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BackgroundScalable interventions to address COVID-19 mental health are needed. Our objective was to assess effects of mental health interventions for community-based children, adolescents, and adults.MethodsWe searched 9 databases (2 Chinese-language) from December 31, 2019 to March 22, 2021. We included randomised controlled trials with non-hospitalised, non-quarantined participants of interventions to address COVID-19 mental health challenges. We synthesized results descriptively but did not pool quantitatively due to substantial heterogeneity of populations and interventions and concerns about risk of bias.FindingsWe identified 9 eligible trials, including 3 well-conducted, well-reported trials that tested interventions designed specifically for COVID-19 mental health challenges, plus 6 trials of standard interventions (e.g., individual or group therapy, expressive writing, mindfulness recordings) minimally adapted for COVID-19, all with risk of bias concerns. Among the 3 COVID-19-specific intervention trials, one (N = 670) found that a self-guided, internet-based cognitive-behavioural intervention targeting dysfunctional COVID-19 worry significantly reduced COVID-19 anxiety (standardized mean difference [SMD] 0.74, 95% CI 0.58 to 0.90) and depression symptoms (SMD 0.38, 95% CI 0.22 to 0.55) in Swedish general population participants. A lay-delivered telephone intervention for homebound older adults in the United States (N = 240) and a peer-moderated education and support intervention for people with a rare autoimmune condition from 12 countries (N = 172) significantly improved anxiety (SMD 0.35, 95% CI 0.09 to 0.60; SMD 0.31, 95% CI 0.03 to 0.58) and depressive symptoms (SMD 0.31, 95% CI 0.05 to 0.56; SMD 0.31, 95% CI 0.07 to 0.55) 6-weeks post-intervention, but these were not significant immediately post-intervention. No trials in children or adolescents were identified.InterpretationInternet-based programs for the general population and lay-or peer-delivered interventions for vulnerable groups may be effective, scalable options for public mental health in COVID-19. More well-conducted trials, including for children and adolescents, are needed.FundingCanadian Institutes of Health Research (CMS-171703; MS1-173070); McGill Interdisciplinary Initiative in Infection and Immunity Emergency COVID-19 Research Fund (R2-42).RegistrationPROSPERO (CRD42020179703); registered on April 17, 2020.RESEARCH IN CONTEXTEvidence before this studyWe searched for systematic reviews of randomised controlled trials of interventions to address mental health challenges in COVID-19. We used searches from our living systematic review, which were not limited by study design and reviewed citations through April 29, 2021 from MEDLINE, PsycINFO, CINAHL, EMBASE, Web of Science, China National Knowledge Infrastructure, Wanfang, medRxiv (preprints), and Open Science Framework Preprints (preprint server aggregator). We identified 4 systematic reviews of interventions for COVID-19 mental health with search dates between April and September 2020. None, however, included evidence from any completed randomised controlled trials on mental health interventions for community-based children, adolescents, or adults during COVID-19.Added value of this studyOur systematic review is the only living systematic review on COVID-19 community-based mental health interventions registered in PROSPERO and, to the best of our knowledge, the first systematic review to synthesize evidence on completed randomised controlled trials of COVID-19 mental health interventions. The sheer volume of evidence being published in COVID-19 poses a barrier to effective synthesis and policy response. We reviewed over 45,000 citations in any language and distilled this to 9 verified eligible community-based trials. Of these, there were 3 well-conducted trials of interventions designed specifically to be scalable to address challenges of public mental health in COVID-19. One trial showed that internet-based cognitive behavioural therapy in the Swedish general population (N = 670) reduced COVID-19 anxiety and symptoms of depression. Trials that tested a lay-delivered telephone support intervention for homebound older adults in the United States (N = 240) and a peer-moderated group intervention for people with a rare autoimmune condition from 12 countries (N = 172) also found that they improved mental health outcomes, although not all outcomes were statistically significant.Implications of all the available evidenceEffective, scalable, and feasibly delivered mental health interventions are needed for the general public and vulnerable groups as lockdown restrictions continue, even intermittently, and because COVID-19 mental health implications will likely persist beyond the pandemic. Although we identified only 3 high-quality trials, they demonstrated approaches that can be feasibly adopted to meet the needs of adults in the general public and vulnerable groups. The successful internet-based cognitive behavioural therapy intervention was made available to the Swedish general public free-of-charge following testing and suggests that online tools tailored for specific concerns in COVID-19 may represent an efficient way of addressing public mental health. Two lay-and peer-delivered interventions, consistent with pre-COVID-19 evidence, suggest that low-intensity, non-professionally delivered, support-oriented approaches can be leveraged among vulnerable groups. The absence of trials of interventions for children and adolescents underlines the need for evidence on scalable strategies for this population, including school-based approaches.

ObjectivesRandomised 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.MethodsThe 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.Results27 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.ConclusionUptake 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.

Background: With the recent legalization of recreational cannabis in Canada, cannabis-impaired driving is an important public safety concern. Our aim was to examine the association between recreational cannabis legalization and fatal motor vehicle collisions using data from the United States, which present a timely natural experiment of cannabis legalization. Methods: We conducted an ecologic study using the number of fatal motor vehicle collisions and the associated number of deaths for US jurisdictions with legalized recreational cannabis (2007–2018) retrieved from the US Fatality Analysis Reporting System. We examined jurisdiction-specific rates of fatal motor vehicle collisions and associated deaths before and after recreational cannabis legalization using Poisson regression and meta-analyzed estimates across jurisdictions using DerSimonian and Laird random-effects models. Results: After adjustment for calendar year, legalization was associated with increases in rates of fatal motor vehicle collisions (incidence rate ratio [IRR] 1.15, 95% confidence interval [CI] 1.06–1.26) and associated deaths (IRR 1.16, 95% CI 1.06–1.27). Differences between the first 12 months after legalization relative to subsequent months were inconclusive for rates of fatal motor vehicle collisions (IRR 0.92, 95% CI 0.84–1.02) and associated deaths (IRR 0.92, 95% CI 0.84–1.01). Interpretation: Recreational cannabis legalization in the US was associated with a relative increased risk of fatal motor vehicle collisions of 15% and a relative increase in associated deaths of 16%, with no conclusive difference between the first and subsequent years after legalization. These findings raise concern that there could be a similar increase in fatal motor vehicle collisions and associated deaths in Canada following recreational cannabis legalization.

