Clinical evaluation in healthcare involves assessing the safety and effectiveness of medical interventions or devices in humans. This process requires a thorough literature search to collect relevant information on the device, including clinical investigations, side effects, and medical alternatives. MEDDEV 2.7/1 revision 4 outlines the importance of using objective, non-biased, systematic search, and review methods to ensure that the selected papers accurately reflect the intended use of the device.
Examples are –
- PICO (patient characteristics, type of intervention, control, and outcome queries)
- Cochrane Handbook for Systematic Reviews of Interventions
- PRISMA (The Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement
- MOOSE Proposal (Meta-analysis Of Observational Studies in Epidemiology) The protocol should specify the elements described in the examples given below, addressing the background, objective, methods for identification, selection, and collection of relevant publications to address the literature review questions
Step 1: Define the research question
The first step in conducting a literature search and study is to define the research question. This involves identifying the intervention or device that needs to be evaluated and the population that will be studied. The research question should be focused and specific to ensure that the literature search is targeted and efficient. Research question(s) should be consistent with the scope of the clinical evaluation and carefully constructed using a process, example PICO:
- P- Population(s)/disease(s) or condition(s)
- I- Intervention(s)
- C- Comparator group(s)/control(s)
- O- Outcome(s)/endpoint(s)
Step 2: Conduct a literature search
Once the research question has been defined, the next step is to conduct a literature search. This involves searching for relevant studies in electronic databases such as PubMed, Cochrane Library, and Embase. The search terms should be carefully selected to ensure that all relevant studies are captured. In addition to electronic databases, relevant grey literature such as conference proceedings, dissertations, and government reports should also be searched.
Step 3: Screen and select studies
After conducting the literature search, the next step is to screen and select studies for inclusion in the study. This involves reviewing titles and abstracts of the studies identified in the literature search and selecting those that meet the inclusion criteria. The inclusion criteria should be defined in advance and should be based on the research question. The selected studies should then be reviewed in detail to determine their relevance and quality.
Step 4: Evaluate study quality
The quality of the studies selected for inclusion in the study should be evaluated using established criteria such as the Cochrane Risk of Bias tool or the appraisal criteria defined in the literature search protocol for the device under assessment. The quality of the studies is important because it affects the reliability and validity of the results. Studies with a high risk of bias should be excluded from the study.
Step 5: Extract data and analyse results
The next step is to extract data from the selected studies and analyse the results. Data extraction involves collecting information on the study design, sample size, intervention or device being evaluated, and outcomes measured. The data should be analysed using appropriate statistical methods to determine the effectiveness and safety of the intervention or device.
Step 6: Interpret and communicate results
The final step is to interpret and communicate the results of the study. The results should be interpreted considering the research question and the study objectives. The implications of the results for clinical practice should be discussed, and recommendations for further research should be made. The results should be communicated clearly and accurately to ensure that they are understood by all stakeholders, including patients, healthcare professionals, and regulators.
In conclusion, conducting a literature search and study for clinical evaluation is a complex and important process that requires careful planning and execution. By following the steps outlined above, healthcare professionals can ensure that the evaluation of medical interventions and devices is evidence-based and of high quality.
At IZiel, we prioritize clarity and structure in alignment with the expectations of European Authorities. Our primary goals are to ensure thoroughness and scientific accuracy throughout the process of gathering and presenting data in the CER. Obtaining approval serves as the definitive endpoint for every report we produce. According to the EU MDR, clinical Evaluation is recognized as a means of evaluating the balance between benefits and risks associated with medical devices. Additionally, conducting risk assessments is crucial for justifying foreseeable risks to subjects in relation to the advantages. These assessments must be well-documented in the clinical evaluation plan, which should also incorporate an ongoing monitoring strategy for risks and the benefit-risk ratio.
At IZiel we provide complete expertise in Literature Search & Study to assist in the clinical evaluation of the product.
