Incidence and Contemporary Management of Delayed Bleeding Following Pancreaticoduodenectomy.

BACKGROUND: Delayed bleeding after pancreaticoduodenectomy (PD) is a life-threatening complication. However, the optimal management remains unclear. We summarize our experience of the management of delayed bleeding after PD and define the outcomes associated with different types of management. METHODS: All patients who underwent a PD between January 1987 and June 2020 at Johns Hopkins University were retrospectively reviewed. Delayed bleeding was defined as bleeding on or after postoperative day 5 following PD. Incidence, outcomes, and trends were reported. RESULTS: Among the 6201 patients that underwent PD, delayed bleeding occurred in 130 (2.1%) at a median of 12 days (IQR: 9, 24) postoperation. The pattern of bleeding was classified as intraluminal (51.5%), extraluminal (40.8%), and mixed (7.7%). A clinically relevant postoperative pancreatic fistula and an intraabdominal abscess preceded the delayed bleeding in 43.1% and 31.5% of cases, respectively. Arterial pseudoaneurysm or bleeding from peripancreatic vessels was the most common reason (54.6%) with the gastroduodenal artery being the most common source (18.5%). Endoscopy, angiography, and reoperation were performed as a first-line approach in 35.4%, 52.3%, and 6.2% of patients, respectively. The overall mortality was 16.2% and decreased over the study period (p < 0.01). CONCLUSIONS: Delayed bleeding following PD remains a life-threatening complication. The most common location of delayed bleeding is from the gastroduodenal artery. Angiography with embolization should be the initial approach for urgent bleeding with surgical re-exploration reserved for unstable patients or failed control of bleeding after interventional angiography or endoscopy.

Robotic pancreas surgery: an overview of history and update on technique, outcomes, and financials.

The use robotics in surgery is gaining momentum. This approach holds substantial promise in pancreas surgery. Robotic surgery for pancreatic lesions and malignancies has become well accepted and is expanding to more and more center annually. The number of centers using robotics in pancreatic surgery is rapidly increasing. The most studied robotic pancreas surgeries are pancreaticoduodenectomy and distal pancreatectomy. Most studies are in their early phases, but they report that robotic pancreas surgery is safe feasible. Robotic pancreas surgery offers several advantages over open and laparoscopic techniques. Data regarding costs of robotics versus conventional techniques is still lacking. Robotic pancreas surgery is still in its early stages. It holds promise to become the new surgical standard for pancreatic resections in the future, however, more research is still needed to establish its safety, cost effectiveness and efficacy in providing the best outcomes.

A Quality Assessment of the Information Accessible to Patients on the Internet About the Whipple Procedure.

BACKGROUND: The Internet has become a central source of information on health-related issues. The aim of this study is to assess the quality and readability of online information present on the Whipple surgical procedure by applying recognized scoring tools. METHODS: A search using the top three online search engines (Google, Bing and Yahoo) was conducted in July 2020. Websites were classified as academic, physician, commercial or unspecified. The quality of information was assessed using the JAMA and DISCERN assessment instruments and presence of a HONcode seal. Readability was assessed using the Flesch Reading Ease Score (FRES). RESULTS: A total of 34 unique sources were included in our study. The average JAMA and DISCERN scores of all websites were 2.22 ± 0.48 and 47.28 ± 1.17, respectively, with a median of 1.9 (range 0-4) and 47 (range 18-71), respectively. Website classification distribution was 38% academic, 18% commercial, 9% unspecified, and 1% from physician-based websites. Physician websites had the highest JAMA score with a mean of 3 ± 0.46. Unspecified websites had the highest DISCERN score with a mean of 54.60 ± 1.09. Only 3 websites had the HONcode seal. Physician websites had a significantly higher JAMA mean score than academic websites (p-value = 0.004). Readability was difficult and is on the level of university students. CONCLUSION: The results of this study show a poor quality of online information present on the Whipple surgery. Academic and physician websites need to improve the quality of their websites on the procedure. More HONcode-certified websites are needed as they are the best source for information on this operation.

Authors of clinical trials seldom reported details when declaring their individual and institutional financial conflicts of interest: a cross-sectional survey.

