Pub Date : 2024-08-28DOI: 10.1136/bmjgast-2024-001452
Kexun Li, Simiao Lu, Changding Li, Wenwu He, Kunyi Du, Kun Liu, Chenghao Wang, Jialong Li, Ziwei Wang, Yehan Zhou, Jiahua Lv, Yongtao Han, Qifeng Wang, Xuefeng Leng, Lin Peng
Background: Oesophageal squamous cell carcinoma (OSCC) poses a considerable health burden, particularly in regions such as East Asia. This study aims to investigate the long-term outcomes of OSCC patients who are smokers and drinkers.
Materials and methods: In this retrospective analysis, data from Sichuan Cancer Hospital and Institute Esophageal Cancer Case Management Database between January 2010 and December 2017 were examined. Patients were categorised into different groups based on their smoking and alcohol consumption history: None, Smoker, Non-Smoker, Smoke-Only, Drinker, Non-Drinker, Drinker-Only, and Both. Survival outcomes were compared between the groups using Kaplan-Meier analysis and propensity score matching (PSM). The primary outcome was overall survival (OS), measured from surgery to death or last follow-up in April 2022.
Results: The OS median was 45.4 months for all patients after oesophagectomy. Smokers had a significantly lower median OS of 36.6 months compared with Non-Smokers with 66.2 months (p<0.001). Similarly, Drinkers had a lower median OS of 34.4 months compared with Non-Drinkers with 52.0 months (p<0.001). PSM analysis confirmed the significant differences in OS between Smokers and Non-Smokers (p=0.002) and between Drinkers and Non-Drinkers (p=0.002). Subgroup analyses showed no significant differences in OS between Group Another and Group Both, Group Smoker-Only and Group Drinker-Only, and Group Drinker-Only and Group Both. (figure 4) CONCLUSION: Smoking and drinking were associated with significantly reduced OS in patients. However, no significant differences were found between the subgroups of patients who only smoked, only drank, or engaged in both habits.
{"title":"Long-term outcomes of smoker and drinker with oesophageal squamous cell carcinoma after oesophagectomy: a large-scale propensity score matching analysis.","authors":"Kexun Li, Simiao Lu, Changding Li, Wenwu He, Kunyi Du, Kun Liu, Chenghao Wang, Jialong Li, Ziwei Wang, Yehan Zhou, Jiahua Lv, Yongtao Han, Qifeng Wang, Xuefeng Leng, Lin Peng","doi":"10.1136/bmjgast-2024-001452","DOIUrl":"10.1136/bmjgast-2024-001452","url":null,"abstract":"<p><strong>Background: </strong>Oesophageal squamous cell carcinoma (OSCC) poses a considerable health burden, particularly in regions such as East Asia. This study aims to investigate the long-term outcomes of OSCC patients who are smokers and drinkers.</p><p><strong>Materials and methods: </strong>In this retrospective analysis, data from Sichuan Cancer Hospital and Institute Esophageal Cancer Case Management Database between January 2010 and December 2017 were examined. Patients were categorised into different groups based on their smoking and alcohol consumption history: None, Smoker, Non-Smoker, Smoke-Only, Drinker, Non-Drinker, Drinker-Only, and Both. Survival outcomes were compared between the groups using Kaplan-Meier analysis and propensity score matching (PSM). The primary outcome was overall survival (OS), measured from surgery to death or last follow-up in April 2022.</p><p><strong>Results: </strong>The OS median was 45.4 months for all patients after oesophagectomy. Smokers had a significantly lower median OS of 36.6 months compared with Non-Smokers with 66.2 months (p<0.001). Similarly, Drinkers had a lower median OS of 34.4 months compared with Non-Drinkers with 52.0 months (p<0.001). PSM analysis confirmed the significant differences in OS between Smokers and Non-Smokers (p=0.002) and between Drinkers and Non-Drinkers (p=0.002). Subgroup analyses showed no significant differences in OS between Group Another and Group Both, Group Smoker-Only and Group Drinker-Only, and Group Drinker-Only and Group Both. (figure 4) CONCLUSION: Smoking and drinking were associated with significantly reduced OS in patients. However, no significant differences were found between the subgroups of patients who only smoked, only drank, or engaged in both habits.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11367364/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-28DOI: 10.1136/bmjgast-2024-001417
Eugenia Uche-Anya, Jane Ha, Raji Balasubramanian, Kathryn M Rexrode, Andrew T Chan
Background and aims: Gallstone disease affects ≥40 million people in the USA and accounts for health costs of ≥$4 billion a year. Risk factors such as obesity and metabolic syndrome are well established. However, data are limited on relevant metabolomic alterations that could offer mechanistic and predictive insights into gallstone disease. This study prospectively identifies and externally validates circulating prediagnostic metabolites associated with incident gallstone disease.
Methods: Female participants in Nurses' Health Study (NHS) and Nurses' Health Study II (NHS II) who were free of known gallstones (N=9960) were prospectively followed up after baseline metabolomic profiling with liquid chromatography-tandem mass spectrometry. Multivariable logistic regression and enrichment analysis were used to identify metabolites and metabolite groups associated with incident gallstone disease at PFDR<0.05. Findings were validated in 1866 female participants in the Women's Health Initiative and a comparative analysis was performed with 2178 male participants in the Health Professionals Follow-up Study.
Results: After multivariate adjustment for lifestyle and putative risk factors, we identified and externally validated 17 metabolites associated with incident gallstone disease in women-nine triacylglycerols (TAGs) and diacylglycerols (DAGs) were positively associated, while eight plasmalogens and cholesterol ester (CE) were negatively associated. Enrichment analysis in male and female cohorts revealed positive class associations with DAGs, TAGs (≤56 carbon atoms and ≤3 double bonds) and de novo TAG biosynthesis pathways, as well as inverse associations with CEs.
