Search

Costs of nursing care among hospital units that adopted a professional practice model (PPM) were compared with traditional nursing units. PPM inpatient units used fewer temporary personnel and nursing aides, resulting in similar RN costs but lower total nursing costs. However, PPM operating rooms were more costly, mostly because of the intense use of RNs. [ABSTRACT FROM AUTHOR]

Thyroid hormones are essential during developmental myelination and may play a direct role in remyelination and repair in the adult central nervous system by promoting the differentiation of oligodendrocyte precursor cells into mature oligodendrocytes. Since tri-iodothyronine (T3) is believed to mediate the majority of important thyroid hormone actions, liothyronine (synthetic T3) has the potential to induce reparative mechanisms and limit neurodegeneration in multiple sclerosis (MS). We completed a phase 1b clinical trial to determine the safety and tolerability of ascending doses of liothyronine in individuals with relapsing and progressive MS. A total of 20 people with MS were enrolled in this single-center trial of oral liothyronine. Eighteen participants completed the 24-week study. Our study cohort included mostly women (11/20), majority relapsing MS (12/20), mean age of 46, and baseline median EDSS of 3.5. Liothyronine was tolerated well without treatment-related severe/serious adverse events or evidence of disease activation/clinical deterioration. The most common adverse events included gastrointestinal distress and abnormal thyroid function tests. No clinical thyrotoxicosis occurred. Importantly, we did not observe a negative impact on secondary clinical outcome measures. The CSF proteomic changes suggest a biological effect of T3 treatment within the CNS. We noted changes primarily in proteins associated with immune cell function and angiogenesis. Liothyronine appeared safe and was well tolerated in people with MS. A larger clinical trial will help assess whether liothyronine can promote oligodendrogenesis and enhance remyelination in vivo, limit axonal degeneration, or improve function., (© 2023. The Author(s).)

