Assessing the impact of headaches and the outcomes of treatment: a systematic review of patient-reported outcome measures (PROMs)

Haywood, Kirstie L; Mars, Tom S; Potter, Rachel; Patel, Shilpa; Matharu, Manjit; Underwood, Martin

doi:10.1177/0333102417731348

Cited by 113Migraine and Headache StudiesHealth Systems, Economic Evaluations, Quality of LifeMusculoskeletal pain and rehabilitation

Assessing the impact of headaches and the outcomes of treatment: a systematic review of patient-reported outcome measures (PROMs)

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Haywood, Kirstie L, Mars, Tom S, Potter, Rachel, Patel, Shilpa, Matharu, Manjit, Underwood, Martin·2018·Cephalalgia

DOI 10.1177/0333102417731348PMC PMC6024352

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Abstract

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.
“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]
The Results (page not provided) list the SF-12 as a generic measure assessed in headache populations and rate one measurement property as adequate, but with limited evidence. The paper does not identify the measure as SF-12 V2, and its Discussion reserves the description of acceptable construct-validity evidence for the SF-36 and SF-8, not the SF-12. It also reports no evidence of responsiveness for the generic measures, so the broader endorsement of SF-12 V2 for assessing overall quality of life is not fully supported. (LLM, conf=0.84)
Experimental — accuracy not yet measured
Prior to selecting outcome measures, the authors did a systematic review of patient-reported outcome measures for headaches.
“Prior to selecting our outcome measures, we did a systematic review of PROMs for headaches.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]
The MSQv2.1 has acceptable evidence of psychometric properties following completion in a migraine population.
“The MSQv2.1 has acceptable evidence of psychometric properties following completion in a migraine population.27–30”
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]
There is no evidence supporting the use of the EQ-5D-5L to assess overall quality of life in a headache population.
“There is no such evidence for the EQ-5D-5L.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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Development and Validation of the Headache Needs Assessment (HANA) Survey
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Establishing the values for patient engagement (PE) in health-related quality of life (HRQoL) research: an international, multiple-stakeholder perspective
Haywood, K. L., Lyddiatt, A., Brace-McDonnell, S. J., Staniszewska, S. H., & Salek, S. (2016) · Quality of Life Research · doi:10.1007/s11136-016-1465-5 · Cited by 42 · see citing works
Validation of the Revised Patient Perception of Migraine Questionnaire: Measuring Satisfaction With Acute Migraine Treatment
Revicki, D. A., Kimel, M., Beusterien, K., Kwong, J. W., Varner, J., Ames, M. H., Mahajan, S., & Cady, R. K. (2006) · Headache The Journal of Head and Face Pain · doi:10.1111/j.1526-4610.2006.00289.x · Cited by 41 · see citing works
Reliability and Validity of the Migraine Therapy Assessment Questionnaire
Chatterton, M. L., Lofland, J. H., Shechter, A. L., Curtice, W. S., Hu, X., Lenow, J. L., Smullens, S. N., Nash, D. B., & Silberstein, S. D. (2002) · Headache The Journal of Head and Face Pain · doi:10.1046/j.1526-4610.2002.02230.x · Cited by 37 · see citing works
Assessing the Impact of Migraine on Health‐Related Quality of Life: An Additional Use of the Quality of Well‐being Scale–Self‐administered
Sieber, W. J., David, K. M., Adams, J., Kaplan, R. M., & Ganiats, T. G. (2000) · Headache The Journal of Head and Face Pain · doi:10.1046/j.1526-4610.2000.040008662.x · Cited by 32 · see citing works
Measuring satisfaction with migraine treatment: Expectations, importance, outcomes, and global ratings
Patrick, D. L., Martin, M. L., Bushmell, D. M., & Pesa, J. A. (2003) · Clinical Therapeutics · doi:10.1016/s0149-2918(03)80345-4 · Cited by 32 · see citing works
