How we made the decision

We check our guidelines regularly to ensure they remain up to date. We based the decision on surveillance 4 years after the publication of anaphylaxis: assessment and referral after emergency treatment (2011) NICE guideline CG134.

For details of the process and update decisions that are available, see ensuring that published guidelines are current and accurate in 'Developing NICE guidelines: the manual'.

Previous surveillance update decisions for the guideline are on our website.

New evidence

We found 7 new studies in a search for randomised controlled trials and systematic reviews published between 19 October 2012 and 17 May 2016. We also considered 5 additional studies identified by members of the guideline committee who originally worked on this guideline.

Evidence identified in an evidence update published 2 years after publication of the guideline was also considered. This included 13 studies identified by search.

From all sources, 25 studies were considered to be relevant to the guideline.

We also checked for relevant ongoing research, which will be evaluated again at the next surveillance review of the guideline.

See appendix A: summary of new evidence from surveillance and references for all new evidence considered.

Views of topic experts

We considered the views of topic experts, including those who helped to develop the guideline and other correspondence we have received since the publication of the guideline.

Views of stakeholders

Stakeholders commented on the decision not to update the guideline. Overall, 6 stakeholders commented. See appendix B for stakeholders' comments and our responses.

Four stakeholders agreed that the guideline should not be updated, one disagreed and another did not comment. The reason the stakeholder disagreed with the decision not to update was because of an ongoing national audit of anaphylaxis associated with anaesthesia (NAP6), which is expected to be published in the next 3 years. The large observational study falls within the scope of NICE guideline CG134. Although no specific recommendations about perioperative anaphylaxis following administration of anaesthesia are made in the clinical guideline, we do anticipate that the results of this study may inform future surveillance review decisions. The progress of the study will be monitored and the results will be considered at the next surveillance time point.

Three stakeholders agreed that the guideline should be placed on the static list, 2 stakeholders disagreed and another did not comment. Stakeholders disagreed because of the aforementioned ongoing NAP6 study. The stakeholders who disagreed with the proposal highlighted that the large observational study may produce data that are of direct relevance to the guideline and will provide valuable insights in current care. Given that this ongoing research is due to be published in the near future, we decided not to place NICE guideline CG134 on the static list.

Five stakeholders agreed with the proposal to remove the research recommendation about examination of the utility of chemical inflammatory mediators other than mast cell tryptase. One stakeholder did not comment.

Four stakeholders agreed with the proposal to remove the research recommendation on the duration of time that a person who has received emergency treatment should be observed. One stakeholder disagreed, citing the NAP6 study, and another stakeholder did not provide any comment. In light of ongoing research that may impact on guideline recommendations, the research recommendation relating to emergency treatment will be retained and reviewed at the next surveillance time point.

Two stakeholders commented on areas excluded from the scope of the guideline. One highlighted an ongoing Medicines and Healthcare Products Regulatory Agency (MHRA) review of 500 microgram adrenaline autoinjectors. Approval of specific medications or medical device falls under the jurisdiction of the MHRA and the European Medicines Agency. Thus, NICE will wait for completion of MHRA and European reviews to establish whether the guideline would be affected. Another stakeholder suggested amendments to the wording of recommendations on timing of mast cell tryptase testing in order to add clarity. The comments were not considered to have any current impact on guideline recommendations because implementation tools have been developed for NICE guideline CG134 to facilitate implementation of guideline recommendations.

See ensuring that published guidelines are current and accurate in 'Developing NICE guidelines: the manual' for more details on our consultation processes.

NICE Surveillance programme project team

Sarah Willett
Associate Director

Philip Alderson
Consultant Clinical Adviser

Emma McFarlane
Technical Adviser

Jeffrey T. Essuman
Technical Analyst

The NICE project team would like to thank the topic experts who participated in the surveillance process.

ISBN: 978-1-4731-2185-0

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