Non‐adherence to medication in patients with psychotic disorders: epidemiology,contributing factors and management strategies

Although non‐adherence is common across all branches of medicine, psychotic disorders pose additional challenges that increase its risk. Despite the importance of non‐adherence, clinicians generally spend too little time on assessing and addressing adherence attitudes and behaviors. Importantly, how adherence is measured significantly impacts the findings, and the most frequently employed methods of asking patients or judging adherence indirectly based on efficacy or tolerability information have poor validity. Novel technologies are being developed that directly assess adherence and that can also be used to both provide real‐time feedback to clinicians and serve as an intervention with patients. Several treatments are available that can positively impact adherence. Among psychosocial interventions, those combining multiple approaches and involving multiple domains seem to be most effective. Although long‐acting injectable antipsychotics are theoretically a very powerful tool to assure adherence and signal non‐adherence, recent results from randomized controlled trials failed to show superiority compared to oral antipsychotics. These data are in contrast to nationwide cohort studies and mirror‐image studies, which arguably include more representative patients receiving long‐acting antipsychotics in clinical practice. This disconnect suggests that traditional randomized controlled trials are not necessarily the best way to study interventions that are thought to work via reducing non‐adherence. Clearly, non‐adherence is likely to remain a major public health problem despite treatment advances. However, increasing knowledge about factors affecting adherence and leveraging novel technologies can enhance its early assessment and adequate management, particularly in patients with psychotic disorders.     

Preventing post-traumatic stress disorder after mass exposure to violence

Bioterrorism preparedness plans must take into account the psychosocial consequences of exposure to mass violence. If possible, post-traumatic stress disorder (PTSD), which is associated with significant morbidity and cost, should be prevented. There are, however, no effective interventions that have been scaled up to prevent PTSD following mass exposure to violence. In fact, randomized controlled trials of the most commonly used preventive intervention, psychological debriefing, suggest no efficacy, or even potential harm. Fortunately, randomized controlled trials of cognitive behavioral therapy--that is, targeting individuals who are symptomatic in the weeks after trauma--reveal significant efficacy. Given the potential for repeated mass violence exposure, public health professionals need to refine methods for screening and tracking large numbers of casualties. At the same time, the use of telephone and internet-based cognitive behavioral therapy protocols should be further tested as strategies for bringing the only effective early intervention for PTSD to scale. Research on preventive pharmacotherapy for PTSD and on the effects of media exposure on PTSD severity is also a priority.     

Intimate Partner Violence and Pregnancy: A Systematic Review of Interventions

Background

Intimate partner violence (IPV) around the time of pregnancy is a widespread global health problem with many negative consequences. Nevertheless, a lot remains unclear about which interventions are effective and might be adopted in the perinatal care context.

Objective

The objective is to provide a clear overview of the existing evidence on effectiveness of interventions for IPV around the time of pregnancy.

Methods

Following databases PubMed, Web of Science, CINAHL and the Cochrane Library were systematically searched and expanded by hand search. The search was limited to English peer-reviewed randomized controlled trials published from 2000 to 2013. This review includes all types of interventions aiming to reduce IPV around the time of pregnancy as a primary outcome, and as secondary outcomes to enhance physical and/or mental health, quality of life, safety behavior, help seeking behavior, and/or social support.

Results

We found few randomized controlled trials evaluating interventions for IPV around the time of pregnancy. Moreover, the nine studies identified did not produce strong evidence that certain interventions are effective. Nonetheless, home visitation programs and some multifaceted counseling interventions did produce promising results. Five studies reported a statistically significant decrease in physical, sexual and/or psychological partner violence (odds ratios from 0.47 to 0.92). Limited evidence was found for improved mental health, less postnatal depression, improved quality of life, fewer subsequent miscarriages, and less low birth weight/prematurity. None of the studies reported any evidence of a negative or harmful effect of the interventions.

