Understanding Evaluation of Patient Information Sheets by User Testing
Understanding Evaluation of Patient Information Sheets of Two Multiple Sclerosis Studies Through User Testing Method in a Randomized, Open Label, Crossover Design
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- PIS User Testing
What it measured
Main measures
percentage of found and understood-if-found items
1 day
Other measures (1)
understanding of the text expressed by subject
1 day
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
Inclusion Criteria: PwMS (60%) and Caregivers (40%): for PwMS: * 18 years or older; * MS diagnosis according to McDonald criteria; * Informed consent to the present study for caregivers: * 18 years or older; * in being a person who takes care of a PwMS; * Informed consent to the present study
Exclusion criteria
- not having taken part in one of the following trials evaluated in the present study: A) Observational Study of the Prevalence of CCSVI in Multiple Sclerosis and in Other Neurodegenerative Diseases (PIS-A); B) BRAin VEnous DRainage Exploited Against Multiple Sclerosis (PIS-B).
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this randomized, open label, crossover, single site study is to compare the PISs of two Multiple Sclerosis clinical trials to elucidate potential aspects of the given written information that could impact on the smooth running of the studies.
Papers
Background
Raynor DK. User testing in developing patient medication information in Europe. Res Social Adm Pharm. 2013 Sep-Oct;9(5):640-5. doi: 10.1016/j.sapharm.2013.02.007. Epub 2013 Apr 10.Background
Knapp P, Raynor DK, Silcock J, Parkinson B. Performance-based readability testing of participant materials for a phase I trial: TGN1412. J Med Ethics. 2009 Sep;35(9):573-8. doi: 10.1136/jme.2008.026708.Background
Knapp P, Raynor DK, Silcock J, Parkinson B. Performance-based readability testing of participant information for a Phase 3 IVF trial. Trials. 2009 Sep 1;10:79. doi: 10.1186/1745-6215-10-79.Background
Knapp P, Raynor DK, Silcock J, Parkinson B. Can user testing of a clinical trial patient information sheet make it fit-for-purpose?--a randomized controlled trial. BMC Med. 2011 Jul 21;9:89. doi: 10.1186/1741-7015-9-89.
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History
Started
Jan 2017
Main results due
Feb 2018
Finished
Dec 2018