Publications by authors named "Tianjing Li"

125 Publications

What do we really know about the effectiveness of glaucoma interventions: An overview of systematic reviews.

Ophthalmol Glaucoma 2021 Feb 9. Epub 2021 Feb 9.

Department of Ophthalmology, School of Medicine, University of Colorado Denver, Aurora, USA. Electronic address:

Objective: To identify systematic reviews on interventions for glaucoma conditions and assess their reliability, thereby generating a list of potentially reliable reviews for updating the glaucoma practice guidelines.

Design: Cross sectional study PARTICIPANTS: Systematic reviews of interventions for glaucoma conditions.

Methods: We used a database of systematic reviews and meta-analyses in vision research and eye care maintained by the Cochrane Eyes and Vision United State Satellite as a source of reviews. We examined all Cochrane systematic reviews of interventions for glaucoma conditions published before August 7, 2019 and all non-Cochrane systematic reviews of interventions for glaucoma conditions published between January 1, 2014 and August 7, 2019.

Main Outcome Measures: We assessed eligible reviews for reliability, extracted characteristics, and summarized key findings from reviews classified as reliable.

Results: Of the 4,451 systematic reviews in eyes and vision identified, 129 met our eligibility criteria and were assessed for reliability. Of these, we classified 49 (38%) as reliable. We found open-angle glaucoma (22/49) to be the condition with the most reviews and medical management (17/49) and intraocular pressure (43/49) to be the most common interventions and outcomes studied. Most reviews found a high degree of uncertainty in the evidence, which hinder the possibility of making strong recommendations in guidelines. These reviews found high-certainty evidence about a few topics: reducing IOP helps prevent glaucoma and its progression; prostaglandin analogues are the most effective medical treatment for lowering IOP; laser trabeculoplasty is as effective as medical treatment as a first-line therapy in controlling IOP; the use of IOP lowering medications peri- or post-operatively to accompany laser (e.g., trabeculoplasty) reduces the risk of post-operative IOP spikes; conventional surgery (i.e., trabeculectomy) are more efficacious than medications in reducing IOP; antimetabolites and beta-radiation improve IOP control after trabeculectomy. There is weak evidence regarding the effectiveness of minimally invasive glaucoma surgeries.

Conclusions: The majority of systematic reviews evaluating interventions for glaucoma are of poor reliability. Even among those that may be considered reliable, there are important limitations in the value of information due to the uncertainty of the evidence as well as small and sometimes unimportant clinical differences between interventions.
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http://dx.doi.org/10.1016/j.ogla.2021.01.007DOI Listing
February 2021

Characterizing Longitudinal Changes in Physical Activity and Fear of Falling after Falls in Glaucoma.

J Am Geriatr Soc 2021 Jan 8. Epub 2021 Jan 8.

Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Background: Older adults with visual impairments experience a higher risk of falling, and are more vulnerable to adverse health consequences associated with falls than those with normal vision. This study characterizes longitudinal changes in objectively measured physical activity and fear of falling (FoF) occurring after various types of falls in visually impaired older adults.

Design: Prospective cohort study.

Setting: Hospital-based enrollment.

Participants: People with glaucoma or suspected glaucoma.

Measurements: Falls were defined as unintentionally coming to rest on the ground or a lower level, and injurious falls were determined though follow-up calls. Study participants were categorized into three groups-fallers with injurious consequences, fallers without injurious consequences, and non-fallers based on fall status in the first year. Physical activity was assessed by waist-bound accelerometer. FoF was evaluated by questionnaire, with Rasch modeling generating FoF scores where higher scores reflected worse FoF. The 3-year longitudinal changes of physical activity and FoF were modeled using mixed-effects models.

Results: In linear models fully adjusted for visual field damage and other covariates, physical activity among injurious fallers showed greater annual (per year) declines in daily steps (-425 steps/d, 95% confidence interval (CI) = -793, -57), daily active minutes (-13 min/d, 95% CI = -21, -6), and daily moderate and vigorous physical activity (MVPA) minutes (-3 MVPA minutes/d, 95% CI = -5, 0) over the 3-year period as compared to non-fallers; however, physical activity did not significantly decline among non-injurious fallers. No longitudinal increases in FoF scores were observed in injurious or non-injurious fallers when compared to non-fallers.

Conclusion: Among visually impaired older adults, injurious falls identified prospectively over 12 months contributed to a significant decline in physical activity over a 3-year period, while minimal changes were observed in FoF.
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http://dx.doi.org/10.1111/jgs.17014DOI Listing
January 2021

Interventions for convergence insufficiency: a network meta-analysis.

Cochrane Database Syst Rev 2020 12 2;12:CD006768. Epub 2020 Dec 2.

Department of Ophthalmology, University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA.

Background: Convergence insufficiency is a common binocular vision disorder in which the eyes have a strong tendency to drift outward (exophoria) with difficulty turning the eyes inward when reading or doing close work.

Objectives: To assess the comparative effectiveness and relative ranking of non-surgical interventions for convergence insufficiency through a systematic review and network meta-analysis (NMA).

Search Methods: We searched CENTRAL, MEDLINE, Embase, PubMed and three trials registers up to 20 September 2019.

Selection Criteria: We included randomized controlled trials (RCTs) examining any form of non-surgical intervention versus placebo, no treatment, sham treatment, or other non-surgical interventions. Participants were children and adults with symptomatic convergence insufficiency.

Data Collection And Analysis: We followed standard Cochrane methodology. We performed NMAs separately for children and adults.

Main Results: We included 12 trials (six in children and six in adults) with a total of 1289 participants. Trials evaluated seven interventions: 1) office-based vergence/accommodative therapy with home reinforcement; 2) home-based pencil/target push-ups; 3) home-based computer vergence/accommodative therapy; 4) office-based vergence/accommodative therapy alone; 5) placebo vergence/accommodative therapy or other placebo intervention; 6) prism reading glasses; and 7) placebo reading glasses. Six RCTs in the pediatric population randomized 968 participants. Of these, the Convergence Insufficiency Treatment Trial (CITT) Investigator Group completed four RCTs with 737 participants. All four CITT RCTs were rated at low risk of bias. Diagnostic criteria and outcome measures were identical or similar among these trials. The four CITT RCTs contributed data to the pediatric NMA, incorporating interventions 1, 2, 3 and 5. When treatment success was defined by a composite outcome requiring both clinical measures of convergence to be normal, and also show a pre-specified magnitude of improvement, we found high-certainty evidence that office-based vergence/accommodative therapy with home reinforcement increases the chance of a successful outcome, compared with home-based computer vergence/accommodative therapy (risk ratio (RR) 1.96, 95% confidence interval (CI) 1.32 to 2.94), home-based pencil/target push-ups (RR 2.86, 95% CI 1.82 to 4.35); and placebo (RR 3.04, 95% CI 2.32 to 3.98). However, there may be no evidence of any treatment difference between home-based computer vergence/accommodative therapy and home-based pencil/target push-ups (RR 1.44, 95% CI 0.93 to 2.24; low-certainty evidence), or between either of the two home-based therapies and placebo therapy, for the outcome of treatment success. When treatment success was defined as the composite convergence and symptom success outcome, we found moderate-certainty evidence that participants who received office-based vergence/accommodative therapy with home reinforcement were 5.12 (95% CI 2.01 to 13.07) times more likely to achieve treatment success than those who received placebo therapy. We found low-certainty evidence that participants who received office-based vergence/accommodative therapy with home reinforcement might be 4.41 (95% CI 1.26 to 15.38) times more likely to achieve treatment success than those who received home-based pencil push-ups, and 4.65 (95% CI 1.23 to 17.54) times more likely than those who received home-based computer vergence/accommodative therapy. There was no evidence of any treatment difference between home-based pencil push-ups and home-based computer vergence/accommodative therapy, or between either of the two home-based therapies and placebo therapy. One RCT evaluated the effectiveness of base-in prism reading glasses in children. When base-in prism reading glasses were compared with placebo reading glasses, investigators found no evidence of a difference in the three outcome measures of near point convergence (NPC), positive fusional vergence (PFV), or symptom scores measured by the Convergence Insufficiency Symptom Survey (CISS). Six RCTs in the adult population randomized 321 participants. We rated only one RCT at low risk of bias. Because not all studies of adults included composite success data, we could not conduct NMAs for treatment success. We thus were limited to comparing the mean difference (MD) between interventions for improving NPC, PFV, and CISS scores individually using data from three RCTs (107 participants; interventions 1, 2, 4 and 5). Compared with placebo treatment, office-based vergence accommodative therapy was relatively more effective in improving PFV (MD 16.73, 95% CI 6.96 to 26.60), but there was no evidence of a difference for NPC or the CISS score. There was no evidence of difference for any other comparisons for any outcomes. One trial evaluated base-in prism glasses prescribed for near-work activities and found that the prism glasses group had fewer symptoms compared with the placebo glasses group at three months (MD -8.9, 95% CI -11.6 to -6.3). The trial found no evidence of a difference with this intervention in NPC or PFV. No adverse effects related to study treatments were reported for any of the included studies. Excellent adherence was reported for office-based vergence/accommodative therapy (96.6% or higher) in two trials. Reported adherence with home-based therapy was less consistent, with one study reporting decreasing adherence over time (weeks 7 to 12) and lower completion rates with home-based pencil/target push-ups.

