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RELEASE-HF study: a protocol for an observational, registry-based study on the effectiveness of telemedicine in heart failure in the Netherlands

Por: van Eijk · J. · Luijken · K. · Jaarsma · T. · Reitsma · J. B. · Schuit · E. · Frederix · G. W. J. · Derks · L. · Schaap · J. · Rutten · F. H. · Brugts · J. · de Boer · R. A. · Asselbergs · F. W. · Trappenburg · J. C. A. · RELEASE-HF Investigators · Jan Borleffs · Dalen · Erol-Yilmaz
Introduction

Meta-analyses show postive effects of telemedicine in heart failure (HF) management on hospitalisation, mortality and costs. However, these effects are heterogeneous due to variation in the included HF population, the telemedicine components and the quality of the comparator usual care. Still, telemedicine is gaining acceptance in HF management. The current nationwide study aims to identify (1) in which subgroup(s) of patients with HF telemedicine is (cost-)effective and (2) which components of telemedicine are most (cost-)effective.

Methods and analysis

The RELEASE-HF (‘REsponsible roLl-out of E-heAlth through Systematic Evaluation – Heart Failure’) study is a multicentre, observational, registry-based cohort study that plans to enrol 6480 patients with HF using data from the HF registry facilitated by the Netherlands Heart Registration. Collected data include patient characteristics, treatment information and clinical outcomes, and are measured at HF diagnosis and at 6 and 12 months afterwards. The components of telemedicine are described at the hospital level based on closed-ended interviews with clinicians and at the patient level based on additional data extracted from electronic health records and telemedicine-generated data. The costs of telemedicine are calculated using registration data and interviews with clinicians and finance department staff. To overcome missing data, additional national databases will be linked to the HF registry if feasible. Heterogeneity of the effects of offering telemedicine compared with not offering on days alive without unplanned hospitalisations in 1 year is assessed across predefined patient characteristics using exploratory stratified analyses. The effects of telemedicine components are assessed by fitting separate models for component contrasts.

Ethics and dissemination

The study has been approved by the Medical Ethics Committee 2021 of the University Medical Center Utrecht (the Netherlands). Results will be published in peer-reviewed journals and presented at (inter)national conferences. Effective telemedicine scenarios will be proposed among hospitals throughout the country and abroad, if applicable and feasible.

Trial registration number

NCT05654961.

Cohort study to characterise surgical site infections after open surgery in the UKs National Health Service

Por: Guest · J. F. · Fuller · G. W. · Griffiths · B.
Objective

To characterise surgical site infections (SSIs) after open surgery in the UK’s National Health Service.

Design

Retrospective cohort analysis of electronic records of patients from Clinical Practice Research Datalink, linked with Hospital Episode Statistics’ secondary care datasets.

Setting

Clinical practice in the community and secondary care.

Participants

Cohort of 50 000 adult patients who underwent open surgery between 2017 and 2022.

Outcome measures

Incidence of SSI, clinical outcomes, patterns of care and costs of wound management.

Results

11% (5281/50 000) of patients developed an SSI a mean of 18.4±14.7 days after their surgical procedure, of which 15% (806/5281) were inpatients and 85% (4475/5281) were in the community after hospital discharge. The incidence of SSI varied according to anatomical site of surgery. The incidence also varied according to a patient’s risk and whether they underwent an emergency procedure. SSI onset reduced the 6 months healing rate by a mean of 3 percentage points and increased time to wound healing by a mean of 15 days per wound. SSIs were predominantly managed in the community by practice and district nurses and 16% (850/5281) of all patients were readmitted into hospital. The total health service cost of surgical wound management following SSI onset was a mean of £3537 per wound ranging from £2542 for a low-risk patient who underwent an elective procedure to £4855 for a high-risk patient who underwent an emergency procedure.

Conclusions

This study provides important insights into several aspects of SSI management in clinical practice in the UK that have been difficult to ascertain from surveillance data. Surgeons are unlikely to be fully aware of the true incidence of SSI and how they are managed once patients are discharged from hospital. Current SSI surveillance services appear to be under-reporting the actual incidence.

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