCTs, 31,756 participants) and bupropion (OR 1.43, 95% CrI 1.26 to 1.62; 71 RCTs, 14,759 participants) were more effective than control, resulting in two (95% CrI 1 to 3), three (95% CrI 2 to 3) and three (95% CrI 2 to 4) additional quitters per 100 respectively. Nortriptyline is probably associated with higher quit rates than control (OR 1.35, 95% CrI 1.02 to 1.81; 10 RCTs, 1290 participants; moderate-certainty evidence), resulting in two (CrI 0 to 5) additional quitters per 100. Non-nicotine/placebo e-cigarettes (OR 1.16, 95% CrI 0.74 to 1.80; 8 RCTs, 1094 participants; low-certainty evidence), equating to one additional quitter (95% CrI -2 to 5), had point estimates favouring the intervention over control, but CrIs encompassed the potential for no difference and harm. There was low-certainty evidence that tapering the dose of NRT prior to stopping treatment may improve effectiveness; however, 95% CrIs also incorporated the null (OR 1.14, 95% CrI 1.00 to 1.29; 111 RCTs, 33,156 participants). This might lead to an additional one quitter per 100 (95% CrI 0 to 2). Harms There were insufficient data to include nortriptyline and non-nicotine EC in the final SAE model. Overall rates of SAEs for the remaining treatments were low (average 3%). Low-certainty evidence did not show a clear difference in the number of people reporting SAEs for nicotine e-cigarettes, varenicline, cytisine or NRT when compared to no pharmacotherapy/e-cigarettes or placebo. Bupropion may slightly increase rates of SAEs, although the CrI also incorporated no difference (moderate certainty). In absolute terms bupropion may cause one more person in 100 to experience an SAE (95% CrI 0 to 2). Authors' conclusions: The most effective interventions were nicotine e-cigarettes, varenicline and cytisine (all high certainty), as well as combination NRT (additive effect, certainty not rated). There was also high-certainty evidence for the effectiveness of nicotine patch, fast-acting NRT and bupropion. Less certain evidence of benefit was present for nortriptyline (moderate certainty), non-nicotine e-cigarettes and tapering of nicotine dose (both low certainty). There was moderate-certainty evidence that bupropion may slightly increase the frequency of SAEs, although there was also the possibility of no increased risk. There was no clear evidence that any other tested interventions increased SAEs. Overall, SAE data were sparse with very low numbers of SAEs, and so further evidence may change our interpretation and certainty. Future studies should report SAEs to strengthen certainty in this outcome. More head-to-head comparisons of the most effective interventions are needed, as are tests of combinations of these. Future work should unify data from behavioural and pharmacological interventions to inform approaches to combined support for smoking cessation.

The Cochrane database of systematic reviews · systematic review · 114 citationsread the source →

Adherence to sleep restriction therapy - An evaluation of existing measures.

Sleep restriction, a key element of cognitive behavioural therapy for insomnia, involves considerable behavioural changes in patients' lives, leading to side-effects like increased daytime sleepiness. Studies on sleep restriction rarely report adherence, and when assessed it is often limited to the average number of therapy sessions attended. This study aims to systematically evaluate different measures of adherence to cognitive behavioural therapy for insomnia and their relationship with treatment outcome. This is a secondary analysis of data from a randomized controlled trial investigating cognitive behavioural therapy for insomnia (Johann et al. (2020) Journal of Sleep Research, 29, e13102). The sample included 23 patients diagnosed with insomnia according to DSM-5 criteria who underwent 8 weeks of cognitive behavioural therapy for insomnia. The following adherence measures based on sleep diary data were used: number of sessions completed; deviations from agreed time in bed; average percentage of patients deviating from bedtime by 15, 30 or 60 min; variability of bedtime and wake-up time; change in time in bed from pre- to post-assessment. Treatment outcome was assessed using the Insomnia Severity Index. Multiple regression models were employed, and insomnia severity was controlled for. Results showed that none of the adherence measures predict insomnia severity. Baseline insomnia severity, dysfunctional thoughts and attitudes about sleep, depression or perfectionism did not predict adherence. The limited variance in the outcome parameter due to most patients benefiting from treatment and the small sample size may explain these findings. Additionally, using objective measures like actigraphy could provide a better understanding of adherence behaviour. Lastly, the presence of perfectionism in patients with insomnia may have mitigated adherence problems in this study.

