Palliative Therapies in Metastatic Pancreatic Cancer: Does Medicaid Expansion Make a Difference?

BACKGROUND: The aim of this study was to evaluate the impact of medicaid expansion (ME) on receipt of palliative therapies in metastatic pancreatic cancer patients. PATIENTS AND METHODS: A difference-in-differences (DID) approach was used to analyze patients with metastatic pancreatic cancer identified from the National Cancer Database diagnosed during two time periods: pre-expansion (2010-2012) and post-expansion (2014-2016). Patients diagnosed while residing in ME states were compared with those in non-ME states. Multivariable logistic regression was used to identify predictors of receipt of palliative therapies. RESULTS: Of 87,738 patients overall, 7483(18.1%) received palliative therapies in the pre-expansion, while 10,211(21.5%) received palliative therapies in the post-expansion period. In the pre-expansion period, treatment at a high-volume facility (HVF) (odds ratio [OR] 1.10, 95% confidence interval [CI] 1.02-1.18) and non-west geographic location were predictive of increased palliative therapies. In the post-expansion period, treatment at an HVF (OR 1.09, 95% CI 1.02-1.16), geographic location, and living in an ME state at the time of diagnosis (OR 1.14, 95% CI 1.06-1.22) were predictive of increased palliative therapies. Older age, highest quartile median income (zip-code based), and treatment at a nonacademic facility were independently associated with decreased palliative therapies in both periods. DID analysis demonstrated that patients with metastatic pancreatic cancer living in ME states had increased receipt of palliative therapies relative to those in non-ME states (DID = 2.68, p < 0.001). CONCLUSIONS: The overall utilization of palliative therapies in metastatic pancreatic cancer is low. Multiple sociodemographic disparities exist in the receipt of palliative therapies. ME is associated with increased receipt of palliative therapies in patients with metastatic pancreatic cancer.

Two-year Outcomes of Prehabilitation Among Obese Patients With Ventral Hernias: A Randomized Controlled Trial (NCT02365194).

OBJECTIVE: To determine if preoperative nutritional counseling and exercise (prehabilitation) improve outcomes in obese patients seeking ventral hernia repair (VHR)? SUMMARY BACKGROUND DATA: Obesity and poor fitness are associated with complications following VHR. It is unknown if preoperative prehabilitation improves outcomes of obese patients seeking VHR. METHODS: This is the 2-year follow-up of a blinded randomized controlled trial from 2015 to 2017 at a safety-net academic institution. Obese patients (BMI 30-40) seeking VHR were randomized to prehabilitation versus standard counseling. Elective VHR was performed once preoperative requirements were met: 7% total body weight loss or 6 months of counseling and no weight gain. Primary outcome was percentage of hernia-free and complication-free patients at 2 years. Complications included recurrence, reoperation, and mesh complications. Primary outcome was compared using chi-square. We hypothesize that prehabilitation in obese patients with VHR results in more hernia- and complication-free patients at 2-years. RESULTS: Of the 118 randomized patients, 108 (91.5%) completed a median (range) follow-up of 27.3 (6.2-37.4) months. Baseline BMI (mean±SD) was similar between groups (36.8 ±â€Š2.6 vs 37.0 ±â€Š2.6). More patients in the prehabilitation group underwent emergency surgery (5 vs 1) or dropped out of the program (3 vs 1) compared to standard counseling (13.6% vs 3.4%, P = 0.094). Among patients who underwent surgery, there was no difference in major complications (10.2% vs 9.1%, P = 0.438). At 2-years, there was no difference in percentage of hernia-free and complication-free patients (72.9% vs 66.1%, P = 0.424, 1.14, 0.88-1.47). CONCLUSION: There is no difference in 2-year outcomes of obese patients seeking VHR who undergo prehabilitation versus standard care. Prehabilitation may not be warranted in obese patients undergoing elective VHR.Clinical Trial Registration: This trial was registered with clinicaltrials.gov (NCT02365194).

Disparities in Access to Oncologic Care in Pancreatic Cancer: A Systematic Review.

