Pub Date : 2026-04-01Epub Date: 2026-02-28DOI: 10.1016/j.conctc.2026.101623
Pierre Mermet-Bouvier , Pierre-Frederic Omnes , Valdo Arnera , Scottie Kern
The European Union's Clinical Trial Regulation 536/2014 (EU-CTR) sought to harmonize clinical trial rules, ensure high standards of safety, and streamline processes through its new Clinical Trials Information System (CTIS). However, confusion remains regarding submission requirements for “patient-facing documents” in Parts I and II of clinical trial applications (CTAs). Misinterpretations—particularly around what qualifies as written information—have led to unnecessary submissions of materials like eCOA or ePRO “screenshots,” which are not legally required.
The EU's EUDRALEX Volume 10 Q&A (notably Question 1.24) clarified that only patient-facing documents linked to trial endpoints, such as questionnaires, diaries, or patient cards, need inclusion in Part I alongside the protocol. There is no legal basis to demand all patient materials or their translations in Part II. Despite this clarification, member states retain autonomy under Article 26 to set national translation and document requirements, leading to inconsistent practices and continued administrative burden.
Recent initiatives, including CTR Collaborate (under the Accelerating Clinical Trials in the EU program) and MedEthics EU, seek to promote harmonization and efficient assessment. Empirical studies show that Ethics Committees (ECs) generally do not expect ePRO screenshots—most require only translated questionnaires.
EU-CTR's success depends on collective awareness and streamlined processes. With ICH E6 Revision 3 and global efforts by organizations like the WHO, there is an opportunity to balance regulatory rigor with practical efficiency—reducing redundant submissions and emphasizing participant protection as the core ethical priority.
{"title":"Electronic clinical outcome assessments and the European Union's clinical trial regulation: Smoothing the path to friction?","authors":"Pierre Mermet-Bouvier , Pierre-Frederic Omnes , Valdo Arnera , Scottie Kern","doi":"10.1016/j.conctc.2026.101623","DOIUrl":"10.1016/j.conctc.2026.101623","url":null,"abstract":"<div><div>The European Union's Clinical Trial Regulation 536/2014 (EU-CTR) sought to harmonize clinical trial rules, ensure high standards of safety, and streamline processes through its new Clinical Trials Information System (CTIS). However, confusion remains regarding submission requirements for “patient-facing documents” in Parts I and II of clinical trial applications (CTAs). Misinterpretations—particularly around what qualifies as written information—have led to unnecessary submissions of materials like eCOA or ePRO “screenshots,” which are not legally required.</div><div>The EU's EUDRALEX Volume 10 Q&A (notably Question 1.24) clarified that only patient-facing documents linked to trial endpoints, such as questionnaires, diaries, or patient cards, need inclusion in Part I alongside the protocol. There is no legal basis to demand all patient materials or their translations in Part II. Despite this clarification, member states retain autonomy under Article 26 to set national translation and document requirements, leading to inconsistent practices and continued administrative burden.</div><div>Recent initiatives, including CTR Collaborate (under the Accelerating Clinical Trials in the EU program) and MedEthics EU, seek to promote harmonization and efficient assessment. Empirical studies show that Ethics Committees (ECs) generally do not expect ePRO screenshots—most require only translated questionnaires.</div><div>EU-CTR's success depends on collective awareness and streamlined processes. With ICH E6 Revision 3 and global efforts by organizations like the WHO, there is an opportunity to balance regulatory rigor with practical efficiency—reducing redundant submissions and emphasizing participant protection as the core ethical priority.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101623"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147386261","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 : 2026-04-01Epub Date: 2026-02-21DOI: 10.1016/j.conctc.2026.101620
Garima Bhatt , Kousar Ishaq , Aatik Arsh , Omara Dogar , Justin Fenty , Cath Jackson , Muqaddas Asif , Jothisha C , Shannon Halmkan , Fahmida Islam , Krishna Prasad Muliyala , Venkata Lakshmi Narasimha , Steve Parrott , Rebecca R , Fahmidur Rahman , Faraz Siddiqui , Heather Thomson , Han-I Wang , Rumana Huque , Imran B. Chaudhry , Pratima Murthy
Background
Tobacco is consumed by two-thirds of individuals with severe mental illness (SMI). Despite a high tobacco-related disease burden, there is a lack of evidence-based cessation interventions for individuals with SMI living in low- and middle-income countries. This study aims to evaluate the feasibility and acceptability of a culturally adapted behavioural intervention for tobacco cessation (SCIMITAR-SA) delivered in mental health services in Bangladesh, India, and Pakistan.
