Minimal important differences for fatigue patient reported outcome measures—a systematic review
Tóm tắt
Fatigue is the most frequent symptom reported by patients with chronic illnesses. As a subjective experience, fatigue is commonly assessed with patient-reported outcome measures (PROMs). Currently, there are more than 40 generic and disease-specific PROMs for assessing fatigue in use today. The interpretation of changes in PROM scores may be enhanced by estimates of the so-called minimal important difference (MID). MIDs are not fixed attributes of PROMs but rather vary in relation to estimation method, clinical and demographic characteristics of the study group, etc. The purpose of this paper is to compile published MIDs for fatigue PROMs, spanning diagnostic/patient groups and estimation methods, and to provide information relevant for appraising their appropriateness for use in specific clinical trials and in monitoring fatigue in defined patient groups in routine clinical practice. A systematic search of three databases (Scopus, CINAHL and Cochrane) for studies published between January 2000 to April 2015 using fatigue and variations of the term MID, e.g. MCID, MIC, etc. Two authors screened search hits and extracted data independently. Data regarding MIDs, anchors used and study designs were compiled in tables. Included studies (n = 41) reported 60 studies or substudies estimating MID for 28 fatigue scales, subscales or single item measures in a variety of diagnostic groups and study designs. All studies used anchor-based methods, 21/60 measures also included distribution-based methods and 17/60 used triangulation of methods. Both similarities and dissimilarities were seen within the MIDs. Magnitudes of published MIDs for fatigue PROMs vary considerably. Information about the derivation of fatigue MIDs is needed to evaluate their applicability and suitability for use in clinical practice and research.
Tài liệu tham khảo
Ream E, Richardson A. Fatigue: a concept analysis. Int J Nurs Stud. 1996;33(5):519–29.
Fisk JD, Pontefract A, Ritvo PG, Archibald CJ, Murray TJ. The impact of fatigue on patients with multiple sclerosis. Canadian J Neurological Sciences. 1994;21(1):9–14.
Pepper CM, Krupp LB, Friedberg F, Doscher C, Coyle PK. A comparison of neuropsychiatric characteristics in chronic fatigue syndrome, multiple sclerosis, and major depression. J Neuropsychiatry Clin Neurosci. 1993;5(2):200–5.
Winningham ML, Nail LM, Burke MB, Brophy L, Cimprich B, Jones LS, Pickard-Holley S, Rhodes V, St Pierre B, Beck S, et al. Fatigue and the cancer experience: the state of the knowledge. Oncol Nurs Forum. 1994;21(1):23–36.
Glaus A. Fatigue--an orphan topic in patients with cancer? Eur J Cancer. 1998;34(11):1649–51.
Vercoulen JH, Swanink CM, Fennis JF, Galama JM, van der Meer JW, Bleijenberg G. Dimensional assessment of chronic fatigue syndrome. J Psychosom Res. 1994;38(5):383–92.
McKenna SP. Measuring patient-reported outcomes: moving beyond misplaced common sense to hard science. BMC Med. 2011;9:86.
Whitehead L. The measurement of fatigue in chronic illness: a systematic review of unidimensional and multidimensional fatigue measures. J Pain Symptom Manage. 2009;37(1):107–28.
Copay AG, Subach BR, Glassman SD, Polly Jr DW, Schuler TC. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J. 2007;7(5):541–6.
Kane RC. The clinical significance of statistical significance. Oncologist. 2008;13(11):1129–33.
Boyce MB, Browne JP, Greenhalgh J. The experiences of professionals with using information from patient-reported outcome measures to improve the quality of healthcare: a systematic review of qualitative research. BMJ Quality Safety. 2014;23(6):508–18.
Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10(4):407–15.
Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol. 2003;56(5):395–407.
Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008;61(2):102–9.
Hays RD, Farivar SS, Liu H. Approaches and recommendations for estimating minimally important differences for health-related quality of life measures. Copd. 2005;2(1):63–7.
Turner D, Schunemann HJ, Griffith LE, Beaton DE, Griffiths AM, Critch JN, Guyatt GH. The minimal detectable change cannot reliably replace the minimal important difference. J Clin Epidemiol. 2010;63(1):28–36.
