Community Guide Methods for Systematic Reviews of Economic Evidence.

INTRODUCTION: Community Guide systematic economic reviews provide information on the cost, economic benefit, cost-benefit, and cost-effectiveness of public health interventions recommended by the Community Preventive Services Task Force on the basis of evidence of effectiveness. The number and variety of economic evaluation studies in public health have grown substantially over time, contributing to methodologic challenges that required updates to the methods for Community Guide systematic economic reviews. This paper describes these updated methods. METHODS: The 9-step Community Guide economic review process includes prioritization of topic, creation of a coordination team, conceptualization of review, literature search, screening studies for inclusion, abstraction of studies, analysis of results, translation of evidence to Community Preventive Services Task Force economic findings, and dissemination of findings and evidence gaps. The methods applied in each of these steps are reported in this paper. RESULTS: Two published Community Guide reviews, tailored pharmacy-based interventions to improve adherence to medications for cardiovascular disease and permanent supportive housing with housing first to prevent homelessness, are used to illustrate the application of the updated methods. The Community Preventive Services Task Force reached a finding of cost-effectiveness for the first intervention and a finding of favorable cost-benefit for the second on the basis of results from the economic reviews. CONCLUSIONS: The updated Community Guide economic systematic review methods provide transparency and improve the reliability of estimates that are used to derive a Community Preventive Services Task Force economic finding. This may in turn augment the utility of Community Guide economic reviews for communities making decisions about allocating limited resources to effective programs.

Non-participation in a targeted prevention program aimed at lifestyle-related diseases: a questionnaire-based assessment of patient-reported reasons.

BACKGROUND: Having an unhealthy lifestyle is associated with a higher risk of developing lifestyle-related diseases. Current evidence suggests that interventions targeting health-risk behaviors can help people improve their lifestyles and prevent lifestyle-related diseases. However, preventive programs are often challenged by low participation rates. Reasons for non-participation include lack of time and/or interest, and/or no perceived need for lifestyle intervention. This study explores causes for non-participation in a sample of people who chose not to take up a targeted preventive program (TOF pilot2 study). Patient-reported reasons as well as sociodemographic characteristics and lifestyle factors are in focus. METHODS: A total of 4633 patients from four Danish GP clinics received an invitation to take part in the TOF pilot2 study. Patients who chose not to participate in the TOF pilot2 study were asked to fill in a questionnaire concerning reasons for non-participation, lifestyle, BMI and self-rated health. Descriptive analyses were used to summarize the results. RESULTS: A total of 2462 patients (53.1%) chose not to participate in the TOF pilot2 study. Among these, 84 (3.4%) answered the full questionnaire on reasons for not participating, lifestyle, BMI and self-rated health. The most common reasons for non-participation were lack of time, having an already healthy lifestyle, and feeling healthy. Based on their self-reported lifestyle 45 (53.6%) of the non-participants had one or more health-risk behaviors including smoking, unhealthy diet, BMI ≥ 35 and/or sedentary lifestyle and were therefore eligible to receive the targeted intervention at the GP or the MHC in the original TOF pilot2 study. CONCLUSION: When planning future preventive programs it is important to know the main reasons for patients to not participate. This study provides rare insight into why people opt out of health interventions and advances the evidence base in this area. Our results may inform efforts to better involve these patients in preventive health programs. TRIAL REGISTRATION: Trial registration number: NCT02797392 .

Evaluating the cost-effectiveness of a pre-exposure prophylaxis program for HIV prevention for men who have sex with men in Japan.

Men who have sex with men (MSM) have been disproportionally affected by the HIV epidemic in many countries, including Japan. Although pre-exposure prophylaxis (PrEP) is a strong prevention tool, it is not yet approved in Japan. A Markov model was developed to describe HIV infection and disease progression in an MSM cohort (N = 1000) in Japan receiving a PrEP program. The model was used to evaluate the cost-effectiveness of a PrEP program. HIV/AIDS treatment, screening, hospitalization due to AIDS, and PrEP were considered as costs and quality-adjusted life-years (QALYs) gained as utilities. Cost-effectiveness was assessed by comparing the incremental cost-effectiveness ratio (ICER) over a 30-year period against the willingness to pay (WTP) threshold. One-way sensitivity and probabilistic sensitivity analyses were performed. With 50% PrEP coverage, the PrEP program became dominant against the program without PrEP, using a threshold of 5.0 million JPY/QALY (45,455 USD). The probabilistic sensitivity analysis revealed that the PrEP program was dominant or at least cost-effective in most cases of 10,000 simulations. Therefore, preparing cheaper PrEP pills, which results in PrEP being dominant or ICER being lower than the WTP threshold, is important to make the program cost-effective. Introduction of PrEP to an MSM cohort in Japan would be cost-effective over a 30-year time horizon.

