Validation of the minimal clinically important difference for modified activities assessment scale.

BACKGROUND: The minimal clinically important difference (MCID) is the smallest change in patient-derived scores that is clinically important. We sought to validate the MCID of the modified activities assessment scale (mAAS). METHODS: Patients were surveyed prior to undergoing abdomen/pelvis CT scans and resurveyed one year later. Before resurvey, patients were asked if they had no change, worsening, or improvement in AW-QOL. The anchor-based MCID was calculated by taking a weighted mean of the difference between control (no change) and study (worsening/improved) groups. Distribution-based approach was calculated by one-half of the standard deviation in the QOL change. RESULTS: 52.8% of 181 patients self-reported no change, 39.2% reported improvement, and 8.3% reported worsening AW-QOL. The anchor-based approach MCID was 4. The distribution-based MCID was 16. CONCLUSION: Our study results validate prior work demonstrating similar ranges of the mAAS MCID. We recommend adopting an MCID of 5 and 15 for AW-QOL with mAAS.

Impact of Early Cholecystectomy on the Cost of Treating Mild Gallstone Pancreatitis: Gallstone PANC Trial.

BACKGROUND: The Gallstone Pancreatitis: Admission vs Normal Cholecystectomy (Gallstone PANC) Trial demonstrated that cholecystectomy within 24 hours of admission (early) compared with after clinical resolution (control) for mild gallstone pancreatitis, significantly reduced 30-day length-of-stay (LOS) without increasing major postoperative complications. We assessed whether early cholecystectomy decreased 90-day healthcare use and costs. STUDY DESIGN: A secondary economic evaluation of the Gallstone PANC Trial was performed from the healthcare system perspective. Costs for index admissions and all gallstone pancreatitis-related care 90 days post-discharge were obtained from the hospital accounting system and inflated to 2020 USD. Negative binomial regression models and generalized linear models with log-link and gamma distribution, adjusting for randomization strata, were used. Bayesian analysis with neutral prior was used to estimate the probability of cost reduction with early cholecystectomy. RESULTS: Of 98 randomized patients, 97 were included in the analyses. Baseline characteristics were similar in early (n = 49) and control (n = 48) groups. Early cholecystectomy resulted in a mean absolute difference in LOS of -0.96 days (95% CI, -1.91 to 0.00, p = 0.05). Ninety-day mean total costs were $14,974 (early) vs $16,190 (control) (cost ratio [CR], 0.92; 95% CI, 0.73-1.15, p = 0.47), with a mean absolute difference of $1,216 less (95% CI, -$4,782 to $2,349, p = 0.50) per patient in the early group. On Bayesian analysis, there was an 81% posterior probability that early cholecystectomy reduced 90-day total costs. CONCLUSION: In this single-center trial, early cholecystectomy for mild gallstone pancreatitis reduced 90-day LOS and had an 81% probability of reducing 90-day healthcare system costs.

Gender Disparity Among American Medicine and Surgery Physicians: A Systematic Review.

BACKGROUND: Disparity exists between men and women physicians. We aimed to examine changes in gender disparity in the medical profession over the last two decades. The study reviewed publications on gender differences and the measures which have been implemented or suggested to rectify these disparities. METHODS: Pubmed, Embase, Scopus, and The Cochrane Library were searched in December 2019 using ("gender disparity" OR "gender gap" OR "pay gap" OR "gender discrimination") from 1998-2019. The sources list of reviewed articles was also used to retrieve more relevant articles. Articles about physicians in the United States were included, and Critical Appraisal Skills Programme (CASP) was used to evaluate the quality of the articles. RESULTS: In this systematic review that includes 49 studies, there is still disparity and discrimination in research, leadership, and pay between male and female physicians. Women have less leadership roles and progress at a slower rate to associate and full professor. Women publish less articles and have a lower h-index than men. Men earn $20,000 more a year after salary adjustment. More women than men experience negative comments about their gender (36% vs 4%), experience gender discrimination (65% vs 10%) and sexual harassment (30% vs 6%). CONCLUSIONS: Although substantial research exists on this topic, there remains significant room for improvement to achieve gender equality. Institutions and individuals should implement interventions to rectify this disparity .

Robotic versus laparoscopic ventral hernia repair: multicenter, blinded randomized controlled trial.