Authors' Conclusions: Current research suggests that office-based vergence/accommodative therapy with home reinforcement is more effective than home-based pencil/target push-ups or home-based computer vergence/accommodative therapy for children. In adults, evidence of the effectiveness of various non-surgical interventions is less clear.
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http://dx.doi.org/10.1002/14651858.CD006768.pub3DOI Listing
December 2020

Intravitreal steroids for macular edema in diabetes.

Cochrane Database Syst Rev 2020 11 17;11:CD005656. Epub 2020 Nov 17.

Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, Italy.

Background: Diabetic macular edema (DME) is secondary to leakage from diseased retinal capillaries with thickening of central retina, and is an important cause of poor central visual acuity in people with diabetic retinopathy. Intravitreal steroids have been used to reduce retinal thickness and improve vision in people with DME.

Objectives: To assess the effectiveness and safety of intravitreal steroid therapy compared with other treatments for DME.

Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase on 15 May, 2019. We also searched reference lists, Science Citation Index, conference proceedings, and relevant trial registers. We conducted a top up search on 21 October, 2020.

Selection Criteria: We included randomized controlled trials that evaluated any type of intravitreal steroids as monotherapy against any other intervention (e.g. observation, laser photocoagulation, anti-vascular endothelial growth factor (antiVEGF) for DME.

Data Collection And Analysis: Two review authors independently assessed study eligibility and risk of bias and extracted data. Where appropriate, we performed meta-analyses.

Main Results: We included 10 trials (4348 participants, 4505 eyes). These trials compared intravitreal steroid therapies versus other treatments, including intravitreal antiVEGF therapy, laser photocoagulation, and sham injection. Most trials had an overall unclear or high risk of bias. One trial (701 eyes ) compared intravitreal dexamethasone implant 0.7mg with sham. We found moderate-certainty evidence that dexamethasone leads to slightly more improvement of visual acuity than sham at 12 months (mean difference [MD] -0.08 logMAR, 95% confidence interval [CI] -0.12 to -0.05 logMAR). Regarding improvement of three or more lines of visual acuity, there was moderate-certainty evidence in favor of dexamethasone at 12 months, but the CI covered the null value (risk ratio (RR) 1.39, 95% CI 0.91 to 2.12). Regarding adverse events, dexamethasone increased by about four times the risk of cataract progression and the risk of using intraocular pressure (IOP)-lowering medications compared to sham (RR 3.89, 95% CI 2.75 to 5.50 and RR 4.54, 95% CI 3.19 to 6.46, respectively; moderate-certainty evidence); about 4 in 10 participants treated with dexamethasone needed IOP-lowering medications. Two trials (451 eyes) compared intravitreal dexamethasone implant 0.7mg with intravitreal antiVEGF (bevacizumab and ranibizumab). There was moderate-certainty evidence that visual acuity improved slightly less with dexamethasone compared with antiVEGF at 12 months (MD 0.07 logMAR, 95% CI 0.04 to 0.09 logMAR; 2 trials; 451 participants/eyes; I = 0%). The RR of gain of three or more lines of visual acuity was inconsistent between trials, with one trial finding no evidence of a difference between dexamethasone and bevacizumab at 12 months (RR 0.99, 95% CI 0.70 to 1.40; 1 trial; 88 eyes), and the other, larger trial finding the chances of vision gain were half with dexamethasone compared with ranibizumab (RR 0.50, 95% CI 0.32 to 0.79; 1 trial; 432 participants). The certainty of evidence was low. Cataract progression and the need for IOP-lowering medications increased more than 4 times with dexamethasone implant compared to antiVEGF (moderate-certainty evidence). One trial (560 eyes) compared intravitreal fluocinolone implant 0.19mg with sham. There was moderate-certainty evidence that visual acuity improved slightly more with fluocinolone at 12 months (MD -0.04 logMAR, 95% CI -0.06 to -0.01 logMAR). There was moderate-certainty evidence that an improvement in visual acuity of three or more lines was more common with fluocinolone than with sham at 12 months (RR 1.79, 95% CI 1.16 to 2.78). Fluocinolone also increased the risk of cataract progression (RR 1.63, 95% CI 1.35 to 1.97; participants = 335; moderate-certainty evidence), which occurred in about 8 in 10 participants, and the use of IOP-lowering medications (RR 2.72, 95% CI 1.87 to 3.98; participants = 558; moderate-certainty evidence), which were needed in 2 to 3 out of 10 participants. One small trial with 43 participants (69 eyes) compared intravitreal triamcinolone acetonide injection 4 mg with sham. There may be a benefit in visual acuity at 24 months (MD -0.11 logMAR, 95% CI -0.20 to -0.03 logMAR), but the certainty of evidence is low. Differences in adverse effects were poorly reported in this trial. Two trials (615 eyes) compared intravitreal triamcinolone acetonide injection 4mg with laser photocoagulation and reached discordant results. The smaller trial (31 eyes followed up to 9 months) found more visual acuity improvement with triamcinolone (MD -0.18 logMAR, 95% CI -0.29 to -0.07 logMAR), but a larger, multicenter trial (584 eyes, 12-month follow-up) found no evidence of a difference regarding change in visual acuity (MD 0.02 logMAR, 95% CI -0.03 to 0.07 logMAR) or gain of three or more lines of visual acuity (RR 0.85, 95% CI 0.55 to 1.30) (overall low-certainty evidence). Cataract progression was about three times more likely (RR 2.68, 95% CI 2.21 to 3.24; moderate-certainty evidence) and the use of IOP-lowering medications was about four times more likely (RR 3.92, 95% CI 2.59 to 5.96; participants = 627; studies = 2; I = 0%; moderate-certainty evidence) with triamcinolone. About 1 in 3 participants needed IOP-lowering medication. One small trial (30 eyes) compared intravitreal triamcinolone acetonide injection 4mg with intravitreal antiVEGF (bevacizumab or ranibizumab). Visual acuity may be worse with triamcinolone at 12 months (MD 0.18 logMAR, 95% CI 0.10 to 0.26 logMAR); the certainty of evidence is low. Adverse effects were poorly reported in this trial. Four trials reported data on pseudophakic participants, for whom cataract is not a concern. These trials found no decrease in visual acuity in the second treatment year due to cataract progression.

Authors' Conclusions: Intravitreal steroids may improve vision in people with DME compared to sham or control. Effects were small, about one line of vision or less in most comparisons. More evidence is available for dexamethasone or fluocinolone implants when compared to sham, and the evidence is limited and inconsistent for the comparison of dexamethasone with antiVEGF treatment. Any benefits should be weighed against IOP elevation, the use of IOP-lowering medication and, in phakic patients, the progression of cataract. The need for glaucoma surgery is also increased, but remains rare.
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http://dx.doi.org/10.1002/14651858.CD005656.pub3DOI Listing
November 2020

Primary Open-Angle Glaucoma Suspect Preferred Practice Pattern®.

