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

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Abstract

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To investigate the responses to public consultation on draft guidance on interventional procedures (IP) for the UK National Health Services, and the changes made as a result of consultation.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Retrospective review of responses received during public consultation for 183 pieces of draft guidance, and subsequent changes made.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Numbers (%) of public consultations receiving responses, and resulting changes made to draft guidance.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 Changes were made to draft guidance following 136 (74.3%) consultations.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This study shows substantial engagement with public consultation and frequent changes made to draft guidance as a result.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.

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