Publications by authors named "Beverley J Shea"

23 Publications

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Harms reported by patients in rheumatology drug trials: a systematic review of randomized trials in the cochrane library from an OMERACT working group.

Semin Arthritis Rheum 2021 Jan 9. Epub 2021 Jan 9.

Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark. Electronic address:

Background: Underreporting of harms in randomized controlled trials (RCTs) may lead to incomplete or erroneous assessments of the perceived benefit-to-harm profile of an intervention. To compare benefit with harm in clinical practice and future clinical studies, adverse event (AE) profiles including severity need to be understood. Even though patients report harm symptoms earlier and more frequently than clinicians, rheumatology RCTs currently do not provide a reporting framework from the patient's perspective regarding harms. Our objective for this meta-research project was to identify AEs in order to determine harm clusters and whether these could be self-reported by patients. Our other objective was to examine reported severity grading of the reported harms.

Methods: We considered primary publications of RCTs eligible if they were published between 2008 and 2018 evaluating pharmacological interventions in patients with a rheumatic or musculoskeletal condition and if they were included in Cochrane reviews. We extracted data on harms such as reported AE terms together with severity (if described), and categorized AE- and severity-terms into overall groups. We deemed all AEs with felt components appropriate for patient self-reporting.

Results: The literature search identified 187 possible Cochrane reviews, of which 94 were eligible for evaluation, comprising 1,297 articles on individual RCTs. Of these RCTs, 93 pharmacological trials met our inclusion criteria (including 31,023 patients; representing 20,844 accumulated patient years), which reported a total of 21,498 AEs, corresponding to 693 unique reported terms for AEs. We further sub-categorized these terms into 280 harm clusters (i.e., themes). AEs appropriate for patient self-reporting accounted for 58% of the AEs reported. Among the reported AEs, we identified medical terms for all of the 117 harm clusters appropriate for patient reporting and lay language terms for 86%. We intended to include severity grades of the reported AEs, but there was no evidence for systematic reporting of clinician- or patient-reported severity in the primary articles of the 93 trials. However, we identified 33 terms suggesting severity, but severity grading was discernible in only 9%, precluding a breakdown by severity in this systematic review.

Conclusions: Our results support the need for a standardized framework for patients' reporting of harms in rheumatology trials. Reporting of AEs with severity should be included in future reporting of harms, both from the patients' and investigators' perspectives.

Registration: PROSPERO: CRD42018108393.
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http://dx.doi.org/10.1016/j.semarthrit.2020.09.023DOI Listing
January 2021

Screening for depression in children and adolescents: a protocol for a systematic review update.

Syst Rev 2021 01 12;10(1):24. Epub 2021 Jan 12.

Knowledge Synthesis Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Centre for Practice-Changing Research, 501 Smyth Road, Box 201, Ottawa, ON, K1H 8L6, Canada.

Background: Major depressive disorder is common, debilitating, and affects feelings, thoughts, mood, and behaviors. Childhood and adolescence are critical periods for the development of depression and adolescence is marked by an increased incidence of mental health disorders. This protocol outlines the planned scope and methods for a systematic review update that will evaluate the benefits and harms of screening for depression in children and adolescents.

Methods: This review will update a previously published systematic review by Roseman and colleagues. Eligible studies are randomized controlled trials (RCTs) assessing formal screening in primary care to identify children or adolescents not already self-reporting symptoms of, diagnosed with, or treated for depression. If no or only a single RCT is available, we will consider controlled studies without random assignment. Studies of participants with characteristics associated with an elevated risk of depression will be analyzed separately. Outcomes of interest are symptoms of depression, classification of major depressive disorder based on a validated diagnostic interview, suicidality, health-related quality of life, social function, impact on lifestyle behavior (e.g., substance use, school performance, lost time at work, or school), false-positive results, overdiagnosis, overtreatment, labeling, and other harms such as those arising from treatment. We will search MEDLINE, Embase, PsycINFO, CINAHL, the Cochrane Library, and grey literature sources. Two reviewers will independently screen the titles and abstracts using the liberal accelerated method. Full-text screening will be performed independently by two reviewers using pre-specified eligibility criteria. Data extraction and risk of bias assessments will be performed independently by two reviewers. Pre-planned analyses, including subgroup and sensitivity analyses, are detailed within this protocol. Two independent reviewers will assess and finalize through consensus the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, and prepare GRADE evidence profiles and summary of findings tables for each outcome of interest.

Discussion: The systematic review will provide a current state of the evidence of benefits and harms of depression screening in children and adolescents. These findings will be used by the Canadian Task Force on Preventive Health Care to inform the development of recommendations on depression screening.

Systematic Review Registration: PROSPERO CRD42020150373.
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http://dx.doi.org/10.1186/s13643-020-01568-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7802305PMC
January 2021

Protocol for a scoping review of outcomes in clinical studies of interventions for venous thromboembolism in adults.

BMJ Open 2020 12 7;10(12):e040122. Epub 2020 Dec 7.

Department of Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada

Introduction: Venous thromboembolism (VTE) is a common, potentially fatal yet treatable disease. Several advances in treatment of VTE have been made over the past decades, but definition and reporting of outcomes across those studies are inconsistent. Development of an international core outcome set for clinical studies of interventions for VTE addresses this lack of standardisation. The first step in the development of a core outcome set is to conduct a scoping review which aims to generate an inclusive list of unique outcomes that have been reported in previous studies.

