Pub Date : 2024-09-03DOI: 10.1136/bmjgast-2024-001410
Introduction: Physical frailty is associated with increased mortality and poor quality of life (QoL) before and after liver transplantation (LT). Evidence is lacking on how to tailor exercise and behavioural techniques in this patient population.
Methods and analysis: Home-based EXercise and motivAtional programme before and after Liver Transplantation (EXALT) is a phase 2b, open-label, two-centre randomised controlled clinical trial designed to investigate whether a remotely monitored 'home-based exercise and theory-based motivation support programme (HBEP)' before and after LT improves QoL in LT recipients. Adult patients awaiting a primary LT will be assessed for eligibility at two LT centres (Birmingham, Royal Free London). Participants will be randomly assigned (1:1) to receive either an HBEP while on the LT waiting list through to 24 weeks after LT (Intervention) or a patient exercise advice leaflet (Control). Using a standard method of difference in means (two-sided significance level 0.05; power 0.90) and accounting for a 35% attrition/withdrawal rate, a minimum of 133 patients will be randomised to each treatment group. The primary outcome measure will be assessed using intention-to-treat analysis of the difference in the Physical Component Score of Short form-36 version 2.0 health-related QoL questionnaire between the groups at 24 weeks post-LT.
Ethics and dissemination: The protocol was approved by the South Central-Hampshire A National Research Ethics Committee. Recruitment into the EXALT trial started in May 2022 and is due to end in June 2024, with 217/266 patients randomised to date. The intervention follow-up is due to finish in May 2026. The findings of this trial will be disseminated through peer-reviewed publications, conferences and social media.
Trial registration number: ISRCTN13476586.
导言:身体虚弱与肝移植(LT)前后死亡率增加和生活质量(QoL)低下有关。方法与分析:肝移植前后的家庭锻炼和激励计划(EXALT)是一项2b期、开放标签、双中心随机对照临床试验,旨在研究肝移植前后远程监控的 "家庭锻炼和基于理论的激励支持计划(HBEP)"是否能改善肝移植受者的生活质量。将在两个LT中心(伯明翰和伦敦皇家自由医院)对等待接受初级LT的成年患者进行资格评估。参与者将被随机分配(1:1),在LT候诊期间至LT术后24周接受HBEP(干预)或患者运动建议宣传单(对照)。采用均值差异标准方法(双侧显著性水平 0.05;功率 0.90),并考虑到 35% 的自然减员/退出率,每个治疗组将随机分配至少 133 名患者。主要结局指标将采用意向治疗分析法进行评估,即在长程治疗后 24 周时,两组患者在 Short form-36 version 2.0 健康相关 QoL 问卷中的身体成分得分的差异:研究方案获得了中南部-汉普郡A国家研究伦理委员会的批准。EXALT试验的招募工作于2022年5月开始,将于2024年6月结束,迄今已有217/266名患者接受了随机治疗。干预随访将于 2026 年 5 月结束。该试验的结果将通过同行评议出版物、会议和社交媒体进行传播。试验注册号:ISRCTN13476586。
{"title":"Home-based EXercise and motivAtional programme before and after Liver Transplantation (EXALT): study protocol for phase II two-centre, randomised controlled trial.","authors":"","doi":"10.1136/bmjgast-2024-001410","DOIUrl":"10.1136/bmjgast-2024-001410","url":null,"abstract":"<p><strong>Introduction: </strong>Physical frailty is associated with increased mortality and poor quality of life (QoL) before and after liver transplantation (LT). Evidence is lacking on how to tailor exercise and behavioural techniques in this patient population.</p><p><strong>Methods and analysis: </strong>Home-based EXercise and motivAtional programme before and after Liver Transplantation (EXALT) is a phase 2b, open-label, two-centre randomised controlled clinical trial designed to investigate whether a remotely monitored 'home-based exercise and theory-based motivation support programme (HBEP)' before and after LT improves QoL in LT recipients. Adult patients awaiting a primary LT will be assessed for eligibility at two LT centres (Birmingham, Royal Free London). Participants will be randomly assigned (1:1) to receive either an HBEP while on the LT waiting list through to 24 weeks after LT (Intervention) or a patient exercise advice leaflet (Control). Using a standard method of difference in means (two-sided significance level 0.05; power 0.90) and accounting for a 35% attrition/withdrawal rate, a minimum of 133 patients will be randomised to each treatment group. The primary outcome measure will be assessed using intention-to-treat analysis of the difference in the Physical Component Score of Short form-36 version 2.0 health-related QoL questionnaire between the groups at 24 weeks post-LT.