Assessing readiness to use electronic health record data for outcome ascertainment in clinical trials - A case study.

BACKGROUND: Variable data quality poses a challenge to using electronic health record (EHR) data to ascertain acute clinical outcomes in multi-site clinical trials. Differing EHR platforms and data comprehensiveness across clinical trial sites, especially if patients received care outside of the clinical site's network, can also affect validity of results. Overcoming these challenges requires a structured approach. METHODS: We propose a framework and create a checklist to assess the readiness of clinical sites to contribute EHR data to a clinical trial for the purpose of outcome ascertainment, based on our experience with the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study, which enrolled 5451 participants in 86 primary care practices across 10 healthcare systems (sites). RESULTS: The site readiness checklist includes assessment of the infrastructure (i.e., size and structure of the site's healthcare system or clinical network), data procurement (i.e., quality of the data), and cost of obtaining study data. The checklist emphasizes the importance of understanding how data are captured and integrated across a site's catchment area and having a protocol in place for data procurement to ensure consistent and uniform extraction across each site. CONCLUSIONS: We suggest rigorous, prospective vetting of the data quality and infrastructure of each clinical site before launching a multi-site trial dependent on EHR data. The proposed checklist serves as a guiding tool to help investigators ensure robust and unbiased data capture for their clinical trials. ORIGINAL TRIAL REGISTRATION NUMBER: NCT02475850.

Validation of a Rule-Based ICD-10-CM Algorithm to Detect Fall Injuries in Medicare Data.

BACKGROUND: Diagnosis-code-based algorithms to identify fall injuries in Medicare data are useful for ascertaining outcomes in interventional and observational studies. However, these algorithms have not been validated against a fully external reference standard, in ICD-10-CM, or in Medicare Advantage (MA) data. METHODS: We linked self-reported fall injuries leading to medical attention (FIMA) from the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial (reference standard) to Medicare fee-for-service (FFS) and MA data from 2015-2019. We measured the area under the receiver operating characteristic curve (AUC) based on sensitivity and specificity of a diagnosis-code-based algorithm against the reference standard for presence or absence of ≥1 FIMA within a specified window of dates, varying the window size to obtain points on the curve. We stratified results by source (FFS versus MA), trial arm (intervention versus control), and STRIDE's ten participating healthcare systems. RESULTS: Both reference standard data and Medicare data were available for 4941 (of 5451) participants. The reference standard and algorithm identified 2054 and 2067 FIMA, respectively. The algorithm had 45% sensitivity (95% confidence interval [CI], 43%-47%) and 99% specificity (95% CI, 99%-99%) to identify reference standard FIMA within the same calendar month. The AUC was 0.79 (95% CI, 0.78-0.81) and was similar by FFS or MA data source or trial arm, but showed variation among STRIDE healthcare systems (AUC range by healthcare system, 0.71 to 0.84). CONCLUSIONS: An ICD-10-CM algorithm to identify fall injuries demonstrated acceptable performance against an external reference standard, in both MA and FFS data.

Human-Centered Design and Development of a Fall Prevention Exercise App For Older Adults in Primary Care Settings.

BACKGROUND: Falls in older adults are a serious public health problem that can lead to reduced quality of life or death. Patients often do not receive fall prevention guidance from primary care providers, despite evidence that falls can be prevented. Mobile health technologies may help to address this disparity and promote evidence-based fall prevention. OBJECTIVE: Our main objective was to use Human-Centered Design (HCD) to develop a user-friendly, fall prevention exercise app using validated user requirements. The app features evidence-based behavior change strategies and exercise content to support older people initiating and adhering to a progressive fall prevention exercise program. METHODS: We organized our multi-stage, iterative design process into three phases: Gathering User Requirements, Usability Evaluation, and Refining App Features. Our methods include focus groups, usability testing, and subject matter expert meetings. RESULTS: Focus groups (Total n=6), usability testing (n=30) including a post-test questionnaire [Health-ITUES score: mean (SD)= 4.2 (1.1)], and subject matter expert meetings demonstrate participant satisfaction with the app concept and design. Overall, participants saw value in receiving exercise prescriptions from the app that would be recommended by their PCP and reported satisfaction with the content of the app, but several participants felt that they were not the right user for the app. CONCLUSIONS: This study demonstrates the development, refinement and usability testing of a fall prevention exercise app and corresponding tools that primary care providers may use to prescribe tailored exercise recommendations to their older patients as an evidence-based fall prevention strategy accessible in the context of busy clinical workflows.

