Clinical Evaluation Report with incomplete documentation of the literature search and review will lead to a non-conformity. Because the MDCG document 2020-13 specifically requires notified bodies to verify the literature search documentation, this can result in unnecessary questions or even audit variations. A search methodology is used to carry out a literature search and review protocol and other data retrieval. The search protocol documents the planning of the search forward to its execution. The process for literature search and review is stated in Appendix A5 of the MEDDEV 2.7/1 guidance.

Importance of Developing a Protocol for Conducting a Literature Review

 A review process is a step-by-step guide for performing literature reviews, which may include systematic reviews, scoping reviews, and meta-analyses. Before beginning the literature review, the protocol must be developed to ensure that the process is clear and consistent throughout. The protocol should include explicit recommendations for identifying and screening appropriate articles for the review, as well as an outline of the overall review methodology. It also gives an overview of the review process, which aids in preparing and anticipating issues that may arise throughout the review. After the review is done, the methodology can assist the review team or other researchers in following the same process to update the literature review when new research becomes available. (Buy Literature Search Protocol and Templates)

Key elements of a literature search and review protocol:

→   Objective of literature search and review Protocol

The first stage in performing a thorough Systematic Search is to create a literature search and review plan that determines the manufacturer’s clinical evaluation scope. The purpose of literature search and review is to determine published scientific studies that include valid results about the safety, performance, and clinical benefits of the medical device in question, as well as the device’s state of the art. The literature search should be exact, detailed, and thoroughly documented, which means it should include all important data, both favorable and unfavorable. For example, if the specific risk associated with the medical device has been recognized then one of the aims might be to find literature that includes information on that associated risk.

→   Defining the review question

A good review question is clear and focused. It should relate to a specific patient problem because this helps to identify the clinically relevant evidence. The exact structure of the review question will depend on what is being asked. The review question will determine not just the search technique, but also the conclusions that can be reached from the review, as they will be dependent on whether studies or other types of evidence are included and excluded from the review. The review question can be categorized into concepts using a variety of frameworks for example the PICO (population, intervention, comparator, and outcome) was designed to answer the review questions.

→   Database for literature searching

The required clinical data is obtained from different sources, including scientific databases, internet searches, unpublished data, and citations. PubMed, Cochrane central trial registry, EMBASE, PDQ evidence, Trip, and CINAHL are only a few of the scientific databases that were used. Google Scholar, manufacturer websites, the FDA, the Cochrane database of systematic reviews, and other websites are used to do internet searches. Instructions for use, implant registries, and data presented at the congress are examples of non-published data.  By creating keywords linked to each of the review questions, the search is conducted across numerous sources. Each term or keyword is carefully chosen to ensure the best possible search results. The use of operators like AND, OR, NOT, and others to combine various keywords to make the search term more understandable.

→   Screening of literature search

The search results are screened at two levels: the title or abstract screening based on inclusion and exclusion criteria, and the full-text screening of the included articles to determine relevance. Screening is an elimination process in which article titles and abstracts are reviewed to see if the study presented exceeds any of the exclusion criteria. Exclusion criteria are created based on the systematic review’s goals and objectives, and each title and abstract are reviewed and evaluated according to criteria. The title/abstract is deleted if it meets a single exclusion condition.

→   Preparation of review report

After including and excluding the literature the literature review reports for each of the review questions are created from the search results that pass the screening. The Literature Search Review Report is used to display the search results, which cover topics such as safety, performance, patient benefits, side effects, adverse reactions, state of the art, and so on. These measures ensure that the literature used in the reports is of high quality. Introduction, Materials and Methods, Results, and Conclusion are common steps in creating literature review reports.

These five points are the key elements of a review protocol. To get a good literature search, the search method must be broad enough to assure that no important information is neglected while still allowing for the accurate analysis of the relevant results. It will be always kept in mind that the Literature Search Protocol must be well-written and exact because it works as the background for all subsequent steps in the clinical evaluation process.

Author: Ms. Sadaf Parveen, Jr. Consultant and Regulatory Expert, I3CGLOBAL