Ophthalmology 2021 Jan 12;128(1):P151-P192. Epub 2020 Nov 12.

Legacy Devers Eye Institute, Portland, Oregon.

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http://dx.doi.org/10.1016/j.ophtha.2020.10.023DOI Listing
January 2021

Primary Angle-Closure Disease Preferred Practice Pattern®.

Ophthalmology 2021 Jan 12;128(1):P30-P70. Epub 2020 Nov 12.

Legacy Devers Eye Institute, Portland, Oregon.

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http://dx.doi.org/10.1016/j.ophtha.2020.10.021DOI Listing
January 2021

Primary Open-Angle Glaucoma Preferred Practice Pattern®.

Ophthalmology 2021 Jan 12;128(1):P71-P150. Epub 2020 Nov 12.

Legacy Devers Eye Institute, Portland, Oregon.

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http://dx.doi.org/10.1016/j.ophtha.2020.10.022DOI Listing
January 2021

Probiotics Contribute to Glycemic Control in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis.

Adv Nutr 2020 Oct 30. Epub 2020 Oct 30.

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

This systematic review aimed to evaluate the effectiveness and safety of probiotics for glycemic control in adults with impaired glucose control, including prediabetes and type 2 diabetes mellitus (T2DM). We searched PubMed, Embase, and Cochrane databases, and trial registries up to February 2019. We included randomized controlled trials (RCTs) of participants with prediabetes or T2DM. Eligible trials compared probiotics versus either placebo, no intervention, or comparison probiotics, or compared synbiotics versus prebiotics. Primary outcomes were mean change in fasting blood glucose (FBG) and glycated hemoglobin (HbA1c) from baseline to short term (<12 wk) and long term (≥12 wk). We performed meta-analyses using the random-effects model. We included 28 RCTs (1947 participants). Overall, probiotics reduced FBG more than the placebo/no intervention group with a mean difference (MD) of -12.99 mg/dL (95% CI: -23.55, -2.42; P value: 0.016) over the short term; and -2.99 mg/dL (95% CI: -5.84, -0.13; P value: 0.040) over the long term. There was also some evidence for reduced HbA1c in the probiotics group at both short term (MD: -0.17; 95% CI: -0.37, 0.02; P value: 0.084) and long term (MD: -0.14; 95% CI: -0.34, 0.06; P value: 0.172), however, these did not reach statistical significance possibly because only a few trials reported HbA1c as an outcome. Subgroup analyses showed a greater reduction in HbA1c in participants not receiving insulin therapy than those receiving insulin therapy. Furthermore, the effect of probiotics on the reduction of FBG was more pronounced in participants with FBG >130 mg/dL and those not receiving insulin therapy than their counterparts. Probiotics were also effective in lowering serum cholesterol over the short and long term. In conclusion, we found that probiotics may have a glucose-lowering effect in T2DM participants. The effect appeared to be stronger in participants with poorly controlled diabetes and those not on insulin therapy. Systematic review registration: CRD42019121682.
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http://dx.doi.org/10.1093/advances/nmaa133DOI Listing
October 2020

Prospective reporting of statistical analysis plans for randomised controlled trials.

Trials 2020 10 28;21(1):898. Epub 2020 Oct 28.

MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London, UK.

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http://dx.doi.org/10.1186/s13063-020-04828-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7594284PMC
October 2020

Assessing the relevance and uptake of core outcome sets (an agreed minimum collection of outcomes to measure in research studies) in Cochrane systematic reviews: a review.

BMJ Open 2020 09 6;10(9):e036562. Epub 2020 Sep 6.

Center for Evidence-based Healthcare, Medizinische Fakultät, Technische Universität Dresden, Dresden, Germany.

Objectives: A core outcome set (COS) is an agreed standardised minimum collection of outcomes that should be measured and reported in research in a specific area of health. Cochrane systematic reviews ('reviews') are rigorous reviews on health-related topics conducted under the auspices of Cochrane. This study examines the use of existing COS to inform the choice of outcomes in Cochrane systematic reviews ('reviews') and investigates the views of the coordinating editors of Cochrane Review Groups (CRGs) on this topic.

Methods: A cohort of 100 recently published or updated Cochrane reviews were assessed for reference to a COS being used to inform the choice of outcomes for the review. Existing COS, published 2 or more years before the review publication, were then identified to assess how often a reviewer could have used a relevant COS if it was available. We asked 52 CRG coordinating editors about their involvement in COS development, how outcomes are selected for reviews in their CRG and their views of the advantages and challenges surrounding the standardisation of outcomes within their CRG.

Results: In the cohort of reviews from 2019, 40% (40/100) of reviewers noted problems due to outcome inconsistency across the included studies. In 7% (7/100) of reviews, a COS was referenced in relation to the choice of outcomes for the review. Relevant existing COS could be considered for a review update in 35% of the others (33/93). Most editors who responded (31/36, 86%) thought that COS should definitely or possibly be used to inform the choice of outcomes in a review.

Conclusions: Systematic reviewers are continuing to note outcome heterogeneity but are starting to use COS to inform their reviews. There is potential for greater uptake of COS in Cochrane reviews.
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http://dx.doi.org/10.1136/bmjopen-2019-036562DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7476465PMC
September 2020

Environmental and behavioural interventions for reducing physical activity limitation and preventing falls in older people with visual impairment.

Cochrane Database Syst Rev 2020 09 3;9:CD009233. Epub 2020 Sep 3.

School of Health & Life Sciences, Institute of Applied Health Research, Glasgow Caledonian University, Glasgow, UK.

Background: Impairment of vision is associated with a decrease in activities of daily living. Avoidance of physical activity in older adults with visual impairment can lead to functional decline and is an important risk factor for falls. The rate of falls and fractures is higher in older people with visual impairment than in age-matched visually normal older people. Possible interventions to reduce activity restriction and prevent falls include environmental and behavioral interventions.

Objectives: We aimed to assess the effectiveness and safety of environmental and behavioral interventions in reducing physical activity limitation, preventing falls and improving quality of life amongst visually impaired older people.

Search Methods: We searched CENTRAL (including the Cochrane Eyes and Vision Trials Register) (Issue 2, 2020), Ovid MEDLINE, Embase and eight other databases to 4 February 2020, with no language restrictions.

Selection Criteria: Eligible studies were randomized controlled trials (RCTs) and quasi-randomized controlled trials (Q-RCTs) that compared environmental interventions, behavioral interventions or both, versus control (usual care or no intervention); or that compared different types of environmental or behavioral interventions. Eligible study populations were older people (aged 60 and over) with irreversible visual impairment, living in their own homes or in residential settings. To be eligible for inclusion, studies must have included a measure of physical activity or falls, the two primary outcomes of interest. Secondary outcomes included fear of falling, and quality of life.

Data Collection And Analysis: We used standard Cochrane methods. We assessed the certainty of the evidence using the GRADE approach.

