Publications by authors named "Brett D Thombs"

362 Publications

The Patient Engagement Evaluation Tool was valid for Clinical Practice Guideline Development.

J Clin Epidemiol 2021 Nov 28. Epub 2021 Nov 28.

Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada.

Objective: To evaluate reliability and validity of the 6-and 12-item Patient Engagement Evaluation Tool (PEET) to inform guideline developers about the quality of patient and public involvement activities.

Study Design And Setting: PEET-12 and 3 embedded validation questions were completed by patients and members of the public who participated in developing 10 guidelines between 2018 and 2020. Confirmatory factor analysis (CFA) was used to assess the validity of a single-dimension factor structure. Cronbach's alpha and Pearson correlations were calculated for internal consistency reliability. Concurrent validation was used to test the construct validity.

Results: 290 participants completed the PEET-12. To improve tool efficiency, based on results indicating redundancy from initial item analysis and experts' review, six of 12 items were included in the final tool (PEET-6). For the PEET-6, CFA supported the single-factor structure (χ(15) = 5173.4, p < 0.001, Tucker-Lewis Index = 1.00, Comparative Fit Index = 0.99, Root Mean Square Error of Approximation = 0.08). Correlation between the total score for the 3 validation questions and the PEET-6 total score was 0.71, 95% CI [0.65, 0.77], supporting construct validity.

Conclusion: PEET-6 and 12 are valid tools to measure patient and public involvement within settings of clinical practice guideline development.
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http://dx.doi.org/10.1016/j.jclinepi.2021.11.034DOI Listing
November 2021

The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial.

Trials 2021 Nov 27;22(1):856. Epub 2021 Nov 27.

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.

Background: Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. We completed an initial feasibility trial of an online self-administered version of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program using the cohort multiple randomized controlled trial (RCT) design. Due to low intervention offer uptake, we will conduct a new feasibility trial with progression to full-scale trial, using a two-arm parallel, partially nested RCT design. The SPIN-SELF Program has also been revised to include facilitator-led videoconference group sessions in addition to online material. We will test the group-based intervention delivery format, then evaluate the effect of the SPIN-SELF Program on disease management self-efficacy (primary) and patient activation, social appearance anxiety, and functional health outcomes (secondary).

Methods: This study is a feasibility trial with progression to full-scale RCT, pending meeting pre-defined criteria, of the SPIN-SELF Program. Participants will be recruited from the ongoing SPIN Cohort ( http://www.spinsclero.com/en/cohort ) and via social media and partner patient organizations. Eligible participants must have SSc and low to moderate disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) Scale score ≤ 7.0). Participants will be randomized (1:1 allocation) to the group-based SPIN-SELF Program or usual care for 3 months. The primary outcome in the full-scale trial will be disease management self-efficacy based on SEMCD Scale scores at 3 months post-randomization. Secondary outcomes include SEMCD scores 6 months post-randomization plus patient activation, social appearance anxiety, and functional health outcomes at 3 and 6 months post-randomization. We will include 40 participants to assess feasibility. At the end of the feasibility portion, stoppage criteria will be used to determine if the trial procedures or SPIN-SELF Program need important modifications, thereby requiring a re-set for the full-scale trial. Otherwise, the full-scale RCT will proceed, and outcome data from the feasibility portion will be utilized in the full-scale trial. In the full-scale RCT, 524 participants will be recruited.

Discussion: The SPIN-SELF Program may improve disease management self-efficacy, patient activation, social appearance anxiety, and functional health outcomes in people with SSc. SPIN works with partner patient organizations around the world to disseminate its programs free-of-charge.

Trial Registration: ClinicalTrials.gov NCT04246528 . Registered on 27 January 2020.
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http://dx.doi.org/10.1186/s13063-021-05827-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8626736PMC
November 2021

External Validation of a Shortened Screening Tool Using Individual Participant Data Meta-Analysis: a Case Study of the Patient Questionnaire-Dep-4.

Methods 2021 Nov 12. Epub 2021 Nov 12.

Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Québec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Québec, Canada; Department of Medicine, McGill University, Montréal, Québec, Canada; Department of Psychiatry, McGill University, Montréal, Québec, Canada; Department of Psychology, McGill University, Montréal, Québec, Canada; Department of Educational and Counselling Psychology, McGill University, Montréal, Québec, Canada; Biomedical Ethics Unit, McGill University, Montréal, Québec, Canada; The DEPRESSD PHQ Collaboration: Chen He, Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Québec, Canada.

Shortened versions of self-reported questionnaires may be used to reduce respondent burden. When shortened screening tools are used, it is desirable to maintain equivalent diagnostic accuracy to full-length forms. This manuscript presents a case study that illustrates how external data and individual participant data meta-analysis can be used to assess the equivalence in diagnostic accuracy between a shortened and full-length form. This case study compares the Patient Health Questionnaire-9 (PHQ-9) and a 4-item shortened version (PHQ-Dep-4) that was previously developed using optimal test assembly methods. Using a large database of 75 primary studies (34,698 participants, 3,392 major depression cases), we evaluated whether the PHQ-Dep-4 cutoff of ≥ 4 maintained equivalent diagnostic accuracy to a PHQ-9 cutoff of ≥ 10. Using this external validation dataset, a PHQ-Dep-4 cutoff of ≥ 4 maximized the sum of sensitivity and specificity, with a sensitivity of 0.88 (95% CI 0.81, 0.93), 0.68 (95% CI 0.56, 0.78), and 0.80 (95% CI 0.73, 0.85) for the semi-structured, fully structured, and MINI reference standard categories, respectively, and a specificity of 0.79 (95% CI 0.74, 0.83), 0.85 (95% CI 0.78, 0.90), and 0.83 (95% CI 0.80, 0.86) for the semi-structured, fully structured, and MINI reference standard categories, respectively. While equivalence with a PHQ-9 cutoff of ≥ 10 was not established, we found the sensitivity of the PHQ-Dep-4 to be non-inferior to that of the PHQ-9, and the specificity of the PHQ-Dep-4 to be marginally smaller than the PHQ-9.
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http://dx.doi.org/10.1016/j.ymeth.2021.11.005DOI Listing
November 2021

PHQ-8 scores and estimation of depression prevalence.