Improved accuracy and efficiency of primary care fall risk screening of older adults using a machine learning approach.

BACKGROUND: While many falls are preventable, they remain a leading cause of injury and death in older adults. Primary care clinics largely rely on screening questionnaires to identify people at risk of falls. Limitations of standard fall risk screening questionnaires include suboptimal accuracy, missing data, and non-standard formats, which hinder early identification of risk and prevention of fall injury. We used machine learning methods to develop and evaluate electronic health record (EHR)-based tools to identify older adults at risk of fall-related injuries in a primary care population and compared this approach to standard fall screening questionnaires. METHODS: Using patient-level clinical data from an integrated healthcare system consisting of 16-member institutions, we conducted a case-control study to develop and evaluate prediction models for fall-related injuries in older adults. Questionnaire-derived prediction with three questions from a commonly used fall risk screening tool was evaluated. We then developed four temporal machine learning models using routinely available longitudinal EHR data to predict the future risk of fall injury. We also developed a fall injury-prevention clinical decision support (CDS) implementation prototype to link preventative interventions to patient-specific fall injury risk factors. RESULTS: Questionnaire-based risk screening achieved area under the receiver operating characteristic curve (AUC) up to 0.59 with 23% to 33% similarity for each pair of three fall injury screening questions. EHR-based machine learning risk screening showed significantly improved performance (best AUROC = 0.76), with similar prediction performance between 6-month and one-year prediction models. CONCLUSIONS: The current method of questionnaire-based fall risk screening of older adults is suboptimal with redundant items, inadequate precision, and no linkage to prevention. A machine learning fall injury prediction method can accurately predict risk with superior sensitivity while freeing up clinical time for initiating personalized fall prevention interventions. The developed algorithm and data science pipeline can impact routine primary care fall prevention practice.

A compressed large language model embedding dataset of ICD 10 CM descriptions.

This paper presents novel datasets providing numerical representations of ICD-10-CM codes by generating description embeddings using a large language model followed by a dimension reduction via autoencoder. The embeddings serve as informative input features for machine learning models by capturing relationships among categories and preserving inherent context information. The model generating the data was validated in two ways. First, the dimension reduction was validated using an autoencoder, and secondly, a supervised model was created to estimate the ICD-10-CM hierarchical categories. Results show that the dimension of the data can be reduced to as few as 10 dimensions while maintaining the ability to reproduce the original embeddings, with the fidelity decreasing as the reduced-dimension representation decreases. Multiple compression levels are provided, allowing users to choose as per their requirements, download and use without any other setup. The readily available datasets of ICD-10-CM codes are anticipated to be highly valuable for researchers in biomedical informatics, enabling more advanced analyses in the field. This approach has the potential to significantly improve the utility of ICD-10-CM codes in the biomedical domain.

Costs of fall injuries in the STRIDE study: an economic evaluation of healthcare system heterogeneity and heterogeneity of treatment effect.

OBJECTIVES: The Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) Study cluster-randomized 86 primary care practices in 10 healthcare systems to a patient-centered multifactorial fall injury prevention intervention or enhanced usual care, enrolling 5451 participants. We estimated total healthcare costs from participant-reported fall injuries receiving medical attention (FIMA) that were averted by the STRIDE intervention and tested for healthcare-system-level heterogeneity and heterogeneity of treatment effect (HTE). METHODS: Participants were community-dwelling adults age ≥ 70 at increased fall injury risk. We estimated practice-level total costs per person-year of follow-up (PYF), assigning unit costs to FIMA with and without an overnight hospital stay. Using independent variables for treatment arm, healthcare system, and their interaction, we fit a generalized linear model with log link, log follow-up time offset, and Tweedie error distribution. RESULTS: Unadjusted total costs per PYF were $2,034 (intervention) and $2,289 (control). The adjusted (intervention minus control) cost difference per PYF was -$167 (95% confidence interval (CI), -$491, $216). Cost heterogeneity by healthcare system was present (p = 0.035), as well as HTE (p = 0.090). Adjusted total costs per PYF in control practices varied from $1,529 to $3,684 for individual healthcare systems; one system with mean intervention minus control costs of -$2092 (95% CI, -$3,686 to -$944) per PYF accounted for HTE, but not healthcare system cost heterogeneity. CONCLUSIONS: We observed substantial heterogeneity of healthcare system costs in the STRIDE study, with small reductions in healthcare costs for FIMA in the STRIDE intervention accounted for by a single healthcare system. TRIAL REGISTRATION: Clinicaltrials.gov (NCT02475850).

