The DOI matches its Crossref record; 85 of the 85 references it cites were found in a registry or an index.
Assessing the impact of headaches and the outcomes of treatment: A systematic review of patient-reported outcome measures (PROMs)
Open accessAbstract
Aims To critically appraise, compare and synthesise the quality and acceptability of multi-item patient reported outcome measures for adults with chronic or episodic headache. Methods Systematic literature searches of major databases (1980-2016) to identify published evidence of PROM measurement and practical properties. Data on study quality (COSMIN), measurement and practical properties per measure were extracted and assessed against accepted standards to inform an evidence synthesis. Results From 10,903 reviewed abstracts, 103 articles were assessed in full; 46 provided evidence for 23 PROMs: Eleven specific to the health-related impact of migraine (n = 5) or headache (n = 6); six assessed migraine-specific treatment response/satisfaction; six were generic measures. Evidence for measurement validity and score interpretation was strongest for two measures of impact, Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) and Headache Impact Test 6-item (HIT-6), and one of treatment response, the Patient Perception of Migraine Questionnaire (PPMQ-R). Evidence of reliability was limited, but acceptable for the HIT-6. Responsiveness was rarely evaluated. Evidence for the remaining measures was limited. Patient involvement was limited and poorly reported. Conclusion While evidence is limited, three measures have acceptable evidence of reliability and validity: HIT-6, MSQ v2.1 and PPMQ-R. Only the HIT-6 has acceptable evidence supporting its completion by all "headache" populations.
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“There is limited, but acceptable, evidence supporting the use of the SF-12 V2 to assess overall quality of life in a headache population.27”
From Usual care and a self-management support programme versus usual care and a relaxation programme for people living with chronic headache disorders: A randomised controlled trial protocol (CHESS) (2020) · cites this paper as [27]
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“Prior to selecting our outcome measures, we did a systematic review of PROMs for headaches.27”
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“The MSQv2.1 has acceptable evidence of psychometric properties following completion in a migraine population.27–30”
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“There is no such evidence for the EQ-5D-5L.27”
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Effect of fremanezumab on quality of life and productivity in patients with chronic migraine
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Underwood, M. R., Achana, F. A., Carnes, D., Eldridge, S. M., Ellard, D. R., Griffiths, F. E., Haywood, K. L., Hee, S. W., Higgins, H. B., Mistry, D., et al. (2022) · Neurology · doi:10.1212/wnl.0000000000201518 · Cited by 32
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“27 However, with the myriad of possible symptoms, often exceeding the classic orthostatic headaches, 3,4,28 SIH might very well be regarded as a poly-symptomatic disease and not just as a headache disorder.”
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A qualitative evidence synthesis of patient perspectives on migraine treatment features and outcomes
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The Environment and Headache: a Narrative Review
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“Moreover, a recent review (Haywood et al., 2018) has recommended headache frequency as a standard outcome for headache, but the findings were not available at the start of our review.”
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Guidelines of the International Headache Society for Clinic-Based Headache Registries, 1 st edition
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“A systematic review of headache PROs published in 2018 found twenty-three evidence-based PRO measures, including five specific to health-related impacts from migraine, six to health-related impacts from headache, six which assess migraine-specific treatment response or satisfaction, and six generic measures (23).”
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Patient-Reported outcomes of pain care research in the adult emergency department: A scoping review
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“Patient reported outcome measures (PROMs) PROM selection was informed by a systematic review of the psychometric properties of available measures for people with chronic headache (Haywood et al., 2018).”
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“There are several validated patient-reported outcome questionnaires that may be used clinically to assess level of acute treatment optimization (eg, mTOQ,Migraine—Assessment of Current Therapy, Patient Perception of Migraine Questionnaire—Revised, Functional Impairment Scale, Patient Global Impression of Change).(21,5…”
BackgroundAre PROMs passing the message? A reflection with real-life migraine patients
Gil‐Gouveia, R., & Oliveira, A. G. (2021) · Cephalalgia · doi:10.1177/03331024211034509 · Cited by 11
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Benefits Beyond Headache Days With OnabotulinumtoxinA Treatment: A Pooled PREEMPT Analysis
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The state of art on the use of patient reported outcomes in migraine
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“SF-36 has also been widely used in epidemiological clinical research and have demonstrated acceptable evidence of validity [24].”
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“It is widely used and recommended for impact assessment in both research and clinical practice (9,11,12).”
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“As part of our preparatory work we did a systematic reviewed of multi-item patient reported outcomes for headache disorders [19].”
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“Currently, parameters related to disability and QoL are becoming more relevant as they reflect the impact of the treatment on the patient’s life [34,35].”