Impact of state-level training requirements for medical providers on receipt of preventive oral health services for young children enrolled in Medicaid.

OBJECTIVES: Young children enrolled in Medicaid make few dental visits and have high rates of tooth decay. To improve access to care, state Medicaid programs have enacted policies encouraging nondental providers to deliver preventive oral health services (POHS) in medical offices. Policies vary by state, with some states requiring medical providers to obtain training prior to delivering POHS. Our objective was to test whether these training requirements were associated with higher rates of POHS for Medicaid-enrolled children <6 years. METHODS: This study took advantage of a natural experiment in which policy enactment occurred across states at different times. We used Medicaid Analytic eXtract enrollment and claims data, public policy data, and Area Health Resource Files data. We examined an unweighted sample of 8,711,192 (45,107,240 weighted) Medicaid-enrolled children <6 years in 38 states from 2006 to 2014. Multivariable logistic regression models estimated the odds a child received POHS in a calendar year. Results are presented as adjusted probabilities. RESULTS: Five or more years after policy enactment, the probability of a child receiving POHS in medical offices was 10.7 percent in states with training requirements compared to 5.0 percent in states without training requirements (P = 0.01). Findings were similar when receipt of any POHS in medical or dental offices was examined 5 or more years post-policy-enactment (requirement = 42.5 percent, no requirement = 33.6 percent, P < 0.001). CONCLUSIONS: Medicaid policies increased young children's receipt of POHS and at higher rates in states that required POHS training. These results suggest that oral health training for nondental practitioners is a key component of policy success.

Actions to Transform US Preventive Services Task Force Methods to Mitigate Systemic Racism in Clinical Preventive Services.

Importance: US life expectancy and health outcomes for preventable causes of disease have continued to lag in many populations that experience racism. Objective: To propose iterative changes to US Preventive Services Task Force (USPSTF) processes, methods, and recommendations and enact a commitment to eliminate health inequities for people affected by systemic racism. Design and Evidence: In February 2021, the USPSTF began operational steps in its work to create preventive care recommendations to address the harmful effects of racism. A commissioned methods report was conducted to inform this process. Key findings of the report informed proposed updates to the USPSTF methods to address populations adversely affected by systemic racism and proposed pilots on implementation of the proposed changes. Findings: The USPSTF proposes to consider the opportunity to reduce health inequities when selecting new preventive care topics and prioritizing current topics; seek evidence about the effects of systemic racism and health inequities in all research plans and public comments requested, and integrate available evidence into evidence reviews; and summarize the likely effects of systemic racism and health inequities on clinical preventive services in USPSTF recommendations. The USPSTF will elicit feedback from its partners and experts and proposed changes will be piloted on selected USPSTF topics. Conclusions and Relevance: The USPSTF has developed strategies intended to mitigate the influence of systemic racism in its recommendations. The USPSTF seeks to reduce health inequities and other effects of systemic racism through iterative changes in methods of developing evidence-based recommendations, with partner and public input in the activities to implement the advancements.

Addressing Racism in Preventive Services: Methods Report to Support the US Preventive Services Task Force.

Importance: In January 2021, the US Preventive Services Task Force (USPSTF) issued a values statement that acknowledged systemic racism and included a commitment to address racism and health equity in recommendations for clinical preventive services. Objectives: To articulate the definitional and conceptual issues around racism and health inequity and to describe how racism and health inequities are currently addressed in preventive health. Methods: An audit was conducted assessing (1) published literature on frameworks or policy and position statements addressing racism, (2) a subset of cancer and cardiovascular topics in USPSTF reports, (3) recent systematic reviews on interventions to reduce health inequities in preventive health or to prevent racism in health care, and (4) health care-relevant professional societies, guideline-making organizations, agencies, and funding bodies to gather information about how they are addressing racism and health equity. Findings: Race as a social category does not have biological underpinnings but has biological consequences through racism. Racism is complex and pervasive, operates at multiple interrelated levels, and exerts negative effects on other social determinants and health and well-being through multiple pathways. In its reports, the USPSTF has addressed racial and ethnic disparities, but not racism explicitly. The systematic reviews to support the USPSTF include interventions that may mitigate health disparities through cultural tailoring of behavioral interventions, but reviews have not explicitly addressed other commonly studied interventions to increase the uptake of preventive services or foster the implementation of preventive services. Many organizations have issued recent statements and commitments around racism in health care, but few have provided substantive guidance on operational steps to address the effects of racism. Where guidance is unavailable regarding the proposed actions, it is principally because work to achieve them is in very early stages. The most directly relevant and immediately useful guidance identified is that from the GRADE working group. Conclusions and Relevance: This methods report provides a summary of issues around racism and health inequity, including the status of how these are being addressed in preventive health.

