Trials最新文献

{"title":"Methodological changes made to NIHR-funded randomised controlled trials: review of 100 trials.","authors":"Andrew Mott, Ellie Fitzmaurice, Judith Watson, Catriona McDaid","doi":"10.1186/s13063-026-09760-x","DOIUrl":"https://doi.org/10.1186/s13063-026-09760-x","url":null,"abstract":"<p><strong>Background: </strong>Previous studies have reviewed protocol amendments to trial methods in commercial studies and single centres. These studies identified that many were avoidable changes. This study aimed to assess the types of changes and rationale for changes in publicly funded randomised controlled trials undertaken in the UK.</p><p><strong>Methods: </strong>The most recent 100 published randomised controlled trials, on 23rd June 2024, in two NIHR Journals (Health Technology Assessment and Efficacy and Mechanism Evaluation), were selected for review. Data was collected on trial characteristics and the changes reported in the protocol, published reports, and trial registry entry.</p><p><strong>Results: </strong>Of the 100 included trials, 90 reported changes to the methods. A total of 846 methodological changes were recorded; 45.49% of the recorded changes occurred within the first year of study conduct. A rationale was provided for 204 of the changes with 39 unique reasons given. Frequent reasons for the changes were oversight committee recommendations, site feedback, COVID, and alignment with clinical guidance. The changes were not universally reported across the report, protocol, and registry entry and less than half were reported on the trial registry.</p><p><strong>Conclusions: </strong>The majority of NIHR-funded trials make methodological changes throughout the duration of the trial, with a large proportion being made within the first year. Consideration should be given to whether a change in the way trials are designed and planned could reduce the need for changes early on. The reporting of methodological changes also needs improvement to ensure trial documentation is consistent and up to date.</p><p><strong>Trial registration: </strong>This project was registered on the OSF registry, the details of the registration are available here: https://doi.org/10.17605/OSF.IO/WV2GX. Registered on July 22 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147821220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ivermectin therapy is associated with changes in SARS-CoV-2 RNA load in asymptomatic patients: a randomized controlled trial.","authors":"Hussein Mouawia, Hamid Bou Saab, Hassan Ayoub, Abbas Mourad, Najwa Yaghi, Ahmad Al Saabi, Mohamed El-Seblani, Houssam Raad","doi":"10.1186/s13063-026-09736-x","DOIUrl":"https://doi.org/10.1186/s13063-026-09736-x","url":null,"abstract":"<p><strong>Background: </strong>Ivermectin, an antiparasitic agent with reported antiviral properties, has been investigated for repurposing in the treatment of COVID-19. This study aimed to assess the efficacy of a single weight-adjusted oral dose of ivermectin in reducing viral load and improving clinical outcomes in asymptomatic individuals infected with SARS-CoV-2.</p><p><strong>Methods: </strong>A randomized controlled trial was conducted with 126 asymptomatic SARS-CoV-2-positive participants. Subjects were assigned to receive either standard care (zinc and vitamin C supplementation) or standard care plus a single dose of ivermectin. Reverse transcription-PCR was used to assess changes in cycle threshold (Ct) values after 96 h. Clinical symptom development and hospitalization rates were also monitored.</p><p><strong>Results: </strong>Baseline Ct values were similar between groups. After 96 h, participants in the ivermectin group showed a greater increase in Ct values (from 15.97 ± 2.823 to 24.35 ± 3.086) compared with controls (from 16.65 ± 3.593 to 19.84 ± 3.743; p < 0.001), the mean increase in Ct was 8.38 (95% CI, 7.56-9.20) in the ivermectin group versus 3.19 (95% CI, 2.36-4.02) in the control group (mean difference 5.19 (95% CI, 3.72 to 6.66); p < 0.001), suggesting a potential for more rapid reduction in viral load. Participants receiving ivermectin also reported fewer symptoms (e.g., anosmia, fatigue, myalgia) and had a lower hospitalization rate, though these clinical trends should be interpreted cautiously.</p><p><strong>Conclusion: </strong>A single oral dose of ivermectin may accelerate viral clearance and reduce symptom progression in asymptomatic SARS-CoV-2-positive individuals. Further large-scale, multi-center randomized trials are warranted to confirm these findings and evaluate ivermectin's potential role in early COVID-19 management.