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Journal articles on the topic 'Randomised clinical trial (RCT)'

Author: Grafiati

Published: 20 July 2024

Last updated: 31 July 2025

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1

Liu, Xiaoqian, Sarah Robbins, Karen Schuck, and David Hunter. "An Online Clinical Trial Model with Secure Data Management System in the Implementation of Randomised Clinical Trials." Journal of Clinical Rheumatology and Immunology 24, supp01 (2024): 43–44. http://dx.doi.org/10.1142/s266134172474033x.

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Background Nowadays, technological advances enable instant data collection in a secure and confidential manner. Integrating electronic data capture technologies into the online clinical trial design, has been rarely investigated. The aim of this study was to test the feasibility and logistics of the online clinical trial model in osteoarthritis. Methods We used Research Electronic Data Capture (REDCap), a versatile and secure database, as the data management platform. Without face-to-face interactions, the majority of the communications among investigators and between investigators and partici

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Chen, Yu, and Ruiqing Yan. "From registration, protocol to report: are COVID-19-related RCTs in mainland China consistent? A systematic review of clinical trial registry and literature." BMJ Open 12, no. 7 (2022): e058070. http://dx.doi.org/10.1136/bmjopen-2021-058070.

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ObjectiveTo provide a comprehensive review of registered COVID-19-related randomised controlled trials (RCTs) in mainland China and evaluate the transparency of reporting through comparison of registrations, protocols and full reports.DesignSystematic review of trial registrations and publications.Data sourcesInternational Clinical Trials Registry Platform, Chinese Clinical Trial Registry, ClinicalTrials.gov, the ISRCTN registry and EU Clinical Trial Register were accessed on 1 February 2022. Publications were searched in PubMed, Embase, Cochrane Library, Google Scholar, CNKI.net and Wanfangda

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Zaghloul, Hadeel, Odette Chagoury, Sara Elhadad, et al. "Clinical and metabolic characteristics of the Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I) randomised clinical trial cohort." BMJ Open 10, no. 12 (2020): e041386. http://dx.doi.org/10.1136/bmjopen-2020-041386.

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ObjectivesDiabetes Intervention Accentuating Diet and Enhancing Metabolism-I (DIADEM-I) is the first randomised controlled trial (RCT) in the Middle East and North Africa (MENA) region testing the effectiveness of an intensive lifestyle intervention (ILI) for weight loss and diabetes remission. We report on the recruitment process and baseline characteristics of the DIADEM-I cohort based on origin (Middle East vs North Africa), and waist circumference.DesignDIADEM-I is an open-label randomised, controlled, parallel group RCT recruiting young individuals (18–50 years) with early type 2 diabetes

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Planas-Cerezales, Lurdes, Laura Fabbri, and Laurence Pearmain. "Add-on therapy for pulmonary fibrosis, a forthcoming era with implications for practice: the BI 101550 and RELIEF trials." Breathe 19, no. 3 (2023): 230090. http://dx.doi.org/10.1183/20734735.0090-2023.

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The therapeutic landscape for idiopathic pulmonary fibrosis (IPF) and progressive fibrosing interstitial lung disease (PFILD) is increasingly complex, with add-on antifibrotic options now in clinical trials, or available for patients progressing on first-line therapy in both conditions. Here, we review two recent trials of potential add-on therapeutic options, the BI 101550 and RELIEF trials. BI 101550 was a phase 2 randomised control trial (RCT) of a novel phosphodiesterase-4 inhibitor in patients with IPF, with a primary end-point of change in forced vital capacity (ΔFVC) (in mL) at 12 weeks

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Jenkins, Valerie A., and Lesley J. Fallowfield. "For the Benefit of Others: Reasons Why Women with Breast Cancer Participate in RCTs." Breast Care 10, no. 2 (2015): 88–93. http://dx.doi.org/10.1159/000376563.

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Background: Appreciation of the barriers and drivers affecting enrolment in randomised clinical trials (RCTs) is important for future trial design, communication and information provision. Methods: As part of an intervention to facilitate UK multidisciplinary team communication about RCTs, women with breast cancer who discussed trials with doctors or research nurses completed questionnaires examining i) clarity of trial information and ii) reasons for their trial decision. Results: 152 women completed the questionnaires; 113/152 (74%) consented to RCT enrolment. Patients' satisfaction with com

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Chen, Stephanie C., Cheryl McCullumsmith, and Scott Y. H. Kim. "Disclosing the potential impact of placebo controls in antidepressant trials." BJPsych Open 1, no. 1 (2015): 1–5. http://dx.doi.org/10.1192/bjpo.bp.115.000109.

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BackgroundAlthough placebo-control clinical trials that withhold effective treatments can be permissible, how best to inform participants of the placebo design has received little attention.AimsTo determine the effect of disclosing quantitative outcome estimates of individual treatment v. entering placebo-control randomised control trial (RCT) on willingness to enrol in such an RCT.MethodWe randomised 278 adult patients at a depression clinic to receive standard disclosure (n = 129) or enhanced (n = 149) quantitative outcome estimates (based on decision analysis) of individual treatment v. RCT

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Hamilton, E. P., G. H. Lyman, S. Kim, and J. Peppercorn. "Availability of experimental therapy outside of randomized clinical trials in oncology." Journal of Clinical Oncology 27, no. 15_suppl (2009): 6539. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.6539.

