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BMC Ophthalmology Oct 2019Real-world data (RWD) has been a valuable addition to the scientific literature regarding treatment pathways, clinical outcomes and characteristics of patients with...
Real-world data in retinal diseases treated with anti-vascular endothelial growth factor (anti-VEGF) therapy - a systematic approach to identify and characterize data sources.
BACKGROUND
Real-world data (RWD) has been a valuable addition to the scientific literature regarding treatment pathways, clinical outcomes and characteristics of patients with retinal diseases in recent years. Registries, observational studies and patient databases are often used for real-world research. However, there is limited information for each data source on the design, consistency, data captured, limitations and usability for assessing research questions. Using a systematic approach, we identified RWD sources for patients with retinal diseases and assessed them for completeness of data relating to different outcomes.
METHODS
A systematic literature review was carried out to identify RWD sources for patients with retinal disease. Potentially relevant articles published between 2006 and 2016 were screened following electronic searches in Embase and MEDLINE. Congress and supplementary searches were undertaken to identify RWD sources that may not be referenced in full publications. For each data source, availability and quantity of data on baseline status, clinical outcomes, treatment and management, safety, and patient-reported and economic burden were assessed using a bespoke completeness assessment tool based on International Consortium for Health Outcomes Measurement guidelines for macular degeneration. Completeness of data for each area of interest in each data source was assessed and rated using a 'good-moderate-poor' rating system based on availability and quantity of available data. Each data source was then given an overall score based on its score for each of the 7 areas of interest.
RESULTS
A total of 128 RWD sources from 32 countries were identified. Of the identified sources, 64 sources from 16 countries of interest were analyzed. Most of these sources provided information on baseline status and clinical outcomes and treatment, but few collected data on economic and patient-reported burden. Of the RWD sources analyzed, 10 scored highly in the overall completeness assessment, collecting data on most or all of the areas of interest; these sources are considered to be robust data sources for performing ophthalmology real-world studies.
CONCLUSIONS
The study provides a comprehensive list of RWD sources for patients with retinal disease, many of which will be useful for conducting real-world studies in the field of ophthalmology.
Topics: Angiogenesis Inhibitors; Humans; Information Storage and Retrieval; Intravitreal Injections; Retinal Diseases; Vascular Endothelial Growth Factor A; Visual Acuity
PubMed: 31619195
DOI: 10.1186/s12886-019-1208-9 -
Eye (London, England) Apr 2020To estimate the incidence of acute cerebral ischaemia detected by magnetic resonance imaging (MRI) in acute central retinal artery occlusion (CRAO), branch retinal... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To estimate the incidence of acute cerebral ischaemia detected by magnetic resonance imaging (MRI) in acute central retinal artery occlusion (CRAO), branch retinal artery occlusion (BRAO) and transient monocular vision loss (TMVL).
METHODS
Studies reporting the incidence of acute cerebral ischaemia, detected by MRI, within 7 days from diagnosis of acute CRAO, BRAO and TMVL up to January 2019 were systematically searched for on Pubmed, Medline and Cochrane Library. Meta-analysis was performed using random effects model. The primary outcome was the pooled estimate of incidence of acute cerebral ischaemia in CRAO, BRAO and TMVL cohorts including both neurologically symptomatic and asymptomatic patients, expressed as a proportion along with 95% confidence intervals (CIs). The pooled estimate of incidence of asymptomatic acute cerebral ischaemia represented a secondary outcome measure.
RESULTS
For the primary outcome, the pooled proportion of acute cerebral ischaemia was 0.30 (CI 0.24-0.36) in the CRAO cohort, and 0.25 (CI 0.16-0.37) in the BRAO cohort, without statistical heterogeneity. The rate of acute cerebral ischaemia was 11.8% in the TMVL cohort. For the secondary outcome, the pooled proportion of asymptomatic acute cerebral ischaemia was 0.22 (CI 0.16-0.28) in the CRAO cohort, 0.29 (CI 0.20-0.41) in the BRAO cohort and 0.08 (CI 0.05-0.15) in the TMVL cohort, with no statistical heterogeneity.
