title: The use of exploratory analyses within the National Institute for Health and Care Excellence single technology appraisal process: an evaluation and qualitative analysis.
abstract: BACKGROUND
  As part of the National Institute for Health and Care Excellence (NICE) single technology appraisal (STA) process, independent Evidence Review Groups (ERGs) critically appraise the company submission. During the critical appraisal process the ERG may undertake analyses to explore uncertainties around the company's model and their implications for decision-making. The ERG reports are a central component of the evidence considered by the NICE Technology Appraisal Committees (ACs) in their deliberations.
  
  
  OBJECTIVE
  The aim of this research was to develop an understanding of the number and type of exploratory analyses undertaken by the ERGs within the STA process and to understand how these analyses are used by the NICE ACs in their decision-making.
  
  
  METHODS
  The 100 most recently completed STAs with published guidance were selected for inclusion in the analysis. The documents considered were ERG reports, clarification letters, the first appraisal consultation document and the final appraisal determination. Over 400 documents were assessed in this study. The categories of types of exploratory analyses included fixing errors, fixing violations, addressing matters of judgement and the ERG-preferred base case. A content analysis of documents (documentary analysis) was undertaken to identify and extract relevant data, and narrative synthesis was then used to rationalise and present these data.
  
  
  RESULTS
  The level and type of detail in ERG reports and clarification letters varied considerably. The vast majority (93%) of ERG reports reported one or more exploratory analyses. The most frequently reported type of analysis in these 93 ERG reports related to the category 'matters of judgement', which was reported in 83 (89%) reports. The category 'ERG base-case/preferred analysis' was reported in 45 (48%) reports, the category 'fixing errors' was reported in 33 (35%) reports and the category 'fixing violations' was reported in 17 (18%) reports. The exploratory analyses performed were the result of issues raised by an ERG in its critique of the submitted economic evidence. These analyses had more influence on recommendations earlier in the STA process than later on in the process.
  
  
  CONCLUSIONS
  The descriptions of analyses undertaken were often highly specific to a particular STA and could be inconsistent across ERG reports and thus difficult to interpret.
  
  
  CONCLUSIONS
  Evidence Review Groups frequently conduct exploratory analyses to test or improve the economic evaluations submitted by companies as part of the STA process. ERG exploratory analyses often have an influence on the recommendations produced by the ACs.
  
  
  CONCLUSIONS
  More in-depth analysis is needed to understand how ERGs make decisions regarding which exploratory analyses should be undertaken. More research is also needed to fully understand which types of exploratory analyses are most useful to ACs in their decision-making.
  
  
  BACKGROUND
  The National Institute for Health Research Health Technology Assessment programme.
authors.affiliation: School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
authors.forename: Eva
authors.initials: E
authors.lastname: Kaltenthaler
authors.affiliation: School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
authors.forename: Christopher
authors.initials: C
authors.lastname: Carroll
authors.affiliation: School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
authors.forename: Daniel
authors.initials: D
authors.lastname: Hill-McManus
authors.affiliation: School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
authors.forename: Alison
authors.initials: A
authors.lastname: Scope
authors.affiliation: School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Holmes
authors.affiliation: Health Economics Group, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Rice
authors.affiliation: Southampton Health Technology Assessments Centre (SHTAC), University of Southampton, Southampton, UK.
authors.forename: Micah
authors.initials: M
authors.lastname: Rose
authors.affiliation: School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Tappenden
authors.affiliation: Centre for Reviews and Dissemination (CRD), University of York, York, UK.
authors.forename: Nerys
authors.initials: N
authors.lastname: Woolacott
mesh_terms: D026683:Advisory Committees; D035843:Biomedical Research / Q000191:economics / Q000592:standards*; D020811:Biomedical Technology / Q000191:economics / Q000592:standards*; D003362:Cost-Benefit Analysis; D003657:Decision Making; D006801:Humans; D009937:Organizational Objectives; D013222:State Medicine; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000592:standards*; D006113:United Kingdom