Lancet Public Health 2021 11;6(11):e793

Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, QC, Canada; Department of Medicine, McGill University, Montréal, QC, Canada; Department of Psychiatry, McGill University, Montréal, QC, Canada; Department of Psychology, McGill University, Montréal, QC, Canada; Department of Educational and Counselling Psychology, McGill University, Montréal, QC, Canada; Biomedical Ethics Unit, McGill University, Montréal, QC, Canada; Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, QC, Canada.

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http://dx.doi.org/10.1016/S2468-2667(21)00229-2DOI Listing
November 2021

Accuracy of the Patient Health Questionnaire-9 for screening to detect major depression: updated systematic review and individual participant data meta-analysis.

BMJ 2021 10 5;375:n2183. Epub 2021 Oct 5.

Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, QC, Canada

Objective: To update a previous individual participant data meta-analysis and determine the accuracy of the Patient Health Questionnaire-9 (PHQ-9), the most commonly used depression screening tool in general practice, for detecting major depression overall and by study or participant subgroups.

Design: Systematic review and individual participant data meta-analysis.

Data Sources: Medline, Medline In-Process, and Other Non-Indexed Citations via Ovid, PsycINFO, Web of Science searched through 9 May 2018.

Review Methods: Eligible studies administered the PHQ-9 and classified current major depression status using a validated semistructured diagnostic interview (designed for clinician administration), fully structured interview (designed for lay administration), or the Mini International Neuropsychiatric Interview (MINI; a brief interview designed for lay administration). A bivariate random effects meta-analytic model was used to obtain point and interval estimates of pooled PHQ-9 sensitivity and specificity at cut-off values 5-15, separately, among studies that used semistructured diagnostic interviews (eg, Structured Clinical Interview for Diagnostic and Statistical Manual), fully structured interviews (eg, Composite International Diagnostic Interview), and the MINI. Meta-regression was used to investigate whether PHQ-9 accuracy correlated with reference standard categories and participant characteristics.

Results: Data from 44 503 total participants (27 146 additional from the update) were obtained from 100 of 127 eligible studies (42 additional studies; 79% eligible studies; 86% eligible participants). Among studies with a semistructured interview reference standard, pooled PHQ-9 sensitivity and specificity (95% confidence interval) at the standard cut-off value of ≥10, which maximised combined sensitivity and specificity, were 0.85 (0.79 to 0.89) and 0.85 (0.82 to 0.87), respectively. Specificity was similar across reference standards, but sensitivity in studies with semistructured interviews was 7-24% (median 21%) higher than with fully structured reference standards and 2-14% (median 11%) higher than with the MINI across cut-off values. Across reference standards and cut-off values, specificity was 0-10% (median 3%) higher for men and 0-12 (median 5%) higher for people aged 60 or older.

Conclusions: Researchers and clinicians could use results to determine outcomes, such as total number of positive screens and false positive screens, at different PHQ-9 cut-off values for different clinical settings using the knowledge translation tool at www.depressionscreening100.com/phq.

Study Registration: PROSPERO CRD42014010673.
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http://dx.doi.org/10.1136/bmj.n2183DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8491108PMC
October 2021

Reporting transparency and completeness in trials: Paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records - room for improvement.

J Clin Epidemiol 2021 Sep 12. Epub 2021 Sep 12.

Nuffield Department of Population Health, National Perinatal Epidemiology Unit Clinical Trials Unit, University of Oxford, Oxford, United Kingdom; Nottingham Clinical Trials Unit, Applied Health Research Building, University of Nottingham, Nottingham, United Kingdom. Electronic address:

Objective: To describe characteristics of randomized controlled trials (RCTs) conducted using electronic health records (EHRs), including completeness and transparency of reporting assessed against the 2021 CONSORT Extension for RCTs Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria.

Study Design: MEDLINE and Cochrane Methodology Register were searched for a sample of RCTs published from 2011-2018. Completeness of reporting was assessed in a random sample using a pre-defined coding form.

Results: Of the 183 RCT publications identified, 122 (67%) used EHRs to identify eligible participants, 139 (76%) used the EHR as part of the intervention and 137 (75%) to ascertain outcomes. When 60 publications were evaluated against the CONSORT 2010 item and the corresponding extension for the 8 modified items, four items were 'adequately reported' for most trials. Five new reporting items were identified for the CONSORT-ROUTINE extension; when evaluated, one was 'adequately reported', three were reported 'inadequately or not at all', the other 'partially'. There were, however, some encouraging signs with adequate and partial reporting of many important items, including descriptions of trial design, the consent process, outcome ascertainment and interpretation.

Conclusion: Aspects of RCTs using EHRs are sub-optimally reported. Uptake of the CONSORT-ROUTINE Extension may improve reporting.
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http://dx.doi.org/10.1016/j.jclinepi.2021.09.011DOI Listing
September 2021

Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results.

J Clin Epidemiol 2021 Sep 12. Epub 2021 Sep 12.

Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland; Meta-Research Innovation Center Berlin (METRIC-B), Berlin Institute of Health, Berlin, Germany; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, USA.

