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"Spin" refers to a manipulation of language that implies benefit for an intervention when none may exist. Randomized clinical trials (RCTs) in other fields have been demonstrated to employ spin, which can mislead clinicians to use ineffective or unsafe interventions. This study's objective was to determine the strategies, severity, and extent of spin in plastic surgery RCTs with non-significant primary outcomes.A literature search of the top 15 plastic surgery journals using MEDLINE was performed (2000-2020). Parallel 1:1 RCTs with a clearly identified primary outcome showing statistically non-significant results (p ≥ .05) were included. Screening, data extraction, and spin analysis were performed by two independent reviewers. The spin analysis was then independently assessed in duplicate by two plastic surgery residents with graduate level training in clinical epidemiology.From 3,497 studies identified, 92 RCTs were included in this study. Spin strategies were identified in 78 RCTs (85%), including 64 Abstracts (70%) and 77 Main Texts (84%). Severity of spin was rated moderate or high in 43 Abstract Conclusions (47%) and 42 Main Text Conclusions (46%). The most identified spin strategy in the Abstract was claiming equivalence for statistically non-significant results (26%), and in the Main Text was focusing on another objective (24%).This study suggests that 85% of statistically non-significant RCTs in plastic surgery employ spin. Readers of plastic surgery research should be aware of strategies, whether intentional or unintentional, used to manipulate language in reports of statistically non-significant RCTs when applying research findings to clinical practice.

In 1906, George Bernard Shaw criticized the medical profession for its lack of science and compassion. Since then, advances in both medical and surgical subspecialties have improved quality of patient care. Unfortunately, the reporting of these advances is variable and is frequently biased. Such limitations lead to false claims, wasted research dollars, and inability to synthesize and apply evidence to practice. It was hoped that the introduction of evidence-based medicine would improve the quality of health care and decrease health dollar waste. For this to occur, however, credible "best evidence"-one of the components of evidence-based medicine-is required. This article provides a framework for credible research evidence in plastic surgery, as follows: (1) stating the clinical research question, (2) selecting the proper study design, (3) measuring critical (important) outcomes, (4) using the correct scale(s) to measure the outcomes, (5) including economic evaluations with clinical (effectiveness) studies, and (6) reporting a study's results using the Enhancing the Quality and Transparency of Health Research, or EQUATOR, guidelines. Surgeon investigators are encouraged to continue improving the science in plastic surgery by applying the framework outlined in this article. Improving surgical clinical research should decrease resource waste and provide patients with improved evidence-based care.

BACKGROUND The fragility index has been proposed as a metric to evaluate the robustness of statistically significant findings in randomized controlled trials. It measures the number of events that a trial result relies on to maintain statistical significance. This study examines the robustness of statistically significant results from randomized controlled trials in the plastic surgery literature. METHODS A systematic literature search of the 15 highest impact plastic surgery journals was conducted to identify randomized controlled trials published between 2000 and 2017 that reported a statistically significant dichotomous outcome (p < 0.05). The fragility index of each study was calculated using Fisher's exact test. Multiple linear regression was used to determine trial characteristics associated with the fragility index. RESULTS The 90 eligible randomized controlled trials had a median sample size of 73.5 patients (25th to 75th percentile, 50 to 115) and a median of 20 events (25th to 75th percentile, 11 to 33.5) for the chosen outcome. The median fragility index was 1 (25th to 75th percentile, 0 to 4), indicating that statistical significance would be lost in half of the randomized controlled trials if a single patient had a change in event status. The fragility index was 0 in 24 of 90 (27 percent) randomized controlled trials, meaning the outcome immediately lost statistical significance on recalculation of the p value using Fisher's exact test. CONCLUSIONS The results of randomized controlled trials in plastic surgery demonstrate substantial fragility, as statistically significant results were found to hinge on a small number of events. The fragility index offers an intuitive and simple metric to complement the p value and determine the confidence in the results of randomized controlled trials.

