Trial Registration: Understanding and Preventing Reporting Bias in Social Work Research

Randomized controlled trials are considered the gold standard for evaluating social work interventions. However, published reports can systematically overestimate intervention effects when researchers selectively report large and significant findings. Publication bias and other types of reporting biases can be minimized through prospective trial registration that is now an accepted part of medical research. In this article, we explain how trial registration can promote ethical and valid trials in social work, and we explain how social work researchers can register trials. We conclude that journal editors should ask authors to report trial registration numbers in all reports of randomized trials in social work

Are manufacturers sharing data as promised?

Over the past two years drug and device manufacturers have been among the most vocal contributors to the discussion about transparency of clinical trial data. In 2013 GlaxoSmithKline (GSK) established its Clinical Study Data Request system to share participant level data, and now 11 other companies are listed as contributors to it (www.clinicalstudydatarequest.com). Other companies have developed similar systems of their own,but it is difficult to evaluate how they are working or even to decide on what basis they should be judged

Interventions to improve the experience of caring for people with severe mental illness: systematic review and meta-analysis

Background Informal caregiving is an integral part of the care of people with severe mental illness, but the support needs of those providing such care are not often met. Aims To determine whether interventions provided to people caring for those with severe mental illness improve the experience of caring and reduce caregiver burden. Method We conducted a systematic review and meta-analyses of randomised controlled trials (RCTs) of interventions delivered by health and social care services to informal carers (i.e. family or friends who provide support to someone with severe mental illness). Results Twenty-one RCTs with 1589 carers were included in the review. There was evidence suggesting that the carers’ experience of care was improved at the end of the intervention by psychoeducation (standardised mean difference –1.03, 95% CI –1.69 to –0.36) and support groups (SMD = –1.16, 95% CI –1.96 to –0.36). Psychoeducation had a benefit on psychological distress more than 6 months later (SMD = –1.79, 95% CI –3.01 to –0.56) but not immediately post-intervention. Support interventions had a beneficial effect on psychological distress at the end of the intervention (SMD = –0.99, 95% CI –1.48 to –0.49) as did problem-solving bibliotherapy (SMD = –1.57, 95% CI –1.79 to –1.35); these effects were maintained at follow-up. The quality of the evidence was mainly low and very low. Evidence for combining these interventions and for self-help and self-management was inconclusive. Conclusions Carer-focused interventions appear to improve the experience of caring and quality of life and reduce psychological distress of those caring for people with severe mental illness, and these benefits may be gained in first-episode psychosis. Interventions for carers should be considered as part of integrated services for people with severe mental health problems

The Cost Effectiveness of Psychological and Pharmacological Interventions for Social Anxiety Disorder:A Model-Based Economic Analysis

Background Social anxiety disorder is one of the most persistent and common anxiety disorders. Individually delivered psychological therapies are the most effective treatment options for adults with social anxiety disorder, but they are associated with high intervention costs. Therefore, the objective of this study was to assess the relative cost effectiveness of a variety of psychological and pharmacological interventions for adults with social anxiety disorder. Methods A decision-analytic model was constructed to compare costs and quality adjusted life years (QALYs) of 28 interventions for social anxiety disorder from the perspective of the British National Health Service and personal social services. Efficacy data were derived from a systematic review and network meta-analysis. Other model input parameters were based on published literature and national sources, supplemented by expert opinion. Results Individual cognitive therapy was the most cost-effective intervention for adults with social anxiety disorder, followed by generic individual cognitive behavioural therapy (CBT), phenelzine and book-based self-help without support. Other drugs, group-based psychological interventions and other individually delivered psychological interventions were less cost-effective. Results were influenced by limited evidence suggesting superiority of psychological interventions over drugs in retaining long-term effects. The analysis did not take into account side effects of drugs. Conclusion Various forms of individually delivered CBT appear to be the most cost-effective options for the treatment of adults with social anxiety disorder. Consideration of side effects of drugs would only strengthen this conclusion, as it would improve even further the cost effectiveness of individually delivered CBT relative to phenelzine, which was the next most cost-effective option, due to the serious side effects associated with phenelzine. Further research needs to determine more accurately the long-term comparative benefits and harms of psychological and pharmacological interventions for social anxiety disorder and establish their relative cost effectiveness with greater certainty