OBJECTIVE: To determine whether robotic ventral hernia repair is associated with fewer days in the hospital 90 days after surgery compared with laparoscopic repair. DESIGN: Pragmatic, blinded randomized controlled trial. SETTING: Multidisciplinary hernia clinics in Houston, USA. PARTICIPANTS: 124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019. INTERVENTIONS: Robotic ventral hernia repair (n=65) versus laparoscopic ventral hernia repair (n=59). MAIN OUTCOME MEASURES: The primary outcome was number of days in hospital within 90 days after surgery. Secondary outcomes included emergency department visits, operating room time, wound complications, hernia recurrence, reoperation, abdominal wall quality of life, and costs from the healthcare system perspective. Outcomes were pre-specified before data collection began and analyzed as intention to treat. RESULTS: Patients from both groups were similar at baseline. Ninety day follow-up was completed in 123 (99%) patients. No evidence was seen of a difference in days in hospital between the two groups (median 0 v 0 days; relative rate 0.90, 95% confidence interval 0.37 to 2.19; P=0.82). For secondary outcomes, no differences were noted in emergency department visits, wound complications, hernia recurrence, or reoperation. However, robotic repair had longer operative duration (141 v 77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125) v $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004). Among patients with robotic ventral hernia repair, two had an enterotomy compared none with laparoscopic repair. The median one month postoperative improvement in abdominal wall quality of life was 3 with robotic ventral hernia repair compared with 15 following laparoscopic repair. CONCLUSION: This study found no evidence of a difference in 90 day postoperative hospital days between robotic and laparoscopic ventral hernia repair. However, robotic repair increased operative duration and healthcare costs. TRIAL REGISTRATION: Clinicaltrials.gov NCT03490266.

Perceptions on gender disparity in surgery and surgical leadership: A multicenter mixed methods study.

BACKGROUND: Our objective was to identify perceptions of the environment for women in surgery among 4 academic institutions. METHODS: Faculty surgeons and senior surgery residents were randomly selected to participate in a parallel study with concurrent quantitative and qualitative data collection. Outcomes were perceptions of the environment for women in surgery. Measures included semi-structured interviews, survey responses, and responses to scenarios. RESULTS: Saturation was achieved after 36 individuals were interviewed: 14 female (8 faculty, 6 residents) and 22 male (18 faculty, 4 residents) surgeons. Men (100%) and women (86%) reported gender disparity in surgery and identified 6 major categories which influence disparity: definitions of gender disparity, gaps in mentoring, family responsibility, disparity in leave, unequal pay, and professional advancement. Overall 94% of participants expressed concerns with gaps in mentoring, but 64% of women versus 14% of men reported difficulties finding role models who faced similar obstacles. Over half (53%) reported time with loved ones as their biggest sacrifice to advance professionally. Both female and male respondents expressed system-based biases favoring individuals willing to sacrifice family. A global subconscious bias against the expectations, abilities, and goals of female surgeons were perceived to impede promotion and advancement. CONCLUSION: Both female and male surgeons report substantial gender-based barriers in surgery for women. Despite improvements, fundamental issues such as lack of senior role models, limited support for surgeons with families, and disparities in hiring and promotion persist. This is an opportunity to make substantive changes to the system and eliminate barriers for women joining surgery, advancing their careers, and achieving their goals in a timely fashion.

Gender Disparity in Authorship of Peer-Reviewed Medical Publications.

BACKGROUND: Women are underrepresented in medicine despite increases in the percentage of female physicians. It is unknown if academic productivity contributes to these differences. We sought to determine whether gender disparity exists in peer-reviewed literature authorship in the United States from 2000 to 2017. METHODS: Medical and surgical peer-reviewed research articles from the United States were retrospectively reviewed using PubMed from 2000 to 2017. Manuscripts were randomly selected within 4 different time periods: 2000-2005, 2006-2010, 2011-2015 and 2016-2017. The gender of the first and last authors was determined and the journal's impact factor recorded. The Accreditation Council for Graduate Medical Education (ACGME) and Association of American Medical Colleges (AAMC) databases were used to determine the percent of female residents, attendings and academic leadership positions. Primary outcome was the prevalence of female authors in peer-reviewed literature. Secondary aims were differences in disparity in medical versus surgical specialties, differences in publications' impact factor among gender and the association between gender and mentoring. RESULTS: Within 1,120 articles reviewed, 31.6% of first authors and 19.4% of last authors were women. Female first and last authors increased over time and authorship was proportional to the number of women in the studied specialties at that specific time period (P = 0.78). There was no difference in the journal's impact factors between gender (P = 0.64). On subgroup analysis of medical and surgical subspecialties, results remained unchanged. CONCLUSIONS: Women publish research at a rate proportional to the number of academic female physicians. Disparities in leadership roles are unlikely explained by differences in publications. While gender disparities in medicine have improved, substantial disparities in leadership persist.

Gender Disparity Among Surgical Peer-Reviewed Literature.

