Consensus on Outcome Measures for Glaucoma Effectiveness Trials: Results From a Delphi and Nominal Group Technique Approaches

Ismail, Rehab; Azuara‐Blanco, Augusto; Ramsay, Craig

doi:10.1097/ijg.0000000000000301

Cited by 43 publications

(25 citation statements)

References 23 publications

(26 reference statements)

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“…A systematic review by Ismail and associates showed that a large variability exists in outcomes selected in glaucoma Cochrane Reviews and Protocols, with IOP being the most commonly used outcome measure; in addition, inconsistency was noted among those reviews and protocols. 21–23 Our main outcome measures were trabeculectomy failure and mean IOP at 24 and 12 months postoperatively. However, glaucoma is a chronic disease and long-term follow-up is needed to assess surgical success.…”

Section: Discussionmentioning

confidence: 99%

Fornix-Based Versus Limbal-Based Conjunctival Trabeculectomy Flaps for Glaucoma: Findings From a Cochrane Systematic Review

Al‐Haddad

Abdulaal

Al-Moujahed

et al. 2017

American Journal of Ophthalmology

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PURPOSE To compare effectiveness of fornix- and limbal-based conjunctival flaps in trabeculectomy surgery. DESIGN Systematic review. METHODS Setting CENTRAL, MEDLINE, LILACS, ISRCTN registry, ClinicalTrials.gov, WHO, and ICTRP were searched to identify eligible randomized controlled trials (RCTs). Study Population RCTs in which benefits and complications of fornix- vs limbal-based trabeculectomy for glaucoma were compared in adult glaucoma patients. Observation Procedure We followed Cochrane methodology for data extraction. Main Outcome Measures Proportion of failed trabeculectomies at 24 months, defined as the need for repeat surgery or uncontrolled intraocular pressure (IOP) > 22 mm Hg, despite topical/systemic medications. RESULTS The review included 6 trials with a total of 361 participants, showing no difference in effectiveness between fornix-based vs limbal-based trabeculectomy surgery, although with a high level of uncertainty owing to low event rates. In the fornix-based and limbal-based surgery, mean IOP at 12 months was similar, with ranges of 12.5–15.5 mm Hg and 11.7–15.1 mm Hg, respectively. Mean difference was 0.44 mm Hg (95% CI −0.45 to 1.33) and 0.86 mm Hg (95% CI −0.52 to 2.24) at 12 and 24 months of follow-up, respectively. Mean number of postoperative glaucoma medications was similar between the 2 groups. Mean difference was 0.02 (95% CI −0.15 to 0.19) at 12 months. As far as postoperative complications, an increased risk of shallow anterior chamber was observed in the limbal-based group. CONCLUSION Similar efficacy of trabeculectomy surgery with respect to bleb failure or IOP control was observed in both types of conjunctival flap incisions. A significant difference was detected in the risk of postoperative shallow anterior chamber, which was increased in the limbal-based group.

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Section: Discussionmentioning

confidence: 99%

Fornix-Based Versus Limbal-Based Conjunctival Trabeculectomy Flaps for Glaucoma: Findings From a Cochrane Systematic Review

Al‐Haddad

Abdulaal

Al-Moujahed

et al. 2017

American Journal of Ophthalmology

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“…32 For cataract, the available core outcome set includes 4 outcomes, 33 of which 3 (visual acuity, ocular adverse events, and vision-related quality of life) are common to the 7 most frequent outcomes in our sample of trials and reviews. Similarly, for glaucoma, the available core outcome set includes 4 outcomes, 35 of which 3 (intraocular pressure, visual field, and ocular adverse events) are common to the 7 most frequent outcomes in our sample of trials and reviews. In addition to published core outcome sets, core outcome sets are being developed for AMD, uveitis, DR, visual impairment after stroke, amblyopia, strabismus, and ocular motility.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Clinical Trial and Systematic Review Outcomes for the 4 Most Prevalent Eye Diseases

