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The impact of sexual violence on women's university education is a major concern on university campuses. This pilot study examined educational outcomes among 27 female undergraduate studen...

OBJECTIVE To assess the frequency and features of secondary publications of randomized controlled trials (RCTs). STUDY DESIGN AND SETTING For 191 RCTs published in high-impact journals in 2009, we searched for secondary publications coauthored by at least one same author of the primary trial publication. We evaluated the probability of having secondary publications, characteristics of the primary trial publication that predict having secondary publications, types of secondary analyses conducted, and statistical significance of those analyses. RESULTS Of 191 primary trials, 88 (46%) had a total of 475 secondary publications by 2/2014. Eight trials had >10 (up to 51) secondary publications each. In multivariable modeling, the risk of having subsequent secondary publications increased 1.32-fold (95% CI 1.05-1.68) per 10-fold increase in sample size, and 1.71-fold (95% CI 1.19-2.45) in the presence of a design article. In a sample of 197 secondary publications examined in depth, 193 tested different hypotheses than the primary publication. Of the 193, 43 tested differences between subgroups, 85 assessed predictive factors associated with an outcome of interest, 118 evaluated different outcomes than the original article, 71 had differences in eligibility criteria, and 21 assessed different durations of follow-up; 176 (91%) presented at least one analysis with statistically significant results. CONCLUSIONS Approximately half of randomized trials in high-impact journals have secondary publications published with a few trials followed by numerous secondary publications. Almost all of these publications report some statistically significant results.

Objectives To identify the impact of industry involvement in the publication and interpretation of meta-analyses of antidepressant trials in depression. Study Design and Setting Using MEDLINE, we identified all meta-analyses evaluating antidepressants for depression published in January 2007–March 2014. We extracted data pertaining to author affiliations, conflicts of interest, and whether the conclusion of the abstract included negative statements on whether the antidepressant(s) were effective or safe. Results We identified 185 eligible meta-analyses. Fifty-four meta-analyses (29%) had authors who were employees of the assessed drug manufacturer, and 147 (79%) had some industry link (sponsorship or authors who were industry employees and/or had conflicts of interest). Only 58 meta-analyses (31%) had negative statements in the concluding statement of the abstract. Meta-analyses including an author who were employees of the manufacturer of the assessed drug were 22-fold less likely to have negative statements about the drug than other meta-analyses [1/54 (2%) vs. 57/131 (44%); P Conclusion There is a massive production of meta-analyses of antidepressants for depression authored by or linked to the industry, and they almost never report any caveats about antidepressants in their abstracts. Our findings add a note of caution for meta-analyses with ties to the manufacturers of the assessed products.

BACKGROUND: Traumatic events often occur in workplace settings and can lead to stress reactions such as Post-Traumatic Stress Disorder (PTSD). One such workplace is the transportation industry, where employees are often exposed to trauma. However, extant research shows that a considerable proportion of people with PTSD do not seek specialty mental health treatment. OBJECTIVE: In this qualitative study, we sought to better understand the experience of a traumatic event at work and the barriers and motivating factors for seeking mental health treatment. PARTICIPANTS: Twenty-nine Toronto Transit Commission (TTC) employees participated in a one-on-one interview, 18 soon after the traumatic event and 11 after entering a specialized treatment program. METHODS: Semi-structured, one-on-one interviews were conducting using qualitative description and analyzed using content analysis. RESULTS: Participants described emotional responses after the trauma such as guilt, anger, disbelief as particularly difficult, and explained that barriers to seeking help included the overwhelming amount and timing of paperwork related to the incident as well as negative interactions with management. Motivating factors included family and peer support, as well as financial and emotional issues which persuaded some to seek help. CONCLUSIONS: Seeking treatment is a multifactorial process. Implications and recommendations for the organization are discussed. Language: en

