Methods for conducting international Delphi surveys to optimise global participation in core outcome set development: a case study in gastric cancer informed by a comprehensive literature review

Copyright © 2021, The Author(s) Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.Background: Core outcome sets (COS) should be relevant to key stakeholders and widely applicable and usable. Ideally, they are developed for international use to allow optimal data synthesis from trials. Electronic Delphi surveys are commonly used to facilitate global participation; however, this has limitations. It is common for these surveys to be conducted in a single language potentially excluding those not fluent in that tongue. The aim of this study is to summarise current approaches for optimising international participation in Delphi studies and make recommendations for future practice. Methods: A comprehensive literature review of current approaches to translating Delphi surveys for COS development was undertaken. A standardised methodology adapted from international guidance derived from 12 major sets of translation guidelines in the field of outcome reporting was developed. As a case study, this was applied to a COS project for surgical trials in gastric cancer to translate a Delphi survey into 7 target languages from regions active in gastric cancer research. Results: Three hundred thirty-two abstracts were screened and four studies addressing COS development in rheumatoid and osteoarthritis, vascular malformations and polypharmacy were eligible for inclusion. There was wide variation in methodological approaches to translation, including the number of forward translations, the inclusion of back translation, the employment of cognitive debriefing and how discrepancies and disagreements were handled. Important considerations were identified during the development of the gastric cancer survey including establishing translation groups, timelines, understanding financial implications, strategies to maximise recruitment and regulatory approvals. The methodological approach to translating the Delphi surveys was easily reproducible by local collaborators and resulted in an additional 637 participants to the 315 recruited to complete the source language survey. Ninety-nine per cent of patients and 97% of healthcare professionals from non-English-speaking regions used translated surveys. Conclusion: Consideration of the issues described will improve planning by other COS developers and can be used to widen international participation from both patients and healthcare professionals.This study is funded by the National Institute for Health Research (NIHR) Doctoral Research Fellowship Grant (DRF-2015-08-023). JMB is partially funded by the NIHR Bristol Biomedical Research Centre and the MRC ConDUCT-II Hub for Trials Methodology Research. PRW was funded by the MRC North West Hub for Trials Methodology Research (Grant ref: MR/K025635/01).info:eu-repo/semantics/publishedVersio

Spleen Rupture Due to Anticoagulant Use: A Case Report

WOS: 000579406500030Spleen rupture caused by anticoagulant drug use is a rare but potentially fatal condition. Co-existence of oral anticoagulant use and complaint of abdominal pain must remind diagnosis of spleen rupture. in this paper, we aimed to present a case of spleen rupture identified in a patient with history of heart valve replacement and concomitant oral anticoagulant use. A 44-year old male patient admitted to emergency service with complaint of abdominal pain sustained for 12 hours. There was no history of trauma. A subcapsular hematoma sized 9x8 cm in spleen and perihepatic fluid were identified in computerized tomography (CT) examination. There was no active bleeding in abdominal CT angiography; however, emergent surgery was planned for patient due to impaired hemodynamic balance and decreasing hemoglobin level. in laparotomy, extensive hemorrhagic fluid in abdomen and active bleeding in spleen were present. Spleenectomy was performed. Patient was discharged at postoperative 5th day without a serious problem during postoperative monitoring. Spleen rupture is a rare condition in patients with anticoagulant use. Lack of trauma history may mislead clinican and may delay diagnosing. Early and accurate diagnosis is critical for patient

The relationship between albumin-bilirubin score and survival in patients operated for pancreatic cancer

Objective: To investigate whether albumin-bilirubin score can be used as a prognostic marker in pancreatic cancer patients post-surgery. Method: The retrospective study was conducted at the Medical Oncology Clinic, Karadeniz Technical University, Trabzon, Turkey, and comprised data from 2010 to 2018 of pancreatic cancer patients who had undergone distal pancreatectomy or pancreaticoduodenectomy and were followed up for 3 years. Preoperative and postoperative serum albumin, carcinoembryonic antigen, carbohydrate antigen 19-9, bilirubin, neutrophil:lymphocyte ratio and platelet:lymphocyte ratio were compared as inflammation markers, while albumin-bilirubin scores were calculated using the equation linear predictor. Data was analysed using SPSS 17. Results: Of the 39 patients, 23(59%) were men and 16(41%) were women. The mean age of the sample was 62.4±10.2 years. No statistically significant changes were observed between preoperative and postoperative albumin-bilirubin scores, carcinoembryonic antigen, neutrophil:lymphocyte ratio and platelet:lymphocyte ratio (p>0.05). Significant decreases were observed in postoperative carbohydrate antigen 19-9, aspartate transaminase and alanine transaminas levels (respectively<0.05). No significant change was determined in postoperative albumin-bilirubin grade distributions compared to preoperative values (p=0.180). Although the rate of recurrence increased in line with preoperative albumin-bilirubin scores, the finding was not statistically significant (p=0.055). Mortality rate increased significantly in line with preoperative albumin-bilirubin scores (p=0.013). Conclusion: The albumin-bilirubin score affected survival in patients with pancreatic cancer, and can be employed as a prognostic factor in this patient group. Key Words: Pancreatic cancer, Albumin-bilirubin score, Prognostic factors

The Diagnostic Value of ischemia-modified albumin (IMA) and signal peptide-CUB-EGF domain-containing protein-1 (SCUBE-1) in an Experimental Model of Strangulated Mechanical Bowel Obstruction

Background Mechanical bowel obstruction (MBO) is one of the principal pathologies requiring emergency surgery and a significant worldwide cause of morbidity. The identification of patients in whom bowel obstruction resolves spontaneously is important in terms of preventing unnecessary surgical interventions and future potential adhesions. The decision-making process is difficult in patients presenting without classic examination findings. Methods 36 female Sprague-Dawley rats randomly divided into six experimental groups. In Group 1, 3 and 5, laparotomy was performed, with blood and tissue specimens being collected after 1, 2 and 6 h, respectively. In Group 2, 4 and 6, the ileum segment was ligated following laparotomy, and blood and tissue specimens were collected after 1, 2 and 6 h, respectively. The ileum specimens were examined macroscopically, after which 1-cm sections were taken and examined in terms of histopathological changes. IMA and SCUBE-1 levels were determined for each group, and macro- and microscopic tissue examination findings were compared between the groups. Results Comparison within the groups exposed to waiting times of 1 h (groups 1 and 2), 2 h (groups 3 and 4) and 6 h (groups 5 and 6) revealed higher mean IMA and SCUBE-1 levels in rats undergoing ligation together with incision (groups 2, 4, and 6) compared to those undergoing laparotomy only (groups 1, 3, and 5). Correlation analysis was applied to determine the relationship between total scores obtained from histopathological examination and IMA and SCUBE-1 values. The analysis revealed strong, significant and positive correlation between histopathological examination scores and IMA (r=0.643, p=0.000) and SCUBE-1 (r=0.509, p=0.002) values. Conclusion The study findings showed that both IMA and SCUBE-1 values increased in a strangulated MBO model in rats. We think that IMA and SCUBE-1 values can be used as a markers of damage in the early period in strangulated MBO, and that the patient's surgery requirement can thus be determined in the early period