Validation of a Questionnaire for Comparing the Tolerability of Ophthalmic Medications

Barber, Beth; Strahlman, Ellen R.; Laibovitz, Robert; Guess, Harry A.; Reines, Scott A.

doi:10.1016/s0161-6420(97)30314-5

Cited by 84 publications

(64 citation statements)

References 4 publications

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“…Compared with the COMTOL, the TSS-IOP demonstrated both a higher quality developmental process in view of identifying and selecting items and showed better validity evidence. [48][49][50] The Glaucoma Satisfaction Questionnaire (Glausat) was created to primarily assess patient satisfaction with eye drop treatment. Besides containing items addressing side effects and general treatment satisfaction, the Glausat also contains items describing the 'ease of use', 'efficacy', 'expectations and beliefs about treatment', 'impact on HRQoL', 'medical care' and 'general satisfaction'.…”

Section: Pro's Addressing Other Aspectsmentioning

confidence: 99%

Patient-reported outcomes (PRO's) in glaucoma: a systematic review

Vandenbroeck

Geest

Zeyen

et al. 2011

Eye

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The aim of this review was to summarize literature in view of patient-reported outcome (PRO) instruments for glaucoma and provide guidance on how outcomes are best assessed based on evidence about their content and validity. A systematic literature review was performed on papers describing the developmental process and/or psychometric properties of glaucoma or vision-specific PRO-instruments. Each of them was assessed on their adherence to a framework of quality criteria. Fifty-three articles were identified addressing 27 PRO-instruments. In all, 18 PRO's were developed for glaucoma and 9 for diverse ophthalmologic conditions. Seven instruments addressed functional status, 11 instruments quality of life and 9 instruments disease and treatment-related factors. Most of the instruments demonstrated only partially adherence to predefined quality standards. The tools for assessing functional status were of poor quality, while the Glaucoma Quality of Life Questionnaire and the Vision Quality of Life Index were well-developed QoL measures, yet only validated using classical techniques. The Rasch-scaled QoL-tools, IVI and VCM1 need to improve their item-content for glaucoma patients. The questionnaires to measure adherence should improve their validity and the Treatment Satisfaction Survey for Intra Ocular Pressure pops out as the highest quality tool for measuring topical treatment side effects. This review revealed that most PRO-instruments demonstrated poor developmental quality, more specifically a lack of conceptual framework and item generation strategies not involving the patients' perspective. Psychometric characteristics were mostly tested using classical validation techniques.

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Section: Pro's Addressing Other Aspectsmentioning

confidence: 99%

Patient-reported outcomes (PRO's) in glaucoma: a systematic review

Vandenbroeck

Geest

Zeyen

et al. 2011

Eye

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“…The side effects of topical glaucoma medication were registered by asking patients to fill in a questionnaire based on "the Comparison of Ophthalmic Medications for Tolerability" (COMTOL) questionnaire [3]. The COMTOL questionnaire was designed and validated for comparing the tolerability of topical glaucoma medications.…”

Section: Variables and Measurementsmentioning

confidence: 99%

Side effects of commonly used glaucoma medications: comparison of tolerability, chance of discontinuation, and patient satisfaction

Beckers

Schouten

Webers

et al. 2008

Graefes Arch Clin Exp Ophthalmol

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Background To compare the tolerability of commonly prescribed topical glaucoma medications by determining frequency and bother of side effects, patient satisfaction with their medication, and the chance of discontinuation of eye drops. Methods The tolerability of topical glaucoma medication was studied in glaucoma patients from nine hospitals. The frequency and severity of side effects was investigated together with patient satisfaction with the medication and the probability to change medication due to reported side effects. To register side effects of topical glaucoma medication, patients were requested to fill in a questionnaire based on "the Comparison of Ophthalmic Medications for Tolerability" (COMTOL) questionnaire supplemented with items based on the most frequently observed and severe side effects.Results The number of patients responding was 3,333 (87%). Most patients (79%) were satisfied with their eye medication. The median score for ocular side effects was 58 on a scale ranging from 0 to 320. The probability that medication would be changed by the ophthalmologist at the next visit due to reported side effects occurring since the patients' last or last but one visit to the ophthalmologist was 9%. The most frequently prescribed drugs were timolol, latanoprost, and the fixed combinations of dorzolamide/ timolol (Cosopt®) and latanoprost/timolol (Xalcom®). Only small differences in tolerability were found between these drugs. Conclusions The tolerability of timolol, latanoprost, and the fixed combinations of latanoprost/timolol (Xalcom®) and dorzolamide/timolol (Cosopt®) seem to be comparable. Patients are satisfied with their glaucoma medication and have a low chance of discontinuation of eye drops due to side effects.

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“…6 The use of the latter option is usually preferred since it improves patients compliance and reduce cost. 7,8 In addition, such therapy reduces the chance of an imprecise dosing or the potential washout effect that may be seen when separate medications are used. The reduced number of administrations provided by the combination product may be of particular benefit for elderly patients, who make up the majority of cataract surgeries.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, single administration of a combination product leads to better compliance and patient comfort. 7,8 In the present study we evaluated both efficacy and safety of a new fixed combination of dexamethasone and netilmicin in patients undergoing cataract surgery. The efficacy of such product was compared to TOBRADEX s , a well accepted steroid/antibiotic combination that is currently marketed in several countries as a standard treatment to control postsurgical inflammation and prevent postsurgical infection.…”

Section: Introductionmentioning

confidence: 99%

Dexamethasone–netilmicin: a new ophthalmic steroid–antibiotic combination. Efficacy and safety after cataract surgery

Russo¹,

Papa²,

Bella³

et al. 2005

Eye

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Purpose The purpose of this study was to evaluate both efficacy and safety of a new ophthalmic steroid-antibiotic fixed combination containing dexamethasone and netilmicin in the postsurgical management of cataract surgery. Methods In total, 223 patients were randomly treated with dexamethasone 1 mg/ml plus netilmicin 3 mg/ml (n ¼ 148), or dexamethasone 1 mg/ml plus tobramycin 3 mg/ ml (n ¼ 75, TOBRADEX s ) four times in a day for 771 days starting immediately after surgery. Efficacy (anterior chamber (AC) inflammation, conjunctival hyperaemia, corneal and lid oedema, ocular infection, pain, photophobia and tearing) and safety (burning, stinging, blurred vision, intraocular pressure, and visual acuity) were analysed in the operated eye after 1 and 771 days. A followup visit was performed at day 1472. The extent of AC inflammation, measured by slitlamp according to a standard scoring system, was used as primary efficacy parameter. Results At the primary end point (day 7) both fixed combinations were equally effective in reducing postoperative inflammation. The safety profile of the dexamethasone/netilmicin combination was excellent with no evidence of poor local tolerance or adverse reaction. Conclusions A new fixed combination of dexamethasone and netilmicin was effective and safe in controlling ocular inflammation after cataract surgery.

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Validation of a Questionnaire for Comparing the Tolerability of Ophthalmic Medications

Cited by 84 publications

References 4 publications

Patient-reported outcomes (PRO's) in glaucoma: a systematic review

Patient-reported outcomes (PRO's) in glaucoma: a systematic review

Side effects of commonly used glaucoma medications: comparison of tolerability, chance of discontinuation, and patient satisfaction

Dexamethasone–netilmicin: a new ophthalmic steroid–antibiotic combination. Efficacy and safety after cataract surgery

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