LIST of ABBREVIATIONS 3
1. Introduction 4
1.1 Importance of readability user test 4
2. Planned Testing procedures for readability testing 4
2.2.1 Recommended for style of questions 5
2.3 Making test materials and pilot testing 5
2.3.1Pilot-testing questionnaire 6
3. Assigning interviewers 6
4. Recruiting test subjects 6
5. Conducting user test 6
5.1 Scheduling test dates and locations 6
5.2 Preparation of testing materials 7
5.2.1 Test methods 7
5.3 Conducting first round of testing 7
6 Compilation of results 8
6.1 Making necessary revisions 8
6.2 Conducting additional rounds of testing 8
7. Summarizing the test results 8
8. Writing up final results 9
9. Key challenges in readability testing 9
10. Bridging 10
10.1 Introduction 10 …show more content…
Readability of many leaflets was difficult due to lengthy the complexity of the SmPC, and poorly lay out. Patients quickly lost interest in the document, failing to read or understand information crucial to the safe use of the medicine. This results in misuse of medication causes life threatening.
Leaflet must reflect the product license (SmPC) of the product to which it refers. Variations in SmPC for same medicine available from different marketing authority (MA) holders with inconsistent information in PL, results in frequent compliment from patients1.
2. Planned Testing procedures for readability testing
To ensure that the most important information is easily located in the product leaflet, product-specific information and performance required to use medication safe and effective way be confirmed before and during writing of the PL.
The most important facts and behaviors must be tested to conform that the information can be found, understood, and that directions followed correctly. The PL translator must be asked for feedback before finalizing the PL for testing, to make sure about that leaflet can be translated to the local language in understandable …show more content…
This will be performed by with unbiased (e.g., non-product connected) company personal. Revisions to the questionnaire, protocol one or both PL have to be finished before field-testing on subjects/patient begins.
3. Assigning interviewers
It is desirable to involve an experienced interviewer to perform the interviews. In addition, it may be useful that a company representative (e.g. the writer of the leaflet) be present as an eye witness. Numerous important observations may possibly make and collected during part of interviews, e.g., spontaneous comments by the subject and/or body language, which would not be understandable from a written report.
4. Recruiting test subjects
For the recruitment of test subjects the following points should be considered:
Overall testing, the user population (e.g., specialist providers) must be engaged according to the type of product (e.g., hospital use, oncology, patient-self-administered). The applicant/MAH has account for running minimum two rounds in addition to pilot