Objective: Registries are important data sources for randomized controlled trials (RCTs), but reporting of how they are used may be inadequate. The objective was to describe the current adequacy of reporting of RCTs using registries.

Study Design And Setting: We used a database of trials using registries from a scoping review supporting the development of the 2021 CONSORT extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reporting completeness of 13 CONSORT-ROUTINE items was assessed.

Results: We assessed reports of 47 RCTs that used a registry, published between 2011 and 2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half of reports (2 in at least 80%). The 7 other items were related to routinely collected data source eligibility (32% adequate), data linkage (8% adequate), validation and completeness of data used for outcome assessment (8% adequate), validation and completeness of data used for participant recruitment (0% adequate), participant flow (9% adequate), registry funding (6% adequate) and interpretation of results in consideration of registry use (25% adequate).

Conclusion: Reporting of trials using registries was often poor, particularly details on data linkage and quality. Better reporting is needed for appropriate interpretation of the results of these trials.
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http://dx.doi.org/10.1016/j.jclinepi.2021.09.012DOI Listing
September 2021

Reporting transparency and completeness in trials: Paper 1: Introduction - Better reporting for disruptive clinical trials using routinely collected data.

J Clin Epidemiol 2021 Sep 12. Epub 2021 Sep 12.

Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Departments of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada.

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http://dx.doi.org/10.1016/j.jclinepi.2021.09.017DOI Listing
September 2021

Reporting transparency and completeness in trials: Paper 3 - trials conducted using administrative databases do not adequately report elements related to use of databases.

J Clin Epidemiol 2021 Sep 11. Epub 2021 Sep 11.

Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada.

Objective: We evaluated reporting completeness and transparency in randomized controlled trials (RCTs) conducted using administrative data based on 2021 CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria.

Study Design And Setting: MEDLINE and the Cochrane Methodology Register were searched (2011 and 2018). Eligible RCTs used administrative databases for identifying eligible participants or collecting outcomes. We evaluated reporting based on CONSORT-ROUTINE, which modified eight items from CONSORT 2010 and added five new items.

Results: Of 33 included trials (76% used administrative databases for outcomes, 3% for identifying participants, 21% both), most were conducted in the United States (55%), Canada (18%), or the United Kingdom (12%). Of eight items modified in the extension; six were adequately reported in a majority (>50%) of trials. For the CONSORT-ROUTINE modification portion of those items, three items were reported adequately in >50% of trials, two in <50%, two only applied to some trials, and one only had wording modifications and was not evaluated. For five new items, four that address use of routine data in trials were reported inadequately in most trials.

Conclusion: How administrative data are used in trials is often sub-optimally reported. CONSORT-ROUTINE uptake may improve reporting.
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http://dx.doi.org/10.1016/j.jclinepi.2021.09.010DOI Listing
September 2021

Intensity of care and perceived burden among informal caregivers to persons with chronic medical conditions: a systematic review and meta-analysis.

Disabil Rehabil 2021 Aug 29:1-17. Epub 2021 Aug 29.

Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Canada.

Purpose: Informal caregivers provide ongoing assistance to a loved one with a health condition. No studies have compared caregiving intensity and perception of burden across chronic medical conditions.

Materials And Methods: Databases were searched from inception through 11 September 2020 to identify studies that included the Level of Care Index or the Zarit Burden Inventory (ZBI) among caregivers for people with chronic diseases. Pooled mean ZBI scores and 95% confidence intervals by medical condition were calculated using a random effects model and heterogeneity with .

Results: Ninety-seven included articles reported on 98 unique samples across 21 chronic diseases. No study used the Level of Care Index. Among 12 disease groups with more than one study, heterogeneity was too high ( range: 0-99.6%, ≥76.5% in 11 groups) to confidently estimate burden. The percent of studies rated high risk of bias ranged from 0% to 98%, but all external validity items were rated as high-risk in >50% of studies.

Conclusions: Findings highlight the need for studies on caregiver burden to improve sampling techniques; better report sampling procedures and caregiver and care recipient characteristics; and develop a standard set of outcomes, including a measure of caregiving intensity. CRD42017080962IMPLICATIONS FOR REHABILITATIONThe amount of burden reported by caregivers to loved ones is associated with reduced physical and mental health.We found considerable heterogeneity in perceived burden reported by informal caregivers across different studies within disease groups, which is likely related to methodological issues, including sampling techniques.Health care providers who use research on caregiver burden should assess how representative study samples may be and exercise caution in drawing conclusions.
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http://dx.doi.org/10.1080/09638288.2021.1966675DOI Listing
August 2021

Does depression screening in primary care improve mental health outcomes?

BMJ 2021 07 19;374:n1661. Epub 2021 Jul 19.

Johns Hopkins University School of Medicine, Baltimore, MD, USA.

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http://dx.doi.org/10.1136/bmj.n1661DOI Listing
July 2021

Conduite avec facultés affaiblies après la légalisation du cannabis à usage récréatif.

CMAJ 2021 Jul;193(27):E1071-E1075

Institut Lady Davis (Windle, Sequeira, Filion, Thombs, Reynier, Grad, Ells, Eisenberg), Hôpital général juif; Département d'épidémiologie, de biostatistique et de santé du travail (Windle, Filion, Thombs, Eisenberg), Université McGill; Faculté de médecine (Filion, Thombs, Eisenberg), Université McGill; Départements de psychiatrie, de psychologie et de psychologie de l'enseignement et du counseling (Thombs), Université McGill; Département de médecine familiale (Grad, Ells), Université McGill; Unité d'éthique biomédicale, Division de médecine expérimentale et Département des sciences sociales en médecine (Ells), Université McGill; Département de cardiologie (Eisenberg), Hôpital général juif, Montréal, Qc.