</p><p><strong>Ethics and dissemination: </strong>The protocol was approved by the South Central-Hampshire A National Research Ethics Committee. Recruitment into the EXALT trial started in May 2022 and is due to end in June 2024, with 217/266 patients randomised to date. The intervention follow-up is due to finish in May 2026. The findings of this trial will be disseminated through peer-reviewed publications, conferences and social media.</p><p><strong>Trial registration number: </strong>ISRCTN13476586.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142131891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective Serum amyloid A (SAA) was found to be positively correlated with the activity of Crohn’s disease (CD); however, its prognostic value remains uncertain. Here, we examined its predictive ability in newly diagnosed CD and explored genetic association. Methods This retrospective cohort study included patients newly diagnosed as CD at the First Affiliated Hospital of Sun Yat-sen University between June 2010 and March 2022. We employed receiver operating characteristic curve, Cox proportional hazard regression models and restricted cubic splines to investigate the prognostic performance of SAA for surgery and disease progression. To assess possible causality, a two-sample Mendelian randomisation (MR) of published genome-wide association study data was conducted. Results During 2187.6 person-years (median age, 28 years, 72.4% male), 87 surgery and 153 disease progression events were documented. A 100-unit increment in SAA level generated 14% higher risk for surgery (adjusted HR (95% CI): 1.14 (1.05–1.23), p=0.001) and 12% for disease progression (1.12 (1.05–1.19), p<0.001). Baseline SAA level ≥89.2 mg/L led to significantly elevated risks for surgery (2.08 (1.31–3.28), p=0.002) and disease progression (1.72 (1.22–2.41), p=0.002). Such associations were assessed as linear. Adding SAA into a scheduled model significantly improved its predictive performances for surgery and disease progression (p for net reclassification indexes and integrated discrimination indexes <0.001). Unfortunately, no genetic causality between SAA and CD was observed in MR analysis. Sensitivity analyses showed robust results. Conclusion Although causality was not found, baseline SAA level was an independent predictor of surgery and disease progression in newly diagnosed CD, and had additive benefit to existing prediction models. Data are available upon reasonable request. The datasets generated for this study are available on request from the corresponding authors.
研究发现,血清淀粉样蛋白 A(SAA)与克罗恩病(CD)的活动性呈正相关,但其预后价值仍不确定。在此,我们对其在新诊断的克罗恩病中的预测能力进行了研究,并探讨了其与遗传的关系。方法 该回顾性队列研究纳入了 2010 年 6 月至 2022 年 3 月期间在中山大学附属第一医院新诊断为 CD 的患者。我们采用接收者操作特征曲线、Cox比例危险回归模型和限制性立方样条来研究SAA对手术和疾病进展的预后表现。为了评估可能的因果关系,我们对已发表的全基因组关联研究数据进行了双样本孟德尔随机化(MR)。结果 在2187.6个人年(中位年龄28岁,72.4%为男性)中,共记录了87例手术和153例疾病进展事件。SAA水平每增加100个单位,手术风险增加14%(调整HR(95% CI):1.14 (1.05-1.23),p=0.001),疾病进展风险增加12%(1.12 (1.05-1.19),p<0.001)。基线 SAA 水平≥89.2 mg/L 会导致手术风险(2.08(1.31-3.28),p=0.002)和疾病进展风险(1.72(1.22-2.41),p=0.002)显著升高。这种关联被评估为线性关系。在预定模型中加入 SAA 可显著提高其对手术和疾病进展的预测性能(净再分类指数和综合判别指数的 p <0.001)。遗憾的是,在 MR 分析中没有观察到 SAA 与 CD 之间的遗传因果关系。敏感性分析表明结果可靠。结论 虽然没有发现因果关系,但基线 SAA 水平是新诊断 CD 患者手术和疾病进展的独立预测因子,并且对现有预测模型有额外的益处。如有合理要求,可提供相关数据。本研究产生的数据集可向相应作者索取。