Conclusions and implications

Strong evidence of effective interventions for IPV during the perinatal period is lacking, but some interventions show promising results. Additional large-scale, high-quality research is essential to provide further evidence about the effect of certain interventions and clarify which interventions should be adopted in the perinatal care context.     

Psychosocial and psychological interventions for prevention of postnatal depression: systematic review

Objective To assess the effects of psychosocial and psychological interventions compared with usual antepartum, intrapartum, or postpartum care on the risk of postnatal depression.Data sources Medline, Embase, CINAHL, Cochrane central register of controlled trials, Cochrane pregnancy and childbirth group trials register, Cochrane depression, anxiety, and neurosis trials register, secondary references and review articles, and experts in the field.Study selection All published and unpublished randomised controlled trials of preventive psychosocial or psychological interventions in which the primary or secondary aim was a reduction in the risk of postnatal depression. All trials recruited pregnant women or new mothers less than six weeks postpartum. Eligible studies were abstracted, assessed for methodological quality, and pooled with relative risk for categorical data and weighted mean difference for continuous data.Results Fifteen trials with 7697 women were included. Although there was no overall statistically significant effect on the prevention of postnatal depression in the meta-analysis of all types of interventions (15 trials, n = 7697; relative risk 0.81, 95% confidence interval 0.65 to 1.02), these results suggest a potential reduction in postnatal depression. The only intervention to have a clear preventive effect was intensive postpartum support provided by a health professional (0.68, 0.55 to 0.84). Identifying women “at risk” assisted in the prevention of postnatal depression (0.67, 0.51 to 0.89). Interventions with only a postnatal component were more beneficial (0.76, 0.58 to 0.98) than interventions that incorporated an antenatal component. In addition, individually based interventions were more effective (0.76, 0.59 to 1.00) than group based interventions (1.03, 0.65 to 1.63).Conclusions Diverse psychosocial or psychological interventions do not significantly reduce the number of women who develop postnatal depression. The most promising intervention is the provision of intensive, professionally based postpartum support.     

Effects of psychosocial support interventions on survival in inpatient and outpatient healthcare settings: A meta-analysis of 106 randomized controlled trials

BackgroundHospitals, clinics, and health organizations have provided psychosocial support interventions for medical patients to supplement curative care. Prior reviews of interventions augmenting psychosocial support in medical settings have reported mixed outcomes. This meta-analysis addresses the questions of how effective are psychosocial support interventions in improving patient survival and which potential moderating features are associated with greater effectiveness.Methods and findingsWe evaluated randomized controlled trials (RCTs) of psychosocial support interventions in inpatient and outpatient healthcare settings reporting survival data, including studies reporting disease-related or all-cause mortality. Literature searches included studies reported January 1980 through October 2020 accessed from Embase, Medline, Cochrane Library, CINAHL, Alt HealthWatch, PsycINFO, Social Work Abstracts, and Google Scholar databases. At least 2 reviewers screened studies, extracted data, and assessed study quality, with at least 2 independent reviewers also extracting data and assessing study quality. Odds ratio (OR) and hazard ratio (HR) data were analyzed separately using random effects weighted models. Of 42,054 studies searched, 106 RCTs including 40,280 patients met inclusion criteria. Patient average age was 57.2 years, with 52% females and 48% males; 42% had cardiovascular disease (CVD), 36% had cancer, and 22% had other conditions. Across 87 RCTs reporting data for discrete time periods, the average was OR = 1.20 (95% CI = 1.09 to 1.31, p < 0.001), indicating a 20% increased likelihood of survival among patients receiving psychosocial support compared to control groups receiving standard medical care. Among those studies, psychosocial interventions explicitly promoting health behaviors yielded improved likelihood of survival, whereas interventions without that primary focus did not. Across 22 RCTs reporting survival time, the average was HR = 1.29 (95% CI = 1.12 to 1.49, p < 0.001), indicating a 29% increased probability of survival over time among intervention recipients compared to controls. Among those studies, meta-regressions identified 3 moderating variables: control group type, patient disease severity, and risk of research bias. Studies in which control groups received health information/classes in addition to treatment as usual (TAU) averaged weaker effects than those in which control groups received only TAU. Studies with patients having relatively greater disease severity tended to yield smaller gains in survival time relative to control groups. In one of 3 analyses, studies with higher risk of research bias tended to report better outcomes. The main limitation of the data is that interventions very rarely blinded personnel and participants to study arm, such that expectations for improvement were not controlled.ConclusionsIn this meta-analysis, OR data indicated that psychosocial behavioral support interventions promoting patient motivation/coping to engage in health behaviors improved patient survival, but interventions focusing primarily on patients’ social or emotional outcomes did not prolong life. HR data indicated that psychosocial interventions, predominantly focused on social or emotional outcomes, improved survival but yielded similar effects to health information/classes and were less effective among patients with apparently greater disease severity. Risk of research bias remains a plausible threat to data interpretation.