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http://dx.doi.org/10.1503/cmaj.191032-fDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8342014PMC
July 2021

Translation and validation in Brazilian Portuguese of the reactions to homosexuality scale.

Psychol Health Med 2021 Jan-Dec;26(sup1):20-36

Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Québec, Canada.

Internalized homonegativity results from the acceptance of negative attitudes about one's same-sex orientation, which has negative consequences for the health of gay, bisexual and other men who have sex with men (GBM). We translated the 7-item Reactions to Homosexuality Scale (RHS) to Brazilian Portuguese and assessed its factor structure, validity and reliability. The first step included the translation, back-translation, evaluation, peer review, and pre-testing of the scale. Then, we piloted the scale in two convenience samples of adult Brazilians recruited online during October 2019 and February to March 2020 through advertisements on Grindr and Hornet, respectively. The largest sample was randomly split into two groups for exploratory factor analysis (EFA) then confirmatory factor analysis (CFA). Criterion and construct validity were assessed via correlations between scale scores and study variables. A total of 5573 GBM (sample 1: 218; sample 2: 5355) completed the RHS. EFA (N = 2652) yielded two eigenvalues greater than one (Factor 1: 3.5 and Factor 2: 1.1). A one-factor solution provided the most interpretable model based on examination of scree plot and item factor loadings (χ2(14) = 1373.1, p < 0.001; CFI = 0.89; TLI = 0.84; RMSEA = 0.19; SRMS = 0.09). Though one-factor CFA showed moderate fit, freeing errors terms to covary, based on item content and interpretation, significantly improved model fit (χ2(12) = 309.1, p < .001; CFI = 0.97; TLI = 0.96; RMSEA = 0.09; SRMR = 0.02). As hypothesized, men who did not self-identify as gay (mean score 17.9 compared to those self-identifying as gay: 11.8) and men who reported no sex with men in the past 6 months (mean score 12.6 compared to those who reported sex with men: 10.6) scored higher reflecting higher internalized homonegativity. The RHS was effectively translated and validated in Brazilian Portuguese and can be used to evaluate the role of internalized homonegativity on GBM's health, as well as its impact on the uptake of HIV prevention technologies.
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http://dx.doi.org/10.1080/13548506.2021.1936580DOI Listing
July 2021

Nutrition Information Resources Used by People With Systemic Sclerosis and Perceived Advantages and Disadvantages: A Nominal Group Technique Study.

ACR Open Rheumatol 2021 Aug 1;3(8):540-549. Epub 2021 Jul 1.

Lady Davis Institute for Medical Research, Jewish General Hospital and McGill University, Montreal, Quebec, Canada.

Objective: Where people with systemic sclerosis (SSc) (or scleroderma) obtain diet and nutrition information to manage their disease is not known. Objectives were to identify 1) resources used by people with SSc for nutrition and diet information and 2) perceived advantages and disadvantages of resources.

Methods: We conducted nominal group technique (NGT) sessions in which people with SSc reported nutrition and diet information resources they have used and perceived advantages and disadvantages of accessing and using resources. Participants indicated whether they had tried each resource. They rated helpfulness and importance of possible advantages and disadvantages. Items elicited across sessions were merged to eliminate overlap.

Results: We conducted four NGT sessions (three English language, one French language; 15 total participants) and identified 33 unique information resources, 147 resource-specific advantages, and 118 resource-specific disadvantages. Resource categories included health care providers, alternative and complementary practitioners, websites and other media platforms, events, and print materials. The most common themes for advantages and disadvantages included quality and individualization of information and accessibility of resources in terms of cost, location, and comprehensibility. Information provided by medical professionals was regarded as most credible and can be obtained through books, articles, and websites if individual consultation is not easily accessible. Web-based information was considered highly accessible, although of variable credibility. In-person events may be an important source of health information for people with SSc.

Conclusion: People with SSc obtain nutrition and diet information from multiple resources. They seek credible and accessible resources that provide SSc-specific and individualized information.
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http://dx.doi.org/10.1002/acr2.11293DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8363851PMC
August 2021

Pain and Self-Efficacy Among Patients With Systemic Sclerosis: A Scleroderma Patient-Centered Intervention Network Cohort Study.

Nurs Res 2021 Set/Oct 01;70(5):334-343

Background: Pain is one of the most common symptoms affecting patients with systemic sclerosis; however, little is known about the relationship between self-efficacy and pain and changes in pain over time.

Objectives: The purpose of this study was to describe the relationships between self-efficacy and pain in patients with systemic sclerosis, as well as determine whether changes in self-efficacy mediate changes in pain.

Methods: A prospective longitudinal study was conducted using data from the Scleroderma Patient-Centered Intervention Network Cohort. The baseline sample included 1,903 adults, with a trajectory subsample of 427 who completed 3-month assessments across 3 years. Hierarchical (sequential) forward multivariable regression, covarying for participant characteristics, was conducted to determine the association between self-efficacy and patient characteristics on pain outcomes. Trajectory models, covarying for participant characteristics, were used to examine changes in self-efficacy and pain outcomes across time and whether self-efficacy mediated the pain trajectories.

Results: Mean time since diagnosis was 9.5 years, with 39.2% diagnosed with diffuse cutaneous systemic sclerosis. Greater self-efficacy was associated with less pain interference and intensity. Increasing age, female gender, finger ulcers, and small joint contractures were related to greater pain interference and intensity. Esophageal gastrointestinal symptoms were associated with more pain interference. Self-efficacy and pain trajectories remained stable across time, and self-efficacy did not mediate the pain trajectories.