Objectives: Estimates of depression prevalence in pregnancy and postpartum are based on the Edinburgh Postnatal Depression Scale (EPDS) more than on any other method. We aimed to determine if any EPDS cutoff can accurately and consistently estimate depression prevalence in individual studies. Methods: We analyzed datasets that compared EPDS scores to Structured Clinical Interview for DSM (SCID) major depression status. Random‐effects meta‐analysis was used to compare prevalence with EPDS cutoffs versus the SCID. Results: Seven thousand three hundred and fifteen participants (1017 SCID major depression) from 29 primary studies were included. For EPDS cutoffs used to estimate prevalence in recent studies (≥9 to ≥14), pooled prevalence estimates ranged from 27.8% (95% CI: 22.0%–34.5%) for EPDS ≥ 9 to 9.0% (95% CI: 6.8%–11.9%) for EPDS ≥ 14; pooled SCID major depression prevalence was 9.0% (95% CI: 6.5%–12.3%). EPDS ≥14 provided pooled prevalence closest to SCID‐based prevalence but differed from SCID prevalence in individual studies by a mean absolute difference of 5.1% (95% prediction interval: 13.7%, 12.3%). Conclusion: EPDS ≥14 approximated SCID‐based prevalence overall, but considerable heterogeneity in individual studies is a barrier to using it for prevalence estimation., This study was funded by the Canadian Institutes of Health Research (CIHR, KRS‐140994). Ms. Lyubenova was supported by the Mitacs Globalink Research Internship Program. Ms. Neupane was supported by G.R. Caverhill Fellowship from the Faculty of Medicine, McGill University. Drs. Levis and Wu were supported by Fonds de recherche du Québec‐Santé (FRQS) Postdoctoral Training Fellowships. Mr. Bhandari was supported by a studentship from the Research Institute of the McGill University Health Centre. Ms. Rice was supported by a Vanier Canada Graduate Scholarship. Ms. Azar was supported by a FRQS Masters Training Award. The primary study by Barnes et al. was supported by a grant from the Health Foundation (1665/608). The primary study by Beck et al. was supported by the Patrick and Catherine Weldon Donaghue Medical Research Foundation and the University of Connecticut Research Foundation. The primary study by Helle et al. was supported by the Werner Otto Foundation, the Kroschke Foundation, and the Feindt Foundation. Prof. Robertas Bunevicius, MD, PhD (1958‐2016) was Principal Investigator of the primary study by Bunevicius et al., but passed away and was unable to participate in this project. The primary study by Chaudron et al. was supported by a grant from the National Institute of Mental Health (grant K23 MH64476). The primary study by Tissot et al. was supported by the Swiss National Science Foundation (grant 32003B 125493). The primary study by Tendais et al. was supported under the project POCI/SAU‐ESP/56397/2004 by the Operational Program Science and Innovation 2010 (POCI 2010) of the Community Support Board III and by the European Community Fund FEDER. The primary study by Garcia‐Esteve et al. was supported by grant 7/98 from the Ministerio de Trabajo y Asuntos Sociales, Women's Institute, Spain. The primary study by Howard et al. was supported by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Grant Reference Numbers RP‐PG‐1210‐12002 and RP‐DG‐1108‐10012) and by the South London Clinical Research Network. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. The primary study by Phillips et al. was supported by a scholarship from the National Health and Medical and Research Council (NHMRC). The primary study by Nakić Radoš et al. was supported by the Croatian Ministry of Science, Education, and Sports (134‐0000000‐2421). The primary study by Navarro et al. was supported by grant 13/00 from the Ministry of Work and Social Affairs, Institute of Women, Spain. The primary study by Pawlby et al. was supported by a Medical Research Council UK Project Grant (number G89292999N). The primary study by Quispel et al. was supported by Stichting Achmea Gezondheid (grant number z‐282). Dr. Robertson‐Blackmore was supported by a Young Investigator Award from the Brain and Behavior Research Foundation and NIMH grant K23MH080290. The primary study by Rochat et al. was supported by grants from the University of Oxford (HQ5035), the Tuixen Foundation (9940), the Wellcome Trust (082384/Z/07/Z and 071571), and the American Psychological Association. Dr. Rochat receives salary support from a Wellcome Trust Intermediate Fellowship (211374/Z/18/Z). The primary study by Prenoveau et al. was supported by The Wellcome Trust (grant number 071571). The primary study by Stewart et al. was supported by Professor Francis Creed's Journal of Psychosomatic Research Editorship fund (BA00457) administered through University of Manchester. The primary study by Tandon et al. was funded by the Thomas Wilson Sanitarium. The primary study by Tran et al. was supported by the Myer Foundation who funded the study under its Beyond Australia scheme. Dr. Tran was supported by an early career fellowship from the Australian National Health and Medical Research Council. The primary study by Vega‐Dienstmaier et al. was supported by Tejada Family Foundation, Inc, and Peruvian‐American Endowment, Inc. Drs. Benedetti and Thombs were supported by FRQS researcher salary awards.

IntroductionMethodological 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 analysisWe 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 disseminationThe 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.RegistrationWe 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).

KEY POINTS Public awareness regarding the importance of disclosing and managing conflicts of interest (COIs) during the development of clinical practice and public health guidelines is growing, owing to recent high-profile news stories within and outside Canada.[1][1]–[9][2] Despite the existence

Background An estimated 20–30% of community-dwelling Canadian adults aged 65 years or older experience one or more falls each year. Fall-related injuries are a leading cause of hospitalization and can lead to functional independence. Many fall prevention interventions, often based on modifiable risk factors, have been studied. Apart from the magnitude of the benefits and harms from different interventions, the preferences of older adults for different interventions as well as the relative importance they place on the different potential outcomes may influence recommendations by guideline panels. These reviews on benefits and harms of interventions, and on patient values and preferences, will inform the Canadian Task Force on Preventive Health Care to develop recommendations on fall prevention for primary care providers. Methods To review the benefits and harms of fall prevention interventions, we will update a previous systematic review of randomized controlled trials with adaptations to modify the classification of interventions and narrow the scope to community-dwelling older adults and primary-care relevant interventions. Four databases (MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Ageline), reference lists, trial registries, and relevant websites will be searched, using limits for randomized trials and date (2016 onwards). We will classify interventions according to the Prevention of Falls Network Europe (ProFANE) Group’s taxonomy. Outcomes include fallers, falls, injurious falls, fractures, hip fractures, institutionalization, health-related quality of life, functional status, and intervention-related adverse effects. For studies not included in the previous review, screening, study selection, data extraction on outcomes, and risk of bias assessments will be independently undertaken by two reviewers with consensus used for final decisions. Where quantitative analysis is suitable, network or pairwise meta-analysis will be conducted using a frequentist approach in Stata. Assessment of the transitivity and coherence of the network meta-analyses will be undertaken. For the reviews on patient preferences and outcome valuation (relative importance of outcomes), we will perform de novo reviews with searches in three databases (MEDLINE, PsycInfo, and CINAHL) and reference lists for cross-sectional, longitudinal quantitative, or qualitative studies published from 2000. Selection, data extraction, and risk of bias assessments suitable for each study design will be performed in duplicate. The analysis will be guided by a narrative synthesis approach, which may include meta-analysis for health-state utilities. We will use the CINeMa approach to a rate the certainty of the evidence for outcomes on intervention effects analyzed using network meta-analysis and the GRADE approach for all other outcomes. Discussion We will describe the flow of literature and characteristics of all studies and present results of all analyses and summary of finding tables. We will compare our findings to others and discuss the limitations of the reviews and the available literature. Systematic review registration This protocol has not been registered.

IntroductionSystemic 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 analysisEligible 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 disseminationWe 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 numberCRD42020219914.

Purpose To inform recommendations by the Canadian Task Force on Preventive Health Care on screening in primary care for the prevention and early detection of cervical cancer by systematically reviewing evidence of (a) effectiveness; (b) test accuracy; (c) individuals’ values and preferences; and (d) strategies aimed at improving screening rates. Methods De novo reviews will be conducted to evaluate effectiveness and to assess values and preferences. For test accuracy and strategies to improve screening rates, we will integrate studies from existing systematic reviews with search updates to the present. Two Cochrane reviews will provide evidence of adverse pregnancy outcomes from the conservative management of cervical intraepithelial neoplasia. We will search Medline, Embase, and Cochrane Central (except for individuals’ values and preferences, where Medline, Scopus, and EconLit will be searched) via peer-reviewed search strategies and the reference lists of included studies and reviews. We will search ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. Two reviewers will screen potentially eligible studies and agree on those to include. Data will be extracted by one reviewer with verification by another. Two reviewers will independently assess risk of bias and reach consensus. Where possible and suitable, we will pool studies via meta-analysis. We will compare accuracy data per outcome and per comparison using the Rutter and Gatsonis hierarchical summary receiver operating characteristic model and report relative sensitivities and specificities. Findings on values and preferences will be synthesized using a narrative synthesis approach and thematic analysis, depending on study designs. Two reviewers will appraise the certainty of evidence for all outcomes using GRADE (Grading of Recommendations Assessment, Development and Evaluation) and come to consensus. Discussion The publication of guidance on screening in primary care for the prevention and early detection of cervical cancer by the Task Force in 2013 focused on cytology. Since 2013, new studies using human papillomavirus tests for cervical screening have been published that will improve our understanding of screening in primary care settings. This review will inform updated recommendations based on currently available studies and address key evidence gaps noted in our previous review.

Randomised controlled trials are increasingly conducted as embedded, nested, or using cohorts or routinely collected data, including registries, electronic health records, and administrative databases, to assess if participants are eligible for the trial and to facilitate recruitment, to deliver an embedded intervention, to collect trial outcome data, or a combination of these purposes. This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE). The extension was developed to look at the unique characteristics of trials conducted with these types of data with the goal of improving reporting quality in the long term by setting standards early in the process of uptake of these trial designs. The extension was developed with a sequential approach, including a Delphi survey, a consensus meeting, and piloting of the checklist. The checklist was informed by the CONSORT 2010 statement and two reporting guidelines for observational studies, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement and the REporting of studies Conducted using Observational Routinely collected Data (RECORD) statement. The extension includes eight items modified from the CONSORT 2010 statement and five new items. Reporting items with explanations and examples are provided, including key aspects of trials conducted using cohorts or routinely collected data that require specific reporting considerations.

