scholarly journals How are trial outcomes prioritised by stakeholders from different regions? Analysis of an international Delphi survey to develop a core outcome set in gastric cancer surgery

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0261937
Author(s):  
Bilal Alkhaffaf ◽  
Aleksandra Metryka ◽  
Jane M. Blazeby ◽  
Anne-Marie Glenny ◽  
Paula R. Williamson ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Intraoperative Complications ◽  
Core Outcome Set ◽  
Disease Free Survival ◽  
Cancer Surgery ◽  
Delphi Survey ◽  
Core Outcome ◽  
Middle Income ◽  
Gastric Cancer Surgery ◽  
Stakeholder Groups

Background International stakeholder participation is important in the development of core outcome sets (COS). Stakeholders from varying regions may value health outcomes differently. Here, we explore how region, health income and participant characteristics influence prioritisation of outcomes during development of a COS for gastric cancer surgery trials (the GASTROS study). Methods 952 participants from 55 countries participating in a Delphi survey during COS development were eligible for inclusion. Recruits were grouped according to region (East or West), country income classification (high and low-to-middle income) and other characteristics (e.g. patients; age, sex, time since surgery, mode of treatment, surgical approach and healthcare professionals; clinical experience). Groups were compared with respect to how they categorised 56 outcomes identified as potentially important to include in the final COS (‘consensus in’, ‘consensus out’, ‘no consensus’). Outcomes categorised as ‘consensus in’ or ‘consensus out’ by all 3 stakeholder groups would be automatically included in or excluded from the COS respectively. Results In total, 13 outcomes were categorised ‘consensus in’ (disease-free survival, disease-specific survival, surgery-related death, recurrence of cancer, completeness of tumour removal, overall quality of life, nutritional effects, all-cause complications, intraoperative complications, anaesthetic complications, anastomotic complications, multiple organ failure, and bleeding), 13 ‘consensus out’ and 31 ‘no consensus’. There was little variation in prioritisation of outcomes by stakeholders from Eastern or Western countries and high or low-to-middle income countries. There was little variation in outcome prioritisation within either health professional or patient groups. Conclusion Our study suggests that there is little variation in opinion within stakeholder groups when participant region and other characteristics are considered. This finding may help COS developers when designing their Delphi surveys and recruitment strategies. Further work across other clinical fields is needed before broad recommendations can be made.

scholarly journals Exploring the impact of regional variation on outcome prioritisation in core outcome set development: a case study in the field of gastric cancer surgery

2021 ◽  
Author(s):  
Bilal Alkhaffaf ◽  
Aleksandra Metryka ◽  
Jane M Blazeby ◽  
Anne-Marie Glenny ◽  
Paula R Williamson ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Stakeholder Participation ◽  
Core Outcome Set ◽  
Cancer Surgery ◽  
Core Outcome ◽  
Middle Income ◽  
Gastric Cancer Surgery ◽  
Middle Income Countries ◽  
Stakeholder Groups ◽  
The Impact

Abstract BackgroundInternational stakeholder participation is important in the development of core outcome sets (COS). Stakeholders, however, may value health outcomes differently when regional differences are considered. Here, we explore how region, health income and participant characteristics influence prioritisation of outcomes during development of a COS for gastric cancer surgery trials (the GASTROS study).Methods952 participants from 55 countries participating in a Delphi survey during COS development were eligible for inclusion. Recruits were grouped according to region (East or West), country income classification (high and low-to-middle income) and other characteristics (e.g. patients; age, sex, time since surgery, mode of treatment, surgical approach and healthcare professionals; clinical experience). Groups were compared with respect to how they categorised outcomes (‘consensus in’, ‘consensus out’, ‘no consensus’). Outcomes categorised as ‘consensus in’ or ‘consensus out’ by all 3 stakeholder groups would be automatically included in or excluded from the COS respectively.ResultsIn total, 13 outcomes were categorised ‘consensus in’, 13 ‘consensus out’ and 31 ‘no consensus’. There was little variation in prioritisation of outcomes by stakeholders from Eastern or Western countries and high or low-to-middle income countries. There was little variation in outcome prioritisation within either health professional or patient groups.ConclusionOur study suggests that there is little variation in opinion within stakeholder groups when participant region and other characteristics are considered. This finding may help COS developers when designing their Delphi surveys and recruitment strategies. Further work across other clinical fields is needed before broad recommendations can be made.