Wyrwich KW, Metz SM, Kroenke K, Tierney WM, Babu AN, Wolinsky FD. Triangulating patient and clinician perspectives on clinically important differences in health-related quality of life among patients with heart disease. Health Serv Res. 2007;42(6 Pt 1):2257–74. discussion 2294–2323.
Terwee CB, Roorda LD, Dekker J, Bierma-Zeinstra SM, Peat G, Jordan KP, Croft P, de Vet HC. Mind the MIC: large variation among populations and methods. J Clin Epidemiol. 2010;63(5):524–34.
Wright A, Hannon J, Hegedus EJ, Kavchak AE. Clinimetrics corner: a closer look at the minimal clinically important difference (MCID). J Manual Manipulative Therapy. 2012;20(3):160–6.
Cella D, Hahn EA, Dineen K. Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening. Qual Life Res. 2002;11(3):207–21.
King MT. A point of minimal important difference (MID): a critique of terminology and methods. Expert Rev Pharmacoecon Outcomes Res. 2011;11(2):171–84.
Baro E, Carulla J, Cassinello J, Colomer R, Mata JG, Gascon P, Gasquet JA, Rodriguez CA, Valentin V. Psychometric properties of the Perform Questionnaire: a brief scale for assessing patient perceptions of fatigue in cancer. Support Care Cancer. 2011;19(5):657–66.
Bedard G, Zeng L, Zhang L, Lauzon N, Holden L, Tsao M, Danjoux C, Barnes E, Sahgal A, Poon M. Minimal clinically important differences in the edmonton symptom assessment system in patients with advanced cancer. J Pain Symptom Manage. 2013;46(2):192–200.
Bedard G, Zeng L, Zhang L, Lauzon N, Holden L, Tsao M, Danjoux C, Barnes E, Sahgal A, Poon M, et al. Minimal important differences in the EORTC QLQ-C15-PAL to determine meaningful change in palliative advanced cancer patients. Asia Pac J Clin Oncol. 2013.
Bedard G, Zeng L, Zhang L, Lauzon N, Holden L, Tsao M, Danjoux C, Barnes E, Sahgal A, Poon M, et al. Minimal important differences in the EORTC QLQ-C30 in patients with advanced cancer. Asia Pac J Clin Oncol. 2014;10(2):109–17.
Bjorner JB, Wallenstein GV, Martin MC, Lin P, Blaisdell-Gross B, Tak Piech C, Mody SH. Interpreting score differences in the SF-36 Vitality scale: using clinical conditions and functional outcomes to define the minimally important difference. Curr Med Res Opin. 2007;23(4):731–9.
Borghs S, de la Loge C, Cramer JA. Defining minimally important change in QOLIE-31 scores: Estimates from three placebo-controlled lacosamide trials in patients with partial-onset seizures. Epilepsy Behavior. 2012;23(3):230–4.
Cella D, Eton DT, Lai JS, Peterman AH, Merkel DE. Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales. J Pain Symptom Manage. 2002;24(6):547–61.
Cella D, Yount S, Sorensen M, Chartash E, Sengupta N, Grober J. Validation of the Functional Assessment of Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients with rheumatoid arthritis. J Rheumatol. 2005;32(5):811–9.
Colangelo KJ, Pope JE, Peschken C. The minimally important difference for patient reported outcomes in systemic lupus erythematosus including the HAQ-DI, pain, fatigue, and SF-36. J Rheumatol. 2009;36(10):2231–7.
de Kleijn WP, De Vries J, Wijnen PA, Drent M. Minimal (clinically) important differences for the Fatigue Assessment Scale in sarcoidosis. Respir Med. 2011;105(9):1388–95.
George A, Pope JE. The minimally important difference (MID) for patient-reported outcomes including pain, fatigue, sleep and the health assessment questionnaire disability index (HAQ-DI) in primary Sjogren’s syndrome. Clin Exp Rheumatol. 2011;29(2):248–53.
Goligher EC, Pouchot J, Brant R, Kherani RB, Avina-Zubieta JA, Lacaille D, Lehman AJ, Ensworth S, Kopec J, Esdaile JM, et al. Minimal clinically important difference for 7 measures of fatigue in patients with systemic lupus erythematosus. J Rheumatol. 2008;35(4):635–42.
