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Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery (DESTINY): a randomized, controlled trial.

Background and purpose: Decompressive surgery (hemicraniectomy) for life-threatening massive cerebral infarction represents a controversial issue in neurocritical care medicine. We report here the 30-day mortality and 6- and 12-month functional outcomes from the DESTINY trial. Methods: DESTINY (ISRCTN01258591) is a prospective, multicenter, randomized, controlled, clinical trial based on a sequential design that used mortality after 30 days as the first end point. When this end point was reached, patient enrollment was interrupted as per protocol until recalculation of the projected sample size was performed on the basis of the 6-month outcome (primary end point=modified Rankin Scale score, dichotomized to 0 to 3 versus 4 to 6). All analyses were based on intention to treat. Results: A statistically significant reduction in mortality was reached after 32 patients had been included: 15 of 17 (88%) patients randomized to hemicraniectomy versus 7 of 15 (47%) patients randomized to conservative therapy survived after 30 days (P=0.02). After 6 and 12 months, 47% of patients in the surgical arm versus 27% of patients in the conservative treatment arm had a modified Rankin Scale score of 0 to 3 (P=0.23). Conclusions: DESTINY showed that hemicraniectomy reduces mortality in large hemispheric stroke. With 32 patients included, the primary end point failed to demonstrate statistical superiority of hemicraniectomy, and the projected sample size was calculated to 188 patients. Despite this failure to meet the primary end point, the steering committee decided to terminate the trial in light of the results of the joint analysis of the 3 European hemicraniectomy trials.

Stroke · randomised controlled trial · 552 citationsread the source →

Randomized, controlled pilot trial of a smartphone app for smoking cessation using acceptance and commitment therapy.

Background: There is a dual need for (1) innovative theory-based smartphone applications for smoking cessation and (2) controlled trials to evaluate their efficacy. Accordingly, this study tested the feasibility, acceptability, preliminary efficacy, and mechanism of behavioral change of an innovative smartphone-delivered acceptance and commitment therapy (ACT) application for smoking cessation vs. an application following US Clinical Practice Guidelines. Method: Adult participants were recruited nationally into the double-blind randomized controlled pilot trial (n=196) that compared smartphone-delivered ACT for smoking cessation application (SmartQuit) with the National Cancer Institute's application for smoking cessation (QuitGuide). Results: We recruited 196 participants in two months. SmartQuit participants opened their application an average of 37.2 times, as compared to 15.2 times for QuitGuide participants (p<0001). The overall quit rates were 13% in SmartQuit vs. 8% in QuitGuide (OR=2.7; 95% CI=0.8-10.3). Consistent with ACT's theory of change, among those scoring low (below the median) on acceptance of cravings at baseline (n=88), the quit rates were 15% in SmartQuit vs. 8% in QuitGuide (OR=2.9; 95% CI=0.6-20.7). Conclusions: ACT is feasible to deliver by smartphone application and shows higher engagement and promising quit rates compared to an application that follows US Clinical Practice Guidelines. As results were limited by the pilot design (e.g., small sample), a full-scale efficacy trial is now needed.

Drug and alcohol dependence · randomised controlled trial · 242 citationsread the source →

Long-term follow-up of internet-delivered exposure and mindfulness based treatment for irritable bowel syndrome.

We conducted a follow-up of a previously reported study of internet-delivered cognitive behavior therapy (CBT) for IBS, based on exposure and mindfulness exercises (Ljótsson et al. (2010). Internet-delivered exposure and mindfulness based therapy for irritable bowel syndrome - a randomized controlled trial. Behaviour Research and Therapy, 48, 531-539). Seventy-five participants from the original sample of 85 (88%) reported follow-up data at 15-18 months (mean 16.4 months) after completing treatment. The follow-up sample included participants from both the original study's treatment group and waiting list after it had been crossed over to treatment. Intention-to-treat analysis showed that treatment gains were maintained on all outcome measures, including IBS symptoms, quality of life, and anxiety related to gastrointestinal symptoms, with mainly large effect sizes (within-group Cohen's d=0.78-1.11). A total of fifty participants (59% of the total original sample; 52% of the original treatment group participants and 65% of the original waiting list participants) reported adequate relief of symptoms. Improvements at follow-up were more pronounced for the participants that had completed the full treatment and maintenance of improvement did not seem to be dependent on further treatment seeking. This study suggests that internet-delivered CBT based on exposure and mindfulness has long-term beneficial effects for IBS-patients.

Behaviour research and therapy · randomised controlled trial · 74 citationsread the source →

Psychotherapy for depression in older veterans via telemedicine: a randomised, open-label, non-inferiority trial.

Background: Many older adults with major depression, particularly veterans, do not have access to evidence-based psychotherapy. Telemedicine could increase access to best-practice care for older adults facing barriers of mobility, stigma, and geographical isolation. We aimed to establish non-inferiority of behavioural activation therapy for major depression delivered via telemedicine to same-room care in largely male, older adult veterans. Methods: In this randomised, controlled, open-label, non-inferiority trial, we recruited veterans (aged ≥58 years) meeting DSM-IV criteria for major depressive disorder from the Ralph H Johnson Veterans Affairs Medical Center and four associated community outpatient-based clinics in the USA. We excluded actively psychotic or demented people, those with both suicidal ideation and clear intent, and those with substance dependence. The study coordinator randomly assigned participants (1:1; block size 2-6; stratified by race; computer-generated randomisation sequence by RGK) to eight sessions of behavioural activation for depression either via telemedicine or in the same room. The primary outcome was treatment response according to the Geriatric Depression Scale (GDS) and Beck Depression Inventory (BDI; defined as a 50% reduction in symptoms from baseline at 12 months), and Structured Clinical Interview for DSM-IV, clinician version (defined as no longer being diagnosed with major depressive disorder at 12 months follow-up), in the per-protocol population (those who completed at least four treatment sessions and for whom all outcome measurements were done). Those assessing outcomes were masked. The non-inferiority margin was 15%. This trial is registered with ClinicalTrials.gov, number NCT00324701. Findings: Between April 1, 2007, and July 31, 2011, we screened 780 patients, and the study coordinator randomly assigned participants to either telemedicine (120 [50%]) or same-room treatment (121 [50%]). We included 100 (83%) patients in the per-protocol analysis in the telemedicine group and 104 (86%) in the same-room group. Treatment response according to GDS did not differ significantly between the telemedicine (22 [22·45%, 90% CI 15·52-29·38] patients) and same-room (21 [20·39%, 90% CI 13·86-26·92]) groups, with an absolute difference of 2·06% (90% CI -7·46 to 11·58). Response according to BDI also did not differ significantly (telemedicine 19 [24·05%, 90% CI 16·14-31·96] patients; same room 19 [23·17%, 90% CI 15·51-30·83]), with an absolute difference of 0·88% (90% CI -10·13 to 11·89). Response on the Structured Clinical Interview for DSM-IV, clinician version, also did not differ significantly (39 [43·33%, 90% CI 34·74-51·93] patients in the telemedicine group and 46 [48·42%, 90% CI 39·99-56·85] in the same-room group), with a difference of -5·09% (-17·13 to 6·95; p=0·487). Results from the intention-to-treat population were similar. MEM analyses showed that no significant differences existed between treatment trajectories over time for BDI and GDS. The criteria for non-inferiority were met. We did not note any adverse events. Interpretation: Telemedicine-delivered psychotherapy for older adults with major depression is not inferior to same-room treatment. This finding shows that evidence-based psychotherapy can be delivered, without modification, via home-based telemedicine, and that this method can be used to overcome barriers to care associated with distance from and difficulty with attendance at in-person sessions in older adults. Funding: US Department of Veterans Affairs.

The lancet. Psychiatry · randomised controlled trial · 123 citationsread the source →

A sexual and reproductive empowerment framework to explore volitional sex in sub-Saharan Africa.

Volitional sex is central to the sexual health and well-being of women and girls globally. To date, few studies have examined women's empowerment and its application to sexual health outcomes, including volitional sex. The aim of this study was to explore the relevance of a sexual and reproductive empowerment framework to volitional sex across four geographically and culturally diverse contexts in sub-Saharan Africa. Qualitative data were collected between July and August 2017 in four sites: Ethiopia, Nigeria (Anambra and Kano states) and Uganda. A total of 352 women aged 15-49 and 88 men aged 18 and older were interviewed through 120 in-depth interviews and 38 focus group discussions (n = 440 total participants). Results describe the substantial barriers restraining women's sexual choices, particularly norms that stigmatise women's requests for sex, even within marriage. Results further highlight women's internal sexual motivations, particularly related to the enjoyment of sex and the role of sex in strengthening partner relationships. Future empowerment research and measurement should focus not only on sexual constraints, but also integrate internal motivations, in order to fully understand the factors that shape women's sexual health outcomes.

Culture, health & sexuality · 23 citationsread the source →

Psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the COVID-19 pandemic.

Background: Before the COVID-19 pandemic, coronaviruses caused two noteworthy outbreaks: severe acute respiratory syndrome (SARS), starting in 2002, and Middle East respiratory syndrome (MERS), starting in 2012. We aimed to assess the psychiatric and neuropsychiatric presentations of SARS, MERS, and COVID-19. Methods: In this systematic review and meta-analysis, MEDLINE, Embase, PsycINFO, and the Cumulative Index to Nursing and Allied Health Literature databases (from their inception until March 18, 2020), and medRxiv, bioRxiv, and PsyArXiv (between Jan 1, 2020, and April 10, 2020) were searched by two independent researchers for all English-language studies or preprints reporting data on the psychiatric and neuropsychiatric presentations of individuals with suspected or laboratory-confirmed coronavirus infection (SARS coronavirus, MERS coronavirus, or SARS coronavirus 2). We excluded studies limited to neurological complications without specified neuropsychiatric presentations and those investigating the indirect effects of coronavirus infections on the mental health of people who are not infected, such as those mediated through physical distancing measures such as self-isolation or quarantine. Outcomes were psychiatric signs or symptoms; symptom severity; diagnoses based on ICD-10, DSM-IV, or the Chinese Classification of Mental Disorders (third edition) or psychometric scales; quality of life; and employment. Both the systematic review and the meta-analysis stratified outcomes across illness stages (acute vs post-illness) for SARS and MERS. We used a random-effects model for the meta-analysis, and the meta-analytical effect size was prevalence for relevant outcomes, I2 statistics, and assessment of study quality. Findings: 1963 studies and 87 preprints were identified by the systematic search, of which 65 peer-reviewed studies and seven preprints met inclusion criteria. The number of coronavirus cases of the included studies was 3559, ranging from 1 to 997, and the mean age of participants in studies ranged from 12·2 years (SD 4·1) to 68·0 years (single case report). Studies were from China, Hong Kong, South Korea, Canada, Saudi Arabia, France, Japan, Singapore, the UK, and the USA. Follow-up time for the post-illness studies varied between 60 days and 12 years. The systematic review revealed that during the acute illness, common symptoms among patients admitted to hospital for SARS or MERS included confusion (36 [27·9%; 95% CI 20·5-36·0] of 129 patients), depressed mood (42 [32·6%; 24·7-40·9] of 129), anxiety (46 [35·7%; 27·6-44·2] of 129), impaired memory (44 [34·1%; 26·2-42·5] of 129), and insomnia (54 [41·9%; 22·5-50·5] of 129). Steroid-induced mania and psychosis were reported in 13 (0·7%) of 1744 patients with SARS in the acute stage in one study. In the post-illness stage, depressed mood (35 [10·5%; 95% CI 7·5-14·1] of 332 patients), insomnia (34 [12·1%; 8·6-16·3] of 280), anxiety (21 [12·3%; 7·7-17·7] of 171), irritability (28 [12·8%; 8·7-17·6] of 218), memory impairment (44 [18·9%; 14·1-24·2] of 233), fatigue (61 [19·3%; 15·1-23·9] of 316), and in one study traumatic memories (55 [30·4%; 23·9-37·3] of 181) and sleep disorder (14 [100·0%; 88·0-100·0] of 14) were frequently reported. The meta-analysis indicated that in the post-illness stage the point prevalence of post-traumatic stress disorder was 32·2% (95% CI 23·7-42·0; 121 of 402 cases from four studies), that of depression was 14·9% (12·1-18·2; 77 of 517 cases from five studies), and that of anxiety disorders was 14·8% (11·1-19·4; 42 of 284 cases from three studies). 446 (76·9%; 95% CI 68·1-84·6) of 580 patients from six studies had returned to work at a mean follow-up time of 35·3 months (SD 40·1). When data for patients with COVID-19 were examined (including preprint data), there was evidence for delirium (confusion in 26 [65%] of 40 intensive care unit patients and agitation in 40 [69%] of 58 intensive care unit patients in one study, and altered consciousness in 17 [21%] of 82 patients who subsequently died in another study). At discharge, 15 (33%) of 45 patients with COVID-19 who were assessed had a dysexecutive syndrome in one study. At the time of writing, there were two reports of hypoxic encephalopathy and one report of encephalitis. 68 (94%) of the 72 studies were of either low or medium quality. Interpretation: If infection with SARS-CoV-2 follows a similar course to that with SARS-CoV or MERS-CoV, most patients should recover without experiencing mental illness. SARS-CoV-2 might cause delirium in a significant proportion of patients in the acute stage. Clinicians should be aware of the possibility of depression, anxiety, fatigue, post-traumatic stress disorder, and rarer neuropsychiatric syndromes in the longer term. Funding: Wellcome Trust, UK National Institute for Health Research (NIHR), UK Medical Research Council, NIHR Biomedical Research Centre at University College London Hospitals NHS Foundation Trust and University College London.

The lancet. Psychiatry · meta-analysis · 1531 citationsread the source →

The Value of Mobile Health in Improving Breastfeeding Outcomes Among Perinatal or Postpartum Women: Systematic Review and Meta-analysis of Randomized Controlled Trials.

Background: Breastfeeding is essential for maintaining the health of mothers and babies. Breastfeeding can reduce the infection rate and mortality in newborns, and can reduce the chances of overweight and obesity in children and adolescents. For mothers, a longer duration of breastfeeding can reduce the risk of breast cancer, ovarian cancer, and type 2 diabetes. Although breastfeeding has many benefits, the global breastfeeding rate is low. With the progress of time, the popularity of mobile devices has increased rapidly, and interventions based on mobile health (mHealth) may have the potential to facilitate the improvement of the breastfeeding status. Objective: The main objective of this study was to analyze the existing evidence to determine whether mHealth-based interventions can improve the status of breastfeeding. Methods: We systematically searched multiple electronic databases (PubMed, Web of Science, The Cochrane Library, Embase, CNKI, WanFang, and Vip ) to identify eligible studies published from 1966 to October 29, 2020. Included studies were randomized controlled trials (RCTs) studying the influence of mHealth on breastfeeding. The Cochrane Collaboration Risk of Bias tool was used to examine the risk of publication bias. RevMan 5.3 was used to analyze the data. Results: A total of 15 RCTs with a total sample size of 4366 participates met the inclusion criteria. Compared with usual care, interventions based on mHealth significantly increased the postpartum exclusive breastfeeding rate (odds ratio [OR] 3.18, 95% CI 2.20-4.59; P<.001), enhanced breastfeeding self-efficacy (mean difference [MD] 8.15, 95% CI 3.79-12.51; P=.002; I2=88%), reduced health problems in infants (OR 0.62, 95% CI 0.43-0.90; P=.01; I2=0%), and improved participants' attitudes toward breastfeeding compared with usual care (MD 3.94, 95% CI 1.95-5.92; P<.001; I2=0%). There was no significant difference in the initiation of breastfeeding within an hour of birth between the intervention group and the usual care group (OR 1.26, 95% CI 0.55-2.90; P=.59). In addition, subgroup analysis was carried out according to different subjects and publication times. The results showed that the breastfeeding rate was not limited by the types of subjects. The breastfeeding rate based on mHealth at 1 month and 2 months after delivery did not change over the time of publication (2009 to 2020), and the breastfeeding rate based on mHealth at 3 months and 6 months after delivery gradually increased with time (2009 to 2020). Conclusions: Interventions based on mHealth can significantly improve the rate of postpartum exclusive breastfeeding, breastfeeding efficacy, and participants' attitudes toward breastfeeding, and reduce health problems in infants. Therefore, encouraging women to join the mHealth team is feasible, and breastfeeding-related information can be provided through simple measures, such as text messages, phone calls, and the internet, to improve the health of postpartum women and their babies.

JMIR mHealth and uHealth · meta-analysis · 49 citationsread the source →

Effectiveness of brief alcohol interventions in primary care populations.

Background: Excessive drinking is a significant cause of mortality, morbidity and social problems in many countries. Brief interventions aim to reduce alcohol consumption and related harm in hazardous and harmful drinkers who are not actively seeking help for alcohol problems. Interventions usually take the form of a conversation with a primary care provider and may include feedback on the person's alcohol use, information about potential harms and benefits of reducing intake, and advice on how to reduce consumption. Discussion informs the development of a personal plan to help reduce consumption. Brief interventions can also include behaviour change or motivationally-focused counselling. This is an update of a Cochrane Review published in 2007. Objectives: To assess the effectiveness of screening and brief alcohol intervention to reduce excessive alcohol consumption in hazardous or harmful drinkers in general practice or emergency care settings. Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and 12 other bibliographic databases to September 2017. We searched Alcohol and Alcohol Problems Science Database (to December 2003, after which the database was discontinued), trials registries, and websites. We carried out handsearching and checked reference lists of included studies and relevant reviews. Selection criteria: We included randomised controlled trials (RCTs) of brief interventions to reduce hazardous or harmful alcohol consumption in people attending general practice, emergency care or other primary care settings for reasons other than alcohol treatment. The comparison group was no or minimal intervention, where a measure of alcohol consumption was reported. 'Brief intervention' was defined as a conversation comprising five or fewer sessions of brief advice or brief lifestyle counselling and a total duration of less than 60 minutes. Any more was considered an extended intervention. Digital interventions were not included in this review. Data collection and analysis: We used standard methodological procedures expected by Cochrane. We carried out subgroup analyses where possible to investigate the impact of factors such as gender, age, setting (general practice versus emergency care), treatment exposure and baseline consumption. Main results: We included 69 studies that randomised a total of 33,642 participants. Of these, 42 studies were added for this update (24,057 participants). Most interventions were delivered in general practice (38 studies, 55%) or emergency care (27 studies, 39%) settings. Most studies (61 studies, 88%) compared brief intervention to minimal or no intervention. Extended interventions were compared with brief (4 studies, 6%), minimal or no intervention (7 studies, 10%). Few studies targeted particular age groups: adolescents or young adults (6 studies, 9%) and older adults (4 studies, 6%). Mean baseline alcohol consumption was 244 g/week (30.5 standard UK units) among the studies that reported these data. Main sources of bias were attrition and lack of provider or participant blinding. The primary meta-analysis included 34 studies (15,197 participants) and provided moderate-quality evidence that participants who received brief intervention consumed less alcohol than minimal or no intervention participants after one year (mean difference (MD) -20 g/week, 95% confidence interval (CI) -28 to -12). There was substantial heterogeneity among studies (I² = 73%). A subgroup analysis by gender demonstrated that both men and women reduced alcohol consumption after receiving a brief intervention. We found moderate-quality evidence that brief alcohol interventions have little impact on frequency of binges per week (MD -0.08, 95% CI -0.14 to -0.02; 15 studies, 6946 participants); drinking days per week (MD -0.13, 95% CI -0.23 to -0.04; 11 studies, 5469 participants); or drinking intensity (-0.2 g/drinking day, 95% CI -3.1 to 2.7; 10 studies, 3128 participants).We found moderate-quality evidence of little difference in quantity of alcohol consumed when extended and no or minimal interventions were compared (-14 g/week, 95% CI -37 to 9; 6 studies, 1296 participants). There was little difference in binges per week (-0.08, 95% CI -0.28 to 0.12; 2 studies, 456 participants; moderate-quality evidence) or difference in days drinking per week (-0.45, 95% CI -0.81 to -0.09; 2 studies, 319 participants; moderate-quality evidence). Extended versus no or minimal intervention provided little impact on drinking intensity (9 g/drinking day, 95% CI -26 to 9; 1 study, 158 participants; low-quality evidence).Extended intervention had no greater impact than brief intervention on alcohol consumption, although findings were imprecise (MD 2 g/week, 95% CI -42 to 45; 3 studies, 552 participants; low-quality evidence). Numbers of binges were not reported for this comparison, but one trial suggested a possible drop in days drinking per week (-0.5, 95% CI -1.2 to 0.2; 147 participants; low-quality evidence). Results from this trial also suggested very little impact on drinking intensity (-1.7 g/drinking day, 95% CI -18.9 to 15.5; 147 participants; very low-quality evidence).Only five studies reported adverse effects (very low-quality evidence). No participants experienced any adverse effects in two studies; one study reported that the intervention increased binge drinking for women and two studies reported adverse events related to driving outcomes but concluded they were equivalent in both study arms. Sources of funding were reported by 67 studies (87%). With two exceptions, studies were funded by government institutes, research bodies or charitable foundations. One study was partly funded by a pharmaceutical company and a brewers association, another by a company developing diagnostic testing equipment. Authors' conclusions: We found moderate-quality evidence that brief interventions can reduce alcohol consumption in hazardous and harmful drinkers compared to minimal or no intervention. Longer counselling duration probably has little additional effect. Future studies should focus on identifying the components of interventions which are most closely associated with effectiveness.

