Participant Information Sheet

 

Addressing multimorbidity in tuberculosis (TB) services: a multinational cross-sectional study in high TB burden countries

Participant Information Sheet

 

Thank you for your interest in participating in this study on tuberculosis multimorbidity (TB Multimorbidity). In the following paragraphs we will give you more details about the study and your participation in it.

 

What is the purpose of this study?

Multimorbidity is defined as the co-occurrence of two or more conditions in a single individual at one point in time. In people with tuberculosis (TB), the likelihood of having certain additional conditions is higher than in people without TB, and some of these conditions in turn might affect TB and its treatment.

Therefore, people with TB and one or more additional conditions (i.e. TB multimorbidity) might require special consideration during their TB treatment. The purpose of this study is to understand if any type of TB Multimorbidity is considered, either at the management level (national TB programme, clinical guidelines, etc.) or in the clinical practice (TB service providers). If any TB Multimorbidity are considered, we are also interested in knowing what comorbidities are considered and how they are taken into account.

 

Who is doing the study?

This study is being conducted by a research team based at the University of York, United Kingdom. This is on behalf of the members of an international TB Multimorbidity Network (https://www.impactsouthasia.com/tbmm/) and the Union (https://theunion.org/). It is part of the TB Multimorbidity Project, funded by the Medical Research Council (Global Challenges Research Fund MC_PC_MR/T037806/), and with Professor Najma Siddiqi as the Principal Investigator.

 

Why have I been asked to participate?

We are asking you to participate in this study because you have a policy, management, advisory or a clinical position in either TB programme or a TB service provider. We are interested in how TB Multimorbidity is considered at multiple levels of the system, which is why we are requesting participation from a variety of professionals in the health care system in each of the 30 high-TB burden country.

 

Do I have to take part?

Taking part in this survey is entirely voluntary and you will be given enough information to make an informed decision regarding consent to participate or not.

 

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

If you consent to participate you will be directed to the TB Multimorbidity Survey, which has questions related to policies, plans, and clinical guidelines, and questions related to TB services and clinical practice. You are not expected to be able to respond to all questions, as some are more tailored to policy makers and managers and others are more appropriate for clinicians and service providers. Just respond to the best of your knowledge.

 

What are the advantages or benefits of taking part?

There is no direct (financial or otherwise) benefit for taking part in the study. However, responding to the TB Multimorbidity survey might increase your awareness of this issue in your setting.

 

What are the disadvantages or risks of taking part?

Other than the time you dedicate to answer the survey and the inconvenience this could entail; we do not envisage any disadvantages for you taking part in the study.

 

Can I withdraw from the study at any time?

Yes, you can withdraw at any time by just closing your browser window, without having to give a reason.

 

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

As you will see, all the data will be collected anonymously (we won’t ask for any personal identifiable data) and will be kept confidential on secure computers. However, please note that, although we are planning on publishing only aggregated data, some of your responses could be traced back to you if you have a unique position in your country (e.g. national tuberculosis program manager).

We will collect data regarding your current position (if it is a management or clinical position, if you work in the public or private sector, etc.), the policies, strategic plans and/or clinical guidelines in your setting, and regarding if/how TB multimorbidity is considered in services and practices of your TB service. Data will be stored at the University of York anonymously and will be processed in line with the principles of General Data Protection Regulation (https://www.york.ac.uk/records-management/dp/). After publication of the results, we will make the data available to other researchers on request (after removing any emails provided by the respondents). The data will be stored for a minimum of ten years as per the University of York’s policy.

 

What will happen to the results of the study?

An overview report of the results of this study, written in layperson’s terms, will be published in our website (https://www.impactsouthasia.com/tbmm/) and can be requested by the participants via email (alexander.jarde@york.ac.uk). In addition, the results will be published in an academic journal and will be presented in conferences and webinars.

 

Who has reviewed and approved this study?

Ethical approval for this study was granted by the University of York’s Health Sciences Research Governance Committee.

 

Who do I contact for more information about the study?

You can contact Dr. Alexander Jarde (alexander.jarde@york.ac.uk) or Professor Najma Siddiqi (najma.siddiqi@york.ac.uk). For further information about the TB Multimorbidity Project you can also visit our website (https://www.impactsouthasia.com/tbmm/).

 

Who do I contact in the event of a complaint?

Besides contacting the researchers, you can also send any complaints to the Health Sciences’ Head of Research Committee (Prof David Torgerson, david.torgerson@york.ac.uk). If your complaint is about the way your personal data is being handled, you have the right to complain to the University’s Data Protection Officer at dataprotection@york.ac.uk; if they 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.