A Compressed Language Model Embedding Dataset of ICD 10 CM Descriptions.

This paper presents novel datasets providing numerical representations of ICD-10-CM codes by generating description embeddings using a large language model followed by a dimension reduction via autoencoder. The embeddings serve as informative input features for machine learning models by capturing relationships among categories and preserving inherent context information. The model generating the data was validated in two ways. First, the dimension reduction was validated using an autoencoder, and secondly, a supervised model was created to estimate the ICD-10-CM hierarchical categories. Results show that the dimension of the data can be reduced to as few as 10 dimensions while maintaining the ability to reproduce the original embeddings, with the fidelity decreasing as the reduced-dimension representation decreases. Multiple compression levels are provided, allowing users to choose as per their requirements. The readily available datasets of ICD-10-CM codes are anticipated to be highly valuable for researchers in biomedical informatics, enabling more advanced analyses in the field. This approach has the potential to significantly improve the utility of ICD-10-CM codes in the biomedical domain.

Testosterone replacement in prostate cancer survivors with testosterone deficiency: Study protocol of a randomized controlled trial.

BACKGROUND: Most men diagnosed with prostate cancer today have organ-confined disease and low risk of disease recurrence after radical prostatectomy. Testosterone deficiency in prostate cancer survivors contributes to impaired health-related quality of life but testosterone treatment is viewed as a contraindication in this population. OBJECTIVES: We describe the design of the first randomized trial to determine the safety and efficacy of testosterone treatment in men who have undergone prostatectomy for non-aggressive prostate cancer and have symptomatic testosterone deficiency. METHODS: Surviving Prostate cancer while Improving quality of life through Rehabilitation with Testosterone Trial is a randomized, placebo-controlled, double-blind, parallel group trial in 142 men, ≥ 40 years, who have undergone radical prostatectomy for organ-confined prostate cancer, Gleason score ≤ 7 (3+4), Stage pT2, N0, M0 lesions and have symptomatic testosterone deficiency and undetectable prostate specific antigen for > 2 years after surgery. Eligible participants are randomized to weekly intramuscular injections of 100-mg testosterone cypionate or placebo for 12 weeks and followed for another 12 weeks. Primary endpoint is change from baseline in sexual activity. Secondary outcomes include change in sexual desire, erectile function, energy, lean and fat mass, physical and cognitive performance. Safety is assessed by monitoring prostate-specific antigen, lower urinary tract symptoms, hemoglobin, and adverse events. RESULTS: The trial is being conducted at two trial sites in Boston, MA and Baltimore, MD. As of July 30, 2022, 42 participants have been randomized. No prostate-specific antigen or clinical recurrence has been noted to-date. DISCUSSION: Recruitment was slowed by coronavirus disease 2019-related closures, slow subsequent ramp-up of research activities, and patient concerns about safety of testosterone treatment. Despite these challenges, participant retention has been high. CONCLUSION: The Surviving Prostate cancer while Improving quality of life through Rehabilitation with Testosterone Trial, a placebo-controlled, randomized trial, will determine whether testosterone replacement therapy is safe and efficacious in correcting symptoms of testosterone deficiency in prostate cancer survivors, and potentially inform clinical practice.

Development and Usability Testing of an Exercise-Based Primary Care Fall Prevention Clinical Decision Support Tool.