The Cochrane database of systematic reviews · meta-analysis · 409 citationsread the source →

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 →

A realist review of which advocacy interventions work for which abused women under what circumstances.

Background: Intimate partner abuse (including coercive control, physical, sexual, economic, emotional and economic abuse) is common worldwide. Advocacy may help women who are in, or have left, an abusive intimate relationship, to stop or reduce repeat victimisation and overcome consequences of the abuse. Advocacy primarily involves education, safety planning support and increasing access to different services. It may be stand-alone or part of other services and interventions, and may be provided within healthcare, criminal justice, social, government or specialist domestic violence services. We focus on the abuse of women, as interventions for abused men require different considerations. Objectives: To assess advocacy interventions for intimate partner abuse in women, in terms of which interventions work for whom, why and in what circumstances. Search methods: In January 2019 we searched CENTRAL, MEDLINE, 12 other databases, two trials registers and two relevant websites. The search had three phases: scoping of articles to identify candidate theories; iterative recursive search for studies to explore and fill gaps in these theories; and systematic search for studies to test, confirm or refute our explanatory theory. Selection criteria: Empirical studies of any advocacy or multi-component intervention including advocacy, intended for women aged 15 years and over who were experiencing or had experienced any form of intimate partner abuse, or of advocates delivering such interventions, or experiences of women who were receiving or had received such an intervention. Partner abuse encompasses coercive control in the absence of physical abuse. For theory development, we included studies that did not strictly fit our original criteria but provided information useful for theory development. Data collection and analysis: Four review authors independently extracted data, with double assessment of 10% of the data, and assessed risk of bias and quality of the evidence. We adopted RAMESES (Realist and meta-narrative evidence syntheses: evolving standards) standards for reporting results. We applied a realist approach to the analysis. Main results: We included 98 studies (147 articles). There were 88 core studies: 37 focused on advocates (4 survey-based, 3 instrument development, 30 qualitative focus) and seven on abused women (6 qualitative studies, 1 survey); 44 were experimental intervention studies (some including qualitative evaluations). Ten further studies (3 randomised controlled trials (RCTs), 1 intervention process evaluation, 1 qualitative study, 2 mixed methods studies, 2 surveys of women, and 1 mixed methods study of women and staff) did not fit the original criteria but added useful information, as befitting a realist approach. Two studies are awaiting classification and three are ongoing. Advocacy interventions varied considerably in contact hours, profession delivering and setting. We constructed a conceptual model from six essential principles based on context-mechanism-outcome (CMO) patterns. We have moderate and high confidence in evidence for the importance of considering both women's vulnerabilities and intersectionalities and the trade-offs of abuse-related decisions in the contexts of individual women's lives. Decisions should consider the risks to the woman's safety from the abuse. Whether actions resulting from advocacy increase or decrease abuse depends on contextual factors (e.g. severity and type of abuse), and the outcomes the particular advocacy intervention is designed to address (e.g. increasing successful court orders versus decreasing depression).We have low confidence in evidence regarding the significance of physical dependencies, being pregnant or having children. There were links between setting (high confidence), and potentially also theoretical underpinnings of interventions, type, duration and intensity of advocacy, advocate discipline and outcomes (moderate and low confidence). A good therapeutic alliance was important (high confidence); this alliance might be improved when advocates are matched with abused women on ethnicity or abuse experience, exercise cultural humility, and remove structural barriers to resource access by marginalised women. We identified significant challenges for advocates in inter-organisational working, vicarious traumatisation, and lack of clarity on how much support to give a woman (moderate and high confidence). To work effectively, advocates need ongoing training, role clarity, access to resources, and peer and institutional support. Our provisional model highlights the complex way that factors combine and interact for effective advocacy. We confirmed the core ingredients of advocacy according to both women and advocates, supported by studies and theoretical considerations: education and information on abuse; rights and resources; active referral and liaising with other services; risk assessment and safety planning. We were unable to confirm the impact of complexity of the intervention (low confidence). Our low confidence in the evidence was driven mostly by a lack of relevant studies, rather than poor-quality studies, despite the size of the review. Authors' conclusions: Results confirm the core ingredients of advocacy and suggest its use rests on sound theoretical underpinnings. We determined the elements of a good therapeutic alliance and how it might be improved, with a need for particular considerations of the factors affecting marginalised women. Women's goals from advocacy should be considered in the contexts of their personal lives. Women's safety was not necessarily at greatest risk from staying with the abuser. Potentially, if undertaken for long enough, advocacy should benefit an abused woman in terms of at least one outcome providing the goals are matched to each woman's needs. Some outcomes may take months to be determined. Where abuse is severe, some interventions may increase abuse. Advocates have a challenging role and must be supported emotionally, through provision of resources and through professional training, by organisations and peers. Future research should consider the different principles identified in this review, and study outcomes should be considered in relation to the mechanisms and contexts elucidated. More longitudinal evidence is needed. Single-subject research designs may help determine exactly when effect no longer increases, to determine the duration of longitudinal work, which will likely differ for vulnerable and marginalised women. Further work is needed to ascertain how to tailor advocacy interventions to cultural variations and rural and resource-poor settings. The methods used in the included studies may, in some cases, limit the applicability and completeness of the data reported. Economic analyses are required to ascertain if resources devoted to advocacy interventions are cost-effective in healthcare and community settings.

The Cochrane database of systematic reviews · meta-analysis · 36 citationsread the source →

Stigma reduction interventions for children and adolescents in low- and middle-income countries: Systematic review of intervention strategies.

Stigmatisation and discrimination are common worldwide, and have profound negative impacts on health and quality of life. Research, albeit limited, has focused predominantly on adults. There is a paucity of literature about stigma reduction strategies concerning children and adolescents, with evidence especially sparse for low- and middle-income countries (LMIC). This systematic review synthesised child-focused stigma reduction strategies in LMIC, and compared these to adult-focused interventions. Relevant publications were systematically searched in July and August 2018 in the following databases; Cochrane, Embase, Global Health, HMIC, Medline, PsycINFO, PubMed and WorldWideScience.org, and through Google Custom Search. Included studies and identified reviews were cross-referenced. Three categories of search terms were used: (i) stigma, (ii) intervention, and (iii) LMIC settings. Data on study design, participants and intervention details including strategies and implementation factors were extracted. Within 61 unique publications describing 79 interventions, utilising 14 unique stigma reduction strategies, 14 papers discussed 21 interventions and 10 unique strategies involving children. Most studies targeted HIV/AIDS (50% for children, 38% for adults) or mental illness (14% vs 34%) stigma. Community education (47%), individual empowerment (15%) and social contact (12%) were most employed in child-focused interventions. Most interventions were implemented at one socio-ecological level; child-focused interventions mostly employed community-level strategies (88%). Intervention duration was mostly short; between half a day and a week. Printed or movie-based material was key to deliver child-focused interventions (37%), while professionals most commonly implemented adult-focused interventions (53%). Ten unique, child-focused strategies were all evaluated positively, using a diverse set of scales. Children and adolescents are under-represented in stigma reduction in LMIC. More stigma reduction interventions in LMIC, addressing a wider variety of stigmas, with children as direct and indirect target group, are needed. This systematic review is registered under International Prospective Register of Systematic Reviews PROSPERO, reference number #CRD42018094700.

Social science & medicine (1982) · systematic review · 77 citationsread the source →

Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis.

Background: Major depressive disorder is one of the most common, burdensome, and costly psychiatric disorders worldwide in adults. Pharmacological and non-pharmacological treatments are available; however, because of inadequate resources, antidepressants are used more frequently than psychological interventions. Prescription of these agents should be informed by the best available evidence. Therefore, we aimed to update and expand our previous work to compare and rank antidepressants for the acute treatment of adults with unipolar major depressive disorder. Methods: We did a systematic review and network meta-analysis. We searched Cochrane Central Register of Controlled Trials, CINAHL, Embase, LILACS database, MEDLINE, MEDLINE In-Process, PsycINFO, the websites of regulatory agencies, and international registers for published and unpublished, double-blind, randomised controlled trials from their inception to Jan 8, 2016. We included placebo-controlled and head-to-head trials of 21 antidepressants used for the acute treatment of adults (≥18 years old and of both sexes) with major depressive disorder diagnosed according to standard operationalised criteria. We excluded quasi-randomised trials and trials that were incomplete or included 20% or more of participants with bipolar disorder, psychotic depression, or treatment-resistant depression; or patients with a serious concomitant medical illness. We extracted data following a predefined hierarchy. In network meta-analysis, we used group-level data. We assessed the studies' risk of bias in accordance to the Cochrane Handbook for Systematic Reviews of Interventions, and certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation framework. Primary outcomes were efficacy (response rate) and acceptability (treatment discontinuations due to any cause). We estimated summary odds ratios (ORs) using pairwise and network meta-analysis with random effects. This study is registered with PROSPERO, number CRD42012002291. Findings: We identified 28 552 citations and of these included 522 trials comprising 116 477 participants. In terms of efficacy, all antidepressants were more effective than placebo, with ORs ranging between 2·13 (95% credible interval [CrI] 1·89-2·41) for amitriptyline and 1·37 (1·16-1·63) for reboxetine. For acceptability, only agomelatine (OR 0·84, 95% CrI 0·72-0·97) and fluoxetine (0·88, 0·80-0·96) were associated with fewer dropouts than placebo, whereas clomipramine was worse than placebo (1·30, 1·01-1·68). When all trials were considered, differences in ORs between antidepressants ranged from 1·15 to 1·55 for efficacy and from 0·64 to 0·83 for acceptability, with wide CrIs on most of the comparative analyses. In head-to-head studies, agomelatine, amitriptyline, escitalopram, mirtazapine, paroxetine, venlafaxine, and vortioxetine were more effective than other antidepressants (range of ORs 1·19-1·96), whereas fluoxetine, fluvoxamine, reboxetine, and trazodone were the least efficacious drugs (0·51-0·84). For acceptability, agomelatine, citalopram, escitalopram, fluoxetine, sertraline, and vortioxetine were more tolerable than other antidepressants (range of ORs 0·43-0·77), whereas amitriptyline, clomipramine, duloxetine, fluvoxamine, reboxetine, trazodone, and venlafaxine had the highest dropout rates (1·30-2·32). 46 (9%) of 522 trials were rated as high risk of bias, 380 (73%) trials as moderate, and 96 (18%) as low; and the certainty of evidence was moderate to very low. Interpretation: All antidepressants were more efficacious than placebo in adults with major depressive disorder. Smaller differences between active drugs were found when placebo-controlled trials were included in the analysis, whereas there was more variability in efficacy and acceptability in head-to-head trials. These results should serve evidence-based practice and inform patients, physicians, guideline developers, and policy makers on the relative merits of the different antidepressants. Funding: National Institute for Health Research Oxford Health Biomedical Research Centre and the Japan Society for the Promotion of Science.

Lancet (London, England) · systematic review · 2220 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 →

Intimate partner violence during pregnancy and perinatal mental disorders in low and lower middle income countries: A systematic review of literature, 1990-2017.

Mental health consequences of intimate partner violence (IPV) against pregnant and postpartum women are poorly understood in low and lower-middle-income countries (LLMIC). We systematically reviewed the evidence from 24 studies (1990-2017) selected via a comprehensive search strategy with 14 inclusion, exclusion, and quality-control criteria to assess the extent to which intimate partner violence during pregnancy adversely affects perinatal mental disorders among participants in 10 LLMIC across 4 economic regions. Mostly cross-sectional, studies included 61-1369 participants selected randomly (88%) or non-randomly (12%) from purposively selected 1-6 clinics or 1-50 communities. Multivariate logistic regression was most frequently used (68%) for association estimates, adjusting for 3-16 socio-demographic variables pertinent to: women; husbands; and/or households. The prevalence of physical IPV ranged 2-35% among participants; sexual IPV ranged 9-40%; and psychological IPV ranged 22-65%. The prevalence of antenatal and postnatal depression ranged 15-65% and 5-35% among participants, respectively. Suicidal ideation ranged 5-11% during pregnancy and 2-22% during the postpartum period. Study participants who had experienced IPV had 1.69-3.76 and 1.46-7.04 higher odds of antenatal and postnatal depression compared to those who had not, depending on country, and IPV type and severity. Considering the strong association between IPV and mental disorders, efforts should focus on developing IPV interventions aimed at preventing pregnancy during IPV and promoting mental health resilience among pregnancy and postpartum women in low and lower-middle-income countries.

Clinical psychology review · systematic review · 106 citationsread the source →

Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis.

Background: Postoperative nausea and vomiting (PONV) is a common adverse effect of anaesthesia and surgery. Up to 80% of patients may be affected. These outcomes are a major cause of patient dissatisfaction and may lead to prolonged hospital stay and higher costs of care along with more severe complications. Many antiemetic drugs are available for prophylaxis. They have various mechanisms of action and side effects, but there is still uncertainty about which drugs are most effective with the fewest side effects. Objectives: • To compare the efficacy and safety of different prophylactic pharmacologic interventions (antiemetic drugs) against no treatment, against placebo, or against each other (as monotherapy or combination prophylaxis) for prevention of postoperative nausea and vomiting in adults undergoing any type of surgery under general anaesthesia • To generate a clinically useful ranking of antiemetic drugs (monotherapy and combination prophylaxis) based on efficacy and safety • To identify the best dose or dose range of antiemetic drugs in terms of efficacy and safety SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), ClinicalTrials.gov, and reference lists of relevant systematic reviews. The first search was performed in November 2017 and was updated in April 2020. In the update of the search, 39 eligible studies were found that were not included in the analysis (listed as awaiting classification). Selection criteria: Randomized controlled trials (RCTs) comparing effectiveness or side effects of single antiemetic drugs in any dose or combination against each other or against an inactive control in adults undergoing any type of surgery under general anaesthesia. All antiemetic drugs belonged to one of the following substance classes: 5-HT₃ receptor antagonists, D₂ receptor antagonists, NK₁ receptor antagonists, corticosteroids, antihistamines, and anticholinergics. No language restrictions were applied. Abstract publications were excluded. Data collection and analysis: A review team of 11 authors independently assessed trials for inclusion and risk of bias and subsequently extracted data. We performed pair-wise meta-analyses for drugs of direct interest (amisulpride, aprepitant, casopitant, dexamethasone, dimenhydrinate, dolasetron, droperidol, fosaprepitant, granisetron, haloperidol, meclizine, methylprednisolone, metoclopramide, ondansetron, palonosetron, perphenazine, promethazine, ramosetron, rolapitant, scopolamine, and tropisetron) compared to placebo (inactive control). We performed network meta-analyses (NMAs) to estimate the relative effects and ranking (with placebo as reference) of all available single drugs and combinations. Primary outcomes were vomiting within 24 hours postoperatively, serious adverse events (SAEs), and any adverse event (AE). Secondary outcomes were drug class-specific side effects (e.g. headache), mortality, early and late vomiting, nausea, and complete response. We performed subgroup network meta-analysis with dose of drugs as a moderator variable using dose ranges based on previous consensus recommendations. We assessed certainty of evidence of NMA treatment effects for all primary outcomes and drug class-specific side effects according to GRADE (CINeMA, Confidence in Network Meta-Analysis). We restricted GRADE assessment to single drugs of direct interest compared to placebo. Main results: We included 585 studies (97,516 randomized participants). Most of these studies were small (median sample size of 100); they were published between 1965 and 2017 and were primarily conducted in Asia (51%), Europe (25%), and North America (16%). Mean age of the overall population was 42 years. Most participants were women (83%), had American Society of Anesthesiologists (ASA) physical status I and II (70%), received perioperative opioids (88%), and underwent gynaecologic (32%) or gastrointestinal surgery (19%) under general anaesthesia using volatile anaesthetics (88%). In this review, 44 single drugs and 51 drug combinations were compared. Most studies investigated only single drugs (72%) and included an inactive control arm (66%). The three most investigated single drugs in this review were ondansetron (246 studies), dexamethasone (120 studies), and droperidol (97 studies). Almost all studies (89%) reported at least one efficacy outcome relevant for this review. However, only 56% reported at least one relevant safety outcome. Altogether, 157 studies (27%) were assessed as having overall low risk of bias, 101 studies (17%) overall high risk of bias, and 327 studies (56%) overall unclear risk of bias. Vomiting within 24 hours postoperatively Relative effects from NMA for vomiting within 24 hours (282 RCTs, 50,812 participants, 28 single drugs, and 36 drug combinations) suggest that 29 out of 36 drug combinations and 10 out of 28 single drugs showed a clinically important benefit (defined as the upper end of the 95% confidence interval (CI) below a risk ratio (RR) of 0.8) compared to placebo. Combinations of drugs were generally more effective than single drugs in preventing vomiting. However, single NK₁ receptor antagonists showed treatment effects similar to most of the drug combinations. High-certainty evidence suggests that the following single drugs reduce vomiting (ordered by decreasing efficacy): aprepitant (RR 0.26, 95% CI 0.18 to 0.38, high certainty, rank 3/28 of single drugs); ramosetron (RR 0.44, 95% CI 0.32 to 0.59, high certainty, rank 5/28); granisetron (RR 0.45, 95% CI 0.38 to 0.54, high certainty, rank 6/28); dexamethasone (RR 0.51, 95% CI 0.44 to 0.57, high certainty, rank 8/28); and ondansetron (RR 0.55, 95% CI 0.51 to 0.60, high certainty, rank 13/28). Moderate-certainty evidence suggests that the following single drugs probably reduce vomiting: fosaprepitant (RR 0.06, 95% CI 0.02 to 0.21, moderate certainty, rank 1/28) and droperidol (RR 0.61, 95% CI 0.54 to 0.69, moderate certainty, rank 20/28). Recommended and high doses of granisetron, dexamethasone, ondansetron, and droperidol showed clinically important benefit, but low doses showed no clinically important benefit. Aprepitant was used mainly at high doses, ramosetron at recommended doses, and fosaprepitant at doses of 150 mg (with no dose recommendation available). Frequency of SAEs Twenty-eight RCTs were included in the NMA for SAEs (10,766 participants, 13 single drugs, and eight drug combinations). The certainty of evidence for SAEs when using one of the best and most reliable anti-vomiting drugs (aprepitant, ramosetron, granisetron, dexamethasone, ondansetron, and droperidol compared to placebo) ranged from very low to low. Droperidol (RR 0.88, 95% CI 0.08 to 9.71, low certainty, rank 6/13) may reduce SAEs. We are uncertain about the effects of aprepitant (RR 1.39, 95% CI 0.26 to 7.36, very low certainty, rank 11/13), ramosetron (RR 0.89, 95% CI 0.05 to 15.74, very low certainty, rank 7/13), granisetron (RR 1.21, 95% CI 0.11 to 13.15, very low certainty, rank 10/13), dexamethasone (RR 1.16, 95% CI 0.28 to 4.85, very low certainty, rank 9/13), and ondansetron (RR 1.62, 95% CI 0.32 to 8.10, very low certainty, rank 12/13). No studies reporting SAEs were available for fosaprepitant. Frequency of any AE Sixty-one RCTs were included in the NMA for any AE (19,423 participants, 15 single drugs, and 11 drug combinations). The certainty of evidence for any AE when using one of the best and most reliable anti-vomiting drugs (aprepitant, ramosetron, granisetron, dexamethasone, ondansetron, and droperidol compared to placebo) ranged from very low to moderate. Granisetron (RR 0.92, 95% CI 0.80 to 1.05, moderate certainty, rank 7/15) probably has no or little effect on any AE. Dexamethasone (RR 0.77, 95% CI 0.55 to 1.08, low certainty, rank 2/15) and droperidol (RR 0.89, 95% CI 0.81 to 0.98, low certainty, rank 6/15) may reduce any AE. Ondansetron (RR 0.95, 95% CI 0.88 to 1.01, low certainty, rank 9/15) may have little or no effect on any AE. We are uncertain about the effects of aprepitant (RR 0.87, 95% CI 0.78 to 0.97, very low certainty, rank 3/15) and ramosetron (RR 1.00, 95% CI 0.65 to 1.54, very low certainty, rank 11/15) on any AE. No studies reporting any AE were available for fosaprepitant. Class-specific side effects For class-specific side effects (headache, constipation, wound infection, extrapyramidal symptoms, sedation, arrhythmia, and QT prolongation) of relevant substances, the certainty of evidence for the best and most reliable anti-vomiting drugs mostly ranged from very low to low. Exceptions were that ondansetron probably increases headache (RR 1.16, 95% CI 1.06 to 1.28, moderate certainty, rank 18/23) and probably reduces sedation (RR 0.87, 95% CI 0.79 to 0.96, moderate certainty, rank 5/24) compared to placebo. The latter effect is limited to recommended and high doses of ondansetron. Droperidol probably reduces headache (RR 0.76, 95% CI 0.67 to 0.86, moderate certainty, rank 5/23) compared to placebo. We have high-certainty evidence that dexamethasone (RR 1.00, 95% CI 0.91 to 1.09, high certainty, rank 16/24) has no effect on sedation compared to placebo. No studies assessed substance class-specific side effects for fosaprepitant. Direction and magnitude of network effect estimates together with level of evidence certainty are graphically summarized for all pre-defined GRADE-relevant outcomes and all drugs of direct interest compared to placebo in http://doi.org/10.5281/zenodo.4066353. Authors' conclusions: We found high-certainty evidence that five single drugs (aprepitant, ramosetron, granisetron, dexamethasone, and ondansetron) reduce vomiting, and moderate-certainty evidence that two other single drugs (fosaprepitant and droperidol) probably reduce vomiting, compared to placebo. Four of the six substance classes (5-HT₃ receptor antagonists, D₂ receptor antagonists, NK₁ receptor antagonists, and corticosteroids) were thus represented by at least one drug with important benefit for prevention of vomiting. Combinations of drugs were generally more effective than the corresponding single drugs in preventing vomiting. NK₁ receptor antagonists were the most effective drug class and had comparable efficacy to most of the drug combinations. 5-HT₃ receptor antagonists were the best studied substance class. For most of the single drugs of direct interest, we found only very low to low certainty evidence for safety outcomes such as occurrence of SAEs, any AE, and substance class-specific side effects. Recommended and high doses of granisetron, dexamethasone, ondansetron, and droperidol were more effective than low doses for prevention of vomiting. Dose dependency of side effects was rarely found due to the limited number of studies, except for the less sedating effect of recommended and high doses of ondansetron. The results of the review are transferable mainly to patients at higher risk of nausea and vomiting (i.e. healthy women undergoing inhalational anaesthesia and receiving perioperative opioids). Overall study quality was limited, but certainty assessments of effect estimates consider this limitation. No further efficacy studies are needed as there is evidence of moderate to high certainty for seven single drugs with relevant benefit for prevention of vomiting. However, additional studies are needed to investigate potential side effects of these drugs and to examine higher-risk patient populations (e.g. individuals with diabetes and heart disease).