In a meta-analysis, Timothy Smith and colleagues study trials of the effectiveness of psychosocial support interventions for improving inpatient and outpatient survival.     

Do Menstrual Hygiene Management Interventions Improve Education and Psychosocial Outcomes for Women and Girls in Low and Middle Income Countries? A Systematic Review

Background

Unhygienic and ineffective menstrual hygiene management has been documented across low resource contexts and linked to negative consequences for women and girls.

Objectives

To summarise and critically appraise evidence for the effectiveness of menstruation management interventions in improving women and girls’ education, work and psychosocial wellbeing in low and middle income countries.

Methods

Structured systematic searches were conducted in peer-reviewed and grey literature to identify studies evaluating education and resource provision interventions for menstruation management. Individual and cluster randomised controlled trials were eligible for inclusion, as were non-randomised controlled trials. Study characteristics, outcomes and risk of bias were extracted using a piloted form. Risk of bias was independently assessed by two researchers.

Results

Eight studies described in ten citations were eligible for inclusion. Studies were highly heterogeneous in design and context. Six included assessment of education-only interventions, and three provided assessment of the provision of different types of sanitary products (menstrual cups, disposable sanitary pads, and reusable sanitary pads). A moderate but non-significant standardised mean difference was found for the two studies assessing the impact of sanitary pad provision on school attendance: 0.49 (95%CI -0.13, 1.11). Included studies were heterogeneous with considerable risk of bias. Trials of education interventions reported positive impacts on menstrual knowledge and practices, however, many studies failed to assess other relevant outcomes. No trials assessed or reported harms.

Conclusions

There is insufficient evidence to establish the effectiveness of menstruation management interventions, although current results are promising. Eight trials have been conducted, but a high risk of bias was found and clinical heterogeneity precluded synthesis of most results. Whilst trials provided some indication of positive results, further research is needed to establish the role of menstruation hygiene management in education performance, employment and other psychosocial outcomes. This review provides a concise summary of present trials and highlights improvements for future work.     

Accumulating Research: A Systematic Account of How Cumulative Meta-Analyses Would Have Provided Knowledge,Improved Health,Reduced Harm and Saved Resources

Background

“Cumulative meta-analysis” describes a statistical procedure to calculate, retrospectively, summary estimates from the results of similar trials every time the results of a further trial in the series had become available. In the early 1990s, comparisons of cumulative meta-analyses of treatments for myocardial infarction with advice promulgated through medical textbooks showed that research had continued long after robust estimates of treatment effects had accumulated, and that medical textbooks had overlooked strong, existing evidence from trials. Cumulative meta-analyses have subsequently been used to assess what could have been known had new studies been informed by systematic reviews of relevant existing evidence and how waste might have been reduced.