Introduction Measures that help detect exaggeration of symptoms can be valuable for informing more accurate diagnoses and aid in treatment and case management. We completed a systematic review to identify measures that assess symptom exaggeration in mental health disorders. Methods Eligible studies assessed exaggeration of symptoms with a psychometrically validated measure in patients presenting with a mental health disorder. We searched MEDLINE and PsycINFO from inception to June 2013 for relevant studies. To determine study eligibility, reviewers screened title and abstracts of identified citations, and reviewed full texts of all potentially eligible citations. Data extractors completed data abstraction of eligible studies. Results Of 8435 unique citations, 105 studies consisting of 112 cohorts were eligible, and we identified 36 unique, validated measures assessing exaggeration of symptoms. The most frequently used measures were symptom validity indicators embedded in the Minnesota Multiphasic Personality Inventory (MMPI-2) (n=48, 46%), the Structured Interview of Reported Symptoms (SIRS) (n=12, 11%), and the Personality Assessment Inventory (PAI) (n=11, 10%). Most studies (n=96; 91%) failed to test reliability of their measure of symptom exaggeration. The symptom validity indicators in the MMPI/MMPI-2 and the SIRS both showed moderate to high internal consistency, range 0.47 to 0.85 and 0.48 to 0.95, respectively. Conclusions Multiple measures assessing symptom exaggeration have been used in patients with mental health disorders. The symptom validity indicators of the MMPI/MMPI-2 are the most widely used measures to assess symptom exaggeration. Assessment and reporting of reliability is poor across studies; we require further assessment of psychometric properties for existing measures of symptom exaggeration.

Fractures are associated with considerable socioeconomic burden1 and may be associated with delayed union and nonunion.2 Delayed union and nonunion can result in loss of function and significant pain and are associated with increased treatment costs and reduced quality of life.2 Factors contributing to delayed union and nonunion include fracture characteristics (e.g., fracture displacement, severity of injury to the soft tissue envelope, infection at the fracture site), iatrogenic factors (e.g., medications, such as anticoagulants, steroids, anti-inflammatory drugs, radiotherapy) and patient characteristics (e.g., vitamin deficiencies, smoking habits).3 The standard care for delayed union and nonunion include nonsurgical (e.g., cast immobilization) and surgical treatment (e.g., external fixation, plating, internal intramedullary nail fixation). Adjunct interventions, such as bone stimulators, are commonly used to facilitate fracture healing. A 2008 survey of 450 Canadian trauma surgeons (79% response rate) showed that 45% of surgeons used bone growth stimulators as part of their treatment strategies for managing fractures.4 Of these, an equal number used low-intensity pulsed ultrasonography (LIPUS) and electrical stimulators (ESTIM). The US Food and Drug Administration approved LIPUS in 1994 for accelerating fresh fracture healing and in 2000 for the treatment of existing nonunions.5 The technique is non-invasive, and its waves induce micromechanical stress in the fracture site, stimulating molecular and cellular responses involved in fracture healing.6,7 Previous systematic reviews evaluating the effectiveness of LIPUS have suggested a moderate effect on surrogate end points (e.g., reducing time to radiographic union), but inconsistent effects on measures of direct importance to patients, such as return to function.8–11 The use of ESTIM is another noninvasive technique marketed for improving fracture healing. It is believed to affect many cellular pathways, including growth factor synthesis, cytokine production, proteoglycan and collagen, which ultimately stimulate pathways that enhance fracture healing.12–14 Previous systematic reviews evaluating ESTIM for healing existing nonunions concluded that the current evidence is inconsistent — neither showing a significant impact nor confidently rejecting the therapeutic effect of ESTIM.3,15 There have been no comparative studies evaluating LIPUS versus ESTIM for fracture healing. Although the clinical effectiveness for both LIPUS and ESTIM is inconsistent, use of these modalities remains high. In 2012, sales of bone stimulators in the United States were approximately $700 million annually, with a projected growth of 6% per year.16 To best inform evidence-based patient care, it is often desirable to compare competing therapies. Network meta-analysis techniques are powerful approaches that allow for indirect comparison of interventions that have not been directly compared.17,18 The main purpose of this study was to systematically review the LIPUS and ESTIM literature and perform a network meta-analysis of these 2 treatments for accelerating fracture healing in both fresh fracture and nonunion populations.

