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BackgroundIn theoretical models of health behavior, knowledge about disease transmission and self-protective behaviors are conceptualized as important drivers of behavior change. Several studies conducted in Brazil point to an unfortunate convergence of sexual and gender minority (SGM) populations with low levels of HIV knowledge and younger age, lower education, engagement in higher-risk sexual behavior, and never having tested for HIV. Measures to assess level of HIV knowledge have been previously published, including the 12-item HIV/AIDS Knowledge Assessment (HIV-KA) tool. However, measure length can be a barrier to assessment. ObjectiveWe started from the 12-item HIV-KA tool and developed candidate short forms using statistical procedures, evaluated their psychometric properties, and tested the equivalency of their associations with other measures of HIV knowledge compared to the 12-item version. MethodsA convenience sample of SGM was recruited during September 2020 to complete an online survey through advertisements on two social networking apps (Grindr and Hornet). The survey instrument included items on sociodemographic information, prior HIV testing and HIV test results, preexposure prophylaxis (PrEP) and antiretroviral treatment use, sexual behavior, and 3 HIV knowledge measures: the HIV-KA, World Health Organization Knowledge About HIV Transmission Prevention Indicator, and the Brief HIV Knowledge Questionnaire. We used exploratory factor analysis and confirmatory factor analysis (CFA) to assess the factor structure of the of the HIV-KA. We used optimal test assembly (OTA) methods to develop candidate short forms of the HIV-KA and evaluated them based on prespecified reliability, concurrent validity, and statistically equivalent convergent validity criteria. ResultsAmong 2552 SGM individuals from Brazil, mean age was 35.1 years, 98.2% (2507/2552) cisgender men and 1.8% (45/2552) transgender/nonbinary, 56.5% (1441/2552) White, and 31.0% (792/2552) self-reported HIV positive. CFA indicated a 1-factor structure for the 12-item HIV-KA. Concurrent validity correlations were high for all short forms with 6 items, but only versions with 9 items were as reliable as the full-length form and demonstrated equivalency for convergent validity correlations. Suggesting post hoc convergent validity, HIV knowledge scores using the 9- and 10-item short forms were higher for participants who perceived the Undetectable Equals Untransmittable (U=U) slogan as completely accurate versus not accurate. Suggesting post hoc concurrent validity, participants of younger age, of Black, Pardo or indigenous race, and reporting lower education and lower income scored lower on HIV knowledge. Participants who never tested for HIV scored lower than those who tested negative or positive, while those currently using PrEP scored higher than those reporting past or never use. ConclusionsOTA methods were used to shorten the 12-item HIV-KA to 9-item and 10-item versions while maintaining comparable reliability and validity among a large sample of Brazilian SGM. However, these short forms did not shorten sufficiently to justify deviation from the full measure.

Introduction Interventions targeting behaviours of physician prescribers of opioids for chronic non-cancer pain have been introduced to combat the opioid crisis. Systematic reviews have evaluated effects of specific interventions (eg, prescriber education, prescription drug monitoring programmes) on patient and population health outcomes and prescriber behaviour. Integration of findings across intervention types is needed to better understand the effects of prescriber-targeted interventions.Methods and analysis We will conduct an overview of systematic reviews. Eligible systematic reviews will include primary studies that evaluated any intervention targeting the behaviours of physician prescribers of opioids for chronic non-cancer pain in an outpatient or mixed setting, compared with no intervention, usual practice or another active or control intervention. Eligible outcomes will pertain to the intervention effect on patient and population health or opioid prescribing behaviour. We will search MEDLINE, Embase and PsycInfo via Ovid; the Cochrane Database of Systematic Reviews and Epistemonikos from inception. We will also hand search reference lists for additional publications. Screening and data extraction will be conducted independently by two reviewers, with disagreements resolved by consensus or consultation with a third reviewer. The risk of bias of included systematic reviews will be assessed in duplicate by two reviewers using the Risk of Bias in Systematic Reviews tool. Results will be synthesised narratively by intervention type and grouped by outcome. To assist with result interpretation, outcomes will be labelled as intended or unintended according to intervention objectives, and as positive, negative, evidence of no effect or inconclusive evidence according to effect on the population (for patient and population health outcomes) or intervention objectives (for prescriber outcomes).Ethics and dissemination As the proposed study will use published data, ethics approval is not required. Dissemination of results will be achieved through publication of a manuscript in a peer-reviewed journal and conference presentations.PROSPERO registration number CRD42020156815.