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Ognard, J., Hajj, G. E., Ghozy, S. A., Cutsforth‐Gregory, J. K., Madhavan, A. A., Kadirvel, R., Kallmes, D. F., & Brinjikji, W. (2025) · Revue Neurologique · doi:10.1016/j.neurol.2025.08.002 · Cited by 7
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Identifying Outcome Measures for Migraine Value‐Based Contracting Using the Delphi Method
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Measuring headache day severity using multiple features in daily diary designs
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“7,8 In particular, improvements in the Headache Impact Test-6 (HIT-6), Migraine-Specific Quality of Life Questionnaire (MSQ; v2.”
Kaniecki, R. G., Friedman, D. I., Asher, D., Hirman, J., & Cady, R. K. (2023) · Pain and Therapy · doi:10.1007/s40122-023-00525-x · Cited by 5
“, reliability and validity that impact data interpretation) [20, 21].”
BackgroundReadability analysis and concept mapping of PROMs used for headache disorders
Hazewinkel, M. H. J., Gfrerer, L., Ashina, S., Austen, W. G., Klassen, A. F., Pusic, A. L., & Kaur, M. N. (2024) · Headache The Journal of Head and Face Pain · doi:10.1111/head.14706 · Cited by 5
“16 While striving for comprehensiveness in PROMs is crucial to capturing the full spectrum of patient experiences and outcomes, it is important to acknowledge the potential downsides associated with overly lengthy and burdensome measures.”
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Genome–phenome wide association study of broadly defined headache
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“22 These include six-item Headache Impact Test (HIT-6), Migraine-Specific Questionnaire (MSQ), Migraine Disability Assessment (MIDAS) questionnaire and Migraine Treatment Optimization Questionnaire (M-TOQ), of which some have demonstrated strong evidence of content validity supportive for use in…”
Cervical musculoskeletal impairments and pressure pain sensitivity in office workers with headache
Ernst, M. J., Sax, N., Meichtry, A., Aegerter, A. M., Luomajoki, H., Lüdtke, K., Gallina, A., Falla, D., Aegerter, A. M., Barbero, M., et al. (2023) · Musculoskeletal Science and Practice · doi:10.1016/j.msksp.2023.102816 · Cited by 4
Trager, R. J., Daniels, C. J., Hawk, C., Taylor, D. N., Walters, S., Price, M. R., Anderson, K. R., Crivelli, L. S., Mooring, S. A., Staab, C. A., et al. (2026) · Journal of Integrative and Complementary Medicine · doi:10.1177/27683605251397769 · Cited by 3
Surgical Management of Headache Disorders - A Systematic Review of the Literature
Hazewinkel, M. H. J., Knoedler, L., Mathew, P. G., Remy, K., Austen, W. G., & Gfrerer, L. (2024) · Current Neurology and Neuroscience Reports · doi:10.1007/s11910-024-01342-1 · Cited by 3
“In addition, current PROMS have not been updated to ensure content validity for minimally invasive device-based and surgical treatments, which precludes comparison of different therapeutic outcomes [93, 94].”
Ernst, M. J., Meichtry, A., Luedtke, K., Aegerter, A. M., Ajeti, A., Barbero, M., Brunner, B., Buob, S., Cornwall, J., Pereira, Y. D. C., et al. (2025) · The Journal of Headache and Pain · doi:10.1186/s10194-025-01963-y · Cited by 4
“…the current study dealt with included headache occurrence (yes/ no), headache frequency (days) and the short-form Headache-Impact Test (HIT-6/), a six item questionnaire assessing the impact of headache on daily life, including the functional and emotional burden that headache can cause [52–55].”
Headache Gauge: a real-life calendar-based tool for headache monitoring
Gil‐Gouveia, R., Marques, I. B., Parreira, E., Martins, I. P., & Oliveira, A. G. (2021) · Neurological Sciences · doi:10.1007/s10072-021-05080-x · Cited by 4
Patient Reported Outcome Measures (PROMs) in Migraine and Headache
Buse, D. C., & Lipton, R. B. (2023) · Headache · doi:10.1007/978-3-031-25938-8_4 · Cited by 2
Review on the Burden of Episodic Migraine and Utilization of Patient Reported Outcome Measures
Ehsani-Nia, M. I., Wannon, A., & Ailani, J. (2024) · Current Neurology and Neuroscience Reports · doi:10.1007/s11910-024-01379-2 · Cited by 2
Chys, M., Meulemeester, K. D., Greef, I. D., Sloovere, M. D., & Cagnie, B. J. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm14186619 · Cited by 2
“Scores range from 36 to 78, with higher scores representing greater disability [55,56].”
