Measuring health-related quality of life in chronic obstructive pulmonary disease: properties of the EQ-5D-5L and PROMIS-43 short form

BMC Medical Research Methodology

Todd A Lee⁵  William M Vollmer³  Edward T Naureckas¹  Richard A Mularski³  Mary Ann McBurnie³  Peter K Lindenauer⁴  Ashley G Henderson²  Suzanne Gillespie³  Shannon S Carson²  David H Au⁷  Min J Joo⁶  Jerry A Krishnan⁶  A Simon Pickard⁸  Fang-Ju Lin⁵ 

[1] University of Chicago, Chicago, IL, USA;University of North Carolina, Chapel Hill, NC, USA;Kaiser Permanente Northwest Center for Health Research, Portland, OR, USA;Tufts University School of Medicine, Boston, MA, USA;University of Illinois at Chicago, Chicago, IL, USA;University of Illinois Hospital & Health Sciences System, Chicago, IL, USA;VA Puget Sound Health Care System and University of Washington, Seattle, WA, USA;Department of Pharmacy Systems, Outcomes and Policy, College of Pharmacy, University of Illinois at Chicago, 833 South Wood St., M/C 886, Chicago, IL 60612, USA

关键词: Psychometric properties;    PROMIS;    EQ-5D-5L;    COPD;   

Others  :  865385
DOI  :  10.1186/1471-2288-14-78

 received in 2014-01-13, accepted in 2014-05-06,  发布年份 2014

【 摘 要 】

Background

The Patient Reported Outcomes Measurement Information System 43-item short form (PROMIS-43) and the five-level EQ-5D (EQ-5D-5L) are recently developed measures of health-related quality of life (HRQL) that have potentially broad application in evaluating treatments and capturing burden of respiratory-related diseases. The aims of this study were: (1) to examine their psychometric properties in patients with chronic obstructive pulmonary disease (COPD), and (2) to identify dimensions of HRQL that differ and do not differ by lung function.

Methods

We conducted a multi-center, cross-sectional study (“COPD Outcomes-based Network for Clinical Effectiveness & Research Translation” [CONCERT]). We analyzed patients who met spirometric criteria for COPD, and completed EQ-5D-5L and PROMIS questionnaires. Disease severity was graded based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification. Pulmonary function test, PROMIS-43, EQ-5D (index score and EQ-Visual Analog Scale [EQ-VAS]), six minute walk test (6MWT), and three dyspnea scales (mMRC, Borg, FACIT-Dyspnea) were administered. Validity and reliability of EQ-5D-5L and PROMIS-43 were examined, and differences in HRQL by GOLD grade were assessed.

Results

Data from 670 patients with COPD were analyzed (mean age 68.5 years; 58% male). More severe COPD was associated with more problems with mobility, self-care and usual activities (all p-values <0.01) according to EQ-5D-5L. Related domains on EQ-5D-5L, PROMIS and clinical measures were moderately (r = 0.30-0.49) to strongly (r ≥ 0.50) correlated. A statistically significant trend of decreasing HRQL with more severe lung functions was observed for EQ-5D-5L index scores, EQ-VAS scores, and PROMIS physical function and social roles.

Conclusions

Results supported the validity of EQ-5D-5L and PROMIS-43 in COPD patients, and indicate that physical function and social activities decrease with level of lung function by GOLD grade, but not pain, mental health, sleep or fatigue as reported by patients.