Psychological and pharmacological interventions for social anxiety disorder in adults: a systematic review and network meta-analysis

SummaryBackgroundSocial anxiety disorder—a chronic and naturally unremitting disease that causes substantial impairment—can be treated with pharmacological, psychological, and self-help interventions. We aimed to compare these interventions and to identify which are most effective for the acute treatment of social anxiety disorder in adults.MethodsWe did a systematic review and network meta-analysis of interventions for adults with social anxiety disorder, identified from published and unpublished sources between 1988 and Sept 13, 2013. We analysed interventions by class and individually. Outcomes were validated measures of social anxiety, reported as standardised mean differences (SMDs) compared with a waitlist reference. This study is registered with PROSPERO, number CRD42012003146.FindingsWe included 101 trials (13 164 participants) of 41 interventions or control conditions (17 classes) in the analyses. Classes of pharmacological interventions that had greater effects on outcomes compared with waitlist were monoamine oxidase inhibitors (SMD −1·01, 95% credible interval [CrI] −1·56 to −0·45), benzodiazepines (−0·96, −1·56 to −0·36), selective serotonin-reuptake inhibitors and serotonin–norepinephrine reuptake inhibitors (SSRIs and SNRIs; −0·91, −1·23 to −0·60), and anticonvulsants (−0·81, −1·36 to −0·28). Compared with waitlist, efficacious classes of psychological interventions were individual cognitive–behavioural therapy (CBT; SMD −1·19, 95% CrI −1·56 to −0·81), group CBT (−0·92, −1·33 to −0·51), exposure and social skills (−0·86, −1·42 to −0·29), self-help with support (−0·86, −1·36 to −0·36), self-help without support (−0·75, −1·25 to −0·26), and psychodynamic psychotherapy (−0·62, −0·93 to −0·31). Individual CBT compared with psychological placebo (SMD −0·56, 95% CrI −1·00 to −0·11), and SSRIs and SNRIs compared with pill placebo (−0·44, −0·67 to −0·22) were the only classes of interventions that had greater effects on outcomes than appropriate placebo. Individual CBT also had a greater effect than psychodynamic psychotherapy (SMD −0·56, 95% CrI −1·03 to −0·11) and interpersonal psychotherapy, mindfulness, and supportive therapy (−0·82, −1·41 to −0·24).InterpretationIndividual CBT (which other studies have shown to have a lower risk of side-effects than pharmacotherapy) is associated with large effect sizes. Thus, it should be regarded as the best intervention for the initial treatment of social anxiety disorder. For individuals who decline psychological intervention, SSRIs show the most consistent evidence of benefit.FundingNational Institute for Health and Care Excellence

Reporting quality of social and psychological intervention trials: a systematic review of reporting guidelines and trial publications

Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. OBJECTIVEDESIGN: We conducted a two-part study that reviewed (1) reporting guidelines for and (2) the reporting quality of social and psychological intervention trials

Caveat emptor: The combined effects of multiplicity and selective reporting

Clinical trials and systematic reviews of clinical trials inform healthcare decisions. There is growing concern, however, about results from clinical trials that cannot be reproduced. Reasons for nonreproducibility include that outcomes are defined in multiple ways, results can be obtained using multiple methods of analysis, and trial findings are reported in multiple sources ("multiplicity"). Multiplicity combined with selective reporting can influence dissemination of trial findings and decision-making. In particular, users of evidence might be misled by exposure to selected sources and overly optimistic representations of intervention effects. In this commentary, drawing from our experience in the Multiple Data Sources in Systematic Reviews (MUDS) study and evidence from previous research, we offer practical recommendations to enhance the reproducibility of clinical trials and systematic reviews

