Digestion最新文献

{"title":"Weight-Loss Endoscopy Trial: A Multicenter, Randomized, Controlled Trial Comparing Weight Loss in Endoscopically Implanted Duodenal-Jejunal Bypass Liners versus Intragastric Balloons versus a Sham Procedure.","authors":"Marcus Hollenbach, Jürgen Feisthammel, Christiane Prettin, Felix Gundling, Wolfgang Schepp, Jürgen Stein, David Petroff, Albrecht Hoffmeister","doi":"10.1159/000539816","DOIUrl":"10.1159/000539816","url":null,"abstract":"<p><strong>Introduction: </strong>Obesity is associated with reduced life expectancy and various comorbidities. Surgical interventions are effective but accompanied by the risk of serious complications. Less invasive endoscopic procedures mainly comprise the intragastric balloon (IB) and the duodenal-jejunal bypass liner (DJBL). A randomized, sham-controlled study comparing both procedures has not been undertaken so far.</p><p><strong>Methods: </strong>We performed a randomized, patient- and assessor-blinded, controlled trial comparing weight loss in IB versus DJBL versus a sham procedure (2:2:1 ratio). Patients with a BMI >35 kg/m2 or >30 with obesity-related comorbidities were included. The IB was removed after 6 months and the DJBL after 12 months. The main objective was successful weight loss (>10% from baseline) 12 months after explantation of the devices. Secondary outcomes were changes in comorbidities, quality of life, and complications.</p><p><strong>Results: </strong>Thirty-three patients were randomized. Recruitment has to be stopped suddenly in after the DJBL device lost its CE mark in Europe. In all, 11 patients received DJBL, 15 IB, and 7 were allocated to the sham group. Blinding was feasible in all patients. Weight decreased from baseline until explantation (DJBL: 129.4 ± 28.3 kg to 107.4 ± 16.7 kg; IB: 118.3 ± 22.8 kg to 107.4 ± 25.7 kg; sham: 134.6 ± 18.0 kg to 131.2 ± 14.3 kg), but patients regained weight almost to the baseline level 12 months after explantation. Only 1 patient in IB group reached the primary endpoint. Severe device-related complications were very rare.</p><p><strong>Conclusion: </strong>Endoscopic bariatric procedures failed to achieve effective weight loss 12 months after explantation of the devices. The results of this trial need to be interpreted with caution due to its early termination.</p>","PeriodicalId":11315,"journal":{"name":"Digestion","volume":" ","pages":"468-479"},"PeriodicalIF":3.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633907/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141418324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association between Sense of Coherence, Disease-Specific Symptoms, and Health-Related Quality of Life among Japanese Patients with Ulcerative Colitis: A Cross-Sectional Study.","authors":"Chika Horanai, Hideki Hashimoto, Tadakazu Hisamatsu, Hiroki Ikeuchi, Kazuhiro Watanabe, Sohachi Nanjo, Riichiro Nezu, Michio Itabashi, Ryota Hokari, Daijiro Higashi, Minoru Matsuura, Takayuki Ogino, Kenichi Takahashi, Akira Andoh, Masaru Shinozaki, Akira Sugita","doi":"10.1159/000538618","DOIUrl":"10.1159/000538618","url":null,"abstract":"<p><strong>Introduction: </strong>We examined the associations among disease-related symptoms, health-related quality of life (HRQOL), and sense of coherence (SOC) in Japanese patients with ulcerative colitis (UC).</p><p><strong>Methods: </strong>This cross-sectional survey involved patients and physicians at 23 hospitals specializing in UC treatment in Japan (December 2019-December 2020). Multiple linear regression analysis was performed using scores on the Mental Health and General Health subscales of the Medical Outcomes Study 36-Item Short-Form Health Survey as outcomes and SOC as the main independent variable. Scores on the Inflammatory Bowel Disease Questionnaire (IBDQ) and Fecal Incontinence Quality of Life Scale (FIQL) were used to measure the effect of disease-related symptoms. The moderating effect of symptoms on the association between HRQOL and SOC was also tested.</p><p><strong>Results: </strong>SOC was positively and independently associated with HRQOL (Mental Health: β = 0.43, 95% confidence interval [CI] = 0.24-0.61, p &lt; 0.001; General Health: β = 0.41, 95% CI = 0.23-0.59, p &lt; 0.001). The association of SOC with Mental Health scores did not differ by symptoms, whereas its association with General Health was attenuated by symptoms (interaction term of IBDQ by SOC: β = -0.0082, 95% CI = -0.017 to 0.00064, p = 0.07; that of FIQL by SOC: β = -0.0052, 95% CI = -0.011 to 0.0010, p = 0.10).