Trials最新文献

{"title":"Resilience And Healthy Lifestyle for Rheumatoid Arthritis (The RA-HEAL trial): a randomised, parallel group, placebo-controlled clinical trial protocol.","authors":"Katherine A Poulsen, Nicola W Burton, Hannah L Mayr, Veronique S Chachay, Jeff S Coombes, Coral E Gartner, Amee Sonigra, Paul Christensen, Karl A Hansford, Dianna J Ang, Jessica Neri, Ramali Mendis, Tom Lynch, Cheryl Dines, Helen Benham, Aoife Sweeney, Lyn M March, Asaduzzaman Khan, Haitham Tuffaha, Ranjeny Thomas","doi":"10.1186/s13063-025-09063-7","DOIUrl":"10.1186/s13063-025-09063-7","url":null,"abstract":"<p><strong>Background: </strong>The importance of self-management strategies that optimise physical health and mental health in the management of rheumatoid arthritis (RA) is recognised, but access to multidisciplinary teams to support this can be challenging. Furthermore, evidence for the impact of multidisciplinary interventions, especially in early RA, is lacking.</p><p><strong>Methods: </strong>The Resilience and Healthy Lifestyle for Rheumatoid Arthritis (RA-HEAL) Trial is a pragmatic RCT that aims to compare the effects of a structured multidisciplinary lifestyle intervention with self-directed activities in best-practice usual care. The 20-week multi-modal intervention incorporates structured resilience training conducted by a clinical health psychologist (CHP), followed by an exercise physiologist (EP)-led exercise programme, dietary education conducted by a dietitian nutritionist (DN), a smoking cessation programme (where applicable) and psychologist-led behaviour-change support. The comparison group will receive written information on a healthy lifestyle in accordance with standard best practice care. The primary outcome is health-related quality of life (QoL) at 6 months.</p><p><strong>Discussion: </strong>RA-HEAL tests whether a tailored intervention including formal resilience training with a clinical psychologist followed by Mediterranean diet, exercise, smoking cessation and behaviour change support has a greater effect on health-related QoL at 6 months than written advice given in current best-practice settings. QoL is a composite endpoint that is highly valued by patients with RA. RA-HEAL is unique in that it targets RA within 12 months of onset. RA-HEAL's linkage with the Australian Autoimmune Arthritis Biobank Cooperative (A3BC) supports 6 monthly follow-up data and biosampling to 24 months post-intervention and linkage to health data collections, creating a valuable resource for future research and the potential to determine medium and long-term effects of behaviour change. In its secondary outcomes, RA-HEAL will analyse the longevity of effects of intervention or best-practice usual care for up to 2 years and cost utility. The outcomes should provide evidence to underpin a scalable approach to support people with newly diagnosed RA.</p><p><strong>Trial registration: </strong>ACTRN12625000050459, ANZCTR. Registered on 20 January 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"376"},"PeriodicalIF":2.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12482164/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145193109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The utility of pericapsular nerve group (PENG) block versus intrathecal morphine for postoperative analgesia in anterior approach total hip arthroplasty: a multicentre triple blinded randomised controlled trial protocol.","authors":"Craig Morrison, Tim Cheok, Brigid Brown, Bronwyn Lock, Gemma Saville, Louise de Prinse, Holly Alford, Marni Calvert, Dimitrios Nikos, Nikki May, Hidde M Kroon, Ruurd Jaarsma, Ki Jinn Chin, D-Yin Lin","doi":"10.1186/s13063-025-09127-8","DOIUrl":"10.1186/s13063-025-09127-8","url":null,"abstract":"<p><strong>Background: </strong>The pericapsular nerve group (PENG) block is a novel regional technique for hip analgesia. Traditionally, intrathecal morphine has been administered for analgesia in hip fracture surgery. Compared with intrathecal morphine, the PENG block may provide superior or equivalent pain score reduction with a more favourable side effect profile and superior patient satisfaction.</p><p><strong>Methods: </strong>This is a multicentre blinded randomised controlled trial (RCT) that is being conducted at present at two large teaching institutions in Australia. The pericapsular nerve group block (PENG block) shall be compared to low-dose intrathecal morphine for analgesic effect in elective total Hip arthroplasty via the direct anterior approach. Primary outcome shall be dynamic pain score evaluation at 3 and 24 h postoperatively.