Centre for Infectious Disease Epidemiology and Research, University of Cape Town, South Africa Department of Epidemiology and Biostatistics, University of California, San Francisco.
Department of HIV/AIDS, World Health Organization, Geneva, Switzerland.
Clin Infect Dis. 2015 Jun 1;60 Suppl 3:S205-11. doi: 10.1093/cid/civ139.
During a World Health Organization-convened Guideline Development Group meeting, recommendations for postexposure prophylaxis (PEP) for human immunodeficiency virus were made and research gaps identified.
We used the PEP clinical management pathway and the Grading of Evidence, Assessment, Development and Evaluation (GRADE) system as a framework to formulate future research questions, describe the most feasible study design, and identify potential biases.
Three key study design formats were identified to address 12 research questions: (1) survey- and interview-driven research to identify barriers to access to PEP and related clinical care; (2) establishment of a global PEP registry to generate data to inform the choice of an optimal PEP drug regimen, record drug toxicities arising from specific PEP regimens, and track follow-up and linkage to care (including transition from PEP to preexposure prophylaxis); and (3) randomized controlled trials to determine the optimal adherence promotion strategies necessary for successful outcomes following PEP.
Positioning key clinical and programmatic research questions within the GRADE framework facilitates the formulation of an evidence-based research agenda and future revisions of guidelines.
在世卫组织召集的指南制定小组会议上，提出了人类免疫缺陷病毒暴露后预防 (PEP) 的建议，并确定了研究空白。
我们使用 PEP 临床管理途径和证据分级、评估、开发和评价 (GRADE) 系统作为框架，制定未来的研究问题，描述最可行的研究设计，并确定潜在的偏倚。
确定了三种关键的研究设计格式来解决 12 个研究问题：(1) 调查和访谈驱动的研究，以确定获得 PEP 和相关临床护理的障碍；(2) 建立全球 PEP 登记册，生成数据以告知选择最佳 PEP 药物方案，记录特定 PEP 方案引起的药物毒性，并跟踪随访和联系护理（包括从 PEP 过渡到暴露前预防）；(3) 随机对照试验，以确定成功进行 PEP 后所需的最佳依从性促进策略。
将关键的临床和计划研究问题置于 GRADE 框架内，有助于制定基于证据的研究议程和未来指南的修订。
