Clinical Trials

Recommendations for a core outcome set for evaluating falls prevention interventions among adults with Multiple Sclerosis, Parkinson’s Disease and stroke: A Consensus-Based Approach

Type of Study/Intervention

Non-interventional

Recruitment Status

Recruiting

Form of MS

Relapsing remitting MS, Relapsing MS, Secondary progressive MS, Primary progressive MS

Brief summary

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 MS, PD 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 MS, PD and stroke.

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 survey 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 an online consensus meeting where the final core outcome set will be agreed upon.

Inclusion criteria

– Confirmed diagnosis of Multiple Sclerosis/Parkinson’s Disease/Stroke
– Researcher with 3 or more publications relating to falls prevention among people with MS/PD/Stroke
– Clinicians delivering falls prevention interventions to people with MS/PD/Stroke
– Service planners or policymakers for falls prevention services
– Aged 18 years or over
– Able to understand and read/write/speak English

Exclusion criteria

– Below 18 years of age
– Unable to understand and read/write/speak English

Anticipated start date

August 2022

Recruitment contacts

Nicola O’Malley: Nicola.OMalley@ul.ie

Further details

Full details for this study are described in the protocol which is available at:
https://hrbopenresearch.org/articles/4-123

This study is registered on the Core Outcome Measures in Effectiveness Trials (COMET) database:
https://www.comet-initiative.org/Studies/Details/1940

Region

NSW/ACT/SA/VIC/QLD/WA/TAS/NT/NZ

Ethics approval

Yes

Last updated

09/08/2022

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