Demo Back to my tasks

Children’s surgery outcome reporting

Inviting parents, carers and guardians of children diagnosed with a condition requiring early life surgery to share views on how best to collect data on children’s surgery outcomes

Total tasks

2

Open until

November 2021

About this project
Information for participants

Treating children for surgical conditions

Across the UK, there is significant variation in the way children are treated for certain surgical conditions:

  • Necrotising enterocolitis (NEC)
  • Hirschsprung’s disease
  • Oesophageal atresia
  • Abdominal wall defects (gastroschisis, exomphalos)
  • Congenital diaphragmatic hernia (CDH)
  • Posterior urethral valves (PUV)

At the moment, we do not know which aspects of these variations affect how successfully children are treated.

Producing evidence requires collecting reliable information about how children are currently treated, and linking this to information about their long-term health and wellbeing.

We are seeking parents, carers and guardians of children diagnosed with a condition requiring early life surgery

Share your views on how best to collect data on children’s surgery outcomes

Collecting data for evidence on how to improve outcomes

The CSOR programme aims to produce evidence by developing a database of children’s surgical outcomes.

This database will link data collected in the process of clinical care to parent-reported outcome data, and Hospital Episodes Statistics (HES) data.

As part of the wider CSOR research programme, this study involves focus groups with parents of children treated for a surgical condition. These online focus groups will explore:

  • how parents would like to be approached to consent to contributing to the database
  • how parents would like to report information about their child’s health post-surgery into this database.

How you can be involved

Register on Thiscovery
It's quick! Before you sign in, we'll ask you to verify your email address by clicking a link.
Take part in an online focus group
Join other parents, guardians, and carers to discuss reporting surgery outcomes.
Complete a follow-up survey
Reflect on what you have heard or share thoughts not expressed in the focus group session.

The CSOR programme is a five-year collaboration between the National Perinatal Epidemiology Unit, paediatric surgeons from Oxford, Southampton, Glasgow, Alder Hey, Cambridge, Royal Manchester, Chelsea & Westminster and Great Ormond Street Children’s Hospitals, and parents of children who have undergone early surgery. It is funded by the National Institute for Health Research.

Information for participants

Key things to know

  • Children’s Surgery Outcome Reporting aims to build a database to collect data about surgery outcomes for certain conditions, including long-term outcomes.
  • This database will collect surgery outcomes for the following conditions:
    • Necrotising enterocolitis (NEC)
    • Hirschsprung’s disease
    • Oesophageal atresia
    • Abdominal wall defects (gastroschisis, exomphalos)
    • Congenital diaphragmatic hernia (CDH)
    • Posterior urethral valves (PUV).
  • While some surgery outcomes are known to clinicians soon after surgery, other outcomes – including medium- and long-term experiences of life after surgery- are only known to children and their parents, guardians, and carers.
  • With this in mind, the database will capture information about these medium- and long-term surgery outcomes, as reported by parents, guardians, and carers.
  • We would like to ask parents, guardians, and carers about how they would like to be involved in reporting their child’s medium- and long-term surgery outcomes into the database, including how and when they would like their consent to be sought
  • This study involves an online focus group and an optional short follow up survey.
  • Participation is entirely voluntary. If at any time you decide you do not want to take part, that’s not a problem – just let us know.
  • The researchers will maintain your confidentiality at all times.
  • This leaflet explains the research in more detail

About this study

Across the UK, there is significant variation in the way children are treated for surgical conditions (conditions that usually, but not always, require an operation). However, at the moment, we do not know which aspects of these variations affect how successfully children are treated. Producing evidence requires collecting reliable information about how children are currently treated, and linking this information to information about their long-term health and wellbeing. The CSOR programme aims to do just this – by developing a system that links data collected in the process of clinical care to parent-reported outcome data, and Hospital Episodes Statistics (HES) data.

As part of the wider CSOR research programme, this study involves focus groups with parents of children treated for a surgical condition to explore (a) how they would like to have their consent to contribute to the dataset sought and (b) how they would like to report information about their child’s health post-surgery into this dataset.

What will happen and how will you be involved?

These focus groups will take place online. Each focus group has two parts – an online focus group and a follow up survey. The follow up survey will include questions similar to the ones asked in the online focus group and will encourage you to reflect on what you have heard as well as to add anything you did not have a chance to say in the online focus group.

You can take part in our study if you are over 18 years old and a parent, guardian, or carer of a child diagnosed (and treated surgically or not yet treated surgically) with the following conditions:

  • Necrotising enterocolitis (NEC)
  • Hirschsprung’s disease
  • Oesophageal atresia
  • Abdominal wall defects
  • Congenital diaphragmatic hernia (CDH)
  • Posterior urethral valves (PUV).

