Harsha Shanthanna1,2, Alka Kaushal3,4, Lawrence Mbuagbaw3,5, Rachel Couban4, Jason Busse3,4, Lehana Thabane6,3,5. 1. Department of Anesthesia, St. Joseph's Healthcare Hamilton, McMaster University, 50 Charlton Avenue East, Hamilton, ON, L8N 4A6, Canada. shanthh@mcmaster.ca. 2. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. shanthh@mcmaster.ca. 3. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. 4. The Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, ON, Canada. 5. Biostatistics Unit, St Joseph's Healthcare, Hamilton, ON, Canada. 6. Department of Anesthesia, St. Joseph's Healthcare Hamilton, McMaster University, 50 Charlton Avenue East, Hamilton, ON, L8N 4A6, Canada.
Abstract
PURPOSE: Pilot trials inform the design and conduct of larger scale trials. Using the Consolidated Standards of Reporting Trials (CONSORT) pilot extension guidelines, we assessed reporting quality in five high-impact anesthesia journals and explored factors associated with reporting quality. METHODS: The five highest-impact anesthesia journals were screened for randomized-controlled trials published as pilot or feasibility trials between 2006 and 2016. A pair of reviewers independently screened citations, extracted data, and assessed reporting quality using the CONSORT pilot trial extension checklists for abstracts and full texts. We reported the percentage adherence for each item, along with the median [interquartile range (IQR)] or mean (standard deviation [SD]) for all items. The factors considered to influence reporting were: 1) trial registration, 2) industry funding, 3) trial identification as a pilot or feasibility in the title or abstract, 4) primary objective as "feasibility", and 5) the specific journal. The association was estimated using generalized estimating equations and reported as incidence rate ratios with 99% confidence intervals. RESULTS: Of 364 citations, 58 articles were eligible. The median [IQR] number of CONSORT abstract items reported was 5 [4-7], and the mean (SD) number of full text items reported was 13 (5). Significantly poor reporting was associated with "not registering the trial" (both abstracts and full texts), "trial not identified as a pilot" (abstracts), and "using clinical hypothesis as the primary objective" (full texts). CONCLUSION: The reporting quality of pilot trials published in leading anesthesia journals is poor. Journal editorial boards can encourage improved reporting by supporting adherence to the CONSORT extension for pilot trials.
PURPOSE: Pilot trials inform the design and conduct of larger scale trials. Using the Consolidated Standards of Reporting Trials (CONSORT) pilot extension guidelines, we assessed reporting quality in five high-impact anesthesia journals and explored factors associated with reporting quality. METHODS: The five highest-impact anesthesia journals were screened for randomized-controlled trials published as pilot or feasibility trials between 2006 and 2016. A pair of reviewers independently screened citations, extracted data, and assessed reporting quality using the CONSORT pilot trial extension checklists for abstracts and full texts. We reported the percentage adherence for each item, along with the median [interquartile range (IQR)] or mean (standard deviation [SD]) for all items. The factors considered to influence reporting were: 1) trial registration, 2) industry funding, 3) trial identification as a pilot or feasibility in the title or abstract, 4) primary objective as "feasibility", and 5) the specific journal. The association was estimated using generalized estimating equations and reported as incidence rate ratios with 99% confidence intervals. RESULTS: Of 364 citations, 58 articles were eligible. The median [IQR] number of CONSORT abstract items reported was 5 [4-7], and the mean (SD) number of full text items reported was 13 (5). Significantly poor reporting was associated with "not registering the trial" (both abstracts and full texts), "trial not identified as a pilot" (abstracts), and "using clinical hypothesis as the primary objective" (full texts). CONCLUSION: The reporting quality of pilot trials published in leading anesthesia journals is poor. Journal editorial boards can encourage improved reporting by supporting adherence to the CONSORT extension for pilot trials.
Authors: Lawrence Mbuagbaw; Sarah Daisy Kosa; Daeria O Lawson; Rosa Stalteri; Oluwatobi R Olaiya; Ahlam Alotaibi; Lehana Thabane Journal: Pilot Feasibility Stud Date: 2019-11-03
Authors: Catherine Hu; Jie Yi Wang; Zoe El Helou; Muhammad Taaha Hassan; Zheng Jing Hu; Gerhard Fusch; Lawrence Mbuagbaw; Salhab El Helou; Lehana Thabane Journal: BMJ Open Qual Date: 2021-06
Authors: Lawrence Mbuagbaw; Daeria O Lawson; Livia Puljak; David B Allison; Lehana Thabane Journal: BMC Med Res Methodol Date: 2020-09-07 Impact factor: 4.615