</p><p><strong>Conclusions: </strong>SOC affected mental health independently, and its protective association with general health perception was affected by symptoms. Further research is required to determine the most effective use of SOC in interventions to improve HRQOL in patients with UC.</p>","PeriodicalId":11315,"journal":{"name":"Digestion","volume":" ","pages":"257-265"},"PeriodicalIF":3.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11318494/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140335097","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Artificial Intelligence in Colorectal Cancer: From Patient Screening over Tailoring Treatment Decisions to Identification of Novel Biomarkers.","authors":"Nic Gabriel Reitsam, Johanna Sophie Enke, Kien Vu Trung, Bruno Märkl, Jakob Nikolas Kather","doi":"10.1159/000539678","DOIUrl":"10.1159/000539678","url":null,"abstract":"<p><strong>Background: </strong>Artificial intelligence (AI) is increasingly entering and transforming not only medical research but also clinical practice. In the last 10 years, new AI methods have enabled computers to perform visual tasks, reaching high performance and thereby potentially supporting and even outperforming human experts. This is in particular relevant for colorectal cancer (CRC), which is the 3rd most common cancer type in general, as along the CRC patient journey many complex visual tasks need to be performed: from endoscopy over imaging to histopathology; the screening, diagnosis, and treatment of CRC involve visual image analysis tasks.</p><p><strong>Summary: </strong>In all these clinical areas, AI models have shown promising results by supporting physicians, improving accuracy, and providing new biological insights and biomarkers. By predicting prognostic and predictive biomarkers from routine images/slides, AI models could lead to an improved patient stratification for precision oncology approaches in the near future. Moreover, it is conceivable that AI models, in particular together with innovative techniques such as single-cell or spatial profiling, could help identify novel clinically as well as biologically meaningful biomarkers that could pave the way to new therapeutic approaches.</p><p><strong>Key messages: </strong>Here, we give a comprehensive overview of AI in colorectal cancer, describing and discussing these developments as well as the next steps which need to be taken to incorporate AI methods more broadly into the clinical care of CRC.</p>","PeriodicalId":11315,"journal":{"name":"Digestion","volume":" ","pages":"331-344"},"PeriodicalIF":3.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11457979/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141310335","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Brain Neuropeptides, Neuroinflammation, and Irritable Bowel Syndrome.","authors":"Masatomo Ishioh, Tsukasa Nozu, Toshikatsu Okumura","doi":"10.1159/000533275","DOIUrl":"10.1159/000533275","url":null,"abstract":"<p><strong>Background: </strong>Irritable bowel syndrome (IBS) is a functional bowel disorder characterized by chronic abdominal symptoms, but its pathogenesis is not fully understood.</p><p><strong>Summary: </strong>We have recently shown in rats that neuropeptides such as orexin, ghrelin, and oxytocin act in the brain to improve the intestinal barrier dysfunction, which is a major pathophysiology of IBS. We have additionally shown that the neuropeptides injected intracisternally induced a visceral antinociceptive action against colonic distension. Since it has been known that intestinal barrier dysfunction causes visceral hypersensitivity, the other main pathophysiology of IBS, the neuropeptides act centrally to reduce leaky gut, followed by improvement of visceral sensation, leading to therapeutic action on IBS. It has been recently reported that there is a bidirectional relationship between neuroinflammation in the brain and the pathophysiology of IBS. For example, activation of microglia in the brain causes visceral hypersensitivity. Accumulating evidence has suggested that orexin, ghrelin, or oxytocin could improve neuroinflammation in the CNS. All these results suggest that neuropeptides such as orexin, ghrelin, and oxytocin act in the brain to improve intestinal barrier function and visceral sensation and also induce a protective action against neuroinflammation in the brain.</p><p><strong>Key messages: </strong>We therefore speculated that orexin, ghrelin, or oxytocin in the brain possess dual actions, improvement of visceral sensation/leaky gut in the gut, and reduction of neuroinflammation in the brain, thereby inducing a therapeutic effect on IBS in a convergent manner.</p>","PeriodicalId":11315,"journal":{"name":"Digestion","volume":" ","pages":"34-39"},"PeriodicalIF":3.