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Digital PROMs in colorectal services research study information

Full title of project: Digital Patient Reported Outcome Measures (PROMs) in Colorectal Services. Establishing tools for continuous improvement and service transformation.

Principal investigator: Prof Tekkis
Co-investigator: Mr Kontovounisios
Centre: Chelsea and Westminster Hospital NHS Foundation Trust
IRAS n°: 250134

Information version 7—18 Mar 2021

Invitation

You are being invited to take part in a research study. We want to emphasise that this is entirely voluntary. Your decision will not affect your care in any way. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully.

What is the project about?

This research project is funded by our hospital charity CW+. It aims to use the Digital Health.London Accelerator company MyClinicalOutcomes (MCO) to design and deliver a new digital way of collecting questionnaires that patients often are asked to fill in when they visit hospitals

What is the purpose of the study?

The study will improve our understanding of patient reported outcomes, expectations, quality of service and experience enabling an unprecedented level of patient-led continuous improvement. It will unify colorectal disorder PROM collection and analysis, creating a colorectal disorder PROM and PREM tool. It is our aspiration that this work will provide a useful base for wider digital Patient-reported outcome measures (PROMs) and Patient-reported experience measures (PREMs) collection tool and utilisation across the Trust and create quality improvement learnings that could be transferred to other clinical departments. In this phase of the study, our purpose is only to collect PREMs and PROMs to develop the tool.

Why am I being invited to take part?

You have been referred to have a colorectal consultation. Participation will help up to obtain information in developing tools in order to improve better quality of care.

Do I have to take part?

It is up to you to decide whether you take part or not. If you do, you will be asked to sign the consent form. You are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time or a decision not to take part will not affect the standard of care you receive. 

Should you no longer meet the inclusion criteria, you will be  withdrawn from the study. Identifiable data collected with consent would be retained and used in the study. No further data would be collected.

What will it involve if I decide to take part?

If you agree to take part in the study, we will first check that there is no reason you are unable to take part. You will have to give your consent online via the link at the end of this page. Following that you will be directed to the web page of the MyClinicalOutcomes company where you will have to answer some questions.

Participation should not involve any extra procedure, inconvenience, distress or pain. If you choose to leave the study, no additional information about you will be collected for the purposes of the study. All information collected about you up to the time you decided to leave the study will still be used and analysed as part of the study.

Many new techniques are likely to be developed and we would like to apply new methods as they are developed to your data. We would also like to collaborate with other scientists worldwide. Your data will only be used in ethically approved research. Data and all appropriate documentation will be stored for a minimum of 10 years after the completion of the study, including the follow-up period.  

What do I have to do?

If you decide to take part, our medical team will ask you to sign a consent form online . Based on your initial diagnosis you will be asked to answer up to a maximum of 8 disease specific and general questionnaires online over a period of up to 2 years. Each questionnaire should take around 10–15minutes to complete. A reminder will be sent by the medical team whenever you have to answer questionnaires. All the information which is collected about you during the course of the research will be kept strictly confidential. Any data will be correlated with data from your medical records. You can change the settings on their MCO account to stop your data being shared, should you wish to. If you lose capacity to consent while taking part in the research you will be withdrawn from the study and any identifiable data already collected with consent will be retained. No further procedures will be undertaken and no further data will be collected.

What are the possible disadvantages and risks of taking part?

There are no additional risks in taking part as we will not interfere with your planned procedure and care.

What are the possible benefits of taking part?

Taking part on the study it will enable us to use a web-based platform that automates the collection  of Patient Reported Outcome Measures (PROMs)and Patient reported experience measures (PREMs) in patients with colon and rectal disease

There is no direct benefit for you for taking part but this tool if developed successfully may help patients and clinicians in the future. 

What if there is a problem?

If you are harmed by taking part in this research project, there are no special compensation arrangements. If you are harmed due to someone's negligence, then you may have grounds for a legal action. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should immediately inform the Investigator. The normal National Health Service mechanisms are also available to you. If you are still not satisfied with the response, you may contact the Imperial College, Joint Research Compliance Office.

If you have a concern about any aspect of this study, you should ask to speak with the researchers who will do their best to answer your questions. If you remain unhappy and wish to complain formally you can do this through the Patient Advice and Liaison service where you will be able to discuss issues, obtain information about aspects of your care and receive support at any stage of the care pathway. PALS can be accessed through the following ways:

What will happen to the results of the research study?

The preliminary results of this study are likely to be available in late 2021. If you would like a summary of the results when available, please inform the doctor/ investigator. All participants to the study will be followed up by the research team using electronic notes.

