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The main objective of this pragmatic randomized clinical trial (PCT) is to identify the optimal dose of aspirin for secondary prevention in atherosclerotic cardiovascular disease (ASCVD). A total of 15,076 high-risk patients with a history of a myocardial infarction (MI) or documented ASCVD were randomized in a 1:1 ratio to receive 81 mgs versus 325 mgs of aspirin every day. This trial addressed the following specific aims:

1. To compare the effectiveness of two doses of aspirin (81 mg and 325 mg) in reducing a composite of all-cause mortality and hospitalization for nonfatal MI, or nonfatal stroke, and the primary safety endpoint of major bleeding. Secondary endpoints include the components of the primary endpoint and hospitalization for transient ischemic attack, unstable angina, or coronary revascularization procedures.
2. To compare the effects of aspirin in selected subgroups of patients by sex, age, race, Internet users vs. non-users, and those with diabetes or advanced chronic kidney disease (CKD).
3. To develop and refine the infrastructure for PCORnet to conduct multiple comparative effectiveness trials in the future.
4. To explore biological mediators of heterogeneity of response to aspirin and of impact on clinical events.

The overall goal for this project was to reduce the incidence of COVID-19, hospitalization, and mortality among adults with serious mental illness (SMI) and intellectual disabilities/developmental disabilities (IDD) in congregate living settings (i.e., group homes) in Massachusetts, as well as to reduce COVID-19 incidence among staff who work in these settings. The research team was guided by two comparative effectiveness questions:

1. With the goal of prioritizing and making actionable best practices available as resources, what is the comparative effectiveness of various types and intensities of preventative interventions (e.g., screening, isolation, contact tracing, hand hygiene, physical distancing, use of face masks) in reducing rates of COVID-19, related hospitalizations, and related mortality in this population?
2. With the goal of effectively implementing best practices, what is the most effective implementation strategy to reduce rates of COVID-19 in this population: using tailored best practices (TBP) with SMI/IDD residents and staff of group homes in mind, or general best practices (GBP) from state and federal standard guidelines for all congregate care settings?

The specific aims of this study were as follows:

Aim 1a. Synthesize existing baseline data collected by 6 state behavioral health agencies on COVID-19 rates, hospitalization, mortality, and use of infection prevention practices.

Aim 1b. Collect stakeholder input via surveys and virtual focus groups on staff and resident experiences and on barriers/facilitators to implementing recommended preventative practices.

Aims 2a and 2b. Determine the comparative effectiveness of various COVID-19 preventative practices by (Aim 2a) using a validated simulation model to estimate COVID-19 spread in group homes and (Aim 2b) obtaining stakeholder input on prioritizing and defining tailored best practices for implementation.

Aim 3. Compare the effectiveness of TBPs with GBPs by using a hybrid effectiveness-implementation cluster randomized controlled trial.

Data collected to answer Aims 1 and 2 served as the foundation for designing the Aim 3 trial. Data for the trial were collected in 3-month intervals beginning January 2021 (baseline) until October 2022 (15-month follow-up). Residents and staff were sampled from approximately 400 group homes. Primary implementation outcome measures were COVID-19 vaccination rates and fidelity scores. The primary effectiveness outcome measure was COVID-19 infection.

Notes: This collection contains only data from Aim 1a and Aim 3. Throughout the data and documentation, "intellectual and/or developmental disabilities" is abbreviated as both IDD and ID/DD.

The COVID-19 Citizen Science (CCS) Study was launched early in the pandemic to collect patient-reported information about exposures, risk behaviors and outcomes relevant to the pandemic. The Patient-Centered Outcomes Research Institute (PCORI) funded the research team to expand recruitment into CCS using PCORnet, the National Patient-Centered Clinical Research Network, and to use the resulting data to compare the patient-reported impact of pandemic associated policies. The research team systematically collected pandemic-associated policies enacted by counties across the United States (focusing in areas where there were many CCS participants), and to do so on a weekly basis from the beginning of the pandemic using publicly available sources.

Researchers combined data from various sources to answer two primary research questions (RQ):

1. What is the comparative impact of different shelter-in-place/reopening policies, overall and in vulnerable populations, on patient-reported financial insecurity, mental health, and other subjective outcomes important to patients?
2. What is the comparative effectiveness of county-level containment and mitigation strategies at achieving timely access to COVID-19 vaccination, testing, healthcare, information and contact tracing?

The research team collected patient-reported data from the CCS study and policy data from the U.S COVID-19 County Policy (UCCP) database. Electronic health record (EHR) data were also available from some participants recruited from health systems located across 7 U.S. states who consented and authorized use of these data for the study. Data for these participants were extracted from the PCORnet Common Data Model (CDM). Additional county-level contextual variables were included in analysis.

