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OBJECTIVES: To investigate the responses to public consultation on draft guidance on interventional procedures (IP) for the UK National Health Services, and the changes made as a result of consultation. DESIGN: Retrospective review of responses received during public consultation for 183 pieces of draft guidance, and subsequent changes made.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 MAIN OUTCOME MEASURES: Numbers (%) of public consultations receiving responses, and resulting changes made to draft guidance.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 Changes were made to draft guidance following 136 (74.3%) consultations.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 CONCLUSIONS: This study shows substantial engagement with public consultation and frequent changes made to draft guidance as a result.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

Identifying and selecting new procedures for health technology assessment: a decade of nice experience in the United Kingdom.

OBJECTIVES: The aim of this study was to analyze the experience of the National Institute for Health and Care Excellence (NICE) in identifying new procedures entering the United Kingdom (UK) healthcare system, for assessment and publication of recommendations on their use. This system is designed to provide guidance in an area where regulation is lacking worldwide. METHODS: Retrospective analysis of all procedures notified to the Interventional Procedures Programme (NICE) between 2002 and 2012. Notifications were analyzed year by year for their source (who notified them), clinical specialties involved, and whether guidance was subsequently published. RESULTS: A total of 1,094 procedures were notified by clinicians (51 percent), and by others, including hospitals (6 percent), horizon scanners (5 percent), patients (4 percent), private health insurers (4 percent), and medical device manufacturers (3 percent). Guidance was published on 44 percent of procedures notified to the program. There was a decrease in the numbers of procedures notified during 2003-2012 (p = .049). There were notifications across all specialties, with the largest numbers in general surgery (125), urology (104), orthopedics (99), interventional radiology (93), cardiology (82), and obstetrics and gynecology (82). CONCLUSIONS: The "open" NICE Web portal allows anyone to notify new procedures, aiming to maximize the opportunity of identifying all those procedures entering clinical practice. This has resulted in identification of large numbers of procedures from across the whole range of medical specialties. The fact that similar proportions of procedures notified from diverse sources have been selected for assessment and publication of practice recommendations suggests that this inclusive approach is worthwhile.

Comparison of the assessment of five new interventional procedures in different countries.

OBJECTIVES: The aim of this study was to identify and compare health technology assessments of the same new interventional procedures produced in different countries. METHODS: We selected five new interventional procedures and studied related assessments produced in different countries. RESULTS: There were twenty assessments (range, 3-5 per procedure) from nine countries--fourteen from Australia, Canada, and United Kingdom. The number of primary RCTs cited by the assessments ranged from 0 to 13. In the assessment reports, "headline" statements about the strength of evidence for efficacy (73 percent) were made more frequently than for safety (53 percent). These statements were scored for their apparent judgment of the strength of the evidence--1 (poor) to 5 (strong)--and received scores of 3 or less in all but four cases. Recommendations about additional research were included in 55 percent of the assessments. Statements in assessments about other aspects of use of the procedures were included more infrequently--in 35 percent for patient selection, in 20 percent for consent issues, and in 15 percent for types of clinical teams. Recommendations about appropriate healthcare settings, or about operator training, were included only in assessments produced by a single organization. CONCLUSION: There was a only small number of assessments world-wide, for a range of new procedures with potentially high impact. Where available, assessments were produced on a relatively poor evidence base. International collaboration in evidence appraisal and review, and in the gathering of new data through research or registers, could improve the advice available to healthcare systems worldwide about the adoption of new interventional procedures.