</p><p><strong>Discussion: </strong>This is the protocol of our RCT which is currently in the early stages of active recruitment.</p><p><strong>Trial registration: </strong>Ethics approval was obtained from the Southern Area Local Health Network prior to recruitment of the first patient. This trial was prospectively registered prior to initiation on the Australian and New Zealand Clinical Trials Registry. Australian New Zealand Clinical Trial Registry, ACTRN12623001309673P, 15/12/23, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=386688&showOriginal=true&isReview=true .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"384"},"PeriodicalIF":2.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12482444/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145193178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of preoperative immunonutrition in malnourished patients undergoing colorectal cancer surgery: a study protocol for a multicenter randomized clinical trial.","authors":"Soo Young Lee, Chang Hyun Kim, Gi Won Ha, Soo Yeun Park, In Jun Yang, Jin Soo Kim, Gyung Mo Son, Sung Il Kang, Sung Uk Bae","doi":"10.1186/s13063-025-09082-4","DOIUrl":"10.1186/s13063-025-09082-4","url":null,"abstract":"<p><strong>Background: </strong>Malnutrition is a significant risk factor for postoperative complications in patients undergoing colorectal cancer surgery. Although current guidelines recommend preoperative immunonutrition for malnourished patients, its clinical benefit remains controversial. Our previous randomized clinical trial assessing immunonutrition in unselected colon cancer patients showed no reduction in infectious complications. This study aims to evaluate the efficacy of preoperative immunonutrition in reducing postoperative complications in malnourished patients undergoing colorectal cancer surgery.</p><p><strong>Methods: </strong>This multicenter, parallel, superiority, randomized clinical trial will include patients with primary colorectal cancer and Nutritional Risk Screening (NRS) 2002 score of 3-5 from eight participating institutions. Patients will be randomly assigned (1:1) to receive either preoperative immunonutrition with oral nutritional supplements (400 mL/day) containing arginine and ω-3 fatty acids for 7 days before surgery (intervention group) or a standard preoperative diet alone (control group). The primary endpoint is the rate of infectious complications within 30 days postoperatively. Secondary endpoints include overall postoperative complication rate, length of hospital stay, perioperative body weight changes, and alterations in nutritional and immune response markers (serum transferrin, prealbumin, albumin, cytokines, prostaglandin E2, high-sensitivity C-reactive protein). A sample size of 176 patients (88 per arm) was determined to detect a significant reduction in infectious complications from 30% (control) to 12% (intervention), with 80% power and a two-sided α of 0.05.</p><p><strong>Discussion: </strong>This study addresses a critical gap in evidence by focusing on nutritionally at-risk colorectal cancer patients. Unlike previous trials on unselected populations, this trial specifically evaluates the impact of immunonutrition in a high-risk group in which nutritional optimization may yield clinical benefits. Additionally, the multicenter design enhances generalizability. If preoperative immunonutrition effectively reduces postoperative complications, it could support a targeted nutritional intervention strategy for malnourished colorectal cancer patients, optimizing perioperative care and potentially reducing the healthcare burden.</p><p><strong>Trial registration: </strong>Clinical Research Information Service KCT0008382. Registered on April 25, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"377"},"PeriodicalIF":2.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12482491/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145193090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Opioid-free anaesthesia based on paravertebral block for thoracotomic paediatric congenital cardiac surgery-effectiveness of postoperative analgesia: a protocol for a prospective, single-blinded, randomised controlled trial (OPTION trial).","authors":"Zhiyao Zou, Sheng Shi, Jinrui Song, Jingfei Guo, Yanyan Zhao, Juxian Yang, Zheng Dai, Fuxia Yan, Ke Yang, Yuan Jia","doi":"10.1186/s13063-025-09067-3","DOIUrl":"10.1186/s13063-025-09067-3","url":null,"abstract":"<p><strong>Background: </strong>Opioids were considered the main analgesics for pain management during and after cardiac surgery. There are many complications associated with the use of opioids. Paravertebral block (PVB) is injecting Anaesthetics into the paravertebral space. We designed a randomised controlled trial to investigate whether PVB-based opioid-free general Anaesthesia, as compared to traditional low-dose opioid-based fast-track anaesthesia, can reduce opioid consumption within 24 h after thoracotomy incision cardiac surgery with cardiopulmonary bypass (CPB) in paediatric patients.