Public consultation changes guidance on the use of health-care interventions. An observational study.

Objectives: To investigate the responses to public consultation on draft guidance on interventional procedures (IP) for the UK National Health Services, and the changes made as a result of consultation.

Design: Retrospective review of responses received during public consultation for 183 pieces of draft guidance, and subsequent changes made.

Setting: The National Institute for Health and Care Excellence in the UK. Guidance produced December 2009-December 2014.

Main Outcome Measures: Numbers (%) of public consultations receiving responses, and resulting changes made to draft guidance.

Results: Responses were received during 159 (86.9%) periods of public consultation, from a total of 853 people or organizations (median number per consultation 3; range 0-82; interquartile range 1-5). Changes were made to draft guidance following 136 (74.3%) consultations. These changes were to the category (2.7%) or wording (8.7%) of the main recommendation; to other recommendations (about consent, patient selection, training and future research) (31.1%); and to other sections of guidance (description of the procedure and of the evidence on its efficacy and safety) (70.5%). Additional published evidence was proffered for 22.4%. Health-care professionals or their specialist societies were the most frequent responders to consultation (68.8%), patients or patient organizations accounted for 22.4% and medical device companies accounted for 8.8%.

Conclusions: This study shows substantial engagement with public consultation and frequent changes made to draft guidance as a result. These findings are likely to be relevant to other areas of health-care and national policymaking that seek to be responsive to their stakeholders.