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Background: Orthopedists and other clinicians assess recovery potential of hip fracture patients at 2 months post‐fracture for care planning. It is unclear if examining physical performance (e.g., balance, gait speed, chair stand) during this follow‐up visit can identify individuals at a risk of poor functional recovery, especially mobility, beyond available information from medical records and self‐report. Methods: Data came from 162 patients with hip fracture enrolled in the Baltimore Hip Studies‐7th cohort. Predictors of mobility status (ability to walk 1 block at 12 months post‐fracture) were the Short Physical Performance Battery (SPPB) comprising balance, walking and chair rise tasks at 2 months; baseline medical chart information (sex, age, American Society of Anesthesiologist physical status rating, type of fracture and surgery, and comorbidities); and self‐reported information about the physical function (ability to walk 10 feet and 1 block at pre‐fracture and at 2 months post‐fracture). Prediction models of 12‐month mobility status were built using two methods: (1) logistic regression with least absolute shrinkage and selection operator (LASSO) regularization, and (2) classification and regression trees (CART). Area under ROC curves (AUROC) assessed discrimination. Results: The participants had a median age of 82 years, and 49.3% (n = 80) were men. Two‐month SPPB and gait speed were selected as predictors of 12‐month mobility by both methods. Compared with an analytic model with medical chart and self‐reported information, the model that additionally included physical performance measures had significantly better discrimination for 12‐month mobility (AUROC 0.82 vs. 0.88, p = 0.004). Conclusion: Assessing SPPB and gait speed at 2 months after a hip fracture in addition to information from medical records and self‐report significantly improves prediction of 12‐month mobility. This finding has important implications in providing tailored clinical care to patients at a greater risk of being functionally dependent who would not otherwise be identified using regularly measured clinical markers. [ABSTRACT FROM AUTHOR]

Background: Mortality rates among men are double that of women in the first 2 years after hip fracture and may be related to more infections. Research has only examined differences in short‐term mortality after hip fracture. Thus, the objective was to determine if long‐term all‐cause mortality and infection‐specific mortality rates are higher in men compared to women. Methods: Data come from a prospective cohort study (Baltimore Hip Studies 7th [BHS‐7]) with up to 10.2 years of follow‐up (2006–2018). The participants were selected from eight acute care hospitals in the 25‐hospital BHS network. Enrolled women were frequency‐matched (1:1) to men on timing of admission for hip fracture that yielded an analytic sample size of 300 participants (155 women, 145 men). Associations between sex and mortality were analyzed using Cox proportional hazard models and cause‐specific Cox models adjusted for age, cognition, body mass index, pre‐fracture lower extremity activities of daily living limitation, depressive symptoms, and comorbidity. Results: Participants had a mean age of 80 years, 48% (n = 145) were men and the median follow‐up was 4.9 (interquartile range = 2.3–8.7) years. Over the follow‐up period after hospital admission for hip fracture, 237 (79.0%) participants died of all causes (132 men and 105 women) and 38 (12.7%) died of infection‐specific causes (25 men and 13 women). Men had significantly higher rates of all‐cause mortality [hazard ratio (HR) = 2.31(95% confidence interval [CI] 2.02–2.59)] and infection‐specific mortality (HR = 4.43, CI 2.07–9.51) compared to women. Conclusions: Men had a two‐fold higher rate of all‐cause mortality and four‐fold higher rate of infection‐specific mortality compared to women over a follow‐up period of up to 10.2 years. Findings suggest that interventions to prevent and treat infections, tailored by sex, may be needed to narrow significant differences in long‐term mortality rates between men and women after hip fracture. [ABSTRACT FROM AUTHOR]