{"title":"Serum amyloid A for predicting prognosis in patients with newly diagnosed Crohn’s disease","authors":"Qia Chen, Xi Zhang, Yizhe Tie, Jianwu Zhang, Pinwei Huang, Yuxuan Xie, Liqian Zhang, Xueer Tang, Zhirong Zeng, Li Li, Minhu Chen, Rirong Chen, Shenghong Zhang","doi":"10.1136/bmjgast-2024-001497","DOIUrl":"https://doi.org/10.1136/bmjgast-2024-001497","url":null,"abstract":"Objective Serum amyloid A (SAA) was found to be positively correlated with the activity of Crohn’s disease (CD); however, its prognostic value remains uncertain. Here, we examined its predictive ability in newly diagnosed CD and explored genetic association. Methods This retrospective cohort study included patients newly diagnosed as CD at the First Affiliated Hospital of Sun Yat-sen University between June 2010 and March 2022. We employed receiver operating characteristic curve, Cox proportional hazard regression models and restricted cubic splines to investigate the prognostic performance of SAA for surgery and disease progression. To assess possible causality, a two-sample Mendelian randomisation (MR) of published genome-wide association study data was conducted. Results During 2187.6 person-years (median age, 28 years, 72.4% male), 87 surgery and 153 disease progression events were documented. A 100-unit increment in SAA level generated 14% higher risk for surgery (adjusted HR (95% CI): 1.14 (1.05–1.23), p=0.001) and 12% for disease progression (1.12 (1.05–1.19), p<0.001). Baseline SAA level ≥89.2 mg/L led to significantly elevated risks for surgery (2.08 (1.31–3.28), p=0.002) and disease progression (1.72 (1.22–2.41), p=0.002). Such associations were assessed as linear. Adding SAA into a scheduled model significantly improved its predictive performances for surgery and disease progression (p for net reclassification indexes and integrated discrimination indexes <0.001). Unfortunately, no genetic causality between SAA and CD was observed in MR analysis. Sensitivity analyses showed robust results. Conclusion Although causality was not found, baseline SAA level was an independent predictor of surgery and disease progression in newly diagnosed CD, and had additive benefit to existing prediction models. Data are available upon reasonable request. The datasets generated for this study are available on request from the corresponding authors.","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142204475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective Chronic pain in inflammatory bowel disease (IBD) is common and detrimental to quality of life. Recent Cochrane reviews identified a multitude of randomised controlled trial interventions, but the certainty of the findings is low or very low. We set out to reach a patient and professional co-produced Delphi consensus on treatment priorities, key outcomes and propose a model for understanding our findings. Methods An online survey was co-produced with Crohn’s and Colitis UK and sent to patients and healthcare professionals in two phases, for prioritisation of treatments and outcome measures. Phase three consisted of four online group interviews, where patients and healthcare professionals discussed the rationale of their choices. Transcripts were combined with the free text data from the Delphi surveys and analysed through a three-phase qualitative technique. Results The phase 1 survey was completed by 128 participants (73 patients, 3 carers and 53 health professionals). Diet was the top priority for both patients (n=26/73, 36.1%) and healthcare professionals (n=29/52, 56.9%). Phase 2 was completed by 68 participants. FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet, stress management therapy and relaxation therapy were the top three consensus priorities. Phase 3 group interviews were attended by 13 patients and 5 healthcare professionals. Key themes included: The patient as an individual, beliefs and experiences, disease activity influencing therapy choice, accessibility barriers and quality of life. Conclusion Low FODMAP diet, followed by psychological therapies were the highest-rated research priorities for healthcare professionals and patients. Funding bodies and researchers should consider these findings, alongside the model for understanding our findings, when making research decisions. Data are available upon reasonable request. We have tried to include all available data in the supplementary files, and we are happy to receive any reasonable requests for additional information.