Methods and Findings

We used a systematic approach to identify and summarise the findings of cumulative meta-analyses of studies of the effects of clinical interventions, published from 1992 to 2012. Searches were done of PubMed, MEDLINE, EMBASE, the Cochrane Methodology Register and Science Citation Index. A total of 50 eligible reports were identified, including more than 1,500 cumulative meta-analyses. A variety of themes are illustrated with specific examples. The studies showed that initially positive results became null or negative in meta-analyses as more trials were done; that early null or negative results were over-turned; that stable results (beneficial, harmful and neutral) would have been seen had a meta-analysis been done before the new trial; and that additional trials had been much too small to resolve the remaining uncertainties.

Conclusions

This large, unique collection of cumulative meta-analyses highlights how a review of the existing evidence might have helped researchers, practitioners, patients and funders make more informed decisions and choices about new trials over decades of research. This would have led to earlier uptake of effective interventions in practice, less exposure of trial participants to less effective treatments, and reduced waste resulting from unjustified research.     

Intimate-Partner and Client-Initiated Violence among Female Street-Based Sex Workers in China: Does a Support Network Help?

Background

Globally, female street-based sex workers are vulnerable to gender-based violence. Previous research has shown having a peer social network can reduce sex workers’ risks of victimization. However, mechanisms of how social network impacts violence among female street-based sex workers are still far from clear.

Methods

Our study was based on data abstracted from a paper-and-pencil survey administered among 218 female street-based sex workers in Shanghai, China. We focused on self-reported client-initiated violence and intimate-partner violence in emotional, physical, and sexual forms. Social networks were characterized by the size and sources of financial and psychosocial support (e.g. family, friends, and peers). Multi-variable logistic regression was used to estimate adjusted odds ratios (AOR) of each type of violence exposure by social network structure after the adjustment of age, education, and years in Shanghai.

Results

The street-based female sex workers in our study were primarily rural-to-urban migrants (95.7%) with an average age of 41 years old. 24.3% and 62.8% of the sex workers reported intimate-partner violence and client-initiated violence respectively. Lack of financial support, as defined by having only one individual or none in her peer support system to help financially, was significantly associated with self-reported intimate-partner violence (AOR: 2.5; 95% CI: 1.1–5.9). Respondents who reported client-initiated violence, by contrast, were more likely to report lacked psychosocial support from family (AOR: 2.2, 95% CI: 1.0–4.6) and peers (AOR: 5.1, 95% CI: 2.2–11).

Conclusion

This study is one of the first to systematically analyze the associations between social network and gender-based violence among street-based female sex worker. We reported a high prevalence of both types of gender-based violence and their complex associations with family, friends, and peer support network. Policies with goals to reduce violence against women may apply these findings to leverage social network in the interventions against gender-based violence.     

Psychosocial assessment for victims of violence in Peru: the importance of local participation

This paper describes a pilot study assessing the psychosocial impact of political violence in the Peruvian Andes, utilizing a collaborative approach with local professionals and communities. The study team prioritized dialogue and information exchange with the local professional community and villagers participating in the assessment in order to raise awareness of psychosocial issues and provide education and support. Participation in the pilot study had positive therapeutic effects for villagers, and inspired ongoing discussion groups to address psychosocial problems in communities. This paper also describes a psychosocial assessment strategy utilizing qualitative methods and an adaptation of the Harvard Trauma Questionnaire in collaboration with Andean villagers. Usefulness and limitations of the data will be reviewed, in terms of cultural and context relevance, usefulness for informing interventions, and comparisons with ethnographic methodologies and other survey instruments.     