For older patients, falls are the leading cause offatal and nonfatal injuries. Guidelines recommend that at-risk older adults are referred to appropriate fall-prevention exercise programs, but many do not receive support for fall-risk management in the primary care setting. Advances in health information technology may be able to address this gap. This article describes the development and usability testing of a clinical decision support (CDS) tool for fall prevention exercise. Using rapid qualitative analysis and human-centered design, our team developed and tested the usability of our CDS prototype with primary care team members. Across 31 Health-Information Technology Usability Evaluation Scale surveys, our CDS prototype received a median score of 5.0, mean (SD) of 4.5 (0.8), and a range of 4.1-4.9. This study highlights the features and usability offall prevention CDS for helping primary care providers deliver patient-centeredfall prevention care.

World guidelines for falls prevention and management for older adults: a global initiative.

BACKGROUND: falls and fall-related injuries are common in older adults, have negative effects on functional independence and quality of life and are associated with increased morbidity, mortality and health related costs. Current guidelines are inconsistent, with no up-to-date, globally applicable ones present. OBJECTIVES: to create a set of evidence- and expert consensus-based falls prevention and management recommendations applicable to older adults for use by healthcare and other professionals that consider: (i) a person-centred approach that includes the perspectives of older adults with lived experience, caregivers and other stakeholders; (ii) gaps in previous guidelines; (iii) recent developments in e-health and (iv) implementation across locations with limited access to resources such as low- and middle-income countries. METHODS: a steering committee and a worldwide multidisciplinary group of experts and stakeholders, including older adults, were assembled. Geriatrics and gerontological societies were represented. Using a modified Delphi process, recommendations from 11 topic-specific working groups (WGs), 10 ad-hoc WGs and a WG dealing with the perspectives of older adults were reviewed and refined. The final recommendations were determined by voting. RECOMMENDATIONS: all older adults should be advised on falls prevention and physical activity. Opportunistic case finding for falls risk is recommended for community-dwelling older adults. Those considered at high risk should be offered a comprehensive multifactorial falls risk assessment with a view to co-design and implement personalised multidomain interventions. Other recommendations cover details of assessment and intervention components and combinations, and recommendations for specific settings and populations. CONCLUSIONS: the core set of recommendations provided will require flexible implementation strategies that consider both local context and resources.

Effect of the STRIDE fall injury prevention intervention on falls, fall injuries, and health-related quality of life.

BACKGROUND: Falls are common in older adults and can lead to severe injuries. The Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial cluster-randomized 86 primary care practices across 10 health systems to a multifactorial intervention to prevent fall injuries, delivered by registered nurses trained as falls care managers, or enhanced usual care. STRIDE enrolled 5451 community-dwelling older adults age ≥70 at increased fall injury risk. METHODS: We assessed fall-related outcomes via telephone interviews of participants (or proxies) every 4 months. At baseline, 12 and 24 months, we assessed health-related quality of life (HRQOL) using the EQ-5D-5L and EQ-VAS. We used Poisson models to assess intervention effects on falls, fall-related fractures, fall injuries leading to hospital admission, and fall injuries leading to medical attention. We used hierarchical longitudinal linear models to assess HRQOL. RESULTS: For recurrent event models, intervention versus control incidence rate ratios were 0.97 (95% confidence interval [CI], 0.93-1.00; p = 0.048) for falls, 0.93 (95% CI, 0.80-1.08; p = 0.337) for self-reported fractures, 0.89 (95% CI, 0.73-1.07; p = 0.205) for adjudicated fractures, 0.91 (95% CI, 0.77-1.07; p = 0.263) for falls leading to hospital admission, and 0.97 (95% CI, 0.89-1.06; p = 0.477) for falls leading to medical attention. Similar effect sizes (non-significant) were obtained for dichotomous outcomes (e.g., participants with ≥1 events). The difference in least square mean change over time in EQ-5D-5L (intervention minus control) was 0.009 (95% CI, -0.002 to 0.019; p = 0.106) at 12 months and 0.005 (95% CI, -0.006 to 0.015; p = 0.384) at 24 months. CONCLUSIONS: Across a standard set of outcomes typically reported in fall prevention studies, we observed modest improvements, one of which was statistically significant. Future work should focus on patient-, practice-, and organization-level operational strategies to increase the real-world effectiveness of interventions, and improving the ability to detect small but potentially meaningful clinical effects. CLINICALTRIALS: gov identifier: NCT02475850.