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6539 Background: Investigational cancer therapies may be available outside of trials, or “off protocol” (OPRx), with implications for patient safety, trial accrual, and access to care. Previous studies suggest OPRx is prevalent in oncology, but there is little consensus on when it should or should not be considered. We evaluated the scope and impact of OPRx through assessment of availability of the experimental arms of recent randomized trials (RCT), and evaluation of study outcomes and accrual. Methods: We conducted a Medline search to identify all English language phase III RCT of medical in

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Keogan, Sheila, Shasha Li, and Luke Clancy. "Allen Carr’s Easyway to Stop Smoking - A randomised clinical trial." Tobacco Control 28, no. 4 (2018): 414–19. http://dx.doi.org/10.1136/tobaccocontrol-2018-054243.

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Objective To determine if Allen Carr’s Easyway to Stop Smoking (AC) was superior to Quit.ie in a randomised clinical trial (RCT). Setting Single centre, open RCT, general population based. Participants 300 adult smokers, 18 years plus, minimum 5 cigarettes daily, and English speaking. AC, 151 (females 44.4%) and Quit.ie, 149 (females 45.6%), mean age 44 years. outcomes for all 300 were analysed (intention-to-treat). Recruited through advertisement from July 2015 to February 2016. Intervention Randomly assigned to AC (n=151) and Quit.ie (n=149), matched for age, sex and education. Block randomi

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Alli, Babatunde Y., Sreenath Madathil, Simon D. Tran, and Belinda Nicolau. "Protocol: carrageenan for the prevention of oral HPV infection – a feasibility randomised clinical trial." BMJ Open 13, no. 7 (2023): e074498. http://dx.doi.org/10.1136/bmjopen-2023-074498.

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IntroductionHead and neck cancers (HNCs) are a significant health burden worldwide. Oral human papillomavirus (HPV) infection is a major risk factor for HNCs. Unfortunately, currently available prophylactic vaccines have limited coverage and potential for HPV type replacement. Carrageenan, a natural product extracted from marine red algae, has demonstrated potency as an HPV inhibitor and could offer a potential alternative to prevent HPV-related diseases, including oral HPV infection. However, there is a lack of clinical studies on the effect of carrageenan on oral HPV infections. As a first s

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Logroscino, Giancarlo. "Randomized clinical trial (RCT): An overview." eNeurologicalSci 38 (March 2025): 100547. https://doi.org/10.1016/j.ensci.2025.100547.

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Watts, Stacey, Yogesh Apte, Thomas Holland, et al. "Randomised, controlled, feasibility trial comparing vasopressor infusion administered via peripheral cannula versus central venous catheter for critically ill adults: A study protocol." PLOS ONE 19, no. 5 (2024): e0295347. http://dx.doi.org/10.1371/journal.pone.0295347.

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Background When clinicians need to administer a vasopressor infusion, they are faced with the choice of administration via either peripheral intravenous catheter (PIVC) or central venous catheter (CVC). Vasopressor infusions have traditionally been administered via central venous catheters (CVC) rather than Peripheral Intra Venous Catheters (PIVC), primarily due to concerns of extravasation and resultant tissue injury. This practice is not guided by contemporary randomised controlled trial (RCT) evidence. Observational data suggests safety of vasopressor infusion via PIVC. To address this evid

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Abbs, Samantha, Barnaby Reeves, Michael R. Whitehouse, et al. "DESIGNING A PRAGMATIC ORTHOPAEDIC TRIAL FOR PATIENTS RECEIVING TOTAL HIP ARTHROPLASTY." Orthopaedic Proceedings 107-B, SUPP_2 (2025): 29. https://doi.org/10.1302/1358-992x.2025.2.029.

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Pragmatic randomised controlled trials (RCTs) are designed to test the effectiveness of interventions in real-life settings, and it is notoriously difficult to achieve clinical equipoise in surgical trials. The HIPPY RCT aims to recruit 7,866 patients to three groups. Surgeon engagement and an efficient use of the budget is paramount for its success.HIPPY is a pragmatic RCT in 60–100 hospitals to determine whether cemented, uncemented, or hybrid implants are better for patients under 70 in terms of revision rates at 10-years post-surgery. Surgeons were invited to take part in a survey and opti

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Udayakumar, Suji, Sasha Thomson, Albiruni Ryan Abdul Razak, and Kelvin K. Chan. "Do early phase trials predict clinical efficacy in subsequent phase III biomarker-enriched randomized trials?" Journal of Clinical Oncology 40, no. 16_suppl (2022): 3152. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.3152.

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3152 Background: Efficacy endpoints of randomized controlled trials (RCT) are commonly used as the basis of regulatory drug approvals. Recently, promising results in early phase trials have resulted in approval of biomarker-targeted therapies. We examined if early phase trial results were associated with efficacy in subsequent biomarker-enriched RCTs. Methods: All cancer drug RCTs conducted between January 2006 and March 2021 were identified through Clinicaltrials.gov. Trials were eligible if a biomarker was used to select a patient population for treatment with a targeted agent. Associated ea

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Kho, Michelle E., Alexander J. Molloy, France J. Clarke, et al. "Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients." BMJ Open Respiratory Research 6, no. 1 (2019): e000383. http://dx.doi.org/10.1136/bmjresp-2018-000383.