CONCLUSIONS
30% of patients with acute CRAO and 25% of patients with acute BRAO presented an acute cerebral ischaemia on MRI. Such high rates support a care pathway of prompt referral of such patients for neurological evaluation and brain imaging.
Topics: Cohort Studies; Humans; Magnetic Resonance Imaging; Retinal Artery Occlusion; Stroke; Visual Acuity
PubMed: 31527762
DOI: 10.1038/s41433-019-0576-y -
The Cochrane Database of Systematic... Aug 2019Amblyopia is defined as impaired visual acuity in one or both eyes without demonstrable abnormality of the visual pathway, and is not immediately resolved by wearing...
BACKGROUND
Amblyopia is defined as impaired visual acuity in one or both eyes without demonstrable abnormality of the visual pathway, and is not immediately resolved by wearing glasses.
OBJECTIVES
In performing this systematic review, we aimed to synthesize the best available evidence regarding the effectiveness and safety of conventional occlusion therapy compared to atropine penalization in treating amblyopia.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2018, Issue 8); Ovid MEDLINE; Ovid Embase; LILACS BIREME; ClinicalTrials.gov; ISRCTN; and the WHO ICTRP on 7 September 2018.
SELECTION CRITERIA
We included randomized/quasi-randomized controlled trials comparing conventional occlusion to atropine penalization for amblyopia.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened abstracts and full-text articles, abstracted data, and assessed risk of bias.
MAIN RESULTS
We included seven trials (five randomized controlled trials and two quasi-randomized controlled trials) conducted in six countries (China, India, Iran, Ireland, Spain, and the United States) with a total of 1177 amblyopic eyes. Three of these seven trials were from the original 2009 version of the review. We assessed two trials as having a low risk of bias across all domains, and the remaining five trials as having unclear or high risk of bias for some domains.As different occlusion modalities, atropine penalization regimens, and populations were used across the included trials, we did not conduct any meta-analysis due to clinical and statistical heterogeneity. Evidence from six trials (two at low risk of bias) suggests that atropine penalization is as effective as conventional occlusion in improving visual acuity. Similar improvement in visual acuity was reported at all time points at which it was assessed, ranging from five weeks (improvement of 1 line) to 10 years (improvement of greater than 3 lines). At six months, although most participants (363/522) come from a trial rated as at low risk of bias with a precise estimate (mean difference (MD) 0.03, 95% confidence interval (CI) 0.00 to 0.06), two other trials rated as at high risk of bias produced inconsistent estimates and wide confidence intervals (MD -0.02, 95% CI -0.11 to 0.07 and MD -0.14, 95% CI -0.23 to -0.05; moderate-certainty evidence). At 24 months, additional improvement was found in both groups, but there continued to be no meaningful difference between those receiving occlusion and those receiving atropine therapies (moderate-certainty evidence).We did not find any difference in ocular alignment, stereo acuity, or sound eye visual acuity between occlusion and atropine penalization groups (moderate-certainty evidence). Both treatments were well tolerated. Atropine was associated with better adherence (moderate-certainty evidence) and quality of life (moderate-certainty evidence), but also a higher reported risk of adverse events in terms of mild reduction in the visual acuity of the sound eye not requiring treatment and light sensitivity (high-certainty evidence). Skin, lid, or conjunctival irritation were more common among participants receiving patching than those receiving atropine (high-certainty evidence). Atropine penalization costs less than conventional occlusion.
AUTHORS' CONCLUSIONS
Both conventional occlusion and atropine penalization produce visual acuity improvement in the amblyopic eye. Atropine penalization appears to be as effective as conventional occlusion, although the magnitude of improvement differed among the trials we analyzed.
Topics: Amblyopia; Atropine; Child; Child, Preschool; Humans; Occlusive Dressings; Ophthalmic Solutions; Randomized Controlled Trials as Topic; Visual Acuity
PubMed: 31461545
DOI: 10.1002/14651858.CD006460.pub3