Methods And Analysis: MEDLINE, Embase and the Cochrane Central Register of Controlled Trials will be searched with no language restriction for prospective studies reporting on interventions for treatment of VTE in patients who are adult and non-pregnant. Records will be sorted in reverse chronological order. Study screening and data extraction will be independently performed by two authors in blocks based on date of publication, starting with 2015 to 2020 and subsequent 1-year periods, until no new outcome measures are identified from the set of included studies. After homogenising spelling and combining outcomes with the same meaning, a list of unique outcomes will be determined. Those outcomes will be grouped into outcome domains. Qualitative analysis and descriptive statistics will be used to report results.

Ethics And Dissemination: Ethical approval is not required for this study. The results of this scoping review will be presented at scientific conferences, published in a peer-reviewed journal, and they will provide candidate outcome domains to be considered in subsequent steps in the development of a core outcome set for clinical studies of interventions for VTE. PROTOCOL REGISTRATION DETAILS: http://hdl.handle.net/10393/40459.
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http://dx.doi.org/10.1136/bmjopen-2020-040122DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7722803PMC
December 2020

Combination Tests in the Diagnosis of Chronic Periprosthetic Joint Infection: Systematic Review and Development of a Stepwise Clinical Decision-Making Tool.

J Bone Joint Surg Am 2020 Nov;102(Suppl 2):114-124

Division of Orthopaedic Surgery (H.A. and P.E.B.) and School of Epidemiology and Public Health (B.J.S. and B.H.), University of Ottawa, Ottawa, Ontario, Canada.

Background: Our objective was to identify combination tests used to diagnose chronic periprosthetic joint infection (PJI) and develop a stepwise decision-making tool to facilitate diagnosis.

Methods: We conducted a systematic review of existing combinations of serum, synovial, and tissue-based tests for diagnosing chronic PJI after hip or knee replacement. This work is an extension of our systematic review of single tests, from which we chose eligible studies that also described the diagnostic performance of combination tests.

Results: Thirty-seven eligible articles described the performance of 56 combination tests, of which 8 combinations had at least 2 studies informing both sensitivity and specificity. We also identified 5 types of combination tests: (1) a type-I Boolean combination, which uses Boolean logic (AND, OR) and usually increases specificity at the cost of sensitivity; (2) a type-II Boolean combination, which usually increases sensitivity at the cost of specificity; (3) a triage-conditional rule, in which the value of 1 test serves to triage the use of another test; (4) an arithmetic operation on the values of 2 tests; and (5) a model-based prediction rule based on a fitted model applied to biomarker values.

Conclusions: Clinicians can initiate their diagnostic process with a type-II Boolean combination of serum C-reactive protein (CRP) and interleukin-6 (IL-6). False negatives of the combination can be minimized when the threshold is chosen to reach 90% to 95% sensitivity for each test. Once a joint infection is suspected on the basis of serum testing, joint aspiration should be performed. If joint aspiration yields a wet tap, a leukocyte esterase (LER) strip is highly recommended for point-of-care testing, with a reading of ++ or greater indicating PJI; a reading below ++ should be followed by one of the laboratory-based synovial tests. If joint aspiration yields a dry tap, clinicians should rely on preoperative tissue culture and histological analysis for diagnosis. Combinations based on triage-conditional, arithmetic, and model-based prediction rules require further research.

Level Of Evidence: Diagnostic Level III. See Instructions for Authors for a complete description of levels of evidence.
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http://dx.doi.org/10.2106/JBJS.20.00097DOI Listing
November 2020

Population characteristics as important contextual factors in rheumatological trials: an exploratory meta-epidemiological study from an OMERACT Working Group.

Ann Rheum Dis 2020 10 30;79(10):1269-1276. Epub 2020 Jun 30.

Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.

Objectives: To explore whether trial population characteristics modify treatment responses across various interventions, comparators and rheumatic conditions.

Methods: In this meta-epidemiological study, we included trials from systematic reviews available from the Cochrane Musculoskeletal Group published up to 23 April 2019 in Cochrane Library with meta-analyses of five or more randomised controlled trials (RCTs) published from year 2000. From trial reports, we extracted data on 20 population characteristics. For characteristics with sufficient data (ie, available for ≥2/3 of the trials), we performed multilevel meta-epidemiological analyses.

Results: We identified 19 eligible systematic reviews contributing 187 RCTs (212 comparisons). Only age and sex were explicitly reported in ≥2/3 of the trials. Using information about the country of the trials led to sufficient data for five further characteristics, that is, 7 out of 20 (35%) protocolised characteristics were analysed. The meta-regressions showed effect modification by economic status, place of residence, and, nearly, from healthcare system (explaining 4.8%, 0.9% and 1.5% of the between-trial variation, respectively). No effect modification was demonstrated from age, sex, patient education/health literacy or predominant religion.

Conclusions: This study demonstrates the scarce reporting of most population characteristics, hampering investigation of their impact with meta-research. Our sparse results suggest that place of residence (ie, continent of the trial), economic status (based on World Bank classifications) and healthcare system (based on WHO index for health system performance) may be important in explaining the variation in treatment response across trials. There is an urgent need for consistent reporting of important population characteristics in trials.

Prospero Registration Number: CRD42019127642.
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http://dx.doi.org/10.1136/annrheumdis-2020-217237DOI Listing
October 2020

Screening for esophageal adenocarcinoma and precancerous conditions (dysplasia and Barrett's esophagus) in patients with chronic gastroesophageal reflux disease with or without other risk factors: two systematic reviews and one overview of reviews to inform a guideline of the Canadian Task Force on Preventive Health Care (CTFPHC).

Syst Rev 2020 Jan 29;9(1):20. Epub 2020 Jan 29.

