Nelson Systematic Reviews to Answer Healthcare, Questions, 2e


Chapter 6 • Selecting Studies for Inclusion

Inclusion criteria: Populations • Adult and adolescent females aged 13 years and older without previously diagnosed generalized anxiety disorder • Studies with 50% or more women enrolled • Studies may include pregnant or postpartum women Interventions and Comparators • KQ1: Screening for anxiety versus no screening • KQ2: Screening tool or method used in primary care applicable settings to assess the presence of anxiety versus a reference standard using DSM or ICD criteria for generalized anxiety disorder Effectiveness outcomes • KQ1: Improvement in anxiety symptoms, quality of life, and function • KQ2: Diagnostic accuracy of the screening test (sensitivity, specificity, PPV, NPV, AUC) Harms outcomes • KQ3: False positive results, worse anxiety, any additional harms reported by the study Study designs • Effectiveness: RCTs of screening effectiveness, high-quality systematic reviews, observational studies with comparison groups (cohort studies including database studies and case–control studies) • Test performance: Diagnostic accuracy studies • Adverse events: RCTs of screening, high-quality systematic reviews, observational studies Abbreviations: AUC, area under the receiver operating characteristic curve; CCRCT, Cochrane Central Register of Controlled Trials; CDSR, Cochrane Database of Systematic Reviews; DSM, Diagnostic and Statistical Manual of Mental Disorders; ICD, International Classification of Diseases; KQ, key question; NPV, negative predictive value; PPV, positive predictive value; RCT, randomized controlled trial. the size and complexity of the review. This approach may be particularly useful for review teams that are geographically separated, which is increasingly more common since the COVID-19 pandemic and adoption of remote work environments. Decisions made during the study selection process that further refine the eligibility criteria, including creation of supplemental criteria, must be amended to the review protocol and docu mented in the review report. Reporting The PRISMA group (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) has published recommendations for reporting the results of the study selection process 22 and pro vides a program for creating literature flow diagrams for reviews that conform to the PRISMA 2020 statement. 23 PRISMA guidance recommends using a flow diagram to report the numbers of studies identified, screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage (Figure 6.1). The diagrams differ depending on whether the systematic review is new or an update of an earlier review, and whether studies were identified by databases and registers only or in addition to other methods. The identification of studies includes reporting the initial litera ture search results, stratified by individual database and other sources, before removing dupli cate publications. Screening refers to the number of publications that remain after removing duplicates and then screened based on their titles and abstracts only, the number of full-text

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