Validity and responsiveness of the EQ-5D in assessing and valuing health status in patients with somatoform disorders

Health and Quality of Life Outcomes

Alexander Konnopka¹  Rainer Schaefert²  Claudia Kaufmann²  Wolfgang Herzog²  Hans-Helmut König¹  Christian Brettschneider¹ 

[1] Department of Medical Sociology and Health Economics, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany;Department of General Internal Medicine and Psychosomatics, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany

关键词: Responsiveness;    Validity;    Medically unexplained symptoms;    Somatoform disorders;    Quality of life;    EQ-5D;   

Others  :  824185
DOI  :  10.1186/1477-7525-11-3

 received in 2012-06-14, accepted in 2012-12-18,  发布年份 2013

【 摘 要 】

Background

The EQ-5D is a generic questionnaire providing a preference-based index score applicable to cost-utility analysis. This is the first study to validate the EQ-5D in patients with somatoform disorders.

Methods

Data of the EQ-5D descriptive system, the British and the German EQ-5D index and the EQ Visual Analogue Scale, the Patient Health Questionnaire 15, the Patient Health Questionnaire 9, the Whiteley Index 7 and the Short Form 36 were collected from 294 patients at baseline, 244 at 6 months and 256 at 12 months after baseline.

The discriminative ability of the EQ-5D was evaluated by comparison with a general population sample and by the ability to distinguish between different symptom severities. Convergent validity was analysed by assessing associations between the EQ-5D and the other instruments. Responsiveness was evaluated by analysing the effects on scores between two measurements in groups of patients reporting worse, same or better health. The Bonferroni correction was employed.

Results

For all items of the EQ-5D except ‘self-care’, patients with somatoform disorders reported more problems than the general population. The EQ-5D showed discriminative ability in patients with different symptom severities. For nearly all reference instruments there were significant differences in mean scores between respondents with and without problems in the various EQ-5D items and strong correlations with the EQ Visual Analogue Scale and the EQ-5D index scores. Evidence for the responsiveness of the EQ-5D could only be found for patients with better health; effects were medium at the utmost.

Conclusions

The EQ-5D showed a considerable validity and a limited responsiveness in patients with somatoform disorders.

