Qualitative Development of the Allergan Satisfaction with Treatment Experience Questionnaire (ASTEQ) Instrument, a Patient-Reported Outcome Measure in Glaucoma and Ocular Hypertension

• Published in: Ophthalmology and therapy Vol. 13; no. 1; pp. 71 - 92
• Main Authors: Evans, Richard M., Gauthier, Martha, Goodkin, Margot L., Huang, Joice T.
• Format: Journal Article
• Language: English
• Published: Cheshire Springer Healthcare 2024; Adis, Springer Healthcare
• Subjects: Allergan Satisfaction with Treatment Experience Questionnaire; Bimatoprost; Glaucoma; Instrument development; Internal Medicine; Intraocular implant; Medicine; Medicine & Public Health; Ocular hypertension; Ophthalmology; Original Research; Glaucoma; Instrument development; Allergan Satisfaction with Treatment Experience Questionnaire; Intraocular implant; Patient-reported outcome measures; Ocular hypertension; Treatment satisfaction; Bimatoprost
• ISSN: 2193-8245; 2193-6528
• DOI: 10.1007/s40123-023-00804-y

Introduction Sustained-release intraocular implants provide a therapeutic option for open-angle glaucoma (OAG) and ocular hypertension (OHT) patients who are non-compliant with eyedrops. Currently, there are no published patient-reported outcome (PRO) measures that assess treatment satisfaction with intraocular implants. To address this gap, a new PRO instrument, the Allergan Satisfaction with Treatment Experience Questionnaire (ASTEQ), has been developed in accordance with Food and Drug Administration guidance. Methods Qualitative research interviews were conducted among patients with OAG/OHT who had received three intraocular injections of a sustained-release bimatoprost (10 or 15 µg) implant within the clinical trial setting. A preliminary conceptual framework capturing treatment satisfaction concepts in glaucoma, as identified from the literature, was used to develop a semi-structured interview guide. A concept elicitation (CE) interview to identify aspects of the glaucoma treatment experience pertinent to intraocular implants provided content for a draft instrument. A cognitive debriefing (CD) interview to test the instrument’s interpretability, relevance, and validity informed its subsequent refinement. Interview analysis followed a grounded theory approach to identify data patterns and relationships. Results CE interviews ( n  = 19) indicated that participants’ main considerations in rating satisfaction with implant treatment were physical comfort during preparation for the implant and implant administration, anxiety about the procedure, frequency of implant administration, possible side effects, convenience and accessibility of the implant, relationship with the clinician, and lifestyle fit. Draft ASTEQ revision based on CD interviews ( n  = 20) and readability tests yielded a nine-item ASTEQ instrument comprising satisfaction with overall implant experience and frequency of administration, occurrence/bother of immediate and long-term side effects, worry about implant administration and possible risks/side effects, and physical discomfort during preparation for the implant and implant administration. Conclusion The ASTEQ instrument has demonstrated content validity in patients with OAG/OHT treated with a sustained-release bimatoprost implant. Further research is necessary to evaluate its psychometric properties.