Related Experiment Videos
Item comprehension and content coverage of patient-reported outcome measures for long COVID: a qualitative study
Christina K Zigler1, Charis Yousefian2, Rikki Mangrum2
1Department of Physical Medicine and Rehabilitation, School of Medicine, University of Pittsburgh, 3471 Fifth Ave, Suite 910, Pittsburgh, PA, 15213, USA. cek53@pitt.edu.
Purpose:
Fit-for-purpose clinical outcome assessments are essential to inform medical product development, but outcome measures for Long COVID, a new and devastating phenomenon, have not yet been established. The objective of this study was to evaluate item comprehension and content coverage of four selected patient-reported outcome measures (PROMs) for use in a Long COVID clinical trial platform.
Methods:
A noninterventional, cross-sectional qualitative cognitive debriefing study of English-speaking adults with Long COVID was conducted, with interviews taking place virtually between August and November 2024. Recruitment was managed by a research firm. The main outcomes of the study were participant comprehension and relevance of the selected PROMs, including symptoms and functioning as measured by modified versions of the DePaul Symptom Questionnaire-Post-Exertional Malaise, Everyday Cognition Scale 2 questionnaire, Composite Autonomic Symptom Score-31, and Orthostatic Hypotension Questionnaire.
Results:
Participants were able to comprehend most items and indicated they were relevant to their experiences with Long COVID. Participants identified potential enhancements to the measures such as simplifying instructions, modifying item wording, and reducing PROM length. Interviewers observed cognitive burden during some of the interviews.
Conclusions:
Based on the overall support for comprehension and relevance of items within each measure, use of these measures within the Long COVID clinical trial platform was generally supported. Future work, including qualitative and quantitative studies, could improve the experience of PROM data collection in this context. Clinical trial protocols for Long COVID should carefully consider burden on participants when collecting PROMs.
Related Concept Videos
Chronic Obstructive Pulmonary Disease-IV: Assessement and Diagnostic Studies
Medical History
Observational Studies
There are three types of observational studies – Prospective, retrospective, and cross-sectional.
Prospective Study
Prospective studies, also known as longitudinal or cohort studies, are carried out by collecting future data from groups sharing similar characteristics. One example of...
Classification of Illness
An illness is a response to a disease in which the person's level of functioning is changed compared with a previous level. The general classification of illness includes acute and chronic.
Acute illness is severe and...
Methods of Documentation II: POMR
Guidelines for Writing Outcome
Patient outcomes reflect the patient's response to the goal rather than what the nurse aims to achieve. Terminology should be observable and measurable to avoid the reader's interpretation. The desired outcome should be realistic and achievable in the designated care timeframe. Expected outcomes should align with adjunctive therapies. The outcome should enhance care evaluation by...
Methods of Documentation V: CBE
In CBE, healthcare professionals establish predefined standards of practice that define what constitutes...