The Cochrane database of systematic reviews · systematic review · 127 citationsread the source →

A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial.

Background: Attention-deficit hyperactivity disorder (ADHD) is a common paediatric neurodevelopmental disorder with substantial effect on families and society. Alternatives to traditional care, including novel digital therapeutics, have shown promise to remediate cognitive deficits associated with this disorder and may address barriers to standard therapies, such as pharmacological interventions and behavioural therapy. AKL-T01 is an investigational digital therapeutic designed to target attention and cognitive control delivered through a video game-like interface via at-home play for 25 min per day, 5 days per week for 4 weeks. This study aimed to assess whether AKL-T01 improved attentional performance in paediatric patients with ADHD. Methods: The Software Treatment for Actively Reducing Severity of ADHD (STARS-ADHD) was a randomised, double-blind, parallel-group, controlled trial of paediatric patients (aged 8-12 years, without disorder-related medications) with confirmed ADHD and Test of Variables of Attention (TOVA) Attention Performance Index (API) scores of -1·8 and below done by 20 research institutions in the USA. Patients were randomly assigned 1:1 to AKL-T01 or a digital control intervention. The primary outcome was mean change in TOVA API from pre-intervention to post-intervention. Safety, tolerability, and compliance were also assessed. Analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02674633 and is completed. Findings: Between July 15, 2016, and Nov 30, 2017, 857 patients were evaluated and 348 were randomly assigned to receive AKL-T01 or control. Among patients who received AKL-T01 (n=180 [52%]; mean [SD] age, 9·7 [1·3] years) or control (n=168 [48%]; mean [SD] age, 9·6 [1·3] years), the non-parametric estimate of the population median change from baseline TOVA API was 0·88 (95% CI 0·24-1·49; p=0·0060). The mean (SD) change from baseline on the TOVA API was 0·93 (3·15) in the AKL-T01 group and 0·03 (3·16) in the control group. There were no serious adverse events or discontinuations. Treatment-related adverse events were mild and included frustration (5 [3%] of 180) and headache (3 [2%] of 180). Patient compliance was a mean of 83 (83%) of 100 expected sessions played (SD, 29·2 sessions). Interpretation: Although future research is needed for this digital intervention, this study provides evidence that AKL-T01 might be used to improve objectively measured inattention in paediatric patients with ADHD, while presenting minimal adverse events. Funding: Sponsored by Akili Interactive Labs.

The Lancet. Digital health · randomised controlled trial · 215 citationsread the source →

Opioid treatment at release from jail using extended-release naltrexone: a pilot proof-of-concept randomized effectiveness trial.

Background and aims: Relapse to addiction following incarceration is common. We estimated the feasibility and effectiveness of extended-release naltrexone (XR-NTX) as relapse prevention among opioid-dependent male adults leaving a large urban jail. Design: Eight-week, proof-of-concept, open-label, non-blinded randomized effectiveness trial. Setting: New York City jails and Bellevue Hospital Center Adult Primary Care clinics, USA. Participants: From January 2010 to July 2013, 34 opioid-dependent adult males with no stated interest in agonist treatments (methadone, buprenorphine) received a counseling and referral intervention and were randomized to XR-NTX (n = 17) versus no medication (n = 17) within one week prior to jail release. Intervention: XR-NTX (Vivitrol(®) ; Alkermes Inc.), a long-acting injectable mu opioid receptor antagonist. Measures: The primary intent-to-treat outcome was post-release opioid relapse at week 4, defined as ≥10 days of opioid misuse by self-report and urine toxicologies. Secondary outcomes were proportion of urine samples negative for opioids and rates of opioid abstinence, intravenous drug use (IVDU), cocaine use, community treatment participation, re-incarceration and overdose. Findings: Acceptance of XR-NTX was high; 15 of 17 initiated treatment. Rates of the primary outcome of week 4 opioid relapse were lower among XR-NTX participants: 38 versus 88% [P<0.004; odds ratio (OR) = 0.08, 95% confidence interval (CI) = 0.01-0.48]; more XR-NTX urine samples were negative for opioids, 59 versus 29% (P<0.009; OR = 3.5, 95% CI = 1.4-8.5). There were no significant differences in the remaining secondary outcomes, including rates of IVDU, cocaine use, re-incarceration and overdose. Conclusion: Extended-release naltrexone is associated with significantly lower rates of opioid relapse among men in the United States following release from jail when compared with a no medication treatment-as-usual condition.

Addiction (Abingdon, England) · randomised controlled trial · 79 citationsread the source →

Effect of Natriuretic Peptide-Guided Therapy on Hospitalization or Cardiovascular Mortality in High-Risk Patients With Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial.

Importance: The natriuretic peptides are biochemical markers of heart failure (HF) severity and predictors of adverse outcomes. Smaller studies have evaluated adjusting HF therapy based on natriuretic peptide levels ("guided therapy") with inconsistent results. Objective: To determine whether an amino-terminal pro-B-type natriuretic peptide (NT-proBNP)-guided treatment strategy improves clinical outcomes vs usual care in high-risk patients with HF and reduced ejection fraction (HFrEF). Design, settings, and participants: The Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure (GUIDE-IT) study was a randomized multicenter clinical trial conducted between January 16, 2013, and September 20, 2016, at 45 clinical sites in the United States and Canada. This study planned to randomize 1100 patients with HFrEF (ejection fraction ≤40%), elevated natriuretic peptide levels within the prior 30 days, and a history of a prior HF event (HF hospitalization or equivalent) to either an NT-proBNP-guided strategy or usual care. Interventions: Patients were randomized to either an NT-proBNP-guided strategy or usual care. Patients randomized to the guided strategy (n = 446) had HF therapy titrated with the goal of achieving a target NT-proBNP of less than 1000 pg/mL. Patients randomized to usual care (n = 448) had HF care in accordance with published guidelines, with emphasis on titration of proven neurohormonal therapies for HF. Serial measurement of NT-proBNP testing was discouraged in the usual care group. Main outcomes and measures: The primary end point was the composite of time-to-first HF hospitalization or cardiovascular mortality. Prespecified secondary end points included all-cause mortality, total hospitalizations for HF, days alive and not hospitalized for cardiovascular reasons, the individual components on the primary end point, and adverse events. Results: The data and safety monitoring board recommended stopping the study for futility when 894 (median age, 63 years; 286 [32%] women) of the planned 1100 patients had been enrolled with follow-up for a median of 15 months. The primary end point occurred in 164 patients (37%) in the biomarker-guided group and 164 patients (37%) in the usual care group (adjusted hazard ratio [HR], 0.98; 95% CI, 0.79-1.22; P = .88). Cardiovascular mortality was 12% (n = 53) in the biomarker-guided group and 13% (n = 57) in the usual care group (HR, 0.94; 95% CI; 0.65-1.37; P = .75). None of the secondary end points nor the decreases in the NT-proBNP levels achieved differed significantly between groups. Conclusions and relevance: In high-risk patients with HFrEF, a strategy of NT-proBNP-guided therapy was not more effective than a usual care strategy in improving outcomes. Trial registration: clinicaltrials.gov Identifier: NCT01685840.

JAMA · randomised controlled trial · 395 citationsread the source →

A co-designed mHealth programme to support healthy lifestyles in Māori and Pasifika peoples in New Zealand (OL@-OR@): a cluster-randomised controlled trial.

Background: The OL@-OR@ mobile health programme was co-designed with Māori and Pasifika communities in New Zealand, to support healthy lifestyle behaviours. We aimed to determine whether use of the programme improved adherence to health-related guidelines among Māori and Pasifika communities in New Zealand compared with a control group on a waiting list for the programme. Methods: The OL@-OR@ trial was a 12-week, two-arm, cluster-randomised controlled trial. A cluster was defined as any distinct location or setting in New Zealand where people with shared interests or contexts congregated, such as churches, sports clubs, and community groups. Members of a cluster were eligible to participate if they were aged 18 years or older, had regular access to a mobile device or computer, and had regular internet access. Clusters of Māori and of Pasifika (separately) were randomly assigned (1:1) to either the intervention or control condition. The intervention group received the OL@-OR@ mHealth programme (smartphone app and website). The control group received a control version of the app that only collected baseline and outcome data. The primary outcome was self-reported adherence to health-related guidelines, which were measured with a composite health behaviour score (of physical activity, smoking, alcohol intake, and fruit and vegetable intake) at 12 weeks. The secondary outcomes were self-reported adherence to health-related behaviour guidelines at 4 weeks; self-reported bodyweight at 12 weeks; and holistic health and wellbeing status at 12 weeks, in all enrolled individuals in eligible clusters; and user engagement with the app, in individuals allocated to the intervention. Adverse events were not collected. This study is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12617001484336. Findings: Between Jan 24 and Aug 14, 2018, we enrolled 337 Māori participants from 19 clusters and 389 Pasifika participants from 18 clusters (n=726 participants) in the intervention group and 320 Māori participants from 15 clusters and 405 Pasifika participants from 17 clusters (n=725 participants) in the control group. Of these participants, 227 (67%) Māori participants and 347 (89%) Pasifika participants (n=574 participants) in the intervention group and 281 (88%) Māori participants and 369 (91%) Pasifika participants (n=650 participants) in the control group completed the 12-week follow-up and were included in the final analysis. Relative to baseline, adherence to health-related behaviour guidelines increased at 12 weeks in both groups (315 [43%] of 726 participants at baseline to 329 [57%] of 574 participants in the intervention group; 331 [46%] of 725 participants to 369 [57%] of 650 participants in the control group); however, there was no significant difference between intervention and control groups in adherence at 12 weeks (odds ratio [OR] 1·13; 95% CI 0·84-1·52; p=0·42). Furthermore, the proportion of participants adhering to guidelines on physical activity (351 [61%] of 574 intervention group participants vs 407 [63%] of 650 control group participants; OR 1·03, 95% CI 0·73-1·45; p=0·88), smoking (434 [76%] participants vs 501 [77%] participants; 1·12, 0·67-1·87; p=0·66), alcohol consumption (518 [90%] participants vs 596 [92%] participants; 0·73, 0·37-1·44; p=0·36), and fruit and vegetable intake (194 [34%] participants vs 196 [30%] participants; 1·08, 0·79-1·49; p=0·64) did not differ between groups. We found no significant differences between the intervention and control groups in any secondary outcome. 147 (26%) intervention group participants engaged with the OL@-OR@ programme (ie, set at least one behaviour change goal online). Interpretation: The OL@-OR@ mobile health programme did not improve adherence to health-related behaviour guidelines amongst Māori and Pasifika individuals. Funding: Healthier Lives He Oranga Hauora National Science Challenge.

The Lancet. Digital health · randomised controlled trial · 45 citationsread the source →

Comparative effectiveness of cognitive behavioural therapy, modafinil, and their combination for treating fatigue in multiple sclerosis (COMBO-MS): a randomised, statistician-blinded, parallel-arm trial.

Background: Fatigue is one of the most disabling symptoms reported by people with multiple sclerosis. Although behavioural and pharmacological interventions might be partly beneficial, their combined effects have not been evaluated for multiple sclerosis fatigue, or examined with sufficient consideration of characteristics that might affect treatment response. In this comparative effectiveness research trial, we compared the effectiveness of cognitive behavioural therapy (CBT), modafinil, and their combination for treating multiple sclerosis fatigue. Methods: This randomised, analyst-blinded, parallel-arm, comparative effectiveness trial was done at two universities in the USA. Adults (aged ≥18 years) with multiple sclerosis and problematic fatigue (Fatigue Severity Scale [FSS] score ≥4) were randomly assigned (1:1:1), using a web-based treatment assignment system with minimisation, to receive CBT, modafinil, or both for 12 weeks. Statisticians were masked to group assignment, but participants, study neurologists, CBT interventionalists, and coordinators were not masked to treatment assignment. The primary outcome was the change in Modified Fatigue Impact Scale (MFIS) from baseline to 12 weeks, assessed using multiple linear regression, adjusted for age, sex, study site, anxiety, pain, baselines MFIS score, and physical activity. Analyses were done by intent to treat. The trial was registered with clinicaltrials.gov, NCT03621761, and is completed. Findings: Between Nov 15, 2018, and June 2, 2021, 336 participants were randomly assigned treatment (114 assigned to CBT, 114 assigned to modafinil, and 108 assigned to combination therapy). At 12 weeks, CBT (n=103), modafinil (n=107), and combination therapy (n=102) were associated with clinically meaningful within-group MFIS reductions of 15·20 (SD 11·90), 16·90 (15·90), and 17·30 (16·20) points, respectively. Change in MFIS scores from baseline to 12 weeks did not differ between groups: relative to combination therapy, the adjusted total mean difference in MFIS change score was 1·88 (95% CI -2·21 to 5·96) for CBT and 1·20 (-2·83 to 5·23) for modafinil. Most common adverse events for modafinil-containing treatment groups included insomnia (eight [7%] for modafinil and eight [7%] for combination therapy) and anxiety (three [3%] for modafinil and nine [8%] for combination therapy). Interpretation: Modafinil, CBT, and combination therapy were associated with similar reductions in the effects of multiple sclerosis fatigue at 12 weeks. Combination therapy was not associated with augmented improvement compared with the individual interventions. Further research is needed to determine whether effects of these interventions on multiple sclerosis-related fatigue is influenced by sleep hygiene and sleepiness. No serious adverse events related to the study drug were encountered. Funding: Patient-Centered Outcomes Research Institute and National Multiple Sclerosis Society.

The Lancet. Neurology · randomised controlled trial · 6 citationsread the source →

Combined prevention for substance use, depression, and anxiety in adolescence: a cluster-randomised controlled trial of a digital online intervention.

