Consensus of recommendations guiding comparative effectiveness research methods.

Area of Science:

• Health Services Research
• Evidence-Based Medicine

Background:

• Increasing demand for high-quality comparative effectiveness research (CER) has led to the publication of methods guidance documents.
• Key organizations like the Agency for Healthcare Research and Quality (AHRQ) and the Patient-Centered Outcomes Research Institute (PCORI) have issued such guidance.

Purpose of the Study:

• To identify CER methods guidance documents.
• To compare these documents and summarize important recommendations, establishing a consensus on CER methods.

Main Methods:

• A systematic literature review was conducted to find CER methods guidance documents published up to 2014.
• Identified documents were analyzed for their methods guidance recommendations.
• Recommendations were categorized to assess overlap and identify common themes.

Main Results:

• Nine CER methods guidance documents were identified, containing 312 recommendations.
• 97% of recommendations appeared in multiple documents, indicating substantial consensus.
• Key shared recommendations include transparency, stakeholder adaptation, a priori study design, focus on clinically relevant knowledge gaps, validity assessment, meaningful outcome measurement, and strategies to minimize bias, confounding, and heterogeneity.

Conclusions:

• A consensus guide for CER methods was developed based on nine key guidance documents.
• This guide aims to assist researchers in designing CER studies and applying effective CER methodologies.