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Bilateral erector spinae plane block on opioid-sparing effect in upper abdominal surgery: study protocol for a bi-center prospective randomized controlled trial. 上腹部手术中双侧竖脊肌平面阻滞对阿片类药物节约效果的影响:双中心前瞻性随机对照试验的研究方案。
IF 2 4区 医学
Trials Pub Date : 2024-11-13 DOI: 10.1186/s13063-024-08612-w
Changzhen Geng, Li Wang, Yaping Shi, Xinnan Shi, Hanyi Zhao, Ya Huang, Qiufang Ji, Yuanqiang Dai, Tao Xu
{"title":"Bilateral erector spinae plane block on opioid-sparing effect in upper abdominal surgery: study protocol for a bi-center prospective randomized controlled trial.","authors":"Changzhen Geng, Li Wang, Yaping Shi, Xinnan Shi, Hanyi Zhao, Ya Huang, Qiufang Ji, Yuanqiang Dai, Tao Xu","doi":"10.1186/s13063-024-08612-w","DOIUrl":"10.1186/s13063-024-08612-w","url":null,"abstract":"<p><strong>Background: </strong>Erector spinae plane block (ESPB) is a promising technique for effective analgesia. It is still uncertain if ESPB offers the same opioid-sparing effect as thoracic paravertebral block (PVB) in midline incision for upper abdominal surgery.</p><p><strong>Methods: </strong>The study is a prospective, bi-center, randomized, controlled, non-inferior trial. One hundred fifty-eight patients scheduled for upper abdominal surgery will be randomly assigned to receive bilateral ESPB or PVB before surgery. The primary outcome will be the equivalent cumulative analgesia dosage of sufentanil during the surgery, which is defined as the total dosage of sufentanil from anesthesia induction to tracheal extubation. The main secondary outcomes include postoperative complications and the quality of recovery-15 score at 24 h, 48 h, and 30 days after surgery.</p><p><strong>Discussion: </strong>This study will assess the opioid-sparing efficacy of ESPB and PVB, complications, and the quality of recovery of two blocks.</p><p><strong>Trial registration: </strong>ChiCTR2300073030 ( https://www.chictr.org.cn/ ). Registered on 30 June 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"761"},"PeriodicalIF":2.0,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11562366/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142629279","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}
引用次数: 0
A survey to determine the zone of equipoise for the Proximal FEmur Resection or Internal Fixation fOR Metastases (PERFORM) randomized controlled trial. 为确定 "肿瘤近端切除术或转移灶内固定术(PERFORM)"随机对照试验的平衡区而进行的调查。
IF 2 4区 医学
Trials Pub Date : 2024-11-13 DOI: 10.1186/s13063-024-08590-z
Jessa Fogel, Vincent Y Ng, Thomas Schubert, Jonathan Forsberg, R Lor Randall, Ricardo Becker, Carol Morris, Michelle Ghert
{"title":"A survey to determine the zone of equipoise for the Proximal FEmur Resection or Internal Fixation fOR Metastases (PERFORM) randomized controlled trial.","authors":"Jessa Fogel, Vincent Y Ng, Thomas Schubert, Jonathan Forsberg, R Lor Randall, Ricardo Becker, Carol Morris, Michelle Ghert","doi":"10.1186/s13063-024-08590-z","DOIUrl":"10.1186/s13063-024-08590-z","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to establish a zone of clinical equipoise for the Proximal FEmur Resection or Internal Fixation fOR Metastases (PERFORM) randomized controlled trial, which will compare resection and endoprosthetic reconstruction to internal fixation for skeletal metastases of the proximal femur.</p><p><strong>Methods: </strong>A survey was developed, piloted, and distributed to self-declared interested stakeholders in the PERFORM trial. The survey targeted orthopedic oncologists and was designed to assess patient and bone lesion characteristics that drive surgical decision-making in the treatment of skeletal metastases in the proximal femur. An Ethics Waiver was obtained at the lead academic institution and data was collected in the REDCap survey database.</p><p><strong>Results: </strong>Responses were complete from 76 surgeons across North America, South America, Europe, Asia, and Africa. Response rate from self-declared interested stakeholders was 70%, with additional responses collected from a broader international audience. Responses indicate that a study population for which either resection and endoprosthetic reconstruction or internal fixation are acceptable options include (1) life expectancy at least 6 months, (2) bone loss of no more than 75% and no less than 25%, and (3) minimal to moderate risk for perioperative complications. Ninety-three percent of respondents indicated that they would be interested in participating in the PERFORM trial.</p><p><strong>Conclusion: </strong>A preliminary zone of equipoise for the PERFORM trial includes patients with 25-75% bone loss, low to moderate risk of operative complications, and life expectancy of at least 6 months. Further stakeholder discussions have finalized the PERFORM trial protocol prior to study initiation.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"759"},"PeriodicalIF":2.0,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11558838/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142629270","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}
