Swipe om te navigeren naar een ander artikel
The online version of this article (doi:10.1007/s11136-011-9921-8) contains supplementary material, which is available to authorized users.
To review the quality and acceptability of condition-specific, domain-specific and generic multi-item patient-reported outcome measures (PROMs) used in the assessment of adults with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME).
Systematic literature searches were made to identify PROMs. Quality and acceptability was assessed against an appraisal framework, which captured evidence of both the thoroughness and results of evaluations: evidence of measurement (reliability, validity, responsiveness, interpretability, data quality/precision) and practical properties (feasibility, patient acceptability), and the extent of active patient involvement was sought.
A total of 11 CFS/ME-specific, 55 domain-specific and 11 generic measures were reviewed. With the exception of the generic SF-36, all measures had mostly limited evidence of measurement and/or practical properties. Patient involvement was poorly reported and often cursory.
The quality and acceptability of reviewed PROMs is limited, and recommendations for patient-reported assessment are difficult. Significant methodological and quality issues in PROM development/evaluation were identified by the appraisal framework, which must be addressed in future research. Clear discrepancies exist between what is measured in research and how patients define their experience of CFS/ME. Future PROM development/evaluation must seek to involve patients more collaboratively to measure outcomes of importance using relevant and credible methods of assessment.
Log in om toegang te krijgen
Met onderstaand(e) abonnement(en) heeft u direct toegang:
Supplementary material 1 (PDF 190 kb)11136_2011_9921_MOESM1_ESM.pdf
Department of Health. (2002). Report of the CFS/ME working group. Para.1.4.2, p6. Accessed 2 March 2009 http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4064840.
Bibby, J., & Kershaw, A. (2006). How much is M.E. costing the country? Report prepared by the survey & Statistical Research Centre. Sheffield, England: Sheffield Hallam University.
Liberating the NHS: legislative framework and next steps. (2010). UK Department of Health. Accessed 4 April 2011. http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_122707.pdf.
Staley, K. (2009). Exploring impact: Public involvement in NHS, public health and social care research. Eastleigh: INVOLVE. Accessed 4 April 2011. http://www.invo.org.uk/pdfs/Involve_Exploring_Impactfinal28.10.09.pdf.
Staniszewska, S., Crowe, S., Badenoch, D., Edwards, C., Savage, J., & Norman, W. (2010). The PRIME project: Developing a patient evidence-base. Health Expectations, 3, 312–322.
Guyatt, G. H., Ferrans, C. E., Halyard, M. Y., et al. (2007). Clinical significance consensus meeting group. Exploration of the value of health-related quality-of-life information from clinical research and into clinical practice. Mayo Clinic Proceedings, 10, 1229–1239. CrossRef
Fitzpatrick, R., Davey, C., Buxton, M. J., & Jones, D. R. (1998). Evaluating patient-based outcome measures for use in clinical trials. Health Technology Assessment, 2(14).
Haywood, K. L., Garratt, A. M., & Fitzpatrick, R. (2005). Quality of life in older people: A structured review of generic self-assessed health instruments. Quality of Life Research, 7, 1651–1668. CrossRef
Nunnally, J. C., & Bernstein, I. H. (1994). Psychometric theory. Third edition. McGraw-Hill Series in Psychology. New York: McGraw-Hill Inc.
Scientific Advisory Committee of the Medical Outcomes Trust. (2002). Assessing health status and quality of life instruments: Attributes and review criteria. Quality of Life Research, 11, 193–205. CrossRef
Streiner, D. L., & Norman, G. R. (2008). Health Measurement Scales. A practical guide to their development and use (4th ed.). Oxford: Oxford Medical Publications Inc.
McDowell, I. (2006). Measuring health: A guide to rating scales and questionnaires (3rd ed.). New York: Oxford University Press.
US Department of Health and Human Services Food and Drug Administration. (2009). Guidance for industry. Patient- reported outcome measures: Use in medical product development to support labelling claims. Accessed 4 April 2011. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf.
Garratt, A. M., Brealey, S., Gillespie, W. J., & DAMASK Trial Team. (2004). Patient-assessed health instruments for the knee: A structured review. Rheumatology (Oxford), 43(11), 1414–1423. CrossRef
Smith, S., Cano, S., Lamping, D., et al. (2005). Patient- reported outcome measures (PROMs) for routine use in treatment centres: recommendations based on a review of the scientific evidence. Final report to the Department of Health. Accessed 4 April 2011. http://www.wmqi.westmidlands.nhs.uk/downloads/file/PROMS%20Final%20report%20Dec%2005.pdf.
Buckland, S., Hayes, H., Ostrer, C., et al. (2007). Public information pack (PIP) how to get actively involved in NHS, public health and social care research. So what is it all about? Eastleigh: INVOLVE. Accessed 4 April 2011. http://www.invo.org.uk/pdfs/PIP1whatisitallabout.pdf.
