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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.

Patient-reported outcome measures, or PROMs, ask patients how they feel and what activities they can do in daily life. Patients receiving cancer treatment, such as chemotherapy, often have side effects. PROMs can help cancer centers know if patients are getting high-quality care that helps manage their side effects.

In this study, the research team wanted to

• Learn from patients and clinicians, like doctors and nurses, what side effects are important to track during chemotherapy
• Create PROMs that can measure important side effects of chemotherapy

The research team also wanted to test the PROMs to see

• If patients find them easy to complete
• If the PROMs can detect differences in how well cancer centers control patients' treatment side effects

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.

Electronic health records store a lot of data about a patient. These data often include age, health problems, current medicines, and lab results. Looking at these data may help doctors treating patients after a trauma predict how likely it is that they will respond well to a treatment and survive. This information can help doctors make better treatment decisions. But first, researchers need to figure out how to combine and analyze data to make accurate predictions. In this study, the research team created new statistical methods to combine data from patient records. They used these methods to predict patient health outcomes. Then the team used health record data collected from patients in hospital trauma centers to test their predictions.

To access the methods and software, please visit the following GitHubs:

• origami
• varimpact
• opttx

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.

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.

This study consists of a two-group, randomized, controlled comparative effectiveness trial with 300 individuals from Appalachian Kentucky who do not have a primary care provider (and thus are not able to receive the standard of care without intercession) and who are at risk for CVD (cardiovascular disease) by virtue of having two or more modifiable CVD risk factors. The researchers compared (1) the standard of care alone, referral to a primary care provider for management of CVD risk factors, with (2) standard of care supplemented by patient-centered, culturally appropriate, self-care CVD risk reduction intervention (HeartHealth) designed to improve multiple CVD risk factors while overcoming barriers to success.

The researchers compared the 4 month (short-term) and 1 year (long-term) impact of the interventions on: 1) CVD risk factors selected by patients (i.e., tobacco use, blood pressure, lipid profile, HgA1c for diabetics, body mass index, waist circumference, depressive symptoms, or physical activity level); 2) all CVD risk factors for each patient; 3) quality of life; 4) patient and healthcare provider satisfaction; 5) desirability and adoptability by assessing adherence to recommended CVD risk reduction protocols, and retention of recruited individuals.

Demographic variables include gender, age, ethnicity, marital status, employment status, and level of education.