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10523500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Belching Disorders and Rumination Syndrome: A Literature Review.","authors":"Akinari Sawada, Yasuhiro Fujiwara","doi":"10.1159/000534092","DOIUrl":"10.1159/000534092","url":null,"abstract":"<p><strong>Background: </strong>Belching disorders and rumination syndrome (RS) are disorders of gut-brain interaction (DGBIs) in Rome IV. Belching disorders are composed of excessive gastric belching (GB) and supragastric belching (SGB). Excessive GB is related to physiological phenomenon whereas excessive SGB and RS are behavioral disorders.</p><p><strong>Summary: </strong>A recent large internet survey found that prevalence of belching disorders and RS were 1% and 2.8%, respectively. It has been recognized that not a few patients with two behavioral disorders, excessive SGB and RS, could be misdiagnosed as proton pump inhibitors (PPI)-refractory gastroesophageal reflux disease (GERD). In patients with reflux symptoms, distinguishing these conditions is essential because they need psychological treatment (i.e., cognitive behavioral therapy (CBT) rather than acid suppressants. Clinicians should take a medical history meticulously first to identify possible excessive SGB and/or RS. High-resolution impedance manometry and/or 24-h impedance-pH monitoring can offer an objective diagnosis of the disorders. Several therapeutic options are available for excessive SGB and RS. The first-line therapy should be CBT using diaphragmatic breathing that can stop the behaviors involving complex muscle contraction (e.g., abdominal straining) to generate SGB or rumination. Overlap with eating disorders and/or other DGBIs such as functional dyspepsia can make management of the behavioral disorders challenging since such coexisting conditions often require additional treatments.</p><p><strong>Key messages: </strong>Excessive SGB and RS are not unusual conditions. It is important to raise awareness of the behavioral disorders for appropriate management.</p>","PeriodicalId":11315,"journal":{"name":"Digestion","volume":" ","pages":"18-25"},"PeriodicalIF":3.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41233276","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and Safety of Cold Snare Polypectomy versus Cold Endoscopic Mucosal Resection for Resecting 3-10 mm Colorectal Polyps: Systematic Review and Meta-Analysis of Randomized Controlled Trials.","authors":"Shao-Tong Wang, Qing-Zhou Kong, Yan-Qing Li, Rui Ji","doi":"10.1159/000535521","DOIUrl":"10.1159/000535521","url":null,"abstract":"<p><strong>Introduction: </strong>The safety and efficacy of cold snare polypectomy (CSP) compared to those of cold endoscopic mucosal resection (CEMR) have been reported. This meta-analysis compared the efficacy and safety of CEMR and CSP.</p><p><strong>Methods: </strong>PubMed, Embase, Web of Science, and Cochrane Library databases were systematically searched to identify randomized controlled trials comparing the efficacy and safety of CEMR and CSP in removing 3-10 mm polyps. The outcomes assessed included complete resection rate, intraoperative bleeding rate, delayed bleeding rate, perforation, and polyp removal time. The results are reported as risk ratios (RR) and 95% confidence intervals (CIs) derived from a Mantel-Haenszel random-effects model.</p><p><strong>Results: </strong>Seven studies comprising 1,911 polyps were included in the analysis. The complete resection rate of CEMR was comparable to that of CSP (RR: 1.01, 95% CI: 0.99-1.04, p = 0.32). Comparable results were also demonstrated for intraoperative bleeding rate (polyp-based analysis: RR: 1.22, 95% CI: 0.33-4.43, p = 0.77), delayed bleeding rate (polyp-based analysis: RR: 1.34, 95% CI: 0.44-4.15, p = 0.61), and polyp removal time (mean difference: 28.31 s, 95% CI: -21.40-78.02, p = 0.26). No studies reported cases of perforation.</p><p><strong>Conclusion: </strong>CEMR has comparable efficacy and safety to CSP in removing 3-10 mm polyps. Further randomized controlled trials with long-term follow-up are warranted to compare and validate efficacy.</p>","PeriodicalId":11315,"journal":{"name":"Digestion","volume":" ","pages":"157-165"},"PeriodicalIF":3.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139416662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gut Frailty: Its Concept and Pathogenesis.","authors":"Yuji Naito","doi":"10.1159/000534733","DOIUrl":"10.1159/000534733","url":null,"abstract":"<p><strong>Background: </strong>There is still a considerable gap between average life expectancy and healthy life expectancy in Japan. Recent research has revealed that gut frailty may be a worsening factor for various diseases, a cause of chronic inflammation, and a precursor to frailty.