scholarly journals Reporting of outcomes in gastric cancer surgery trials: a systematic review

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e021796 ◽  
Author(s):  
Bilal Alkhaffaf ◽  
Jane M Blazeby ◽  
Paula R Williamson ◽  
Iain A Bruce ◽  
Anne-Marie Glenny
Keyword(s):  
Gastric Cancer ◽  
Core Outcome Set ◽  
Cancer Surgery ◽  
Measurement Instruments ◽  
International Consensus ◽  
Surgical Interventions ◽  
Gastric Cancer Surgery ◽  
Study Protocols ◽  
Patient Reported ◽  
Randomised Controlled

BackgroundThe development of clinical guidelines for the surgical management of gastric cancer should be based on robust evidence from well-designed trials. Being able to reliably compare and combine the outcomes of these trials is a key factor in this process.ObjectivesTo examine variation in outcome reporting by surgical trials for gastric cancer and to identify outcomes for prioritisation in an international consensus study to develop a core outcome set in this field.Data sourcesSystematic literature searches (Evidence Based Medicine, MEDLINE, EMBASE, CINAHL, ClinicalTrials.gov and WHO ICTRP) and a review of study protocols of randomised controlled trials, published between 1996 and 2016.InterventionTherapeutic surgical interventions for gastric cancer. Outcomes were listed verbatim, categorised into groups (outcome themes) and examined for definitions and measurement instruments.ResultsOf 1919 abstracts screened, 32 trials (9073 participants) were identified. A total of 749 outcomes were reported of which 96 (13%) were accompanied by an attempted definition. No single outcome was reported by all trials. ‘Adverse events’ was the most frequently reported ‘outcome theme’ in which 240 unique terms were described. 12 trials (38%) classified complications according to severity, with 5 (16%) using a formal classification system (Clavien-Dindo or Accordion scale). Of 27 trials which described ‘short-term’ mortality, 15 (47%) used one of five different definitions. 6 out of the 32 trials (19%) described ‘patient-reported outcomes’.ConclusionReporting of outcomes in gastric cancer surgery trials is inconsistent. A consensus approach to develop a minimum set of well-defined, standardised outcomes to be used by all future trials examining therapeutic surgical interventions for gastric cancer is needed. This should consider the views of all key stakeholders, including patients.

scholarly journals Nutrition update in gastric cancer surgery

2020 ◽  
Vol 4 (4) ◽  
pp. 360-368 ◽  
Author(s):  
Takeshi Kubota ◽  
Katsutoshi Shoda ◽  
Hirotaka Konishi ◽  
Kazuma Okamoto ◽  
Eigo Otsuji
Keyword(s):  
Gastric Cancer ◽  
Cancer Surgery ◽  
Gastric Cancer Surgery

scholarly journals Risk of venous thromboembolism in patients undergoing gastric cancer surgery: protocol for a systematic review and meta-analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e033267
Author(s):  
Dengfeng Wang ◽  
Yang Yu ◽  
Pengxian Tao ◽  
Dan Wang ◽  
Yajing Chen ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Systematic Review ◽  
Venous Thromboembolism ◽  
Evaluation Method ◽  
Clinical Decision Making ◽  
Meta Analysis ◽  
Cancer Surgery ◽  
Published Data ◽  
Gastric Cancer Surgery ◽  
Positive Prevention