Introduction Systemic sclerosis (SSc; scleroderma) is a rare, chronic, autoimmune disease with a high level of burden, a significant impact on the ability to carry out daily activities, and a considerable negative impact on health-related quality of life. Non-pharmacological interventions could be provided to potentially improve mental and physical health outcomes. However, the effectiveness of non-pharmacological interventions on health and well-being among individuals with SSc has not been well established. The proposed living systematic review aims to identify and evaluate randomised controlled trial (RCT) evidence on the effectiveness of non-pharmacological and non-surgical interventions on mental and physical health outcomes and on the delivery of such services in SSc.Methods and analysis Eligible studies will be RCTs that examine non-pharmacological and non-surgical interventions aimed at improving health outcomes among individuals with SSc or the delivery of services intended to improve healthcare or support of people with SSc (eg, support groups). All RCTs included in a previous systematic review that sought studies published between 1990 and March 2014 will be evaluated for inclusion. Additional trials will be sought from January 2014 onwards using a similar, augmented search strategy developed by a health sciences librarian. We will search the MEDLINE, Embase, CINAHL, PsycINFO, Cochrane Library and Web of Science databases and will not restrict by language. Two independent reviewers will determine the eligibility of identified RCTs and will extract data using a prespecified standardised form in DistillerSR. Meta-analyses will be considered if ≥2 eligible RCTs report similar non-pharmacological interventions and comparable health outcomes. We will conduct a qualitative synthesis for interventions that cannot be synthesised via meta-analysis.Ethics and dissemination We will post initial and ongoing results via a website, publish results periodically via peer-reviewed journal publication, and present results at patient-oriented events.PROSPERO registration number CRD42020219914.

Objectives Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist.Methods The development process involved five stages: (1) identification of the need for a reporting guideline and project launch; (2) conduct of a scoping review to identify possible modifications to CONSORT 2010 checklist items and possible new extension items; (3) a three-round modified Delphi study involving key stakeholders to gather feedback on the checklist; (4) a consensus meeting to finalise items to be included in the extension, followed by stakeholder piloting of the checklist; and (5) publication, dissemination and implementation of the final checklist.Results 27 items were initially developed and rated in Delphi round 1, 13 items were rated in round 2 and 11 items were rated in round 3. Response rates for the Delphi study were 92 of 125 (74%) invited participants in round 1, 77 of 92 (84%) round 1 completers in round 2 and 62 of 77 (81%) round 2 completers in round 3. Twenty-seven members of the project team representing a variety of stakeholder groups attended the in-person consensus meeting. The final checklist includes five new items and eight modified items. The extension Explanation & Elaboration document further clarifies aspects that are important to report.Conclusion Uptake of CONSORT-ROUTINE and accompanying Explanation & Elaboration document will improve conduct of trials, as well as the transparency and completeness of reporting of trials conducted using cohorts and routinely collected data.

Objective Visible differences in appearance are associated with poor social and psychological outcomes. Effectiveness of non-surgical cosmetic and other camouflage interventions is poorly understood. The objective was to evaluate effects of cosmetic and other camouflage interventions on appearance-related outcomes, general psychological outcomes and adverse effects for adults with visible appearance differences.Design Systematic review.Data sources MEDLINE (Ovid), EMBASE (Ovid), PsycINFO (Ovid) CINAHL and Cochrane Central databases searched from inception to 24 October 2020. Two reviewers independently reviewed titles and abstracts and full texts.Eligibility criteria Randomised controlled trials in any language on non-surgical cosmetic or other camouflage interventions that reported appearance-related outcomes, general psychological outcomes or adverse effects for adults with visible appearance differences.Data extraction and synthesis Two reviewers independently extracted data, assessed intervention reporting using the Template for Intervention Description and Replication checklist, and assessed risk of bias using the Cochrane risk of bias tool. Outcomes included appearance-related outcomes, general psychological outcomes (eg, depression, anxiety) and adverse effects.Results One head-to-head trial and five trials with waiting list or routine care comparators were included. All had unclear or high risk of bias in at least five of seven domains. Effect sizes could not be determined for most outcomes due to poor reporting. Between-group statistically significant differences were not reported for any appearance-related outcomes and for only 5 of 25 (20%) other psychological outcomes. Given heterogeneity of populations and interventions, poor reporting and high risk of bias, quantitative synthesis was not possible.Conclusions Conclusions about effectiveness of non-surgical cosmetic or other camouflage interventions could not be drawn. Well-designed and conducted trials are needed. Without such evidence, clinicians or other qualified individuals should engage with patients interested in cosmetic interventions in shared decision making, outlining potential benefits and harms, and the lack of evidence to inform decisions.PROSPERO registration number CRD42018103421.

