title: Assessing quality of life in a clinical study on heart rehabilitation patients: how well do value sets based on given or experienced health states reflect patients' valuations?
abstract: BACKGROUND
  Quality of life as an endpoint in a clinical study may be sensitive to the value set used to derive a single score. Focusing on patients' actual valuations in a clinical study, we compare different value sets for the EQ-5D-3L and assess how well they reproduce patients' reported results.
  
  
  METHODS
  A clinical study comparing inpatient (n = 98) and outpatient (n = 47) rehabilitation of patients after an acute coronary event is re-analyzed. Value sets include: 1. Given health states and time-trade-off valuation (GHS-TTO) rendering economic utilities; 2. Experienced health states and valuation by visual analog scale (EHS-VAS). Valuations are compared with patient-reported VAS rating. Accuracy is assessed by mean absolute error (MAE) and by Pearson's correlation ρ. External validity is tested by correlation with established MacNew global scores. Drivers of differences between value sets and VAS are analyzed using repeated measures regression.
  
  
  RESULTS
  EHS-VAS had smaller MAEs and higher ρ in all patients and in the inpatient group, and correlated best with MacNew global score. Quality-adjusted survival was more accurately reflected by EHS-VAS. Younger, better educated patients reported lower VAS at admission than the EHS-based value set. EHS-based estimates were mostly able to reproduce patient-reported valuation. Economic utility measurement is conceptually different, produced results less strongly related to patients' reports, and resulted in about 20 % longer quality-adjusted survival.
  
  
  CONCLUSIONS
  Decision makers should take into account the impact of choosing value sets on effectiveness results. For transferring the results of heart rehabilitation patients from another country or from another valuation method, the EHS-based value set offers a promising estimation option for those decision makers who prioritize patient-reported valuation. Yet, EHS-based estimates may not fully reflect patient-reported VAS in all situations.
authors.affiliation: Institute for Health Economics and Health Care Management, Helmholtz Zentrum München, Postfach 1129, 85758, Neuherberg, Germany. leidl@helmholtz-muenchen.de.|Munich Center of Health Sciences, Ludwig-Maximilians-University, Ludwigstr. 28 RG, 80539, Munich, Germany. leidl@helmholtz-muenchen.de.
authors.forename: Reiner
authors.identifier: http://orcid.org/0000-0002-7115-7510
authors.initials: R
authors.lastname: Leidl
authors.affiliation: Institute for Health Economics and Health Care Management, Helmholtz Zentrum München, Postfach 1129, 85758, Neuherberg, Germany.|Mapi Group, Konrad-Zuse-Platz 11, 81829, Munich, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Schweikert
authors.affiliation: Waldburg-Zeil Kliniken - Klinik Schwabenland, Waldburgallee 3-5, 88316, Isny-Neutrauchburg, Germany.
authors.forename: Harry
authors.initials: H
authors.lastname: Hahmann
authors.affiliation: Division of Sports and Rehabilitation Medicine, Dept. Internal Medicine II, Ulm University Medical Centre, Frauensteige 6, 89075, Ulm, Germany.
authors.forename: Juergen M
authors.initials: JM
authors.lastname: Steinacker
authors.affiliation: Institute for Health Economics and Health Care Management, Helmholtz Zentrum München, Postfach 1129, 85758, Neuherberg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Reitmeir
mesh_terms: D054058:Acute Coronary Syndrome / Q000523:psychology* / Q000534:rehabilitation*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D007297:Inpatients / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D010045:Outpatients / Q000523:psychology*; D017060:Patient Satisfaction; D011788:Quality of Life / Q000523:psychology*; D012044:Regression Analysis; D057566:Self Report; D011795:Surveys and Questionnaires; D013548:Sweden
keywords: Decision utility; EQ-5D-3L; Experience-based valuation; Patient benefit; Patient-reported outcome