Factors Affecting Outcomes of Craniofacial Clinical Trials.
Journal
The Journal of craniofacial surgery
ISSN: 1536-3732
Titre abrégé: J Craniofac Surg
Pays: United States
ID NLM: 9010410
Informations de publication
Date de publication:
01 Oct 2021
01 Oct 2021
Historique:
entrez:
27
10
2021
pubmed:
28
10
2021
medline:
30
10
2021
Statut:
ppublish
Résumé
This study aims to provide a cross-sectional view of craniofacial trials and to identify factors associated with completion, publication, and trial longevity. This is a cross-sectional study of cleft and craniofacial clinical trials registered with ClinicalTrials.gov between September 1999 and April 2020. Predictor variables included funding source, trial design, trial location, number of recruitment sites, and investigator specialty.Study outcomes were completion status, publication status, and trial duration. Univariate comparisons and multivariate regression models were calculated for each outcome. The final sample included 179 clinical trials pertaining to craniofacial care. Nearly all trials were single-center (86.5%), and roughly half of trials were interventional (57.0%) or conducted in the United States (40.5%). No single specialty predominated, although plastic surgery (13.4%) was the most common investigator specialty. The completion rate was 82.7%, the publication rate was 40.8%, and the mean trial duration was 39.1 months. Interventional design (odds ratio = 0.30, P = 0.02) and United States location (odds ratio = 0.15, P < 0.01) were each independently associated with lower odds of trial completion. Trial longevity was independently associated with the National Institute of Health-funding (P < 0.01) and multicenter design (P < 0.01). Craniofacial trials are multidisciplinary and have a high rate of completion. Although most existing trials were conducted at only a single-center, multicenter efforts significantly increased trial longevity without compromising completion and publication rates. Given the diverse array of conditions and lines of inquiry that compose craniofacial care, it is reassuring that collaboration did not negatively affect trial outcomes.
Identifiants
pubmed: 34705392
doi: 10.1097/SCS.0000000000007747
pii: 00001665-202110000-00057
doi:
Types de publication
Journal Article
Multicenter Study
Langues
eng
Pagination
2484-2486Informations de copyright
Copyright © 2021 by Mutaz B. Habal, MD.
Déclaration de conflit d'intérêts
The authors report no conflicts of interest.
Références
Greer W. A facial index for oral surgery. R Soc Med 1966; 59:71–74.
Craniofacial Anomalies and Associated Birth Defects. Report of a WHO Registry Meeting on Craniofacial Anomalies. https://www.who.int/genomics/anomalies/en/CFA-RegistryMeeting-2001.pdf
Carlson L, Hatcher KW, Vander Burg R. Elevated infant mortality rates among oral cleft and isolated oral cleft cases: a meta-analysis of studies from 1943 to 2010. Cleft Palate Craniofac J 2013; 50:2–12.
Thompson PW, Roser SM. Do the science, own the field. Are we doing the science? J Oral Maxillofac Surg 2015; 73:S153–S154.
Hariton E, Locascio JJ. Randomised controlled trials - the gold standard for effectiveness research: study design: randomised controlled trials. BJOG 2018; 125:1716.
Greenwald A, Boden S, Goldberg V, et al. Bone graft substitutes: facts, fictions, and applications. J Bone Joint Surg 2001; 83:98–103.
Fullarton M, Sweet C, Robertson B, et al. Cleft and craniofacial surgery - how do we inspire and recruit the next generation of oral and maxillofacial surgeons? Br J Oral Maxillofac Surg 2019; 57:395–396.
Moar K, Butterworth S. If you present will you publish? An analysis of abstracts at the craniofacial society of great britain and ireland conferences 2000-2009. Cleft Palate Craniofac J 2013; 50:713–716.
Steiner C, Elixhauser A, Schnaier J. The healthcare cost and utilization project: an overview. Eff Clin Pract 2002; 5:143–151.
Singh VP, Moss TP. Psychological impact of visible differences in patients with congenital craniofacial anomalies. Prog Orthod 2015; 16:51–9.
Gourion D, Goldberger C, Bourdel MC, et al. Minor physical anomalies in patients with schizophrenia and their parents: prevalence and pattern of craniofacial abnormalities. Psychiatry Res 2004; 125:21–28.
Lam DJ, Jensen CC, Mueller BA, et al. Pediatric sleep apnea and craniofacial anomalies: a population-based case-control study. Laryngoscope 2010; 120:2098–2105.
Johnson AL, Fladie I, Anderson JM, et al. Rates of discontinuation and nonpublication of head and neck cancer randomized clinical trials. JAMA Otolaryngol Head Neck Surg 2019; 146:176–182.
Cox TC, Luquetti DV, Cunningham ML. Perspectives and challenges in advancing research into craniofacial anomalies. Am J Med Genet C Semin Med Genet 2013; 163c:213–217.
Van Otterloo E, Williams T, Artinger KB. The old and new face of craniofacial research: how animal models inform human craniofacial genetic and clinical data. Dev Biol 2016; 415:171–187.
Trainor PA, Richtsmeier JT. Facing up to the challenges of advancing craniofacial research. Am J Med Genet A 2015; 167:1451–1454.
Kestle JRW, Lee A, Anderson RCE, et al. Variation in the management of isolated craniosynostosis: a survey of the Synostosis Research Group. J Neurosurg Pediatr 2018; 22:627–631.
Dunn J, Lai E, Brooks C, et al. The outcome of research training during surgical residency. J Pediatr Surg 1998; 33:362–364.
Robertson CM, Klingensmith ME, Coopersmith CM. Long-term outcomes of performing a postdoctoral research fellowship during general surgery residency. Ann Surg 2007; 245:516–523.
Mohammad AE, Best AM, Laskin DM. Attitudes and opinions of residency directors and residents about the importance of research in oral and maxillofacial surgery residencies. J Oral Maxillofac Surg 2011; 69:2064–2069.
Best AM, Laskin DM. Oral and maxillofacial surgery residents have poor understanding of biostatistics. J Oral Maxillofac Surg 2013; 71:227–234.