Validation of the Revised Patient Perception of Migraine Questionnaire (PPMQ-R): Measuring Satisfaction with Acute Migraine Treatment in Clinical Trials
Kimel, M., Hsieh, R., McCormack, J., Burch, S. P., & Revicki, D. A. (2008) · Cephalalgia · doi:10.1111/j.1468-2982.2007.01524.x · Cited by 31 · see citing works
Migraine Frequency and Health Utilities: Findings from a Multisite Survey
Brown, J. S., Neumann, P. J., Papadopoulos, G., RUOFF, G. E., Diamond, M. L., & Menzin, J. (2007) · Value in Health · doi:10.1111/j.1524-4733.2007.00246.x · Cited by 29 · see citing works
Validation of the Patient Perception of Migraine Questionnaire
Davis, K. H., Black, L. K., & Sleath, B. L. (2002) · Value in Health · doi:10.1046/j.1524-4733.2002.55120.x · Cited by 28 · see citing works
Reliability, Validity, and Clinical Utility of the Migraine‐ACT Questionnaire
Kilminster, S. G., Dowson, A. J., Tepper, S. J., Baos, V., Baudet, F., & D’Amico, D. (2006) · Headache The Journal of Head and Face Pain · doi:10.1111/j.1526-4610.2006.00403.x · Cited by 27 · see citing works
Functional Assessment in Migraine (FAIM) Questionnaire: Development of an Instrument Based Upon the WHO's International Classification of Functioning, Disability, and Health
Pathak, D. S., Chisolm, D. J., & Weis, K. A. (2005) · Value in Health · doi:10.1111/j.1524-4733.2005.00047.x · Cited by 27 · see citing works
Development of the Headache Activities of Daily Living Index: Initial Validity Study
Vernon, H. T., & Lawson, G. E. (2015) · Journal of Manipulative and Physiological Therapeutics · doi:10.1016/j.jmpt.2014.12.002 · Cited by 24 · see citing works
Fears aroused in patients by migraine.
Blau, J. N. (1984) · BMJ · doi:10.1136/bmj.288.6424.1126 · Cited by 21 · see citing works
Methodological Issues in Systematic Reviews of Headache Trials: Adapting Historical Diagnostic Classifications and Outcome Measures to Present‐Day Standards
McCrory, D. C., Gray, R. N., Tfelt‐Hansen, P. C., Steiner, T. J., & Taylor, F. R. (2005) · Headache The Journal of Head and Face Pain · doi:10.1111/j.1526-4610.2005.05097.x · Cited by 20 · see citing works
Development of a headache-specific disability questionnaire for patients attending physiotherapy
Niere, K. R., & Quin, A. (2007) · Manual Therapy · doi:10.1016/j.math.2007.09.006 · Cited by 15 · see citing works
Further Validation of an Individualized Migraine Treatment Satisfaction Measure
Martin, M. L., Patrick, D. L., Bushnell, D. M., Gandra, S. R., & Gilchrist, K. (2008) · Value in Health · doi:10.1111/j.1524-4733.2008.00320.x · Cited by 14 · see citing works
The Development of a Survey to Measure Completeness of Response to Migraine Therapy
Coon, C. D., Fehnel, S. E., Davis, K. H., Runken, M. C., Beach, M. E., & Cady, R. K. (2012) · Headache The Journal of Head and Face Pain · doi:10.1111/j.1526-4610.2012.02099.x · Cited by 10 · see citing works
Modification of the SF‐36 for a Headache Population Changes Patient‐Reported Health Status
Magnusson, J. E., Riess, C. M., & Becker, W. J. (2012) · Headache The Journal of Head and Face Pain · doi:10.1111/j.1526-4610.2012.02156.x · Cited by 10 · see citing works
Assessing disability using the migraine disability assessment questionnaire
Lipton, R. B., BIGAL, M. E., & Stewart, W. F. (2003) · Expert Review of Neurotherapeutics · doi:10.1586/14737175.3.3.317 · Cited by 7 · see citing works
Mimicry of dimerization by synthetic peptides designed to target homologous regions of proteins
Dwyer, D. S., & Ardizzone, T. D. (2003) · PROTEOMICS · doi:10.1002/pmic.200390045 · Cited by 6 · see citing works

Flagged first, then by citations

Sorted by citations

Patient‐reported outcome measures (PROMs): A review of generic and condition‐specific measures and a discussion of trends and issues
Churruca, K., Pomare, C., Ellis, L. A., Long, J. C., Henderson, S. B., Murphy, L. E., Leahy, C. J., & Braithwaite, J. (2021) · Health Expectations · doi:10.1111/hex.13254 · Cited by 725 · see citing works
