Economic Impact of Insufficient and Disturbed Sleep in the Workplace.

OBJECTIVE: Insufficient and disturbed sleep are associated with significant morbidity among working-age adults. Poor sleep results in negative health outcomes and increases economic costs to employers. The current systematic review surveyed the peer-reviewed scientific literature and aggregated scientific evidence of sleep-related economic burdens borne by employers. METHODS: A systematic review was performed to identify peer-reviewed, English language studies evaluating the economic impact of insufficient and disturbed sleep among adult employee populations. An exhaustive literature search was performed using keywords related to sleep, economics, and the workplace. Included were scientific studies (randomized controlled trials, cohort and case control studies, cross-sectional and longitudinal studies) examining specific employee populations with relevant sleep and economic outcomes. Each included study was evaluated for risk of bias and relevant data was extracted and summarized. RESULTS: Sleep problems among employee populations are associated with worsened workplace outcomes, such as presenteeism, absenteeism, and accidents. Sleep problems also increased costs to employers, ranging from US$322 to US$1967 per employee. Interventions to improve sleep, such as the use of blue-light filtering glasses, strategic shift scheduling, and targeted interventions to treat insomnia, may improve workplace outcomes and reduce costs. CONCLUSIONS: This review synthesizes the existing data regarding the negative impacts of insufficient and disturbed sleep on the workplace, suggesting that employers have an economic stake in their employees' sleep. TRIAL REGISTRATION: PROSPERO: CRD42021224212.

Blood pressure control for diabetic retinopathy.

BACKGROUND: Diabetic retinopathy is a common complication of diabetes and a leading cause of visual impairment and blindness. Research has established the importance of blood glucose control to prevent development and progression of the ocular complications of diabetes. Concurrent blood pressure control has been advocated for this purpose, but individual studies have reported varying conclusions regarding the effects of this intervention. OBJECTIVES: To summarize the existing evidence regarding the effect of interventions to control blood pressure levels among diabetics on incidence and progression of diabetic retinopathy, preservation of visual acuity, adverse events, quality of life, and costs. SEARCH METHODS: We searched several electronic databases, including CENTRAL, and trial registries. We last searched the electronic databases on 3 September 2021. We also reviewed the reference lists of review articles and trial reports selected for inclusion. SELECTION CRITERIA: We included randomized controlled trials (RCTs) in which either type 1 or type 2 diabetic participants, with or without hypertension, were assigned randomly to more intense versus less intense blood pressure control; to blood pressure control versus usual care or no intervention on blood pressure (placebo); or to one class of antihypertensive medication versus another or placebo. DATA COLLECTION AND ANALYSIS: Pairs of review authors independently reviewed the titles and abstracts of records identified by the electronic and manual searches and the full-text reports of any records identified as potentially relevant. The included trials were independently assessed for risk of bias with respect to outcomes reported in this review. MAIN RESULTS: We included 29 RCTs conducted in North America, Europe, Australia, Asia, Africa, and the Middle East that had enrolled a total of 4620 type 1 and 22,565 type 2 diabetic participants (sample sizes from 16 to 4477 participants). In all 7 RCTs for normotensive type 1 diabetic participants, 8 of 12 RCTs with normotensive type 2 diabetic participants, and 5 of 10 RCTs with hypertensive type 2 diabetic participants, one group was assigned to one or more antihypertensive agents and the control group to placebo. In the remaining 4 RCTs for normotensive participants with type 2 diabetes and 5 RCTs for hypertensive type 2 diabetic participants, methods of intense blood pressure control were compared to usual care. Eight trials were sponsored entirely and 10 trials partially by pharmaceutical companies; nine studies received support from other sources; and two studies did not report funding source. Study designs, populations, interventions, lengths of follow-up (range less than one year to nine years), and blood pressure targets varied among the included trials. For primary review outcomes after five years of treatment and follow-up, one of the seven trials for type 1 diabetics reported incidence of retinopathy and one trial reported progression of retinopathy; one trial reported a combined outcome of incidence and progression (as defined by study authors). Among normotensive type 2 diabetics, four of 12 trials reported incidence of diabetic retinopathy and two trials reported progression of retinopathy; two trials reported combined incidence and progression. Among hypertensive type 2 diabetics, six of the 10 trials reported incidence of diabetic retinopathy and two trials reported progression of retinopathy; five of the 10 trials reported combined incidence and progression. The evidence supports an overall benefit of more intensive blood pressure intervention for five-year incidence of diabetic retinopathy (11 studies; 4940 participants; risk ratio (RR) 0.82, 95% confidence interval (CI) 0.73 to 0.92; I2 = 15%; moderate certainty evidence) and the combined outcome of incidence and progression (8 studies; 6212 participants; RR 0.78, 95% CI 0.68 to 0.89; I2 = 42%; low certainty evidence). The available evidence did not support a benefit regarding five-year progression of diabetic retinopathy (5 studies; 5144 participants; RR 0.94, 95% CI 0.78 to 1.12; I2 = 57%; moderate certainty evidence), incidence of proliferative diabetic retinopathy, clinically significant macular edema, or vitreous hemorrhage (9 studies; 8237 participants; RR 0.92, 95% CI 0.82 to 1.04; I2 = 31%; low certainty evidence), or loss of 3 or more lines on a visual acuity chart with a logMAR scale (2 studies; 2326 participants; RR 1.15, 95% CI 0.63 to 2.08; I2 = 90%; very low certainty evidence). Hypertensive type 2 diabetic participants realized more benefit from intense blood pressure control for three of the four outcomes concerning incidence and progression of diabetic retinopathy. The adverse event reported most often (13 of 29 trials) was death, yielding an estimated RR 0.87 (95% CI 0.76 to 1.00; 13 studies; 13,979 participants; I2 = 0%; moderate certainty evidence). Hypotension was reported in two trials, with an RR of 2.04 (95% CI 1.63 to 2.55; 2 studies; 3323 participants; I2 = 37%; low certainty evidence), indicating an excess of hypotensive events among participants assigned to more intervention on blood pressure. AUTHORS' CONCLUSIONS: Hypertension is a well-known risk factor for several chronic conditions for which lowering blood pressure has proven to be beneficial. The available evidence supports a modest beneficial effect of intervention to reduce blood pressure with respect to preventing diabetic retinopathy for up to five years, particularly for hypertensive type 2 diabetics. However, there was a paucity of evidence to support such intervention to slow progression of diabetic retinopathy or to affect other outcomes considered in this review among normotensive diabetics. This weakens any conclusion regarding an overall benefit of intervening on blood pressure in diabetic patients without hypertension for the sole purpose of preventing diabetic retinopathy or avoiding the need for treatment for advanced stages of diabetic retinopathy.

Tocilizumab for giant cell arteritis.

