Trials最新文献

Background: In an aging surgical patient population, preventing complications such as oversedation has taken increasing priority in perioperative care. Intraoperative use of virtual reality (VR) may decrease sedative requirements. We hypothesize that the use of immersive VR during total knee arthroplasty (TKA) will lead to decreased propofol requirements, improved patient-reported satisfaction, and reduced postoperative opioid requirements compared to active and usual care controls.

Methods: This is a single-center, randomized clinical trial of older (age > 60) patients undergoing TKA. Participants will be randomized into three groups (2:2:1): VR immersion, music, and sham VR plus usual care. All patients will receive a regional block and spinal anesthesia. Patients in the immersive VR and music groups will use patient-controlled sedation (PCS) with propofol, while those in the sham VR group will act as the standard of care control group and will receive monitored anesthesia care (MAC) with propofol infusion.

Statistical analysis: Analyses will be conducted using IBM SPSS Statistics Version 25, considering a two-sided p-value < 0.05 to be statistically significant. The primary outcome is the intraoperative dose of propofol (mg kg^-1 min^-1). Secondary outcomes include patient satisfaction, post-anesthesia care unit (PACU) length of stay, postoperative pain scores and analgesic requirements, functional outcomes, postoperative delirium, and postoperative neurocognition.

Discussion: VR used as a non-pharmacological adjunct to regional and spinal anesthesia during TKA may reduce sedative requirements while maintaining patient satisfaction. If true, this approach to minimizing sedation may impact clinical outcomes including perioperative complications and length of stay for older patients, while maintaining a high degree of patient satisfaction.

Trial registration: This trial was registered on ClinicalTrials.gov on January 29, 2021. The registration number is NCT04748549.

Background: Traffic crashes are the leading cause of death globally for people aged 5-29 years, with 90% of mortality occurring in low- and middle-income countries (LMICs). The STABLE (Slashing Two-wheeled Accidents by Leveraging Eyecare) trial was designed to determine whether providing spectacles could reduce risk among young myopic motorcycle users in Vietnam.

Methods: This investigator-masked, stepped-wedge, cluster randomised naturalistic driving trial will recruit 625 students aged 18-23 years, driving ≥ 50 km/week, with ≥ 1-year driving experience and using motorcycles as their primary means of transport, in 25 clusters of 25 students in Ho Chi Minh City, Vietnam. Motorcycles of consenting students who have failed self-testing on the WHOeyes app will be fitted with Data Acquisition Systems (DAS) with video cameras and accelerometers. Video clips (± 30 s) of events flagged by the accelerometer will be reviewed for crash and near-crash events per 1000 km driven (main outcome). Five clusters of 25 students will be randomly selected every 12 weeks to undergo ocular examination and an estimated 40% of these will have bilateral spherical equivalent < - 0.5 D, and better-eye presenting distance visual acuity < 6/12, correctable bilaterally to ≥ 6/7.5. They will be given free distance spectacles and their driving data before receiving spectacles will be analysed as the control condition and subsequent data as the intervention condition. Secondary outcomes include visual function, cost-effectiveness and self-reported crash events.

Discussion: STABLE will be the first randomised trial of vision interventions and driving safety in a LMIC.

Trial registration: ClinicalTrials.gov, NCT05466955 . Initial registration: 20 July 2022, most recent update: 9 July 2024.

Background: The American College of Cardiology, American Heart Association, and Centers for Medicare and Medicaid Services recommend shared decision-making (SDM) for patients with severe aortic stenosis choosing between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). Although tools such as patient decision aids (DAs) and training in SDM have been shown to improve SDM, implementation of SDM and DAs is limited. The IMproving treatment decisions for Patients with AortiC stenosis Through Shared Decision Making (IMPACT SDM) study aims to (1) determine the effectiveness of the interventions (a DA and clinician SDM training) in achieving SDM (primary outcome) and improving the quality of decisions about aortic valve replacement, (2) determine the reach of the DAs and adoption of training, and (3) explore potential mechanisms of effectiveness and implementation at the patient-, clinician-, and clinic-level.

