PRISMA harms checklist: improving harms reporting in systematic reviews

Area of Science:

• Medical Research Methodology
• Evidence Synthesis
• Health Intervention Evaluation

Background:

• Accurate assessment of health intervention benefits and harms is crucial.
• Systematic reviews often inadequately report harms, leading to imbalanced evaluations.
• The PRISMA statement primarily focuses on efficacy, necessitating improved harms reporting.

Purpose of the Study:

• To develop and introduce the PRISMA harms checklist.
• To enhance the reporting of adverse events in systematic reviews.
• To promote a more comprehensive assessment of health intervention safety.

Main Methods:

• Utilized a development strategy endorsed by the EQUATOR Network and existing PRISMA guidelines.
• Employed a modified Delphi process involving three rounds of electronic feedback and an in-person meeting.
• Drafted a checklist of essential reporting items for harms in systematic reviews.

Main Results:

• The PRISMA harms checklist includes four key reporting elements: title, synthesis of results, study characteristics, and causality assessment.
• Guidance is provided on specifying 'harms' in the title, handling zero events, defining harms and ascertainment, and assessing causality.
• Additional guidance enhances the relevance of existing PRISMA items for harms reporting.

Conclusions:

• The PRISMA harms checklist provides a minimal set of items for reporting adverse events.
• This guideline extension aims to improve harms reporting in systematic reviews, regardless of outcome focus.
• Enhanced harms reporting facilitates a more balanced assessment of health interventions.