IntroductionVenous thromboembolism (VTE) is a serious life-threatening complication in patients with gastric cancer. Abnormal coagulation function and tumour-related treatment may contribute to the occurrence of VTE. Many guidelines considered that surgical treatment would put patients with cancer at high risk of VTE, so positive prevention is needed. However, there are no studies that have systematically reviewed the postoperative risk and distribution of VTE in patients with gastric cancer. We thus conduct this systematic review to determine the risk of VTE in patients with gastric cancer undergoing surgery and provide some evidence for clinical decision-making.Methods and analysisStudies reporting the incidence of VTE after gastric cancer surgery will be included. Primary studies of randomised controlled trials, cohort studies, population-based surveys and cross-sectional studies are eligible for this review and only studies published in Chinese and English will be included. We will search the Medline, Embase, Web of Science, CBM, CNKI and Wanfang data from their inception to November 2019. Two reviewers will independently select studies and extract data. The quality of each included study will be assessed with tools corresponding to their study design. Meta-analysis will be used to pool the incidence data from included studies. Heterogeneity of the estimates across studies will be assessed, if necessary, a subgroup analysis will be performed to explore the source of heterogeneity. The Grades of Recommendation, Assessment, Development and Evaluation method is applied to assess the level of evidence obtained from this systematic review.Ethics and disseminationThis proposed systematic review and meta-analysis is based on published data, and thus ethical approval is not required. The results of this review will be sought for publication.PROSPERO registration numberCRD42019144562

scholarly journals 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

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Bilal Alkhaffaf ◽  
Jane M. Blazeby ◽  
Aleksandra Metryka ◽  
Anne-Marie Glenny ◽  
Ademola Adeyeye ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Literature Review ◽  
Healthcare Professionals ◽  
Vascular Malformations ◽  
Methodological Approach ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Comprehensive Literature Review ◽  
International Participation

Abstract 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.

scholarly journals Prognosis after surgery for gastric adenocarcinoma in the Swedish Gastric Cancer Surgery Study (SWEGASS)

2021 ◽  
pp. 1-8
Author(s):  
Johannes Asplund ◽  
Eivind Gottlieb-Vedi ◽  
Wilhelm Leijonmarck ◽  
Fredrik Mattsson ◽  
Jesper Lagergren
Keyword(s):  
Gastric Cancer ◽  
Gastric Adenocarcinoma ◽  
Cancer Surgery ◽  
Gastric Cancer Surgery

scholarly journals A Prospective Multicenter Observational Study of Venous Thromboembolism after Gastric Cancer Surgery (SHISA-1601)

2021 ◽  
pp. 1-10
Author(s):  
Sachiko Kaida ◽  
Toru Miyake ◽  
Satoshi Murata ◽  
Tsuyoshi Yamaguchi ◽  
Takeshi Tatsuta ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Venous Thromboembolism ◽  
Blood Transfusion ◽  
Observational Study ◽  
Characteristic Curve ◽  
Cancer Surgery ◽  
Gastric Cancer Surgery ◽  
Multicenter Observational Study ◽  
Prospective Multicenter Observational Study ◽  
D Dimer

Introduction: This study aimed to clarify the frequency and risk factors of intercurrent venous thromboembolism (VTE) in patients undergoing major curative gastric cancer surgery. Methods: This prospective, multicenter, observational study included patients with gastric cancer who underwent radical gastrectomy at 5 hospitals between June 2016 and May 2018. Patients who were preoperatively administered anticoagulants were excluded. Results: A total of 126 patients were eligible to participate. VTE occurred within 9 days postoperatively in 5 cases (4.0%; 2 symptomatic and 3 asymptomatic). Postoperative day (POD) 1 plasma D-dimer and soluble fibrin (SF) levels were significantly higher in the VTE group than in the non-VTE group. Receiver-operating characteristic curve (ROC) analysis indicated a statistically significant ability of POD 1 D-dimer and SF levels to predict postoperative VTE development after gastrectomy; this finding was reflected by an area under the curve (AUC) of 0.97 (95% CI 0.92–1.0) and 0.87 (95% CI 0.74–1.0), respectively. Cutoff values of D-dimer (24.6 µg/mL) and SF (64.1 µg/mL) were determined. Intraoperative blood transfusion (odds ratio [OR] 7.86), POD 1 D-dimer ≥24.6 µg/mL (OR 17.35), and POD 1 SF ≥64.1 µg/mL (OR 19.5) were independent predictive factors for postoperative VTE (p < 0.05). Conclusion: VTE occurred in 4.0% patients (1.6% symptomatic and 2.4% asymptomatic) after gastric cancer surgery; however, with an early diagnosis and anticoagulant therapy, no patients experienced progression. Careful observation of patients with a high risk for VTE, including intraoperative blood transfusion and high POD 1 D-dimer or SF levels, would contribute to the early detection of VTE.

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