Clinical Decision Support for Fall Prevention: Defining End-User Needs.

BACKGROUND AND SIGNIFICANCE: Falls in community-dwelling older adults are common, and there is a lack of clinical decision support (CDS) to provide health care providers with effective, individualized fall prevention recommendations. OBJECTIVES: The goal of this research is to identify end-user (primary care staff and patients) needs through a human-centered design process for a tool that will generate CDS to protect older adults from falls and injuries. METHODS: Primary care staff (primary care providers, care coordinator nurses, licensed practical nurses, and medical assistants) and community-dwelling patients aged 60 years or older associated with Brigham & Women's Hospital-affiliated primary care clinics and the University of Florida Health Archer Family Health Care primary care clinic were eligible to participate in this study. Through semi-structured and exploratory interviews with participants, our team identified end-user needs through content analysis. RESULTS: User needs for primary care staff (n = 24) and patients (n = 18) were categorized under the following themes: workload burden; systematic communication; in-person assessment of patient condition; personal support networks; motivational tools; patient understanding of fall risk; individualized resources; and evidence-based safe exercises and expert guidance. While some of these themes are specific to either primary care staff or patients, several address needs expressed by both groups of end-users. CONCLUSION: Our findings suggest that there are many care gaps in fall prevention management in primary care and that personalized, actionable, and evidence-based CDS has the potential to address some of these gaps.

Barriers to implementation of STRIDE, a national study to prevent fall-related injuries.

BACKGROUND/OBJECTIVES: Evaluations of complex models of care for older adults may benefit from simultaneous assessment of intervention implementation. The STRIDE (Strategies To Reduce Injuries and Develop confidence in Elders) pragmatic trial evaluated the effectiveness of a multifactorial intervention to reduce serious fall injuries in older adults. We conducted multi-level stakeholder interviews to identify barriers to STRIDE intervention implementation and understand efforts taken to mitigate these barriers. DESIGN: Qualitative interviews with key informants. SETTING: Ten clinical trial sites affiliated with practices that provided primary care for persons at increased risk for fall injuries. PARTICIPANTS: Specially trained registered nurses working as Falls Care Managers (FCMs) who delivered the intervention (n = 13 individual interviews), Research Staff who supervised trial implementation locally (n = 10 group interviews, 23 included individuals), and members of Central Project Management and the National Patient Stakeholder Council who oversaw national implementation (n = 2 group interviews, six included individuals). MEASUREMENTS: A semi-structured interview guide derived from the consolidated framework for implementation research (CFIR). RESULTS: We identified eight key barriers to STRIDE intervention implementation. FCMs navigated complex relationships with patients and families while working with Research Staff to implement the intervention in primary care practices with limited clinical space, variable provider buy-in, and significant primary care practice staff and provider turnover. The costs of the intervention to individual patients and medical practices amplified these barriers. Efforts to mitigate these barriers varied depending on the needs and opportunities of each primary care setting. CONCLUSION: The many barriers to implementation and the variability in how stakeholders addressed these locally may have affected the overall STRIDE intervention's effectiveness. Future pragmatic trials should incorporate simultaneous implementation aims to better understand how research interventions translate into clinical care that improves the lives of older adults.

Effect of a Multifactorial Fall Injury Prevention Intervention on Patient Well-Being: The STRIDE Study.

