Outcome measures for assessing the effectiveness of non-pharmacological interventions in frequent episodic or chronic migraine: a delphi study
Open accessAbstract
OBJECTIVES: The 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. SETTING: University-initiated international survey. PARTICIPANTS: The 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. PROCEDURES: The 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. RESULTS: Results 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. CONCLUSIONS: Recommendations 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 NUMBER: German Register of Clinical Trials (DRKS00011777).
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A ≥30% reduction threshold for response is realistic to detect minor changes that can represent a veritable improvement for patients and is more suitable for non-pharmacological interventions than a ≥50% threshold.
“In contrast to a more conservative ≥50% response operationalization, this threshold seems realistic to detect minor changes that can represent a veritable improvement for patients as well and can be considered more suitable for non-pharmacological interventions (46).”
From Efficacy of Cognitive-Behavioral Therapy for the Prophylaxis of Migraine in Adults: A Three-Armed Randomized Controlled Trial (2022) · cites this paper as [46]
The Discussion says a ≥50% reduction in headache frequency is difficult to achieve with non-pharmacological interventions and that a lower target should be considered. Patient interviews also found that small improvements mattered to patients. But the Discussion reports no agreement on a specific cut-off: it mentions 30% as an accepted responder rate for chronic migraine, not as the study’s recommended threshold for non-pharmacological interventions. Page numbers are unavailable in our copy. (LLM, conf=0.88)
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Cites
Using thematic analysis in psychology
Braun, V., & Clarke, V. (2006) · Qualitative Research in Psychology · doi:10.1191/1478088706qp063oa · Cited by 194,414 · see citing works
Arnold, M. (2018) · Cephalalgia · doi:10.1177/0333102417738202 · Cited by 11,090 · see citing works
Research guidelines for the Delphi survey technique
Hasson, F. (2000) · Journal of Advanced Nursing · doi:10.1046/j.1365-2648.2000.01567.x · Cited by 5,951 · see citing works
The Delphi Technique: Making Sense of Consensus
Hsu, C.-C., & Sandford, B. A. (2007) · University of Massachusetts Amherst · doi:10.7275/pdz9-th90 · Cited by 4,500 · see citing works
Consensus development methods, and their use in clinical guideline development.
Murphy, M., Black, Lamping, McKee, M., Sanderson, Askham, & Marteau (1998) · Health Technology Assessment · doi:10.3310/hta2030 · Cited by 2,042 · see citing works
Stewart, W. F., Lipton, R. B., Dowson, A. J., & Sawyer, J. (2001) · Neurology · doi:10.1212/wnl.56.suppl_1.s20 · Cited by 1,210 · see citing works
Consensus development methods, and their use in clinical guideline development.
Murphy, M. P., Black, N. A., Lamping, D. L., et al. (1998) · PubMed · Cited by 965 · see citing works
Pariani, E., Martinelli, M., Canuti, M., Farsani, S. M. J., Munnink, B. B. O., Deijs, M., Tanzi, E., Zanetti, A. R., van der Hoek, L., & Amendola, A. (2014) · BioMed Research International · doi:10.1155/2014/241298 · Cited by 652 · see citing works
Stewart, W. F., Lipton, R. B., Kolodner, K. B., Sawyer, J., Lee, C., & Liberman, J. N. (2000) · Pain · doi:10.1016/s0304-3959(00)00305-5 · Cited by 622 · see citing works
Smitherman, T. A., Burch, R. C., Sheikh, H. U., & Loder, E. (2013) · Headache The Journal of Head and Face Pain · doi:10.1111/head.12074 · Cited by 386 · see citing works