This collection contains CCS survey data on patient-reported anxiety with county-level policies data (DS1), respondent demographics (DS2), baseline survey results (DS3), daily (DS4) and weekly (DS5) COVID-19 symptoms reports, COVID-19 vaccination surveys repeated monthly (DS6) as well as a one-time vaccination survey (DS7), and pandemic impacts check-in surveys (DS8). CDM datasets include logistic regression model outcomes to predict study enrollment among all invited participants (DS9), codes for immunizations (DS10), laboratory tests (DS11), and procedures (DS12). County-level variables are also available for years 2021 (DS13) and 2023 (DS14).

For people with serious chronic conditions, healthcare that defaults to all available treatments without considering patient preferences risks harms that may exceed benefits. Advance care planning (ACP) has the potential to align healthcare with what is important to patients and maximize quality of life. While primary care is where most people receive most of their care, engaging patients in ACP is not routine in primary care given competing demands and limited resources. Primary care clinicians, patients, and families agree that it is preferred to make plans before there is a medical crisis. The research team's goal was to make ACP routine in primary care and to "move it upstream" so that it included improving the quality of the last years of life as well as respecting wishes for end of life care.

This study included a comparative effectiveness trial of team-based versus individual clinician-focused ACP in primary care practices. The research team adapted Ariadne Labs' Serious Illness Care Program (SICP) and aimed to determine if a team approach produces better patient outcomes and explore factors influencing implementation of ACP across practices.

Seven practice-based research networks (PBRNs) in the United States and Canada randomized their primary care practices to team-based or individual clinician-focused versions of SICP. Team members and clinicians completed training, and implementation was supported through practice facilitation. Consented patient participants completed a baseline survey after initial conversations and follow-up surveys at 6 and 12 months later. Forty practices (21 team, 19 clinician) completed training and referred patients to the study. Half of the practices were rural, 80 percent were family medicine, and 33 percent were medical residency training sites. 535 healthcare staff completed training. Both arms trained primary care providers; the team arm also trained nurses, medical assistants, and other roles. 1,321 patients and care partners were referred; and 917 consented and were enrolled (455 from team practices, 462 from clinician). Data from 802 patients were included in the primary analyses. Qualitative implementation data was collected during practice facilitation and from practice interviews.

This collection includes quantitative data collected from primary care practices (DS1) and team members and clinicians (DS2) from study sites located in the United States.

The University of Pennsylvania Health System (Penn Medicine) developed COVID Watch, an automated text message-based, remote monitoring program with 24/7 clinical support. Remote outpatient monitoring of patients with COVID-19 became needed because patients with SARS-CoV-2 infection can decline rapidly and unpredictably, and because of their own limited capacity to manage acute symptoms and concerns about staff safety, office-based outpatient practices often redirect patients with confirmed or suspected COVID-19 to hospitals. As a result, emergency departments (EDs) and hospitals became overwhelmed during surge periods of high community incidence rates and prevalence. Remote monitoring has the potential to facilitate ED- and hospital-level care for patients who require it while supporting access to care for patients who can safely remain at home.

This study compared outcomes for patients enrolled in COVID Watch with those of patients who were eligible to enroll but received usual care, with the hypothesis that enrollment in COVID Watch was associated with reduced mortality. The present research examined whether patients with COVID-19 who were enrolled in COVID Watch experienced better health outcomes compared with usual care (Aim 1) and whether augmenting COVID Watch with at-home monitoring of SpO2 (blood-oxygen saturation) improves patient outcomes (Aim 2).

The Comprehensive Post-Acute Stroke Services (COMPASS) Study is a pragmatic cluster-randomized clinical trial that evaluated the real-world effectiveness of the COMPASS transitional care (COMPASS-TC) model compared to usual care among adult stroke and transient ischemic attack (TIA) patients discharged home between 2016 and 2018. In Phase 1, 40 North Carolina hospital units were randomized 1:1 to the COMPASS-TC intervention or usual care, stratified by stroke patient volume and stroke center certification. In Phase 2, hospitals randomized to usual care crossed over to implement COMPASS-TC, and hospitals randomized to the intervention sustained COMPASS-TC. The intervention was patient-centered and assessed social and functional determinates of health to inform individualized care plans for secondary prevention, recovery, and referrals to services and community-based resources. COMPASS-TC was consistent with Centers for Medicare and Medicaid Services (CMS) TC management reimbursement requirements.

The primary outcome was functional status (Stroke Impact Scale-16; SIS-16) at 90 days; secondary outcomes were mortality, disability, medication adherence, depression, cognition, self-rated health, fatigue, care satisfaction, home blood pressure monitoring, falls, and caregiver strain. Telephone interviewers, blinded to treatment assignment, assessed these outcomes at 90 days.