Methods
A two-arm, parallel-group, individually randomised, multi-country feasibility trial will be conducted across six mental health facilities in urban centres. All trial participants will receive Very Brief Advice (VBA) and an educational leaflet from their clinical team. Additionally, those in the intervention arm will receive up to seven structured behavioural support sessions. Salivary cotinine and anabasine will be used to biochemically verify abstinence at seven months post-randomisation. Quantitative outcomes will assess feasibility of conducting a definitive trial, including recruitment and retention rates, session attendance, completeness of baseline assessments and outcome measures at four and seven months and use of health resources. An embedded process evaluation will explore the feasibility and acceptability of trial processes, and of the delivery and receipt of the VBA and SCIMITAR-SA interventions. Economic outcomes will assess the feasibility of collecting cost and resource-use data to inform a future definitive trial.
Discussion
The SCIMITAR-SA trial will provide essential evidence on the feasibility of delivering culturally adapted cessation support for people with SMI in South Asia and inform scalable integration into routine psychiatric care across low- and middle-income settings.
{"title":"Tobacco cessation intervention for individuals with severe mental illness in Bangladesh, India, and Pakistan: protocol for a multi-country feasibility randomised controlled trial (SCIMITAR-SA)","authors":"Garima Bhatt , Kousar Ishaq , Aatik Arsh , Omara Dogar , Justin Fenty , Cath Jackson , Muqaddas Asif , Jothisha C , Shannon Halmkan , Fahmida Islam , Krishna Prasad Muliyala , Venkata Lakshmi Narasimha , Steve Parrott , Rebecca R , Fahmidur Rahman , Faraz Siddiqui , Heather Thomson , Han-I Wang , Rumana Huque , Imran B. Chaudhry , Pratima Murthy","doi":"10.1016/j.conctc.2026.101620","DOIUrl":"10.1016/j.conctc.2026.101620","url":null,"abstract":"<div><h3>Background</h3><div>Tobacco is consumed by two-thirds of individuals with severe mental illness (SMI). Despite a high tobacco-related disease burden, there is a lack of evidence-based cessation interventions for individuals with SMI living in low- and middle-income countries. This study aims to evaluate the feasibility and acceptability of a culturally adapted behavioural intervention for tobacco cessation (SCIMITAR-SA) delivered in mental health services in Bangladesh, India, and Pakistan.</div></div><div><h3>Methods</h3><div>A two-arm, parallel-group, individually randomised, multi-country feasibility trial will be conducted across six mental health facilities in urban centres. All trial participants will receive Very Brief Advice (VBA) and an educational leaflet from their clinical team. Additionally, those in the intervention arm will receive up to seven structured behavioural support sessions. Salivary cotinine and anabasine will be used to biochemically verify abstinence at seven months post-randomisation. Quantitative outcomes will assess feasibility of conducting a definitive trial, including recruitment and retention rates, session attendance, completeness of baseline assessments and outcome measures at four and seven months and use of health resources. An embedded process evaluation will explore the feasibility and acceptability of trial processes, and of the delivery and receipt of the VBA and SCIMITAR-SA interventions. Economic outcomes will assess the feasibility of collecting cost and resource-use data to inform a future definitive trial.</div></div><div><h3>Discussion</h3><div>The SCIMITAR-SA trial will provide essential evidence on the feasibility of delivering culturally adapted cessation support for people with SMI in South Asia and inform scalable integration into routine psychiatric care across low- and middle-income settings.</div></div><div><h3>Registration</h3><div>ISRCTN registry (ISRCTN91038721)</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101620"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147386240","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}
Shikuwasa (Citrus depressa Hayata) essential oil, rich in limonene and γ-terpinene, produces calming effects, but its psychological and physiological relaxation effects in humans remain unclear. This study examined the short-term relaxation effects of inhaling Shikuwasa essential oil compared to odor-free air among young adult females.
Methods
In this two-arm, parallel-group, open-label, randomized controlled superiority trial, healthy females aged 18–39 were randomly assigned to either the Shikuwasa essential oil group (n = 20) or the odor-free air group (n = 20). The primary outcome was subjective tense-arousal, measured using the Japanese version of the University of Wales Institute of Science and Technology Mood Adjective Checklist (JUMACL). Secondary outcomes included miosis rate, peripheral skin temperature, and cerebral blood flow. Due to measurement constraints, the experiment was divided into three 2-min inhalation phases.
Results
No significant between-group differences were observed in tense-arousal, miosis rate, or cerebral blood flow. Additional analyses of covariance, performed for each outcome variable using the Visual Analog Scale score and its interaction with the group as covariates, revealed a trend toward an interaction effect for the JUMACL tense-arousal subscale score, although the overall effects were not statistically significant.
Conclusions
Short-term inhalation of Shikuwasa essential oil did not significantly reduce tense-arousal or affect physiological indices in healthy, normal-to-low stress young adult females. However, aroma preference may influence psychological and neural responses. Future studies should consider pre-assessed aroma preference, longer inhalation durations, single-phase protocols, extended rest periods, and participants’ baseline mood.
