An Analysis of the Evidence Underpinning the American Academy Orthopaedic Surgery Pediatrics Clinical Practice Guidelines.
Journal
Journal of pediatric orthopedics
ISSN: 1539-2570
Titre abrégé: J Pediatr Orthop
Pays: United States
ID NLM: 8109053
Informations de publication
Date de publication:
01 Feb 2022
01 Feb 2022
Historique:
pubmed:
6
11
2021
medline:
12
1
2022
entrez:
5
11
2021
Statut:
ppublish
Résumé
Randomized control trials (RCTs) serve as evidentiary support for recommendations underpinning clinical practice guidelines (CPGs) with the goal of optimizing patient care. A knowledge gap exists within scientific literature when evaluating the quality of RCTs used as evidence in the American Academy of Orthopaedic Surgery (AAOS) pediatric CPGs. We aim to evaluate the reporting quality and risk of bias in RCTs underlying AAOS Pediatric CPG recommendations. We located all AAOS Pediatric CPGs. We then extracted all RCTs from the CPG reference sections. All included RCTs were evaluated using the Consolidated Standards of Reporting Trials (CONSORT) checklist and Cochrane Collaboration risk of bias assessment tool (RoB 2.0). Descriptive statistics were recorded, and bivariate analysis was used to account for variance in CONSORT scores. A Mann-Whitney U test was completed to compare CONSORT studies published before and after 2010. Three CPGs and 23 RCTs met inclusion criteria. Mean CONSORT adherence was 69.8% (21.6/31). The lowest adhered to CONSORT items were 10, 23, and 24, while items 2a, 13a, and 18 displayed the highest adherence. Ten RCTs (43.5%, 10/23) had "low" risk of bias, 5 RCTs (21.7%, 5/23) were of "some concerns," and 8 RCTs (34.8%, 8/23) received a "high" designation for risk of bias. There were no statistically significant associations in the bivariate regression analysis or Mann-Whitney U test. Our results suggest that CONSORT adherence within RCTs used as evidence in AAOS Pediatric CPGs is substandard-relying on evidence that, in some cases, is >20 years old. Many of the RCTs cited as supporting evidence have a "high" risk of bias. Altogether, these CPGs may need to be updated or expanded to include more recent evidence relevant to pediatric orthopaedic surgery.
Sections du résumé
BACKGROUND
BACKGROUND
Randomized control trials (RCTs) serve as evidentiary support for recommendations underpinning clinical practice guidelines (CPGs) with the goal of optimizing patient care. A knowledge gap exists within scientific literature when evaluating the quality of RCTs used as evidence in the American Academy of Orthopaedic Surgery (AAOS) pediatric CPGs. We aim to evaluate the reporting quality and risk of bias in RCTs underlying AAOS Pediatric CPG recommendations.
METHODS
METHODS
We located all AAOS Pediatric CPGs. We then extracted all RCTs from the CPG reference sections. All included RCTs were evaluated using the Consolidated Standards of Reporting Trials (CONSORT) checklist and Cochrane Collaboration risk of bias assessment tool (RoB 2.0). Descriptive statistics were recorded, and bivariate analysis was used to account for variance in CONSORT scores. A Mann-Whitney U test was completed to compare CONSORT studies published before and after 2010.
RESULTS
RESULTS
Three CPGs and 23 RCTs met inclusion criteria. Mean CONSORT adherence was 69.8% (21.6/31). The lowest adhered to CONSORT items were 10, 23, and 24, while items 2a, 13a, and 18 displayed the highest adherence. Ten RCTs (43.5%, 10/23) had "low" risk of bias, 5 RCTs (21.7%, 5/23) were of "some concerns," and 8 RCTs (34.8%, 8/23) received a "high" designation for risk of bias. There were no statistically significant associations in the bivariate regression analysis or Mann-Whitney U test.
CONCLUSIONS
CONCLUSIONS
Our results suggest that CONSORT adherence within RCTs used as evidence in AAOS Pediatric CPGs is substandard-relying on evidence that, in some cases, is >20 years old. Many of the RCTs cited as supporting evidence have a "high" risk of bias. Altogether, these CPGs may need to be updated or expanded to include more recent evidence relevant to pediatric orthopaedic surgery.
Identifiants
pubmed: 34739437
doi: 10.1097/BPO.0000000000002002
pii: 01241398-202202000-00028
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e218-e223Informations de copyright
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
M.H. reports receiving funding from the National Institute of Justice for work unrelated to the current subject. M.V. reports receipt of funding from the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the US Office of Research Integrity, Oklahoma Center for Advancement of Science and Technology, and internal grants from Oklahoma State University Center for Health Sciences—all outside of the present work. The remaining authors declare no conflicts of interest.
Références
Wright JG, Swiontkowski MF, Heckman JD. Introducing levels of evidence to the journal. J Bone Joint Surg Am. 2003;85:1–3.
Littlejohns P. Developing guidelines is expensive. BMJ. 2018;360:k900.