Background: It is not known how many people with depression respond and remit without treatment. Control conditions in psychotherapy trials, including care-as-usual (CAU) and waiting lists, may generate estimates of response and remission. Methods: We selected trials comparing psychotherapies with control conditions from a large database of trials and extracted response (50% symptoms reduction) and remission (HAMD < 7) rates from these conditions. Response and remission rates were pooled in a meta-analysis using random-effects models. Findings: 264 studies were included with 12,790 participants in control conditions. The mean response rates at 2 (± 1) months after baseline were 0.18 (95% CI: 0.16~0.20) for waiting lists, 0.19 (95% CI: 0.17~0.22) for CAU and 0.29 (95% CI: 0.22~0.38) for pill placebo. Remission rates were 0.11, 0.15 and 0.18, respectively. At 6 to 12 months, response and remission rates increased for waiting lists (0.32, 95% CI:0.26~0.38 and 0.29, 95% CI:0.21~0.39, respectively) and for CAU (0.23; 95% CI: 0.18~0.29 and 0.17, 95%CI: 0.09~0.28, respectively). Response and remission did not differ by the setting where CAU was delivered (specialized mental health care, primary care, general medical care, perinatal care, no treatment). No indication was found that response and remission changed by year of publication. Heterogeneity was high in almost all analyses. Interpretation: More than 75% of patients in CAU and waiting lists do not respond or remit within one to three months. CAU has not improved over time suggesting that evidence-based interventions may not have been implemented. Funding Statement: No funding was received for this study. Declaration of Interests: TAF reports grants and personal fees from Mitsubishi-Tanabe, personal fees from MSD, personal fees from Shionogi, outside the submitted work. In addition, TAF has a patent 2018-177688 concerning smartphone CBT apps pending and intellectual properties for Kokoro-app licensed to Tanabe-Mitsubishi. HN reported personal fees from Boehringer Ingelheim, Kyowa Kirin, ASKA Pharmaceutical, and Toyota Motor Corporation outside the submitted work. The other authors declare no competing interests.

Contains fulltext : 219490.pdf (Publisher’s version ) (Open Access) Purpose: Many people with scleroderma rely on peer-led support groups as a coping resource. Reasons for not attending support groups in scleroderma have been investigated only in North American participants. This study assesses reasons for nonattendance in European countries and compares results with previously published North American findings. Materials and Methods: The same 21-item survey as used in the North American sample assessed possible reasons for not attending scleroderma support groups. Proportions of items rated Important or Very Important were compared between samples. Results: Consistent with the North American survey findings (N = 242), the two items most commonly rated as (Very) Important reasons for nonattendance among 228 European participants were (1) already having enough support (57%), and (2) not knowing of any local scleroderma support groups (58%). Compared to North American non-attenders, European patients were significantly more likely to rate not knowing enough about what happens at support groups (46% vs 19%), not having reliable ways to get to meetings (35% vs 17%), and being uncomfortable sharing experiences with a group (22% vs 11%) as (Very) Important reasons for nonattendance. Conclusions: Improving access to European support groups, providing education about support groups and group leader training may encourage participation. 8 p.

Background: Protocols are an essential document for conducting randomised controlled trials (RCTs). However, the completeness of the information provided is often inadequate. To help improve the content of trial protocols, an international group of stakeholders published the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Initiative in 2013. Presently, there is increasing use of cohorts and routinely collected data (RCD) for RCTs because these data have the potential to improve efficiencies by facilitating recruitment, simplifying, and reducing the cost of data collection. Reporting guidelines have been shown to improve the quality of reporting, but there is currently no specific SPIRIT guidance on protocols for trials conducted using cohorts and RCD. This protocol outlines steps for developing SPIRIT-ROUTINE, which aims to address this gap by extending the SPIRIT guidance to protocols for trials conducted using cohorts and RCD. Methods: The development of the SPIRIT-ROUTINE extension comprises five stages. Stage 1 consists of a project launch and a meeting to finalise the membership of the steering group and scope of the extension. In Stage 2, a rapid review will be performed to identify possible modifications to the original SPIRIT 2013 checklist. Other key reporting guidelines will be reviewed to identify areas where additional items may be needed, such as the Consolidated Standards of Reporting Trials (CONSORT) extension for trials conducted using cohorts and RCD (CONSORT-ROUTINE). Stage 3 will involve an online Delphi exercise, consisting of two rounds and involving key international stakeholders to gather feedback on the preliminary checklist items. In Stage 4, a consensus meeting of the SPIRIT-ROUTINE steering group will finalise the items to include in the extension. Stage 5 will involve the publication preparation and dissemination of the final checklist. Conclusion: The SPIRIT-ROUTINE extension will contribute to improving design of trials using cohorts and RCD and transparency of reporting.

Summary Background Pain is an important and detrimental feature of systemic sclerosis but is often overlooked or deprioritised in research and clinical care. Raynaud's phenomenon, arthritis, and cutaneous ulcers are among the commonly reported disease manifestations of systemic sclerosis that could be associated with pain. We aimed to assess levels of pain intensity and interference and to evaluate disease factors associated with pain intensity and interference. Methods In this multicentre cross-sectional study, participants from the Scleroderma Patient-centered Intervention Network cohort who completed pain intensity and interference measures (Patient Reported Outcomes Information System-29 profile, version 2·0) as part of baseline assessments were included. Patients were recruited from 46 centres in Australia, Canada, France, Mexico, Spain, the UK, and the USA between April 15, 2014, and Jan 7, 2020. Eligible patients included those aged 18 years or older who met the criteria for systemic sclerosis devised by the American College of Rheumatology and the European League Against Rheumatism. Associations of pain intensity and pain interference with systemic sclerosis-related variables and overlap syndromes, controlling for sociodemographic variables, were assessed with multiple linear regression. Continuous independent variables were standardised. Findings Among 2157 participants with systemic sclerosis (268 [12%] males and 1889 [88%] females), 1870 (87%) reported mild, moderate, or severe pain (defined as ≥1 on a 0 to 10 scale), and 815 (38%) reported moderate or severe pain (defined as ≥5). Moreover, 757 (35%) participants reported moderate or severe pain interference. Greater pain intensity was independently associated with female sex (0·58 points [95% CI 0·26–0·90]), non-White race or ethnicity (0·50 points [0·21–0·79]), fewer years in formal education (0·30 points per SD [0·19–0·41]), country (reference: USA; Canada: 0·29 points [0·01–0·57] and UK: 0·58 points [0·21–0·95]), greater body-mass index (0·35 points per SD [0·24–0·45]); joint contractures (0·67 points [0·39–0·94]), digital ulcers (0·33 points [0·10–0·55]), gastrointestinal involvement (0·66 points [0·33–0·98]), skin involvement (measured using modified Rodnan skin score; 0·22 points per SD [0·10–0·35]), rheumatoid arthritis (0·96 points [0·50–1·43]), and Sjogren's syndrome (0·42 points [0·01–0·83]). Pain interference results were similar. Interpretation Pain is common among people with systemic sclerosis. Controlling for sociodemographic variables, greater pain was associated with multiple systemic sclerosis-related manifestations, including joint contractures, digital ulcers, gastrointestinal involvement, skin involvement, and the presence of overlap syndromes. Health-care providers should work with patients to address pain, including identifying and addressing systemic sclerosis manifestations associated with their pain, and supporting behavioural approaches to minimise impact on function and quality of life. Funding Canadian Institutes of Health Research, Arthritis Society, The Lady Davis Institute for Medical Research of the Jewish General Hospital, Jewish General Hospital Foundation, McGill University, Scleroderma Society of Ontario, Scleroderma Canada, Sclerodermie Quebec, Scleroderma Manitoba, Scleroderma Atlantic, Scleroderma Association of BC, Scleroderma SASK, Scleroderma Australia, Scleroderma New South Wales, Scleroderma Victoria, and Scleroderma Queensland.

For many users of the biomedical literature, abstracts may be the only source of information about a study. Hence, abstracts should allow readers to evaluate the objectives, key design features, and main results of the study. Several evaluations have shown deficiencies in the reporting of journal and conference abstracts across study designs and research fields, including systematic reviews of diagnostic test accuracy studies. Incomplete reporting compromises the value of research to key stakeholders. The authors of this article have developed a 12 item checklist of preferred reporting items for journal and conference abstracts of systematic reviews and meta-analyses of diagnostic test accuracy studies (PRISMA-DTA for Abstracts). This article presents the checklist, examples of complete reporting, and explanations for each item of PRISMA-DTA for Abstracts.

IntroductionInterventions 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 analysisWe 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 disseminationAs 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 numberCRD42020156815.