Conflicting Notions on Violence and PTSD in the Military: Institutional and Personal Narratives of Combat-Related Illness

Research indicates that soldiers struggling with PTSD under-utilize mental health care. Quantitative studies of barriers to care point to the importance of soldiers’ beliefs about mental health and mental health interventions in their care-seeking behavior, yet these studies still struggle to understand the particular beliefs involved and the ways they impact care-seeking behavior. This preliminary study makes a start in examining these questions through qualitative literature analysis. It maps out dominant messages surrounding PTSD in military mental health interventions, and explores how they can both shape and conflict with soldiers’ personal notions. It does so by analyzing these messages and notions as institutional and personal (illness) narratives. Institutional military PTSD-narratives, which draw on mainstream scientific and clinical models, appear to communicate contradictory notions on the meanings of violence and its psychological consequences, often without acknowledging these contradictions. As such, these narratives seem to shape struggles of soldiers, both within themselves and with the military institution. The identified conflicts indicate, contrary to the individualizing and decontextualizing focus of dominant PTSD-understandings, that soldiers’ struggles also have social and moral dimensions. This has important implications for both research into PTSD-interventions and understandings of PTSD as such.     

Effectiveness of programs for reducing the stigma associated with mental disorders. A meta‐analysis of randomized controlled trials

The stigma associated with mental disorders is a global public health problem. Programs to combat it must be informed by the best available evidence. To this end, a meta‐analysis was undertaken to investigate the effectiveness of existing programs. A systematic search of PubMed, PsycINFO and Cochrane databases yielded 34 relevant papers, comprising 33 randomized controlled trials. Twenty‐seven papers (26 trials) contained data that could be incorporated into a quantitative analysis. Of these trials, 19 targeted personal stigma or social distance (6,318 participants), six addressed perceived stigma (3,042 participants) and three self‐stigma (238 participants). Interventions targeting personal stigma or social distance yielded small but significant reductions in stigma across all mental disorders combined (d=0.28, 95% CI: 0.17‐0.39, p<0.001) as well as for depression (d=0.36, 95% CI: 0.10‐0.60, p<0.01), psychosis (d=0.20, 95% CI: 0.06‐0.34, p<0.01) and generic mental illness (d=0.30, 95% CI: 0.10‐0.50, p<0.01). Educational interventions were effective in reducing personal stigma (d=0.33, 95% CI: 0.19‐0.42, p<0.001) as were interventions incorporating consumer contact (d=0.47, 95% CI: 0.17‐0.78, p<0.001), although there were insufficient studies to demonstrate an effect for consumer contact alone. Internet programs were at least as effective in reducing personal stigma as face‐to‐face delivery. There was no evidence that stigma interventions were effective in reducing perceived or self‐stigma. In conclusion, there is an evidence base to inform the roll out of programs for improving personal stigma among members of the community. However, there is a need to investigate methods for improving the effectiveness of these programs and to develop interventions that are effective in reducing perceived and internalized stigma.     

Trialling of an optimal health programme (OHP) across chronic disease

Population ageing is a worldwide phenomenon, most advanced in developed countries and expected to continue over the next few decades. As people are surviving longer with age-associated disease and disability, there is an imperative to identify innovative solutions for an already overburdened health care system. Such innovations need to be focused on disease management, taking into consideration the strong associations that have been established between psychosocial factors and pathophysiological mechanisms associated with chronic disease. Aside from personal and community costs, chronic diseases produce a significant economic burden due to the culmination of health care costs and lost productivity. This commentary reports on a programme of research, Translating Research, Integrated Public Health Outcomes and Delivery, which will evaluate an optimal health programme that adopts a person-centred approach and engages collaborative therapy to educate, support and improve the psychosocial health of those with chronic disease. The effectiveness of the optimal health programme will be evaluated across three of the most significant contributors to disease burden: diabetes mellitus, chronic kidney disease and stroke. Cost-effectiveness will also be evaluated. The findings derived from this series of randomised controlled trials will also provide evidence attesting to the potential applicability of the optimal health programme in other chronic conditions.     

Psychosocial Interventions for Perinatal Common Mental Disorders Delivered by Providers Who Are Not Mental Health Specialists in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis

Background

Perinatal common mental disorders (PCMDs) are a major cause of disability among women. Psychosocial interventions are one approach to reduce the burden of PCMDs. Working with care providers who are not mental health specialists, in the community or in antenatal health care facilities, can expand access to these interventions in low-resource settings. We assessed effects of such interventions compared to usual perinatal care, as well as effects of interventions based on intervention type, delivery method, and timing.