BACKGROUND: Women remain under-represented in academic surgery despite increasing percentages of female surgeons and surgery residents. Publications and leadership positions are used for hiring and promoting academic surgeons. We sought to determine the disparity of female authorship when compared with male authors in surgical peer-reviewed publications. METHODS: PubMed was searched for surgical publications from the United States. Obstetrics and gynecology was selected as a control specialty owing to its history of high female representation. Thirteen other surgical specialties were randomly selected from the Accreditation Council for Graduate Medical Education specialty list. Manuscripts from four time periods, 2000-2005, 2006-2010, 2011-2015, and 2016-2017, were randomly selected, and the gender of the first and last authors was determined. The Accreditation Council for Graduate Medical Education and Association of American Medical Colleges databases were used to determine women representation in surgery. Trends were assessed using the Cochran-Armitage test. RESULTS: In total, 560 manuscripts in 14 specialties were reviewed. In the control specialty, 51% of first authors were female compared with 18% of those in study specialties, and 39% of last authors were female compared with 11% of those in study specialties. No difference was found when comparing the gender of first (P-value = 0.393) and/or last authors (P-value = 0.281) with the proportion of female residents and attendings. CONCLUSIONS: Women surgeons publish research at a rate proportional to the number of females involved in that specialty. Disparities in leadership roles are unlikely explained by differences in publications. Instead, disparities are likely due to other reasons such as failure to attract women to academic surgery and failure to promote and mentor women surgeons into leadership positions.

Lack of Regulations and Conflict of Interest Transparency of New Hernia Surgery Technologies.

BACKGROUND: Medical devices introduced to market through the 510K process often have limited research of low quality and substantial conflict of interest (COI). By the time high-quality safety and effectiveness research is performed, thousands of patients may have already been treated by the device. Our aim was to systematically review the trends of outcomes, research quality, and financial relationships of published studies related to de-adopted meshes for ventral hernia repair. MATERIALS AND METHODS: Literature was systematically reviewed using PubMed to obtain all published studies related to three de-adopted meshes: C-QUR, Physiomesh, and meshes with polytetrafluoroethylene. Primary outcome was change in cumulative percentage of subjects with positive published outcomes. Secondary outcome was percentage of published manuscript with COI. RESULTS: A total of 723 articles were screened, of which, 129 were analyzed and included a total of 8081 subjects. Percentage of subjects with positive outcomes decreased over time for all groups: (1) C-QUR from 100% in 2009 to 22% in 2018, (2) Physiomesh from 100% in 2011 to 20% in 2018, and (3) polytetrafluoroethylene from 100% in 1979 to 49% in 2018. Authors of only 20% of articles self-reported no COI, most representing later publications and were more likely to show neutral or negative results. CONCLUSIONS: Among three de-adopted meshes, early publications demonstrated overly optimistic results followed by disappointing outcomes. Skepticism over newly introduced, poorly proven therapies is essential to prevent adoption of misleading practices and products. Devices currently approved under the 510K processes should undergo blinded, randomized controlled trials before introduction to the market.

Gender Disparity in Surgery: An Evaluation of Surgical Societies.

Background: The percentage of female surgeons and surgery residents has increased slowly to 24% and 35%, respectively. However, women remain under-represented in surgical leadership positions (<20%). Society awards and leadership positions are used for hiring and promoting surgeons. We hypothesized that within the Surgical Infection Society (SIS), females are under-represented. Methods: The SIS website and databases were consulted for the number of female members, awardees, and leaders. Representation was divided into four time periods: 2000-2005, 2006-2010, 2011-2015, and 2016-2017 and compared for changes over time utilizing a Χ2 test. In addition, we reviewed the council members of five other surgical societies and compared the percentage of female representation in leadership positions. Results: Since the SIS was founded, there have been 587 members of whom only 135 (23%) are female. There has been an increase in female membership over time (p < 0.001). The number of female awardees rose from 37% during the first two study periods to more than 50% in the last two periods (p = 0.002). However, female representation in leadership positions decreased from 26% in 2000-2005 to less than 15% in the last three study periods (p = 0.234). Similar disparities emerged when comparing the SIS with other surgical societies: Women have represented only 24% (range 8%-42%) of leaders and 4% (range 0-11%) of society presidents. Conclusions: Female surgeons are under-represented in the SIS membership and leadership positions. Whereas the number of female surgeons and residents has increased, these trends have not occurred with council membership and leadership within the SIS. There is a need to address this gender disparity.

The Effect of Financial Conflict of Interest, Disclosure Status, and Relevance on Medical Research from the United States.