BACKGROUND/OBJECTIVES: In the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study, a multifactorial intervention was associated with a nonsignificant 8% reduction in time to first serious fall injury but a significant 10% reduction in time to first self-reported fall injury relative to enhanced usual care. The effect of the intervention on other outcomes important to patients has not yet been reported. We aimed to evaluate the effect of the intervention on patient well-being including concern about falling, anxiety, depression, physical function, and disability. DESIGN: Pragmatic cluster-randomized trial of 5,451 community-living persons at high risk for serious fall injuries. SETTING: A total of 86 primary care practices within 10 U.S. healthcare systems. PARTICIPANTS: A random subsample of 743 persons aged 75 and older. MEASUREMENTS: The well-being measures, assessed at baseline, 12 months, and 24 months, included a modified version of the Fall Efficacy Scale, Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and depression scales, and Late-Life Function and Disability Instrument. RESULTS: Participants in the intervention (n = 384) and control groups (n = 359) were comparable in age: mean (standard deviation) of 81.9 (4.7) versus 81.8 (5.0) years. Mean scores were similar between groups at 12 and 24 months for concern about falling, physical function, and disability, whereas the intervention group's mean scores on anxiety and depression were .7 points lower (i.e., better) at 12 months and .6 to .8 points lower at 24 months. For each of these outcomes, differences between the groups' adjusted least square mean changes from baseline to 12 and 24 months, respectively, were quantitatively small. The overall difference in means between groups over 2 years was statistically significant only for depression, favoring the intervention: -1.19 (99% confidence interval, -2.36 to -.02), with 3.5 points representing a minimally important difference. CONCLUSIONS: STRIDE's multifactorial intervention to reduce fall injuries was not associated with clinically meaningful improvements in patient well-being.

Maximizing Participant and Staff Safety During Assessment of Physical Function in the COVID-19 Era.

Physical performance measures, including cardiopulmonary exercise testing (CPXT), are widely used in geriatric practice and aging research. Theoretically, research participants and study personnel could get infected in the closed environment of the exercise laboratory by contact with respiratory droplets from an infected person, by breathing virus-laden aerosols, or by touching fomites. Older adults are at increased risk of developing more severe disease and of dying from SARS-CoV-2 infection. This special article offers guidance-informed by a synthesis of scientific data and recommendations of the CDC and WHO-on procedures that can be implemented in exercise laboratories to minimize risk of SARS-CoV-2 and other respiratory infections. Most tests of physical function (e.g., gait speed, Short Physical Performance Battery) are not aerosol-generating and are associated with only a small increase in minute ventilation; in contrast, CPXT markedly increases minute ventilation and is potentially aerosol-generating. Researchers should evaluate the benefit-to-risk ratio of information gained from the laboratory assessment versus the risk of SARS-CoV2 infection. Risk mitigation strategies described here fall into four categories: personal hygiene and the use of personal protective equipment; standardized screening; reconfiguration of laboratory space; and optimization of laboratory ventilation. The proposed safety measures are not intended to replace institutional policy, state, or federal guidelines; they may not apply to all settings and are expected to evolve as more definitive information becomes available. These practical measures to maximize protection against SARS-CoV2 infection can help maximize participant and staff safety, reduce anxiety, and facilitate protocol adherence, and study integrity.

A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries.

BACKGROUND: Injuries from falls are major contributors to complications and death in older adults. Despite evidence from efficacy trials that many falls can be prevented, rates of falls resulting in injury have not declined. METHODS: We conducted a pragmatic, cluster-randomized trial to evaluate the effectiveness of a multifactorial intervention that included risk assessment and individualized plans, administered by specially trained nurses, to prevent fall injuries. A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each). The participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries. The primary outcome, assessed in a time-to-event analysis, was the first serious fall injury, adjudicated with the use of participant report, electronic health records, and claims data. We hypothesized that the event rate would be lower by 20% in the intervention group than in the control group. RESULTS: The demographic and baseline characteristics of the participants were similar in the intervention group (2802 participants) and the control group (2649 participants); the mean age was 80 years, and 62.0% of the participants were women. The rate of a first adjudicated serious fall injury did not differ significantly between the groups, as assessed in a time-to-first-event analysis (events per 100 person-years of follow-up, 4.9 in the intervention group and 5.3 in the control group; hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P = 0.25). The rate of a first participant-reported fall injury was 25.6 events per 100 person-years of follow-up in the intervention group and 28.6 events per 100 person-years of follow-up in the control group (hazard ratio, 0.90; 95% CI, 0.83 to 0.99; P = 0.004). The rates of hospitalization or death were similar in the two groups. CONCLUSIONS: A multifactorial intervention, administered by nurses, did not result in a significantly lower rate of a first adjudicated serious fall injury than enhanced usual care. (Funded by the Patient-Centered Outcomes Research Institute and others; STRIDE ClinicalTrials.gov number, NCT02475850.).

