Trials最新文献

{"title":"Efficacy of the preformulated irrigation solution Bactisure® in acute periprosthetic joint infection debridement surgery: study protocol for a randomized controlled trial.","authors":"Rafael Oleo-Taltavull, Matías Vicente Gomà-Camps, Nayana Joshi Jubert, Pablo S Corona","doi":"10.1186/s13063-024-08637-1","DOIUrl":"10.1186/s13063-024-08637-1","url":null,"abstract":"<p><strong>Background: </strong>Despite significant progress in orthopaedic surgery, the prevalence of periprosthetic joint infections (PJIs) remains persistent, and future increases are expected due to the increasing number of joint arthroplasties. PJIs are intricately connected to biofilm-producing bacteria, which encase infected prostheses, impairing the effectiveness of antibiotics and the immune system. Acute PJIs with immature biofilms are traditionally managed with debridement, antibiotics, and implant retention (DAIR). However, to date, there has not been a conclusive direct clinical comparison (in vivo) demonstrating the superiority of one irrigation solution over others. Recently, there has been a growing interest in irrigation solutions with antibiofilm properties demonstrated in in vitro studies, exemplified by the preformulated Bactisure® irrigation solution, which contains ethanol, acetic acid, sodium acetate, benzalkonium chloride, and sterile water. The main objective of this study was to evaluate the effectiveness (infection cure rate) of preformulated Bactisure® irrigation solution in vivo compared with saline solution in a control group of patients with acute knee and/or hip periprosthetic infections treated with DAIR.</p><p><strong>Methods: </strong>Prospective single-centre randomized controlled trial involving patients with acute haematogenous PJI who received standard DAIR surgery from December 2022 to December 2024. The type of irrigation solution used during surgery will include two groups allocated at a 1:1 ratio: a control group (n = 25) with saline solution and an experimental group (n = 25) receiving the Bactisure® preformulated solution. The sample size was calculated based on an expected reduction in reinfection rates from 45% in the control group to 10% in the experimental group. Data on baseline patient characteristics, clinical and radiological information, and healthcare questionnaires will be recorded. All patients will be followed for minimum of 12 months. The infection cure rate at 1 year will be the primary outcome.</p><p><strong>Discussion: </strong>This study is the first to compare the effectiveness of preformulated Bactisure® irrigation solution with that of saline solution in real clinical practice (in vivo) in patients with acute knee and/or hip periprosthetic infections treated with DAIR. Our main hypothesis is that, compared with saline solution, Bactisure® provides a better infection cure rate at 1 year post-DAIR.</p><p><strong>Trial registration: </strong>International Standard Randomized Controlled Trial Number (ISRCTN): https://doi.org/10.1186/ISRCTN10873696 . Registered on December 19, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"775"},"PeriodicalIF":2.0,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11568522/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644752","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":"Effects of ultrasound-guided external oblique intercostal plane block on the postoperative analgesia after open liver surgery: study protocol for a randomised controlled trial.","authors":"Jiali Tang, Qingqing Hua, Yuelun Zhang, Weihua Nie, Songlin Yu, Jinlan Zhang","doi":"10.1186/s13063-024-08449-3","DOIUrl":"10.1186/s13063-024-08449-3","url":null,"abstract":"<p><strong>Background: </strong>Open liver surgery remains a primary surgical approach for complex liver resections and liver transplantation. However, the postoperative pain management is still a major challenge. Ultrasound-guided external oblique intercostal (EOI) plane block is a novel approach of regional anaesthesia and has a great potential to relieve postoperative pain after upper abdominal surgeries. This study aims to investigate the efficacy and safety of ultrasound-guided EOI plane block in managing postoperative pain after open liver surgery.</p><p><strong>Methods: </strong>Seventy-four participants scheduled for open liver surgery will be randomly assigned to either the intervention group, receiving an ultrasound-guided EOI plane block with a single dose of 30 ml 0.375% ropivacaine, or the control group, which will not receive this block. All participants will be provided with opioid-based patient-controlled intravenous analgesia (PCIA) postoperatively. The primary outcome is resting pain score at 3 h postoperatively, assessed using numerical rating scale. Secondary outcomes include pain score at 6, 24, 48, and 72 h postoperatively, perioperative opioid consumption, remedial analgesics within 72 h postoperatively, PCIA usage within postoperative 72 h, postoperative recovery, length of hospital stay, postoperative side effects, block-related complications, and ropivacaine plasma concentration of participants receiving the block.