Trial registration

Current Controlled Trials ISRCTN55280791

【 授权许可】

   
2013 Brettschneider et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Food and Drug Administration: Guidance to the industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Rockville: Food and Drug Administration; 2009.
• [2]Drummond MF: O´Brien B, Stoddart GL, Torrance GW: Methods for the economic evaluation of health care programmes. Oxford, UK: Oxford University Press; 1997.
• [3]Gold M, Siegel J, Russel L, Weinstein M: Cost-effectiveness in health and medicine. New York: Oxford University Press; 1996.
• [4]Räsänen P, Roine E, Sintonen H, Semberg-Konttinen V, Ryynanen OP, Roine R: Use of quality-adjusted life years for the estimation of effectiveness of health care: A systematic literature review Int J Technol Assess Health Care. 2006, 22:235-241.
• [5]König HH, Ulshöfer A, Gregor M, von Tirpitz C, Reinshagen M, Adler G, Leidl R: Validation of the EuroQol questionnaire in patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol 2002, 14(11):1205-1215.
• [6]Nowels D, McGloin J, Westfall JM, Holcomb S: Validation of the EQ-5D quality of life instrument in patients after myocardial infarction. Qual Life Res 2005, 14:95-105.
• [7]Matza LS, Boye KS, Yurgin N: Validation of two generic patient-reported outcome measures in patients with type 2 diabetes. Health Qual Life Outcomes 2007, 5:47. BioMed Central Full Text
• [8]König HH, Roick C, Angermeyer MC: Validity of the EQ-5D in assessing and valuing health status in patients with schizophrenic, schizotypal or delusional disorders. Eur Psychiatry 2007, 22(3):177-187.
• [9]Öster C, Willebrand M, Dyster-Aas J, Kildal M, Ekselius L: Validation of the EQ-5D questionnaire in burn injured adults. Burns 2009, 35:723-732.
• [10]König HH, Born A, Günther O, Matschinger H, Heinrich S, Riedel-Heller SG, Angermeyer MC, Roick C: Validity and responsiveness of the EQ-5D in assessing and valuing health status in patients with anxiety disorders. Health Qual Life Outcomes 2010, 8:47. BioMed Central Full Text
• [11]International Statistical Classification of Diseases and Related Health Problemshttp://apps.who.int/classifications/apps/icd/icd10online/ webcite
• [12]American Psychiatric Association: Diagnostic and Statistical Manual for Mental Disorders. 4th edition. Washington: APA Press; 1994.
• [13]Roca M, Gili M, Garcia-Garcia M, Salva J, Vives M, Comas CJ: Prevalence and comorbidity of common mental disorders in primary care. J Affect Disord 2009, 119(1–3):52-58.
• [14]Creed F, Barsky A: A systematic review of the epidemiology of somatisation disorder and hypochondriasis. J Psychosom Res 2004, 56(4):391-408.
• [15]de Waal MW, Arnold IA, Eekhof JA, van Hemert AM: Somatoform disorders in general practice: prevalence, functional impairment and comorbidity with anxiety and drepressive disorders. Br J Psychiatry 2004, 184:470-476.
• [16]Schaefert R, Kaufmann C, Wild B, Schellberg D, Boelter R, Faber R, Szecsenyi J, Sauer N, Guthrie E, Herzog W: Specific Collaborative Group Intervention for Patients with Medically Unexplained Symptoms in General Practice (speciAL): A Cluster Randomized Controlled Trial. Psychother Psychosom (in Press) 2012.
• [17]Schag CC, Heinrich RL, Ganz PA: Karnofsky performance status revisited: reliability, validity, and guidelines. J Clin Oncol 1984, 2:187-193.
• [18]Kroenke K, Spitzer RL, Williams JB, Löwe B: The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review. Gen Hosp Psychiatry 2010, 32:345-359.
• [19]Fink P, Ewald H, Jensen J, Sorensen L, Engberg M, Holm M, Munk-Jorgensen P: Screening for somatization and hypochondriasis in primary care and neurological in-patients: a seven-item scale for hypochondriasis and somatizazion. J Psychosom Res 1999, 46(3):261-273.
• [20]Christensen KS, Fink P, Toft T, Frostholm L, Ombol E, Olesen F: A brief case-finding questionnaire for common mental disorders: the CMDQ. Fam Pract 2005, 22(4):448-457.
• [21]Conradt M, Cavanagh M, Franklin J, Rief W: Dimensionality of the Whiteley Index: Assessment of Hypochondriasis in an Australian sample of primary care patients. J Psychosom Res 2006, 60:137-143.
• [22]Benedikt G, Schulmeister E, Sattel H, Schaefert R, Sauer N, Herzog W, Henningsen P: Somatic symptoms and illness worries in primary care - a study of 1751 general practice attenders. Z Psychiatr Psychol Psychother 2007, 55:21-29.
• [23]Schaefert R, Kaufmann C, Wild B, Schellberg D, Boelter R, Faber R, Szecsenyi J, Sauer N, Guthrie E, Herzog W: Specific Collaborative Group Intervention for Patients with Medically Unexplained Symptoms in General Practice: A Cluster Randomized Controlled Trial. Psychother Psychosom 2013, 82:106-119.
