Cooperation in Clinical Trials

Wood, William C.

doi:10.1016/j.jamcollsurg.2011.01.039

Cited by 1 publication

(1 citation statement)

References 22 publications

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“…Likewise, it is ostensibly more feasible to institute a registry than the stricter standards and massive expense of RCTs. 18 As an added benefit, because registries collect data from routine practice rather than introducing a change of practice or a therapeutic intervention, the method does not require informed consent or many other restrictions placed on research but not quality improvement projects.…”

Section: Scientific Foundationmentioning

confidence: 99%

Registries and Evidence-Based Medicine in Craniofacial and Plastic Surgery

Drolet¹,

Lorenzi²

2012

Journal of Craniofacial Surgery

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Evidence-based medicine is a vital process for maintaining and improving quality and value in health care. However, evidence-based practice is most limited by the availability of research and outcomes data. Although randomized controlled trials (RCTs) have been identified by numerous research organizations as the criterion standard for research methodology (eg, "level I evidence"), the execution of well-designed RCTs has proved either challenging or impossible in many surgical fields and with rare disease conditions. In particular, craniofacial and plastic surgery has been noted to be lacking in both the number and quality of RCTs. Many reasons are discussed for this dearth of research including inadequate sample size and challenges in randomization, blinding, and clinical equipoise. Yet, data for outcomes assessment are highly valued by surgeons and by consumers and payers. Therefore, alternative and more practical means for research and data collection must be sought. Observational studies of clinical practice are particularly useful for outcomes assessment despite relegation to a lower tier of evidence (eg, "level II evidence"). Functional databases with well-defined processes for data collection, called medical data registries, are an essential informatics tool to collect and store outcomes data and produce high-quality observational, practice-based research studies. A properly designed and implemented registry can provide surgeons with an abundance of data to perform research and quality improvement projects. In fact, registries may be superior in many ways to RCTs for craniofacial and plastic surgeons both pragmatically and functionally. In this commentary, we discuss the production of such registries in the framework of evidence-based practice and the relevant studies in craniofacial surgery.

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Section: Scientific Foundationmentioning

confidence: 99%