Is equipoise a useful concept to justify randomised controlled trials in the cultural context of Pakistan? A survey of clinicians in relation to a trial of talking therapy for young people who self-harm
ConclusionsThe paper highlights that clinicians in Pakistan accept the notion of clinical equipoise as an ethical justification for patient participation in RCTs. The need for conducting RCTs to generate evidence base and to reduce bias was considered important by the clinical community. (Source: Trials)
Source: Trials - August 8, 2023 Category: Research Source Type: clinical trials
The importance of clinical importance when determining the target difference in sample size calculations
AbstractRecently, it was argued that clinically important differences should play no role in sample size calculations. Instead, it was proposed that sample size calculations should focus on setting realistic estimates of treatment benefit. We disagree, and argue in this article that considering the importance of a target difference is necessary in the context of randomised controlled trials of effectiveness, particularly definitive phase III trials. Ignoring clinical importance could have serious ethical and practical consequences. (Source: Trials)
Source: Trials - August 4, 2023 Category: Research Source Type: clinical trials
Study on self-management of real-time and individualized support in stroke patients based on resilience: a protocol for a randomized controlled trial
This study uses a randomized controlled trial design to assess the efficacy of using wearable technology to realize real-time and individualized self-management support in stroke patients ’ self-management behavior during the transitional period following discharge from hospital.MethodsThis parallel-group randomized controlled trial will be conducted in two hospitals and patients ’ homes. A total of 183 adult stroke patients will be enrolled in the study and randomly assigned to three groups in a 1:1:1 ratio. The smartwatch intervention group (n = 61) will receive Real-time and Individualized Self-management Suppor...
Source: Trials - August 3, 2023 Category: Research Source Type: clinical trials
Pre-notifications increase retention in a 17-year follow-up of adolescents born very preterm
ConclusionsPre-notifications decreased the need for post-notifications and may increase retention in 17-year-old adolescents. Based on our findings, pre-notification letters are recommended in future follow-up studies in adolescents.Trial registrationThe Ethics Review Committee of the Hospital District of South-West Finland approved the 17-year PIPARI Study protocol in January 2018 (23.1.2018; 2/180/2012). The study has been registered to the SWAT repository as SWAT 179. Filetoupload,1457904,en.pdf (qub.ac.uk). (Source: Trials)
Source: Trials - July 26, 2023 Category: Research Source Type: clinical trials
The effect of a parental preparation video (Take5) on child and parent anxiety during anaesthetic induction: a protocol for a randomised controlled trial
This study aims to test the efficacy of the Take5 video (now referred to as ‘Take5’), a short and cost-efficient interv ention for child peri-operative anxiety.MethodsA randomised, controlled, superiority trial of Take5 compared to standard care. Take5 was developed by paediatric anaesthetists, child psychologists and a consumer panel of parents of children who had experienced surgery and anaesthesia.Children aged 3 –10 years presenting for elective surgery at a quaternary paediatric facility will be randomly allocated to the intervention group or standard care. Intervention group parents will be shown Take5 prior ...
Source: Trials - July 8, 2023 Category: Research Source Type: clinical trials
Effects of low-dose intravenous heparin therapy in aneurysmal subarachnoid hemorrhage: a randomized controlled clinical trial protocol
This study protocol obtained ethical approval from the Ethics Committee of Baoan People ’s Hospital, Shenzhen, Guangdong (approval number: BYL20220805). This work will be published in peer-reviewed international medical journals and presented at medical conferences.Trial registrationClinicalTrials ID: NCT05696639. Registered on March 30, 2023. (Source: Trials)
Source: Trials - July 8, 2023 Category: Research Source Type: clinical trials
Informed consent in cancer clinical drug trials in China: a narrative literature review of the past 20 years
ConclusionBased on our analysis of publications over the past two decades, there are currently frequent challenges related to various aspects of informed consent in cancer clinical drug trials in China. Furthermore, only a limited number of high-quality research studies on informed consent in cancer clinical drug trials in China are available to date. Efforts toward improvement of informed consent practice, in the form of guidelines or further regulations in China, should draw on both experience from other countries and high-quality local evidence. (Source: Trials)
Source: Trials - July 7, 2023 Category: Research Source Type: clinical trials
Cervical collar use following anterior cervical hybrid surgery: protocol for a prospective randomized, time-controlled trial
This study aims to determine whether the cervical collar is effective and how long it should be worn after surgery.MethodsThis is a randomized, single-center, prospective, parallel-controlled trial. Eligible participants will be selected according to the inclusion and exclusion criteria. The primary outcome is the neck disability index, which will be evaluated before surgery and at one week, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months following surgery. The secondary outcomes consist of the Japanese Orthopedic Association Scores, MOS 36-item short-form health survey (SF-36), visual analog scale, Pittsburgh Sl...