</p><p><strong>Discussion: </strong>This study is a randomised controlled trial to evaluate the efficacy and safety of ultrasound-guided EOI plane block for postoperative analgesia after open liver surgery. As regional anaesthesia plays an important role in the multimodal pain management, EOI plane block may prove to be an effective regional technique for enhancing postoperative pain relief and contributing to enhanced recovery after open liver surgery.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry ChiCTR2200065745. Registered on November 14, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"776"},"PeriodicalIF":2.0,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11568687/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644587","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":"Evaluating effects of community-based social healing model on Ubuntu, mental health and psychosocial functioning in post-genocide Rwanda: protocol for cluster randomized control trial.","authors":"Stefan Jansen, Jean Bosco Niyonzima, Patricia Gerbarg, Richard P Brown, Alice Nsengiyumva, Japhet Niyonsenga, Epaphrodite Nsabimana","doi":"10.1186/s13063-024-08632-6","DOIUrl":"10.1186/s13063-024-08632-6","url":null,"abstract":"<p><strong>Background: </strong>The community-based social healing (CBSH) model, developed by Ubuntu Centre for Peace, aims to support individuals with traumatic experiences and mental health challenges in achieving better mental health. CBSH combines BREATH-BODY-MIND™ (BBM) practices with collective narrative and rituals, facilitated by Community Healing Assistants in therapeutic groups. A previous pilot study involving 1889 Rwandan CBSH participants showed significant mental health improvements, including reductions in depression, anxiety, and PTSD, along with enhanced work productivity, and decreased intimate partner violence. The trial investigates the CBSH model's impact on Ubuntu and mental health. Ubuntu, a concept that encompasses humanness, compassion, and interconnectedness, is deeply rooted in the African philosophy.</p><p><strong>Methods/design: </strong>This cluster randomized controlled trial will involve 54 villages randomly selected in the Kirehe district, with 1080 participants randomly allocated equally to the CBSH intervention or a wait-list control group. While the trial will be conducted at the village (cluster) level, both primary and secondary outcomes will be measured individually for participants within each cluster. The Primary outcome \"Ubuntu\" will be measured using a context-adapted Ubuntu measurement scale. Secondary outcomes include psychosocial indicators which will be assessed through standardized tools such as the Patient Health Questionnaire for depression (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), Warwick-Edinburgh Mental Wellbeing scale (WEMWS), Connor-Davidson Resilience scale (CD-RISK-10), Somatic Symptom Severity Scale (PHQ-15), Revised Conflict Tactics scale (CTS2S), and Adapted Social Capital Assessment Tool (SASCAT).</p><p><strong>Conclusion: </strong>This trial aims to evaluate the CBSH model's impacts on Ubuntu, mental health, and social functioning among trauma-affected Rwandans, including those impacted by the 1994 Genocide against the Tutsi, mass killings, sexual abuse, and domestic violence. The findings could be of value to the Ubuntu Centre for Peace, policymakers, healthcare practitioners, and other stakeholders, by highlighting the significance of promoting Ubuntu as a foundation for addressing mental health challenges and the consequences of psychosocial trauma.</p><p><strong>Trial registration: </strong>ISRCTN ISRCTN17659369. Registered on February 09, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"773"},"PeriodicalIF":2.0,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11568552/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644827","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":"Accuracy of healthcare systems data for identifying cardiovascular outcomes after stroke due to intracerebral haemorrhage in the United Kingdom.","authors":"Alice Hosking, Jacqueline Stephen, Jonathan Drever, William N Whiteley, Cathie L M Sudlow, Rustam Al-Shahi Salman","doi":"10.1186/s13063-024-08631-7","DOIUrl":"10.1186/s13063-024-08631-7","url":null,"abstract":"<p><strong>Background: </strong>Healthcare systems data (HCSD) could improve the efficiency of clinical trials, but their accuracy and validity are uncertain. Our objective was to assess the accuracy of HCSD as the sole method of outcome detection in the REstart or STop Antithrombotics Randomised Trial (RESTART; ISRCTN71907627) compared with adjudicated questionnaire follow-up and compare estimates of treatment effect.</p><p><strong>Methods: </strong>RESTART was a prospective, open, assessor-blind, parallel-group randomised controlled trial (RCT) of antiplatelet therapy after intracerebral haemorrhage (ICH) in the UK. We included 496 (92%) of 537 RESTART participants, who were resident in England or Scotland at randomisation. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. RESTART used annual questionnaires to detect its primary outcome (recurrent ICH) and secondary outcome (a composite of haemorrhagic or ischemic major adverse cardiovascular events [MACE]) over a median of 2.0 years; an independent adjudication committee verified outcomes using medical records and brain imaging. We obtained ICD10-coded HCSD on hospital admissions and deaths in England and Scotland to identify primary and secondary outcomes. We compared HCSD with a reference standard of adjudicated outcomes. We estimated the effects of antiplatelet therapy using HCSD alone in a Cox proportional hazards model adjusted for minimisation variables.