POINTS CLES En 2019, on a estime a 6 par 100 000 le nombre de nouveaux cas de cancer de l’œsophage diagnostiques chez les Canadiens[1][1]. Evalue a 15 %, le taux de survie net a 5 ans est parmi les plus faibles de tous les pronostics de cancer[1][1]. Les hommes presentent une incidence

Introduction No studies have examined factors associated with fear in any group of people vulnerable during COVID-19 due to pre-existing medical conditions. Objective To investigate factors associated with fear of consequences of COVID-19 among people living with a pre-existing medical condition, the autoimmune disease systemic sclerosis (SSc; scleroderma), including country. Methods Pre-COVID-19 data from the Scleroderma Patient-centered Intervention Network (SPIN) Cohort were linked to COVID-19 data collected in April 2020. Multivariable linear regression was used to assess factors associated with continuous scores of the 10-item COVID-19 Fears Questionnaire for Chronic Medical Conditions, controlling for pre-COVID-19 anxiety symptoms. Results Compared to France (N = 156), COVID-19 Fear scores among participants from the United Kingdom (N = 50) were 0.12 SD (95% CI 0.03 to 0.21) higher; scores for Canada (N = 97) and the United States (N = 128) were higher, but not statistically significant. Greater interference of breathing problems was associated with higher fears due to COVID-19 (Standardized regression coefficient = 0.12, 95% CI 0.01 to 0.23). Participants with higher financial resources adequacy scores had lower COVID-19 Fear scores (Standardized coefficient = −0.18, 95% CI −0.28 to −0.09). Conclusions Fears due to COVID-19 were associated with clinical and functional vulnerabilities in this chronically ill population. This suggests that interventions may benefit from addressing specific clinical issues that apply to specific populations. Financial resources, health policies and political influences may also be important. The needs of people living with chronic illness during a pandemic may differ depending on the social and political context in which they live., Highlights • People with chronic diseases may experience high levels of fear due to COVID-19. • We examined factors associated with fears due to COVID-19 in an at-risk population. • We used the validated COVID-19 Fears Questionnaire for Chronic Medical Conditions. • Fears due to COVID-19 among people with SSc differed substantially by country. • Interference of breathing problems and financial adequacy were related to fears.

Objective To evaluate the Edinburgh Postnatal Depression Scale (EPDS) for screening to detect major depression in pregnant and postpartum women. Design Individual participant data meta-analysis. Data sources Medline, Medline In-Process and Other Non-Indexed Citations, PsycINFO, and Web of Science (from inception to 3 October 2018). Eligibility criteria for selecting studies Eligible datasets included EPDS scores and major depression classification based on validated diagnostic interviews. Bivariate random effects meta-analysis was used to estimate EPDS sensitivity and specificity compared with semi-structured, fully structured (Mini International Neuropsychiatric Interview (MINI) excluded), and MINI diagnostic interviews separately using individual participant data. One stage meta-regression was used to examine accuracy by reference standard categories and participant characteristics. Results Individual participant data were obtained from 58 of 83 eligible studies (70%; 15 557 of 22 788 eligible participants (68%), 2069 with major depression). Combined sensitivity and specificity was maximised at a cut-off value of 11 or higher across reference standards. Among studies with a semi-structured interview (36 studies, 9066 participants, 1330 with major depression), sensitivity and specificity were 0.85 (95% confidence interval 0.79 to 0.90) and 0.84 (0.79 to 0.88) for a cut-off value of 10 or higher, 0.81 (0.75 to 0.87) and 0.88 (0.85 to 0.91) for a cut-off value of 11 or higher, and 0.66 (0.58 to 0.74) and 0.95 (0.92 to 0.96) for a cut-off value of 13 or higher, respectively. Accuracy was similar across reference standards and subgroups, including for pregnant and postpartum women. Conclusions An EPDS cut-off value of 11 or higher maximised combined sensitivity and specificity; a cut-off value of 13 or higher was less sensitive but more specific. To identify pregnant and postpartum women with higher symptom levels, a cut-off of 13 or higher could be used. Lower cut-off values could be used if the intention is to avoid false negatives and identify most patients who meet diagnostic criteria. Registration PROSPERO (CRD42015024785).

Selective cut-off reporting in primary diagnostic accuracy studies with continuous or ordinal data may result in biased estimates when meta-analyzing studies. Collecting individual participant data (IPD) and estimating accuracy across all relevant cut-offs for all studies can overcome such bias but is labour-intensive.We meta-analyzed the diagnostic accuracy of the Patient Health Questionnaire-9 (PHQ-9) depression screening tool. We compared results for two statistical methods proposed by Steinhauser and by Jones to account for missing cut-offs, with results from a series of bivariate random effects models (BRM) estimated separately at each cut-off. We applied the methods to a dataset that contained information only on cut-offs that were reported in the primary publications,and to the full IPD dataset that contained information for all cut-offs for every study. For each method, we estimated pooled sensitivity and specificity and associated 95% confidence intervals for each cut-off and area under the curve (AUC).The full IPD dataset comprised data from 45 studies, 15,020 subjects and 1,972 cases of major depression, and included information on every possible cut-off.When using data available in publications, using statistical approaches out-performed the BRM applied to the same data.AUC was similar for all approaches when using the full IPD dataset, though pooled estimates were slightly different.Overall, using statistical methods to fill in missing cut-off data recovered the receiver operating characteristic (ROC) curve from the full IPD dataset well when using only the published subset. All methods performed similarly when applied to the full IPD dataset.

The Maternal Mental Health in Canada, 2018/2019, survey reported that 18% of 7,085 mothers who recently gave birth reported "feelings consistent with postpartum depression" based on scores ≥7 on a 5-item version of the Edinburgh Postpartum Depression Scale (EPDS-5). The EPDS-5 was designed as a screening questionnaire, not to classify disorders or estimate prevalence; the extent to which EPDS-5 results reflect depression prevalence is unknown. We investigated EPDS-5 ≥7 performance relative to major depression prevalence based on a validated diagnostic interview, the Structured Clinical Interview for DSM (SCID)., The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by the Canadian Institutes of Health Research (CIHR, KRS-140994). Drs. Thombs and Benedetti were supported by Fonds de recherche du Qu´ebec–Sant´e (FRQS) researcher salary awards. Dr. Levis was supported by a FRQS Postdoctoral Training Fellowship. Ms. Lyubenova was supported by theMitacs Globalink Research Internship Program. Ms. Neupane was supported by G.R. Caverhill Fellowship from the Faculty of Medicine, McGill University. Dr. Wu was supported by a FRQS Postdoctoral Training Fellowship. Ms. Rice was supported by a Vanier Canada Graduate Scholarship. Mr. Bhandari was supported by a studentship from the Research Institute of the McGill University Health Centre. Ms. Azar was supported by a FRQS Masters Training Award. The primary study by Barnes et al. was supported by a grant from the Health Foundation (1665/608). The primary study by Beck et al. was supported by the Patrick and Catherine Weldon Donaghue Medical Research Foundation and the University of Connecticut Research Foundation. The primary study by de Figueiredo et al. was supported by Fundacão de Amparo à Pesquisa do Estado de São Paulo. The primary study by Tendais et al. was supported under the project POCI/SAU-ESP/56397/2004 by the Operational Program Science and Innovation 2010 (POCI 2010) of the Community Support Board III and by the European Community Fund FEDER. The primary study by Helle et al. was supported by the Werner Otto Foundation, the Kroschke Foundation, and the Feindt Foundation. The primary study by Howard et al. was supported by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Grant Reference Numbers RPPG-1210-12002 and RP-DG-1108-10012) and by the South London Clinical Research Network. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. The primary study by Phillips et al. was supported by a scholarship from the National Health and Medical and Research Council (NHMRC). The primary study by Nakic´ Radoˇs et al. was supported by the Croatian Ministry of Science, Education, and Sports (134-0000000-2421). The primary study by Quispel et al. was supported by Stichting Achmea Gezondheid (grant number z-282). The primary study by Rochat et al. was supported by grants from the University of Oxford (HQ5035), the Tuixen Foundation (9940), the Wellcome Trust (082384/Z/07/Z and 071571), and the American Psychological Association. Dr. Rochat receives salary support from a Wellcome Trust Intermediate Fellowship (211374/Z/18/Z). The primary study by Prenoveau et al. was supported by The Wellcome Trust (grant number 071571). The primary study by Stewart et al. was supported by Professor Francis Creed’s Journal of Psychosomatic Research Editorship fund (BA00457) administered through University of Manchester. The primary study by Tandon et al. was funded by the Thomas Wilson Sanitarium. The primary study by Tran et al. was supported by the Myer Foundation who funded the study under its Beyond Australia scheme. Dr. Tran was supported by an early career fellowship from the Australian National Health and Medical Research Council. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. The primary study by Vega-Dienstmaier et al. was supported by Tejada Family Foundation, Inc, and Peruvian-American Endowment, Inc. No other authors reported funding for primary studies or for their work on this study.