Introduction Methodological studies (ie, studies that evaluate the design, conduct, analysis or reporting of other studies in health research) address various facets of health research including, for instance, data collection techniques, differences in approaches to analyses, reporting quality, adherence to guidelines or publication bias. As a result, methodological studies can help to identify knowledge gaps in the methodology of health research and strategies for improvement in research practices. Differences in methodological study names and a lack of reporting guidance contribute to lack of comparability across studies and difficulties in identifying relevant previous methodological studies. This paper outlines the methods we will use to develop an evidence-based tool—the MethodologIcal STudy reportIng Checklist—to harmonise naming conventions and improve the reporting of methodological studies.Methods and analysis We will search for methodological studies in the Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Embase, MEDLINE, Web of Science, check reference lists and contact experts in the field. We will extract and summarise data on the study names, design and reporting features of the included methodological studies. Consensus on study terms and recommended reporting items will be achieved via video conference meetings with a panel of experts including researchers who have published methodological studies.Ethics and dissemination The consensus study has been exempt from ethics review by the Hamilton Integrated Research Ethics Board. The results of the review and the reporting guideline will be disseminated in stakeholder meetings, conferences, peer-reviewed publications, in requests to journal editors (to endorse or make the guideline a requirement for authors), and on the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network and reporting guideline websites.Registration We have registered the development of the reporting guideline with the EQUATOR Network and publicly posted this project on the Open Science Framework (www.osf.io/9hgbq).

Objectives The Social Appearance Anxiety Scale (SAAS) is a 16-item questionnaire developed to evaluate fear of appearance-based evaluation by others. The primary objective of this research was to investigate the existence of differential item functioning (DIF) for the 16 SAAS items, comparing patients who completed the SAAS in English and French, either to confirm that scores are comparable or provide guidance on calculating comparable scores. A secondary research objective was to investigate the existence of DIF based on sex and disease status. A tertiary research objective was to assess DIF related to language, sex, and disease status on the recently developed SAAS-5.Design This was a cross-sectional analysis using baseline data from patients enrolled in the Scleroderma Patient-centred Intervention Network (SPIN).Setting SPIN patients included in the present study were enrolled at 43 centres in Canada, USA, UK, France and Australia, with questionnaires completed in April 2014 to July 2019.Participants 1640 SPIN patients completed the SAAS in French (n=600) or English (n=1040).Primary and secondary measures The SAAS was collected along with demographic and disease characteristics.Results Six items were identified with statistically significant language-based DIF, four with sex-based DIF and one with disease type-based DIF. However, factor scores before and after accounting for DIF were similar (Pearson correlation >0.99), and individual score differences were small. This was true for both the full and shortened versions of the SAAS.Conclusion SAAS and SAAS-5 scores are comparable across language, sex, and disease-type, despite small differences in how patients respond to some items.

Objective To (1) investigate the extent to which recently published meta-analyses report trial funding, author–industry financial ties and author–industry employment from included randomised controlled trials (RCTs), comparing Cochrane and non-Cochrane meta-analyses; (2) examine characteristics of meta-analyses independently associated with reporting funding sources of included RCTs; and (3) compare reporting among recently published Cochrane meta-analyses to Cochrane reviews published in 2010.Design Review of consecutive sample of recently published meta-analyses.Data sources MEDLINE database via PubMed searched on 19 October 2018.Eligibility criteria for selecting articles We selected the 250 most recent meta-analyses listed in PubMed that included a documented search of at least one database, statistically combined results from ≥2 RCTs and evaluated the effects of a drug or class of drugs.Results 90 of 107 (84%) Cochrane meta-analyses reported funding sources for some or all included trials compared with 21 of 143 (15%) non-Cochrane meta-analyses, a difference of 69% (95% CI 59% to 77%). Percent reporting was also higher for Cochrane meta-analyses compared with non-Cochrane meta-analyses for trial author–industry financial ties (44% versus 1%; 95% CI for difference 33% to 52%) and employment (17% versus 1%; 95% CI for difference 9% to 24%). In multivariable analysis, compared with Cochrane meta-analyses, the odds ratio (OR) for reporting trial funding was ≤0.11 for all other journal category and impact factor combinations. Compared with Cochrane reviews from 2010, reporting of funding sources of included RCTs among recently published Cochrane meta-analyses improved by 54% (95% CI 42% to 63%), and reporting of trial author–industry financial ties and employment improved by 37% (95% CI 26% to 47%) and 10% (95% CI 2% to 19%).Conclusions Reporting of trial funding sources, trial author–industry financial ties and trial author–industry employment in Cochrane meta-analyses has improved since 2010 and is higher than in non-Cochrane meta-analyses.