</p><p><strong>Methods: </strong>This is a single-centre, single-blinded, randomised controlled trial with a 1:1 allocation ratio. Patients will be randomised into two groups (control group and PVB group); 20 children will be enrolled in this trial, with 10 subjects in each group. Block randomisation will be performed. Patients aged 1-6 years, with the diagnosis of atrial and/or ventricular septal deficient And scheduled for cardiac surgery via a right thoracotomic incision, will be eligible for enrolment. The primary outcome is opioid consumption during the first 24 h after surgery. The main secondary outcomes include the perioperative stress response, inflammatory level, and intraoperative haemodynamics.</p><p><strong>Discussion: </strong>This is the first randomised clinical study investigating opioid-free anaesthesia based on PVB for paediatric congenital thoracotomy surgery with CPB. If the OPTION trial proves that opioid-free anaesthesia based on PVB is safe for children undergoing thoracotomic cardiac surgery, we would be glad to provide an OPTION for the perioperative management of these children, especially in the era of ERAS.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry: ChiCTR2200066517 ( www.chictr.org.cn ), Registered on December 7, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"374"},"PeriodicalIF":2.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12482201/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145193092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Transcranial Doppler to guide early discharge after mild traumatic brain injury, the TRUST trial: study protocol for an open-label multisite noninferiority randomized controlled trial.","authors":"Pierre Bouzat, Tobias Gauss, Anais Adolle, Mathieu Roustit, Jean-Luc Bosson, Karim Tazarourte","doi":"10.1186/s13063-025-09086-0","DOIUrl":"10.1186/s13063-025-09086-0","url":null,"abstract":"<p><strong>Background: </strong>After mild traumatic brain injury (TBI), discharge from the emergency department (ED) relies on clinical examination and brain imaging, but triaging of these patients can be challenging in specific situations. Transcranial Doppler (TCD) after mild TBI may rule out early neurologic worsening. We hypothesize that patients with mild TBI and normal TCD can be safely discharged home immediately after the ED.</p><p><strong>Methods: </strong>This is a prospective, open-label, multisite, randomized controlled noninferiority trial. Eligible patients are mild TBI patients (Glasgow Coma Scale, GCS, 13-15 on admission) with minor lesions on brain CT scan or normal CT scan but one of the following risk factors: (1) GCS = 14 after CT scan; (2) alcoholic intoxication, (3) ongoing treatment with anticoagulants or anti-platelet therapy; (4) persisting nausea, vomiting, and/or headaches; or (5) early initial CT scan (< 4 h after TBI). Patients randomized in the intervention group have TCD within 12 h after TBI and can be immediately discharged from the ED if TCD is normal (diastolic flow velocity higher than 25 cm/s and pulsatility index lower than 1.25). Discharge of patients in the control group relies on clinical examination and brain imaging only. The primary outcome is the 3-month neurological outcome measured with the Extended Glasgow Outcome Scale (GOS-E). Secondary outcomes are the GOS-E at 1 month, the QOLIBRI (Quality of life after TBI) and EQ-5D-5L questionnaires at 1 month and 3 months after TBI, the Rivermead Post-Concussion Symptoms questionnaire at 1 month and 3 months after TBI, mortality within the first 3 months, the number of cerebral CT scans, length of stay in hospital, the number of thromboembolic events or diagnosed nosocomial infections, and the number of patients re-admitted to hospital in relation with the initial TBI. Inclusions have started in February 2020 and are expected to be complete by June 2025.</p><p><strong>Discussion: </strong>Transcranial Doppler in mild TBI patients may help immediate discharge from the ED after CT scanning.</p><p><strong>Trial registration: </strong>This study has been prospectively registered on clinical trial on June 14, 2019, NCT03989999.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"371"},"PeriodicalIF":2.