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The online version of this article (https://doi.org/10.1007/s11136-018-2053-7) contains supplementary material, which is available to authorized users.
Given the global and economic burden of stroke as a major cause of long-term disability, patient-reported outcomes (PRO) data from clinical trials can elucidate differential benefits/harms of interventions from patients’ perspectives and influence clinical decision making in stroke care management.
This systematic review examines stroke-related randomized controlled trials (RCT) published in 12 high-impact journals between 2002 and 2016 for (1) associations between trial characteristics and the reporting of PRO measures; and (2) psychometric properties of PRO instruments used in these studies. The study combines clinical trials identified in a prior review with trials identified with an updated literature search.
Only 34 of 159 stroke-related RCTs reported PRO measures. Among the 34 trials, most were published in rehabilitation and general medical journals, were conducted in the United States or Europe, were funded by government/non-industry sponsors, and focused on post-stroke care. Thirty-one PRO instruments were employed in these studies. Only 5 instruments were stroke-specific measures, whereas the remaining 26 instruments were generic measures. Eight instruments assessed functional status, 9 measured quality of life, and 14 assessed symptoms. The most common health domains measured were emotional status and physical function.
This study highlights the paucity of information from patients’ perspective in stroke-related RCTs. This trend may change over time as researchers increase adherence to reporting guidelines for clinical trial protocols.
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Supplementary material 1 (DOCX 32 KB)11136_2018_2053_MOESM1_ESM.docx
Benjamin, E. J., Blaha, M. J., Chiuve, S. E., Cushman, M., Das, S. R., Deo, R., et al. American Heart Association Statistics Committee and Stroke Statistics Subcommittee. (2017). Heart disease and stroke statistics-2017 update: a report from the American Heart Association. Circulation, 135(10), e146–e603. CrossRefPubMedPubMedCentral
Food and Drug Administration. (2009). Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. U.S. Department of Health and Human Services. Retrieved 19 March, 2018, from https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm193282.pdf.
Ahmed, S., Berzon, R. A., Revicki, D. A., Lenderking, W. R., Moinpour, C. M., Basch, E., et al. International Society for Quality of Life Research (2012). The use of patient-reported outcomes (PRO) within comparative effectiveness research: Implications for clinical practice and health care policy. Med Care, 50(12), 1060–1070. CrossRefPubMed
Stewart, A. L., & Ware, J. E. (1992). Measuring functioning and well-being: The medical outcomes study approach. Durham: Duke University Press.
Firth, D., & “Bias (1993). Reduction of maximum likelihood estimates. Biometrika, 80, 27–38. CrossRef
Watkins, C., Leathley, M., & Davies, A. (1998). The stroke expectations questionnaire (seq): Identification of patients’ ideas about recovery. Clinical Rehabilitation, 12, 173–175.
Watkins, C., Leathley, M., & Davies, A. (1998). The stroke expectations questionnaire (seq): A predictor of outcome? Clinical Rehabilitation, 12, 173.
