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Ophthalmology and Therapy

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Open Access 22-09-2023 | Glaucoma | ORIGINAL RESEARCH

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

Authors: Richard M. Evans, Martha Gauthier, Margot L. Goodkin, Joice T. Huang

Published in: Ophthalmology and Therapy | Issue 1/2024

Abstract

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.

Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014;121:2081–90. https://doi.org/10.1016/j.ophtha.2014.05.013.CrossRefPubMed

Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: a review. JAMA. 2014;311:1901–11. https://doi.org/10.1001/jama.2014.3192.CrossRefPubMedPubMedCentral

Le A, Mukesh BN, McCarty CA, Taylor HR. Risk factors associated with the incidence of open-angle glaucoma: the visual impairment project. Invest Ophthalmol Vis Sci. 2003;44:3783–9. https://doi.org/10.1167/iovs.03-0077.CrossRefPubMed

Gordon MO, Beiser JA, Brandt JD, et al. The Ocular Hypertension Treatment Study: baseline factors that predict the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002;120:714–20. https://doi.org/10.1001/archopht.120.6.714.CrossRefPubMed

Chan MPY, Broadway DC, Khawaja AP, et al. Glaucoma and intraocular pressure in EPIC-Norfolk Eye Study: cross sectional study. BMJ. 2017;358:j3889. https://doi.org/10.1136/bmj.j3889.CrossRefPubMedPubMedCentral

Heijl A, Leske MC, Bengtsson B, et al. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002;120:1268–79. https://doi.org/10.1001/archopht.120.10.1268.CrossRefPubMed

Garway-Heath DF, Crabb DP, Bunce C, et al. Latanoprost for open-angle glaucoma (UKGTS): a randomised, multicentre, placebo-controlled trial. Lancet. 2015;385:1295–304. https://doi.org/10.1016/S0140-6736(14)62111-5.CrossRefPubMed

Ernest PJ, Schouten JS, Beckers HJ, Hendrikse F, Prins MH, Webers CA. An evidence-based review of prognostic factors for glaucomatous visual field progression. Ophthalmology. 2013;120:512–9. https://doi.org/10.1016/j.ophtha.2012.09.005.CrossRefPubMed

Kass MA, Heuer DK, Higginbotham EJ, et al. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002;120:701–13. https://doi.org/10.1001/archopht.120.6.701.CrossRefPubMed

10.

Leske MC, Heijl A, Hussein M, et al. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch Ophthalmol. 2003;121:48–56. https://doi.org/10.1001/archopht.121.1.48.CrossRefPubMed

11.

Sleath B, Robin AL, Covert D, Byrd JE, Tudor G, Svarstad B. Patient-reported behavior and problems in using glaucoma medications. Ophthalmology. 2006;113:431–6. https://doi.org/10.1016/j.ophtha.2005.10.034.CrossRefPubMed

12.

Olthoff CM, Schouten JSAG, van de Borne BW, Webers CA. Noncompliance with ocular hypotensive treatment in patients with glaucoma or ocular hypertension an evidence-based review. Ophthalmology. 2005;112:953-61.e7. https://doi.org/10.1016/j.ophtha.2004.12.035.CrossRefPubMed

13.

Reardon G, Kotak S, Schwartz GF. Objective assessment of compliance and persistence among patients treated for glaucoma and ocular hypertension: a systematic review. Patient Prefer Adher. 2011;5:441–63. https://doi.org/10.2147/PPA.S23780.CrossRef

14.

Friedman DS, Okeke CO, Jampel HD, et al. Risk factors for poor adherence to eyedrops in electronically monitored patients with glaucoma. Ophthalmology. 2009;116:1097–105. https://doi.org/10.1016/j.ophtha.2009.01.021.CrossRefPubMed

15.

Medeiros FA, Walters TR, Kolko M, et al. Phase 3, randomized, 20-month study of bimatoprost implant in open-angle glaucoma and ocular hypertension (ARTEMIS 1). Ophthalmology. 2020;127:1627–41. https://doi.org/10.1016/j.ophtha.2020.06.018.CrossRefPubMed

16.

Bacharach J, Tatham A, Ferguson G, et al. Phase 3, randomized, 20-month study of the efficacy and safety of bimatoprost implant in patients with open-angle glaucoma and ocular hypertension (ARTEMIS 2). Drugs. 2021;81:2017–33. https://doi.org/10.1007/s40265-021-01624-9.CrossRefPubMedPubMedCentral

17.

U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. 2009. Available at: https://www.fda.gov/media/77832/download. Accessed 11 May 2023.

18.

U.S. Department of Health and Human Services, Food and Drug Administration. Patient-focused drug development: selecting, developing, or modifying fit-for-purpose clinical outcome assessments. 2022. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-focused-drug-development-selecting-developing-or-modifying-fit-purpose-clinical-outcome. Accessed 11 May 2023.

19.

Glaser BG, Strauss AL. The constant comparative method of qualitative analysis. In: Discovery of grounded theory: strategies for qualitative research. New York: Aldine de Gruyter; 1967. p. 101–16.

20.

Charmaz K. Grounded theory. In: Smith JA, Harré R, Van Langenhove L, editors. Rethinking methods in psychology. London: Sage Publications; 1995. p. 27–49.CrossRef

21.

Lasch KE, Hassan M, Endicott J, et al. Development and content validity of a patient reported outcomes measure to assess symptoms of major depressive disorder. BMC Psychiatry. 2012;12:34. https://doi.org/10.1186/1471-244X-12-34.CrossRefPubMedPubMedCentral

22.