Methods: The study is a hybrid type II effectiveness-implementation study using a cluster randomized batched stepped wedge trial with 8 sites across the USA. Eligible patients will be surveyed before and after visits with the heart valve team; clinicians will be surveyed after visits. Reach of DAs and adoption of training will be tracked. Clinicians will be interviewed regarding barriers and facilitators to implementation.

Discussion: The IMPACT SDM Study seeks to provide evidence of the ability of the interventions to improve SDM and decision quality, and also to shed light on barriers and facilitators to SDM implementation to promote future implementation efforts.

Trial registration: ClinicalTrials.gov NCT06171737. Registered on December 15, 2023.

Background: Pragmatic clinical trials evaluate the effectiveness of health interventions in real-world settings. Negative spillover can arise in a pragmatic trial if the study intervention affects how scarce resources are allocated across patients in the intervention and comparison groups.

Main body: Negative spillover can lead to overestimation of treatment effect and harm to patients assigned to usual care in trials of diverse health interventions. While this type of spillover has been addressed in trials of social welfare and public health interventions, there is little recognition of this source of bias in the medical literature. In this commentary, I examine what causes negative spillover and how it may have led clinical trial investigators to overestimate the effect of patient navigation, AI-based physiological alarms, and elective induction of labor. Trials discussed here are a convenience sample and not the result of a systematic review. I also suggest ways to detect negative spillover and design trials that avoid this potential source of bias.

Conclusion: As new clinical practices and technologies that affect care delivery are considered for widespread adoption, well-designed trials are needed to provide valid evidence on their risks and benefits. Understanding all sources of bias that could affect these trials, including negative spillover, is a critical part of this effort. Future guidance on clinical trial design should consider addressing this form of spillover, just as current guidance often discusses bias due to lack of blinding, differential attrition, or contamination.

This manuscript, a Letter to the Editor, is in response to the study protocol that intended to analyze the effect of the erector spinae plane block (ESPB) in pediatric patients undergoing posterior spinal fusion (PSF) for the correction of adolescent idiopathic scoliosis (AIS). A few concerns regarding that protocol are raised here.

Monetary incentives are commonly used to help recruit trial participants. Some studies have found greater recruitment with larger incentives, while others have found smaller incentives more cost-effective in terms of cost per participant. As part of an implementation study, we compared the impact of four approaches to recruitment, three of which involved phone recruitment with varying financial incentives. Adding modest financial incentives reliably increased the recruitment ratio, and greater incentives increased recruitment more than smaller incentives. However, recruiters required less time to obtain agreement to participate when the greater incentive was offered, and these time savings made the greater incentive cost-saving relative to the smaller incentive and cost-effective relative to no incentive. Our results suggest the possibility of a "sweet spot" for financial incentives, and that trial designers should consider pilot-testing incentive levels in the context of their other recruitment costs to determine whether paying participants more may be cost-saving for trial sponsors.

Background: Randomised controlled trials (RCTs) often struggle with recruitment and many need extensions which leads to delayed implementation of effective interventions. Recruitment to complex intervention trials have similar difficulties. Alongside this, the COVID-19 pandemic had a major impact upon trial recruitment. Research has shown that many other recruitment issues can be anticipated, for example overestimating target population prevalence; however, a range of factors may play a role. The aim of this study is to investigate facilitators and barriers to recruitment from the perspective of the recruiter.

Methods: Fracture in the Elderly Multidisciplinary Rehabilitation - phase III (FEMuR III) was a RCT of a complex intervention post-surgery for hip fracture in patients over 60 years old. A process evaluation was undertaken, and semi-structured interviews were conducted with seven recruiters between November 2022 and March 2023 to identify barriers and facilitators to recruitment. A thematic analysis was undertaken in NVIVO (Version 12) using a critical realist perspective.