During the COVID-19 pandemic, telemedicine emerged as the primary method of providing outpatient care in many regions with shelter-in-place and social distancing policies. This study aimed understand the impact of this rapid and widespread transition from in-person to remote visits on disparities in access to primary care, especially in chronic disease where ongoing communication between providers and patients is essential.

The newly developed or expanded telemedicine programs varied widely, raising questions about the effect of these differences on uptake of telemedicine among different patient populations and on patient-centered outcomes. Leveraging a natural experiment approach, this study examined rapidly changing telemedicine and in-person models of care during and after the COVID-19 crisis to determine whether certain patients could safely choose to continue telemedicine or telemedicine-supplemented care, rather than return to in-person care.

Amplification is an evidence-based front-line treatment for those with impaired communication secondary to Age Related Hearing Loss (ARHL). ARHL is the most prevalent cause of communication impairment among older adults and multiple existing evidence-based care models exist to address it. This study compared the two most common models of care (defined below) for ARHL provided to adults in assisted living/personal care communities.

• The Consult Model (i.e., usual care) was an acute care strategy, relying on a monthly Audiologist visit to the facility.
• The Engage Model was a chronic care approach to supportive hearing loss self-management of ARHL. Engage includes (a) hearing screening for all residents, (b) an individualized communication plan for those with an identified hearing loss (e.g., one-to-one, group, telephone, television plans, hearing aid trouble shooting, communication strategies, etc.), (c) provision of simple, non-custom amplifiers, (d) referral to audiology if needed, and (e) ongoing support provided by trained personnel (Communication Facilitator) under the supervision of the audiologist.

This study included three separate sample populations at 10 medical facilities. The staff at the medical facilities were selected to measure job satisfaction (DS1). Residents of the medical facilities were sampled to collect measures related to the impact of hearing on an individual's life and general demographics (DS2 and DS3). And the family of the residents were sampled to measure caregiver burden (DS4).

To study the impact of COVID-19 pandemic on frontline healthcare workers in the United States over time, the Healthcare Worker Exposure Response and Outcomes (HERO) Registry was created in 2020 to form a virtual research community of healthcare workers (and later, their family members and community members). The registry was intended for healthcare workers interested in completing research studies related to the COVID-19 pandemic and its impacts on their lives. Observational data were collected at various timepoints between April 2020 and September 2022 via web-based questionnaires available on the HERO Registry online portal.

This collection contains 39 sets of data from over 50,000 HERO Registry members. Datasets represent separate surveys with distinct survey designs and sampling criteria. Surveys focused on health history, workplace experiences, COVID-19 exposure, social support, mental health, and the respondents' willingness to remain in or leave the healthcare field. Datasets 24 through 39 represent "hot topics" such as vaccines, vaccine willingness and uptake, childcare and school arrangements, and staffing shortages. Datasets for registry administration, respondent demographics, and survey eligibility criteria are also included.

A rare disease is one that affects fewer than 200,000 people in the United States. Because few people have these diseases, clinical studies on treatments can be hard to conduct. One way to study rare disease treatments is with an small n sequential multiple assignment randomized trial (snSMART) study.

snSMART studies have two stages. In the first stage, researchers assign patients to a treatment by chance. In the second stage, patients may stay with the same treatment or switch treatments. Patients stay on the same treatment if it's working well. If the treatment isn't working, researchers assign patients by chance to a new treatment.

snSMARTs can help researchers learn more from a smaller number of patients than a standard clinical study. But most current methods for analyzing snSMARTs use data only from the first stage, which can lead to inefficient results.

In this project, the research team developed and tested new methods that use data from both stages to analyze snSMARTs. The team compared results from the new methods to actual treatment effectiveness to see:

• Bias, or whether results are too high or too low
• Efficiency, or how big the difference is between the results and actual treatment effectiveness

This study contains two supplementary documentation files. There is no data included in this release.

One goal of comparative effectiveness research is to find out which treatments work best for different groups of patients. For example, treatments may work differently for patients with only one health problem than for those with more than one health problem.

In observational studies, researchers look at health outcomes when patients and their doctors choose the treatments. These studies often use data from electronic health records, or EHRs. Researchers can apply propensity score, or PS, methods to look at different groups of patients. With PS methods, researchers create groups of patients with similar traits who had different treatments. But PS methods require researchers to have data on all patient traits that could affect how well the treatment works. With EHR data, data on some patient traits, like health problems, may be missing. Using current PS methods in observational studies may lead to biased results.

In this study, the research team created new guidance for using PS methods with EHR data to look at the effects of treatment in different groups of patients. The team also created and tested new PS methods to make groups of patients with similar traits.

