Invitation Paragraph
We would like to invite you to participate in this research project. You should only participate if you want to; choosing not to take part will not disadvantage you in any way. Before you decide whether you want to take part, it is important for you to understand why the research is being done and what your participation will involve. If you have any questions, you can contact us using the contact details at the end of this information sheet.
We are conducting this questionnaire as part of a research study aiming to develop customised software that will determine the likelihood of pain associated with Chiari-malformation (hereafter referred to as CM-P) and give the owner and the vet information on the likelihood of CM-P before recommendation for expensive diagnostic tests. Ultimately, we aim to combine this diagnostic tool to a generic and validated Health Related Quality of Life (HRQoL) to create a CM-P specific HRQoL tool. We plan to offer this tool as a means of “scoring” a dog’s degree of pain and quality of life so that the owner and their vet can use it to make informed decisions about medication etc.
We are collecting information from the owners of dogs that fulfil the following criteria 1) diagnosis of CM-P or syringomyelia 2) healthy dogs from toy dog breeds commonly affected by CM-P 3) toy dog breed with another chronic health condition other than CM-P or syringomyelia 4) any dog with a painful condition for example osteoarthritis that is not CM-P or syringomyelia.
Participation is voluntary and your responses to the questionnaire will be anonymous and confidential. After completion, you may also discuss the study with others if you wish. If you find any of the questions distressing or become upset at any point, you have the right to discontinue and exit the survey without penalty. No personal data will be recorded to help ensure that all participants cannot be identified and so their identity cannot be revealed during analysis and write-up. The results of the completed questionnaires will be stored in line with GDPR legislation.
This research is being undertaken by Prof Clare Rusbridge (Professor in Veterinary Neurology) and Dr Mariam Cirovic (Lecturer at the Department of Computer Science).
By clicking START SURVEY you are verifying that you have read the explanation of the study, that you are over the age of 18, and that you agree to participate. You also understand that your participation in this study is strictly voluntary.
What is the purpose of the study?
Background
Canine Chiari like malformation (CM) is characterised by a short skull resulting in brain and upper spinal cord overcrowding causing pain and leading to spinal cord cavities called syringomyelia (SM). It is common - one UK referral practice found that 9.7% of all dogs presented with neck pain had CM (CM-P) or SM. SM can result in neurological problems include debilitating “phantom” scratching, spinal curvature and weakness. Currently SM is diagnosed by MRI. However, diagnosis of CM-P is more challenging and is made a combination of appropriate history, clinical signs and MRI and by exclusion of other causes of pain and head scratching tendency.
The aim and objectives of this study:
We are aiming to create a tool that may make a diagnosis of CM-P easier and less subjective.
Ultimately, we plan to combine the CM-P tool to a generic and validated Health Related Quality of Life (HRQoL) to create a CM-P specific HRQoL tool with the purpose creating a tool that can track comfort and quality of life over time for example to evaluate a response to medication.
We also plan to use the CM-P tool in future long-term studies for example to assess environmental influences on pain for example weather conditions.
We are specifically interested in:
Quantifying and analysing the specific and non-specific signs of pain in dogs with CM-P, their quality of life and how these signs compare to healthy dogs and dogs with other painful conditions such as osteoarthritis.
This will involve:
We will ask a series of questions related to your dog including comfort, exercise ability, previous medical diagnosis, and medication history. We will use the responses to input and improve an algorithm to generate a CM-P score reflecting the likelihood and degree of CM-P. Invitation to participate in the study will be posted on social media websites on specified dog forums and groups (Facebook, Twitter) with a link to the application. You may also be invited to complete the study if your dog is a patient of Clare Rusbridge.
You will be asked to register / login on the application with your email and dog details (date of birth gender and broad geographical location). Registration (through an initial email verification link) will allow multiple logins and CM-P score for the same dog allowing the ability to track the CM-P score over time. As one of the study aims is improve the algorithm over the phase of model building and validation it is expected that the sensitivity and specificity of the CM-P score will improve over time.
Who is responsible for this study?
This study is the responsibility of Prof Clare Rusbridge (Professor in Veterinary Neurology), Dr Mariam Cirovic (Lecturer, Programme Leader Computing and Information Technology at the Department of Computer Science) and Kristiana Ivanova (Undergraduate Computer Science student).