Trial registration
This study was prospectively registered with the UMIN-CTR, UMIN000053914.
{"title":"Relaxation effects of Shikuwasa (Citrus depressa Hayata) essential oil inhalation: A randomized controlled trial in young adult females","authors":"Fumitake Yamaguchi , Miho Kuroki , Naoki Yoshinaga , Michikazu Nakai , Yasuji Arimura","doi":"10.1016/j.conctc.2026.101613","DOIUrl":"10.1016/j.conctc.2026.101613","url":null,"abstract":"<div><h3>Background</h3><div>Shikuwasa (<em>Citrus depressa</em> Hayata) essential oil, rich in limonene and γ-terpinene, produces calming effects, but its psychological and physiological relaxation effects in humans remain unclear. This study examined the short-term relaxation effects of inhaling Shikuwasa essential oil compared to odor-free air among young adult females.</div></div><div><h3>Methods</h3><div>In this two-arm, parallel-group, open-label, randomized controlled superiority trial, healthy females aged 18–39 were randomly assigned to either the Shikuwasa essential oil group (n = 20) or the odor-free air group (n = 20). The primary outcome was subjective tense-arousal, measured using the Japanese version of the University of Wales Institute of Science and Technology Mood Adjective Checklist (JUMACL). Secondary outcomes included miosis rate, peripheral skin temperature, and cerebral blood flow. Due to measurement constraints, the experiment was divided into three 2-min inhalation phases.</div></div><div><h3>Results</h3><div>No significant between-group differences were observed in tense-arousal, miosis rate, or cerebral blood flow. Additional analyses of covariance, performed for each outcome variable using the Visual Analog Scale score and its interaction with the group as covariates, revealed a trend toward an interaction effect for the JUMACL tense-arousal subscale score, although the overall effects were not statistically significant.</div></div><div><h3>Conclusions</h3><div>Short-term inhalation of Shikuwasa essential oil did not significantly reduce tense-arousal or affect physiological indices in healthy, normal-to-low stress young adult females. However, aroma preference may influence psychological and neural responses. Future studies should consider pre-assessed aroma preference, longer inhalation durations, single-phase protocols, extended rest periods, and participants’ baseline mood.</div></div><div><h3><strong>Trial registration</strong></h3><div>This study was prospectively registered with the UMIN-CTR, UMIN000053914.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101613"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146154175","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 : 2026-04-01Epub Date: 2026-02-26DOI: 10.1016/j.conctc.2025.101546
Emily Jansen , Divya A. Shankar , Tabitha Cherilus , Emily Foster , Lisa Ben-Horin , Nicholas Cordella , Nicholas A. Bosch , Kirsten Austad
Background
Fecal immunochemical testing (FIT) – a non-invasive colorectal cancer (CRC) screening method offers an opportunity to bridge CRC screening gaps in underserved settings. The effectiveness of FIT as a screening tool, however, is limited by low return rates of stool samples. Patient navigation has been demonstrated to successfully improve FIT return rates in randomized trial settings, however, in real-world settings, navigation may not achieve the same impact due to resource constraints. Text-based reminders offer a low-cost alternative to patient navigation to facilitate FIT test returns. In the NAVIGATE-FIT project, we seek to use rapid randomized testing to compare a text-based intervention to patient navigation in a quality improvement effort assessing if a text-based reminder program is non-inferior to patient navigation to improve FIT return rates in a safety-net hospital system.
Methods
We will randomize primary care patients (English- or Spanish-speaking) due for CRC screening at Boston Medical Center (BMC) with an unreturned FIT test (ordered 30-37 days prior) to either a text messaging system (Artera) or patient navigation. Artera is an artificial intelligence enabled system which has been programmed with conversation text flows to facilitate FIT test returns. The patient navigation arm will prioritize patients with overdue FIT tests for a navigation phone call the week of randomization. Outcomes will be assessed in accordance with the Reach, Effectiveness, Adoption, Implementation, and Maintenance (REAIM) framework, and the project has been powered based on the effectiveness outcome of percentage of patients with a completed FIT test within 30 days of randomization. We have selected a non-inferiority margin of 13% on the risk difference scale and anticipate 80% power with inclusion of 196 patients in each arm. Primary analysis will be intention-to-treat. The primary project goal is to generate local knowledge to select a strategy to improve screening at BMC.
Conclusions
The NAVIGATE-FIT project is well-positioned to test the hypothesis that a conversational text-based reminder and follow-up system is non-inferior to the current usual care patient navigation system at BMC, a large, academic, urban, safety-net hospital, for improving return rates of FIT screening tests. This protocol can serve as a model to other health systems seeking to undertake randomized quality improvement projects.
