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In an effort to make hearing aids more affordable and accessible to U.S. adults with hearing difficulty, the Food and Drug Administration (FDA) empowered these adults to self-fit over-the-counter (OTC) hearing aids. The effectiveness of two self-fit methods, Consumer Decides (CD) and Efficient Fitting (EF), was hypothesized to be non-inferior to the professional-fit method, (Audiology Based, AB). This was evaluated for both short-term (6 weeks post-fit) and long-term (6 months post-fit) outcomes.

As people age, medical decisions become more complex, including conversations about cancer screening. For patients aged 76-85, the United States Preventive Services Task Force (USPSTF) advises clinicians that decisions about colorectal cancer (CRC) screening should be individualized based on overall health and prior screening history (C recommendation). However, studies find that many older adults are not well-informed about, nor meaningfully engaged in, decisions about whether to continue CRC screening. Shared decision making (SDM) has been shown to improve the quality of decisions about initiating cancer screening but little is known about its effectiveness for decisions about stopping interventions. This study addresses a gap in the understanding of how to support clinicians and older patients in making good decisions about whether to continue CRC screening or not.

The researchers conducted a comparative effectiveness trial that randomly assigned clinicians at participating academic and community practices to one of two different decision support strategies. The first strategy (Registry arm) took a population health management (PHM) approach and used a patient registry to identify and track use of CRC screening among older adults for each clinician. The second strategy enhanced the registry by adding a multi-faceted SDM training program for clinicians (SDM Skills arm). The researchers enrolled patients of participating primary care providers (PCPs), aged 76-85, who are due or overdue for CRC screening, and survey them shortly after an office visit to determine the impact of the two strategies on outcomes of importance to patients. The study randomly assigned about 60 participating PCPs to the SDM skills or Registry arms, and enroll about 500 of their eligible patients.

Chronic low back pain is a leading cause of disability and reduced quality of life for nearly 100 million individuals in the United States. Approximately 5 to 10 percent of these individuals are prescribed opioids for treating their chronic low back pain. Limited data exists on the long-term efficacy of opioid treatment while much concern exists regarding the harm they can do to a person. Despite medication treatment patients still suffer from inadequate pain relief, impaired function, and quality of life.

This study sought to compare the long-term effectiveness of two types of alternative therapy approaches - mindfulness based therapy (MBT) and cognitive behavioral therapy (CBT) - for treating chronic low back pain especially those being treated by opioids.

The Preserving Kidney Function in Children With Chronic Kidney Disease (PRESERVE) study was designed to provide new knowledge to inform shared decision-making regarding blood pressure (BP) management for pediatric chronic kidney disease (CKD). PRESERVE compared the effectiveness of alternative strategies for monitoring and treating hypertension on preserving kidney function; expanded the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model by adding pediatric- and kidney-specific variables and linking electronic health record data to other kidney disease databases; and assessed the lived experiences of patients related to BP management.

Participants were recruited from 15 clinical institutions across the United States. The research team analyzed electronic health record (EHR) data from 11,851 children with CKD and their caregivers to compare different ways to monitor and treat BP to preserve kidney function. In addition, a subset of patients and caregivers completed an online survey detailing patient-reported outcomes, such as fatigue, life satisfaction, pain levels, sleep disturbance, anxiety, and peer relationships (n=395).

Due to the risk of re-identification based on unique patterns in the individual-level PCORnet electronic health record (EHR) data, patient privacy regulations prohibit the public release of the individual-level data. This collection contains the code underlying the analysis; instructions, codesets, and output lists for the PCORnet queries; and the survey questionnaires for patients and family members.

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).

Based on the state of the scientific evidence, the Sequenced Treatment Effectiveness for Posttraumatic Stress (STEPS) Trial was designed to address three specific aims. The first aim was to quantitatively compare engagement, self-reported PTSD symptom severity (primary outcome), quality of life, and recovery outcomes of primary care patients randomized to initially receive brief psychotherapy (Written Exposure Therapy - WET) or their choice of the three selective serotonin reuptake inhibitors (SSRIs). The second aim was, among patients not responding to initial treatment, to quantitatively compare outcomes of primary care patients randomized to: 1) augment the SSRI with WET, 2) switch from the SSRI to another class of antidepressants (serotonin-norepinephrine reuptake inhibitors - SNRI), or 3) switch from WET to the choice of the three SSRIs. The third specific aim was to quantitatively examine treatment heterogeneity among subgroups of primary care patients receiving pharmacotherapy and psychotherapy, including veterans, women, and those using cannabis.