BACKGROUND: Giant cell arteritis (GCA) is the most common form of systemic vasculitis in people older than 50 years of age. It causes granulomatous inflammation of medium- to large-sized vessels. Tocilizumab is a recombinant monoclonal antibody directed against interleukin-6 receptors (IL-6R). OBJECTIVES: To assess the effectiveness and safety of tocilizumab, given alone or with corticosteroids, compared with therapy without tocilizumab for treatment of GCA. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2020, Issue 1); Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Health Science Information database (LILACS); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). There were no date or language restrictions in the electronic search for trials. We last searched the electronic databases on 3 January 2020. SELECTION CRITERIA: We included only randomized controlled trials (RCTs) that compared tocilizumab of any dosage regimen (alone or with corticosteroids) with therapy without tocilizumab that had a minimum follow-up of six months. Participants were at least 50 years of age, with biopsy-proven GCA or by large-vessel vasculitis by angiography, and met the American College of Rheumatology 1990 guidelines for GCA. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodology. MAIN RESULTS: Main results We included two RCTs in the review. The studies were conducted in the USA, Canada, and Europe and enrolled a total of 281 participants with GCA, of whom 74% were women. The mean age of participants was 70 years, with new-onset or relapsing GCA, and fulfilled the 1990 American College of Rheumatology criteria with no uncontrolled comorbidities. Both studies were funded by F. Hoffmann-La Roche AG, the manufacturer of tocilizumab. Findings One RCT (30 participants) compared tocilizumab administered every four weeks versus placebo. Point estimates at 12 months and beyond favored tocilizumab over placebo in terms of sustained remission (risk ratio (RR) 4.25, 95% confidence interval (CI) 1.21 to 14.88; moderate-certainty evidence). Point estimates suggest no evidence of a difference for all-cause mortality at 12 months or more (RR 0.17, 95% CI 0.01 to 3.94; moderate-certainty evidence). At 12 months, mean time to first relapse after induction of remission was 25 weeks in favor of participants receiving tocilizumab compared to placebo (mean difference (MD) 25, 95% CI 11.4 to 38.6; moderate-certainty evidence). The second RCT (250 participants) randomized participants into two intervention and two comparator groups to receive tocilizumab weekly (100 participants), bi-weekly (49 participants), weekly placebo + 26-week taper (50 participants), or weekly placebo + 52-week taper (51 participants). At 12 months, point estimates from this study on proportion of participants with sustained remission favored participants who received tocilizumab weekly versus placebo + 52-week taper (RR 3.17, 95% CI 1.71 to 5.89; 151 participants); tocilizumab weekly versus placebo + 26-week taper (RR 4.00, 95% CI 1.97 to 8.12; 150 participants); tocilizumab every other week versus placebo + 52-week taper (RR 3.01, 95% CI 1.57 to 5.75; 100 participants); tocilizumab every other week versus placebo + 26-week taper (RR 3.79, 95% CI 1.82 to 7.91; 99 participants) (moderate-certainty evidence). Point estimates on proportion of participants who did not need escape therapy (defined by the study as the inability to keep to the protocol-defined prednisone taper) favored participants who received tocilizumab weekly versus placebo + 52-week taper (RR 1.71, 95% CI 1.24 to 2.35; 151 participants); tocilizumab weekly versus placebo + 26-week taper (RR 2.96, 95% CI 1.83 to 4.78; 150 participants); tocilizumab every other week versus placebo + 52-week taper (RR 1.49, 95% CI 1.04 to 2.14; 100 participants) but not tocilizumab every other week versus placebo + 26-week taper (RR 0.65, 95% CI 0.27 to 1.54; 99 participants) (moderate-certainty evidence). This study did not report mean time to first relapse after induction of remission or all-cause mortality.  Across comparison groups, the same study found no evidence of a difference  in vision changes and inconsistent evidence with regard to quality of life. Evidence on quality of life as assessed by the physical (MD 8.17, 95% CI 4.44 to 11.90) and mental (MD 5.61, 95% CI 0.06 to 11.16) component score of the 36-Item Short Form Health Survey (SF-36) favored weekly tocilizumab versus placebo + 52-week taper but not bi-weekly tocillizumab versus placebo + 26-week taper (moderate-certainty evidence). Adverse events One RCT reported a lower percentage of participants who experienced serious adverse events when receiving tocilizumab every four weeks versus placebo. The second RCT reported no evidence of a difference among groups with regard to adverse events; however, fewer participants reported serious adverse events in the tocilizumab weekly and tocilizumab biweekly interventions compared with the placebo + 26-week taper and placebo + 52-week taper comparators. Investigators in both studies reported that infection was the most frequently reported adverse event. AUTHORS' CONCLUSIONS: This review indicates that tocilizumab therapy may be beneficial in terms of proportion of participants with sustained remission, relapse-free survival, and the need for escape therapy. While the evidence was of moderate certainty, only two studies were included in the review, suggesting that further research is required to corroborate these findings. Future trials should address issues related to the required duration of therapy, patient-reported outcomes such as quality of life and economic outcomes, as well as the clinical outcomes evaluated in this review.

Tocilizumab for giant cell arteritis.

BACKGROUND: Giant cell arteritis (GCA) is the most common form of systemic vasculitis in people older than 50 years of age. It causes granulomatous inflammation of medium- to large-sized vessels. Tocilizumab is a recombinant monoclonal antibody directed against interleukin-6 receptors (IL-6R). OBJECTIVES: To assess the effectiveness and safety of tocilizumab, given alone or with corticosteroids, compared with therapy without tocilizumab for treatment of GCA. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2020, Issue 1); Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Health Science Information database (LILACS); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). There were no date or language restrictions in the electronic search for trials. We last searched the electronic databases on 3 January 2020. SELECTION CRITERIA: We included only randomized controlled trials (RCTs) that compared tocilizumab of any dosage regimen (alone or with corticosteroids) with therapy without tocilizumab that had a minimum follow-up of six months. Participants were at least 50 years of age, with biopsy-proven GCA or by large-vessel vasculitis by angiography, and met the American College of Rheumatology 1990 guidelines for GCA. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodology. MAIN RESULTS: Main results We included two RCTs in the review. The studies were conducted in the USA, Canada, and Europe and enrolled a total of 281 participants with GCA, of whom 74% were women. The mean age of participants was 70 years, with new-onset or relapsing GCA, and fulfilled the 1990 American College of Rheumatology criteria with no uncontrolled comorbidities. Both studies were funded by F. Hoffmann-La Roche AG, the manufacturer of tocilizumab. Findings One RCT (30 participants) compared tocilizumab administered every four weeks versus placebo. Point estimates at 12 months and beyond favored tocilizumab over placebo in terms of sustained remission (risk ratio (RR) 4.25, 95% confidence interval (CI) 1.21 to 14.88; moderate-certainty evidence). Point estimates suggest no evidence of a difference for all-cause mortality at 12 months or more (RR 0.17, 95% CI 0.01 to 3.94; moderate-certainty evidence). At 12 months, mean time to first relapse after induction of remission was 25 weeks in favor of participants receiving tocilizumab compared to placebo (mean difference (MD) 25, 95% CI 11.4 to 38.6; moderate-certainty evidence). The second RCT (251 participants) randomized participants into two intervention and two comparator groups to receive tocilizumab weekly (100 participants), bi-weekly (49 participants), weekly placebo + 26-week taper (50 participants), or weekly placebo + 52-week taper (51 participants). At 12 months, point estimates from this study on proportion of participants with sustained remission favored participants who received tocilizumab weekly versus placebo + 52-week taper (RR 3.17, 95% CI 1.71 to 5.89; 151 participants); tocilizumab weekly versus placebo + 26-week taper (RR 4.00, 95% CI 1.97 to 8.12; 150 participants); tocilizumab every other week versus placebo + 52-week taper (RR 3.01, 95% CI 1.57 to 5.75; 100 participants); tocilizumab every other week versus placebo + 26-week taper (RR 3.79, 95% CI 1.82 to 7.91; 99 participants) (moderate-certainty evidence). Point estimates on proportion of participants who did not need escape therapy (defined by the study as the inability to keep to the protocol-defined prednisone taper) favored participants who received tocilizumab weekly versus placebo + 52-week taper (RR 1.71, 95% CI 1.24 to 2.35; 151 participants); tocilizumab weekly versus placebo + 26-week taper (RR 2.96, 95% CI 1.83 to 4.78; 150 participants); tocilizumab every other week versus placebo + 52-week taper (RR 1.49, 95% CI 1.04 to 2.14; 100 participants); tocilizumab every other week versus placebo + 26-week taper (RR 0.65, 95% CI 0.27 to 1.54; 99 participants) (moderate-certainty evidence). This study did not report mean time to first relapse after induction of remission or all-cause mortality. The same study found no evidence of a difference between groups with regard to vision changes and quality of life, except for the assessment of quality of life with the physical component score of the 36-Item Short Form Health Survey (SF-36), which favored weekly tocilizumab versus placebo + 52-week taper (MD 8.17, 95% CI 4.44 to 11.90; moderate-certainty evidence). Adverse events One RCT reported a lower percentage of participants who experienced serious adverse events when receiving tocilizumab every four weeks versus placebo. The second RCT reported no evidence of a difference among groups with regard to adverse events; however, fewer participants reported serious adverse events in the tocilizumab weekly and tocilizumab biweekly interventions compared with the placebo + 26-week taper and placebo + 52-week taper comparators. Investigators in both studies reported that infection was the most frequently reported adverse event. AUTHORS' CONCLUSIONS: This review indicates that tocilizumab therapy may be beneficial in terms of proportion of participants with sustained remission, relapse-free survival, and the need for escape therapy. While the evidence was of moderate certainty, only two studies were included in the review, suggesting that further research is required to corroborate these findings. Future trials should address issues related to the required duration of therapy, patient-reported outcomes such as quality of life and economic outcomes, as well as the clinical outcomes evaluated in this review.

