title: Registries and evidence-based medicine in craniofacial and plastic surgery.
abstract: 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.
authors.affiliation: Department of Plastic and General Surgery, Alpert Medical School, Brown University, Providence, Rhode Island 02903, USA. brian.c.drolet@gmail.com
authors.forename: Brian C
authors.initials: BC
authors.lastname: Drolet
authors.forename: Nancy M
authors.initials: NM
authors.lastname: Lorenzi
mesh_terms: D002971:Cleft Lip / Q000601:surgery; D002972:Cleft Palate / Q000601:surgery; D055812:Community-Based Participatory Research / Q000592:standards; D019992:Databases as Topic; D019317:Evidence-Based Medicine; D005145:Face / Q000601:surgery; D006302:Health Services Research / Q000592:standards; D006801:Humans; D016247:Information Storage and Retrieval; D008490:Medical Informatics; D017063:Outcome Assessment, Health Care; D011787:Quality of Health Care / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D019651:Plastic Surgery Procedures / Q000592:standards; D012042:Registries / Q000145:classification / Q000592:standards; D012107:Research Design / Q000592:standards; D018401:Sample Size; D012886:Skull / Q000601:surgery; D013043:Specialties, Surgical / Q000592:standards*; D013518:Surgery, Plastic / Q000592:standards*