Ottawa Hospital Research Institute, Knowledge Synthesis Group, 501 Smyth Road, Ottawa, ON, Canada.

Background: Two reviews and an overview were produced for the Canadian Task Force on Preventive Health Care guideline on screening for esophageal adenocarcinoma in patients with chronic gastroesophageal reflux disease (GERD) without alarm symptoms. The goal was to systematically review three key questions (KQs): (1) The effectiveness of screening for these conditions; (2) How adults with chronic GERD weigh the benefits and harms of screening, and what factors contribute to their preferences and decision to undergo screening; and (3) Treatment options for Barrett's esophagus (BE), dysplasia or stage 1 EAC (overview of reviews).

Methods: Bibliographic databases (e.g. Ovid MEDLINE®) were searched for each review in October 2018. We also searched for unpublished literature (e.g. relevant websites). The liberal accelerated approach was used for title and abstract screening. Two reviewers independently screened full-text articles. Data extraction and risk of bias assessments were completed by one reviewer and verified by another reviewer (KQ1 and 2). Quality assessments were completed by two reviewers independently in duplicate (KQ3). Disagreements were resolved through discussion. We used various risk of bias tools suitable for study design. The GRADE framework was used for rating the certainty of the evidence.

Results: Ten studies evaluated the effectiveness of screening. One retrospective study reported no difference in long-term survival (approximately 6 to 12 years) between those who had a prior esophagogastroduodenoscopy and those who had not (adjusted HR 0.93, 95% confidence interval (CI) 0.58-1.50). Though there may be higher odds of a stage 1 diagnosis than a more advanced diagnosis (stage 2-4) if an EGD had been performed in the previous 5 years (OR 2.27, 95% CI 1.00-7.67). Seven studies compared different screening modalities, and showed little difference between modalities. Three studies reported on patients' unwillingness to be screened (e.g. due to anxiety, fear of gagging). Eleven systematic reviews evaluated treatment modalities, providing some evidence of early treatment effect for some outcomes.

Conclusions: Little evidence exists on the effectiveness of screening and values and preferences to screening. Many treatment modalities have been evaluated, but studies are small. Overall, there is uncertainty in understanding the effectiveness of screening and early treatments.

Systematic Review Registrations: PROSPERO (CRD42017049993 [KQ1], CRD42017050014 [KQ2], CRD42018084825 [KQ3]).
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http://dx.doi.org/10.1186/s13643-020-1275-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990541PMC
January 2020

Introduction.

J Rheumatol 2019 08;46(8):962-968

Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, and Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.

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http://dx.doi.org/10.3899/jrheum.190105DOI Listing
August 2019

Uptake of the OMERACT-OARSI Hip and Knee Osteoarthritis Core Outcome Set: Review of Randomized Controlled Trials from 1997 to 2017.

J Rheumatol 2019 08 1;46(8):976-980. Epub 2019 Mar 1.

From the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; School of Health and Social Care, London South Bank University, London; Institute of Translational Medicine, University of Liverpool, Liverpool; Faculty of Health and Medical Sciences, University of Surrey, Guildford; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; National Institute for Health Research (NIHR) Leeds Biomedical Research Centre (BRC), Leeds, UK; Department of Medicine, Faculty of Medicine, and Institute of Health Policy, Management, and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Institute of Bone and Joint Research, Department of Rheumatology, School of Medicine, University of Sydney and Royal North Shore Hospital, Sydney, Australia; Department of Epidemiology and Biostatistics, Amsterdam University Medical Centres, location VUmc; Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health, Amsterdam; Departments of Rheumatology and Clinical Epidemiology, Leiden University Medical Centre, Leiden, the Netherlands; Musculoskeletal Statistics Unit, the Parker Institute, Bispebjerg and Frederiksberg Hospital and Department of Rheumatology, Odense University Hospital; Center for Muscle and Joint Health, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Université de Lorraine, APEMAC, Nancy, France; Division of Rheumatology, Allergy and Immunology, Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, North Carolina; Department of Physical Medicine and Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago; Sections of Clinical Epidemiology and Rheumatology, Boston University School of Medicine, Boston; TissueGene Inc., Rockville; Division of Rheumatology and Clinical Immunology, Department of Medicine and Division of Gerontology, Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA; Merck Biopharma, Merck KGaA, Darmstadt; University Pain Centre, University Hospital Carl Gustav Carus, Dresden, Germany; Inner West Psychology; Institute of Bone and Joint Research, Department of Rheumatology, School of Medicine, University of Sydney and Royal North Shore Hospital; School of Biological, Earth and Environmental Sciences, University of New South Wales, Sydney, Australia; Department of Regenerative Medicine, State Research Institute Centre for Innovative Medicine, Vilnius, Lithuania; Faculty of Humanities and Social Sciences, University of Lucerne, Lucerne, Switzerland.

Objective: To assess the uptake of the OMERACT-OARSI (Outcome Measures in Rheumatology- Osteoarthritis Research Society International) core outcome set (COS) domains in hip and/or knee osteoarthritis (OA) trials.

Methods: There were 382 trials of hip and/or knee OA identified from the ClinicalTrial.gov registry from 1997 to 2017. Frequency of COS adoption was assessed by year and per 5-yearly phases.

Results: COS adoption decreased from 61% between 1997 and 2001 to 38% between 2012 and 2016. Pain (95%) and physical function (86%) were most consistently adopted. Patient's global assessment (48%) was the principal missing domain.

Conclusion: Limited adoption of the COS domains indicates that further consideration to improve uptake is required.
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http://dx.doi.org/10.3899/jrheum.181066DOI Listing
August 2019

OMERACT Filter 2.1: Elaboration of the Conceptual Framework for Outcome Measurement in Health Intervention Studies.