The impact of headache in Europe: principal results of the Eurolight project
Steiner, T. J., Stovner, L. J., Katsarava, Z., Lainez, J. M., Lampl, C., Lantéri-Minet, M., Rastenyte, D., Ruiz de la Torre, E., Tassorelli, C., Barré, J., et al. (2014) · The Journal of Headache and Pain · doi:10.1186/1129-2377-15-31 · Cited by 382 · see citing works
Guidelines for controlled trials of drugs in migraine: Third edition. A guide for investigators
Tfelt‐Hansen, P. C., Pascual, J., Ramadan, N. M., Dahlöf, C. G. H., D’Amico, D., Diener, H.-C., Hansen, J. M., Lantéri‐Minet, M., Loder, E., McCrory, D. C., et al. (2012) · Cephalalgia · doi:10.1177/0333102411417901 · Cited by 365 · see citing works
Holland, S., Silberstein, S. D., Freitag, F. G., et al. (2012) · Neurology · doi:10.1212/wnl.0b013e3182535d0c · Cited by 347 · see citing works
Bloudek, L. M., Stokes, M., Buse, D. C., Wilcox, T. K., Lipton, R. B., Goadsby, P. J., Varon, S. F., Blumenfeld, A. M., Katsarava, Z., Pascual, J., et al. (2012) · The Journal of Headache and Pain · doi:10.1007/s10194-012-0460-7 · Cited by 339 · see citing works
Lyngberg, A. C., Rasmussen, B. K., J��rgensen, T., & Jensen, R. (2005) · European Journal of Epidemiology · doi:10.1007/s10654-004-6519-2 · Cited by 313 · see citing works
Guidelines for Controlled Trials of Prophylactic Treatment of Chronic Migraine in Adults
Silberstein, S. D., Tfelt‐Hansen, P. C., Dodick, D., Limmroth, V., Lipton, R. B., Pascual, J., & Wang, S. J. (2008) · Cephalalgia · doi:10.1111/j.1468-2982.2008.01555.x · Cited by 303 · see citing works
Canadian Headache Society guideline for migraine prophylaxis.
Pringsheim, T. M., Davenport, W. J., Mackie, G. F., et al. (2012) · PubMed · Cited by 271 · see citing works
MacLeod, Grant, Donaldson, C., Khan, Campbell, M., Daly, Lawrence, Wallace, S. A., Vale, L. D., Cody, et al. (1998) · Health Technology Assessment · doi:10.3310/hta2050 · Cited by 254 · see citing works
Development and Validation of the Migraine‐Specific Quality of Life Questionnaire
Jhingran, P., Osterhaus, J. T., Miller, D. W., Lee, J. T., & Kirchdoerfer, L. (1998) · Headache: The Journal of Head and Face Pain · doi:10.1046/j.1526-4610.1998.3804295.x · Cited by 252 · see citing works
Pryse-Phillips, W. E. M., Dodick, D. W., Edmeads, J. G., Gawel, M. J., Nelson, R. F., Purdy, R. A., Robinson, G., Stirling, D., & Worthington, I. (1997) · Europe PMC (PubMed Central) · Cited by 214 · see citing works
Luedtke, K., Allers, A., Schulte, L. H., & May, A. (2015) · Cephalalgia · doi:10.1177/0333102415597889 · Cited by 211 · see citing works
Self-citationNew therapeutic approaches for the prevention and treatment of migraine
Diener, H., Charles, A. C., Goadsby, P. J., & Holle, D. (2015) · The Lancet Neurology · doi:10.1016/s1474-4422(15)00198-2 · Cited by 191 · see citing works
The short-form headache impact test (HIT-6) was psychometrically equivalent in nine languages
Martin, M., Blaisdell, B., Kwong, J. W., & Bjorner, J. B. (2004) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2004.05.004 · Cited by 170 · see citing works
Validating Migraine‐Specific Quality of Life Questionnaire v2.1 in Episodic and Chronic Migraine
Bagley, C. L., Rendas‐Baum, R., Maglinte, G. A., Yang, M. S., Varon, S. F., Lee, J., & Kosinski, M. R. (2011) · Headache The Journal of Head and Face Pain · doi:10.1111/j.1526-4610.2011.01997.x · Cited by 161 · see citing works
Validity and Reliability of the Turkish Migraine Disability Assessment (MIDAS) Questionnaire
Ertaş, M., Sıva, A., Dalkara, T., Üzüner, N., Dora, B., İnan, L. E., İdiman, F., Sarıca, Y., Selçuki, D., ŞİRİN, H., et al. (2004) · Headache The Journal of Head and Face Pain · doi:10.1111/j.1526-4610.2004.04146.x · Cited by 149 · see citing works