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IntroductionAcute rehabilitation in critically ill patients can improve post-intensive care unit (post-ICU) physical function. In-bed cycling early in a patient’s ICU stay is a promising intervention. The objective of this study was to determine the feasibility of recruitment, intervention delivery and retention in a multi centre randomised clinical trial (RCT) of early in-bed cycling with mechanically ventilated (MV) patients.MethodsWe conducted a pilot RCT conducted in seven Canadian medical-surgical ICUs. We enrolled adults who could ambulate independently before ICU admission, within the f

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Soomro, Naeem, Jan Lecouturier, Deborah D. Stocken, et al. "Surveillance versus ablation for incidentally diagnosed small renal tumours: the SURAB feasibility RCT." Health Technology Assessment 21, no. 81 (2017): 1–68. http://dx.doi.org/10.3310/hta21810.

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Background There is uncertainty around the appropriate management of small renal tumours. Treatments include partial nephrectomy, ablation and active surveillance. Objectives To explore the feasibility of a randomised trial of ablation versus active surveillance. Design Two-stage feasibility study: stage 1 – clinician survey and co-design work; and stage 2 – randomised feasibility study with qualitative and economic components. Methods Stage 1 – survey of radiologists and urologists, and development of patient information materials. Stage 2 – patients identified across eight UK centres with sm

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Kristensen, Anne Wilhøft, Kenneth Jensen, Annesofie L. Jensen, et al. "Factors associated with participation in a proton therapy clinical trial: a cross-sectional survey of Danish patients with head and neck cancer." Acta Oncologica 64 (July 10, 2025): 879–88. https://doi.org/10.2340/1651-226x.2025.43912.

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Background and purpose: Participation in proton therapy (PT) trials may be affected by structural, clinical, and individual factors, potentially excluding certain patient groups. Such disparities can lead to unequal access to potential research benefits and may limit the generalisability of trial findings. This study aimed to identify factors associated with participation in a Danish randomised controlled trial (RCT) comparing proton versus photon radiotherapy for head and neck cancer. Patients and methods: This national cross-sectional study invited patients with pharyngeal and laryngeal canc

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Kragsnaes, Maja Skov, Shaun Theodor Sødergren, Jens Kjeldsen, et al. "Experiences and perceptions of patients with psoriatic arthritis participating in a trial of faecal microbiota transplantation: a nested qualitative study." BMJ Open 11, no. 3 (2021): e039471. http://dx.doi.org/10.1136/bmjopen-2020-039471.

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ObjectivesPatients’ first-hand experiences of faecal microbiota transplantation (FMT) performed in a rheumatological care setting have yet to be elucidated. The objectives were to explore participants’ perceptions of being part of an FMT trial thereby identifying potential trial participation effects and enlightening the patient perspective on the outlook for future FMT trials in rheumatic diseases.DesignIn a qualitative study nested within a double-blind, randomised, placebo-controlled trial (RCT) testing FMT as a potential new antirheumatic treatment, semistructured telephone interviews were

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Wied, Stephanie, Ralf-Dieter Hilgers, Nicole Heussen, et al. "Methodological insights from the EPISTOP trial to designing clinical trials in rare diseases—A secondary analysis of a randomized clinical trial." PLOS ONE 19, no. 12 (2024): e0312936. https://doi.org/10.1371/journal.pone.0312936.

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Background In clinical research, the most appropriate way to assess the effect of an intervention is to conduct a randomized controlled trial (RCT). In the field of rare diseases, conducting an RCT is challenging, resulting in a low rate of clinical trials, with a high frequency of early termination and unpublished trials. The aim of the EPISTOP trial was to compare outcomes in infants with tuberous sclerosis (TSC) who received vigabatrin preventively before the seizures onset with those who received it conventionally after. The study was designed as a prospective, multicentre, randomized clin

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Little, John D., Lorraine Davison, and Robert D. Little. "Clinically, what ought we to believe?" Australasian Psychiatry 27, no. 1 (2018): 72–74. http://dx.doi.org/10.1177/1039856218810160.

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Objective: To question the status of the randomised controlled trial (RCT) in the hierarchy of evidence. Conclusions: The RCT provides important and clinically relevant information, particularly in psychopharmacology. However, and as with other methodologies, RCTs too are flawed and automatic abdication to their conclusions, especially in complex social interventions, is unwise. A clinical example with conflicting and polarising views, each with their evidence base, is described alongside a suggested clinical strategy for resolving differences of opinion.

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Young, Amber E., Anna Davies, Sophie Bland, Sara Brookes, and Jane M. Blazeby. "Systematic review of clinical outcome reporting in randomised controlled trials of burn care." BMJ Open 9, no. 2 (2019): e025135. http://dx.doi.org/10.1136/bmjopen-2018-025135.