Introduction The link between education and clinical practice is vital, yet the current state of research suggests there is a substantial gap between medical education research and practice. This too is the case in the domain of anaesthesiology education research, as much of the research focuses on simulation studies, and a narrow range of research methods. The aim of this study is to comprehensively review the existing literature in postgraduate anaesthesiology education research in order to identify key research priorities. The findings from this review will be used to establish a base for developing a strategic research programme in anaesthesia education and practice. Methods and analysis We will employ the scoping review methodology outlined by Arksey and O9Malley (2005) to comprehensively search the literature pertaining to postgraduate anaesthesiology education. We will search relevant electronic databases (eg, MEDLINE, EMBASE) and grey literature. After conducting calibration exercises, two authors will independently apply inclusion criteria to all titles and abstracts and perform full-text review of all eligible articles. Data to be extracted will include basic information about the study (eg, location, design) as well as detailed information regarding the context of the research and type of education examined. Our results will be used to develop a framework of themes that outline the research currently being conducted and identify gaps in research. Ethics and dissemination This review is the first step in a strategic research plan in postgraduate anaesthesiology education. We plan to disseminate this research through publications, presentations and meetings with relevant stakeholders. Ethical approval was not sought for this scoping review.

Background There is growing evidence of the effectiveness of Cognitive Behavioural Therapy (CBT) for a wide range of psychological disorders. There is a continued controversy about whether challenging maladaptive thoughts rather than use of behavioural interventions alone is associated with the greatest efficacy. However little is known about the relative efficacy of various components of CBT. This review aims to compare the relative efficacy of Cognitive Therapy (CT) versus Exposure (E) for a range of anxiety disorders using the most clinically relevant outcome measures and estimating the summary relative efficacy by combining the studies in a meta-analysis. Methods Psych INFO, MEDLINE and EMBASE were searched from the first available year to May 2010. All randomised controlled studies comparing the efficacy of exposure with cognitive therapy were included. Odds ratios (OR) or standardised means' differences (Hedges' g) for the most clinically relevant primary outcomes were calculated. Outcomes of the studies were grouped according to specific disorders and were combined in meta-analyses exploring short-term and long-term outcomes. Results 20 Randomised Controlled Trials with (n = 1,308) directly comparing the efficacy of CT and E in anxiety disorders were included in the meta-analysis. No statistically significant difference in the relative efficacy of CT and E was revealed in Post Traumatic Stress Disorder (PTSD), in Obsessive Compulsive Disorder (OCD) and in Panic Disorder (PD). There was a statistically significant difference favouring CT versus E in Social Phobia both in the short-term (Z = 3.72, p = 0.0002) and the long-term (Z = 3.28, p = 0.001) outcomes. Conclusions On the basis of extant literature, there appears to be no evidence of differential efficacy between cognitive therapy and exposure in PD, PTSD and OCD and strong evidence of superior efficacy of cognitive therapy in social phobia