引用次数: 0
Effectiveness of a digital health and financial incentive intervention to promote physical activity in patients with type 2 diabetes: study protocol for a randomised controlled trial with a nested qualitative study-ACTIVATE trial. 促进 2 型糖尿病患者体育锻炼的数字健康和经济激励干预措施的效果:带有嵌套定性研究的随机对照试验--ACTIVATE 试验的研究方案。
IF 2 4区 医学
Trials Pub Date : 2024-11-12 DOI: 10.1186/s13063-024-08513-y
James P Sanders, Amanda J Daley, Dale W Esliger, Andrea K Roalfe, Antoanela Colda, Joanne Turner, Soma Hajdu, Andrew Potter, Asif M Humayun, Ioannis Spiliotis, Ian Reckless, Oliver Mytton
{"title":"Effectiveness of a digital health and financial incentive intervention to promote physical activity in patients with type 2 diabetes: study protocol for a randomised controlled trial with a nested qualitative study-ACTIVATE trial.","authors":"James P Sanders, Amanda J Daley, Dale W Esliger, Andrea K Roalfe, Antoanela Colda, Joanne Turner, Soma Hajdu, Andrew Potter, Asif M Humayun, Ioannis Spiliotis, Ian Reckless, Oliver Mytton","doi":"10.1186/s13063-024-08513-y","DOIUrl":"10.1186/s13063-024-08513-y","url":null,"abstract":"<p><strong>Background: </strong>The prevention of type 2 diabetes (T2DM) is recognised as a health care priority in the UK. In people living with T2DM, lifestyle changes (e.g. increasing physical activity) have been shown to slow disease progression and protect from the development of associated comorbidities. The use of digital health technologies provides a strategy to increase physical activity in patients with chronic disease. Furthermore, behaviour economics suggests that financial incentives may be a useful strategy for increasing the maintenance and effectiveness of behaviour change intervention, including physical activity intervention using digital health technologies. The Milton Keynes Activity Rewards Programme (MKARP) is a 24-month intervention which combines the use of a mobile health app, smartwatch (Fitbit or Apple watch) and financial incentives to encourage people living with T2DM to increase physical activity to improve health. Therefore, this randomised controlled trial aims to examine the long-term acceptability, health effects and cost-effectiveness of the MKARP on HbA1c in patients living with T2DM versus a waitlist usual care comparator.</p><p><strong>Methods: </strong>A two-arm, single-centre, randomised controlled trial aiming to recruit 1018 participants with follow-up at 12 and 24 months. The primary outcome is the change in HbA1c at 12 months. Secondary outcomes included changes in markers of metabolic, cardiovascular, anthropometric, and psychological health along with cost-effectiveness. Recruitment will be via annual diabetes review in general practices, retinal screening services and social media. Participants aged 18 or over, with a diagnosis of type 2 diabetes and a valid HbA1c measurement in the last 2 months are invited to take part in the trial. Participants will be individually randomised (1:1 ratio) to receive either the Milton Keynes Activity Rewards Programme or usual care. The intervention will last for 24 months with assessment for outcomes at baseline, 12 and 24 months.</p><p><strong>Discussion: </strong>This study will provide new evidence of the long-term effectiveness of an activity rewards scheme focused on increasing physical activity conducted within routine care in patients living with type 2 diabetes in Milton Keynes, UK. It will also investigate the cost-effectiveness of the intervention.</p><p><strong>Trial registration: </strong>ISRCTN 14925701. Registered on 30 October 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"755"},"PeriodicalIF":2.0,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11559103/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142629299","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}
引用次数: 0
Statistical analysis plan for the FiO2-C trial: effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcomes of extremely preterm infants-a randomized-controlled parallel group multicentre trial for safety and efficacy. FiO2-C 试验的统计分析计划:闭环自动控制吸入氧气分数 (FiO2-C) 对极早产儿预后的影响--一项随机对照平行组多中心安全性和有效性试验。