BACKGROUND: Pancreatic cancer care is complex, and multiple disparities in receipt of therapies have been documented. The authors aimed to conduct a systematic review of the literature to critically assess and summarize disparities in access to oncologic therapies for pancreatic cancer. METHODS: A search of PubMed, Scopus, Web of Science, and Cochrane databases were performed for studies reporting disparities in access to oncologic care for pancreatic cancer. Primary research articles published in the United States from 2000 to 2020 were included. Data were independently extracted, and risk of bias was assessed using the modified Newcastle-Ottawa scale. RESULTS: The inclusion criteria were met by 47 studies. All the studies used retrospective data, with 70 % involving national database studies, 41 assessing the impact of race/ethnicity, 22 assessing the impact of socioeconomic status, 18 assessing the impact of insurance status, 23 assessing the impact of gender, 26 assessing the impact of age, and 3 assessing the impact of location on the delivery of cancer-directed therapies. Race, socioeconomic status, insurance status, gender, and age- based disparities in receipt of surgical resection, treatment at high-volume facilities and multimodal therapy for resectable pancreatic cancer, receipt of systemic chemotherapy for metastatic cancer, and receipt of expected standard-of-care treatment are reported. CONCLUSION: Significant sociodemographic disparities in access to equitable oncologic care exist along the continuum of pancreatic cancer care. Multiple patient, provider, and systemic factors contribute to these disparities. The ongoing study of these disparities is important to elucidate processes that may be targeted to improve access to equitable oncologic care for patients with pancreatic cancer.

Association of Medicaid Expansion with Pancreatic Cancer Treatment and Outcomes: Evidence from the National Cancer Database.

BACKGROUND: Socioeconomic- and demographic-based disparities exist in the treatment of pancreatic adenocarcinoma (PDAC). Medicaid expansion (ME) may have an impact on these disparities. Analyses of patients with PDAC from the National Cancer Database (NCDB) were performed to examine the impact of ME on access to treatment and outcomes. METHODS: Patients with non-metastatic PDAC diagnosed between 2006 and 2016 were identified. Multiple logistic regression analyses were performed to evaluate factors associated with curative-intent surgical resection, multimodal therapy, treatment at a high-volume facility (HVF), and survival. RESULTS: The study identified 41,876 patients who met the criteria. Medicaid expansion was independently associated with curative-intent resection (odds ratio [OR] 1.54; 95 % confidence interval [CI] 1.43-1.67; p < 0.001). In a multivariable analysis, ME was independently associated with multimodal therapy (OR 1.60; 95 % CI 1.44-1.76; p < 0.001) and treatment at an HVF (OR 1.57; 95 % CI 1.42-1.74; p < 0.001). Medicaid expansion was independently associated with improved 30-day mortality (OR 0.49; 95 % CI 0.34-0.79) and 90-day mortality (OR 0.48 95 % CI 0.35-0.59). Cox regression analysis demonstrated that after adjustment for other variables, ME status was associated with improved overall survival (hazard ratio [HR], 0.82; 95 % CI 0.73-0.90; p < 0.001). CONCLUSIONS: Medicaid expansion is associated with increased use of care processes that improve outcomes in PDAC, operative outcomes, and overall survival. The study data suggest that ME has helped to improve disparities in PDAC in ME states.