Depression is common among cardiac patients and associated with adverse cardiovascular outcomes. Bright light therapy has emerged as a promising treatment for depressive symptoms, however it has not yet been investigated in this population. We conducted a double-blind, randomized, placebo-controlled pilot trial to assess the feasibility of a larger-scale trial testing bright light therapy for depressive symptoms in cardiac patients. Patients hospitalized for an acute coronary syndrome or undergoing cardiac surgery were randomized to either bright light (10,000 lux) or dim light placebo (500 lux) lamps for 30 minutes each day over 4 weeks, beginning in-hospital. Depression was quantified using the Patient Health Questionnaire 9 (PHQ-9) and Depression Anxiety and Stress Scales (DASS-21). The Short-Form Health Survey 36 (SF-36) was used to measure quality of life. A total of 175 patients were screened and 15 were randomized (8 treatment, 7 placebo) (8.6%) over 10 months. Despite protocol amendments which broadened the inclusion criteria, the trial was terminated early for infeasibility based on the rate of enrollment (1-2 participants/month), with 39.5% of the target sample (38 participants) enrolled. Future trials should take into account the timing of the onset of depressive symptoms in these patients, and consider a less conservative approach to eligibility as well as ways to increase the acceptability of bright light therapy in hospitalized cardiac patients. Once enrolled, our findings suggest that most participants will adhere to the assigned treatment and complete follow-up.

Abstract Background Randomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their methodology in a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data. Methods The development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial “long list” of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the “long list” and generate a “short list” of key items. In phase 4, these items will serve as the basis for an in-person consensus meeting to finalize a core set of items to be included in the reporting guideline and checklist. Phase 5 will involve drafting the checklist and elaboration-explanation documents, and dissemination and implementation of the guideline. Discussion Development of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data.

Objectives The Scleroderma Patient-centered Intervention Network—Scleroderma Support group Leader EDucation (SPIN-SSLED) Programme was designed to improve confidence and self-efficacy and to reduce burden for support group leaders. Objectives were to (1) evaluate feasibility of programme delivery, including required resources, management issues and scientific aspects (eg, performance of outcome measures) and (2) assess user satisfaction and identify any modifications needed to improve programme content or delivery based on participant feedback.Design Non-randomised feasibility trial.Setting North American patient organisations.Participants Current support group leaders or potential new leaders referred by patient organisations.Intervention The programme included 13 modules delivered live via videoconference over 3 months (April to July 2018) in 60 to 90 min sessions.Outcome measures (1) Elements of feasibility, including enrolment and consent procedures, percentage of referred group leaders who consented to participate, session attendance and technical support requirements; (2) programme usability, understandability, organisation and clarity; (3) leader satisfaction with the programme and (4) planned trial outcome measures, including support group leader self-efficacy, burnout, emotional distress and physical function.Results All 12 referred potential participants consented to enrol, and 10 were included in two training groups of five participants each. Participants attended 95% of sessions. Required technical support was minimal, and videoconferencing technology functioned well. Overall programme satisfaction rating was 9.4/10. Mean item rating on the eight items of the Client Satisfaction Questionnaire-8 was 3.83 (1=low satisfaction; 4=high satisfaction). Pre-post scores on the Scleroderma Support Group Leader Self-efficacy Scale increased by 1.7 SDs (large effect); scores on burnout, emotional distress and physical function improved by 0.44, 0.38 and 0.45 SDs (moderate effects).Conclusion The SPIN-SSLED Programme was feasibly delivered, including management, resource and scientific aspects. Participant satisfaction was high. The programme is ready to be tested in a full-scale randomised controlled trial.Trial registration number NCT03508661

Introduction The Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D) has been recommended for depression screening in medically ill patients. Many existing HADS-D studies have used exploratory methods to select optimal cut-offs. Often, these studies report results from a small range of cut-off thresholds; cut-offs with more favourable accuracy results are more likely to be reported than others with worse accuracy estimates. When published data are combined in meta-analyses, selective reporting may generate biased summary estimates. Individual patient data (IPD) meta-analyses can address this problem by estimating accuracy with data from all studies for all relevant cut-off scores. In addition, a predictive algorithm can be generated to estimate the probability that a patient has depression based on a HADS-D score and clinical characteristics rather than dichotomous screening classification alone. The primary objectives of our IPD meta-analyses are to determine the diagnostic accuracy of the HADS-D to detect major depression among adults across all potentially relevant cut-off scores and to generate a predictive algorithm for individual patients. We are already aware of over 100 eligible studies, and more may be identified with our comprehensive search.Methods and analysis Data sources will include MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, PsycINFO and Web of Science. Eligible studies will have datasets where patients are assessed for major depression based on a validated structured or semistructured clinical interview and complete the HADS-D within 2 weeks (before or after). Risk of bias will be assessed with the Quality Assessment of Diagnostic Accuracy Studies-2 tool. Bivariate random-effects meta-analysis will be conducted for the full range of plausible cut-off values, and a predictive algorithm for individual patients will be generated.Ethics and dissemination The findings of this study will be of interest to stakeholders involved in research, clinical practice and policy.