Probyn, K., Bowers, H., Mistry, D., Caldwell, F., Underwood, M., Patel, S., Sandhu, H. K., Matharu, M., & Pincus, T. (2017) · BMJ Open · doi:10.1136/bmjopen-2017-016670 · Cited by 149 · see citing works
Multispecialty consensus on diagnosis and treatment of headache
Silberstein, S. D., & Rosenberg, J. (2000) · Neurology · doi:10.1212/wnl.54.8.1553 · Cited by 138 · see citing works
Economic Burden and Costs of Chronic Migraine
Lantéri‐Minet, M. (2013) · Current Pain and Headache Reports · doi:10.1007/s11916-013-0385-0 · Cited by 137 · see citing works
Penzien, D. B., Andrasik, F., Freidenberg, B. M., Houle, T. T., Lake, A. E., Lipchik, G. L., Holroyd, K. A., Lipton, R. B., McCrory, D. C., Nash, J. M., et al. (2005) · Headache: The Journal of Head and Face Pain · doi:10.1111/j.1526-4610.2005.4502004.x · Cited by 135 · see citing works
Smelt, A. F., Assendelft, W. J., Terwee, C. B., Ferrari, M. D., & Blom, J. W. (2013) · Cephalalgia · doi:10.1177/0333102413497599 · Cited by 124 · see citing works
Rendas‐Baum, R., Bloudek, L. M., Maglinte, G. A., & Varon, S. F. (2012) · Quality of Life Research · doi:10.1007/s11136-012-0230-7 · Cited by 121 · see citing works
The Economic Burden of Lost Productivity Due to Migraine Headache: A Specific Worksite Analysis
Burton, W. N., Conti, D. J., Chen, C., Schultz, A. B., & Edington, D. W. (2002) · Journal of Occupational and Environmental Medicine · doi:10.1097/00043764-200206000-00013 · Cited by 119 · see citing works
Cost of migraine and other headaches in Europe
Berg, J., & Stovner, L. J. (2005) · European Journal of Neurology · doi:10.1111/j.1468-1331.2005.01192.x · Cited by 117 · see citing works
Luedtke, K., Boissonnault, W. G., Caspersen, N., Castien, R., Chaibi, A., Falla, D., Fernández‐de‐las‐Peñas, C., Hall, T. M., Hirsvang, J. R., Horre, T., et al. (2016) · Manual Therapy · doi:10.1016/j.math.2016.02.010 · Cited by 111 · see citing works
Self-citationUse of Complementary and Alternative Medicine in Patients Suffering from Primary Headache Disorders
Gaul, C., Eismann, R., Schmidt, T., May, A., Leinisch, E., Wieser, T., Evers, S., Henkel, K., Franz, G., & Zierz, S. (2009) · Cephalalgia · doi:10.1111/j.1468-2982.2009.01841.x · Cited by 110 · see citing works
MSQ: Migraine-Specific Quality-of-Life Questionnaire
Jhingran, P. M., Thomas, S., LaVange, L. M., Miller, D. W., & Helms, R. W. (1998) · PharmacoEconomics · doi:10.2165/00019053-199813060-00007 · Cited by 99 · see citing works
Cole, J., Lin, P., & Rupnow, M. F. T. (2009) · Cephalalgia · doi:10.1111/j.1468-2982.2009.01852.x · Cited by 96 · see citing works
Psychometric Properties of the HIT‐6 Among Patients in a Headache‐Specialty Practice
Kawata, A. K., Coeytaux, R. R., DeVellis, R. F., Finkel, A. G., Mann, J. D., & Kahn, K. A. (2005) · Headache The Journal of Head and Face Pain · doi:10.1111/j.1526-4610.2005.05130.x · Cited by 94 · see citing works
Economic Impact of Migraine and Other Episodic Headaches in France
Pradalier, A., Auray, J., Hasnaoui, A. E., Alzahouri, K., Dartigues, J., Duru, G., Henry, P., Lantéri‐Minet, M., Lucas, C., Chazot, G., et al. (2004) · PharmacoEconomics · doi:10.2165/00019053-200422150-00003 · Cited by 92 · see citing works
Manual therapies for primary chronic headaches: a systematic review of randomized controlled trials
Chaibi, A., & Russell, M. B. (2014) · The Journal of Headache and Pain · doi:10.1186/1129-2377-15-67 · Cited by 86 · see citing works
Self-citationReliability and Validity of the Japanese Migraine Disability Assessment (MIDAS) Questionnaire
