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Catheter-associated urinary tract infection (CAUTI) is a major preventable cause of harm for patients in hospital. We aimed to establish whether short-term routine use of antimicrobial catheters reduced risk of CAUTI compared with standard polytetrafluoroethylene (PTFE) catheterisation. In our parallel, three group, multicentre, randomised controlled superiority trial, we enrolled adults (aged ≥16 years) requiring short-term (≤14 days) catheterisation at 24 hospitals in the UK. Participants were randomly allocated 1:1:1 with a remote computer allocation to receive a silver alloy-coated catheter, a nitrofural-impregnated catheter, or a PTFE-coated catheter (control group). Patients undergoing unplanned catheterisation were also included and consent for participation was obtained retrospectively. Participants and trial staff were unmasked to treatment assignment. Data were collected by trial staff and by patient-reported questionnaires for 6 weeks after randomisation. The primary outcome was incidence of symptomatic urinary tract infection for which an antibiotic was prescribed by 6 weeks. We postulated that a 3·3% absolute reduction in CAUTI would represent sufficient benefit to recommend routine use of antimicrobial catheters. This study is registered, number ISRCTN75198618. 708 (10%) of 7102 randomly allocated participants were not catheterised, did not confirm consent, or withdrew, and were not included in the primary analyses. Compared with 271 (12·6%) of 2144 participants in the control group, 263 (12·5%) of 2097 participants allocated a silver alloy catheter had the primary outcome (difference −0·1% [95% CI −2·4 to 2·2]), as did 228 (10·6%) of 2153 participants allocated a nitrofural catheter (−2·1% [−4·2 to 0·1]). Rates of catheter-related discomfort were higher in the nitrofural group than they were in the other groups. Silver alloy-coated catheters were not effective for reduction of incidence of symptomatic CAUTI. The reduction we noted in CAUTI associated with nitrofural-impregnated catheters was less than that regarded as clinically important. Routine use of antimicrobial-impregnated catheters is not supported by this trial. UK National Institute for Health Research Health Technology Assessment Programme.

IntroductionEmotional disorders (such as anxiety and depression) are associated with considerable distress and impairment in day-to-day function for affected children and young people and for their families. Effective evidence-based interventions are available but require appropriate identification of difficulties to enable timely access to services. Standardised diagnostic assessment (SDA) tools may aid in the detection of emotional disorders, but there is limited evidence on the utility of SDA tools in routine care and equipoise among professionals about their clinical value.Methods and analysisA multicentre, two-arm, parallel group randomised controlled trial, with embedded qualitative and health economic components. Participants will be randomised in a 1:1 ratio to either the Development and Well-Being Assessment SDA tool as an adjunct to usual clinical care, or usual care only. A total of 1210 participants (children and young people referred to outpatient, specialist Child and Adolescent Mental Health Services with emotional difficulties and their parent/carers) will be recruited from at least 6 sites in England. The primary outcome is a clinician-made diagnosis about the presence of an emotional disorder within 12 months of randomisation. Secondary outcomes include referral acceptance, diagnosis and treatment of emotional disorders, symptoms of emotional difficulties and comorbid disorders and associated functional impairment.Ethics and disseminationThe study received favourable opinion from the South Birmingham Research Ethics Committee (Ref. 19/WM/0133). Results of this trial will be reported to the funder and published in full in the Health Technology Assessment (HTA) Journal series and also submitted for publication in a peer reviewed journal.Trial registration number ISRCTN15748675; Pre-results.

Background Researchers often rely on trial participants to self-report clinical outcomes (for example, fractures, re-operations). Little information exists as to the ‘accuracy’ of participant-reported clinical outcomes, particularly in randomised controlled trials (RCTs). To help address this evidence gap, we report four case studies, nested within different RCTs where participant-reported clinical outcome data were compared with those reported by clinicians or extracted from medical notes. Methods Four publicly-funded RCTs with different methods of verifying participant-reported outcomes were identified. In KAT, the participants were asked about hospital admissions for any reason. Where it was thought to be relevant to the trial knee, further information was sought from the lead surgeon at the admitting site to confirm whether or not the admission was relevant to the trial knee. In REFLUX, participants were asked about hospital admissions for any reason. For participants who reported a re-operation, further information was sought from the lead surgeon at the admitting site to confirm this. In RECORD, participants were asked three questions regarding broken bones. Where low-trauma fractures were reported, clinical verification was sought, initially from the research nurse at the site. In CATHETER, participants were asked about urinary tract infections (UTIs), and a prescription of antibiotics was provided for the treatment of UTIs following urethral catheterisation. The GPs of those who reported a UTI were contacted to confirm that an antibiotic prescription had been issued for the suspected UTI. Results In KAT, 397 of 6882 (6%) participant-reported hospital admissions were confirmed as relevant to the trial knee. In REFLUX, 16 of 19 participants (84%) who appeared to have had a re-operation were confirmed as having had one. In RECORD, 473 of 781 (61%) fractures reported by participants were confirmed as being low-trauma fractures. In CATHETER, 429 of 830 participant-reported UTIs (52%) were confirmed as such by the GPs. Conclusions We used different approaches in our verification of participant-reported outcomes in clinical trials, and we believe there is no one optimal solution. Consideration of issues such as what information is sought from participants, the phrasing of questions, whether the medical records are a true ‘gold standard’ and costs and benefits to the RCT may help determine the appropriate approach.