</p><p><strong>Results: </strong>In the original RESTART trial, 31 people experienced a primary outcome event. HCSD had sensitivity of 84% (95% CI 66 to 95%) and positive predictive value of 68% (51 to 82%) for recurrent ICH. HCSD estimated an effect of antiplatelet therapy (adjusted hazard ratio [aHR] 0.51, 95% CI 0.27 to 0.98; p = 0.044) that was almost identical to adjudicated outcomes (aHR 0.51, 95% CI 0.25 to 1.03; p = 0.060). HCSD had sensitivity of 84% (76 to 91%) and positive predictive value of 78% (69 to 85%) for MACE, on which HCSD estimated an effect of antiplatelet therapy (aHR 0.81, 95% CI 0.56 to 1.16; p = 0.247) that was similar to adjudicated outcomes (aHR 0.65, 95% CI 0.44 to 0.95; p = 0.025).</p><p><strong>Conclusions: </strong>In a RCT of antiplatelet therapy for people with ICH, HCSD was reasonably accurate and provided similar estimates of treatment effect compared with adjudicated outcomes.</p><p><strong>Trial registration: </strong>ISRCTN71907627 . Registered on 25 April 2013.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"774"},"PeriodicalIF":2.0,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11568574/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644658","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":"How should trial teams make decisions about the proportions and diversity of the ethnic groups in their trial?","authors":"Shaun Treweek, Katie Gillies, Miles D Witham, Declan Devane, Kamlesh Khunti, Peter Bower, Adwoa Parker, Irene Soulsby, Bārbala Ostrovska, Sarah Prowse, Heidi Green","doi":"10.1186/s13063-024-08625-5","DOIUrl":"10.1186/s13063-024-08625-5","url":null,"abstract":"<p><strong>Background: </strong>The benefits of randomised trials are not shared equally, and people from ethnic minority groups are a key constituency under-served by clinical research and clinical care. The STRIDE project aimed to give trialists practical information about how to decide which ethnic groups should be in their trials, and at what proportion.</p><p><strong>Methods: </strong>We considered trials in six clinical areas: cancer, cardiovascular, diabetes, maternal health, mental health, and smoking cessation. We created a summary for each, including participants-intervention-comparators-outcomes, and data on disease prevalence by ethnicity. These were discussed with panels with clinical expertise, trial and methodology expertise, lived experience, funding, and experience of working with and on behalf of ethnic communities. For each trial, we asked panel members to decide which ethnic groups should have been involved and at what proportion.</p><p><strong>Results: </strong>We discussed 23 trials with 40 individual panel members. Panels found our questions difficult to answer. The lack of publicly available data on prevalence by ethnicity was central to this. Where data were available, decision-making was easier but not simple. The discussions led to eight STRIDE recommendations. We recommend that discussions involve diverse teams and that discussions need time, with access to the best available data. In the absence of data or consensus, we recommend the adoption of 'default' minimum rates of inclusion, with oversampling considered. These discussions should inform site selection, and the practical challenges of recruitment and retention should not determine which groups are to be included. We also suggest five policy initiatives to support implementation of the recommendations. Broadly, these are (1) funders need to signal that ethnic diversity is expected, (2) trial teams need access to better data, (3) funders and others need to signal that ethnic diversity means better science, (4) more funding is needed for evaluation, and (5) Good Clinical Practice training should cover ethnic diversity.</p><p><strong>Conclusions: </strong>Agreeing targets for which ethnic groups to involve in a trial is essential but difficult. Our eight recommendations could help to make trials more ethnically diverse if followed, and we suggest five policy initiatives that would create a supportive environment for their implementation.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"768"},"PeriodicalIF":2.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566274/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142626826","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":"Evaluation of a multi-component prevention concept for hazardous substance use among refugees in shared accommodations: study protocol for a cluster randomized controlled trial.","authors":"Miriam Hedwig Lorenz, Jonathan Uricher, Markus Iwan Pauzar, Johannes Michalak, Marion Laging, Thomas Heidenreich","doi":"10.1186/s13063-024-08558-z","DOIUrl":"10.1186/s13063-024-08558-z","url":null,"abstract":"<p><strong>Background: </strong>Refugees are exposed to various risk factors in shared accommodations in Germany where they are housed after their arrival. Due to their often traumatic experiences before, during, and after their flight and socio-structural post-migration stressors, refugees are potentially vulnerable to hazardous substance use. They form a structurally disadvantaged group for substance use prevention and intervention. Various barriers make it difficult for them to access the healthcare system and to get health information. Therefore, a participatory multi-component prevention concept for refugees in shared accommodations was developed. The aim of the trial is to evaluate the efficacy of this concept regarding the increase in knowledge about substance use among refugees living in shared accommodations.