</p><p><strong>Summary: </strong>Among self-reported symptoms, constipation is particularly significant as one of the key symptoms of gut frailty. Studies have demonstrated that individuals with constipation have significantly lower survival rates and are also at a higher risk of developing various diseases such as chronic kidney disease, cardiovascular diseases, and neurodegenerative disorders like Parkinson's disease. Various molecular mechanisms could contribute to gut frailty, and the decrease in mucus secretion is an extremely early-stage pathology. Dysbiosis of gut microbiota has a major impact on many conditions associated with gut frailty. Prebiotics, probiotics, post-biotics, and fecal microbiota transplantation are under investigation as a treatment option for gut frailty.</p><p><strong>Key message: </strong>Although the concept of gut frailty has not yet gained widespread recognition, we hope to propose more practical screening methods, diagnostic approaches, and specific interventions in the future.</p>","PeriodicalId":11315,"journal":{"name":"Digestion","volume":" ","pages":"49-57"},"PeriodicalIF":3.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10777716/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134648647","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evidence-Based Clinical Guidelines for Chronic Diarrhea 2023.","authors":"Eikichi Ihara, Noriaki Manabe, Hidenori Ohkubo, Naotaka Ogasawara, Haruei Ogino, Kazuki Kakimoto, Motoyori Kanazawa, Hidejiro Kawahara, Chika Kusano, Shiko Kuribayashi, Akinari Sawada, Tomohisa Takagi, Shota Takano, Toshihiko Tomita, Toshihiro Noake, Mariko Hojo, Ryota Hokari, Tatsuhiro Masaoka, Tomohiko Machida, Noboru Misawa, Yoshiyuki Mishima, Hiroshi Yajima, Sayuri Yamamoto, Hiroshi Yamawaki, Tatsuya Abe, Yasumi Araki, Kunio Kasugai, Takeshi Kamiya, Akira Torii, Atsushi Nakajima, Koji Nakada, Shin Fukudo, Yasuhiro Fujiwara, Hiroto Miwa, Hiromi Kataoka, Akihito Nagahara, Kazuhide Higuchi","doi":"10.1159/000541121","DOIUrl":"10.1159/000541121","url":null,"abstract":"<p><p>The Japan Gastroenterological Association (JGA) published the first version of clinical guidelines for chronic diarrhea 2023. These guidelines describe the definition, classification, diagnostic criteria, diagnostic testing methods, epidemiology, pathophysiology, and treatment of chronic diarrhea, and provide flowcharts for the diagnosis and treatment of chronic diarrhea based on the latest evidence. Treatment for chronic diarrhea begins by distinguishing secondary chronic constipation with a clear etiology, such as drug-induced diarrhea, food-induced diarrhea, systemic disease-associated diarrhea, infection-associated diarrhea, organic disease-associated diarrhea, and bile acid diarrhea. The first line of treatment for chronic diarrhea in the narrow sense, defined in these guidelines as functional diarrhea in routine medical care, is lifestyle modification and dietary therapy. The first medicines to be considered for oral treatment are probiotics for regulating the gut microbiome and anti-diarrheals. Other medications, such as 5HT3 receptor antagonists, anticholinergics, Kampo medicine, psychotherapy, antibiotics, bulking agents, adrenergic agonists, and somatostatin analogs, lack sufficient evidence for their use, highlighting a challenge for future research. This Clinical Guidelines for Chronic Diarrhea 2023, which provides the best clinical strategies for treating chronic diarrhea in Japan, will also be useful for medical treatment worldwide.</p>","PeriodicalId":11315,"journal":{"name":"Digestion","volume":" ","pages":"480-497"},"PeriodicalIF":3.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633876/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142092482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Endoscopic Artificial Intelligence for Image Analysis in Gastrointestinal Neoplasms.","authors":"Ryosuke Kikuchi, Kazuaki Okamoto, Tsuyoshi Ozawa, Junichi Shibata, Soichiro Ishihara, Tomohiro Tada","doi":"10.1159/000540251","DOIUrl":"10.1159/000540251","url":null,"abstract":"<p><strong>Background: </strong>Artificial intelligence (AI) using deep learning systems has recently been utilized in various medical fields. In the field of gastroenterology, AI is primarily implemented in image recognition and utilized in the realm of gastrointestinal (GI) endoscopy. In GI endoscopy, computer-aided detection/diagnosis (CAD) systems assist endoscopists in GI neoplasm detection or differentiation of cancerous or noncancerous lesions. Several AI systems for colorectal polyps have already been applied in colonoscopy clinical practices. In esophagogastroduodenoscopy, a few CAD systems for upper GI neoplasms have been launched in Asian countries. The usefulness of these CAD systems in GI endoscopy has been gradually elucidated.