Conclusions: This study highlights several metabolites (TAGs, DAGs, plasmalogens and CE) that could be implicated in the aetiopathogenesis of gallstone disease and serve as clinically relevant markers.
背景和目的:胆石症在美国的发病人数≥4000 万,每年的医疗费用≥40 亿美元。肥胖和代谢综合征等风险因素已得到公认。然而,能为胆石症提供机理和预测性见解的相关代谢组学改变的数据却很有限。这项研究前瞻性地确定并从外部验证了与胆石症相关的循环诊断前代谢物:护士健康研究(NHS)和护士健康研究II(NHS II)中没有已知胆结石的女性参与者(N=9960)在使用液相色谱-串联质谱进行基线代谢组学分析后接受了前瞻性随访。采用多变量逻辑回归和富集分析来确定与PFDRR结果中发生胆石症相关的代谢物和代谢物组:在对生活方式和假定风险因素进行多变量调整后,我们确定并从外部验证了 17 种与女性胆石症发病相关的代谢物--9 种三酰甘油 (TAG) 和二酰甘油 (DAG) 呈正相关,而 8 种质粒和胆固醇酯 (CE) 呈负相关。对男性和女性队列进行的富集分析表明,DAGs、TAGs(碳原子数≤56,双键数≤3)和从头开始的 TAG 生物合成途径呈正相关,而 CE 呈反相关:本研究强调了几种代谢物(TAGs、DAGs、质醛和CE),它们可能与胆石症的发病机制有关,并可作为临床相关标记物。
{"title":"Metabolomic profiles of incident gallstone disease.","authors":"Eugenia Uche-Anya, Jane Ha, Raji Balasubramanian, Kathryn M Rexrode, Andrew T Chan","doi":"10.1136/bmjgast-2024-001417","DOIUrl":"10.1136/bmjgast-2024-001417","url":null,"abstract":"<p><strong>Background and aims: </strong>Gallstone disease affects ≥40 million people in the USA and accounts for health costs of ≥$4 billion a year. Risk factors such as obesity and metabolic syndrome are well established. However, data are limited on relevant metabolomic alterations that could offer mechanistic and predictive insights into gallstone disease. This study prospectively identifies and externally validates circulating prediagnostic metabolites associated with incident gallstone disease.</p><p><strong>Methods: </strong>Female participants in Nurses' Health Study (NHS) and Nurses' Health Study II (NHS II) who were free of known gallstones (N=9960) were prospectively followed up after baseline metabolomic profiling with liquid chromatography-tandem mass spectrometry. Multivariable logistic regression and enrichment analysis were used to identify metabolites and metabolite groups associated with incident gallstone disease at P<sub>FDR</sub><0.05. Findings were validated in 1866 female participants in the Women's Health Initiative and a comparative analysis was performed with 2178 male participants in the Health Professionals Follow-up Study.</p><p><strong>Results: </strong>After multivariate adjustment for lifestyle and putative risk factors, we identified and externally validated 17 metabolites associated with incident gallstone disease in women-nine triacylglycerols (TAGs) and diacylglycerols (DAGs) were positively associated, while eight plasmalogens and cholesterol ester (CE) were negatively associated. Enrichment analysis in male and female cohorts revealed positive class associations with DAGs, TAGs (≤56 carbon atoms and ≤3 double bonds) and de novo TAG biosynthesis pathways, as well as inverse associations with CEs.</p><p><strong>Conclusions: </strong>This study highlights several metabolites (TAGs, DAGs, plasmalogens and CE) that could be implicated in the aetiopathogenesis of gallstone disease and serve as clinically relevant markers.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11367368/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-25DOI: 10.1136/bmjgast-2024-001430
Kohilan Gananandan, Rabiah Singh, Gautam Mehta
Background and aims: The transition from compensated to decompensated cirrhosis is crucial, drastically reducing prognosis from a median survival of over 10 years to 2 years. There is currently an unmet need to accurately predict decompensation. We systematically reviewed and meta-analysed data regarding biomarker use to predict decompensation in individuals with compensated cirrhosis.
Methods: PubMed and EMBASE database searches were conducted for all studies from inception until February 2024. The study was carried out according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The Quality of Prognosis Studies framework was used to assess the risk of bias. The meta-analysis was conducted with a random effects model using STATA software.
Results: Of the 652 studies initially identified, 63 studies (n=31 438 patients) were included in the final review, examining 49 biomarkers. 25 studies (40%) were prospective with the majority of studies looking at all-cause decompensation (90%). The most well-studied biomarkers were platelets (n=17), Model for End-Stage Liver Disease (n=17) and albumin (n=16). A meta-analysis revealed elevated international normalised ratio was the strongest predictor of decompensation, followed by decreased albumin. However, high statistical heterogeneity was noted (l2 result of 96.3%). Furthermore, 21 studies were assessed as having a low risk of bias (34%), 26 (41%) moderate risk and 16 (25%) high risk.
Conclusions: This review highlights key biomarkers that should potentially be incorporated into future scoring systems to predict decompensation. However, future biomarker studies should be conducted with rigorous and standardised methodology to ensure robust and comparable data.