Why have I been invited to take part?
We are inviting you and other similar potential participants to take part in this study because you own a dog affected by CM-P or because of your membership in a dog forum specifically targeted for owners of dogs that are ether Cavalier King Charles spaniels or have CM-P, syringomyelia or osteoarthritis. No personal contact details have been provided to us, our method of obtaining data and contacting potential research participants is by posting on public forums. The exception to this is veterinary patients of Clare Rusbridge who may receive a personal invitation to participate.
To be eligible to take part in this study you must be at least 18 years of age, comprehend English, have a living dog residing at home (healthy or sick) and complete the protocol correctly to its full extent. You are not eligible to take part in the study if your dog is deceased or you do not have sufficient time to complete the full form.
Do I have to take part?
Participation is voluntary and you do not have to take part. We will describe the study in this information sheet and will leave it accessible for two months, so you can decide whether you wish to take part in this study. Please contact us if there is anything that is not clear, or if you have any questions, or if you would like more information about this research.
What will happen to me if I decide to take part?
If you decide to take part, you can download this information sheet to keep for your records. Your consent to take part will be given by clicking ‘start survey’ to begin the questionnaire. This will verify that you have read the explanation of the study, that you are over the age of 18 and are otherwise eligible, and that you agree to participate. You also understand that your participation in this study is strictly voluntary.
We will then ask you a series of questions about you and your dog in the form of tick box and open questions. All questions should be answered honestly, and you should not proceed until answers are provided for all questions. Failure to answer all questions will result in exclusion from the study, so please do not omit any sections. The survey should take approximately 30 minutes. No personal information such as names will be collected. Results will be anonymous and confidential, and collected data will be securely stored in line with GDPR policies.
What happens if I do not want to take part or if I change my mind?
You are free to withdraw from the study at any time, without giving a reason and without a penalty, by exiting the protocol website. If you withdraw early, your results will be excluded from the study and data will not be stored. No personal information will be collected in this case either.
What are the possible benefits in taking part?
Whilst there are no immediate benefits for those people participating in the project, it is hoped that the information we acquire from the study will help develop a tool to improve the diagnosis and monitoring of CM-P.
After completing the questionnaire, you will be given a preliminary CM-P score and interpretation. There is the option to resubmit data in the future to monitor your dog’s CM-P score although it should be remembered that during the building and validation phase, we will be using the data to improve the specificity of the CM-P score i.e., the score will be less accurate in the early phases.
Are there any potential risks involved?
Asking you as an owner of a dog who may have health issues to participate in a questionnaire could incidentally lead to the discovery of previously unknown or unnoticed concerns about your dog’s health, stress and wellbeing. If you have such concerns, then please contact your veterinary surgeon for advice. Information on sources of support can be found at the end of this information sheet.
How is the project being funded?
This research is a student project and is being funded by from CavalierHealth.org and its Cavalier Health Fund charitable trust
https://cavalierhealthfund.org/ . Cavalier Health Fund is a charitable trust created to fund sound scientific research that will help cavalier King Charles spaniels (CKCS) live longer, healthier lives. Their grants are limited to research projects into the origins of cavaliers' illnesses, the diagnosis of cavaliers' diseases, and the development of effective treatments of cavaliers' diseases and prevention strategies. There is no conflict of interest.
Will my participation be kept confidential?
All the information that we collect about you during the course of the survey will be kept strictly confidential and only accessed by members of the research team Your information may be subject to review for monitoring and audit purposes, by individuals from the University of Surrey and/or regulators who will treat your data in confidence. You will not be able to be identifiable from the information gathered nor will you be identified in any ensuing reports or publications. All data is kept secure and used only in the way described in this information sheet.
Will my data be shared or used in future research studies?
We would like your permission to use anonymised data in future research studies, and to share data with other researchers in future opportunities (e.g. in online databases). No personal information that could identify you will be collected or stored.
We will also ask you permission for whether you would consent to be contacted in future for an longitudinal studies for example assessing whether weather conditions affect your dog’s pain score.
What will happen to the results of the study?