{"title":"Patients’ and health professionals’ research priorities for chronic pain associated with inflammatory bowel disease: a co-produced sequential mixed methods Delphi consensus study","authors":"Morris Gordon, Vassiliki Sinopoulou, Roxana Mardare, Mansour Abdulshafea, Ciaran Grafton-Clarke, Jessica Vasiliou","doi":"10.1136/bmjgast-2024-001483","DOIUrl":"https://doi.org/10.1136/bmjgast-2024-001483","url":null,"abstract":"Objective Chronic pain in inflammatory bowel disease (IBD) is common and detrimental to quality of life. Recent Cochrane reviews identified a multitude of randomised controlled trial interventions, but the certainty of the findings is low or very low. We set out to reach a patient and professional co-produced Delphi consensus on treatment priorities, key outcomes and propose a model for understanding our findings. Methods An online survey was co-produced with Crohn’s and Colitis UK and sent to patients and healthcare professionals in two phases, for prioritisation of treatments and outcome measures. Phase three consisted of four online group interviews, where patients and healthcare professionals discussed the rationale of their choices. Transcripts were combined with the free text data from the Delphi surveys and analysed through a three-phase qualitative technique. Results The phase 1 survey was completed by 128 participants (73 patients, 3 carers and 53 health professionals). Diet was the top priority for both patients (n=26/73, 36.1%) and healthcare professionals (n=29/52, 56.9%). Phase 2 was completed by 68 participants. FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet, stress management therapy and relaxation therapy were the top three consensus priorities. Phase 3 group interviews were attended by 13 patients and 5 healthcare professionals. Key themes included: The patient as an individual, beliefs and experiences, disease activity influencing therapy choice, accessibility barriers and quality of life. Conclusion Low FODMAP diet, followed by psychological therapies were the highest-rated research priorities for healthcare professionals and patients. Funding bodies and researchers should consider these findings, alongside the model for understanding our findings, when making research decisions. Data are available upon reasonable request. We have tried to include all available data in the supplementary files, and we are happy to receive any reasonable requests for additional information.","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142204474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1136/bmjgast-2024-001372
Ruth M Ayling, Finbarr Cotter
Objective Colorectal cancer (CRC) is the fourth most common cancer in the UK. Patients with symptoms suggestive of CRC should be referred for urgent investigation. However, gastrointestinal symptoms are often non-specific and there is a need for suitable triage tools to enable prioritisation of investigations. In this study, the performance of the faecal immunochemical test (FIT), anaemia and the artificial intelligence algorithm ColonFlag were retrospectively examined and evaluated for their potential clinical benefits in patients who had been referred on an urgent lower gastrointestinal cancer pathway. Design All patients aged over 40 years referred in a 12-month period were included. After 6 months, clinical outcomes were determined and the performance of the triage tests was evaluated. Results A total of 3822 patients completed investigations and received a diagnosis. 143 had CRC, 126 high-risk adenomas (HRA). ColonFlag would have missed 27 CRC and 29 HRA. Faecal haemoglobin (f-Hb) at a cut-off of 10 µg/g would have missed 10 CRC and 26 HRA; f-Hb in combination with anaemia would have missed 2 CRC and 14 HRA. Using f-Hb in combination with ColonFlag would have missed only 1 CRC and 5 HRA and would have reduced the need for urgent referral by over 400 patients. Conclusion ColonFlag has potential to assist detection of CRC and HRA, alone where no faecal sample is present and in combination with FIT and to reduce the need for urgent referral. Data are available on reasonable request.
{"title":"Diagnostic application of the ColonFlag AI tool in combination with faecal immunochemical test in patients on an urgent lower gastrointestinal cancer pathway","authors":"Ruth M Ayling, Finbarr Cotter","doi":"10.1136/bmjgast-2024-001372","DOIUrl":"https://doi.org/10.1136/bmjgast-2024-001372","url":null,"abstract":"Objective Colorectal cancer (CRC) is the fourth most common cancer in the UK. Patients with symptoms suggestive of CRC should be referred for urgent investigation. However, gastrointestinal symptoms are often non-specific and there is a need for suitable triage tools to enable prioritisation of investigations. In this study, the performance of the faecal immunochemical test (FIT), anaemia and the artificial intelligence algorithm ColonFlag were retrospectively examined and evaluated for their potential clinical benefits in patients who had been referred on an urgent lower gastrointestinal cancer pathway. Design All patients aged over 40 years referred in a 12-month period were included. After 6 months, clinical outcomes were determined and the performance of the triage tests was evaluated. Results A total of 3822 patients completed investigations and received a diagnosis. 143 had CRC, 126 high-risk adenomas (HRA). ColonFlag would have missed 27 CRC and 29 HRA. Faecal haemoglobin (f-Hb) at a cut-off of 10 µg/g would have missed 10 CRC and 26 HRA; f-Hb in combination with anaemia would have missed 2 CRC and 14 HRA. Using f-Hb in combination with ColonFlag would have missed only 1 CRC and 5 HRA and would have reduced the need for urgent referral by over 400 patients. Conclusion ColonFlag has potential to assist detection of CRC and HRA, alone where no faecal sample is present and in combination with FIT and to reduce the need for urgent referral. Data are available on reasonable request.","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142269129","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-29DOI: 10.1136/bmjgast-2024-001470
Bruno Bohn, Curtis Tilves, Yingan Chen, Myriam Doyon, Luigi Bouchard, Patrice Perron, Renée Guérin, Éric Massé, Marie-France Hivert, Noel T Mueller
Objective: Gut microbes and microbe-dependent metabolites (eg, tryptophan-kynurenine-serotonin pathway metabolites) have been linked to systemic inflammation, but the microbiota-metabolite-inflammation axis remains uncharacterised in children. Here we investigated whether gut microbiota features and circulating metabolites (both microbe-dependent and non-microbe-dependent metabolites) associated with circulating inflammation markers in children.