Background: The U.S. clinical research enterprise in nursing homes was unprepared to mount clinical trials in nursing homes to address urgent questions relevant to prevention and treatment during the COVID‐19 pandemic. We identify priorities essential for establishing a supportive environment for future clinical trials in nursing homes. Methods: Two cross‐sectional online questionnaires were administered between January and February 2021. One was administered to nursing home providers, researchers, and policymakers; respondents rated the importance of attributes of researchers, facilities, leaders and staff for conducting clinical trials in nursing homes. Because importance may depend on trial type, respondents rated each attribute for efficacy trials (testing an intervention in ideal circumstances) and effectiveness trials (testing an intervention in "real world" circumstances). We calculated the attribute rating means and standard deviations, and used content analysis to characterize open‐ended responses. The second questionnaire for resident family members and advocates included open‐ended questions about nursing home research, and factors influencing willingness to participate. Results: The attributes rated as most essential for conducting efficacy and effectiveness trials in nursing homes are research team attributes, that is, that researchers recognize regulatory constraints; understand and adapt to nursing home workflow; and work collaboratively with nursing home leaders to identify priorities. Resident and facility diversity emerged as essential for effectiveness trials; important dimensions included resident race, ethnicity and income, as well as nursing home urban/rural location, quality ratings, geography, staffing ratios, size, and profit status. Caregivers and resident advocates stressed the importance of communication among participants, researchers, and nursing home leadership and staff at all stages of a trial. Conclusion: Developing a robust U.S. clinical research enterprise capable of efficiently mounting future clinical trials in nursing homes will require a reimagining of the relationships that exist between researchers, facilities, nursing home leaders, and residents, with a research infrastructure specifically focused on supporting and fostering these connections. [ABSTRACT FROM AUTHOR]

An effective clinical research effort in nursing homes to address prevention and treatment of COVID‐19 faced overwhelming challenges. Under the Health Care Systems Research Network‐Older Americans Independence Centers AGING Initiative, a multidisciplinary Stakeholder Advisory Panel was convened to develop recommendations to improve the capability of the clinical research enterprise in US nursing homes. The Panel considered the nursing home as a setting for clinical trials, reviewed the current state of clinical trials in nursing homes, and ultimately developed recommendations for the establishment of a nursing home clinical trials research network that would be centrally supported and administered. This report summarizes the Panel's recommendations, which were developed in alignment with the following core principles: build on available research infrastructure where appropriate; leverage existing productive partnerships of researchers with groups of nursing homes and nursing home corporations; encompass both efficacy and effectiveness clinical trials; be responsive to a broad range of stakeholders including nursing home residents and their care partners; be relevant to an expansive range of clinical and health care delivery research questions; be able to pivot as necessary to changing research priorities and circumstances; create a pathway for industry‐sponsored research as appropriate; invest in strategies to increase diversity in study populations and the research workforce; and foster the development of the next generation of nursing home researchers. See related editorial by Zimmerman et al. and Special Articles by Levy et al. and Resnick et al. in this issue. [ABSTRACT FROM AUTHOR]

Background: Males have worse outcomes after hip fracture than female counterparts. Cognitive impairment (CI) also increases the risk of poor recovery from hip fracture; however, CI is under‐recognized. Patient sex may contribute to this under‐recognition through differential misclassification. The objective of this study was to measure under‐recognition and differential misclassification of CI by patient sex. Methods: A cross‐sectional analysis of baseline data from an observational cohort study of community‐dwelling hip fracture patients aged 65 and older (n = 339; females = 171, males = 168) recruited from eight hospitals in the greater Baltimore, MD area within 15 days of hospitalization for surgical repair with cognitive testing within 22 days of admission. Indication of Alzheimer's disease or related dementias and/or delirium as a postoperative complication in the medical record was considered evidence of documented CI. Observed CI was measured with the Modified Mini‐Mental State Examination (3MS, ≤78). Source of cognitive impairment identification (SCI) was defined as: "3MS Only," "Hospital Record Only," "Both," "No CI" was compared between males and females using logistic regression. Results: Males had more comorbidities and worse physical status upon admission, but otherwise had similar hospital experiences. SCI distribution was 12.7% "3MS Only" (n = 42), 11.5% "Hospital Record Only" (n = 38), 9.4% "Both" (n = 31), and "No CI" (n = 219). Males were more likely to be identified with CI using the "3MS Only" and "Both," and females were more likely to have no indication of CI. Conclusion: There were sex differences in the documentation of CI versus observed impairment. Males had more CI using direct testing. This may be contributing to sex differences in recovery outcomes after hip fracture. Results support the implementation of cognitive testing in hip fracture patients to reduce the impact of differential misclassification by patient sex. [ABSTRACT FROM AUTHOR]

The authors examine various challenges facing the execution of clinical research in nursing homes in the U.S. prior to and during the COVID-19 pandemic. The article discusses the relative lack of organization and resources in the nursing home industry, federal and state government regulations that can have a negative effect upon research in nursing homes, and an absence of clinical research framework in nursing homes.