Background The reconstruction module of the BREAST-Q patient-reported outcome measure is frequently used by investigators and in clinical practice. A minimal important difference establishes the smallest change in outcome measure score that patients perceive to be important. To enhance interpretability of the BREAST-Q reconstruction module, the authors determined minimal important difference estimates using distribution-based methods. Methods An analysis of prospectively collected data from 3052 Mastectomy Reconstruction Outcomes Consortium patients was performed. The authors used distribution-based methods to investigate the minimal important difference for the entire patient sample and three clinically relevant groups. The authors used both 0.2 SD units (effect size) and the standardized response mean value of 0.2 as distribution-based criteria. Clinical experience was used to guide and assess appropriateness of results. Results A total of 3052 patients had BREAST-Q data available for analysis. The average age and body mass index were 49.5 and 26.8, respectively. The minimal important difference estimates for each domain were 4 (Satisfaction with Breasts), 4 (Psychosocial Well-being), 3 (Physical Well-being), and 4 (Sexual Well-being). The minimal important difference estimates for each domain were similar when compared within the three clinically relevant groups. Conclusions The authors propose that a minimal important difference score of 4 points on the transformed 0 to 100 scale is clinically useful when assessing an individual patient's outcome using the reconstruction module of the BREAST-Q. When designing research studies, investigators should use the minimal important difference estimate for their domain of interest when calculating sample size. The authors acknowledge that distribution-based minimal important differences are estimates and may vary based on patient population and context.

BACKGROUND The authors examined industry support, conflict of interest, and sample size in plastic surgery randomized controlled trials that compared surgical interventions. They hypothesized that industry-funded trials demonstrate statistically significant outcomes more often, and randomized controlled trials with small sample sizes report statistically significant results more frequently. METHODS An electronic search identified randomized controlled trials published between 2000 and 2013. Independent reviewers assessed manuscripts and performed data extraction. Funding source, conflict of interest, primary outcome direction, and sample size were examined. Chi-squared and independent-samples t tests were used in the analysis. RESULTS The search identified 173 randomized controlled trials, of which 100 (58 percent) did not acknowledge funding status. A relationship between funding source and trial outcome direction was not observed. Both funding status and conflict of interest reporting improved over time. Only 24 percent (six of 25) of industry-funded randomized controlled trials reported authors to have independent control of data and manuscript contents. The mean number of patients randomized was 73 per trial (median, 43, minimum, 3, maximum, 936). Small trials were not found to be positive more often than large trials (p = 0.87). CONCLUSIONS Randomized controlled trials with small sample size were common; however, this provides great opportunity for the field to engage in further collaboration and produce larger, more definitive trials. Reporting of trial funding and conflict of interest is historically poor, but it greatly improved over the study period. Underreporting at author and journal levels remains a limitation when assessing the relationship between funding source and trial outcomes. Improved reporting and manuscript control should be goals that both authors and journals can actively achieve.

Background The authors investigated the methodological validity of plastic surgery randomized controlled trials that compared surgical interventions. Methods An electronic search identified randomized controlled trials published between 2000 and 2013. Reviewers, independently and in duplicate, assessed manuscripts and performed data extraction. Methodological safeguards (randomization, allocation concealment, blinding, and incomplete outcome data) were examined using the Cochrane risk of bias tool. Regression analysis was used to identify trial characteristics associated with risk of bias. Results Of 1664 potentially eligible studies, 173 randomized controlled trials were included. Proper randomization and allocation concealment methods were described in 61 of 173 (35 percent) and 21 of 173 (12 percent), respectively. Outcome assessors were blinded in 58 of 173 (34 percent) trials, and patients were blinded in 45 of 173 (26 percent). Follow-up rates were high, with 99 of 173 (57 percent) randomized controlled trials appearing to have complete follow-up. An intention-to-treat analysis was used in 19 of 173 (11 percent) trials. One-third (58 of 173, 34 percent) did not state their primary outcomes. The most common type of primary outcome used was a symptom/quality of life, class III, outcome (73 of 173, 42 percent). Multinomial regression demonstrated trials reporting an a priori sample size as more likely to have a low risk of bias (p = 0.001). Conclusions This article highlights methodological safeguards that plastic surgeons should consider when interpreting results of a surgical randomized controlled trial. Allocation concealment, outcome assessor blinding, and patient blinding were identified as areas of concern. Valid and reliable outcome measures are being used in plastic surgery. This analysis provides strong rationale for continued focus on the performance and reporting of clinical trials within our specialty.