{"title":"Protocol for a pragmatic trial comparing navigator and automated virtual interventions for guaranteeing adherence to fecal immunochemical testing (NAVIGATE-FIT)","authors":"Emily Jansen , Divya A. Shankar , Tabitha Cherilus , Emily Foster , Lisa Ben-Horin , Nicholas Cordella , Nicholas A. Bosch , Kirsten Austad","doi":"10.1016/j.conctc.2025.101546","DOIUrl":"10.1016/j.conctc.2025.101546","url":null,"abstract":"<div><h3>Background</h3><div>Fecal immunochemical testing (FIT) – a non-invasive colorectal cancer (CRC) screening method offers an opportunity to bridge CRC screening gaps in underserved settings. The effectiveness of FIT as a screening tool, however, is limited by low return rates of stool samples. Patient navigation has been demonstrated to successfully improve FIT return rates in randomized trial settings, however, in real-world settings, navigation may not achieve the same impact due to resource constraints. Text-based reminders offer a low-cost alternative to patient navigation to facilitate FIT test returns. In the NAVIGATE-FIT project, we seek to use rapid randomized testing to compare a text-based intervention to patient navigation in a quality improvement effort assessing if a text-based reminder program is non-inferior to patient navigation to improve FIT return rates in a safety-net hospital system.</div></div><div><h3>Methods</h3><div>We will randomize primary care patients (English- or Spanish-speaking) due for CRC screening at Boston Medical Center (BMC) with an unreturned FIT test (ordered 30-37 days prior) to either a text messaging system (Artera) or patient navigation. Artera is an artificial intelligence enabled system which has been programmed with conversation text flows to facilitate FIT test returns. The patient navigation arm will prioritize patients with overdue FIT tests for a navigation phone call the week of randomization. Outcomes will be assessed in accordance with the Reach, Effectiveness, Adoption, Implementation, and Maintenance (REAIM) framework, and the project has been powered based on the effectiveness outcome of percentage of patients with a completed FIT test within 30 days of randomization. We have selected a non-inferiority margin of 13% on the risk difference scale and anticipate 80% power with inclusion of 196 patients in each arm. Primary analysis will be intention-to-treat. The primary project goal is to generate local knowledge to select a strategy to improve screening at BMC.</div></div><div><h3>Conclusions</h3><div>The NAVIGATE-FIT project is well-positioned to test the hypothesis that a conversational text-based reminder and follow-up system is non-inferior to the current usual care patient navigation system at BMC, a large, academic, urban, safety-net hospital, for improving return rates of FIT screening tests. This protocol can serve as a model to other health systems seeking to undertake randomized quality improvement projects.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101546"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147378912","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 : 2026-04-01Epub Date: 2026-02-18DOI: 10.1016/j.conctc.2026.101612
Quan-yao Li , Xi Li , Hui Liu , Ying Lu , Zhao-wei Guo , Wen-chao Qiu , Pin-kang Wei , Jun Shi
Background
Gastric cancer (GC) is a highly prevalent malignancy worldwide. Approximately 20%–43% of patients present with peritoneal metastasis (PM) at initial diagnosis, resulting in a 5-year survival rate of less than 20%. Peritoneal metastasis frequently induces severe complications including malignant ascites and intestinal obstruction, significantly compromising patients' quality of life. Traditional Chinese Medicine (TCM) has demonstrated unique advantages in GC treatment. Xiaotan Sanjie (XTSJ) decoction, an empirical prescription based on the "phlegm syndrome" theory, has been shown in previous studies to inhibit GC proliferation and metastasis, modulate immune function, and enhance therapeutic efficacy while reducing toxicity. However, no scientific evidence currently supports the clinical efficacy of XTSJ decoction specifically in treating GC with peritoneal metastasis (GCPM). Therefore, this study aims to evaluate the efficacy and safety of XTSJ decoction in managing GCPM.
Methods/Design
The study protocol has been approved by the ethics committee and registered with the International Traditional Medicine Clinical Trial Registry. This prospective randomized controlled clinical trial will enroll 150 GCPM patients who will be randomly assigned in a 1:1 ratio to either the TCM treatment group or the conventional treatment group. Each group will undergo two treatment cycles totaling 6 weeks. The primary outcome measure is the clinical objective response rate (ORR). Secondary outcome measures include progression-free survival (PFS), overall survival (OS), tumor markers, peripheral blood immune indices, high-sensitivity modified Glasgow Prognostic Score (HS-mGPS), Karnofsky Performance Status (KPS) score, and Eastern Cooperative Oncology Group (ECOG) performance status score.
Discussion
This study investigates the synergistic mechanisms of integrated traditional Chinese and Western medicine in treating advanced GC, aiming to provide scientific evidence for the clinical application and further optimization of treatment strategies for GCPM.
