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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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          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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          Most cited references62

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          A six-item short-form survey for measuring headache impact: the HIT-6.

          Migraine and other severe headaches can cause suffering and reduce functioning and productivity. Patients are the best source of information about such impact. To develop a new short form (HIT-6) for assessing the impact of headaches that has broad content coverage but is brief as well as reliable and valid enough to use in screening and monitoring patients in clinical research and practice. HIT-6 items were selected from an existing item pool of 54 items and from 35 items suggested by clinicians. Items were selected and modified based on content validity, item response theory (IRT) information functions, item internal consistency, distributions of scores, clinical validity, and linguistic analyses. The HIT-6 was evaluated in an Internet-based survey of headache sufferers (n = 1103) who were members of America Online (AOL). After 14 days, 540 participated in a follow-up survey. HIT-6 covers six content categories represented in widely used surveys of headache impact. Internal consistency, alternate forms, and test-retest reliability estimates of HIT-6 were 0.89, 0.90, and 0.80, respectively. Individual patient score confidence intervals (95%) of app. +/-5 were observed for 88% of all respondents. In tests of validity in discriminating across diagnostic and headache severity groups, relative validity (RV) coefficients of 0.82 and 1.00 were observed for HIT-6, in comparison with the Total Score. Patient-level classifications based in HIT-6 were accurate 88.7% of the time at the recommended cut-off score for a probability of migraine diagnosis. HIT-6 was responsive to self-reported changes in headache impact. The IRT model estimated for a 'pool' of items from widely used measures of headache impact was useful in constructing an efficient, reliable, and valid 'static' short form (HIT-6) for use in screening and monitoring patient outcomes.
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            Multiattribute and single-attribute utility functions for the health utilities index mark 3 system.

            The Health Utilities Index Mark 3 (HUI3) is a generic multiattribute preference-based measure of health status and health-related quality of life that is widely used as an outcome measure in clinical studies, in population health surveys, in the estimation of quality-adjusted life years, and in economic evaluations. HUI3 consists of eight attributes (or dimensions) of health status: vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain with 5 or 6 levels per attribute, varying from highly impaired to normal. The objectives are to present a multiattribute utility function and eight single-attribute utility functions for the HUI3 system based on community preferences. Two preference surveys were conducted. One, the modeling survey, collected preference scores for the estimation of the utility functions. The other, the direct survey, provided independent scores to assess the predictive validity of the utility functions. Preference measures included value scores obtained on the Feeling Thermometer and standard gamble utility scores obtained using the Chance Board. A random sample of the general population (> or =16 years of age) in Hamilton, Ontario, Canada. Estimates were obtained for eight single-attribute utility functions and an overall multiattribute utility function. The intraclass correlation coefficient between directly measured utility scores and scores generated by the multiattribute function for 73 health states was 0.88. The HUI3 scoring function has strong theoretical and empirical foundations. It performs well in predicting directly measured scores. The HUI3 system provides a practical way to obtain utility scores based on community preferences.
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              Prevalence and burden of migraine in the United States: data from the American Migraine Study II.

              To describe the prevalence, sociodemographic profile, and the burden of migraine in the United States in 1999 and to compare results with the original American Migraine Study, a 1989 population-based study employing identical methods. A validated, self-administered questionnaire was mailed to a sample of 20 000 households in the United States. Each household member with severe headache was asked to respond to questions about symptoms, frequency, and severity of headaches and about headache-related disability. Diagnostic criteria for migraine were based on those of the International Headache Society. This report is restricted to individuals 12 years and older. Of the 43 527 age-eligible individuals, 29 727 responded to the questionnaire for a 68.3% response rate. The prevalence of migraine was 18.2% among females and 6.5% among males. Approximately 23% of households contained at least one member suffering from migraine. Migraine prevalence was higher in whites than in blacks and was inversely related to household income. Prevalence increased from aged 12 years to about aged 40 years and declined thereafter in both sexes. Fifty-three percent of respondents reported that their severe headaches caused substantial impairment in activities or required bed rest. Approximately 31% missed at least 1 day of work or school in the previous 3 months because of migraine; 51% reported that work or school productivity was reduced by at least 50%. Two methodologically identical national surveys in the United States conducted 10 years apart show that the prevalence and distribution of migraine have remained stable over the last decade. Migraine-associated disability remains substantial and pervasive. The number of migraineurs has increased from 23.6 million in 1989 to 27.9 million in 1999 commensurate with the growth of the population. Migraine is an important target for public health interventions because it is highly prevalent and disabling.
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                Author and article information

                Journal
                Cephalalgia
                Cephalalgia
                CEP
                spcep
                Cephalalgia
                SAGE Publications (Sage UK: London, England )
                0333-1024
                1468-2982
                18 September 2017
                June 2018
                : 38
                : 7
                : 1374-1386
                Affiliations
                [1 ]Warwick Research in Nursing, Department of Health Sciences, Warwick Medical School, The University of Warwick, Gibbet Hill, Coventry, UK
                [2 ]On behalf of the CHESS team; Warwick Clinical Trials Unit, Warwick Medical School, The University of Warwick, Gibbet Hill, Coventry, UK
                [3 ]Warwick Clinical Trials Unit, Warwick Medical School, The University of Warwick, Gibbet Hill, Coventry, UK
                [4 ]Headache Group, UCL Institute of Neurology, Queen Square, London, UK
                Author notes
                [*]Kirstie L Haywood, Warwick Research in Nursing, Department of Health Sciences, Warwick Medical School, The University of Warwick, Gibbet Hill, Coventry CV4 7AL, UK. Email: k.l.haywood@ 123456warwick.ac.uk
                Author information
                http://orcid.org/0000-0002-5405-187X
                Article
                10.1177_0333102417731348
                10.1177/0333102417731348
                6024352
                28920448
                55abb8d4-cf23-4853-b25d-98d41a6d4c4d
                © International Headache Society 2017

                This article is distributed under the terms of the Creative Commons Attribution 4.0 License ( http://www.creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 13 January 2017
                : 25 May 2017
                : 12 June 2017
                Categories
                Reviews

                Neurology
                headache,patient-reported outcome,validity,reliability,systematic review
                Neurology
                headache, patient-reported outcome, validity, reliability, systematic review

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