BACKGROUND:Systemic sclerosis, or scleroderma, is a chronic and rare connective tissue disease with negative physical and psychological implications. Sources of emotional distress and the impact they have on the lives of people with scleroderma are not well understood. OBJECTIVES:To gain an in-depth understanding of the emotional experiences and sources of emotional distress for women and men living with scleroderma through focus group discussions. METHODS:Three semi-structured focus group discussions were conducted (two in English, one in French) with a total of 22 people with scleroderma recruited through the Scleroderma Society of Ontario in Hamilton, Ontario and a scleroderma clinic in Montreal, Canada. Interviews were recorded, transcribed, and then coded for emerging themes using thematic inductive analysis. RESULTS:Core themes representing sources of emotional distress were identified, including: (a) facing a new reality; (b) the daily struggle of living with scleroderma; (c) handling work, employment and general financial burden; (d) changing family roles; (e) social interactions; and (f) navigating the health care system. Collectively, these themes refer to the stressful journey of living with scleroderma including the obstacles faced and the emotional experiences beginning prior to receiving a diagnosis and continuing throughout the participants' lives. CONCLUSION:Scleroderma was portrayed as being an unpredictable and overwhelming disease, resulting in many individuals experiencing multiple sources of emotional distress. Interventions and supportive resources need to be developed to help individuals with scleroderma and people close to them manage and cope with the emotional aspects of the disease.

BACKGROUND:A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified. METHODS:CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses. RESULTS:108 (87%) of 124 published trials reported ≥1 positive outcome in the abstract, and 109 (88%) concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7). Of 21 trial registrations, 13 (62%) remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases. CONCLUSIONS:The proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice.

BACKGROUND:Depression screening can improve upon usual care only if screening tools accurately identify depressed patients who would not otherwise be recognized by healthcare providers. Inclusion of patients already being treated for depression in studies of screening tool accuracy would inflate estimates of screening accuracy and yield. The present study investigated (1) the proportion of primary studies of depression screening tool accuracy that were recently published in journals listed in MEDLINE, which appropriately excluded currently diagnosed or treated patients; and (2) whether recently published meta-analyses identified the inclusion of currently diagnosed or treated patients as a potential source of bias. METHODS:MEDLINE was searched from January 1, 2013 through March 27, 2015 for primary studies and meta-analyses on depression screening tool accuracy. RESULTS:Only 5 of 89 (5.6%) primary studies excluded currently diagnosed or treated patients from any analyses and only 3 (3.4%) from main analyses. In 3 studies that reported the number of patients excluded due to current treatment, the number of excluded patients was more than twice the number of newly identified depression cases. None of 5 meta-analyses identified the inclusion of currently diagnosed and treated patients as a potential source of bias. CONCLUSIONS:The inclusion of currently diagnosed and treated patients in studies of depression screening tool accuracy is a problem that limits the applicability of research findings for actual clinical practice. Studies are needed that evaluate the diagnostic accuracy of depression screening tools among only untreated patients who would potentially be screened in practice.

To investigate the effect of the neighbourhood built environment on trajectories of depression symptom episodes in adults from the general Canadian population.We used 10 years of data collection (2000/01-2010/11) from the Canadian National Population Health Study (n = 7114). Episodes of depression symptoms were identified using the Composite International Diagnostic Interview Short-Form. We assessed the presence of local parks, healthy food stores, fast food restaurants, health services and cultural services using geospatial data. We used latent class growth modelling to identify different trajectories of depression symptom episodes in the sample and tested for the effect of neighbourhood variables on the trajectories over time.We uncovered three distinct trajectories of depression symptom episodes: low prevalence (76.2% of the sample), moderate prevalence (19.2%) and high prevalence of depression symptom episodes (2.8%). The presence of any neighbourhood service (healthy food store, fast-food restaurant, health service, except for cultural service) was significantly associated with a lower probability of a depression symptom episode for those following a trajectory of low prevalence of depression symptom episodes. The presence of a local park was also a significant protective factor in trajectory groups with both low and moderate prevalence of depression symptom episodes. Neighbourhood characteristics did not significantly affect the trajectory of high prevalence of depression symptom episodes.For individuals following a trajectory of low and moderate prevalence of depression symptom episodes, the neighbourhood built environment was associated with a shift in the trajectory of depression symptom episodes. Future intervention studies are recommended to make policy recommendations.

Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709).The quality of published outcome analysis definitions and trial registrations in JCCP is suboptimal. Greater attention to proper trial registration and outcome analysis definition in published reports is needed.