Background: Substance use, depression, and anxiety in adolescence are major public health problems requiring new scalable prevention strategies. We aimed to assess the effectiveness of a combined online universal (ie, delivered to all pupils) school-based preventive intervention targeting substance use, depression, and anxiety in adolescence. Methods: We did a multicentre, cluster-randomised controlled trial in secondary schools in Australia, with pupils in year 8 or 9 (aged 13-14 years). Participating schools were randomly assigned (1:1:1:1) to one of four intervention conditions: (1) Climate Schools-Substance Use, focusing on substance use only; (2) Climate Schools-Mental Health, focusing on depression and anxiety only; (3) Climate Schools-Combined, focusing on the prevention of substance use, depression, and anxiety; or (4) active control. The interventions were delivered in school classrooms in an online delivery format and used a mixture of peer cartoon storyboards and classroom activities that were focused on alcohol, cannabis, anxiety, and depression. The interventions were delivered for 2 years and primary outcomes were knowledge related to alcohol, cannabis, and mental health; alcohol use, including heavy episodic drinking; and depression and anxiety symptoms at 12, 24, and 30 months after baseline. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613000723785) and an extended follow-up is underway. Findings: Between Sept 1, 2013, and Feb 28, 2014, we recruited 88 schools (12 391 pupils), of whom 71 schools and 6386 (51·5%) pupils were analysed (17 schools dropped out and 1308 pupils declined to participate). We allocated 18 schools (1739 [27·25%] pupils; 1690 [97·2%] completed at least one follow-up) to the substance use condition, 18 schools (1594 [25·0%] pupils; 1560 [97·9%] completed at least one follow-up) to the mental health condition, 16 schools (1497 [23·4%] pupils; 1443 [96·4%] completed at least one follow-up) to the combined condition, and 19 schools (1556 [23·4%] pupils; 1513 [97·2%] completed at least one follow-up) to the control condition. Compared with controls, the combined intervention group had increased knowledge related to alcohol and cannabis at 12, 24, and 30 months (standardised mean difference [SMD] for alcohol 0·26 [95% CI 0·14 to 0·39] and for cannabis 0·17 [0·06 to 0·28] at 30 months), increased knowledge related to mental health at 24 months (0·17 [0·08 to 0·27]), reduced growth in their odds of drinking and heavy episodic drinking at 12, 24, and 30 months (odds ratio for drinking 0·25 [95% CI 0·12 to 0·51], and for heavy episodic drinking 0·15 [0·04 to 0·58] at 30 months), and reduced increases in anxiety symptoms at 12 and 30 months (SMD -0·12 [95% CI -0·22 to -0·01] at 30 months). We found no difference in symptoms or probable diagnosis of depression. The combined intervention group also showed improvement in alcohol use outcomes compared with the substance use and mental health interventions and improvements in anxiety outcomes when compared with the mental health intervention only. Interpretation: Combined online prevention of substance use, depression, and anxiety led to increased knowledge of alcohol, cannabis, and mental health, reduced increase in the odds of any drinking and heavy episodic drinking, and reduced symptoms of anxiety over a 30-month period. These findings provide the first evidence of the effectiveness of an online universal school-based preventive intervention targeting substance use, depression, and anxiety in adolescence. Funding: Australian National Health and Medical Research Council.

The Lancet. Digital health · randomised controlled trial · 62 citationsread the source →

Male Partner Linkage to Clinic-Based Services for Sexually Transmitted Infections and Human Immunodeficiency Virus Services Following Couple Home-Based Education and Testing.

Background: Home-based human immunodeficiency virus (HIV) testing and education has increased HIV test uptake and access to health services among men. We studied how a home-based antenatal intervention influenced male partner utilization of clinic-based HIV and sexually transmitted infection (STI) services, linkage to HIV care and medical circumcision. Methods: We conducted a secondary analysis within a randomized controlled trial of pregnant women attending antenatal care in Kenya. Women and their male partners received either a home-based couple intervention or an invitation letter for clinic-based couple HIV testing. The home-based intervention included education on STI symptoms, STI and HIV treatment and male circumcision for HIV prevention. Male self-reported outcomes were compared using relative risks at 6 months postpartum. Results: Among 525 women, we reached 487 (93%) of their male partners; 247 men in the intervention arm and 240 men in the control arm. Men who received the intervention were more likely to report an STI consultation (n = 47 vs. 16; relative risk, 1.59; 95% confidence interval, 1.33-1.89). Among 23 men with newly diagnosed HIV, linkage to HIV care was reported by 4 of 15 in the intervention (3 men had missing linkage data) and 3 of 5 men in the control arms (relative risk, 0.66; 95% confidence interval, 0.34-1.29). Although the intervention identified 3 times more men with new HIV infection, the study lacked power to find significant differences in linkage to HIV care. Few eligible men sought medical circumcision (4 of 72 intervention and 2 of 88 control). Conclusions: Home-based couple education and testing increased STI consultations among male partners of pregnant women, but appeared insufficient to overcome the barriers involved in linkage to HIV care and medical circumcision.

Sexually transmitted diseases · randomised controlled trial · 3 citationsread the source →

Internet-based behavioural activation with lay counsellor support versus online minimal psychoeducation without support for treatment of depression: a randomised controlled trial in Indonesia.

Background: Depression is one of the leading contributors to the global burden of disease. However, treatment availability is often very poor in low-income and middle-income countries. In a randomised clinical trial, we investigated the efficacy of internet-based behavioural activation with lay counsellor support compared with online minimal psychoeducation without support for depression in Indonesia (a middle-income country). Methods: We did a community-based, two-group, randomised controlled trial in Indonesia. Eligible participants were aged 16 years or older, scored 10 or above on the Patient Health Questionnaire 9 (PHQ-9), met the criteria for major depressive disorder or persistent depressive disorder based on the Structured Clinical Interview for DSM-5, were proficient in Bahasa Indonesia, and could use the internet. Participants were randomly allocated (1:1) by a research assistant using a web-based randomisation program to online behavioural activation with lay support (termed Guided Act and Feel Indonesia [GAF-ID]) or online psychoeducation without further support. Randomisation was done within a random permuted block design and was stratified by sex and depression severity (ie, PHQ-9 10-14 vs ≥15). The primary outcome was self-reported PHQ-9 score at 10 weeks from baseline. Research assistants were masked to group allocation until after the assessment of the primary outcome. Interventions were described to participants during the consent procedure and after randomisation, but no indication was given as to which was the intervention of interest and which was the control. Analysis was by intention to treat. The trial was registered in the Netherlands Trial Register, number NTR5920. It is closed to new particpants, and follow-up has been completed. Findings: Between Sept 6, 2016, and May 1, 2017, 313 participants were enrolled and randomly assigned, 159 to the GAF-ID group and 154 to the online psychoeducation group. At 10 weeks, PHQ-9 scores were significantly lower in the GAF-ID group than in the online psychoeducation group (mean difference -1·26 points [95% CI -2·29 to -0·23]; p=0·017), and participants in the GAF-ID group had a 50% higher chance of remission at 10 weeks (relative risk 1·50 [95% CI 1·19 to 1·88]; p<0·0001). An effect size of 0·24 for the GAF-ID group compared with the control group at 10 weeks was sustained over time (effect size 0·24 at 3 months, and 0·27 at 6 months). No adverse events were reported in either group. Interpretation: To our knowledge, ours is the first adequately powered randomised clinical trial of an internet-based intervention for depression in a low-income or middle-income country. Online behavioural activation with lay counsellor support efficaciously reduced symptoms of depression, and could help to bridge the mental health gap in low-income and middle-income countries. Funding: Indonesia Endowment Fund for Education, University of Groningen.

The lancet. Psychiatry · randomised controlled trial · 66 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 →

Effectiveness of a peer-delivered, psychosocial intervention on maternal depression and child development at 3 years postnatal: a cluster randomised trial in Pakistan.

Background: Maternal depression has a recurring course that can influence offspring outcomes. Evidence on how to treat maternal depression to improve longer-term maternal outcomes and reduce intergenerational transmission of psychopathology is scarce, particularly for task-shifted, low-intensity, and scalable psychosocial interventions. We evaluated the effects of a peer-delivered, psychosocial intervention on maternal depression and child development at 3 years postnatal. Methods: 40 village clusters in Pakistan were randomly allocated using a computerised randomisation sequence to receive a group-based, psychosocial intervention and enhanced usual care for 36 months, or enhanced usual care alone. Pregnant women (≥18 years) were screened for moderate or severe symptoms of depression (patient health questionnaire-9 [PHQ-9] score ≥10) and were recruited into the trial (570 participants), and a cohort without depression (PHQ-9 score <10) was also enrolled (584 participants). Including the non-depressed dyads enabled us to determine how much of the excess risk due to maternal depression exposure the intervention could mitigate. Research teams responsible for identifying, obtaining consent, and recruiting trial participants were blind to the allocation status throughout the duration of the study, and principal investigators, site coordinators, statisticians, and members of the trial steering committee were also blinded to the allocation status until the analysis of 6-month data for the intervention. Primary outcomes were maternal depression symptoms and remission (PHQ-9 score <10) and child socioemotional skills (strengths and difficulties questionnaire [SDQ-TD]) at 36-months postnatal. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, NCT02658994. Findings: From Oct 15, 2014 to Feb 25, 2016 46 village clusters were assessed for eligibility, of which 40 (including 1910 mothers were enrolled. After exclusions, 288 women were randomly assigned to the enhanced usual care group and 284 to the intervention group, and 1159 women were included in a group without prenatal depression. At 36-months postnatal, complete data were available from 889 mother-child dyads: 206 (72·5%) in the intervention group, 216 (75·3%) in the enhanced usual care group, and 467 (80·0%) women who did not have prenatal-depression. We did not observe significant outcome differences between the intervention group and the enhanced usual care group for the primary outcomes. The standardised mean difference of PHQ-9 total score was -0·13 (95% CI -0·33 to 0·07), relative risk of patient health questionnaire-9 remission was 1·00 (95% CI 0·88 to 1·14), and the SDQ-TD treatment estimate was -0·10 (95% CI -1·39 to 1·19). Interpretation: Reduced symptom severity and high remission rates were seen across both the intervention and enhanced usual care groups, possibly masking any effects of the intervention. A multi-year, psychosocial intervention can be task-shifted via peers but might be susceptible to reductions in fidelity and dosage over time (which were not among the outcomes of this trial). Early intervention efforts might need to rely on multiple models (eg, collaborative care), be of greater intensity, and potentially targeted at mothers who are at high risk for depression to reduce the intergenerational transmission of psychopathology from mothers to children. Funding: National Institutes of Health.

The lancet. Psychiatry · randomised controlled trial · 57 citationsread the source →

A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial.

Background: The rising number of young people going to university has led to concerns about an increasing demand for student mental health services. We aimed to assess whether provision of mindfulness courses to university students would improve their resilience to stress. Methods: We did this pragmatic randomised controlled trial at the University of Cambridge, UK. Students aged 18 years or older with no severe mental illness or crisis (self-assessed) were randomly assigned (1:1), via remote survey software using computer-generated random numbers, to receive either an 8 week mindfulness course adapted for university students (Mindfulness Skills for Students [MSS]) plus mental health support as usual, or mental health support as usual alone. Participants and the study management team were aware of group allocation, but allocation was concealed from the researchers, outcome assessors, and study statistician. The primary outcome was self-reported psychological distress during the examination period, as measured with the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), with higher scores indicating more distress. The primary analysis was by intention to treat. This trial is registered with the Australia and New Zealand Clinical Trials Registry, number ACTRN12615001160527. Findings: Between Sept 28, 2015, and Jan 15, 2016, we randomly assigned 616 students to the MSS group (n=309) or the support as usual group (n=307). 453 (74%) participants completed the CORE-OM during the examination period and 182 (59%) MSS participants completed at least half of the course. MSS reduced distress scores during the examination period compared with support as usual, with mean CORE-OM scores of 0·87 (SD 0·50) in 237 MSS participants versus 1·11 (0·57) in 216 support as usual participants (adjusted mean difference -0·14, 95% CI -0·22 to -0·06; p=0·001), showing a moderate effect size (β -0·44, 95% CI -0·60 to -0·29; p<0·0001). 123 (57%) of 214 participants in the support as usual group had distress scores above an accepted clinical threshold compared with 88 (37%) of 235 participants in the MSS group. On average, six students (95% CI four to ten) needed to be offered the MSS course to prevent one from experiencing clinical levels of distress. No participants had adverse reactions related to self-harm, suicidality, or harm to others. Interpretation: Our findings show that provision of mindfulness training could be an effective component of a wider student mental health strategy. Further comparative effectiveness research with inclusion of controls for non-specific effects is needed to define a range of additional, effective interventions to increase resilience to stress in university students. Funding: University of Cambridge and National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care East of England.

The Lancet. Public health · randomised controlled trial · 217 citationsread the source →

Smoking cessation for people with severe mental illness (SCIMITAR+): a pragmatic randomised controlled trial.

Background: People with severe mental illnesses such as schizophrenia are three times more likely to smoke than the wider population, contributing to widening health inequalities. Smoking remains the largest modifiable risk factor for this health inequality, but people with severe mental illness have not historically engaged with smoking cessation services. We aimed to test the effectiveness of a combined behavioural and pharmacological smoking cessation intervention targeted specifically at people with severe mental illness. Methods: In the smoking cessation intervention for severe mental illness (SCIMITAR+) trial, a pragmatic, randomised controlled study, we recruited heavy smokers with bipolar disorder or schizophrenia from 16 primary care and 21 community-based mental health sites in the UK. Participants were eligible if they were aged 18 years or older, and smoked at least five cigarettes per day. Exclusion criteria included substantial comorbid drug or alcohol problems and people who lacked capacity to consent at the time of recruitment. Using computer-generated random numbers, participants were randomly assigned (1:1) to a bespoke smoking cessation intervention or to usual care. Participants, mental health specialists, and primary care physicians were unmasked to assignment. The bespoke smoking cessation intervention consisted of behavioural support from a mental health smoking cessation practitioner and pharmacological aids for smoking cessation, with adaptations for people with severe mental illness-such as, extended pre-quit sessions, cut down to quit, and home visits. Access to pharmacotherapy was via primary care after discussion with the smoking cessation specialist. Under usual care participants were offered access to local smoking cessation services not specifically designed for people with severe mental illnesses. The primary endpoint was smoking cessation at 12 months ascertained via carbon monoxide measurements below 10 parts per million and self-reported cessation for the past 7 days. Secondary endpoints were biologically verified smoking cessation at 6 months; number of cigarettes smoked per day, Fagerström Test for Nicotine Dependence (FTND) and Motivation to Quit (MTQ) questionnaire; general and mental health functioning determined via the Patient Health Questionnaire-9 (PHQ-9), the Generalised Anxiety Disorder-7 (GAD-7) questionnaire, and 12-Item Short Form Health Survey (SF-12); and body-mass index (BMI). This trial was registerd with the ISRCTN registry, number ISRCTN72955454, and is complete. Findings: Between Oct 7, 2015, and Dec 16, 2016, 526 eligible patients were randomly assigned to the bespoke smoking cessation intervention (n=265) or usual care (n=261). 309 (59%) participants were male, median age was 47·2 years (IQR 36·3-54·5), with high nicotine dependence (mean 24 cigarettes per day [SD 13·2]), and the most common severe mental disorders were schizophrenia or other psychotic illness (n=343 [65%]), bipolar disorder (n=115 [22%]), and schizoaffective disorder (n=66 [13%]). 234 (88%) of intervention participants engaged with the treatment programme and attended 6·4 (SD 3·5) quit smoking sessions, with an average duration of 39 min (SD 17; median 35 min, range 5-120). Verified quit data at 12 months were available for 219 (84%) of 261 usual care and 223 (84%) of 265 intervention participants. The proportion of participants who had quit at 12 months was higher in the intervention group than in the usual care group, but non-significantly (34 [15%] of 223 [13% of those assigned to group] vs 22 [10%] of 219 [8% of those assigned to group], risk difference 5·2%, 95% CI -1·0 to 11·4; odds ratio [OR] 1·6, 95% CI 0·9 to 2·9; p=0·10). The proportion of participants who quit at 6 months was significantly higher in the intervention group than in the usual care group (32 [14%] of 226 vs 14 [6%] of 217; risk difference 7·7%, 95% CI 2·1 to 13·3; OR 2·4, 95% CI 1·2 to 4·6; p=0·010). The incidence rate ratio for number of cigarettes smoked per day at 6 months was 0·90 (95% CI 0·80 to 1·01; p=0·079), and at 12 months was 1·00 (0·89 to 1·13; p=0·95). At both 6 months and 12 months, the intervention group was non-significantly favoured in the FTND (adjusted mean difference 6 months -0·18, 95% CI -0·53 to 0·17, p=0·32; and 12 months -0·01, -0·39 to 0·38, p=0·97) and MTQ questionnaire (adjusted mean difference 0·58, -0·01 to 1·17, p=0·056; and 12 months 0·64, 0·04 to 1·24, p=0·038). The PHQ-9 showed no difference between the groups (adjusted mean difference at 6 months 0·20, 95% CI -0·85 to 1·24 vs 12 months -0·12, -1·18 to 0·94). For the SF-12 survey, we saw evidence of improvement in physical health in the intervention group at 6 months (adjusted mean difference 1·75, 95% CI 0·21 to 3·28), but this difference was not evident at 12 months (0·59, -1·07 to 2·26); and we saw no difference in mental health between the groups at 6 or 12 months (adjusted mean difference at 6 months -0·73, 95% CI -2·82 to 1·36, and 12 months -0·41, -2·35 to 1·53). The GAD-7 questionnaire showed no difference between the groups (adjusted mean difference at 6 months -0·32 95% CI -1·26 to 0·62 vs 12 months -0·10, -1·05 to 0·86). No difference in BMI was seen between the groups (adjusted mean difference 6 months 0·16, 95% CI -0·54 to 0·85; 12 months 0·25, -0·62 to 1·13). Interpretation: This bespoke intervention is a candidate model of smoking cessation for clinicians and policy makers to address high prevalence of smoking. The incidence of quitting at 6 months shows that smoking cessation can be achieved, but the waning of this effect by 12 months means more effort is needed for sustained quitting. Funding: National Institute for Health Research Health Technology Assessment Programme.

The lancet. Psychiatry · randomised controlled trial · 134 citationsread the source →

Decision aids for people facing health treatment or screening decisions.