Fukuda, K., Straus, S. E., Hickie, I., Sharpe, M. C., Dobbins, J. G., & Komaroff, A. (1994). The chronic fatigue syndrome: A comprehensive approach to its definition and study. International Chronic Fatigue Syndrome Study Group. Annals of Internal Medicine, 121(12), 953–959. PubMed
Wagner, D., Nisenbaum, R., Heim, C., Jones, J. F., Unger, E. R., & Reeves, W. C. (2005). Psychometric properties of the CDC Symptom Inventory for assessment of Chronic Fatigue Syndrome. Population Health Metrics, 3, 8. doi: 10.1186/1478-7954-3-8.
Nijs, J., Vaes, P., Hoof, E. V., & Becker, P. D. (2002). Activity limitations and participation restrictions in patients with Chronic Fatigue Syndrome—construction of a disease specific questionnaire. Journal of Chronic Fatigue Syndrome, 10(3–4), 3–23. CrossRef
Lloyd, A. R., Hickie, I., Boughton, C. R., Spencer, O., & Wakefield, D. (1990). Prevalence of chronic fatigue syndrome in an Australian population. Medical Journal of Australia, 153(9), 522–528. PubMed
Jason, L. A., Ropacki, M. T., Santoro, N. B., Richman, J. A., Heatherly, W., et al. (1997). A screening instrument for chronic fatigue syndrome: Reliability and validity. Journal of Chronic Fatigue Syndrome, 3(1), 39–59. CrossRef
Dougall, A. L., Baum, A., & Jenkins, F. J. (1998). Daily fluctuation in Chronic Fatigue Syndrome severity and symptoms. Journal of Applied Biobehavioral Research, 3(1), 12–28. CrossRef
Heijmans, M. J. (1998). Coping and adaptive outcome in chronic fatigue syndrome: importance of illness cognitions. Journal of Psychosomatic Research, 45(1 Spec No).
Knussen, C., & Lee, D. (1998). Chronic fatigue syndrome: Symptoms, appraisal and ways of coping. British Journal of Health Psychology, 3, 111–121. CrossRef
Wagner, D., Nisenbaum, R., et al. (2005) Psychometric properties of the CDC Symptom Inventory for assessment of Chronic Fatigue Syndrome. Population Health Metrics.
Nijs, J., & Thielemans, A. (2008). Kinesiophobia and symptomology in chronic fatigue syndrome: A psychometric study of two questionnaires. Psychology and Psychotherapy: Theory, Research and Practice., 81, 273–283. CrossRef
Cox, D. (2002). Chronic fatigue syndrome: An evaluation of an occupational therapy inpatient intervention. British Journal of Occupational Therapy, 65(10), 461–468.
Spielberger, C., Jacobs, G., Russell, S., & Crane, R. (1983). The Assessment of anger: The State-Trait Anger Scale. In J. N. Butcherem & C. Spielberger (Eds.), Advances in personality assessment (pp. 159–187). Hillsdale, NJ: Lawrence Erlbaum Associates.
Spielberger, C. D., Gorsuch, R. L., & Lushene, R. E. (1970). Test manual for the state-trait anxiety inventory. Palo Alto, CA: Consulting Pyschologists Press.
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
Goldberg, D. P. (1972). The detection of psychiatric illness by questionnaire. London: Oxford University Press (Maudsley Monograph no.21).
Zigmond, A. S., & Snaith, R. P. (1983). The hospital anxiety and depression scale. Acta Psychiatrica Scandinavia, 67, 361–370. CrossRef
Derogatis, L. R., Rickels, K., & Rock, A. (1977). SCL- 90- R: Administration, scoring and procedures manual, I. Baltimore, MD: Clinical Psychometric Research.
Carver, C. S. (1997). If you want to measure coping but your protocol’s too long: Consider the Brief-COPE. International Journal of Behavioural Medicine, 4, 92–100. CrossRef
Folkman, S., & Lazarus, R. S. (1988). Manual of the ways of coping questionnaire. Palo Alta, CA: Consulting Psychologists Press.
Schreurs, P. J. G., van der Willige, G., Tellegen, B., & Brosschot, J. F. (1993). The Utrecht coping list-manual. Lisse: Swets & Zeitlinger.
Weinman, X. (1996). The illness perception questionnaire: A new method for assessing the cognitive representation of illness. Psychology and Health, 11, 431–446. CrossRef
Moss-Morris, R., Weinman, J., Petrie, K. J., Horne, R., Cameron, L. D., & Buick, D. (2002). The revised illness perception questionnaire (IPQ-R). Psychology & Health, 17, 1–6. CrossRef
McNair, D. M., Lorr, M., & Dropplemann, L. F. (1992). EdITS manual for the profile of mood states (POMS). San Diego, CA: EdITS/Educational and Industrial Testing Services.
Rosenberg, M. (1989). Society and the adolescent self-image. Revised Edition. Middletown, CT: Wesleyan University Press.
Derogatis, L. R. (1987). The derogatis stress profile (DSP): Quantification of psychological distress. Advances in Psychosomatic Medicine, 17, 30–54. PubMed
Fix, A. J., & Daughton, D. (1988). Human activity profile professional manual. Odessa, FL: Psychological Assessment Resources, Inc.