</p><p><strong>Methods: </strong>Based on a randomized controlled stepped-wedge design, the study will be conducted in a multicenter setting in nine shared accommodations and will aim to include refugees living in shared accommodations as well as social workers and psychologists working there.</p><p><strong>Discussion: </strong>This trial will be one of the first to generate evidence about effective participatory prevention concepts for refugees in shared accommodations. Evidence-based concepts for refugees can improve access to health care and might be helpful for the multidisciplinary workforce in shared accommodations.</p><p><strong>Trial registration: </strong>OSF Registry: osf.io/ebnj3. Registered on May 24, 2024. Registration DOI: https://doi.org/10.17605/OSF.IO/EBNJ3.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"770"},"PeriodicalIF":2.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566282/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644828","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":"Effects on tricuspid regurgitation by different techniques for passing permanent pacemaker leads through the tricuspid valve: a randomized, open-label, superiority clinical trial study protocol.","authors":"Jianan Hong, Zhanyi Qiu, Zhongbo Xiao, Xiaobin Ni, Yanling Fang, Shiwan Wu, Yandan Xie, Chang Chen, Yequn Chen, Muli Wu","doi":"10.1186/s13063-024-08630-8","DOIUrl":"10.1186/s13063-024-08630-8","url":null,"abstract":"<p><strong>Background: </strong>In recent years, lead-induced tricuspid regurgitation (LITR) has attracted increasing attention. At present, there are two commonly used transvalvular methods for pacing lead wires to enter the right ventricle. The first transvalvular approach involves placing the tip of the pacing lead directly through the tricuspid valve into the right ventricle, including \"direct-crossing\" and \"drop-down.\" The second transvalvular approach is to bend the pacing lead so that the reflexed lead body crosses the tricuspid valve and then enters the right ventricle, which is \"prolapsing.\" However, there are no clinical trials to evaluate or compare the effects of the above two different pacing lead transvalvular approaches on tricuspid regurgitation. In this study, we will perform a randomized clinical trial to understand the effect of different transvalvular lead wire transversal techniques on the incidence of tricuspid regurgitation.</p><p><strong>Methods: </strong>Three hundred seventy-six subjects with right ventricular single-chamber pacemaker implantation or dual-chamber pacemaker implantation were recruited in the First Affiliated Hospital of Shantou University Medical College. Participants will be randomized into the direct group (\"direct-crossing\" and \"drop-down\") or the bending group (\"prolapsing\"). The primary objective will be new tricuspid regurgitation or exacerbation of existing tricuspid regurgitation within 1 year of follow-up.</p><p><strong>Discussion: </strong>This study aims to verify whether different transvalvular approaches influence the incidence of LITR, and is expected to provide an optimized method for routine pacemaker surgery and improve the long-term prognosis and quality of life of patients.</p><p><strong>Trial registration: </strong>Chinese Clinical Trials Registry ChiCTR2100045558. Registered on April 19, 2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"772"},"PeriodicalIF":2.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11568686/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644588","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":"Intravenous versus oral iron supplementation for iron deficiency anemia in patients with rectal cancer undergoing neoadjuvant chemoradiotherapy: a study protocol for a randomized controlled trial.","authors":"Hyeung-Min Park, Jaram Lee, Soo Young Lee, Chang Hyun Kim, Hyeong Rok Kim","doi":"10.1186/s13063-024-08624-6","DOIUrl":"10.1186/s13063-024-08624-6","url":null,"abstract":"<p><strong>Background: </strong>Numerous studies have been conducted to manage anemia in surgical patients through iron supplementation as an alternative to blood transfusion. However, patients with locally advanced rectal cancer have often been excluded from these studies, due to their standard treatment involving neoadjuvant chemoradiotherapy. This study aims to evaluate the impact of intravenous versus oral iron supplementation on iron deficiency anemia in patients with rectal cancer receiving preoperative chemoradiotherapy.