Journal of sleep research · randomised controlled trial · 7 citationsread the source →

Meditation lowers stress and supports forgiveness among college students: a randomized controlled trial.

Objective and participants: The authors evaluated the effects on stress, rumination, forgiveness, and hope of two 8-week, 90-min/wk training programs for college undergraduates in meditation-based stress-management tools. Methods: After a pretest, the authors randomly allocated college undergraduates to training in mindfulness-based stress reduction (MBSR; n = 15), Easwaran's Eight-Point Program (EPP; n = 14), or wait-list control (n = 15). The authors gathered pretest, posttest, and 8-week follow-up data on self-report outcome measures. Results: The authors observed no post-treatment differences between MBSR and EPP or between posttest and 8-week follow-up (p > .10). Compared with controls, treated participants (n = 29) demonstrated significant benefits for stress (p < .05, Cohen's d = -.45) and forgiveness (p < .05, d = .34) and marginal benefits for rumination (p < .10, d = -.34). Conclusions: Evidence suggests that meditation-based stress-management practices reduce stress and enhance forgiveness among college undergraduates. Such programs merit further study as potential health-promotion tools for college populations.

Journal of American college health : J of ACH · randomised controlled trial · 93 citationsread the source →

A randomised trial comparing weight loss with aerobic exercise in overweight individuals with coronary artery disease: The CUT-IT trial.

Background: We aimed to compare the effect of aerobic interval training (AIT) versus a low energy diet (LED) on physical fitness, body composition, cardiovascular risk factors and symptoms in overweight individuals with coronary artery disease (CAD). Methods and design: Seventy non-diabetic participants with CAD, a BMI>28 kg/m(2) and aged 45 to 75 years were randomised to 12 weeks' AIT at 90% peak heart rate three times a week or LED (800-1000 kcal/day) for 8-10 weeks followed by 2-4 weeks' weight maintenance diet. Results: Twenty-six (74%) AIT and 29 (83%) LED participants completed intervention per protocol. VO2peak (mL/kg fat free mass(0.67)/min) increased by 10.4% (p = 0.002) following AIT, whereas no change was observed after LED (-3.0%, p = 0.095). The LED group lost 10.6% body weight and 26.6% body fat mass (p < 0.001) compared to 1.6% (p = 0.002) and 5.5% (p < 0.001) following AIT. Waist circumference and visceral abdominal fat were reduced by both interventions but were most pronounced following LED (between-group, p < 0.001). Total cholesterol, non-HDL-C and triglycerides decreased significantly in both groups whereas HDL-C and blood pressure were unchanged. Six participants had their antihypertensive treatment reduced following LED (between-group, p = 0.032). Canadian Cardiovascular Society (CCS), New York Heart Association (NYHA) and anxiety scores were improved, while depressive symptoms remained unchanged. Intention-to-treat analyses including 65 participants (93%) were similar to per protocol analysis. Conclusion: Both interventions were feasible and effective in achieving the desired effects. LED was superior in improving body composition and blood pressure, whereas effects on lipids and symptoms were similar in the two groups. Thus, both AIT and LED improve the cardiovascular risk profile in overweight individuals with contemporarily treated CAD.

European journal of preventive cardiology · randomised controlled trial · 30 citationsread the source →

Targeting risk factors for type 2 diabetes in American Indian youth: the Tribal Turning Point pilot study.