BACKGROUND: Financial interactions between industry and healthcare providers are reportable. Substantial discrepancies have been detected between industry and self-report of these conflicts of interest (COIs). OBJECTIVE: Our aim was to determine if authors who fail to disclose reportable COI are more likely to publish findings that are favorable to industry than authors with no COI. DESIGN: In this blinded, observational study of medical and surgical primary research articles in PubMed, 590 articles were reviewed. MAIN MEASURES: Reportable financial relationships between authors and industry were evaluated. COIs were considered to have relevance if they were associated with the product(s) mentioned by an article. Primary outcome was favorability, defined as an impression favorable to the product(s) discussed by an article and determined by 3 independent, blinded clinicians for each article. Primary analysis compared Incomplete Self-Disclosure to No COI. Two-level multivariable mixed-effects ordered logistic regression was used to assess factors associated with favorability. KEY RESULTS: A 69% discordance rate existed between industry and self-report in COI disclosure. When authors failed to disclose COI, their conclusions were more likely to favor industry partners than authors without COI (favorable ratings 73% versus 62%, RR 1.18, p = < 0.001). On univariate (any COI 74% versus no COI 62%, RR 1.11, p = < 0.001) and multivariable analyses, any COI was associated with favorability. CONCLUSIONS: All financial COIs (disclosed or undisclosed, relevant or not relevant, research or non-research) influence whether studies report findings favorable to industry sponsors.

Clinical assessment, radiographic imaging, and patient self-report for abdominal wall hernias.

BACKGROUND: Increasingly, abdominal wall hernias are being diagnosed incidentally through radiographic imaging. Such hernias are referred to as occult. However, the clinical significance of occult hernias is unknown. The objective of this study is to determine the prevalence of occult hernias and to assess the abdominal wall quality of life (AW-QOL) among patients with occult hernias. MATERIALS AND METHODS: A blinded, observational, cross-sectional study, October-December 2016, of patients presenting to single academic institution's general surgery clinics was performed. Inclusion criteria included all patients with a computed tomography scan of the abdomen or pelvis within the last year with no intervening abdominal or pelvic surgery. Patients were administered a validated AW-QOL survey and underwent a standardized clinical examination. Computed tomography scans were reviewed. Primary outcomes were prevalence and AW-QOL measured by the modified Activities Assessment Scale. AW-QOL of patients with no hernias was compared to that of those with occult hernias and clinically apparent hernias using Mann-Whitney U test. RESULTS: A total of 250 patients were enrolled of whom 97 (38.8%) had a hernia noted on clinical examination and 132 (52.8%) had a hernia noted on radiographic imaging. The prevalence of occult hernias was 38 (15.2%). Patients with no hernia had a median (interquartile range) AW-QOL of 82.5 (55.0-95.3), patients with clinically apparent hernias had AW-QOL of 47.7 (31.2-81.6; P < 0.001), and patients with occult hernias had AW-QOL of 72.4 (38.5-97.2; P = 0.36). CONCLUSIONS: Both clinically apparent and occult hernias are prevalent. However, only patients with clinically apparent hernias had differences in AW-QOL when compared to patients with no hernias. Prospective trials are needed to assess the outcomes of patients with occult hernias managed with and without surgical repair.

The Impact of Financial Conflict of Interest on Surgical Research: An Observational Study of Published Manuscripts.

BACKGROUND: Substantial discrepancies exist between industry-reported and self-reported conflicts of interest (COI). Although authors with relevant, self-reported financial COI are more likely to write studies favorable to industry sponsors, it is unknown whether undisclosed COI have the same effect. We hypothesized that surgeons who fail to disclose COI are more likely to publish findings that are favorable to industry than surgeons with no COI. METHODS: PubMed was searched for articles in multiple surgical specialties. Financial COI reported by surgeons and industry were compared. COI were considered to be relevant if they were associated with the product(s) mentioned by an article. Primary outcome was favorability, which was defined as an impression favorable to the product(s) discussed by an article and was determined by 3 independent, blinded clinicians for each article. Primary analysis compared incomplete self-disclosure to no COI. Ordered logistic multivariable regression modeling was used to assess factors associated with favorability. RESULTS: Overall, 337 articles were reviewed. There was a high rate of discordance in the reporting of COI (70.3%). When surgeons failed to disclose COI, their conclusions were significantly more likely to favor industry than surgeons without COI (RR 1.2, 95% CI 1.1-1.4, p < 0.001). On multivariable analysis, any COI (regardless of relevance, disclosure, or monetary amount) were significantly associated with favorability. CONCLUSIONS: Any financial COI (disclosed or undisclosed, relevant or not relevant) significantly influence whether studies report findings favorable to industry. More attention must be paid to improving research design, maximizing transparency in medical research, and insisting that surgeons disclose all COI, regardless of perceived relevance.