The Oxford Implementation Index: A new tool for incorporating implementation data into systematic reviews and meta-analyses

Objectives: This article presents a new tool that helps systematic reviewers to extract and compare implementation data across primary trials. Currently, systematic review guidance does not provide guidelines for the identification and extraction of data related to the implementation of the underlying interventions. Study Design and Setting: A team of systematic reviewers used a multistaged consensus development approach to develop this tool. First, a systematic literature search on the implementation and synthesis of clinical trial evidence was performed. The team then met in a series of subcommittees to develop an initial draft index. Drafts were presented at several research conferences and circulated to methodological experts in various health-related disciplines for feedback. The team systematically recorded, discussed, and incorporated all feedback into further revisions. A penultimate draft was discussed at the 2010 Cochrane-Campbell Collaboration Colloquium to finalize its content. Results: The Oxford Implementation Index provides a checklist of implementation data to extract from primary trials. Checklist items are organized into four domains: intervention design, actual delivery by trial practitioners, uptake of the intervention by participants, and contextual factors. Systematic reviewers piloting the index at the Cochrane-Campbell Colloquium reported that the index was helpful for the identification of implementation data. Conclusion: The Oxford Implementation Index provides a framework to help reviewers assess implementation data across trials. Reviewers can use this tool to identify implementation data, extract relevant information, and compare features of implementation across primary trials in a systematic review. The index is a work-in-progress, and future efforts will focus on refining the index, improving usability, and integrating the index with other guidance on systematic reviewing

Harms in Systematic Reviews Paper 2: Methods used to assess harms are neglected in systematic reviews of gabapentin

Objective: We compared methods used with current recommendations for synthesizing harms in systematic reviews and meta-analyses (SRMAs) of gabapentin. Study Design & Setting: We followed recommended systematic review practices. We selected reliable SRMAs of gabapentin (i.e., met a pre-defined list of methodological criteria) that assessed at least one harm. We extracted and compared methods in four areas: pre-specification, searching, analysis, and reporting. Whereas our focus in this paper is on the methods used, Part 2 examines the results for harms across reviews. Results: We screened 4320 records and identified 157 SRMAs of gabapentin, 70 of which were reliable. Most reliable reviews (51/70; 73%) reported following a general guideline for SRMA conduct or reporting, but none reported following recommendations specifically for synthesizing harms. Across all domains assessed, review methods were designed to address questions of benefit and rarely included the additional methods that are recommended for evaluating harms. Conclusion: Approaches to assessing harms in SRMAs we examined are tokenistic and unlikely to produce valid summaries of harms to guide decisions. A paradigm shift is needed. At a minimal, reviewers should describe any limitations to their assessment of harms and provide clearer descriptions of methods for synthesizing harms

Harms in Systematic Reviews Paper 3: Given the same data sources, systematic reviews of gabapentin have different results for harms

Objective: In this methodologic study (Part 2 of 2), we examined the overlap in sources of evidence and the corresponding results for harms in systematic reviews for gabapentin. Study Design & Setting: We extracted all citations referenced as sources of evidence for harms of gabapentin from 70 systematic reviews, as well as the harms assessed and numerical results. We assessed consistency of harms between pairs of reviews with a high degree of overlap in sources of evidence (>50%) as determined by corrected covered area (CCA). Results: We found 514 reports cited across 70 included reviews. Most reports (244/514, 48%) were not cited in more than one review. Among 18 pairs of reviews, we found reviews had differences in which harms were assessed and their choice to meta-analyze estimates or present descriptive summaries. When a specific harm was meta-analyzed in a pair of reviews, we found similar effect estimates. Conclusion: Differences in harms results across reviews can occur because the choice of harms is driven by reviewer preferences, rather than standardized approaches to selecting harms for assessment. A paradigm shift is needed in the current approach to synthesizing harms