Background: American Indian (AI) youth are at high risk for type 2 diabetes. Objectives: To partner with Eastern Band of Cherokee Indians and Navajo Nation to develop a culturally sensitive behavioural intervention for youth (Tribal Turning Point; TTP) and assess feasibility in an 8-month randomized pilot study. Methods: We enrolled 62 overweight/obese AI children (7-10 years) who participated with ≥1 parent/primary caregiver. Intervention participants (n = 29) attended 12 group classes and five individual sessions. Control participants (n = 33) attended three health and safety group sessions. We analysed group differences for changes in anthropometrics (BMI, BMI z-score, waist circumference), cardiometabolic (insulin, glucose, blood pressure) and behavioural (physical activity and dietary self-efficacy) outcomes. Results: Study retention was 97%, and intervention group attendance averaged 84%. We observed significant treatment effects (p = 0.02) for BMI and BMI z-score: BMI increased in control (+1.0 kg m-2 , p < 0.001) but not intervention participants (+0.3 kg m-2 , p = 0.13); BMI z-score decreased in intervention (-0.17, p = 0.004) but not control participants (0.01, p = 0.82). There were no treatment effects for cardiometabolic or behavioural outcomes. Conclusions: We demonstrated that a behavioural intervention is feasible to deliver and improved obesity measures in AI youth. Future work should evaluate TTP for effectiveness, sustainability and long-term impact in expanded tribal settings.

Pediatric obesity · randomised controlled trial · 32 citationsread the source →

Engaging Fathers to Increase Physical Activity in Girls: The "Dads And Daughters Exercising and Empowered" (DADEE) Randomized Controlled Trial.

Background: Existing strategies to increase girls' physical activity levels have seen limited success. Fathers may influence their children's physical activity, but often spend more time with their sons and rarely participate in family-based programs. Purpose: To test a novel program designed to increase the physical activity levels of fathers and their daughters. Methods: In a two-arm RCT, 115 fathers (29-53 years) and 153 daughters (4-12 years) were randomized to (i) the "Dads And Daughters Exercising and Empowered" (DADEE) program, or (ii) a wait-list control. The 8-week program included weekly educational and practical sessions plus home tasks. Assessments were at baseline, 2 months (postintervention), and 9 months. The primary outcomes were father-daughter physical activity levels (pedometry). Secondary outcomes included screen-time, daughters' fundamental movement skill proficiency (FMS: perceived and objective), and fathers' physical activity parenting practices. Results: Primary outcome data were obtained from 88% of daughters and 90% of fathers at 9 months. Intention-to-treat analyses revealed favorable group-by-time effects for physical activity in daughters (p = .02, d = 0.4) and fathers (p < .001, d = 0.7) at postintervention, which were maintained at 9 months. At postintervention and follow-up, significant effects (p < .05) were also identified for daughters' FMS competence (objective: d = 1.1-1.2; perceived: d = 0.4-0.6), a range of fathers' physical activity parenting practices (d = 0.3-0.8), and screen-time for daughters (d = 0.5-0.8) and fathers (d = 0.4-0.6, postintervention only). Program satisfaction and attendance were very high. Conclusions: This study provided the first experimental evidence that efforts to increase physical activity behavior in preadolescent girls would benefit from a meaningful engagement of fathers. Clinical Trial information: Australian New Zealand Clinical Trials Registry: ACTRN12615000022561.

Annals of behavioral medicine : a publication of the Society of Behavioral Medicine · randomised controlled trial · 86 citationsread the source →

Dialectical behavior therapy for high suicide risk in individuals with borderline personality disorder: a randomized clinical trial and component analysis.

