ALSFRS-R Online Validation Study

Study titleValidation study of administration of an online Amyotrophic Lateral Sclerosis Functional Rating Scale (Revised)
UK Chief InvestigatorProfessor Kevin Talbot
Research summaryThe ALSFRS-R is a functional rating scale designed to be administered by a healthcare professional asking a person with motor neuron disease (MND) a series of questions about activities of daily living that they are able or unable to perform by themselves. It is widely used in clinical practice and research. There has been previous research showing that people can complete the ALSFRS-R themselves online, using the original ALSFRS-R questions (Maier et al., 2012). This research showed that the scores on the ALSFRS-R completed by people with MND matched the scores from questionnaires completed by health professionals quite closely, meaning that a self-administered ALSFRS-R can be a scientifically valid way of measuring MND symptoms. We propose to modify the ALSFRS-R so that it is suitable for online administration by patients themselves, and to confirm that such an administration maintains its scientific validity while minimising any potential distress caused to people with MND by the wording of the questions. We have converted the ALSFRS-R scale to a series of questions to bring it in line with standard operating procedures and ensure the wording is free of medical jargon and is appropriately sensitive to people who have just received a diagnosis of MND. We hope to use this modified version of the ALSFRS-R in future research.
Inclusion/exclusion criteriaINCLUSION CRITERIA
Participant is willing and able to give informed consent for participation in the study
Aged 18 years or above
Diagnosed with any form of motor neuron disease by a consultant neurologist.

EXCLUSION CRITERIA
Participant lacks capacity to give informed consent for participation in the study
Aged under 18 years
Any comorbid condition that in the opinion of the investigator would make interpretation of responses to the ALSFRS-R questions difficult
No access to a computer or internet to complete the online questionnaire.
Current statusActive – recruiting
LocationsOxford
King's College Hospital, London
Contact detailsCoordinating centre:
Email: Lynn Ossher (lynn.ossher@ndcn.ox.ac.uk) or Andrea Bredin (andrea.bredin@kcl.ac.uk); Telephone: 01865 227714
Recruitment group(s)Patients with MND.
Recruitment target(s)200 patients.
Key datesActual opening date: 19 February 2018
Recruitment planned end date: 31 October 2019
Funder(s)Motor Neurone Disease Association (MNDA)
SponsorUniversity of Oxford
Study designObservational. Study administering questionnaires/interviews for quantitative analysis,
Intervention (if applicable)Not applicable
Phase (if applicable)Not applicable
Outcome measuresThe main objective is to develop a version of the ALSFRS-R using patient-friendly language that can be self-administered online. The secondary objective is to evaluate participant satisfaction with the online version of the ALSFRS-R
Publications / Results reportsLinks will be provided when papers are published.
Participant Information Sheet