Main Results: We included six RCTs (686 participants) conducted in five countries (Australia, Hungary, New Zealand, UK, US) with follow-up periods ranging from two to 12 months. Participants in these trials included older adults (mean age 80 years) and were mostly female (69%), with visual impairments of varying severity and underlying causes. Participants mostly lived in their homes and were physically independent. We classified all trials as having high risk of bias for masking of participants, and three trials as having high or unclear risk of bias for all other domains. The included trials evaluated various intervention strategies (e.g. an exercise program versus home safety modifications). Heterogeneity of study characteristics, including interventions and outcomes, (e.g. different fall measures), precluded any meta-analysis. Two trials compared the home safety modification by occupational therapists versus social/home visits. One trial (28 participants) reported physical activity at six months and showed no evidence of a difference in mean estimates between groups (step counts: mean difference (MD) = 321, 95% confidence interval (CI) -1981 to 2623; average walking time (minutes): MD 1.70, 95% CI -24.03 to 27.43; telephone questionnaire for self-reported physical activity: MD -3.68 scores, 95% CI -20.6 to 13.24; low-certainty of evidence for each outcome). Two trials reported the proportion of participants who fell at six months (risk ratio (RR) 0.76, 95% CI 0.38 to 1.51; 28 participants) and 12 months (RR 0.59, 95% CI 0.43 to 0.80, 196 participants) with low-certainty of evidence for each outcome. One trial (28 participants) reported fear of falling at six months, using the Short Falls Efficacy Scale-International, and found no evidence of a difference in mean estimates between groups (MD 2.55 scores, 95% CI -0.51 to 5.61; low-certainty of evidence). This trial also reported quality of life at six months using 12-Item Short Form Health Survey, and showed no evidence of a difference in mean estimates between groups (MD -3.14 scores, 95% CI -10.86 to 4.58; low-certainty of evidence). Five trials compared a behavioral intervention (exercise) versus usual activity or social/home visits. One trial (59 participants) assessed self-reported physical activity at six months and showed no evidence of a difference between groups (MD 9.10 scores, 95% CI -13.85 to 32.5; low-certainty of evidence). Three trials investigated different fall measures at six or 12 months, and found no evidence of a difference in effect estimates (RRs for proportion of fallers ranged from 0.54 (95% CI 0.29 to 1.01; 41 participants); to 0.93 (95% CI 0.61 to 1.39; 120 participants); low-certainty of evidence for each outcome). Three trials assessed the fear of falling using Short Falls Efficacy Scale-International or the Illinois Fear of Falling Measure from two to 12 months, and found no evidence of a difference in mean estimates between groups (the estimates ranged from -0.88 score (95% CI -2.72 to 0.96, 114 participants) to 1.00 score (95% CI -0.13 to 2.13; 59 participants); low-certainty of evidence). One trial (59 participants) assessed the European Quality of Life scale at six months (MD -0.15 score, 95% CI -0.29 to -0.01), and found no evidence of a clinical difference between groups (low-certainty of evidence).

Authors' Conclusions: There is no evidence of effect for most of the environmental or behavioral interventions studied for reducing physical activity limitation and preventing falls in visually impaired older people. The certainty of evidence is generally low due to poor methodological quality and heterogeneous outcome measurements. Researchers should form a consensus to adopt standard ways of measuring physical activity and falls reliably in older people with visual impairments. Fall prevention trials should plan to use objectively measured or self-reported physical activity as outcome measures of reduced activity limitation. Future research should evaluate the acceptability and applicability of interventions, and use validated questionnaires to assess the adherence to rehabilitative strategies and performance during activities of daily living.
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http://dx.doi.org/10.1002/14651858.CD009233.pub3DOI Listing
September 2020

Authorship diversity among systematic reviews in eyes and vision.

Syst Rev 2020 08 27;9(1):192. Epub 2020 Aug 27.

Department of Ophthalmology, School of Medicine, University of Colorado Anschutz Medical Campus, 1675 Aurora Ct. F731, Aurora, CO, 80045, USA.

Importance: The inclusion of authors from diverse backgrounds and with different lived experiences is critical to ensuring the questions addressed in systematic reviews (SRs), as well as the subsequent conclusions and recommendations made, are representative of the global community.

Objective: To assess the gender and geographic diversity of authors among all Cochrane SRs in eyes and vision as compared with a random sample of non-Cochrane SRs of interventions in the field of eyes and vision.

Design: The Cochrane Eyes and Vision US Satellite maintains a database of SRs in the field of eyes and vision. We selected all (n = 313) eyes and vision intervention SRs published in The Cochrane Library and a random sample of 313 eyes and vision intervention SRs published elsewhere for this study. We determined gender of the first and corresponding authors ("woman," "man," or "unknown") using a previously developed algorithm and their location based on institution country and the World Health Organization region.

Results: From the 626 reviews included in our sample, we identified 751 unique authors who comprised 887 author positions (i.e., first and/or corresponding authors). We were able to ascertain the gender of 647/751 (86%) authors: 276 women and 371 men. Among Cochrane eyes and vision SRs, the proportions of women in first and/or corresponding author positions were consistent and approximately equal to men. Among non-Cochrane eyes and vision SRs, the representation of women was markedly lower as corresponding authors than other positions. Most authors of Cochrane eyes and vision SRs were from the UK (31%) and USA (26%), whereas most authors of non-Cochrane SRs were from China (34%).

Conclusions And Relevance: Compared with authors of non-Cochrane SRs in eyes and vision, authors of Cochrane SRs appear to have approximately equal representation of women and men among perceived important author positions and be located in European and North American countries, possibly due to the locations of the Cochrane editorial teams. Cochrane Eyes and Vision should continue to recruit authors from around the world in locations that reflect the global burden of eye disease.
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http://dx.doi.org/10.1186/s13643-020-01451-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7450569PMC
August 2020

Prenatal diagnosis of left-sided aortic arch, right descending aorta and right-sided ductus arteriosus associated with anomalous origin of left pulmonary artery from ascending aorta.

Echocardiography 2020 09 10;37(9):1506-1508. Epub 2020 Aug 10.

Beijing Key Laboratory of Maternal-Fetus Medicine in Fetal Heart Disease, Department of Ultrasound, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.

Left-sided aortic arch (LAA), right descending aorta (rDAo), and right-sided ductus arteriosus (RDA) constitute a rare aortic arch anomaly. Moreover, anomalous origin of the pulmonary artery from the ascending aorta, especially that of the left pulmonary artery, is also a rare anomaly of the pulmonary artery branches. Because of the presence of the ductus arteriosus, prenatal ultrasound is an optimal diagnostic tool for the LAA with rDAo. Four-dimensional color Doppler can clearly demonstrate the spatial relationship between the LAA, rDAo, and RDA and the anomalous origin of the left pulmonary artery from the ascending aorta.
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http://dx.doi.org/10.1111/echo.14821DOI Listing
September 2020

Priorities and Treatment Preferences among Surgery-Naive Patients with Moderate to Severe Open-Angle Glaucoma.

Ophthalmol Glaucoma 2020 Sep - Oct;3(5):377-383. Epub 2020 May 16.

Department of Ophthalmology, University of Colorado Denver-Anschutz Medical Campus, Aurora, Colorado.

Purpose: To explore patients' perspectives and experiences living with moderate to severe glaucoma through qualitative, semistructured interviews and to identify important benefits and risks that patients consider when choosing glaucoma treatments.

Design: Semistructured, in-person qualitative interviews with a convenience sample of patients seen at the Johns Hopkins Wilmer Eye Institute.

Participants: Surgery-naive patients 21 years of age or older with moderate to severe open-angle glaucoma seeking treatment at the Wilmer Eye Institute's Glaucoma Center of Excellence between August and December 2018.

Methods: We conducted semistructured interviews with patients diagnosed with moderate to severe open-angle glaucoma, focusing on outcomes they prioritize when considering various treatment options. We used Atlas.ti software version 7.5.12 (Scientific Software Development GmbH, Berlin, Germany) to process interview transcripts and the framework approach to analyze the qualitative data.

Main Outcome Measures: Patients' descriptions of outcomes important to them in management of moderate to severe open-angle glaucoma.

Results: Thirteen men and 15 women with a median age 67 years participated in the study. Compared with the mild-to-moderate glaucoma patients interviewed previously, these participants similarly emphasized (1) activities of daily living, (2) visual symptoms, (3) treatment burden, and (4) intraocular pressure (IOP) control, but unlike patients with milder disease, most related IOP control directly to (5) avoiding disease progression. Almost all (27/28) had also given significant thought to (6) surgical decision making and could describe how they would decide for or against a particular procedure. Finally, two thirds (18/28) expressed (7) significant fear and worry related to their glaucoma diagnosis.

Conclusions: We identified outcomes that matter to patients who are undergoing treatment for moderate to severe glaucoma, many of which may serve as end points in clinical trials, such as functional independence in vision-dependent activities of daily living, avoidance of visual symptoms, and disease progression via maintenance of IOP control. We also observed that these patients have varied and nuanced perspectives on surgical management and its outcomes. It behooves providers and trial designers to consider these in future evaluations of new treatments for moderate to severe glaucoma.
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http://dx.doi.org/10.1016/j.ogla.2020.05.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7529737PMC
May 2020

Registration of phase 3 crossover trials on ClinicalTrials.gov.

Trials 2020 Jul 6;21(1):613. Epub 2020 Jul 6.

