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

Gil‐Gouveia, Raquel; Oliveira, António Gouveia

doi:10.1177/03331024211034509

Cited by 4 publications

(5 citation statements)

References 13 publications

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“…intra-personal variation in reliability, persisting in repeated applications, decrease motivation to respond etc.) [ 47 ], we cannot exclude that in the future, a more complex scores, encompassing the overall migraine experience, could be proposed. However, herein we have observed a notable reduction in both the number of mean monthly days with painkillers intake and total painkillers intake after the third and sixth galcanezumab administration compared with baseline.…”

Section: Discussionmentioning

confidence: 99%

Galcanezumab effect on “whole pain burden” and multidimensional outcomes in migraine patients with previous unsuccessful treatments: a real-world experience

et al. 2022

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Background Clinical trials have demonstrated galcanezumab as safe and effective in migraine prevention. However, real-life data are still lacking and overlook the impact of galcanezumab on those different migraine facets strongly contributing to migraine burden. Herein we report the clinical experience from an Italian real-world setting using galcanezumab in patients with migraine experiencing previous unsuccessful preventive treatments. Methods Forty-three patients with migraine and failure of at least 3 migraine preventive medication classes received monthly galcanezumab 120 mg s.c. At the first administration and after 3 and 6 months, patients underwent extensive interviews to assess clinical parameters of disease severity. Furthermore, validated questionnaires were administered to explore migraine-related disability, impact, and quality of life as well as symptoms of depression or anxiety, pain catastrophizing, sleep quality and the ictal cutaneous allodynia. Results After the third and the sixth administration of monthly galcanezumab 120 mg s.c., headache attacks frequency reduced from 20.56 to 7.44 and 6.37 headache days per month, respectively. Moreover, a significant improvement in headache pain intensity (from 8.95 to 6.84 and 6.21) and duration (from 9.03 to 3.75 and 2.38) as well as in scores assessing migraine related disability and impact, depressive and anxious symptoms, and pain catastrophizing was observed. Furthermore, we demonstrated a significant reduction in the values of “whole pain burden”, a composite score derived from the product of the average of headache frequency, intensity, and duration in the last three months. Conclusion Real-world data support monthly galcanezumab 120 mg s.c. as a safe and effective preventive treatment in reducing headache frequency, intensity, and duration as well as comorbid depressive or anxious symptoms, pain catastrophizing and quality of life in both episodic and chronic migraine patients with previous unsuccessful preventive treatments. Furthermore, we demonstrated that monthly galcanezumab 120 mg s.c. is able to induce a significant improvement in the scores of “whole pain burden”. The latter is a reliable and easy-to-handle tool to be employed in clinical setting to evaluate the effectiveness of preventive drugs (in this case, galcanezumab) or when the decision of continuing the treatment with anti-CGRP mAbs is mandatory.

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Section: Discussionmentioning

confidence: 99%

Galcanezumab effect on “whole pain burden” and multidimensional outcomes in migraine patients with previous unsuccessful treatments: a real-world experience

et al. 2022

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“…Monitoring patients with PROMS is less reliable than expected and selecting the ideal set of short and non-intrusive tests to provide useful information is very difficult. Gil-Gouveia et al showed that patients in a PROM assessment can give different answers to the same question asked minutes apart [ 50 ]. This is most likely related to various factors such as interpretive difficulties, educational status, long-term motivation and secondary benefits (e.g., access to reimbursable treatment) but also concentration abilities and current pain status [ 51 ].…”

Section: Discussionmentioning

confidence: 99%

The impact of primary headaches on disability outcomes: a literature review and meta-analysis to inform future iterations of the Global Burden of Disease study

