The Role of PRISMA in Evidence-Based Medicine

Scientific Communications

Introduction

Systematic reviews present comprehensive data about a research question and are regarded as the gold standard for evidence synthesis in health care because they use a structured, transparent, and reproducible methodology to identify, evaluate, and summarize all relevant studies on a particular topic. In the medical field, systematic reviews offer insight about the safety and effectiveness of treatments and interventions. For example, a meta-analysis might assess and compare complication rates among similar medical devices. The clinical evidence synthesized from a systematic review of literature is often leveraged for regulatory submissions, such as those needed to obtain approval for marketing medical devices in the European Union. Robust literature search methods not only support regulatory acceptance but also elevate the scientific integrity and clinical relevance of clinical evaluation reports. Systematic reviews often provide the foundation for meta-analyses, which quantitatively combine data to test specific hypotheses.

Recognizing High-Quality Evidence

To standardize reporting, the quality of reporting of meta-analyses (QUOROM) checklist was developed. This later developed into the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines in 2009 which were subsequently updated in 2020. The PRISMA guidelines are available for no charge online.  Accompanying the checklist is an explanation and elaboration paper which describes the rationale for the items and provides examples. The checklist is used as a tool to guide writing and confirm that the necessary elements are included. In addition to the report guidelines, there are also protocol guidelines (PRISMA for Protocols, PRISMA-P, 2015) to help prospectively plan the systematic review to reduce bias. The PRISMA-P items are coordinated with the PRISMA checklist for reports to facilitate transparency and methodological rigor throughout the review process.

The checklists in the guidelines were designed to enhance transparency, quality, and consistency of systematic reviews and meta-analyses – the cornerstone of evidence-based medicine. For authors, the checklists are helpful not only during finalization, but also early in the writing process. Reviewers and editors can use PRISMA to assess the quality and completeness of the review. PRISMA is now one of the most cited reporting guidelines in biomedical literature. Cochrane and several hundred journal publishers endorse these guidelines. These endorsements can increase the credibility of the review for readers. For trained medical writers, PRISMA-compliant systematic reviews can serve as reliable sources.

While PRISMA enhances reporting quality, the rigor of the review’s methodology depends on adherence to methodological standards and best practices. Trained medical writers must still be able to recognize bias, the comprehensiveness and validity of the literature searches employed, the use of appropriate statistical methods, and whether the discussion of findings and limitations is balanced. The main PRISMA reporting guidelines were designed to improve the reporting of systematic literature reviews and meta-analyses evaluating the effects of interventions; there are several s to PRISMA that provide reporting guidance for other aspects of the systematic review process such as development and reporting of the protocol, abstract, and search strategy as well as for other types of evidence syntheses (e.g., scoping reviews, network meta-analyses, living systematic reviews).

Leveraging High-Quality Evidence

Methodical and transparent literature searches and the ability to recognize unbiased, high-quality evidence-based medicine can elevate the quality of clinical evaluation reports or summaries of real-world evidence used in a regulatory submission. For example, recognizing publication bias is essential. When some published meta-analyses suggest an increased risk of a particular adverse event but company-sponsored studies report favorable results, an inclusive, unbiased evidence-based search strategy is critical for credibility. An extended, rigorous search might identify additional studies reporting higher than anticipated adverse event rates, but their inclusion provides a balanced, comprehensive risk profile and demonstrates commitment to patient safety. When an unexpected adverse event is uncovered, risk management files can be updated, showcasing a proactive and risk-based approach to compliance.

Expert medical writers will also recognize and prioritize the hierarchy of evidence. They will critically appraise studies including randomized controlled trials, systematic reviews, and large observational studies, weighting these appropriately in the benefit-risk analysis. An experienced medical writer will identify and document limitations and biases, clearly distinguishing between high-quality and lower-quality studies. A less experienced writer might treat all studies as equally valid, citing small case series or anecdotal reports without critical appraisal. They may overlook methodological flaws or fail to explain how evidence quality impacts the overall benefit-risk assessment, undermining the credibility of the final report.

Conclusion

The PRISMA guidelines offer a means to recognize systematic reviews and meta-analyses that adhere to high standards of scientific rigor and transparency allowing medical writers to recognize and utilize credible, robust evidence for their synthesis in support of better clinical decision making and improved patient outcomes. Using well-trained medical writers enables manufacturers to deliver high-quality documents, such as clinical evaluation reports that withstand regulatory scrutiny.

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