Department of Ophthalmology, School of Medicine, University of Colorado Denver, Aurora, CO, USA.

Background: In a randomized crossover trial, each participant is randomized to a sequence of treatments and treatment effect is estimated based on within-individual difference because each participant serves as his/her own control. This feature makes the design and reporting of randomized crossover trials different from that of parallel trials. Our objective was to characterize phase 3 crossover trials with results reported on ClinicalTrials.gov and identify issues and best practices for reporting.

Methods: We searched ClinicalTrials.gov for phase 3 randomized crossover trials that provided results, registered at least one primary outcome, and included at least one link to a results publication in the record by August 6, 2019. Two reviewers independently assessed the eligibility and extracted information from each record into an electronic form developed and maintained in the Systematic Review Data Repository.

Results: Of the 124 crossover trials analyzed, two thirds were a simple "Intervention A then B" or "Intervention B then A" (AB|BA) design. Most trials (78%, 97/124) provided enough information to understand the participant flow throughout the trial. Baseline characteristics were most often reported for all participants as a single group (52%, 65/124). Primary outcomes and adverse events were most commonly reported "per intervention" (85%, 105/124, and 80%, 99/124, respectively).

Conclusions: The registration and reporting of randomized crossover trials must account for the paired nature of the design. Our observations and recommendations informed the development of guidelines for good reporting practices in the registration and reporting of randomized crossover trials.
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http://dx.doi.org/10.1186/s13063-020-04545-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7336618PMC
July 2020

Patterns of Daily Physical Activity across the Spectrum of Visual Field Damage in Glaucoma Patients.

Ophthalmology 2021 Jan 29;128(1):70-77. Epub 2020 Jun 29.

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Center on Aging and Health, Johns Hopkins University, Baltimore, Maryland; Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address:

Purpose: To define and quantify patterns of objectively measured daily physical activity by level of visual field (VF) damage in glaucoma patients including: (1) activity fragmentation, a metric of health and physiologic decline, and (2) diurnal patterns of activity, a measure of rest and activity rhythms.

Design: Prospective cohort study.

Participants: Older adults diagnosed with glaucoma or suspected glaucoma.

Methods: Degree of VF damage was defined by the average VF sensitivity within the integrated VF (IVF). Each participant wore a hip accelerometer for 1 week to measure daily minute-by-minute activity for 7 consecutive days. Activity fragmentation was calculated as the reciprocal of the average activity bout duration in minutes, with higher fragmentation indicating more transient, rather than sustained, activity. Multivariate linear regression was used to test for cross-sectional associations between VF damage and activity fragmentation. Multivariate linear mixed-effects models were used to assess the associations between VF damage and accumulation of activity across 6 3-hour intervals from 5 am to 11 pm.

Main Outcome Measures: Activity fragmentation and amount of activity (steps) over the course of the day.

Results: Each 5-dB decrement in IVF sensitivity was associated with 16.3 fewer active minutes/day (P < 0.05) and 2% higher activity fragmentation (P < 0.05), but not with the number of active bouts per day (P = 0.30). In time-of-day analyses, lower IVF sensitivity was associated with fewer steps over the 11 am to 2 pm, 2 pm to 5 pm, and 5 pm to 8 pm periods (106.6, 93.1, and 89.2 fewer steps, respectively; P < 0.05 for all), but not over other periods. The activity midpoint (the time at which half of the daily activity is completed) did not vary across level of VF damage.

Conclusions: At worse levels of VF damage, glaucoma patients demonstrate shorter, more fragmented bouts of physical activity throughout the day and lower activity levels during typical waking hours, reflecting low physiologic functioning. Further work is needed to establish the temporality of this association and whether glaucoma patients with such activity patterns are at a greater risk of adverse health outcomes associated with activity fragmentation.
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http://dx.doi.org/10.1016/j.ophtha.2020.06.053DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7755661PMC
January 2021

Accuracy of optical coherence tomography for diagnosing glaucoma: an overview of systematic reviews.

Br J Ophthalmol 2020 Jun 3. Epub 2020 Jun 3.

Eye Clinic, Department of NEUROFARBA, University of Florence, Florence, Italy.

Aims: To assess the diagnostic accuracy (DTA) of optical coherence tomography (OCT) for detecting glaucoma by systematically searching and appraising systematic reviews (SRs) on this issue.

Methods: We searched a database of SRs in eyes and vision maintained by the Cochrane Eyes and Vision United States on the DTA of OCT for detecting glaucoma. Two authors working independently screened the records, abstracted data and assessed the risk of bias using the Risk of Bias in Systematic Reviews checklist. We extracted quantitative DTA estimates as well as qualitative statements on their relevance to practice.

Results: We included four SRs published between 2015 and 2018. These SRs included between 17 and 113 studies on OCT for glaucoma diagnosis. Two reviews were at low risk of bias and the other two had two to four domains at high or unclear risk of bias with concerns on applicability. The two reliable SRs reported the accuracy of average retinal nerve fibre layer (RNFL) thickness and found a sensitivity of 0.69 (0.63 to 0.73) and 0.78 (0.74 to 0.83) and a specificity of 0.94 (0.93 to 0.95) and 0.93 (0.92 to 0.95) in 57 and 50 studies, respectively. Only one review included a clear specification of the clinical pathway. Both reviews highlighted the limitations of primary DTA studies on this topic.

Conclusions: The quality of published DTA reviews on OCT for diagnosing glaucoma was mixed. Two reliable SRs found moderate sensitivity at high specificity for average RNFL thickness in diagnosing manifest glaucoma. Our overview suggests that the methodological quality of both primary and secondary DTA research on glaucoma is in need of improvement.
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http://dx.doi.org/10.1136/bjophthalmol-2020-316152DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7876780PMC
June 2020

Post-Left Atrium Space Index in Fetuses With Total Anomalous Pulmonary Venous Connection and Other Congenital Heart Diseases.

J Ultrasound Med 2020 Dec 3;39(12):2405-2412. Epub 2020 Jun 3.

Department of Ultrasound, Beijing Anzhen Hospital, Capital Medical University, Beijing Key Laboratory of Maternal-Fetal Medicine in Fetal Heart Disease, Beijing, China.

Objectives: We aimed to explore the value of the post-left atrium space (PLAS) index in the diagnosis of total anomalous pulmonary venous connection (TAPVC) and the effect of other congenital heart diseases on the PLAS index in the fetus.

Methods: The PLAS index of 69 fetuses with TAPVC was analyzed retrospectively. Approximately 252 healthy fetuses were randomly selected as controls, and 110 cases of intracardiac malformations were randomly selected for comparison. The PLAS index was defined as the ratio of the left atrium-descending aorta distance divided by the descending aorta diameter from the 4-chamber view in the end-systolic phase.

Results: There were no significant differences in the PLAS index among the 3 groups of isolated TAPVC subtypes (P > .05), or among the isolated TAPVC group and the simple and complex cardiac anomaly groups (P > .05). Compared with the control group, the PLAS index of the TAPVC group was significantly increased (P < .001). The PLAS index was significantly higher in the TAPVC group than in hypoplastic left heart syndrome, endocardial cushion defect, conotruncal defect, and ventricular septal defect groups (P < .05). The PLAS indices of the hypoplastic left heart syndrome, endocardial cushion defect, and conotruncal defect groups were all higher than that of the control group (P < .05). There was no significant difference in the PLAS index between the ventricular septal defect and control groups (P > .05).

Conclusions: The PLAS index is a sensitive parameter for the diagnosis of fetal TAPVC. There were no significant differences in the PLAS index among different TAPVC types. Complex intracardiac anomalies have an influence on the PLAS index.
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http://dx.doi.org/10.1002/jum.15362DOI Listing
December 2020

Identifying outcomes that are important to patients with ocular hypertension or primary open-angle glaucoma: a qualitative interview study.

Ophthalmol Glaucoma 2019 Nov-Dec;2(6):374-382. Epub 2019 Jul 31.

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.

Purpose: To explore patients' perspectives and experiences living with glaucoma and identify important benefits and risks that patients consider before electing for new glaucoma treatments, such as minimally invasive glaucoma surgical (MIGS) devices.