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12482328/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145193141","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Circular stapled end colostomy versus conventional end colostomy creation in patients undergoing a permanent stoma: a randomized controlled trial.","authors":"Avanish Saklani, Mufaddal Kazi, Ankit Sharma, Ashwin Desouza","doi":"10.1186/s13063-025-09135-8","DOIUrl":"10.1186/s13063-025-09135-8","url":null,"abstract":"<p><strong>Background: </strong>Parastomal herniation is a prevalent complication of colostomies, with rates as high as 60% at 2 years. Traditional methods, including mesh use, have shown limited success. Here, we aim to compare 1-year PSH rates and evaluate stoma-related complications using a stapled versus conventional approach.</p><p><strong>Methods: </strong>This randomized controlled trial investigates the efficacy of using a circular stapler to create an end colostomy for reducing parastomal hernia (PSH) incidence compared to conventional techniques. Eligible patients (aged 18-70) undergoing end colostomy for rectal cancer at Tata Memorial Hospital will be randomized into two groups: circular stapled versus conventional cruciate incision. Primary outcomes will be 1-year PSH rates, determined clinically and radiologically, with secondary outcomes including short-term stoma-related complications and reoperation rates.</p><p><strong>Discussion: </strong>The study's findings will provide evidence on the circular stapler's effectiveness in reducing PSH incidence, potentially offering an innovative approach to ostomy creation. If successful, this technique may improve patient outcomes and reduce long-term healthcare costs related to PSH management. Trial registration CTRI/2023/10/059362; protocol version 1.2. Registered on March 11, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"379"},"PeriodicalIF":2.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12481906/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145193005","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation of shared decision making in rheumatoid arthritis: study protocol for RAiSeD (Rheumatoid Arthritis Shared Decision Making) stepped wedge, cluster-randomized trial.","authors":"Jennifer L Barton, Meike Niederhausen, Anaïs Tuepker, Gabriela Schmajuk, Joshua Baker, Travis I Lovejoy, Benjamin J Morasco, Marleen Kunneman, Isabelle Scholl","doi":"10.1186/s13063-025-09015-1","DOIUrl":"10.1186/s13063-025-09015-1","url":null,"abstract":"<p><strong>Background: </strong>Rheumatoid arthritis (RA) impacts quality of life causing disability and increased mortality. Treatment decisions are complex and require individualization. Shared decision making (SDM) is the first principle of RA treat-to-target guidelines, but uptake is suboptimal. We aim to evaluate the effectiveness of a multicomponent SDM intervention on RA disease activity and explore the early implementation of the intervention within three geographically diverse rheumatology services.</p><p><strong>Methods: </strong>The RAiSeD trial uses a stepped-wedge, cluster-randomized trial design at three U.S. Veterans Health Administration rheumatology clinics, targeted to enroll more than 400 patients and over 45 clinicians. The multicomponent SDM intervention consists of three parts: (1) rheumatology clinician training and a pocket card on SDM and fostering choice awareness (\"acknowledging when there is more than one sensible option available to address a patient's situation\"), (2) RA patient activation using the AskShareKnow questions, and (3) a point-of-care decision aid (RA Choice) and medication summary guide. We will conduct a mixed-methods outcomes and process evaluation. Outcomes will be evaluated during a pre-intervention (usual care) and intervention period. The primary outcome is disease activity as measured by the validated Clinical Disease Activity Index (CDAI), with secondary outcomes of RA knowledge and medication adherence. SDM will be measured by two brief, validated patient-reported measures. A subgroup of clinic visits will be audio-recorded and clinicians' efforts to involve patients in SDM will be assessed. The implementation process will be evaluated using stakeholder interviews and field notes at each of the three sites.</p><p><strong>Discussion: </strong>This study is the first multi-site trial of a multicomponent intervention to facilitate SDM among veterans with RA. We expect to improve uptake of SDM across geographically distinct rheumatology clinics and hypothesize that patients exposed to the interventions will have a greater decrease in disease activity and an increase in knowledge of RA medications compared to usual care. Insights gained from this study will inform broader dissemination and implementation of SDM across VA rheumatology clinics and beyond, with the goal of improving quality of care for all persons with RA.