Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults

Tassorelli, Cristina; Diener, Hans-Christoph; Dodick, David W.; Silberstein, Stephen D.; Lipton, Richard B.; Ashina, Messoud; Becker, Werner J.; Ferrari, Michel D.; Goadsby, PJ; Pozo‐Rosich, Patricia; Wang, Shuu Jiun

doi:10.1177/0333102418758283

Cited by 267 publications

(361 citation statements)

References 63 publications

(63 reference statements)

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“…46 However, efficacy is variable between patients, and a successful therapeutic outcome depends not only on a reduction in MHD frequency, but also on the persistence and severity of pain and associated symptoms, level of disability, and functional capacity. In general, a significant reduction (eg, 50%) in MHDs is a useful benchmark in both clinical trials and practice.…”

Section: Preventive Treatmentmentioning

confidence: 99%

“…In general, a significant reduction (eg, 50%) in MHDs is a useful benchmark in both clinical trials and practice. 46 However, efficacy is variable between patients, and a successful therapeutic outcome depends not only on a reduction in MHD frequency, but also on the persistence and severity of pain and associated symptoms, level of disability, and functional capacity. Therefore, patientcentric and validated outcome measures that evaluate the effect of treatment on functional capacity, disability, and quality of life are important for determining whether meaningful change has occurred and, often, guiding clinical decision-making with respect to changes in dose, adding additional preventive treatment, or switching to an alternative treatment.…”

Section: -Ichd-3 Criteria For Medication Overuse Headachementioning

confidence: 99%

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

2018

Headache

406

155

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Objective.-To provide healthcare professionals with updated guidance in the use of novel preventive and acute treatments for migraine in adults.Background.-The principles of preventive and acute pharmacotherapy for patients with migraine have been outlined previously, but the emergence of new technologies and treatments, as well as new formulations of previously established treatments, has created a need for an updated guidance on the preventive and acute treatment of migraine.Methods.-This statement is based on a review of existing guidelines and principles for preventive and acute treatment of migraine, as well as the results of recent clinical trials of drugs and devices for these indications. Input was sought from health insurance providers, employers, pharmacy benefit service companies, device manufacturers, pharmaceutical and biotechnology companies, patients, and patient advocates. Expert clinicians and researchers in the field of headache medicine from across North America and the European Union provided input and feedback.Results.-The principles of pharmacologic preventive treatment of migraine with oral treatments have been as follows: use evidence-based treatments when possible and appropriate; start with a low dose and titrate slowly; reach a therapeutic dose if possible; allow for an adequate treatment trial duration; establish expectations of therapeutic response and adverse events; and maximize adherence. Newer injectable treatments may work faster and may not need titration. The principles of acute treatment include: use evidence-based treatments when possible and appropriate; treat early after the onset of a migraine attack; choose a nonoral route of administration for selected patients; account for tolerability and safety issues; consider self-administered rescue treatments; and avoid overuse of acute medications. Neuromodulation and biobehavioral therapy may be appropriate for preventive and acute treatment, depending on the needs of individual patients. Neuromodulation may be useful for patients who prefer nondrug therapies or who respond poorly, cannot tolerate, or have contraindications to pharmacotherapy.Conclusions.-This statement updates prior recommendations and outlines the indications for initiating, continuing, combining, and switching preventive and acute treatments of migraine.

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Section: Preventive Treatmentmentioning

confidence: 99%

Section: -Ichd-3 Criteria For Medication Overuse Headachementioning

confidence: 99%

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

2018

Headache

406

155

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“…Dedicated, well‐powered clinical trials in MOH patients may offer new answers and are awaited 24 . The International Headache Society (HIS) guidelines contain subsections on comorbid MOH, with chronic migraine to guide trial developers in assessing the effects of drugs or interventions on MOH 189 …”