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IntroductionSystematic reviews collate trial data to provide evidence to support clinical decision-making. For effective synthesis, there must be consistency in outcome reporting. There is no agreed set of outcomes for reporting the effect of burn care interventions. Issues with outcome reporting have been identified, although not systematically investigated. This study gathers empirical evidence on any variation in outcome reporting and assesses the need for a core outcome set for burn care research.MethodsElectronic searches of four search engines were undertaken from January 2012 to Decembe

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Ong, Sean W. X., Todd C. Lee, Robert A. Fowler, et al. "Evaluating the impact of a SIMPlified LaYered consent process on recruitment of potential participants to theStaphylococcus aureusNetwork Adaptive Platform trial: study protocol for a multicentre pragmatic nested randomised clinical trial (SIMPLY-SNAP trial)." BMJ Open 14, no. 1 (2024): e083239. http://dx.doi.org/10.1136/bmjopen-2023-083239.

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IntroductionInformed consent forms (ICFs) for randomised clinical trials (RCTs) can be onerous and lengthy. The process has the potential to overwhelm patients with information, leading them to miss elements of the study that are critical for an informed decision. Specifically, overly long and complicated ICFs have the potential to increase barriers to trial participation for patients with mild cognitive impairment, those who do not speak English as a first language or among those with lower medical literacy. In turn, this can influence trial recruitment, completion and external validity.Metho

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Ladwa, Rahul, Elizabeth P. Pinkham, Laisa Teleni, et al. "Telehealth cancer-related fatigue clinic model for cancer survivors: a pilot randomised controlled trial protocol (the T-CRF trial)." BMJ Open 12, no. 5 (2022): e059952. http://dx.doi.org/10.1136/bmjopen-2021-059952.

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IntroductionCancer-related fatigue (CRF) is one of the most common and debilitating adverse effects of cancer and its treatment reported by cancer survivors. Physical activity, psychological interventions and management of concurrent symptoms have been shown to be effective in alleviating CRF. This pilot randomised controlled trial (RCT) will determine the feasibility of a telehealth CRF clinic intervention (T-CRF) to implement evidence-based strategies and assess the impact of the intervention on CRF and other clinical factors in comparison to usual care.Methods and analysisA parallel-arm (in

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Ene, Crina Georgiana, Fergus Gracey, and Catherine Ford. "Trainee tips for conducting a clinical trial during the Clinical Psychology Doctorate." Clinical Psychology Forum 1, no. 377 (2024): 25–28. http://dx.doi.org/10.53841/bpscpf.2024.1.377.25.

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The research component of doctoral training in clinical psychology can evoke a range of emotions, from excitement to apprehension, often influenced by prior experience and the nature of the research undertaken. This article shares reflections on conducting a feasibility randomised controlled trial (RCT) as part of a clinical psychology thesis, offering practical advice to ease the process for trainee clinical psychologists considering a clinical trial for their doctoral research. Key insights include the importance of selecting experienced supervisors, starting early, deciding between a feasib

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Mellish, Louise C., Colin Dunkley, Colin D. Ferrie, and Deb K. Pal. "Antiepileptic drug treatment of rolandic epilepsy and Panayiotopoulos syndrome: clinical practice survey and clinical trial feasibility." Archives of Disease in Childhood 100, no. 1 (2014): 62–67. http://dx.doi.org/10.1136/archdischild-2013-304211.

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BackgroundThe evidence base for management of childhood epilepsy is poor, especially for the most common specific syndromes such as rolandic epilepsy (RE) and Panayiotopoulos syndrome (PS). Considerable international variation in management and controversy about non-treatment indicate the need for high quality randomised controlled trials (RCT). The aim of this study is, therefore, to describe current UK practice and explore the feasibility of different RCT designs for RE and PS.MethodsWe conducted an online survey of 590 UK paediatricians who treat epilepsy. Thirty-two questions covered annua

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Bajwa, Mandeep S., Richard Jackson, Jagtar Dhanda, Catrin Tudur Smith, Richard J. Shaw, and Andrew G. Schache. "Determining the Effectiveness of Fibrin Sealants in Reducing Complications in Patients Undergoing Lateral Neck Dissection (DEFeND): A Randomised External Pilot Trial." Cancers 15, no. 20 (2023): 5073. http://dx.doi.org/10.3390/cancers15205073.

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Objectives: High-quality randomised controlled trials (RCT) to support the use of Fibrin Sealants (FS) in neck dissection (ND) are lacking. The DEFeND trial assessed critical pilot/feasibility questions and signals from clinical outcomes to inform a future definitive trial. Patients and Methods: The study design piloted was a blinded surgical RCT. All participants underwent unilateral ND for head and neck cancer. Interventional arm: ND with application of FS. Control arm: ND alone. Feasibility outcomes included recruitment, effectiveness of blinding, protocol adherence and evaluating administr

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Asai, Nobuhiro, Yuichi Shibata, Jun Hirai, et al. "A Gap of Patients with Infective Endocarditis between Clinical Trials and the Real World." Journal of Clinical Medicine 12, no. 4 (2023): 1566. http://dx.doi.org/10.3390/jcm12041566.