BACKGROUND: The main objective of this study was to document details of both individual and institutional financial conflicts of interest (FCOIs) reported by the authors of clinical trials. An additional objective was to assess the predictors of having at least one author reporting any FCOI. METHODS: We used a sample of randomized controlled trials from a previous cross-sectional survey and included the trials, which reported at least one FCOI disclosure. We categorized the types of disclosed FCOI as grant, employment income, personal fees, nonmonetary support, drug or equipment supplies, patent, stocks, and other types. We collected data on the characteristics of the included RCTs, of the authors, and of the reported FCOI disclosures. We conducted descriptive analyses and a regression analysis to assess the predictors of having at least one author reporting any FCOI. RESULTS: All 108 included RCTs reported being funded, with 58% reporting funding by a private-for-profit source. Out of 1,687 authors, 814 (48%) reported at least one, and a median of 2, FCOI disclosures. Of the 814 reporting disclosures, far more reported individual FCOIs (99%) than institutional FCOIs (6%). The most commonly reported individual FCOI subtypes were grant (49%), personal fees (48%), and employment income (22%). Of the 99% of disclosures that included the source of FCOI, a private-for-profit entity provided the funds in 85%. Reporting about the relation of the FCOI source's to the product investigated in the trial, the timing of FCOI, and monetary value of FCOI was limited. Reporting of FCOIs proved most strongly associated with author affiliation being an academic institution (OR = 2.981; 95% CI: 2.415-3.680) and trial funding from entity other than a private-for-profit entity (OR = 2.809; 95% CI: 2.274-3.470). CONCLUSION: Approximately half of the trial authors report individual FCOIs, often three or more, but seldom provide details related to source's relation to the trial, or the timing and monetary value of the FCOI.

The reporting of funding in health policy and systems research: a cross-sectional study.

BACKGROUND: Major research-reporting statements, such as PRISMA and CONSORT, require authors to provide information about funding. The objectives of this study were (1) to assess the reporting of funding in health policy and systems research (HPSR) papers and (2) to assess the funding reporting policies of journals publishing on HPSR. METHODS: We conducted two cross-sectional surveys for papers published in 2016 addressing HPSR (both primary studies and systematic reviews) and for journals publishing on HPSR (both journals under the 'Health Policy and Services' (HPS) category in the Web of Science, and non-HPS journals that published on HPSR). Teams of two reviewers selected studies and abstracted data in duplicate and independently. We conducted descriptive analyses and a regression analysis to investigate the association between reporting of funding by papers and the journal's characteristics. RESULTS: We included 400 studies (200 systematic reviews and 200 primary studies) that were published in 198 journals. Approximately one-third (31%) of HPSR papers did not report on funding. Of those that did, only 11% reported on the role of funders (15% of systematic reviews and 7% of primary studies). Of the 198 journals publishing on HPSR, 89% required reporting of the source of funding. Of those that did, about one-third (34%) required reporting of the role of funders. Journals classified under the HPS category (n = 72) were less likely than non-HPS journals that published HPSR studies (n = 142) to require information on the role of funders (15% vs. 32%). We did not find any of the journals' characteristics to be associated with the reporting of funding by papers. CONCLUSIONS: Despite the majority of journals publishing on HPSR requiring the reporting of funding, approximately one-third of HPSR papers did not report on the funding source. Moreover, few journals publishing on HPSR required the reporting of the role of funders, and few HPSR papers reported on that role.

Public health journals' requirements for authors to disclose funding and conflicts of interest: a cross-sectional study.

BACKGROUND: Public health journals need to have clear policies for reporting the funding of studies and authors' personal financial and non-financial conflicts of interest (COI) disclosures. This study aims to assess the policies of public health journals on reporting of study funding and the disclosure of authors' COIs. METHODS: This is a cross-sectional study of "Public, Environmental & Occupational Health" journals. Teams of two researchers abstracted data in duplicate and independently using REDCap software. RESULTS: Of 173 public health journals, 155 (90%) had a policy for reporting study funding information. Out of these, a majority did not require reporting of the phase of the study for which funding was received (88%), nor the types of funding sources (87%). Of the 173 journals, 163 (94%) had a policy requiring disclosure of authors' COI. However, the majority of these journals did not require financial conflicts of interest disclosures relating to institutions (75%) nor to the author's family members (90%) while 56% required the disclosure of at least one form of non-financial COI. CONCLUSIONS: The policies of the majority of public health journals do not require the reporting of important details such as the role of the funder, and non-financial COI. Journals and publishers should consider revising their editorial policies to ensure complete and transparent reporting of funding and COI.