IF 2 4区 医学
Trials Pub Date : 2024-11-12 DOI: 10.1186/s13063-024-08615-7
Jochem König, Anette Stauch, Corinna Engel, Michael S Urschitz, Axel R Franz
{"title":"Statistical analysis plan for the FiO<sub>2</sub>-C trial: effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO<sub>2</sub>-C) on outcomes of extremely preterm infants-a randomized-controlled parallel group multicentre trial for safety and efficacy.","authors":"Jochem König, Anette Stauch, Corinna Engel, Michael S Urschitz, Axel R Franz","doi":"10.1186/s13063-024-08615-7","DOIUrl":"10.1186/s13063-024-08615-7","url":null,"abstract":"<p><strong>Background: </strong>Extremely low gestational age neonates (ELGANs, i.e. those born before 28 weeks postmenstrual age (PMA)) often require supplemental oxygen and frequently experience intermittent hypo- and hyperoxemic episodes. Exposure to episodes with inadequate oxygen concentrations has been shown to be associated with an increased risk of retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), neurodevelopmental impairment (NDI) and death. Closed-loop automatic control of the inspiratory fraction of oxygen (FiO<sub>2</sub>-C) reduces number and duration of hypo- and hyperoxemic episodes in ELGANs. Its impacts on clinically important short- and long-term outcomes such as ROP, BPD, NEC, NDI and mortality have not yet been studied.</p><p><strong>Methods: </strong>An outcome-assessor-blinded, multicentre, randomized-controlled, parallel-group trial for superiority was designed to study the effects of FiO<sub>2</sub>-C (provided by standard infant ventilators) in addition to routine manual control (RMC) during respiratory support, compared to RMC only, on short- and long-term clinical outcomes in ELGANs. Two co-primary composite outcomes were defined: (i) death, severe ROP, BPD or NEC, assessed at 36 weeks PMA or, in case of ROP, until complete vascularization of the retina; (ii) death or NDI (defined as language/cognitive delay, motor impairment, severe visual impairment or hearing impairment), assessed at 2 years corrected age.</p><p><strong>Results: </strong>Primary outcomes will be compared between the two intervention groups using a Cochran-Mantel-Haenszel test. The factors considered for randomization (centre, sex and gestational age at birth (< 26 weeks and ≥ 26 weeks)) will be used to define strata. Results will be presented as adjusted odds ratios with two-sided 95% and 97.5% confidence intervals and two-sided p values.</p><p><strong>Conclusions: </strong>The statistical analyses for the FiO<sub>2</sub>-C trial were defined in the study protocol and specified in detail in this statistical analysis plan published prior to any statistical analysis. This is in accordance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03168516. Registered on May 30, 2017.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"756"},"PeriodicalIF":2.0,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11559155/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628590","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}
引用次数: 0
Effect of wearing glasses for prevention of SARS-CoV-2 on visits to health care providers-additional results from a randomized controlled trial. 戴眼镜预防 SARS-CoV-2 对就医的影响--随机对照试验的补充结果。
IF 2 4区 医学
Trials Pub Date : 2024-11-12 DOI: 10.1186/s13063-024-08602-y
Ingeborg Hess Elgersma, Petter Elstrøm, Lars G Hemkens, Arnfinn Helleve, Oliver Kacelnik, Atle Fretheim
{"title":"Effect of wearing glasses for prevention of SARS-CoV-2 on visits to health care providers-additional results from a randomized controlled trial.","authors":"Ingeborg Hess Elgersma, Petter Elstrøm, Lars G Hemkens, Arnfinn Helleve, Oliver Kacelnik, Atle Fretheim","doi":"10.1186/s13063-024-08602-y","DOIUrl":"10.1186/s13063-024-08602-y","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"753"},"PeriodicalIF":2.0,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11555958/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142629296","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}
引用次数: 0
PRO-P: evaluating the effect of electronic patient-reported outcome measures monitoring compared with standard care in prostate cancer patients undergoing surgery-study protocol for a randomized controlled trial. PRO-P:评估前列腺癌手术患者接受电子患者报告结果监测与标准护理的效果--随机对照试验研究方案。
IF 2 4区 医学
Trials Pub Date : 2024-11-12 DOI: 10.1186/s13063-024-08579-8
