Systematic review of outcomes and endpoints in acute migraine clinical trials

Houts, Carrie R.; McGinley, James S.; Nishida, Tracy; Buse, Dawn C.; Wirth, R.; Dodick, David W.; Goadsby, PJ; Lipton, Richard B.

doi:10.1111/head.14067

Cited by 37 publications

(41 citation statements)

References 23 publications

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“…Further understanding of the impact of stigma on the lived experience of migraine is also critical to ensure that patients do not feel judged for their migraine‐induced debilitations or lessen their self‐worth due to their disease 34,37 . As reflected by recent expert international consensus 44 and systematic reviews, 45,46 clinical trials should always include outcomes that reflect the full impact of migraine on patient lives through assessing both disability and quality of life. Both disability and quality of life are worthy of being a primary outcome, including for pharmacological treatments as well as for implementation science and nonpharmacological treatment approaches 20,44,47 …”

Section: Discussionmentioning

confidence: 99%

Learning the full impact of migraine through patient voices: A qualitative study

et al. 2021

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Objective: To better characterize the ways that migraine affects multiple domains of life.Background: Further understanding of migraine burden is needed. Methods: Adults with migraine randomized to mindfulness-based stress reduction or headache education arms (n = 81) in two separate randomized clinical trials participated in semistructured in-person qualitative interviews conducted after the interventions. Interviews queried participants on migraine impact on life and were audio-recorded, transcribed, and summarized into a framework matrix. A master codebook was created until meaning saturation was reached and magnitude coding established code frequency. Themes and subthemes were identified using a constructivist grounded theory approach. Results: Despite most participants being treated with acute and/or prophylactic medications, 90% (73/81) reported migraine had a negative impact on overall life, with 68% (55/81) endorsing specific domains of life impacted and 52% (42/81) describing impact on emotional health. Six main themes of migraine impact emerged: (1) global negative impact on overall life; (2) impact on emotional health; (3) impact on cognitive function; (4) impact on specific domains of life (work/career, family, social); (5) fear and avoidance (pain catastrophizing and anticipatory anxiety); and (6) internalized and externalized stigma. Participants reported how migraine (a) controls life, (b) makes life How to cite this article:

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Section: Discussionmentioning

confidence: 99%

Learning the full impact of migraine through patient voices: A qualitative study

et al. 2021

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“…Implementing PROMs in real life has additional challenges, such as choosing the ideal set of PROMs to provide useful information while trying to keep the evaluation short and not bothersome, but also ensuring that patients fulfill them adequately, which may imply the help of an assistant or nurse, resulting in extra costs. In a more conceptual perspective, it is very challenging to define clinical meaningful change in PROMs results and even to be able to comprehensively englobe patients’ experiences in disorders that involve a multitude of concepts, as was recently exposed in a systematic review (12). Also, accepting PROMs as endpoints may be problematic because achieving one goal doesn’t mean that the patients’ problem is solved – by reaching a milestone, patients’ priorities in health goals change, and we may need another PROM to capture it (13).…”

Section: Discussionmentioning

confidence: 99%

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

Gil‐Gouveia

Oliveira

2021

Cephalalgia

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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.

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“…Patient-reported outcome measures (PROMs) play an increasingly important role in the field of neurology, particularly in headache medicine (10)(11)(12)23). There are several PROMs currently seeing wide use in headache studies and clinical trials, such as the Migraine Disability Assessment Test (MIDAS), the 6-item Headache Impact Test (HIT-6), the Migraine-specific Quality of Life Questionnaire (MSQ) (24)(25)(26)(27)(28)(29). These existing PROMs provide valuable insights on domains such as headache-related disability and quality of life.…”

Section: Discussionmentioning

confidence: 99%

Measuring headache day severity using multiple features in daily diary designs

et al. 2021

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Objective Though migraine is thought of as a symptom complex, symptoms are typically assessed one at a time. For use in clinical research, we developed a composite measure of headache day severity by combining eight well-known symptoms captured in daily diaries. Subjects and Methods Data came from adults with a self-reported diagnosis of migraine (n = 4380) who provided daily diary information assessed using a novel digital platform. Nine observed features theoretically linked to headache day severity were analyzed using latent variable modeling to create a psychometrically robust headache day severity score. Logistic regression was used to assess the cross-sectional relationships of headache day severity scores against an array of clinically-relevant outcomes. Results Participants were largely females (90%), approaching middle age (mean age of 37.3) and living in the United States (49%) or United Kingdom (23%). Findings supported a single latent headache day severity construct based on eight observed headache features. Headache day severity scores were associated with an increased odds of physician visits (Odds ratio[95% CI]: 1.71[1.32–2.21]), emergency department visits (4.12[2.23-7.60]), missed school/work (2.90[2.56–3.29]), missed household work (3.37[3.06–3.72]), and missed other activities (3.29[2.97–3.64]) (p < .0001 for all). Conclusions Modern measurement techniques support a single headache day severity construct that reflects migraine is a symptom complex. The headache day severity scores were associated with external validators and initial visualizations showed how headache day severity scores can be applied broadly in clinical practice and research.

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Systematic review of outcomes and endpoints in acute migraine clinical trials

Abstract: This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Cited by 37 publications

References 23 publications

Learning the full impact of migraine through patient voices: A qualitative study

Learning the full impact of migraine through patient voices: A qualitative study

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

Measuring headache day severity using multiple features in daily diary designs

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