title: A systematic review of patient-reported and economic outcomes: value to stakeholders in the decision-making process in patients with type 2 diabetes mellitus.
abstract: BACKGROUND
  The need for an approach to measuring health results that incorporates patients' and payers' perspectives has generated a wide range of health care outcomes (HCOs), but it is yet unknown whether these HCOs are appropriate or valid for the health care decision-making process.
  
  
  OBJECTIVE
  The goal of this study was to assess HCOs, patient-reported outcomes (PROs), and economic outcomes in terms of validity and appropriateness to health care decision making in type 2 diabetes mellitus (T2DM).
  
  
  METHODS
  This systematic review of studies published between January 1, 1996, and November 1, 2010, comprised an electronic literature search of MEDLINE and Centre for Reviews and Dissemination databases. Studies included were clinical trials, observational studies, economic analyses, and studies on the development and validation of HCOs in T2DM in the adult population. HCOs were assessed and classified according to their relevance for decision makers in terms of feasibility for routine use, validity, sensitivity, reliability, understanding, and scope.
  
  
  RESULTS
  Two independent reviewers screened 4497 citations. Of these, 281 potentially eligible full articles were retrieved, and 185 met the inclusion criteria. A total of 121 HCOs in T2DM were identified: 80 (66.1%) PROs and 41 (33.9%) economic outcomes. Only 44.6% of the outcomes assessed were appropriate and valid for health care decision making. Greater deficiencies in evidence were found for PROs (61.3%), followed by economic outcomes (43.9%).
  
  
  CONCLUSIONS
  A large number of HCOs are being used in the health care decision-making process, but a significant proportion of these new outcomes have not been properly validated. Despite the fact that appropriate measures will depend on the specific needs of the decision makers, researchers need to use HCOs for which evidence of quality and appropriateness is available.
authors.affiliation: IMS, Health Economics and Outcomes Research, Barcelona, Spain. avieta@imscg.com
authors.forename: Ana
authors.initials: A
authors.lastname: Vieta
authors.forename: Xavier
authors.initials: X
authors.lastname: Badia
authors.forename: José A
authors.initials: JA
authors.lastname: Sacristán
mesh_terms: D003362:Cost-Benefit Analysis; D003657:Decision Making; D003661:Decision Support Techniques; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy / Q000191:economics*; D006801:Humans; D055118:Medication Adherence; D017063:Outcome Assessment, Health Care / Q000191:economics*; D010353:Patient Education as Topic / Q000379:methods; D010358:Patient Participation