Kahale Lara A, Ouertatani Hella, Brahem Asma Ben, Grati Hela, Hamouda Mohammed Ben, Saz-Parkinson Zuleika, Akl Elie A
American University of Beirut, Beirut, Lebanon.
L'Instance Nationale de l'Evaluation et de l'Accréditation en Santé (INEAS), Tunis, Tunisia.
Health Res Policy Syst. 2021 May 13;19(1):80. doi: 10.1186/s12961-021-00731-z.
Breast cancer is a common disease in Tunisia and is associated with high mortality rates. The "Instance Nationale de l'Evaluation et de l'Accréditation en Santé" (INEAS) and the Tunisian Society of Oncology decided to develop practice guidelines on the subject. While the development of de novo guidelines on breast cancer screening is a demanding process, guideline adaptation appears more appropriate and context sensitive. The objective of this paper is to describe the adaptation process of the European Guidelines on Breast Cancer Screening and Diagnosis to the Tunisian setting in terms of the methodological process, contextual differences between the source and adoloped guideline, and changes in the recommendations.
We used the 'Grading of Recommendations Assessment, Development and Evaluation' (GRADE)-ADOLOPMENT methodology to prioritize the topic, select the source guideline, and prioritize the questions and the outcomes. Once the source guideline was selected-the European Breast Cancer Guidelines-the European Commission´s Joint Research Centre shared with the project team in Tunisia all relevant documents and files. In parallel, the project team searched for local studies on the disease prevalence, associated outcomes' baseline risks, patients' values and preferences, cost, cost-effectiveness, acceptability, and feasibility. Then, the adoloping panel reviewed the GRADE evidence tables and the Evidence to Decision tables and discussed whether their own judgments were consistent with those from the source guideline or not. They based their judgments on the evidence on health effects, the contextual evidence, and their own experiences.
The most relevant contextual differences between the source and adoloped guidelines were related to the perspective, scope, prioritized questions, rating of outcome importance, baseline risks, and indirectness of the evidence. The ADOLOPMENT process resulted in keeping 5 out of 6 recommendations unmodified. One recommendation addressing "screening versus no screening with ultrasound in women with high breast density on mammography screening" was modified from 'conditional against' to 'conditional for either' due to more favorable ratings by the adoloping panel in terms of equity and feasibility.
This process illustrates both the feasibility of GRADE-ADOLOPMENT approach and the importance of consideration of contextual evidence. It also highlights the value of collaboration with the organization that developed the source guideline.
乳腺癌在突尼斯是一种常见疾病，且死亡率很高。突尼斯国家卫生评估与认证机构（INEAS）和突尼斯肿瘤学会决定制定关于该主题的实践指南。虽然从头制定乳腺癌筛查指南是一个艰巨的过程，但指南改编似乎更合适且符合具体情况。本文的目的是从方法学过程、源指南与改编后指南的背景差异以及建议的变化等方面，描述欧洲乳腺癌筛查与诊断指南在突尼斯背景下的改编过程。
我们使用“推荐分级评估、制定与评价”（GRADE）-ADOLOPMENT方法对主题进行优先级排序、选择源指南，并对问题和结果进行优先级排序。一旦选定源指南——欧洲乳腺癌指南，欧盟委员会联合研究中心就与突尼斯的项目团队分享了所有相关文件和档案。与此同时，项目团队搜索了关于疾病患病率、相关结果的基线风险、患者的价值观和偏好、成本、成本效益、可接受性和可行性的本地研究。然后，改编小组审查了GRADE证据表和证据到决策表，并讨论他们自己的判断是否与源指南的判断一致。他们基于健康影响证据、背景证据和自身经验做出判断。
源指南与改编后指南之间最相关的背景差异与视角、范围、优先问题、结果重要性评级、基线风险和证据的间接性有关。ADOLOPMENT过程导致6条建议中有5条未作修改。一条关于“乳腺钼靶筛查显示乳腺密度高的女性进行超声筛查与不筛查”的建议，由于改编小组在公平性和可行性方面给予了更有利的评级，从“有条件反对”改为“有条件支持二者中的任何一个”。
这一过程既说明了GRADE-ADOLOPMENT方法的可行性，也说明了考虑背景证据的重要性。它还强调了与制定源指南的组织合作的价值。
