Abstract:
PURPOSE:Retinal gene therapy trials are currently ongoing in a small number of inherited retinal disorders and this number is expected to rise significantly. The aim of this study was to analyze the psychological aspects of patients with RPE65 deficiency awaiting potential enrollment in gene therapy trials. METHODS:Five patients with genetically proven RPE65 deficiency took part in this study. They were asked to complete the German versions of (i) the Patient Health Questionnaire (PHQ-D), (ii) the National Eye Institute Visual Function Questionnaire (NEI-VFQ), (iii) the Shared Decision Making Questionnaire (PEF-FB-9), and (iv) the Autonomy Preference Index (API-Dm), and in addition they took part in qualitative interviews. RESULTS:The evaluations of the questionnaires and the interviews showed that the patients have quite high information needs and wish to take part in medical decisions. The perspective to participate in gene therapy trials does not seem to cause pronounced worries. Only the insecurity about if and when enrollment in a trial takes place may be burdensome. DISCUSSION:This study generated important data about the psychological situation of patients awaiting potential enrollment in clinical trials, which can be used to improve patient care in the increasing number of future gene therapy trials around the world.
journal_name
Ophthalmic Resjournal_title
Ophthalmic researchauthors
Nelles M,Stieger K,Preising MN,Kruse J,Lorenz Bdoi
10.1159/000435887subject
Has Abstractpub_date
2015-01-01 00:00:00pages
96-102issue
2eissn
0030-3747issn
1423-0259pii
000435887journal_volume
54pub_type
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