COHESION Study Phase 3

Phase 3: Delphi Survey to prioritise outcomes on their importance

We are asking you to take part in the COHESION study by completing an online survey. Please find information below about the survey and/ or watch our recruitment video https://www.youtube.com/watch?v=lRW7n8HtczQ&t=6s

Once you have read the information below and are happy to take part, please register for the survey here: (insert link).

Why is this study important?

Neonatal encephalopathy is a condition that can occur in newborn infants when they have had a lack of oxygen, and this can cause complications with the infant’s brain. Neonatal Encephalopathy is one of the leading causes of brain injury in newborn infants.

At the moment, different studies into how to best treat neonatal encephalopathy measure how well the treatment works in different ways (called ‘outcomes’). This often means that when health care professionals or parents want to compare or combine different studies, they are unable to do so.

We know it would be impossible to measure everything; so in this study we want to find out which outcomes should be collected in all studies. This set of outcomes is called a ‘core outcome set’.

What is a core outcome set?

Core outcomes sets (COS) are the minimum set of outcomes that should be measured and reported in studies evaluating a health intervention. An intervention is anything that aims to make a change to someone’s health. For example, providing a counselling service, giving a drug, or giving people information and training are all described as interventions. Researchers may wish to explore other outcomes relevant to their research, but the COS should always be included. Agreeing the set of outcomes that must be reported in all studies allows us to pool the evidence from different studies, which helps inform health care decisions and also reduces research waste.

How do I know if I can take part in this study?

You can take part in this study if you are over 18 years of age and are a;

• Parent of an infant who has been diagnosed with, and received treatment for, neonatal encephalopathy (or hypoxic ischemic encephalopathy), or other family members who may care for the infant
• Healthcare provider or
• Researcher/Academic with expertise in neonatal encephalopathy

What will I have to do?

If you agree to take part, you will take part in an online survey called a ‘Delphi survey’ where we will provide a list of possible outcomes related to the treatment of neonatal encephalopathy and ask you to rate the importance of each outcome on a 9-point scale.

When you sign up, you will be allocated by computer (at random) to answer the survey in one of two formats.

Format 1: we will send you a series of 3 online surveys called ‘rounds’ over a 4-6 month period. Each ‘round’ will take approximately 15-20 minutes to complete.

Format 2: we will send you a single survey that remains live for a 4-5-week period. It will take approximately 15-20 minutes to complete the survey. You must visit the survey and rate all the outcomes at least twice during the 4-5-week period.

The outcomes from Format 1 and Format 2 will be brought to a face-to-face meeting where a final list of outcomes for inclusion in the COS will be agreed

Are there any benefits or risks to me taking part?

Your participation will help us establish which outcomes are important and should be measured in all future studies of treatments for neonatal encephalopathy. There are no known risks to taking part in this study.

Do I have to take part?

No. You do not have to take part if you don’t want to. You have the right to stop being in the study at any time. If you decide not to take part in this study, or if you decide to stop, you do not have to give a reason.

Voluntary participation

Participation is entirely voluntary, and you have the right to withdraw from the study at any time. If you decide not to participate in this study, or if you withdraw, there will be no negative consequences, and you will not be expected to give any reason for your decision. We do hope that you will consider completing all questions within the survey, but if you do decide to exit the study early, all questions that you had completed up to that point will be submitted as complete. If you are a maternity service user and decide not to participate, or to withdraw from the study, your care will not be affected in any way. If you do decide to stop being in the study, please send an email to the COHESION research team to tell us this.

Confidentiality

Your identity will remain confidential. All data will be coded, meaning that your name will not be published, and it will not be disclosed. All data retrieved from the survey will be stored securely in the National University of Ireland, Galway under the stewardship of the research team and destroyed after a period of seven years as in accordance with the National University of Ireland, Galway Data Retention Policy.

What will happen to the findings of this study?

The findings of the survey will inform the development of a core set of outcomes to determine the effectiveness of treatment for neonatal encephalopathy. The findings of the interviews may be submitted to a journal for publication.

Compensation

This study is covered by standard institutional indemnity insurance. Nothing in this document restricts or curtails your rights.

Funding

This study has been funded through the Health Research Board (Ireland).

Has this study received ethical approval?

Yes, this study has received approval from the following research ethics committee

National University of Ireland, Galway Research Ethics Committee

Research Office

Room 212

Research and Innovation Centre

NUI Galway

Tel:  353 91 495312

Who can I ask if I have questions?

You can get more information about the study by asking the COHESION research team. Contact details are as follows:

COHESION (Core Outcomes in Neonatal Encephalopathy) Team

Fiona Quirke, PhD Fellow, NUI Galway (f.quirke1@nuigalway.ie; +353 91 495 481).

Additional Information

If you have any issues or queries about the data protection for this project, please find the contact email address of the NUI Galway Data Protection Officer at dataprotection@nuigalway.ie

Please note that you have the right to request from the data controller for COHESION, access to your data, to rectify or erase your data, or to object to the processing of your data.

Please note that you have the right to lodge a complaint with the Data Protection Commissioner, see www.dataprotection.ie for contact details

Thank you for taking the time to read the information within this participant information leaflet. We hope you will consider taking part.