Optimizing Retention in a Pragmatic Trial of Community-Living Older Persons: The STRIDE Study.

OBJECTIVES: The Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study is testing the effectiveness of a multifactorial intervention to prevent serious fall injuries. Our aim was to describe procedures that were implemented to optimize participant retention; report retention yields by age, sex, clinical site, and follow-up time; provide reasons for study withdrawals; and highlight the successes and lessons learned from the STRIDE retention efforts. DESIGN: Pragmatic cluster randomized trial. SETTING: A total of 86 primary care practices within 10 US healthcare systems. PARTICIPANTS: A total of 5451 community-living persons, 70 years of age or older, at high risk for serious fall injuries. MEASUREMENTS: Study outcomes were collected every 4 months by a central call center. Reconsent was required to extend follow-up beyond the originally planned 36 months. RESULTS: Over a median follow-up of 3.2 years (interquartile range = 2.8-3.7 y), 439 (8.1%) participants died and 600 (11.0%) withdrew their consent or did not reconsent to extend follow-up beyond 36 months, yielding rates (per 100 person-years) of deaths and withdrawals of 2.6 and 3.6, respectively. The withdrawal rate increased with advancing age, was comparable for men and women, and did not differ much by clinical site. The most common reasons for withdrawal were illness and unable to contact for reconsent at 36 months. Completion of the follow-up interviews was greater than 93% at each time point. Most participants completed all (71.8%) or all but one (9.2%) of the follow-up interviews. The most common reason for not completing a follow-up interview was unable to contact, with rates ranging from 2.8% at 40 months to 4.6% at 20 months. CONCLUSION: Completion of the thrice-yearly follow-up interviews in STRIDE was high, and retention of participants over 44 months exceeded the original projections. The procedures used in STRIDE, together with lessons learned, should assist other investigators who are planning or conducting large pragmatic trials of vulnerable older persons. J Am Geriatr Soc 68:1242-1249, 2020.

Establishing the Link Between Lean Mass and Grip Strength Cut Points With Mobility Disability and Other Health Outcomes: Proceedings of the Sarcopenia Definition and Outcomes Consortium Conference.

BACKGROUND: Lack of consensus on how to diagnose sarcopenia has limited the ability to diagnose this condition and hindered drug development. The Sarcopenia Definitions and Outcomes Consortium (SDOC) was formed to develop evidence-based diagnostic cut points for lean mass and/or muscle strength that identify people at increased risk of mobility disability. We describe here the proceedings of a meeting of SDOC and other experts to discuss strategic considerations in the development of evidence-based sarcopenia definition. METHODS: Presentations and panel discussions reviewed the usefulness of sarcopenia as a biomarker, the analytical approach used by SDOC to establish cut points, and preliminary findings, and provided strategic direction to develop an evidence-based definition of sarcopenia. RESULTS: The SDOC assembled data from eight epidemiological cohorts consisting of 18,831 participants, clinical populations from 10 randomized trials and observational studies, and 2 nationally representative cohorts. In preliminary assessments, grip strength or grip strength divided by body mass index was identified as discriminators of risk for mobility disability (walking speed <0.8 m/s), whereas dual-energy X-ray absorptiometry-derived lean mass measures were not good discriminators of mobility disability. Candidate definitions based on grip strength variables were associated with increased risk of mortality, falls, mobility disability, and instrumental activities of daily living disability. The prevalence of low grip strength increased with age. The attendees recommended the establishment of an International Expert Panel to review a series of position statements on sarcopenia definition that are informed by the findings of the SDOC analyses and synthesis of literature. CONCLUSIONS: International consensus on an evidence-based definition of sarcopenia is needed. Grip strength-absolute or adjusted for body mass index-is an important discriminator of mobility disability and other endpoints. Additional research is needed to develop a predictive risk model that takes into account sarcopenia components as well as age, sex, race, and comorbidities.