Khanna D, Pope JE, Khanna PP, Maloney M, Samedi N, Norrie D, Ouimet G, Hays RD. The minimally important difference for the fatigue visual analog scale in patients with rheumatoid arthritis followed in an academic clinical practice. J Rheumatol. 2008;35(12):2339–43.
Kosinski M, Zhao SZ, Dedhiya S, Osterhaus JT, Ware Jr JE. Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis. Arthritis Rheum. 2000;43(7):1478–87.
Kvam AK, Wisløff F, Fayers PM. Minimal important differences and response shift in health-related quality of life; a longitudinal study in patients with multiple myeloma. In: Health and Quality of Life Outcomes, vol. 8. 2010. p. 79.
Kwok T, Pope JE. Minimally important difference for patient-reported outcomes in psoriatic arthritis: Health Assessment Questionnaire and pain, fatigue, and global visual analog scales. J Rheumatol. 2010;37(5):1024–8.
Lai JS, Beaumont JL, Ogale S, Brunetta P, Cella D. Validation of the functional assessment of chronic illness therapy-fatigue scale in patients with moderately to severely active systemic lupus erythematosus, participating in a clinical trial. J Rheumatol. 2011;38(4):672–9.
Lasch K, Joish VN, Zhu Y, Rosa K, Qiu C, Crawford B. Validation of the sleep impact scale in patients with major depressive disorder and insomnia. In: Current medical research and opinion, vol. 25. 2009. p. 1699–710.
Maringwa J, Quinten C, King M, Ringash J, Osoba D, Coens C, Martinelli F, Reeve BB, Gotay C, Greimel E, et al. Minimal clinically meaningful differences for the EORTC QLQ-C30 and EORTC QLQ-BN20 scales in brain cancer patients. Ann Oncol. 2011;22(9):2107–12.
Maringwa JT, Quinten C, King M, Ringash J, Osoba D, Coens C, Martinelli F, Vercauteren J, Cleeland CS, Flechtner H, et al. Minimal important differences for interpreting health-related quality of life scores from the EORTC QLQ-C30 in lung cancer patients participating in randomized controlled trials. Support Care Cancer. 2011;19(11):1753–60.
Mathias SD, Gao SK, Rutstein M, Snyder CF, Wu AW, Cella D. Evaluating clinically meaningful change on the ITP-PAQ: preliminary estimates of minimal important differences. In: Current medical research and opinion, vol. 25. 2009. p. 375–83.
Matza LS, Wyrwich KW, Phillips GA, Murray LT, Malley KG, Revicki DA. The Fatigue Associated with Depression Questionnaire (FAsD): Responsiveness and responder definition. Qual Life Res. 2013;22(2):351–60.
Mills RJ, Calabresi M, Tennant A, Young CA. Perceived changes and minimum clinically important difference of the Neurological Fatigue Index for multiple sclerosis (NFI-MS). Mult Scler. 2013;19(4):502–5.
Patrick DL, Gagnon DD, Zagari MJ, Mathijs R, Sweetenham J. Assessing the clinical significance of health-related quality of life (HrQOL) improvements in anaemic cancer patients receiving epoetin alfa. Eur J Cancer. 2003;39(3):335–45.
Pouchot J, Kherani RB, Brant R, Lacaille D, Lehman AJ, Ensworth S, Kopec J, Esdaile JM, Liang MH. Determination of the minimal clinically important difference for seven fatigue measures in rheumatoid arthritis. J Clin Epidemiol. 2008;61(7):705–13.
Purcell A, Fleming J, Bennett S, Burmeister B, Haines T. Determining the minimal clinically important difference criteria for the Multidimensional Fatigue Inventory in a radiotherapy population. Support Care Cancer. 2010;18(3):307–15.
Reddy S, Bruera E, Pace E, Zhang K, Reyes-Gibby CC. Clinically important improvement in the intensity of fatigue in patients with advanced cancer. J Palliat Med. 2007;10(5):1068–75.
