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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Background
This study compared functional outcomes at 3 months after hip fracture surgery between nursing home residents participating in a 10-week outreach rehabilitation program and those ...receiving usual care. Function, health-related quality of life, and mortality were also compared over 12 months, and outreach program feasibility was assessed.
Methods
A feasibility trial was undertaken in Canadian nursing homes; of 77 participants, 46 were allocated to Outreach and 31 to Control prior to assessing function or cognition. Outreach participants received 10 weeks of rehabilitation (30 sessions), and Control participants received usual posthospital fracture care in their nursing homes. The primary outcome was the Functional Independence Measure Physical Domain (FIMphysical) score 3 months post-fracture; we also explored FIM Locomotion and Mobility. Secondary outcomes were FIM scores, EQ-5D-3L scores, and mortality over 12 months. Program feasibility was also evaluated.
Results
The mean age was 88.7 ± 7.0 years, 55 (71%) were female, and 58 (75%) had severe cognitive impairment with no significant group differences (p > .14). Outreach participants had significantly higher FIM Locomotion than usual care (p = .02), but no significant group differences were seen in FIMphysical or FIM Mobility score 3 months post-fracture. In adjusted analyses, Outreach participants reported significant improvements in all FIM and EQ-5D-3L scores compared with Control participants over 12 months (p < .05). Mortality did not differ by group (p = .80). Thirty (65%) Outreach participants completed the program.
Conclusions
Our feasibility trial demonstrated that Outreach participants achieved better locomotion by 3 months post-fracture compared with participants receiving usual postfracture care; benefits were sustained to 12 months post-fracture. In adjusted analyses, Outreach participants also showed sustained benefits in physical function and health-related quality of life.
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.
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.
IntroductionMore than 1 million elective total hip and knee replacements are performed annually in the USA with 2% risk of clinical pulmonary embolism (PE), 0.1%–0.5% fatal PE, and over 1000 deaths. ...Antithrombotic prophylaxis is standard of care but evidence is limited and conflicting. We will compare effectiveness of three commonly used chemoprophylaxis agents to prevent all-cause mortality (ACM) and clinical venous thromboembolism (VTE) while avoiding bleeding complications.Methods and analysisPulmonary Embolism Prevention after HiP and KneE Replacement is a large randomised pragmatic comparative effectiveness trial with non-inferiority design and target enrolment of 20 000 patients comparing aspirin (81 mg two times a day), low-intensity warfarin (INR (International Normalized Ratio) target 1.7–2.2) and rivaroxaban (10 mg/day). The primary effectiveness outcome is aggregate of VTE and ACM, primary safety outcome is clinical bleeding complications, and patient-reported outcomes are determined at 1, 3 and 6 months. Primary data analysis is per protocol, as preferred for non-inferiority trials, with secondary analyses adherent to intention-to-treat principles. All non-fatal outcomes are captured from patient and clinical reports with independent blinded adjudication. Study design and oversight are by a multidisciplinary stakeholder team including a 10-patient advisory board.Ethics and disseminationThe Institutional Review Board of the Medical University of South Carolina provides central regulatory oversight. Patients aged 21 or older undergoing primary or revision hip or knee replacement are block randomised by site and procedure; those on chronic anticoagulation are excluded. Recruitment commenced at 30 North American centres in December 2016. Enrolment currently exceeds 13 500 patients, representing 33% of those eligible at participating sites, and is projected to conclude in July 2024; COVID-19 may force an extension. Results will inform antithrombotic choice by patients and other stakeholders for various risk cohorts, and will be disseminated through academic publications, meeting presentations and communications to advocacy groups and patient participants.Trial registrationNCT02810704.
Abstract
Objective
To determine if adjusted mortality, walking ability or return home differed after hip fracture surgery between Canada and the USA.
Design
Secondary analysis of the Functional ...Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS) trial data.
Setting
Data were collected from 47 American and Canadian hospitals.
Participants
Overall, 2016 subjects with a hip fracture (USA = 1222 (60.6%); Canada = 794 (39.4%)) were randomized to a liberal or restrictive transfusion strategy. Subjects were 50 years and older, with cardiovascular disease and/or risk factors and hemoglobin <100 g/L within 3 days post-surgery. The average age was 82 years and 1527(76%) subjects were females.
Intervention
Demographics, health status and health services data were collected up to 60 days post-surgery and mortality to a median of 3 years post-surgery.
Main outcomes
Mortality, inability to walk and return home.
Results
US subjects had higher adjusted mortality than Canadians at 30 days (odds ratio = 1.78; 95% confidence interval: 1.09–2.90), 60 days (1.53; 1.02–2.29) and up to 3 years (hazard ratio = 1.25; 1.07–1.45). There were no differences in adjusted outcomes for walking ability or return home at 30 or 60 days post-surgery. Median hospital length of stay was longer (P < 0.0001) in Canada (9 days; interquartile range: 5–18 days) than the US (3 days; 2–5 days). US subjects (52.9%) were more likely than Canadians (16.8%) to be discharged to nursing homes for rehabilitation (P < 0.001).
Conclusions
Adjusted survival favored Canadians post hip fracture while walking ability and return home were not different between countries. The reason(s) for mortality differences warrant further investigation.
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