Understanding Evaluation of Patient Information Sheets by User Testing Method

Study Overview
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Brief Summary
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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.

Detailed Description
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The participation to a clinical trial is based on two forms of information: the spoken information, usually given by a clinician during the enrolment meeting, and the written information, reported on the Participant Information Sheet (PIS). Numerous studies performed to improve and enhance informed consent, have used different methods to evaluate the quality of the given information such as: interview, checklist, questionnaire, readability formulae. Even if these tools can be useful, they show evident limits in detecting the real efficacy of the proposed consent form in terms of the patient's comprehension. User Testing (UT) is a method originally developed in the 1990 in Australia, to assess how a text about medicinal products performs with its intended users and not just its content. Generally, the UT is based on an iterative 4-step process in a cohort of participants (the target group): individual reading of the text; individual questionnaire for a quantitative and qualitative evaluation; a brief semi-structured interview to each participant; a text revision to address any problems identified from participant feedback; Then the revised document is tested again with a second cohort and this iterative process continues until all issues with the document are resolved. However, a methodological issue not yet explored is whether the UT could be used to compare two different PISs, in order to elucidate aspects that could be involved in improving or worsening the understanding of a PIS. UT has been recently used to evaluate the PIS belonging to phase I and phase III clinical trials (CT) in Myeloid Leukemia, immunomodulatory therapy and for poor responders in vitro fertilization. To date, in no case the UT method has been tested in patients affected by chronic disease like Multiple Sclerosis (MS). We want to apply the UT approach to highlight the critical issues and communication difficulties present in PISs used in MS clinical trials.

Official Title
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Understanding Evaluation of Patient Information Sheets of Two Multiple Sclerosis Studies Through User Testing Method in a Randomized, Open Label, Crossover Design

Conditions
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MS (Multiple Sclerosis)

Intervention / Treatment
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* Other: PIS User Testing


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prevalence of CCSVI in MS<br>Subjects with prevalence of CCSVI in Multiple Sclerosis and in Other Neurodegenerative Diseases - PIS User Testing | Other: PIS User Testing<br>* PIS User Testing based on an iterative 4-step process in a cohort of participants (the target group): individual reading of the text; individual questionnaire for a quantitative and qualitative evaluation; a brief semi-structured interview to each participant; a text revision to address any problems identified from participant feedback.<br>|
| Other: BVD Exploited Against MS<br>Subjects suffering from Brain venous drainage exploited against Multiple Sclerosis - PIS User Testing | Other: PIS User Testing<br>* PIS User Testing based on an iterative 4-step process in a cohort of participants (the target group): individual reading of the text; individual questionnaire for a quantitative and qualitative evaluation; a brief semi-structured interview to each participant; a text revision to address any problems identified from participant feedback.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of found and understood-if-found items | percentage | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| understanding of the text expressed by subject | Visual Analogue Scale (VAS) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis; Patient Information Sheet; User Testing