Rendas-Baum R, Yang M, Cattelin F, Wallenstein GV, Fisk JD. A novel approach to estimate the minimally important difference for the Fatigue Impact Scale in multiple sclerosis patients. Qual Life Res. 2010;19(9):1349–58.
Robinson Jr D, Zhao N, Gathany T, Kim LL, Cella D, Revicki D. Health perceptions and clinical characteristics of relapsing-remitting multiple sclerosis patients: baseline data from an international clinical trial. Curr Med Res Opin. 2009;25(5):1121–30.
Schwartz AL, Meek PM, Nail LM, Fargo J, Lundquist M, Donofrio M, Grainger M, Throckmorton T, Mateo M. Measurement of fatigue. determining minimally important clinical differences. J Clin Epidemiol. 2002;55(3):239–44.
Schünemann HJ, Puhan M, Goldstein R, Jaeschke R, Guyatt GH. Measurement properties and interpretability of the Chronic Respiratory disease Questionnaire (CRQ). COPD: J Chron Obstruct Pulmon Dis. 2005;2(1):81–9.
Sekhon S, Pope J, Baron M. The minimally important difference in clinical practice for patient-centered outcomes including health assessment questionnaire, fatigue, pain, sleep, global visual analog scale, and SF-36 in scleroderma. J Rheumatol. 2010;37(3):591–8.
Spiegel BM, Younossi ZM, Hays RD, Revicki D, Robbins S, Kanwal F. Impact of hepatitis C on health related quality of life: a systematic review and quantitative assessment. Hepatology. 2005;41(4):790–800.
Twiss J, Doward LC, McKenna SP, Eckert B. Interpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS). Health Qual Life Outcomes. 2010;8:117.
Ward MM, Guthrie LC, Alba M. Domain-specific transition questions demonstrated higher validity than global transition questions as anchors for clinically important improvement. J Clin Epidemiol. 2015.
Wells G, Li T, Maxwell L, MacLean R, Tugwell P. Determining the minimal clinically important differences in activity, fatigue, and sleep quality in patients with rheumatoid arthritis. J Rheumatol. 2007;34(2):280–9.
Wheaton L, Pope J. The minimally important difference for patient-reported outcomes in spondyloarthropathies including pain, fatigue, sleep, and Health Assessment Questionnaire. J Rheumatol. 2010;37(4):816–22.
Wyrwich KW, Fihn SD, Tierney WM, Kroenke K, Babu AN, Wolinsky FD. Clinically important changes in health-related quality of life for patients with chronic obstructive pulmonary disease: an expert consensus panel report. J Gen Intern Med. 2003;18(3):196–202.
Wyrwich KW, Spertus JA, Kroenke K, Tierney WM, Babu AN, Wolinsky FD. Clinically important differences in health status for patients with heart disease: an expert consensus panel report. Am Heart J. 2004;147(4):615–22.
Yost KJ, Eton DT, Garcia SF, Cella D. Minimally important differences were estimated for six Patient-Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients. J Clin Epidemiol. 2011;64(5):507–16.
Zeng L, Chow E, Zhang L, Tseng LM, Hou MF, Fairchild A, Vassiliou V, Jesus-Garcia R, El-Din MAA, Kumar A, et al. An international prospective study establishing minimal clinically important differences in the EORTC QLQ-BM22 and QLQ-C30 in cancer patients with bone metastases. Support Care Cancer. 2012;20(12):3307–13.
Revicki DA, Erickson PA, Sloan JA, Dueck A, Guess H, Santanello NC. Interpreting and reporting results based on patient-reported outcomes. Value Health. 2007;10 Suppl 2:S116–124.
Crosby RD, Kolotkin RL, Williams GR. An integrated method to determine meaningful changes in health-related quality of life. J Clin Epidemiol. 2004;57(11):1153–60.
Beaton DE, Boers M, Wells GA. Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research. Curr Opin Rheumatol. 2002;14(2):109–14.
Niebauer K, Dewilde S, Fox-Rushby J, Revicki DA. Impact of omalizumab on quality-of-life outcomes in patients with moderate-to-severe allergic asthma. Annals Allergy Asthma Immunology. 2006;96(2):316–26.