We will publish the results and a final report of the research study will be published in veterinary clinical practice journals. Any published findings will maintain your confidentiality and anonymity. You will not be personally identified in any reports or publications. You can contact the study team to find out the results of the research in the future.
Who has reviewed this study?
This research has been reviewed by an independent group of people, called an Ethics Committee. This study was reviewed and given a favourable ethical opinion by the University of Surrey Ethics Committee.
What is personal data?
‘Personal Data’ means any information that identifies you as an individual. We will be collecting and using some of your personal data that is relevant to completing the study and this section describes what that means. we are not collecting any personal identifiable data that may lead to identification of any participants. We will use all information as explained in the ‘What is the purpose of the study’ section above.
To allow a Log in link we ask for your email address and there is a check box for if you consent for future communication about the project for example to participate in further studies.
The information that we will collect will include your county and country of residence as well as your dog’s name and birth date– this is so that the dog can be identified in any longitudinal studies – i.e., where you have made multiple entries to allow monitoring of the CM-P score.
We will not collect or hold any demographic data for reasons other than for the analytic component of this research. The information will be securely, confidentially, and anonymously on a GDPR compliant programme and will only be accessible to the three above-mentioned researchers.
This information sheet forms part of the transparency information that Data Controllers must provide for you, in order to be compliant with current data protection legislation.
Who is handling my personal data?
The University of Surrey, who has the legal responsibility for managing the personal data in this study, will act as the ‘Data Controller’ for this study. The research team will process your personal data on behalf of the controller and are responsible for looking after your information and using it properly.
What will happen to my personal data?
As a publicly funded organisation, we must ensure that when we use identifiable personal information from people who have agreed to take part in research, that this data is processed fairly and lawfully. The University of Surrey processes personal data for the purposes of carrying out research in the public interest and special category data is processed on an additional condition necessary for research purposes. This means that when you agree to take part in this research study, we will use and look after your data in the ways needed to achieve the outcomes of the study.
Your personal data will be held and processed in the strictest confidence, and in accordance with current data protection regulations. When acting as the data controller, the University will keep identifiable information about you for 6 years after the study has finished after which time any identifiers will be removed from the aggregated research data. We will only collect and hold the minimum amount of special category data we need for our research purpose and hold no more than that.
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 decide to withdraw from the study, we may not be able to withdraw your data. We will keep and use the minimum amount of personally-identifiable information about you that we have already obtained in order to complete the study.
If you wish to make a complaint about how we have handled your personal data, you can contact our Data Protection Officer Suzie Mereweather who will investigate the matter (
dataprotection@surrey.ac.uk). 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) (
https://ico.org.uk/).
You can find out more about how we use your information
here and/or by contacting
dataprotection@surrey.ac.uk.
What if you have a query or something goes wrong?
If you are unsure about something you can contact the research team for further advice using the contact details at the bottom of this information sheet.
However, if your query has not been handled to your satisfaction, or if you are unhappy and wish to make a formal complaint to someone independent of the research team, then please contact:
Research Integrity and Governance Office (RIGO)
Research and Innovation Services
University of Surrey
Senate House, Guildford, Surrey, GU2 7XH
Phone: +44 (0)1483 689110
Email:
rigo@surrey.ac.uk
The University has in place the relevant insurance policies which apply to this study. 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 follow the instructions given above.
Who should I contact for further information?
If you have any questions or require more information about this study, please contact the research team using the following contact details: Please note we are not able to provide medical advice for any individual animal. Information on diagnosis and treatment of CM and SM can be found
here and
here.
Prof Clare Rusbridge
Professor in Veterinary Neurology
VSM, University of Surrey, Daphne Jackson Rd, Guildford GU2 7AL, UK
Email:
c.rusbridge@surrey.ac.uk
Dr Mariam Cirovic
Lecturer, Programme Leader Computing, and Information Technology
Department of Computer Science, University of Surrey, Guildford, Surrey, GU2 7XH
Email:
m.cirovic@surrey.ac.uk
For anything related to the website's functionality please contact:
Kristiana Ivanova
Developer and maintainer of Chiari-check website, BSc in Computer Science, Master's student in Information Security
Department of Computer Science, University of Surrey, Guildford, Surrey, GU2 7XH
Email:
ki00113@surrey.ac.uk