a1 National Institute for Health and Clinical Excellence (NICE); University of Cambridge [email protected]
a2 National Institute for Health and Clinical Excellence (NICE)
a3 National Institute for Health and Clinical Excellence (NICE); Peninsula College of Medicine and Dentistry
Background: Keeping clinical practice recommendations up-to-date with a continually evolving evidence base presents challenges. Resources required to update recommendations compete with those needed to evaluate newer treatments.
Methods: We describe an approach developed by the UK National Institute for Health and Clinical Excellence (NICE) for updating clinical practice recommendations for new interventional procedures and we evaluate relevant initial experience of using this system. Depending on whether evidence for a procedure is judged adequate or inadequate for safety and efficacy, use in clinical practice is usually recommended with either “normal” or “special” arrangements for patient consent, data collection and institutional oversight, respectively. We examined whether differences in the state of the evidence at the initial and the updated appraisal of procedures were associated with changed recommendations.
Results: Since 2008, updating of recommendations focuses on procedures with initially inadequate evidence. “Special arrangements” recommendations about eleven procedures were updated after 3.3–6.5 years (median, 5.3 years), and recommendations for six were changed to “normal arrangements.” Overall, procedures with changed (“special-to-normal”) recommendations had a greater increase in the number of patients included in observational studies published since the initial guidance.
Conclusions: Procedures with changed (“special-to-normal”) recommendations generally had greater increases in their evidence base. Although uncertainties about optimal methods for keeping evidence-based recommendations up-to-date remain, this experience should be useful to policy makers in developing processes for prioritizing scarce resources for updating clinical practice recommendations. Further studies are needed about the value placed on “updated” recommendations by clinicians, policy-makers, and patients.
The authors have no conflict of interest. They work for the National Institute for Health and Clinical Excellence (NICE). The authors’ employer had no involvement or influence in the concept, design, analysis and write up of the study. No external sources of funding. Ethical approval is not required. All the empirical material for this study is freely available on NICE's Web site, and anyone in the world can have access to the information. G.L. is guarantor. G.L. conceived the original idea for study. S.B., H.S., and S.P. collected and analysed data and all five authors were involved in discussions and decisions about methods of analysis. G.L. wrote the initial and final draft, along with B.C. and all other authors. We acknowledge the help and support of Ms. Mirella Marlow, Director, Devices and Diagnostics, NICE.