【 授权许可】

   
2014 Lin et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Deaths: preliminary data for 2009 [http://www.cdc.gov/nchs/data/nvsr/nvsr59/nvsr59_04.pdf webcite]
• [2]Mathers CD, Loncar D: Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med 2006, 3(11):e442.
• [3]Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R: Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med 2013, 187(4):347-365.
• [4]Morbidity and mortality: 2009 chartbook on cardiovascular, lung and blood diseases [http://www.nhlbi.nih.gov/resources/docs/2009_ChartBook.pdf webcite]
• [5]Mapel DW, Hurley JS, Frost FJ, Petersen HV, Picchi MA, Coultas DB: Health care utilization in chronic obstructive pulmonary disease. A case-control study in a health maintenance organization. Arch Intern Med 2000, 160(17):2653-2658.
• [6]Sullivan SD, Ramsey SD, Lee TA: The economic burden of COPD. Chest 2000, 117(2 Suppl):5S-9S.
• [7]Stahl E, Lindberg A, Jansson SA, Ronmark E, Svensson K, Andersson F, Lofdahl CG, Lundback B: Health-related quality of life is related to COPD disease severity. Health Qual Life Outcomes 2005, 3:56.
• [8]Kaplan RM, Tally S, Hays RD, Feeny D, Ganiats TG, Palta M, Fryback DG: Five preference-based indexes in cataract and heart failure patients were not equally responsive to change. J Clin Epidemiol 2011, 64(5):497-506.
• [9]Patrick DL, Deyo RA: Generic and disease-specific measures in assessing health status and quality of life. Med Care 1989, 27(3 Suppl):S217-S232.
• [10]Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M: The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care 2007, 45(5 Suppl 1):S3-S11.
• [11]Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X: Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011, 20(10):1727-1736.
• [12]Buist AS, McBurnie MA, Vollmer WM, Gillespie S, Burney P, Mannino DM, Menezes AM, Sullivan SD, Lee TA, Weiss KB, Jensen RL, Marks GB, Gulsvik A, Nizankowska-Mogilnicka E, BOLD Collaborative Research Group: International variation in the prevalence of COPD (the BOLD Study): a population-based prevalence study. Lancet 2007, 370(9589):741-750.
• [13]ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories: ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002, 166(1):111-117.
• [14]Brooks SM: Surveillance for respiratory hazards. ATS News 1982, 8:12-16.
• [15]Borg GAV: Psychophysical bases of perceived exertion. Med Sci Sports Exerc 1982, 14(5):377-381.
• [16]Yount SE, Choi SW, Victorson D, Ruo B, Cella D, Anton S, Hamilton A: Brief, valid measures of dyspnea and related functional limitations in chronic obstructive pulmonary disease (COPD). Value Health 2011, 14(2):307-315.
• [17]Choi SW, Victorson DE, Yount S, Anton S, Cella D: Development of a conceptual framework and calibrated item banks to measure patient-reported dyspnea severity and related functional limitations. Value Health 2011, 14(2):291-306.
• [18]Hinchcliff M, Beaumont JL, Thavarajah K, Varga J, Chung A, Podlusky S, Carns M, Chang RW, Cella D: Validity of two new patient-reported outcome measures in systemic sclerosis: Patient-Reported Outcomes Measurement Information System 29-item Health Profile and Functional Assessment of Chronic Illness Therapy-Dyspnea short form. Arthritis Care Res (Hoboken) 2011, 63(11):1620-1628.
• [19]Rabin R, de Charro F: EQ-5D: a measure of health status from the EuroQol Group. Ann Med 2001, 33(5):337-343.
• [20]van Hout B, Janssen MF, Feng YS, Kohlmann T, Busschbach J, Golicki D, Lloyd A, Scalone L, Kind P, Pickard AS: Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health 2012, 15(5):708-715.
• [21]EuroQoL Group: Crosswalk value sets for the EQ-5D-5L. http://www.euroqol.org/about-eq-5d/valuation-of-eq-5d/eq-5d-5l-value-sets.html webcite
• [22]Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R, PROMIS Cooperative Group: The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol 2010, 63(11):1179-1194.
• [23]Liu H, Cella D, Gershon R, Shen J, Morales LS, Riley W, Hays RD: Representativeness of the Patient-Reported Outcomes Measurement Information System Internet panel. J Clin Epidemiol 2010, 63(11):1169-1178.