According to the World Health Organization, palliative care is "an approach that improves the quality of life of patients and their families facing the problems associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psycho-social and spiritual." The goal of the study was to generate comparative effectiveness research evidence to support the delivery of coordinated, community-based palliative care that effectively implements care plans consistent with the goals and preferences of older adults with advanced illness and their caregivers.

This study included a pragmatic, two-arm, multi-site randomized controlled trial of older adults (50+ years) with either poor prognosis cancer or end-stage organ failure who were recruited during an emergency department (ED) visit, along with their informal caregivers, to compare nurse-led telephonic case management to facilitated, outpatient specialty palliative care on: 1) quality of life in patients, 2) loneliness, 3) healthcare use in the 12 months following enrollment, 4) symptom burden, 5) caregiver strain, 6) caregiver quality of life, and 7) bereavement.

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.

Patients treated for metastatic cancer, or cancer that has spread to another part of the body, often have symptoms from cancer and its treatment. They may feel tired, depressed, or nauseated. They may find it hard to do their usual activities. Better symptom tracking may help improve patients' care. For example, symptom tracking could quickly alert doctors when a patient may need a different medicine. In this study, the research team compared use of a weekly electronic symptom tracking system versus usual care for patients with cancer. Patients receiving usual care could report their symptoms to their care team during regular clinic visits. The research team wanted to see if the tracking system helped patients live longer, have better quality of life, or go to the hospital or emergency room less often. The aims of this study were as follows:

1. Determine whether integrating electronic patient-reported outcomes (ePRO) in cancer care improves patient-centered outcomes;
2. Elicit perspectives about benefit burden tradeoffs for integrating patient-reported outcomes into clinical workflow; and
3. Identify barriers, facilitators, and strategies used by practices to integrate patient-reported outcomes into clinical workflow.

A total of 1,191 patients were enrolled from 52 U.S.-based community oncology practices. Randomization into intervention and control conditions occurred at the site level. Data collected as part of this study included patient clinical information; weekly symptom surveys, quality of life surveys, and cancer care surveys completed by patients; feedback on the ePRO intervention from patients, clinical research associates, nurses, and physicians; and symptom alerts sent to nursing staff. Please note that while qualitative data were collected as part of this study, they are not available.

People experiencing homelessness (PEH) were among the most likely to contract the novel coronavirus disease 2019 (COVID-19). Many PEH utilized high-density public places to satisfy their basic needs (e.g., soup kitchens for sustenance, public libraries for restrooms). This made it difficult for them to limit close contact with others and put them at increased risk of contracting and transmitting COVID-19. Furthermore, it was difficult to follow recommended protective measures--such as handwashing and social distancing--when living in shelters or on the streets.

PEH were at higher risk of COVID-19 related hospitalization and death than the rest of the population. The poor living conditions of PEH accelerated aging, leading them to experience geriatric conditions and medical complications more typical of individuals 10-20 years older. They were also at increased risk of cardiovascular and respiratory disease, HIV/AIDS, and diabetes, all conditions that increase vulnerability to serious COVID-19-related complications and death. These risks were compounded by the fact that PEH also faced significant barriers to accessing quality health care. In the absence of protective action, it was estimated that more than 21,000 PEH would require hospitalization due to COVID-19, more than 7,000 would require critical care, and nearly 3,500 would die.

Consequently, the COVID-19 pandemic made housing and health care for PEH one of the top priorities for the U.S. health care and public health systems. State and local governments across the country used federal relief funds to allocate private hotel rooms as protective shelter for vulnerable PEH. In Los Angeles County (LAC), which contains the largest unsheltered homeless population in the nation, 2,400 PEH were placed in hotels. COVID-19 response plans included accommodating up to 15,000 PEH in hotels who would then be moved to permanent housing in 90 days. This rapid push into housing amid a pandemic necessitated a delicate balance between social distancing and maintaining patients' basic needs, continuity of existing care, and personal and social well-being.

Permanent supportive housing (PSH)--programs that provide immediate access to independent living situations coupled with support services--is the most effective approach for serving PEH. Numerous studies have demonstrated PSH's effectiveness in improving housing retention, quality of life, and HIV outcomes. Though evidence concerning its impact on other health outcomes, health behaviors, and health care utilization is limited, the National Academies of Sciences, Engineering, and Medicine has nonetheless recognized PSH as extremely beneficial for PEH's health. COVID-19 was what this organization termed a "housing-sensitive condition"--one whose transmissibility, course, and medical management are particularly influenced by homelessness. Consequently, the National Alliance to End Homelessness recommended the use of PSH as part of its framework to address COVID-19 and homelessness.

