title: Bridging trial and decision: a checklist to frame health technology assessments for resource allocation decisions.
abstract: OBJECTIVE
  Health technology assessments (HTAs) intend to inform real-world decisions. They often draw on data from explanatory trials and hence are not always applicable to the decision problem. HTAs may therefore not meet the needs of decision makers. Our objective was to develop and apply a checklist to: 1) systematically frame HTAs in a way that they are applicable to the decision problem; and 2) assess if a decision problem can be informed by an available HTA.
  
  
  METHODS
  We reviewed published literature to identify factors that should be considered when framing HTAs for resource allocation decisions. The checklist was finalized in collaboration with clinicians and policy makers. We applied the checklist to the economic evaluation of trastuzumab in early breast cancer. We defined a reference case and for each study, retrieved through a systematic review, we examined if each factor was explicitly considered.
  
  
  RESULTS
  A checklist was developed with 11 factors (e.g., clinical practice, consequences, and patient use). In the case of trastuzumab, most factors were considered by the 11 retrieved economic evaluations. Two factors, being the inclusion of all relevant comparators and professional use, were considered by none of the studies.
  
  
  CONCLUSIONS
  We developed a comprehensive checklist with 11 factors to frame HTAs and to assess the applicability of HTAs to resource allocation decisions. Economic evaluations on trastuzumab considered some of these factors, but overlooked others. The proposed checklist assists in systematically considering all factors in developing the conceptual model of an HTA, to make HTAs better reflect the decision problem.
authors.affiliation: Department of Health Organization, Policy, and Economics, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands. j.grutters@maastrichtuniversity.nl
authors.forename: Janneke P C
authors.initials: JP
authors.lastname: Grutters
authors.forename: Shanly C
authors.initials: SC
authors.lastname: Seferina
authors.forename: Vivianne C G
authors.initials: VC
authors.lastname: Tjan-Heijnen
authors.forename: Roel J W
authors.initials: RJ
authors.lastname: van Kampen
authors.forename: Wim G
authors.initials: WG
authors.lastname: Goettsch
authors.forename: Manuela A
authors.initials: MA
authors.lastname: Joore
mesh_terms: D000911:Antibodies, Monoclonal / Q000191:economics / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000191:economics / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy / Q000191:economics / Q000473:pathology; D057189:Checklist; D002986:Clinical Trials as Topic / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D003661:Decision Support Techniques; D019317:Evidence-Based Medicine; D005260:Female; D015276:Health Care Rationing / Q000191:economics; D006302:Health Services Research; D006801:Humans; D018803:Models, Economic; D010043:Outcome and Process Assessment, Health Care / Q000191:economics; D012107:Research Design; D013673:Technology Assessment, Biomedical / Q000191:economics; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068878:Trastuzumab