Iigaya, M., Sakai, F., Kolodner, K. B., Lipton, R. B., & Stewart, W. F. (2003) · Headache The Journal of Head and Face Pain · doi:10.1046/j.1526-4610.2003.03069.x · Cited by 83 · see citing works
Pryse-Phillips, W. E. M., Dodick, D. W., Edmeads, J. G., Gawel, M. J., Nelson, R. F., Purdy, R. A., Robinson, G., Stirling, D., & Worthington, I. (1998) · PubMed Central · Cited by 66 · see citing works
Zandifar, A., Asgari, F., Haghdoost, F., Masjedi, S. S., Manouchehri, N., Banihashemi, M., Ghorbani, A., Najafi, M. R., Saadatnia, M., & Lipton, R. B. (2014) · BioMed Research International · doi:10.1155/2014/978064 · Cited by 56 · see citing works
Reliability and Validity of the Persian HIT ‐6 Questionnaire in Migraine and Tension‐type Headache
Zandifar, A., Banihashemi, M., Haghdoost, F., Masjedi, S. S., Manouchehri, N., Asgari, F., Najafi, M. R., Ghorbani, A., Zandifar, S., Saadatnia, M., et al. (2013) · Pain Practice · doi:10.1111/papr.12120 · Cited by 49 · see citing works
Cephalalgiaphobia as a feature of high-frequency migraine: a pilot study
Giannini, G., Zanigni, S., Grimaldi, D., Melotti, R., Pierangeli, G., Cortelli, P., & Cevoli, S. (2013) · The Journal of Headache and Pain · doi:10.1186/1129-2377-14-49 · Cited by 45 · see citing works
Gaul, C., Schmidt, T., Czaja, E., et al. (2011) · BMC Complementary and Alternative Medicine · doi:10.1186/1472-6882-11-89 · Cited by 43 · see citing works
Raggi, A., Giovannetti, A. M., Schiavolin, S., Leonardi, M., Bussone, G., Grazzi, L., Usai, S., Curone, M., Fiore, P. D., & D’Amico, D. (2013) · Quality of Life Research · doi:10.1007/s11136-013-0556-9 · Cited by 39 · see citing works
MIDAS and HIT-6 French Translation: Reliability and Correlation Between Tests
Magnoux, E., Freeman, M., & Zlotnik, G. (2007) · Cephalalgia · doi:10.1111/j.1468-2982.2007.01461.x · Cited by 39 · see citing works
Benz, T., Lehmann, S., Gantenbein, A. R., Sándor, P. S., Stewart, W. F., Elfering, A., Aeschlimann, A., & Angst, F. (2018) · Health and Quality of Life Outcomes · doi:10.1186/s12955-018-0871-5 · Cited by 37 · see citing works
A 3‐Month Analysis of Disability, Quality of Life, and Disease Course in Patients With Migraine
Raggi, A., Leonardi, M., Bussone, G., & D’Amico, D. (2012) · Headache The Journal of Head and Face Pain · doi:10.1111/j.1526-4610.2012.02279.x · Cited by 29 · see citing works
Mauskop, A. (2013) · Neurology · doi:10.1212/wnl.0b013e318287d94b · Cited by 26 · see citing works
Reliability and Validity of the Greek Migraine Disability Assessment (MIDAS) Questionnaire
Oikonomidi, T., Vikelis, M., Artemiadis, A., Chrousos, G. P., & Darviri, C. (2017) · PharmacoEconomics - Open · doi:10.1007/s41669-017-0034-3 · Cited by 25 · see citing works
Garg, R. K., Juyal, R., Verma, R. K., Shukla, R., Agarwal, A. K., & Singh, M. (2010) · Annals of Indian Academy of Neurology · doi:10.4103/0972-2327.74201 · Cited by 23 · see citing works
Headache research in 2014: advancing migraine therapy
Schulte, L. H., & May, A. (2014) · The Lancet Neurology · doi:10.1016/s1474-4422(14)70295-9 · Cited by 15 · see citing works
Chaibi, A., Benth, J. Š., Tuchin, P. J., & Russell, M. B. (2017) · Musculoskeletal Science and Practice · doi:10.1016/j.msksp.2017.03.003 · Cited by 15 · see citing works
Self-citationSeo, J.-G., & Park, S.-P. (2017) · Journal of Oral & Facial Pain and Headache · doi:10.11607/ofph.1769 · Cited by 11 · see citing works
Wang, J., Zhang, B., Shen, C., Zhang, J., & Wang, W. (2017) · BMC Neurology · doi:10.1186/s12883-017-0973-4 · Cited by 9 · see citing works
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Learning the full impact of migraine through patient voices: A qualitative study.