Background: Decision aids are intended to help people participate in decisions that involve weighing the benefits and harms of treatment options often with scientific uncertainty. Objectives: To assess the effects of decision aids for people facing treatment or screening decisions. Search methods: For this update, we searched from 2009 to June 2012 in MEDLINE; CENTRAL; EMBASE; PsycINFO; and grey literature. Cumulatively, we have searched each database since its start date including CINAHL (to September 2008). Selection criteria: We included published randomized controlled trials of decision aids, which are interventions designed to support patients' decision making by making explicit the decision, providing information about treatment or screening options and their associated outcomes, compared to usual care and/or alternative interventions. We excluded studies of participants making hypothetical decisions. Data collection and analysis: Two review authors independently screened citations for inclusion, extracted data, and assessed risk of bias. The primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were:A) 'choice made' attributes;B) 'decision-making process' attributes. Secondary outcomes were behavioral, health, and health-system effects. We pooled results using mean differences (MD) and relative risks (RR), applying a random-effects model. Main results: This update includes 33 new studies for a total of 115 studies involving 34,444 participants. For risk of bias, selective outcome reporting and blinding of participants and personnel were mostly rated as unclear due to inadequate reporting. Based on 7 items, 8 of 115 studies had high risk of bias for 1 or 2 items each. Of 115 included studies, 88 (76.5%) used at least one of the IPDAS effectiveness criteria: A) 'choice made' attributes criteria: knowledge scores (76 studies); accurate risk perceptions (25 studies); and informed value-based choice (20 studies); and B) 'decision-making process' attributes criteria: feeling informed (34 studies) and feeling clear about values (29 studies).A) Criteria involving 'choice made' attributes:Compared to usual care, decision aids increased knowledge (MD 13.34 out of 100; 95% confidence interval (CI) 11.17 to 15.51; n = 42). When more detailed decision aids were compared to simple decision aids, the relative improvement in knowledge was significant (MD 5.52 out of 100; 95% CI 3.90 to 7.15; n = 19). Exposure to a decision aid with expressed probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.82; 95% CI 1.52 to 2.16; n = 19). Exposure to a decision aid with explicit values clarification resulted in a higher proportion of patients choosing an option congruent with their values (RR 1.51; 95% CI 1.17 to 1.96; n = 13).B) Criteria involving 'decision-making process' attributes:Decision aids compared to usual care interventions resulted in:a) lower decisional conflict related to feeling uninformed (MD -7.26 of 100; 95% CI -9.73 to -4.78; n = 22) and feeling unclear about personal values (MD -6.09; 95% CI -8.50 to -3.67; n = 18);b) reduced proportions of people who were passive in decision making (RR 0.66; 95% CI 0.53 to 0.81; n = 14); andc) reduced proportions of people who remained undecided post-intervention (RR 0.59; 95% CI 0.47 to 0.72; n = 18).Decision aids appeared to have a positive effect on patient-practitioner communication in all nine studies that measured this outcome. For satisfaction with the decision (n = 20), decision-making process (n = 17), and/or preparation for decision making (n = 3), those exposed to a decision aid were either more satisfied, or there was no difference between the decision aid versus comparison interventions. No studies evaluated decision-making process attributes for helping patients to recognize that a decision needs to be made, or understanding that values affect the choice.C) Secondary outcomes Exposure to decision aids compared to usual care reduced the number of people of choosing major elective invasive surgery in favour of more conservative options (RR 0.79; 95% CI 0.68 to 0.93; n = 15). Exposure to decision aids compared to usual care reduced the number of people choosing to have prostate-specific antigen screening (RR 0.87; 95% CI 0.77 to 0.98; n = 9). When detailed compared to simple decision aids were used, fewer people chose menopausal hormone therapy (RR 0.73; 95% CI 0.55 to 0.98; n = 3). For other decisions, the effect on choices was variable. The effect of decision aids on length of consultation varied from 8 minutes shorter to 23 minutes longer (median 2.55 minutes longer) with 2 studies indicating statistically-significantly longer, 1 study shorter, and 6 studies reporting no difference in consultation length. Groups of patients receiving decision aids do not appear to differ from comparison groups in terms of anxiety (n = 30), general health outcomes (n = 11), and condition-specific health outcomes (n = 11). The effects of decision aids on other outcomes (adherence to the decision, costs/resource use) were inconclusive. Authors' conclusions: There is high-quality evidence that decision aids compared to usual care improve people's knowledge regarding options, and reduce their decisional conflict related to feeling uninformed and unclear about their personal values. There is moderate-quality evidence that decision aids compared to usual care stimulate people to take a more active role in decision making, and improve accurate risk perceptions when probabilities are included in decision aids, compared to not being included. There is low-quality evidence that decision aids improve congruence between the chosen option and the patient's values. New for this updated review is further evidence indicating more informed, values-based choices, and improved patient-practitioner communication. There is a variable effect of decision aids on length of consultation. Consistent with findings from the previous review, decision aids have a variable effect on choices. They reduce the number of people choosing discretionary surgery and have no apparent adverse effects on health outcomes or satisfaction. The effects on adherence with the chosen option, cost-effectiveness, use with lower literacy populations, and level of detail needed in decision aids need further evaluation. Little is known about the degree of detail that decision aids need in order to have a positive effect on attributes of the choice made, or the decision-making process.

The Cochrane database of systematic reviews · meta-analysis · 891 citationsread the source →

A biobehavioral home-based intervention and the well-being of patients with dementia and their caregivers: the COPE randomized trial.

Context: Optimal treatment to postpone functional decline in patients with dementia is not established. Objective: To test a nonpharmacologic intervention realigning environmental demands with patient capabilities. Design, setting, and participants: Prospective 2-group randomized trial (Care of Persons with Dementia in their Environments [COPE]) involving patients with dementia and family caregivers (community-living dyads) recruited from March 2006 through June 2008 in Pennsylvania. Interventions: Up to 12 home or telephone contacts over 4 months by health professionals who assessed patient capabilities and deficits; obtained blood and urine samples; and trained families in home safety, simplifying tasks, and stress reduction. Control group caregivers received 3 telephone calls and educational materials. Main outcome measures: Functional dependence, quality of life, frequency of agitated behaviors, and engagement for patients and well-being, confidence using activities, and perceived benefits for caregivers at 4 months. Results: Of 284 dyads screened, 270 (95%) were eligible and 237 (88%) randomized. Data were collected from 209 dyads (88%) at 4 months and 173 (73%) at 9 months. At 4 months, compared with controls, COPE patients had less functional dependence (adjusted mean difference, 0.24; 95% CI, 0.03-0.44; P = .02; Cohen d = 0.21) and less dependence in instrumental activities of daily living (adjusted mean difference, 0.32; 95% CI, 0.09-0.55; P = .007; Cohen d = 0.43), measured by a 15-item scale modeled after the Functional Independence Measure; COPE patients also had improved engagement (adjusted mean difference, 0.12; 95% CI, 0.07-0.22; P = .03; Cohen d = 0.26), measured by a 5-item scale. COPE caregivers improved in their well-being (adjusted mean difference in Perceived Change Index, 0.22; 95% CI, 0.08-0.36; P = .002; Cohen d = 0.30) and confidence using activities (adjusted mean difference, 0.81; 95% CI, 0.30-1.32; P = .002; Cohen d = 0.54), measured by a 5-item scale. By 4 months, 64 COPE dyads (62.7%) vs 48 control group dyads (44.9%) eliminated 1 or more caregiver-identified problems (chi(2/1) = 6.72, P = . 01). Conclusion: Among community-living dyads, a nonpharmacologic biobehavioral environmental intervention compared with control resulted in better outcomes for COPE dyads at 4 months. Although no group differences were observed at 9 months for patients, COPE caregivers perceived greater benefits. Trial registration: clinicaltrials.gov Identifier: NCT00259454.

JAMA · randomised controlled trial · 235 citationsread the source →

Mindfulness training for smoking cessation: results from a randomized controlled trial.

Background: Cigarette smoking is the leading cause of preventable death in the world, and long-term abstinence rates remain modest. Mindfulness training (MT) has begun to show benefits in a number of psychiatric disorders, including depression, anxiety and more recently, in addictions. However, MT has not been evaluated for smoking cessation through randomized clinical trials. Methods: 88 treatment-seeking, nicotine-dependent adults who were smoking an average of 20cigarettes/day were randomly assigned to receive MT or the American Lung Association's freedom from smoking (FFS) treatment. Both treatments were delivered twice weekly over 4 weeks (eight sessions total) in a group format. The primary outcomes were expired-air carbon monoxide-confirmed 7-day point prevalence abstinence and number of cigarettes/day at the end of the 4-week treatment and at a follow-up interview at week 17. Results: 88% of individuals received MT and 84% of individuals received FFS completed treatment. Compared to those randomized to the FFS intervention, individuals who received MT showed a greater rate of reduction in cigarette use during treatment and maintained these gains during follow-up (F=11.11, p=.001). They also exhibited a trend toward greater point prevalence abstinence rate at the end of treatment (36% vs. 15%, p=.063), which was significant at the 17-week follow-up (31% vs. 6%, p=.012). Conclusions: This initial trial of mindfulness training may confer benefits greater than those associated with current standard treatments for smoking cessation.

Drug and alcohol dependence · randomised controlled trial · 217 citationsread the source →

User-Centered Design of Learn to Quit, a Smoking Cessation Smartphone App for People With Serious Mental Illness.

Background: Smoking rates in the United States have been reduced in the past decades to 15% of the general population. However, up to 88% of people with psychiatric symptoms still smoke, leading to high rates of disease and mortality. Therefore, there is a great need to develop smoking cessation interventions that have adequate levels of usability and can reach this population. Objective: The objective of this study was to report the rationale, ideation, design, user research, and final specifications of a novel smoking cessation app for people with serious mental illness (SMI) that will be tested in a feasibility trial. Methods: We used a variety of user-centered design methods and materials to develop the tailored smoking cessation app. This included expert panel guidance, a set of design principles and theory-based smoking cessation content, development of personas and paper prototyping, usability testing of the app prototype, establishment of app's core vision and design specification, and collaboration with a software development company. Results: We developed Learn to Quit, a smoking cessation app designed and tailored to individuals with SMI that incorporates the following: (1) evidence-based smoking cessation content from Acceptance and Commitment Therapy and US Clinical Practice Guidelines for smoking cessation aimed at providing skills for quitting while addressing mental health symptoms, (2) a set of behavioral principles to increase retention and comprehension of smoking cessation content, (3) a gamification component to encourage and sustain app engagement during a 14-day period, (4) an app structure and layout designed to minimize usability errors in people with SMI, and (5) a set of stories and visuals that communicate smoking cessation concepts and skills in simple terms. Conclusions: Despite its increasing importance, the design and development of mHealth technology is typically underreported, hampering scientific innovation. This report describes the systematic development of the first smoking cessation app tailored to people with SMI, a population with very high rates of nicotine addiction, and offers new design strategies to engage this population. mHealth developers in smoking cessation and related fields could benefit from a design strategy that capitalizes on the role visual engagement, storytelling, and the systematic application of behavior analytic principles to deliver evidence-based content.

JMIR serious games · 62 citationsread the source →

Abusive head trauma and accidental head injury: a 20-year comparative study of referrals to a hospital child protection team.

Aim: To describe children referred for suspected abusive head trauma (AHT) to a hospital child protection team in Auckland, New Zealand. Methods: Comparative review of demographics, histories, injuries, investigations and diagnostic outcomes for referrals under 15 years old from 1991 to 2010. Results: Records were available for 345 children. Referrals increased markedly (88 in the first decade, 257 in the second), but the diagnostic ratio was stable: AHT 60%, accidental or natural 29% and uncertain cause 11%. The probability of AHT was similar regardless of socio-economic status or ethnicity. In children under 2 years old with accidental head injuries (75/255, 29%) or AHT (180/255, 71%), characteristics of particular interest for AHT included no history of trauma (88/98, 90%), no evidence of impact to the head (84/93, 90%), complex skull fractures with intracranial injury (22/28, 79%), subdural haemorrhage (160/179, 89%) and hypoxic ischaemic injury (38/39, 97%). In children over 2 years old, these characteristics did not differ significantly between children with accidental head injuries (21/47, 45%) and AHT (26/47, 55%). The mortality of AHT was higher in children over 2 years old (10/26, 38%) than under 2 years (19/180, 11%). Conclusions: The striking increase in referrals for AHT probably represents increasing incidence. The decision to refer a hospitalised child with a head injury for assessment for possible AHT should not be influenced by socio-economic status or ethnicity. Children over 2 years old hospitalised for AHT are usually injured by mechanisms involving impact and should be considered at high risk of death.

Archives of disease in childhood · cohort or longitudinal · 63 citationsread the source →

International development and psychometric properties of the Child and Adolescent Trauma Screen (CATS).

Background: Systematic screening is a powerful means by which children and adolescents with posttraumatic stress symptoms (PTSS) can be detected. Reliable and valid measures based on current diagnostic criteria are needed. Aim: To investigate the internal consistency and construct validity of the Child and Adolescent Trauma Screen (CATS) in three samples of trauma-exposed children in the US (self-reports: n=249; caregiver reports: n=267; pre-school n=190), in Germany (self-reports: n=117; caregiver reports: n=95) and in Norway (self-reports: n=109; caregiver reports: n=62). Method: Internal consistency was calculated using Cronbach's α. Convergent-discriminant validity was investigated using bivariate correlation coefficients with measures of depression, anxiety and externalizing symptoms. CFA was used to investigate the DSM-5 factor structure. Results: In all three language samples the 20 item symptom score of the self-report and the caregiver report proved good to excellent reliability with α ranging between .88 and .94. The convergent-discriminant validity pattern showed medium to strong correlations with measures of depression (r =.62-.82) and anxiety (r =.40-.77) and low to medium correlations with externalizing symptoms (r =-.15-.43) within informants in all language versions. Using CFA the underlying DSM-5 factor structure with four symptom clusters (re-experiencing, avoidance, negative alterations in mood and cognitions, hyperarousal) was supported (n =475 for self-report; n =424 for caregiver reports). Limitations: The external validation of the CATS with a DSM-5 based semi-structured clinical interview and corresponding determination of cut-points is pending. Conclusion: The CATS has satisfactory psychometric properties. Clinicians may consider the CATS as a screening tool and for symptom monitoring.

Journal of affective disorders · cohort or longitudinal · 189 citationsread the source →

What Are the Minimal and Substantial Improvements in the HOOS and KOOS and JR Versions After Total Joint Replacement?

Background: Patient-reported outcome measures (PROMs) are a gold standard for measuring therapeutic outcomes in research. Extending their use to inform clinical care decisions, determine the appropriateness of therapeutic choices, and assess healthcare quality is attractive but will require our professional community to establish valid estimates of minimal and substantial clinical improvements. Questions/purposes: The purposes of this study were (1) to assess the validity of estimates for the minimal clinically important difference (MCID) calculated using distribution- and anchor-based methods by determining whether they exceed the minimal detectable change (MDC) for the Hip Disability and Osteoarthritis Outcome Score (HOOS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) domains, the HOOS, joint replacement (JR) and the KOOS, JR among patients who underwent THA or TKA; (2) to determine substantial clinical benefit thresholds for the HOOS and KOOS domains, the HOOS, JR, and the KOOS, JR among patients who underwent THA or TKA; and (3) to assess the proportions of patients who underwent THA or TKA who achieved an MCID for the HOOS and KOOS domains, HOOS, JR, and KOOS, JR based on distribution-based and anchor-based methods as well as the percentages of patients who achieved substantial clinical benefit using the anchor-based method. Methods: Medicare patients enrolled in our institutional joint replacement registry who subsequently underwent THA (n = 2323) or TKA (n = 2630) between 2007 and 2012 completed HOOS or KOOS preoperatively and 2 years postoperatively. Short-form joint replacement (JR) versions of each PROM were derived from the full PROMs. Of all eligible patients, 78% (3161 of 4080) of THAs and 74% of TKAs (3815 of 5156) consented to join the registry and completed a baseline survey, 88% (2796 of 3161) of THAs and 85% (3230 of 3815) of TKAs were eligible for followup survey administration, and 83% of THAs (2323 of 2796) and 81% (2630 of 3230) of TKAs returned 2-year surveys. For each HOOS domain, KOOS domain, HOOS, JR, and KOOS, JR, we calculated the calibration variation of the instrument (MDC) with confidence intervals (CIs) reflecting 80% (MDC80), 90% (MDC90), and 95% (MDC95) certainty; we calculated the smallest difference joint health patients might detect (MCID) using distribution- and anchor-based approaches and the difference that can be considered a large improvement in joint health (substantial clinical benefit) using an anchor-based approach. Results: Patients undergoing THA were 57% female with a mean (± SD) age of 73 ± 6 years, whereas patients undergoing TKA were 63% female with a mean age of 74 ± 6 years. Depending on the CI chosen for the MDC, values ranged from 7 to 16 for the HOOS and KOOS domains and the JRs. The MCIDs ranged from 6 to 9 for the distribution-based approach and 7 to 36 for the anchor-based approach. All HOOS and KOOS domains and all JR scores are scores from 0 (worst joint health) to 100 (best joint health). The MCIDs calculated using the distribution-based approach were not valid, because they were lower than the MDC for all HOOS/KOOS domains and both JRs at every confidence level. The anchor-based receiver operating characteristic approach, on the other hand, resulted in MCIDs exceeding MDC80 for seven of eight HOOS/KOOS domains and MDC95 for both JR scores. For all domains and JR versions, substantial clinical benefits ranged from 15 to 36, exceeding MDC95 in all domains and JR scores. Across HOOS and KOOS domains as well as the JR, the proportion of patients undergoing THA who achieved an MCID ranged from 77% to 95% with the distribution-based method and from 67% to 96% using the anchor-based method. The proportion achieving substantial clinical benefit ranged from 67% to 85%. Conclusions: The MDC and MCID differ greatly based on assumptions and methods used. The MCID anchor-based approach had superior construct and face validity compared with the MCID distribution-based approach, which never exceeded even small MDCs. Achieving consensus about standard definitions of meaningful improvement will be necessary to maximize utility of these PROMs to inform clinical care or performance measurement. Level of evidence: Level III, diagnostic study.

Clinical orthopaedics and related research · cohort or longitudinal · 400 citationsread the source →

[Discrimination perceived by people with a diagnosis of schizophrenic disorders. INternational study of DIscrimination and stiGma Outcomes (INDIGO): French results].

Introduction: The INDIGO study (INternational study of DIscrimination and stiGma Outcomes) aims at assessing the impact of schizophrenic disorders diagnosis on privacy, social and professional life, in terms of discrimination. In the general population, and even among health and social professionals, erroneous negative stereotypes (double personality, dangerosity) lead to high social distance. And this has an impact on various parts of daily life: employment, housing, compliance, self-esteem… About a tenth of the adult population suffers from mental disorders at any one time. These disorders now account for about 12% of the global impact of disability, and this will rise to 15% by the year 2020. People living with schizophrenia, for example, experience reduced social participation, whilst public images of mental illness and social reactions add a dimension of suffering, which has been described as a "second illness". Stigmatizing attitudes and discriminatory behavior among the general population against people with severe mental illness are common in all countries. Globally, little is known of effective interventions against stigma. It is clear that the negative effects of stigma can act as formidable barriers to active recovery. Methodology: The INDIGO study intends to establish detailed international data on how stigma and discrimination affect the lives of people with a diagnosis of schizophrenia. The first aim of the INDIGO study is to conduct qualitative and quantitative interviews with 25 people with a diagnosis of schizophrenia in each participating site, to elicit information on how the condition affects their everyday lives, with a focus upon sites in Europe. The second is to gather data for all participating countries on the laws, policies and regulations which set a clear distinction between people with a diagnosis of mental illness and others, to establish an international profile of such discrimination. A new scale (Discrimination and Stigma Scale [DISC]), used in a face-to-face setting was developed. Interviewers asked service users to comment on how far their mental disorder has affected key areas of their lives, including work, marriage and partnerships, housing, leisure, and religious activities. For country-level information, staff at each national site gathered the best available data on whether special legal, policy or administrative arrangements are made for people with a diagnosis of mental illness. These items included, for example, information on access to insurance, financial services, driving licenses, voting, jury service, or travel visas. The INDIGO study is conducted within the framework of the WPA global program to fight stigma and discrimination because of schizophrenia. French interviews occurred in two sites (Lille and Nice) on a sample of 25 patients. Results: First, expressed disadvantages are high for several items (all relations, work and training, housing). In addition, we wish to highlight three specific points: almost half of the participants (46%) suffer from not being respected because of contacts with services, 88% of them felt rejected by people who know their diagnosis, and 76% hide/conceal their diagnosis. Positive experienced discrimination was rare. Two thirds of participants anticipated discrimination for job seeking and close personal relationships, sometimes with no experienced discrimination. Conclusions: This study, one of the rare in France adopting the point of view of a stigmatized group, revealed the numerous impacts of a diagnosis of schizophrenic disorders on everyday life. Comparisons between French and international results confirmed that the situation is not different in France, and even highlighted the extent of the stigmatization in the country.

L'Encephale · cohort or longitudinal · 20 citationsread the source →

Correlation of optic nerve sheath diameter with direct measurement of intracranial pressure.