Pharmacologic interventions for mydriasis in cataract surgery.

BACKGROUND: Cataract surgery is one of the most common surgical procedures performed worldwide. Achieving appropriate intraoperative mydriasis is one of the critical factors associated with the safety and performance of the surgery. Inadequate pupillary dilation or constriction of the pupil during cataract surgery can impair the surgeon's field of view and make it difficult to maneuver instruments. OBJECTIVES: To evaluate the relative effectiveness of achieving pupillary dilation during phacoemulsification for cataract extraction using three methods of pupillary dilation: topical mydriatics, intracameral mydriatics, or depot delivery systems. We also planned to document and compare the risk of intraoperative and postoperative complications following phacoemulsification for cataract extraction, as well as the cost-effectiveness of these methods for pupillary dilation. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Eyes and Vision Trials Register) (2021, Issue 1); Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Health Sciences Literature Database (LILACS); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 22 January 2021. SELECTION CRITERIA: We included only randomized controlled trial (RCTs) in which participants underwent phacoemulsification for cataract extraction. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methodology. MAIN RESULTS: We included a total of 14 RCTs (1670 eyes of 1652 participants) in this review. Of the 14 trials, 7 compared topical versus intracameral mydriatics, 6 compared topical mydriatics versus depot delivery systems, and 1 compared all three methods. We were unable to calculate overall estimates of comparative effectiveness for most outcomes due to statistical heterogeneity among the estimates from individual studies or because outcome data were available from only a single study. Furthermore, the certainty of evidence for most outcomes was low or very low, due primarily to imprecision and risk of bias. Comparison 1: topical mydriatics versus intracameral mydriatics Four RCTs (739 participants, 757 eyes) of the 8 RCTs that had compared these two methods reported mean pupillary diameters at the time surgeons had performed capsulorhexis; all favored topical mydriatics, but heterogeneity was high (I2 = 95%). After omitting 1 RCT that used a paired-eyes design, evidence from three RCTs (721 participants and eyes) suggests that mean pupil diameter at the time of capsulorhexis may be greater with topical mydriatics than with intracameral mydriatics, but the evidence is of low certainty (mean difference 1.06 mm, 95% confidence interval (CI) 0.81 mm to 1.31 mm; I2 = 49%). Four RCTs (224 participants, 242 eyes) reported mean pupillary diameter at the beginning of cataract surgery; the effect estimates from all trials favored topical mydriatics, with very low-certainty evidence. Five RCTs (799 participants, 817 eyes) reported mean pupillary diameter at the end of cataract surgery. Data for this outcome from the largest RCT (549 participants and eyes) provided evidence of a small difference in favor of intracameral mydriasis. On the other hand, 2 small RCTs (78 participants, 96 eyes) favored topical mydriatics, and the remaining 2 RCTs (172 participants) found no meaningful difference between the two methods, with very low-certainty evidence. Five RCTs (799 participants, 817 eyes) reported total intraoperative surgical time. The largest RCT (549 participants and eyes) reported decreased total intraoperative time with intracameral mydriatics, whereas 1 RCT (18 participants, 36 eyes) favored topical mydriatics, and the remaining 3 RCTs (232 participants) found no difference between the two methods, with very low-certainty evidence. Comparison 2: topical mydriatics versus depot delivery systems Of the 7 RCTs that compared these two methods, none reported mean pupillary diameter at the time surgeons performed capsulorhexis. Six RCTs (434 participants) reported mean pupillary diameter at the beginning of cataract surgery. After omitting 1 RCT suspected to be responsible for high heterogeneity (I2 = 80%), meta-analysis of the other 5 RCTs (324 participants and eyes) found no evidence of a meaningful difference between the two methods, with very low-certainty evidence. Three RCTs (210 participants) reported mean pupillary diameter at the end of cataract surgery, with high heterogeneity among effect estimates for this outcome. Estimates of mean differences and confidence intervals from these three RCTs were consistent with no difference between the two methods. A fourth RCT reported only means for this outcome, with low-certainty evidence. Two small RCTs (118 participants) reported total intraoperative time. Surgical times were lower when depot delivery was used, but the confidence interval estimated from one trial was consistent with no difference, and only mean times were reported from the other trial, with very low-certainty evidence. Comparison 3: Intracameral mydriatics versus depot delivery systems Only one RCT (60 participants) compared intracameral mydriatics versus depot delivery system. Mean pupillary diameter at the time the surgeon performed capsulorhexis, phacoemulsification time, and cost outcomes were not reported. Mean pupil diameter at the beginning and end of cataract surgery favored the depot delivery system, with very low-certainty evidence. Adverse events Evidence from one RCT (555 participants and eyes) comparing topical mydriatics versus intracameral mydriatics suggests that ocular discomfort may be greater with topical mydriatics than with intracameral mydriatics at one week (risk ratio (RR) 10.57, 95% CI 1.37 to 81.34) and one month (RR 2.51, 95% CI 1.36 to 4.65) after cataract surgery, with moderate-certainty evidence at both time points. Another RCT (30 participants) reported iris-related complications in 11 participants in the intracameral mydriatics group versus no complications in the depot delivery system group, with very low-certainty evidence. Cardiovascular related adverse events were rarely mentioned. AUTHORS' CONCLUSIONS: Data from 14 completed RCTs were inadequate to establish the superiority of any of three methods to achieve mydriasis for cataract surgery, based on pupillary dilation at different times during the surgery or on time required for surgery. Only one trial had a sample size adequate to yield a robust effect estimate. Larger, well-designed trials are needed to provide robust estimates for the comparison of mydriasis approaches for beneficial and adverse effects.

Wavefront excimer laser refractive surgery for adults with refractive errors.