Objectives To prioritize research topics relevant to the care of the growing population of older adults with multiple chronic conditions ( MCCs). Design Survey of experts in MCC practice, research, and policy. Topics were derived from white papers, funding announcements, or funded research projects relating to older adults with MCCs. Setting Survey conducted through the Health Care Systems Research Network ( HCSRN) and Claude D. Pepper Older Americans Independence Centers ( OAICs) Advancing Geriatrics Infrastructure and Network Growth Initiative, a joint endeavor of the HCSRN and OAICs. Participants Individuals affiliated with the HCSRN or OAICs and national MCC experts, including individuals affiliated with funding agencies having MCC-related grant portfolios. Measurements A 'top box' methodology was used, counting the number of respondents selecting the top response on a 5-point Likert scale and dividing by the total number of responses to calculate a top box percentage for each of 37 topics. Results The highest-ranked research topics relevant to the health and healthcare of older adults with MCCs were health-related quality of life in older adults with MCCs; development of assessment tools (to assess, e.g., symptom burden, quality of life, function); interactions between medications, disease processes, and health outcomes; disability; implementation of novel (and scalable) models of care; association between clusters of chronic conditions and clinical, financial, and social outcomes; role of caregivers; symptom burden; shared decision-making to enhance care planning; and tools to improve clinical decision-making. Conclusion Study findings serve to inform the development of a comprehensive research agenda to address the challenges relating to the care of this 'high-need, high-cost' population and the healthcare delivery systems responsible for serving it. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To determine the efficacy of once-yearly intravenous zoledronic acid (ZOL) 5 mg in reducing risk of clinical vertebral, nonvertebral, and any clinical fractures in elderly osteoporotic postmenopausal women. DESIGN: A post hoc subgroup analysis of pooled data from the Health Outcome and Reduced Incidence with Zoledronic Acid One Yearly (HORIZON) Pivotal Fracture Trial and the HORIZON Recurrent Fracture Trial. SETTING: Multicenter, randomized, double-blind, placebo-controlled trials. PARTICIPANTS: Postmenopausal women (aged ≥75) with documented osteoporosis ( T-score ≤−2.5 at femoral neck or ≥1 prevalent vertebral or hip fracture) or a recent hip fracture. INTERVENTION: Patients were randomized to receive an intravenous infusion of ZOL 5 mg (n=1,961) or placebo (n=1,926) at baseline and 12 and 24 months. MEASUREMENTS: Primary endpoints were incidence of clinical vertebral and nonvertebral and any clinical fracture after treatment. RESULTS: At 3 years, incidence of any clinical, clinical vertebral, and nonvertebral fracture were significantly lower in the ZOL group than in the placebo group (10.8% vs 16.6%, 1.1% vs 3.7%, and 9.9% vs 13.7%, respectively) (hazard ratio (HR)=0.65, 95% confidence interval (CI)=0.54–0.78, P<.001; HR=0.34, 95% CI=0.21–0.55, P<.001; and HR=0.73, 95% CI=0.60–0.90, P=.002, respectively). The incidence of hip fracture was lower with ZOL but did not reach statistical significance. The incidence rate of postdose adverse events were higher with ZOL, although the rate of serious adverse events and deaths was comparable between the two groups. CONCLUSION: Once-yearly intravenous ZOL 5 mg was associated with a significant reduction in the risk of new clinical fractures (vertebral and nonvertebral) in elderly postmenopausal women with osteroporosis. [ABSTRACT FROM AUTHOR]