Protocol for assessing the impact of the 6th National Audit Project recommendations on practice

Abstract

Patient safety has been a growing area of concern, especially within perioperative care where risks of major complications during surgery exist. Anaphylaxis in the operating theatre is a life-threatening drug reaction that happens suddenly, without warning and can affect anyone. The 6th National Audit Project (NAP6) of the Royal College of Anaesthetists (RCoA): Perioperative Anaphylaxis was the largest ever prospective study of anaphylaxis related to anaesthesia and surgery. The findings from the audit were collated into a report and included recommendations for improved patient care. The purpose of this study is to understand the perceptions of the NAP6 recommendations and their impact on practice. This study will use ethnographic qualitative methods in the form of observations, interviews and a documentary analysis. The sessions targeted for observations will include departmental or hospital meetings, and educational or training sessions, related to perioperative anaphylaxis. The target sample size of 78 healthcare professionals across six hospitals within England, will include individuals with roles specific to anaesthesia, surgery, immunology, allergy and governance. Additionally, six stakeholders will be interviewed who can provide insights into the NAP6 recommendations at the national level. Across the six sites, local collaborators will share any relevant documents related to perioperative anaphylaxis or the NAP-6 recommendations. The study has received regulatory approvals from the Health Research Authority and has been funded by the National Institute for Health and Care Research.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study has been funded by the National Institute for Health and Care Research.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study has received regulatory approvals from the Health Research Authority.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors.

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