Background: Measurements of the optic nerve sheath diameter (ONSD) using bedside ultrasound (US) have been shown to correlate with clinical and radiologic signs and symptoms of increased intracranial pressure (ICP). Objectives: Previous literature has identified 5 mm as the ONSD measurement above which patients exhibit either clinical or radiologic signs of elevated ICP. The goals of this study were to evaluate the association between ONSD and ICP and to validate the commonly used ONSD threshold of 5 mm using direct measurements of ICP as measured by ventriculostomy. Methods: A prospective blinded observational study was performed using a convenience sample of adult patients in both the emergency department (ED) and the neurologic intensive care unit (ICU) who had invasive intracranial monitors placed as part of their clinical care. Ocular USs were performed with a 10(-5) MHz linear probe. Emergency physicians (EPs) with previous ocular US experience performed ONSD measurements while blinded to the contemporaneous ICP reading obtained directly from invasive monitoring. The association between ONSD and ICP was assessed with the Spearman rank correlation coefficient, and a receiver operator characteristic (ROC) curve was created to determine the optimal ONSD cutoff to detect ICP > 20 cm H2O. Results: Thirty-eight ocular USs were performed on 15 individual patients. Spearman rank correlation coefficient of ONSD and ICP was 0.59 (p < 0.0005) demonstrating a significant positive correlation. An ROC curve was created to assess the ability of ONSD to distinguish an abnormal ICP greater than 20 cm H2O. The area under the ROC curve was 0.93 (95% confidence interval [CI] = 0.84 to 0.99). Based on inspection of the ROC curve, ONSD > 5 mm performed well to detect ICP > 20 cm H(2)O with a sensitivity of 88% (95% CI = 47% to 99%) and specificity of 93% (95% CI = 78% to 99%). Conclusions: Using an ROC curve the authors systematically confirmed the commonly used threshold of ONSD > 5 mm to detect ICP > 20 cm H2O. This study directly correlates ventriculostomy measurements of ICP with US ONSD measurements and provides further support for the use of ONSD measurements as a noninvasive test for elevated ICP.

Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · cohort or longitudinal · 328 citationsread the source →

Intensive Care Syndrome: Promoting Independence and Return to Employment (InS:PIRE). Early evaluation of a complex intervention.

Background: Many patients suffer significant physical, social and psychological problems in the months and years following critical care discharge. At present, there is minimal evidence of any effective interventions to support this patient group following hospital discharge. The aim of this project was to understand the impact of a complex intervention for ICU survivors. Methods: Quality improvement project conducted between September 2014 and June 2016, enrolling 49 selected patients from one ICU in Scotland. To evaluate the impact of this programme outcomes were compared to an existing cohort of patients from the same ICU from 2008-2009. Patients attended a five week peer supported rehabilitation programme. This multidisciplinary programme included pharmacy, physiotherapy, nursing, medical, and psychology input. The primary outcome in this evaluation was the EQ-5D, a validated measure of health-related quality of life. The minimally clinically important difference (MCID) in the EQ-5D is 0.08. We also measured change in self-efficacy over the programme duration. Based on previous research, this study utilised a 2.4 (6%) point change in self-efficacy scores as a MCID. Results: 40 patients (82%) completed follow-up surveys at 12 months. After regression adjustment for those factors known to impact recovery from critical care, there was a 0.07-0.16 point improvement in quality of life for those patients who took part in the intervention compared to historical controls from the same institution, depending on specific regression strategy used. Self-efficacy scores increased by 2.5 points (6.25%) over the duration of the five week programme (p = 0.003), and was sustained at one year post intervention. In the year following ICU, 15 InS:PIRE patients returned to employment or volunteering roles (88%) compared with 11 (46%) in the historical control group (p = 0.15). Conclusions and relevance: This historical control study suggests that a complex intervention may improve quality of life and self-efficacy in survivors of ICU. A larger, multi-centre study is needed to investigate this intervention further.

PloS one · 55 citationsread the source →

Changes in life satisfaction among unaccompanied asylum-seeking and refugee minors who participated in teaching recovery techniques (TRT).

Background: Unaccompanied asylum-seeking and refugee minors report low life satisfaction and high levels of mental health problems, nevertheless they often do not seek or receive help for their problems. Teaching Recovery Techniques (TRT) is a low-threshold, five sessions intervention developed to reduce distressing war- and disaster-related trauma reactions among children and youth. In this study, we investigate if TRT can contribute to increased life satisfaction among unaccompanied asylum-seeking and refugee minors. Methods: Asylum-seeking and resettled unaccompanied minors participated in TRT carried out in 15 locations throughout Norway, n = 147, mean age = 16.61 (SD = 1.80), 88% boys, and 67% from Afghanistan. Life satisfaction was measured by the Cantril Ladder before the intervention, and two- and eight weeks post-intervention. We also included indices of intervention compliance and contextual variables, such as asylum status. We applied a pre- and post-intervention design with linear mixed model analyses to investigate change in life satisfaction. Results: Life satisfaction significantly increased from pre- to post- intervention, but not for youth whose asylum application had been rejected or who were still awaiting a decision. Indices of intervention compliance were associated with an increase in life satisfaction. Conclusions: TRT is a potential useful intervention to enhance life satisfaction among unaccompanied asylum-seeking and refugee minors and can be a measure to support positive development among youth at risk for mental health problems. However, TRT initiatives should consider the participant's stage of asylum process, because harsh immigration policies may overburden the coping capacity. Without further adaptation, TRT seems most useful for youth granted residence. The manual has been revised to include asylum-related stressors. Trial registration: ClinicalTrials.gov (16/54,571, registered 30.01.2019).

Child and adolescent psychiatry and mental health · 4 citationsread the source →

Characteristics of breastfeeding practices among US mothers.

Objectives: Although much has been published about breastfeeding rates, little is known about how breastfeeding is practiced in the United States. We describe the distributions and characteristics of practices related to common advice about breastfeeding during the infant's first year of life. Participants and methods: Participants in the 2005-2007 Infant Feeding Practices Study II received monthly questionnaires during their infants' first year of life. Among breastfeeding respondents, we investigated patterns and trends in types of breastfeeding (supplementing with formula or not, and at the breast or not) and maternal report of infant feeding behaviors corresponding to common breastfeeding advice on frequency, duration, and intervals of feedings. Results: More than half of the breastfeeding mothers fed their infants nothing other than breast milk until 4 months of age. Formula supplementation declined from 42% at 1 month to 15% at 1 year; adding other foods/liquids increasingly surpassed supplementing with formula beginning at 5 months of age. Six percent of the mothers reported that the only breast milk the infant was fed was expressed, rather than at the breast. Frequency of breast milk feedings per day declined from 8 at 1 month to 3.5 at 1 year. Reported feeding durations of <20 minutes increased from 46% at 1 month to 88% at 1 year. Feeding from both breasts per feeding decreased 15% over the infant's first year (from 69% to 59%). Longest interfeeding intervals more than doubled over the year. Conclusions: Exclusive breastfeeding was common up to 4 but not to 6 months of age. Breastfeeding with only expressed milk was rare. Considerable variation existed in maternal report of practices that correspond to common breastfeeding advice. More research is needed to better understand how these variations relate to breastfeeding outcomes and the role of common breastfeeding advice in infant feeding decisions.

Pediatrics · 50 citationsread the source →

Prevalence of post-traumatic stress disorder and common mental disorders in health-care workers in England during the COVID-19 pandemic: a two-phase cross-sectional study.

Background: Previous studies on the impact of the COVID-19 pandemic on the mental health of health-care workers have relied on self-reported screening measures to estimate the point prevalence of common mental disorders. Screening measures, which are designed to be sensitive, have low positive predictive value and often overestimate prevalence. We aimed to estimate prevalence of common mental disorders and post-traumatic stress disorder (PTSD) among health-care workers in England using diagnostic interviews. Methods: We did a two-phase, cross-sectional study comprising diagnostic interviews within a larger multisite longitudinal cohort of health-care workers (National Health Service [NHS] CHECK; n=23 462) during the COVID-19 pandemic. In the first phase, health-care workers across 18 NHS England Trusts were recruited. Baseline assessments were done using online surveys between April 24, 2020, and Jan 15, 2021. In the second phase, we selected a proportion of participants who had responded to the surveys and conducted diagnostic interviews to establish the prevalence of mental disorders. The recruitment period for the diagnostic interviews was between March 1, 2021 and Aug 27, 2021. Participants were screened with the 12-item General Health Questionnaire (GHQ-12) and assessed with the Clinical Interview Schedule-Revised (CIS-R) for common mental disorders or were screened with the 6-item Post-Traumatic Stress Disorder Checklist (PCL-6) and assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) for PTSD. Findings: The screening sample contained 23 462 participants: 2079 participants were excluded due to missing values on the GHQ-12 and 11 147 participants due to missing values on the PCL-6. 243 individuals participated in diagnostic interviews for common mental disorders (CIS-R; mean age 42 years [range 21-70]; 185 [76%] women and 58 [24%] men) and 94 individuals participated in diagnostic interviews for PTSD (CAPS-5; mean age 44 years [23-62]; 79 [84%] women and 15 [16%] men). 202 (83%) of 243 individuals in the common mental disorders sample and 83 (88%) of 94 individuals in the PTSD sample were White. GHQ-12 screening caseness for common mental disorders was 52·8% (95% CI 51·7-53·8). Using CIS-R diagnostic interviews, the estimated population prevalence of generalised anxiety disorder was 14·3% (10·4-19·2), population prevalence of depression was 13·7% (10·1-18·3), and combined population prevalence of generalised anxiety disorder and depression was 21·5% (16·9-26·8). PCL-6 screening caseness for PTSD was 25·4% (24·3-26·5). Using CAPS-5 diagnostic interviews, the estimated population prevalence of PTSD was 7·9% (4·0-15·1). Interpretation: The prevalence estimates of common mental disorders and PTSD in health-care workers were considerably lower when assessed using diagnostic interviews compared with screening tools. 21·5% of health-care workers met the threshold for diagnosable mental disorders, and thus might benefit from clinical intervention. Funding: UK Medical Research Council; UCL/Wellcome; Rosetrees Trust; NHS England and Improvement; Economic and Social Research Council; National Institute for Health and Care Research (NIHR) Biomedical Research Centre at the Maudsley and King's College London (KCL); NIHR Protection Research Unit in Emergency Preparedness and Response at KCL.

The lancet. Psychiatry · 57 citationsread the source →

Burden of 375 diseases and injuries, risk-attributable burden of 88 risk factors, and healthy life expectancy in 204 countries and territories, including 660 subnational locations, 1990-2023: a systematic analysis for the Global Burden of Disease Study 2023.

Background: For more than three decades, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) has provided a framework to quantify health loss due to diseases, injuries, and associated risk factors. This paper presents GBD 2023 findings on disease and injury burden and risk-attributable health loss, offering a global audit of the state of world health to inform public health priorities. This work captures the evolving landscape of health metrics across age groups, sexes, and locations, while reflecting on the remaining post-COVID-19 challenges to achieving our collective global health ambitions. Methods: The GBD 2023 combined analysis estimated years lived with disability (YLDs), years of life lost (YLLs), and disability-adjusted life-years (DALYs) for 375 diseases and injuries, and risk-attributable burden associated with 88 modifiable risk factors. Of the more than 310 000 total data sources used for all GBD 2023 (about 30% of which were new to this estimation round), more than 120 000 sources were used for estimation of disease and injury burden and 59 000 for risk factor estimation, and included vital registration systems, surveys, disease registries, and published scientific literature. Data were analysed using previously established modelling approaches, such as disease modelling meta-regression version 2.1 (DisMod-MR 2.1) and comparative risk assessment methods. Diseases and injuries were categorised into four levels on the basis of the established GBD cause hierarchy, as were risk factors using the GBD risk hierarchy. Estimates stratified by age, sex, location, and year from 1990 to 2023 were focused on disease-specific time trends over the 2010-23 period and presented as counts (to three significant figures) and age-standardised rates per 100 000 person-years (to one decimal place). For each measure, 95% uncertainty intervals [UIs] were calculated with the 2·5th and 97·5th percentile ordered values from a 250-draw distribution. Findings: Total numbers of global DALYs grew 6·1% (95% UI 4·0-8·1), from 2·64 billion (2·46-2·86) in 2010 to 2·80 billion (2·57-3·08) in 2023, but age-standardised DALY rates, which account for population growth and ageing, decreased by 12·6% (11·0-14·1), revealing large long-term health improvements. Non-communicable diseases (NCDs) contributed 1·45 billion (1·31-1·61) global DALYs in 2010, increasing to 1·80 billion (1·63-2·03) in 2023, alongside a concurrent 4·1% (1·9-6·3) reduction in age-standardised rates. Based on DALY counts, the leading level 3 NCDs in 2023 were ischaemic heart disease (193 million [176-209] DALYs), stroke (157 million [141-172]), and diabetes (90·2 million [75·2-107]), with the largest increases in age-standardised rates since 2010 occurring for anxiety disorders (62·8% [34·0-107·5]), depressive disorders (26·3% [11·6-42·9]), and diabetes (14·9% [7·5-25·6]). Remarkable health gains were made for communicable, maternal, neonatal, and nutritional (CMNN) diseases, with DALYs falling from 874 million (837-917) in 2010 to 681 million (642-736) in 2023, and a 25·8% (22·6-28·7) reduction in age-standardised DALY rates. During the COVID-19 pandemic, DALYs due to CMNN diseases rose but returned to pre-pandemic levels by 2023. From 2010 to 2023, decreases in age-standardised rates for CMNN diseases were led by rate decreases of 49·1% (32·7-61·0) for diarrhoeal diseases, 42·9% (38·0-48·0) for HIV/AIDS, and 42·2% (23·6-56·6) for tuberculosis. Neonatal disorders and lower respiratory infections remained the leading level 3 CMNN causes globally in 2023, although both showed notable rate decreases from 2010, declining by 16·5% (10·6-22·0) and 24·8% (7·4-36·7), respectively. Injury-related age-standardised DALY rates decreased by 15·6% (10·7-19·8) over the same period. Differences in burden due to NCDs, CMNN diseases, and injuries persisted across age, sex, time, and location. Based on our risk analysis, nearly 50% (1·27 billion [1·18-1·38]) of the roughly 2·80 billion total global DALYs in 2023 were attributable to the 88 risk factors analysed in GBD. Globally, the five level 3 risk factors contributing the highest proportion of risk-attributable DALYs were high systolic blood pressure (SBP), particulate matter pollution, high fasting plasma glucose (FPG), smoking, and low birthweight and short gestation-with high SBP accounting for 8·4% (6·9-10·0) of total DALYs. Of the three overarching level 1 GBD risk factor categories-behavioural, metabolic, and environmental and occupational-risk-attributable DALYs rose between 2010 and 2023 only for metabolic risks, increasing by 30·7% (24·8-37·3); however, age-standardised DALY rates attributable to metabolic risks decreased by 6·7% (2·0-11·0) over the same period. For all but three of the 25 leading level 3 risk factors, age-standardised rates dropped between 2010 and 2023-eg, declining by 54·4% (38·7-65·3) for unsafe sanitation, 50·5% (33·3-63·1) for unsafe water source, and 45·2% (25·6-72·0) for no access to handwashing facility, and by 44·9% (37·3-53·5) for child growth failure. The three leading level 3 risk factors for which age-standardised attributable DALY rates rose were high BMI (10·5% [0·1 to 20·9]), drug use (8·4% [2·6 to 15·3]), and high FPG (6·2% [-2·7 to 15·6]; non-significant). Interpretation: Our findings underscore the complex and dynamic nature of global health challenges. Since 2010, there have been large decreases in burden due to CMNN diseases and many environmental and behavioural risk factors, juxtaposed with sizeable increases in DALYs attributable to metabolic risk factors and NCDs in growing and ageing populations. This long-observed consequence of the global epidemiological transition was only temporarily interrupted by the COVID-19 pandemic. The substantially decreasing CMNN disease burden, despite the 2008 global financial crisis and pandemic-related disruptions, is one of the greatest collective public health successes known. However, these achievements are at risk of being reversed due to major cuts to development assistance for health globally, the effects of which will hit low-income countries with high burden the hardest. Without sustained investment in evidence-based interventions and policies, progress could stall or reverse, leading to widespread human costs and geopolitical instability. Moreover, the rising NCD burden necessitates intensified efforts to mitigate exposure to leading risk factors-eg, air pollution, smoking, and metabolic risks, such as high SBP, BMI, and FPG-including policies that promote food security, healthier diets, physical activity, and equitable and expanded access to potential treatments, such as GLP-1 receptor agonists. Decisive, coordinated action is needed to address long-standing yet growing health challenges, including depressive and anxiety disorders. Yet this can be only part of the solution. Our response to the NCD syndemic-the complex interaction of multiple health risks, social determinants, and systemic challenges-will define the future landscape of global health. To ensure human wellbeing, economic stability, and social equity, global action to sustain and advance health gains must prioritise reducing disparities by addressing socioeconomic and demographic determinants, ensuring equitable health-care access, tackling malnutrition, strengthening health systems, and improving vaccination coverage. We live in times of great opportunity. Funding: Gates Foundation and Bloomberg Philanthropies.

Lancet (London, England) · 257 citationsread the source →

Childhood trauma and posttraumatic stress disorder in a real-world Veterans Affairs clinic: Examining treatment preferences and dropout.

Objective: The Department of Veterans Affairs (VA) has promoted large-scale dissemination efforts of evidence-based psychotherapies (EBPs) for posttraumatic stress disorder (PTSD). In spite of efforts to make gold-standard treatments available to veterans, few veterans with PTSD receive a full course of psychotherapy. It is unclear if type of trauma experienced is related to treatment initiation and completion. This study aimed to identify patient factors, including experiencing childhood trauma that related to treatment preferences and dropout in a real-world VA PTSD clinic. Method: A chart review was conducted for veterans who were referred for individual EBPs for PTSD (N = 199). Extracted variables included demographics, PTSD symptoms, treatment preferences, and treatment completion/dropout. Results: Veterans choose to engage in individual EBP (48%), group treatment (11%), nontrauma focused psychotherapy (15%), or no psychotherapy (26%). Slightly over half of the veterans who began individual EBP completed it, with no statistical differences in completion rates for prolonged exposure and cognitive processing therapy. Childhood trauma was the second-most common type of trauma experienced, next to combat exposure. Those who completed EBP had higher rates of combat trauma (88%) than noncompleters (70%), and noncompleters (50%) had higher rates of childhood trauma than completers (29%). Regardless of trauma experienced, those who completed an EBP experienced substantial reductions in PTSD symptoms. Conclusions: Assessing veterans for childhood trauma and emotion regulation difficulties may be beneficial even in VA clinics where treatment is most often focused on combat trauma. (PsycINFO Database Record

Psychological trauma : theory, research, practice and policy · 16 citationsread the source →

Effects of Intermittent Versus Continuous Energy Intakes on Insulin Sensitivity and Metabolic Risk in Women with Overweight.

Objective: This study aimed to compare intermittent fasting (IF) versus continuous energy intakes at 100% or 70% of calculated energy requirements on insulin sensitivity, cardiometabolic risk, body weight, and composition. Methods: Women with overweight (n = 88; 50 ± 1 years, BMI 32.3 ± 0.5 kg/m2 ) were randomized to one of four diets (IF70, IF100, dietary restriction [DR70], or control) in a 2:2:2:1 ratio for 8 weeks. IF groups fasted for 24 hours after breakfast on three nonconsecutive days per week. All foods were provided and diets matched for macronutrient composition (35% fat, 15% protein, 50% carbohydrate). Insulin sensitivity by hyperinsulinemic-euglycemic clamp, weight, body composition, and plasma markers were assessed following a "fed" day (12-hour fast) and a 24-hour fast (IF only). Results: IF70 displayed greater reductions in weight, fat mass, total- and low-density lipoprotein cholesterol, and nonesterified fatty acids compared with DR70 and IF100 (all P ≤ 0.05). IF100 lost more weight and fat than control. However, fasting insulin was increased. There were no group differences in insulin sensitivity by clamp; however, a 24-hour fast transiently reduced insulin sensitivity. Conclusions: When prescribed at matched energy restriction, IF reduced weight and fat mass and improved total and low-density lipoprotein cholesterol more than DR. IF prescribed in energy balance did not improve health compared with other groups, despite modest weight loss.

