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The International Committee of Medical Journal Editors (ICMJE) believes there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk. In January 2016 we published a proposal aimed at helping to create an environment in which the sharing of deidentified individual participant data becomes the norm. In response to our request for feedback we received many comments from individuals and groups. 1 Some applauded the proposals while others expressed disappointment they did not more quickly create a commitment to data sharing. Many raised valid concerns regarding the feasibility of the . . .

The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk. In a growing consensus, many funders around the world — foundations, government agencies, and industry — now mandate data sharing. Here we outline the ICMJE’s proposed requirements to help meet this obligation. We encourage feedback on the proposed requirements. Anyone can provide feedback at www.icmje.org by 18 April 2016. The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to . . .

BackgroundInfected pancreatic necrosis (IPN) is a major complication of acute pancreatitis (AP), which may require necrosectomy. Minimally invasive surgical step-up therapy is preferred for IPN.AimTo assess the effectiveness of percutaneous endoscopic step-up therapy in patients with IPN and identify predictors of its success.MethodsConsecutive patients with AP hospitalized to our tertiary care academic center were studied prospectively. Patients with IPN formed the study group. The treatment protocol for IPN was percutaneous endoscopic step-up approach starting with antibiotics and percutaneous catheter drainage, and if required necrosectomy. Percutaneous endoscopic necrosectomy (PEN) was performed using a flexible endoscope through the percutaneous tract under conscious sedation. Control of sepsis with resolution of collection(s) was the primary outcome measure.ResultsA total of 415 patients with AP were included. Of them, 272 patients had necrotizing pancreatitis and 177 (65%) developed IPN. Of these 177 patients, 27 were treated conservatively with antibiotics alone, 56 underwent percutaneous drainage alone, 53 required underwent PEN as a step-up therapy, 1 per-oral endoscopic necrosectomy, and 52 required surgery. Of the 53 patients in the PEN group, 42 (79.2%) were treated successfully—34 after PEN alone and 8 after additional surgery. Eleven of 53 patients died due to organ failure—7 after PEN and 4 after surgery. Independent predictors of mortality were > 50% necrosis and early organ failure.ConclusionPercutaneous endoscopic step-up therapy is an effective strategy for IPN. Organ failure and extensive pancreatic necrosis predicted a suboptimal outcome in patients with infected necrotizing pancreatitis.

BackgroundSarcopenia and visceral fat independently predict poor outcomes in Crohn’s disease (CD). However, combined influence of these parameters on outcomes is unknown, and was investigated in the present study.MethodsThis retrospective study evaluated skeletal muscle index (SMI-cross-sectional area of five skeletal muscles normalized for height), visceral and subcutaneous fat area and their ratio (VF/SC) on single-slice computed tomography (CT) images at L3 vertebrae in CD patients (CT done: January 2012-December 2015, patients followed till December 2019). Sarcopenia was defined as SMI < 36.5 cm2/m2 and 30.2 cm2/m2 for males and females, respectively. Disease severity, behavior, and long-term outcomes (surgery and disease course) were compared with respect to sarcopenia and VF/SC ratio.ResultsForty-four patients [age at onset: 34.4 ± 14.1 years, median disease duration: 48 (24–95) months, follow-up duration: 32 (12–53.5) months, males: 63.6%] were included. Prevalence of sarcopenia was 43%, more in females, but independent of age, disease severity, behavior and location. More patients with sarcopenia underwent surgery (31.6% vs 4%, p = 0.01). VF/SC was significantly higher in patients who underwent surgery (1.76 + 1.31 vs 0.9 + 0.41, p = 0.002), and a cutoff of 0.88 could predict surgery with sensitivity and specificity of 71% and 65% respectively. On survival analysis, probability of remaining free of surgery was lower in patients with sarcopenia (59.6% vs 94.1% p = 0.01) and those with VF/SC > 0.88 (66.1% vs 91.1%, p = 0.1), and still lower in those with both sarcopenia and VF/SC > 0.88 than those with either or none (38% vs 82% vs 100%, p = 0.01).ConclusionsCombination of sarcopenia and high visceral fat predict worse outcomes in CD than either.

In this Editorial, representatives of the International Committee of Medical Editors discuss the need for multi-stakeholder involvement to recognize and counter the actions of predatory journals.In this Editorial, representatives of the International Committee of Medical Editors discuss the need for multi-stakeholder involvement to recognize and counter the actions of predatory journals.

In a joint publication across 14 member journals, the International Committee of Medical Journal Editors (ICMJE) proposes to require sharing of deidentified individual patient data underlying published clinical trials.

Aim To compare the technical difficulty, safety, radiation exposure and success rates between right-sided and left-sided percutaneous transhepatic biliary drainage (RPTBD and LPTBD) in patients with malignant biliary obstruction (MBO). Materials and Methods Fifty patients (28 males, 22 females; mean age 51.78 years) with MBO were randomized to undergo either RPTBD or LPTBD during the study period between June 2016 and May 2018. The procedure time, fluoroscopy time, radiation doses to the operators and patients, technical success, clinical success, complications and effect on quality of life were evaluated and compared between the two groups. Results Twenty-five patients were included in each group. The technical success was 100% in both groups. There was no significant difference between RPTBD and LPTBD groups in terms of major complications [4% and 12%, respectively; p  = 0.297] and minor complications [40% and 32%, respectively; p  = 0.597]. Further, the average procedure time (37.80 ± 13.07 min vs 41.04 ± 14.94 min), fluoroscopy time (5.88 ± 4.2 min vs 5.97 ± 3.8 min), radiation doses to the operator (136.84 ± 106.67 μSv vs 130.40 ± 106.46 μSv) and to the patient (8.23 ± 5.80 Gycm 2 vs 11.74 ± 11.28 Gycm 2 ) were not significantly different between the groups. Clinical success was achieved in 21 patients (84%) of RPTBD group and 17 patients (68%) of LPTBD group with no significant difference ( p  = 0.416) between them. Conclusion There was no significant difference between RPTBD and LPTBD with reference to the technique, safety, radiation dose, success rates and impact on quality of life suggesting no laterality advantage for biliary drainage in cases of MBO.