Design: Semi-structured, in-person qualitative interviews with patients seen at the Johns Hopkins Wilmer Eye Institute.

Participants: Adults older than 21 years of age who were suspected or diagnosed with ocular hypertension or mild to moderate primary open-angle glaucoma (POAG) (and thus eligible for treatment with a MIGS procedure) presenting to a glaucoma clinic in Baltimore, Maryland, between May and December 2016.

Method: We conducted in-person interviews with patients recently diagnosed with ocular hypertension or POAG. We focused on considerations patients take into account when deciding between different treatments. We used the framework approach to code and analyze the qualitative data. Considerations of special interest to us were those that can be translated into outcomes (or endpoints) in clinical trials.

Main Outcome Measures: Patients' perspectives concerning outcomes that matter to them when managing ocular hypertension or POAG.

Results: Ten male and fifteen female patients participated in our study. The median participant age was 69 years (range 47 - 82 years). We identified outcomes that patients expressed as important, which we grouped into four thematic categories: (1) limitations in performing specific vision-dependent activities of daily living; (2) problems with general visual function or perceptions; (3) treatment burden, including ocular adverse events; and (4) intraocular pressure (IOP). All 25 participants expressed some concerns with their ability to perform vision-dependent activities, such as reading and driving. Most (23/25) participants had an opinion about IOP, and among those currently taking ocular hypotensive eye drops, all recognized the relationship between eye drops and IOP.

Conclusion: We have identified outcomes that matter to patients who are deciding between different treatments for ocular hypertension and POAG, such as the ability to drive or maintain mobility outside the home. These outcomes will be important in future evaluations of new treatments for glaucoma.
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http://dx.doi.org/10.1016/j.ogla.2019.07.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7243613PMC
July 2019

Characterizing the Impact of Fear of Falling on Activity and Falls in Older Adults with Glaucoma.

J Am Geriatr Soc 2020 08 15;68(8):1847-1851. Epub 2020 May 15.

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.

Objective: Fear of falling (FoF) may alter mobility in older adults, especially among those with visual impairment. Using a longitudinal prospective cohort of older glaucoma patients, we investigated whether and how FoF is associated with future falls and physical activity.

Design: Prospective observational cohort study.

Setting: Hospital-based single-center recruitment.

Participants: Individuals with glaucoma or suspected glaucoma.

Measurements: FoF was measured annually over a 3-year period using the University of Illinois at Chicago FoF Questionnaire, with lower Rasch-analyzed FoF scores (in logit units) indicating less fear. Participants recorded falls prospectively over the 3-year period using monthly mail-in calendars. Daily steps were collected annually over 7 days using an accelerometer. Visual field (VF) sensitivity was derived by combining sensitivities from monocular VF results. Participants completed questionnaires to determine other demographic/health characteristics. Multivariate random effects models evaluated within-participant changes in fall rates and physical activity across study years.

Results: At lower FoF levels (FoF≤0), each one-unit worsening in FoF score across study years was associated with 2.73 times higher odds of reporting at least one fall in the next year (95% confidence interval [CI] = 1.55-4.81) but was not associated with average daily steps (P = .44). Similar results were seen when fall rates were normalized by number of steps taken (P = .97). At higher FoF levels (FoF > 0), inter-year changes in FoF scores were not significantly associated with reporting a fall in the following year (P = .78) but were associated with 407 fewer average daily steps per one-unit change in FoF (95% CI = -743 to -71).

Conclusion: FoF is an important psychological factor associated with mobility in glaucoma patients, although specific aspects of mobility (fall rates vs activity levels) affected vary by the degree of FoF. Our findings suggest that customizing behavioral interventions for older adults based on their levels of FoF may be an important strategy for fall prevention and activity promotion. J Am Geriatr Soc 68:1847-1851, 2020.
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http://dx.doi.org/10.1111/jgs.16516DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7537827PMC
August 2020

Prioritizing outcome preferences in patients with ocular hypertension and open-angle glaucoma using best-worst scaling.

Ophthalmol Glaucoma 2019 Nov-Dec;2(6):367-373. Epub 2019 Sep 3.

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.

Purpose: To quantify patients' preferences for glaucoma outcomes and use this information to prioritize outcomes that are important to patients.

Design: A cross-sectional study using best-worst scaling object case (BWS).

Participants: Two hundred seventy-four participants newly diagnosed with ocular hypertension or mild to moderate open angle glaucoma from three private practices and one academic medical center in the United States.

Methods: We designed a preference-elicitation survey based on findings from 25 semi-structured, qualitative interviews with patients with glaucoma (reported elsewhere). The survey asked participants to rate the importance of 13 glaucoma outcomes on a Likert scale as a warm-up exercise followed by completion of 13 BWS tasks. For each task, we presented participants a subset of four outcomes from the possible thirteen, and participants chose the most important and least important outcome. Outcomes included in the survey pertain to maintaining ability to perform vision-dependent activities of daily living (e.g., driving), maintaining visual function and perception (e.g., depth perception), minimizing need to take glaucoma drops, not experiencing ocular surface symptoms (e.g., red eyes, teary eyes), and having adequate control of intraocular pressure (IOP). We administered the survey online and analyzed response patterns using conditional logistic regression to determine the relative importance of different outcomes.

Main Outcome: Ordinal ranking of glaucoma outcomes based on preference weights.

Results: Between September 1, 2017 and February 28, 2018, we invited 1035 patients to complete our survey, among whom 274 (26%) responded. Most participants were older than 65 years of age (146/274, 53%) and currently on IOP-lowering drops (179/274, 65%). Participants identified that outcomes with the largest relative importance weight were having "adequate IOP control" and ability to "drive a car during the day," and the outcomes with the smallest relative importance weights were "maintaining appearance of the eye" and "reducing the number of IOP-lowering drops".

Conclusions: Determining the relative importance of glaucoma outcomes to patients can help researchers design studies that may better inform clinical and regulatory decision-making. Although IOP is an outcome that researchers often measure in glaucoma clinical trials, patients also prioritized outcomes related to the ability to perform vision-dependent activities such as driving.
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http://dx.doi.org/10.1016/j.ogla.2019.08.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7192342PMC
September 2019

Frequency of Abstracts Presented at Eye and Vision Conferences Being Developed Into Full-Length Publications: A Systematic Review and Meta-analysis.

JAMA Ophthalmol 2020 Apr 30:689-697. Epub 2020 Apr 30.

Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.

Importance: Conference proceedings are platforms for early communication and dissemination of relevant and timely topics of interest. More than half of abstracts presented at biomedical conferences fail to be published in full, resulting in wasted time and resources.

Objective: To systematically review reports evaluating the proportion of abstracts presented at eye and vision conferences that are subsequently published in full and investigate factors associated with publication.

Data Sources: MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, and reference lists of included reports were systematically searched from inception to January 11, 2019.

Study Selection: Reports that examined the proportion of abstracts presented at eye and vision conferences and subsequently published in peer-reviewed journals 24 or more months later.

Data Extraction And Synthesis: Two reviewers independently assessed study eligibility, abstracted data, and evaluated the risk of bias. A meta-analysis was conducted to determine the proportion of abstracts published in full and assess factors associated with subsequent full publication.

Main Outcomes And Measures: Proportion of abstracts presented at eye and vision conferences subsequently published in full.

Results: There were 19 reports covering 12 261 abstracts presented at 11 unique eye and vision conferences. The overall risk of bias of the reports was low. The weighted proportion of abstracts published in full was 38.0% (95% CI, 31.7%-44.3%) and 54.9% (95% CI, 34.6%-73.7%) among reports restricted to abstracts describing randomized clinical trials. Nine reports (47.4%) investigated the proportion of abstracts subsequently published by ophthalmic subspecialties, ranging from 28.3% (oculoplastics: 95% CI, 17.2%-42.9%) to 42.7% (glaucoma: 95% CI, 34.7%-51.0%). Oral presentation (risk ratio, 1.45; 95% CI, 1.20-1.76) and basic science (risk ratio, 1.25; 95% CI, 1.05-1.47) were significantly associated with higher full publication; factors not significantly associated with full publication included positive results, randomized clinical trial vs other study design, multicenter study, and industry funding.

