Information Sheet for Healthcare professionals and researchers
Research Ethics Approval ID Number: 305160
Title of Study: Core outcome set for Infection prevention and control trials for prevention of transmission of MDRGNB (the COSTrans-MDRGNB study)
Department: Leeds Institute of Medical Research (LIMR)
Researchers:
Dr Razan Saman, St James’s University Hospital Beckett Street Leeds LS7 9TF
Dr Andrew Kirby, Microbiology department Old Medical School, Leeds General Infirmary LS1 3EX
Background
Multi drug resistant gram-negative bacteria (MDRGNB) including carbapenemase-producing Enterobacterles(CPE) and Extended-spectrum beta-lactamase Enterobacterales (ESBL-E), are increasingly reported worldwide with increasing rates of hospital outbreaks. In fact, prior to the COVID-19 pandemic, MDRGNB were widely viewed as the foremost infectious threat to mankind on a global level. Treatment options for infections due to MDRGNB are limited, and there is a great reliance on Infection prevention and control (IPC) procedures like handwashing or PPE to prevent transmission.
Clinical trials, systematic reviews and guidelines have compared various interventions for the prevention and control of MDRGNBs. However, studies on IPC measures often do not address the same outcomes, making it difficult to draw conclusions when the evidence is synthesised. If all studies in IPC used the same outcomes, they could all be compared and combined. When a set of main outcomes has been agreed for a health condition, it’s called a ‘core outcome set’ (COS). A COS would help in bringing together all the studies to get a better understanding of which interventions are best and avoid the problem of some studies only reporting a selection of the outcomes that were measured.
Deciding which outcomes should be core requires a great deal of discussion. Core outcomes must be relevant to patients, and health professionals. Working on a core outcome set, we need to make sure that this expertise – from patients, and professionals – is used to agree on the core outcomes.
Purpose of the study
The aim of our project is to develop a ‘core outcome set’ for IP studies for prevention of transmission of MDRGNB or superbugs.
Generating a list of core outcomes relevant to patients, and health professionals requires the use of a ‘consensus method’ involving these people. Consensus methods are surveys, meetings and discussions where the opinions of relevant experts are drawn together.
Following a systematic review of outcomes reported in contemporary IPC trials and interviews with patients asking about what outcomes are most important to them, we compiled a long list of outcomes. Using this list of outcomes, we would like to generate a core outcome set through a consensus method called Delphi technique.
Who is taking part?
What does this study involve?
We will use an e-Delphi survey to gain consensus from patients, researchers and healthcare professionals. This will be conducted via e-mail and Microsoft Teams as follows:
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1. A list of outcomes is produced by the research team and sent to each patient researcher, and health professional (in the form os a survey) to score the importance of each one. (Each survey should take 15-20 minutes to complete).
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2. Round 1 survey results are summarised and sent back to each person, together with a reminder of the person’s own score for each outcome. Each person is asked to think about the group’s results and decide if they want to change their score.
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3. The process of seeing the results and re-scoring the outcomes can be repeated in a 3rd round
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4. Face-to-face (virtual) meeting of participants from all groups to discuss the results (1-2 hours)
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5. Report produced identifying agreed outcomes of importance (core outcomes)
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Consent and confidentiality
Consent will be gained on registration for the study via the link in the e-mail invite. Demographic data will be captured during the e-Delphi survey, including your professional background and years of experience. No personal data will be used in the analysis or dissemination of findings.
Who is organising and funding the research?
This research is conducted as part of a research degree with the University of Leeds. Funding was awarded by the Healthcare Infection Society as part of the Graham Ayliffe Training fellowship.
Contact for further information
Dr Razan Saman
St James’s University Hospital Beckett Street Leeds LS7 9TF,
umrsa@leeds.ac.uk
Thank you for reading this information sheet and for considering taking part in this research study.
Additional Information
Will my taking part in the study be kept confidential and how will my data be managed?
Your participation in this project will be kept strictly confidential. We will store your identifiable personal data (name and e-mail address) securely and separate from other study documents. A study number will be allocated to you and any identifiable information will not be attached to any data collected in this study (questionnaires).
The University of Leeds is the sponsor for this study based in the United Kingdom. We will be using information from you in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. The University of Leeds will keep identifiable information until the end of the study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
Individuals from the University of Leeds and regulatory organisations may look at your research records to check the accuracy of the research study. The only people in the University of Leeds who will have access to information that identifies you will be the research team running the study or those auditing the data collection process. The people who analyze the information will not be able to identify you and will not be able to find out your name or contact details.
When you agree to take part in a research study, your data may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research. This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and social care research, and cannot be used to contact you.
You can find out more about how we use your information: https://dataprotection.leeds.ac.uk/wp-content/uploads/sites/48/2019/02/Research-Privacy-Notice.pdf. or contact Email: umrsa@leeds.ac.uk.
University data protection Officer can be contacted at: dpo@leeds.ac.uk
Link to the Health Research Authority patient data and research leaflet: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/data-protection-and-information-governance/gdpr-guidance/templates/template-wording-for-generic-information-document/
COSTrans-MDRGNB HCP/researcher PIS version 1.2 18/2/2022 IRAS ID: 305160