Multidomain Intervention for Reversal of Cognitive Frailty, Towards a Personalized Approach (AGELESS Trial): Study Design.

BACKGROUND: Cognitive frailty (CF) is identified as one of the main precursors of dementia. Multidomain intervention has been found to delay or prevent the onset of CF. OBJECTIVE: The aim of our present study is to determine the effectiveness of a comprehensive, multidomain intervention on CF; to evaluate its cost effectiveness and the factors influencing adherence toward this intensive intervention. METHODS: A total of 1,000 community dwelling older adults, aged 60 years and above will be screened for CF. This randomized controlled trial involves recruitment of 330 older adults with CF from urban, semi-urban, and rural areas in Malaysia. Multidomain intervention comprised of physical, nutritional, cognitive, and psychosocial aspects will be provided to participants in the experimental group (n = 165). The control group (n = 165) will continue their usual care with their physician. Primary outcomes include CF status, physical function, psychosocial and nutritional status as well as cognitive performance. Vascular health and gut microbiome will be assessed using blood and stool samples. A 24-month intensive intervention will be prescribed to the participants and its sustainability will be assessed for the following 12 months. The effective intervention strategies will be integrated as a personalized telerehabilitation package for the reversal of CF for future use. RESULTS: The multidomain intervention developed from this trial is expected to be cost effective compared to usual care as well as able is to reverse CF. CONCLUSION: This project will be part of the World-Wide FINGERS (Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability) Network, of which common identifiable data will be shared and harmonized among the consortia.

Assessing Electronic Nicotine Delivery Systems Use at NCI-Designated Cancer Centers in the Cancer Moonshot-funded Cancer Center Cessation Initiative.

Assessing tobacco product use and delivering tobacco dependence treatment is an essential part of cancer care; however, little is known about electronic nicotine delivery systems (ENDS) or e-cigarette use assessment in cancer treatment settings. Given the importance of tailoring tobacco treatment, it is critical to understand how ENDS use is assessed in the electronic health record (EHR) in cancer care settings. Two questionnaires were completed by tobacco treatment program leads at 42 NCI-Designated Cancer Centers in the Cancer Center Cessation Initiative (January 1 to June 30 and July 1 to December 31, 2019). Items assessed how often smoking status and ENDS use were recorded in the EHR. An open-ended item recorded the text and response categories of each center's ENDS assessment question. All 42 centers assessed smoking status at both time periods. Twenty-five centers (59.5%) assessed ENDS use in the first half of 2019, increasing to 30 (71.4%) in the last half of 2019. By the end of 2019, 17 centers assessed smoking status at every patient visit while six assessed ENDS use at every visit. A checkbox/drop-down menu rather than scripted text was used at 30 centers (73.2%) for assessing smoking status and at 18 centers (42.9%) for assessing ENDS use. Our findings underscore the gap in systematic ENDS use screening in cancer treatment settings. Requiring ENDS use measures in the EHR as part of quality measures and providing scripted text scripts to providers may increase rates of ENDS use assessment at more cancer centers. PREVENTION RELEVANCE: This study identifies a gap in the systematic assessment of ENDS use among patients seen at 42 NCI-Designated cancer centers. Requiring the systematic assessment of both ENDS use and use of other tobacco products can inform evidence-based treatment of tobacco dependence and lead to improved cancer treatment outcomes.

Barriers to accessing preventive health care among African-born individuals in King County, Washington: A qualitative study involving key informants.