BACKGROUND Nerve repair may be effective in improving function following obstetrical brachial plexus injury. No previous review has directly compared nerve repair to nonoperative management for similar patients, and no previous analysis has been adequately powered to determine whether nerve repair reduces impairment. METHODS Electronic databases were searched (MEDLINE, Embase, CINAHL, and Cochrane Central). Eligible studies were randomized controlled trials, observational studies, and case series (n > 9); included patients younger than 2 years undergoing nerve repair or nonoperative management of obstetrical brachial plexus injury; and reported functional impairment. Two reviewers independently screened articles using objective a priori criteria. Bias was assessed for each study. Overall quality of evidence was evaluated for each outcome. RESULTS Among nine cohort studies including 222 patients, nerve repair significantly reduced functional impairment compared with nonoperative management (relative risk, 0.58; 95 percent CI, 0.43 to 0.79; p < 0.001; I = 0 percent; absolute risk reduction, 19 percent; number needed to treat, six). Findings are consistent with comparison of similar patients from case series. With operative management, no deaths were reported; major adverse events were reported in 1.5 percent, and minor adverse events were reported in 5.0 percent of cases. Among demographic (all severities) samples managed nonoperatively, residual impairment remains in 27 percent (19 to 36 percent). CONCLUSIONS Nerve repair reduces functional impairment in obstetrical brachial plexus injury. Nonoperative management in patients with a deficit at 3 months of age leads to a high proportion of functional impairment. Mortality is not a common risk of modern pediatric microsurgical nerve repair. Residual impairment with nonoperative management is underestimated in the reported literature. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, IV.

The authors analyzed arterial complications in patients undergoing breast reconstruction with superficial inferior epigastric artery (SIEA) flaps compared with deep inferior epigastric artery perforator (DIEP) flaps. The variability, caliber, and angiosome of the SIEA are cited as limitations. Experts currently limit SIEA reconstruction to cases with favorable arterial anatomy on preoperative imaging.In this retrospective cohort study, consecutive flaps for breast reconstruction from the initial 7 years of a single microsurgeon's practice (2007 to 2013) were reviewed. Preoperative imaging was not used. Consistent intraoperative criteria for SIEA flap selection were used. All complications were abstracted independently in duplicate using a standardized form and a priori criteria.One hundred sixty-nine free flaps (SIEA, n = 44; DIEP, n = 125) were performed on 112 patients for unilateral or bilateral breast reconstruction. Significantly more SIEA flaps required reexploration versus DIEP flaps (20 percent versus 7 percent; p = 0.03). Arterial insufficiency was significantly higher among SIEA flaps (14 percent versus 1 percent; p = 0.001). There was no difference in venous insufficiency (p = 0.92). Significantly more SIEA flaps had necrosis requiring intervention (p = 0.03). Ultimately, significantly more SIEA flaps failed completely (14 percent versus 2 percent; p0.01). All SIEA flap failures were attributable to arterial thrombosis.Compared with DIEP flaps, SIEA flaps had significantly higher proportions of reexploration, arterial complication, necrosis, and failure. No difference in venous complications was found. DIEP outcomes agree with existing literature from specialized centers. Complications and failures in SIEA flaps were attributed to arterial thrombosis. Given the authors' practice setting, SIEA flaps are no longer performed.Therapeutic, III.

