Trials最新文献

{"title":"Effects of melatonin supplementation on metabolic parameters, oxidative stress, and inflammatory biomarkers in diabetic patients with chronic kidney disease: study protocol for a double-blind, randomized controlled trial.","authors":"Sara Sadeghi, Monir Sadat Hakemi, Fatemeh Pourrezagholie, Fatemeh Naeini, Hossein Imani, Hamed Mohammadi","doi":"10.1186/s13063-024-08584-x","DOIUrl":"10.1186/s13063-024-08584-x","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic kidney disease (CKD) is a pervasive disease of the current century that usually affects the adult population, especially people with diabetes and hypertension. According to the recent studies, inflammation, oxidative stress, apoptosis, and mitochondrial dysfunction are determining risk factors in the pathogenesis of CKD. Melatonin as a strong antioxidant is produced in various tissues including the kidneys. The present clinical trial aims to examine the efficacy of melatonin supplementation on metabolic parameters, oxidative stress, and inflammatory biomarkers in diabetic patients with CKD.</p><p><strong>Methods: </strong>This is a double-blind, randomized, placebo-controlled clinical study that will be investigated the impacts of melatonin supplementation in diabetic patients with CKD. Laboratory findings will be applied to diagnose diabetic CKD. Forty-eight eligible diabetic subjects with CKD will be selected and randomly assigned to receive 5 mg melatonin tablets or identical placebo twice daily for 10 weeks. Participants will be asked to remain on their usual diet and physical activity. The primary outcome of this study is changes in oxidative stress and inflammatory biomarkers. The secondary outcomes include changes in lipid profile, renal function indicators, fasting blood sugar and serum insulin, systolic and diastolic blood pressure (SBP and DBP), serum phosphorous concentration, sleep quality, body weight, body mass index (BMI), and waist circumference (WC). Statistical analysis will be conducted using the SPSS software (version 25).</p><p><strong>Discussion: </strong>We hypothesize that melatonin administration may be useful for treating diabetic CKD by modulating oxidative stress, inflammation, regulating lipid metabolism, and increasing insulin sensitivity through different mechanisms. The current trial will exhibit the effects of melatonin, whether negative or positive, on diabetic CKD status.</p><p><strong>Ethical aspects: </strong>The current trial received approval from Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.SHARIATI.REC.1402.072).</p><p><strong>Trial registration: </strong>This study had been registered in Iranian Registry of Clinical Trials.</p><p><strong>Registration number: </strong>IRCT20170202032367N9 on 11 August 2023. https://www.irct.ir/trial/70709 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"757"},"PeriodicalIF":2.0,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11559127/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142629302","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":"SMILE-stereotactic multiple fraction radiotherapy for non-spine bone metastases: study protocol for a multicenter, open-label phase III randomized controlled trial.","authors":"Robert Foerster, Daniel R Zwahlen, Christina Schroeder, Paul Windisch, Marc-Eric Halatsch, Alex Alfieri, Christoph Meier, Hossein Hemmatazad, Daniel M Aebersold, André Buchali, Daniel Habermehl, Nidar Batifi","doi":"10.1186/s13063-024-08608-6","DOIUrl":"10.1186/s13063-024-08608-6","url":null,"abstract":"<p><strong>Background: </strong>The SMILE study addresses a significant need in palliative oncology by evaluating the non-inferiority of a shortened, 3-fraction stereotactic body radiotherapy (SBRT) schedule against the traditional 5-fraction approach for non-spine bone metastases in terms of pain control. Optimizing SBRT could significantly enhance the quality of life for patients by providing effective pain relief while minimizing treatment sessions.</p><p><strong>Methods: </strong>This international, multicenter phase III trial will randomize 162 patients to receive either a 3-fraction regimen (9 Gy per fraction) or a standard 5-fraction regimen (7 Gy per fraction). Outcomes, assessed at 3 months post-treatment, will focus on pain response, quality of life, and control of metastasis. With a hypothesis-driven design, the study will incorporate intent-to-treat and per-protocol analyses, incorporating appropriate measures for data integrity and handling of missing information.</p><p><strong>Discussion: </strong>If the 3-fraction SBRT regimen demonstrates non-inferiority, it could streamline palliative care protocols, reduce patient burden, and set a new standard for treatment, reflecting a patient-centered approach in palliative radiation oncology.</p><p><strong>Trial registration: </strong>The trial has been registered prospectively on ClinicalTrials.gov under the identifier NCT05406063, as of May 3, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"762"},"PeriodicalIF":2.0,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11562624/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628536","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":"Anorexia nervosa-specific home treatment in children and adolescents and their families (the HoT study): a study protocol of a randomized, controlled, multicenter, open-label, parallel group superiority trial.","authors":"Brigitte Dahmen, Ingar Zielinski-Gussen, Manuel Föcker, Freia Hahn, Tanja Legenbauer, Ulf Thiemann, Astrid Dempfle, Beate Herpertz-Dahlmann","doi":"10.1186/s13063-024-08566-z","DOIUrl":"10.1186/s13063-024-08566-z","url":null,"abstract":"<p><strong>Background: </strong>New treatment approaches are urgently needed to improve the prognosis of children and adolescents with anorexia nervosa (AN). Recently, the feasibility of multidisciplinary home treatment that strongly involves the patients' parents/caregivers has been investigated. However, no RCT has yet been performed to test the efficacy and safety of this approach compared to standard treatment approaches, such as inpatient treatment.</p><p><strong>Methods: </strong>In this multicenter randomized-controlled trial, home treatment for children and adolescents with AN aged 12 to 18 years is established at 5 major treatment centers for AN in Germany. Approximately 240 patients who are admitted to the hospital for AN will be included in the trial. After a short inpatient somatic stabilization phase (5-8 weeks), patients are randomized to receive either treatment as usual (TAU), in the form of continued inpatient or day patient treatment, or the newly developed home treatment (HoT) (n = 82/arm, n = 164 in total). There are three assessments throughout treatment (admission, randomization, and discharge), as well as follow-up assessments at 9 and 12 months after admission. The BMI at 12 months after admission (primary outcome) is compared between groups (adjusted for premorbid BMI and admission BMI); secondary outcomes include eating disorder and general psychopathology, the number and duration of psychiatric rehospitalizations, quality of life, motivation for treatment and treatment satisfaction. Other secondary outcomes include the primary caregivers' burden and skills in handling the child's illness and direct treatment costs. Statistical analysis will be based on intention-to-treat principles, using mixed models for repeated measures. (Serious) adverse events are assessed throughout treatment. In addition, the feasibility and implementation of HoT as well as the satisfaction and workload of the members of the multidisciplinary treatment teams in both arms will be assessed.</p><p><strong>Discussion: </strong>In the case of a positive evaluation, HoT can be considered an effective treatment method to replace or complete established treatment methods, such as IP, for treating AN in children and adolescents. The home treatment setting might shorten inpatient stays in this patient group, increase treatment satisfaction, and help to reduce the risk of rehospitalization, which is associated with a better outcome in this vulnerable patient group.</p><p><strong>Trial registration: </strong>The trial was registered with the German Clinical Trial Register (DRKS) under the ID DRKS00025925 on November 26, 2021 (prospectively registered): https://drks.de/search/de/trial/DRKS00025925 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"760"},"PeriodicalIF":2.0,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11559055/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142629276","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":"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}

{"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}

{"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}

{"title":"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.","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 (FiO₂-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 FiO₂-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 FiO₂-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}

{"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}

{"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}

{"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}