{"title":"Systematic review and meta-analysis of biomarkers predicting decompensation in patients with compensated cirrhosis.","authors":"Kohilan Gananandan, Rabiah Singh, Gautam Mehta","doi":"10.1136/bmjgast-2024-001430","DOIUrl":"10.1136/bmjgast-2024-001430","url":null,"abstract":"<p><strong>Background and aims: </strong>The transition from compensated to decompensated cirrhosis is crucial, drastically reducing prognosis from a median survival of over 10 years to 2 years. There is currently an unmet need to accurately predict decompensation. We systematically reviewed and meta-analysed data regarding biomarker use to predict decompensation in individuals with compensated cirrhosis.</p><p><strong>Methods: </strong>PubMed and EMBASE database searches were conducted for all studies from inception until February 2024. The study was carried out according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The Quality of Prognosis Studies framework was used to assess the risk of bias. The meta-analysis was conducted with a random effects model using STATA software.</p><p><strong>Results: </strong>Of the 652 studies initially identified, 63 studies (n=31 438 patients) were included in the final review, examining 49 biomarkers. 25 studies (40%) were prospective with the majority of studies looking at all-cause decompensation (90%). The most well-studied biomarkers were platelets (n=17), Model for End-Stage Liver Disease (n=17) and albumin (n=16). A meta-analysis revealed elevated international normalised ratio was the strongest predictor of decompensation, followed by decreased albumin. However, high statistical heterogeneity was noted (l<sup>2</sup> result of 96.3%). Furthermore, 21 studies were assessed as having a low risk of bias (34%), 26 (41%) moderate risk and 16 (25%) high risk.</p><p><strong>Conclusions: </strong>This review highlights key biomarkers that should potentially be incorporated into future scoring systems to predict decompensation. However, future biomarker studies should be conducted with rigorous and standardised methodology to ensure robust and comparable data.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11404266/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142054960","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-24DOI: 10.1136/bmjgast-2024-001377
Sven Heiko Loosen, Alexander Mertens, Isabel Klein, Catherine Leyh, Sarah Krieg, Jennis Kandler, Tom Luedde, Christoph Roderburg, Karel Kostev
Background: Helicobacter pylori (H. pylori) is a gram-negative gastrointestinal pathogen that colonises the human stomach and is considered a major risk factor for gastric cancer and mucosa-associated lymphoid tissue lymphoma. Furthermore, H. pylori is a potential trigger of a wide spectrum of extragastric cancer entities, extraintestinal chronic inflammatory processes and autoimmune diseases. In the present study, we evaluated the association between H. pylori infection and its eradication with the development of subsequent gastrointestinal and non-gastrointestinal cancer.
Methods: We identified 25 317 individuals with and 25 317 matched individuals without a diagnosis of H. pylori from the Disease Analyzer database (IQVIA). A subsequent cancer diagnosis was analysed using Kaplan-Meier and conditional Cox-regression analysis as a function of H. pylori and its eradication.
Results: After 10 years of follow-up, 12.8% of the H. pylori cohort and 11.8% of the non-H. pylori cohort were diagnosed with cancer (p=0.002). Results were confirmed in regression analysis (HR: 1.11; 95% CI 1.04 to 1.18). Moreover, a non-eradicated H. pylori status (HR: 1.18; 95% CI 1.07 to 1.30) but not an eradicated H. pylori status (HR: 1.06; 95% CI 0.97 to 1.15) was associated with a subsequent diagnosis of cancer. In subgroup analyses, H. pylori eradication was negatively associated with bronchus and lung cancer (HR: 0.60; 95% CI 0.44 to 0.83).
Conclusion: Our data from a large outpatient cohort in Germany reveal a distinct association between H. pylori infection and the subsequent development of cancer. These data might help to identify patients at risk and support eradication strategies in the future.
背景:幽门螺杆菌(H. pylori)是一种革兰氏阴性胃肠道病原体,定植于人类胃部,被认为是胃癌和粘膜相关淋巴组织淋巴瘤的主要危险因素。此外,幽门螺杆菌还是多种胃癌、肠道外慢性炎症过程和自身免疫性疾病的潜在诱因。在本研究中,我们评估了幽门螺杆菌感染及其根除与后续胃肠道和非胃肠道癌症发展之间的关联:方法:我们从疾病分析仪数据库(IQVIA)中确定了 25 317 名幽门螺杆菌感染者和 25 317 名未被诊断出感染幽门螺杆菌的匹配者。采用卡普兰-梅耶分析法和条件 Cox 回归分析法将随后的癌症诊断与幽门螺杆菌及其根除情况联系起来进行分析:结果:随访 10 年后,幽门螺杆菌组群中有 12.8%、非幽门螺杆菌组群中有 11.8%确诊为癌症(P=0.002)。回归分析证实了这一结果(HR:1.11;95% CI 1.04 至 1.18)。此外,未根除幽门螺杆菌状态(HR:1.18;95% CI 1.07 至 1.30)而非根除幽门螺杆菌状态(HR:1.06;95% CI 0.97 至 1.15)与随后的癌症诊断相关。在亚组分析中,幽门螺杆菌根除与支气管癌和肺癌呈负相关(HR:0.60;95% CI 0.44 至 0.83):我们从德国大型门诊病人队列中获得的数据显示,幽门螺杆菌感染与随后的癌症发展之间存在明显的关联。这些数据可能有助于识别高危患者并支持未来的根除策略。
{"title":"Association between <i>Helicobacter pylori</i> and its eradication and the development of cancer.","authors":"Sven Heiko Loosen, Alexander Mertens, Isabel Klein, Catherine Leyh, Sarah Krieg, Jennis Kandler, Tom Luedde, Christoph Roderburg, Karel Kostev","doi":"10.1136/bmjgast-2024-001377","DOIUrl":"10.1136/bmjgast-2024-001377","url":null,"abstract":"<p><strong>Background: </strong><i>Helicobacter pylori</i> (<i>H. pylori</i>) is a gram-negative gastrointestinal pathogen that colonises the human stomach and is considered a major risk factor for gastric cancer and mucosa-associated lymphoid tissue lymphoma. Furthermore, <i>H. pylori</i> is a potential trigger of a wide spectrum of extragastric cancer entities, extraintestinal chronic inflammatory processes and autoimmune diseases. In the present study, we evaluated the association between <i>H. pylori</i> infection and its eradication with the development of subsequent gastrointestinal and non-gastrointestinal cancer.</p><p><strong>Methods: </strong>We identified 25 317 individuals with and 25 317 matched individuals without a diagnosis of <i>H. pylori</i> from the Disease Analyzer database (IQVIA). A subsequent cancer diagnosis was analysed using Kaplan-Meier and conditional Cox-regression analysis as a function of <i>H. pylori</i> and its eradication.</p><p><strong>Results: </strong>After 10 years of follow-up, 12.8% of the <i>H. pylori</i> cohort and 11.8% of the non-<i>H. pylori</i> cohort were diagnosed with cancer (p=0.002). Results were confirmed in regression analysis (HR: 1.11; 95% CI 1.04 to 1.18). Moreover, a non-eradicated <i>H. pylori</i> status (HR: 1.18; 95% CI 1.07 to 1.30) but not an eradicated <i>H. pylori</i> status (HR: 1.06; 95% CI 0.97 to 1.15) was associated with a subsequent diagnosis of cancer. In subgroup analyses, <i>H. pylori</i> eradication was negatively associated with bronchus and lung cancer (HR: 0.60; 95% CI 0.44 to 0.83).</p><p><strong>Conclusion: </strong>Our data from a large outpatient cohort in Germany reveal a distinct association between <i>H. pylori</i> infection and the subsequent development of cancer. These data might help to identify patients at risk and support eradication strategies in the future.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11344509/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142054959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-21DOI: 10.1136/bmjgast-2024-001375