</p><p><strong>Summary: </strong>In this review, we outline recent articles on several studies of endoscopic AI systems for GI neoplasms, focusing on esophageal squamous cell carcinoma (ESCC), esophageal adenocarcinoma (EAC), gastric cancer (GC), and colorectal polyps. In ESCC and EAC, computer-aided detection (CADe) systems were mainly developed, and a recent meta-analysis study showed sensitivities of 91.2% and 93.1% and specificities of 80% and 86.9%, respectively. In GC, a recent meta-analysis study on CADe systems demonstrated that their sensitivity and specificity were as high as 90%. A randomized controlled trial (RCT) also showed that the use of the CADe system reduced the miss rate. Regarding computer-aided diagnosis (CADx) systems for GC, although RCTs have not yet been conducted, most studies have demonstrated expert-level performance. In colorectal polyps, multiple RCTs have shown the usefulness of the CADe system for improving the polyp detection rate, and several CADx systems have been shown to have high accuracy in colorectal polyp differentiation.</p><p><strong>Key messages: </strong>Most analyses of endoscopic AI systems suggested that their performance was better than that of nonexpert endoscopists and equivalent to that of expert endoscopists. Thus, endoscopic AI systems may be useful for reducing the risk of overlooking lesions and improving the diagnostic ability of endoscopists.</p>","PeriodicalId":11315,"journal":{"name":"Digestion","volume":" ","pages":"419-435"},"PeriodicalIF":3.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141787551","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and Validation of a Simple and Multifaceted Instrument, Chronic Constipation-Therapeutic Efficacy and Satisfaction Test, for the Clinical Evaluation of Patients with Chronic Constipation.","authors":"Koji Nakada, Akihito Nagahara, Kimio Isshi, Tadayuki Oshima, Seiji Futagami, Yoshimasa Tanaka, Yoshiharu Yamaguchi, Shiko Kuribayashi, Seiji Arihiro, Atsushi Oshio, Noriaki Manabe","doi":"10.1159/000539788","DOIUrl":"10.1159/000539788","url":null,"abstract":"<p><strong>Introduction: </strong>This study evaluated the psychometric properties of the newly developed chronic constipation-therapeutic efficacy and satisfaction test (CC-TEST) among patients with chronic constipation.</p><p><strong>Methods: </strong>Japanese patients with moderate or severe chronic constipation underwent a 4-week remedy. The baseline, 2-week, and 4-week assessments included the CC-TEST, Constipation Scoring System (CSS), Medical Outcome Study Short Form-8 Health Survey (SF-8), and Hospital Anxiety and Depression Scale (HADS). The CC-TEST comprises three domains: (1) symptoms; chronic constipation symptom severity (seven items), defecation status (five items), (2) impact for daily life; dissatisfaction with daily life level (DS; four items), and (3) therapeutic response; therapeutic efficacy measured by patients and medication compliance (four items).</p><p><strong>Results: </strong>Of 201 eligible patients at baseline, 110 completed the 4-week treatment and the survey responses. Cronbach's α values for the stool, defecation, and abdominal symptom subscales, as well as the total symptom score and DS subscale, showed good internal consistency reliability (0.72-0.80). Pearson's r for comparisons between corresponding items (CC-TEST symptoms with CSS, and CC-TEST DS with SF-8 physical and mental component summary scores) was significant. After 4 weeks, scores for symptoms, defecation status, and DS items/subscales notably decreased, with a significant effect size (p &lt; 0.005, Cohen's d; 0.30-1.16). Statistically significant differences emerged between treatment responders and nonresponders using the three responder definitions, in changes in scores for most CC-TEST symptoms, defecation status, and DS items/subscales (p &lt; 0.05).</p><p><strong>Conclusion: </strong>CC-TEST demonstrates commendable reliability, convergent and known-group validity, and responsiveness to treatment effects. As a simple, comprehensive, and versatile patient-reported outcome measure, CC-TEST may be well suited for clinical trials and primary care of Japanese patients with chronic constipation.</p>","PeriodicalId":11315,"journal":{"name":"Digestion","volume":" ","pages":"359-372"},"PeriodicalIF":3.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141317154","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}