Obesity (Silver Spring, Md.) · 94 citationsread the source →

Epidemiological characteristics of infertility, 1990-2021, and 15-year forecasts: an analysis based on the global burden of disease study 2021.

Background: Infertility, defined as the inability to achieve pregnancy after 1 year of regular unprotected intercourse, affects approximately 186 million people globally, with consistent prevalence across different income levels. Globally, the rising infertility rates are impacting population growth and individual quality of life. Infertility is not just a personal issue but also a public health concern, with social and economic implications, including stigmatization, marital discord, and mental strain. The COVID-19 pandemic has further exacerbated mental health issues among individuals with infertility, underscoring the need for research into the mental health impacts and access to fertility services. Economically, infertility poses a significant financial burden, especially in regions where Assisted Reproductive Technology (ART) costs can be up to 200% of the GDP per capita. Understanding the complexities and spread of infertility is essential for guiding policy decisions and program rollouts, with studies analyzing infertility issues based on the Global Burden of Disease (GBD) database. Methods: The study leverages data from the GBD 2021, encompassing 371 conditions or injuries and 88 risk factors across 204 nations. It examines prevalence, disability-adjusted life years (DALYs), age-standardized prevalence rate (ASPR), and age-standardized DALYs rate (ASDR) for infertility, categorized by sex, age, regions, and nations. The Social and Demographic Index (SDI), reflecting socio-economic levels, is used to analyze its correlation with infertility burden. The study employs decomposition analysis and frontier analysis methods to assess changes in infertility prevalence and DALYs, and Spearman's rank correlation coefficient to confirm relationships between age-standardized rates (ASRs) and SDI. The estimated annual percentage change (EAPC) of rates, with 95% confidence intervals (CIs), was calculated. Results: In 2021, it was calculated that the global ASPR for male infertility stood at 1354.76 cases per 100,000 individuals, with a 95% Uncertainty Interval ranging from 802.12 to 2174.77 cases per 100,000 individuals. For female infertility, the ASPR was recorded at 2764.62 per 100,000 individuals (95% UI: 1476.33-4862.57 per 100,000 individuals). Between 1990 and 2021, the EAPC in ASPR was observed to be 0.5% (95% CI 0.36-0.64) for males and 0.7% (95% CI 0.53-0.87) for females. In that same year, the global ASDR attributed to male infertility was 7.84 per 100,000 individuals (95% UI: 2.85-18.56 per 100,000 individuals), while for female infertility, it amounted to 15.12 per 100,000 individuals (95% UI: 5.35-36.88 per 100,000 individuals). The EAPC for ASDR linked to male and female infertility from 1990 to 2021 was assessed at 0.51% (95% CI 0.38-0.65) and 0.71% (95% CI 0.54-0.88), respectively. Among the 204 countries and territories in 2021, India ranked first in both the prevalence of cases and DALYs associated with male and female infertility, followed by China and Indonesia. Additionally, the investigation revealed a slight negative correlation between the ASPR and ASDR of infertility and the SDI. Decomposition analysis indicated that approximately 65% of the rise in the global burden of infertility could be attributed to population growth. Frontier analysis suggested that the variations in efficiency frontiers across specific SDI levels diminish as the SDI increases. Looking forward, the study projects a global rise in ASPR and ASDR for infertility between 2022 and 2036. Conclusions: The worldwide prevalence of infertility has substantially increased between 1990 and 2021, largely as a result of population growth. This trend highlights the pressing necessity for better strategies concerning prevention, diagnosis, and treatment, particularly in low and middle-income nations. Strengthening healthcare infrastructures, enhancing access to high-quality medical services, and raising awareness about infertility are vital measures to tackle this issue. The results of the study offer essential information to help policymakers and health officials formulate targeted strategies for the prevention and management of infertility.

Reproductive health · 16 citationsread the source →

Relaxation with Immersive Natural Scenes Presented Using Virtual Reality.

Introduction: Virtual reality (VR) can provide exposure to nature for those living in isolated confined environments. We evaluated VR-presented natural settings for reducing stress and improving mood. Methods: There were 18 participants (9 men, 9 women), ages 32 ± 12 yr, who viewed three 15-min 360° scenes (an indoor control, rural Ireland, and remote beaches). Subjects were mentally stressed with arithmetic before scenes. Electrodermal activity (EDA) and heart rate variability measured psycho-physiological arousal. The Positive and Negative Affect Schedule and the 15-question Modified Reality Judgment and Presence Questionnaire (MRJPQ) measured mood and scene quality. Results: Reductions in EDA from baseline were greater at the end of the natural scenes compared to the control scene (-0.59, -0.52, and 0.32 μS, respectively). The natural scenes reduced negative affect from baseline ( 1.2 and 1.1 points), but the control scene did not ( 0.4 points). MRJPQ scores for the control scene were lower than both natural scenes (4.9, 6.7, and 6.5 points, respectively). Within the two natural scenes, the preferred scene reduced negative affect ( 2.4 points) more than the second choice scene ( 1.8 points) and scored higher on the MRJPQ (6.8 vs. 6.4 points). Discussion: Natural scene VR provided relaxation both objectively and subjectively, and scene preference had a significant effect on mood and perception of scene quality. VR may enable relaxation for people living in isolated confined environments, particularly when matched to personal preferences. Anderson AP, Mayer MD, Fellows AM, Cowan DR, Hegel MT, Buckey JC. Relaxation with immersive natural scenes presented using virtual reality. Aerosp Med Hum Perform. 2017; 88(6):520526.

Aerospace medicine and human performance · 147 citationsread the source →

Optimizing expectations and distraction leads to lower cortisol levels after acute stress.

Background: A new approach of psychological interventions prior to stress aiming to optimize expectations may have beneficial effects on a person's health status by reducing physiological stress. The purpose of this experiment was to determine whether a brief psychological intervention designed to optimize personal control expectations prior to acute stress would affect perceived and biological stress responsiveness in comparison to two more established interventions (fostering gratitude or distraction) in a healthy sample. Methods: 74 healthy participants were randomized to one of three psychological interventions prior to stress: (i) writing about ways to influence stress to optimize personal control expectations (EXPECTATION), (ii) writing a gratitude-letter (GRATITUDE) (iii) or a distraction writing task (DISTRACTION). After completing the intervention, the Maastricht acute stress test was administered to induce (psychosocial and physiological) stress. Assessments took place at baseline, post-intervention (15 min writing task) and after stress induction (additional salivary assessments: 15 and 30 min after stress). Main outcomes were expectations, emotions, perceived stress, salivary cortisol and alpha-amylase. Personality traits (eg, optimism) were assessed at baseline. Results: EXPECTATION specifically increased personal control expectations (p = .016, d = .72) and GRATITUDE specifically increased gratitude (p = .026, d = .68). EXPECTATION and DISTRACTION led to lower cortisol concentrations after stress induction than GRATITUDE (time x group interaction: p < .001, d = .88). We detected no intervention effects on alpha-amylase or perceived stress. Optimism moderated intervention effects on cortisol (p = .023, d = .74). Conclusions: Brief psychological interventions aiming to optimize expectations or distraction prior to stress reduce the cortisol response in healthy participants after an acute stressor.

Psychoneuroendocrinology · 21 citationsread the source →

Adverse effects of COVID-19-related lockdown on pain, physical activity and psychological well-being in people with chronic pain.

Countries across the world imposed lockdown restrictions during the COVID-19 pandemic. It has been proposed that lockdown conditions, including social and physical distancing measures, may disproportionately impact those living with chronic pain and require rapid adaptation to treatment and care strategies. Using an online methodology, we investigated how lockdown restrictions in the United Kingdom impacted individuals with chronic pain (N = 431) relative to a healthy control group (N = 88). Data were collected during the most stringent period of lockdown in the United Kingdom (mid-April to early-May 2020). In accordance with the fear-avoidance model, we hypothesised lockdown-related increases in pain and psychological distress, which would be mediated by levels of pain catastrophising. Responses indicated that people with chronic pain perceived increased pain severity, compared to their estimation of typical pain levels prior to lockdown (p < .001). They were also more adversely affected by lockdown conditions compared to pain-free individuals, demonstrating greater self-perceived increases in anxiety and depressed mood, increased loneliness and reduced levels of physical exercise (p ⩽ .001). Hierarchical regression analysis revealed that pain catastrophising was an important factor relating to the extent of self-perceived increases in pain severity during lockdown (β = .27, p < .001) and also mediated the relationship between decreased mood and pain. Perceived decreases in levels of physical exercise also related to perceptions of increased pain (β = .15, p < .001). Interestingly, levels of pain intensity (measured at two time points at pre and during lockdown) in a subgroup (N = 85) did not demonstrate a significant change. However, individuals in this subgroup still reported self-perceived pain increases during lockdown, which were also predicted by baseline levels of pain catastrophising. Overall, the findings indicate that people with chronic pain suffer adverse effects of lockdown including self-perceived increases in their pain. Remote pain management provision to target reduction of pain catastrophising and increase health behaviours including physical activity could be beneficial for this vulnerable population.

British journal of pain · 83 citationsread the source →

Longitudinal Changes in Posttraumatic Stress Disorder After Resettlement Among Yazidi Female Refugees Exposed to Violence.

Importance: Posttraumatic stress disorder (PTSD) is highly prevalent among refugees surviving mass atrocities, especially among women. Longitudinal studies investigating factors associated with PTSD course are essential to enable adequate treatment yet widely lacking. Objective: To identify longitudinal changes in PTSD severity and posttraumatic coping among severely traumatized female refugees as well as risk and protective factors for PTSD course. Design, setting, and participants: This prospective cohort study took place in 14 German cities in the context of a humanitarian admission program that resettled 1000 especially vulnerable women and children from northern Iraq to Germany. Approximately 400 adult beneficiaries of the humanitarian admission program were eligible for the study. At baseline, a total of 116 of the 400 beneficiaries (29.0%) participated, with 96 (82.8%) of these women participating in the follow-up assessment. The study included a baseline assessment conducted 2 years after resettlement (September 1, 2017, to January 12, 2018) and a 1-year follow-up (August 29, 2018, to January 15, 2019). Exposures: Violence and/or captivity during the 2014 genocide in northern Iraq by the so-called Islamic State. Main outcomes and measures: Posttraumatic stress disorder severity and coping strategies were assessed in interpreter-aided interviews using the Impact of Event Scale-Revised. Results: A total of 116 women (mean [SD] age, 32.2 [8.2] years; 115 [99.1%] Yazidi; 1 [0.9%] Christian) participated at baseline. According to the Impact of Event Scale-Revised, a high PTSD severity was found (mean [SD] raw sum score, 60.88 [15.75] of 88, with higher scores indicating greater distress), with no significant change over time. Helpful coping strategies included prayer, belief in collective strength, and belief in personal strength. Earlier symptoms of intrusions (β = 0.389, P = .007) and longer captivity (β = 0.218, P = .02) were identified as being associated with PTSD severity 1 year later. Longer captivity was associated with PTSD aggravation over time (β = 0.227, P = .04). Posttraumatic strengthening in faith (β = -0.206, P = .05) and in social relationships (β = -0.221, P = .03) were associated with a reduction in PTSD symptoms. Conclusions and relevance: These findings suggest that female refugee survivors of genocide are at high risk for severe and chronic PTSD beyond the initial years of resettlement. The findings provide suggestions for mental health care specialized for particularly vulnerable populations.

JAMA network open · 9 citationsread the source →

Predictors of treatment resistance in patients with schizophrenia: a population-based cohort study.

Background: Identification of patients at high risk of treatment-resistant schizophrenia at the time of schizophrenia diagnosis would be of great clinical benefit in minimising the delay to clozapine treatment in patients unlikely to respond to non-clozapine antipsychotics. However, little is known about predictors of treatment resistance in this patient population. We used a treatment-based proxy for treatment-resistant schizophrenia to identify candidate predictors of treatment resistance at first hospital contact with a schizophrenia diagnosis. Methods: In this population-based cohort study, we obtained Danish national registry data for all adult patients (≥18 years) with incident schizophrenia diagnosed between Jan 1, 1996, and Dec 31, 2006, and followed up until Dec 31, 2010. Our main proxy definition of treatment-resistant schizophrenia was the earliest instance of either clozapine initiation or hospital admission for schizophrenia after having had two periods of different antipsychotic monotherapy. We did multivariable Cox proportional hazards regression analysis to estimate the association between baseline candidate predictors and treatment resistance. Findings: 8624 patients fulfilled the criteria for inclusion. In multivariable complete-case analyses, 1703 (21%) of 8044 patients fulfilled the main proxy definition of treatment-resistant schizophrenia during a median follow-up of 9·1 years (IQR 6·3-11·9). Younger age (hazard ratio 0·96 [95% CI 0·95-0·97]), living in a less urban area (provincial 1·38 [1·23-1·56], rural 1·44 [1·25-1·65]), primary education level (0·88 [0·79-0·98]), more than 30 bed-days in psychiatric hospital in the year before first schizophrenia diagnosis (1·54 [1·35-1·75]), inpatient at first schizophrenia diagnosis (2·07 [1·87-2·29]), paranoid subtype (1·24 [1·13-1·37]), comorbid personality disorder (1·24 [1·11-1·39]), psychotropic drug use (antipsychotics 1·51 [1·35-1·69], antidepressants 1·15 [1·03-1·29], and benzodiazepines 1·22 [1·10-1·37]), and previous suicide attempt (1·21 [1·07-1·39]) were all significantly associated with treatment-resistant schizophrenia. Interpretation: Our study identifies several candidate predictors that could potentially be included in future prediction models for treatment-resistant schizophrenia. Notably, established risk factors for schizophrenia did not predict treatment resistance, suggesting that treatment-resistant disease might be a distinct subtype of schizophrenia and not merely a more severe form. Funding: European Community's Seventh Framework Programme.

The lancet. Psychiatry · 127 citationsread the source →

The relationship between addictive use of social media and video games and symptoms of psychiatric disorders: A large-scale cross-sectional study.

Over the last decade, research into "addictive technological behaviors" has substantially increased. Research has also demonstrated strong associations between addictive use of technology and comorbid psychiatric disorders. In the present study, 23,533 adults (mean age 35.8 years, ranging from 16 to 88 years) participated in an online cross-sectional survey examining whether demographic variables, symptoms of attention-deficit/hyperactivity disorder (ADHD), obsessive-compulsive disorder (OCD), anxiety, and depression could explain variance in addictive use (i.e., compulsive and excessive use associated with negative outcomes) of two types of modern online technologies: social media and video games. Correlations between symptoms of addictive technology use and mental disorder symptoms were all positive and significant, including the weak interrelationship between the two addictive technological behaviors. Age appeared to be inversely related to the addictive use of these technologies. Being male was significantly associated with addictive use of video games, whereas being female was significantly associated with addictive use of social media. Being single was positively related to both addictive social networking and video gaming. Hierarchical regression analyses showed that demographic factors explained between 11 and 12% of the variance in addictive technology use. The mental health variables explained between 7 and 15% of the variance. The study significantly adds to our understanding of mental health symptoms and their role in addictive use of modern technology, and suggests that the concept of Internet use disorder (i.e., "Internet addiction") as a unified construct is not warranted.

Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors · 743 citationsread the source →

Written Exposure Therapy vs Prolonged Exposure Therapy in the Treatment of Posttraumatic Stress Disorder: A Randomized Clinical Trial.

Importance: Evidence-based treatments for posttraumatic stress disorder (PTSD) exist, but all require 8 to 15 sessions and thus are less likely to be completed than brief treatments. Written exposure therapy (WET) is a brief and efficacious treatment that has not been directly compared with prolonged exposure therapy (PE), a more time-intensive, exposure-based treatment. Objective: To determine whether WET is noninferior to PE in treating PTSD among veterans. Design, setting, and participants: A randomized noninferiority clinical trial was conducted between September 9, 2019, and April 30, 2022. Participants were 178 veterans with PTSD presenting to 1 of 3 Veterans Affairs medical centers. Inclusion criteria consisted of a primary diagnosis of PTSD and stable medication. Exclusion criteria included current psychotherapy for PTSD, high suicide risk, active psychosis, unstable bipolar disorder, and severe cognitive impairment. Independent evaluations were conducted at baseline and 10, 20, and 30 weeks after the first treatment session. Data were analyzed from January 1 to March 31, 2023. Interventions: Participants assigned to WET (n = 88) received five to seven 45- to 60-minute sessions. Participants assigned to PE (n = 90) received eight to fifteen 90-minute sessions. The WET sessions included 30 minutes of writing-based imaginal exposure conducted in session, whereas PE sessions included 40 minutes of in-session imaginal exposure and between-session in vivo exposures. Main outcomes and measures: The primary outcome was change in PTSD symptom severity measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) from baseline to the 20-week assessment; noninferiority was defined as a less than 10-point difference between the 2 treatment groups. Difference in treatment dropout was also examined. Results: Of the 178 participants, 134 (75.3%) were men, and the mean (SD) age was 44.97 (13.66) years. In terms of race, 37 participants (20.8%) were Black, 112 (62.9%) were White, 11 (6.2%) were more than 1 race, and 18 (10.1%) were of other race (including American Indian or Alaska Native, Asian, and Native Hawaiian or Other Pacific Islander [some participants did not specify their race when selecting the category "other"]); in terms of ethnicity, 19 participants (10.7%) were Hispanic. Changes in PTSD symptom severity from baseline to all subsequent assessments among individuals randomized to WET were noninferior relative to individuals randomized to PE. The largest difference between treatments was observed at 10 weeks and was in favor of WET (mean difference, 2.42 [95% CI, 0.35-1.46] points). Participants were significantly less likely to drop out of WET compared with PE (11 [12.5%] vs 32 [35.6%]; χ2 = 12.91; Cramer V = 0.27). Conclusions and relevance: In this study, WET was noninferior to PE in PTSD symptom change and was associated with significantly less attrition. Findings suggest that WET may transcend previously observed barriers to PTSD treatment for both patients and clinicians. Trial registration: ClinicalTrials.gov Identifier: NCT03962504.

JAMA psychiatry · 48 citationsread the source →

Psychological Symptoms Among Evacuees From the 2016 Fort McMurray Wildfires: A Population-Based Survey One Year Later.

Background: The 2016 wildfires in Fort McMurray (Alberta, Canada) led to a massive displacement of 88,000 people and destroyed 2,400 homes. Although no direct human fatality resulted, many individuals feared for their lives or those of their loved ones. Objectives: (1) To estimate the prevalence of post-traumatic stress, major depressive, insomnia, generalized anxiety, and substance use disorders in the adult population of Fort McMurray 1 year after the evacuation; (2) To identify pre-, peri-, and post-disaster correlates of mental health disorders. Methods: A phone survey using random digit sampling was used to survey evacuees. A total of 1,510 evacuees (response rate = 40.2%, 55.5% women, mean age = 44.11, SD = 12.69) were interviewed between May 9th and July 28th, 2017. Five validated scales were administered: the PTSD Symptoms Checklist (PCL-5), the Insomnia Severity Index (ISI), the depression and anxiety subscales of the Patient Health Questionnaire (PHQ-9, GAD-7), and the CAGE Substance Abuse Screening Tool. Results: One year after the wildfires, 38% had a probable diagnosis of either post-traumatic stress, major depressive, insomnia, generalized anxiety, or substance use disorder, or a combination of these. Insomnia disorder was the most common, with an estimated prevalence of 28.5%. Post-traumatic stress, major depressive and generalized anxiety disorders were almost equally prevalent, with ~15% each. The estimated prevalence of substance use disorder was 7.9%. For all five mental health disorders, having a mental health condition prior to the fires was a significant risk factor, as well as having experienced financial stress or strain due to the economic decline already present in Fort McMurray. Five post-disaster consequences were significant predictors of four of the five disorders: decrease in work, decrease in social life, poorer current health status, increase in drug and alcohol use, and higher level of stress experienced since the fires. Conclusion: One year after the fires, more than one third of the evacuees had clinically significant psychological symptoms, including those of insomnia, post-traumatic stress, depression, anxiety, and substance use. This study helped identify individuals more at risk for mental health issues after a natural disaster and could guide post-disaster psychosocial support strategies.