Rouvier Al-Monajjed, Peter Albers, Johanna Droop, Dominik Fugmann, Joachim Noldus, Rein-Jüri Palisaar, Manuel Ritter, Jörg Ellinger, Philipp Krausewitz, Michael Truß, Boris Hadaschik, Viktor Grünwald, Andres-Jan Schrader, Philipp Papavassilis, Nicole Ernstmann, Barbara Schellenberger, Anna Moritz, Christoph Kowalski, Martin Hellmich, Pierce Heiden, Anna Hagemeier, Dirk Horenkamp-Sonntag, Markus Giessing, Luis Pauler, Sebastian Dieng, Maria Peters, Günter Feick, André Karger
{"title":"PRO-P: evaluating the effect of electronic patient-reported outcome measures monitoring compared with standard care in prostate cancer patients undergoing surgery-study protocol for a randomized controlled trial.","authors":"Rouvier Al-Monajjed, Peter Albers, Johanna Droop, Dominik Fugmann, Joachim Noldus, Rein-Jüri Palisaar, Manuel Ritter, Jörg Ellinger, Philipp Krausewitz, Michael Truß, Boris Hadaschik, Viktor Grünwald, Andres-Jan Schrader, Philipp Papavassilis, Nicole Ernstmann, Barbara Schellenberger, Anna Moritz, Christoph Kowalski, Martin Hellmich, Pierce Heiden, Anna Hagemeier, Dirk Horenkamp-Sonntag, Markus Giessing, Luis Pauler, Sebastian Dieng, Maria Peters, Günter Feick, André Karger","doi":"10.1186/s13063-024-08579-8","DOIUrl":"10.1186/s13063-024-08579-8","url":null,"abstract":"<p><strong>Background: </strong>With over 65,000 new cases per year in Germany, prostate cancer (PC) is the most common cancer in men in Germany. Localized PC is often treated by radical prostatectomy and has a very good prognosis. Postoperative quality of life (QoL) is significantly influenced by the side effects of surgery. One possible approach to improve QoL is postoperative symptom monitoring using ePROMs (electronic patient-reported outcome measures) to accurately identify any need for support.</p><p><strong>Methods: </strong>The PRO-P (\"Influence of ePROMS in surgical therapy of PC on the postoperative course\") study is a randomized controlled trial employing 1:1 randomization at 6 weeks postoperatively, involving 260 patients with incontinence (≥ 1 pad/day) at six participating centers. Recruitment is planned for 1 year with subsequent 1-year follow-up. PRO-monitoring using domains of EPIC-26, psychological burden, and QoL are assessed 6, 12, 18, 24, 36, and 52 weeks postoperatively. Exceeding predefined PRO-score cutoffs triggers an alert at the center, prompting patient contact, medical consultation, and potential interventions. The primary endpoint is urinary continence. Secondary endpoints refer to EPIC-26 domains, psychological distress, and QoL. Aspects of feasibility, effect, and implementation of the intervention will be investigated within the framework of a qualitative process evaluation.</p><p><strong>Discussion: </strong>PRO-P investigates the effect on postoperative symptom monitoring of a structured follow-up using ePROMs in the first year after prostatectomy. It is one of the first studies in cancer surgery investigating PRO-monitoring and its putative applicability to routine care. Patient experiences with intensified monitoring of postoperative symptoms and reflective counseling will be examined in order to improve primarily urinary continence, and secondly other burdens of physical and psychological symptoms, quality-of-life, and patient competence. The potential applicability of the intervention in clinical practice is facilitated by IT adaption to the certification standards of the German Cancer Society and the integration of the ePROMs survey via a joint patient portal. Positive outcomes could readily translate this complex intervention into routine clinical care. PRO-P might improve urinary incontinence and QoL in patients with radical prostatectomy through the structured use of ePROMs.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05644821. Registered on 09 December 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"754"},"PeriodicalIF":2.0,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11556073/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628037","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}
引用次数: 0
Detailed statistical analysis plan for a guided self-determination intervention versus an attention control for outpatients with type 2 diabetes in the randomised OVERCOME trial. 在随机 OVERCOME 试验中,针对门诊 2 型糖尿病患者的引导式自我决定干预与注意力对照的详细统计分析计划。
IF 2 4区 医学
Trials Pub Date : 2024-11-11 DOI: 10.1186/s13063-024-08589-6
Anne Sophie Mathiesen, Vibeke Zoffmann, Jane Lindschou, Janus Christian Jakobsen, Christian Gluud, Markus Harboe Olsen, Bodil Rasmussen, Emilie Haarslev Schröder Marqvorsen, Mette Juel Rothmann