</p><p><strong>Trial registration: </strong>This randomized controlled trial was conducted between November and December 2021 and was registered in the World Health Organization Clinical Trial Registry (ChiCTR2000033627; Date of Registration: 2020-06-07).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147821296","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bictegravir/emtricitabine/tenofovir alafenamide versus dolutegravir plus lamivudine plus tenofovir disoproxil fumarate in people living with HIV experiencing virologic failure in China: a study protocol for a multicenter, open-label, randomized controlled non-inferiority trial.","authors":"Ran Wang, Yiming Ren, Rui Li, Hao Liu, Xuan Liu, Wei Hua, Xi Wang, Yu Cao, Lijun Sun, Lili Dai","doi":"10.1186/s13063-026-09749-6","DOIUrl":"https://doi.org/10.1186/s13063-026-09749-6","url":null,"abstract":"<p><strong>Background: </strong>In China, non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens remain widely utilized as first-line antiretroviral therapy (ART) despite issues of low resistance barriers and significant side effects, leading to frequent treatment interruptions and virologic failures. Timely drug-resistance testing is often inaccessible, complicating subsequent treatment management. This trial aims to fill this critical gap by comparing the efficacy, safety, and tolerability of the single-tablet regimen (STR) of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) with the multi-tablet regimen (MTR) of dolutegravir plus lamivudine plus tenofovir disoproxil fumarate (DTG+3TC+TDF) in people living with HIV (PLWH) experiencing virologic failure.</p><p><strong>Methods: </strong>This multicenter, open-label, randomized controlled non-inferiority trial will enroll 374 PLWH experiencing virologic failure of first-line NNRTI-based therapy from 14 clinics across China. Participants will be randomized 1:1 to receive either a once-daily STR of BIC/FTC/TAF or a once-daily MTR of DTG+3TC+TDF. The primary endpoint is the proportion achieving viral suppression (HIV-1 RNA < 50 copies/mL) at week 48. Secondary endpoints include the time to viral suppression, emergence of resistance-associated mutations (RAMs), immunologic markers, treatment adherence, patient-reported outcomes, and safety profiles. Data will be analyzed using intention-to-treat (ITT) and per-protocol (PP) populations, with non-inferiority defined using a margin of 12%.</p><p><strong>Discussion: </strong>This trial aims to provide high-quality evidence for a simplified, high-barrier, STR as an optimized second-line strategy in resource-limited settings where drug resistance testing is inaccessible.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry (Trial ID: ChiCTR2500108287). Registered on 27 August 2025. Retrospectively registered. https://www.chictr.org.cn.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147821223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"AdoHealth e-wellness initiative for adolescent non-communicable disease risk reduction: protocol for a school-based cluster randomised controlled trial in SAS Nagar (Mohali), Punjab, India.","authors":"Amrit Virk, Dhruvendra Lal, Sahil Sharma, Ashish Goel, Anu Bhardwaj, Anuradha Nadda, Akshay Kumar, Bhavneet Bharti, Sukhbir Singh","doi":"10.1186/s13063-026-09724-1","DOIUrl":"https://doi.org/10.1186/s13063-026-09724-1","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Non-communicable diseases (NCDs) increasingly affect adolescents, particularly in low- and middle-income countries. Seven key lifestyle behaviours, alcohol and tobacco use, consumption of JUNCS foods (junk, ultra-processed, nutritionally inappropriate, caffeinated/coloured/carbonated foods/beverages, sugar-sweetened beverages); physical inactivity; inadequate sleep; excessive screen time; and stress, collectively termed the 'Big-7 Behavioural Risk Determinants', contribute to NCD onset in adolescence and persistence into adulthood.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To determine the effectiveness of the AdoHealth e-wellness initiative in reducing the Big-7 Behavioural Risk Determinants among school-going adolescents aged 14-17 years, measured as change from baseline at 6 and 12 months post-intervention compared with control schools.