Chen, E., Rowe, M., Khan, A. Z., Gardner, T., Bratten, C., Young, A., Paul, E., Nees, D., Ford, A. I., & Vassar, M. B. (2025) · The Journal of Headache and Pain · doi:10.1186/s10194-025-02158-1 · Cited by 2
“PROMs allow trials to capture outcomes that matter to patients–such as reduction in missed workdays, improved ability to care for children, or restored participation in social life–which may not always align with traditional endpoints like two-hour pain relief [9, 10, 12].”
The importance of an early onset of migraine preventive disease control: A roundtable discussion
Gottschalk, C. H., Basu, A., Blumenfeld, A. M., Torphy, B. D., Marmura, M. J., Pavlovic, J. M., Dumas, P. K., Lalvani, N., & Buse, D. C. (2022) · Cephalalgia Reports · doi:10.1177/25158163221134593 · Cited by 2
“These PROMs vary in parameters covered, response categories, and recall time frames, making selection and interpretation challenging based on context.(87) We believe that standardized use of PROMs in future clinical trials will be invaluable in evaluating the benefits of an early onset of prevention in patients with m…”
BackgroundErenumab versus topiramate: migraine‐related disability, impact and health‐related quality of life
Reuter, U., Heinze, A., Gendolla, A., Sieder, C., & Hentschke, C. (2024) · European Journal of Neurology · doi:10.1111/ene.16437 · Cited by 3
Althagafi, S. M., & Hughes, J. A. (2022) · International Emergency Nursing · doi:10.1016/j.ienj.2022.101152 · Cited by 2
Clinical Scales for Headache and Migraine
Dikmen, P. Y., & Baykan, B. B. (2023) · Headache · doi:10.1007/978-3-031-25938-8_2 · Cited by 1
Rosa, R., Lionetto, F., Angilecchia, D., Carmillo, L., Castaldo, M., Giovannico, G., Lorenzo, C. D., & Pellicciari, L. (2024) · Headache The Journal of Head and Face Pain · doi:10.1111/head.14883 · Cited by 1
Gunasekera, L., Ray, J. C., Kaul, N., Butzkueven, H., Hutton, E. J., & O'Brien, T. J. (2025) · The Journal of Headache and Pain · doi:10.1186/s10194-025-02019-x · Cited by 1
“However, a systematic review of headache PROMs found a significant lack of patient involvement in their creation which may mean a lack of relevance to what the patient is experiencing [8].”
Khan, F., Herzog, S., Smith, R. M., Buse, D. C., Soni-Brahmbhatt, S., Awad, S. F., Grossman, S., Asher, D., Patel, F. P., & Argoff, C. E. (2025) · The Journal of Headache and Pain · doi:10.1186/s10194-025-02227-5 · Cited by 1
“Current literature has established correlations between monthly migraine day (MMD) responder rates (≥ 50% or ≥ 75% reduction in MMDs) and improvements in many PROMs [20, 21].”
Lipton, R. B., Mosher, L., & Fountaine, R. J. (2025) · Pain and Therapy · doi:10.1007/s40122-025-00800-z · Cited by 1
“The utility of PROMs for migraine—including the Migraine Disability Assessment (MIDAS) and Migraine-Specific Pain Ther (2026) 15:325–340 Quality of Life questionnaire—has been well established [13–15].”
Marchenko, M., Domingues, L., Barbero, M., Cescon, C., Falla, D., Ernst, M. J., & the NEXpro collaboration group (2025) · Physiotherapy Theory and Practice · doi:10.1080/09593985.2025.2596179 · Cited by 3
Lampl, C., Lipton, R. B., Lipsius, S., Ford, J. H., Dell’Agnello, G., Viktrup, L., & Buse, D. C. (2026) · Frontiers in Neurology · doi:10.3389/fneur.2026.1808619 · Cited by 1
Spiegler, K. M., Ezzati, A., Fanning, K. M., Bostic, R. C., Urani, A., Cadiou, F., Lipton, R. B., & Vgontzas, A. (2026) · Headache The Journal of Head and Face Pain · doi:10.1111/head.70165 · Cited by 1
Pozo‐Rosich, P., Gil‐Gouveia, R., Donnet, A., Poole, A. C., Gendolla, A., Afridi, S. K., la Rosa, R. S.-D., Terwindt, G. M., & Tassorelli, C. (2021) · European Journal of Pain · doi:10.1002/ejp.1831 · Cited by 1
“However, currently used PROMs may not adequately reflect patients’ satisfaction and a broader consensus on the most important outcomes and how to assess them is required (Haywood et al., 2018; Mannix et al., 2016; Smelt et al., 2014).”