Suliman Alhaidari, Ibrahim Alzahrani, Manar Alhanaee, Alan Decanini, Mahmod Mohamed, Sergio Zepeda-Gomez, Pamela Mathura, Julie Zhang, Gurpal Sandha
Background: A retrospective chart audit was performed to review biliary stent utilisation from January 2020 to January 2021. Non-guideline-based stent insertion was identified in 16% of patients with common bile duct (CBD) stones presenting for endoscopic retrograde cholangiopancreatography (ERCP). To improve this knowledge-practice gap, a quality improvement (QI) intervention was devised and trialled.
Aim: To synchronise clinical indications for biliary stent insertion in patients with CBD stones in accordance with published guidelines.
Methods: Using a QI pre-post study design, chart audits were completed and shared with the ERCP team (n=6). Indication for biliary stent insertion was compared to published guidelines assessed by two reviewers independently (kappa statistic calculated). The QI intervention included an education session and quarterly practice audits. An interrupted time series with segmented regression was completed.
Results: A total of 661 patients (337 F), mean age 59±19 years (range 12-98 years), underwent 885 ERCPs during this postintervention period. Of 661 patients, 384 (58%) were referred for CBD stones. A total of 192 biliary stents (105 plastic, 85 metal) were placed during the first ERCP (192/661, 29%), as compared with the preintervention year (223/598, 37%, p=0.2). Furthermore, 13/192 stents (7%) were placed not in accordance with published guidelines (kappa=0.53), compared with 63/223 (28%) in the preintervention year (p<0.0001). A 75% reduction in overall avoidable stent placement was achieved with a direct cost avoidance of $C97 500. For the CBD stone subgroup, there was an 88% reduction in avoidable biliary stent placement compared with the preintervention year (8/384, 2% vs 61/375, 16%, p<0.0001).
Conclusions: Education with audit and feedback supported the closing of a knowledge-to-practice gap for biliary stent insertion during ERCP, especially in patients with CBD stones. This has resulted in a notable reduction of avoidable stent placements and additional follow-up ERCPs and an overall saving of healthcare resources.
{"title":"Optimising the indications for biliary stent placement during endoscopic retrograde cholangiopancreatography: a quality improvement initiative to enhance patient care and reduce healthcare resource utilisation.","authors":"Suliman Alhaidari, Ibrahim Alzahrani, Manar Alhanaee, Alan Decanini, Mahmod Mohamed, Sergio Zepeda-Gomez, Pamela Mathura, Julie Zhang, Gurpal Sandha","doi":"10.1136/bmjgast-2024-001375","DOIUrl":"10.1136/bmjgast-2024-001375","url":null,"abstract":"<p><strong>Background: </strong>A retrospective chart audit was performed to review biliary stent utilisation from January 2020 to January 2021. Non-guideline-based stent insertion was identified in 16% of patients with common bile duct (CBD) stones presenting for endoscopic retrograde cholangiopancreatography (ERCP). To improve this knowledge-practice gap, a quality improvement (QI) intervention was devised and trialled.</p><p><strong>Aim: </strong>To synchronise clinical indications for biliary stent insertion in patients with CBD stones in accordance with published guidelines.</p><p><strong>Methods: </strong>Using a QI pre-post study design, chart audits were completed and shared with the ERCP team (n=6). Indication for biliary stent insertion was compared to published guidelines assessed by two reviewers independently (<i>kappa</i> statistic calculated). The QI intervention included an education session and quarterly practice audits. An interrupted time series with segmented regression was completed.</p><p><strong>Results: </strong>A total of 661 patients (337 F), mean age 59±19 years (range 12-98 years), underwent 885 ERCPs during this postintervention period. Of 661 patients, 384 (58%) were referred for CBD stones. A total of 192 biliary stents (105 plastic, 85 metal) were placed during the first ERCP (192/661, 29%), as compared with the preintervention year (223/598, 37%, p=0.2). Furthermore, 13/192 stents (7%) were placed not in accordance with published guidelines (<i>kappa</i>=0.53), compared with 63/223 (28%) in the preintervention year (p<0.0001). A 75% reduction in overall avoidable stent placement was achieved with a direct cost avoidance of $C97 500. For the CBD stone subgroup, there was an 88% reduction in avoidable biliary stent placement compared with the preintervention year (8/384, 2% vs 61/375, 16%, p<0.0001).</p><p><strong>Conclusions: </strong>Education with audit and feedback supported the closing of a knowledge-to-practice gap for biliary stent insertion during ERCP, especially in patients with CBD stones. This has resulted in a notable reduction of avoidable stent placements and additional follow-up ERCPs and an overall saving of healthcare resources.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11340697/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142035312","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-19DOI: 10.1136/bmjgast-2024-001403
Sanja Vanhatalo, Ermei Mäkilä, Antti J Hakanen, Eveliina Munukka, Jarno Salonen, Timo Saarinen, Juha Grönroos, Suvi Sippola, Paulina Salminen
Objective: Appendicoliths are associated with a more complicated course of acute appendicitis and failure of non-operative treatment. We aimed to update the appendicolith classification originally described in 1966 and to assess the association of appendicolith characteristics with appendicitis severity.