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This multisite, open-label, superiority cluster randomised controlled trial will include 180 high and senior secondary schools (Classes 9-12, ages 14-17 years; including public and private) in SAS Nagar (Mohali), Punjab, India, randomly assigned in a 1:1 ratio to intervention or control groups, stratified by school location (urban/rural) and school type (government/private). Participants will be recruited by trained field investigators. Eligible participants are students aged 14-17 years enrolled in participating schools, with written parental consent and adolescent assent; students with serious health conditions or planned school transfer will be excluded. The intervention comprises e-modules (10-15 min each) on the Big-7 Behavioural Risk Determinants, delivered via classroom smartboards with facilitator support, over 8 weekly sessions. A pilot phase will be conducted in one school (approximately 100 adolescents) prior to full-scale implementation. Behavioural and biochemical assessments using standardised tools will be conducted at baseline, 6 months, and 12 months post-intervention. Safety monitoring includes adverse event reporting and referral for psychological support as needed. The planned sample size is 18,000 students (9000 per arm across 90 clusters each). The primary endpoint is the change in the 'Big-7 Behavioural Risk Determinants' at 12 months post-intervention, while secondary endpoints include intermediate behavioural changes, biochemical risk markers, and overall well-being.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Expected impact: &lt;/strong&gt;This study aims to evaluate the feasibility and potential effectiveness of school-based e-wellness interventions targeting multiple health behaviours simultaneously. If successful, findings may contribute to early NCD prevention strategies and inform policy development for adolescent health promotion programs in low- and middle-income countries.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration statement: &lt;/strong&gt;Trial registration: Clinical Trials Registry of India (CTRI), CTRI/2025/01/079797. Registered on January 30, 2025. https://ctri.nic.in","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147821276","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Early secondary outcome analysis in multi-phase randomised-controlled trials, a pragmatic approach: the Healthy Life Trajectories Initiative (HeLTI).","authors":"Kalyanaraman Kumaran, Jean-Patrice Baillargeon, Catherine S Birken, Cindy-Lee Dennis, Jianxia Fan, William D Fraser, Hefeng Huang, Rayjean J Hung, Kumar Gavali Suryanarayana, Stephen J Lye, Shane A Norris, Stephen G Matthews","doi":"10.1186/s13063-026-09737-w","DOIUrl":"https://doi.org/10.1186/s13063-026-09737-w","url":null,"abstract":"<p><strong>Background: </strong>The extended time frame of some trials can cause significant challenges in delaying all analyses until the primary outcome is attained. This may particularly affect any mechanistic studies linked to secondary outcomes, as well as impact the involvement of trainees and junior investigators in the project. This manuscript describes the strategy and process by which the leadership of the Healthy Life Trajectories Initiative (HeLTI) developed an analysis approach.</p><p><strong>Methods: </strong>The study involved the engagement of an expert panel with broad knowledge in disciplines relevant to the study.</p><p><strong>Results: </strong>Several reviewers emphasised the importance of undertaking analysis only after the primary outcome has been achieved. However, the majority of reviewers highlighted that this was not practical in the context of the HeLTI consortium because valuable interim analysis would be missed.</p><p><strong>Conclusion: </strong>After careful consideration of the issue and feedback received, the HeLTI leadership agreed to an approach that allowed publishing between-group comparisons of secondary outcomes and linked mechanistic studies before the primary outcome, using an a priori agreed phased approach.