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05530694. Registered on September 7, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"381"},"PeriodicalIF":2.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12482761/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145193155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Different types of cluster membership in parallel-group cluster-randomised trials, where the clusters are institutions: a classification system to aid identification, with six proposed designs.","authors":"L E Marsden, C A Surr, A W Griffiths, A J Farrin, A J Copas, R E A Walwyn","doi":"10.1186/s13063-025-09066-4","DOIUrl":"10.1186/s13063-025-09066-4","url":null,"abstract":"<p><strong>Background: </strong>Four main types of cluster-randomised trial (CRT) are well known: parallel-group (PG), factorial, stepped-wedge and crossover designs. This established typology relates to how clusters are exposed to intervention(s) or control(s) during the trial. Published guidance is lacking on how to link design features to how individuals within clusters may be exposed and measured. Thus, the aim of this paper was to develop a classification system for different types of cluster membership in CRTs, focussing on PG designs and building on our experiences of delivering a care home trial.</p><p><strong>Methods: </strong>The classification system was developed in seven stages: (i) a scoping review was conducted to explore the use of open-cohort PG-CRTs in a range of settings; (ii) a version of the classification system was developed, using the stepped-wedge CRT typology; (iii) this was tested using a sample of published trials from the scoping review; (iv) a second version was developed, reviewed and further amendments made to aid clarity; (v) 15 trialists with experience of CRTs in a range of settings provided feedback in a 1-day, face-to-face user engagement workshop; (vi) a wider group of 39 trialists completed an online survey, providing examples and additional feedback; and (vii) all authors reviewed and approved the final version.</p><p><strong>Results: </strong>Six types of cluster membership in PG-CRTs are proposed: the closed-cohort and cross-sectional designs already established, a new-admission-continuous-recruitment, open-cohort with discrete-recruitment, open-cohort with continuous-recruitment, and a non-standard closed-cohort design. The final classification system is made up of six core design features and five additional design considerations. Diagrams of each type of cluster membership are introduced and used to illustrate examples.</p><p><strong>Conclusions: </strong>Implications of distinctions between the six types of cluster membership for the statistical analysis require further research. CONSORT guidance needs updating to include specific guidance on reporting the type of cluster membership alongside the description of how design features apply to clusters. Further methodological research is required into both the statistical and the practical implications of adopting previously unlabelled but frequently used types of cluster membership.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"380"},"PeriodicalIF":2.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12482407/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145193048","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Seasonal mass vaccination with R21/Matrix-M for malaria elimination (SERVAL): protocol of the cluster randomised trial.","authors":"Edgard D Dabira, H Magloire Natama, Fatou Jaiteh, Koen Peeters Grietens, Fadima Y Bocoum, Mamadou Ousmane Ndiath, Nuredin Mohammed, Balla Gibba, Adrian V S Hill, Azra Ghani, Annette Erhart, Halidou Tinto, Umberto D'Alessandro","doi":"10.1186/s13063-025-09048-6","DOIUrl":"10.1186/s13063-025-09048-6","url":null,"abstract":"<p><strong>Introduction: </strong>Progress in malaria control has stalled since 2015, highlighting the need for new control tools. The R21/Matrix-M (R21) malaria vaccine, a pre-erythrocytic vaccine recently approved by WHO for small children, may be one of these tools. This trial aims to assess whether seasonal mass vaccination with R21 reduces malaria transmission in The Gambia and Burkina Faso, two countries at the extreme of the transmission spectrum.