National Institute for Health and Clinical Excellence (NICE).
Int J Technol Assess Health Care. 2012 Jan;28(1):29-35. doi: 10.1017/S0266462311000675. Epub 2012 Jan 23.
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.
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.
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.
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.
将临床实践建议与不断发展的证据基础保持同步更新面临挑战。更新建议所需的资源与评估新治疗方法所需的资源相竞争。
我们描述了英国国家卫生与临床优化研究所(NICE)为更新新介入性手术的临床实践建议而开发的方法,并评估了使用该系统的相关初步经验。根据程序的证据是否被认为在安全性和疗效方面足够或不足够,通常建议在临床实践中使用“正常”或“特殊”的患者同意、数据收集和机构监督安排,分别。我们检查了程序初始评估和更新评估中证据状态的差异是否与建议的改变有关。
自 2008 年以来,建议的更新重点是最初证据不足的程序。“特殊安排”建议的十一项程序在 3.3-6.5 年后(中位数为 5.3 年)进行了更新,其中六项建议改为“正常安排”。总体而言,建议改变的程序(“特殊到正常”)在初始指导后发表的观察性研究中纳入的患者数量增加了。
建议改变的程序(“特殊到正常”)通常在其证据基础上有更大的增加。尽管对于保持基于证据的建议更新的最佳方法仍存在不确定性,但这一经验对于决策者制定优先考虑更新临床实践建议的稀缺资源的流程应是有用的。需要进一步研究临床医生、政策制定者和患者对“更新”建议的重视程度。