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Curated

Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS), United States, 2017-2020 (ICPSR 39186)

Released/updated on: 2025-07-01
Geographic coverage: United States
Time period: 2017-01-01--2020-01-01
This study was a multicenter, randomized, controlled, rater-blinded, phase 4, non-inferiority trial. Individuals with multiple sclerosis of any subtype, 55 years or older, with no relapse within the past 5 years or new MRI lesion in the past 3 years while continuously taking an approved disease-modifying therapy were enrolled at 19 multiple sclerosis centers in the USA. Participants were randomly assigned (1:1 by site) with an interactive response technology system to either continue or discontinue disease-modifying therapy. Relapse assessors and MRI readers were masked to patient assignment; patients and treating investigators were not masked. The primary outcome was percentage of individuals with a new disease event, defined as a multiple sclerosis relapse or a new or expanding T2 brain MRI lesion, over 2 years. The study assessed whether discontinuation of disease-modifying therapy was non-inferior to continuation using a non-inferiority, intention-to-treat analysis of all randomly assigned patients, with a predefined non-inferiority margin of 8%.
Curated

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)

Released/updated on: 2021-10-07
Geographic coverage: Baltimore, United States, Massachusetts, Salt Lake City, Maryland, Utah, Pennsylvania, Boston, Pittsburgh
Time period: 2016-01-01--2019-12-31

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
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