Publications by authors named "J Devin Peipert"

Article Synopsis
  • This study focuses on evaluating two patient-reported outcome measures for people with non-small cell lung cancer (NSCLC), specifically the PROMIS Physical Function short form and the NSCLC Symptom Assessment Questionnaire.
  • Data were derived from two clinical trials involving a total of 915 participants, assessing the reliability, validity, and thresholds for meaningful changes in these measures.
  • The findings showed that both measures are reliable and valid for clinical use, with specific thresholds identified for meaningful changes: a decrease of 6-7 points for PROMIS PF-SF indicating worsening physical function and an increase of 2-3 points for NSCLC-SAQ indicating worsening symptoms.
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Introduction: Fluid overload is a source of substantial morbidity for adults and children with nephrotic syndrome (NS). Preparation and Rationale for a Fluid Overload in Nephrotic Syndrome Clinical Outcomes Assessment Set for Drug Development (Prepare-NS, 5UG3FD007308) was funded by the US Food and Drug Administration to develop a core set of patient-reported and observer-reported (for young children) outcome measures of fluid overload for use in pharmaceutical trials across the lifespan.

Methods: The Prepare-NS study team developed the proposed context of use with input from stakeholders.

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Article Synopsis
  • Early phase clinical trials focus on evaluating the safety and tolerability of new therapies, primarily using investigator and lab results rather than patient feedback.
  • A recent expert roundtable brought together 22 stakeholders to discuss the need for a universal patient-reported outcomes (PRO) model in early phase trials and how to effectively incorporate PROs to assess tolerability and guide treatment decisions.
  • The discussions yielded key recommendations and identified priority areas for further research on integrating patient feedback into early trials to improve safety and symptom management.
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Interpretation of patient-reported outcome (PRO) scores has been supported by identifying score thresholds or ranges that indicate clinical importance. There has been a recent focus on the estimation of meaningful within patient change (MWPC). While much attention has been focused on anchor-based methods, some researchers prefer that a lower bound to these estimates should exceed a change score that could be observed due to measurement error alone as a safeguard against misclassifying individual patients as changed when they have not.

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Background: The authors examined baseline physical functional (PF) impairment among cancer outpatients in the National Cancer Institute Cancer Moonshot study Northwestern University Improving the Management of Symptoms During and Following Cancer Treatment (NU IMPACT). They hypothesized that PF impairment, measured with the Patient Reported Outcome Measurement Information System-Physical Function (PROMIS-PF) survey, would (1) be common and more prevalent for patients receiving treatment compared with no treatment and (2) differ across tumor types, independent of cancer continuum phase.

Methods: Adults who were diagnosed with cancer in NU IMPACT (n = 2273) were sampled, and their PROMIS-PF scores were compared across tumor types and cancer continuum (curative, noncurative, or no treatment), with scores ≤40 indicating moderate-severe impairment.

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