Conclusion
This study will evaluate the efficacy and safety of XTSJ decoction combined with trastuzumab and chemotherapy in patients with GCPM through a randomized controlled trial, providing evidence-based basis for the integrated treatment of traditional Chinese and Western medicine.
{"title":"Clinical efficacy of Xiaotan Sanjie decoction in treating gastric cancer with peritoneal metastases: A study protocol for a randomized controlled trial","authors":"Quan-yao Li , Xi Li , Hui Liu , Ying Lu , Zhao-wei Guo , Wen-chao Qiu , Pin-kang Wei , Jun Shi","doi":"10.1016/j.conctc.2026.101612","DOIUrl":"10.1016/j.conctc.2026.101612","url":null,"abstract":"<div><h3>Background</h3><div>Gastric cancer (GC) is a highly prevalent malignancy worldwide. Approximately 20%–43% of patients present with peritoneal metastasis (PM) at initial diagnosis, resulting in a 5-year survival rate of less than 20%. Peritoneal metastasis frequently induces severe complications including malignant ascites and intestinal obstruction, significantly compromising patients' quality of life. Traditional Chinese Medicine (TCM) has demonstrated unique advantages in GC treatment. Xiaotan Sanjie (XTSJ) decoction, an empirical prescription based on the \"phlegm syndrome\" theory, has been shown in previous studies to inhibit GC proliferation and metastasis, modulate immune function, and enhance therapeutic efficacy while reducing toxicity. However, no scientific evidence currently supports the clinical efficacy of XTSJ decoction specifically in treating GC with peritoneal metastasis (GCPM). Therefore, this study aims to evaluate the efficacy and safety of XTSJ decoction in managing GCPM.</div></div><div><h3>Methods/Design</h3><div>The study protocol has been approved by the ethics committee and registered with the International Traditional Medicine Clinical Trial Registry. This prospective randomized controlled clinical trial will enroll 150 GCPM patients who will be randomly assigned in a 1:1 ratio to either the TCM treatment group or the conventional treatment group. Each group will undergo two treatment cycles totaling 6 weeks. The primary outcome measure is the clinical objective response rate (ORR). Secondary outcome measures include progression-free survival (PFS), overall survival (OS), tumor markers, peripheral blood immune indices, high-sensitivity modified Glasgow Prognostic Score (HS-mGPS), Karnofsky Performance Status (KPS) score, and Eastern Cooperative Oncology Group (ECOG) performance status score.</div></div><div><h3>Discussion</h3><div>This study investigates the synergistic mechanisms of integrated traditional Chinese and Western medicine in treating advanced GC, aiming to provide scientific evidence for the clinical application and further optimization of treatment strategies for GCPM.</div></div><div><h3>Conclusion</h3><div>This study will evaluate the efficacy and safety of XTSJ decoction combined with trastuzumab and chemotherapy in patients with GCPM through a randomized controlled trial, providing evidence-based basis for the integrated treatment of traditional Chinese and Western medicine.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101612"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147311013","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 : 2026-04-01Epub Date: 2026-02-14DOI: 10.1016/j.conctc.2026.101617
Ayse Uneri , Jason T. Fanning , John R. Beck , Edward H. Ip , Paul J. Laurienti , Jessie Laurita-Spanglet , Robert G. Lyday , Barbara J. Nicklas , Bonnie C. Sachs , Christina T. Soriano , Christina E. Hugenschmidt
Background
Accumulating evidence supports the importance of physical activity for maintaining or improving cognitive and cardiovascular health. Dance movement has been emerging as a form of physical activity that may protect and enhance physical and cognitive function in older adults. Research suggests that dance benefits cognitive health, cardiorespiratory fitness, mobility, and psychosocial function in older adults. However, the amount of dance movement needed to see these benefits cannot be ascertained from the highly heterogenous dance literature. This study aims to characterize the weekly frequency of dance movement needed to benefit cognitive and cardiorespiratory health over 6 months.
Methods
IGROOVE is a single-center, randomized, single-blind clinical trial that randomly assigns adults with subjective cognitive decline aged 62 years or older to one of 4 study conditions. Three of the conditions are 60-min dance classes attended once, twice, or three times a week, and the fourth condition is a control music appreciation class that meets once a week for 60 min, for 24 weeks. The primary aim of the study is to determine the optimal frequency of dance movement to achieve improvement in cognition and cardiorespiratory fitness.
Discussion
IGROOVE aims to fill a gap in the knowledge about the minimum number of weekly dance classes needed to see benefits in cognition and cardiorespiratory fitness by systematically exploring how the frequency of dance movement can affect cognitive function and cardiorespiratory fitness. This information will inform future definitive studies of dance and public health recommendations for dance as physical activity to promote healthy aging.