If you would like to take part, you will need to register on the Thiscovery website (https://www.thiscovery.org/), which has been developed by The Healthcare Improvement Studies (THIS) Institute at the University of Cambridge.

You will then be taken to a short eligibility check, and an availability survey where you will indicate when you could participate in a focus group. Once at least 4 participants indicate their availability for a given time slot, you will then be sent a Zoom link for a specific time and date of the online focus group, as well as instructions on how to join.

Shortly after the online focus group, you will be sent a link to a short follow up survey. The survey will include similar questions to the ones asked at the online focus group and will ask you to reflect on what you have heard or to share your thoughts that you may not have had the chance to express during the online group. You will be able to save and resume the survey if you wish. The survey will be open for 7 days following the Zoom focus group – you will be sent a reminder before it closes if you have not returned it before.

What are the benefits of this study?

Taking part in this study will help to inform the design of the database collecting information about children’s surgery that includes medium- and long-term experiences of living after the surgery. Your participation gives you the opportunity to provide your views and experiences, and influence what we include in tools and support for healthcare professionals. There is no direct benefit to you but your contribution will improve our knowledge of long-term outcomes of children’s surgery in the future and will benefit others.

You will be compensated for your time with a £20 shopping voucher.

Are there any risks?

You may become upset during the online focus groups although the researchers will take utmost care to notice any signs of distress and to support participants in a sensitive manner. There will be an opportunity to speak to the researchers following the online focus groups or to get follow-up information about support organisations. You may stop participating at any point without giving a reason.

Important details

  • This study is organised by an independent and highly experienced team from the University of Cambridge.
  • This study is funded by the National Institute for Health Research (NIHR HS&DR Reference Number NIHR127844).
  • This research will be led by Dr Lisa Hinton, Senior Research Associate, THIS Institute, University of Cambridge and Dr Karolina Kuberska, THIS Institute, University of Cambridge with support from co-investigators Professor Marian Knight, National Perinatal Epidemiology Unit (NPEU), Nuffield Department of Population Health, University of Oxford and Mr Benjamin Allin, National Perinatal Epidemiology Unit (NPEU), Nuffield Department of Population Health, University of Oxford.
  • This study has been reviewed by the Cambridge Psychology Research Ethics Committee PRE.2021.056, 24/08/2021

How will we use information about you?

The University of Cambridge are the sponsors for this study based in the United Kingdom. We will be using information from you to carry out this study, so we are the data controller for this study.  This means that we are responsible for looking after your information and using it properly. We will keep identifiable information about you for as long as it is required. This will be stored securely by THIS Institute, University of Cambridge. Some of the information that you provide might be considered as health data or other data that would be classed as Special Category data under Article 9 of the General Data Protection Regulation (GDPR). As part of the consent process for this project we therefore need to seek your consent for the processing of this data.

We will need to use the following information from you for this study:

  • Your name and contact details to arrange the online focus group, invite you to the follow up survey and to share the study results with you if you ask for them;
  • Your consent form;
  • Your survey answers;
  • Audio recording of the online focus group.

We will audio record the focus group and this will be transcribed and anonymised by a third party who is subject to the University’s data protection processes. All transcripts will be fully anonymised to remove any information that could identify people or places. The anonymised transcripts will be stored on the University of Cambridge secure sever. We will keep all information about you safe and secure. For more information about our secure data area please see: https://www.medschl.cam.ac.uk/research/information-governance/the-secure-data-hosting-service/. In the future, this data may be shared anonymously with other academic researchers working at, or in partnership with, THIS Institute. These partners will hold a data agreement with THIS Institute and will be bound by the same ethical requirements.

Only the direct recruiting team, data management and authorised audit systems will have access to your personal information.  All transcripts for analysis and all reports will be robustly anonymised. Your data will have a code number instead. People will use this information to do the research or to check your records to make sure that the research is being done properly.

If you agree to take part in this study, the information we gather may be shared anonymously with academic and commercial researchers external to the study in and outside the UK. This is so that our research can be used to support other like-minded researchers.

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study. Any links to the personal data held in Thiscovery and any unique user IDs will be destroyed 24 months after the end of the project. This is to allow us to communicate any results from the project to those participants who want to be kept informed and agree to be recontacted.

What are your choices about how your information is used?

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.

Where to find out more about how your information is used?

You can find more about how we use your information:

Get in touch

For questions or concerns about anything to do with the study

Dr Karolina Kuberska
Dr Karolina Kuberska
01223 761881
csor@thisinstitute.cam.ac.uk

For any complaints or concerns

Contact the University of Cambridge Research Governance office:

01223 769291

SchoolSec@medschl.cam.ac.uk