Dr. Heeckt and colleagues have raised a number of potential issues with our systematic review and network meta-analysis on low-intensity pulsed ultrasound (LIPUS) versus electrical stimulation for fracture healing.1 Their first concern was that “fracture nonunion was improperly defined,” specifically with respect to our definition of fracture union only including bridging at 4 cortices, and our decision to merge possible union (bridging at 3 cortices) and nonunion (bridging at ≤ 2 cortices) into 1 category (nonunion). To facilitate our standard meta-analyses and network meta-analysis, we dichotomized the outcome of fracture union to create a common outcome measure across trials. Our decision to merge possible union and nonunion into 1 category was informed by an experienced orthopedic surgeon who was blinded to the eligible studies in our review. This description was provided in the “Synthesis of results” subsection in the Methods section of our review. Their second concern was that “reduced time to radiographic union was considered a surrogate end point.” Dr. Heeckt and colleagues cited a survey,2 led by one of us (M.B.), that found orthopedic surgeons consider radiographic outcomes to be more important than functional outcomes when designing clinical trials. Our systematic review specifically considered patient-important outcomes (Table 4, Question C in the systematic review). Return to functioning is a patient-important outcome, whereas radiographic outcomes are an indirect measure of functional recovery. This is an important distinction for readers, as improvements in surrogate outcomes may not translate to commensurate improvements in function. A systematic review by Busse and colleagues3 on the effectiveness of LIPUS for fracture healing found that although there was low-quality evidence from 6 trials to suggest that LIPUS was effective in reducing time to radiographic healing, only 4 trials directly assessed functional recovery, with 3 showing no effect. Their third concern was that “seminal LIPUS papers were omitted.” Our extraction and analysis did include data from the trials they cited as being omitted,4,5 but the cited references were incorrect. Thank you for bringing this to our attention; we have now provided the correct references to CJS. Their fourth concern was that “the selection of studies for analysis was biased” and that studies with high risk of bias should have been excluded. Although these studies suffer from high risk of bias in multiple components on the Cochrane Risk of Bias tool, this does not warrant exclusion of the studies simply on the basis of risk of bias. It is inappropriate to exclude studies from meta-analyses based on arbitrary thresholds for study quality without first conducting subgroup analyses to explore whether or not treatment effect estimates differ among trials with low risk of bias and trials with high risk of bias.6 We planned to perform such subgroup analyses to explore components of risk of bias as a factor to explain heterogeneity in treatment effect estimates, and we included this in our review as follows: We generated the following a priori hypothesis to explain variability between studies: studies with greater risk of bias will have larger effects than studies with lower risk of bias. This subgroup analysis was completed only on a risk of bias component × component basis if there was considerable variability within the risk of bias component. On consulting with a methodologist, we performed subgroup analyses only when there were at least 5 studies to avoid high risk of spurious subgroup findings.1 Given that each of our analyses consisted of fewer than 5 trials, we were underpowered to perform subgroup analyses to explore risk of bias as a factor to explain heterogeneity in effect estimates. To provide transparency to readers, we provided a risk of bias summary and a GRADE summary of findings table (Table 2 and 3 in the systematic review1). Additionally, the ESTIM studies (with multiple components of high risk of bias) were not excluded from our review because of risk of bias, but because they did not report the outcome of interest (union rates) for our analysis. This was described in our Results section as follows: Eight trials evaluating LIPUS (7 fresh fracture and 1 nonunion populations), and 7 trials evaluating ESTIM (3 fresh fracture and 5 nonunion populations), reported union rates as one of their outcomes and were used in the network meta-analyses.1 Their final concern was the claim that “whether fractures were fresh or nonunion prior to treatment was ignored.” This distinction was not ignored in our review and we separated these 2 types of fractures in our analyses. This was stated in our objectives as follows: (...) to systematically review the LIPUS and ESTIM literature and perform a network meta-analysis of these 2 treatments for accelerating fracture healing in both fresh fracture and nonunion populations.1 We also provided the results separately for these 2 populations — we found that in patients with a fresh fracture, there was a nonsignificant benefit of LIPUS versus standard care and ESTIM on union rates at 6 months, and in patients with an existing nonunion or delayed union, we found a nonsignificant benefit of ESTIM over standard care on union rates at 3 months. We thank Dr. Heeckt and colleagues for their interest in our paper and continue to believe our findings represent a careful and systematic review and analysis of the literature. Ultimately, the goal of our review was to shed light on knowledge gaps and we stand by our recommendation for large head-to-head trials with safeguards against bias that assess patient-important outcomes to confirm or refute the role of bone stimulation devices for fracture healing in either fresh fracture or non-union populations.

Introduction Factors that are important to the competence of healthcare providers have important consequences for quality of healthcare. Although some previous research has discussed risks or supports to the competence of clinicians, a thorough exploration is currently lacking. The purpose of this review is to examine the literature examining risks and supports to clinical competence of healthcare practitioners and trainees engaged in field-based education. In this study, field-based education refers to teaching or training in a real-world/work-based setting. Methods and analysis We will employ an established scoping review methodology. Eligible studies will include those that mention (1) a healthcare professional, (2) competence from field-based education throughout the lifespan/career and (3) a risk or support to competence. Four authors will independently apply the inclusion criteria to all studies, regardless of study design. Our data extraction will include information on study design, location and type of study and we will develop a comprehensive list of risks and supports that are discussed in the literature. Ethics and dissemination Since this is a review of the literature, ethics approval is not indicated. We will disseminate the findings from this study in publications in peer-reviewed journals as well as presentations at relevant national and international conferences.