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147782314","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment guided by cerebral oximetry monitoring in extremely preterm infants: a Bayesian analysis of the SafeBoosC-III randomised clinical trial.","authors":"Mathias Lühr Hansen, Markus Harboe Olsen, Theis Lange, Christian Gluud, Tobias Haugegaard, Robin Christensen, Lehana Thabane, Gorm Greisen, Janus Christian Jakobsen","doi":"10.1186/s13063-026-09742-z","DOIUrl":"https://doi.org/10.1186/s13063-026-09742-z","url":null,"abstract":"<p><strong>Purpose: </strong>The SafeBoosC-III trial compared treatment guided by cerebral oximetry monitoring for the first 72 h after birth with usual care in 1601 extremely preterm infants. Incidence of death or severe brain injury at 36 weeks of postmenstrual age did not differ between the cerebral oximetry and usual care group (relative risk with cerebral oximetry, 1.03; 95% CI 0.90 to 1.18). To assess the probability of clinically important benefit or harm, we conducted secondary analyses in a Bayesian framework.</p><p><strong>Methods: </strong>Primary analyses used a weakly informative prior assuming a wide range of effects, to assess the probability that treatment guided by cerebral oximetry monitoring carried an a priori defined clinically important benefit or harm (a relative risk below 0.90 or above 1.10) or any benefit or harm (a relative risk differing from 1.0) for death or severe brain injury. Secondary analyses used an evidence-based prior derived from relevant prior trials.</p><p><strong>Results: </strong>Posterior probabilities of clinically important benefit or harm were 1.5% and 19.2%, respectively. Posterior probabilities of any benefit or harm were 28.7% and 71.3%, respectively. Probabilities derived from secondary analyses using evidence-based priors were consistent with those from the primary analysis.</p><p><strong>Conclusion: </strong>Treatment guided by cerebral oximetry monitoring during the first 72 h after birth in extremely preterm infants resulted in posterior probabilities of 1.5% for a clinically important benefit and 19.2% for a clinically important harm with respect to the incidence of death or severe brain injury at 36 weeks of postmenstrual age.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03770741. Registered on 12 July 2018.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147782266","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimizing metabolic management on integrase-based ART (OPTIMAR): study protocol for a 2 × 2 factorial, randomised, double-blind placebo-controlled trial to compare the addition of dapagliflozin versus placebo, and rosuvastatin plus ezetimibe versus pitavastatin, in people with HIV on integrase strand transfer inhibitor-based antiretroviral therapy with elevated metabolic risk.","authors":"Phyo Pyae Nyein, Hila Haskelberg, Marianne Martinello, Margaret Lowe, David Goodman-Meza, Anchalee Avihingsanon, Anthony D Kelleher, Anthony Rodgers, Aletta E Schutte, Eriobu Chukwudalu Nnakelu, Helen Byakwaga, Janine Trevillyan, Marcelo Losso, Nagalingeswaran Kumarasamy, Raja Iskandar Shah Raja Azwa, Richard Kaplan, Brent Clifton, Clare Arnott, Nila J Dharan, Kathy Petoumenos, Gail V Matthews","doi":"10.1186/s13063-026-09723-2","DOIUrl":"https://doi.org/10.1186/s13063-026-09723-2","url":null,"abstract":"<p><strong>Background: </strong>People with HIV have an increased cardiovascular disease (CVD) risk due to both HIV and adverse effects of treatments. The currently preferred class of anti-retroviral drugs, integrase strand transfer inhibitors (INSTIs), has variably been linked to higher CVD risk and weight gain. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce CVD events and heart failure hospitalisations in people with or without type 2 diabetes, while also reducing weight and blood pressure, but have not been studied in people with HIV. Pitavastatin lowers CVD events in those with HIV, although it is not widely available.</p><p><strong>Methods: </strong>OPTIMAR is a 2 × 2 factorial, randomised, placebo-controlled, double-blind, phase III/IV trial and will examine the efficacy and safety of dapagliflozin 10 mg versus placebo on metabolic parameters and of rosuvastatin 10 mg + ezetimibe 10 mg versus pitavastatin 4 mg. A cardiac substudy will determine the effect of dapagliflozin versus placebo on epicardial adipose tissue (EAT) volume and coronary plaque characteristics. Virologically suppressed individuals with HIV on INSTI-based ART aged 40-75 years who had a significant weight gain after starting INSTI or BMI ≥ 30 kg/m² will be included. Participants will be randomised 1:1 to blinded dapagliflozin or placebo, followed by 1:1 to open-label rosuvastatin + ezetimibe or pitavastatin for 48 weeks. The primary endpoints will be body weight and LDL reduction for the SGLT2i and statin randomisations respectively in the modified intention-to-treat population. Follow-up will continue to 48 weeks with primary analysis at week-24 and follow-up analysis at week-48.