Importance: Dialectical behavior therapy (DBT) is an empirically supported treatment for suicidal individuals. However, DBT consists of multiple components, including individual therapy, skills training, telephone coaching, and a therapist consultation team, and little is known about which components are needed to achieve positive outcomes. Objective: To evaluate the importance of the skills training component of DBT by comparing skills training plus case management (DBT-S), DBT individual therapy plus activities group (DBT-I), and standard DBT which includes skills training and individual therapy. Design, setting, and participants: We performed a single-blind randomized clinical trial from April 24, 2004, through January 26, 2010, involving 1 year of treatment and 1 year of follow-up. Participants included 99 women (mean age, 30.3 years; 69 [71%] white) with borderline personality disorder who had at least 2 suicide attempts and/or nonsuicidal self-injury (NSSI) acts in the last 5 years, an NSSI act or suicide attempt in the 8 weeks before screening, and a suicide attempt in the past year. We used an adaptive randomization procedure to assign participants to each condition. Treatment was delivered from June 3, 2004, through September 29, 2008, in a university-affiliated clinic and community settings by therapists or case managers. Outcomes were evaluated quarterly by blinded assessors. We hypothesized that standard DBT would outperform DBT-S and DBT-I. Interventions: The study compared standard DBT, DBT-S, and DBT-I. Treatment dose was controlled across conditions, and all treatment providers used the DBT suicide risk assessment and management protocol. Main outcomes and measures: Frequency and severity of suicide attempts and NSSI episodes. Results: All treatment conditions resulted in similar improvements in the frequency and severity of suicide attempts, suicide ideation, use of crisis services due to suicidality, and reasons for living. Compared with the DBT-I group, interventions that included skills training resulted in greater improvements in the frequency of NSSI acts (F1,85 = 59.1 [P < .001] for standard DBT and F1,85 = 56.3 [P < .001] for DBT-S) and depression (t399 = 1.8 [P = .03] for standard DBT and t399 = 2.9 [P = .004] for DBT-S) during the treatment year. In addition, anxiety significantly improved during the treatment year in standard DBT (t94 = -3.5 [P < .001]) and DBT-S (t94 = -2.6 [P = .01]), but not in DBT-I. Compared with the DBT-I group, the standard DBT group had lower dropout rates from treatment (8 patients [24%] vs 16 patients [48%] [P = .04]), and patients were less likely to use crisis services in follow-up (ED visits, 1 [3%] vs 3 [13%] [P = .02]; psychiatric hospitalizations, 1 [3%] vs 3 [13%] [P = .03]). Conclusions and relevance: A variety of DBT interventions with therapists trained in the DBT suicide risk assessment and management protocol are effective for reducing suicide attempts and NSSI episodes. Interventions that include DBT skills training are more effective than DBT without skills training, and standard DBT may be superior in some areas. Trial registration: clinicaltrials.gov Identifier: NCT00183651.

JAMA psychiatry · randomised controlled trial · 325 citationsread the source →

Preventing relapse to smoking with transcranial magnetic stimulation: Feasibility and potential efficacy.

Many smokers attempt to quit every year, but 90% relapse within 12 months. Converging evidence suggests relapse is associated with insufficient activation of the prefrontal cortex. Delay discounting rate reflects relative activity in brain regions associated with relapse. High-frequency repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (LDLPFC) increases cortical excitability and reduces delay discounting rates, but little is known about feasibility, tolerability, and potential efficacy for smoking cessation. We hypothesized that 8 sessions of 20Hz rTMS of the LDLPFC combined with an evidence-based self-help intervention will demonstrate feasibility, tolerability, and potential efficacy in a limited double-blind randomized control trial. Smokers (n=29), abstinent for 24h, motivated to quit, and not using cessation medications, were randomized to active 20Hz rTMS at 110% of Motor Threshold or sham stimulation that replicated the look and sound of active stimulation. Stimulation site was located using the 6cm rule and neuro-navigation. Multiple clinical, feasibility, tolerability, and efficacy measures were examined. Active rTMS decreased delay discounting of $100 (F (1, 25.3694)=4.14, p=.05) and $1000 (F (1, 25.169)=8.42, p<.01), reduced the relative risk of relapse 3-fold (RR 0.29, CI 0.10-0.76, Likelihood ratio χ2 with 1 df=6.40, p=.01), increased abstinence rates (active 50% vs. sham 15.4%, Χ2 (df=1)=3.80, p=.05), and increased uptake of the self-help intervention. Clinical, feasibility, and tolerability assessments were favorable. Combining 20Hz rTMS of the LDLPFC with an evidence-based self-help intervention is feasible, well-tolerated, and demonstrates potential efficacy.

Drug and alcohol dependence · randomised controlled trial · 62 citationsread the source →

Effect of a Workplace Wellness Program on Employee Health and Economic Outcomes: A Randomized Clinical Trial.

