Advancing Patient Centered Outcomes Research in Survival Data with Unmeasured Confounding to Improve Patient Risk Communication [Methods Study], United States and Canada, 2015-2019 (ICPSR 39631)
Researchers often use data from patients' health records to compare treatments. But many things--not just treatments--affect patients' health. To figure out whether changes in patients' health result from treatment or something else, researchers can use statistical methods called instrumental variables, or IVs. IV methods account for factors that affect health but aren't in patients' health records, such as eating habits. Existing IV methods work well when looking at health outcomes that are measured using certain types of scales, such as blood pressure. But existing methods don't work as well to measure the time until a health event occurs, particularly when an event, like death, has not occurred for many patients in the study.
In this study, the research team created and tested a new IV method to more accurately estimate how a treatment relates to the time until a health event.
Development of Reporting Guidelines for Psychometric Research on Patient-Reported Outcome Measures [Methods Study], United States, 2017-2024 (ICPSR 39632)
Patient-reported outcome measures, or PROMs, are surveys that ask patients how they feel and what activities they can do. All PROMs have measurement properties. These properties help researchers understand how well the PROM was designed. For example, one property is the ability to get consistent responses over time. Another is how accurately the PROM measures how patients feel about a health problem. But researchers may not consistently report these properties in studies about PROMs.
In this study, the research team created guidance about reporting measurement properties in studies on PROM.
Methods for Prioritizing Surrogate Desired Health Outcomes for Patients [Methods Study], Washington, DC and Maryland, 2013-2018 (ICPSR 39516)
Children with intellectual and cognitive disabilities often have problems with reasoning, learning, and problem solving. With such challenges, caregivers may have to make choices for their children about their health care and treatments. These children may need such help into young adulthood.
In this study, the research team wanted to find out what matters most to caregivers about their children's care. Caregivers had children with an intellectual or cognitive disability plus a mental health condition, such as depression or anxiety. The team interviewed caregivers about their preferences. Then the team used this information to design a survey. A larger group of caregivers filled out the survey.
Patient-Centered Enrollment in Comparative Effectiveness Trials: Mathematical Equipoise [Methods Study], Massachusetts, 2013-2018 (ICPSR 39483)
Comparative effectiveness research compares two or more treatments to see which one works better for certain patients. This research may include randomized controlled trials, or RCTs, in which researchers assign patients to one of the treatments by chance.
A patient may enroll in an RCT when, based on current knowledge of that patient's traits, the treatments being tested have about the same chance of helping. If one treatment is known to have a better chance of helping a patient, then the patient would not enroll and would receive that treatment from the doctor.
Sometimes there isn't enough research to show if one treatment has a better chance of helping than another. In this case, researchers may use computer programs. The programs estimate how well different treatments work in patients with certain traits. For example, a person's age and pain level may affect how much a treatment helps.
These programs would be useful for patients with knee osteoarthritis. Not many RCTs have compared total knee replacement surgery with other treatments such as medicine or physical therapy.
In this study, the research team made a computer program for patients with knee osteoarthritis. It uses data from electronic health records. The program could help identify patients for whom
- The treatments in the study have about the same chance of helping. These patients may wish to take part in an RCT.
- A certain treatment may help more than another. These patients could choose that treatment.
The research team also made an online system based on the program for patients and doctors to use during a visit. Doctors can use the results from the system to talk with patients about treatment. If appropriate, they could talk about taking part in an RCT.
Promoting Shared Decision-Making About Colorectal Cancer Testing for Older Adults (PRIMED) Study, Maine and Massachusetts, 2019-2022 (ICPSR 39523)
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.
Structured Approach to Prioritizing Cancer Research Using Stakeholders and Value of Information [Methods Study], United States, 2008-2018 (ICPSR 39518)
Organizations that fund cancer research need to decide which studies to fund. Value of information (VOI) is a way to help rank research studies. VOI estimates the value of research by looking at the impacts on health and on healthcare that could result from the research.
SWOG (formerly the Southwest Oncology Group) is a network of cancer researchers funded by the National Cancer Institute. SWOG leaders review and score new study proposals based on the scientific value of the studies and their potential impact. Based on a study's score, SWOG's leadership committee decides whether to send the study to the National Cancer Institute for funding review.
In this study, the research team wanted to learn if giving VOI data to the committee affected its scoring of proposals. The team also wanted to see if providing VOI data was helpful in deciding which studies to fund. The study had two parts. The research team created a process to quickly estimate VOI. Then, the team tested the process on nine study proposals that the SWOG committee reviewed.