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Introduction: A randomized control trial (RCT) is considered to be the highest level in the Evidence-Based Medicine (EBM) pyramid. While EBM is essential to make a practical tool such as a prognostic guideline, it has been unclear how many patients in the real world can be eligible for a randomized control trial (RCT). Patients and method: This study was performed to clarify if there is a difference in patients’ profiles and clinical outcomes between the patients eligible and not eligible for any RCT. We reviewed all IE patients at our institute between 2007 and 2019. The patients were divided

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Adams, Scott C., Julia McMillan, Kirsten Salline, et al. "Comparing the reporting and conduct quality of exercise and pharmacological randomised controlled trials: a systematic review." BMJ Open 11, no. 8 (2021): e048218. http://dx.doi.org/10.1136/bmjopen-2020-048218.

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ObjectiveEvaluate the quality of exercise randomised controlled trial (RCT) reporting and conduct in clinical populations (ie, adults with or at risk of chronic conditions) and compare with matched pharmacological RCTs.DesignSystematic review.Data sourcesEmbase (Elsevier), PubMed (NLM) and CINAHL (EBSCO).Study selectionRCTs of exercise in clinical populations with matching pharmacological RCTs published in leading clinical, medical and specialist journals with impact factors ≥15.Review methodsOverall RCT quality was evaluated by two independent reviewers using three research reporting guidelin

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Mitchell-Jones, Nicola, Jessica Alice Farren, Aurelio Tobias, Tom Bourne, and Cecilia Bottomley. "Ambulatory versus inpatient management of severe nausea and vomiting of pregnancy: a randomised control trial with patient preference arm." BMJ Open 7, no. 12 (2017): e017566. http://dx.doi.org/10.1136/bmjopen-2017-017566.

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ObjectiveTo determine whether ambulatory (outpatient (OP)) treatment of severe nausea and vomiting of pregnancy (NVP) is as effective as inpatient (IP) care.DesignNon-blinded randomised control trial (RCT) with patient preference arm.SettingTwo multicentre teaching hospitals in London.ParticipantsWomen less than 20 weeks’ pregnant with severe NVP and associated ketonuria (>1+).MethodsWomen who agreed to the RCT were randomised via web-based application to either ambulatory or IP treatment. Women who declined randomisation underwent the treatment of their choice in the patient preference tri

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Russell, Ailsa, Kate Cooper, Stephen Barton, et al. "Protocol for a feasibility study and randomised pilot trial of a low-intensity psychological intervention for depression in adults with autism: the Autism Depression Trial (ADEPT)." BMJ Open 7, no. 12 (2017): e019545. http://dx.doi.org/10.1136/bmjopen-2017-019545.

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IntroductionHigh rates of co-occurring depression are reported in autism spectrum disorder (ASD), a neurodevelopmental condition characterised by social communication impairments and repetitive behaviours. Cognitive-behavioural interventions adapted for ASD have been effective for anxiety problems. There have been evaluation studies of group cognitive-behavioural therapy for co-occurring depression, but no randomised trials investigating low-intensity psychological interventions as recommended in clinical guidelines for mild-moderate depression.Methods and analysisA feasibility study comprisin

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Russell, Ailsa, Kate Cooper, Stephen Barton, et al. "Protocol for a feasibility study and randomised pilot trial of a low-intensity psychological intervention for depression in adults with autism: the Autism Depression Trial (ADEPT)." BMJ Open 7, no. 12 (2017): e019545. https://doi.org/10.1136/bmjopen-2017-019545.

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IntroductionHigh rates of co-occurring depression are reported in autism spectrum disorder (ASD), a neurodevelopmental condition characterised by social communication impairments and repetitive behaviours. Cognitive-behavioural interventions adapted for ASD have been effective for anxiety problems. There have been evaluation studies of group cognitive-behavioural therapy for co-occurring depression, but no randomised trials investigating low-intensity psychological interventions as recommended in clinical guidelines for mild-moderate depression.Methods and analysisA feasibility study comprisin

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Abbott, Penelope, Deborah Askew, Chelsea Watego, et al. "Randomised clinical trial research within Aboriginal and Torres Strait Islander primary health services: a qualitative study." BMJ Open 11, no. 12 (2021): e050839. http://dx.doi.org/10.1136/bmjopen-2021-050839.

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ObjectiveTo better understand how to undertake valuable, ethical and sustainable randomised controlled clinical trial (RCT) research within Aboriginal and Torres Strait Islander primary health services.DesignIn a qualitative approach, we utilised data collected between 2013 and 2020 during the planning and implementation of two RCTs. The data comprised agreed records of research meetings, and semistructured interviews with clinical trial stakeholders. The stakeholders were parents/carers of child participants, and site-based research officers, healthcare providers and community advisory groups

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Novick, D., A. Gonzalez-Pinto, J. M. Haro, et al. "Translation of Randomised Controlled Trial Findings into Clinical Practice: Comparison of Olanzapine and Valproate in the Emblem Study." European Psychiatry 24, S1 (2009): 1. http://dx.doi.org/10.1016/s0924-9338(09)70547-4.