J Rheumatol 2019 08 15;46(8):1021-1027. Epub 2019 Feb 15.

From the Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit; Department of Medical Humanities, VU University Medical Centre/EMGO+ institute, Amsterdam, the Netherlands; Institute for Work & Health and Institute for Health Policy Management and Evaluation, University of Toronto, Toronto; Centre for Practice-Changing Research, Ottawa Hospital Research Institute; Cardiovascular Research Methods Centre, University of Ottawa Heart Institute; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario; McGill Centre for Outcomes Research and Evaluation, Montreal, Quebec, Canada; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland; Medicine Service, VA Medical Center; Department of Medicine, School of Medicine, University of Alabama; Division of Epidemiology, School of Public Health, University of Alabama, Birmingham, Alabama; SDG LLC, Cambridge, Massachusetts; Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK; Hôpital Ambroise Paré, Rheumatology Department, Boulogne-Billancourt; INSERM U1173, Laboratoire d'Excellence INFLAMEX, UFR Simone Veil, Versailles-Saint-Quentin University, Saint-Quentin en Yvelines; Sorbonne Université; Pitié Salpêtrière hospital, AP-HP, Rheumatology Department, Paris, France; Sydney Medical School, Institute of Bone and Joint Research; Department of Rheumatology, Royal North Shore Hospital, St Leonards, Australia.

Objective: The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 framework was developed in 2014 to aid core outcome set development by describing the full universe of "measurable aspects of health conditions" from which core domains can be selected. This paper provides elaborations and updated concepts (OMERACT Filter 2.1).

Methods: At OMERACT 2018, we discussed challenges in the framework application caused by unclear or ambiguous wording and terms and incompletely developed concepts.

Results: The updated OMERACT Filter 2.1 framework makes benefits and harms explicit, clarifies concepts, and improves naming of various terms.

Conclusion: We expect that the Filter 2.1 framework will improve the process of core set development.
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http://dx.doi.org/10.3899/jrheum.181096DOI Listing
August 2019

Core Domain Set Selection According to OMERACT Filter 2.1: The OMERACT Methodology.

J Rheumatol 2019 08 15;46(8):1014-1020. Epub 2019 Feb 15.

From the Centre for Practice-Changing Research, Ottawa Hospital Research Institute; Ottawa Hospital Research Institute, Clinical Epidemiology Program; School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa; Cardiovascular Research Methods Centre, University of Ottawa Heart Institute; Department of Epidemiology and Community Medicine, University of Ottawa; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa; Institute for Work & Health; Institute Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Clinical Epidemiology, Amsterdam UMC, Vrije Universiteit Amsterdam; Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health, Amsterdam, the Netherlands; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland; Medicine and Epidemiology, Department of Medicine at the School of Medicine, University of Alabama, Birmingham, Alabama; SDG LLC, Cambridge, Massachusetts; Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; UK National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds, UK; Hôpital Ambroise Paré, Rheumatology Department, Boulogne-Billancourt; INSERM U1173, Laboratoire d'Excellence INFLAMEX, UFR Simone Veil, Versailles-Saint-Quentin University, Saint-Quentin en Yvelines; Sorbonne Universités, UPMC Univ Paris 06; AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; Rheumatology and Musculoskeletal Epidemiology, Sydney Medical School, Institute of Bone and Joint Research; Department of Rheumatology, Royal North Shore Hospital, St Leonards, Australia.

Objective: To describe the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 methodology for core domain set selection.

Methods: The "OMERACT Way for Core Domain Set selection" framework consists of 3 stages: first, generating candidate domains through literature reviews and qualitative work, then a process of consensus to obtain agreement from those involved, and finally formal voting on the OMERACT Onion. The OMERACT Onion describes the placement of domains in layers/circles: mandatory in all trials/mandatory in specific circumstances (inner circle); important but optional (middle circle); or research agenda (outer circle). Five OMERACT working groups presented their core domain sets for endorsement by the OMERACT community. Tools including a workbook and whiteboard video were created to assist the process. The methods workshop at OMERACT 2018 introduced participants to this framework.

Results: The 5 OMERACT working groups achieved consensus on their proposed core domain sets. After the Methodology Workshop training exercise at OMERACT 2018, over 90% of participants voted that they were confident that they understood the process of core domain set selection.

Conclusion: The methods described in this paper were successfully used by the 5 working groups voting on domains at the OMERACT 2018 meeting, demonstrating the feasibility of the process. In addition, participants at OMERACT 2018 expressed increased confidence and understanding of the core domain set selection process after the training exercise. This methodology will continue to evolve, and we will use innovative technology such as whiteboard videos as a key part of our dissemination and implementation strategy for new methods.
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http://dx.doi.org/10.3899/jrheum.181097DOI Listing
August 2019

Instrument Selection Using the OMERACT Filter 2.1: The OMERACT Methodology.

J Rheumatol 2019 08 1;46(8):1028-1035. Epub 2019 Feb 1.