Background: Vitamin D insufficiency is associated with risk of multiple sclerosis (MS) relapse; whether supplementation influences prognosis is unknown. The Vitamin D to Ameliorate MS (VIDAMS) trial aimed to determine if high dose (5000 International Units (IU)/day) versus low dose (600 IU/day) vitamin D 3, added to daily glatiramer acetate (GA), reduced the risk of clinical relapse in people with established relapsing remitting MS (RRMS) over 96 weeks., Methods: VIDAMS is a randomised, phase 3, double-blind, multi-centre, controlled trial conducted at sixteen neurology clinics in the United States. Participants with MAGNIMS 2010 RRMS, aged 18-50 years, with recent disease activity were eligible to enroll if they had an Expanded Disability Status Scale score ≤4.0; minimum serum 25-hydroxyvitamin D level of 15 ng/ml within 30 days of screening; and average ≤ 1000 IU supplemental vitamin D 3 daily in the 90 days prior to screening. Of 203 screened, 183 were eligible for the 30-day run-in to assess GA adherence, after which 172 were randomised 1:1 to low dose vitamin D 3 (LDVD) or high dose vitamin D 3 (HDVD), and were followed every 12 weeks for 96 weeks. The primary outcome was the proportion that experienced a confirmed relapse and analyses used Kaplan Meier and Cox proportional hazards models. 165 participants returned for ≥1 follow-up visit and were included in the primary and safety analyses; 140 completed a week 96 visit. This study was registered with ClinicalTrials.gov, NCT01490502., Findings: Between March 22, 2012 and March 8, 2019, 172 participants were enrolled and randomised (83 LDVD, 89 HDVD) and differed at baseline only in gender and race: more males received HDVD (31%) than LDVD (16%), and fewer Black participants received HDVD (12%) than LDVD (22%). Among 165 participants with at least one follow-up visit, the proportion experiencing confirmed relapse did not differ between LDVD and HDVD [at 96 weeks: 32% vs. 34%, p = 0.60; hazard ratio (HR): 1.17 (0.67, 2.05), p = 0.57]. There was no hypercalcaemia. Three participants developed nephrolithiasis or ureterolithiasis (1 in the LDVD and 2 in the HDVD group). Two were possibly related to study drug; and one was presumed related to concomitant treatment with topiramate for migraine., Interpretation: VIDAMS provides evidence that HDVD supplementation, added to GA, does not reduce the risk of clinical relapse in people with RRMS. Taken together with the null findings of previous trials, these results suggest that prescribing higher doses of vitamin D for purposes of modifying the RRMS course may not be beneficial., Funding: This investigation was supported by a grant from the National Multiple Sclerosis Society (RG 4407A2/1). Teva Neuroscience, Inc. provided Copaxone (GA) for the duration of the trial., Competing Interests: SD Cassard, SE Emrich, and D Pelletier have nothing to disclose. KC Fitzgerald reports research funding from NIH, NMSS, and the DoD. She has served on Data and Safety Monitoring Boards for trials funded by the NIH and NMSS, and has received honorarium for serving as an external thesis committee reviewer. P Qian reports research funding for this clinical trial. She has served on a Data and Safety Monitoring Board for a trial funded by Janssen and has received speaking honorariums from Biogen and Bristol Myers Squibb. EA Sugar reports receiving salary support from NIH funds for statistical assistance with the design, execution and analysis of this project. CJ Azevedo has received personal compensation for participation on advisory boards or data and safety monitoring boards for Horizon Therapeutics, Genentech, Sanofi Genzyme, and TG Therapeutics; she has received honoraria for participation in CME activities from Catamount Medical Education, American Academy of Neurology, Spire Learning, and Efficient LLC,; she has received payment for serving on a grant review committee from the Department of Defense and for serving on a data and safety monitoring board from Genentech; she receives grant support from the National Multiple Sclerosis Society and the National Institutes of Health. AD Goodman has received personal compensation for consulting from Genentech-Roche, Janssen, TG Therapeutics, Novartis, payment for expert testimony from EMD Serono, support for attending meetings from Biogen, payment for participation on a data and safety monitoring board from IMCYSE, and research support from Atara, Biogen, EMD Serono, and Sanofi Genzyme. E Waubant has participated in multicentre clinical trials funded by Genentech, Alexion and Biogen; she has current support from the NIH, NMSS, PCORI, CMSC and Race to Erase MS. She has received consulting fees from Emerald Pharmaceuticals, payments from Neurology Live and Yoga Moves MS, had support for attending the ACTRIMS 2022 and ECTRIMS 2022 conferences, volunteered on a data and safety monitoring board for a Novartis trial, chaired the International Women in Multiple Sclerosis (iWiMS) network (unpaid), and served as President-elect of ACTRIMS forum (unpaid). EM Mowry has received grant or research support from the National MS Society, Biogen, Genentech and Teva Neuroscience, has served on a data and safety monitoring board for an NIH trial and receives honoraria from UpToDate (editorial duties) and consulting fees from BeCare Link LLC., (© 2023 The Author(s).)