Sudden cardiac arrest survivorship: a scientific statement from the American Heart Association
Sawyer, K. N., Camp-Rogers, T. R., Kotini-Shah, P., Del Rios, M., Gossip, M. R., Moitra, V. K., Haywood, K. L., Dougherty, C. M., Lubitz, S. A., Rabinstein, A. A., et al. (2020) · Circulation · doi:10.1161/cir.0000000000000747 · Cited by 311 · see citing works
Content Validity of HIT‐6 as a Measure of Headache Impact in People With Migraine: A Narrative Review
Houts, C. R., Wirth, R. J., McGinley, J. S., Gwaltney, C. J., Kassel, E., Snapinn, S. M., & Cady, R. K. (2019) · Headache The Journal of Head and Face Pain · doi:10.1111/head.13701 · Cited by 96 · see citing works
An update on idiopathic intracranial hypertension in adults: a look at pathophysiology, diagnostic approach and management
Toscano, S., Fermo, S. L., Reggio, E., Chisari, C. G., Patti, F., & Zappia, M. (2020) · Journal of Neurology · doi:10.1007/s00415-020-09943-9 · Cited by 86 · see citing works
Advances in the understanding of headache in idiopathic intracranial hypertension
Mollan, S. P., Hoffmann, J., & Sinclair, A. J. (2018) · Current Opinion in Neurology · doi:10.1097/wco.0000000000000651 · Cited by 82 · see citing works
Manual Therapy and Quality of Life in People with Headache: Systematic Review and Meta-analysis of Randomized Controlled Trials
Maistrello, L. F., Rafanelli, M., & Turolla, A. (2019) · Current Pain and Headache Reports · doi:10.1007/s11916-019-0815-8 · Cited by 72 · see citing works
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, M., Montisano, D. A., Antolak, M., Bighiani, F., Cammarota, F., Cetta, I., Corrado, M., Ihara, K., Kartamysheva, R., Petrušić, I., et al. (2024) · The Journal of Headache and Pain · doi:10.1186/s10194-024-01735-0 · Cited by 63 · see citing works
“They provide valuable information about the experience of the disease and the patient’s perspective [23].”
Background
Identifying and managing refractory migraine: barriers and opportunities?
D’Antona, L., & Matharu, M. S. (2019) · The Journal of Headache and Pain · doi:10.1186/s10194-019-1040-x · Cited by 61 · see citing works
Assessing health-related quality of life (HRQoL) in survivors of out-of-hospital cardiac arrest: A systematic review of patient-reported outcome measures
Haywood, K. L., Pearson, N. A., Morrison, L. J., Castrén, M. K., Lilja, G., & Perkins, G. D. (2017) · Resuscitation · doi:10.1016/j.resuscitation.2017.11.065 · Cited by 58 · see citing works
Current clinical practice in disabling and chronic migraine in the primary care setting: results from the European My-LIFE anamnesis survey
Ryvlin, P., Владимирович, С. К., Negro, A., la Rosa, R. S.-D., Israel-Willner, H., Sundal, C., MacGregor, E. A., & Peral, Á. L. G. (2021) · BMC Neurology · doi:10.1186/s12883-020-02014-6 · Cited by 53 · see citing works
In search of a gold standard patient-reported outcome measure to use in the evaluation and treatment-decision making in migraine prevention. A real-world evidence study
Alpuente, A., Gallardo, V. J., Caronna, E., Torres‐Ferrús, M., & Pozo‐Rosich, P. (2021) · The Journal of Headache and Pain · doi:10.1186/s10194-021-01366-9 · Cited by 47 · see citing works
“MSQ also helps monitor treatment response in migraine patients with preventive treatment [15].”
Background
Core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG): an international, consensus-derived and multistakeholder initiative
Haywood, K. L., Potter, R. C., Froud, R., Pearce, G., Box, B., Muldoon, L., Lipton, R. B., Petrou, S., Rendas‐Baum, R., Logan, A.-M., et al. (2021) · BMJ Open · doi:10.1136/bmjopen-2020-043242 · Cited by 46 · see citing works
Health technology assessment for the acute and preventive treatment of migraine: A position statement of the International Headache Society
Diener, H., Ashina, M., Durand‐Zaleski, I., Kurth, T., Lantéri‐Minet, M., Lipton, R. B., Ollendorf, D. A., Pozo‐Rosich, P., Tassorelli, C., & Terwindt, G. M. (2021) · Cephalalgia · doi:10.1177/0333102421989247 · Cited by 46 · see citing works
“1) are frequently used (32) and have a reasonable reliability.”
