title: A thematic analysis of the strengths and weaknesses of manufacturers' submissions to the NICE Single Technology Assessment (STA) process.
abstract: OBJECTIVE
  The NICE Single Technology Appraisal (STA) process in the UK has been underway for five years. Evidence Review Groups (ERGs) critically appraise submissions from manufacturers on the clinical and cost effectiveness of new technologies. This study analysed the ERGs' assessment of the strengths and weaknesses of 30 manufacturers' submissions to the STA process.
  
  
  METHODS
  Thematic analysis was performed on the textual descriptions of the strengths and weakness of manufacturer submissions, as outlined by the ERGs in their reports.
  
  
  RESULTS
  Various themes emerged from the data. These themes related to the processes applied in the submissions; the content of the submission (e.g. the amount and quality of evidence); the reporting of the submissions' review and analysis processes; the reliability and validity of the submissions' findings; and how far the submission had satisfied the STA process objectives.
  
  
  CONCLUSIONS
  STA submissions could be improved if attention were paid to transparency in the reporting, conduct and justification of review and modelling processes and analyses, as well as greater robustness in the choice of data and closer adherence to the scope or decision problem. Where this adherence is not possible, more detailed justification of the choice of evidence or data is required.
authors.affiliation: Health Economics and Decision Science, School of Health and Related Research, University of Sheffield, Regent Court, Regent Street, Sheffield S1 4DA, UK. c.carroll@sheffield.ac.uk
authors.forename: Christopher
authors.initials: C
authors.lastname: Carroll
authors.forename: Eva
authors.initials: E
authors.lastname: Kaltenthaler
authors.forename: Patrick
authors.initials: P
authors.lastname: FitzGerald
authors.forename: Angela
authors.initials: A
authors.lastname: Boland
authors.forename: Rumona
authors.initials: R
authors.lastname: Dickson
mesh_terms: D000047:Academies and Institutes; D035843:Biomedical Research / Q000191:economics / Q000592:standards*; D020811:Biomedical Technology / Q000191:economics / Q000592:standards*; D003362:Cost-Benefit Analysis; D004864:Equipment and Supplies / Q000191:economics / Q000592:standards*; D019317:Evidence-Based Medicine; D006801:Humans; D017410:Practice Guidelines as Topic; D055553:Prescription Drugs / Q000191:economics / Q000592:standards*; D017064:Process Assessment, Health Care; D015397:Program Evaluation; D011787:Quality of Health Care / Q000191:economics / Q000592:standards; D013222:State Medicine; D013673:Technology Assessment, Biomedical; D006113:United Kingdom
chemical_list: D055553:Prescription Drugs