Methods and Findings

We conducted a systematic review, meta-analysis, and meta-regression. We searched databases including Embase and the Global Health Library (up to 7 July 2013) for randomized and non-randomized trials of psychosocial interventions delivered by non-specialist mental health care providers in community settings and antenatal health care facilities in low- and middle-income countries. We pooled outcomes from ten trials for 18,738 participants. Interventions led to an overall reduction in PCMDs compared to usual care when using continuous data for PCMD symptomatology (effect size [ES] −0.34; 95% CI −0.53, −0.16) and binary categorizations for presence or absence of PCMDs (odds ratio 0.59; 95% CI 0.26, 0.92). We found a significantly larger ES for psychological interventions (three studies; ES −0.46; 95% CI −0.58, −0.33) than for health promotion interventions (seven studies; ES −0.15; 95% CI −0.27, −0.02). Both individual (five studies; ES −0.18; 95% CI −0.34, −0.01) and group (three studies; ES −0.48; 95% CI −0.85, −0.11) interventions were effective compared to usual care, though delivery method was not associated with ES (meta-regression β coefficient −0.11; 95% CI −0.36, 0.14). Combined group and individual interventions (based on two studies) had no benefit compared to usual care, nor did interventions restricted to pregnancy (three studies). Intervention timing was not associated with ES (β 0.16; 95% CI −0.16, 0.49). The small number of trials and heterogeneity of interventions limit our findings.

Conclusions

Psychosocial interventions delivered by non-specialists are beneficial for PCMDs, especially psychological interventions. Research is needed on interventions in low-income countries, treatment versus preventive approaches, and cost-effectiveness. Please see later in the article for the Editors'' Summary     

Atherosclerosis imaging as a benchmark in the development of novel cardiovasular drugs

PURPOSE OF REVIEW: Imaging of the arterial wall yields validated surrogate markers that can provide an early indication with regards to efficacy of novel cardiovascular drugs. This paper attempts to address the use of atherosclerosis imaging as a benchmarking tool for a well informed decision whether to proceed to large morbidity and mortality studies in the assessment of a novel therapeutic strategy. RECENT FINDINGS: Imaging of the artery wall can be used to evaluate individual cardiovascular risk and has additive value over conventional risk scores as it directly addresses the disease process. In controlled clinical trials, vascular imaging has shown that the efficacy of lipid-modifying pharmacotherapy can be evaluated in both high and low-risk populations and that the findings parallel outcomes of clinical studies with similar interventions. SUMMARY: Arterial imaging may provide the first glimpse of the efficacy or failure of a novel strategy to combat atherosclerosis. These findings suggest that vascular imaging could be employed to probe whether or not a large morbidity and mortality endpoint study should be the next step in a clinical development program.     

Non-Specialist Psychosocial Interventions for Children and Adolescents with Intellectual Disability or Lower-Functioning Autism Spectrum Disorders: A Systematic Review

Background

The development of effective treatments for use by non-specialists is listed among the top research priorities for improving the lives of people with mental illness worldwide. The purpose of this review is to appraise which interventions for children with intellectual disabilities or lower-functioning autism spectrum disorders delivered by non-specialist care providers in community settings produce benefits when compared to either a no-treatment control group or treatment-as-usual comparator.

