Division of Surgical Oncology, Department of Surgery, University of Michigan, Ann Arbor, MI 48109-5932, USA.
J Clin Oncol. 2013 Jul 10;31(20):2563-8. doi: 10.1200/JCO.2012.46.8371. Epub 2013 Jun 10.
Significant concerns exist regarding the content and reliability of oncology clinical practice guidelines (CPGs). The Institute of Medicine (IOM) report "Clinical Practice Guidelines We Can Trust" established standards for developing trustworthy CPGs. By using these standards as a benchmark, we sought to evaluate recent oncology guidelines.
CPGs and consensus statements addressing the screening, evaluation, or management of the four leading causes of cancer-related mortality in the United States (lung, breast, prostate, and colorectal cancers) published between January 2005 and December 2010 were identified. A standardized scoring system based on the eight IOM standards was used to critically evaluate the methodology, content, and disclosure policies of CPGs. All CPGs were given two scores; points were awarded for eight standards and 20 subcriteria.
No CPG fully met all the IOM standards. The average overall scores were 2.75 of 8 possible standards and 8.24 of 20 possible subcriteria. Less than half the CPGs were based on a systematic review. Only half the CPG panels addressed conflicts of interest. Most did not comply with standards for inclusion of patient and public involvement in the development or review process, nor did they specify their process for updating. CPGs were most consistent with IOM standards for transparency, articulation of recommendations, and use of external review.
The vast majority of oncology CPGs fail to meet the IOM standards for trustworthy guidelines. On the basis of these results, there is still much to be done to make guidelines as methodologically sound and evidence-based as possible.
人们对肿瘤临床实践指南(CPG)的内容和可靠性存在重大担忧。美国医学研究所(IOM)的报告《值得信赖的临床实践指南》为制定可靠的 CPG 确立了标准。我们使用这些标准作为基准,旨在评估最近的肿瘤学指南。
确定了 2005 年 1 月至 2010 年 12 月期间发布的针对美国四大癌症相关死亡原因(肺癌、乳腺癌、前列腺癌和结直肠癌)的筛查、评估或管理的 CPG 和共识声明。使用基于 IOM 八项标准的标准化评分系统对 CPG 的方法、内容和披露政策进行严格评估。所有 CPG 均获得两个分数;八项标准和 20 个子标准各得一分。
没有 CPG 完全符合 IOM 的所有标准。平均总分是 8 个可能标准中的 2.75 分和 20 个可能子标准中的 8.24 分。不到一半的 CPG 基于系统评价。只有一半的 CPG 小组解决了利益冲突问题。大多数 CPG 不符合将患者和公众纳入发展或审查过程的标准,也没有指定更新程序。CPG 在透明度、建议的表达以及外部审查的使用方面与 IOM 标准最一致。
绝大多数肿瘤学 CPG 不符合 IOM 制定可靠指南的标准。根据这些结果,仍有许多工作要做,以使指南尽可能具有方法学上的合理性和基于证据。