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 considering taking 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 who has invited you to take part.

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.

To help patients and health professionals make decisions about treatments, we need evidence about what works best. 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 an improvement in the quality of life of the person with asthma. However studies often do not include the outcomes that are most important to people living with the condition, or they measure different outcomes so their results cannot be combined and treatments cannot be compared.

The development of “core outcome sets” is an approach that addresses these challenges by involving patients, carers and researchers in agreeing which are the most important outcomes to measure in trials. Core outcome sets are those outcomes that all studies for a particular health condition(s) should include.

The decisions regarding which outcomes should be included in the core outcome set need to be made after discussion with the people who will be most affected.

We have made an initial long list of outcomes that may be relevant to report when studying multimorbidity in low and middle income countries (by searching through existing literature and interviewing patients and carers with experience of multimorbidity).

In this study we want to use a 2-round online survey (Delphi Survey) to ask you to rate individual outcomes in this list according to how important you think they are. In the second round of the survey we will give you your score from round 1, along with the overall scores for other participants and you will be asked again to score the outcomes. In this way we can find out which outcomes are the most important ones for studies investigating multimorbidity.

We have separated out the outcomes into prevention outcomes and treatment outcomes. We will therefore ask you to complete two surveys- one on prevention and the other on treatment.

Who is doing the study?

The COSMOS research team is led by Najma Siddiqi, Professor of 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 countries including Australia, Bangladesh, India, Pakistan, UK and USA).

Why have I been asked to take part?

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

  1. Be 18 years and over
  2. Have experience of  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 the surveys is voluntary, you are free to decline participation or decide to withdraw from the study at any time.

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

There are 2 surveys to complete- one on prevention outcomes and one on treatment outcomes.  Surveys are wholly online, to be completed in two consecutive rounds. Each round will take between 5-15 minutes to read, rate the importance of the items, and add any additional outcomes and comments, if you wish. You are requested to read the information sheet and register below or from the original email to start the surveys. 

Information provided will be used to develop a Core Outcome Set for the prevention and management of multimorbidity in low and middle income countries. Data will be stored at the University of York, compliant with the General Data Protection Regulation (see below).

 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 in 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 by improving the choice of outcomes measured in future trials of interventions to prevent or manage multimorbidity.

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 kept confidential. Once the project is completed, only the anonymised data will be archived.

Can I withdraw from the study?

You can withdraw from this study at any point before submitting 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 to register for this study will be used to contact you for the 2nd round of the Delphi survey. After completion of the second round, it will be used to send you information about the outputs from the project.

To agree the final core outcome set, a series of meetings with stakeholders will take place. At these meetings the results of the Delphi surveys will be discussed before making final decisions about which outcomes to include. The team would like to inform you about this step. After that your email information will be deleted.

The answers that you provide in the survey will be used to inform the core outcome set and will then become part of a research paper. 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 lead researcher and a lawful handling and 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?

The 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 who sent you this information sheet. You can also contact the Principal Investigator of this study, Professor Najma Siddiqi by e-mail at:

University of York

Department of Health Sciences

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:

Professor 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 have 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.

 

TO REGISTER FOR THE PREVENTION OUTCOMES SURVEY PLEASE CLICK HERE

TO REGISTER FOR THE TREATMENT OUTCOMES SURVEY PLEASE CLICK HERE