BACKGROUND: Refractive errors (conditions in which the eye fails to focus objects accurately on the retina due to defects in the refractive system), are the most common cause of visual impairment. Myopia, hyperopia, and astigmatism are low-order aberrations, usually corrected with spectacles, contact lenses, or conventional refractive surgery. Higher-order aberrations (HOAs) can be quantified with wavefront aberration instruments and corrected using wavefront-guided or wavefront-optimized laser surgery. Wavefront-guided ablations are based on preoperative measurements of HOAs; wavefront-optimized ablations are designed to minimize induction of new HOAs while preserving naturally occurring aberrations. Two wavefront procedures are expected to produce better visual acuity than conventional procedures. OBJECTIVES: The primary objective was to compare effectiveness and safety of wavefront procedures, laser-assisted in-situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) or laser epithelial keratomileusis (LASEK) versus corresponding conventional procedures, for correcting refractive errors in adults for postoperative uncorrected visual acuity, residual refractive errors, and residual HOAs. The secondary objective was to compare two wavefront procedures. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, which contains the Cochrane Eyes and Vision Trials Register; 2019, Issue 8); Ovid MEDLINE; Ovid Embase; Latin American and Caribbean Health Sciences (LILACS); the ISRCTN registry; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 6 August 2019. We imposed no restrictions by language or year of publication. We used the Science Citation Index (September 2013) and searched the reference lists of included trials to identify additional relevant trials. SELECTION CRITERIA: We included randomized controlled trials (RCTs) comparing either wavefront modified with conventional refractive surgery or wavefront-optimized with wavefront-guided refractive surgery in participants aged ⪰ 18 years with refractive errors. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodology. MAIN RESULTS: We identified 33 RCTs conducted in Asia, Europe and United States, totaling 1499 participants (2797 eyes). Participants had refractive errors ranging from high myopia to low hyperopia. Studies reported at least one of the following review-specific outcomes based on proportions of eyes: with uncorrected visual acuity (UCVA) of 20/20 or better, without loss of one or more lines of best spectacle-corrected visual acuity (BSCVA), within ± 0.50 diopters (D) of target refraction, with HOAs and adverse events. Study characteristics and risk of bias Participants were mostly women, mean age 29 and 53 years, and without previous refractive surgery, ocular pathology or systemic comorbidity. We could not judge risks of bias for most domains of most studies. Most studies in which both eyes of a participant were analyzed failed to account for correlations between two eyes in the analysis and reporting of outcomes. Findings For the primary comparison between wavefront (PRK or LASIK or LASEK) and corresponding conventional procedures, 12-month outcome data were available from only one study of PRK with 70 participants. No evidence of more favorable outcomes of wavefront PRK on proportion of eyes: with UCVA of 20/20 or better (risk ratio [RR] 1.03, 95% confidence interval (CI) 0.86 to 1.24); without loss of one or more lines of BSCVA (RR 0.94, 95% CI 0.81 to 1.09); within ± 0.5 D of target refraction (RR 1.03, 95% CI 0.86 to 1.24); and mean spherical equivalent (mean difference [MD] 0.04, 95% CI -0.11 to 0.18). The evidence for each effect estimate was of low certainty. No study reported HOAs at 12 months. At six months, the findings of two to eight studies showed that overall effect estimates and estimates by subgroup of PRK or LASIK or LASEK were consistent with those for PRK at 12 month, and suggest no difference in all outcomes. The certainty of evidence for each outcome was low. For the comparison between wavefront-optimized and wavefront-guided procedures at 12 months, the overall effect estimates for proportion of eyes: with UCVA of 20/20 or better (RR 1.00, 95% CI 0.99 to 1.02; 5 studies, 618 participants); without loss of one or more lines of BSCVA (RR 0.99, 95% CI 0.96 to 1.02; I2 = 0%; 5 studies, 622 participants); within ± 0.5 diopters of target refraction (RR 1.02, 95% CI 0.95 to 1.09; I2 = 33%; 4 studies, 480 participants) and mean HOAs (MD 0.03, 95% CI -0.01 to 0.07; I2 = 41%; 5 studies, 622 participants) showed no evidence of a difference between the two groups. Owing to substantial heterogeneity, we did not calculate an overall effect estimate for mean spherical equivalent at 12 months, but point estimates consistently suggested no difference between wavefront-optimized PRK versus wavefront-guided PRK. However, wavefront-optimized LASIK compared with wavefront-guided LASIK may improve mean spherical equivalent (MD -0.14 D, 95% CI -0.19 to -0.09; 4 studies, 472 participants). All effect estimates were of low certainty of evidence. At six months, the results were consistent with those at 12 months based on two to six studies. The findings suggest no difference between two wavefront procedures for any of the outcomes assessed, except for the subgroup of wavefront-optimized LASIK which showed probable improvement in mean spherical equivalent (MD -0.12 D, 95% CI -0.19 to -0.05; I2 = 0%; 3 studies, 280 participants; low certainty of evidence) relative to wavefront-guided LASIK. We found a single study comparing wavefront-guided LASIK versus wavefront-guided PRK at six and 12 months. At both time points, effect estimates consistently supported no difference between two procedures. The certain of evidence was very low for all estimates. Adverse events Significant visual loss or optical side effects that were reported were similar between groups. AUTHORS' CONCLUSIONS: This review suggests that at 12 months and six months postoperatively, there was no important difference between wavefront versus conventional refractive surgery or between wavefront-optimized versus wavefront-guided surgery in the clinical outcomes analyzed. The low certainty of the cumulative evidence reported to date suggests that further randomized comparisons of these surgical approaches would provide more precise estimates of effects but are unlikely to modify our conclusions. Future trials may elect to focus on participant-reported outcomes such as satisfaction with vision before and after surgery and effects of remaining visual aberrations, in addition to contrast sensitivity and clinical outcomes analyzed in this review.

Vitamin A and fish oils for preventing the progression of retinitis pigmentosa.

BACKGROUND: Retinitis pigmentosa (RP) comprises a group of hereditary eye diseases characterized by progressive degeneration of retinal photoreceptors. It results in severe visual loss that may lead to blindness. Symptoms may become manifest during childhood or adulthood which include poor night vision (nyctalopia) and constriction of peripheral vision (visual field loss). Visual field loss is progressive and affects central vision later in the disease course. The worldwide prevalence of RP is approximately 1 in 4000, with 100,000 individuals affected in the USA. At this time, there is no proven therapy for RP. OBJECTIVES: The objective of this review was to synthesize the best available evidence regarding the effectiveness and safety of vitamin A and fish oils (docosahexaenoic acid (DHA)) in preventing the progression of RP. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Eyes and Vision Trials Register (2020, Issue 2); Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Health Sciences Literature Database (LILACS); ClinicalTrials.gov; the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP); and OpenGrey. We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 7 February 2020. SELECTION CRITERIA: We included randomized controlled trials that enrolled participants of any age diagnosed with any degree of severity or type of RP, and evaluated the effectiveness of vitamin A, fish oils (DHA), or both compared to placebo, vitamins (other than vitamin A), or no therapy, as a treatment for RP. We excluded cluster-randomized trials and cross-over trials. DATA COLLECTION AND ANALYSIS: We prespecified the following outcomes: mean change from baseline visual field, mean change from baseline electroretinogram (ERG) amplitudes, and anatomic changes as measured by optical coherence tomography (OCT), at one-year follow-up, and mean change in visual acuity, at five-year follow-up. Two review authors independently extracted data and evaluated risk of bias for all included trials. We also contacted study investigators for further information when necessary. MAIN RESULTS: In addition to three trials from the previous version of this review, we included a total of four trials with 944 participants aged 4 to 55 years. Two trials included only participants with X-linked RP and the other two included participants with RP of all forms of genetic predisposition. Two trials evaluated the effect of DHA alone; one trial evaluated vitamin A alone; and one trial evaluated DHA and vitamin A versus vitamin A alone. Two trials recruited participants from the USA, and the other two recruited from the USA and Canada. All trials were at low risk of bias for most domains. We did not perform meta-analysis due to clinical heterogeneity. Four trials assessed visual field sensitivity. Investigators found no evidence of a difference in mean values between the groups. However, one trial found that the annual rate of change of visual field sensitivity over four years favored the DHA group in foveal (-0.02 ± 0.55 (standard error (SE)) dB versus -0.47 ± 0.03 dB, P = 0.039), macular (-0.42 ± 0.05 dB versus -0.85 ± 0.03 dB, P = 0.031), peripheral (-0.39 ± 0.02 versus -0.86 ± 0.02 dB, P < 0.001), and total visual field sensitivity (-0.39 ± 0.02 versus -0.86 ± 0.02 dB, P < 0.001). The certainty of the evidence was very low. The four trials evaluated visual acuity (LogMAR scale) at a follow-up of four to six years. In one trial (208 participants), investigators found no evidence of a difference between the two groups, as both groups lost 0.7 letters of the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity per year. In another trial (41 participants), DHA showed no evidence of effect on visual acuity (mean difference -0.01 logMAR units (95% confidence interval -0.14 to 0.12; one letter difference between the two groups; very low-certainty evidence). In the third trial (60 participants), annual change in mean number of letters correct was -0.8 (DHA) and 1.4 letters (placebo), with no evidence of between-group difference. In the fourth trial (572 participants), which evaluated (vitamin A + vitamin E trace) compared with (vitamin A trace + vitamin E trace), decline in ETDRS visual acuity was 1.1 versus 0.9 letters per year, respectively. All four trials reported electroretinography (ERG). Investigators of two trials found no evidence of a difference between the DHA and placebo group in yearly rates of change in 31 Hz cone ERG amplitude (mean ± SE) (-0.028 ± 0.001 log µV versus -0.022 ± 0.002 log µV; P = 0.30); rod ERG amplitude (mean ± SE) (-0.010 ± 0.001 log µV versus -0.023 ± 0.001 log µV; P = 0.27); and maximal ERG amplitude (mean ± SE) (-0.042 ± 0.001 log µV versus -0.036 ± 0.001 log µV; P = 0.65). In another trial, a slight difference (6.1% versus 7.1%) in decline of ERG per year favored vitamin A (P = 0.01). The certainty of the evidence was very low. One trial (51 participants) that assessed optical coherence tomography found no evidence of a difference in ellipsoid zone constriction (P = 0.87) over two years, with very low-certainty evidence. The other three trials did not report this outcome. Only one trial reported adverse events, which found that 27/60 participants experienced 42 treatment-related emergent adverse events (22 in DHA group, 20 in placebo group). The certainty of evidence was very low. The rest of the trials reported no adverse events, and no study reported any evidence of benefit of vitamin supplementation on the progression of visual acuity loss. AUTHORS' CONCLUSIONS: Based on the results of four studies, it is uncertain if there is a benefit of treatment with vitamin A or DHA, or both for people with RP. Future trials should also take into account the changes observed in ERG amplitudes and other outcome measures from trials included in this review.