Pal, J., Hale, L. A., & Skinner, M. A. (2005). Investigating the reliability and validity of two balance measures in adults with stroke. International Journal of Therapy and Rehabilitation, 12, 308–315. CrossRef
Nouri, F., & Lincoln, N. (1987). An extended activities of daily living scale for stroke patients. Clinical Rehabilitation, 1, 301–305. CrossRef
Dorman, P. J., Waddell, F., Slattery, J., Dennis, M., & Sandercock, P. (1997). Is the euroqol a valid measure of health-related quality of life after stroke? Stroke, 28, 1876. CrossRef
Wilke, C. T., Pickard, A. S., Walton, S. M., Moock, J., Kohlmann, T., & Lee, T. A. (2010). Statistical implications of utility weighted and equally weighted hrql measures: An empirical study. Health Economics, 19, 101–110. PubMed
Goldberg, D. P., & Hillier, V. F. (1979). A scaled version of the general health questionnaire. Psychological Medicine, 9, 139–145. CrossRef
Goldberg, D. P., Gater, R., Sartorius, N., Ustun, T. B., Piccinelli, M., Gureje, O., et al. (1997). The validity of two versions of the GHQ in the who study of mental illness in general health care. Psychological Medicine, 27, 191–197. CrossRef
Gandek, B., Ware, J. E., Aaronson, N. K., Apolone, G., Bjorner, J. B., Brazier, J. E., et al. (1998). Cross-validation of item selection and scoring for the sf-12 health survey in nine countries: Results from the iqola project. International quality of life assessment. Journal of Clinical Epidemiology, 51, 1171–1178. CrossRef
McHorney, C. A., Ware, J. E. Jr., & Raczek, A. E. (1993). The mos 36-item short-form health survey (sf-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Medical Care, 31, 247–263. CrossRef
Beck, A. T., Steer, R. A., & Garbin, M. G. (1988). Psychometric properties of the beck depression inventory: Twenty-five years of evaluation. Clinical Psychology Review, 8, 77–100. CrossRef
Radloff, L. S. (1977). The ces-d scale: A self-report depression scale for research in the general population. Applied Psychological Measurement, 1, 385–401. CrossRef
Worm-Smeitink, M., Gielissen, M., Bloot, L., van Laarhoven, H. W. M., van Engelen, B. G. M., van Riel, P., et al. (2017). The assessment of fatigue: Psychometric qualities and norms for the checklist individual strength. Journal of Psychosomatic Research, 98, 40–46. CrossRef
Nadarajah, M., Mazlan, M., Abdul-Latif, L., & Goh, H. T. (2016) Test-retest reliability, internal consistency and concurrent validity of fatigue severity scale in measuring post-stroke fatigue. European Journal of Physical and Rehabilitation Medicine, 53(5), 703–709. PubMed
Yesavage, J. A., & Sheikh, J. I. (2008). 9/geriatric depression scale (gds). Clinical Gerontologist, 5, 165–173. CrossRef
Bjelland, I., Dahl, A. A., Haug, T. T., & Neckelmann, D. (2002). The validity of the hospital anxiety and depression scale. An updated literature review. Journal of Psychosomatic Research, 52, 69–77. CrossRef
Zigmond, A. S., & Snaith, R. P. (1983). The hospital anxiety and depression scale. Acta Psychiatrica Scandinavica, 67, 361–370. CrossRef
Snaith, R. P., & Taylor, C. M. (1985). Rating scales for depression and anxiety: A current perspective. British Journal of Clinical Pharmacology, 19(Suppl 1), 17 s–20 s. CrossRef
Wikberg, C., Nejati, S., Larsson, M. E., Petersson, E. L., Westman, J., Ariai, N., et al. Comparison between the montgomery-asberg depression rating scale-self and the beck depression inventory ii in primary care. The Primary Care Companion for CNS Disorders. 2015;17.
McNair, D. M., Lorr, M., & Droppleman, L. F. (1971). Manual for the profile of mood states. San Diego: Educational and Industrial Testing Services.
Mercieca-Bebber, R., Rouette, J., Calvert, M., King, M. T., McLeod, L., Holch, P., Palmer, M. J., & Brundage, M. (2017). International Society for Quality of Life Research (ISOQOL) best practice for PROs—reporting taskforce. Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension. Quality of Life Research, 26(6), 1427–1437. CrossRefPubMed
Kane, R. L., & Radosevich, D. M. (LLC 2011). Conducting health outcomes research. Sudbury: Johns & Bartlett Learning.
Reeve, B. B., Wyrwich, K. W., Wu, A. W., Velikova, G., Terwee, C. B., Snyder, C. F., et al. (2013). ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Quality of Life Research, 22(8), 1889–1905. CrossRefPubMed
- Patient-reported outcomes in stroke clinical trials 2002–2016: a systematic review
Eboni G. Price-Haywood
Lydia A. Bazzano
Mieke L. van Driel
- Springer International Publishing