</p><p><strong>Discussion: </strong>OPTIMAR is the first trial to investigate the use of SGLT2i as a cardiometabolic intervention in people with HIV. Demonstrating favourable cardiometabolic effects of SGLT2i will introduce an innovative approach to primary CVD prevention in this at-risk population and support conducting larger trials evaluating clinical endpoints including major adverse cardiovascular events. If the combination of rosuvastatin and ezetimibe is found to be similar or superior to pitavastatin, this will inform a more feasible lipid management approach for people with HIV internationally, especially in resource-limited settings. The cardiac sub-study will further clarify the cardioprotective role of SGLT2i and provide mechanistic insights.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT06317051 (https://clinicaltrials.gov/study/NCT06317051?cond=HIV&intr=Dapagliflozin&aggFilters=status:not%20rec&rank=2). Registration on 21 February 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147782341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of transcutaneous spinal cord stimulation combined with resistance training on motor function in motor-incomplete spinal cord injury: protocol for an open-label, single-blind randomized controlled trial.","authors":"Jibao Chen, Xiaoming Luo, Yuxin Zhang, Yingguo Li, Yan Wang, Jiamei Ye, Jing Sun, Handong Huang, Zengqiang OuYang, Yaxin Yuan, Yue Wang","doi":"10.1186/s13063-026-09741-0","DOIUrl":"https://doi.org/10.1186/s13063-026-09741-0","url":null,"abstract":"<p><strong>Background: </strong>Spinal cord injury (SCI) commonly results in substantial motor impairments, particularly in standing and walking abilities, due to the disruption of the sensory-motor circuits. Conventional rehabilitation approaches have limited effectiveness in restoring motor function. The present study investigates the combined effects of transcutaneous spinal cord stimulation (tSCS) and resistance training (RT) on improving motor function in patients with motor-incomplete SCI. Furthermore, it examines the underlying mechanisms of these improvements through the use of advanced neuroimaging and electrophysiological techniques.</p><p><strong>Methods: </strong>This open-label, single-blind, randomized controlled trial will be conducted over 28 days at Shanghai Yangzhi Rehabilitation Hospital. A total of 56 participants with motor-incomplete SCI will be randomly assigned to two groups: the intervention group (tSCS + RT) and the control group (RT only). The intervention group will receive tSCS in combination with RT 3 times per week for 4 weeks, while the control group will undergo RT without tSCS. Primary outcomes will include peak torque measurements and secondary outcomes will involve motor functions and multimodal neurofunctional metrics. Data will be analyzed to evaluate the efficacy of the combined treatment in improving lower limb motor function.</p><p><strong>Discussion: </strong>The novel combination of tSCS and RT aims to enhance motor function by providing dual-channel neuromodulation that targets both sensory and motor pathways. The results of this study could inform future therapeutic strategies and the broader clinical application of neuromodulation technologies in spinal cord injury rehabilitation.</p><p><strong>Trial registration: </strong>This study was prospectively registered at the Chinese Clinical Trials Registry, ChiCTR2400089603, registered on September 11, 2024, https://www.chictr.org.cn.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147782176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Digital tools for recruitment and retention of participants in paediatric clinical research: a scoping review.","authors":"Eunicia Tan, Kate Loveys, William Ali, Christopher J D McKinlay, Stuart R Dalziel","doi":"10.1186/s13063-026-09612-8","DOIUrl":"https://doi.org/10.1186/s13063-026-09612-8","url":null,"abstract":"<p><strong>Background: </strong>Digital tools are increasingly used to support recruitment and retention of participants in paediatric research, particularly since the COVID-19 pandemic. However, the extent of the evidence supporting this method in paediatric populations has yet to be evaluated. This scoping review aimed to review the literature on digital tools for recruitment and/or retention of participants in paediatric research, including emerging evidence following the pandemic.