Effect of fremanezumab on quality of life and productivity in patients with chronic migraine
Lipton, R. B., Cohen, J. M., Gandhi, S. K., Yang, R., Yeung, P. P., & Buse, D. C. (2020) · Neurology · doi:10.1212/wnl.0000000000010000 · Cited by 41 · see citing works
The use of clinical scales and PROMs in headache disorders and migraine, summarizing their dissemination and operationalization
Dikmen, P. Y., Özge, A., & Martelletti, P. (2023) · Heliyon · doi:10.1016/j.heliyon.2023.e16187 · Cited by 36 · see citing works
“In the headache population, the SF-36 has acceptable evidence of construct validity [17].”
BackgroundMethod
Living with migraine: A meta-synthesis of qualitative studies
Battista, S., Lazzaretti, A., Coppola, I., Maistrello, L. F., Rania, N., & Testa, M. (2023) · Frontiers in Psychology · doi:10.3389/fpsyg.2023.1129926 · Cited by 31 · see citing works
Guidelines of the International Headache Society for Controlled Clinical Trials in Cluster Headache
Schoenen, J. E., Snoer, A. H., Brandt, R. B., Fronczek, R., Wei, D. Y., Chung, C., Diener, H., Dodick, D. W., Fontaine, D., Goadsby, P. J., et al. (2022) · Cephalalgia · doi:10.1177/03331024221120266 · Cited by 30 · see citing works
“PROMs, not specific for CH, may include (42) the Patient Global Impression of Change scale (PGIC) as a measure of patient satisfaction (43) the Functional Impairment Scale (FIS) (44), a four-point scale that addresses functional status and intensity of impairment during daily activities; the EuroQoL- 5 Dimension Quest…”
BackgroundMethod
Supportive Self-Management Program for People With Chronic Headaches and Migraine
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 29 · see citing works
Real-World Treatment Profiles, Clinical Outcomes, and Healthcare Resource Utilization of Patients with Migraine Prescribed Erenumab: A Multicenter Chart-Review Study of US Headache Centers
Faust, E., Pivneva, I., Yang, K., Betts, K. A., Ahmed, Z. A., Joshi, S., Hogan, R., Blumenfeld, A. M., Schim, J. D., Feoktistov, A., et al. (2021) · Neurology and Therapy · doi:10.1007/s40120-021-00245-4 · Cited by 28 · see citing works
Medium-term real-world data for erenumab in 177 treatment resistant or difficult to treat chronic migraine patients: persistence and patient reported outcome measures after 17–30 months
Troy, E., Shrukalla, A. A., Buture, A., Conaty, K., Macken, E., Lonergan, R. M., Melling, J., Long, N., Shaikh, E., Birrane, K., et al. (2023) · The Journal of Headache and Pain · doi:10.1186/s10194-022-01536-3 · Cited by 27 · see citing works
“It may have been useful to compare our patient group to studies using this parameter [28].”
Result
Changes in migraine interictal burden following treatment with galcanezumab: Results from a phase III randomized, placebo‐controlled study
Lipton, R. B., Buse, D. C., Sandoe, C. H., Ford, J. H., Hand, A. L., Jedynak, J., Port, M. D., & Detke, H. C. (2023) · Headache The Journal of Head and Face Pain · doi:10.1111/head.14460 · Cited by 27 · see citing works
“Asian 37 (16) 35 (15) 14 (10) 12 (9) 23 (24) 23 (23)”
Neuroimaging features of whole‐brain functional connectivity predict attack frequency of migraine
Mu, J., Chen, T., Quan, S., Wang, C., Zhao, L., & Liu, J. (2019) · Human Brain Mapping · doi:10.1002/hbm.24854 · Cited by 27 · see citing works
“, recall headache days may be higher than the actual headache days) (Berger et al., 2018; Haywood et al., 2018).”
Background
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)
Patel, S., Achana, F., Carnes, D., Eldridge, S., Ellard, D. R., Griffiths, F., Haywood, K., Hee, S. W., Mistry, D., Mistry, H., et al. (2020) · BMJ Open · doi:10.1136/bmjopen-2019-033520 · Cited by 24 · see citing works
“27 30 To inform our selection of outcome measures, we undertook interviews (n=14) with people with chronic headache.”
Influential
Measuring health-related quality of life in chronic headache: A comparative evaluation of the Chronic Headache Quality of Life Questionnaire and Headache Impact Test (HIT-6)
Haywood, K. L., Achana, F. A., Nichols, V. P., Pearce, G., Box, B., Muldoon, L., Patel, S., Griffiths, F. E., Stewart, K., Underwood, M. R., et al. (2021) · Cephalalgia · doi:10.1177/03331024211006045 · Cited by 24 · see citing works
“There is substantial heterogeneity in PROMS used in trials of headache disorders (7).”
