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Related Experiment Videos

Some methodological points to consider when performing systematic reviews in comparative effectiveness research.

Jesse A Berlin¹, M Soledad Cepeda

¹Johnson & Johnson Pharmaceutical Research and Development, Titusville, NJ 08560, USA. jberlin@its.jnj.com

Clinical Trials (London, England)

|November 4, 2011

Summary

This summary is machine-generated.

Comparative Effectiveness Research (CER) reviews face methodological challenges. This analysis highlights how certain study designs, like noninferiority trials, can inform CER despite potential biases, improving healthcare decisions.

Related Experiment Videos

Area of Science:

Health Services Research
Evidence-Based Medicine

Background:

Comparative Effectiveness Research (CER) aims to inform healthcare decisions for consumers, clinicians, purchasers, and policymakers.
There is ongoing debate regarding appropriate evidence types and interpretation for CER.

Purpose of the Study:

To highlight key methodological issues encountered in conducting CER reviews.
To discuss the appropriate use and interpretation of various study designs within CER.

Main Methods:

Focus on challenges in randomized trials, including noninferiority studies and their use of active comparators for assay sensitivity.
Exploration of using randomized studies for indirect treatment comparisons.
Brief discussion on the role of observational studies in CER, particularly for assessing rare harms.

Main Results:

Studies perceived as unsuitable for some CER questions may be appropriate for others.
Noninferiority studies, when properly designed, can be valuable for CER, as potential bias toward equality actually works against the sponsor's claim of superiority.
The interpretation of study suitability depends on the specific CER question being addressed.

Conclusions:

Systematic reviews should prioritize head-to-head comparisons with relevant populations and patient-centered outcomes.
Indirect comparisons and mixed treatment meta-analyses are useful for multi-treatment comparisons if underlying assumptions are met.
Acknowledges that this is not an exhaustive review and dissenting opinions may exist.