The primary aim of this randomized clinical trial is to compare the effectiveness of the Specific Carbohydrate Diet (SCD) and the Mediterranean style diet (MSD) in inducing symptomatic and clinical remission in patients with Crohn's disease. Secondary objectives are to compare the effectiveness of the SCD and MSD in reducing mucosal and systemic inflammation, assessed by measuring the concentration of fecal calprotectin (FCP) and C-reactive protein (CRP) respectively; to compare the diets' effectiveness in improving fatigue, pain, and joint symptoms; and to determine the proportion of patients who continue study diets when prepared food is no longer provided without cost and their reasons for discontinuing the diets. The research aims were guided by crowdsourcing patient-generated research priorities; those that received the most support from Patient-Powered Research Network (PPRN) members were related to diet.

Based on the book Breaking the Vicious Cycle (Gottschall 1987), the Specific Carbohydrate Diet (SCD) restricts all but simple carbohydrates. Fresh fruits, vegetables, unprocessed meats, lactose-free cheeses, and certain legumes are permitted; grains, processed foods, canned foods, and milk are not permitted. The Mediterranean style diet (MSD) involves a high intake of olive oil, fruit, nuts, vegetables, and cereals; moderate intake of legumes, fish, seafood, and poultry; and low dairy intake. Red and processed meats, soda drinks, bakery foods, and sweets are not permitted. The MSD was selected as the alternative diet in this trial due to its easier implementation, consistency with U.S. Department of Agriculture and World Health Organization recommendations, and evidence of its role in overall health and specific benefits for Crohn's patients.

A total of 194 adult patients with mild to moderate Crohn's disease were enrolled and randomized into either the SCD (intervention) or MSD (control) diet groups at 33 different sites across the United States. Patients received meal delivery for their assigned diet for six weeks, then were provided instructions and recipes to adhere to the diet on their own for weeks seven through twelve. Outcome measures were taken at baseline, six weeks, and twelve weeks.

This study addressed whether it is better to expand the scope of collaborative care programs to treat patients with more complex psychiatric disorders or to facilitate successful referrals to specialty mental health care. The primary objective of this study is to compare Telepsychiatry Collaborative Care (TCC) and Telepsychiatry Enhanced Referral (TER) from the patient and provider perspective. The secondary objective is to determine whether patients not engaging and responding to TER, improve with Phone-Psychiatry Enhanced Referral (PER). There are four specific aims.

Aim #1: To quantitatively compare the treatment experience, engagement, self-reported clinical outcomes, and recovery-oriented outcomes of patients initially randomized to TCC and TER.

Aim #2: For the subset of patients randomized to TER who do not engage in treatment and are still symptomatic at 6 months, quantitatively compare treatment experience, treatment engagement, self-reported clinical outcomes and recovery-oriented outcomes of patients randomized to continued-TER or PER.

Aim #3: To gain an in-depth understanding of patients' and providers' treatment experience, qualitatively compare those randomized to TCC, TER and PER.

Aim #4: To examine treatment heterogeneity among subgroups of patients randomized to TCC and TER based on race/ethnicity, age and clinical severity.

The TARGET (Targeted Interventions to Prevent Chronic Low Back Pain in High-Risk Patients) Trial was a primary care-based, multisite, cluster randomized, pragmatic trial comparing guideline-based care (GBC) to GBC + referral to Psychologically Informed Physical Therapy (PIPT) for patients presenting with acute lower back pain (LBP) and identified as high risk for persistent disabling symptoms. Chronic lower back pain (LBP) is defined as a response of "more than three months" to question 1, and a response of "half the days or more than half the days" in the past 6 months to question 2. See Appendix 1 for the LBP Questionnaire in the Protocol report.

Study sites included primary care clinics within each of four geographical regions in the United States, with clinics randomized to either GBC or GBC+PIPT. Acute LBP patients at all clinics were risk stratified (high, medium, low) using the STarT Back Tool. The primary outcomes were the presence of chronic LBP and LBP-related functional disability determined by the Oswestry Disability Index at 6 months. Secondary outcomes were LBP-related processes of health care and utilization of services over 12 months, determined through electronic medical records.

Study enrollment began in May 2016 and concluded in June 2018. The trial was powered to include at least 1,860 high-risk patients in the cluster-randomized controlled trial cohort. A prospective observational cohort of approximately 6,900 low and medium-risk acute LBP patients was enrolled concurrently.

This data collection contains a single data file with 223 variables and 9,730 cases. The number of respondents at each of the study locations were:

• Boston Medical Center: 997 respondents
• Intermountain Health (Salt Lake City): 2,094 respondents
• Johns Hopkins University (Baltimore): 1,615 respondents
• University of Pittsburg Medical Center: 5,024 respondents