BackgroundInfluential
Patient‐reported outcome measures for facial skin cancer: a systematic review and evaluation of the quality of their measurement properties
Dobbs, T. D., Samarendra, H., Hughes, S., Hutchings, H. A., & Whitaker, I. S. (2018) · British Journal of Dermatology · doi:10.1111/bjd.17342 · Cited by 24 · see citing works
Patient-Reported Outcomes from a 1-Year, Real-World, Head-to-Head Comparison of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine
Blumenfeld, A. M., Patel, A. T., Turner, I. M., Mullin, K., Adams, A. M., & Rothrock, J. F. (2020) · Journal of Primary Care & Community Health · doi:10.1177/2150132720959936 · Cited by 23 · see citing works
Impact of Spinal CSF Leaks on Quality of Life and Mental Health and Long-Term Reversal by Surgical Closure
Volz, F., Wolf, K., Fung, C., Carroll, I. R., Lahmann, C., Lützen, N., Urbach, H., Klingler, J., Beck, J., & Rahal, A. E. (2024) · Neurology Clinical Practice · doi:10.1212/cpj.0000000000200272 · Cited by 23 · see citing works
“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.”
Background
How much do calcitonin gene-related peptide monoclonal antibodies improve the quality of life in migraine? A patient's perspective
Torres‐Ferrús, M., Alpuente, A., & Pozo‐Rosich, P. (2019) · Current Opinion in Neurology · doi:10.1097/wco.0000000000000689 · Cited by 22 · see citing works
A qualitative evidence synthesis of patient perspectives on migraine treatment features and outcomes
Urtecho, M., Wagner, B. L., Wang, Z., VanderPluym, J. H., Singh, R. B. H., Noyes, J., Butler, M. E., & Murad, M. H. (2023) · Headache The Journal of Head and Face Pain · doi:10.1111/head.14430 · Cited by 21 · see citing works
Priority acute and preventive migraine treatment benefits: Results of the Migraine Clinical Outcome Assessment System (MiCOAS) qualitative study of people living with migraine
Mangrum, R., Gerstein, M. T., Hall, C. J., Buse, D. C., Houts, C. R., McGinley, J. S., McCarrier, K. P., Lipton, R. B., & Wirth, R. J. (2023) · Headache The Journal of Head and Face Pain · doi:10.1111/head.14521 · Cited by 20 · see citing works
The Environment and Headache: a Narrative Review
Elser, H. C., Kruse, C. F. G., Schwartz, B. S., & Casey, J. A. (2024) · Current Environmental Health Reports · doi:10.1007/s40572-024-00449-4 · Cited by 23 · see citing works
“2), and the Headache Impact Test (HIT-6) [102].”
What is changing in chronic migraine treatment? An algorithm for onabotulinumtoxinA treatment by the Italian chronic migraine group
Sacco, S., Russo, A., Geppetti, P., Grazzi, L., Negro, A., Tassorelli, C., Tedeschi, G., & Martelletti, P. (2020) · Expert Review of Neurotherapeutics · doi:10.1080/14737175.2020.1825077 · Cited by 19 · see citing works
Chronic Headache Education and Self-management Study (CHESS) – a mixed method feasibility study to inform the design of a randomised controlled trial
on behalf of the CHESS team, White, K., Potter, R., Patel, S., Nichols, V. P., Haywood, K. L., Hee, S. W., Mistry, D., Carnes, D., Taylor, S. J. C., et al. (2019) · BMC Medical Research Methodology · doi:10.1186/s12874-019-0672-5 · Cited by 18 · see citing works
Self-citation
Matching‐adjusted indirect comparisons of oral rimegepant versus placebo, erenumab, and galcanezumab examining monthly migraine days and health‐related quality of life in the treatment of migraine
Popoff, E., Johnston, K., Croop, R. S., Thiry, A., Harris, L. A., Powell, L. C., Coric, V., L'Italien, G. J., & Moren, J. (2021) · Headache The Journal of Head and Face Pain · doi:10.1111/head.14128 · Cited by 17 · see citing works
Diagnostic Delay and Its Predictors in Cluster Headache
Kim, B., Chung, P., Kim, B., Lee, M. J., Chu, M. K., Ahn, J., Bae, D. W., Song, T., Sohn, J., Oh, K., et al. (2022) · Frontiers in Neurology · doi:10.3389/fneur.2022.827734 · Cited by 17 · see citing works
Do patients have a say? A narrative review of the development of patient-reported outcome measures used in elective procedures for coronary revascularisation
Peeters, G. M. E. E., Barker, A. L., Talevski, J., Ackerman, I. N., Ayton, D., Reid, C. M., Evans, S., Stoelwinder, J. U., & McNeil, J. J. (2018) · Quality of Life Research · doi:10.1007/s11136-018-1795-6 · Cited by 17 · see citing works
Effectiveness of Hands-Off Therapy in the Management of Primary Headache: A Systematic Review and Meta-Analysis
Mukhtar, N. B., Meeus, M., Gürşen, C., Mohammed, J., Pauw, R. D., & Cagnie, B. J. (2021) · Evaluation & the Health Professions · doi:10.1177/0163278720983408 · Cited by 17 · see citing works
“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.”