{"title":"IGROOVE: Protocol for a randomized, controlled, single-blind trial of dance intervention in older adults with subjective cognitive decline","authors":"Ayse Uneri , Jason T. Fanning , John R. Beck , Edward H. Ip , Paul J. Laurienti , Jessie Laurita-Spanglet , Robert G. Lyday , Barbara J. Nicklas , Bonnie C. Sachs , Christina T. Soriano , Christina E. Hugenschmidt","doi":"10.1016/j.conctc.2026.101617","DOIUrl":"10.1016/j.conctc.2026.101617","url":null,"abstract":"<div><h3>Background</h3><div>Accumulating evidence supports the importance of physical activity for maintaining or improving cognitive and cardiovascular health. Dance movement has been emerging as a form of physical activity that may protect and enhance physical and cognitive function in older adults. Research suggests that dance benefits cognitive health, cardiorespiratory fitness, mobility, and psychosocial function in older adults. However, the amount of dance movement needed to see these benefits cannot be ascertained from the highly heterogenous dance literature. This study aims to characterize the weekly frequency of dance movement needed to benefit cognitive and cardiorespiratory health over 6 months.</div></div><div><h3>Methods</h3><div>IGROOVE is a single-center, randomized, single-blind clinical trial that randomly assigns adults with subjective cognitive decline aged 62 years or older to one of 4 study conditions. Three of the conditions are 60-min dance classes attended once, twice, or three times a week, and the fourth condition is a control music appreciation class that meets once a week for 60 min, for 24 weeks. The primary aim of the study is to determine the optimal frequency of dance movement to achieve improvement in cognition and cardiorespiratory fitness.</div></div><div><h3>Discussion</h3><div>IGROOVE aims to fill a gap in the knowledge about the minimum number of weekly dance classes needed to see benefits in cognition and cardiorespiratory fitness by systematically exploring how the frequency of dance movement can affect cognitive function and cardiorespiratory fitness. This information will inform future definitive studies of dance and public health recommendations for dance as physical activity to promote healthy aging.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101617"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147327453","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 : 2026-04-01Epub Date: 2026-02-14DOI: 10.1016/j.conctc.2026.101618
Wen Teng , Yongdong Ouyang , Jose Dianti , Niall D. Ferguson , Ewan C. Goligher , Anna Heath
Background:
Intercurrent events in clinical trials can disrupt the interpretation and/or measurement of clinical endpoints. This article focuses on terminal intercurrent events that preclude complete measurement of a longitudinal outcome. When such events are related to the underlying outcome, particularly for physical signs, analyses based only on the available measurements can yield biased estimates. Consequently, a principled methodology is needed to effectively handle these intercurrent events.
Methods:
We propose a Bayesian joint modeling approach to account for terminal intercurrent events. Our model jointly analyzes longitudinal outcomes and terminal events using shared random effects. We employ multiple discrete-time survival submodels to accommodate different event types and evaluate operating characteristics through extensive simulations that resemble a clinical trial with recovery and death as competing events.
Results:
The proposed Bayesian joint modeling strategy demonstrates higher power than models that do not account for intercurrent events. Specifically, power increases by approximately 15% when bias due to intercurrent events is substantial and can be reduced by joint modeling.
Conclusion:
Our Bayesian joint modeling approach effectively addresses terminal intercurrent events in both the design and analysis phases of clinical trials. By explicitly accounting for event-related truncation of longitudinal follow-up, it improves the precision and reliability of treatment effect estimation when outcome measurement is incomplete.