• [24]The Euroqol Group: EuroQol* - a new facility for the measurement of health-related quality of life. Health Policy 1990, 16:199-208.
• [25]Dolan P: Modeling Valuations for EuroQol Health States. Med Care 1997, 35(11):1095-1108.
• [26]Greiner W, Claes C, Busschbach JJV, von der Schuldenburg J-MG: Validating the EQ-5D with time trade off for the German population. Eur J Health Econ 2005, 6:124-130.
• [27]Spitzer RL, Kroenke K, Williams JBW, Group PHQPCS: Validation and utility of a self-report Version of PRIME-MD: The PHQ Primary Care Study. JAMA 1999, 282(18):1737-1744.
• [28]Kroenke K, Spitzer RL, Williams JBW: The PHQ-15: Validity of a New Measure for Evaluating the severity of Somatic Symptoms. Psychosom Med 2002, 64:258-266.
• [29]Löwe B, Spitzer RL, Zipfel J, Herzog W: PHQ-D Geusndheitsfragebogen für Patienten; Manual und Kurzform. Volume 2. Karlsruhe: Pfizer; 2002.
• [30]Kroenke K, Spitzer RL, Williams JBW: The PHQ-9: Validity of a Brief Depression Severity Measure. J Gen Intern Med 2001, 16(9):606-613.
• [31]Hanel H, Henningsen P, Herzog W, Sauer N, Schaefert R, Szecsenyi J, Löwe B: Depression, anxiety, and somatoform disorders: Vague or distinct categories in primary care? Results from a large cross-sectional study. J Psychosom Res 2009, 67:189-197.
• [32]Pilowsky I: Dimensions of Hypochondriasis. Br J Psychiatry 1967, 113:89-93.
• [33]Hiller W, Rief W: Internationale Skalen für Hypochondrie. Deutschsprachige Adaptation des Whiteley-Index (WI) und der Illness Attitude Scales (IAS). 1st edition. Bern: Huber; 2004.
• [34]Rief W, Hiller W, Geissner E, Fichtner MM: Hypochondriasis: Assessment and initial clinical results. Z Klin Psychol Psychother 1994, 23(1):34-42.
• [35]Ware JE, Sherbourne CD: The MOS 36-Item Short-Form Health Survey (SF-36): I. Conceptual Framework and Item. Selection Med Care 1992, 30(6):473-483.
• [36]Bullinger M: German translation and psychometric testing of the SF-36 Health Survey: Preliminary results from the IQOLA Project. Soc Sci Med 1995, 41(10):1359-1366.
• [37]Bullinger M, Kirchberger I: SF-36. Fragebogen zum Gesundheitszustand. Handanweisungen und Fragebögen. Göttingen: Hogrefe; 1998.
• [38]Hoedeman R, Krol B, Blankenstein N, Koopmans PC, Groothoff JW: Severe MUPS in a sick-listed population: a cross-sectional study on prevalence, recognition, psychiatric co-morbidity and impairment. BMC Publ Health 2009, 9:440. BioMed Central Full Text
• [39]Hansen HS, Rosendal M, Oernboel E, Fink P: Are medically unexplained symptoms and functional disorders predictive for the illness course? A two-year follow-up on patients' health and health care utilisation. J Psychosom Res 2011, 71(1):38-44.
• [40]van Fenema EM, van der Wee NJ, Giltay EJ, den Hollander-Gijsman ME, Zitman FG: Vitality predicts level of guideline-concordant care in routine treatment of mood, anxiety and somatoform disorders. J Eval Clin Pract 2012, 18(2):441-448.
• [41]Zonneveld LN, van Rood YR, Timman R, Kooiman CG, Van't Spijker A, Busschbach JJ: Effective group training for patients with unexplained physical symptoms: a randomized controlled trial with a non-randomized one-year follow-up. PLoS One 2012, 7:8.
• [42]Luo X, Capelleri J: A practical guide on incorporating and evaluating patient-reported outcomes in clinical trials. Clin Res Regul Aff 2008, 25(4):197-211.
• [43]König HH, Bernert S, Angermeyer MC: Health Status of the German Population: Results of a Representative Survey Using the EuroQol Questionnaire. Gesundheitswesen 2005, 67:173-182.
• [44]Frost MH, Reeve BB, Liepa AM, Stauffer JW, Hays RD, Group MFP-ROCM: What is sufficient evidence for the reliability and validity of patient-reported outcome measures? Value Health 2007, 10(Suppl 2):S94-S105.
• [45]Revicki DA, Gnanasakthy A, Weinfurt K: Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier. Qual Life Res 2007, 16(4):717-723.
• [46]Garratt AM, Ruta DA, Abdalla MI, Russell IT: SF-36 health survey questionnaire: II. Responsiveness to changes in health status in four common conditions. Qual Health Care 1994, 3:186-192.
• [47]Cohen J: Statistical power analysis for behavioral sciences. Hillsdale, NJ: Lawrence Earlbaum associates; 1988.
• [48]Kontodimopoulos N, Pappa E, Niakis D, Yfantopoulos J, Dimitrakaki C, Tountas Y: Validity of the EuroQol (EQ-5D) Instrument in a Greek General Population. Value Health 2008, 11(7):1162-1169.
• [49]Baker R: Measuring change in health in general practice: a comparison of a simple transition question with the Nottingham Health Profile. Int J Qual Health Care 1998, 10(3):207-212.