{"title":"Detailed statistical analysis plan for a guided self-determination intervention versus an attention control for outpatients with type 2 diabetes in the randomised OVERCOME trial.","authors":"Anne Sophie Mathiesen, Vibeke Zoffmann, Jane Lindschou, Janus Christian Jakobsen, Christian Gluud, Markus Harboe Olsen, Bodil Rasmussen, Emilie Haarslev Schröder Marqvorsen, Mette Juel Rothmann","doi":"10.1186/s13063-024-08589-6","DOIUrl":"10.1186/s13063-024-08589-6","url":null,"abstract":"<p><strong>Background: </strong>Autonomy-supporting interventions may be a prerequisite to achieve better long-term management of type 2 diabetes. Evidence suggests that the guided self-determination (GSD) method might improve haemoglobin A1c and diabetes distress in people with type 1 diabetes. The evidence of an effect of a GSD intervention compared with an attention control group in adults with type 2 diabetes is unknown.</p><p><strong>Methods/design: </strong>The trial is designed as a pragmatic, investigator-initiated, dual-centre, randomised, parallel-group, assessor-blinded, superiority clinical trial of persons with type 2 diabetes. A nurse will administer GSD intervention versus an attention control. The primary outcome is diabetes distress, and secondary outcomes are quality of life, depressive symptoms, and non-serious adverse events. Exploratory outcomes are haemoglobin A1c, motivation, and serious adverse events. Participants are assessed at baseline, 5-, and 12-month follow-up. Here, we present a detailed, comprehensive plan of all statistical analyses, including methods to handle missing data, and assessments of the underlying statistical assumptions. The statistical analyses will be conducted independently by two statisticians following the present plan.</p><p><strong>Discussion: </strong>To mitigate the risk of analysis bias and increase the validity of the OVEROME trial, this statistical analysis plan was developed prior to unblinding of the trial results in concordance with the Declaration of Helsinki and the Conference on Harmonization of Good Clinical Practice Guidelines.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT04601311. Registered on October 2020.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"751"},"PeriodicalIF":2.0,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11552130/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142629286","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}
引用次数: 0
The cerebral and cognitive changes after intermittent theta burst stimulation (iTBS) treatment for depression: study protocol for a randomized double-blind sham-controlled trial. 间歇θ脉冲刺激(iTBS)治疗抑郁症后的大脑和认知变化:随机双盲假对照试验研究方案。
IF 2 4区 医学
Trials Pub Date : 2024-11-11 DOI: 10.1186/s13063-024-08606-8
Marte C Ørbo, Sabine Høier, Torgil R Vangberg, Gabor Csifcsak, Ole K Grønli, Per M Aslaksen
{"title":"The cerebral and cognitive changes after intermittent theta burst stimulation (iTBS) treatment for depression: study protocol for a randomized double-blind sham-controlled trial.","authors":"Marte C Ørbo, Sabine Høier, Torgil R Vangberg, Gabor Csifcsak, Ole K Grønli, Per M Aslaksen","doi":"10.1186/s13063-024-08606-8","DOIUrl":"10.1186/s13063-024-08606-8","url":null,"abstract":"<p><strong>Background: </strong>The therapeutic use of intermittent theta burst stimulation (iTBS) delivered to the left dorsolateral prefrontal cortex (LDLPFC) is a relatively new but promising treatment option for depression. There is a need for more knowledge on the mechanisms involved in its antidepressant effects.</p><p><strong>Methods: </strong>This is a single-centre, prospective, randomized, double-blind, placebo-controlled trial with two arms, iTBS and sham iTBS. Adult outpatients with unipolar major depressive disorder of at least moderate severity will undergo cognitive assessment with an N-back task (0-back and 2-back), functional and structural magnetic resonance imaging and assessment of depression severity before and after brain stimulation. Neuronavigated iTBS or sham stimulation will be targeted at the LDPFC once a day for 10 consecutive workdays. ITBS will be delivered with the parameters 120% of resting motor threshold, triplet 50 Hz bursts repeated at 5 Hz; 2 s on and 8 s off, 600 pulses per session with a total duration of 3 min 9 s. The severity of depression will be measured with the Montogomery Aasberg Depression Rating Scale and the Beck Depression Inventory - second edition. In the iTBS group relative to sham, we expect significant antidepressant effects and improved N-back performance, associated with increased integrity in white matter tracts functionally connected with the LDLPFC and emotion regulation areas within the rostral anterior cingulate cortices, alongside potential increases in cortical thickness in these regions. On functional imaging, we expect to observe increased brain activity in the LDPFC during the performance of the N-back condition with higher cognitive load (2-back) in the iTBS group relative to sham.