Outcome measures for assessing the effectiveness of non-pharmacological interventions in frequent episodic or chronic migraine: a Delphi study

Abstract

ObjectivesThe aim of this Delphi survey was to establish an international consensus on the most useful outcome measures for research on the effectiveness of non-pharmacological interventions for migraine. This is important, since guidelines for pharmacological trials recommend measuring the frequency of headaches with 50% reduction considered a clinically meaningful effect. It is unclear whether the same recommendations apply to complementary (or adjunct) non-pharmacological approaches, whether the same cut-off levels need to be considered for effectiveness when used as an adjunct or stand-alone intervention, and what is meaningful to patients.SettingUniversity-initiated international survey.ParticipantsThe expert panel was chosen based on publications on non-pharmacological interventions in migraine populations and from personal contacts. 35 eligible researchers were contacted, 12 agreed to participate and 10 completed all 3 rounds of the survey. To further explore how migraine patients viewed potential outcome measures, four migraine patients were interviewed and presented with the same measurement tools as the researchers.ProceduresThe initial Delphi round was based on a systematic search of the literature for outcome measures used in non-pharmacological interventions for headache. Suggested outcome measures were rated by each expert, blinded towards the other members of the panel, for its usefulness on a 5-point Likert scale ranging from definitely not useful to extremely useful. Results were combined using median values and IQRs. Tools rated overall as definitely or probably not useful were excluded from subsequent rounds. Experts further suggested additional outcome measures that were presented to the panel in subsequent rounds. Additionally, experts were asked to rank the most useful tools and provide information on feasible cut-off levels for effectiveness for the three highest ranked tools.ResultsResults suggest the use of the Migraine Disability Assessment (MIDAS), Headache Impact Test (HIT-6) and headache frequency as primary outcome measures. Patient experts suggested the inclusion of a measure of quality of life and evaluation of associated symptoms and fear of attacks.ConclusionsRecommendations are for the use of the MIDAS, the HIT-6 and headache frequency, in combination with an outcome measure for quality of life. Associated symptoms and fear of attacks should also be considered as secondary outcomes, if relevant for the individual target population. The cut-off level for effectiveness should be lower for non-pharmacological interventions, especially when used as an adjunct to medication.Trial registration numberGerman Register of Clinical Trials (DRKS00011777)

Acupuncture Therapy for Cognitive Impairment: A Delphi Expert Consensus Survey

“…Hence, agreement of a certain item is at a particular timepoint and may be altered with emerging new evidence and experience. Third, in spite of the existing differences between doctors' and patients' opinions toward one therapy (Luedtke et al, 2020), our clinical question investigation was conducted merely among clinicians, which means the consensus was ground on doctors' general perspective but not patient specific.…”

Identifying Outcome Measures for Migraine Value‐Based Contracting Using the Delphi Method

“…Several studies have utilized the Delphi method to achieve consensus on clinical decision-making and outcomes for migraine, although none aimed to identify meaningful and measurable outcomes to incorporate into a pharmaceutical value-based contract. 27,[43][44][45][46][47] Some of these studies focused on improving medical communication in migraine management 42 and determining which physical examinations were the most useful for patients with headache. 43,45 Another study assessed outcome measures for determining the effectiveness of non-pharmacological interventions, and 29- †Non-patient and non-employer participants responded to prompt, "Please rate each measure below on how feasible they are to collect in an integrated delivery and finance system where both administrative claims and EHR data are accessible."…”

“…similarly found that headache frequency was a top primary outcome measure. 44 Smelt et al performed a similar Delphi study to understand what patients find most bothersome during a migraine attack and to evaluate currently used outcome measures to see what the most desirable effect of a new migraine medication would be. 27 Like our study, Smelt et al directly asked patients to rate which migraine outcome measures are most important to them; however, since only patients were surveyed, other important migraine stakeholder perspectives (eg, provider, payer, employer, or pharmacy) were not captured.…”

“…However, we purposely oversampled patients, providers and employers for our study, and our Delphi panel size was larger than, or similar to, other published Delphi studies in migraine. [44][45][46]…”

“…1 1010 405 223 301 (10) 10 488 (44) 26 (29) 16 (20) Decrease in emergency department/urgent care visits ¶, † † 0 (0) 0 (0) 1 (10) 1 105 204 175 503 (30) 5 244 2216 (18) 12 (15) Decrease in need for abortive/rescue medications "decrease in migraine frequency" as the 2 most feasibly collected migraine outcomes, with 95% (40/42) and 90% (38/42) agreement in the consensus round, respectively (Table 3). Panelists also reached consensus on a third outcome, "decrease in need for abortive/rescue medications," at 76% agreement (32/42).…”