Objectives Independent medical evaluations (IMEs) are a common and influential form of assessment, often influencing whether patients receive compensation for an injury or illness. To inform the evidence-base underlying IMEs, we conducted a systematic review of all primary literature conducted in North America. Method We searched CINAHL, EMBASE, MEDLINE and PsycINFO and other sources for studies published through to Sept. 20, 2011. We included all primary literature on the topic of IMEs from a North American perspective. Assessment for study inclusion, data extraction and risk-of-bias analyses were performed in duplicate. Results We included 52 studies, all of which were observational in design and most of which focussed on determining the rate of malingering among examinees. Estimates of non-credible symptom over-reporting among patients presenting for IMEs ranged from 16% to 55%, with studies at lower risk of bias finding higher estimates. Other studies found that inter-rater reliability among IME assessors for assigning degree of impairment to the same IME report was poor, and that patients presenting for an IME with external incentive (e.g. litigation, disability benefits) perform systematically worse across a range of psychometric tests versus patients presenting with similar illness/injury but without external incentive. Conclusions Symptom exaggeration is common among patients presenting for IMEs, and particularly among those patients with external incentive. IME assessors reviewing the same case demonstrate little agreement regarding the degree of impairment that should be assigned. Standards for IME assessment and reporting are urgently needed to ensure greater reliability and validity of this common form of assessment.

Objectives Symptom exaggeration is a significant issue in patients receiving disability benefits secondary to mental health disorders. Measures designed to detect exaggeration of symptoms are valuable for informing more accurate diagnoses, which can impact claim decision-making, both for disability claim approval and patient management. Our objectives were: 1) to complete a systematic review to identify measures that assess symptom exaggeration in mental health disorders, and 2) using the results from the review, develop an instrument assessing symptom exaggeration in individuals receiving disability benefits secondary to mental health disorders. Method We completed searches of MEDLINE and PSYCInfo from inception of each database to June 2013, to identify primary studies evaluating symptom exaggeration among patients with mental health disorders. Teams of reviewers completed title and abstract screening of citations, full text review of potentially eligible articles, data extraction, and quality assessment of eligible studies. Findings from our review and input from content experts informed the development of a summary instrument. Results We identified 8435 unique citations; 102 studies were eligible. Studies reported on 55 different instruments to assess symptom exaggeration; 42% of studies used the MMPI-2. Quality of studies ranged from low to moderate. Items that comprise our summary instrument will be presented at EPICOH. Conclusions Multiple instruments are available to assess symptom exaggeration among patients presenting with mental illness; however, no instrument has shown ideal psychometric properties. We are hopeful that our instrument will facilitate the testing and development of a novel tool with superior sensitivity and specificity for detecting symptom exaggeration.

Objectives Of workers approved for long-term disability benefits, 31.6% suffer from a primary mental illness. Negative patient recovery expectations are associated with worse outcome in many conditions. Our objectives were: 1) to complete a systematic review to identify measures that assess patient recovery expectations, and 2) using the results from our review, develop an instrument designed to assess recovery expectations in individuals receiving disability benefits secondary to a mental health disorder. Method We completed searches of MEDLINE and PSYCInfo from inception of each database to June 2013, to identify primary studies evaluating patient’s recovery expectations across all clinical populations. Teams of reviewers completed title and abstract screening of citations, full text review of potentially eligible articles, data extraction, and quality assessment of eligible studies. Findings from the review and input from content experts informed the development of a comprehensive list of items that captured patient’s recovery expectations. Results We identified 12 599 unique citations; 46 studies were eligible. Studies reported on 20 different instruments assessing patient’s recovery expectations. A minority (20%) of studies included measurement properties of reported instruments; 11% evaluated mental health conditions. No instruments were validated among patients receiving disability benefits or explored associations with return to work. Generalizability to disabled patients receiving wage replacement benefits is therefore unclear. Items that comprise our summary instrument will be presented at EPICOH. Conclusions Our instrument holds promise for identifying claimants holding negative recovery expectations, which may be associated with prolonged recovery. These unhelpful beliefs may be a useful target for early interventional therapies.