Page 1: Participant Information Sheet

Title of Study: Core Outcome Set Development: Studies of Pregnant Women with 2 or More Long-term Health Conditions (Delphi Surveys)

Name of Researcher(s): Professor Krishnarajah Nirantharankumar (Principal Investigator) on behalf of MuM-PreDiCT research group

 

What is the purpose of the study?

We would like to find out what maternal and children's outcomes are important to you that should be reported in all future research studies of pregnant women with 2 or more long-term physical / mental health conditions.

Click here for examples of pre-existing long-term health conditions in pregnancy.

 

What is a Core Outcome Set?

Outcomes are what researchers measure to find out the impact of a health condition or a treatment has on a person. If studies researching a health condition report the same outcomes, they can be compared so we get a better idea of whether a new treatment works. A Core Outcome Set is a standard list of outcomes that should ideally be reported in all research studies for a health condition or treatment. It is agreed by people with the health condition, their health care professionals and researchers.

Short video on Core Outcome Set: http://www.comet-initiative.org/Patients

Study protocol: https://bmjopen.bmj.com/content/11/10/e044919.long

 

Inclusivity statement

Where the terms ‘women’, 'mother' or 'maternal' are used, these should be taken to include people who do not identify as women but have been pregnant, planning a pregnancy or have given birth. 

 

Why have I been invited to take part?

You have been invited to take part because either:

(i) you are planning a pregnancy / have been pregnant in the last 5 years, AND you have 2 or more long-term physical / mental health conditions (e.g. diabetes, asthma, depression, anxiety, other examples); or

(ii) you are a family member / partner / carer of a woman with 2 or more long-term health conditions who has been pregnant in the last 5 years / planning a pregnancy; or 

(iii) you are a health / social care professional looking after women with 2 or more long-term health conditions or their children; or

(iv) you are a researcher interested in 2 or more long-term health conditions in pregnancy.

 

Do I have to take part?

Your participation in this project is entirely voluntary. Completion and return of the online survey will be taken as consent.

 

What will happen if I take part?

You will be invited to take part in an online survey. This survey will take 20 to 25 minutes. 

All the outcomes are important, but we need your help to identify the small number of outcomes that are so important they should be reported in all research studies of pregnant women with 2 or more long-term conditions.

The outcomes in this survey were reported in previous research studies. We also held focus groups and asked pregnant women and health care professionals what outcomes were important to them. The list is very long, so we need you to help us prioritise the outcomes.

After the first survey, you will be invited to two follow up surveys. Each follow up survey will be sent 1 month after the previous survey. We will send you the overall anonymised survey results by the different groups (women/family/carers/partners, health professionals/researchers) after each survey. Sometimes after seeing how other people have voted, you may change your mind and vote differently.

In total there will be 3 rounds of the survey to help us reach a decision and prioritise the final list of core outcomes as rated by all survey participants.You don't have to take part in all 3 surveys, but it will really help if you do.

The survey is hosted on Online Surveys, which is fully compliant with UK data protection laws, survey responses will be collected in a way that protects your privacy (over encrypted connections).

 

Are there any benefits in taking part?

Your contribution will help shape the design of future studies for pregnant women with 2 or more long-term conditions. Having the Core Outcome Set ready will encourage researchers to do studies in this area, ensure study findings can be compared and combined and are relevant to people like you. There will be no direct benefit to you from taking part in this research, but we are interested in what you think, and you may be interested to learn what other people consider important.

 

What are the possible disadvantages and risks of taking part?

The outcomes listed in the survey may make you feel anxious about your health conditions. Should this happen we would advise that you speak to your health care team (e.g. your GP, specialist doctor, midwife or health visitor).

 

Will my time be reimbursed?

Participants will not receive payments/reimbursement, but we greatly appreciate you taking the time to complete the surveys.  

 

Will my taking part in the study be kept confidential?

We will follow ethical and legal practice and all information you provide will be handled in confidence.