Requirements of health policy and services journals for authors to disclose financial and non-financial conflicts of interest: a cross-sectional study.

BACKGROUND: The requirements of the health policy and services journals for authors to report their financial and non-financial conflicts of interest (COI) are unclear. The present article aims to assess the requirements of health policy and services journals for authors to disclose their financial and non-financial COIs. METHODS: This is a cross-sectional study of journals listed by the Web of Science under the category of 'Health Policy and Services'. We reviewed the 'Instructions for Authors' on the journals' websites and then simulated the submission of a manuscript to obtain any additional relevant information made available during that step. We abstracted data in duplicate and independently using a standardised form. RESULTS: Out of 72 eligible journals, 67 (93%) had a COI policy. A minority of policies described how the disclosed COIs of authors would impact the editorial process (34%). None of the policies had clear-cut criteria for rejection based on the content of the disclosure. Approximately a fifth of policies (21%) explicitly stated that inaccurate or incomplete disclosures might lead to manuscript rejection or retraction. No policy described whether the journal would verify the accuracy or completeness of authors' disclosed COIs. Most journals' policies (93%) required the disclosure of at least one form of financial COI. While the majority asked for specification of source of payment (71%), a minority asked for the amount (18%). Overall, 81% of policies explicitly required disclosure of non-financial COIs. CONCLUSION: A majority of health policy and services journal policies required the disclosure of authors' financial and non-financial COIs, but few required details on disclosed COIs. Health policy journals should provide specific definitions and instructions for disclosing non-financial COIs. A framework providing clear typology and operational definitions of the different types of COIs will facilitate both their disclosure by authors and reviewers and their assessment and management by the editorial team and the readers.

Effects of Blood Transfusion on Cause-Specific Late Mortality After Coronary Artery Bypass Grafting-Less Is More.

BACKGROUND: Red blood cell transfusion after coronary artery bypass graft surgery has been associated with increased late all-cause death. Yet, whether this association is, first, independent of the packed red blood cells and perioperative morbidity association, and second, of a cardiac versus noncardiac etiology remains unknown. METHODS: We analyzed patients undergoing coronary artery bypass graft surgery at two Ohio hospitals (n = 6,947) from 1994 to 2007. Salvage operations and patients with preoperative renal failure were excluded. Long-term outcomes and leading cause of death (cardiac, noncardiac, all cause) were derived from the US Social Security Death Index and later from Ohio Department of Health Death Index. Fifteen-year mortality cumulative incidence functions were compared for transfusion groups (yes, n = 2,540; no, n = 4,806) overall, and then stratified based on perioperative complications status (yes, n = 2,638; no, n = 4,708). Comprehensive, 32 covariates, risk-adjusted transfusion effects were estimated by competing risk regression. Results were confirmed by propensity score adjusted analysis. RESULTS: Perioperative transfusions and complications occurred in 33.9% and 35.2% of patients, respectively. In all, 3,108 deaths (48.1%) have been documented (median time to death, 7.43 years). Both transfusion rates (25.6% versus 49.1%, p < 0.001) and deaths (58.2% versus 38.5%, p < 0.001) were more frequent among complications patients. Red blood cells transfusion increased intermediate to late mortality risk overall (15-year adjusted hazard ratio [AHR] 1.21, 95% confidence interval [CI]: 1.11 to 1.31), and for complications (AHR 1.24, 95% CI: 1.11 to 1.39) and no complications (AHR 1.16, 95% CI: 1.03 to 1.31). The increased mortality was true for cardiac and noncardiac etiologies (AHR 1.19, 95% CI: 1.03 to 1.36, and AHR 1.14, 95% CI: 1.01 to 1.29, respectively). Red blood cell transfusion increased mostly cardiac deaths (AHR 1.38, 95% CI: 1.14 to 1.66) among the complications group, and noncardiac mortality (AHR 1.24, 95% CI: 1.05 to 1.47) for the no complications group. A parallel propensity matched sensitivity analysis confirmed these findings. CONCLUSIONS: Perioperative red blood cells transfusion is associated with significant adverse late death effects among both complicated patients and noncomplicated patients, principally seen between 0 and 5 years postoperatively, and is driven by both increased cardiovascular and noncardiovascular mortality. Further studies are needed to elucidate the mechanisms behind these findings, including their potential dose dependence.