Impact of sleeve gastrectomy and Roux-en-Y gastric bypass on biopsy-proven non-alcoholic fatty liver disease.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD)/steatohepatitis (NASH) is the hepatic manifestation of metabolic syndrome. Our aim was to study the long-term effects of sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) on NAFLD/NASH. METHODS: Between 2008 and 2015, 3813 patients had an intraoperative liver biopsy performed at the time of primary RYGB and SG at a single academic center. Utilizing strict inclusion criteria, 487 patients with biopsy-proven NAFLD who had abnormal alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values (≥ 40 IU/L) at baseline were identified. Matching of SG to RYGB patients (1:4) was performed via logistic regression and propensity scores adjusting for clinical and liver histological characteristics. Changes in liver function tests (LFTs) at least 1 year after surgery were compared to baseline values and between the surgical groups. RESULTS: A total of 310 (weighted) patients (SG n = 62, and RYGB n = 248) with a median follow-up time of 4 years (range, 1-10) were included in the analysis. The distribution of covariates was well-balanced after propensity matching. In 84% of patients, LFT values normalized after bariatric surgery at the last follow-up time. The proportions of patients having normalized LFT values did not differ significantly between the SG and RYGB groups (82% vs. 84%, p = 0.66). The AST decreased from (SG: 49.1 ± 21.5 vs. RYGB: 49.3 ± 22.0, p = 0.93) at baseline to (SG: 28.0 ± 16.5 vs. RYGB: 26.5 ± 15.5, p = 0.33) at the last follow-up. Similarly, a significant reduction in ALT values from (SG: 61.7 ± 30.0 vs. RYGB 59.4 ± 24.9, p = 0.75) at baseline to (SG: 27.2 ± 21.5 vs. RYGB: 26.1 ± 19.2, p = 0.52) at the last follow-up was observed. CONCLUSIONS: In patients with biopsy-proven NAFLD/NASH, abnormal LFTs are normalized in most SG and RYGB patients by the end of the first postoperative year and remain normal until the last follow-up. This study also suggests that both bariatric procedures are similarly effective in improving liver function.

Are online surgical discussion boards a safe and useful venue for surgeons to ask for advice? A review of the International Hernia Collaboration Facebook Group.

BACKGROUND: Social media is a growing medium for disseminating information among surgeons. The International Hernia Collaboration Facebook Group (IHC) is a widely utilized social media platform to share ideas and advice on managing patients with hernia-related diseases. Our objective was to assess the safety and utility of advice provided. METHODS: Overall, 60 consecutive de-identified clinical threads were extracted from the IHC in reverse chronological order. A group of three hernia specialists evaluated all threads for unsafe posts, unhelpful comments, and if an established evidence-based management strategy was provided. Positive and negative controls for safe and unsafe answers were included in seven threads and reviewers were blinded to their presence. Reviewers were free to access all online and professional resources (except the IHC). RESULTS: There were 598 unique responses (median 10, 1-26 responses per thread) to the 60 clinical threads/scenarios. The review team correctly identified all seven positive and negative controls. Most responses were safe (96.6%) but some were unhelpful (28.4%). For sixteen threads, the reviewers believed there was an established evidence-based answer; however, only six were provided. In addition, 14 responses were considered unsafe, but only four were corrected. CONCLUSIONS: The vast majority of responses were considered helpful; however, evidence-based management is typically not provided and unsafe recommendations often go uncontested. While the IHC allows wide dissemination of hernia-related surgical advice/discussions, surgeons should be cautious when using the IHC for clinical advice. Mechanisms to provide evidence-based management strategies and to identify unsafe advice are needed to improve quality within online forums and to prevent patient harm.

Port Site Hernias Following Laparoscopic Ventral Hernia Repair.

BACKGROUND: Port site hernias (PSH) are underreported following laparoscopic ventral hernia repair (LVHR). Most occur at the site of laterally placed 10-12-mm ports used to introduce large pieces of mesh. One alternative is to place the large port through the ventral hernia defect; however, there is potential for increased risk of surgical site infection (SSI). This study evaluates the outcomes when introducing mesh through a 10-12-mm port placed through the hernia defect. METHODS: This was a retrospective case series of patients who underwent LVHR in three prospective trials from 2014-2017 at one institution. All patients had mesh introduced through a 10-12-mm port placed through the ventral hernia defect. The primary outcome was SSI. Secondary outcomes were hernia occurrences including recurrences and PSH. RESULTS: A total of 315 eligible patients underwent LVHR with a median (range) follow-up of 21 (11-41) months. Many patients were obese (66.9%), recently quit tobacco use (8.8%), or had diabetes (18.9%). Most patients had an incisional hernia (61.2%), and 19.2% were recurrent. Hernias were on average 4.8 ± 3.8 cm in width. Two patients (0.6%) had an SSI. Fourteen patients had a hernia occurrence-13 (4.4%) had a recurrent hernia, and one patient (0.3%) had a PSH. CONCLUSION: During LVHR, introduction of mesh through a 10-12-mm port placed through the hernia defect is associated with a low risk of SSI and low risk of hernia occurrence. While further studies are needed to confirm these results, mesh can be safely introduced through a port through the defect.