Methods: We studied children from the prospective Gen3G birth cohort who had data on untargeted plasma metabolome (n=321 children; Metabolon platform), gut microbiota (n=147; 16S rRNA sequencing), and inflammation markers (plasminogen activator inhibitor-1 (PAI-1), monocyte chemoattractant protein-1, and tumour necrosis factor-α) measured at 5-7 years. We examined associations of microbial taxa and metabolites-examining microbe-dependent and non-microbe-dependent metabolites separately-with each inflammatory marker and with an overall inflammation score (InfSc), adjusting for key confounders and correcting for multiple comparisons. We also compared the proportion of significantly associated microbe-dependent versus non-microbe-dependent metabolites, identified a priori (Human Microbial Metabolome Database), with each inflammation marker.
Results: Of 335 taxa tested, 149 were associated (qFDR<0.05) with at least one inflammatory marker; 10 of these were robust to pseudocount choice. Several bacterial taxa involved in tryptophan metabolism were associated with inflammation, including kynurenine-degrading Ruminococcus, which was inversely associated with all inflammation markers. Of 1037 metabolites tested, 315 were previously identified as microbe dependent and were more frequently associated with PAI-1 and the InfSc than non-microbe dependent metabolites. In total, 87 metabolites were associated (qFDR<0.05) with at least one inflammation marker, including kynurenine (positively), serotonin (positively), and tryptophan (inversely).
Conclusion: A distinct set of gut microbes and microbe-dependent metabolites, including those involved in the tryptophan-kynurenine-serotonin pathway, may be implicated in inflammatory pathways in childhood.
{"title":"Associations of gut microbiota features and circulating metabolites with systemic inflammation in children.","authors":"Bruno Bohn, Curtis Tilves, Yingan Chen, Myriam Doyon, Luigi Bouchard, Patrice Perron, Renée Guérin, Éric Massé, Marie-France Hivert, Noel T Mueller","doi":"10.1136/bmjgast-2024-001470","DOIUrl":"10.1136/bmjgast-2024-001470","url":null,"abstract":"<p><strong>Objective: </strong>Gut microbes and microbe-dependent metabolites (eg, tryptophan-kynurenine-serotonin pathway metabolites) have been linked to systemic inflammation, but the microbiota-metabolite-inflammation axis remains uncharacterised in children. Here we investigated whether gut microbiota features and circulating metabolites (both microbe-dependent and non-microbe-dependent metabolites) associated with circulating inflammation markers in children.</p><p><strong>Methods: </strong>We studied children from the prospective Gen3G birth cohort who had data on untargeted plasma metabolome (n=321 children; Metabolon platform), gut microbiota (n=147; 16S rRNA sequencing), and inflammation markers (plasminogen activator inhibitor-1 (PAI-1), monocyte chemoattractant protein-1, and tumour necrosis factor-α) measured at 5-7 years. We examined associations of microbial taxa and metabolites-examining microbe-dependent and non-microbe-dependent metabolites separately-with each inflammatory marker and with an overall inflammation score (InfSc), adjusting for key confounders and correcting for multiple comparisons. We also compared the proportion of significantly associated microbe-dependent versus non-microbe-dependent metabolites, identified a priori (Human Microbial Metabolome Database), with each inflammation marker.</p><p><strong>Results: </strong>Of 335 taxa tested, 149 were associated (q<sub>FDR</sub><0.05) with at least one inflammatory marker; 10 of these were robust to pseudocount choice. Several bacterial taxa involved in tryptophan metabolism were associated with inflammation, including kynurenine-degrading <i>Ruminococcus</i>, which was inversely associated with all inflammation markers. Of 1037 metabolites tested, 315 were previously identified as microbe dependent and were more frequently associated with PAI-1 and the InfSc than non-microbe dependent metabolites. In total, 87 metabolites were associated (q<sub>FDR</sub><0.05) with at least one inflammation marker, including kynurenine (positively), serotonin (positively), and tryptophan (inversely).</p><p><strong>Conclusion: </strong>A distinct set of gut microbes and microbe-dependent metabolites, including those involved in the tryptophan-kynurenine-serotonin pathway, may be implicated in inflammatory pathways in childhood.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11367355/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104494","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 : 2024-08-29DOI: 10.1136/bmjgast-2024-001510
Daniele Napolitano, Ercole Vellone, Paolo Iovino, Franco Scaldaferri, Antonello Cocchieri