{"title":"Adjusting for intercurrent events using Bayesian joint models for longitudinal outcomes in clinical trials","authors":"Wen Teng , Yongdong Ouyang , Jose Dianti , Niall D. Ferguson , Ewan C. Goligher , Anna Heath","doi":"10.1016/j.conctc.2026.101618","DOIUrl":"10.1016/j.conctc.2026.101618","url":null,"abstract":"<div><h3>Background:</h3><div>Intercurrent events in clinical trials can disrupt the interpretation and/or measurement of clinical endpoints. This article focuses on terminal intercurrent events that preclude complete measurement of a longitudinal outcome. When such events are related to the underlying outcome, particularly for physical signs, analyses based only on the available measurements can yield biased estimates. Consequently, a principled methodology is needed to effectively handle these intercurrent events.</div></div><div><h3>Methods:</h3><div>We propose a Bayesian joint modeling approach to account for terminal intercurrent events. Our model jointly analyzes longitudinal outcomes and terminal events using shared random effects. We employ multiple discrete-time survival submodels to accommodate different event types and evaluate operating characteristics through extensive simulations that resemble a clinical trial with recovery and death as competing events.</div></div><div><h3>Results:</h3><div>The proposed Bayesian joint modeling strategy demonstrates higher power than models that do not account for intercurrent events. Specifically, power increases by approximately 15% when bias due to intercurrent events is substantial and can be reduced by joint modeling.</div></div><div><h3>Conclusion:</h3><div>Our Bayesian joint modeling approach effectively addresses terminal intercurrent events in both the design and analysis phases of clinical trials. By explicitly accounting for event-related truncation of longitudinal follow-up, it improves the precision and reliability of treatment effect estimation when outcome measurement is incomplete.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101618"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147277315","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 : 2026-04-01Epub Date: 2026-01-16DOI: 10.1016/j.conctc.2026.101602
Wendy van Vlerken , Jeroen S. Legerstee , Robert G. Belleman , Samantha Bouwmeester , Lynn F. Meester , Annelot Roorda , Ramón J.L. Lindauer , Elisabeth M.W.J. Utens , Luuk Stapersma
Background
Selective Mutism (SM) is a rare childhood anxiety disorder characterized by an inability to speak in specific social situations, despite speaking freely in others. School is typically the environment where the disorder manifests itself most clearly. Children with SM often have difficulty generalizing speaking across different social situations. Parents and teachers often struggle to practice speaking with the child outside of therapy due to practical reasons and time constraints. Virtual Reality Exposure Therapy (VRET) at home has potential to enhance the treatment of SM by providing an alternative and engaging method for delivering exercises that support behavioral treatment.
Methods
This paper describes the development of the VRET application Speaking at School-VR and the methodology of the single case experimental design (SCED) to evaluate the feasibility and preliminary effects of the behavioral treatment at school, complemented with VRET at home, for children with SM, aged 4–13. A secondary aim is to evaluate the feasibility and adherence of home-based VRET based on qualitative information to capture participants’ experiences. A total of 15 children with SM and their families will be enrolled in the study to examine the potential effectiveness of the combined treatment. The treatment consists of 10 behavioral steps, each accompanied by complementary VRET exercises.
Conclusion
This is the first study to examine the feasibility and the potential effectiveness of home-delivered VRET as an adjunct to behavioral treatment for children with SM. The addition of VRET to behavioral treatment has the potential to enhance the generalization and transfer of skills across different situations in a facilitative and engaging way.
背景：选择性缄默症（SM）是一种罕见的儿童焦虑症，其特征是在特定的社交场合无法说话，尽管在其他场合可以自由说话。学校是这种障碍最明显地表现出来的典型环境。患有SM的儿童通常很难在不同的社交场合中概括说话。由于实际原因和时间限制，父母和老师经常在治疗之外与孩子练习说话。家庭虚拟现实暴露疗法（VRET）有可能通过提供一种替代的、有吸引力的方法来提供支持行为治疗的练习，从而加强对SM的治疗。方法：本文介绍了VRET应用程序“在学校说话”（Speaking at school - vr）的开发和单例实验设计（SCED）的方法，以评估4-13岁SM儿童在学校进行行为治疗并辅以在家进行VRET治疗的可行性和初步效果。第二个目的是基于定性信息来评估基于家庭的VRET的可行性和依从性，以捕捉参与者的经验。总共有15名患有SM的儿童及其家庭将被纳入这项研究，以检验联合治疗的潜在有效性。治疗包括10个行为步骤，每个步骤都伴随着补充的VRET练习。结论：本研究首次探讨了家庭提供的VRET作为SM儿童行为治疗辅助手段的可行性和潜在有效性。在行为治疗中加入VRET有可能以促进和参与的方式增强技能在不同情况下的泛化和转移。
{"title":"The efficacy of home-based virtual reality exposure therapy as an add-on to behavioral therapy for children with selective mutism: Protocol for a single-case experimental design","authors":"Wendy van Vlerken , Jeroen S. Legerstee , Robert G. Belleman , Samantha Bouwmeester , Lynn F. Meester , Annelot Roorda , Ramón J.L. Lindauer , Elisabeth M.W.J. Utens , Luuk Stapersma","doi":"10.1016/j.conctc.2026.101602","DOIUrl":"10.1016/j.conctc.2026.101602","url":null,"abstract":"<div><h3>Background</h3><div>Selective Mutism (SM) is a rare childhood anxiety disorder characterized by an inability to speak in specific social situations, despite speaking freely in others. School is typically the environment where the disorder manifests itself most clearly. Children with SM often have difficulty generalizing speaking across different social situations. Parents and teachers often struggle to practice speaking with the child outside of therapy due to practical reasons and time constraints. Virtual Reality Exposure Therapy (VRET) at home has potential to enhance the treatment of SM by providing an alternative and engaging method for delivering exercises that support behavioral treatment.</div></div><div><h3>Methods</h3><div>This paper describes the development of the VRET application Speaking at School-VR and the methodology of the single case experimental design (SCED) to evaluate the feasibility and preliminary effects of the behavioral treatment at school, complemented with VRET at home, for children with SM, aged 4–13. A secondary aim is to evaluate the feasibility and adherence of home-based VRET based on qualitative information to capture participants’ experiences. A total of 15 children with SM and their families will be enrolled in the study to examine the potential effectiveness of the combined treatment. The treatment consists of 10 behavioral steps, each accompanied by complementary VRET exercises.</div></div><div><h3>Conclusion</h3><div>This is the first study to examine the feasibility and the potential effectiveness of home-delivered VRET as an adjunct to behavioral treatment for children with SM. The addition of VRET to behavioral treatment has the potential to enhance the generalization and transfer of skills across different situations in a facilitative and engaging way.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101602"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147277329","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}
Intestinal permeability is an important determinant in intensive care unit patients. Enteral nutrition is vital for nutritional supplementation in critically ill ICU patients. The amount of Enteral nutrition protein and its impact on intestinal barrier permeability and function are challenging issues. Zonulin is a protein that regulates intestinal epithelial cell tight junction permeability and has the potential to be used as a biomarker for assessing the integrity of the intestinal barrier. However, there are few data from studies on intestinal permeability and the effects of enteral feeding of protein on zonulin levels in critically ill patients. This study was conducted to investigate the effect of high-protein enteral nutrition on intestinal permeability in ICU patients.