If you join the study, we will use information collected from you during the course of the research. Your personal details (name and contact details) will be kept strictly confidential. The survey response will be stored in a password protected secure database at the University of Birmingham. 

Under UK Data Protection laws the University is the Data Controller (legally responsible for the data security) and the Principal Investigator of this study (named above) is the Data Custodian (manages access to the data). This means we are responsible for looking after your information and using it properly. Your rights to access, change or move your information are limited as we need to manage your information in specific ways to comply with certain laws and for the research to be reliable and accurate. To safeguard your rights we will use the minimum personally – identifiable information possible.

You can find out more about how we use your information and to read our privacy notice at: https://www.birmingham.ac.uk/privacy/index.aspx.  

The data collected for the study will be looked at and stored by authorised persons from the University of Birmingham who are organising the research. They may also be looked at by authorised people from regulatory organisations to check that the study is being carried out correctly. All will have a duty of confidentiality to you as a research participant and we will do our best to meet this duty.

We will ask for your name and contact details to send you subsequent rounds of survey, reminders and clarify study responses if needed. Following this, your name and contact details will be separated from the survey responses. Where possible information about you which leaves the University of Birmingham will have your name and contact details removed and a unique code will be used so that you cannot be recognised from it.

Your contact information will be kept by the University of  Birmingham for 12 months after the end of the study so that we are able to contact you about the findings of the study and possible follow-up studies (unless you advise us that you do not wish to be contacted). This information will be kept separately from the research data collected and only those who need to will have access to it.  All other data (research data) will be kept securely for 10 years.  After this time your data will be disposed of securely.  During this time all precautions will be taken by all those involved to maintain your confidentiality, only members of the research team given permission by the data custodian will have access to your personal data.

Although what you say to us is confidential, should you disclose anything to us which we feel puts you or anyone else at any risk, we may feel it necessary to report this to the appropriate persons.

 

What will happen if I don’t want to carry on with the study?

After you have submitted any survey (which implies consent), you are free to withdraw your submitted response from the study within one week, without giving any reason and without your legal rights being affected. You may withdraw your submitted response by emailing the research team at s.i.lee@bham.ac.uk. Any personal data will be destroyed. Once identifiable data (your name and contact details) has been separated from the survey responses, the survey data cannot be withdrawn as it will no longer be identifiable.

If after the first survey, you do not want to complete the follow up surveys, you are under no obligation to do so. You do not have to give any reasons.

 

What will happen to the results of the research?

Results will be presented at conferences and published as scientific papers, but you will not be individually identified in any report or publication. We will provide you with a summary of the study findings and signpost you to the publication once the study is published.

 

Who has reviewed this study?

All research involving people is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by the University of Birmingham Research Ethics Committee (Reference number: ERN 20-1264). Women with experience of pregnancy who live with 2 or more long-term conditions have also reviewed and advised on this study.

 

Who is organising and funding the research?

The study is being organised by the MuM-PreDiCT research team. This study is funded by the  Strategic Priority Fund “Tackling multimorbidity at scale” programme (grant number MR/W014432/1), delivered by the Medical Research Council (MRC) and the National Institute for Health Research (NIHR) in partnership with the Economic and Social Research Council and in collaboration with the Engineering and Physical Sciences Research Council.

 

What if something goes wrong?

If you have a concern about any aspect of this project, please contact Siang Ing Lee (Clinical Research Fellow, s.i.lee@bham.ac.uk), who will do her best to answer your query. The researcher should acknowledge your concern within 10 working days and give you an indication of how she intends to deal with it. 

 

Contact Details

If you would like to discuss the research with someone beforehand (or if you have questions afterwards), please contact:

Dr Siang Ing Lee (Clinical Research Fellow) s.i.lee@bham.ac.uk

 

Thank you for your help with this project.

 

1.1. Have you read and understood the Participant Information Sheet (above) and are you happy to proceed with the survey? Required

The survey is divided into 3 sections:

(1) Information about you

(2) Rating maternal outcomes

(3) Rating children's outcomes

Example preview of the outcomes.