ABSTRACT
BACKGROUND: With the increasing number of randomized control trials being conducted and published in plastic surgery, complete reporting of trial information is critical for readers to properly evaluate a trial's methodology and arrive at appropriate conclusions about its merits and applicability to patients. The Template for Intervention Description and Replication (TIDieR) checklist was introduced to address the limited guidance for reporting trial interventions. OBJECTIVES: The authors applied the TIDieR checklist to evaluate the completeness of intervention reporting of randomized control trials in plastic surgery, compare the quality of intervention reporting before and after the guideline was published, and evaluate characteristics associated with TIDieR compliance. METHODS: A PubMed search identified 1 cohort published prior to the release of TIDieR and another published after its release. From the final sample, the TIDieR checklist was applied to intervention descriptions, and relevant study characteristics were extracted in a duplicate, blinded manner. RESULTS: In total, 130 trials were included for analysis. The mean TIDieR score was 6.4 of 12. Five items were reported 90% of the time, and 4 items were reported less than 10% of the time. We found that TIDieR publication did not affect intervention reporting (P = 0.22). CONCLUSIONS: Our study identified areas in which intervention reporting could be improved. The extent of TIDieR adoption by trialists appears to be limited, and greater efforts are needed to disseminate this reporting guideline if widespread uptake is to be expected. Alternately, it may be beneficial to incorporate TIDieR into the more widely recognized Consolidated Standards of Reporting Trials statement.
Subject(s)
Surgery, Plastic , Checklist , Humans , Randomized Controlled Trials as Topic , Research Design , Research ReportABSTRACT
BACKGROUND: Randomized controlled trials (RCTs) are critical in developing new therapeutic approaches. Historically, in plastic surgery, RCTs are uncommon as they make up less than 2% of all publications. However there has recently been an increase in RCTs appearing in plastic surgery but the quality of these articles has yet to be assessed. We aim to determine the completeness of intervention reporting in plastic surgery RCTs using the TIDieR checklist. METHODS: A search of Pubmed for RCTs published in the top 10 plastic surgery journals as determined by the Google h5-index will be performed by two investigators. All identified articles will be isolated and a random selection of 300 articles will be screened for inclusion in the study by two different investigators. All types of RCTs will be included in this study. Articles will be excluded if they are nonrandomized, observational, follow-up studies, or secondary analyses. Full exclusion criteria can be found within this protocol. Extracted data includes all 12 points of the TIDieR checklist, journal, intervention type, sample size, and funding source. A complete list of what data will be extracted is listed within this protocol. All data extraction will be performed by two independent investigators. All work will be verified by the two investigators and any discrepancies will be resolved via consensus between investigators or with third party adjudication. DISSEMINATION: We plan to publish this review in a peer-reviewed journal. We may also present this review at local and/or national conferences.
ABSTRACT
BACKGROUND: Recent studies have highlighted the risk of bias and the fragility of results in randomized controlled trials (RCTs). The aim of our study was to evaluate the clinical practice guidelines created by the Society for Gastrointestinal and Endoscopic Surgeons (SAGES) for fragility, statistical power, and risk of bias. MATERIALS AND METHODS: We screened the SAGES clinical practice guideline references for qualifying RCTs. RCTs were assessed for risk of bias using the Cochrane Collaboration Risk of Bias tool 2.0. We used the fragility index and fragility quotient to evaluate the robustness of trial results and conducted a power analysis using G*Power to determine if trials were adequately powered. RESULTS: Twenty-two (40.7%) of the 54 trials that we assessed were rated as having a high risk of bias, 17 (31.5%) were rated as having a low risk of bias, and 15 (27.8%) were rated as having some concerns. The median fragility index was 2.5 (interquartile range 1-7). The median fragility quotient was 0.021 (interquartile range 0.003-0.045). Mean sample size was 108, and the mean loss to follow-up was eight patients. Eight of 33 trials (24.2%) were found to be underpowered according to the sample size used in the primary outcome. CONCLUSIONS: Guidelines created by SAGES are supported by RCTs that are frequently fragile or underpowered or have a high risk of bias. Future RCTs should utilize the Consolidated Standards of Reporting Trials statement, implement strategies to minimize loss to follow-up, and use properly powered sample sizes.