Background Economic evaluations are quantitative methods comparing alternative interventions using cost data and expected outcomes. They are used to recommend/dissuade adoption of new surgical interventions and compare different clinical pathways, settings (inpatient/outpatient), or time horizons to determine which procedure may be more cost-effective. The objective of this systematic review was to describe all published English economic evaluations related to a plastic surgery domain. Methods A comprehensive English literature review of the MEDLINE, EMBASE, The Cochrane Library, Health Economic Evaluations Database, Ovid Health Star, and Business Source Complete databases was conducted (January 1, 1986, to June 15, 2012). Articles were assessed by two independent reviewers using predefined data fields and selected using specific inclusion criteria. Extracted information included country of origin, journal, and date of publication. Domain of plastic surgery and type of economic evaluation were ascertained. Results Ninety-five articles were included in the final analysis, with cost analysis being the most common economic evaluation (82 percent). Full economic evaluations represented 18 percent. General cutaneous disorders/burns (24 percent), breast surgery (20 percent), and "multiple" (15 percent) were the top domains studied. Authors were predominantly based in the United States (56 percent) and published in the journal Plastic and Reconstructive Surgery (22 percent), with a significant proportion (40 percent) published in the last 5 years. Conclusions Partial economic assessments (cost analyses) with limited benefit represent the majority of economic evaluations in plastic surgery. This suggests an urgent need to alert plastic surgeons to the advantages of full economic evaluations (cost-effectiveness and cost utility analyses) and the need to perform such rigorous analyses.

The authors investigated the methodological validity of plastic surgery randomized controlled trials that compared surgical interventions.An electronic search identified randomized controlled trials published between 2000 and 2013. Reviewers, independently and in duplicate, assessed manuscripts and performed data extraction. Methodological safeguards (randomization, allocation concealment, blinding, and incomplete outcome data) were examined using the Cochrane risk of bias tool. Regression analysis was used to identify trial characteristics associated with risk of bias.Of 1664 potentially eligible studies, 173 randomized controlled trials were included. Proper randomization and allocation concealment methods were described in 61 of 173 (35 percent) and 21 of 173 (12 percent), respectively. Outcome assessors were blinded in 58 of 173 (34 percent) trials, and patients were blinded in 45 of 173 (26 percent). Follow-up rates were high, with 99 of 173 (57 percent) randomized controlled trials appearing to have complete follow-up. An intention-to-treat analysis was used in 19 of 173 (11 percent) trials. One-third (58 of 173, 34 percent) did not state their primary outcomes. The most common type of primary outcome used was a symptom/quality of life, class III, outcome (73 of 173, 42 percent). Multinomial regression demonstrated trials reporting an a priori sample size as more likely to have a low risk of bias (p = 0.001).This article highlights methodological safeguards that plastic surgeons should consider when interpreting results of a surgical randomized controlled trial. Allocation concealment, outcome assessor blinding, and patient blinding were identified as areas of concern. Valid and reliable outcome measures are being used in plastic surgery. This analysis provides strong rationale for continued focus on the performance and reporting of clinical trials within our specialty.

Background: Debate continues about what split-thickness skin graft donor-site dressing provides the best outcomes for patients at the lowest cost. The goal of this systematic review was to determine which donor-site dressings are associated with the best outcomes for the following: pain, infection rate, healing quality, healing rate, quality of life, and cost. Methods: A comprehensive literature review and assessment was undertaken by two independent reviewers. Articles were selected using specific inclusion criteria. Split-thickness skin graft donor-site dressings were classified as either moist or nonmoist based on the state of the dressing upon initial application. Methodological quality of randomized controlled trials was assessed using the Jadad scale. Results: Seventy-five relevant articles were included in the final analysis, three of which were review articles. The most commonly measured outcome was healing rate (64 of 72), followed by pain (58 of 72), infection rate (40 of 72), healing quality (40 of 72), and cost (15 of 72). No studies measured quality of life. The majority of articles were randomized controlled trials (35 of 75), followed by observational studies (22 of 75), unsystematic clinical observations (15 of 75), and review articles (three of 75). It was difficult to compare moist and nonmoist dressings in this review because of the methodological heterogeneity of the included articles. The available evidence suggests, however, that moist dressings are superior in terms of pain. Conclusions: Some weak evidence exists that supports "wet dressings." To determine the best split-thickness skin graft donor-site dressing, more methodologically sound randomized controlled trials are needed. Trials with parallel economic evaluations should be undertaken to answer this question.