Understanding Evaluation of Patient Information Sheets by User Testing Method

MS (Multiple Sclerosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03155334
• Other study ID #: FISM 2012R2
• Status: Recruiting
• Phase: N/A
• First received: May 15, 2017
• Last updated: January 12, 2018
• Start date: January 31, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: January 2018
• Source: Fondazione Italiana Sclerosi Multipla
• Contact: Dionisio Barattini, MD
• Phone: +393355437574
• Email: barattini[@]operacro.ro
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• MS (Multiple Sclerosis)
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• PIS User Testing
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.

Locations

Country	Name	City	State
Italy	Fondazione Italiana Sclerosi Multipla (FISM)	Genova	Liguria
Romania	Opera Contract Research Organization SRL	Timisoara	Timis

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Italiana Sclerosi Multipla	Opera Contract Research Organization SRL

Countries where clinical trial is conducted

Italy,  Romania, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of found and understood-if-found items	percentage	1 day
Secondary	understanding of the text expressed by subject	Visual Analogue Scale (VAS)	1 day

External Links

•   BRAin VEnous DRainage Exploited Against Multiple Sclerosis (BRAVE-DREAMS), ClinicalTrials.gov Identifier: NCT01371760
•   Observational Study of the Prevalence of CCSVI in Multiple Sclerosis and in Other Neurodegenerative Diseases (COSMO), ClinicalTrials.gov Identifier: NCT01384825