Discussion: This study identified self-efficacy, age, gender, finger ulcers, small joint contractures, and esophageal gastrointestinal symptoms as important correlates associated with pain in patients with systemic sclerosis. In addition, this study found that self-efficacy and pain outcomes remained stable over time, providing important insights into the longitudinal pain experiences of patients with systemic sclerosis.
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http://dx.doi.org/10.1097/NNR.0000000000000528DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8543734PMC
September 2021

Peer-to-Peer Support for Older Adults-What Do We Know and Where Do We Go?

JAMA Netw Open 2021 Jun 1;4(6):e2113941. Epub 2021 Jun 1.

Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Québec, Canada.

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http://dx.doi.org/10.1001/jamanetworkopen.2021.13941DOI Listing
June 2021

The CODIACS-QoL trial: Ineffective but cost-effective?

Gen Hosp Psychiatry 2021 Jul-Aug;71:140-141. Epub 2021 May 24.

Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Québec, Canada; Department of Psychiatry, McGill University, Montréal, Québec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Québec, Canada; Department of Medicine, McGill University, Montréal, Québec, Canada; Department of Psychology, McGill University, Montréal, Québec, Canada; Department of Educational and Counselling Psychology, McGill University, Montréal, Québec, Canada; Department of Biomedical Ethics Unit, McGill University, Montréal, Québec, Canada.

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http://dx.doi.org/10.1016/j.genhosppsych.2021.05.002DOI Listing
May 2021

Selective cutoff reporting in studies of the accuracy of the Patient Health Questionnaire-9 and Edinburgh Postnatal Depression Scale: Comparison of results based on published cutoffs versus all cutoffs using individual participant data meta-analysis.

Int J Methods Psychiatr Res 2021 09 12;30(3):e1873. Epub 2021 May 12.

Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Québec, Canada.

Objectives: Selectively reported results from only well-performing cutoffs in diagnostic accuracy studies may bias estimates in meta-analyses. We investigated cutoff reporting patterns for the Patient Health Questionnaire-9 (PHQ-9; standard cutoff 10) and Edinburgh Postnatal Depression Scale (EPDS; no standard cutoff, commonly used 10-13) and compared accuracy estimates based on published cutoffs versus all cutoffs.

Methods: We conducted bivariate random effects meta-analyses using individual participant data to compare accuracy from published versus all cutoffs.

Results: For the PHQ-9 (30 studies, N = 11,773), published results underestimated sensitivity for cutoffs below 10 (median difference: -0.06) and overestimated for cutoffs above 10 (median difference: 0.07). EPDS (19 studies, N = 3637) sensitivity estimates from published results were similar for cutoffs below 10 (median difference: 0.00) but higher for cutoffs above 13 (median difference: 0.14). Specificity estimates from published and all cutoffs were similar for both tools. The mean cutoff of all reported cutoffs in PHQ-9 studies with optimal cutoff below 10 was 8.8 compared to 11.8 for those with optimal cutoffs above 10. Mean for EPDS studies with optimal cutoffs below 10 was 9.9 compared to 11.8 for those with optimal cutoffs greater than 10.

Conclusion: Selective cutoff reporting was more pronounced for the PHQ-9 than EPDS.
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http://dx.doi.org/10.1002/mpr.1873DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8412225PMC
September 2021

Accuracy of the Hospital Anxiety and Depression Scale Depression subscale (HADS-D) to screen for major depression: systematic review and individual participant data meta-analysis.

BMJ 2021 05 10;373:n972. Epub 2021 May 10.

Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, QC, Canada

Objective: To evaluate the accuracy of the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D) to screen for major depression among people with physical health problems.

Design: Systematic review and individual participant data meta-analysis.

Data Sources: Medline, Medline In-Process and Other Non-Indexed Citations, PsycInfo, and Web of Science (from inception to 25 October 2018).

Review Methods: Eligible datasets included HADS-D scores and major depression status based on a validated diagnostic interview. Primary study data and study level data extracted from primary reports were combined. For HADS-D cut-off thresholds of 5-15, a bivariate random effects meta-analysis was used to estimate pooled sensitivity and specificity, separately, in studies that used semi-structured diagnostic interviews (eg, Structured Clinical Interview for ), fully structured interviews (eg, Composite International Diagnostic Interview), and the Mini International Neuropsychiatric Interview. One stage meta-regression was used to examine whether accuracy was associated with reference standard categories and the characteristics of participants. Sensitivity analyses were done to assess whether including published results from studies that did not provide raw data influenced the results.

Results: Individual participant data were obtained from 101 of 168 eligible studies (60%; 25 574 participants (72% of eligible participants), 2549 with major depression). Combined sensitivity and specificity was maximised at a cut-off value of seven or higher for semi-structured interviews, fully structured interviews, and the Mini International Neuropsychiatric Interview. Among studies with a semi-structured interview (57 studies, 10 664 participants, 1048 with major depression), sensitivity and specificity were 0.82 (95% confidence interval 0.76 to 0.87) and 0.78 (0.74 to 0.81) for a cut-off value of seven or higher, 0.74 (0.68 to 0.79) and 0.84 (0.81 to 0.87) for a cut-off value of eight or higher, and 0.44 (0.38 to 0.51) and 0.95 (0.93 to 0.96) for a cut-off value of 11 or higher. Accuracy was similar across reference standards and subgroups and when published results from studies that did not contribute data were included.

Conclusions: When screening for major depression, a HADS-D cut-off value of seven or higher maximised combined sensitivity and specificity. A cut-off value of eight or higher generated similar combined sensitivity and specificity but was less sensitive and more specific. To identify medically ill patients with depression with the HADS-D, lower cut-off values could be used to avoid false negatives and higher cut-off values to reduce false positives and identify people with higher symptom levels.