Who is organising the research?

The research is being funded by our hospital charity CW+. The sponsor is Imperial College London.

Will my taking part in this study be kept confidential?

Imperial College London is the sponsor for this study based in the United Kingdom. We will be using information from you and your medical records 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. Imperial College London will keep identifiable information about you for 10 years after the study has finished in relation to data subject consent forms and primary research data. This will be held at Chelsea and Westminster Hospital NHS Foundation Trust.

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.

Legal basis 

As a university we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. 

Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research. 

International transfers 

There may be a requirement to transfer information to countries outside the European Economic Area (for example, to a research partner). Where this information contains your personal data, Imperial College London will ensure that it is transferred in accordance with data protection legislation. If the data is transferred to a country which is not subject to a European Commission (EC) adequacy decision in respect of its data protection standards, Imperial College London will enter into a data sharing agreement with the recipient organisation that incorporates EC approved standard contractual clauses that safeguard how your personal data is processed. 

Handling of personal data

If you wish to raise a complaint on how we have handled your personal data or if you want to find out more about how we use your information, please contact Imperial College London’s Data Protection Officer via email at , via telephone on 020 7594 3502 and via post at Imperial College London, Data Protection Officer, Faculty Building Level 4, London SW7 2AZ. 

If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO). The ICO does recommend that you seek to resolve matters with the data controller (us) first before involving the regulator. 

Chelsea and Westminster Hospital NHS Foundation Trust will collect information from you and/or your medical records for this research study in accordance with our instructions.

Chelsea and Westminster Hospital NHS Foundation Trust will keep your name, NHS number and contact details add other identifiers confidential and will not pass this information to Imperial College London. Chelsea and Westminster Hospital NHS Foundation Trust will use this information as needed, to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Certain individuals from Imperial College London and regulatory organisations may look at your medical and research records to check the accuracy of the research study. Imperial College London will only receive information without any identifying information. The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details. 

Chelsea and Westminster Hospital NHS Foundation Trust will keep identifiable information about you from this study 10 years after the study has finished.  

When you agree to take part in a research study, the information about your health and care 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 care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.

The data will be stored by a company called MyClinicalOutcomes (MCO). MCO will process data on behalf of Imperial College London for this project and will collect identifiers as well as health data. They are under contractual obligation to ensure your confidentiality is maintained as well as to have proportionate technical and governance controls. MyClinicalOutcomes will store information required to create your patient account, including any of the following, such as name, date of birth, email address, NHS number, date of appointment/admission, online identifier, information about dates of treatment and assessment responses. MyClinicalOutcomes employees will have access to the data in the system, however this access will be restricted to staff who provide user support services—developers will not have access to patient information. 

Research team members such as consultants and research nurses employed by the Trust will be the only personnel with access to both the patient profile and the answers of the questionnaires.

All patients’ identifiable data will be stored on a password protected Chelsea and Westminster Hospital desktop computer. You are consenting for your information to be shared by MCO with your named hospital and clinicians during the registration process. The data kept at MCO will be pseudoanonymised. The key that links the pseudonymised data set with the identifiable data set will also be stored on a password protected Chelsea and Westminster Hospital desktop computer, and will be accessible to the principal investigator and the co-investigators only. Staff at MCO will not know which patient the data belongs to. Personal data shall not be kept for longer than is necessary—at the end of the study, MCO shall deliver to the medical team a complete copy of all patient data and then remove, delete or destroy all your data and all elements relating to the data. 

In 2014, MCO were one of the first four suppliers to be accredited by the International Consortium for Health Outcomes Measurement (ICHOM). ICHOM have published Standard Sets covering more than 50% of the global disease burden. MCO are proud to be an ICHOM Technology Affiliate.

MCO has also been assessed and certified against the internationally recognised standard of ISO/IEC 27001 showing ongoing commitment to information and data security.

Who has reviewed the study?

The London-Brent Research Ethics Committee, which has responsibility for scrutinising all proposals for medical research on humans has examined the proposal and has raised no objections from the point of view of medical ethics. It is a requirement that your records in this research, together with any relevant records, be made available for scrutiny by monitors from the Imperial College London, whose role is to check that research is properly conducted and the interests of those taking part are adequately protected.’ 

Further information

If you have any further questions or if you want to find out more about how we use your information, please contact:

Christos Kontovounisios (Researcher)
T: 020 3315 8529 
E: 

Thank you for considering taking part in this study.

Consenting to take part

Contributors
George Vasilopoulos