Importance: Employers have increasingly invested in workplace wellness programs to improve employee health and decrease health care costs. However, there is little experimental evidence on the effects of these programs. Objective: To evaluate a multicomponent workplace wellness program resembling programs offered by US employers. Design, setting, and participants: This clustered randomized trial was implemented at 160 worksites from January 2015 through June 2016. Administrative claims and employment data were gathered continuously through June 30, 2016; data from surveys and biometrics were collected from July 1, 2016, through August 31, 2016. Interventions: There were 20 randomly selected treatment worksites (4037 employees) and 140 randomly selected control worksites (28 937 employees, including 20 primary control worksites [4106 employees]). Control worksites received no wellness programming. The program comprised 8 modules focused on nutrition, physical activity, stress reduction, and related topics implemented by registered dietitians at the treatment worksites. Main outcomes and measures: Four outcome domains were assessed. Self-reported health and behaviors via surveys (29 outcomes) and clinical measures of health via screenings (10 outcomes) were compared among 20 intervention and 20 primary control sites; health care spending and utilization (38 outcomes) and employment outcomes (3 outcomes) from administrative data were compared among 20 intervention and 140 control sites. Results: Among 32 974 employees (mean [SD] age, 38.6 [15.2] years; 15 272 [45.9%] women), the mean participation rate in surveys and screenings at intervention sites was 36.2% to 44.6% (n = 4037 employees) and at primary control sites was 34.4% to 43.0% (n = 4106 employees) (mean of 1.3 program modules completed). After 18 months, the rates for 2 self-reported outcomes were higher in the intervention group than in the control group: for engaging in regular exercise (69.8% vs 61.9%; adjusted difference, 8.3 percentage points [95% CI, 3.9-12.8]; adjusted P = .03) and for actively managing weight (69.2% vs 54.7%; adjusted difference, 13.6 percentage points [95% CI, 7.1-20.2]; adjusted P = .02). The program had no significant effects on other prespecified outcomes: 27 self-reported health outcomes and behaviors (including self-reported health, sleep quality, and food choices), 10 clinical markers of health (including cholesterol, blood pressure, and body mass index), 38 medical and pharmaceutical spending and utilization measures, and 3 employment outcomes (absenteeism, job tenure, and job performance). Conclusions and relevance: Among employees of a large US warehouse retail company, a workplace wellness program resulted in significantly greater rates of some positive self-reported health behaviors among those exposed compared with employees who were not exposed, but there were no significant differences in clinical measures of health, health care spending and utilization, and employment outcomes after 18 months. Although limited by incomplete data on some outcomes, these findings may temper expectations about the financial return on investment that wellness programs can deliver in the short term. Trial registration: ClinicalTrials.gov Identifier: NCT03167658.

JAMA · randomised controlled trial · 170 citationsread the source →

Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial.

Background: Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical and cost-effectiveness of sleep restriction therapy, a key component of CBT, which has the potential to be widely implemented. Methods: We did a pragmatic, superiority, open-label, randomised controlled trial of sleep restriction therapy versus sleep hygiene. Adults with insomnia disorder were recruited from 35 general practices across England and randomly assigned (1:1) using a web-based randomisation programme to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only. There was no restriction on usual care for either group. Outcomes were assessed at 3 months, 6 months, and 12 months. The primary endpoint was self-reported insomnia severity at 6 months measured with the insomnia severity index (ISI). The primary analysis included participants according to their allocated group and who contributed at least one outcome measurement. Cost-effectiveness was evaluated from the UK National Health Service and personal social services perspective and expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The trial was prospectively registered (ISRCTN42499563). Findings: Between Aug 29, 2018, and March 23, 2020 we randomly assigned 642 participants to sleep restriction therapy (n=321) or sleep hygiene (n=321). Mean age was 55·4 years (range 19-88), with 489 (76·2%) participants being female and 153 (23·8%) being male. 580 (90·3%) participants provided data for at least one outcome measurement. At 6 months, mean ISI score was 10·9 (SD 5·5) for sleep restriction therapy and 13·9 (5·2) for sleep hygiene (adjusted mean difference -3·05, 95% CI -3·83 to -2·28; p<0·0001; Cohen's d -0·74), indicating that participants in the sleep restriction therapy group reported lower insomnia severity than the sleep hygiene group. The incremental cost per QALY gained was £2076, giving a 95·3% probability that treatment was cost-effective at a cost-effectiveness threshold of £20 000. Eight participants in each group had serious adverse events, none of which were judged to be related to intervention. Interpretation: Brief nurse-delivered sleep restriction therapy in primary care reduces insomnia symptoms, is likely to be cost-effective, and has the potential to be widely implemented as a first-line treatment for insomnia disorder. Funding: The National Institute for Health and Care Research Health Technology Assessment Programme.

