Abstract
PurposeTo inform recommendations by the Canadian Task Force on Preventive Health Care by systematically reviewing direct evidence on the effectiveness and acceptability of screening adults 40 years and older in primary care to reduce fragility fractures and related mortality and morbidity, and indirect evidence on the accuracy of fracture risk prediction tools. Evidence on the benefits and harms of pharmacological treatment will be reviewed, if needed to meaningfully influence the Task Force’s decision-making.MethodsA modified update of an existing systematic review will evaluate screening effectiveness, the accuracy of screening tools, and treatment benefits. For treatment harms, we will integrate studies from existing systematic reviews. A de novo review on acceptability will be conducted. Peer-reviewed searches (Medline, Embase, Cochrane Library, PsycINFO [acceptability only]), grey literature, and hand searches of reviews and included studies will update the literature. Based on pre-specified criteria, we will screen studies for inclusion following a liberal-accelerated approach. Final inclusion will be based on consensus. Data extraction for study results will be performed independently by two reviewers while other data will be verified by a second reviewer; there may be some reliance on extracted data from the existing reviews. The risk of bias assessments reported in the existing reviews will be verified and for new studies will be performed independently. When appropriate, results will be pooled using either pairwise random effects meta-analysis (screening and treatment) or restricted maximum likelihood estimation with Hartun-Knapp-Sidnick-Jonkman correction (risk prediction model calibration). Subgroups of interest to explain heterogeneity are age, sex, and menopausal status. Two independent reviewers will rate the certainty of evidence using the GRADE approach, with consensus reached for each outcome rated as critical or important by the Task Force.DiscussionSince the publication of other guidance in Canada, new trials have been published that are likely to improve understanding of screening in primary care settings to prevent fragility fractures. A systematic review is required to inform updated recommendations that align with the current evidence base.
Highlights
In this review, we will synthesize evidence related to screening to prevent fragility fractures and related mortality and morbidity among adults 40 years and older in primary care
The United States National Osteoporosis Foundation [70] recommends initiating pharmacological treatment in individuals with osteoporosis or with low bone mineral density (BMD) (T-score between − 1.0 and − 2.5, osteopenia) and either a 10-year hip fracture probability ≥ 3% or a 10year major osteoporosis-related fracture probability ≥ 20%. This decision was supported by a costeffectiveness analysis based on assumptions from one-step BMD screening followed by treatment with a generic bisphosphonate, and a willingness-to-pay threshold of $60,000 per qualityadjusted life-year gained [71, 72]
We will consider evidence from controlled clinical trials if certainty in the evidence from randomized controlled trials is limited and poses a barrier to the development of recommendations, and the Task Force believes that further evidence from controlled clinical trials may influence their recommendations
Summary
Systematic review scope and approach The Evidence Review and Synthesis Centre at the University of Alberta will conduct this review on behalf of the Task Force and following the research methods outlined in the Task Force methods manual [114]. We will consider evidence from controlled clinical trials (i.e., that includes a comparison [control] group and contains all of the key components of a true experimental design other than randomization: assignment of groups is determined by study design, and the administration of screening and endpoint ascertainment follows a protocol) if certainty in the evidence from randomized controlled trials is limited and poses a barrier to the development of recommendations, and the Task Force believes that further evidence from controlled clinical trials may influence their recommendations We expect that this could occur due to limited available evidence overall or lack of evidence for selected subgroups (e.g., by age, sex, or different risk assessment approaches). Important ■ Overdiagnosis ■ Discontinuations due to adverse events ■ Non-serious adverse events (including any adverse events or adverse (drug) reactions; any non-serious adverse events)
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