From the Institute for Work & Health and Institute for Health Policy Management and Evaluation, University of Toronto, Toronto; Clinical Epidemiology Program, and Centre for Practice-Changing Research, Ottawa Hospital Research Institute; Cardiovascular Research Methods Centre, University of Ottawa Heart Institute; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ontario, Canada; Department of Epidemiology and Biostatistics, and Department of Medical Humanities, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland; Medicine Service, VA Medical Center; Department of Medicine, School of Medicine, University of Alabama; Division of Epidemiology, School of Public Health, University of Alabama, Birmingham, Alabama; SDG LLC, Cambridge, Massachusetts, USA; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; UK National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds, UK; Hôpital Ambroise Paré, Rheumatology Department, Boulogne-Billancourt; INSERM U1173, Laboratoire d'Excellence INFLAMEX, UFR Simone Veil, Versailles-Saint-Quentin University, Saint-Quentin en Yvelines; Sorbonne Université; Pitié Salpêtrière hospital, AP-HP, Rheumatology Department, Paris, France; Sydney Medical School, Institute of Bone and Joint Research and Department of Rheumatology, Royal North Shore Hospital, St. Leonards, Australia.

Objective: Outcome Measures in Rheumatology (OMERACT) Filter 2.1 revised the process used for core outcome measurement set selection to add rigor and transparency in decision making. This paper describes OMERACT's methodology for instrument selection.

Methods: We presented instrument selection processes, tools, and reporting templates at OMERACT 2018, introducing the concept of "3 pillars, 4 questions, 7 measurement properties, 1 answer." Truth, discrimination, and feasibility are the 3 original OMERACT pillars. Based on these, we developed 4 signaling questions. We introduced the Summary of Measurement Properties table that summarizes the 7 measurement properties: truth (domain match, construct validity), discrimination [test-retest reliability, longitudinal construct validity (responsiveness), clinical trial discrimination, thresholds of meaning], and feasibility. These properties address a set of standards which, when met, answer the one question: Is there enough evidence to support the use of this instrument in clinical research of the benefits and harms of treatments in the population and study setting described? The OMERACT Filter 2.1 was piloted on 2 instruments by the Psoriatic Arthritis Working Group.

Results: The methodology was reviewed in a full plenary session and facilitated breakout groups. Tools to facilitate retention of the process (i.e., "The OMERACT Way") were provided. The 2 instruments were presented, and the recommendation of the working group was endorsed in the first OMERACT Filter 2.1 Instrument Selection votes.

Conclusion: Instrument selection using OMERACT Filter 2.1 is feasible and is now being implemented.
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http://dx.doi.org/10.3899/jrheum.181218DOI Listing
August 2019

Effectiveness of stop smoking interventions among adults: protocol for an overview of systematic reviews and an updated systematic review.

Syst Rev 2019 01 19;8(1):28. Epub 2019 Jan 19.

Knowledge Synthesis Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Centre for Practice-Changing Research, 501 Smyth Road, Box 201, Ottawa, Ontario, K1H 8L6, Canada.

Background: Tobacco smoking is the leading cause of cancer, preventable death, and disability. Smoking cessation can increase life expectancy by nearly a decade if achieved in the third or fourth decades of life. Various stop smoking interventions are available including pharmacotherapies, electronic cigarettes, behavioural support, and alternative therapies. This protocol outlines an evidence review which will evaluate the benefits and harms of stop smoking interventions in adults.

Methods: The evidence review will consist of two stages. First, an overview of systematic reviews evaluating the benefits and harms of various stop smoking interventions delivered in or referred from the primary care setting will be conducted. The second stage will involve updating a systematic review on electronic cigarettes identified in the overview; randomized controlled trials will be considered for outcomes relating to benefits while randomized controlled trials, non-randomized controlled trials, and comparative observational studies will be considered for evaluating harms. Search strategies will be developed and peer-reviewed by medical information specialists. The search strategy for the updated review on e-cigarettes will be developed using that of the candidate systematic review. The MEDLINE®, PsycINFO, Embase, and the Cochrane Library electronic databases will be searched as of 2008 for the overview of reviews and from the last search date of the selected review for the updated review. Organizational websites and trial registries will be searched for unpublished or ongoing reviews/studies. Two reviewers will independently screen the title and abstracts of citations using the liberal accelerated method. Full-text screening will be performed independently by two reviewers. Extracted data will be verified by a second reviewer. Disagreements regarding full-text screening and data extraction will be resolved by consensus or third-party adjudication. The methodological quality of systematic reviews, risk of bias of randomized and non-randomized trials, and methodological quality of cohort studies will be evaluated using AMSTAR 2, the Cochrane risk of bias tool, and a modified version of the Scottish Intercollegiate Guidelines Network critical appraisal tool, respectively. The GRADE framework will be used to assess the quality of the evidence for outcomes.

Discussion: The evidence review will evaluate the benefits and harms of various stop smoking interventions for adults. Findings will be used to inform a national tobacco cessation guideline by the Canadian Task Force on Preventive Health Care.

Systematic Review Registration: PROSPERO (CRD42018099691, CRD42018099692).
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http://dx.doi.org/10.1186/s13643-018-0928-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6339342PMC
January 2019

Screening for depression in women during pregnancy or the first year postpartum and in the general adult population: a protocol for two systematic reviews to update a guideline of the Canadian Task Force on Preventive Health Care.

Syst Rev 2019 01 19;8(1):27. Epub 2019 Jan 19.

Knowledge Synthesis Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.

Background: In 2018, the World Health Organization reported that depression is the most common cause of disability worldwide, with over 300 million people currently living with depression. Depression affects an individual's physical health and well-being, impacts psychosocial functioning, and has specific negative short- and long-term effects on maternal health, child health, developmental trajectories, and family health. The aim of these reviews is to identify evidence on the benefits and harms of screening for depression in the general adult population and in pregnant and postpartum women.