Background
Patient-Reported Outcome in Two Chronic Diseases: A Comparison of Quality of Life and Response Profiles in Severe Migraine and Severe Asthma
Lucas, C., Aly, S., Touboul, C., Sellami, R., Guillaume, X., & Garcia, G. (2020) · Patient Related Outcome Measures · doi:10.2147/prom.s222597 · Cited by 15 · see citing works
Guidelines of the International Headache Society for Clinic-Based Headache Registries, 1 st edition
Schwedt, T. J., Tassorelli, C., Silberstein, S. D., Szperka, C. L., Kurth, T., Pozo‐Rosich, P., Amin, F. M., Lipton, R. B., Dodick, D. W., Ashina, M., et al. (2022) · Cephalalgia · doi:10.1177/03331024221099035 · Cited by 15 · see citing works
“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).”
Background
Patient-Reported Outcome Measures for Soft-Tissue Facial Reconstruction: A Systematic Review and Evaluation of the Quality of Their Measurement Properties
Dobbs, T. D., Gibson, J. A. G., Hughes, S., Thind, A., Patel, B., Hutchings, H. A., & Whitaker, I. S. (2018) · Plastic & Reconstructive Surgery · doi:10.1097/prs.0000000000005112 · Cited by 14 · see citing works
Patient-Reported outcomes of pain care research in the adult emergency department: A scoping review
Wong, A., Potter, J., Brown, N. J., Chu, K., & Hughes, J. A. (2020) · Australasian Emergency Care · doi:10.1016/j.auec.2020.10.003 · Cited by 14 · see citing works
Patient and public involvement in a UK National Institute for Health Research Programme Grant for Applied Research: experiences from the Chronic Headache Education and Self-management Study (CHESS)
Nichols, V. P., Pearce, G., Ellard, D. R., Evans, S., Haywood, K., Norman, C., Potter, R., Sandhu, H. K., Stewart, K., Underwood, M. R., et al. (2021) · Primary Health Care Research & Development · doi:10.1017/s1463423621000670 · Cited by 13 · see citing works
“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).”