Background: Intermittent fasting or calorie restriction (CR) diets provide anti-inflammatory and neuroprotective advantages in models of multiple sclerosis (MS); data in humans are sparse., Methods: We conducted a randomised-controlled feeding study of different CR diets in 36 people with MS over 8 weeks. Participants were randomised to 1 of 3 diets: 1) a control diet, in which the participant received 100% of his or her calorie needs 7 days per week, 2) a daily CR diet, in which the participant received 78% of his or her calorie needs 7 days per week, or 3) an intermittent CR diet, in which the participant received 100% of his or her calorie needs on 5 days per week and 25% of his or her calorie needs 2 days per week (i.e., a "5:2" style diet). Untargeted metabolomics was performed on plasma samples at weeks 0, 4 and 8 at Metabolon Inc (Durham, NC). Flow cytometry of cryopreserved peripheral blood mononuclear cells at weeks 0 and 8 were used to identify CD3 + ;CD4 + (CD4 + ) and CD3 + ;CD4 - (as a proxy for CD8 + ) T cell subsets including effector memory, central memory, and naïve cells., Findings: 31 (86%) completed the trial. Over time, individuals randomised to intermittent CR had significant reductions in effector memory (for CD4 - EM : -3.82%; 95%CI: -7.44, -0.21; for CD4 - : -6.96%; 95%CI: -11.96, -1.97) and Th1 subsets (-4.26%; 95% CI: -7.11, -1.40) and proportional increases in naïve subsets (for CD4 - : 10.11%; 95%CI: 3.30, 16.92%). No changes were observed for daily CR or weight-stable diets. Larger within-person changes in lysophospholipid and lysoplasmalogen metabolites in intermittent CR were associated with larger reductions in memory T cell subsets and larger increases in naïve T cell subsets., Interpretation: In people with MS, an intermittent CR diet was associated with reduction in memory T cell subsets and certain biologically-relevant lipid markers., Funding: National MS Society, NIH, Johns Hopkins Catalyst Award., Competing Interests: Declaration of interests Mr. Smith, Ms. Henry-Barron, Ms. Vizthum, Dr. Cassard, Dr. Kappogiannis, Mr. Sullivan, and Dr. Baer report no disclosures. Dr. Fitzgerald and Dr. Bhargava reports grants from NIH, grants from National MS Society, during the conduct of the study. Dr. Kornberg has received consulting fees from Biogen Idec, Janssen Pharmaceuticals, Novartis, OptumRx, and TG Therapeutics and received grants from NIH and the Department of Defense. Dr. Calabresi has received consulting fees from Disarm, NervGen, and Biogen and is PI on grants to JHU from Genentech. Dr. Mowry has grants from Biogen, is site PI for studies sponsored by Biogen and Genentech, has received free medication for a clinical trial from Teva, and receives royalties for editorial duties from UpToDate., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)

Objective: To compare clinical and imaging features of multiple sclerosis (MS) severity between Black Americans (BAs) and White Americans (WAs) and to evaluate the role of socioeconomic status., Methods: We compared BA and WA participants in the Multiple Sclerosis Partners Advancing Technology Health Solutions (MS PATHS) cohort with respect to MS characteristics, including self-reported disability, objective neurologic function assessments, and quantitative brain MRI measurements, after covariate adjustment (including education level, employment, or insurance as socioeconomic indicators). In a subgroup, we evaluated within-race, neighborhood-level indicators of socioeconomic status (SES) using 9-digit zip codes., Results: Of 1,214 BAs and 7,530 WAs with MS, BAs were younger, had lower education level, and were more likely to have Medicaid insurance or to be disabled or unemployed than WAs. BAs had worse self-reported disability (1.47-fold greater odds of severe vs mild disability, 95% confidence interval [CI] 1.18, 1.86) and worse performances on tests of cognitive processing speed (-5.06 fewer correct, 95% CI -5.72, -4.41), walking (0.66 seconds slower, 95% CI 0.36, 0.96), and manual dexterity (2.11 seconds slower, 95% CI 1.69, 2.54). BAs had more brain MRI lesions and lower overall and gray matter brain volumes, including reduced thalamic (-0.77 mL, 95% CI -0.91, -0.64), cortical (-30.63 mL, 95% CI -35.93, -25.33), and deep (-1.58 mL, 95% CI -1.92, -1.23) gray matter volumes. While lower SES correlated with worse neuroperformance scores in WAs, this association was less clear in BAs., Conclusion: We observed a greater burden of disease in BAs with MS relative to WAs with MS, despite adjustment for SES indicators. Beyond SES, future longitudinal studies should also consider roles of other societal constructs (e.g., systemic racism). Such studies will be important for identifying prognostic factors; developing optimal treatment strategies among BAs with MS is warranted., (© 2021 American Academy of Neurology.)