Mulpuri K, Song KM. AAOS Clinical Practice Guideline: detection and nonoperative management of pediatric developmental dysplasia of the hip in infants up to six months of age. J Am Acad Orthop Surg. 2015;23:206–207.
Cowan J, Lozano-Calderón S, Ring D. Quality of prospective controlled randomized trials. Analysis of trials of treatment for lateral epicondylitis as an example. J Bone Joint Surg Am. 2007;89:1693–1699.
Schulz KF, Altman DG, Moher D. CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9:672–677.
Higgins JPT, Savović J, Page MJ, et al. RoB 2: a revised Cochrane risk-of-bias tool for randomized trials. 2019. Available at: https://methods.cochrane.org/bias/resources/rob-2-revised-cochrane-risk-bias-tool-randomized-trials . Accessed June 25, 2021.
Office for Human Research Protections (OHRP). 45 CFR 46. HHS.gov; 2016. Available at: www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html . Accessed July 10, 2018.
International Committee of Medical Journal Editors (ICMJE). Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. 2019. Available at: http://icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html . Accessed June 3, 2021.
Endorsers. CONSORT Endorsers: Journals and Organizations. 2021. Available at: www.consort-statement.org/about-consort/endorsers1 . Accessed June 2, 2021.
Nagendran M, Harding D, Teo W, et al. Poor adherence of randomised trials in surgery to CONSORT guidelines for non-pharmacological treatments (NPT): a cross-sectional study. BMJ Open. 2013;3:e003898.
Ngah VD, Mazingisa AV, Zunza M, et al. A review of adherence and predictors of adherence to the CONSORT Statement in the Reporting of Tuberculosis Vaccine Trials. Vaccines. 2020;8:770.
Institute of Medicine, Board on Health Care Services, Committee on Standards for Systematic Reviews of Comparative Effectiveness Research. Finding What Works in Health Care: Standards for Systematic Reviews. Washington, DC: National Academies Press; 2011.
Turner L, Shamseer L, Altman DG, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev. 2012;11:MR000030.
Huang YQ, Traore K, Ibrahim B, et al. Reporting quality of randomized controlled trials in otolaryngology: review of adherence to the CONSORT statement. J Otolaryngol Head Neck Surg. 2018;47:34.
Reis A, de Geus JL, Wambier L, et al. Compliance of randomized clinical trials in noncarious cervical lesions with the CONSORT statement: a systematic review of methodology. Oper Dent. 2018;43:E129–E151.
Mozetic V, Leonel L, Leite Pacheco R, et al. Reporting quality and adherence of randomized controlled trials about statins and/or fibrates for diabetic retinopathy to the CONSORT checklist. Trials. 2019;20:729.
Lee S-Y, Teoh PJ, Camm CF, et al. Compliance of randomized controlled trials in trauma surgery with the CONSORT statement. J Trauma Acute Care Surg. 2013;75:562–572.
Liu LQ, Morris PJ, Pengel LHM. Compliance to the CONSORT statement of randomized controlled trials in solid organ transplantation: a 3-year overview. Transpl Int. 2013;26:300–306.
Borrelli MR, Farwana R, Andrew TW, et al. Assessing the compliance of randomized controlled trials published in craniofacial surgery journals with the CONSORT statement. J Craniofac Surg. 2019;30:96–104.
Crocetti MT, Amin DD, Scherer R. Assessment of risk of bias among pediatric randomized controlled trials. Pediatrics. 2010;126:298–305.
Zhai X, Cui J, Wang Y, et al. Quality of reporting randomized controlled trials in five leading neurology journals in 2008 and 2013 using the modified “Risk of Bias” tool. World Neurosurg. 2017;99:687.e7–694.e7.
Checketts JX, Scott JT, Meyer C, et al. The robustness of trials that guide evidence-based orthopaedic surgery. J Bone Joint Surg Am. 2018;100:e85.
Laborie LB, Engesæter IØ, Lehmann TG, et al. Screening strategies for hip dysplasia: long-term outcome of a randomized controlled trial. Pediatrics. 2013;132:492–501.
Wojtys EM. Emerging technologies. Sports Health. 2016;8:403–404.
Soldado F, Knorr J, Haddad S, et al. Ultrasound-guided percutaneous medial pinning of pediatric supracondylar humeral fractures to avoid ulnar nerve injury. Arch Bone Jt Surg. 2015;3:169–172.
Zhao H, Xu S, Liu G, et al. Comparison of lateral entry and crossed entry pinning for pediatric supracondylar humeral fractures: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2021;16:366.
Mackey TK, Liang BA. The role of practice guidelines in medical malpractice litigation. Virtual Mentor. 2011;13:36–41.
Horsley T, Galipeau J, Petkovic J, et al. Reporting quality and risk of bias in randomised trials in health professions education. Med Educ. 2017;51:61–71.
Higgins J, Thomas J. Cochrane Handbook for Systematic Reviews of Interventions, 2nd ed. Chichester, UK: John Wiley & Sons; 2019.
Burns PB, Rohrich RJ, Chung KC. The levels of evidence and their role in evidence-based medicine. Plast Reconstr Surg. 2011;128:305–310.