et al. 2017

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IMPORTANCE Suboptimal overlap in outcomes reported in clinical trials and systematic reviews compromises efforts to compare and summarize results across these studies.OBJECTIVES To examine the most frequent outcomes used in trials and reviews of the 4 most prevalent eye diseases (age-related macular degeneration [AMD], cataract, diabetic retinopathy [DR], and glaucoma) and the overlap between outcomes in the reviews and the trials included in the reviews. DESIGN, SETTING, AND PARTICIPANTSThis cross-sectional study examined all Cochrane reviews that addressed AMD, cataract, DR, and glaucoma; were published as of July 20, 2016; and included at least 1 trial and the trials included in the reviews. For each disease, a pair of clinical experts independently classified all outcomes and resolved discrepancies. Outcomes (outcome domains) were then compared separately for each disease. MAIN OUTCOMES AND MEASURES Proportion of review outcomes also reported in trials and vice versa.RESULTS This study included 56 reviews that comprised 414 trials. Although the median number of outcomes per trial and per review was the same (n = 5) for each disease, the trials included a greater number of outcomes overall than did the reviews, ranging from 2.9 times greater (89 vs 30 outcomes for glaucoma) to 4.9 times greater (107 vs 22 outcomes for AMD). Most review outcomes, ranging from 14 of 19 outcomes (73.7%) (for DR) to 27 of 29 outcomes (93.1%) (for cataract), were also reported in the trials. For trial outcomes, however, the proportion also named in reviews was low, ranging from 19 of 107 outcomes (17.8%) (for AMD) to 24 of 89 outcomes (27.0%) (for glaucoma). Only 1 outcome (visual acuity) was consistently reported in greater than half the trials and greater than half the reviews. CONCLUSIONS AND RELEVANCEAlthough most review outcomes were reported in the trials, most trial outcomes were not reported in the reviews. The current analysis focused on outcome domains, which might underestimate the problem of inconsistent outcomes. Other important elements of an outcome (ie, specific measurement, specific metric, method of aggregation, and time points) might have differed even though the domains overlapped. Inconsistency in trial outcomes may impede research synthesis and indicates the need for disease-specific core outcome sets in ophthalmology.

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“…Because a ‘Summary of findings’ table was not part of the original Cochrane protocol, we chose the outcomes presented in the table post hoc. We based our selection on core outcomes for glaucoma research that have been proposed in the literature (Ismail 2016). The main outcomes for this review include:…”

Section: Methodsmentioning

confidence: 99%

Cyclodestructive procedures for non-refractory glaucoma

Chen

Kim

Coleman

2018

Cochrane Database of Systematic Reviews

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Background Glaucoma is a leading cause of blindness worldwide. It results in a progressive loss of peripheral vision and, in late stages, loss of central vision leading to blindness. Early treatment of glaucoma aims to prevent or delay vision loss. Elevated intraocular pressure (IOP) is the main causal modifiable risk factor for glaucoma. Aqueous outflow obstruction is the main cause of IOP elevation, which can be mitigated either by increasing outflow or reducing aqueous humor production. Cyclodestructive procedures use various methods to target and destroy the ciliary body epithelium, the site of aqueous humor production, thereby lowering IOP. The most common approach is laser cyclophotocoagulation. Objectives To assess the effectiveness and safety of cyclodestructive procedures for the management of non-refractory glaucoma (i.e. glaucoma in an eye that has not undergone incisional glaucoma surgery). We also aimed to compare the effect of different routes of administration, laser delivery instruments, and parameters of cyclophotocoagulation with respect to IOP control, visual acuity, pain control, and adverse events. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2017, Issue 8); Ovid MEDLINE; Embase.com; LILACS; the metaRegister of Controlled Trials (mRCT) and ClinicalTrials.gov . The date of the search was 7 August 2017. We also searched the reference lists of reports from included studies. Selection criteria We included randomized controlled trials of participants who had undergone cyclodestruction as a primary treatment for glaucoma. We included only head-to-head trials that had compared cyclophotocoagulation to other procedural interventions, or compared cyclophotocoagulation using different types of lasers, delivery methods, parameters, or a combination of these factors. Data collection and analysis Two review authors independently screened search results, assessed risks of bias, extracted data, and graded the certainty of the evidence in accordance with Cochrane standards. Main results We included one trial (92 eyes of 92 participants) that evaluated the efficacy of diode transscleral cyclophotocoagulation (TSCPC) as primary surgical therapy. We identified no other eligible ongoing or completed trial. The included trial compared low-energy versus high-energy TSCPC in eyes with primary open-angle glaucoma. The trial was conducted in Ghana and had a mean follow-up period of 13.2 months post-treatment. In this trial, low-energy TSCPC was defined as 45.0 J delivered, high-energy as 65.5 J delivered; it is worth noting that other trials have defined high- and low-energy TSCPC differently. We assessed this trial to have had low risk of selection bias and reporting bias, unclear risk of performance bias, and high risk of detection bias and attrition bias. Trial authors excluded 13 participants with missing follow-up data; the analyses therefore included 40 (85%) of 47 participants in the low-energy ...

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Consensus on Outcome Measures for Glaucoma Effectiveness Trials: Results From a Delphi and Nominal Group Technique Approaches

Abstract: Consensus was reached among glaucoma experts on how best to measure IOP, VF, and anatomic outcomes in glaucoma randomized controlled trials.

Cited by 43 publications

References 23 publications

Fornix-Based Versus Limbal-Based Conjunctival Trabeculectomy Flaps for Glaucoma: Findings From a Cochrane Systematic Review

Fornix-Based Versus Limbal-Based Conjunctival Trabeculectomy Flaps for Glaucoma: Findings From a Cochrane Systematic Review

Comparison of Clinical Trial and Systematic Review Outcomes for the 4 Most Prevalent Eye Diseases

Cyclodestructive procedures for non-refractory glaucoma

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