Comparing Two Ways to Manage Symptoms for Patients Who Have Chronic Migraine and Frequent Medication Use (The MOTS Trial), United States, 2017-2020 (ICPSR 38546)
Extending the Patient-Reported Outcomes Measurement Information System Pain Item Banks: Pain Self-Efficacy and Pain Catastrophizing [Methods Study], United States, 2014-2018 (ICPSR 39507)
Chronic pain, which lasts for months or even years, can disturb people's daily lives and their relationships with others. Doctors want to measure how chronic pain affects people's lives so they can help their patients manage pain.
In this study, the research team wanted to measure two aspects of living with and managing chronic pain:
- Pain appraisal describes how people think about their pain. It measures how much people worry about their pain and how well they cope with pain or distract themselves from thinking about it.
- Pain-related self-efficacy describes how confident a person is that they can live well with pain.
The research team created two pools of questions, called item banks, to measure each of the two aspects of living with chronic pain. From these larger item banks, the team created and tested brief versions using two and six questions. These brief versions take people less time to finish than the full item banks.
Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients: A Multi-Site Pragmatic Randomized Controlled Trial (TARGET Trial), 4 U.S. cities, 2016-2019 (ICPSR 38145)
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