Trifocal intraocular lenses versus bifocal intraocular lenses after cataract extraction among participants with presbyopia.

BACKGROUND: Presbyopia occurs when the lens of the eyes loses its elasticity leading to loss of accommodation. The lens may also progress to develop cataract, affecting visual acuity and contrast sensitivity. One option of care for individuals with presbyopia and cataract is the use of multifocal or extended depth of focus intraocular lens (IOL) after cataract surgery. Although trifocal and bifocal IOLs are designed to restore three and two focal points respectively, trifocal lens may be preferable because it restores near, intermediate, and far vision, and may also provide a greater range of useful vision and allow for greater spectacle independence in individuals with presbyopia. OBJECTIVES: To assess the effectiveness and safety of implantation with trifocal versus bifocal IOLs during cataract surgery among participants with presbyopia. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2019, Issue 9); Ovid MEDLINE; Embase.com; PubMed; ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 26 September 2019. We searched the reference lists of the retrieved articles and the abstracts from the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) for the years 2005 to 2015. SELECTION CRITERIA: We included randomized controlled trials that compared trifocal and bifocal IOLs among participants 30 years or older with presbyopia undergoing cataract surgery. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodology. MAIN RESULTS: We identified five studies conducted in Europe with a total of 175 participants. All five studies assessed uncorrected distance visual acuity (primary outcome of the review), while some also examined our secondary outcomes including uncorrected near, intermediate, and best-corrected distance visual acuity, as well as contrast sensitivity. Study characteristics All participants had bilateral cataracts with no pre-existing ocular pathologies or ocular surgery. Participants' mean age ranged from 58 to 64 years. Only one study reported on gender of participants, and they were mostly women. We assessed all the included studies as being at unclear risk of bias for most domains. Two studies received financial support from manufacturers of lenses evaluated in this review, and at least one author of another study reported receiving payments for delivering lectures with lens manufacturers. Findings All studies compared trifocal versus bifocal IOL implantation on visual acuity outcomes measured on a LogMAR scale. At one year, trifocal IOL showed no evidence of effect on uncorrected distance visual acuity (mean difference (MD) 0.00, 95% confidence interval (CI) -0.04 to 0.04; I2 = 0%; 2 studies, 107 participants; low-certainty evidence) and uncorrected near visual acuity (MD 0.01, 95% CI -0.04 to 0.06; I2 = 0%; 2 studies, 107 participants; low-certainty evidence). Trifocal IOL implantation may improve uncorrected intermediate visual acuity at one year (MD -0.16, 95% CI -0.22 to -0.10; I2= 0%; 2 studies, 107 participants; low-certainty evidence), but showed no evidence of effect on best-corrected distance visual acuity at one year (MD 0.00, 95% CI -0.03 to 0.04; I2= 0%; 2 studies, 107 participants; low-certainty evidence). No study reported on contrast sensitivity or quality of life at one-year follow-up. Data from one study at three months suggest that contrast sensitivity did not differ between groups under photopic conditions, but may be worse in the trifocal group in one of the four frequencies under mesopic conditions (MD -0.19, 95% CI -0.33 to -0.05; 1 study; I2 = 0%, 25 participants; low-certainty evidence). In two studies, the investigators observed that participants' satisfaction or spectacle independence may be higher in the trifocal group at six months, although another study found no evidence of a difference in participant satisfaction or spectacle independence between groups. Adverse events Adverse events reporting varied among studies. Two studies reported information on adverse events at one year. One study reported that participants showed no intraoperative or postoperative complications, while the other study reported that four eyes (11.4%) in the bifocal and three eyes (7.5%) in the trifocal group developed significant posterior capsular opacification requiring YAG capsulotomy. The certainty of the evidence was low. AUTHORS' CONCLUSIONS: There is low-certainty of evidence that compared to bifocal IOL, implantation of trifocal IOL may improve uncorrected intermediate visual acuity at one year. However, there is no evidence of a difference between trifocal and bifocal IOL for uncorrected distance visual acuity, uncorrected near visual acuity, and best-corrected visual acuity at one year. Future research should include the comparison of both trifocal IOL and specific bifocal IOLs that correct intermediate visual acuity to evaluate important outcomes such as contrast sensitivity and quality of life.

Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy.

BACKGROUND: Retinal detachment (RD) with proliferative vitreoretinopathy (PVR) often requires surgery to restore normal anatomy and to stabilize or improve vision. PVR usually occurs in association with recurrent RD (that is, after initial retinal re-attachment surgery), but occasionally may be associated with primary RD. Either way, for both circumstances a tamponade agent (gas or silicone oil) is needed during surgery to reduce the rate of postoperative recurrent RD. OBJECTIVES: The objective of this review was to assess the relative safety and effectiveness of various tamponade agents used with surgery for RD complicated by PVR. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (the Cochrane Library 2019, Issue 1), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to January 2019), Embase (January 1980 to January 2019), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to January 2019), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 2 January 2019. SELECTION CRITERIA: We included randomized controlled trials (RCTs) on participants undergoing surgery for RD associated with PVR that compared various tamponade agents. DATA COLLECTION AND ANALYSIS: Two review authors screened the search results independently. We used the standard methodological procedures expected by Cochrane. MAIN RESULTS: We identified four RCTs (601 participants) that provided data for the primary and secondary outcomes. Three RCTs provided data on visual acuity, two reported on macular attachment, one on retinal reattachment and another two on adverse events such as RD, worsening visual acuity and intraocular pressure. Study Characteristics Participants' characteristics varied across studies and across intervention groups, with an age range between 21 to 89 years, and were predominantly men. The Silicone Study was conducted in the USA and consisted of two RCTs: (silicone oil versus sulfur hexafluoride (SF6) gas tamponades; 151 participants) and (silicone oil versus perfluropropane (C3F8) gas tamponades; 271 participants). The third RCT compared heavy silicone oil (a mixture of perfluorohexyloctane (F6H8) and silicone oil) with standard silicone oil (either 1000 centistokes or 5000 centistokes; 94 participants). The fourth RCT compared 1000 centistokes with 5000 centistokes silicone oil in 85 participants. We assessed most RCTs at low or unclear risk of bias for most 'Risk of bias' domains. Findings Although SF6 gas was reported to be associated with worse anatomic and visual outcomes than was silicone oil at one year (quantitative data not reported), at two years, silicone oil compared to SF6 gas showed no evidence of a difference in visual acuity (33% versus 51%; risk ratio (RR) 1.57; 95% confidence interval (CI) 0.93 to 2.66; 1 RCT, 87 participants; low-certainty evidence). At one year, another RCT comparing silicone oil and C3F8 gas found no evidence of a difference in visual acuity between the two groups (41% versus 39%; RR 0.97; 95% CI 0.73 to 1.31; 1 RCT, 264 participants; low-certainty evidence). In a third RCT, participants treated with standard silicone oil compared to those receiving heavy silicone oil also showed no evidence of a difference in the change in visual acuity at one year, measured on logMAR scale ( mean difference -0.03 logMAR; 95% CI -0.35 to 0.29; 1 RCT; 93 participants; low-certainty evidence). The fourth RCT with 5000-centistoke and 1000-centistoke comparisons did not report data on visual acuity. For macular attachment, participants treated with silicone oil may probably experience more favorable outcomes than did participants who received SF6 at both one year (quantitative data not reported) and two years (58% versus 79%; RR 1.37; 95% CI 1.01 to 1.86; 1 RCT; 87 participants; low-certainty evidence). In another RCT, silicone oil compared to C3F8 at one year found no evidence of difference in macular attachment (RR 1.00; 95% CI 0.86 to 1.15; 1 RCT, 264 participants; low-certainty evidence). One RCT that compared 5000 centistokes to 1000 centistoke reported that retinal reattachment was successful in 67 participants (78.8%) with first surgery and 79 participants (92.9%) with the second surgery, and no evidence of between-group difference (1 RCT; 85 participants; low-certainty evidence). The fourth RCT that compared standard silicone oil with heavy silicone oil did not report on macular attachment. Adverse events In one RCT (86 participants), those receiving standard 1000 centistoke silicone oil compared with those of the 5000 centistoke silicone oil showed no evidence of a difference in intraocular pressure elevation at 18 months (24% versus 22%; RR 0.90; 95% CI 0.41 to 1.94; low-certainty evidence), visually significant cataract (49% versus 64%; RR 1.30; 95% CI 0.89 to 1.89; low-certainty evidence), and incidence of retina detachment after the removal of silicone oil (RR 0.36 95% CI 0.08 to 1.67; low-certainty evidence). Another RCT that compared standard silicone oil with heavy silicone oil suggests no difference in retinal detachment at one year (25% versus 22%; RR 0.89; 95% CI 0.54 to 1.48; 1 RCT; 186 participants; low-certainty evidence). Retinal detachment was not reported in the RCTs that compared silicone oil versus SF6 and silicone oil versus to C3F8. AUTHORS' CONCLUSIONS: There do not appear to be any major differences in outcomes between C3F8 and silicone oil. Silicone oil may be better than SF6 for macular attachment and other short-term outcomes. The choice of a tamponade agent should be individualized for each patient. The use of either C3F8 or standard silicone oil appears reasonable for most patients with RD associated with PVR. Heavy silicone oil, which is not available for routine clinical use in the USA, may not demonstrate evidence of superiority over standard silicone oil.

