Understanding Evaluation of Patient Information Sheets by User Testing Method

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

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.

Study Overview

• Status: Unknown
• Conditions: MS (Multiple Sclerosis)
• Intervention / Treatment: Other: PIS User Testing

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Liguria
    • Genova, Liguria, Italy
      • Recruiting
      • Fondazione Italiana Sclerosi Multipla (FISM)
      • Contact: Stefano Lionetti, MD
      • Principal Investigator: Stefano Lionetti, MD
• Romania
  • Timis
    • Timisoara, Timis, Romania, 300209
      • Recruiting
      • Opera Contract Research Organization SRL
      • Contact: Barattini Dionisio, MD; Phone Number: +393355437574; Email: barattini@operacro.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Prevalence of CCSVI in MS; Subjects with prevalence of CCSVI in Multiple Sclerosis and in Other Neurodegenerative Diseases - PIS User Testing	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.
OTHER: BVD Exploited Against MS; Subjects suffering from Brain venous drainage exploited against Multiple Sclerosis - PIS User Testing	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione Italiana Sclerosi Multipla
• Collaborators: Opera CRO, a TIGERMED Group Company
• Investigators: Study Director: Mario Alberto Battaglia, Prof., Fondazione Italiana Sclerosi Multipla (FISM), Genova , (Italy)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2017
• Primary Completion (ANTICIPATED): February 20, 2018
• Study Completion (ANTICIPATED): December 30, 2018

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (ACTUAL): May 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 16, 2018
• Last Update Submitted That Met QC Criteria: January 12, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Patient Information Sheet; User Testing
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: FISM 2012R2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No