Verifying participant-reported clinical outcomes : challenges and implications

The parent trials KAT, REFLUX and CATHETER were all funded by the UK NIHR Health Technology Assessment Programme. RECORD was funded by the UK Medical Research Council. Suzanne Breeman and Lynda Constable are joint first authors.Peer reviewedPublisher PD

Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital : a multicentre randomised controlled trial

Copyright © 2012 Elsevier Ltd. All rights reserved. PMID: 23134837 [PubMed - indexed for MEDLINE]Peer reviewedPostprin

Shockwave lithotripsy compared with ureteroscopic stone treatment for adults with ureteric stones : the TISU non-inferiority RCT

Acknowledgements The authors wish to thank the patients who participated in the TISU trial.We also thank Stanley Coutts (patient representative) and Charles Clark (patient representative and co-applicant) for their contribution to the design of the participant-facing documents (patient information sheet and questionnaires); Sharon Wren for her secretarial support and data management; previous data co-ordinators, Jessica Wood and Margery Heath, for their data and trial management support; the CHaRT programming team led by Gladys McPherson (to 2016) and Mark Forrest (2016–present); other staff within CHaRT and the HSRU for their assistance with the trial (Cynthia Fraser); members of the PMG for their ongoing advice and support of the trial, plus the independent members of the TSC and DMC; and the staff at the recruitment sites who facilitated the recruitment, treatment and follow-up of trial participants (all listed below); and, finally, we would like to thank the National Institute for Health Research and the Health Technology Assessment programme for funding the TISU trial. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 19. See the NIHR Journals Library website for further project information.Peer reviewedPublisher PD

Prehospital optimal shock energy for defibrillation (POSED) : a cluster randomised controlled feasibility trial

We explored the feasibility of a large-scale UK ambulance services trial of optimal defibrillation shock energy for out-of-hospital cardiac arrest. The primary objective of this feasibility study was to establish the number of eligible patients and the number recruited. Secondary outcomes were adherence to allocated treatment and data completeness. We conducted a three-arm parallel group cluster randomised controlled feasibility study in a single ambulance service in southern England. Adult patients in out-of-hospital cardiac arrest 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. Between 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)) to the study. The recruitment rate per cluster was 0.07 per month. The median patient age was 71 years (IQR 59-81 years); 79% were male. Twenty-eight cardiac arrests (74%) occurred in a private residence, 29 (76%) were witnessed and 32 (84%) patients received bystander CPR. Treatment adherence was 93% and completeness of clinical and electrical outcomes was 86%. At 30 days, 3/36 (8.3%) patients survived; we were unable to collect survival outcomes for two patients. Defibrillation data collection became difficult when defibrillators became separated from their allocated vehicles. We have demonstrated the feasibility of a cluster randomised controlled trial of optimal shock energy for defibrillation in a UK ambulance service. We have identified possible solutions to issues relating to trial design. [Abstract copyright: © 2024 The Author(s).

Cost−utility analysis of shockwave lithotripsy vs ureteroscopic stone treatment in adults

Objectives: To assess the cost‐effectiveness, resource use implications, quality‐adjusted life‐years (QALYs) and cost per QALY of care pathways starting with either extracorporeal shockwave lithotripsy (SWL) or with ureteroscopic retrieval (ureteroscopy [URS]) for the management of ureteric stones. Patients and Methods: Data on quality of life and resource use for 613 patients, collected prospectively in the Therapeutic Interventions for Stones of the Ureter (TISU) randomized controlled trial (ISRCTN 92289221), were used to assess the cost‐effectiveness of two care pathways, SWL and URS. A health provider (UK National Health Service) perspective was adopted to estimate the costs of the interventions and subsequent resource use. Quality‐of‐life data were calculated using a generic instrument, the EuroQol EQ‐5D‐3L. Results are expressed as incremental cost‐effectiveness ratios and cost‐effectiveness acceptability curves. Results: The mean QALY difference (SWL vs URS) was −0.021 (95% confidence interval [CI] −0.033 to −0.010) and the mean cost difference was −£809 (95% CI −£1061 to −£551). The QALY difference translated into approximately 10 more healthy days over the 6‐month period for the patients on the URS care pathway. The probabaility that SWL is cost‐effective is 79% at a society's willingness to pay (WTP) threshold for 1 QALY of £30,000 and 98% at a WTP threshold of £20,000. Conclusion: The SWL pathway results in lower QALYs than URS but costs less. The incremental cost per QALY is £39 118 cost saving per QALY lost, with a 79% probability that SWL would be considered cost‐effective at a WTP threshold for 1 QALY of £30 000 and 98% at a WTP threshold of £20 000. Decision‐makers need to determine if costs saved justify the loss in QALYs

Route of drug administration in out-of-hospital cardiac arrest: A protocol for a randomised controlled trial (PARAMEDIC-3)

© 2023 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).AIMS: The PARAMEDIC-3 trial evaluates the clinical and cost-effectiveness of an intraosseous first strategy, compared with an intravenous first strategy, for drug administration in adults who have sustained an out-of-hospital cardiac arrest. METHODS: PARAMEDIC-3 is a pragmatic, allocation concealed, open-label, multi-centre, superiority randomised controlled trial. It will recruit 15,000 patients across English and Welsh ambulance services. Adults who have sustained an out-of-hospital cardiac arrest are individually randomised to an intraosseous access first strategy or intravenous access first strategy in a 1:1 ratio through an opaque, sealed envelope system. The randomised allocation determines the route used for the first two attempts at vascular access. Participants are initially enrolled under a deferred consent model.The primary clinical-effectiveness outcome is survival at 30-days. Secondary outcomes include return of spontaneous circulation, neurological functional outcome, and health-related quality of life. Participants are followed-up to six-months following cardiac arrest. The primary health economic outcome is incremental cost per quality-adjusted life year gained. CONCLUSION: The PARAMEDIC-3 trial will provide key information on the clinical and cost-effectiveness of drug route in out-of-hospital cardiac arrest.Trial registration: ISRCTN14223494, registered 16/08/2021, prospectively registered.Peer reviewe