Fries, J. F., Cella, D., Rose, M., Krishnan, E., & Bruce, B. (2009). Progress in assessing physical function in arthritis: PROMIS short forms and computerized adaptive testing. The Journal of Rheumatology, 36(9):2061–2066. Accessed 4 April 2011 http://aramis.stanford.edu/downloads/PROMIS%20HAQ%20-%202007.pdf.
Ray, C., Weir, W., Philips, S., & Cullen, S. (1992). Development of a measure of symptoms in chronic fatigue syndrome: The Profile of Fatigue-Related Symptoms/PFRS. Psychology and Health, 7, 27–43. CrossRef
Cleeland, C. S., & Ryan, K. M. (1994). Pain assessment: global use of the brief pain inventory. Annals Academy of Medicine, 23(2), 129–138.
Johns, M. W. (1992). Reliability and factor analysis of the Epworth Sleepiness Scale. Sleep, 15(4), 376–381. PubMed
Meijman, T., & de Vries-Griever, A. (1985). The construction and evaluation of a one-dimensional scale measuring subjective sleep quality. Heijmans bulletins psychologische instituten. Groningen: University of Groningen.
Cesta, A., Moldofsky, H., & Sammut, C. (1996). The University of Toronto Sleep Assessment Questionnaire. Sleep Research, 25, 486.
Douglass, Ab., Bornstein, R., Nino-Murcia, G., Keenan, S., Miles, L., et al. (1994). The Sleep Disorders Questionnaire I: Creation and multivariate structure of SDQ. Sleep, 17, 160–167. PubMed
Lee, K. A. (1991). Fatigue in employed childbearing women. In Proceedings of the international nursing research conference (p. 432). Los Angeles, CA: American Nurses Association.
Ellis, B. W., Johns, M. W., Lancaster, R., Raptopoulos, P., Angelopoulos, N., & Priest, R. G. (1981). The St Mary’s Hospital Sleep Questionnaire: A study of reliability. Sleep, 4(1), 93–97. PubMed
Whiteneck, G. G., Charlifue, S. W., Gerhart, K. A., Overholser, J. D., & Richardson, G. N. (1992). Quantifying handicap: A new measure of long-term rehabilitation outcomes. Archives of Physical Medicine and Rehabilitation, 73, 519–526. PubMed
Cohen, S., & Hoberman, H. M. (1983). Positive events and social supports as buffers of life changes stress. Journal of Applied Social Psychology, 13, 99–125. CrossRef
Stulemeijer, M., de Jong, L., et al. (2005). Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: Randomised controlled trial. BMJ, 330(7481), 15. CrossRef
Ware, J. E. (1997). SF- 36 health survey. Manual and interpretation guide, 2nd edn. The Health Institute, New England Medical Centre, Boston, MA, Nimrod Press.
The EuroQol Group. (1990). EuroQol: A new facility for the measurement of health-related quality of life. Health Policy, 16, 199–208. CrossRef
Ferrans, C. E., & Powers, M. J. (1985). Quality of life index: Development and psychometric properties. Advances in Nursing Science, 8, 15–24. PubMed
Ware, J. E., Kosinski, M., & Dewey, J. E. (2000). How to score version two of the SF-36 Health Survey (standard and acute forms). Lincoln, RI: Quality Metric Inc.
WHOQoL Group. (1994). The development of the World Health Organisation quality of life assessment instrument (the WHOQoL). In J. Orley & W. Kuyken (Eds.), Quality of life assessment: International perspectives (pp. 41–47). Berlin: Springer. CrossRef
WHOQoL Group. (1996). World Health Organisation Quality of Life—Brief Form (WHOQoL-BREF). Geneva: World Health Organisation.
Lowry, T. J., & Pakenham, K. I. (2008). Health-related quality of life in chronic fatigue syndrome: Predictors of physical functioning and psychological distress. Psychology, Health and Medicine, 13(2), 222–238. CrossRef
Nicklin, J., Cramp, F., Kirwan, J., Urban, M., & Hewlett, S. (2010). Collaboration with patients in the design of patient-reported outcome measures: Capturing the experience of fatigue in rheumatoid arthritis. Arthritis Care Research (Hoboken), 62(11), 1552–1558. CrossRef
Staniszewska, S., Haywood, K. L., Brett, J., & Tutton, E. (2011). Patient and public involvement in PROMS: Evolution not revolution. The Patient (in press).
NICE Guideline (Consultation). Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and management of chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy) in adults and children. Draft for Consultation. September 2006. National Collaborating Centre for Primary Care. Accessed 4 April 2011. http://www.nice.org.uk/guidance/index.jsp?action=download&r=true&o=34187.
Haywood, K., Marshall, S. S., & Fitzpatrick, R. (2006). Patient participation in the consultation process: A structured review of intervention strategies. Patient Education and Counselling, 63(1–2), 12–23. CrossRef
- Quality and acceptability of patient-reported outcome measures used in chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME): a systematic review
Kirstie L. Haywood
- Springer Netherlands