Conclusion And Relevance: More than 60% of abstracts presented at eye and vision conferences were not published in full within 2 years of conference presentation. Failure to disseminate research studies in peer-reviewed journals is not desired, especially when involving human participants.
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http://dx.doi.org/10.1001/jamaophthalmol.2020.1264DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7193525PMC
April 2020

Generating comparative evidence on new drugs and devices after approval.

Lancet 2020 03;395(10228):998-1010

Department of Health Policy, London School of Economics and Political Science, London, UK.

Certain limitations of evidence available on drugs and devices at the time of market approval often persist in the post-marketing period. Often, post-marketing research landscape is fragmented. When regulatory agencies require pharmaceutical and device manufacturers to conduct studies in the post-marketing period, these studies might remain incomplete many years after approval. Even when completed, many post-marketing studies lack meaningful active comparators, have observational designs, and might not collect patient-relevant outcomes. Regulators, in collaboration with the industry and patients, ought to ensure that the key questions unanswered at the time of drug and device approval are resolved in a timely fashion during the post-marketing phase. We propose a set of seven key guiding principles that we believe will provide the necessary incentives for pharmaceutical and device manufacturers to generate comparative data in the post-marketing period. First, regulators (for drugs and devices), notified bodies (for devices in Europe), health technology assessment organisations, and payers should develop customised evidence generation plans, ensuring that future post-approval studies address any limitations of the data available at the time of market entry impacting the benefit-risk profiles of drugs and devices. Second, post-marketing studies should be designed hierarchically: priority should be given to efforts aimed at evaluating a product's net clinical benefit in randomised trials compared with current known effective therapy, whenever possible, to address common decisional dilemmas. Third, post-marketing studies should incorporate active comparators as appropriate. Fourth, use of non-randomised studies for the evaluation of clinical benefit in the post-marketing period should be limited to instances when the magnitude of effect is deemed to be large or when it is possible to reasonably infer the comparative benefits or risks in settings, in which doing a randomised trial is not feasible. Fifth, efficiency of randomised trials should be improved by streamlining patient recruitment and data collection through innovative design elements. Sixth, governments should directly support and facilitate the production of comparative post-marketing data by investing in the development of collaborative research networks and data systems that reduce the complexity, cost, and waste of rigorous post-marketing research efforts. Last, financial incentives and penalties should be developed or more actively reinforced.
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http://dx.doi.org/10.1016/S0140-6736(19)33177-0DOI Listing
March 2020

Synthesis of Triarylmethanes by Decarbonylation of 3,3-Diaryl Benzofuranones.

J Org Chem 2020 04 1;85(8):5300-5311. Epub 2020 Apr 1.

State Key Laboratory of Chemo/Biosensing and Chemometrics, College of Chemistry and Chemical Engineering, Hunan University, Changsha 410082, P. R. China.

A simple protocol for the synthesis of triarylmethane derivatives with three different (hetero)aryl groups by decarbonylation of 3,3-diaryl benzofuranones, which can easily be prepared via arylation of benzofuranones, was developed. The reaction proceeds on heating in dimethylformamide (DMF) in the presence of CHONa and water to generate the products in good to excellent yields. This reaction can be easily scaled up to give a triarylmethane in a gram scale. Further chemical manipulation of the products enabled useful transformations of the phenol ring, including reduction, arylation, cyclization, etc.
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http://dx.doi.org/10.1021/acs.joc.9b03433DOI Listing
April 2020

Telerehabilitation for people with low vision.

Cochrane Database Syst Rev 2020 02 27;2:CD011019. Epub 2020 Feb 27.

Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology, 615 North Wolfe Street, E6011, Baltimore, Maryland, USA, 21205.

Background: Low vision affects over 300 million people worldwide and can compromise both activities of daily living and quality of life. Rehabilitative training and vision assistive equipment (VAE) may help, but some visually impaired people have limited resources to attend in-person visits at rehabilitation clinics to receive training to learn to use VAE. These people may be able to overcome barriers to care through remote, Internet-based consultation (i.e. telerehabilitation).

Objectives: To compare the effects of telerehabilitation with face-to-face (e.g. in-office or inpatient) vision rehabilitation services for improving vision-related quality of life and near reading ability in people with visual function loss due to any ocular condition. Secondary objectives were to evaluate compliance with scheduled rehabilitation sessions, abandonment rates for VAE devices, and patient satisfaction ratings.

Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2019, Issue 6); Ovid MEDLINE; Embase.com; PubMed; ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any language restriction or study design filter in the electronic searches; however, we restricted the searches from 1980 onwards because the Internet was not introduced to the public until 1982. We last searched the electronic databases on 24 June 2019.

Selection Criteria: We planned to include randomized controlled trials (RCTs) or controlled clinical trials (CCTs) in which participants diagnosed with low vision were undergoing low vision rehabilitation using an Internet, web-based technology compared with an approach involving in-person consultations.

Data Collection And Analysis: Two review authors independently screened titles and abstracts and then full-text articles against the eligibility criteria. We planned to have two review authors independently abstract data from the included studies. Any discrepancies were resolved by discussion.

Main Results: We identified two ongoing studies, but did not find any completed RCTs and CCTs that met the inclusion criteria for this review. We did not conduct a quantitative analysis. We discussed review articles on telemedicine for facilitating communication with elderly individuals or for providing remote ophthalmological care.

Authors' Conclusions: We did not find any evidence from RCTs or CCTs on the efficacy of using telerehabilitation for remote delivery of rehabilitation services to individuals with low vision. Given the disease burden and the growing interest in telemedicine, the two ongoing studies, when completed, may provide evidence in understanding the potential for telerehabilitation as a platform for providing services to people with low vision.
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http://dx.doi.org/10.1002/14651858.CD011019.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7043933PMC
February 2020

Cumulative network meta-analyses, practice guidelines, and actual prescriptions for postmenopausal osteoporosis: a meta-epidemiological study.

Arch Osteoporos 2020 02 23;15(1):21. Epub 2020 Feb 23.

Department of Health Promotion and Human Behavior, School of Public Health in the Graduate School of Medicine, Kyoto University, Yoshida Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan.

We compared the cumulative network meta-analyses with the recommendations in postmenopausal osteoporosis practice guidelines and actual prescribing practices in the USA. There was no apparent discrepancy between guideline recommendations and drug prescribing rankings, with the exception of vitamin D and calcium, when we used cumulative NMAs as references.

Purpose: To compare the results of cumulative network meta-analyses (NMAs) with the recommendations in postmenopausal osteoporosis practice guidelines and actual prescribing practices in the USA.

Methods: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science, and Scopus were searched to retrieve randomized controlled trials (RCTs) in July 2017. The Agency for Healthcare Research and Quality's National Guideline Clearinghouse and associated society websites were searched to retrieve guidelines in June 2018. We used the Medical Expenditure Panel Survey (MEPS) to analyze prescription data from 1996 to 2015. Two independent investigators selected eligible RCTs. One investigator selected potential eligible guidelines, which were confirmed by another investigator. Two independent investigators extracted data from included RCTs. One investigator extracted recommendations from guidelines, which were confirmed by another investigator. (Registration: UMIN000031894) RESULTS: We analyzed data from 1995, 2000, 2005, 2010, and 2015. We chose hip fracture as the primary outcome of cumulative NMAs. We included 51 trials, 17 guidelines, and 5099 postmenopausal osteoporosis patients from the MEPS. Bisphosphonate, including alendronate, and combination of vitamin D and calcium (vDCa) were consistently recommendable from an efficacy viewpoint in NMAs and recommended in guidelines. Alendronate was the most prescribed drug (more than 30% over the observation period); however, vDCa was seldom prescribed. The maximum proportion was 5.3% from 2011 to 2015.

Conclusions: In postmenopausal osteoporosis, there was no apparent discrepancy between guideline recommendations and drug prescribing rankings, with the exception of vDCa, when we used cumulative NMAs as references.
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http://dx.doi.org/10.1007/s11657-020-0697-8DOI Listing
February 2020

Acupuncture for glaucoma.

Cochrane Database Syst Rev 2020 02 7;2:CD006030. Epub 2020 Feb 7.

Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology, Baltimore, Maryland, USA.

Background: Glaucoma is a multi-factorial optic neuropathy characterized by an acquired loss of retinal ganglion cells at levels beyond normal age-related loss and corresponding atrophy of the optic nerve. Although many treatments are available to manage glaucoma, patients may seek complementary or alternative medicine approaches such as acupuncture to supplement their regular treatment. The underlying plausibility of acupuncture is that disorders related to the flow of Chi (traditional Chinese concept of vital force or energy) can be managed by stimulating relevant points on the body surface.

Objectives: To assess the effectiveness and safety of acupuncture compared with other treatments, no treatment, or placebo in patients with glaucoma.

Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Eyes and Vision Trials Register (2018, Issue 11); Ovid MEDLINE; Embase.com; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); the Allied and Complementary Medicine Database (AMED); PubMed; Latin American and Caribbean Literature on Health Sciences (LILACS); ZETOC; the metaRegister of Controlled Trials (mRCT); ClinicalTrials.gov; the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP); and the National Center for Complementary and Alternative Medicine (NCCAM) website. We did not use any language or date restrictions in the search for trials. We last searched electronic databases on November 16, 2018, with the exception of NCCAM, which we last searched on July 14, 2010, and the metaRegister of Controlled Trials (mRCT), which we last searched on January 8, 2013. We handsearched Chinese medical journals at Peking Union Medical College Library in April 2007. We searched the Chinese Acupuncture Trials Register, the Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS), the Chinese Biological Database (CBM), and the China National Knowledge Infrastructure (CNKI). We last searched Chinese electronic databases on November 19, 2018.

Selection Criteria: We included randomized controlled trials (RCTs) in which one arm involved acupuncture treatment.

Data Collection And Analysis: Two review authors independently screened results, then extracted the data and assessed risk of bias for eligible trials.

Main Results: We included three completed trials and one ongoing trial in the 2019 update of this review. The three completed trials, conducted in Taiwan and the United States, included participants with glaucoma or intraocular hypertension. The interventions investigated varied across trials. One trial compared auricular acupressure-a non-standard acupuncture technique-with the sham procedure in 33 patients. Another trial compared transcutaneous electrical nerve stimulation (TENS) with a sham procedure in 82 patients. The third trial compared 12 sessions of acupuncture on eye-points versus on non-eye-points in 22 patients. All three trials were rated at high risk of bias for at least one domain. The certainty of evidence across all outcomes was very low due to high risk of bias in at least one contributing study; substantial clinical heterogeneity and methodological heterogeneity; and imprecision of results. One trial reported change in the visual field from baseline without any between-group comparison. Because of the quantity of missing data (50%), we did not calculate a between-group comparison, as the quantitative results are difficult to interpret. All three trials reported data for estimation of reduction of intraocular pressure (IOP). However, time points of IOP measurement varied. For the trial comparing acupressure to a sham procedure, the difference in IOP reduction (measured in mm Hg) is estimated to be -3.70 (95% confidence interval [CI] -7.11 to -0.29) for the right eye and -4.90 (95% CI -8.08 to -1.72) for the left eye at four weeks, and -1.30 mm Hg (95% CI -4.78 to 2.18) for the right eye and -2.30 mm Hg (95% CI -5.73 to 1.13) for the left eye at eight weeks. For the trial comparing TENS to sham treatment, the difference reduction is estimated to be -2.81 (95% CI -3.8 to -1.84) for the right eye and -2.58 (95% CI -3.36 to -1.80) for the left eye immediately after treatment, -2.93 (95% CI -3.72 to -2.13) for the right eye and -3.56 (95% CI -4.35 to 2.78) for the left eye 30 minutes after treatment, and finally -3.61 (95% CI -4.47 to -2.75) for the right eye and -3.61 (95% -4.47 to -2.74) for the left eye. For the trial that compared acupuncture on eye-points versus non-eye-points, 11 out of 22 (50%) participants did not complete the treatment. One trial reported data for estimation of visual acuity. When acupressure is compared to sham treatment, the difference in uncorrected visual acuity (UCVA, measured in logMAR) is estimated to be -0.01 (95% CI -0.24 to 0.22) for the right eye and -0.04 (95% CI -0.27 to 0.19) for the left eye at four months, and -0.03 logMAR (95% CI -0.27 to 0.21) for the right eye and -0.16 logMAR (95% CI -0.43 to 0.11) for the left eye at eight months. The difference in best corrected visual acuity (BCVA) is estimated to be 0.10 (95% CI -0.06 to 0.26) for the right eye and 0 (95% CI -0.14 to 0.14) for the left eye at four months, and -0.04 logMAR (95% CI -0.09 to 0.17) for the right eye and -0.04 logMAR (95% CI -0.18 to 0.10) for the left eye at eight months. One trial reported progression of optic disc damage or nerve fiber layer loss without any between-group comparison. Because of the quantity of missing data (50%), we did not calculate a between-group comparison, as the quantitative results are difficult to interpret. One trial reported adverse events in two patients (out of 22) who experienced needle sensitivity. However, the study did not report between-group comparisons. Because of the quantity of missing data (50%), we did not calculate a between-group comparison, as the quantitative results are difficult to interpret.

Authors' Conclusions: At this time, it is impossible to draw reliable conclusions from available data to support the use of acupuncture for treatment of patients with glaucoma. Because of ethical considerations, RCTs comparing acupuncture alone with standard glaucoma treatment or placebo are unlikely to be justified in countries where the standard of care has already been established.
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http://dx.doi.org/10.1002/14651858.CD006030.pub4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7006956PMC
February 2020

Adjudication rather than experience of data abstraction matters more in reducing errors in abstracting data in systematic reviews.

Res Synth Methods 2020 May 10;11(3):354-362. Epub 2020 Feb 10.

Department of Ophthalmology, School of Medicine, University of Colorado Denver, Aurora, Colorado.

Background: During systematic reviews, "data abstraction" refers to the process of collecting data from reports of studies. The data abstractors' level of experience may affect the accuracy of data abstracted. Using data from a randomized crossover trial in which different data abstraction approaches were compared, we examined the association between abstractors' level of experience and accuracy of data abstraction.

Methods: We classified abstractors as "more experienced" if they had authored three or more published systematic reviews, and "less experienced" otherwise. Each abstractor abstracted data related to study design, baseline characteristics, and outcomes/results from six articles. We considered two types of errors: incorrect abstraction and errors of omission. We estimated the proportion of errors by level of experience using a binomial generalized linear mixed model.

Results: We used data from 25 less experienced and 25 more experienced data abstractors. Overall error proportions were similar for less experienced abstractors (21%) and more experienced abstractors (19%). Compared with less experienced abstractors, more experienced abstractors had a lower odds of errors for data items related to outcomes/results (adjusted odds ratio [OR] = 0.53; 95% CI, 0.34-0.82) and potentially for data items related to study design (adjusted OR = 0.83; 95% CI, 0.64-1.09) but a potentially higher odds of errors for items related to baseline characteristics (adjusted OR = 1.42; 95% CI, 0.97-2.06).

Conclusion: Experience of data abstraction matters little. Errors are reduced by adjudication but still remain high for data items related to outcomes/results.
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http://dx.doi.org/10.1002/jrsm.1396DOI Listing
May 2020

Diagnosis of double-chambered left ventricle by echocardiogram and cardiac magnetic resonance imaging: A rare case in an adult.

Echocardiography 2020 02 19;37(2):368-369. Epub 2020 Jan 19.

Department of Ultrasound, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.

Double-chambered left ventricle (DCLV) is a very rare malformation which is congenital. In most cases, the left ventricle (LV) is divided into two parallel chambers by a septum or aberrant muscular structure, with fewer superior-inferior arrangement. Here, we present the case of an asymptomatic 25-year-old man who was diagnosed with superior-inferior arrangement DCLV on transthoracic echocardiography and cardiac magnetic resonance (CMR). DCLV generally does not cause serious outcomes. Owing to absence of any symptoms, no treatment was provided, and the patient was regularly followed up.
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http://dx.doi.org/10.1111/echo.14590DOI Listing
February 2020