Methods: Search strategies were developed and tested through an iterative process by an experienced medical information specialist in consultation with the review team. We will search MEDLINE, Embase, PsycINFO, CINAHL, and the Cochrane Library, and a randomized controlled trial filter will be used. The general adult review will be an update of a systematic review previously used by the Canadian Task Force on Preventive Health Care for their 2013 guideline recommendation. The search strategy will be updated and will start from the last search date of the previous review (May 2012). The pregnant and postpartum review will be a de novo review with no date restriction. For both reviews, we will search for unpublished documents following the CADTH Grey Matters checklist and relevant websites. Titles and abstracts will be screened using the liberal accelerated method. Two reviewers will independently screen full-text articles for relevance using pre-specified eligibility criteria and assess the risk of bias of included studies using the Cochrane Risk of Bias tool. Outcomes of interest for the general adult population review include symptoms of depression or diagnosis of major depressive disorder, health-related quality of life, day-to-day functionality, lost time at work/school, impact on lifestyle behaviour, suicidality, false-positive result, labelling/stigma, overdiagnosis or overtreatment, and harms of treatment. Outcomes of interest for the pregnant and postpartum review include mental health outcomes (e.g. diagnosis of major depressive disorder), parenting outcomes (e.g. mother-child interactions), and infant outcomes (e.g. infant health and development).

Discussion: These two systematic reviews will offer informative evaluations of depression screening. The findings will be used by the Task Force to help develop guideline recommendations on depression screening in the general adult population and in pregnant and postpartum women in Canada.

Systematic Review Registration: PROSPERO (CRD42018099690).
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http://dx.doi.org/10.1186/s13643-018-0930-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6339426PMC
January 2019

The OMERACT-OARSI Core Domain Set for Measurement in Clinical Trials of Hip and/or Knee Osteoarthritis.

J Rheumatol 2019 08 15;46(8):981-989. Epub 2019 Jan 15.

From the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, and UK National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford; Institute of Translational Medicine, University of Liverpool, Liverpool; Faculty of Health and Medical Sciences, University of Surrey, Guildford; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; NIHR Leeds Biomedical Research Centre, Leeds, UK; Department of Medicine, Faculty of Medicine, and Institute of Health Policy, Management, and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Institute of Bone and Joint Research, Department of Rheumatology, School of Medicine, University of Sydney and Royal North Shore Hospital; Inner West Psychology; School of Biological, Earth and Environmental Sciences, University of New South Wales, Sydney, Australia; Department of Epidemiology and Biostatistics, Amsterdam University Medical Centers, location VUmc; Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health, Amsterdam; Departments of Rheumatology and Clinical Epidemiology, Leiden University Medical Centre, Leiden, the Netherlands; Musculoskeletal Statistics Unit, the Parker Institute, Bispebjerg and Frederiksberg Hospital, and Department of Rheumatology, Odense University Hospital; Center for Muscle and Joint Health, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Université de Lorraine, Approches Épidémiologiques et Psychologiques (APEMAC), Nancy, France; Division of Rheumatology, Allergy and Immunology, Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, North Carolina; Department of Physical Medicine and Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago, Illinois; Sections of Clinical Epidemiology and Rheumatology, Boston University School of Medicine, Boston, Massachusetts; TissueGene Inc., Rockville; Division of Rheumatology and Clinical Immunology, Department of Medicine and Division of Gerontology, Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA; Merck Biopharma, Merck KGaA, Darmstadt; University Pain Centre, University Hospital Carl Gustav Carus, Dresden, Germany; Department of Regenerative Medicine, State Research Institute Centre for Innovative Medicine, Vilnius, Lithuania; Faculty of Humanities and Social Sciences, University of Lucerne, Lucerne, Switzerland.

Objective: To update the 1997 OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) core domain set for clinical trials in hip and/or knee osteoarthritis (OA).

Methods: An initial review of the COMET database of core outcome sets (COS) was undertaken to identify all domains reported in previous COS including individuals with hip and/or knee OA. These were presented during 5 patient and health professionals/researcher meetings in 3 continents (Europe, Australasia, North America). A 3-round international Delphi survey was then undertaken among patients, healthcare professionals, researchers, and industry representatives to gain consensus on key domains to be included in a core domain set for hip and/or knee OA. Findings were presented and discussed in small groups at OMERACT 2018, where consensus was obtained in the final plenary.

Results: Four previous COS were identified. Using these, and the patient and health professionals/researcher meetings, 50 potential domains formed the Delphi survey. There were 426 individuals from 25 different countries who contributed to the Delphi exercise. OMERACT 2018 delegates (n = 129) voted on candidate domains. Six domains gained agreement as mandatory to be measured and reported in all hip and/or knee OA clinical trials: pain, physical function, quality of life, and patient's global assessment of the target joint, in addition to the mandated core domain of adverse events including mortality. Joint structure was agreed as mandatory in specific circumstances, i.e., depending on the intervention.

Conclusion: The updated core domain set for hip and/or knee OA has been agreed upon. Work will commence to determine which outcome measurement instrument should be recommended to cover each core domain.
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http://dx.doi.org/10.3899/jrheum.181194DOI Listing
August 2019

Engaging Stakeholders and Promoting Uptake of OMERACT Core Outcome Instrument Sets.

J Rheumatol 2017 Oct 1;44(10):1551-1559. Epub 2017 Aug 1.