Trial Registration: PROSPERO CRD42015016761.
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http://dx.doi.org/10.1136/bmj.n972DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8107836PMC
May 2021

Effects of non-pharmacological and non-surgical interventions on health outcomes in systemic sclerosis: protocol for a living systematic review.

BMJ Open 2021 05 4;11(5):e047428. Epub 2021 May 4.

Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada

Introduction: Systemic sclerosis (SSc; scleroderma) is a rare, chronic, autoimmune disease with a high level of burden, a significant impact on the ability to carry out daily activities, and a considerable negative impact on health-related quality of life. Non-pharmacological interventions could be provided to potentially improve mental and physical health outcomes. However, the effectiveness of non-pharmacological interventions on health and well-being among individuals with SSc has not been well established. The proposed living systematic review aims to identify and evaluate randomised controlled trial (RCT) evidence on the effectiveness of non-pharmacological and non-surgical interventions on mental and physical health outcomes and on the delivery of such services in SSc.

Methods And Analysis: Eligible studies will be RCTs that examine non-pharmacological and non-surgical interventions aimed at improving health outcomes among individuals with SSc or the delivery of services intended to improve healthcare or support of people with SSc (eg, support groups). All RCTs included in a previous systematic review that sought studies published between 1990 and March 2014 will be evaluated for inclusion. Additional trials will be sought from January 2014 onwards using a similar, augmented search strategy developed by a health sciences librarian. We will search the MEDLINE, Embase, CINAHL, PsycINFO, Cochrane Library and Web of Science databases and will not restrict by language. Two independent reviewers will determine the eligibility of identified RCTs and will extract data using a prespecified standardised form in DistillerSR. Meta-analyses will be considered if ≥2 eligible RCTs report similar non-pharmacological interventions and comparable health outcomes. We will conduct a qualitative synthesis for interventions that cannot be synthesised via meta-analysis.

Ethics And Dissemination: We will post initial and ongoing results via a website, publish results periodically via peer-reviewed journal publication, and present results at patient-oriented events.

Prospero Registration Number: CRD42020219914.
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http://dx.doi.org/10.1136/bmjopen-2020-047428DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8098987PMC
May 2021

Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE).

BMJ Open 2021 04 29;11(4):e049093. Epub 2021 Apr 29.

Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada

Objectives: Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist.

Methods: The development process involved five stages: (1) identification of the need for a reporting guideline and project launch; (2) conduct of a scoping review to identify possible modifications to CONSORT 2010 checklist items and possible new extension items; (3) a three-round modified Delphi study involving key stakeholders to gather feedback on the checklist; (4) a consensus meeting to finalise items to be included in the extension, followed by stakeholder piloting of the checklist; and (5) publication, dissemination and implementation of the final checklist.

Results: 27 items were initially developed and rated in Delphi round 1, 13 items were rated in round 2 and 11 items were rated in round 3. Response rates for the Delphi study were 92 of 125 (74%) invited participants in round 1, 77 of 92 (84%) round 1 completers in round 2 and 62 of 77 (81%) round 2 completers in round 3. Twenty-seven members of the project team representing a variety of stakeholder groups attended the in-person consensus meeting. The final checklist includes five new items and eight modified items. The extension Explanation & Elaboration document further clarifies aspects that are important to report.

Conclusion: Uptake of CONSORT-ROUTINE and accompanying Explanation & Elaboration document will improve conduct of trials, as well as the transparency and completeness of reporting of trials conducted using cohorts and routinely collected data.
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http://dx.doi.org/10.1136/bmjopen-2021-049093DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8094349PMC
April 2021

Effects of a multi-faceted education and support programme on anxiety symptoms among people with systemic sclerosis and anxiety during COVID-19 (SPIN-CHAT): a two-arm parallel, partially nested, randomised, controlled trial.

Lancet Rheumatol 2021 Jun 16;3(6):e427-e437. Epub 2021 Apr 16.

Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC, Canada.

Background: No trials have tested multifaceted mental health interventions recommended by public health organisations during COVID-19. The objective of this trial was to evaluate the effect of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Program on anxiety symptoms and other mental health outcomes among people vulnerable during COVID-19 owing to a pre-existing medical condition.

Methods: The SPIN-CHAT Trial was a pragmatic, two-arm, parallel, partially nested, randomised, controlled trial (1:1 allocation to intervention or waitlist). Eligible participants with systemic sclerosis were recruited from the international SPIN COVID-19 Cohort. SPIN COVID-19 Cohort participants were eligible for the trial if they completed baseline measures and had at least mild anxiety symptoms, had not tested positive for COVID-19, and were not currently receiving mental health counselling. SPIN-CHAT is a 4-week (3 sessions per week) videoconference-based group intervention that provided education and practice with mental health coping strategies, and provided social support to reduce isolation. Groups included 6-10 participants. The primary outcome analysed in the intention-to-treat population was anxiety symptoms (PROMIS Anxiety 4a version 1.0) immediately post-intervention. This trial is registered with ClinicalTrials.gov, NCT04335279 and is complete.

Findings: Of participants who completed baseline measures between April 9, 2020, and April 27, 2020, 560 participants were eligible and 172 participants were randomly assigned to intervention (n=86) or waitlist (n=86). Mean age was 55·0 years (SD 11·4 years), 162 (94%) were women, and 136 (79%) identified as White. In intention-to-treat analyses, the intervention did not significantly reduce anxiety symptoms post-intervention (-1·57 points, 95% CI -3·59 to 0·45; standardised mean difference [SMD] -0·22 points) but reduced symptoms 6 weeks later (-2·36 points, 95% CI -4·56 to -0·16; SMD -0·31). Depression symptoms were significantly lower 6 weeks post-intervention (-1·64 points, 95% CI -2·91 to -0·37; SMD -0·31); no other secondary outcomes were significant. No adverse events were reported.

