A Study To Look At Memory Post-Surgery
There is some evidence that having surgery may adversely affect a person’s on memory. To better understand this, our Research Team have developed this study to assess memory post-operatively. Led by Dr Lisa Gibbons working with our Research Fellows Dr Emma Parker and Dr Rachael Meek, they are collaborating with anaesthetists based in both Plymouth and Exeter Hospitals.
This study tests the memory of two groups of people, those having surgery (Surgery Group) and those not having surgery (Comparison Group). We will ask people to go onto an easy to use website to do memory tests.
We are taking part in the “Comparison Group” here at Claremont. We want to know if this new study design is practical, user friendly and a good way to test memory.
If you have been invited to take part or wish to do so please email us at: firstname.lastname@example.org or telephone the Practice and leave a message for the research team to call you back.
Cognitive Monitoring in Planned Arthroplasty Surgery Study
Help us improve memory
- Before you decide whether to take part it is important to understand why the research is being done and what it will involve.
- Please take the time to read the following information carefully and discuss it with family, friends or your GP if you wish.
- You are free to decide if you want to take part in this research study. You can decide to stop taking part (stop completing the assessments) in the study at any time without giving a reason.
- Please ask us if anything is not clear or if you would like more information.
Find out more by emailing: email@example.com or telephoning your surgery
Why are we doing this research?
There is some evidence that surgery may have an effect on memory. We are going to test the memory of two groups of people, those having surgery (Surgery Group) and those not having surgery (Comparison Group). We will ask people to go onto an easy to use website to do memory tests. We want to know if this new study design is practical, user friendly and a good way to test memory.
Why have I been invited to take part?
We are looking for people over the age of 60 to take part in the Comparison Group of this study.
What would my participation involve?
Your participation will involve completing an online memory test (called CogTrack™) and answering questions about your medications, pain levels and mood on 7 different occasions in a 3-month period. 3 tests will take place at your GP practice, and 4 in your own home.
The CogTrack™ test consists of a series of tasks displayed on a screen that will require you to respond using a keyboard. You will be shown how to complete the CogTrack™ test on your first visit to your GP practice, and there will be clear instructions every time you open the test at home. Each CogTrack™ test takes 20 minutes to complete. Reminders to complete the CogTrack™ test will be sent by email and/or text message. You will need access to your own desktop or laptop computer with a keyboard.
At the 3 GP practice visits you will be asked some questions on your medical history and questions about your memory and concentration which will take approximately 15 minutes. We would also like to ask a personal contact (for example a family member) some questions about your memory at these 3 GP practice visits (this is optional). We can reimburse your travel expenses for when you travel to the surgery specifically for this study.
What are the possible benefits and risks of taking part?
By participating in this study, you will play a vital role in helping us learn more about memory. Results from the online memory test (CogTrack™) will not be available to you or the practice researcher. If during the other questions anything unexpected arises we will explain this to you and advise you to make an appointment to see your usual GP. If you wish we can pass this information on to your GP. Your feedback about your participation can help us design future studies.
What will happen to my data?
All data will be stored anonymously under a unique study number for confidentiality. All information will be stored electronically on a secure computer. Your participation in this study will be kept confidential within in your GP record. The anonymised results of your testing may be held for up to five years after the study finishes. All information will be handled in compliance with the General Data Protection Regulations (see notes).
What will happen to the results of the study?
Participants will be sent a newsletter informing them of results of the study following its completion. We hope that the results of this research will be published. When published all data will be anonymous and no link will be made to any personal identifiers of participants.
What if there is a problem?
The research team will be happy to discuss any problems you may have. However, if you have concerns or complaints arising from your experience of participating in this study which you do not wish to discuss with the research team directly, the NHS patient advisory liaison service (PALS) will provide independent advice (01752 439884, email plh-tr.PALS@nhs.net).
Who is organising and funding this research?
The organisers of the study are Dr Johannes Retief and Dr Gary Minto (Anaesthetists at Derriford Hospital, Plymouth). This research is funded by the Peninsula Clinical Research Network, Collaboration for Leadership in Applied Health Research and Care South West Peninsula, Association of Anaesthetists of Great Britain and Ireland and Plymouth Hospitals NHS Trust Department of Anaesthesia Research Fund.
Who has reviewed this study?
In line with good research practice this project has been reviewed by the Peninsula Patient Involvement Group and approved by the Research and Development team at Derriford Hospital and the South Central, Berkshire NHS Research Ethics Committee (IRAS ID: 214288)
Thank you for reading this leaflet. If you wish to take part in this study, you will be asked to agree to the consent statements below in the presence of a member of the research team.
A note about your data
University Hospitals Plymouth NHS Trust is the sponsor for this study based in England. We will be using information from you and/or 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. University Hospitals Plymouth NHS Trust will keep identifiable information about you for 5 years after the study has finished. 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. You can find out more about how we use your information by contacting the Research, Development and Innovation Department, University Hospitals Plymouth NHS Trust, Level 2, MSCP, Bircham Park Offices, 1 Roscoff Rise, Derriford, Plymouth, PL6 5FP. Email: plh-tr.RD-Office@nhs.net
University Hospitals Plymouth NHS Trust/Torbay and South Devon NHS Foundation Trust (to be deleted as appropriately electronically) will collect information from you and/or your medical records for this research study in accordance with our instructions.
University Hospitals Plymouth NHS Trust/Torbay and South Devon NHS Foundation Trust (to be deleted as appropriate) will use your name, NHS number and contact details 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. Individuals from University Hospitals Plymouth NHS Trust and regulatory organisations may look at your medical and research records to check the accuracy of the research study.
University Hospitals Plymouth NHS Trust/Torbay and South Devon NHS Foundation Trust (to be deleted as appropriate) will pass these details to University Hospitals Plymouth NHS Trust along with the information collected from you and/or your medical records. The only people in University Hospitals Plymouth NHS Trust who will have access to information that identifies you will be people who need to contact you to for reasons directly related to the research study or audit the data collection process. 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.
University Hospitals Plymouth NHS Trust/Torbay and South Devon NHS Foundation Trust (to be deleted as appropriate) will keep identifiable information about you from this study [for 5 years after the study has finished.
Data obtained from medical records: University Hospitals Plymouth NHS Trust will collect information about you for this research study from your medical notes. This information will include your name, NHS number, contact details and health information, which is regarded as a special category of information. We will use this information to ensure all data recorded for this study is completely accurate.
Data for future research: 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.