Introduction: Supporting patient self-care and the contribution of their caregivers is crucial in chronic illness care. Inflammatory bowel disease (IBD) is a chronic condition whose prevalence is expected to double, especially in Western countries. IBD symptoms can negatively impact patients' well-being, causing high anxiety, depression, stress and reduced quality of life. These symptoms also affect the health of family members and friends, who often take on caregiving roles during exacerbations. Knowledge about self-care in IBD (IBD-SELF) is limited, and few studies have explored this context. This paper outlines a research protocol for a multicentre longitudinal study to investigate patient self-care and caregiver contributions to IBD-SELF.
Methods and analysis: A sample of 250 consecutive patients diagnosed with IBD and their caregivers will be recruited from 9 dedicated IBD units in northern, central and southern Italy during outpatient visits. Data collection will occur at baseline, 6 and 12 months after enrolment. Multivariable regressions, path analyses and structural equation models will identify predictors (eg, health literacy, caregiver burden and depression) and outcomes (use of healthcare services, disease severity and quality of life) of self-care and caregiver contributions. Dyadic analyses will control for the interdependence of dyad members.
Ethics and dissemination: Ethical approval was obtained from the Territorial Ethics Committee (Lazio 3) N. 0023486/23 and registered on ClinicalTrials.gov (Identifier number: NCT06015789). This study will enhance our understanding of the self-care process in the patient-caregiver dyad in IBD, aiding the design of future educational interventions and promoting greater patient and caregiver involvement in the care pathway.
{"title":"Self-care in patients affected by inflammatory bowel disease and caregiver contribution to self-care (IBD-SELF): a protocol for a longitudinal observational study.","authors":"Daniele Napolitano, Ercole Vellone, Paolo Iovino, Franco Scaldaferri, Antonello Cocchieri","doi":"10.1136/bmjgast-2024-001510","DOIUrl":"https://doi.org/10.1136/bmjgast-2024-001510","url":null,"abstract":"<p><strong>Introduction: </strong>Supporting patient self-care and the contribution of their caregivers is crucial in chronic illness care. Inflammatory bowel disease (IBD) is a chronic condition whose prevalence is expected to double, especially in Western countries. IBD symptoms can negatively impact patients' well-being, causing high anxiety, depression, stress and reduced quality of life. These symptoms also affect the health of family members and friends, who often take on caregiving roles during exacerbations. Knowledge about self-care in IBD (IBD-SELF) is limited, and few studies have explored this context. This paper outlines a research protocol for a multicentre longitudinal study to investigate patient self-care and caregiver contributions to IBD-SELF.</p><p><strong>Methods and analysis: </strong>A sample of 250 consecutive patients diagnosed with IBD and their caregivers will be recruited from 9 dedicated IBD units in northern, central and southern Italy during outpatient visits. Data collection will occur at baseline, 6 and 12 months after enrolment. Multivariable regressions, path analyses and structural equation models will identify predictors (eg, health literacy, caregiver burden and depression) and outcomes (use of healthcare services, disease severity and quality of life) of self-care and caregiver contributions. Dyadic analyses will control for the interdependence of dyad members.</p><p><strong>Ethics and dissemination: </strong>Ethical approval was obtained from the Territorial Ethics Committee (Lazio 3) N. 0023486/23 and registered on ClinicalTrials.gov (Identifier number: NCT06015789). This study will enhance our understanding of the self-care process in the patient-caregiver dyad in IBD, aiding the design of future educational interventions and promoting greater patient and caregiver involvement in the care pathway.</p><p><strong>Trial registration number: </strong>ClinicalTrials.gov: NCT06015789.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104498","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-28DOI: 10.1136/bmjgast-2024-001463
Dena Bravata, Hau Liu, Meghan M Colosimo, Alexander C Bullock, Erin Commons, Mark Pimentel
Objective: Considerable disparities exist in access to gastrointestinal (GI) care and digestive outcomes across gender, racial, and socioeconomic groups. We evaluated (1) whether adults with chronic GI symptoms from diverse demographic groups would use a digital digestive care programme and (2) the effects of participation on GI symptom severity and other patient-reported outcomes.