Chall JS, Dale E. Readability revisited: the new Dale-Chall readability formula. Cambridge, MA: Brookline Books; 1995.

23.

McClure GM. Readability formulas, useful or useless? IEEE Trans Prof Commun. 1987;30:12–5. https://doi.org/10.1109/TPC.1987.6449109.CrossRef

24.

Nordmann JP, Denis P, Vigneux M, Trudeau E, Guillemin I, Berdeaux G. Development of the conceptual framework for the Eye-Drop Satisfaction Questionnaire (EDSQ^©) in glaucoma using a qualitative study. BMC Health Serv Res. 2007;7:124. https://doi.org/10.1186/1472-6963-7-124.CrossRefPubMedPubMedCentral

25.

Regnault A, Viala-Danten M, Gilet H, Berdeaux G. Scoring and psychometric properties of the Eye-Drop Satisfaction Questionnaire (EDSQ), an instrument to assess satisfaction and compliance with glaucoma treatment. BMC Ophthalmol. 2010;10:1. https://doi.org/10.1186/1471-2415-10-1.CrossRefPubMedPubMedCentral

26.

Ruiz MA, Pardo A, Martinez-de-la-Casa JM, Polo V, Esquiro J, Soto J. Development of a specific questionnaire measuring patient satisfaction with glaucoma treatment: Glausat. Ophthalmic Epidemiol. 2010;17:131–43. https://doi.org/10.3109/09286581003734852.CrossRefPubMed

27.

Kerr NM, Patel HY, Chew SSL, Ali NQ, Eady EK, Danesh-Meyer HV. Patient satisfaction with topical ocular hypotensives. Clin Exp Ophthalmol. 2013;41:27–35. https://doi.org/10.1111/j.1442-9071.2012.02823.x.CrossRefPubMed

28.

Atkinson MJ, Stewart WC, Fain JM, et al. A new measure of patient satisfaction with ocular hypotensive medications: the Treatment Satisfaction Survey for Intraocular Pressure (TSS-IOP). Health Qual Life Outcomes. 2003;1:67. https://doi.org/10.1186/1477-7525-1-67.CrossRefPubMedPubMedCentral

29.

Barber BL, Strahlman ER, Laibovitz R, Guess HA, Reines SA. Validation of a questionnaire for comparing the tolerability of ophthalmic medications. Ophthalmology. 1997;104:334–42. https://doi.org/10.1016/s0161-6420(97)30314-5.CrossRefPubMed

30.

Sleath B, Blalock S, Covert D, et al. The relationship between glaucoma medication adherence, eye drop technique, and visual field defect severity. Ophthalmology. 2011;118:2398–402. https://doi.org/10.1016/j.ophtha.2011.05.013.CrossRefPubMed

31.

Newman-Casey PA, Niziol LM, Gillespie BW, Janz NK, Lichter PR, Musch DC. The association between medication adherence and visual field progression in the Collaborative Initial Glaucoma Treatment Study. Ophthalmology. 2020;127:477–83. https://doi.org/10.1016/j.ophtha.2019.10.022.CrossRefPubMed

32.

Rossi GC, Pasinetti GM, Scudeller L, Radaelli R, Bianchi PE. Do adherence rates and glaucomatous visual field progression correlate? Eur J Ophthalmol. 2011;21:410–4. https://doi.org/10.5301/EJO.2010.6112.CrossRefPubMed

33.

Stewart WC, Chorak RP, Hunt HH, Sethuraman G. Factors associated with visual loss in patients with advanced glaucomatous changes in the optic nerve head. Am J Ophthalmol. 1993;116:176–81. https://doi.org/10.1016/s0002-9394(14)71282-6.CrossRefPubMed

34.

Singh RB, Ichhpujani P, Thakur S, Jindal S. Promising therapeutic drug delivery systems for glaucoma: a comprehensive review. Ther Adv Ophthalmol. 2020. https://doi.org/10.1177/2515841420905740.CrossRefPubMedPubMedCentral

35.

Alm A, Grierson I, Shields MB. Side effects associated with prostaglandin analog therapy. Surv Ophthalmol. 2008;53(Suppl 1):S93-105. https://doi.org/10.1016/j.survophthal.2008.08.004.CrossRefPubMed

36.

Rabinowitz MP, Katz LJ, Moster MR, et al. Unilateral prostaglandin-associated periorbitopathy: a syndrome involving upper eyelid retraction distinguishable from the aging sunken eyelid. Ophthalmic Plast Reconstr Surg. 2015;31:373–8. https://doi.org/10.1097/IOP.0000000000000351.CrossRefPubMed

37.

Cvenkel B, Kolko M. Devices and treatments to address low adherence in glaucoma patients: a narrative review. J Clin Med. 2022;12:151. https://doi.org/10.3390/jcm12010151.CrossRefPubMedPubMedCentral

Title: Qualitative Development of the Allergan Satisfaction with Treatment Experience Questionnaire (ASTEQ) Instrument, a Patient-Reported Outcome Measure in Glaucoma and Ocular Hypertension
Authors: Richard M. Evans
Martha Gauthier
Margot L. Goodkin
Joice T. Huang
Publication date: 22-09-2023
Publisher: Springer Healthcare
Keywords: Glaucoma
Bimatoprost
Hypertension
Hypertension
Published in: Ophthalmology and Therapy / Issue 1/2024
Print ISSN: 2193-8245
Electronic ISSN: 2193-6528
DOI: https://doi.org/10.1007/s40123-023-00804-y

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

Abstract

Introduction

Methods

Results

Conclusion

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