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.
RCT Entities:
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: S Trent Rosenbloom; Jennifer L Madison; Kyle B Brothers; Erica A Bowton; Ellen Wright Clayton; Bradley A Malin; Dan M Roden; Jill Pulley Journal: J Am Med Inform Assoc Date: 2013-07-25 Impact factor: 4.497
Authors: Freddie C Hamdy; Jenny L Donovan; J Athene Lane; Malcolm Mason; Chris Metcalfe; Peter Holding; Julia Wade; Sian Noble; Kirsty Garfield; Grace Young; Michael Davis; Tim J Peters; Emma L Turner; Richard M Martin; Jon Oxley; Mary Robinson; John Staffurth; Eleanor Walsh; Jane Blazeby; Richard Bryant; Prasad Bollina; James Catto; Andrew Doble; Alan Doherty; David Gillatt; Vincent Gnanapragasam; Owen Hughes; Roger Kockelbergh; Howard Kynaston; Alan Paul; Edgar Paez; Philip Powell; Stephen Prescott; Derek Rosario; Edward Rowe; David Neal Journal: Health Technol Assess Date: 2020-08 Impact factor: 4.014