Expectant Management of Patients with Ventral Hernias: 3 Years of Follow-up.

BACKGROUND: The safety and effectiveness of expectant management (e.g., watchful waiting or initially managing non-operatively) for patients with a ventral hernia is unknown. We report our 3-year results of a prospective cohort of patients with ventral hernias who underwent expectant management. METHODS: A hernia clinic at an academic safety-net hospital was used to recruit patients. Any patient undergoing expectant management with symptoms and high-risk comorbidities, as determined by a surgeon based on institutional criteria, would be included in the study. Patients unlikely to complete follow-up assessments were excluded from the study. Patient-reported outcomes were collected by phone and mailed surveys. A modified activities assessment scale normalized to a 1-100 scale was used to measure results. The rate of operative repair was the primary outcome, while secondary outcomes include rate of emergency room (ER) visits and both emergent and elective hernia repairs. RESULTS: Among 128 patients initially enrolled, 84 (65.6%) completed the follow-up at a median (interquartile range) of 34.1 (31, 36.2) months. Overall, 28 (33.3%) patients visited the ER at least once because of their hernia and 31 (36.9%) patients underwent operative management. Seven patients (8.3%) required emergent operative repair. There was no significant change in quality of life for those managed non-operatively; however, substantial improvements in quality of life were observed for patients who underwent operative management. CONCLUSIONS: Expectant management is an effective strategy for patients with ventral hernias and significant comorbid medical conditions. Since the short-term risk of needing emergency hernia repair is moderate, there could be a safe period of time for preoperative optimization and risk-reduction for patients deemed high risk.

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.

Modifying Risks in Ventral Hernia Patients With Prehabilitation: A Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to determine whether preoperative nutritional counseling and exercise (prehabilitation) in obese patients with ventral hernia repair (VHR) results in more hernia-free and complication-free patients. BACKGROUND: Obesity and poor fitness are associated with complications following VHR. These issues are prevalent in low socioeconomic status patients. METHODS: This was a blinded, randomized controlled trial at a safety-net academic institution. Obese patients (BMI 30 to 40) seeking VHR were randomized to prehabilitation versus standard counseling. VHR was performed once preoperative requirements were met: 7% total body weight loss or 6 months of counseling and no weight gain. Primary outcome was the proportion of hernia-free and complication-free patients. Secondary outcomes were wound complications at 1 month postoperative and weight loss measures. Univariate analysis was performed. RESULTS: Among 118 randomized patients, prehabilitation was associated with a higher percentage of patients who lost weight and achieved weight loss goals; however, prehabilitation was also associated with a higher dropout rate and need for emergent repair. VHR was performed in 44 prehabilitation and 34 standard counseling patients. There was a trend toward less wound complication in prehabilitation patients (6.8% vs 17.6%, P = 0.167). The prehabilitation group was more likely to be hernia-free and complication-free (69.5% vs 47.5%, P = 0.015). CONCLUSIONS: It is feasible to implement a prehabilitation program for obese patients at a safety-net hospital. Prehabilitation patients have a higher likelihood of being hernia-free and complication-free postoperatively. Although further trials and long-term outcomes are needed, prehabilitation may benefit obese surgical patients, but there may be increased risks of dropout and emergent repair. CLINICAL TRIAL REGISTRATION: This trial was registered with clinicaltrials.gov (NCT02365194).

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.

Computed tomography in ventral hernia diagnosis: have we improved? A quality improvement initiative.