Systematic reviews of diagnostic test accuracy (DTA) studies are fundamental to the decision-making process in evidence-based medicine. Although such studies are regarded as high-level evidence, these reviews are not always reported completely and transparently. Sub-optimal reporting of DTA systematic reviews compromises their validity and generalizability, and subsequently their value to key stakeholders. PRISMA-DTA, an extension of the PRISMA statement, was recently developed to improve the quality of reporting of DTA systematic reviews. The PRISMA-DTA statement consists of 27 items, of which 8 are unmodified from the original PRISMA statement. This document provides an explanation for the 19 new and modified items, along with their meaning and rationale. Examples of complete reporting are used for each item to illustrate best practices. The PRISMA-DTA statement, this explanation and elaboration document, and the associated web site (http://www.prisma-statement.org/Extensions/DTA) provide resources to support the complete and transparent reporting of DTA systematic reviews.

Little is known about the benefits, and barriers and facilitators to providing psychosocial support to caregivers to a loved one with a rare disease. The aim of our scoping review was to map evidence on (1) perceived benefits and (2) barriers and facilitators of establishing and maintaining services. The CINAHL and PubMed databases were searched in December 2018. Qualitative and quantitative studies in any language that described perceived or tested benefits of participating in psychosocial interventions for caregivers, or the barriers and facilitators of providing these interventions, were eligible. Thirty-four studies were included. Interventions were behavioural or psychological, supportive, educational, or multicomponent. All included studies reported on the benefits of participating in psychosocial interventions; 14 (41%) studies also reported on facilitators and 19 (56%) reported on barriers. Benefits that were most commonly found included statistically significant improvements in emotional states (e.g. stress) and caregiver burden and narrative reports of intervention helpfulness. Statistically significant improvements in mental health outcomes (e.g. depression symptoms) were rarely detected. Four themes for facilitators were identified, including intervention characteristics, intervention delivery characteristics, provision of necessary resources, and support provided outside of the intervention. Four barrier themes were also identified: misalignment of intervention to caregiver needs, inability to make time for intervention, practical barriers, emotional barriers. Psychosocial interventions for caregivers to a loved one with a rare disease may be helpful in reducing stress, burden, and feelings of isolation among caregivers. Future research should design interventions for caregivers that take into account facilitators and barriers to establishing and maintaining such interventions.

Objectives Validated diagnostic interviews are required to classify depression status and estimate prevalence of disorder, but screening tools are often used instead. We used individual participant data meta-analysis to compare prevalence based on standard Hospital Anxiety and Depression Scale – depression subscale (HADS-D) cutoffs of ≥8 and ≥11 versus Structured Clinical Interview for DSM (SCID) major depression and determined if an alternative HADS-D cutoff could more accurately estimate prevalence. Methods We searched Medline, Medline In-Process & Other Non-Indexed Citations via Ovid, PsycINFO, and Web of Science (inception-July 11, 2016) for studies comparing HADS-D scores to SCID major depression status. Pooled prevalence and pooled differences in prevalence for HADS-D cutoffs versus SCID major depression were estimated. Results 6005 participants (689 SCID major depression cases) from 41 primary studies were included. Pooled prevalence was 24.5% (95% Confidence Interval (CI): 20.5%, 29.0%) for HADS-D ≥8, 10.7% (95% CI: 8.3%, 13.8%) for HADS-D ≥11, and 11.6% (95% CI: 9.2%, 14.6%) for SCID major depression. HADS-D ≥11 was closest to SCID major depression prevalence, but the 95% prediction interval for the difference that could be expected for HADS-D ≥11 versus SCID in a new study was −21.1% to 19.5%. Conclusions HADS-D ≥8 substantially overestimates depression prevalence. Of all possible cutoff thresholds, HADS-D ≥11 was closest to the SCID, but there was substantial heterogeneity in the difference between HADS-D ≥11 and SCID-based estimates. HADS-D should not be used as a substitute for a validated diagnostic interview.

Purpose. To inform recommendations by the Canadian Task Force on Preventive Health Care on cervical cancer screening by systematically reviewing evidence of: (a) the effectiveness; (b) test accuracy; (c) individuals’ values and preferences, and (d) strategies aimed at improving screening rates.Methods. De novo reviews will be conducted to evaluate effectiveness and to assess values and preferences. For test accuracy and strategies to improve screening rates, we will integrate studies from existing systematic reviews with search updates to the present. Two Cochrane reviews will provide evidence of adverse pregnancy outcomes from the conservative management of cervical intraepithelial neoplasia. We will search Medline, Embase, and Cochrane Central (except for individuals’ values and preferences, where Medline, Scopus, and EconLit will be searched) via peer-reviewed search strategies, and the reference lists of included studies and reviews. We will search ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. Two reviewers will screen potentially eligible studies and agree on those to include. Data will be extracted by one reviewer with verification by another. Two reviewers will independently assess risk of bias and reach consensus. Where possible and suitable, we will pool studies via meta-analysis. We will compare accuracy data per outcome and per comparison using the Rutter and Gatsonis hierarchical summary receiver operating characteristic model and report relative sensitivities and specificities. Findings on values and preferences will be synthesized using a narrative synthesis approach and thematic analysis, depending on study designs. Two reviewers will appraise the certainty of evidence for all outcomes using GRADE (Grading of Recommendations Assessment, Development and Evaluation) and come to consensus.Discussion. The publication of guidance on cervical cancer screening by the Task Force in 2013 focused on cytology. Since 2013, new studies using human papillomavirus tests for detection of cervical cancer have been published that will improve our understanding of screening in primary care settings. This review will inform updated recommendations based on currently available studies and address key evidence gaps noted in our previous review.Systematic review registration: not registered.

[See related article at [www.cmaj.ca/lookup/doi/10.1503/cmaj.200697][2]][2] KEY POINTS In 2019, an estimated 6 new cases of esophageal cancer were diagnosed per 100 000 Canadians.[1][2] The 5-year net survival rate, estimated at 15%, is among the poorest of all cancer prognoses. [1][2] Men have a

BackgroundNo studies have reported comparisons of mental health symptoms prior to and during COVID-19 in vulnerable populations. Objectives were to compare anxiety and depression symptoms among people with a pre-existing medical condition, the autoimmune disease systemic sclerosis (SSc; scleroderma), including continuous change scores, proportion with change ≥ 1 minimal clinically important difference (MCID), and factors associated with changes, including country.MethodsPre-COVID-19 Scleroderma Patient-centered Intervention Network Cohort data were linked to COVID-19 data collected April 9 to April 27, 2020. Anxiety symptoms were assessed with the PROMIS Anxiety 4a v1.0 scale (MCID = 4 points) and depression symptoms with the Patient Health Questionnaire-8 (MCID = 3 points). Multiple linear and logistic regression were used to assess factors associated with continuous change and change ≥ 1 MCID.FindingsAmong 435 participants (Canada = 98; France = 159; United Kingdom = 50; United States = 128), mean anxiety symptoms increased 4.9 points (95% confidence interval [CI] 4.0 to 5.7). Depression symptom change was negligible (0.3 points; 95% CI −0.7 to 0.2). Compared to France, adjusted scores from the United States and United Kingdom were 3.8 points (95% CI 1.7 to 5.9) and 2.9 points higher (95% CI 0.0 to 5.7); scores for Canada were not significantly different. Odds of increasing by ≥ 1 MCID were twice as high for the United Kingdom (2.0, 95% CI 1.0 to 4.2) and United States (1.9, 95% CI 1.1 to 3.2). Participants who used mental health services pre-COVID had adjusted increases 3.7 points (95% CI 1.7 to 5.7) less than other participants.InterpretationAnxiety symptoms, but not depression symptoms, increased dramatically during COVID-19 among people with a pre-existing medical condition. Increase was larger in the United Kingdom and United States than in Canada and France but substantially less for people with pre-COVID-19 mental health treatment.RESEARCH IN CONTEXTEvidence before this studyWe referred to a living systematic review that is evaluating mental health changes from pre-COVID-19 to COVID-19 by searching 7 databases, including 2 Chinese language databases, plus preprint servers, with daily updates (https://www.depressd.ca/covid-19-mental-health). As of June 13, 2020, only 5 studies had compared mental health symptoms prior to and during COVID-19. In 4 studies of university students, there were small increases in depression or general mental health symptoms but minimal or no increases in anxiety symptoms. A general population study from the United Kingdom reported a small increase in general mental health symptoms but did not differentiate between types of symptoms. No studies have reported changes from pre-COVID-19 among people vulnerable due to pre-existing medical conditions. No studies have compared mental health changes between countries, despite major differences in pandemic responses.Added value of this studyWe evaluated changes in anxiety and depression symptoms among 435 participants with the autoimmune condition systemic sclerosis and compared results from Canada, France, the United Kingdom, and the United States. To our knowledge, this is the first study to compare mental health symptoms prior to and during COVID-19 in any vulnerable population. These are the first data to document the substantial degree to which anxiety symptoms have increased and the minimal changes in depression symptoms among vulnerable individuals. It is also the first study to examine the association of symptom changes with country of residence and to identify that people receiving pre-COVID-19 mental health services may be more resilient and experience less substantial symptom increases than others.Implications of all the available evidenceAlthough this was an observational study, it provided evidence that vulnerable people with a pre-existing medical condition have experienced substantially increased anxiety symptoms and that these increases appear to be associated with where people live and, possibly, different experiences of the COVID-19 pandemic across countries. By comparing with evidence from university samples, which found that depression symptoms were more prominent, these data underline the need for accessible interventions tailored to specific needs of different populations. They also suggest that mental health treatments may help people to develop skills or create resilience, which may reduce vulnerability to major stressors such as COVID-19.

