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Systematic Literature Search

Systematic Literature Search is performed to identify suitable clinical data, which is not available with the manufacturer to demonstrate clinical performance and safety.

 

The selected clinical data identified undergo a series of stringent checks to assess its suitability before being included in the clinical evaluation. The data obtained from various sources are appraised to evaluate their relevance and contribution to the evaluation of safety and clinical performance. The appraised data-set is then analyzed to check if they can be used collectively to demonstrate the compliance of the device to general safety and performance requirements.

 

Clinical evaluation is a continuous process used to evaluate the conformity of medical devices to general safety and performance requirements when used as intended by the manufacturer
Scientific Literature Search

Importance of Systematic Literature Search

The search for literature forms an important part of clinical evaluation as it is used during various stages of clinical evaluation as explained in MEDDEV 2.7/1 Rev. 4.

 

The clinical data obtained from the scientific literature together with the data held by the manufacturer provides the clinical evidence needed to prove the safety and performance of the device as well as to inform current knowledge and/or state of the art (SOA) sections.

 

In some cases when the data from the manufacturer is insufficient, clinical data from scientific literature of equivalent/similar devices will represent a major part of clinical evidence.

Systematic Literature Search & Reporting Process

1. Preparation of Literature Search(LS) and Review Plan

The first step towards conducting a thorough Systematic Search is to prepare a literature search and review plan considering the scope of the clinical evaluation set by the manufacturer.

 

The review questions based on which the search will be conducted are mentioned in the plan. A literature search strategy with different searching techniques must be set out before starting the search. The most used methodology is PICO (P- Population, I- Intervention, C- Control or Comparison, O- Outcome).

 

Depending on the device, the PICO framework can be adapted to include T-time (PICOT), S- Study design (PICOS) or C- Context (PICOS). Other examples of LS and review methods are PRISMA statement, MOOSE proposal, SPICE, PEO and ECLIPSE, which are also available.

2. Identification of Literature Search Databases

The quality of the data is determined by the sources of the literature – Literature Search Databases. Different sources like scientific databases, internet searches, non-published data, and citations are used to obtain the required clinical data.

 

Some of the scientific databases used are Pubmed, Cochrane central trial register, EMBASE, PDQ evidence, Trip and CINAHL. Internet search is mainly conducted on Google Scholar, manufacturer website, FDA, Cochrane database of systematic review, etc.

 

Non-published data include information from instructions for use, implant registries information and data presented in congress. The index of citation in scientific literature is available in Scopus and Web of science. The search is performed across various sources by forming keywords related to each of the review questions.

 

Each keyword or phrase is carefully selected to get the best possible results while searching.  Boolean search strategy could be applied where operators like AND, OR, NOT, etc. are used to combine different keywords to make the search term more meaningful. Another method to improve the results of the search is the use of MeSH terms.

 

Filters are also applied to refine the search results to meet the expected criteria.

3. Screening of Scientific Literature

A two-level screening of the search results is performed – the title or abstract screening based on inclusion and exclusion criteria, and a full-text screening of the included articles to determine the relevancy.

4. Preparation of Literature Search Review Report

The search results that pass the screening are used to form the literature review reports for each of the review questions.

 

The Literature Search Review Report is used to present the results of the search that address the aspects like safety, performance, benefits to the patient, side-effects, adverse reactions, state of the art, etc.

 

These steps ensure the quality of the literature included in the reports. Typical steps involved in writing literature review reports are- Introduction, Materials and Methods, Results and Conclusion.

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Advantages of Comprehensive and Systematic LS

A comprehensive and systematic LS is performed to obtain clinical evidence corresponding to the safety and performance requirements being evaluated since any lack in clinical data held by the manufacturer is compensated using the data obtained through a LS.

 

A systematic LS will also provide exact evidence as well as saves time and effort.

 

Systematic reviews mainly resolve the problems by identifying, critically evaluating and integrating the findings of all relevant, high-quality individual studies addressing one or more research questions hence the search for literature in a systematic way forms an important part of clinical evaluation.

The search for literature forms an important part of clinical evaluation as it is used during various stages of clinical evaluation explained in MEDDEV 2.7/1 Rev 4.

 

The clinical data obtained from the literature together with the data held by the manufacturer provides the clinical evidence needed to prove the safety and performance of the device.

 

In some cases when the data from the manufacturer is insufficient, clinical data from the literature will represent a major part of clinical evidence. It can, therefore, be concluded that the LS is vital for clinical evaluation.

Literature Search Protocol and Templates for Sale!!

Our team of technical experts and trained specialists have prepared literature search protocol and related templates. This ready to use and customizable documents are now available online for purchase.
We recommend that relevant department personnel only should purchase the protocol and templates otherwise it is of no use.

Write to us for more information.

enquiry@i3cglobal.com

Could the abstract of a paper considered to be relevant during the literature search?

Abstracts lack enough detail to allow issues to be evaluated thoroughly and independently but may be enough to allow a first screening of the relevance of a paper. Copies of the full text papers and documents should be obtained for the appraisal stage.

What comprises the clinical evidence during LS for clinical evaluation?

The clinical data obtained from scientific literature forms clinical evidence for clinical evaluation.

What is PICO, Cochrane Handbook for Systematic Reviews of Interventions, PRISMA and MOOSE Proposal?

PICO, Cochrane Handbook for Systematic Reviews of Interventions, PRISMA and MOOSE Proposal are a few examples of objective, non-biased, systematic search and review methods.

Full-form of Search and Review Methods

  1. PRISMA statement: Preferred Reporting Items for Systematic Review and Meta Analysis
  2. MOOSE proposal: Meta-Analysis Of Observational Studies in Epidemiology
  3. SPICE: Setting, Population Perspective, Intervention, Comparison, Evaluation
  4. PEO: Population, Exposure, Outcomes
  5. ECLIPSE: Expectation, Client group, Location, Impact, Professionals, SErvice