Deepa V. Cherla

Comparison of Conflicts of Interest among Published Hernia Researchers Self-Reported with the Centers for Medicare and Medicaid Services Open Payments Database

BACKGROUND Many healthcare providers have financial interests and relationships with healthcare companies. To maintain transparency, investigators are expected to disclose their conflicts of interest (COIs). Recently, the Centers for Medicare and Medicaid Services developed the Open Payment database of COIs reported by industry. We hypothesize that there is discordance between industry-reported and physician self-reported COIs in ventral hernia publications. STUDY DESIGN PubMed was searched for ventral hernia studies accepted for publication between June 2013 and October 2015 and published by authors from the US. Conflicts of interest were defined as payments received as honoraria, consulting fees, compensation for serving as faculty or as a speaker at a venue, research funding payments, or having ownerships/partnerships in companies. Conflicts of interest disclosed on the published articles were compared with the financial relationships in the Open Payments database. RESULTS A total of 100 studies were selected with 497 participating authors. Information was available from the Open Payments database for 245 (49.2%) authors, of which 134 (26.9%) met the definition for COI. When comparing COIs disclosed by authors and data in the Open Payments database, 81 (16.3%) authors had at least 1 COI but did not declare any, 35 (7.0%) authors had COIs other than what they declared, and 20 (4.0%) declared a COI not listed in the Open Payments database, for a combined discordance rate of 27.3%. CONCLUSIONS There is substantial discordance between self-reported COI in published articles compared with those in the Centers for Medicare and Medicaid Services Open Payments database. Additional studies are needed to determine the reasons for these differences, as COI can influence the validity of the design, conduct, and results of a study.

External Validation of the HERNIAscore: An Observational Study

BACKGROUND The HERNIAscore is a ventral incisional hernia (VIH) risk assessment tool that uses only preoperative variables and predictable intraoperative variables. The aim of this study was to validate and modify, if needed, the HERNIAscore in an external dataset. STUDY DESIGN This was a retrospective observational study of all patients undergoing resection for gastrointestinal malignancy from 2011 through 2015 at a safety-net hospital. The primary end point was clinical postoperative VIH. Patients were stratified into low-risk, medium-risk, and high-risk groups based on HERNIAscore. A revised HERNIAscore was calculated with the addition of earlier abdominal operation as a categorical variable. Cox regression of incisional hernia with stratification by risk class was performed. Incidence rates of clinical VIH formation within each risk class were also calculated. RESULTS Two hundred and forty-seven patents were enrolled. On Cox regression, in addition to the 3 variables of the HERNIAscore (BMI, COPD, and incision length), earlier abdominal operation was also predictive of VIH. The revised HERNIAscore demonstrated improved predictive accuracy for clinical VIH. Although the original HERNIAscore effectively stratified the risk of an incisional radiographic VIH developing, the revised HERNIAscore provided a statistically significant stratification for both clinical and radiographic VIHs in this patient cohort. CONCLUSIONS We have externally validated and improved the HERNIAscore. The revised HERNIAscore uses BMI, incision length, COPD, and earlier abdominal operation to predict risk of postoperative incisional hernia. Future research should assess methods to prevent incisional hernias in moderate-to-high risk patients.

Multicenter review of robotic versus laparoscopic ventral hernia repair: is there a role for robotics?

BackgroundThe utilization of robotic platforms for general surgery procedures such as hernia repair is growing rapidly in the United States. A limited amount of data are available evaluating operative outcomes in comparison to standard laparoscopic surgery. We completed a retrospective review comparing robotic and laparoscopic ventral hernia repair to provide safety and outcomes data to help design a future prospective trial design.MethodsA retrospective review of 215 patients undergoing ventral hernia repair (142 robotic and 73 laparoscopic) was completed at two large academic centers. Primary outcome measure evaluated was recurrence. Secondary outcomes included incidence of primary fascial closure, and surgical site occurrences.ResultsPropensity for treatment match comparison demonstrated that robotic repair was associated with a decreased incidence of recurrence (2.1 versus 4.2%, p < 0.001) and surgical site occurrence (4.2 versus 18.8%, p < 0.001). This may be because robotic repair was associated with increased incidence of primary fascial closure (77.1 versus 66.7%, p < 0.01). Analysis of baseline patient populations showed that robotic repairs were completed on patients with lower body mass index (28.1 ± 3.6 versus 34.2 ± 6.4, p < 0.001) and fewer comorbidities.ConclusionsOur retrospective data show that robotic repair was associated with decreased recurrence and surgical site occurrence. However, the differences noted in the patient populations limit the interpretability of these results. As adoption of robotic ventral hernia repair increases, prospective trials need to be designed in order to investigate the efficacy, safety, and cost effectiveness of this evolving technique.

Recurrence and mesh-related complications after incisional hernia repair

challenging to treat. Even though the mean age was older than in the other studies mentioned by Blok, half were younger than 65 years. Although the study population may not represent the wider spectrum of women with overactive bladder symptoms, it does address the population with more severe symptoms refractory to conservative therapies. We recognize the importance of the design concerns raised by Dr McCauley and colleagues but disagree that our design decisions limit study validity. Asserting design bias (defined as incorrect design architecture to answer the research question4,5) in hypothesis selection for this randomized clinical trial is questionable. For a comparative effectiveness trial with no assumed direction of relative effectiveness of the 2 comparators, a superiority design with a 2-sided hypothesis test is preferred over a noninferiority design, which is inherently 1-sided. The former design allows either treatment to demonstrate superiority, whereas the latter allows only a 1-way comparison. Furthermore, the study conduct and results would be identical under either hypothesis choice. A small set of participants provided no postrandomization outcome data. We recognized this possibility and treated those data as missing at random in a likelihood-based analysis, which excluded participants with no follow-up data from the primary analysis. Because the sensitivity analyses reported in the article imputed data for those individuals (and hence included all randomized participants) and yielded the same results, the study results are robust to our missing at random assumption (ie, using a modified intent-to-treat population). Prior placebo (or sham) controlled trials demonstrated each of the active treatment regimens to be superior to placebo. Including a placebo group in this trial was not necessary and doing so could be considered unethical.