BACKGROUND: Previous studies suggest that agreement between readers of computed tomography (CT) scans for the diagnosis of a ventral hernia (VH) is poor (32% agreement, κ = 0.21). Recommendations were developed by surgeons and radiologists after determining common reasons for disagreement among CT reviewers; however, the long-term effect of adoption of these recommendations has not been assessed. The aim of this quality improvement (QI) project was to determine whether the incorporation of recommendations developed by surgeons and radiologists improves agreement among reviewers of CT scans in diagnosing a VH. METHODS: A prospective cohort of patients, with a CT scan of the abdomen and pelvis in the past 1 y, attending a surgery clinic at a single institution was enrolled. Enrolled subjects underwent a standardized physical examination by a trained hernia surgeon to determine the likelihood of a clinical VH (no, indeterminate, or yes). The QI intervention was the distribution and implementation of previously described recommendations. After a year of intervention, independent radiologists assessed patients' CT scans for the presence or absence of a VH. Percent agreement and kappa were calculated to determine interobserver reliability. In-person discussion on scans with disagreement was held, and the results were used as a "gold standard" to calculate sensitivity, specificity, positive, and negative predictive values for CT scan diagnosis of a VH. RESULTS: A total of 79 patients were included in the study. After QI intervention, seven radiologists agreed on 43% of the scans, and κ was 0.50 (P < 0.001). Agreement was highest among patients with a high clinical likelihood of a VH and lowest among patients with an indeterminate clinical likelihood. Sensitivity and specificity were 0.369 and 0.833, respectively. CONCLUSIONS: After the implementation of recommendations, there is improved agreement among radiologists reading CT scans for the diagnosis of a VH. However, there is substantial room for improvement, and CT scans for the diagnosis of VH is not ready for widespread use.

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

BACKGROUND: The 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. METHODS: A 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. RESULTS: Propensity 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. CONCLUSIONS: Our 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.

Differences of alternative methods of measuring abdominal wall hernia defect size: a prospective observational study.

BACKGROUND: Despite the importance of defect size, there are no standardized recommendations on how to measure ventral hernias. Our aims were to determine (1) if any significant differences existed between various methods of measuring ventral hernias and (2) the effect of these methods of measurement on selection of mesh size. METHOD: A prospective study of all patients enrolled in a randomized trial assessing laparoscopic ventral hernia repair at a single institution from 3/2015 to 7/2016 was eligible for inclusion. Abdominal wall hernia defect size was determined by multiplying defect length and width obtained separately using each of five methods: radiographic (CT), intraoperative with abdomen desufflated, intraoperative with abdomen insufflated to 15 mmHg (intra-abdominal aspect), intraoperative with abdomen insufflated to 15 mmHg (extra-abdominal aspect), and clinical. The primary outcome was intraclass correlation between the five different methods of measurement for each patient. Secondary outcome was changes in mesh selection assuming a 5 cm overlap in each direction. RESULTS: Fifty patients met inclusion criteria for assessment. The five different measurement methods had an intraclass correlation for each patient of 0.533 (95% CI 0.373-0.697) (weak correlation) for length; 0.737 (95% CI 0.613-0.844) (moderate correlation) for width; and 0.684 (95% CI 0.544-0.810) (moderate correlation) for area. Different types of measurements affected mesh selection in up to 56% of cases. CONCLUSION: Among five common methods of measuring abdominal wall hernia defect, sizes are only weakly to moderately correlated. Further studies are needed to determine which method results in optimally sized abdominal wall prostheses and superior ventral hernia 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.

Impact of Abdominal Wall Hernias and Repair on Patient Quality of Life.

BACKGROUND: The modified Activities Assessment Scale (AAS) is a 13-question abdominal wall quality of life (AW-QOL) survey validated in patients undergoing ventral hernia repair (VHR). No studies have assessed AW-QOL among individuals without abdominal wall pathology. The minimal clinically important difference (MCID) of the modified AAS and its implications for the threshold at which VHR should be offered also remain unknown. Our objectives were to (1) establish the AW-QOL of patients with a clinical abdominal wall hernia versus those with no hernia, (2) determine the MCID of the modified AAS, and (3) identify the baseline quality of life (QOL) score at which patients derive little clinical benefit from VHR. METHODS: Patient-centered outcomes data for all patients presenting to General Surgery and Hernia Clinics October-December 2016 at a single safety-net institution were collected via a prospective, cross-sectional observational study design. Primary outcome was QOL measured using the modified AAS. Secondary outcome was the MCID. RESULTS: Patients with no hernia had modified AAS scores of 81.6 (50.4-94.4), while patients with a clinically apparent hernia had lower modified AAS scores of 31.4 (12.6-58.7) (p < 0.001). The MCID threshold was 7.6 for a "slight" change and 14.9 for "definite" change. Above a modified AAS score of 81, the risk of worsening a patient's QOL by surgery is higher than the chances of improvement. CONCLUSIONS: VHR can improve 1-year postsurgical AW-QOL to levels similar to that of the general population. The MCID of the modified AAS is 7.6 points. Patients with high baseline scores should be counseled about the lack of potential benefit in QOL from elective VHR.