Studies of African immigrant health in the U.S. have traditionally focused on infectious diseases. However, the rising burden of non-communicable diseases (NCDs) indicates the increasing importance of general preventive health care. As part of a series of community health events designed for African-born individuals in King County, Washington, we administered key informant interviews (KIIs) with 16 health event participants, medical professionals, and community leaders to identify barriers and facilitators to use of preventive health care among African-born individuals. We used descriptive thematic analysis to organize barriers according to the socio-ecological model. Within the individual domain, KII participants identified lack of knowledge and awareness of preventive health benefits as barriers to engagement in care. Within the interpersonal domain, language and cultural differences frequently complicated relationships with health care providers. Within the societal and policy domains, healthcare costs, lack of insurance, and structural racism were also reported as major barriers. Participants identified community outreach with culturally competent and respectful providers as key elements of interventions to improve uptake. In conclusion, African immigrant communities face several barriers, ranging from individual to policy levels, to accessing health services, resulting in substantial unmet need for chronic disease prevention and treatment. Community-centered and -led care may help facilitate uptake and engagement in care.

The Paradox of Readmission Prevention Interventions: Missing Those Most in Need.

BACKGROUND: Post-hospitalization transition interventions remain a priority in preventing rehospitalization. However, not all patients referred for readmission prevention interventions receive them. We sought to 1) define patient characteristics associated with non-receipt of readmission prevention interventions (among those eligible for them), and 2) determine whether these same patient characteristics are associated with hospital readmission at the state level. METHODS: We used state-wide data from the Maryland Health Services Cost Review Commission to determine patient-level factors associated with state-wide readmissions. Concurrently, we conducted a retrospective analysis of discharged patients referred to receive 1 of 3 post-discharge interventions between January 2013 and July 2019-a nurse transition guide, post-discharge phone call, or follow-up appointment in our post-discharge clinic-to determine patient-level factors associated with not receiving the intervention. Multivariable generalized estimating equation logistic regression models were used to calculate the odds of not accepting or not receiving the interventions. RESULTS: Older age, male gender, black race, higher expected readmission rate, and lower socioeconomic status were significantly associated with 30-day readmission in hospitalized Maryland patients. Most of these variables (age, sex, race, payer type [Medicaid or non-Medicaid], and socioeconomic status) were also associated with non-receipt of intervention. CONCLUSIONS: We found that many of the same patient-level characteristics associated with the highest readmission risk are also associated with non-receipt of readmission reduction interventions. This highlights the paradox that patients at high risk of readmission are least likely to accept or receive interventions for preventing readmission. Identifying strategies to engage hard-to-reach high-risk patients continues to be an unmet challenge in readmission prevention.

Effects of a Co-Design-Based Invitation Strategy on Participation in a Preventive Health Check Program: Randomized Controlled Trial.

BACKGROUND: Preventive primary care programs that aim to reduce morbidity and mortality from lifestyle-related diseases are often affected by low-to-moderate participation rates. Improving participation rates is essential for clinical effectiveness and cost-effectiveness. In 2016-2017, we conducted a pilot study (TOF pilot1) for a preventive primary care intervention (TOF is the Danish abbreviation for "Early Detection and Prevention"). Among 8814 invited patients, 3545 (40.22%) consented to participate, with the highest participation rates among women and patients with higher income, education, and employment. OBJECTIVE: The aim of this study was to evaluate the effects of a revised invitation strategy on invitation comprehensibility, the overall participation rate, and participant demography. The new strategy specifically targeted men and patients of low educational attainment. METHODS: This study was embedded in the second TOF pilot study (TOF pilot2, initiated in October 2018) that tested an adjusted intervention. The revised invitation strategy comprised a prenotification postcard and a new invitation that specifically targeted men and patients of low educational attainment. The new invitation was developed in a co-design process that included communication professionals and target-group representatives. The study sample consisted of 4633 patients aged between 29 and 59 years, who resided in one of two municipalities in the Region of Southern Denmark. Eligible patients were randomly assigned to one of four invitation groups. The control group (Group 1) received the original invitation used in TOF pilot1. The intervention groups received the original invitation and the prenotification postcard (Group 2), the new revised invitation and the prenotification postcard (Group 3), or the new invitation but no prenotification postcard (Group 4). RESULTS: Overall, 2171 (46.86%) patients consented to participate. Compared to the control group, participation rates increased significantly in all three intervention groups (all P<.001). Participation across the three intervention groups increased for women and men, as well as for patients with high and low educational attainment and high and low family income. The largest relative increase in participation rates occurred among men, patients with low educational attainment, and patients with low family income. No increase in participation was detected for unemployed patients or patients of non-Danish origin. Most participants found the original (813/987, 82.37%) and new (965/1133, 85.17%) invitations easy to understand with no significant difference (P=.08) in comprehensibility between invitations. CONCLUSIONS: The results suggest that participation in preventive primary care interventions can be greatly increased by implementing a co-design-based invitation strategy that includes prenotification postcards and targeted invitations. Although firm conclusions cannot be made from this study, the observed increased participation rates for men and patients of low socioeconomic status may be relevant in programs that aim to reduce social inequality in health. TRIAL REGISTRATION: ClinicalTrials.gov NCT03913585; https://clinicaltrials.gov/ct2/show/NCT03913585.