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Aims:To contrast the outcomes of olanzapine- and valproate-treated patients in an observational study of acute mania with the results of a RCT assessing the same treatments (Tohen et al., 2002).Methods:EMBLEM (European Mania in Bipolar Evaluation of Medication) was a 2-year, prospective, observational study of health outcomes associated with treatment of mania. Severity of mania and depression was assessed at baseline and 6 weeks using the YMRS and 5-item version of the HAMD, respectively. The RCT was a 3-week, randomised, double-blind comparison of olanzapine (n=125) and divalproate-treated (

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Lo, Heidi Ka Ying, Suet Ying Yuen, Iris Wai Tung Tsui, et al. "Transcranial Direct Current Stimulation (tDCS) in the Treatment of Youth Depression: Integrating Literature Review Insights in a Pilot Clinical Trial." Journal of Clinical Medicine 14, no. 9 (2025): 3152. https://doi.org/10.3390/jcm14093152.

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Background: Youth (ages 16–25) is a key window for mental health interventions, as depression rates significantly increase during this developmental stage. However, transcranial direct current stimulation (tDCS) application in youth depression remains underexplored. To reduce the uncertainty of a future trial, we conducted a review and a pilot randomised controlled trial (RCT) of tDCS for youth depression. Methods: Following the PRISMA guidelines, the first part of this study was a review across databases including PubMed, MEDLINE, PsychInfo, CINAHL, Open Access Theses and Dissertations (OATD)

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Gryaznov, Dmitry, Belinda von Niederhäusern, Benjamin Speich, et al. "Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE)." BMJ Open 12, no. 5 (2022): e053417. http://dx.doi.org/10.1136/bmjopen-2021-053417.

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ObjectivesComprehensive protocols are key for the planning and conduct of randomised clinical trials (RCTs). Evidence of low reporting quality of RCT protocols led to the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist in 2013. We aimed to examine the quality of reporting of RCT protocols from three countries before and after the publication of the SPIRIT checklist.DesignRepeated cross sectional study.SettingSwiss, German and Canadian research ethics committees (RECs).ParticipantsRCT protocols approved by RECs in 2012 (n=257) and 2016 (n

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Heyard, Rachel, Leonhard Held, Sebastian Schneeweiss, and Shirley V. Wang. "Design differences and variation in results between randomised trials and non-randomised emulations: meta-analysis of RCT-DUPLICATE data." BMJ Medicine 3, no. 1 (2024): e000709. http://dx.doi.org/10.1136/bmjmed-2023-000709.

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ObjectiveTo explore how design emulation and population differences relate to variation in results between randomised controlled trials (RCT) and non-randomised real world evidence (RWE) studies, based on the RCT-DUPLICATE initiative (Randomised, Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology).DesignMeta-analysis of RCT-DUPLICATE data.Data sourcesTrials included in RCT-DUPLICATE, a demonstration project that emulated 32 randomised controlled trials using three real world data sources: Optum Clinformatics Data Mart, 2004-19; IBM

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Tarrant, Mark, Mary Carter, Sarah Gerard Dean, et al. "Singing for people with aphasia (SPA): results of a pilot feasibility randomised controlled trial of a group singing intervention investigating acceptability and feasibility." BMJ Open 11, no. 1 (2021): e040544. http://dx.doi.org/10.1136/bmjopen-2020-040544.

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ObjectivesPilot feasibility randomised controlled trial (RCT) for the singing groups for people with aphasia (SPA) intervention to assess: (1) the acceptability and feasibility of participant recruitment, randomisation and allocation concealment; (2) retention rates; (3) variance of continuous outcome measures; (4) outcome measure completion and participant burden; (5) fidelity of intervention delivery; (6) SPA intervention costs; (7) acceptability and feasibility of trial and intervention to participants and others involved.DesignA two-group, assessor-blinded, randomised controlled external p

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Audisio, Katia, Hillary Lia, Newell Bryce Robinson, et al. "Impact of the COVID-19 Pandemic on Non-COVID-19 Clinical Trials." Journal of Cardiovascular Development and Disease 9, no. 1 (2022): 19. http://dx.doi.org/10.3390/jcdd9010019.

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Randomized controlled trials (RCT) were impacted by the COVID-19 pandemic, but no systematic analysis has evaluated the overall impact of COVID-19 on non-COVID-19-related RCTs. The ClinicalTrials.gov database was queried in February 2020. Eligible studies included all randomized trials with a start date after 1 January 2010 and were active during the period from 1 January 2015 to 31 December 2020. The effect of the pandemic period on non-COVID-19 trials was determined by piece-wise regression models using 11 March 2020 as the start of the pandemic and by time series analysis (models fitted usi

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SINGH, JASVINDER A., STEPHEN MURPHY, and MOHIT BHANDARI. "Assessment of the Methodologic Quality of Medical and Surgical Clinical Trials in Patients with Arthroplasty." Journal of Rheumatology 36, no. 12 (2009): 2642–54. http://dx.doi.org/10.3899/jrheum.090333.