• [24]PROMIS Scoring Manuals [http://www.assessmentcenter.net/Manuals.aspx webcite]
• [25]Cohen J: Statistical Power Analysis for the Behavioral Sciences. 2nd edition. New Jersey: Lawrence Erlbaum Associates; 1988.
• [26]Brown CA, Cheng EM, Hays RD, Vassar SD, Vickrey BG: SF-36 includes less Parkinson Disease (PD)-targeted content but is more responsive to change than two PD-targeted health-related quality of life measures. Qual Life Res 2009, 18(9):1219-1237.
• [27]Hays RD, Anderson R, Revicki D: Psychometric considerations in evaluating health-related quality of life measures. Qual Life Res 1993, 2(6):441-449.
• [28]Liang MH, Larson MG, Cullen KE, Schwartz JA: Comparative measurement efficiency and sensitivity of five health status instruments for arthritis research. Arthritis Rheum 1985, 28(5):542-547.
• [29]Lix LM, Keselman JC, Keselman HJ: Consequences of assumption violations revisited: A quantitative review of alternatives to the one-way analysis of variance F test. Rev Educ Res 1996, 66(4):579-619.
• [30]Nunnally JC, Bernstein IH: Psychometric Theory. 3rd edition. New York: McGraw-Hill; 1994.
• [31]Stavem K: Reliability, validity and responsiveness of two multiattribute utility measures in patients with chronic obstructive pulmonary disease. Qual Life Res 1999, 8(1–2):45-54.
• [32]Wijnhoven HA, Kriegsman DM, Hesselink AE, Penninx BW, de Haan M: Determinants of different dimensions of disease severity in asthma and COPD: pulmonary function and health-related quality of life. Chest 2001, 119(4):1034-1042.
• [33]Hesselink AE, van der Windt DA, Penninx BW, Wijnhoven HA, Twisk JW, Bouter LM, van Eijk JT: What predicts change in pulmonary function and quality of life in asthma or COPD? J Asthma 2006, 43(7):513-519.
• [34]Hajiro T, Nishimura K, Tsukino M, Ikeda A, Oga T, Izumi T: A comparison of the level of dyspnea vs disease severity in indicating the health-related quality of life of patients with COPD. Chest 1999, 116(6):1632-1637.
• [35]Pickard AS, Yang Y, Lee TA: Comparison of health-related quality of life measures in chronic obstructive pulmonary disease. Health Qual Life Outcomes 2011, 9:26.
• [36]Rodriguez Gonzalez-Moro JM, de Lucas RP, Izquierdo Alonso JL, Lopez-Muniz Ballesteros B, Anton Diaz E, Ribera X, Martin A: Impact of COPD severity on physical disability and daily living activities: EDIP-EPOC I and EDIP-EPOC II studies. Int J Clin Pract 2009, 63(5):742-750.
• [37]Rothrock NE, Hays RD, Spritzer K, Yount SE, Riley W, Cella D: Relative to the general US population, chronic diseases are associated with poorer health-related quality of life as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS). J Clin Epidemiol 2010, 63(11):1195-1204.
• [38]Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J: Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res 2013, 22(7):1717-1727.
• [39]Pickard AS, Wilke C, Jung E, Patel S, Stavem K, Lee TA: Use of a preference-based measure of health (EQ-5D) in COPD and asthma. Respir Med 2008, 102(4):519-536.
• [40]Punekar YS, Rodriguez-Roisin R, Sculpher M, Jones P, Spencer M: Implications of chronic obstructive pulmonary disease (COPD) on patients’ health status: a western view. Respir Med 2007, 101(3):661-669.
• [41]Antonelli-Incalzi R, Imperiale C, Bellia V, Catalano F, Scichilone N, Pistelli R, Rengo F: Do GOLD stages of COPD severity really correspond to differences in health status? Eur Respir J 2003, 22(3):444-449.
• [42]Norman GR, Sloan JA, Wyrwich KW: Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003, 41(5):582-592.
• [43]Blinderman CD, Homel P, Billings JA, Tennstedt S, Portenoy RK: Symptom distress and quality of life in patients with advanced chronic obstructive pulmonary disease. J Pain Symptom Manage 2009, 38(1):115-123.
• [44]Livneh H, Antonak RF: Psychosocial adaptation to chronic illness and disability: a primer for counselors. J Couns Dev 2005, 83(1):12-20.
• [45]Revicki DA, Kawata AK, Harnam N, Chen WH, Hays RD, Cella D: Predicting EuroQol (EQ-5D) scores from the patient-reported outcomes measurement information system (PROMIS) global items and domain item banks in a United States sample. Qual Life Res 2009, 18(6):783-791.