Importance The Patient Health Questionnaire depression module (PHQ-9) is a 9-item self-administered instrument used for detecting depression and assessing severity of depression. The Patient Health Questionnaire-2 (PHQ-2) consists of the first 2 items of the PHQ-9 (which assess the frequency of depressed mood and anhedonia) and can be used as a first step to identify patients for evaluation with the full PHQ-9. Objective To estimate PHQ-2 accuracy alone and combined with the PHQ-9 for detecting major depression. Data sources MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, PsycINFO, and Web of Science (January 2000-May 2018). Study selection Eligible data sets compared PHQ-2 scores with major depression diagnoses from a validated diagnostic interview. Data extraction and synthesis Individual participant data were synthesized with bivariate random-effects meta-analysis to estimate pooled sensitivity and specificity of the PHQ-2 alone among studies using semistructured, fully structured, or Mini International Neuropsychiatric Interview (MINI) diagnostic interviews separately and in combination with the PHQ-9 vs the PHQ-9 alone for studies that used semistructured interviews. The PHQ-2 score ranges from 0 to 6, and the PHQ-9 score ranges from 0 to 27. Results Individual participant data were obtained from 100 of 136 eligible studies (44 318 participants; 4572 with major depression [10%]; mean [SD] age, 49 [17] years; 59% female). Among studies that used semistructured interviews, PHQ-2 sensitivity and specificity (95% CI) were 0.91 (0.88-0.94) and 0.67 (0.64-0.71) for cutoff scores of 2 or greater and 0.72 (0.67-0.77) and 0.85 (0.83-0.87) for cutoff scores of 3 or greater. Sensitivity was significantly greater for semistructured vs fully structured interviews. Specificity was not significantly different across the types of interviews. The area under the receiver operating characteristic curve was 0.88 (0.86-0.89) for semistructured interviews, 0.82 (0.81-0.84) for fully structured interviews, and 0.87 (0.85-0.88) for the MINI. There were no significant subgroup differences. For semistructured interviews, sensitivity for PHQ-2 scores of 2 or greater followed by PHQ-9 scores of 10 or greater (0.82 [0.76-0.86]) was not significantly different than PHQ-9 scores of 10 or greater alone (0.86 [0.80-0.90]); specificity for the combination was significantly but minimally higher (0.87 [0.84-0.89] vs 0.85 [0.82-0.87]). The area under the curve was 0.90 (0.89-0.91). The combination was estimated to reduce the number of participants needing to complete the full PHQ-9 by 57% (56%-58%). Conclusions and relevance In an individual participant data meta-analysis of studies that compared PHQ scores with major depression diagnoses, the combination of PHQ-2 (with cutoff ≥2) followed by PHQ-9 (with cutoff ≥10) had similar sensitivity but higher specificity compared with PHQ-9 cutoff scores of 10 or greater alone. Further research is needed to understand the clinical and research value of this combined approach to screening.

Objectives: Depression symptom questionnaires are not for diagnostic classification. Patient Health Questionnaire-9 (PHQ-9) scores >= 10 are nonetheless often used to estimate depression prevalence. We compared PHQ-9 >= 10 prevalence to Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID) major depression prevalence and assessed whether an alternative PHQ-9 cutoff could more accurately estimate prevalence. Study Design and Setting: Individual participant data meta-analysis of datasets comparing PHQ-9 scores to SCID major depression status. Results: A total of 9,242 participants (1,389 SCID major depression cases) from 44 primary studies were included. Pooled PHQ-9 >= 10 prevalence was 24.6% (95% confidence interval [CI]: 20.8%, 28.9%); pooled SCID major depression prevalence was 12.1% (95% CI: 9.6%, 15.2%); and pooled difference was 11.9% (95% CI: 9.3%, 14.6%). The mean study-level PHQ-9 >= 10 to SCID-based prevalence ratio was 2.5 times. PHQ-9 >= 14 and the PHQ-9 diagnostic algorithm provided prevalence closest to SCID major depression prevalence, but study-level prevalence differed from SCID-based prevalence by an average absolute difference of 4.8% for PHQ-9 >= 14 (95% prediction interval: -13.6%, 14.5%) and 5.6% for the PHQ-9 diagnostic algorithm (95% prediction interval: -16.4%, 15.0%). Conclusion: PHQ-9 >= 10 substantially overestimates depression prevalence. There is too much heterogeneity to correct statistically in individual studies. (C) 2020 Elsevier Inc. All rights reserved.

Background Systemic sclerosis (SSc), or scleroderma, is a rare disease that often results in significant disruptions to activities of daily living and can negatively affect physical and psychological well-being. Because there is no known cure, SSc treatment focuses on reducing symptoms and disability and improving health-related quality of life (HRQoL). Self-management programs are known to increase self-efficacy for disease management in many chronic diseases. The Scleroderma Patient-centered Intervention Network (SPIN) developed a Web-based self-management program (SPIN self-management; SPIN-SELF) to increase self-efficacy for disease management and to improve HRQoL for patients with SSc. Objective The proposed study aims to assess the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF program by evaluating the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-SELF program. Methods The SPIN-SELF feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale score ≤7), who have indicated interest in using a Web-based self-management program, will be randomized with a 3:2 ratio into the SPIN-SELF program or usual care for 3 months. Feasibility outcomes include trial implementation processes, required resources and management, scientific aspects, and patient acceptability and usage of the SPIN-SELF program. Results Enrollment of the 40 participants occurred between July 5, 2019, and July 27, 2019. By November 25, 2019, data collection of trial outcomes was completed. Data analysis is underway, and results are expected to be published in 2020. Conclusions The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL in patients with SSc. The SPIN-SELF feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-SELF program. International Registered Report Identifier (IRRID) DERR1-10.2196/16799

People with systemic sclerosis (scleroderma) face difficulties being physically active. This study identified physical activity barriers and facilitators experienced by people with scleroderma.We conducted nominal group technique sessions with scleroderma patients who shared physical activity barriers, barrier-specific facilitators, and general facilitators. Participants rated importance of barriers and likelihood of using facilitators from 0 to 10, and indicated whether they had tried facilitators. Barriers and facilitators across sessions were merged to eliminate overlap; edited by investigators, patient advisors, and clinicians; and categorized using qualitative content analysis.We conducted 9 sessions (Scleroderma patients reported many barriers related to health and medical aspects of scleroderma and several barriers in other categories. They reported facilitators to remain physically active despite the barriers.Implications for RehabilitationPeople with scleroderma experience difficulty being physically active due to the diverse and often severe manifestations of the disease, including involvement of the skin, musculoskeletal system, and internal organs.In addition to regular care of scleroderma-related symptoms, patients overcome many exercise challenges by selecting physical activities that are comfortable for them, adjusting the intensity and duration of activities, adapting activities, and using adapted equipment or other materials to reduce discomfort.Rehabilitation professionals should help people with scleroderma to tailor activity options to their capacity and needs when providing care and advice to promote physical activity.