Design: This prospective predefined MAPPAC-trial (ClinicalTrials.gov NCT03257423) substudy included patients with CT diagnosed appendicitis presenting with an appendicolith. CT visible appendicoliths were harvested at surgery, measured and characterised by morphological examination complemented with micro-CT and micro-X-ray fluorescence spectroscopy. Patients were categorised into two groups: appendicolith appendicitis without other complications and appendicolith appendicitis with complications (appendiceal gangrene, perforation and/or abscess). The association of appendicolith classification and characteristics with appendicitis severity was evaluated.
Results: Of 78 patients with a CT appendicolith, 41 appendicoliths were collected and classified based on the degree of hardness into three classes. The hardest appendicoliths (class 3) were less common (19.5%) presenting with a stone-hard outer layer and concentrically layered inner structure around a core. The layered inner structure was also observed in class 2 appendicoliths, but was absent in soft, class 1 appendicoliths. Appendicolith hardness or measures (maximum length, diameter and weight) were not associated with appendicitis severity. The spatial distribution of the main inorganic elements of calcium and phosphorus varied within most appendicoliths.
Conclusion: This updated classification confirms categorisation of CT visible appendicoliths into three classes based on their physical and chemical characteristics. The data on clinical and aetiopathological characteristics of appendicoliths is scarce and using this systematic classification would add to this understanding.
{"title":"Appendicolith classification: physical and chemical properties of appendicoliths in patients with CT diagnosed acute appendicitis - a prospective cohort study.","authors":"Sanja Vanhatalo, Ermei Mäkilä, Antti J Hakanen, Eveliina Munukka, Jarno Salonen, Timo Saarinen, Juha Grönroos, Suvi Sippola, Paulina Salminen","doi":"10.1136/bmjgast-2024-001403","DOIUrl":"10.1136/bmjgast-2024-001403","url":null,"abstract":"<p><strong>Objective: </strong>Appendicoliths are associated with a more complicated course of acute appendicitis and failure of non-operative treatment. We aimed to update the appendicolith classification originally described in 1966 and to assess the association of appendicolith characteristics with appendicitis severity.</p><p><strong>Design: </strong>This prospective predefined MAPPAC-trial (ClinicalTrials.gov NCT03257423) substudy included patients with CT diagnosed appendicitis presenting with an appendicolith. CT visible appendicoliths were harvested at surgery, measured and characterised by morphological examination complemented with micro-CT and micro-X-ray fluorescence spectroscopy. Patients were categorised into two groups: appendicolith appendicitis without other complications and appendicolith appendicitis with complications (appendiceal gangrene, perforation and/or abscess). The association of appendicolith classification and characteristics with appendicitis severity was evaluated.</p><p><strong>Results: </strong>Of 78 patients with a CT appendicolith, 41 appendicoliths were collected and classified based on the degree of hardness into three classes. The hardest appendicoliths (class 3) were less common (19.5%) presenting with a stone-hard outer layer and concentrically layered inner structure around a core. The layered inner structure was also observed in class 2 appendicoliths, but was absent in soft, class 1 appendicoliths. Appendicolith hardness or measures (maximum length, diameter and weight) were not associated with appendicitis severity. The spatial distribution of the main inorganic elements of calcium and phosphorus varied within most appendicoliths.</p><p><strong>Conclusion: </strong>This updated classification confirms categorisation of CT visible appendicoliths into three classes based on their physical and chemical characteristics. The data on clinical and aetiopathological characteristics of appendicoliths is scarce and using this systematic classification would add to this understanding.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11337665/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142003640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-17DOI: 10.1136/bmjgast-2024-001450
Jemma S Cleminson, Julian Thomas, Christopher J Stewart, David Campbell, Andrew Gennery, Nicholas D Embleton, Jutta Köglmeier, Theodoric Wong, Marie Spruce, Janet E Berrington
Introduction: Short bowel syndrome (SBS) is the predominant cause of paediatric intestinal failure. Although life-saving, parenteral nutrition (PN) is linked to complications and may impact quality of life (QoL). Most children will experience intestinal rehabilitation (IR), but the mechanisms underpinning this remain to be understood. SBS is characterised by abnormal microbiome patterns, which might serve as predictive indicators for IR. We aim to characterise the microbiome profiles of children with SBS during IR, concurrently exploring how parental perspectives of QoL relate to IR.
