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Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma (BRIOChe) - protocol for a multi-centre open-label randomised trial

Por: Hudson · E. M. · Noutch · S. · Webster · J. · Brown · S. R. · Boele · F. W. · Al-Salihi · O. · Baines · H. · Bulbeck · H. · Currie · S. · Fernandez · S. · Hughes · J. · Lilley · J. · Smith · A. · Parbutt · C. · Slevin · F. · Short · S. · Sebag-Montefiore · D. · Murray · L.
Introduction

Glioblastoma (GBM) is the most common adult primary malignant brain tumour. The condition is incurable and, despite aggressive treatment at first presentation, almost all tumours recur after a median of 7 months. The aim of treatment at recurrence is to prolong survival and maintain health-related quality of life (HRQoL). Chemotherapy is typically employed for recurrent GBM, often using nitrosourea-based regimens. However, efficacy is limited, with reported median survivals between 5 and 9 months from recurrence. Although less commonly used in the UK, there is growing evidence that re-irradiation may produce survival outcomes at least similar to nitrosourea-based chemotherapy. However, there remains uncertainty as to the optimum approach and there is a paucity of available data, especially with regards to HRQoL. Brain Re-Irradiation Or Chemotherapy (BRIOChe) aims to assess re-irradiation, as an acceptable treatment option for recurrent IDH-wild-type GBM.

Methods and analysis

BRIOChe is a phase II, multi-centre, open-label, randomised trial in patients with recurrent GBM. The trial uses Sargent’s three-outcome design and will recruit approximately 55 participants from 10 to 15 UK radiotherapy sites, allocated (2:1) to receive re-irradiation (35 Gy in 10 daily fractions) or nitrosourea-based chemotherapy (up to six, 6-weekly cycles). The primary endpoint is overall survival rate for re-irradiation patients at 9 months. There will be no formal statistical comparison between treatment arms for the decision-making primary analysis. The chemotherapy arm will be used for calibration purposes, to collect concurrent data to aid interpretation of results. Secondary outcomes include HRQoL, dexamethasone requirement, anti-epileptic drug requirement, radiological response, treatment compliance, acute and late toxicities, progression-free survival.

Ethics and dissemination

BRIOChe obtained ethical approval from Office for Research Ethics Committees Northern Ireland (reference no. 20/NI/0070). Final trial results will be published in peer-reviewed journals and adhere to the ICMJE guidelines.

Trial registration number

ISRCTN60524.

Nurse practitioner led telehealth services: A scoping review

Abstract

Aim

To explore the educational preparation of nurse practitioners to deliver telehealth services and their impact on access to care.

Design

Scoping review.

Methods

A search was undertaken 4 April 2022. Primary studies that focused on nurse practitioners and their patients/clients engaging in telehealth services in any healthcare setting or clinical area within Australia, New Zealand, United States, Canada, United Kingdom, and Ireland, published between 2010 to 2022, were included. Study findings were analysed using the Levesque et al. (2013) access to care framework and the Patterns, Advances, Gaps, Evidence for Practice and Research Recommendations framework (Bradbury-Jones et al., 2021). The PRISMA-ScR checklist was used to guide reporting.

Data Sources

CINAHL, Medline, Scopus, and Embase databases.

Results

Forty-two studies were included. Studies (n = 28) relating to access to care focused on appropriateness/ability to engage (n = 14), affordability/ability to pay (n = 1), and availability/ability to reach (n = 13). High levels of telehealth satisfaction were reported, including reduced travel time and costs, and appointment flexibility. Telehealth satisfaction was reduced when a perceived need for physical assessment, or privacy concerns were present. Service providers reported decreased emergency presentations, fewer missed appointments and improved consumer engagement. Fourteen studies related to nurse practitioner education, using a range of approaches such as didactic education modules, simulations and clinical experiences, all published within the past 3 years.

Conclusion

Findings suggest that nurse practitioner-led telehealth has improved access to care. High levels of satisfaction indicate patients accept nurse practitioner-led telehealth. Impacts to healthcare service use and patient engagement further support the viability of nurse practitioner-led telehealth. The recent increase in telehealth education studies reflects the rapid uptake of telehealth care in the mainstream.

Implications for the profession and/or patient care

Patients perceive telehealth as acceptable and appropriate to meet their healthcare needs and improve access to care. Telehealth is likely to be a mainstay in ongoing healthcare delivery, therefore, nurse practitioners must have educational preparation to provide telehealth.

Impact

This scoping review provides insight into the ways nurse practitioners deliver telehealth services, how they are educated to provide telehealth services, and their impact on access to care. Nurse practitioner-led telehealth improves access to care across service provision and consumer perspective domains. Nurse practitioner telehealth education is an emerging topic. This research is valuable for nurse practitioners using telehealth, nurse practitioner educators and telehealth policy decision makers.

Reporting Method

Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR).

Patient or Public Contribution

No Patient or Public Contribution.

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