The incidence of anal carcinoma is increasing, with the current gold standard treatment being chemoradiotherapy. There is currently a wide range in the radiotherapy dose used internationally which may lead to overtreatment of early-stage disease and potential undertreatment of locally advanced disease.
PLATO is an integrated umbrella trial protocol which consists of three trials focused on assessing risk-adapted use of adjuvant low-dose chemoradiotherapy in anal margin tumours (ACT3), reduced-dose chemoradiotherapy in early anal carcinoma (ACT4) and dose-escalated chemoradiotherapy in locally advanced anal carcinoma (ACT5), given with standard concurrent chemotherapy.
The primary endpoints of PLATO are locoregional failure (LRF)-free rate for ACT3 and ACT4 and LRF-free survival for ACT5. Secondary objectives include acute and late toxicities, colostomy-free survival and patient-reported outcome measures. ACT3 will recruit 90 participants: participants with removed anal tumours with margins ≤1 mm will receive lower dose chemoradiotherapy, while participants with anal tumours with margins >1 mm will be observed. ACT4 will recruit 162 participants, randomised on a 1:2 basis to receive either standard-dose intensity modulated radiotherapy (IMRT) in combination with chemotherapy or reduced-dose IMRT in combination with chemotherapy. ACT5 will recruit 459 participants, randomised on a 1:1:1 basis to receive either standard-dose IMRT in combination with chemotherapy, or one of two increased-dose experimental arms of IMRT with synchronous integrated boost in combination with chemotherapy.
This study has been approved by Yorkshire & The Humber – Bradford Leeds Research Ethics Committee (ref: 16/YH/0157, IRAS: 204585), July 2016. Results will be disseminated via national and international conferences, peer-reviewed journal articles and social media. A plain English report will be shared with the study participants, patients’ organisations and media.
To identify, synthesise and map systematic reviews of the effectiveness of nursing interventions undertaken in a neonatal intensive care unit or special care nursery.
This scoping review was conducted according to the JBI scoping review framework.
Review included systematic reviews that evaluated any nurse-initiated interventions that were undertaken in an NICU or SCN setting. Studies that reported one or more positive outcomes related to the nursing interventions were only considered for this review. Each outcome for nursing interventions was rated a ‘certainty (quality) of evidence’ according to the Grading of Recommendations, Assessment, Development and Evaluations criteria.
Systematic reviews were sourced from the Cochrane Database of Systematic Reviews and Joanna Briggs Institute Evidence Synthesis for reviews published until February 2023.
A total of 428 articles were identified; following screening, 81 reviews underwent full-text screening, and 34 articles met the inclusion criteria and were included in this review. Multiple nursing interventions reporting positive outcomes were identified and were grouped into seven categories. Respiratory 7/34 (20%) and Nutrition 8/34 (23%) outcomes were the most reported categories. Developmental care was the next most reported category 5/34 (15%) followed by Thermoregulation, 5/34 (15%) Jaundice 4/34 (12%), Pain 4/34 (12%) and Infection 1/34 (3%).
This review has identified nursing interventions that have a direct positive impact on neonatal outcomes. However, further applied research is needed to transfer this empirical knowledge into clinical practice.
Implementing up-to-date evidence on effective nursing interventions has the potential to significantly improving neonatal outcomes.
No patient or public involvement in this scoping review.