Method
Effectiveness and safety of erenumab and galcanezumab in the prevention of chronic and episodic migraine: A retrospective cohort study
Viudez‐Martínez, A., Carrasco, Á. P., Blasco, I. B., Lorido, R. H., & de Apodaca, R. F. R. (2022) · Journal of Clinical Pharmacy and Therapeutics · doi:10.1111/jcpt.13620 · Cited by 13 · see citing works
Transvenous Embolization versus Surgical Intervention for CSF Venous Fistulas: A Systematic Review and Meta-Analysis
Jazayeri, S. B., Eraghi, M. M., Ognard, J., Ghozy, S. A., Kadirvel, R., Brinjikji, W., & Kallmes, D. F. (2025) · American Journal of Neuroradiology · doi:10.3174/ajnr.a8839 · Cited by 12 · see citing works
Inter-rater reliability, discriminatory and predictive validity of neck movement control tests in office workers with headache and/or neck pain
Ernst, M. J., Klaus, S., Lüdtke, K., Gallina, A., Falla, D., Aegerter, A. M., Barbero, M., Brunner, B., Cornwall, J., Pereira, Y. D. C., et al. (2022) · Musculoskeletal Science and Practice · doi:10.1016/j.msksp.2022.102685 · Cited by 12 · see citing works
Optimized Acute Treatment of Migraine Is Associated With Greater Productivity in People With Migraine
Buse, D. C., Nahas, S. J., Stewart, W. F., Armand, C., Reed, M. L., Fanning, K. M., Adams, A. M., & Lipton, R. B. (2023) · Journal of Occupational and Environmental Medicine · doi:10.1097/jom.0000000000002801 · Cited by 11 · see citing works
“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…”
Background
Are 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 · see citing works
Associated Factors and Clinical Implication of Cutaneous Allodynia in Patients with Cluster Headache: A Prospective Multicentre Study
Kim, B., Park, J. W., Sohn, J., Lee, M. J., Kim, B., Chu, M. K., Ahn, J. Y., Choi, Y.-J., Song, T., Chung, P., et al. (2019) · Scientific Reports · doi:10.1038/s41598-019-43065-1 · Cited by 11 · see citing works
Benefits Beyond Headache Days With OnabotulinumtoxinA Treatment: A Pooled PREEMPT Analysis
Diener, H., Dodick, D. W., Lipton, R. B., Adams, A. M., DeGryse, R. E., & Silberstein, S. D. (2020) · Pain and Therapy · doi:10.1007/s40122-020-00198-w · Cited by 11 · see citing works
The state of art on the use of patient reported outcomes in migraine
Alpuente, A., Torres‐Ferrús, M., Caronna, E., & Pozo‐Rosich, P. (2024) · Current Opinion in Neurology · doi:10.1097/wco.0000000000001267 · Cited by 10 · see citing works
“SF-36 has also been widely used in epidemiological clinical research and have demonstrated acceptable evidence of validity [24].”
Method
Functional Connectivity Features of Resting-State Functional Magnetic Resonance Imaging May Distinguish Migraine From Tension-Type Headache
Wang, Y., Wang, Y., Bu, L., Wang, S., Xie, X., Lin, F., & Xiao, Z. (2022) · Frontiers in Neuroscience · doi:10.3389/fnins.2022.851111 · Cited by 10 · see citing works
Non-pharmacological educational and self-management interventions for people with chronic headache: the CHESS research programme including a RCT
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“It is widely used and recommended for impact assessment in both research and clinical practice (9,11,12).”
BackgroundMethod
Does pain self-efficacy predict, moderate or mediate outcomes in people with chronic headache; an exploratory analysis of the CHESS trial
Hee, S. W., Patel, S., Sandhu, H. K., Matharu, M. S., Underwood, M. R., on behalf of the CHESS Team, Achana, F. A., Carnes, D., Eldridge, S. M., Ellard, D. R., et al. (2024) · The Journal of Headache and Pain · doi:10.1186/s10194-024-01768-5 · Cited by 8 · see citing works
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Method
Evaluation of the concomitant use of oral preventive treatments and onabotulinumtoxinA in chronic migraine: the PREVENBOX study
Alpuente, A., Gallardo, V. J., Torres‐Ferrús, M., Lasaosa, S. S., Guerrero, A. L., Laínez, J. M., Viguera, J., Gago‐Veiga, A. B., Irimia, P., del Río, M. S., et al. (2020) · European Journal of Neurology · doi:10.1111/ene.14331 · Cited by 8 · see citing works
“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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Neck Disability Index in patients with cervicogenic headache
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Identifying Outcome Measures for Migraine Value‐Based Contracting Using the Delphi Method
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False nonresponders to anti‐calcitonin gene‐related peptide monoclonal antibodies: A real‐world analysis beyond migraine frequency reduction
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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.”
Improving to Four or Fewer Monthly Headache Days Per Month Provides a Clinically Meaningful Therapeutic Target for Patients with Chronic Migraine
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 · see citing works
“, reliability and validity that impact data interpretation) [20, 21].”
Background
Readability 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 · see citing works
“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.”