</p><p><strong>Discussion: </strong>iTBS is a promising, time-efficient, and considered a safe treatment option for depression according to existing evidence. This trial aims to assess the neurocognitive impact of a 2-week, once-daily iTBS compared to sham iTBS, targeting the LDLPFC in depressed adult outpatients. The study investigates the relationships between changes in cerebral measures and cognitive performance on an N-back task in relation to the antidepressant effect following iTBS. This trial delves into the neurocognitive mechanisms of iTBS in depression, potentially offering novel scientific insights into its treatment effects and mechanisms of action.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06534684. Retrospectively registered on August 1st 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"752"},"PeriodicalIF":2.0,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11555895/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628641","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}
引用次数: 0
Addressing Hypertension and Diabetes through Community-Engaged Systems (ANDES) in Puno, Peru: rationale and study protocol for a hybrid type 2 effectiveness and implementation randomized controlled trial. 在秘鲁普诺通过社区参与系统(ANDES)解决高血压和糖尿病问题:2 型有效性和实施随机对照混合试验的原理和研究方案。
IF 2 4区 医学
Trials Pub Date : 2024-11-09 DOI: 10.1186/s13063-024-08586-9
Lindsay J Underhill, Kendra N Williams, Lucy Cordova-Ascona, Karina Campos, Lisa de Las Fuentes, Mark D Huffman, Joel Gittelsohn, Kenneth B Schechtman, Zoila Vela-Clavo, Carla Tarazona-Meza, Laura K Beres, Parker K Acevedo, Abigail Barker, Nishadi Rajapakse, Makeda Williams, Veronica Tonwe, Aaloke Mody, Raquel Hurtado, Juan Carlos Mendoza, Gonzalo Cuentas, Elvin H Geng, William Checkley, Victor G Dávila-Román, Stella M Hartinger-Peña
{"title":"Addressing Hypertension and Diabetes through Community-Engaged Systems (ANDES) in Puno, Peru: rationale and study protocol for a hybrid type 2 effectiveness and implementation randomized controlled trial.","authors":"Lindsay J Underhill, Kendra N Williams, Lucy Cordova-Ascona, Karina Campos, Lisa de Las Fuentes, Mark D Huffman, Joel Gittelsohn, Kenneth B Schechtman, Zoila Vela-Clavo, Carla Tarazona-Meza, Laura K Beres, Parker K Acevedo, Abigail Barker, Nishadi Rajapakse, Makeda Williams, Veronica Tonwe, Aaloke Mody, Raquel Hurtado, Juan Carlos Mendoza, Gonzalo Cuentas, Elvin H Geng, William Checkley, Victor G Dávila-Román, Stella M Hartinger-Peña","doi":"10.1186/s13063-024-08586-9","DOIUrl":"10.1186/s13063-024-08586-9","url":null,"abstract":"<p><strong>Background: </strong>Hypertension is the most common cardiovascular disease in Peru despite the availability of cost-effective, evidence-based treatment. Here we describe the rationale and study design for a hybrid type 2 randomized controlled trial to test the implementation and effectiveness of a community health worker (CHW)-led hypertension control program within the national primary care system in Puno, Peru.</p><p><strong>Methods: </strong>We will recruit 1068 adult participants with hypertension aged ≥ 18 years in Puno, Peru, via facility-based enrollment and community health fairs. Participants will be individually randomized (1:1) to either continue with usual care or participate in a 12-month CHW-led home-based hypertension control program consisting of blood pressure monitoring, medication adherence support, and healthy lifestyle counseling. Outcome development and reporting are guided by the Consolidated Framework for Implementation Research (CFIR), the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, and the Proctor et al. framework. Clinical effectiveness outcomes include mean change in systolic blood pressure (primary outcome), diastolic blood pressure, and HbA1C. Implementation outcomes include fidelity (i.e., CHW protocol adherence and dose), reach, adoption, sustainability, acceptability, and cost-effectiveness.