COSMOS Participant Information Sheet

 

Development of a core outcome set for multimorbidity studies in low- and middle-income countries (COSMOS)

 Participant Information Sheet- Delphi Survey

 

Thank you for your willingness to take part in our study. Before you decide to continue please read the following information. If you have any questions, please feel free to ask the researcher.

 

What is the purpose of this study?

Multimorbidity is the existence of two or more health conditions in one person at the same time such as diabetes and depression or heart disease and hypertension. People with multimorbidity have complex care needs. Therefore, it is important to know which treatments work best so that we can improve the lives of those living with multimorbidity.

To help patients and health professionals make decisions about treatments, we need evidence about what works best in order to improve the lives of patients. This is done by looking at the effect of a treatment also known as the ‘outcome’ of a treatment. For example, in a study conducted to see the effect of a new treatment for asthma, outcomes of the study may include increases in lung capacity, or a questionnaire to check if there has been (improvement) in the quality of life of the patient with asthma.

The development of “core outcome sets” is an approach that addresses these challenges by involving patients, carers and researchers. Core outcome sets are those outcomes that all studies for a particular health condition should include. If studies exploring the same health condition use the same set of outcomes, they can easily be compared and combined. This helps health professionals make better decisions about the treatments they offer to patients. For the purpose of this research, we are focusing on Multimorbidity.

The decisions regarding which outcomes should be included in the core outcome set need to be made after a discussion with the right kind of people. Earlier in the study we made a long list of outcomes that may be relevant to report when studying multimorbidity by searching through existing literature and interviewing patients and carers with experience of multimorbidity. In this study we want to use an online survey (Delphi Survey) and ask you to rate individual outcomes according to how important you think they are. We will then see which outcomes are seen as important. In the second survey we will give you your previous score, other participants’ overall scores and you will be asked again to score the outcomes. This way we can find out which outcomes are the most important ones for studies investigating multimorbidity.

 

Who is doing the study?

The research team is led by Najma Siddiqi, Professor in Psychiatry in the Department of Health Sciences, University of York, UK.

The study is sponsored by the University of York, UK, and funded by the National Institute of Health Research (NIHR) in the UK. The study is a collaboration of researchers from all over the world from over 36 different countries such as the UK, USA, Australia, India, Pakistan, Bangladesh and many more.

 

Why have I been asked to participate?

Your experience of multimorbidity will help us gain a deeper understanding of the outcomes that we must address in our study. In order to be eligible for the survey you must be:

  1. 18 years and over
  2. Experience having or dealing with multimorbidity, be it as
    • a patient or person living with multimorbidity;
    • a carer for someone living with multimorbidity (e.g. a partner or family member);
    • a health professional dealing with patients living with multimorbidity;
    • or a health researcher investigating multimorbidity.

 

Do I have to take part?

No. Taking part in this survey is voluntary, you are free to decline participation or decide to withdraw from the study at any time you wish to.  After data collection is complete it may not be possible for you to withdraw from the study because data collected is not intended to identify individual respondents, making it impossible to locate and remove your inputs.

 

What will be involved if I take part in this study?

The survey is wholly online, to be completed in two consecutive rounds. Each round will take about 30 minutes to read, rate the importance of the items, and add content and comments. You are requested to read the information sheet and click on the consent box to start the survey. Information provided will be used for the prevention and management of multimorbidity and data will be stored at the University of York, compliant with the General Data Protection Regulation.

 

 What are the advantages or benefits of taking part?

There is no direct benefit as a result of participating in this study. However, there is a potential wider benefit of extending your knowledge and expertise to developing a standard set of outcomes for the prevention and treatment of multimorbidity. The outcome set will help researchers and organisations improve the lives of those living with multimorbidity. It will also benefit the patient population by improving quality of care.

 

 

What are the disadvantages or risks of taking part?

The study is an online experts’ consensus survey, thus there is no risk associated with participation. All personal data will be pseudonymised and treated with utmost confidentiality. Once the project is completed, only the anonymised data will be archived.

 

Can I withdraw from the study at any time?

You can withdraw from this study at any point before starting the survey. Since the data are collected anonymously, we will be unable to identify and delete your responses in case you decide to withdraw from the study after completing the survey.

 

 

How will the information and personal data I give be handled?

The email address you provide for the participation in this study will be used after completion of the second round of the Delphi survey to send you information about the last planned stage of the project. To derive the final core outcome set a meeting with stakeholders takes place and the team would like to inform you about this step. After that your email information will be removed.

Any answers that you provide on the survey will be used to inform the core outcomes list and will then become part of the research paper produced. This would mean that you would have a joint copyright to your answers with the COSMOS team. Data collected from the study will be used only for the purposes for which it is collected and then stored at the University of York. The stored and fully anonymised data will be held for a period of 10 years and may potentially be accessed and or re-used in the future. Where the need to dispose of the archived data arises the University of York archivist will contact the researcher and a lawful handling and possible disposal will be conducted. Please visit the following links for more information on our record keeping policies:

https://www.york.ac.uk/records-management/dp/

https://www.york.ac.uk/records-management/dp/guidance/gdprcompliantresearch/

https://www.york.ac.uk/records-management/dp/your-info/generalprivacynotice/

Please visit the following two links to Health Sciences’ webpages that contain information about General Data Protection Regulation (GDPR) and data management:

https://www.york.ac.uk/healthsciences/research/trials/trials-gdpr/

https://www.york.ac.uk/healthsciences/research/trials/trials-gdpr/research-partcipants/

 

What will happen to the results of the study?

The results from this study (containing only the anonymised data) will be presented as a report and also published in journals. We may also present the findings at conferences. You will not be identified in any reports, publications or presentations.

 

Who has reviewed and approved this study?

University of York’s Health Sciences Research Governance Committee has reviewed and approved this study.

 

Who do I contact for more information about the study?

If you want to know more about the study or if you have a concern about any aspect of this study, you may ask the researcher now. You can also contact the Principle Investigator of this study later, Dr. Najma Siddiqi, with any questions you might have either personally, by e-mail or by telephone at:

University of York

Department of Health Sciences

Tel (work): 01904 32(1681)

Email: najma.siddiqi@york.ac.uk

 

Who do I contact in the event of a complaint?

For general complaints, please contact the Principal Investigator of the study:

Dr. Najma Siddiqi

University of York

Department of Health Sciences

Tel (work): 01904 32(1681)

Email: najma.siddiqi@york.ac.uk

If you are unhappy or wish to complain, you may do so directly to the University of York Ethics committee:

Professor Stephen Holland

University of York

Chair, Department of Health Sciences’ Research Governance Committee

Tel (work): 01904 323253

Email: stephen.holland@york.ac.uk

If you are unhappy with the way your personal data has been handled, you have a right to complain to the University’s Data Protection Officer at dataprotection@york.ac.uk; If you are still unsatisfied, you have a right to report concerns to the Information Commissioner’s Office at www.ico.org.uk/concerns.

 

Thank you for taking the time to read this information sheet.