[Evaluation of a novel training course for hoof trimmers to participate in a Swiss national cattle claw health monitoring programme]. / Evaluation eines Ausbildungskonzeptes für Klauenpfleger zur Durchführung eines schweizweiten Klauengesundheitsmonitorings für Rinder.

INTRODUCTION: The main goal of the resources project «Healthy claws - the foundation for the future¼ is to establish a Swiss national claw health monitoring programme for cattle, similar to what has already been established in other countries (e. g. Finland, Sweden). So far in the course of the project, 30 claw trimmers have been trained to use a digital recording software. An appropriate training concept and information to the work environment of Swiss claw trimmers are necessary to ensure that the recorded claw health data is of good quality. The newly developed training programme for claw trimmers was evaluated using the 30 first trained claw trimmers of the project. The training consisted of group events and individual schooling sessions, during which the claw trimmers were trained to recognise, classify and digitally record foot and claw disorders according to the «ICAR claw health atlas¼. At the end of the training programme, demographic and work relevant data about the claw trimmers was collected and their abilities when using the recording software, as well as recognising and classifying foot and claw disorders using pictures or live animals, were evaluated. The demographic and work relevant data collected at the end of the training showed an ageing of the profession (43% of the participants were over 50 years old), a lack of full-time claw trimmers (23% of the claw trimmers worked 90% or 100%), a neglect of locomotion scoring during claw trimming (no locomotion scoring standing from 60% and in movement from 33% of the participants) and a broad use of the Swiss claw trimming method (90% of the claw trimmers indicate using this method). An average Cohens kappa value of 0,74, and thus an overall substantial agreement with the first author, respectively the ICAR Atlas, was achieved for the identification and classification of foot and claw disorders. It was also noted, that all the participants were capable of using the recording software in practice after their schooling. The calculation of Cohens kappa values helps to recognise claw trimmers which fall below the limiting value and therefore show an insufficient agreement. These claw trimmers can thus be excluded from the scientific evaluation or undergo further training. It was concluded that the described training concept is suitable to establish a national claw health monitoring programme.

INTRODUCTION: L'objectif principal du projet «Des onglons sains ­ de bon pied vers l'avenir¼ est la mise en place d'un programme national suisse de surveillance de la santé des onglons des bovins, similaire à ce qui a déjà été mis en place dans d'autres pays (par ex. Finlande, Suède). Jusqu'à présent, au cours du projet, 30 pareurs d'onglons ont été formés à l'utilisation d'un logiciel de documentation électronique. Un concept de formation approprié et des informations sur l'environnement de travail des pareurs suisses sont nécessaires pour garantir la bonne qualité des données enregistrées. Le programme de formation nouvellement mis au point a été évalué à l'aide des 30 premiers pareurs formés. La formation a consisté en des formations de groupe et des formations individuelles, au cours desquelles les pareurs ont été formés à reconnaître, classifier et enregistrer électroniquement les maladies des onglons selon l'«Atlas ICAR santé des onglons¼. À la fin de la formation, des données démographiques et professionnelles concernant les pareurs ont été collectées et leurs capacités à utiliser le logiciel d'enregistrement, à reconnaître et classifier les maladies des onglons à l'aide d'images ou sur des animaux vivants, ont été évaluées. Les données démographiques et professionnelles collectées à l'issue de la formation ont entre autre montré un vieillissement de la profession (43% des participants avaient plus de 50 ans), un manque d'ongleurs à temps plein (23% des ongleurs travaillent à 90% resp. 100%), une négligence de la notation de la motricité lors du parage des onglons (pas de notation de la motricité stationnaire chez de 60% et en mouvement chez33% des participants) et une large utilisation de la méthode suisse de parage des onglons (90% des ongleurs indiquent utiliser cette méthode). Une valeur moyenne du coefficient kappa de Cohens de 0,74, et donc une concordance globale avec le premier auteur, respectivement l'Atlas ICAR, a été obtenue pour l'identification et la classification des maladies des onglons. Il a également été constaté que tous les participants étaient capables après leur formation d'utiliser le logiciel d'enregistrement dans la pratique. Le calcul de valeurs kappa de Cohens permet de reconnaître les pareurs qui descendent en dessous d'une valeur limite et présentent donc une concordance insuffisante. Ces pareurs peuvent ainsi être exclus de l'évaluation scientifique ou suivre une formation complémentaire. On peut en conclure que le concept de formation décrit convient pour la mise en place d'un programme national de surveillance de la santé des onglons.