Methods and analysis: This study will enrol a minimum of 20 paediatric patients with SBS (0-18 years). Clinical data and biological samples will be collected over a 2-year study period. We will apply 16S rRNA gene sequencing to analyse the microbiome from faecal and gut tissue samples, with additional shotgun metagenomic sequencing specifically on samples obtained around the time of IR. Gas chromatography with flame ionisation detection will profile faecal short-chain fatty acids. Plasma citrulline and urinary intestinal fatty acid binding proteins will be measured annually. We will explore microbiome-clinical covariate interactions. Furthermore, we plan to assess parental perspectives on QoL during PN and post-IR by inviting parents to complete the Paediatric Quality of Life questionnaire at recruitment and after the completion of IR.
Ethics and dissemination: Ethical approval was obtained from the East Midlands-Nottingham 2 Research Ethics Committee (22/EM/0233; 28 November 2022). Recruitment began in February 2023. Outcomes of the study will be published in peer-reviewed scientific journals and presented at scientific meetings. A lay summary of the results will be made available to participants and the public.
Trial registration number: ISRCTN90620576.
简介:短肠综合征(SBS)是导致儿科肠功能衰竭的主要原因。肠外营养(PN)虽然能挽救生命,但也与并发症有关,并可能影响生活质量(QoL)。大多数患儿都会经历肠道康复(IR),但其机制仍有待了解。SBS 的特点是微生物组模式异常,这可能成为 IR 的预测指标。我们的目标是描述肠道康复期间 SBS 患儿微生物组的特征,同时探索家长对 QoL 的看法与肠道康复的关系:本研究将至少招募 20 名儿童 SBS 患者(0-18 岁)。在为期两年的研究期间,将收集临床数据和生物样本。我们将采用 16S rRNA 基因测序法对粪便和肠道组织样本中的微生物组进行分析,并专门对发生 IR 前后获得的样本进行额外的霰弹枪元基因组测序。采用火焰离子化检测的气相色谱法将分析粪便中的短链脂肪酸。血浆瓜氨酸和尿液中的肠脂肪酸结合蛋白将每年进行一次测定。我们将探索微生物组与临床协变量之间的相互作用。此外,我们还计划在招募时和IR结束后邀请家长填写儿科生活质量问卷,以评估家长对PN期间和IR后生活质量的看法:该研究已获得东米德兰兹-诺丁汉第二研究伦理委员会(East Midlands-Nottingham 2 Research Ethics Committee)的伦理批准(22/EM/0233;2022 年 11 月 28 日)。招募工作于 2023 年 2 月开始。研究结果将在同行评审的科学杂志上发表,并在科学会议上展示。试验注册号:ISRCTN90620576。
{"title":"Gut microbiota and intestinal rehabilitation: a prospective childhood cohort longitudinal study of short bowel syndrome (the MIRACLS study): study protocol.","authors":"Jemma S Cleminson, Julian Thomas, Christopher J Stewart, David Campbell, Andrew Gennery, Nicholas D Embleton, Jutta Köglmeier, Theodoric Wong, Marie Spruce, Janet E Berrington","doi":"10.1136/bmjgast-2024-001450","DOIUrl":"10.1136/bmjgast-2024-001450","url":null,"abstract":"<p><strong>Introduction: </strong>Short bowel syndrome (SBS) is the predominant cause of paediatric intestinal failure. Although life-saving, parenteral nutrition (PN) is linked to complications and may impact quality of life (QoL). Most children will experience intestinal rehabilitation (IR), but the mechanisms underpinning this remain to be understood. SBS is characterised by abnormal microbiome patterns, which might serve as predictive indicators for IR. We aim to characterise the microbiome profiles of children with SBS during IR, concurrently exploring how parental perspectives of QoL relate to IR.</p><p><strong>Methods and analysis: </strong>This study will enrol a minimum of 20 paediatric patients with SBS (0-18 years). Clinical data and biological samples will be collected over a 2-year study period. We will apply 16S rRNA gene sequencing to analyse the microbiome from faecal and gut tissue samples, with additional shotgun metagenomic sequencing specifically on samples obtained around the time of IR. Gas chromatography with flame ionisation detection will profile faecal short-chain fatty acids. Plasma citrulline and urinary intestinal fatty acid binding proteins will be measured annually. We will explore microbiome-clinical covariate interactions. Furthermore, we plan to assess parental perspectives on QoL during PN and post-IR by inviting parents to complete the Paediatric Quality of Life questionnaire at recruitment and after the completion of IR.</p><p><strong>Ethics and dissemination: </strong>Ethical approval was obtained from the East Midlands-Nottingham 2 Research Ethics Committee (22/EM/0233; 28 November 2022). Recruitment began in February 2023. Outcomes of the study will be published in peer-reviewed scientific journals and presented at scientific meetings. A lay summary of the results will be made available to participants and the public.</p><p><strong>Trial registration number: </strong>ISRCTN90620576.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11331872/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-05DOI: 10.1136/bmjgast-2024-001434
Manuel Zorzi, Lucia Calciano, Nicola Gennaro, Laura Memo, Silvia Rizzato, Carmen Stocco, Emanuele D L Urso, Silvia Negro, Gaya Spolverato, Salvatore Pucciarelli, Marta Sbaraglia, Stefano Guzzinati
Background: Faecal immunochemical test (FIT)-based screening is effective in reducing colorectal cancer (CRC) incidence, but its sensitivity for proximal lesions remains low.
Objectives: We compared age-adjusted CRC surgical resection rates across anatomic sites (proximal colon, distal colon, rectum), age groups and sex over 20 years in a large Italian population. We particularly focused on changes in trends following FIT-screening implementation in the target population (50-69 years).