Section: Discussion and Future Directionsmentioning

confidence: 99%

The Many Faces of Medication‐Overuse Headache in Clinical Practice

2020

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The management of medication-overuse headache (MOH) is multifaceted and headache experts have different views on the optimal strategy to tackle this type of secondary headache. The purpose of this review is to provide an overview of the literature on the management of MOH, and to highlight important considerations in the clinical evaluation of the MOH patient.Managing MOH in clinical practice starts by evaluating the headache patient with medication overuse, determining the overused drug(s), assessing the impact of headaches on the patient and assessing comorbid conditions and disorders. Withdrawal of the overused medication is the cornerstone of treatment. An inpatient or outpatient setting is chosen based on the clinical profile of the patient. There is evidence for abrupt withdrawal combined with headache preventive treatment.Bridging therapy to bring relief to withdrawal headaches and/or symptoms should be offered. Education and motivational work through multidisciplinary assessment show benefits in sustaining withdrawal and preventing relapse.Although the reversal of chronic headache after cessation of overused acute medication has been noticed worldwide, different aspects of the management of MOH, such as complete or gradual withdrawal, or preventive treatment with or without withdrawal are still debated.

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“…A version of the MFIQ (version 2.0, following item reduction) has been included in recent clinical trials of preventive treatment for migraine and in observational studies (NCT02456740 and NCT02483585). The MFIQ has also been mentioned as a PRO tool that can be used to support secondary endpoints in clinical trials of preventive treatment, in the recent ‘ Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults’ . Requests for copies of the final version of the instrument may be addressed to the corresponding author.…”

Section: Discussionmentioning

confidence: 99%

Development of a New Tool for Evaluating the Benefit of Preventive Treatments for Migraine on Functional Outcomes – The Migraine Functional Impact Questionnaire (MFIQ)

et al. 2018

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ObjectiveThe objective of this study was to develop a method for evaluating patient‐relevant outcomes of interventions for preventing migraine attacks, followed by an assessment of the content validity of a new patient‐reported outcome (PRO) instrument: the Migraine Functional Impact Questionnaire (MFIQ).BackgroundThe aim of preventive treatments for migraine is not only to reduce migraine frequency, but also to restore patients’ ability to function and improve quality of life.MethodsA multi‐stage process based on best practice methods and regulatory guidelines for ensuring content validity of PRO instruments for evaluating treatment benefit was followed. Qualitative concept elicitation interviews conducted to understand the experiences of adults with migraine underpinned the development of the instrument. The initial stage included the development of a conceptual disease model (CDM) based on information from these interviews. This CDM was used to identify the concepts of interests (COI) to evaluate outcomes of preventive treatments. The results of the interviews were also used in stage 2, to develop a measurement framework for collecting data about these COI. In the third stage, existing instruments were reviewed for coverage of the concepts in the framework and evidence of concept elicitation to the point of saturation, to support content validity. In the fourth stage, an instrument was drafted to evaluate concepts in the framework, based on the qualitative data collected from the interviews. Following a review by clinical and translation experts, the new instrument was tested in adults with migraine in the fifth stage using 2 rounds of cognitive interviews, and was modified based on interview feedback. In the last stage, the instrument was linguistically adapted, using methods recommended for PRO instruments, to ensure conceptual equivalence of language versions for use in international studies. Each language version was tested in at least 5 native speakers using cognitive interviews.ResultsResults from the concept elicitation interviews suggested that migraine had an impact on various aspects of functioning. A conceptual framework for evaluating functional outcomes was developed for the concept selected based on a review of the CDM – physical and emotional functioning, every day activities, and social/leisure activities. Existing PROs lacked coverage of some concepts in the conceptual framework, had recall periods that were inappropriate for capturing the experience of COI or did not have evidence of content validity. A novel PRO instrument, the MFIQ, was developed to address these gaps. Cognitive interviews with 9 adults with migraine resulted in minor changes to the items of the MFIQ, and a final round of 8 interviews confirmed the changes were acceptable and supported its validity. The interviews conducted to test linguistic adaptations confirmed conceptual equivalence in the 25 countries evaluated.ConclusionsDevelopment of the MFIQ followed best measurement practices to ensure content validity and followe...

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Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults

Cited by 267 publications

References 63 publications

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

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

The Many Faces of Medication‐Overuse Headache in Clinical Practice

Development of a New Tool for Evaluating the Benefit of Preventive Treatments for Migraine on Functional Outcomes – The Migraine Functional Impact Questionnaire (MFIQ)

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