Methods and Findings

We systematically searched electronic databases through 24 June 2013 to locate prospective controlled studies of psychosocial interventions delivered by non-specialist providers to children with intellectual disabilities or lower-functioning autism spectrum disorders. We screened 234 full papers, of which 34 articles describing 29 studies involving 1,305 participants were included. A majority of the studies included children exclusively with a diagnosis of lower-functioning autism spectrum disorders (15 of 29, 52%). Fifteen of twenty-nine studies (52%) were randomized controlled trials and just under half of all effect sizes (29 of 59, 49%) were greater than 0.50, of which 18 (62%) were statistically significant. For behavior analytic interventions, the best outcomes were shown for development and daily skills; cognitive rehabilitation, training, and support interventions were found to be most effective for improving developmental outcomes, and parent training interventions to be most effective for improving developmental, behavioral, and family outcomes. We also conducted additional subgroup analyses using harvest plots. Limitations include the studies'' potential for performance bias and that few were conducted in lower- and middle-income countries.

Conclusions

The findings of this review support the delivery of psychosocial interventions by non-specialist providers to children who have intellectual disabilities or lower-functioning autism spectrum disorders. Given the scarcity of specialists in many low-resource settings, including many lower- and middle-income countries, these findings may provide guidance for scale-up efforts for improving outcomes for children with developmental disorders or lower-functioning autism spectrum disorders.

Protocol Registration

PROSPERO CRD42012002641 Please see later in the article for the Editors'' Summary     

The unpredictability paradox: review of empirical comparisons of randomised and non-randomised clinical trials

Objective To summarise comparisons of randomised clinical trials and non-randomised clinical trials, trials with adequately concealed random allocation versus inadequately concealed random allocation, and high quality trials versus low quality trials where the effect of randomisation could not be separated from the effects of other methodological manoeuvres.Design Systematic review.Selection criteria Cohorts or meta-analyses of clinical trials that included an empirical assessment of the relation between randomisation and estimates of effect.Data sources Cochrane Review Methodology Database, Medline, SciSearch, bibliographies, hand searching of journals, personal communication with methodologists, and the reference lists of relevant articles.Main outcome measures Relation between randomisation and estimates of effect.Results Eleven studies that compared randomised controlled trials with non-randomised controlled trials (eight for evaluations of the same intervention and three across different interventions), two studies that compared trials with adequately concealed random allocation and inadequately concealed random allocation, and five studies that assessed the relation between quality scores and estimates of treatment effects, were identified. Failure to use random allocation and concealment of allocation were associated with relative increases in estimates of effects of 150% or more, relative decreases of up to 90%, inversion of the estimated effect and, in some cases, no difference. On average, failure to use randomisation or adequate concealment of allocation resulted in larger estimates of effect due to a poorer prognosis in non-randomly selected control groups compared with randomly selected control groups.Conclusions Failure to use adequately concealed random allocation can distort the apparent effects of care in either direction, causing the effects to seem either larger or smaller than they really are. The size of these distortions can be as large as or larger than the size of the effects that are to be detected.

Key messages

• Empirical studies support using random allocation in clinical trials and ensuring that the allocation process is concealed—that is, that assignment is impervious to any influence by the people making the allocation
• The effect of not using concealed random allocation can be as large or larger than the effects of worthwhile interventions
• On average, failure to use concealed random allocation results in overestimates of effect due to a poorer prognosis in non-randomly selected control groups compared with randomly selected control groups, but it can result in underestimates of effect, reverse the direction of effect, mask an effect, or give similar estimates of effect
• The adequacy of allocation concealment may be a more sensitive measure of bias in clinical trials than scales used to assess the quality of clinical trials
• It is a paradox that the unpredictability of randomisation is the best protection against the unpredictability of the extent and direction of bias in clinical trials that are not properly randomised

     

A systematic review of treatment of settling problems and night waking in young children

OBJECTIVE: To assess the efficacy of treatment of settling problems and night waking in young children. DESIGN: A systematic review of randomized controlled trials of interventions. SETTING: Electronic bibliographic databases and references on identified papers, hand searches, and personal contact with specialists. SUBJECTS: Children aged 5 years or younger who had established settling problems or night waking. INTERVENTIONS: Interventions had to be described and a placebo, waiting list, or another intervention needed to have been used as a comparison. Interventions comprised drug trials or nondrug trials. Main outcome measures Number of wakes at night, time to settle, or number of nights in which these problems occurred. RESULTS: Drugs seemed to be effective in treating night waking in the short term, but long-term efficacy was questionable. In contrast, specific behavioral interventions showed both short-term efficacy and possible longer term effects for dealing with settling problems and night walking. CONCLUSIONS: Given the prevalence and persistence of childhood sleep problems and the effects they can have no children and families, treatments that offer long-lasting benefits are more appealing, and these are likely to be behavioral interventions.     

