Objectives: In preparation of a clinical trial, the existing evidence on the topic needs to be systematically reviewed to avoid research waste and to provide a rationale for the planned trial. If a current systematic review (SR) is not available, a new one should be conducted. However, such an evidence-based research approach is rarely used, and no guidance for clinical researchers exists. Therefore, we aimed 1) to develop a practical guide for clinical researchers to rapidly review the literature before starting a new trial and 2) to conduct formal usability testing of the guidance.
Methods: We developed the guidance for clinical researchers in several steps: 1) literature search for existing rapid review (RR) methods guidance, guidance on conducting literature reviews specifically for clinical research, and relevant methods research; 2) literature selection including a relevancy rating; 3) data extraction; 4) consultation with our stakeholder panel on the first draft; 5) usability testing of the first interim version; and 6) final version of the guidance.
Results: We screened 602 documents and included 24 existing guidances and 29 methods studies. We extracted and synthesized recommendations for each literature review domain (i.e., research question, eligibility criteria, screening, etc.). Our interim guidance consists of two documents—the practical guide listing essential and optional tasks, explanations, and recommended tools, and a template with signaling questions, which allows users to efficiently complete and document the work process. The suggested approach consists of two parts: Part A “Evidence from existing SRs and ongoing trials” and Part B “Evidence from primary studies.” Decision points for “How to proceed from here” with several possible scenarios are presented.
Conclusions: To make clinical research more evidence based, we developed a systematic approach for clinical researchers to rapidly review the literature when planning a new clinical trial.
Patient, public and/or healthcare consumer involvement: The interim guidance and template will undergo formal usability testing, where the main target group of the guide—researchers in the planning phase of a clinical trial—will apply the guide, use the template, and provide feedback thereafter.