Background The producers of clinical practice guidelines (CPGs) may not disclose industry funding in their CPGs. We reviewed Canadian national CPGs to examine the existence and disclosure of industry-related organizational funding in the CPGs, financial conflicts of interest of committee members and organizational procedures for managing financial conflicts of interest. Methods For this descriptive study, we searched the asset map of the Strategy for Patient-Oriented Research Evidence Alliance and the CPG Infobase for CPGs published between Jan. 1, 2016, and Nov. 30, 2018. Eligible guidelines had to have a national focus and either a first-line drug recommendation or a screening recommendation leading to drug treatment. One investigator reviewed all CPG titles to exclude those that were clearly ineligible. Two reviewers independently reviewed all remaining guidelines and extracted data. We analyzed the data descriptively. Results We included 21 CPGs: 3 from government-sponsored organizations, 9 from disease or condition interest groups and 9 from medical professional societies. None of the 3 government-sponsored organizations reported industry funding, and none of their committee members disclosed financial conflicts of interest. Among the 18 disease or condition interest groups and medical professional societies, 14 (93%) of the 15 that disclosed funding sources on websites (3 did not disclose) reported organizational funding from industry, but none disclosed this information in the CPGs; 12 (86%) of the 14 with conflict-of-interest disclosure statements in the CPG (4 did not include disclosures) had at least 1 committee member with a financial conflict (mean proportion of committee members with a conflict 56%); and for all 8 CPGs with identifiable chairs or cochairs (chairs or cochairs not reported for 10) at least 1 of these people had a financial conflict of interest. None of the guidelines described a plan to manage organizational financial conflicts of interest. Interpretation Canadian CPGs are vulnerable to industry influence through funding of producers of guidelines and through the financial conflicts of interest of committee members. The CPG producers that receive industry funding should disclose organizational financial conflicts in the CPGs, should engage independent oversight committees and should restrict voting on recommendations to guideline panelists who have no financial conflicts.

The Canadian Task Force on Preventive Health Care is an independent body that develops evidence-based guidelines to support primary care providers to deliver the best possible preventive health care to Canadians. It comprises experts in primary care, public health, preventive medicine and guideline

Objective Two previous individual participant data meta-analyses (IPDMAs) found that different diagnostic interviews classify different proportions of people as having major depression overall or by symptom levels. We compared the odds of major depression classification across diagnostic interviews among studies that administered the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). Methods Data accrued for an IPDMA on HADS-D diagnostic accuracy were analysed. We fit binomial generalized linear mixed models to compare odds of major depression classification for the Structured Clinical Interview for DSM (SCID), Composite International Diagnostic Interview (CIDI), and Mini International Neuropsychiatric Interview (MINI), controlling for HADS-D scores and participant characteristics with and without an interaction term between interview and HADS-D scores. Results There were 15,856 participants (1942 [12%] with major depression) from 73 studies, including 15,335 (97%) non-psychiatric medical patients, 164 (1%) partners of medical patients, and 357 (2%) healthy adults. The MINI (27 studies, 7345 participants, 1066 major depression cases) classified participants as having major depression more often than the CIDI (10 studies, 3023 participants, 269 cases) (adjusted odds ratio [aOR] = 1.70 (0.84, 3.43)) and the semi-structured SCID (36 studies, 5488 participants, 607 cases) (aOR = 1.52 (1.01, 2.30)). The odds ratio for major depression classification with the CIDI was less likely to increase as HADS-D scores increased than for the SCID (interaction aOR = 0.92 (0.88, 0.96)). Conclusion Compared to the SCID, the MINI may diagnose more participants as having major depression, and the CIDI may be less responsive to symptom severity.

Background: Screening for major depression with the Patient Health Questionnaire-9 (PHQ-9) can be done using a cutoff or the PHQ-9 diagnostic algorithm. Many primary studies publish results for only one approach, and previous meta-analyses of the algorithm approach included only a subset of primary studies that collected data and could have published results. Objective: To use an individual participant data meta-analysis to evaluate the accuracy of two PHQ-9 diagnostic algorithms for detecting major depression and compare accuracy between the algorithms and the standard PHQ-9 cutoff score of ≥10. Methods: Medline, Medline In-Process and Other Non-Indexed Citations, PsycINFO, Web of Science (January 1, 2000, to February 7, 2015). Eligible studies that classified current major depression status using a validated diagnostic interview. Results: Data were included for 54 of 72 identified eligible studies (n participants = 16,688, n cases = 2,091). Among studies that used a semi-structured interview, pooled sensitivity and specificity (95% confidence interval) were 0.57 (0.49, 0.64) and 0.95 (0.94, 0.97) for the original algorithm and 0.61 (0.54, 0.68) and 0.95 (0.93, 0.96) for a modified algorithm. Algorithm sensitivity was 0.22–0.24 lower compared to fully structured interviews and 0.06–0.07 lower compared to the Mini International Neuropsychiatric Interview. Specificity was similar across reference standards. For PHQ-9 cutoff of ≥10 compared to semi-structured interviews, sensitivity and specificity (95% confidence interval) were 0.88 (0.82–0.92) and 0.86 (0.82–0.88). Conclusions: The cutoff score approach appears to be a better option than a PHQ-9 algorithm for detecting major depression.

BackgroundItem 9 of the Patient Health Questionnaire-9 (PHQ-9) queries about thoughts of death and self-harm, but not suicidality. Although it is sometimes used to assess suicide risk, most positive responses are not associated with suicidality. The PHQ-8, which omits Item 9, is thus increasingly used in research. We assessed equivalency of total score correlations and the diagnostic accuracy to detect major depression of the PHQ-8 and PHQ-9.MethodsWe conducted an individual patient data meta-analysis. We fit bivariate random-effects models to assess diagnostic accuracy.Results16 742 participants (2097 major depression cases) from 54 studies were included. The correlation between PHQ-8 and PHQ-9 scores was 0.996 (95% confidence interval 0.996 to 0.996). The standard cutoff score of 10 for the PHQ-9 maximized sensitivity + specificity for the PHQ-8 among studies that used a semi-structured diagnostic interview reference standard (N = 27). At cutoff 10, the PHQ-8 was less sensitive by 0.02 (−0.06 to 0.00) and more specific by 0.01 (0.00 to 0.01) among those studies (N = 27), with similar results for studies that used other types of interviews (N = 27). For all 54 primary studies combined, across all cutoffs, the PHQ-8 was less sensitive than the PHQ-9 by 0.00 to 0.05 (0.03 at cutoff 10), and specificity was within 0.01 for all cutoffs (0.00 to 0.01).ConclusionsPHQ-8 and PHQ-9 total scores were similar. Sensitivity may be minimally reduced with the PHQ-8, but specificity is similar.

Objective Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. Methods The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score ≥ 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via videoconference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention. Ethics and dissemination The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak., Highlights • No RCTs have tested mental health interventions in contagious disease outbreaks. • People with scleroderma face fear and isolation during COVID-19. • SPIN-CHAT is designed to improve mental health in SSc patients during COVID-19. • SPIN-CHAT provides 12 group sessions over 4 weeks. • The SPIN-CHAT trial will randomize 162 participants to intervention or waitlist.

A global team of influential researchers, clinicians, regulators, and citizen advocates suggest how we can start to build an evidence base for healthcare that is free of commercial influences

‘Overdiagnosis means making people patients unnecessarily, by identifying problems that were never going to cause harm or by medicalising ordinary life experiences through expanded definitions of diseases’ (Broderson et al). That definition seems intuitive and for certain diseases (like cancers), measurement of the extent of this phenomenon has been described. Measurement relies sometimes on data from randomized trials, e.g. the comparison of the number of incident cases in a screened group versus a non-screened group. In high-quality randomized screening trials with sufficient follow-up time and little or no contamination of the control group, the excess number of diagnosed cases in the screened group represents the degree of overdiagnosis. But, what about when there is no disease, when we are identifying problems defined by an estimated risk of a future event? That was the question faced by members of the Canadian Task Force on Preventive Health Care when developing a protocol for an evidence synthesis to support a guideline on screening to prevent fragility fractures. In that setting, the screened group is given a risk of a future event, not a diagnosis that could become apparent in the non-screened group. In fact, there are no symptoms to diagnose before somebody experiences a fracture, so these individuals would experience the outcome, not the ‘disease’ hereby defined as a risk. For the Task Force, in the setting of screening to prevent fragility fractures, overdiagnosed individuals are those who are deemed to be at excess risk of fracture – either according to a set threshold or based on shared decision-making –but who would have never known they were at risk because, without screening, they would not have experienced a fracture. We will explain the process that lead us to this definition and will give our perspective on how to calculate the degree of overdiagnosis when it is not possible to compare the occurrence of disease in screened and not screened groups. We believe this extension of the definition and the proposed way of calculating overdiagnosis in the setting of risk assessment is a way forward in the conceptualization of the overdiagnosis phenomenon. We will suggest that this could be applied to other chronic diseases, including, for example hypercholesterolemia and the risk of cardiovascular disease, where the value of cholesterol is also used (with other factors) to estimate risk and inform decisions. To our knowledge, it is the first time that overdiagnosis in risk assessment has been defined in this manner. Objectives Propose a way to conceptualize overdiagnosis and calculate its extent in the context of risk assessment. Method This is the result of a group reflection on the topic that started while trying to define outcomes for a systematic review on the prevention of fragility fractures. Results Starting from more common ways of understanding and calculating overdiagnosis we will present how we propose to achieve this in the setting of risk assessment. We will share the logic we followed and some graphical representation of our idea. Conclusions Overdiagnosis is not an easy concept to grasp when there is no disease. At times this has been simplified by labeling a risk as a disease (ex: osteoporosis is not a disease in itself; it confers a certain amount of risk of fractures). We will share our thoughts about a way to further understanding of overdiagnosis in the context of risk assessment.

