title: Feasibility and cost of obtaining informed consent for essential review of medical records in large-scale health services research.
abstract: OBJECTIVE
  To evaluate the effectiveness and cost of obtaining consent for review of medical records within the passively observed non-intervention arm of a cluster randomized controlled trial, 'Comparison Arm for ProtecT'.
  
  
  METHODS
  Two hundred and thirty men, who had been notified to the trial by cancer registries as having prostate cancer, were sent a consent form from their general practitioner or secondary care clinician. The consent rate of participants to the review of their medical records and the estimated costs of the process were evaluated.
  
  
  RESULTS
  One hundred and seventy-nine men (84%: 95% CI = 78%, 89%) consented to have their medical notes reviewed at an estimated cost of pound123 (euro172, $248) per person.
  
  
  CONCLUSIONS
  A high consent rate for review of medical notes is achievable but at a cost. There needs to be renewed debate about the automatic need for consent to review medical records where the chance of personal harm is negligible and the purpose of the review is to provide robust evidence to save lives, prevent needless suffering, and improve the effectiveness and efficiency of health care delivery.
authors.affiliation: Department of Social Medicine, University of Bristol, Bristol, UK. s.m.noble@bristol.ac.uk
authors.forename: Sian
authors.initials: S
authors.lastname: Noble
authors.forename: Jenny
authors.initials: J
authors.lastname: Donovan
authors.forename: Emma
authors.initials: E
authors.lastname: Turner
authors.forename: Chris
authors.initials: C
authors.lastname: Metcalfe
authors.forename: Athene
authors.initials: A
authors.lastname: Lane
authors.forename: Mari-Anne
authors.initials: MA
authors.lastname: Rowlands
authors.forename: David
authors.initials: D
authors.lastname: Neal
authors.forename: Freddie
authors.initials: F
authors.lastname: Hamdy
authors.forename: Yoav
authors.initials: Y
authors.lastname: Ben-Shlomo
authors.forename: Richard
authors.initials: R
authors.lastname: Martin
mesh_terms: D003362:Cost-Benefit Analysis; D005194:Family Practice; D005240:Feasibility Studies; D006302:Health Services Research; D006801:Humans; D007258:Informed Consent; D008297:Male; D008485:Medical Audit; D011471:Prostatic Neoplasms; D016032:Randomized Controlled Trials as Topic; D006113:United Kingdom