Lancet (London, England) · randomised controlled trial · 59 citationsread the source →

Effectiveness of the Extension for Community Health Outcomes Model as Applied to Primary Care for Autism: A Partial Stepped-Wedge Randomized Clinical Trial.

Importance: The Extension for Community Health Outcomes (ECHO) model is a widely adopted technology-based model for training primary care physicians and practitioners (PCPs) to care for patients with complex conditions. Despite its popularity, to our knowledge, direct effects of ECHO on clinical practice have not been tested in a large-scale study. Objective: To test the effectiveness of the ECHO model as applied to primary care for autism and whether it resulted in improved clinical practice, knowledge, and self-efficacy regarding autism screening and comorbidity management. Design, setting, and participants: Primary care physicians and practitioners were recruited to participate in a 6-month ECHO Autism program delivered by 1 of 10 academic medical center sites. A sequential, staggered rollout of ECHO Autism was delivered to 5 cohorts of participants (15 per site; 2 sites per cohort). Sites were randomized after recruitment to cohort/start time. Cohorts launched every 3 months. The ECHO Autism program used videoconferencing technology to connect community-based PCPs with interdisciplinary expert teams at academic medical centers. There were 148 participants (PCPs [family practice physicians, pediatricians, nurse practitioners, and physician assistants] providing outpatient services to underserved children) studied between December 2016 and November 2018. Interventions: The 6-month ECHO Autism program included twelve 2-hour sessions connecting PCP participants with an interdisciplinary expert team. Sessions included didactics, case-based learning, guided practice, and discussion. Main outcomes and measures: Coprimary outcomes were autism screening practices and comorbidity management (assessed by medical record review). Secondary outcomes were knowledge (assessed by direct testing) and self-efficacy (assessed by self-report survey). Assessments were conducted at baseline, mid-ECHO, post-ECHO, and follow-up (3 months after ECHO). Results: Ten sites were randomized to 1 of 5 cohorts. Participants were 82% female (n = 108), 76% white (n = 100), and 6% Hispanic or Latino (n = 8); the median age was 46 years (interquartile range, 37-55 years). Significant changes in autism screening and treatment of comorbidities in children with autism were not observed. Participants demonstrated significant improvements in knowledge (9%; 95% CI, 4-13; P < .001) and self-efficacy (29%; 95% CI, 25-32; P < .001). Conclusions and relevance: The ECHO model was developed to increase access to high-quality health care for underserved patients with complex conditions. Study results provide support for the model in improving clinician knowledge and confidence but little support for achieving practice change. Trial registration: ClinicalTrials.gov Identifier: NCT03677089.

JAMA pediatrics · randomised controlled trial · 63 citationsread the source →

Effect of Varenicline Combined With Medical Management on Alcohol Use Disorder With Comorbid Cigarette Smoking: A Randomized Clinical Trial.