Estave, P. M., Beeghly, S., Anderson, R., Margol, C., Shakir, M., George, G., Berger, A., O’Connell, N., Burch, R., Haas, N., et al. (2021) · Headache The Journal of Head and Face Pain · doi:10.1111/head.14151 · Cited by 81 · see citing works
Self-citationUlrich, S., Gantenbein, A. R., Zuber, V., Von Wyl, A., Kowatsch, T., & Künzli, H. (2024) · Journal of Medical Internet Research · doi:10.2196/50132 · Cited by 36 · see citing works
“A recent Delphi study by Leudtke et al [132] emphasized the need for outcome measures that truly reflect patients’ experiences.”
Klan, T., Gaul, C., Liesering-Latta, E., Both, B., Held, I., Hennemann, S., & Witthöft, M. (2022) · Frontiers in Neurology · doi:10.3389/fneur.2022.852616 · Cited by 22 · see citing works
“In contrast to a more conservative ≥50% response operationalization, this threshold seems realistic to detect minor changes that can represent a veritable improvement for patients as well and can be considered more suitable for non-pharmacological interventions (46).”
Background
- Authors
- Luedtke, K., Basener, A., Bedei, S., Castien, R., Chaibi, A., Falla, D., Fernández-de-las-Peñas, C., Gustafsson, M., Hall, T., Jull, G., Kropp, P., Madsen, B. K., Schaefer, B., Seng, E., Steen, C., Tuchin, P., von Piekartz, H., & Wollesen, B.
- Affiliations
- Universität Hamburg (DE)
- Amsterdam Public Health research institute, VU University Medical Center, Amsterdam, Netherlands
- Akershus University Hospital (NO)
- University of Birmingham (GB)
- Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain
- Curtin University (AU)
- Centre of Clinical Research Excellence in Spinal Pain, Injury and Health, The University of Queensland, Brisbane, Queensland, Australia
- Institut für Medizinische Psychologie (DE)
- University of Copenhagen (DK)
- Migräne Klinik Königstein (DE)
- Albert Einstein College of Medicine (US)
- Macquarie University (AU)
- Hochschule Osnabruck, Osnabruck, Niedersachsen, Germany
- Corresponding author
- Luedtke, Kerstin
- ORCID
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2020-02
- Volume
- 10
- Issue
- 2
- Pages
- e029855
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC7044826
- OpenAlex
- W3006624400
- Cited by
- 52
- References
- 57
- Citations by year
- 2026: 3 · 2025: 10 · 2024: 5 · 2023: 8 · 2022: 11 · 2021: 9 · 2020: 6
- FWCI
- 6.20
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMJ Open (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, other-oa)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion, other-oa)
- VU Research Portal (publishedVersion, other-oa)
- Library Osnabrück University (Hochschule Osnabrück) (submittedVersion, cc-by-nc)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- HighWire Press Open Archive (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion, cc-by-nc)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Migraine and Headache Studies
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Health Sciences › Health Professions › Complementary and Manual Therapy › Temporomandibular Joint Disorders
- Keywords
- migraine, non-pharmacological treatment, outcome measures, consensus, Migraine Disability Assessment, Headache Impact Test, headache frequency, quality of life, adjunctive therapy, patient perspectives
- MeSH terms
- Chronic Disease, Delphi Technique, Exercise Therapy, Humans, Migraine Disorders, Relaxation Therapy, Exercise, Cognitive Behavioral Therapy, Treatment Outcome, Acupuncture, Manipulation, Chiropractic, Internationality
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