Center for Epidemiologic Studies Depression (CES-D) Scale scores in English- and French-speaking Canadian systemic sclerosis (SSc) patients are commonly pooled in analyses, but no studies have evaluated the metric equivalence of the English and French CES-D. The study objective was to examine the metric equivalence of the CES-D in English- and French-speaking SSc patients.The CES-D was completed by 1007 English-speaking and 248 French-speaking patients from the Canadian Scleroderma Research Group Registry. Confirmatory factor analysis (CFA) was used to assess the factor structure in both samples. The Multiple-Indicator Multiple-Cause (MIMIC) model was utilized to assess differential item functioning (DIF).A two-factor model (Positive and Negative affect) showed excellent fit in both samples. Statistically significant, but small-magnitude, DIF was found for 3 of 20 CES-D items, including items 3 (Blues), 10 (Fearful), and 11 (Sleep). Prior to accounting for DIF, French-speaking patients had 0.08 of a standard deviation (SD) lower latent scores for the Positive factor (95% confidence interval [CI]-0.25 to 0.08) and 0.09 SD higher scores (95% CI-0.07 to 0.24) for the Negative factor than English-speaking patients. After DIF correction, there was no change on the Positive factor and a non-significant increase of 0.04 SD on the Negative factor for French-speaking patients (difference = 0.13 SD, 95% CI-0.03 to 0.28).The English and French versions of the CES-D, despite minor DIF on several items, are substantively equivalent and can be used in studies that combine data from English- and French-speaking Canadian SSc patients.

The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is commonly used to assess fatigue in rheumatic diseases, and has shown to discriminate better across levels of the fatigue spectrum than other commonly used measures. The aim of this study was to assess the cross-language measurement equivalence of the English, French, and Dutch versions of the FACIT-F in systemic sclerosis (SSc) patients.The FACIT-F was completed by 871 English-speaking Canadian, 238 French-speaking Canadian and 230 Dutch SSc patients. Confirmatory factor analysis was used to assess the factor structure in the three samples. The Multiple-Indicator Multiple-Cause (MIMIC) model was utilized to assess differential item functioning (DIF), comparing English versus French and versus Dutch patient responses separately.A unidimensional factor model showed good fit in all samples. Comparing French versus English patients, statistically significant, but small-magnitude DIF was found for 3 of 13 items. French patients had 0.04 of a standard deviation (SD) lower latent fatigue scores than English patients and there was an increase of only 0.03 SD after accounting for DIF. For the Dutch versus English comparison, 4 items showed small, but statistically significant, DIF. Dutch patients had 0.20 SD lower latent fatigue scores than English patients. After correcting for DIF, there was a reduction of 0.16 SD in this difference.There was statistically significant DIF in several items, but the overall effect on fatigue scores was minimal. English, French and Dutch versions of the FACIT-F can be reasonably treated as having equivalent scoring metrics.

The aim of this cluster randomized trial was to evaluate the effectiveness of a school-based theatre intervention program for immigrant and refugee youth in special classes for improving mental health and academic outcomes. The primary hypothesis was that students in the theatre intervention group would report a greater reduction in impairment from symptoms compared to students in the control and tutoring groups.Special classrooms in five multiethnic high schools were randomly assigned to theater intervention (n = 10), tutoring (n = 10) or control status (n = 9), for a total of 477 participants. Students and teachers were non-blinded to group assignment. The primary outcome was impairment from emotional and behavioural symptoms assessed by the Impact Supplement of the Strengths and Difficulties Questionnaire (SDQ) completed by the adolescents. The secondary outcomes were the SDQ global scores (teacher and youth reports), impairment assessed by teachers and school performance. The effect of the interventions was assessed through linear mixed effect models which incorporate the correlation between students in the same class, due to the nature of the randomization of the interventions by classroom.The theatre intervention was not associated with a greater reduction in self-reported impairment and symptoms in youth placed in special class because of learning, emotional and behavioural difficulties than a tutoring intervention or a non-active control group. The estimates of the different models show a non-significant decrease in both self-reported and impairment scores in the theatre intervention group for the overall group, but the impairment score decreased significantly for first generation adolescents while it increased for second generation adolescents.The difference between the population of immigrant and refugee youth newcomers studied previously and the sample of this trial may explain some of the differences in the observed impact of the theatre intervention.ClinicalTrials.gov NCT01426451.

To systematically review evidence on depression screening in coronary heart disease (CHD) by assessing the (1) accuracy of screening tools; (2) effectiveness of treatment; and (3) effect of screening on depression outcomes.A 2008 American Heart Association (AHA) Science Advisory recommended routine depression screening in CHD.CINAHL, Cochrane, EMBASE, ISI, MEDLINE, PsycINFO and SCOPUS databases searched through December 2, 2011; manual journal searches; reference lists; citation tracking; trial registries. Included articles (1) compared a depression screening instrument to a depression diagnosis; (2) compared depression treatment to placebo or usual care in a randomized controlled trial (RCT); or (3) assessed the effect of screening on depression outcomes in a RCT.There were few examples of screening tools with good sensitivity and specificity using a priori-defined cutoffs in more than one patient sample among 15 screening accuracy studies. Depression treatment with antidepressants or psychotherapy generated modest symptom reductions among post-myocardial infarction (post-MI) and stable CHD patients (N = 6; effect size = 0.20-0.38), but antidepressants did not improve symptoms more than placebo in 2 heart failure (HF) trials. Depression treatment did not improve cardiac outcomes. No RCTs investigated the effects of screening on depression outcomes.There is evidence that treatment of depression results in modest improvement in depressive symptoms in post-MI and stable CHD patients, although not in HF patients. There is still no evidence that routine screening for depression improves depression or cardiac outcomes. The AHA Science Advisory on depression screening should be revised to reflect this lack of evidence.