Importance: Individuals with alcohol use disorder have high rates of cigarette smoking. Varenicline tartrate, an approved treatment for smoking cessation, may reduce both drinking and smoking. Objectives: To test the efficacy of varenicline with medical management for patients with alcohol use disorder and comorbid smoking seeking alcohol treatment, and to evaluate the secondary effects on smoking abstinence. Design, setting, and participants: This phase 2, randomized, double-blind, parallel group, placebo-controlled trial was conducted at 2 outpatient clinics from September 19, 2012, to August 31, 2015. Eligible participants met alcohol-dependence criteria and reported heavy drinking (≥5 drinks for men and ≥4 drinks for women) 2 or more times per week and smoking 2 or more times per week; 131 participants were randomized to either varenicline or placebo stratified by sex and site. All analyses were of the intention-to-treat type. Data analysis was conducted from February 5, 2016, to September 29, 2017. Interventions: Varenicline tartrate, 1 mg twice daily, and matching placebo pills for 16 weeks. Medical management emphasized medication adherence for 4 weeks followed by support for changing drinking. Main outcomes and measures: Percentage of heavy drinking days (PHDD) weeks 9 to 16, no heavy drinking days (NHDD) weeks 9 to 16, and prolonged smoking abstinence weeks 13 to 16. Results: Of 131 participants, 39 (29.8%) were women and 92 (70.2%) were men, the mean (SD) age was 42.7 (11.7) years, and the race/ethnicity self-identified by most respondents was black (69 [52.7%]). Sixty-four participants were randomized to receive varenicline, and 67 to receive placebo. Mean change in PHDD between varenicline and placebo across sex and site was not significantly different. However, a significant treatment by sex by time interaction for PHDD (F1,106 = 4.66; P = .03) revealed that varenicline compared with placebo resulted in a larger decrease in log-transformed PHDD in men (least square [LS] mean difference in change from baseline, 0.54; 95% CI, -0.09 to 1.18; P = .09; Cohen d = 0.45) but a smaller decrease in women (LS mean difference, -0.69; 95% CI, -1.63 to 0.25; P = .15; Cohen d = -0.53). Thirteen of 45 men (29%) had NHDD taking varenicline compared with 3 of 47 men (6%) taking placebo (Cohen h = 0.64; 95% CI, 0.22-1.03), whereas 1 of 19 women (5%) had NHDD compared with 5 of 20 women (25%) taking placebo (Cohen h = -0.60; 95% CI, -1.21 to 0.04). Taking varenicline, 8 of 64 participants (13%) achieved prolonged smoking abstinence; no one (0 of 67) quit smoking taking placebo (P = .003; Cohen h = 0.72; 95% CI, 0.38-1.07). Conclusions and relevance: Varenicline with medical management resulted in decreased heavy drinking among men and increased smoking abstinence in the overall sample. Varenicline could be considered to promote improvements in men with these dual behavioral health risks. Trial registration: clinicaltrials.gov Identifier: NCT01553136.

JAMA psychiatry · randomised controlled trial · 77 citationsread the source →

Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study.

Objective: To evaluate the feasibility, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS) for the prevention of chronic migraine (CM) attacks. Methods: In this first prospective, multicenter, double-blind, sham-controlled pilot study of nVNS in CM prophylaxis, adults with CM (≥15 headache d/mo) entered the baseline phase (1 month) and were subsequently randomized to nVNS or sham treatment (2 months) before receiving open-label nVNS treatment (6 months). The primary endpoints were safety and tolerability. Efficacy endpoints in the intent-to-treat population included change in the number of headache days per 28 days and acute medication use. Results: Fifty-nine participants (mean age, 39.2 years; mean headache frequency, 21.5 d/mo) were enrolled. During the randomized phase, tolerability was similar for nVNS (n = 30) and sham treatment (n = 29). Most adverse events were mild/moderate and transient. Mean changes in the number of headache days were -1.4 (nVNS) and -0.2 (sham) (Δ = 1.2; p = 0.56). Twenty-seven participants completed the open-label phase. For the 15 completers initially assigned to nVNS, the mean change from baseline in headache days after 8 months of treatment was -7.9 (95% confidence interval -11.9 to -3.8; p < 0.01). Conclusions: Therapy with nVNS was well-tolerated with no safety issues. Persistent prophylactic use may reduce the number of headache days in CM; larger sham-controlled studies are needed. Clinicaltrialsgov identifier: NCT01667250. Classification of evidence: This study provides Class II evidence that for patients with CM, nVNS is safe, is well-tolerated, and did not significantly change the number of headache days. This pilot study lacked the precision to exclude important safety issues or benefits of nVNS.

Neurology · randomised controlled trial · 162 citationsread the source →

Promoting school climate and health outcomes with the SEHER multi-component secondary school intervention in Bihar, India: a cluster-randomised controlled trial.