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Objective.To assess the methodological quality of randomized controlled trials (RCT) of medical and surgical therapy in patients with arthroplasty.Methods.We conducted a Medline database search for all arthroplasty RCT from 1997 and 2006. The quality of the methods of all eligible RCT was assessed by a trained abstractor. We used a checklist of trial quality characteristics, and the overall trial quality was assessed by 3 scales: Jadad (range 0–5), Delphi list (range 0–9), and numeric rating scale (NRS; range 1–10), based on User’s Guides to the Medical Literature.Results.A total of 196 articl

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Jensen, Sofie Anne-Marie Skovbo, Siv Fonnes, Jacob Rosenberg, Hanne Tønnesen, and Susanne Vahr Lauridsen. "Patient Reflections on Participation in a Randomised Controlled Multimodal Prehabilitation Trial Before Ventral Hernia Repair." International Journal of Environmental Research and Public Health 22, no. 7 (2025): 1039. https://doi.org/10.3390/ijerph22071039.

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Background: The aim was to explore patients’ reflections related to their choice of participating or not in a multimodal prehabilitation randomised controlled trial (RCT) in relation to minor surgery. Methods: A qualitative study with 22 semi-structured in-depth interviews on patients awaiting ventral hernia repair was conducted between March and May 2024 and reported according to the COREQ guideline. All were eligible to participate in a prehabilitation RCT; twelve had accepted, and ten had declined. The interviews were analysed using Kirsti Malterud’s method of systematic text condensation,

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Apte, Sameer S., Husein Moloo, Ahwon Jeong, et al. "Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol." BMJ Open 10, no. 7 (2020): e036866. http://dx.doi.org/10.1136/bmjopen-2020-036866.

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IntroductionDespite 40 randomised controlled trials (RCTs) investigating preoperative oral antibiotics (OA) and mechanical bowel preparation (MBP) to reduce surgical site infection (SSI) rate following colon surgery, there has never been an RCT published comparing OA alone versus no preparation. Of the four possible regimens (OA alone, MBP alone, OA plus MBP and no preparation), randomised evidence is conflicting for studied groups. Furthermore, guidelines vary, with recommendations for OA alone, OA plus MBP or no preparation. The National Surgical Quality Improvement Program (NSQIP) has autom

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Yang, Min, De Zheng, Xingtao Jin, et al. "The efficacy of acupuncture in relieving postoperative pain in patients with low simple anal fistula: Protocol of a prospective, randomised, controlled trial." PLOS ONE 20, no. 1 (2025): e0317902. https://doi.org/10.1371/journal.pone.0317902.

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Background Anal fistula surgery often leads to postoperative pain, which can hinder recovery and negatively impact patients’ quality of life. This prospective, randomised, controlled trial (RCT) aims to investigate the efficacy of acupuncture in alleviating postoperative pain and reducing the usage of analgesic medications following anal fistula surgery. Methods This single-centre, patient-blinded, assessor-blinded, placebo-controlled randomised controlled trial (RCT) will be conducted at a tertiary referral hospital. A total of 66 patients with low simple anal fistula will be randomised at a

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PAI, N., J. Popov, E. Hartung, et al. "P375 Feasibility of the first paediatric randomised controlled pilot trial of faecal microbiota transplant for ulcerative colitis." Journal of Crohn's and Colitis 14, Supplement_1 (2020): S353—S354. http://dx.doi.org/10.1093/ecco-jcc/jjz203.504.

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Abstract Background The first multicentre paediatric randomised-controlled trial (RCT) of faecal microbiota transplant (FMT) in ulcerative colitis (UC) was recently completed in Ontario and Quebec, Canada. The use of FMT in paediatric UC treatment has been limited to small, open-label case series. Unique clinical and patient factors necessitated a paediatric-specific pilot RCT. Our aim was to assess key feasibility measures of conducting an FMT trial in paediatric patients to inform design, and feasibility of larger, future multicentre studies. Methods Patients were randomised (1:1) to receive

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McCrann, Saoirse, Ian Flitcroft, Niall C. Strang, et al. "Myopia Outcome Study of Atropine in Children (MOSAIC): an investigator-led, double-masked, placebo-controlled, randomised clinical trial protocol." HRB Open Research 2 (September 25, 2019): 15. http://dx.doi.org/10.12688/hrbopenres.12914.2.

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Background: The Myopia Outcome Study of Atropine in Children (MOSAIC) aims to explore the efficacy, safety, acceptability and mechanisms of action of 0.01% unpreserved atropine for myopia control in a European population. Methods: MOSAIC is an investigator-led, double-masked, placebo-controlled, randomised clinical trial (RCT) investigating the efficacy, safety and mechanisms of action of 0.01% atropine for managing progression of myopia. During Phase 1 of the trial, 250 children aged 6-16 years with progressive myopia instil eye drops once nightly in both eyes from randomisation to month 24.

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De Neubourg, Diane, Lara Janssens, Iris Verhaegen, Elke Smits, Ben W. Mol, and Ella Roelant. "Live birth after additional tubal flushing with oil-based contrast versus no additional flushing: a randomised, multicentre, parallel-group pragmatic trial in infertile women with at least one patent tube at hysterosalpingo-foam sonography (HYFOIL study)." BMJ Open 11, no. 11 (2021): e054845. http://dx.doi.org/10.1136/bmjopen-2021-054845.