However, significant questions remain about what types of PSH programs can best address COVID-19-related risk and promote patient-centered outcomes at a time of social and community disruption. There are two distinct approaches to implementing PSH: place-based (PB) PSH, or single-site housing placement in a congregate residence with on-site services, and scattered-site (SS) PSH, which uses apartments rented from a private landlord to house clients while providing mobile case management services. The strengths and weaknesses of these two approaches remain largely unknown but may have direct implications for adherence to COVID-19 prevention protocols and other health-related outcomes.

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).

INtegrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE) was a pragmatic randomized trial conducted from 2019 to 2023 with adults receiving chronic opioid therapy (COT) of at least 20 morphine milligram equivalents (MME) daily for chronic noncancer pain (CNCP). Participants were recruited from primary care and specialty pain clinics at three academic health centers in North Carolina and Tennessee. The study compared the effectiveness of the two behavioral interventions, 1) shared decision making (SDM) versus 2) motivational interviewing plus cognitive behavioral therapy for chronic pain (MI+CBT), on change in opioid dose, physical function, and pain interference. INSPIRE combined data from electronic health records (EHR) on opioid dose from baseline to 18 months and comorbidities with participant survey data at baseline, 6, and 12 months on the following topics:

• physical function,
• pain interference,
• pain intensity,
• anxiety,
• depression,
• pain severity,
• discontinuation of opioids,
• intent to reduce opioids,
• opioid use relative to baseline,
• adverse events,
• demographics,
• health insurance coverage,
• health literacy,
• patient-centered communication, and
• types of pain treatment used.

The collection includes three analysis datasets:

1. Adverse Events Dataset - one record per subject per adverse event
2. Opioid Prescriptions Dataset (post-processed opioid prescriptions used to derive the study's primary outcome) - one record per subject per opioid prescription
3. Outcomes Dataset (contains all of the study's demographics, primary, secondary, exploratory, and subgroup analysis variables) - one record per subject per timepoint

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.

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.

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.

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).

Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations. PREPARE (PESRAMHIP) is a pragmatic, open-label trial of 1201 randomly assigned African American/Black and Hispanic/Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled corticosteroid strategy (PARTICS) plus usual care (intervention) or to continue usual care.

Participants had one in-person visit to consent, randomize and collect baseline data followed by 15 monthly questionnaires. The primary end point of this study was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed.

Severe acute respiratory syndrome coronavirus 2 associated disease (COVID-19) is caused by a novel betacoronavirus, SARS-CoV-2, that was first isolated in January 2020 and has since caused a global pandemic unseen in decades in cases and mortality. At the time of initial protocol submission in April 2020, human vaccine clinical trials had just begun and experts predicted that a vaccine would not be available until April 2021 at the earliest. Therefore, new measures remained needed to prevent the spread of disease. In vitro studies suggested a potential moderate antiviral effect of hydroxychloroquine (HCQ).

This study aimed to evaluate the efficacy of HCQ to prevent COVID-19 clinical infection and to prevent viral shedding of SARS-CoV-2 among healthcare workers (HCWs), as well as to evaluate the safety and tolerability of HCQ. Participants prescreened through the Healthcare Exposure Response and Outcomes (HERO) Registry across 34 U.S. clinical centers were randomly assigned to take a placebo (n=676) or HCQ (n=683) for 30 days, with in-person clinic visits at baseline and 30 days, and an end-of-study virtual visit at 60 days. This collection contains analysis (DS1 through DS6) and tabulation (DS7 through DS44) data and accompanying documentation.

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 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.

Antibiotics are considered a feasible treatment for appendicitis, yet appendectomy remains the treatment standard in the United States. Previous randomized trials comparing these treatments excluded important subgroups and recruited small sample sizes but questions remain about the applicability of these previous findings. This study conducted the Comparison of Outcomes of antibiotic Drugs and Appendectomy (CODA) randomized clinical trial to compare antibiotics with appendectomy among adults with appendicitis, including those with appendicolith. Those recruited comprised a diverse population, compared an overall measure of health status as the primary outcome, and included several secondary clinical and patient-reported outcomes, complications, and measures of healthcare utilization.

Community-engaged research is an umbrella term for forms of research that have community and stakeholder engagement as a core principle, for example, patient-centered outcomes research (PCOR), participatory action research, and community-based participatory research. However, the implementation and category of community engagement can vary across a spectrum from minimal engagement to fully collaborative engagement. A major methodological gap is the assessment of stakeholder engagement from a stakeholder perspective. Evaluation of the impact of stakeholder engagement on research development, implementation, and outcomes requires the development and validation of tools that assess engagement. This study's objective was to develop and validate comprehensive and condensed versions of a survey instrument that will be completed by stakeholders and used to assess engagement in research studies from a stakeholder perspective.

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