Effectiveness of vaginal microbicides in preventing HIV transmission.

OBJECTIVE: To evaluate the evidence on the effectiveness of vaginal microbicides in preventing HIV transmission in women. METHODS: Systematic review through a comprehensive search of relevant electronic databases for eligible randomised controlled trials (RCTs) published through June 2019. Two authors independently screened titles and abstracts according to eligibility criteria, then extracted data and assessed risk of bias of included studies. We conducted a random-effects meta-analysis of risk ratios (RR) of HIV infection and assessed heterogeneity using chi-squared and I2 tests. Sources of heterogeneity were investigated through subgroup analysis, publication bias was assessed using funnel plots, and certainty of evidence was graded using GRADEPro software. RESULTS: We included 18 RCTs which enrolled 40,048 sexually active, HIV-negative, non-pregnant women, aged 16 years and older, mainly from sub-Saharan Africa. The intravaginal ring containing dapivirine significantly reduced HIV risk by 29% (RR 0.71, 95% CI: 0.57-0.89; 2 RCTs, 4,564 women, moderate certainty of evidence). Estimates of effect of tenofovir 1% (RR 0.83, 95% CI: 0.65-1.06), nonoxynol-9 (RR 1.15, 95% CI: 0.93-1.42), cellulose sulphate (RR 1.16, 95% CI: 0.61-2.21), SAVVY (RR 1.34, 95% CI: 0.69-2.59), Carraguard (RR 0.89, 95% CI: 0.71-1.10), BufferGel (RR 1.02, 95% CI: 0.71-1.46), 0.5% PRO2000 (RR 0.88, 95% CI: 0.60-1.28) and 2% PRO2000 (RR 0.81, 95% CI: 0.58-1.12) failed to reach statistical significance; each had low certainty of evidence. CONCLUSION: The long-acting intravaginal ring containing dapivirine significantly reduced risk of HIV transmission in women by 29%. The remaining microbicides had no evident effect.

OBJECTIF: Evaluer les données probantes sur l'efficacité des microbicides vaginaux dans la prévention de la transmission du VIH chez les femmes. MÉTHODES: Analyse systématique à travers une recherche exhaustive des bases de données électroniques pertinentes pour les essais contrôlés randomisés (ECR) éligibles publiés jusqu'en juin 2019. Deux auteurs ont indépendamment passé en revue les titres et résumés selon des critères d'éligibilité, les données ont alors été extraites et le risque de biais évalué pour des études incluses. Nous avons effectué une méta-analyse des effets aléatoires des rapports de risque (RR) de l'infection par le VIH et évalué l'hétérogénéité à l'aide des tests Chi2 et I2 . Les sources d'hétérogénéité ont été étudiées par analyse de sous-groupes, le biais de publication a été évalué à l'aide de graphiques en entonnoir et la certitude des données a été évaluée à l'aide du logiciel GRADEPro. RÉSULTATS: Nous avons inclus 18 ECR qui ont recruté 40.048 femmes sexuellement actives, négatives pour le VIH, non enceintes, âgées de 16 ans et plus, principalement d'Afrique subsaharienne. L'anneau intravaginal contenant de la dapivirine a significativement réduit le risque de VIH de 29% (RR: 0,71 ; IC95%: 0,57-0,89; 2 ECR, 4564 femmes, certitude modérée des preuves). Les estimations de l'effet du ténofovir 1% (RR: 0,83 ; IC95%: 0,65-1,06), du nonoxynol-9 (RR: 1,15 ; IC95%: 0,93-1,42), du sulfate de cellulose (RR: 1,16 ; IC 95%: 0,61-2,21 ), du SAVVY (RR: 1,34 ; IC95%: 0,69-2,59), du Carraguard (RR: 0,89, IC95%: 0,71-1,10), du BufferGel (RR: 1,02 ; IC95%: 0,71-1,46), du PRO2000 à 0,5% (RR: 0,88 ; IC95%: 0,60-1,28) et du PRO2000 à 2% (RR: 0,81 ; IC95%: 0,58-1,12) n'ont pas atteint la signification statistique; tous avaient une faible certitude d'évidence. CONCLUSION: L'anneau intravaginal à longue durée d'action contenant de la dapivirine a réduit de manière significative le risque de transmission du VIH chez les femmes de 29%. Les autres microbicides n'ont eu aucun effet évident.

Impact of the 2017 American College of Cardiology/American Heart Association Guidelines on Prevalence of Hypertension in Ghana.

We investigated the prevalence of hypertension in Ghana using the 2017 American College of Cardiology/American Heart Association (ACC/AHA) criteria and compared with prevalence estimates using the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7) criteria. Among 13,220 Ghanaians aged 15-49 years, the prevalence of hypertension was 30.4% (95% CI: 29.3-31.6) based on the 2017 ACC/AHA guideline compared with 12.8% (95% CI: 12.0-13.6) when using the JNC7 guideline. The overall increase in prevalence was 17.6% (95% CI: 16.8-18.6). The increment in prevalence was 19.0% (95% CI: 17.5-20.7) among men and 17.7% (95% CI: 16.1-18.2) among women. People aged 40-49 years had the highest prevalence (51.1%; 95% CI: 49.0-53.3). We used multiple logistic regressions to obtain odds ratios. Urban dwelling, tertiary education, or being in higher wealth status was significantly associated with the odds of hypertension. The 2017 ACC/AHA guideline resulted in a significant increase in the prevalence of hypertension in Ghana. Scaling up of existing prevention and control strategies for hypertension such as health education through already established community health implementation and planning programs as well as improved screening and diagnostic protocols for hypertension should be prioritized.

Antimetabolites as an adjunct to dacryocystorhinostomy for nasolacrimal duct obstruction.