Source: Trials - June 16, 2023 Category: Research Source Type: clinical trials
Does closed-loop automated oxygen control reduce the duration of supplementary oxygen treatment and the amount of time spent in hyperoxia? A randomised controlled trial in ventilated infants born at or near term
This study investigates whether CLAC compared with manual oxygen control reduces the time spent in hyperoxia and the overall duration of supplemental oxygen treatment in ventilated infants born at or above 34 weeks gestation.MethodsThis randomised controlled trial performed at a single tertiary neonatal unit is recruiting 40 infants born at or above 34 weeks of gestation and within 24 h of initiation of mechanical ventilation. Infants are randomised to CLAC or manual oxygen control from recruitment till successful extubation. The primary outcome is the percentage of time spent in hyperoxia (SpO2 > 96%). The se...
Source: Trials - June 15, 2023 Category: Research Source Type: clinical trials
Bipolar haemostatic forceps versus standard therapy by haemoclip + / − epinephrine injection as initial endoscopic treatment in active non-variceal upper GI bleeding: study protocol for a prospective, randomized multicentre trial (BeBop-Trial)
In conclusion, this randomized, prospective, multicentre study could make an important contribution to answering the question of whether bipolar haemostatic forceps could be the first-line therapy in the endoscopic treatment of stage Forrest I a + b NVUGIB.Trial registrationClinicalTrials.gov NCT05353062. Registered on April 30 2022. (Source: Trials)
Source: Trials - June 15, 2023 Category: Research Source Type: clinical trials
Effect of aerobic exercise training on the fat fraction of the liver in persons with chronic hepatitis B and hepatic steatosis: Trial protocol for a randomized controlled intervention trial — The FitLiver study
DiscussionThis trial, investigating high-intensity interval training in persons with chronic hepatitis B and hepatic steatosis, is the first exercise intervention trial performed on this group of patients. If exercise reduces hepatic steatosis and induces other beneficial effects of clinical markers in this group of patients, there might be an indication to recommend exercise as part of treatment. Furthermore, the investigation of the effect of exercise on hepatokine secretion will provide more knowledge on the effects of exercise on the liver.Trial registrationDanish Capital Regions committee on health research ethics ref...
Source: Trials - June 13, 2023 Category: Research Source Type: clinical trials
Treatment of haemorrhoids: rubber band ligation or sclerotherapy (THROS)? Study protocol for a multicentre, non-inferiority, randomised controlled trial
DiscussionThe THROS trial is the first large multicentre randomised trial to study the difference in effectivity between RBL and SCL for the treatment of grade 1 –2 HD. It will provide information as to which treatment method (RBL or SCL) is the most effective, gives fewer complications and is experienced by the patient as the best option.Ethics and disseminationThe study protocol has been approved by the Medical Ethics Review Committee of the Amsterdam University Medical Centers, location AMC (nr. 2020_053). The gathered data and results will be submitted for publication in peer-reviewed journals and spread to coloproct...
Source: Trials - June 3, 2023 Category: Research Source Type: clinical trials
