What is the project about?
Falls prevention programmes are developed and tested by researchers to determine if they work and are safe. To do this researchers need to look at the effects those programmes have on patients, which they do by measuring an ‘outcome’.
At the moment, studies investigating the effectiveness of falls prevention programmes for people with Multiple Sclerosis, Parkinson’s Disease and stroke often measure different outcomes. This means that when the studies are finished, it is not possible to compare or combine their results. If all studies used the same outcomes it would help progress the development of effective falls prevention programmes. When a set of main outcomes has been agreed it is called a ‘core outcome set’.
The aim of this study is to get agreement or ‘consensus’ on a core outcome set for falls prevention programmes for people with Multiple Sclerosis, Parkinson’s Disease and stroke. The successful development of a core outcome set will help in the design and provision of effective evidence-based falls prevention programmes for people with Multiple Sclerosis, Parkinson's Disease and stroke.
Who is organising the study?
Nicola O’Malley is a PhD student at the University of Limerick. She will be supervised throughout this process by Dr Amanda Clifford and Prof Susan Coote at the University of Limerick.
What will I have to do?
If you choose to take part then you will be asked to register with the study online, which includes consenting to take part in the study. There will be a maximum of three rounds comprising one questionnaire per round. The questionnaires will ask you to rate the importance of each outcome in a list. After each round, the answers everyone has given will be analysed and then, during the next round, you will have feedback on how the group has responded. You will have time to consider this feedback before deciding whether you wish to change your score for each outcome or keep it the same.
We will notify you by email at the start of each round, which will include a link to the questionnaire. Questionnaires will take approximately 15 minutes to complete. You will be able to save your progress and return to the survey over multiple sessions, to allow you ample time to review your answers prior to return. We will send reminders to participants three working days before the questionnaire round closes. Participants will need to take part in all rounds. If you would rather not complete the survey online, you will have the option to respond to the questionnaire over the phone.
At the end of the final round of the survey, you will be asked if you want to take part in a consensus meeting where the final core outcome set will be agreed upon. This meeting will take place on Zoom and will be audio-recorded. The recording and transcription of this meeting will be General Data Protection Regulation (GDPR) compliant. This meeting will be approximately two hours in duration.
What are the benefits?
The successful development of a core outcome set will facilitate progress in the design and provision of effective evidence-based falls prevention programmes for people with Multiple Sclerosis, Parkinson's Disease and stroke. It is hoped that the data collected for this study will ensure that these outcomes are meaningful and important to participants.
What are the risks?
You might decide that you don’t want to answer a question. If this happens, you do not have to answer any question you do not wish to.
What if I do not want to take part?
Participation in this study is voluntary and you can choose not to take part or to stop your involvement in this study at any time.
What happens to the information?
The information that is collected will be kept private and stored securely on the researchers’ computers. The computers are protected with a password. No identifying information about you will be reported in any publication arising from this study.
Who else is taking part?
Participants in this study will include people with a confirmed diagnosis of Multiple Sclerosis, Parkinson’s Disease and stroke, researchers actively involved in falls prevention research for people with these neurological conditions, clinicians currently providing falls prevention interventions to people with these neurological conditions, and service-planners/policy-makers involved in decision-making regarding the provision of falls prevention services.
What happens at the end of the study?
At the end of the study the information will be analysed and results will be identified. Information that is stored on a password-protected computer will be stored by Nicola O’Malley initially and then transferred to a hard drive stored securely and safely by Dr Amanda Clifford in the School of Allied Health at the University of Limerick for 7 years and then destroyed.
What if I have more questions or do not understand something?
If you have any questions about the study you may contact any of the researchers. It is important that you feel that all your questions have been answered.
What if I change my mind during the study?
At any stage should you feel that you want to stop taking part in the study, you are free to stop and take no further part. There are no consequences for changing your mind about being in the study.
Thank you for taking the time to read this information sheet.