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Background This paper describes a protocol for determining the incidence of serious fall injuries for Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE), a large, multicenter pragmatic clinical trial with limited resources for event adjudication. We describe how administrative data (from participating health systems and Medicare claims) can be used to confirm participant-reported events, with more time- and resource-intensive full-text medical record data used only on an “as-needed” basis. Methods STRIDE is a pragmatic cluster-randomized controlled trial involving 5451 participants age ≥ 70 and at increased risk for falls, served by 86 primary care practices in 10 US health systems. The STRIDE intervention involves a nurse falls care manager who assesses a participant’s underlying risks for falls, suggests interventions using motivational interviewing, and then creates, implements and longitudinally follows up on an individualized care plan with the participant (and caregiver when appropriate), in partnership with the participant’s primary care provider. STRIDE’s primary outcome is serious fall injuries, defined as a fall resulting in: (1) medical attention billable according to Medicare guidelines with a) fracture (excluding isolated thoracic vertebral and/or lumbar vertebral fracture), b) joint dislocation, or c) cut requiring closure; OR (2) overnight hospitalization with a) head injury, b) sprain or strain, c) bruising or swelling, or d) other injury determined to be “serious” (i.e., burn, rhabdomyolysis, or internal injury). Two sources of data are required to confirm a serious fall injury. The primary data source is the participant’s self-report of a fall leading to medical attention, identified during telephone interview every 4 months, with the confirmatory source being (1) administrative data capturing encounters at the participating health systems or Medicare claims and/or (2) the full text of medical records requested only as needed. Discussion Adjudication is ongoing, with over 1000 potentially qualifying events adjudicated to date. Administrative data can be successfully used for adjudication, as part of a hybrid approach that retrieves full-text medical records only when needed. With the continued refinement and availability of administrative data sources, future studies may be able to use administrative data completely in lieu of medical record review to maximize the quality of adjudication with finite resources. Trial registration ClinicalTrials.gov (NCT02475850). Electronic supplementary material The online version of this article (10.1186/s40621-019-0190-2) contains supplementary material, which is available to authorized users.

OBJECTIVES: The World Health Organization (WHO) and other currently used criteria for defining anemia in older women are mainly based on statistical distribution considerations. To explore their clinical appropriateness, we evaluated the relationship between hemoglobin (Hb) concentration, prevalent mobility difficulty, and the Summary Performance Score (SPS). DESIGN: Cross-sectional study. SETTING: Two population-based studies, the Women's Health and Aging Studies I and II, Baltimore, Maryland. PARTICIPANTS: Six hundred thirty-three community-dwelling women aged 70 to 80 with Hb levels obtained within 90 days from baseline assessment. MEASUREMENTS: Mobility difficulty (self-reported difficulty walking one-quarter of a mile or climbing 10 steps (primary outcome)). SPS, a performance-based summary measure of lower extremity function that combines the results of walking, chair stands, and balance tests (secondary outcome). RESULTS: Mobility difficulty prevalence was not constant within the WHO “normal” Hb range (12.0–16.0 g/dL). For example, a Hb of 13.5 g/dL was associated with a significantly lower mobility difficulty prevalence than a Hb of 12.0 g/dL (OR = 0.68, 95% CI = 0.47–0.93), even after adjustment for chronic diseases and other relevant health indicators. A consistent trend of improvement in performance-based scores with increasing Hb categories less than 12.0 g/dL, 12.0 to 13.0g/dL, and 13.0–14.0 g/dL was observed. CONCLUSION: Our findings raise two hypotheses: (1) Hb currently perceived as “mildly-low” and even “low-normal” might have an independent, adverse effect on mobility function, and (2) Hb of 12.0 g/dL might be a suboptimal criterion for defining anemia in older women. Formal testing of these hypotheses might prove relevant for anemia- and mobility disability–related clinical decision-making.