Purpose: Our study aimed to identify caregiver characteristics (gender, age, occupational status, educational attainment, relation to care recipient), care recipient characteristics (age, disease subtype), and caregiving factors (hours of care, perceived caregiving burden) associated with symptoms of depression among informal caregivers of persons with systemic sclerosis (also known scleroderma). as Materials and methods: A questionnaire was developed and administered online from December 2016 to June 2017 to informal caregivers of people with scleroderma, including the Patient Health Questionnaire-9 to assess depressive symptoms. Multiple linear regression was used to identify factors associated with depressive symptoms. Results: Caregivers (n = 202) were 60.9% male. Average age was 57.2 years (standard deviation = 14.4 years). Most caregivers were partners (72.3%), children (11.9%), or parents (7.4%), of care recipients. Self-reported caregiving burden (standardized regression coefficient b = 0.54, p < 0.001) and hours of care per week ((Formula presented.) = 0.17, p = 0.005) were significantly associated with greater symptoms of depression. Conclusions: Depressive symptoms were primarily associated with caregiving burden among a sample of scleroderma caregivers. There is need to develop interventions targeting caregivers in scleroderma. Rehabilitation professionals should consider the specific needs of scleroderma caregivers and should provide or refer to support services as appropriate.Implications for Rehabilitation Most people diagnosed with scleroderma are cared for by an informal caregiver and the majority of these caregivers experience mild symptoms of depression. For caregivers that experience moderate to severe symptoms of depression, the ability to provide care to a loved one with scleroderma may be more difficult. Rehabilitation professionals should be aware of the burden faced by caregivers of persons with scleroderma and provide support services or referrals as appropriate.

KEY POINTS This guideline from the Canadian Task Force on Preventive Health Care focuses on screening for asymptomatic bacteriuria in pregnancy and re-examines the evidence supporting this routine practice in prenatal care. Asymptomatic bacteriuria is defined as a quantitative count of > 100 × 106

People with visible differences are often confronted with negative observer responses, including stares, disgust, and avoidance. Characteristics of negative observer responses are well-documented, but less is known about associated factors. We conducted a scoping review to map what is known about factors associated with negative observer responses. Web of Science, PubMed, PsycINFO, and CINAHL databases were searched, and 16 articles met inclusion criteria. Two general categories of factors were identified: (1) observer characteristics, including age, sex, and socioeconomic status, experiences with disfigurements, and personal beliefs or attitudes related to visible differences; and (2) evolved internal mechanisms, including threat-detection, disgust, and disease avoidance. Additionally, there was evidence that lack of anonymity influences lower reporting of observer reactions. Efforts that increase exposure to individuals with visible differences may ameliorate adverse reactions; however, due to the limited nature of evidence reviewed, further research is needed before more concrete recommendations can be made.

BackgroundDifferent diagnostic interviews are used as reference standards for major depression classification in research. Semi-structured interviews involve clinical judgement, whereas fully structured interviews are completely scripted. The Mini International Neuropsychiatric Interview (MINI), a brief fully structured interview, is also sometimes used. It is not known whether interview method is associated with probability of major depression classification.AimsTo evaluate the association between interview method and odds of major depression classification, controlling for depressive symptom scores and participant characteristics.MethodData collected for an individual participant data meta-analysis of Patient Health Questionnaire-9 (PHQ-9) diagnostic accuracy were analysed and binomial generalised linear mixed models were fit.ResultsA total of 17 158 participants (2287 with major depression) from 57 primary studies were analysed. Among fully structured interviews, odds of major depression were higher for the MINI compared with the Composite International Diagnostic Interview (CIDI) (odds ratio (OR) = 2.10; 95% CI = 1.15–3.87). Compared with semi-structured interviews, fully structured interviews (MINI excluded) were non-significantly more likely to classify participants with low-level depressive symptoms (PHQ-9 scores ≤6) as having major depression (OR = 3.13; 95% CI = 0.98–10.00), similarly likely for moderate-level symptoms (PHQ-9 scores 7–15) (OR = 0.96; 95% CI = 0.56–1.66) and significantly less likely for high-level symptoms (PHQ-9 scores ≥16) (OR = 0.50; 95% CI = 0.26–0.97).ConclusionsThe MINI may identify more people as depressed than the CIDI, and semi-structured and fully structured interviews may not be interchangeable methods, but these results should be replicated.Declaration of interestDrs Jetté and Patten declare that they received a grant, outside the submitted work, from the Hotchkiss Brain Institute, which was jointly funded by the Institute and Pfizer. Pfizer was the original sponsor of the development of the PHQ-9, which is now in the public domain. Dr Chan is a steering committee member or consultant of Astra Zeneca, Bayer, Lilly, MSD and Pfizer. She has received sponsorships and honorarium for giving lectures and providing consultancy and her affiliated institution has received research grants from these companies. Dr Hegerl declares that within the past 3 years, he was an advisory board member for Lundbeck, Servier and Otsuka Pharma; a consultant for Bayer Pharma; and a speaker for Medice Arzneimittel, Novartis, and Roche Pharma, all outside the submitted work. Dr Inagaki declares that he has received grants from Novartis Pharma, lecture fees from Pfizer, Mochida, Shionogi, Sumitomo Dainippon Pharma, Daiichi-Sankyo, Meiji Seika and Takeda, and royalties from Nippon Hyoron Sha, Nanzando, Seiwa Shoten, Igaku-shoin and Technomics, all outside of the submitted work. Dr Yamada reports personal fees from Meiji Seika Pharma Co., Ltd., MSD K.K., Asahi Kasei Pharma Corporation, Seishin Shobo, Seiwa Shoten Co., Ltd., Igaku-shoin Ltd., Chugai Igakusha and Sentan Igakusha, all outside the submitted work. All other authors declare no competing interests. No funder had any role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication.

KEY POINTS This guideline is available in French at [www.cmaj.ca/lookup/suppl/doi:10.1503/cmaj.171430/-/DC2][1] Impaired vision is an important health burden in both developed and developing countries, particularly among older adults.[1][2] The 2006 Participation and Activity Limitation Survey

Importance: Systematic reviews of diagnostic test accuracy synthesize data from primary diagnostic studies that have evaluated the accuracy of 1 or more index tests against a reference standard, provide estimates of test performance, allow comparisons of the accuracy of different tests, and facilitate the identification of sources of variability in test accuracy.Objective: To develop the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagnostic test accuracy guideline as a stand-alone extension of the PRISMA statement. Modifications to the PRISMA statement reflect the specific requirements for reporting of systematic reviews and meta-analyses of diagnostic test accuracy studies and the abstracts for these reviews.Design: Established standards from the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network were followed for the development of the guideline. The original PRISMA statement was used as a framework on which to modify and add items. A group of 24 multidisciplinary experts used a systematic review of articles on existing reporting guidelines and methods, a 3-round Delphi process, a consensus meeting, pilot testing, and iterative refinement to develop the PRISMA diagnostic test accuracy guideline. The final version of the PRISMA diagnostic test accuracy guideline checklist was approved by the group.Findings: The systematic review (produced 64 items) and the Delphi process (provided feedback on 7 proposed items; 1 item was later split into 2 items) identified 71 potentially relevant items for consideration. The Delphi process reduced these to 60 items that were discussed at the consensus meeting. Following the meeting, pilot testing and iterative feedback were used to generate the 27-item PRISMA diagnostic test accuracy checklist. To reflect specific or optimal contemporary systematic review methods for diagnostic test accuracy, 8 of the 27 original PRISMA items were left unchanged, 17 were modified, 2 were added, and 2 were omitted.Conclusions and Relevance: The 27-item PRISMA diagnostic test accuracy checklist provides specific guidance for reporting of systematic reviews. The PRISMA diagnostic test accuracy guideline can facilitate the transparent reporting of reviews, and may assist in the evaluation of validity and applicability, enhance replicability of reviews, and make the results from systematic reviews of diagnostic test accuracy studies more useful.