</p><p><strong>Methods: </strong>This is a multi-centre open cluster-randomised controlled trial to assess the impact of mass vaccination with R21 on malaria transmission and morbidity. The trial will be implemented in eastern Gambia (low to moderate transmission) and Central Burkina Faso (intense transmission). Thirty medium-sized villages in The Gambia and 24 in Burkina Faso will be randomised (1:1) to either intervention or control arm. All eligible residents in intervention villages will receive R21 vaccinations in three-monthly rounds, from May to July 2024, prior to the malaria transmission season. A booster vaccine dose will be administered the following year, in June 2025. The primary outcome is malaria prevalence at peak transmission (November 2024). Secondary outcomes include safety and tolerability, incidence of clinical malaria, vaccination coverage and community acceptability, cost and cost-effectiveness of the intervention.</p><p><strong>Discussion: </strong>This is the first trial on seasonal mass vaccination aiming at reducing malaria transmission. Strengths of the study include its design as an adequately powered cluster-randomised trial and the inclusion of study sites with differing transmission intensity which will also provide safety and efficacy data for different age groups. Key challenges remain vaccine hesitancy and vaccination coverage. If successful, R21 seasonal mass vaccination will be an innovative intervention to accelerate malaria elimination efforts and reach the goal set in the Global Technical Strategy for malaria 2016-2030.</p><p><strong>Trial registration: </strong>Clinical trials.gov, NCT06578572. Registered on 27 March 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"382"},"PeriodicalIF":2.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12481873/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145193175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Spirometry to manage asthma in children: study protocol for a randomised controlled trial (SPIROMAC).","authors":"Victoria Bell, Nicole Sergenson, Seonaidh Cotton, Chukwuemeka David Emele, Ruth Thomas, Lorna Aucott, Mark Forrest, Erol A Gaillard, Erika J Kennington, Graeme MacLennan, Ian Sinha, Thenmalar Vadiveloo, Neil W Scott, Steve Turner","doi":"10.1186/s13063-025-09104-1","DOIUrl":"10.1186/s13063-025-09104-1","url":null,"abstract":"<p><strong>Background: </strong>Asthma affects over 1 million children across the UK, and preventative treatment is guided subjectively by patient symptoms. Spirometry is an objective test of lung function and can be used in children to guide treatment. However, current guidelines do not indicate how asthma treatment should change in the context of changing spirometry results. This study will evaluate how spirometry can be used to guide asthma treatment and reduce the risk for asthma attacks in children.</p><p><strong>Methods: </strong>This is a multi-centre, randomised controlled trial. Children aged 6-15 years, who have a diagnosis of asthma and have had an exacerbation requiring oral or intravenous corticosteroids in the previous 12 months, will be eligible. Exclusion criteria include being unable to provide spirometry measurement at baseline assessment, having another chronic respiratory condition and being currently treated with maintenance oral steroids or biologicals. Participants will be recruited in both primary and secondary care settings and will be randomised to either receive asthma treatment guided by spirometry plus symptoms (intervention group) or asthma treatment guided by symptoms only (standard care group). Within the spirometry group, treatment recommendations will be dependent on changes in spirometry measurements. Participants will attend assessments 3, 6, 9 and 12 months post-randomisation, where treatment recommendations will be made. The primary outcome is the number of asthma attacks per participant requiring treatment with 1-7 days of oral or intravenous corticosteroid over 12 months, as recorded by the participant or parent. Secondary outcomes include time to first attack, any asthma attack, adverse events, dose of inhaled corticosteroids, asthma control and quality of life. Adherence to inhaled corticosteroid treatment is measured by an electronic logging device.</p><p><strong>Discussion: </strong>This study will evaluate whether asthma treatment guided by spirometry will reduce future asthma attacks in children. Our findings may be relevant to national and international asthma guidelines.</p><p><strong>Trial registration: </strong>ISRCTN, ISRCTN31849868. Registered on 01.07.2022. Prospectively registered.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"373"},"PeriodicalIF":2.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12482643/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145193084","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}