Publications by authors named "J 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.
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.
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.
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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