Interpretation: The intervention did not significantly improve anxiety symptoms or other mental health outcomes post-intervention. However, anxiety and depression symptoms were significantly lower 6 weeks later, potentially capturing the time it took for new skills and social support between intervention participants to affect mental health. Multi-faceted interventions such as SPIN-CHAT have potential to address mental health needs in vulnerable groups during COVID-19, yet uncertainty remains about effectiveness.

Funding: Canadian Institutes of Health Research (CIHR; VR4-172745, MS1-173066); McGill Interdisciplinary Initiative in Infection and Immunity Emergency COVID-19 Research Fund; Scleroderma Canada, made possible by an educational grant for patient support programming from Boehringer Ingelheim; the Scleroderma Society of Ontario; Scleroderma Manitoba; Scleroderma Atlantic; Scleroderma Australia; Scleroderma New South Wales; Scleroderma Victoria; Scleroderma Queensland; Scleroderma SASK; the Scleroderma Association of BC; and Sclérodermie Québec.
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http://dx.doi.org/10.1016/S2665-9913(21)00060-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8051930PMC
June 2021

Recommandation relative au dépistage de la chlamydia et de la gonorrhée en soins primaires chez les personnes non connues comme appartenant à un groupe à risque.

CMAJ 2021 04;193(16):E573-E584

Département de médecine familiale (Moore), Université McMaster, Hamilton, Ont.; Agence de la santé publique du Canada ( Subnath, Traversy), Ottawa, Ont.; Département de médecine familiale et communautaire (Reynolds), Université de Toronto, Toronto, Ont.; Département de médecine familiale (Riva), Université McMaster, Hamilton, Ont.; Faculté de médecine (Thériault), Université McGill, Montréal, Qc; Division de santé communautaire et humanités (Wilson), Université Memorial, T.-N.-L.; Institut Lady Davis et Département de psychiatrie (Thombs), Hôpital général juif et Université McGill, Montréal, Qc.

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http://dx.doi.org/10.1503/cmaj.201967-fDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8084558PMC
April 2021

Recommendation on screening for chlamydia and gonorrhea in primary care for individuals not known to be at high risk.

CMAJ 2021 04;193(16):E549-E559

Department of Family Medicine (Moore), McMaster University, Hamilton, Ont.; Public Health Agency of Canada (Subnath, Traversy), Ottawa, Ont.; Department of Family and Community Medicine (Reynolds), University of Toronto, Toronto, Ont.; Department of Family Medicine (Riva), McMaster University, Hamilton, Ont.; Faculty of Medicine (Thériault) McGill University, Montréal, Que.; Division of Community Health and Humanities (Wilson), Memorial University, NFLD; Lady Davis Institute and Department of Psychiatry (Thombs), Jewish General Hospital and McGill University, Montréal, Que.

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http://dx.doi.org/10.1503/cmaj.201967DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8084554PMC
April 2021

Data-driven methods distort optimal cutoffs and accuracy estimates of depression screening tools: a simulation study using individual participant data.

J Clin Epidemiol 2021 09 8;137:137-147. Epub 2021 Apr 8.

Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montréal, Québec, Canada. Electronic address:

Objective: To evaluate, across multiple sample sizes, the degree that data-driven methods result in (1) optimal cutoffs different from population optimal cutoff and (2) bias in accuracy estimates.

Study Design And Setting: A total of 1,000 samples of sample size 100, 200, 500 and 1,000 each were randomly drawn to simulate studies of different sample sizes from a database (n = 13,255) synthesized to assess Edinburgh Postnatal Depression Scale (EPDS) screening accuracy. Optimal cutoffs were selected by maximizing Youden's J (sensitivity+specificity-1). Optimal cutoffs and accuracy estimates in simulated samples were compared to population values.

Results: Optimal cutoffs in simulated samples ranged from ≥ 5 to ≥ 17 for n = 100, ≥ 6 to ≥ 16 for n = 200, ≥ 6 to ≥ 14 for n = 500, and ≥ 8 to ≥ 13 for n = 1,000. Percentage of simulated samples identifying the population optimal cutoff (≥ 11) was 30% for n = 100, 35% for n = 200, 53% for n = 500, and 71% for n = 1,000. Mean overestimation of sensitivity and underestimation of specificity were 6.5 percentage point (pp) and -1.3 pp for n = 100, 4.2 pp and -1.1 pp for n = 200, 1.8 pp and -1.0 pp for n = 500, and 1.4 pp and -1.0 pp for n = 1,000.

Conclusions: Small accuracy studies may identify inaccurate optimal cutoff and overstate accuracy estimates with data-driven methods.
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http://dx.doi.org/10.1016/j.jclinepi.2021.03.031DOI Listing
September 2021

Cross-cultural adaptation of the Perceived Risk of HIV Scale in Brazilian Portuguese.

Health Qual Life Outcomes 2021 Apr 9;19(1):117. Epub 2021 Apr 9.

Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Québec, Canada.

Background: Valid and reliable instruments are needed to measure the multiple dimensions of perceived risk. The Perceived Risk of HIV Scale is an 8-item measure that assesses how people think and feel about their risk of infection. We set out to perform a cross-cultural adaptation of the scale to Brazilian Portuguese among key populations (gay, bisexual and other men who have sex with men and transgender/non-binary) and other populations (cisgender heterosexual men and cisgender women).