Investigation of Financial Conflict of Interest among Published Ventral Hernia Research.

BACKGROUND: Discordance exists between author self-disclosure and the Open Payments Database in various surgical fields, but the effects of this discordance on study design and presentation are unknown. We hypothesized that, among ventral hernia publications, discordance exists between industry and physician self-reported conflicts of interest (COIs); authors disclose relevant COIs; and disclosure and relevant COIs affect study favorability. STUDY DESIGN: We conducted a double-blinded, prospective, observational study of published articles. PubMed was searched in reverse chronological order for clinical articles pertaining to ventral hernias. Authors' self-disclosed conflicts were compared with those on the Open Payments Database. Two reviewers blinded to article disclosure status determined jointly whether the COIs were relevant to the article. Three blinded referees independently voted whether each article was favorable to discussed subject matter. The primary end point was study favorability. Secondary outcomes included disclosure status and relevance. RESULTS: One hundred articles were included. Compared with authors with no COIs, authors with a COI, self-disclosed or not, were twice as likely to write results favorable to industry. Of those with a COI, most of the articles had a relevant COI (37 of 45 [82.2%]), and 25% of relevant COIs were not disclosed by authors. Among authors with a relevant COI, study favorability remained unchanged at 68.5% (control: no COI 33.3%; p < 0.001). CONCLUSIONS: Within the ventral hernia literature, 70% of articles have a COI. Self-reporting of COI is discordant in 63% of articles. Twenty-five percent of relevant COI are not disclosed. Having a COI increases the chances that an article will cast a favorable impression on the company paying the authors by 200%.

Discordance of conflict of interest self-disclosure and the Centers of Medicare and Medicaid Services.

BACKGROUND: The Open Payments Database (OPD) discloses financial transactions between manufacturers and physicians. The concordance of OPD versus self-reported conflicts of interest (COI) is unknown. MATERIALS AND METHODS: Our objectives were to compare (1) industry and self-disclosed COI in clinical literature, (2) payments within each disclosure level, and (3) industry- and self-disclosed COI and payments by specialty. This was an observational study. PubMed was searched for clinical studies accepted for publication from January 2014 to June 2016. Author and OPD-disclosed COIs were compared. Articles and authors were divided into full disclosure, incomplete industry disclosure, incomplete self-disclosure, and no COI. Primary outcome (differences in reported COI per article) was assessed using McNemar's test. Payment differences were compared using Kruskal-Wallis test. RESULTS: OPD- and self-disclosed COI differed (65.0% discordance rate by article, P < 0.001). Percentages of authors within each disclosure category differed between specialties (P < 0.001). Hematology articles exhibited the highest discordance rate (79.0%) and received the highest median payment for incomplete self-disclosure ($30,812). CONCLUSIONS: Significant discordance exists between self- and OPD-reported COI. Additional research is needed to determine reasons for these differences.

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.

A Prospective Assessment of Clinical and Patient-Reported Outcomes of Initial Non-Operative Management of Ventral Hernias.

BACKGROUND: Little is known about the clinical or patient-reported outcomes with non-operative management of ventral hernias. The aim of this prospective study is to determine the clinical and patient-reported outcomes of patients undergoing initial non-operative treatment of their ventral hernia. STUDY DESIGN: This was a prospective observational study of patients undergoing non-operative management of ventral hernias. Primary outcome was rate of surgical repair of the ventral hernias. Secondary outcomes included rate of emergency repair, elective repair, and emergency room visits. In addition, validated measurement tools for patient satisfaction and cosmetic satisfaction with their abdomen, abdominal pain, and patient function (modified Activities Assessment Scale, AAS) were utilized. RESULTS: Of 128 patients who underwent non-operative management of a ventral hernia, 99(77.3%) patients were followed for a median (interquartile range) of 12.2(10.4-13.5) months. Twenty (20.2%) patients had at least 1 emergency room visit associated with their hernia. One-quarter (n = 2323.2%) underwent ventral hernia repair following enrollment. Twenty (20.2%) underwent elective repair, and 3 (3.0%) underwent emergent repair. Based on the modified AAS survey, patients who were managed non-operatively experienced no change in patient centered outcomes, while patients converted to operative management had improved scores. CONCLUSIONS AND RELEVANCE: While the short-term risk of emergency surgery with non-operative management of ventral hernias is moderate, the chance of an emergency room visit and surgery is high. Patients who undergo non-operative management of their ventral hernias have no change in patient-reported outcomes at one year, while those converted to operative management experience improvement.