Background: School environments affect health and academic outcomes. With increasing secondary school retention in low-income and middle-income countries, promoting quality school social environments could offer a scalable opportunity to improve adolescent health and wellbeing. Methods: We did a cluster-randomised trial to assess the effectiveness of a multi-component whole-school health promotion intervention (SEHER) with integrated economic and process evaluations in grade 9 students (aged 13-14 years) at government-run secondary schools in the Nalanda district of Bihar state, India. Schools were randomly assigned (1:1:1) to three groups: the SEHER intervention delivered by a lay counsellor (the SEHER Mitra [SM] group), the SEHER intervention delivered by a teacher (teacher as SEHER Mitra [TSM] group), and a control group in which only the standard government-run classroom-based life-skills Adolescence Education Program was implemented. The primary outcome was school climate measured with the Beyond Blue School Climate Questionnaire (BBSCQ). Students were assessed at the start of the academic year (June, 2015) and again 8 months later at the end of the academic year (March, 2016) via self-completed questionnaires. This study is registered with ClinicalTrials.gov, number NCT02484014. Findings: Of the 112 eligible schools in the Nalanda district, 75 were randomly selected to participate in the trial. We randomly assigned 25 schools to each of the three groups. One school subsequently dropped out of the TSM group, leaving 24 schools in this group. The baseline survey included a total of 13 035 participants, and the endpoint survey included 14 414 participants. Participants in the SM-delivered intervention schools had substantially higher school climate scores at endpoint survey than those in the control group (BBSCQ baseline-adjusted mean difference [aMD] 7·57 [95% CI 6·11-9·03]; effect size 1·88 [95% CI 1·44-2·32], p<0·0001) and the TSM-delivered intervention (aMD 7·57 [95% CI 6·06-9·08]; effect size 1·88 [95% CI 1·43-2·34], p<0·0001). There was no effect of the TSM-delivered intervention compared with control (aMD -0·009 [95% CI -1·53 to 1·51], effect size 0·00 [95% CI -0·45 to 0·44], p=0·99). Compared with the control group, participants in the SM-delivered intervention schools had moderate to large improvements in the secondary outcomes of depression (aMD -1·23 [95% CI -1·89 to -0·57]), bullying (aMD -0·91 [95% CI -1·15 to -0·66]), violence victimisation (odds ratio [OR] 0·62 [95% CI 0·46-0·84]), violence perpetration (OR 0·68 [95% CI 0·48-0·96]), attitude towards gender equity (aMD 0·41 [95% CI 0·21-0·61]), and knowledge of reproductive and sexual health (aMD 0·29 [95% CI 0·06-0·53]). Similar results for these secondary outcomes were noted for the comparison between SM-delivered intervention schools and TSM-delivered intervention schools (depression: aMD -1·23 [95% CI -1·91 to -0·55]; bullying: aMD -0·83 [95% CI -1·08 to -0·57]; violence victimisation: OR 0·49 [95% CI 0·35-0·67]; violence perpetration: OR 0·49 [95% CI 0·34-0·71]; attitude towards gender equity: aMD 0·23 [95% CI 0·02-0·44]; and knowledge of reproductive and sexual health: aMD 0·22 [95% CI -0·02 to 0·47]). However, no effects on these secondary outcomes were observed for the TSM-delivered intervention schools compared with the control group (depression: aMD -0·03 [95% CI -0·70 to 0·65]; bullying: aMD -0·08 [95% CI -0·34 to 0·18]; violence victimisation: OR 1·27 [95% CI 0·93-1·73]; violence perpetration: OR 1·37 [95% CI 0·95-1·95]; attitude towards gender equity: aMD 0·17 [95% CI -0·09 to 0·38]; and knowledge of reproductive and sexual health: aMD 0·06 [95% CI -0·18 to 0·32]). Interpretation: The multi-component whole-school SEHER health promotion intervention had substantial beneficial effects on school climate and health-related outcomes when delivered by lay counsellors, but no effects when delivered by teachers. Future research should focus on the evaluation of the scaling up of the SEHER intervention in diverse contexts and delivery agents. Funding: John D. and Catherine T. MacArthur Foundation, USA and the United Nations Population Fund India Office.

Lancet (London, England) · randomised controlled trial · 121 citationsread the source →