BACKGROUND: Nasolacrimal duct obstruction (NLDO) is a condition that results in the overflow of tears (epiphora) or infection of the nasolacrimal sac (dacryocystitis). The etiology of acquired NLDO is multifactorial and is not fully understood. Dacryocystorhinostomy (DCR) is the surgical correction of NLDO, which aims to establish a new drainage pathway between the lacrimal sac and the nose. The success of DCR is variable; the most common cause of failure is fibrosis and stenosis of the surgical ostium. Antimetabolites such as mitomycin-C (MMC) and 5-fluorouracil (5-FU) have been shown to be safe and effective in reducing fibrosis and improving clinical outcomes in other ophthalmic surgery settings (e.g. glaucoma and cornea surgery). Application of antimetabolites at the time of DCR has been studied, but the utility of these treatments remains uncertain. OBJECTIVES: Primary objective: To determine if adjuvant treatment with antimetabolites improves functional success in the setting of DCR compared to DCR alone. Secondary objectives: To determine if anatomic success of DCR is increased with the use of antimetabolites, and if the surgical ostium is larger in participants treated with antimetabolites. SEARCH METHODS: We searched the Cochrane Register for Controlled Trials (CENTRAL) (which contains the Cochrane Eye and Vision Trials Register) (2019, Issue 9), Ovid MEDLINE, Embase.com, PubMed, LILACS (Latin American and Caribbean Health Sciences Literature database), ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic searches. We last searched the electronic databases on 6 September 2019. SELECTION CRITERIA: We only included randomized controlled trials. Eligible studies were those that compared the administration of antimetabolites of any dose and concentration versus placebo or another active treatment in participants with NLDO undergoing primary DCR and reoperation. We only included studies that had enrolled adults 18 years or older. We also included studies that used silicone intubation as part of the DCR procedure. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Two review authors independently screened the search results, assessed risk of bias, and extracted data from the included studies using an electronic data collection form. MAIN RESULTS: We included 31 studies in the review, of which 23 (1309 participants) provided data relating to our primary and secondary outcomes. Many of the 23 studies evaluated functional success, while others also assessed our secondary outcomes of anatomic success or ostium size, or both. Study characteristics Participant characteristics varied across studies, with the age of participants ranging from 30 to 70 years. Participants were predominantly women. These demographics correspond to those most frequently affected by nasolacrimal duct obstruction. Almost all of the studies utilized MMC as the antimetabolite, with only one using 5-FU. We assessed most trials as at unclear risk of bias for most domains. Conflicts of interest were not frequently reported, although the antimetabolites used are generic medications, and studies were not likely to be conducted for financial interest. Findings Twenty studies provided data on the primary outcome of functional success, of which 7 (356 participants) provided data at 6 months and 14 (909 participants) provided data beyond 6 months. At six months, the results showed no evidence of effect of antimetabolite on functional success (risk ratio (RR) 1.12, 95% confidence interval (CI) 0.98 to 1.29; low-certainty evidence). Beyond six months, the results favored the antimetabolite group (RR 1.15, 95% CI 1.07 to 1.25; moderate-certainty evidence). Fourteen studies reported data on the secondary outcome of anatomic success, of which 4 (306 participants) reported data at 6 months and 12 (831 participants) provided data beyond 6 months. Results at six months showed no evidence of effect of antimetabolite on anatomic success (RR 1.02, 95% CI 0.95 to 1.11; low-certainty evidence). Beyond six months, participants in the antimetabolite group were more likely to achieve anatomic success than those receiving DCR alone (RR 1.09, 95% CI 1.04 to 1.15; moderate-certainty evidence). At six months and beyond six months follow-up, two studies reported mean change in ostium size. We did not conduct meta-analysis for the various follow-up periods due to clinical, methodological, and statistical heterogeneity. However, point estimates from these studies at six months consistently favored participants in the antimetabolite group (low-certainty evidence). Beyond six months, while point estimates from one study favored participants in the antimetabolite group, estimates from another study showed no evidence of a difference between the two groups. The certainty of evidence at both time points was low. Adverse events Adverse events were rare. One study reported that one participant in the MMC group experienced delayed wound healing. Other studies reported no significant adverse events related to the application of antimetabolites. AUTHORS' CONCLUSIONS: There is moderate-certainty evidence that application of antimetabolites at the time of DCR increases functional and anatomic success of DCR when patients are followed for more than six months after surgery, but no evidence of a difference at six months, low-certainty of evidence. There is low-certainty evidence that combining antimetabolite with DCR increases the size of the lacrimal ostium at six months. However, beyond six months, the evidence remain uncertain. Adverse effects of the application of antimetabolites were minimal.

Receipt of Treatment for Depression Following Traumatic Brain Injury.

OBJECTIVE: Lack of evidence for efficacy and safety of treatment and limited clinical guidance have increased potential for undertreatment of depression following traumatic brain injury (TBI). METHODS: We conducted a retrospective cohort study among individuals newly diagnosed with depression from 2008 to 2014 to assess the impact of TBI on receipt of treatment for incident depression using administrative claims data. We created inverse probability of treatment-weighted populations to evaluate the impact of TBI on time to receipt of antidepressants or psychotherapy following new depression diagnosis during 24 months post-TBI or matched index date (non-TBI cohort). RESULTS: Of 10 428 individuals with incident depression in the TBI cohort, 44.7% received 1 or more antidepressants and 20.0% received 1 or more psychotherapy visits. Of 10 463 in the non-TBI cohort, 41.2% received 1 or more antidepressants and 17.6% received 1 or more psychotherapy visits. TBI was associated with longer time to receipt of antidepressants compared with the non-TBI cohort (average 39.6 days longer than the average 126.2 days in the non-TBI cohort; 95% confidence interval [CI], 24.6-54.7). Longer time to psychotherapy was also observed among individuals with TBI at 6 months post-TBI (average 17.1 days longer than the average 47.9 days in the non-TBI cohort; 95% CI, 4.2-30.0), although this association was not significant at 12 and 24 months post-TBI. CONCLUSIONS: This study raises concerns about the management of depression following TBI.

Incidence of New Neuropsychiatric Disorder Diagnoses Following Traumatic Brain Injury.

BACKGROUND: Neuropsychiatric disturbances (NPDs) are common following traumatic brain injury (TBI) and associated with poor recovery. Prior estimates of NPD following TBI failed to account for preexisting NPDs or potential confounding. METHODS: We estimated the risk of anxiety, posttraumatic stress disorder (PTSD), bipolar disorder, and alcohol and substance dependence disorder diagnoses associated with TBI using administrative claims data from a large insurer in the United States, 2008-2014. We calculated rates of new NPD diagnoses during the 12 months before and 24 months after TBI and estimated the risk of NPD following TBI using a difference-in-difference approach and adjusting for confounders. RESULTS: Before the TBI occurred, rates of NPD diagnoses were more than double in the TBI cohort (n = 207 354) relative to the no-TBI cohort (n = 414 708). TBI was associated with an increased risk of anxiety (rate ratio [RtR] = 1.08; 95% confidence interval [CI], 1.05-1.12) and PTSD (RtR = 1.41; 95% CI, 1.24-1.60) diagnoses. Rates of alcohol (RtR = 0.32; 95% CI, 0.30-0.34) and substance use disorder (RtR = 0.57; 95% CI, 0.55-0.59) diagnoses decreased following TBI. CONCLUSIONS: In this large national study, rates of NPD were much higher among individuals with TBI than those in a non-TBI cohort, even before the TBI took place. TBI was associated with an increased risk of anxiety and PTSD diagnoses. Results from this study also suggest that individuals who sustain TBI have increased contact with the healthcare system during the months prior to injury, providing a window for intervention, especially for individuals diagnosed with alcohol dependence disorder.

Topical mydriatics as adjunctive therapy for traumatic iridocyclitis.

BACKGROUND: Traumatic eye complaints account for 3% of all hospital emergency department visits. The most common traumatic injury to the eye is blunt trauma, which accounts for 30% of these visits. Blunt trauma frequently leads to traumatic iridocyclitis, thus causing anterior uveitis. Iridocyclitis frequently causes tearing, photophobia, eye pain, and vision loss. These symptoms are a result of the inflammatory processes and ciliary spasms to iris muscles and sphincter. The inflammatory process is usually managed with topical corticosteroids, while the ciliary spasm is blunted by dilating the pupils with topical mydriatic agents, an adjuvant therapy. However, the effectiveness of mydriatic agents has not been quantified in terms of reduction of ocular pain and visual acuity loss. OBJECTIVES: To evaluate the effectiveness and safety of topical mydriatics as adjunctive therapy to topical corticosteroids for traumatic iridocyclitis. 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; Cumulative Index to Nursing and Allied Health Literature (CINAHL) Plus; PubMed; ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 12 June 2019. SELECTION CRITERIA: We planned to include randomized controlled trials (RCTs) that compared topical mydriatic agents in conjunction with topical corticosteroid therapy versus topical corticosteroids alone, in participants with traumatic iridocyclitis. DATA COLLECTION AND ANALYSIS: Two review authors (JH, MK) independently screened titles and abstracts, then full-text reports, against eligibility criteria. We planned to have two authors independently extract data from included studies. We resolved differences in opinion by discussion. MAIN RESULTS: There were no eligible RCTs that compared the interventions of interest in people with traumatic iridocyclitis. AUTHORS' CONCLUSIONS: We did not find any evidence from RCTs about the efficacy of topical mydriatic agents as an adjunctive therapy with topical corticosteroids for treating traumatic iridocyclitis. In the absence of these types of studies, we cannot draw any firm conclusions. Controlled trials that compare the combined use of topical mydriatic agents and corticosteroid drops against standard corticosteroid drops alone, in people with traumatic iridocyclitis are required. These may provide evidence about the efficacy and risk of topical mydriatic drops as adjuvant therapy for traumatic iridocyclitis.

Prevalence and Determinants of Hypertension in India Based on the 2017 ACC/AHA Guideline: Evidence from the India National Family Health Survey.