Methods: Access to a digital digestive chronic care programme was provided to participants regardless of prior digestive diagnoses or symptoms for 90 days. The intervention included GI symptom tracking, personalised medical nutrition therapy, GI-specific health coaching, and targeted education on common GI symptoms. We assigned a Social Vulnerability Index (SVI) score to each participant according to their home address and compared baseline and end-intervention symptoms and other patient-reported outcomes by gender, race/ethnicity, and SVI.
Results: Of the 1936 participants, mean age was 43.1 years; 67% identified as white/Caucasian, 11% Asian/Pacific Islander, 6% Hispanic/Latinx, 7% black/African American, and 7% of multiple races. Participants of all demographic groups used the app symptom logging, reviewed educational materials, and interacted with their care team and reported similar statistically significant improvements in GI symptoms (by the end of the intervention, 85% improved, p<0.05). Participants reported feeling greater control of their health (83%), better able to manage their digestive symptoms (83%), increased happiness (76%), and greater productivity at work (54%), with black/African Americans and Native Americans most likely to report these changes.
Conclusion: We conclude that a digital GI disease management programme may be of value in reducing disparities in access to GI care.
{"title":"Digital disease management programme reduces chronic gastrointestinal symptoms among racially and socially vulnerable populations.","authors":"Dena Bravata, Hau Liu, Meghan M Colosimo, Alexander C Bullock, Erin Commons, Mark Pimentel","doi":"10.1136/bmjgast-2024-001463","DOIUrl":"10.1136/bmjgast-2024-001463","url":null,"abstract":"<p><strong>Objective: </strong>Considerable disparities exist in access to gastrointestinal (GI) care and digestive outcomes across gender, racial, and socioeconomic groups. We evaluated (1) whether adults with chronic GI symptoms from diverse demographic groups would use a digital digestive care programme and (2) the effects of participation on GI symptom severity and other patient-reported outcomes.</p><p><strong>Methods: </strong>Access to a digital digestive chronic care programme was provided to participants regardless of prior digestive diagnoses or symptoms for 90 days. The intervention included GI symptom tracking, personalised medical nutrition therapy, GI-specific health coaching, and targeted education on common GI symptoms. We assigned a Social Vulnerability Index (SVI) score to each participant according to their home address and compared baseline and end-intervention symptoms and other patient-reported outcomes by gender, race/ethnicity, and SVI.</p><p><strong>Results: </strong>Of the 1936 participants, mean age was 43.1 years; 67% identified as white/Caucasian, 11% Asian/Pacific Islander, 6% Hispanic/Latinx, 7% black/African American, and 7% of multiple races. Participants of all demographic groups used the app symptom logging, reviewed educational materials, and interacted with their care team and reported similar statistically significant improvements in GI symptoms (by the end of the intervention, 85% improved, p<0.05). Participants reported feeling greater control of their health (83%), better able to manage their digestive symptoms (83%), increased happiness (76%), and greater productivity at work (54%), with black/African Americans and Native Americans most likely to report these changes.</p><p><strong>Conclusion: </strong>We conclude that a digital GI disease management programme may be of value in reducing disparities in access to GI care.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11367377/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104495","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-2024-001452
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":null,"pages":null},"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":null,"pages":null},"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":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142054960","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}