</p><p><strong>Methods: </strong>This open-label, single-center, parallel, superiority, randomized trial includes patients with primary rectal cancer who are candidates for preoperative chemoradiotherapy and have confirmed iron-deficiency anemia. A total of 94 patients will be randomly assigned in a 1:1 ratio to receive either intravenous or oral iron supplementation. Stratification factors include age (> 70 vs. ≤ 70 years) and baseline serum hemoglobin levels (7-10 g/dL vs. 10-13 g/dL). The primary endpoint is the percentage of patients achieving normalized hemoglobin levels from the start of treatment to the day of admission for surgery. Secondary endpoints include changes in serum hemoglobin from baseline to postoperatively, changes in iron assay parameters, time needed to hemoglobin normalization, volume of blood transfusions required, and incidence of postoperative complications.</p><p><strong>Discussion: </strong>This study is the first randomized controlled trial investigating the effect of iron supplementation in iron-deficient patients with rectal cancer undergoing neoadjuvant chemoradiotherapy. This trial is expected to provide evidence for the benefits of administering iron supplementation in patients with rectal cancer undergoing neoadjuvant chemoradiotherapy.</p><p><strong>Trial registration: </strong>Clinical Research Information Service (CRIS) of Republic of Korea, KCT0009260, Registered on March 21, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"771"},"PeriodicalIF":2.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566736/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644830","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":"Correction: Normal saline versus lactated Ringer's solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocol.","authors":"Lucía Guilabert, Karina Cárdenas-Jaén, Alicia Vaillo-Rocamora, Ana García García de Paredes, Ankit Chhoda, Sunil G Sheth, Carlos López-Valero, Pedro Zapater, Eva M Navarrete-Muñoz, Patrick Maisonneuve, Yasmin G Hernández-Barco, Gabriele Capurso, James L Buxbaum, Enrique de-Madaria","doi":"10.1186/s13063-024-08581-0","DOIUrl":"10.1186/s13063-024-08581-0","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"769"},"PeriodicalIF":2.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566695/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644659","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":"Theoretically-informed vs standard cover letter to improve participant response to mailed questionnaire: results of an embedded randomised retention trial.","authors":"Colin C Everett, Sarah T Brown, Joanna L Dennett, Howard Collier, Claire L Davies, Frances Game, E Andrea Nelson","doi":"10.1186/s13063-024-08565-0","DOIUrl":"10.1186/s13063-024-08565-0","url":null,"abstract":"<p><strong>Background: </strong>Participant non-response is a source of bias in all research, especially in randomised controlled trials. Participants followed up remotely can have high non-response rates. Four such trials have been conducted of a cover letter with content informed by behaviour change theory to overcome hypothesised barriers to responding to a mailed questionnaire. Pooled results to date have suggested further research to be worthwhile. We conducted an embedded randomised study within a trial of such cover letters in the hope that we would improve response rates to our postal quality of life questionnaires.</p><p><strong>Methods: </strong>One hundred forty-eight participants in the CODIFI2 diabetic foot ulcer sampling trial were randomised 1:1 to receive one of two different cover letters at follow-up timepoints: either a standard cover letter accompanying their postal follow-up questionnaires or to an 'enhanced' (theory-informed) cover letter. Questionnaires were mailed at 39, 52 and (for some participants) 104 weeks post randomisation. Outcome measures were response to mailing at each timepoint. Analysis was restricted to those for whom a questionnaire and letter was issued. Owing to limited recruitment, a reduced analysis plan, comprising solely observed response rates and 95% confidence intervals for difference in response rates was followed. Post hoc, we added our week 52 results to an already-published meta-analysis.</p><p><strong>Results: </strong>Sixty-seven out of 74 enhanced cover letter group (Enhanced) and 67/74 standard cover letter group (Standard) participants who had not already died or withdrawn were sent their first mailing at 39 weeks. The 39-week response rates were 47/67 (70.1%) and 39/67 (58.2%) for Enhanced and Standard participants, respectively. At week 52, the response rates were 45/64 (70.3%) and 35/63 (55.6%) for Enhanced and Standard participants, respectively. At week 104, the response rates were 24/33 (72.7%) and 19/33 (57.6%) for the Enhanced and Standard participants, respectively. Adding our week 52 results to a published meta-analysis increased the pooled estimate of differences in response rates to 0.04 (- 0.01 to 0.09) favouring enhanced letters.</p><p><strong>Conclusion: </strong>While this embedded randomised controlled trial observed greater response rates at all times among those randomised to the enhanced letter, the reduced sample size meant that these results are imprecise.</p><p><strong>Trial registration: </strong>ISRCTN registry ISRCTN74929588. Registered on 5 March 2019.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"763"},"PeriodicalIF":2.0,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11562673/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628645","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}