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.

Long-term Outcomes of Sphincter-Saving Procedures for Diffuse Crohn's Disease of the Large Bowel.

BACKGROUND: Total abdominal colectomy with ileorectal anastomosis for Crohn's colitis is acceptable in the presence of a suitable rectum. Intentional IPAA has been proposed for diffuse Crohn's proctocolitis without enteric or anoperineal disease. OBJECTIVE: The aim of this study was to evaluate the long-term outcomes of sphincter-saving procedures for large-bowel Crohn's disease. DESIGN: Patients with preoperative Crohn's disease diagnosis undergoing intentional IPAA and ileorectal anastomosis were included. SETTINGS: The study was conducted at a tertiary care research center. PATIENTS: Ileorectal anastomosis was performed in 75 patients with Crohn's disease, whereas 32 patients underwent intentional IPAA. MAIN OUTCOME MEASURES: Long-term functional results and permanent stoma requirement of sphincter-saving operations were assessed. Quality of life and postoperative medication use were also compared with a control group of patients undergoing total proctocolectomy and end ileostomy. RESULTS: Patients undergoing ileorectal anastomosis were older and had longer disease duration, higher prevalence of perianal and penetrating disease, and history of small-bowel resection than those receiving IPAA. Indications for surgery, preoperative use of immunomodulators, and postoperative use of biologics were also significantly different. Although functional defecatory outcomes were comparable, reported quality of life 3 years after surgery was significantly better in patients who underwent IPAA than in patients with ileorectal anastomosis. Patients with IPAA were associated with significantly lower cumulative rates of surgical recurrence (HR = 0.28 (95% CI, 0.09-0.84); p = 0.017), indefinite stoma diversion (HR = 0.35 (95% CI, 0.13-0.99); p = 0.039), and proctectomy with end ileostomy (HR = 0.27 (95% CI, 0.07-0.96); p = 0.030) than those with ileorectal anastomosis. LIMITATIONS: The study was limited by its retrospective nature and small sample size. CONCLUSIONS: Contemporary patients selected to have intentional IPAA for Crohn's colitis have disease characteristics very different from those selected to have ileorectal anastomosis. Long-term follow-up confirms intentional IPAA as an acceptable option in selected patients with Crohn's colitis.

Readability Assessment of Internet-Based Patient Education Materials Related to Parathyroid Surgery.

OBJECTIVES: Patient education is critical in obtaining informed consent and reducing preoperative anxiety. Written patient education material (PEM) can supplement verbal communication to improve understanding and satisfaction. Published guidelines recommend that health information be presented at or below a sixth-grade reading level to facilitate comprehension. We investigate the grade level of online PEMs regarding parathyroid surgery. METHODS: A popular internet search engine was used to identify PEM discussing parathyroid surgery. Four formulas were used to calculate readability scores: Flesch Reading Ease (FRE), Flesch-Kincaid Grade Level (FKGL), Gunning Frequency of Gobbledygook (GFOG), and Simple Measure of Gobbledygook (SMOG). RESULTS: Thirty web-based articles discussing parathyroid surgery were identified. The average FRE score was 42.8 (±1 standard deviation [SD] 16.3; 95% confidence interval [CI], 36.6-48.8; range, 6.1-71.3). The average FKGL score was 11.7 (±1 SD 3.3; 95% CI, 10.5-12.9; range, 6.1-19.0). The SMOG scores averaged 14.2 (±1 SD 2.6; 95% CI, 13.2-15.2; range, 10.7-21.9), and the GFOG scores averaged 15.0 (±1 SD 3.5; 95% CI, 13.7-16.3; range, 10.6-24.8). CONCLUSION: Online PEM on parathyroid surgery is written above the recommended sixth-grade reading level. Improving readability of PEM may promote better health education and compliance.