Waliszewska-Prosół,

Montisano,

Antolak

et al. 2024

J Headache Pain

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Background The burden and disability associated with headaches are conceptualized and measured differently at patients’ and populations’ levels. At the patients’ level, through patient-reported outcome measures (PROMs); at population level, through disability weights (DW) and years lived with a disability (YLDs) developed by the Global Burden of Disease Study (GBD). DW are 0–1 coefficients that address health loss and have been defined through lay descriptions. With this literature review, we aimed to provide a comprehensive analysis of disability in headache disorders, and to present a coefficient referring to patients’ disability which might inform future GBD definitions of DW for headache disorders. Methods We searched SCOPUS and PubMed for papers published between 2015 and 2023 addressing disability in headache disorders. The selected manuscript included a reference to headache frequency and at least one PROM. A meta-analytic approach was carried out to address relevant differences for the most commonly used PROMs (by headache type, tertiles of medication intake, tertiles of females’ percentage in the sample, and age). We developed a 0–1 coefficient based on the MIDAS, on the HIT-6, and on MIDAS + HIT-6 which was intended to promote future DW iterations by the GBD consortium. Results A total of 366 studies, 596 sub-samples, and more than 133,000 single patients were available, mostly referred to cases with migraine. Almost all PROMs showed the ability to differentiate disability severity across conditions and tertiles of medication intake. The indexes we developed can be used to inform future iterations of DW, in particular considering their ability to differentiate across age and tertiles of medication intake. Conclusions Our review provides reference values for the most commonly used PROMS and a data-driven coefficient whose main added value is its ability to differentiate across tertiles of age and medication intake which underlie on one side the increased burden due to aging (it is likely connected to the increased impact of common comorbidities), and by the other side the increased burden due to medication consumption, which can be considered as a proxy for headache severity. Both elements should be considered when describing disability of headache disorders at population levels.

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“…As healthcare professionals strive to enhance patient care, evaluating the effectiveness of these measures in practical day-to-day clinical settings becomes essential. Ensuring the reliability of these measures is crucial for their meaningful integration into the healthcare [77]. The development of new PROMs should focus more on capturing patient perspectives, and direct input from patients is necessary in creating these measures.…”

Section: Patient-reported Outcome Measures Current Challenges and Opp...mentioning

confidence: 99%

The state of art on the use of patient reported outcomes in migraine

Alpuente,

Torres-Ferrus,

Caronna

et al. 2024

Current Opinion in Neurology

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Purpose of review This review aims to explore the use of patient-reported outcome measures (PROMs) in migraine. Traditionally assessed through specific features, recent adoption of PROMs allows for a more objective and quantifiable evaluation. PROMs, which are standardized questionnaires collecting health information directly from a patients’ perspective, cover various aspects, including migraine specific aspects. The review focuses on delineating the applications and interpretation of commonly used PROMs in migraine research, with an emphasis on their integration in clinical care. Recent findings Generic and migraine-specific PROMs play a crucial role in clinical research, particularly in assessing health-related quality of life, disability, impact, and associated comorbidities. Some of these measures are strongly recommended to be used by the International Guidelines and are, in fact, mandated by the FDA for product labeling. Recently, there has been an expansion in the use of PROMs to assess migraine in diverse populations, in particular pediatric patients. However, the application of these measures in clinical care shows considerable heterogeneity, and some have not been validated specifically for migraine. The existing multitude of PROMs, coupled with ongoing development of new ones to better capture patient concerns, creates complexity in their research and clinical application. To address these challenges, it becomes imperative to streamline their use, focusing on those that are more validated and better aligned with the patients’ perspective including different populations’ needs. Summary The utilization of PROMs in evaluating migraine enables a more holistic assessment, helps quantify the impact of the disease facilitating change measurement, improves communication between healthcare providers and patients and, guides treatment decisions for improved outcomes. However, the increasing number of PROMs questionnaires, underscores the importance of validating these tools for migraine and, the dynamic nature of the disease makes it relevant to decide with whom, why and when these should be used.

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

Cited by 4 publications

References 13 publications

Galcanezumab effect on “whole pain burden” and multidimensional outcomes in migraine patients with previous unsuccessful treatments: a real-world experience

Galcanezumab effect on “whole pain burden” and multidimensional outcomes in migraine patients with previous unsuccessful treatments: a real-world experience

The impact of primary headaches on disability outcomes: a literature review and meta-analysis to inform future iterations of the Global Burden of Disease study

The state of art on the use of patient reported outcomes in migraine

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