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Table 1 Key question 1 (benefits and harms of screening) study eligibility criteria

From: Screening to prevent fragility fractures among adults 40 years and older in primary care: protocol for a systematic review

CriteriaIncludeExclude
PopulationAsymptomatic adults ≥ 40 years in the general population (we will include studies where ≥ 80% of the sample or the sample mean age − 1 standard deviation is ≥ 40 years)
Subgroups for decision-making: age, sex, menopausal status
Methods subgroups: diabetes, presence of prior fractures, baseline predicted fracture risk, length of follow-up
 ■ Adults < 40 years
 ■ Treatment with anti-osteoporosis drugs at baseline
 ■ > 50% with prior diagnosis of osteoporosis, prior fragility fracture, endocrine or other disorders likely to be related to metabolic bone disease, chronic use of glucocorticoid medications, cancer
InterventionScreeninga to prevent fragility fracture with any of the following:
 ■ Fracture risk assessment alone (validated or non-validated tools; with or without BMD incorporated, if applicable to tool)
 ■ Bone mineral density (BMD) alone by dual-energy x-ray absorptiometry of the femoral neck and/or lumbar spine (DXA) ± vertebral fracture assessment (VFA)/spinal radiography
 ■ Fracture risk assessment followed by BMD (DXA) if indicated ± vertebral fracture assessment/spinal radiography
Treatment of any form is offered for those participants reaching a threshold that is either investigator-defined or based on patient and/or clinician decision making.
 ■ Other BMD or osteoporosis screening tests (e.g., quantitative ultrasound, quantitative computed tomography, peripheral DXA, trabecular bone score, bone turnover markers)
 ■ VFA without BMD
ComparatorKQ1a: No screening
KQ1b:
 ■ Another screening strategy (e.g., 1 vs. 2 step screening)
 ■ Screening using a different risk assessment tool
 ■ Other BMD or osteoporosis-related screening tests
 ■ Fracture liaison services
OutcomesBenefits
Critical
 ■ Hip fractures
 ■ Fracture-related mortality
 ■ Functionality and disability (includes surrogate measures such as frailty questionnaires and long-term care admissions)
 ■ Quality of life or well being
 ■ All clinical fragility fracturesb
Important
 ■ All-cause mortality
Harms
Critical
 ■ Serious adverse eventsc (including all serious cardiovascular events; serious cardiac rhythm disturbances (e.g., atrial fibrillation or ventricular arrhythmia); serious gastrointestinal (GI) events (excluding cancers); GI cancer; atypical femoral fractures; osteonecrosis of the jaw)
Important
 ■ Overdiagnosis
 ■ Discontinuations due to adverse events
 ■ Non-serious adverse events (including any adverse events or adverse (drug) reactions; any non-serious adverse events)
 
TimingFollow-up ≥ 6 monthsFollow-up < 6 months
SettingPrimary health care [117]Long-term care facilities
Study design and publication status ■ Randomized controlled trials
 ■ Clinical controlled trials, only if neededd
 ■ Manuscripts, reports, abstracts, dissertations, and clinical trials registers, if data are available
 ■ Systematic reviews, meta-analyses, and pooled analyses
 ■ All other primary study designs
 ■ Non-research (e.g., editorials)
 ■ Studies available only as conference proceedings or other grey literature, unless data are available and adequate to assess study design and risk of bias
LanguageEnglish or FrenchAll other languages
Date of publicationAnyNot applicable
  1. a Screening includes the intervention, follow-up, referral and/or treatment. Fracture risk assessment tools are considered to be any paper or electronic tool or set of questions using ≥ 2 demographic and/or clinical risk factors to assess risk of future fracture
  2. b Clinical fragility fractures include only symptomatic and radiologically confirmed fractures, sites per author definition, and may be defined as major osteoporotic fracture
  3. c A serious adverse event is any untoward medical occurrence that at any dose (a) results in death, (b) is life-threatening, (c) requires inpatient hospitalization or prolongation of existing hospitalization, (d) results in persistent or significant disability/incapacity, (e) is a congenital anomaly/birth defect, (f) is a medically important event or reaction [118]
  4. d If certainty in the evidence is a barrier to the development of recommendations, and the CTFPHC believes that further evidence from CCTs may influence their recommendations