Background
The The Effects of Massage Therapy on a Patient with Migraines and Cervical Spondylosis: a Case Report
Rostron, R. S. (2021) · International Journal of Therapeutic Massage & Bodywork Research Education & Practice · doi:10.3822/ijtmb.v14i3.629 · Cited by 5 · see citing works
Genome–phenome wide association study of broadly defined headache
Hsu, W., Lee, Y.-T., Tan, J., Chang, Y.-H., Qian, F., Liu, K.-Y., Hsiung, J.-C., Yo, C., Tang, S., Jiang, X., et al. (2023) · Brain Communications · doi:10.1093/braincomms/fcad167 · Cited by 4 · see citing works
“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 · see citing works
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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 · see citing works
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Effects of neck-exercise and health promotion on headache outcomes in office workers: secondary analysis of the NEXpro stepped wedge cluster randomised controlled trial
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“…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
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Patient Reported Outcome Measures (PROMs) in Migraine and Headache
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Review on the Burden of Episodic Migraine and Utilization of Patient Reported Outcome Measures
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Effects of Dry Needling of the Obliquus Capitis Inferior in Patients with Cervicogenic Headache and Upper Cervical Dysfunction: An Exploratory Randomized Sham-Controlled Trial
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“Scores range from 36 to 78, with higher scores representing greater disability [55,56].”
Bridging the gap between evidence and clinical practice for migraine headaches: a systematic review (2019–2024)
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 · see citing works
“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 · see citing works
“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…”
Background
Erenumab 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 2 · see citing works
Identifying the relationship between patient-reported outcomes and treatment with opiates in the adult emergency department – A cross-sectional study
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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 · see citing works
Italian version of the Headache Disability Inventory: Cross‐cultural adaptation, validity, and reliability
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 · see citing works
Prioritising patient involvement in patient reported outcome measures– a PROMising way to improve headache care
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 · see citing works
“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].”
Associations between good days per month and migraine-related disease impact in the real-world: a post hoc analysis from the REVIEW study of eptinezumab in chronic migraine
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 · see citing works
“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].”
Patient-Reported Outcomes During the Acute Treatment of Migraine with Zavegepant Nasal Spray: Results from a 52-Week, Open-Label Study
Lipton, R. B., Mosher, L., & Fountaine, R. J. (2025) · Pain and Therapy · doi:10.1007/s40122-025-00800-z · Cited by 1 · see citing works
“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].”
Headache, not neck pain, primarily influences the extent of pain in the neck region in symptomatic office workers. Cross-sectional and longitudinal evaluations
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 · see citing works
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Relevant factors for neurologists to define effectiveness of migraine preventive drugs and take decisions on treatment. My‐LIFE European Delphi survey
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 · see citing works
“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).”
BackgroundInfluential
Übersetzung, kulturelle Adaptation und Test-Retest-Reliabilität der deutschen Version des Headache Disability Questionnaire
Ivanov, D., & Ernst, M. J. (2023) · physioscience · doi:10.1055/a-2001-5129 · Cited by 1 · see citing works
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Diagnostics and Management of Pediatric Headache: An Exploratory Study among Dutch Physical Therapists
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Adaptação transcultural do Headache Disability Inventory (HDI), validade e confiabilidade do HDI e da versão brasileira do teste do impacto da dor de cabeça (HIT-6TM) em pacientes com cefaleias
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The Use of a New Clinical Reasoning Framework to Facilitate The Assessment and Management of Temporomandibular Disorders
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
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Prioritising patient involvement in patient reported outcome measures– a PROMising way to improve headache care
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 · see citing works
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Hazewinkel, M. H. J., Kaur, M. N., Tsangaris, E., Ashina, S., Austen, W. G., Klassen, A. F., Pusic, A. L., & Gfrerer, L. (2023) · Plastic & Reconstructive Surgery Global Open · doi:10.1097/01.gox.0000992268.44704.ac
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
Quality of life measurement instruments for headache and migraine disorders
Maniu, I., Maniu, G., & Neamtu, B. M. (2019) · DOAJ (DOAJ: Directory of Open Access Journals)
MEASUREMENT INSTRUMENTS FOR SCREENING AND ASSESSING DIFFERENT ASPECTS OF HEADACHE AND MIGRAINE
Maniu, I., Maniu, G., & Neamtu, B. M. (2018) · RePEc: Research Papers in Economics

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
ORCID: Haywood, Kirstie L
Potter, Rachel
Patel, Shilpa
Matharu, Manjit
Underwood, Martin
Venue: Cephalalgia
Publisher: SAGE Publications
Published: 2017-09-18
Volume: 38
Issue: 7
Pages: 1374-1386
ISSN: 0333-1024 (ISSN-L)
1468-2982
DOI: 10.1177/0333102417731348
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
Licence: cc-by
journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
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 › Psychiatry and Mental health › Migraine and Headache Studies
Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
Health Sciences › Medicine › Pharmacology › 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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Assessing the impact of headaches and the outcomes of treatment: a systematic review of patient-reported outcome measures (PROMs)

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