Design: This retrospective study analysed data from the Veneto Region's administrative Hospital Discharge Dataset, involving over 54 000 patients aged 40-89 (43.4% female) who underwent CRC surgery between 2002 and 2021.
Results: Overall, surgery rates increased until 2007 (annual percentage changes: 2.5% in males, 2.9% in females) and then declined (-4.2% in males, -3.4% in females). This decline was steeper for distal and rectal cancers compared with proximal cancer, suggesting a shift towards more right-sided CRC surgery.In males, the prescreening increase in proximal surgery was reversed after screening implementation (slope change: -6%) while the prescreening decline accelerated for distal (-4%) and rectal (-3%) surgeries. In females, stable prescreening trends shifted downward for all sites (-5% for proximal, -8% for distal and -7% for rectal surgery). However, the change in trends between prescreening and postscreening periods was not different across anatomic sites for either sex (all slope change differences in pairwise comparisons were not statistically significant).
Conclusion: The shift towards proximal surgery may not be entirely due to the FIT's low sensitivity but may reflect an underlying upward trend in proximal cancers independent of screening.
{"title":"Trends in colorectal cancer surgical resection rates during the screening era: a retrospective study in Italy.","authors":"Manuel Zorzi, Lucia Calciano, Nicola Gennaro, Laura Memo, Silvia Rizzato, Carmen Stocco, Emanuele D L Urso, Silvia Negro, Gaya Spolverato, Salvatore Pucciarelli, Marta Sbaraglia, Stefano Guzzinati","doi":"10.1136/bmjgast-2024-001434","DOIUrl":"10.1136/bmjgast-2024-001434","url":null,"abstract":"<p><strong>Background: </strong>Faecal immunochemical test (FIT)-based screening is effective in reducing colorectal cancer (CRC) incidence, but its sensitivity for proximal lesions remains low.</p><p><strong>Objectives: </strong>We compared age-adjusted CRC surgical resection rates across anatomic sites (proximal colon, distal colon, rectum), age groups and sex over 20 years in a large Italian population. We particularly focused on changes in trends following FIT-screening implementation in the target population (50-69 years).</p><p><strong>Design: </strong>This retrospective study analysed data from the Veneto Region's administrative Hospital Discharge Dataset, involving over 54 000 patients aged 40-89 (43.4% female) who underwent CRC surgery between 2002 and 2021.</p><p><strong>Results: </strong>Overall, surgery rates increased until 2007 (annual percentage changes: 2.5% in males, 2.9% in females) and then declined (-4.2% in males, -3.4% in females). This decline was steeper for distal and rectal cancers compared with proximal cancer, suggesting a shift towards more right-sided CRC surgery.In males, the prescreening increase in proximal surgery was reversed after screening implementation (slope change: -6%) while the prescreening decline accelerated for distal (-4%) and rectal (-3%) surgeries. In females, stable prescreening trends shifted downward for all sites (-5% for proximal, -8% for distal and -7% for rectal surgery). However, the change in trends between prescreening and postscreening periods was not different across anatomic sites for either sex (all slope change differences in pairwise comparisons were not statistically significant).</p><p><strong>Conclusion: </strong>The shift towards proximal surgery may not be entirely due to the FIT's low sensitivity but may reflect an underlying upward trend in proximal cancers independent of screening.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11308884/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141896850","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-24DOI: 10.1136/bmjgast-2024-001439
Leonard Fehring, Hendrik Brinkmann, Sven Hohenstein, Andreas Bollmann, Patrick Dirks, Jörg Pölitz, Christian Prinz
Objective: Cholecystectomy is one of the most frequently performed surgeries in Germany and is performed as a treatment of acute cholecystitis (guideline S3 IIIB.8) and after endoscopic retrograde cholangiopancreatography for choledocholithiasis with simultaneous cholecystolithiasis (guideline S3 IIIC.6). This article examines the effects of a guideline update from 2017, which recommends prompt cholecystectomy within 24 hours of admission due to cholecystitis or within 72 hours after bile duct repair. In addition, it aims to identify reasons (eg, financial disincentives) and potential for improvement for non-adherence to the guidelines.
Design: Methodologically, a retrospective analysis based on routine billing data from 84 Helios Group hospitals from 2016 and 2022, with a total of 45 393 included cases, was applied. The guideline adherence rate is used as the main outcome measure.
Results: Results show the guideline updates led to a statistically significant increase in the proportion of cholecystectomy performed in a timely manner (guideline S3 IIIB.8: increase from 43% to 49%, p<0.001; guideline S3 IIIC.6: increase from 7% to 20%, p<0.001). Medical, structural and financial reasons for non-adherence could be identified.
Conclusion: As possible reasons for non-adherence, medical factors such as advanced age, multimorbidity and frailty could be identified. Analyses of structural factors revealed that hospitals in very rural regions are less likely to perform timely cholecystectomies, presumably due to infrastructural and personnel-capacity bottlenecks. A similar picture emerges for maximum-care hospitals, which might be explained by more severe and complex cases on average. Further evaluation indicates that an increase in and better hospital-internal participation of gastroenterologists in remuneration could lead to even greater adherence to the S3 IIIC.6 guideline.