BackgroundInfluentialIvanov, D., & Ernst, M. J. (2023) · physioscience · doi:10.1055/a-2001-5129 · Cited by 1
“[11] Haywood KL, Mars TS, Potter R et al.”
BackgroundInfluentialBot, M. N., van der Meer, H. A., de Vries, M. M., Bronkhorst, E. M., Kalaykova, S., & Creugers, N. H. J. (2023) · Children · doi:10.3390/children10071135 · Cited by 1
Outcome measures for migraine: Measuring the impact of migraine and results of migraine treatment
Hareendran, A., & Mannix, S. (2024) · Handbook of clinical neurology · doi:10.1016/b978-0-12-823357-3.00022-7 · Cited by 1
Hussein, M., Hassan, A., Nada, M., Mohammed, Z., Fathy, W., Ghaffar, N. F. A., Kedah, H. M., & Magdy, R. (2024) · Headache The Journal of Head and Face Pain · doi:10.1111/head.14874 · Cited by 1
Impact on the quality of life of patients with migraine
Rojas, E., & Compen, L. (2021) · Revista Médica de Trujillo · doi:10.17268/rmt.2021.v16i03.08
Weden, A. (2022) · Journal of Dentistry and Oral Epidemiology · doi:10.54289/jdoe2200101
Measurement properties of instruments for migraine impact in Brazil: a systematic review
de Menezes, M. C. M., Lemos, A., Feitosa, H., Toscano, R. C. S., & de Oliveira, D. A. (2022) · Research Society and Development · doi:10.33448/rsd-v11i7.30248
Clinical Instruments for Treatment Monitoring and Optimization in Headache and Migraine
Ashina, S., & Macone, A. (2023) · Headache · doi:10.1007/978-3-031-25938-8_10
Other Questionnaires We Don’t Want to Miss in Headache Studies
Polat, B., Özge, A., & Dikmen, P. Y. (2023) · Headache · doi:10.1007/978-3-031-25938-8_11
A EFICÁCIA DO CAMPO ELETROMAGNÉTICO PULSADO NO TRATAMENTO DA CEFALEIA: UMA REVISÃO SISTEMÁTICA
Cordeiro, A. A. C., Júnior, J. V. D. A. A., Guedes, F. M. S., Medeiros, M. D. P., Leal, M. V. A., de Sousa, V., Gomes, K. D. S., de Lira, M. G., de Almeida, R. S., Neto, J. A. O., et al. (2024) · Revista Contemporânea · doi:10.56083/rcv4n8-113
CDA-AMC (2024) · Canadian Journal of Health Technologies · doi:10.51731/cjht.2024.1045
Effectiveness of a Multidisciplinary Headache Management Program: An Open-Label Pilot Study
Souren, R., Winteler, B., Bischoff, N., Fluri, O., Grolimund, J., Scutelnic, A., Streitberger, K., Beckwée, D., & Schankin, C. J. (2025) · Clinical and Translational Neuroscience · doi:10.3390/ctn9020027
Metadata
- Authors
- Haywood, K. L., Mars, T. S., Potter, R., Patel, S., Matharu, M., & Underwood, M.
- Affiliations
- University of Warwick (GB)
- Corresponding author
- Haywood, Kirstie L
- Venue
- Cephalalgia
- Publisher
- SAGE Publications
- Published
- 2017-09-18
- Volume
- 38
- Issue
- 7
- Pages
- 1374-1386
- ISSN
- 0333-1024 (ISSN-L)
- 1468-2982
- PMC
- PMC6024352
- OpenAlex
- W2755034339
- Cited by
- 113
- References
- 85
- Citations by year
- 2026: 8 · 2025: 13 · 2024: 17 · 2023: 17 · 2022: 11 · 2021: 21 · 2020: 14 · 2019: 7 · 2018: 4 · 2017: 1
- FWCI
- 1.08
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Cephalalgia (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Warwick Research Archive Portal (University of Warwick) (acceptedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Funders
- National Institute for Health and Care Research (RP-PG-1212-20018, NF-SI-0512-10103, NF-SI-0616-10043)
- Programme Grants for Applied Research (RP-PG-1212-20018)
- Topics
- Health Sciences › Medicine › Clinical Neurology › Migraine and Headache Studies
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Musculoskeletal pain and rehabilitation
- Keywords
- patient-reported outcome measures, chronic headache, episodic headache, migraine, headache impact, treatment response, HIT-6, measurement validity, reliability statistics, responsiveness, patient involvement, COSMIN
- MeSH terms
- Patient Reported Outcome Measures, Headache, Humans, Treatment Outcome
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