Methods: Methodological study with cross-sectional design conducted online during October/2019 (key populations [sample 1] and other populations) and February-March/2020 (key populations not on pre-exposure prophylaxis [sample 2]). Cross-cultural adaptation of the Perceived Risk of HIV Scale followed Beaton et al. 2000 guidelines and included confirmatory factor analysis, differential item functioning (DIF) using the Multiple-Indicator Multiple-Cause model, and concurrent validity to verify if younger individuals, those ever testing for HIV, and engaging in high-risk behaviors had higher scores on the scale.

Results: 4342 participants from key populations (sample 1 = 235; sample 2 = 4107) and 155 participants from other populations completed the measure. We confirmed the single-factor structure of the original measure (fit indices for sample 1 plus other populations: CFI = 0.98, TLI = 0.98, RMSEA = 0.07; sample 2 plus other populations: CFI = 0.97, TLI = 0.95, RMSEA = 0.09). For the comparisons between key populations and other populations, three items (item 2: "I worry about getting infected with HIV", item 4: "I am sure I will not get infected with HIV", and item 8: "Getting HIV is something I have") exhibited statistically significant DIF. Items 2 and 8 were endorsed at higher levels by key populations and item 4 by other populations. However, the effect of DIF on overall scores was negligible (0.10 and 0.02 standard deviations for the models with other populations plus sample 1 and 2, respectively). Those ever testing for HIV scored higher than those who never tested (p < .001); among key populations, those engaging in high-risk behaviors scored higher than those reporting low-risk.

Conclusion: The Perceived Risk of HIV Scale can be used among key populations and other populations from Brazil.
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http://dx.doi.org/10.1186/s12955-021-01760-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8033701PMC
April 2021

Impaired driving and legalization of recreational cannabis.

CMAJ 2021 Apr;193(14):E481-E485

Lady Davis Institute (Windle, Sequeira, Filion, Thombs, Reynier, Grad, Ells, Eisenberg), Jewish General Hospital; Department of Epidemiology, Biostatistics and Occupational Health (Windle, Filion, Thombs, Eisenberg), McGill University; Department of Medicine (Filion, Thombs, Eisenberg), McGill University; Departments of Psychiatry, of Psychology, and of Educational and Counselling Psychology (Thombs), McGill University; Department of Family Medicine (Grad, Ells), McGill University; Biomedical Ethics Unit, Division of Experimental Medicine, and Department of Social Sciences of Medicine (Ells), McGill University; Division of Cardiology (Eisenberg), Jewish General Hospital, Montréal, Que.

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http://dx.doi.org/10.1503/cmaj.191032DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8049641PMC
April 2021

Association between legalization of recreational cannabis and fatal motor vehicle collisions in the United States: an ecologic study.

CMAJ Open 2021 Jan-Mar;9(1):E233-E241. Epub 2021 Mar 17.

Lady Davis Institute (Windle, Eisenberg, Reynier, Cabaussel, Thombs, Grad, Ells, Sequeira, Filion) and Division of Cardiology (Eisenberg), Jewish General Hospital; Departments of Epidemiology, Biostatistics and Occupational Health (Windle, Eisenberg, Thombs, Filion), Medicine (Eisenberg, Thombs, Filion), Psychiatry (Thombs), Psychology (Thombs), Educational and Counselling Psychology (Thombs), Family Medicine (Grad, Ells) and Social Studies of Medicine (Ells), McGill University; Biomedical Ethics Unit (Ells), Division of Experimental Medicine, McGill University, Montréal, Que.

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.
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http://dx.doi.org/10.9778/cmajo.20200155DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8096392PMC
July 2021

Effects of cosmetic and other camouflage interventions on appearance-related and psychological outcomes among adults with visible differences in appearance: a systematic review.

BMJ Open 2021 03 9;11(3):e046634. Epub 2021 Mar 9.

Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada

Objective: Visible differences in appearance are associated with poor social and psychological outcomes. Effectiveness of non-surgical cosmetic and other camouflage interventions is poorly understood. The objective was to evaluate effects of cosmetic and other camouflage interventions on appearance-related outcomes, general psychological outcomes and adverse effects for adults with visible appearance differences.

Design: Systematic review.

Data Sources: MEDLINE (Ovid), EMBASE (Ovid), PsycINFO (Ovid) CINAHL and Cochrane Central databases searched from inception to 24 October 2020. Two reviewers independently reviewed titles and abstracts and full texts.

Eligibility Criteria: Randomised controlled trials in any language on non-surgical cosmetic or other camouflage interventions that reported appearance-related outcomes, general psychological outcomes or adverse effects for adults with visible appearance differences.

Data Extraction And Synthesis: Two reviewers independently extracted data, assessed intervention reporting using the Template for Intervention Description and Replication checklist, and assessed risk of bias using the Cochrane risk of bias tool. Outcomes included appearance-related outcomes, general psychological outcomes (eg, depression, anxiety) and adverse effects.

Results: One head-to-head trial and five trials with waiting list or routine care comparators were included. All had unclear or high risk of bias in at least five of seven domains. Effect sizes could not be determined for most outcomes due to poor reporting. Between-group statistically significant differences were not reported for any appearance-related outcomes and for only 5 of 25 (20%) other psychological outcomes. Given heterogeneity of populations and interventions, poor reporting and high risk of bias, quantitative synthesis was not possible.

Conclusions: Conclusions about effectiveness of non-surgical cosmetic or other camouflage interventions could not be drawn. Well-designed and conducted trials are needed. Without such evidence, clinicians or other qualified individuals should engage with patients interested in cosmetic interventions in shared decision making, outlining potential benefits and harms, and the lack of evidence to inform decisions.

Prospero Registration Number: CRD42018103421.
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http://dx.doi.org/10.1136/bmjopen-2020-046634DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8098928PMC
March 2021
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