{"title":"Timely cholecystectomy: important factors to improve guideline adherence and patient treatment.","authors":"Leonard Fehring, Hendrik Brinkmann, Sven Hohenstein, Andreas Bollmann, Patrick Dirks, Jörg Pölitz, Christian Prinz","doi":"10.1136/bmjgast-2024-001439","DOIUrl":"10.1136/bmjgast-2024-001439","url":null,"abstract":"<p><strong>Objective: </strong>Cholecystectomy is one of the most frequently performed surgeries in Germany and is performed as a treatment of acute cholecystitis (guideline S3 IIIB.8) and after endoscopic retrograde cholangiopancreatography for choledocholithiasis with simultaneous cholecystolithiasis (guideline S3 IIIC.6). This article examines the effects of a guideline update from 2017, which recommends prompt cholecystectomy within 24 hours of admission due to cholecystitis or within 72 hours after bile duct repair. In addition, it aims to identify reasons (eg, financial disincentives) and potential for improvement for non-adherence to the guidelines.</p><p><strong>Design: </strong>Methodologically, a retrospective analysis based on routine billing data from 84 Helios Group hospitals from 2016 and 2022, with a total of 45 393 included cases, was applied. The guideline adherence rate is used as the main outcome measure.</p><p><strong>Results: </strong>Results show the guideline updates led to a statistically significant increase in the proportion of cholecystectomy performed in a timely manner (guideline S3 IIIB.8: increase from 43% to 49%, p<0.001; guideline S3 IIIC.6: increase from 7% to 20%, p<0.001). Medical, structural and financial reasons for non-adherence could be identified.</p><p><strong>Conclusion: </strong>As possible reasons for non-adherence, medical factors such as advanced age, multimorbidity and frailty could be identified. Analyses of structural factors revealed that hospitals in very rural regions are less likely to perform timely cholecystectomies, presumably due to infrastructural and personnel-capacity bottlenecks. A similar picture emerges for maximum-care hospitals, which might be explained by more severe and complex cases on average. Further evaluation indicates that an increase in and better hospital-internal participation of gastroenterologists in remuneration could lead to even greater adherence to the S3 IIIC.6 guideline.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11284926/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141757282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-17DOI: 10.1136/bmjgast-2024-001376
Kathleen J Yost, Rachel E Carlson, Christine R Kirt, Emily J Kirsch, Bonny Kneedler, Jennifer J Laffin, Jennifer L St Sauver, Lila J Finney Rutten, Jessica A Grimm, Janet E Olson
Objective: To identify the optimal incentive protocol for maximising participation while managing study costs during the Voyage trial.
Design: Prospective cohort (Voyage trial) of colorectal cancer (CRC) incidence and mortality outcomes in individuals screened with multitarget stool DNA (mt-sDNA) served as the population. A subset was randomised to receive postage stamps as a pre-consent incentive, or as a post-consent incentive after completion of the consent and questionnaire. Descriptive statistics from year 1 are reported.
Results: During year 1 of the Voyage trial, a total of 600 258 individuals with mt-sDNA orders received at Exact Sciences Laboratories were randomly selected and invited to participate. Of those, 26 429 (4.4%) opted in, 14 365 of whom (54.3%) consented. The opt-in and consent samples were similar to the target population with respect to sex but differed by geographic residence and age (p<0.001). For the embedded incentive experiment, 2333 were randomised to the pre-incentive arm, while 2342 were randomised to the post-incentive arm. Overall consent rate in the incentive trial was 56.4% (60.9% for the pre-consent incentive arm (1421/2333) vs 52.0% for the post-consent incentive arm (1217/2342), p<0.001). Cost reduction was observed for the pre-consent incentive group, and higher response rates were seen among older versus younger individuals.
Conclusions: Pre-consent incentive option was associated with a higher participation rate and lower costs and was used for the remainder of study recruitment. CRC incidence and mortality vary with age; thus, adjusting for differential participation by age and region will be important in analyses of Voyage data.
{"title":"Recruitment strategies and consent rates in a national prospective colorectal cancer screening cohort: results from year 1 of the Voyage Study.","authors":"Kathleen J Yost, Rachel E Carlson, Christine R Kirt, Emily J Kirsch, Bonny Kneedler, Jennifer J Laffin, Jennifer L St Sauver, Lila J Finney Rutten, Jessica A Grimm, Janet E Olson","doi":"10.1136/bmjgast-2024-001376","DOIUrl":"10.1136/bmjgast-2024-001376","url":null,"abstract":"<p><strong>Objective: </strong>To identify the optimal incentive protocol for maximising participation while managing study costs during the Voyage trial.</p><p><strong>Design: </strong>Prospective cohort (Voyage trial) of colorectal cancer (CRC) incidence and mortality outcomes in individuals screened with multitarget stool DNA (mt-sDNA) served as the population. A subset was randomised to receive postage stamps as a pre-consent incentive, or as a post-consent incentive after completion of the consent and questionnaire. Descriptive statistics from year 1 are reported.</p><p><strong>Results: </strong>During year 1 of the Voyage trial, a total of 600 258 individuals with mt-sDNA orders received at Exact Sciences Laboratories were randomly selected and invited to participate. Of those, 26 429 (4.4%) opted in, 14 365 of whom (54.3%) consented. The opt-in and consent samples were similar to the target population with respect to sex but differed by geographic residence and age (p<0.001). For the embedded incentive experiment, 2333 were randomised to the pre-incentive arm, while 2342 were randomised to the post-incentive arm. Overall consent rate in the incentive trial was 56.4% (60.9% for the pre-consent incentive arm (1421/2333) vs 52.0% for the post-consent incentive arm (1217/2342), p<0.001). Cost reduction was observed for the pre-consent incentive group, and higher response rates were seen among older versus younger individuals.</p><p><strong>Conclusions: </strong>Pre-consent incentive option was associated with a higher participation rate and lower costs and was used for the remainder of study recruitment. CRC incidence and mortality vary with age; thus, adjusting for differential participation by age and region will be important in analyses of Voyage data.</p><p><strong>Trial registration number: </strong>NCT04124406.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11288143/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141632671","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}