Increasingly, medical research involves patients who complete outcomes in different languages. This occurs in countries with more than one common language, such as Canada (French/English) or the United States (Spanish/English), as well as in international multi-centre collaborations, which are utilized frequently in rare diseases such as systemic sclerosis (SSc). In order to pool or compare outcomes, instruments should be measurement equivalent (invariant) across cultural or linguistic groups. This study provides an example of how to assess cross-language measurement equivalence by comparing the Center for Epidemiologic Studies Depression (CES-D) scale between English-speaking Canadian and Dutch SSc patients.The CES-D was completed by 922 English-speaking Canadian and 213 Dutch SSc patients. Confirmatory factor analysis (CFA) was used to assess the factor structure in both samples. The Multiple-Indicator Multiple-Cause (MIMIC) model was utilized to assess the amount of differential item functioning (DIF).A two-factor model (positive and negative affect) showed excellent fit in both samples. Statistically significant, but small-magnitude, DIF was found for 3 of 20 items on the CES-D. The English-speaking Canadian sample endorsed more feeling-related symptoms, whereas the Dutch sample endorsed more somatic/retarded activity symptoms. The overall estimate in depression scores between English and Dutch was not influenced substantively by DIF.CES-D scores from English-speaking Canadian and Dutch SSc patients can be compared and pooled without concern that measurement differences may substantively influence results. The importance of assessing cross-language measurement equivalence in rheumatology studies prior to pooling outcomes obtained in different languages should be emphasized.

Body image concerns are infrequently studied in systemic sclerosis (SSc), even though significant visible disfigurement is common. The objective of this study was to identify sociodemographic and disease-related correlates of dissatisfaction with appearance and social discomfort among people with SSc.SSc patients came from the 15-center Canadian Scleroderma Research Group Registry. Sociodemographic information was based on patient self-report. Disease characteristics were obtained via physician examinations. The Brief-SWAP was used to assess dissatisfaction with appearance and social discomfort. Structural equation models were conducted with MPlus to determine the relationship of dissatisfaction with appearance and social discomfort with age, sex, education, marital status, race/ethnicity, disease duration, skin involvement, telangiectasias, skin pigmentation changes, and hand contractures.A total of 489 SSc patients (432 female, 57 male) were included. Extent of skin involvement was significantly associated with both dissatisfaction with appearance and social discomfort (standardized regression coefficients = 0.02, p = 0.001; 0.02, p = 0.020, respectively), as was skin involvement in the face (0.18, p = 0.016; 0.23, p = 0.006, respectively). Greater social discomfort was robustly associated with younger age (-0.017, p

Medical research increasingly utilizes patient-reported outcome measures administered and scored in different languages. In order to pool or compare outcomes from different language versions, instruments should be measurement equivalent across linguistic groups. The objective of this study was to examine the cross-language measurement equivalence of the Patient Health Questionnaire-9 (PHQ-9) between English- and French-speaking Canadian patients with systemic sclerosis (SSc).The sample consisted of 739 English- and 221 French-speaking SSc patients. Multiple-Indicator Multiple-Cause (MIMIC) modeling was used to identify items displaying possible differential item functioning (DIF).A one-factor model for the PHQ-9 fit the data well in both English- and French-speaking samples. Statistically significant DIF was found for 3 of 9 items on the PHQ-9. However, the overall estimate in depression latent scores between English- and French-speaking respondents was not influenced substantively by DIF.Although there were several PHQ-9 items with evidence of minor DIF, there was no evidence that these differences influenced overall scores meaningfully. The PHQ-9 can reasonably be used without adjustment in Canadian English- and French-speaking samples. Analyses assessing measurement equivalence should be routinely conducted prior to pooling data from English and French versions of patient-reported outcome measures.