Methods
Participants were selected from 88 adult patients with critical illness aged 18-65 years who were admitted to the ICU of Hazrat Rasoul Akram Hospital in Tehran. In this randomized controlled clinical trial, patients will be allocated randomly into two groups of 44. The intervention group will receive high-protein (HP) enteral nutrition (1.6 g/kg/day), and the control group will receive conventional-protein (CP) enteral nutrition (1.2 g/kg/day) for 10 days. The primary outcome will be the change in serum Zonulin levels during the intervention period. Zonulin will be measured on days 0, 5, and 10. The SOFA, APACHE II, and mNUTRIC scores will also be assessed. Mortality will be calculated at 30 and 60 days after the intervention. The secondary outcomes will be SOFA score and 30- and 60-day mortality.
Discussion
Our study aims to present new evidence about the role of protein in enteral nutrition on intestinal permeability in critically ill patients in the ICU.
Trial registrations
The clinical trial was registered on December 11, 2024 in the Iranian Registry of Clinical Trials (IRCT) (IRCT20241129063891N1).
{"title":"The effects of high-protein vs conventional protein enteral nutrition on intestinal permeability, severity of disease, and mortality in critically ill intensive care unit Patients: Protocol for a randomized controlled trial","authors":"Shonaz Ahmadikhatir , Pardis Irandoost , Omid Moradi Moghaddam , Mohammad Safarian","doi":"10.1016/j.conctc.2026.101621","DOIUrl":"10.1016/j.conctc.2026.101621","url":null,"abstract":"<div><h3>Background</h3><div>Intestinal permeability is an important determinant in intensive care unit patients. Enteral nutrition is vital for nutritional supplementation in critically ill ICU patients. The amount of Enteral nutrition protein and its impact on intestinal barrier permeability and function are challenging issues. Zonulin is a protein that regulates intestinal epithelial cell tight junction permeability and has the potential to be used as a biomarker for assessing the integrity of the intestinal barrier. However, there are few data from studies on intestinal permeability and the effects of enteral feeding of protein on zonulin levels in critically ill patients. This study was conducted to investigate the effect of high-protein enteral nutrition on intestinal permeability in ICU patients.</div></div><div><h3>Methods</h3><div>Participants were selected from 88 adult patients with critical illness aged 18-65 years who were admitted to the ICU of Hazrat Rasoul Akram Hospital in Tehran. In this randomized controlled clinical trial, patients will be allocated randomly into two groups of 44. The intervention group will receive high-protein (HP) enteral nutrition (1.6 g/kg/day), and the control group will receive conventional-protein (CP) enteral nutrition (1.2 g/kg/day) for 10 days. The primary outcome will be the change in serum Zonulin levels during the intervention period. Zonulin will be measured on days 0, 5, and 10. The SOFA, APACHE II, and mNUTRIC scores will also be assessed. Mortality will be calculated at 30 and 60 days after the intervention. The secondary outcomes will be SOFA score and 30- and 60-day mortality.</div></div><div><h3>Discussion</h3><div>Our study aims to present new evidence about the role of protein in enteral nutrition on intestinal permeability in critically ill patients in the ICU.</div></div><div><h3>Trial registrations</h3><div>The clinical trial was registered on December 11, 2024 in the Iranian Registry of Clinical Trials (IRCT) (IRCT20241129063891N1).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101621"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147378962","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}
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