Comparative Effectiveness PTSD Trial of Sequenced Pharmacotherapy and Psychotherapy in Primary Care, 11 U.S. States, 2021-2024 (ICPSR 39425)
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.
Comparison of Direct to Consumer Delivery Models for Hearing Devices, Illinois and Texas, 2020-2025 (ICPSR 39653)
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.
Development and Evaluation of a Patient-Centered Approach to Assess Quality of Care: Patient-Reported Outcomes-Based Performance Measures (PRO-PMs) [Methods Study], 6 U.S. States, 2016-2020 (ICPSR 39628)
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