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'Super Rehab: can we achieve coronary artery disease regression? A feasibility study protocol

Por: Graby · J. · Khavandi · A. · Gillison · F. · Smith · T. · Murphy · D. · Peacock · O. · McLeod · H. · Dastidar · A. · Antoniades · C. · Thompson · D. · Rodrigues · J. C. L.
Introduction

Patients diagnosed with coronary artery disease (CAD) are currently treated with medications and lifestyle advice to reduce the likelihood of disease progression and risk of future major adverse cardiovascular events (MACE). Where obstructive disease is diagnosed, revascularisation may be considered to treat refractory symptoms. However, many patients with coexistent cardiovascular risk factors, particularly those with metabolic syndrome (MetS), remain at heightened risk of future MACE despite current management.

Cardiac rehabilitation is offered to patients post-revascularisation, however, there is no definitive evidence demonstrating its benefit in a primary prevention setting. We propose that an intensive lifestyle intervention (Super Rehab, SR) incorporating high-intensity exercise, diet and behavioural change techniques may improve symptoms, outcomes, and enable CAD regression.

This study aims to examine the feasibility of delivering a multicentre randomised controlled trial (RCT) testing SR for patients with CAD, in a primary prevention setting.

Methods and analysis

This is a multicentre randomised controlled feasibility study of SR versus usual care in patients with CAD. The study aims to recruit 50 participants aged 18–75 across two centres. Feasibility will be assessed against rates of recruitment, retention and, in the intervention arm, attendance and adherence to SR. Qualitative interviews will explore trial experiences of study participants and practitioners. Variance of change in CAD across both arms of the study (assessed with serial CT coronary angiography) will inform the design and power of a future, multi-centre RCT.

Ethics and dissemination

Ethics approval was granted by South West—Frenchay Research Ethics Committee (reference: 21/SW/0153, 18 January 2022). Study findings will be disseminated via presentations to relevant stakeholders, national and international conferences and open-access peer-reviewed research publications.

Trial registration number

ISRCTN14603929.

Developing a model of neonatal nurse‐controlled analgesia: A Delphi study

Abstract

Aim

To develop a nurse-led model of analgesia to manage post-operative pain in the surgical neonate.

Design

A four-round e-Delphi study was conducted from March to December 2022.

Methods

An e-Delphi method was used seeking a consensus of 70% or greater. Fifty-one experts were invited to join the panel. Members consisted of multi-disciplinary healthcare professionals who work in areas associated with neonatal care. In round 1, 49 statements relative to neonatal pain assessment and management were distributed to the panel. Panel members were asked to rate their level of agreeance on a Likert scale from 1 to 5 (1 = strongly disagree to 5 = strongly agree). Ratings equal to or greater than 4 represented agreement, 3 indicated uncertainty and 2 or less disagreement with the proposed statement. An opportunity for free-text responses after each statement was provided. This iterative process continued for three rounds. In the fourth and final round, the completed model of neonatal nurse-controlled analgesia was presented along with a further opportunity to provide feedback on the final version.

Results

Four rounds of statements and voting were required to reach consensus on a model of neonatal nurse-controlled analgesia. The model consists of criteria for use, over-arching guidelines and three separate pathways based on an individual baby's pain assessment scores, need for pain relieving interventions and time-lapsed post-surgical procedure.

Conclusion

A comprehensive model of neonatal nurse-controlled analgesia, applicable to the Australasian context, was developed in collaboration with a group of neonatal experts.

Impact

This study provides a multi-modal family-integrated model to manage neonatal post-operative pain. By providing nurses with increased autonomy to assess and manage acute pain, this model has the potential to not only provide a more responsive and individualized approach to alleviate discomfort, but highlights the integral role of parent partnerships in the neonatal intensive care.

Reporting Method

This study was reported in line with the Conducting and REporting of DElphi studies (CREDE) guidance on Delphi studies.

Patient or Public Contribution

No patient or public contribution was utilized for this study.

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