Methodology for the Literature Search
Scientific Literature is a permanent record of the collective achievements based on the research, and it is the principle medium for conveying the result of the scientific research. A literature search is systematic, and thorough by nature that pertains to a specific topic. A manufacturer needs to evaluate pre-market clinical investigations to measure the clinical performance and safety of a Medical device. The evaluation is based on the comparison of an equivalent device or the relevant preclinical studies. Sometimes the clinical investigation data also includes the manufacturer’s own evaluation and report. Literature searching is to identify the data not held by the manufacturer that are needed for the clinical evaluation. The literature search protocols, search reports, and the full text documents of the relevant literatures are used for the preparation of the technical documentation of any Medical Device.
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Planning the search strategy is so important to get the clinical data relevant to the device under evaluation and the planning strategy start with the proper understanding of the review questions and the scientific areas covered by the devices such as clinical background, added impurities, clinical hazards and current knowledge/ state-of- the-art. The searching include different scientific literature sources to retrieve the articles which enhances the relevance. The searched articles should be in a way that critically appraises the research in order to answer the formulated questions. Conducting systematic searches results in scientific evidences for the research. For a full systematic review, the search strategy needs to be comprehensive, clear and reproducible. For some Medical devices, a greater part of the clinical evidence is based on the clinical data from Literature searching.
Some Search Frameworks are used to develop the search concepts and terms from the review questions. The input for the review questions are the device description and the intended use of the device. PICO is one of the most available Search Frameworks used in health science to focus on clinical questions. PICO stands for Population/ Patient/ Problem, Intervention, comparison and Outcome. PICOT, PICOS, PICOC are other search frameworks used for developing search terms. A comprehensive search strategy is required, involving multiple literature databases. Some popular scientific literature databases are MEDLINE or PubMed, EMBASE, Web of Science, Cochrane Library and PROSPERO. Additional databases can be used to ensure the adequate coverage of the devices to identify relevant clinical trials. Randomized Controlled trial type literature are highly prioritized in the selection process. The scientific validity of the information will be more in these type of literature’s. Several searches with different search criteria should be applied to obtain necessary and precise data.
Question 01: How to Establish the methodology for the literature search?
Question 02 : How to identify relevant documentation from the literature search done?
Questions 03: How to check Literature search adequacy?
1. As the blogger has mentioned, the literature search methodology could be established using search frameworks like PICO, PICOT, PICOS, PICOC, etc. Other examples of search methodologies are PRISMA, MOOSE Proposal, Cochrane Handbook for Systematic Reviews of Interventions. The input for literature review questions for PICO methodology should be the device description and intended performance of the device along with any claims on clinical performance and clinical safety which the manufacturer wants to use. The research questions should be in the scope of the clinical evaluation.
2. The identification of relevant documentation from the literature search can be done based on the selection criteria or the inclusion/exclusion criteria.
3. Based on my understanding, the adequacy of the literature search depends on the quality of the literature review, not the number of literature included. The evaluator has to check if the literature review would be able to provide an answer to all the literature review questions in regard to the relevant safety and performance claims, device description, and clinical performance.