From the Center for Medical Technology Policy; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland; University of Alabama at Birmingham and Birmingham Veterans Affairs Medical Center, Birmingham, Alabama; SDG LLC, Cambridge, Massachusetts; Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA; Centre for Practice-Changing Research, Ottawa Hospital Research Institute; Ottawa Hospital Research Institute, Clinical Epidemiology Program; School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa; Cardiovascular Research Methods Centre, University of Ottawa Heart Institute; Department of Epidemiology and Community Medicine, University of Ottawa; Department of Medicine, Faculty of Medicine, University of Ottawa; Cochrane Musculoskeletal, University of Ottawa, Ottawa; Musculoskeletal Health and Outcomes Research, St. Michael's Hospital; Institute for Work and Health; Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute and the Institute for Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Centre for Health Policy, Melbourne School of Population and Global Health, University of Melbourne, Melbourne; Sydney Medical School, Institute of Bone and Joint Research and Department of Rheumatology, Royal North Shore Hospital, St. Leonards, Australia; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK; Hôpital Ambroise Paré, Rheumatology Department, Boulogne-Billancourt; INSERM U1173, Laboratoire d'Excellence INFLAMEX, UFR Simone Veil, Versailles-Saint-Quentin University, Montigny-le-Bretonneux; Sorbonne Universités, UPMC Univ Paris 06; AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; Department of Medical Humanities, VU University Medical Centre/EMGO+ Institute, Amsterdam, the Netherlands.

Objective: While there has been substantial progress in the development of core outcomes sets, the degree to which these are used by researchers is variable. We convened a special workshop on knowledge translation at the Outcome Measures in Rheumatology (OMERACT) 2016 with 2 main goals. The first focused on the development of a formal knowledge translation framework and the second on promoting uptake of recommended core outcome domain and instrument sets.

Methods: We invited all 189 OMERACT 2016 attendees to the workshop; 86 attended, representing patient research partners (n = 15), healthcare providers/clinician researchers (n = 52), industry (n = 4), regulatory agencies (n = 4), and OMERACT fellows (n = 11). Participants were given an introduction to knowledge translation and were asked to propose and discuss recommendations for the OMERACT community to (1) strengthen stakeholder involvement in the core outcome instrument set development process, and (2) promote uptake of core outcome sets with a specific focus on the potential role of post-regulatory decision makers.

Results: We developed the novel "OMERACT integrated knowledge translation" framework, which formalizes OMERACT's knowledge translation strategies. We produced strategies to improve stakeholder engagement throughout the process of core outcome set development and created a list of creative and innovative ways to promote the uptake of OMERACT's core outcome sets.

Conclusion: The guidance provided in this paper is preliminary and is based on the views of the participants. Future work will engage OMERACT groups, "post-regulatory decision makers," and a broad range of different stakeholders to identify and evaluate the most useful methods and processes, and to revise guidance accordingly.
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http://dx.doi.org/10.3899/jrheum.161273DOI Listing
October 2017

Potential predatory and legitimate biomedical journals: can you tell the difference? A cross-sectional comparison.

BMC Med 2017 Mar 16;15(1):28. Epub 2017 Mar 16.

Knowledge Synthesis Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, K1H 8L6, Canada.

Background: The Internet has transformed scholarly publishing, most notably, by the introduction of open access publishing. Recently, there has been a rise of online journals characterized as 'predatory', which actively solicit manuscripts and charge publications fees without providing robust peer review and editorial services. We carried out a cross-sectional comparison of characteristics of potential predatory, legitimate open access, and legitimate subscription-based biomedical journals.

Methods: On July 10, 2014, scholarly journals from each of the following groups were identified - potential predatory journals (source: Beall's List), presumed legitimate, fully open access journals (source: PubMed Central), and presumed legitimate subscription-based (including hybrid) journals (source: Abridged Index Medicus). MEDLINE journal inclusion criteria were used to screen and identify biomedical journals from within the potential predatory journals group. One hundred journals from each group were randomly selected. Journal characteristics (e.g., website integrity, look and feel, editors and staff, editorial/peer review process, instructions to authors, publication model, copyright and licensing, journal location, and contact) were collected by one assessor and verified by a second. Summary statistics were calculated.

Results: Ninety-three predatory journals, 99 open access, and 100 subscription-based journals were analyzed; exclusions were due to website unavailability. Many more predatory journals' homepages contained spelling errors (61/93, 66%) and distorted or potentially unauthorized images (59/93, 63%) compared to open access journals (6/99, 6% and 5/99, 5%, respectively) and subscription-based journals (3/100, 3% and 1/100, 1%, respectively). Thirty-one (33%) predatory journals promoted a bogus impact metric - the Index Copernicus Value - versus three (3%) open access journals and no subscription-based journals. Nearly three quarters (n = 66, 73%) of predatory journals had editors or editorial board members whose affiliation with the journal was unverified versus two (2%) open access journals and one (1%) subscription-based journal in which this was the case. Predatory journals charge a considerably smaller publication fee (median $100 USD, IQR $63-$150) than open access journals ($1865 USD, IQR $800-$2205) and subscription-based hybrid journals ($3000 USD, IQR $2500-$3000).

Conclusions: We identified 13 evidence-based characteristics by which predatory journals may potentially be distinguished from presumed legitimate journals. These may be useful for authors who are assessing journals for possible submission or for others, such as universities evaluating candidates' publications as part of the hiring process.
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http://dx.doi.org/10.1186/s12916-017-0785-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5353955PMC
March 2017

Patient-centered rapid reviews will drive local decision making: commentary on Hartling et al.

J Clin Epidemiol 2015 Dec 12;68(12):1526-8. Epub 2015 Aug 12.

Bruyère Continuing Care and University of Ottawa, Bruyère Research Institute, 85 Primrose, 304, Ottawa, Ontario, Canada.

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http://dx.doi.org/10.1016/j.jclinepi.2015.07.009DOI Listing
December 2015

A decade of knowledge translation research--what has changed?