Background Data collection consumes a large proportion of clinical trial resources. Each data item requires time and effort for collection, processing and quality control procedures. In general, more data equals a heavier burden for trial staff and participants. It is also likely to increase costs. Knowing the types of data being collected, and in what proportion, will be helpful to ensure that limited trial resources and participant goodwill are used wisely. Aim The aim of this study is to categorise the types of data collected across a broad range of trials and assess what proportion of collected data each category represents. Methods We developed a standard operating procedure to categorise data into primary outcome, secondary outcome and 15 other categories. We categorised all variables collected on trial data collection forms from 18, mainly publicly funded, randomised superiority trials, including trials of an investigational medicinal product and complex interventions. Categorisation was done independently in pairs: one person having in-depth knowledge of the trial, the other independent of the trial. Disagreement was resolved through reference to the trial protocol and discussion, with the project team being consulted if necessary. Key results Primary outcome data accounted for 5.0% (median)/11.2% (mean) of all data items collected. Secondary outcomes accounted for 39.9% (median)/42.5% (mean) of all data items. Non-outcome data such as participant identifiers and demographic data represented 32.4% (median)/36.5% (mean) of all data items collected. Conclusion A small proportion of the data collected in our sample of 18 trials was related to the primary outcome. Secondary outcomes accounted for eight times the volume of data as the primary outcome. A substantial amount of data collection is not related to trial outcomes. Trialists should work to make sure that the data they collect are only those essential to support the health and treatment decisions of those whom the trial is designed to inform.

In a trial involving adults with out-of-hospital cardiac arrest, an intraosseous-first strategy for vascular access did not result in a higher incidence of 30-day survival than an intravenous-first strategy.

BackgroundDespite defibrillation being proven to increase patients’ chances of survival following out-of-hospital cardiac arrest (OHCA) with shockable rhythm, the best shock energies are unknown. Literature comprises studies with outdated resuscitation protocols and a variety of endpoints. We explored the feasibility of a trial of optimal shock energy for OCHA. Our primary objective was to establish the number of eligible and recruited patients; secondary outcomes were adherence and data completeness.MethodsWe conducted a three-arm parallel group cluster randomised controlled trial in South Central ambulance service. Adult patients in OHCA treated for a shockable rhythm were included. Zoll X series defibrillators (clusters) were randomised to deliver 120–150–200 J, 150–200–200 J, or 200–200–200 J shock strategies.ResultsBetween March 2022 and February 2023, we randomised 38 eligible patients (120–150–200 J (n = 12), 150–200–200 J (n = 10), 200–200– 200 J (n = 16)). The recruitment rate (cluster/month) was 0.07 . Treatment adherence was 93% and completeness of secondary outcomes was 86%. At 30 days, 3/36 (8.3%) patients survived. Due to the limited data storage on defibrillators, the window of opportunity for data collection was short. Data collection was challenging when defibrillators became separated from their allocated vehicles.ConclusionWe demonstrated the feasibility of a cluster randomised controlled trial of optimal shock energy for defibrillation in a UK ambulance service. We identified strategies that would aid data collection. The location of study defibrillators could be monitored using Bluetooth tracking or radio frequency identification (RFID) scanning. Remote upload to a data repository or download to a USB device at the end of each shift would help to ensure that defibrillator data were obtained before being overwritten.

Background Researchers often rely on trial participants to self-report clinical outcomes (for example fracture, re-operation). Little information exists as to the “accuracy” of participant reported clinical outcomes, particularly in randomised controlled trials (RCTs). To help address this evidence gap, we report four case-studies, nested within different RCTs where participant reported clinical outcome data were compared with that reported by clinicians or extracted from medical notes. Methods Four publicly-funded RCTs with different methods of verifying participant reported outcomes were identified: KAT: Participants were asked about hospital admissions for any reason. Where it was thought to be relevant to the trial knee, further information was sought from the lead surgeon at the admitting site to confirm whether or not the admission was relevant to the trial knee. REFLUX: Participants were asked about hospital admissions for any reason. For participants who reported a re-operation, further information was sought from the lead surgeon at the admitting site to confirm this. RECORD: Participants were asked three questions regarding broken bones. Where they were thought to be low-trauma fractures, clinical verification was sought, initially from the research nurse at site. CATHETER: Participants were asked about urinary tract infections (UTIs) and a prescription of antibiotics for treatment of UTIs following urethral catheterisation. The GPs of those who reported a UTI were contacted to confirm that an antibiotic prescription had been issued for the suspected UTI. Results KAT: 397 of 6882 (6%) participant reported hospital admissions were confirmed as relevant to the trial knee. REFLUX: 16 of 19 participants (84%) who appeared to have had a re-operation were confirmed as having had one. RECORD: 473 of 781 (61%) fractures reported by participants were confirmed as low-trauma fractures. CATHETER: 429 of 830 participant reported UTIs (52%) were confirmed as such by the GPs. Conclusions We used different approaches to the verification of participant reported outcomes in clinical trials, and it is our opinion that there is no one optimal solution. Consideration of issues such as what information is sought from participants, the phrasing of questions, whether the medical records are a true “gold standard” and costs and benefits to the RCT may help determine the appropriate approach.