</p><p><strong>Discussion: </strong>The ANDES trial is testing the first CHW-led multicomponent strategy for hypertension and type 2 diabetes management in Peru. This type 2 hybrid trial will provide critical insights into the individual, community, and system-level factors necessary for successful implementation and effectiveness. These data can inform the future adaptation and scaling of the ANDES strategy in Peru and other LMICs, as well as influence policies at the system level to support this transition. Furthermore, by addressing both hypertension and diabetes, the ANDES strategy supports integrated care approaches advocated by the WHO HEARTS technical package, ultimately enhancing health outcomes and reducing morbidity and mortality in the region.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, ID: NCT05524987 , Addressing Hypertension and Diabetes through Community-Engaged Systems in Puno, Peru (ANDES study), prospectively registered on September 1, 2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"747"},"PeriodicalIF":2.0,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11549830/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142629273","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}
引用次数: 0
A new trial monitoring plan (TMP) template for clinical trials: output from a Delphi process. 用于临床试验的新试验监测计划(TMP)模板:德尔菲进程的成果。
IF 2 4区 医学
Trials Pub Date : 2024-11-09 DOI: 10.1186/s13063-024-08601-z
Shiva Taheri, Victoria Yorke-Edwards, Matthew R Sydes, Talia Isaacs, Sharon B Love
{"title":"A new trial monitoring plan (TMP) template for clinical trials: output from a Delphi process.","authors":"Shiva Taheri, Victoria Yorke-Edwards, Matthew R Sydes, Talia Isaacs, Sharon B Love","doi":"10.1186/s13063-024-08601-z","DOIUrl":"10.1186/s13063-024-08601-z","url":null,"abstract":"<p><strong>Background: </strong>Monitoring is a crucial part of trial conduct and ensures that participants' data is fairly represented, and future healthcare information is enhanced. This project aims to improve trial monitoring by creating a trial monitoring plan (TMP) template with input from individuals experienced in monitoring clinical trials.</p><p><strong>Methods: </strong>A review of monitoring plans received from UK Clinical Research Collaboration (UKCRC) registered clinical trials units (CTU)s created the basis for a preliminary TMP template and a Delphi survey. The TMP template was finalised after 2 rounds of a Delphi survey and a two-part consensus meeting including trialists with experience and expertise in monitoring clinical trials.</p><p><strong>Results: </strong>We received 31 monitoring plans from UKCRC-registered CTUs and reviewed over 800 monitoring items for inclusion in a TMP template, selecting items based on guidelines such as Good Clinical Practice (GCP) and our monitoring experiences. For certain items, further expert input was required. A total of 66 items were chosen for a Delphi survey involving 47 participants from 25 UK CTUs and industry. After the first round, all 66 items were retained, and six additional items were suggested by Delphi participants. In the second round, 37 items reached consensus for inclusion in the TMP template. The Delphi process was followed by a consensus meeting with 9 participants from 9 UK CTUs and industry. Participants in the consensus meeting voted on the 32 further items that had not reached the definition of consensus within the Delphi, regarding each item's inclusion in or exclusion from the TMP template. The voting resulted in 18 items being excluded, leaving 14 items to be included in the TMP template. The process overall resulted in a standardised TMP template with input from many individuals with interest, experience, or expertise in monitoring clinical trials.</p><p><strong>Conclusion: </strong>A TMP template was developed building on the currently used monitoring plans and with input from those experienced in clinical trial monitoring. Using a centrally developed good quality TMP template should contribute towards maintaining consistency in monitoring standards across all CTUs, resulting in higher research quality and improved quality assurance. Its use should provide reassurance to participants that their participation is carefully monitored to ensure that their data or any samples provided are treated with confidentiality, integrity, and respect and that their rights and well-being are protected.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"748"},"PeriodicalIF":2.0,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11549859/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142629268","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}
引用次数: 0
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