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IntroductionTubal patency testing is an essential part in the fertility workup of many subfertile women. Hysterosalpingography (HSG) has long been the test of choice in many clinics. There is evidence from a large randomised multicentre trial and from a recent meta-analysis that women who had HSG using oil soluble contrast medium (OSCM) had higher rates of ongoing pregnancy compared with women who underwent this procedure using water contrast. However, the field is moving away from HSG and nowadays hysterosalpingo-foam sonography (Hyfosy) using ultrasound guidance is considered as the first li

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Magro, Elsa, Jean-Christophe Gentric, André Lima Batista, et al. "The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research." Journal of Neurosurgery 128, no. 6 (2018): 1823–29. http://dx.doi.org/10.3171/2017.2.jns162751.

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OBJECTIVEThe management of brain arteriovenous malformations (bAVMs) remains controversial. The Treatment of Brain AVMs Study (TOBAS) was designed to manage patients with bAVMs within a clinical research framework. The objective of this study was to study trial feasibility, recruitment rates, patient allocation to the various management groups, and compliance with treatment allocation.METHODSTOBAS combines two randomized care trials (RCTs) and a registry. Designed to be all-inclusive, the study offers randomized allocation of interventional versus conservative management to patients eligible f

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Badian, Reza A., Brendan McCormack, and Vibeke Sundling. "Person-Centered Research: A novel approach to Randomized Controlled Trials." European Journal for Person Centered Healthcare 6, no. 2 (2018): 209. http://dx.doi.org/10.5750/ejpch.v6i2.1435.

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Introduction: Integrating person-centered values with randomized controlled trials methodology is a novel idea. Person-centeredness is gaining steadily more prominence and attention in healthcare and health-related policy and research. Randomized controlled trials are considered as the gold standard in evidence-based medicine for evaluating the effects of treatment or determining the causal effect. A wide array of study designs is available, but there is a lack of designs with both strong person-centered principles and a strong position with respect to the level of evidence. In this paper we i

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Coon, Eric R., Corrie E. McDaniel, Natalia Paciorkowski, et al. "Prioritization of Randomized Clinical Trial Questions for Children Hospitalized With Common Conditions." JAMA Network Open 7, no. 5 (2024): e2411259. http://dx.doi.org/10.1001/jamanetworkopen.2024.11259.

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ImportanceThere is a lack of randomized clinical trial (RCT) data to guide many routine decisions in the care of children hospitalized for common conditions. A first step in addressing the shortage of RCTs for this population is to identify the most pressing RCT questions for children hospitalized with common conditions.ObjectiveTo identify the most important and feasible RCT questions for children hospitalized with common conditions.Design, Setting, and ParticipantsFor this consensus statement, a 3-stage modified Delphi process was used in a virtual conference series spanning January 1 to Sep

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Griffin, Damian, Peter Wall, Alba Realpe, et al. "UK FASHIoN: feasibility study of a randomised controlled trial of arthroscopic surgery for hip impingement compared with best conservative care." Health Technology Assessment 20, no. 32 (2016): 1–172. http://dx.doi.org/10.3310/hta20320.

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BackgroundFemoroacetabular impingement (FAI) is a syndrome of hip or groin pain associated with shape abnormalities of the hip joint. Treatments include arthroscopic surgery and conservative care. This study explored the feasibility of a randomised controlled trial to compare these treatments.ObjectivesThe objectives of this study were to estimate the number of patients available for a full randomised controlled trial (RCT); to explore clinician and patient willingness to participate in such a RCT; to develop consensus on eligibility criteria, surgical and best conservative care protocols; to

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Hill, L., J. Popov, E. Hartung, M. Moshkovich, M. Figueiredo, and N. Pai. "P517 A randomised, placebo-controlled pilot trial of faecal microbiota transplantation for paediatric Crohn’s disease." Journal of Crohn's and Colitis 14, Supplement_1 (2020): S447—S448. http://dx.doi.org/10.1093/ecco-jcc/jjz203.645.

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Abstract Background The role of faecal microbiota transplant (FMT) in Crohn’s disease (CD) remains unclear. Small, open-label case series have shown high rates of clinical remission but protocols have varied across studies, and no randomised controlled trials (RCT) have been performed. We present a protocol for the first pilot RCT of FMT in paediatric CD patients, using a novel colonoscopic + oral capsular intervention that uses fresh-frozen and prepared, lyophilised donor stool. We will measure improvements in clinical disease activity, inflammatory biomarkers, endoscopic markers of mucosal i

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Smeets, Annemie, Feryal Ghafelzadeh Ahwaz, Stijn Bogaerts, et al. "Pilot study to investigate the feasibility of conducting a randomised controlled trial that compares Immediate versus Optional Delayed surgical repair for treatment of acute Anterior cruciate ligament injury: IODA pilot trial." BMJ Open 12, no. 3 (2022): e055349. http://dx.doi.org/10.1136/bmjopen-2021-055349.

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IntroductionStandard care for anterior cruciate ligament (ACL) injuries includes surgical reconstruction of the ACL. However, two randomised controlled trials (RCTs) concluded that conservative treatment does not result in inferior clinical outcomes compared with immediate ACL reconstruction. More research is needed to in the first place verify these results, and second to assess whether patient-specific parameters determine whether a patient would benefit from one treatment option over the other. However, before running a full RCT, it seems necessary to perform a pilot study that assesses the

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