Are PROMs passing the message? A reflection with real-life migraine patients

Author:

Gil-Gouveia Raquel1ORCID,Oliveira António Gouveia2

Affiliation:

1. Hospital da Luz Headache Center, Lisboa, Portugal

2. Pharmacy Department, Universidade Federal do Rio Grande do Norte, Natal, Brasil

Abstract

Background Several patient-reported outcome measures are available to monitor headache impact, but are those reliable in real-life clinical practice? Methods Two identical patient-reported outcome measures (HALT-90 and MIDAS) were applied simultaneously in each clinical visit to a series of patients treated with monoclonal antibodies for migraine and intra-individual agreement was evaluated using the intraclass correlation coefficients. Results Our sample included 92 patients, 92.4% females, 45 years old on average. Moderate (0.50 to 0.75) and even poor (<0.50) ICC were observed in all but the first item of these patient-reported outcome measures in at least one evaluation. Over time, missing data were more frequent and no learning effect was detected. Discussion We observed intra-personal variation in reliability when answering patient-reported outcome measures, persisting in repeated applications, and a decrease in the motivation to respond, which should alert clinicians for these additional challenges in real-life clinical practice.

Publisher

SAGE Publications

Subject

Neurology (clinical),General Medicine

Reference14 articles.

1. Cella D, Hahn E, Jensen S, et al. Patient-Reported Outcomes In Performance Measurement. RTI Press, USA, 2015.

2. Food and Drug Administration (FDA), US Department of Health and Human Services (HHS). Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Guidance for Industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims (2009, accessed 21 July 2021).

3. The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice

4. Patient-relevant outcomes: what are we talking about? A scoping review to improve conceptual clarity

5. Assessing the impact of headaches and the outcomes of treatment: A systematic review of patient-reported outcome measures (PROMs)

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