PEACHY FAQ

When is PEACHY happening?
  • PEACHY has launched and is open for registration
  • Data collection during a four week window from 9th September to 6th October
  • This is a prospective observational cohort study
  • The data collection period will be over 7 consecutive days
  • The exact dates within the study period can be chosen by individual local centres
  • The study period will last a total of 4 weeks
What are the inclusion / exclusion criteria?

Inclusion

  • All children aged 2 – 16 years having a general anaesthetic within the study period
  • This includes remote sites such as MRI / IR / CT and endoscopy
  • Elective, day case and emergency cases
  • Including oncology and dental cases
  • Weight > 12 Kg
  • Private cases occurring in an NHS hospital

 

Exclusion

  • <2 year olds and > 16 year olds
  • Children having procedures under local / regional anaesthesia or sedation
  • Children having a general anaesthetic for surgery on the neonatal intensive care unit or paediatric intensive care unit
  • Children requiring general anaesthesia as part of their intensive care treatment only
  • Children who are already anaesthetised in the intensive care setting being transferred for a scan or procedure without any intervention to their airway planned
  • Weight <12Kg
What is PEACHY looking at?
  1. To establish the proportion of overweight and obese children aged 2 – 16 years attending hospitals for surgery across the PEACHY registered centres.
  2. To establish whether obese children are at increased risk of defined adverse perioperative events as compared to their health weight counterparts in this study population
  3. To assess variation in perioperative paracetamol dosing for overweight and obese children in the study population
Is there ethics approval?

PEACHY has HRA and REC approval as a non-consenting study- 18/WM/0394

What roles are required in each study centre?
  • The research team in Southampton consists of the  Chief Investigator, the R&D department and Principle Investigator.
  • In each study site, there will need to be a lead local collaborator as a point of contact and to ensure that the study is running according to protocol.  This is likely to be a consultant lead and the data collection will be performed by a group of trainees.
  • We will also need a point of contact in your local R&D.  This will be required for the form to enrol in the study.
Do we need GCP to participate?
  • The lead collaborator in each site will need to be GCP trained
  • The remaining team members need to be appropriately trained in research and currently, the best way to do this is GCP.
  • Training is available online here: https://www.niaa.org.uk/Introduction-to-Good-Clinical-Practice-e-learning

  • To complete the module you will first need to register with the NIHR Learning Management System to create an account using your NHS or university email address.

Since this study is an NIHR Portfolio study, will it count towards accruals / Will there be any financial incentive?

No, as PEACHY is a non-consenting study

When will we be notified if we have been accepted as a site for PEACHY?

Your site will be accepted into the study once you have submitted your registration form. 

I cannot see my Trust on the IRAS form?

PEACHY has been approved as a multi-centre study. Registered sites will be added as a non-substantial amendment to the IRAS form as sites formally register; this can take four weeks from submission and an updated version of the IRAS form will then appear on the study website.

We are a split site – on the registration form you ask for a Trust only?

The study requires agreement between the sponsor and your Trust R&D therefore please register as a Trust.  For registration purposes, choose a trainee, local lead and main R&D contact to manage the study across the sites.

  
In the Organisation Information Document (OID), please add each separate hospital/site in your Trust under Section 6.  

Can a research officer act as the Local Lead?

No, the local Principal Investigator needs to be part of the clinical team as per our ethics agreement. This should be a Consultant with up to date Good Clinical Practice training. 

What is confirmation of capacity and capability (C&C)?

This is a local assessment made by your R&D team. Please liaise with them directly and they will guide you through the process to get your site set up for the study. 

Do we need to notify ethics of the Local Lead/PI before confirmation of capacity and capability?

No this is not required. Ethics approval has been gained through the sponsor site, University Hospital Southampton. 

Is there any funding for participating sites from APAGBI?

No, there is no additional funding.  The study is a trainee led project and should be largely delivered by trainees, as has been the case for previous national PATRN projects. 

What is the recruitment window?

Your site will collect data for a one-week (7 day) period only. The recruitment window is from 9th September 2019 to 6th October 2019 to allow you some flexibility in when you conduct your data collection.  

What is the target number of sites joining the study?

We based our initial estimates on the PAPAYA numbers of around 90 sites.  This project, while starting as a similar audit, has grown into a NIHR portfolio study therefore the sign-up process is a little more robust.  We currently have around 70 sites registered. 

How many participants each site should recruit?

There is no set number of cases each site should recruit.  The absolute numbers will vary from site to site as we will be recruiting from small DGHs to large tertiary centres. The important thing is that each site collects data for ALL eligible children in the study period. 

Will there be a site initiation visit (SIV)?

No. If you have specific queries with regard to the set-up process, please direct these to the PEACHY team (uhs.peachy@nhs.net) but we are hoping that most of the information you require will be available via the study website.  

What do I do if I can’t measure standing height?

There will be some patients (eg with an acute abdomen or musculoskeletal problems) that you may not be able to measure a standing height. If this is the case please follow your local policy for measuring height lying down or sitting. If this isn’t clarified within a local policy, a supine height, with the patient lying on their bed (ideally with feet against the footboard) would be acceptable.

If you are unable to measure height at all for a patient please start a case record form (CRF) for the patient but do not collect any further data. This case will then be uploaded as a “missed” case. This will mean we know how many cases we have missed and have not been able to calculate a BMI for during the study period.