The value of the polypill in cardiovascular disease: an Italian multidisciplinary Delphi panel consensus.

The purpose of this work was to reach the consensus of a multidisciplinary and multistakeholder Italian panel on the value of polypill in cardiovascular disease, with respect to the clinical, technological, economic and organizational dimension. A three-step modified Delphi method was used to establish consensus. Eleven experts in the area of cardiology, pharmaceutical technology, general practice, hospital pharmacy, pharmacology, and health economics participated in the expert panel. To identify existing evidence concerning the value of polypill in the prevention of patients with cardiovascular disease, a systematic literature review was carried out according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses statement guidelines. In the first round, 22 statements were distributed to the panel. Panel members were asked to mark 'agree' or 'disagree' for each statement and provide any comments. The same voting method was again used for the second round. In the first round nine statements met consensus. In the second round, 10 statements reached consensus. Overall, consensus was reached for 19 statements representing five value polypill domains: clinical, technological, economic and organizational. During a final web meeting with all panel members consensus document open points were discussed. Panel members agreed to recognize polypill as effective in reducing cardiovascular events, blood pressure and lipids, cardiovascular risk and the weight of therapy, in therapeutic adherence improvement, in the absence of differences in bioavailability between drugs administered in fixed or free combinations and the better cost-effectiveness profile compared with standard care. This document represents a knowledge framework to inform decision makers of the value of polypill in cardiovascular prevention.

Effect of Intensive Versus Standard Blood Pressure Control on Stroke Subtypes.

[Figure: see text].

Improving Cardiovascular Health in a Pediatric Preventive Cardiology Practice.

Poor childhood cardiovascular health translates into poor adult cardiovascular health. We hypothesized care in a preventive cardiology clinic would improve cardiovascular health after lifestyle counseling. Over a median of 3.9 months, mean cardiovascular health score (range 0-11) improved from 5.8 ± 2.2 to 6.3 ± 2.1 (P < .001) in 767 children.

Women's Health Initiative Strong and Healthy Pragmatic Physical Activity Intervention Trial for Cardiovascular Disease Prevention: Design and Baseline Characteristics.

BACKGROUND: National guidelines promote physical activity to prevent cardiovascular disease (CVD), yet no randomized controlled trial has tested whether physical activity reduces CVD. METHODS: The Women's Health Initiative (WHI) Strong and Healthy (WHISH) pragmatic trial used a randomized consent design to assign women for whom cardiovascular outcomes were available through WHI data collection (N = 18 985) or linkage to the Centers for Medicare and Medicaid Services (N30 346), to a physical activity intervention or "usual activity" comparison, stratified by ages 68-99 years (in tertiles), U.S. geographic region, and outcomes data source. Women assigned to the intervention could "opt out" after receiving initial physical activity materials. Intervention materials applied evidence-based behavioral science principles to promote current national recommendations for older Americans. The intervention was adapted to participant input regarding preferences, resources, barriers, and motivational drivers and was targeted for 3 categories of women at lower, middle, or higher levels of self-reported physical functioning and physical activity. Physical activity was assessed in both arms through annual questionnaires. The primary outcome is major cardiovascular events, specifically myocardial infarction, stroke, or CVD death; primary safety outcomes are hip fracture and non-CVD death. The trial is monitored annually by an independent Data Safety and Monitoring Board. Final analyses will be based on intention to treat in all randomized participants, regardless of intervention engagement. RESULTS: The 49 331 randomized participants had a mean baseline age of 79.7 years; 84.3% were White, 9.2% Black, 3.3% Hispanic, 1.9% Asian/Pacific Islander, 0.3% Native American, and 1% were of unknown race/ethnicity. The mean baseline RAND-36 physical function score was 71.6 (± 25.2 SD). There were no differences between Intervention (N = 24 657) and Control (N = 24 674) at baseline for age, race/ethnicity, current smoking (2.5%), use of blood pressure or lipid-lowering medications, body mass index, physical function, physical activity, or prior CVD (10.1%). CONCLUSION: The WHISH trial is rigorously testing whether a physical activity intervention reduces major CV events in a large, diverse cohort of older women. Clinical Trials Registration Number: NCT02425345.