</p><p><strong>Methods: </strong>A scoping review was conducted following Joanna Briggs Institute methodology. We included peer-reviewed quantitative, qualitative, and mixed-method studies evaluating a digital tool for recruitment or retention in paediatric research in any patient population aged <13 years. Records were identified from systematic database searches with a librarian (EMBASE, MEDLINE, CINAHL), limited to English, from 2013 onwards (last search 03/07/2024), and manual searches. Records were screened and extracted independently in duplicate. The data were charted and narratively summarised.</p><p><strong>Results: </strong>Sixty-one out of 4988 records were included. Most evaluations used an observational design; only 5 (8%) involved a randomised experiment. The host studies were mostly aiming to recruit children aged 5-12 years (n = 42; 69%), with a predominantly health promotion (n = 18; 30%), developmental (n = 12; 20%), or oncology (n = 9; 15%) focus. Most studies used multi-component digital interventions for recruitment (n = 39/53; 74%) or retention (n = 17/31; 55%). Social media (n = 33/52; 62%) and websites (n = 19/53; 36%) were most commonly used for recruitment, whereas text/instant messaging (n = 17/31; 55%) and email (n = 11/31; 36%) were the most common retention strategies. The estimates of recruitment and retention rates, and reach per digital tool varied widely between studies. Strategies in underserved populations reflected those used most commonly overall. Multi-component digital strategies were found to support a high rate of retention (84.1-90.7%) during pandemic restrictions.</p><p><strong>Conclusions: </strong>This scoping review highlights the broad array of digital tools that have been used to support recruitment and retention in studies of infants and children, including in subgroups of underserved populations and in response to the COVID-19 pandemic. Most evaluations were observational and examined multi-component digital interventions. The lack of studies with a robust analytical design in the literature signals a need for further high-quality, randomised, within-study evaluations following standardised reporting criteria.</p><p><strong>Registration: </strong>The protocol was registered on the Open Science Framework (OSF) at https://osf.io/ybfhr/. Registered on July 5 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147782282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Transcutaneous tibial nerve stimulation versus sham stimulation for the treatment of catheter-related bladder discomfort in patients undergoing transurethral resection of the prostate: a prospective, randomized, placebo-controlled, double-blind trial.","authors":"Yanwen Song, Xiangyu Sun, Ling Mei, Yongqiang Wang, Jiangang Song","doi":"10.1186/s13063-026-09743-y","DOIUrl":"https://doi.org/10.1186/s13063-026-09743-y","url":null,"abstract":"<p><strong>Background: </strong>Catheter-related bladder discomfort (CRBD), characterized by urinary urgency, frequency, and suprapubic pain, is a clinically significant complication following transurethral resection of the prostate (TURP). Current CRBD pharmacotherapy faces inherent limitations due to adverse effect profiles. Transcutaneous tibial nerve stimulation (TTNS), a noninvasive neuromodulation therapy with demonstrated efficacy in bladder dysfunction management, shows particular promise as a safe and effective alternative for CRBD treatment.</p><p><strong>Methods: </strong>This prospective, randomized, double-blind, placebo-controlled clinical trial enrolled patients undergoing TURP under general anesthesia. Participants were randomly allocated in a 1:1 ratio to either active TTNS intervention or sham stimulation. The primary outcome focused on CRBD-related discomfort severity assessed via the Numeric Rating Scale (NRS) immediately post-intervention. Secondary outcomes comprised CRBD severity and pain scores at 1-, 2-, and 6-h post-intervention intervals, analgesic consumption, patient satisfaction ratings, and occurrence of postoperative delirium.</p><p><strong>Discussion: </strong>This protocol evaluates the therapeutic potential of TTNS for CRBD following TURP, exploring its viability as a non-invasive alternative to current CRBD management.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry ChiCTR2400088488. Registered on 20th August 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147782268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}