Validating English- and Spanish-language patient-reported outcome measures in underserved patients with rheumatic disease

Introduction  

Rheumatic diseases are among the most common and debilitating health problems in the United States. These diseases are chronic, can result in severe decrements of physical and psychosocial functioning and affect patients' overall quality of life. A consensus regarding the best patient outcomes to be measured in randomized, controlled trials and prospective natural history studies is essential to provide best estimates of efficacy and safety of interventions across diverse patient populations.     

Partner Violence and Psychosocial Distress among Female Sex Workers in China

Background

Despite recognized vulnerability of female sex workers (FSW), most data on this population are focused on their HIV and STI prevalence; studies on their experience of partner violence and psychosocial distress are limited, especially FSW in China.

Methods and Findings

A cross-sectional survey was administered among 1,022 FSW recruited from 9 different types of commercial sex venues in Southwest China. Partner violence scales were adapted from WHO''s Women''s Health and Domestic Violence scale and psychosocial distress was measured by five indicators, including alcohol intoxication, drug use, suicidal behavior, depression, and loneliness. Random effects modeling was used to control for cluster effects. Findings: About 58% of FSW ever experienced violence from their stable partners, and 45% suffered it from their clients. Partner violence was strongly associated with each of the five measures of psychosocial distress, even after controlling for potential confounders.

Conclusion

This study is one of the first to examine the association between partner violence and psychosocial distress among FSW in China. The high prevalence of violence experience and distress in this population suggests urgency for intervention. The public health programs targeting FSW should go beyond the focus on HIV/STI prevention and care for the fundamental health and human rights of millions of FSW in China.     

Psychosocial Health Problems Associated with Increased HIV Risk Behavior among Men Who Have Sex with Men in Nepal: A Cross-Sectional Survey

Background

Men who have sex with men (MSM) are marginalized, hidden, underserved and at high risk for HIV in Nepal. We examined the association between MSM sub-populations, psychosocial health problems and support, access to prevention and non-use of condoms.

Methods

Between September-November of 2010, a cross-sectional survey on HIV-related risk behavior was performed across Nepal through snowball sampling facilitated by non-governmental organizations, recruiting 339 MSM, age 15 or older. The primary outcomes were: (a) non-use of condoms at least once in last three anal sex encounters with men and (b) non-use of condoms with women in the last encounter. The secondary outcome was participation in HIV prevention interventions in the past year.

Results

Among the 339 MSM interviewed, 78% did not use condoms at their last anal sex with another man, 35% did not use condoms in their last sex with a woman, 70% had experienced violence in the last 12 months, 61% were experiencing depression and 47% had thought of committing suicide. After adjustment for age, religion, marital status, and MSM subpopulations (bisexual, ta, meti, gay), non-use of condoms at last anal sex with a man was significantly associated with non-participation in HIV interventions, experience of physical and sexual violence, depression, repeated suicidal thoughts, small social support network and being dissatisfied with social support. Depression was marginally associated with non-use of condoms with women. The findings suggest that among MSM who reported non-use of condoms at last anal sex, the ta subgroup and those lacking family acceptance were the least likely to have participated in any preventive interventions.

Conclusions

MSM in Nepal have a prevalence of psychosocial health problems in turn associated with high risk behavior for HIV. Future HIV prevention efforts targeting MSM in Nepal should cover all MSM subpopulations and prioritize psychosocial health interventions.