Frontiers in public health · 36 citationsread the source →

Prevalence of depressive disorders and treatment in China: a cross-sectional epidemiological study.

Background: In China, depressive disorders have been estimated to be the second leading cause of years lived with disability. However, nationally representative epidemiological data for depressive disorders, in particular use of mental health services by adults with these disorders, are unavailable in China. The present study, part of the China Mental Health Survey, 2012-15, aims to describe the socioeconomic characteristics and the use of mental health services in people with depressive disorders in China. Methods: The China Mental Health Survey was a cross-sectional epidemiological survey of mental disorders in a multistage clustered-area probability sample of adults of Chinese nationality (≥18 years) from 157 nationwide representative population-based disease surveillance points in 31 provinces across China. Trained investigators interviewed the participants with the Composite International Diagnostic Interview 3.0 to ascertain the presence of lifetime and 12-month depressive disorders according to DSM-IV criteria, including major depressive disorder, dysthymic disorder, and depressive disorder not otherwise specified. Participants with 12-month depressive disorders were asked whether they received any treatment for their emotional problems during the past 12 months and, if so, the specific types of treatment providers. The Sheehan Disability Scale (SDS) was used to assess impairments associated with 12-month depressive symptoms. Data-quality control procedures included logic check by computers, sequential recording check, and phone-call check by the quality controllers, and reinterview check by the psychiatrists. Data were weighted according to the age-sex-residence distribution data from China's 2010 census population survey to adjust for differential probabilities of selection and differential response, as well as to post-stratify the sample to match the population distribution. Findings: 28 140 respondents (12 537 [44·6%] men and 15 603 [55·4%] women) completed the survey between July 22, 2013, and March 5, 2015. Ethnicity data (Han or non-Han) were collected for only a subsample. Prevalence of any depressive disorders was higher in women than men (lifetime prevalence odds ratio [OR] 1·44 [95% CI 1·20-1·72] and 12-month prevalence OR 1·41 [1·12-1·78]), in unemployed people than employed people (lifetime OR 2·38 [95% CI 1·68-3·38] and 12-month OR 2·80 [95% CI 1·88-4·18]), and in people who were separated, widowed, or divorced compared with those who were married or cohabiting (lifetime OR 1·87 [95% CI 1·39-2·51] and 12-month OR 1·85 [95% CI 1·40-2·46]). Overall, 574 (weighted % 75·9%) of 744 people with 12-month depressive disorders had role impairment of any SDS domain: 439 (83·6%) of 534 respondents with major depressive disorder, 207 (79·8%) of 254 respondents with dysthymic disorder, and 122 (59·9%) of 189 respondents with depressive disorder not otherwise specified. Only an estimated 84 (weighted % 9·5%) of 1007 participants with 12-month depressive disorders were treated in any treatment sector: 38 (3·6%) in speciality mental health, 20 (1·5%) in general medical, two (0·3%) in human services, and 21 (2·7%) in complementary and alternative medicine. Only 12 (0·5%) of 1007 participants with depressive disorders were treated adequately. Interpretation: Depressive disorders in China were more prevalent in women than men, unemployed people than employed, and those who were separated, widowed, or divorced than people who were married or cohabiting. Most people with depressive disorders reported social impairment. Treatment rates were very low, and few people received adequate treatment. National programmes are needed to remove barriers to availability, accessibility, and acceptability of care for depression in China. Funding: National Health Commission and Ministry of Science and Technology of People's Republic of China. Translation: For the Chinese translation of the abstract see Supplementary Materials section.

The lancet. Psychiatry · 591 citationsread the source →

Maternal health care service utilization among young married women in India, 1992-2016: trends and determinants.

Background: Maternal deaths among young women (15-24 years) shares 38% of total maternal mortality in India. Utilizing maternal health care services can reduce a substantial proportion of maternal mortality. However, there is a paucity of studies focusing on young women in this context. This paper, therefore, aimed to examine the trends and determinants of full antenatal care (ANC) and skilled birth attendance (SBA) utilization among young married women in India. Methods: The study analysed data from the four rounds of National Family Health Surveys conducted in India during the years 1992-93, 1998-99, 2005-06 and 2015-16. Young married women aged 15-24 years with at least one live birth in the 3 years preceding the survey were considered for analysis in each survey round. We used descriptive statistics to assess the prevalence and trends in full ANC and SBA use. Pooled multivariate logistic regression was conducted to identify the demographic and socioeconomic determinants of the selected maternity care services. The significance level for all analyses was set at p ≤ 0.05. Results: The use of full ANC among young mothers increased from 27 to 46% in India, and from 9 to 28% in EAG (Empowered Action Group) states during 1992-2016. SBA utilization was 88 and 83% during 2015-16 by showing an increment of 20 and 50% since 1992 in India and EAG states, respectively. Findings from multivariate analysis revealed a significant difference in the use of selected maternal health care services by maternal age, residence, education, birth order and wealth quintile. Additionally, Muslim women, women belonging to scheduled caste (SC)/ scheduled tribe (ST) social group, and women unexposed to mass media were less likely to utilize both the maternal health care services. Concerning the time effect, the odds of the utilization of full ANC and SBA among young women was found to increase over time. Conclusions: In India coverage of full ANC among young mothers remained unacceptably low, with a wide and persistent gap in utilization between EAG and non-EAG states since 1992. Targeted health policies should be designed to address low coverage of ANC and SBA among underprivileged young mothers and increased efforts should be made to ensure effective implementation of ongoing programs, especially in EAG states.

BMC pregnancy and childbirth · 50 citationsread the source →

Long-term developmental effect of withholding parenteral nutrition in paediatric intensive care units: a 4-year follow-up of the PEPaNIC randomised controlled trial.

Background: The PEPaNIC randomised controlled trial, which recruited 1440 critically ill infants and children in 2012-15, showed that withholding parenteral nutrition for 1 week (late-parenteral nutrition), compared with early supplementation within 24 h of admission to the paediatric intensive care unit (early-parenteral nutrition), prevented infections, accelerated recovery, and improved neurocognitive development assessed 2 years later. Because several neurocognitive domains can only be thoroughly assessed from age 4 years onwards, we aimed to determine the effect of late-parenteral nutrition versus early-parenteral nutrition on physical, neurocognitive, and emotional and behavioural development 4 years after randomisation. Methods: This is a preplanned, blinded, 4-year follow-up study of participants included in the PEPaNIC trial (done at University Hospitals Leuven, Belgium; Erasmus Medical Centre Sophia Children's Hospital, Rotterdam, Netherlands; and Stollery Children's Hospital, Edmonton, AB, Canada) and of matched healthy children. Studied outcomes were anthropometrics; health status; parent-reported or caregiver-reported executive functions, and emotional and behavioural problems; and clinical tests for intelligence, visual-motor integration, alertness, motor coordination, and memory. Through multivariable linear and logistic regression analyses, after imputation for missing values (≤30%) and adjustment for risk factors, we investigated the effect of early-parenteral nutrition versus late-parenteral nutrition. This trial is registered with ClinicalTrials.gov, NCT01536275. Findings: Between March 8, 2016, and Nov 8, 2019, 684 children from the original PEPaNIC trial (356 from the late-parenteral nutrition group and 328 from the early-parenteral nutrition group) were assessed for neurocognitive development at 4-years follow-up. Compared with the control group (369 healthy children), children who had critical illness had lower height (β-estimate -2·11 [95% CI -3·15 to -1·06]; p<0·0001) and head circumference (-0·42 [-0·67 to -0·18]; p=0.00077); and worse health status (eg, hospital admission odds ratio 4·27 [95% CI 3·12 to 5·84]; p<0·0001), neurocognitive (eg, parent-reported or caregiver-reported total executive functioning β-estimate 3·57 [95% CI 1·95 to 5·18], p<0·0001; total intelligence quotient -7·35 [-9·31 to -5·39], p<0·0001), and parent-reported or caregiver-reported emotional and behavioural developmental outcomes (internalising 2·73 [1·19 to 4·28], p=0·00055; externalising 1·63 [0·19 to 3·08], p=0·027; and total behavioural problems 2·95 [1·44 to 4·46], p=0·00013), adjusted for risk factors. Outcomes were never worse in the late-parenteral nutrition group compared with the early-parenteral nutrition group, but patients in the late-parenteral nutrition group had fewer parent-reported or caregiver-reported internalising (β-estimate -1·88 [95% CI -3·69 to -0·07]; p=0·042), externalising (-1·73 [-3·43 to -0·03]; p=0·046), and total emotional and behavioural problems (-2·44 [-4·22 to -0·67]; p=0·0070) than patients who had received early-parenteral nutrition, after adjusting for risk factors, and were no longer different from healthy controls for these outcomes. Interpretation: Omitting early parenteral nutrition use for critically ill children did not adversely affect long-term outcomes 4 years after randomisation and protected against emotional and behavioural problems, further supporting the deimplementation of early parenteral nutrition. Funding: European Research Council, Methusalem, Flanders Institute for Science and Technology, Research Foundation Flanders, Sophia Foundation, Stichting Agis Zorginnovatie, Erasmus Trustfonds, and the European Society for Clinical Nutrition and Metabolism.

The Lancet. Child & adolescent health · 46 citationsread the source →

Temporal trends and patterns in atrial fibrillation incidence: A population-based study of 3·4 million individuals.

Background: Population-based studies of atrial fibrillation (AF) incidence are needed to inform health-service planning, but evidence is conflicting. We assessed trends of AF incidence in a large general population cohort from England. Methods: We used linked primary and secondary electronic health records of 3.4 million individuals. Eligible patients aged 16 years and older contributed data between Jan 2 1998 and Dec 31 2017. For patients with incident AF, we extracted baseline characteristics, comorbidities, socioeconomic status and geographic region. We calculated standardised rates by applying direct age and sex standardisation to the 2013 European Standard Population. We applied year-specific, age-specific and sex-specific incidence to UK census mid-year population estimates for yearly total incident AF. Findings: Comparing 2017 to 1998 standardised AF incidence increased by 30% (322 vs. 247 per 100 000 person-years; adjusted incidence ratio [IRR] 1·30, 95% CI 1·27-1·33). Absolute number of incident AF increased by 72% (202 333 vs. 117 880), due to an increasing number of older persons. Comorbidity burden at diagnosis of AF increased (3·74 [SD 2·29] vs 2·58 [1·83]; adjusted difference 1·26, 95% CI 1·14-1·39). The age of AF diagnosis declined in the most deprived individuals compared to the most affluent (adjusted difference 0·74 years, 0·62-0·88). Across the study period, age-standardised incidence was higher in men than women (IRR 1·49; 95% CI 1·46-1·52), and men were younger at diagnosis (adjusted difference 5·53 years; 95% CI 5·36 to 5·69). Socioeconomically deprived individuals had more comorbidities and a higher incidence of AF than the most affluent individuals (IRR 1·20; 95% CI 1·15-1·24). Interpretation: In England AF incidence has increased, and the socioeconomic gradient in age at diagnosis and comorbidity burden widened. This changing burden requires policy-based interventions to achieve health equity. Funding: British Heart Foundation and National Institute for Health Research.

The Lancet regional health. Europe · 80 citationsread the source →

The adult galactosemic phenotype.

Background: Classic galactosemia is an autosomal recessive disorder due to galactose-1-phosphate uridyltransferase (GALT) deficiency. Newborn screening and early treatment do not completely prevent tremor, speech deficits, and diminished IQ in both sexes and premature ovarian insufficiency (POI) in women. Data on how individuals with galactosemia fare as adults will improve our ability to predict disease progression. Methods: Thirty-three adults (mean age = 32.6 ± 11.7 years; range = 18-59) with classic galactosemia, confirmed by genotype and undetectable GALT enzyme activity, were evaluated. Analyses assessed associations among age, genotype, clinical features and laboratory measures. Results: The sample included 17 men and 16 women. Subjects exhibited cataracts (21%), low bone density (24%), tremor (46%), ataxia (15%), dysarthria (24%), and apraxia of speech (9%). Subjects reported depression (39%) and anxiety (67%). Mean full scale IQ was 88 ± 20, (range = 55-122). All subjects followed a dairy-free diet and 75-80% reported low intake of calcium and vitamin D. Mean height, weight and body mass were within established norms. All female subjects had been diagnosed with POI. One woman and two men had had children. Logistic regression analyses revealed no associations between age, genotype or gender with IQ, tremor, ataxia, dysarthria, apraxia of speech or anxiety. Each 10- year increment of age was associated with a twofold increase in odds of depression. Conclusions: Taken together, these data do not support the hypothesis that galactosemia is a progressive neurodegenerative disease. However, greater attention to depression, anxiety, and social relationships may relieve the impact of this disorder in adults.

Journal of inherited metabolic disease · 134 citationsread the source →

In the aftermath of teenage suicide: a qualitative study of the psychosocial consequences for the surviving family members.

Background: Studies of family reactions following teenage suicide are hampered by the psychological difficulties of approaching families and recruiting an unbiased sample of study subjects. By using a small but consecutive series of cases, we examined the qualitative aspects of loosing a teenage family member due to suicide. Such an understanding is important for future organisation of proper programs that provide professional support in the grief process. Methods: From a large project on teenage unnatural death in northern Sweden 1981-2000 (including 88 suicides), 13 cases from 1995 through 1998 were retrospectively identified and consecutively analysed. Ten families agreed to participate. The open interviews took place 15 to 25 months after the suicide. The information gathered was manually analysed according to a grounded theory model, resulting in allocation of data into one of three domains: post-suicidal reactions, impact on daily living, and families' need for support. Results: Teenager suicide is a devastating trauma for the surviving family and the lack of sustainable explanations for the suicide is a predominant issue in the grief process. The prolonged social and psychological isolation of the families in grief should be challenged. At the time of the interview, the families were still struggling with explaining why the suicide occurred, especially since most suicides had occurred without overt premonitory signs. The bereaved family members were still profoundly affected by the loss, but all had returned to an ostensibly normal life. Post-suicide support was often badly timed and insufficient, especially for younger siblings. Conclusion: Family doctors can organise a long-term, individually formulated support scheme for the bereaved, including laymen who can play a most significant role in the grief process. There is also a need for better understanding of the families who have lost a teenager whom committed suicide and for the development and testing of treatment schemes for the bereaved family.

BMC psychiatry · 26 citationsread the source →

Parents' perspective on symptoms, quality of life, characteristics of death and end-of-life decisions for children dying from cancer.

Background: In the present study, we investigated the situation of children who had succumbed to their malignancy in Germany as perceived by their parents. Specifically, we were interested in bereaved parents' perspective on five essential areas: 1) symptoms and quality of life, 2) characteristics of the child's death, 3) anticipation of their child's death and care delivery, 4) end-of-life decisions and 5) impact of the child's death on the parents and perceived social support by the health care team. Materials and methods: We contacted all existing departments for paediatric oncology in the German federal state of Nordrhein Westfalen and asked them to contact all parents for participation in our study who had lost their child to cancer in 1999 and 2000. Upon agreement, we interviewed the parents utilising a validated semi-structured interview on distressing symptoms and quality of life of their children during the end-of-life care period. Results: Six of the 19 departments agreed to participate. Parents of 48 children (31 boys, 17 girls) were interviewed. The main distressing symptoms were fatigue, pain, loss of appetite, and dyspnoea according to the parents. While parents perceived pain and constipation to have been treated successfully, loss of appetite and anxiety were not treated effectively. 75% of the children died due to a progression of their malignancy. Of these, 50% obtained cancer-directed therapy at the end of life, which was negatively rated by the parents in hindsight. 48% of the children died at home even though 88% of the parents chose 'at home' as the most appropriate locale of death in hindsight. Parents anticipated their child's death on average 9 weeks prior to the child's death. 41% of the parents provided palliative home care for their child and the majority (88%) rated the quality of care as good or very good. 64% discussed end-of-life decisions with the health care team, 36% did not have a discussion. Parents were clearly affected by their child's death. However, 15% of the parents were not contacted by the health care team following the child's death. Conclusions: The present study demonstrated that psychological symptoms (e.g. anxiety) are frequent symptoms in the end-of-life care period and cause severe suffering in the children. Questions in terms of benefits and costs of cancer-directed therapy in the end-of-life care period need to be addressed in future prospective studies. Parents' perspective on their child's death and related end-of-life decisions highlighted the importance of communication between parents and the health care team. Future studies need to investigate potential barriers in the communication between parents and the team to optimise end-of-life decisions and hence, reduce parents' long-term distress. In line with the previous, the present data demonstrated that there is still a lack of routine contact from the health care team following the child's death despite existing guidelines. Research is therefore needed into the implementation of guidelines for routine contact into clinical practice following a child's death.

Klinische Padiatrie · 105 citationsread the source →

"This does my head in". Ethnographic study of self-management by people with diabetes.

Background: Self-management is rarely studied 'in the wild'. We sought to produce a richer understanding of how people live with diabetes and why self-management is challenging for some. Method: Ethnographic study supplemented with background documents on social context. We studied a socio-economically and ethnically diverse UK population. We sampled 30 people with diabetes (15 type 1, 15 type 2) by snowballing from patient groups, community contacts and NHS clinics. Participants (aged 5-88, from a range of ethnic and socio-economic groups) were shadowed at home and in the community for 2-4 periods of several hours (total 88 visits, 230 hours); interviewed (sometimes with a family member or carer) about their self-management efforts and support needs; and taken out for a meal. Detailed field notes were made and annotated. Data analysis was informed by structuration theory, which assumes that individuals' actions and choices depend on their dispositions and capabilities, which in turn are shaped and constrained (though not entirely determined) by wider social structures. Results: Self-management comprised both practical and cognitive tasks (e.g. self-monitoring, menu planning, medication adjustment) and socio-emotional ones (e.g. coping with illness, managing relatives' input, negotiating access to services or resources). Self-management was hard work, and was enabled or constrained by economic, material and socio-cultural conditions within the family, workplace and community. Some people managed their diabetes skilfully and flexibly, drawing on personal capabilities, family and social networks and the healthcare system. For others, capacity to self-manage (including overcoming economic and socio-cultural constraints) was limited by co-morbidity, cognitive ability, psychological factors (e.g. under-confidence, denial) and social capital. The consequences of self-management efforts strongly influenced people's capacity and motivation to continue them. Conclusion: Self-management of diabetes is physically, intellectually, emotionally and socially demanding. Non-engagement with self-management may make sense in the context of low personal resources (e.g. health literacy, resilience) and overwhelming personal, family and social circumstances. Success of self-management as a policy solution will be affected by interacting influences at three levels: [a] at micro level by individuals' dispositions and capabilities; [b] at meso level by roles, relationships and material conditions within the family and in the workplace, school and healthcare organisation; and [c] at macro level by prevailing economic conditions, cultural norms and expectations, and the underpinning logic of the healthcare system. We propose that the research agenda on living with diabetes be extended and the political economy of self-management systematically studied.

BMC health services research · 99 citationsread the source →