Results: The trial took place mostly during the COVID-19 pandemic, and the unique impact of this on reported barriers is considered. A key finding included recruiter reluctance to approach patients that they felt would not benefit from the trial due to other factors (e.g. comorbidities or complex living situations). A possible barrier to recruiting carers appeared to be that family members did not relate to the label of 'carer' and so did not take part. Facilitators included recruiters approaching patients with other clinical or research staff. This approach, which included tailored initial information on the trial, reduced participant stress by increasing patient familiarity with recruiting staff and allowing staff time to develop relationships with patients.

Conclusion: This paper identifies barriers and facilitators of recruitment to FEMuR III with six broad themes for both barriers and facilitators identified in the qualitative data synthesis. The impact of the COVID-19 pandemic was the main, but not sole, barrier to recruitment. Key findings concern reluctance to approach some eligible patients, the label of 'carer', the involvement of clinical staff and patient preference for trial group. Strategies to identify and overcome recruitment problems are highlighted and should be implemented and evaluated in further RCTs of complex interventions.

Trial registration: ISRCTN28376407. November 23, 2018.

Background: Older people with joint contractures in nursing homes often experience severe restrictions in their activities and participation. The effectiveness of an individually tailored complex intervention to improve residents' activities and participation by incorporating the biopsychosocial perspective into nursing care using a structured facilitator approach could not be established in the JointConEval cluster-randomised controlled trial. This process evaluation aimed to systematically identify factors influencing implementation and effectiveness.

Methods: The mixed-methods process evaluation analysed recruitment, implementation, mechanisms of impact, and context. Qualitative data was generated in semi-structured focus groups and in individual interviews with facilitators, nursing and social care staff, residents, relatives and guardians. Quantitative data was recorded with facilitators and 20% of nursing and social care staff using standardised documentation forms and questionnaires. Qualitative data was analysed using qualitative thematic content analysis, while the quantitative data was analysed descriptively. An interpretation was performed by combining and comparing the qualitative and quantitative results after the separate analyses.

Results: The implementation was realised as planned, but the intervention did not always reach the nursing home staff, which hindered the planned change in attitude and behaviour. The attitude of the facilitators was mainly in line with the intervention. However, the intervention reached only half the residents. We identified various key influencing factors related to the context, setting and implementation agents. Nursing homes lacking facilitator support from staff or management or experiencing staff shortages and facing organisational weaknesses had difficulties in achieving the desired behavioural changes and positive primary outcomes.

Conclusions: The complex intervention was delivered as planned with several factors affecting the implementation. A key influencing factor was the organisational structure and leadership of the nursing homes, which had an impact on the behaviour and motivation of the implementation agents. The findings highlight challenges in achieving behavioural changes among nursing staff in the context of long-term care in Germany. We recommend a systematic organisational context analysis for similar complex interventions in long-term care, involving stakeholders and improving leadership participation for more effective implementation.

Trial registration: DRKS (German Clinical Trials Register), number DRKS00015185. Registered on 1 August 2018, https://drks.de/search/en/trial/DRKS00015185 . Universal Trial Number U1111-1218-1555.

Randomized controlled trials are considered the "gold standard" for evaluating the effectiveness of an intervention. However, large-scale, cluster-randomized trials are complex and costly to implement. The generation of accurate, reliable, and high-quality data is essential to ensure the validity and generalizability of findings. Robust quality assurance and quality control procedures are important to optimize and validate the quality, accuracy, and reliability of trial data. To date, few studies have reported on study procedures to assess and optimize data integrity during the implementation of large cluster-randomized trials. The dearth of literature on these methods of trial implementation may contribute to questions about the quality of data collected in clinical trials. Trial protocols should consider the inclusion of quality assurance indicators and targets for implementation. Publishing quality assurance and control measures implemented in clinical trials should increase public trust in the findings from such studies. In this manuscript, we describe the development and implementation of internal and external quality assurance and control procedures and metrics in the Pneumococcal Vaccine Schedules trial currently ongoing in rural Gambia. This manuscript focuses on procedures and metrics to optimize trial implementation and validate clinical, laboratory, and field data. We used a mixture of procedure repetition, supervisory visits, checklists, data cleaning and verification methods and used the metrics to drive process improvement in all domains.