OBJECTIVE: To estimate the prevalence and determinants of hypertension in India based on a new definition by the 2017 American College of Cardiology/American Heart Association (2017 ACC/AHA) Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults, and compare prevalence estimates with those of the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7). METHODS: We used the National Family Health Survey (NFHS-4) conducted in India (n = 212,007). We accounted for the sampling strategy by applying survey weights. RESULTS: Prevalence of hypertension among Indians aged 15-49 years was 40.6% (95% confidence interval [CI]: 40.3-41.0) and 13.0% (95% CI: 12.8-13.2) based on 2017 ACC/AHA and JNC7 guidelines respectively. The overall absolute increase in prevalence was 27.6% (95% CI:27.3-27.9). The absolute changes in crude prevalence of hypertension between the JNC7 and 2017 ACC/AHA guidelines for men and women were 31.4% (95% CI: 30.9-31.9) and 23.7% (95% CI: 23.5-23.9), respectively. As per both guidelines, the overall prevalence was significantly higher among older people, age, male sex, overweight/obesity, higher wealth status, and urban residence. CONCLUSION: Applying the 2017 ACC/AHA guideline to the Indian population led to a significant increase in the proportion of Indians with hypertension. There is also socioeconomic differences in the prevalence of hypertension as per both guidelines. Implementation and expansion of public health efforts for prevention and control strategies for hypertension is warranted.

The Impact of Treatments for OSA on Monetized Health Economic Outcomes: A Systematic Review.

OBJECTIVE: To review systematically the published literature regarding the impact of treatment for OSA on monetized health economic outcomes. METHODS: Customized structured searches were performed in PubMed, Embase (Embase.com), and the Cochrane Central Register of Controlled Trials (Wiley) databases. Reference lists of eligible studies were also analyzed. Titles and abstracts were examined, and articles were identified for full-text review. Studies that met inclusion criteria were evaluated in detail, and study characteristics were extracted using a standardized template. Quantitative characteristics of the studies were summarized, and a qualitative synthesis was performed. RESULTS: Literature searches identified 2,017 nonredundant abstracts, and 196 full-text articles were selected for review. Seventeen studies met inclusion criteria and were included in the final synthesis. Seven studies included formal cost-effectiveness or cost-utility analyses. Ten studies employed cohort designs, and four studies employed randomized controlled trial or quasi-experimental designs. Positive airway pressure was the most common treatment modality, but oral appliances and surgical approaches were also included. The most common health economic outcomes were health-care use (HCU) and quality-adjusted life years (QALYs). Follow-ups ranged from 6 weeks to 5 years. Overall, 15 of 18 comparisons found that treatment of OSA resulted in a positive economic impact. Treatment adherence and OSA severity were positively associated with cost-effectiveness. CONCLUSIONS: Although study methodologies varied widely, evidence consistently suggested that treatment of OSA was associated with favorable economic outcomes, including QALYs, within accepted ranges of cost-effectiveness, reduced HCU, and reduced monetized costs.

Risk of Depression after Traumatic Brain Injury in a Large National Sample.

Depression is associated with poorer recovery after traumatic brain injury (TBI), yet awareness of depression risk post-TBI among providers and patients is low. The aim of this study was to estimate risk of depression post-TBI among adults 18 years of age and older and to identify risk factors associated with developing depression post-TBI. We conducted a retrospective, matched cohort study using claims data for privately insured and Medicare Advantage enrollees in a large U.S. health plan. Adults ≥18 years of age diagnosed with TBI (n = 207,354) with 12 months continuous insurance coverage pre-TBI and 24 months post-TBI were matched to controls without TBI (n = 414,708). We identified the presence of depression on any in- or outpatient claim occurring during the study period (both before and after TBI). Of the initial 622,062 individuals, 62,963 (10%) had depression pre-TBI and were excluded from incidence calculations. Incidence of depression post-TBI was 79.5 (95% confidence interval [CI], 78.5,80.5) per 1,000 person-years compared to 33.5 (95% CI, 33.1,34.0) per 1,000 person-years for those without TBI. The adjusted hazard ratio for depression post-TBI was 1.83 (95% CI, 1.79,1.86). We observed effect modification by sex and age, with males and older adults at increased risk. History of neuropsychiatric disturbances pre-TBI was the strongest predictor of depression post-TBI. Risk of depression increases substantially post-TBI. Groups at increased risk include those with a history of neuropsychiatric disturbances, older adults, and men. This study highlights the importance of long-term monitoring for depression post-TBI.

Determinants of hypertension among adults in Bangladesh as per the Joint National Committee 7 and 2017 American College of Cardiology/American Hypertension Association hypertension guidelines.

We investigated determinants of hypertension in Bangladesh using both Joint National Committee 7 (JNC7) and 2017 American College of Cardiology/American Hypertension Association (2017 ACC/AHA) guidelines. After reporting background characteristics, odds ratios (ORs) were obtained by multilevel logistic regression. Among 7839 respondents aged ≥35 years, 25.7% (n = 2016) and 48.0% (n = 3767) respondents had hypertension as per the JNC7 and 2017 ACC/AHA guidelines, respectively. The following factors were significant according to the 2017 ACC/AHA guideline: ≥65 years (adjusted OR [AOR]: 2.4, 95% confidence interval [CI]: 2.2-3.0), 55-64 years (AOR: 1.6, 95% CI: 1.4-1.9), and 45-54 years (AOR: 1.4, 95% CI: 1.3-1.6) age groups, females (AOR: 2.0, 95% CI: 1.7-2.2), overweight/obesity (AOR: 2.4, 95% CI: 2.0-2.8), diabetes (AOR: 1.4, 95% CI: 1.2-1.6), secondary (AOR: 1.2, 95% CI: 1.1-1.4), or college education level (AOR: 1.8, 95% CI: 1.4-2.3), middle (AOR: 1.3, 95% CI: 1.1-1.6), richer (AOR: 1.5, 95% CI: 1.2-1.8) or richest (AOR: 2.0, 95% CI: 1.6-2.4) wealth quintiles, residence in Khulna (AOR: 1.5, 95% CI: 1.2-1.9), and Rangpur (AOR: 1.7, 95% CI: 1.3-2.2) divisions. All factors were significant as per the JNC7 guideline too. Both guidelines found similar determinants. Prevention and control programs should prioritize increasing awareness among people with higher likelihood of hypertension.

Periodontitis and gestational diabetes mellitus: a systematic review and meta-analysis of observational studies.

BACKGROUND: Gestational diabetes mellitus (GDM) is glucose intolerance with first onset during pregnancy and is associated with serious maternal and fetal complications. The etiology of GDM is not well understood, but systemic inflammation effects on insulin signaling and glucose metabolism is suspected. Periodontal disease is a chronic inflammatory condition that induces local and host immune responses and has been evaluated for a potential role in development of GDM. Results from studies evaluating the association between periodontitis and GDM are mixed. We performed a systematic review and meta-analysis to summarize available data regarding the association between periodontitis and GDM. METHODS: Twelve electronic databases were searched for observational studies of the association between periodontitis and GDM through March 2016. Eligible studies were assessed for quality and heterogeneity. Random effects models were used to estimate summary measures of association. RESULTS: We identified 44 articles from 115 potentially relevant reports of which 10 studies met our eligibility criteria. Clinical diagnostic criteria for periodontitis and GDM varied widely among studies, and moderate heterogeneity was observed. Random effects meta-analysis of all included studies with a total of 5724 participants including 624 cases, showed that periodontitis is associated with an increased risk of GDM by 66 %, (OR = 1.66, 95 % CI: 1.17 to 2.36; p < 0.05), I2 = 50.5 %. Similar results were seen in sub-analysis restricted to data from methodologically high quality case-control studies including 1176 participants including 380 cases, (OR = 1.85, 95 % CI: 1.03 to 3.32); p < 0.05), I2 = 68.4 %. Meta-analysis of studies that adjusted for potential confounders estimated more than 2-fold increased odds of GDM among women with periodontitis (aOR = 2.08, 95 % CI: 1.21 to 3.58, p = 0.009, I2 = 36.9 %). CONCLUSION: Meta-analysis suggests that periodontitis is associated with a statistically significant increased risk for GDM compared to women without periodontitis. Robust prospective study designs and uniform definition for periodontitis and GDM definitions are urgently needed to substantiate these findings.