Women have a higher prevalence of Major Depressive Disorder (MDD) and report more severe depressive symptoms than men. Several studies have suggested that gender differences in depression may occur because women report higher levels of somatic symptoms than men. Those studies, however, have not controlled or matched for non-somatic symptoms. The objective of this study was to examine if women report relatively more somatic symptoms than men matched on cognitive/affective symptoms.Male and female patients receiving treatment for MDD in outpatient psychiatric clinics in New Jersey and Pennsylvania, USA were matched on Beck Depression Inventory-II (BDI-II) cognitive/affective symptom scores. Male and female BDI-II somatic symptom scores were compared using independent samples 2-tailed t-tests.Of 472 male and 1,026 female patients, there were 470 male patients (mean age = 40.1 years, SD = 15.1) and 470 female patients (mean age = 43.1 years, SD = 17.2) successfully matched on BDI-II cognitive/affective symptom scores. Somatic symptoms accounted for 35% of total BDI-II scores for male patients versus 38% for matched female patients. Female patients had somatic symptom scores on average 1.3 points higher than males (p

Reports of low sexual activity rates and high impairment rates among women with chronic diseases have not included comparisons to general population data. The objective of this study was to compare sexual activity and impairment rates of women with systemic sclerosis (SSc) to general population data and to identify domains of sexual function driving impairment in SSc.Canadian women with SSc were compared to women from a UK population sample. Sexual activity and, among sexually active women, sexual impairment were evaluated with a 9-item version of the Female Sexual Function Index (FSFI).Among women with SSc (mean age = 57.0 years), 296 of 730 (41%) were sexually active, 181 (61%) of whom were sexually impaired, resulting in 115 of 730 (16%) who were sexually active without impairment. In the UK population sample (mean age = 55.4 years), 956 of 1,498 women (64%) were sexually active, 420 (44%) of whom were impaired, with 536 of 1,498 (36%) sexually active without impairment. Adjusting for age and marital status, women with SSc were significantly less likely to be sexually active (OR = 0.34, 95%CI = 0.28-0.42) and, among sexually active women, significantly more likely to be sexually impaired (OR = 1.88, 95%CI = 1.42-2.49) than general population women. Controlling for total FSFI scores, women with SSc had significantly worse lubrication and pain scores than general population women.Sexual functioning is a problem for many women with scleroderma and is associated with pain and poor lubrication. Evidence-based interventions to support sexual activity and function in women with SSc are needed.

Background and objectivesDepression is common among acute coronary syndrome (ACS) patients and is associated with poor prognosis. Cardiac side effects of older antidepressants were well-known, but newer antidepressants are generally thought of as safe to use in patients with heart disease. The objective was to assess rates of antidepressant use or prescription to patients within a year of an ACS.MethodsPubMed, PsycINFO, and CINAHL databases searched through May 29, 2009; manual searching of 33 journals from May 2009 to September 2010. Articles in any language were included if they reported point or period prevalence of antidepressant use or prescription in the 12 months prior or subsequent to an ACS for ≥100 patients. Two investigators independently selected studies for inclusion/exclusion and extracted methodological characteristics and outcomes from included studies (study setting, inclusion/exclusion criteria, sample size, prevalence of antidepressant prescription/use, method of assessing antidepressant prescription/use, time period of assessment).ResultsA total of 24 articles were included. The majority were from North America and Europe, and most utilized chart review or self-report to assess antidepressant use or prescription. Although there was substantial heterogeneity in results, overall, rates of antidepressant use or prescription increased from less than 5% prior to 1995 to 10-15% after 2000. In general, studies from North America reported substantially higher rates than studies from Europe, approximately 5% higher among studies that used chart or self-report data.ConclusionsAntidepressant use or prescription has increased considerably, and by 2005 approximately 10% to 15% of ACS patients were prescribed or using one of these drugs.

Several practice guidelines recommend screening for depression in cancer care, but no systematic reviews have examined whether there is evidence that depression screening benefits cancer patients. The objective was to evaluate the potential benefits of depression screening in cancer patients by assessing the (1) accuracy of depression screening tools; (2) effectiveness of depression treatment; and (3) effect of depression screening, either alone or in the context of comprehensive depression care, on depression outcomes.Data sources were CINAHL, Cochrane, EMBASE, ISI, MEDLINE, PsycINFO and SCOPUS databases through January 24, 2011; manual journal searches; reference lists; citation tracking; trial registry reviews. Articles on cancer patients were included if they (1) compared a depression screening instrument to a valid criterion for major depressive disorder (MDD); (2) compared depression treatment with placebo or usual care in a randomized controlled trial (RCT); (3) assessed the effect of screening on depression outcomes in a RCT.There were 19 studies of screening accuracy, 1 MDD treatment RCT, but no RCTs that investigated effects of screening on depression outcomes. Screening accuracy studies generally had small sample sizes (median = 17 depression cases) and used exploratory methods to set sample-specific cutoff scores that varied substantially across studies. A nurse-delivered intervention for MDD reduced depressive symptoms moderately (effect size = 0.37).The one treatment study reviewed reported modest improvement in depressive symptoms, but no evidence was found on whether or not depression screening in cancer patients, either alone or in the context of optimal depression care, improves depression outcomes compared to usual care. Depression screening in cancer should be evaluated in a RCT in which all patients identified as depressed, either through screening or via physician recognition and referral in a control group, have access to comprehensive depression care.