Errors in answering migraine patient-reported outcome measure questions: patients consider training necessary in clinical trials
Background: In migraine clinical trials, patients’ understanding of the terminology used in patient-reported outcome (PRO) measures is important as variability in completing PRO measures can reduce the power to detect treatment efficacy. This study examines patients’ understanding of how to complete PRO measures in the absence of training, if minimal training can improve the accuracy of answering PRO items, and patients’ opinion on the necessity of training and their preference for the method of training.
Methods: Participants reporting a diagnosis of migraine completed online surveys. Participants were given scenarios of how to report headache days and pain severity. Respondents were asked about their opinions on the necessity of training, and their preference for the method of training. In a second study, participants were given a hypothetical scenario on how to report pain severity before and after a short training.
Results: The majority of participants had different criteria to interpret PRO questions and provided incorrect answers to our scenarios. In the second study, with minimal training, errors were reduced by 7.5%. Over 90% of participants viewed educational materials and training as necessary and preferred electronic modes of training with the ability to review training materials as needed for the duration of the trial.
Conclusions: Patient training may improve data quality and inter-rater reliability in clinical trials. Electronic interactive training could be used as an approach to reduce inconsistencies in PRO measures and improve data quality.
Food and Drug Administration. Migraine: Developing Drugs for Acute Treatment Guidance for Industry. February 2018. Available at: https://www.fdanews.com/ext/resources/files/2018/02-15-18-Guidances.pdf?1520798582. Accessed on 7 May 2019.
Burch R, Rizzoli P, Loder E. The Prevalence and Impact of Migraine and Severe Headache in the United States: Figures and Trends From Government Health Studies. Headache. 2018;58(4):496-505.
Woldeamanuel Y, Cowan R. Migraine affects 1 in 10 people worldwide featuring recent rise: A systematic review and meta-analysis of community-based studies involving 6 million participants. J Neurol Sci. 2017;372:307-15.
GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1545-602.
Food and Drug Administration. Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. 2009. Available at: https://www.fda.gov/media/77832/download. Accessed on 7 May 2019.
European Medicines Agency. Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials. 2010. Available at: https://www.ema. europa.eu/en/documents/regulatory-procedural-guideline/reflection-paper-expectations-electronic-source-data-data-transcribed-electronic-data-collection_en.pdf. Accessed on 7 May 2019.