Authors:
Beverley J Shea

J Clin Epidemiol 2011 Jan;64(1):3-5

Community Interventions and Epidemiological Technologies (CIET Canada), Institute of Population Health, University of Ottawa, Ottawa, Ontario, Canada.

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http://dx.doi.org/10.1016/j.jclinepi.2010.07.009DOI Listing
January 2011

AMSTAR is a reliable and valid measurement tool to assess the methodological quality of systematic reviews.

J Clin Epidemiol 2009 Oct 20;62(10):1013-20. Epub 2009 Feb 20.

Community Information and Epidemiological Technologies (CIET), Institute of Population Health, Ottawa, Ontario, Canada.

Objective: Our purpose was to measure the agreement, reliability, construct validity, and feasibility of a measurement tool to assess systematic reviews (AMSTAR).

Study Design And Setting: We randomly selected 30 systematic reviews from a database. Each was assessed by two reviewers using: (1) the enhanced quality assessment questionnaire (Overview of Quality Assessment Questionnaire [OQAQ]); (2) Sacks' instrument; and (3) our newly developed measurement tool (AMSTAR). We report on reliability (interobserver kappas of the 11 AMSTAR items), intraclass correlation coefficients (ICCs) of the sum scores, construct validity (ICCs of the sum scores of AMSTAR compared with those of other instruments), and completion times.

Results: The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 (95% confidence interval [CI]: 0.57, 0.83) (range: 0.38-1.0). Kappas recorded for the other instruments were 0.63 (95% CI: 0.38, 0.78) for enhanced OQAQ and 0.40 (95% CI: 0.29, 0.50) for the Sacks' instrument. The ICC of the total score for AMSTAR was 0.84 (95% CI: 0.65, 0.92) compared with 0.91 (95% CI: 0.82, 0.96) for OQAQ and 0.86 (95% CI: 0.71, 0.94) for the Sacks' instrument. AMSTAR proved easy to apply, each review taking about 15 minutes to complete.

Conclusions: AMSTAR has good agreement, reliability, construct validity, and feasibility. These findings need confirmation by a broader range of assessors and a more diverse range of reviews.
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http://dx.doi.org/10.1016/j.jclinepi.2008.10.009DOI Listing
October 2009

External validation of a measurement tool to assess systematic reviews (AMSTAR).

PLoS One 2007 Dec 26;2(12):e1350. Epub 2007 Dec 26.

Community Information and Epidemiological Technologies, Ottawa, Ontario, Canada.

Background: Thousands of systematic reviews have been conducted in all areas of health care. However, the methodological quality of these reviews is variable and should routinely be appraised. AMSTAR is a measurement tool to assess systematic reviews.

Methodology: AMSTAR was used to appraise 42 reviews focusing on therapies to treat gastro-esophageal reflux disease, peptic ulcer disease, and other acid-related diseases. Two assessors applied the AMSTAR to each review. Two other assessors, plus a clinician and/or methodologist applied a global assessment to each review independently.

Conclusions: The sample of 42 reviews covered a wide range of methodological quality. The overall scores on AMSTAR ranged from 0 to 10 (out of a maximum of 11) with a mean of 4.6 (95% CI: 3.7 to 5.6) and median 4.0 (range 2.0 to 6.0). The inter-observer agreement of the individual items ranged from moderate to almost perfect agreement. Nine items scored a kappa of >0.75 (95% CI: 0.55 to 0.96). The reliability of the total AMSTAR score was excellent: kappa 0.84 (95% CI: 0.67 to 1.00) and Pearson's R 0.96 (95% CI: 0.92 to 0.98). The overall scores for the global assessment ranged from 2 to 7 (out of a maximum score of 7) with a mean of 4.43 (95% CI: 3.6 to 5.3) and median 4.0 (range 2.25 to 5.75). The agreement was lower with a kappa of 0.63 (95% CI: 0.40 to 0.88). Construct validity was shown by AMSTAR convergence with the results of the global assessment: Pearson's R 0.72 (95% CI: 0.53 to 0.84). For the AMSTAR total score, the limits of agreement were -0.19+/-1.38. This translates to a minimum detectable difference between reviews of 0.64 'AMSTAR points'. Further validation of AMSTAR is needed to assess its validity, reliability and perceived utility by appraisers and end users of reviews across a broader range of systematic reviews.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0001350PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2131785PMC
December 2007

Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews.

BMC Med Res Methodol 2007 Feb 15;7:10. Epub 2007 Feb 15.

EMGO Institute, VU University Medical Center, Amsterdam, The Netherlands.

Background: Our objective was to develop an instrument to assess the methodological quality of systematic reviews, building upon previous tools, empirical evidence and expert consensus.

Methods: A 37-item assessment tool was formed by combining 1) the enhanced Overview Quality Assessment Questionnaire (OQAQ), 2) a checklist created by Sacks, and 3) three additional items recently judged to be of methodological importance. This tool was applied to 99 paper-based and 52 electronic systematic reviews. Exploratory factor analysis was used to identify underlying components. The results were considered by methodological experts using a nominal group technique aimed at item reduction and design of an assessment tool with face and content validity.

Results: The factor analysis identified 11 components. From each component, one item was selected by the nominal group. The resulting instrument was judged to have face and content validity.

Conclusion: A measurement tool for the 'assessment of multiple systematic reviews' (AMSTAR) was developed. The tool consists of 11 items and has good face and content validity for measuring the methodological quality of systematic reviews. Additional studies are needed with a focus on the reproducibility and construct validity of AMSTAR, before strong recommendations can be made on its use.
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http://dx.doi.org/10.1186/1471-2288-7-10DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1810543PMC
February 2007