Background: Methods of screening for infections at the time of suspected relapse in people with multiple sclerosis (MS) vary across physicians. People with multiple sclerosis (MS) are at an increased risk of urinary tract infection (UTI). Data evaluating the utility of screening for potential UTI at the time of suspected relapse and whether there are key subgroups of patients in which screening would be most effective are sparse., Objectives: To evaluate demographic and clinical predictors of UTI in the context of a suspected acute relapse in (1) a retrospective hospital admission cohort and (2) a prospectively-enrolled, ambulatory care-based cohort, and to determine an approximate number needed to screen to detect one UTI in both healthcare settings., Methods: For the hospital admissions cohort, we included individuals with a known or new diagnosis of MS or clinically isolated syndrome who were admitted at least once to the Johns Hopkins Neurology Inpatient Service (March 2012 to December 2014). We considered those screened via urinalysis. Possible UTI was defined as leukocyte esterase OR nitrite positive. For the ambulatory population, we enrolled a cohort of RRMS patients aged 18-65 who were suspected of suffering from an acute MS relapse who either called or came into clinic. Participants were screened via urinalysis; possible UTI was similarly defined. Participants also completed questionnaires (disability, history of Uhthoff's-type phenomenon, recent sexual intercourse, and new urologic symptoms). For both cohorts, we calculated an approximate number needed to screen, and tested if demographic and patient characteristics were associated with possible UTI using logistic regression models., Results: For the hospital admissions cohort, we included 158 individuals; 48 (30.4%) were identified as possibly having a UTI. For possible UTI, the approximate number needed to screen in order to detect 1 possible UTI is 3 (95% CI: 2, 6). Female sex was the only factor associated with increased odds of UTI (odds ratio [OR]: 3.90; 95% CI: 1.59-9.61; p = 0.003). For the ambulatory cohort, we included 50 participants; 10 (20.0%) with possible UTI. The approximate number needed to screen in order to detect 1 possible UTI was 5 (95% CI: 3, 11) in this cohort. Foul-smelling urine was positively associated with UTI (OR: 5.36; 95% CI: 1.10, 26.17; p = 0.04); no men had a possible UTI in this cohort, so we could not estimate odds ratios associated with sex., Conclusion: UTIs at the time of a suspected MS relapse are relatively uncommon. Female sex is a strong risk factor for UTI in people with MS; foul-smelling urine is a potential predictor of UTI in people with MS. Larger studies are needed to comprehensively evaluate the utility of screening and risk factors for UTI at the time of suspected MS relapse., (Copyright © 2019 Elsevier B.V. All rights reserved.)

An intermittent fasting or calorie restriction diet has favorable effects in the mouse forms of multiple sclerosis (MS) and may provide additional anti-inflammatory and neuroprotective advantages beyond benefits obtained from weight loss alone. We conducted a pilot randomized controlled feeding study in 36 people with MS to assess safety and feasibility of different types of calorie restriction (CR) diets and assess their effects on weight and patient reported outcomes in people with MS. Patients were randomized to receive 1 of 3 diets for 8 weeks: daily CR diet (22% daily reduction in energy needs), intermittent CR diet (75% reduction in energy needs, 2 days/week; 0% reduction, 5 days/week), or a weight-stable diet (0% reduction in energy needs, 7 days/week). Of the 36 patients enrolled, 31 (86%) completed the trial; no significant adverse events occurred. Participants randomized to CR diets lost a median 3.4 kg (interquartile range [IQR]: -2.4, -4.0). Changes in weight did not differ significantly by type of CR diet, although participants randomized to daily CR tended to have greater weight loss (daily CR: -3.6 kg [IQR: -3.0, -4.1] vs. intermittent CR: -3.0 kg [IQR: -1.95, -4.1]; P = 0.15). Adherence to study diets differed significantly between intermittent CR vs. daily CR, with lesser adherence observed for intermittent CR (P = 0.002). Randomization to either CR diet was associated with significant improvements in emotional well-being/depression scores relative to control, with an average 8-week increase of 1.69 points (95% CI: 0.72, 2.66). CR diets are a safe/feasible way to achieve weight loss in people with MS and may be associated with improved emotional health., (Copyright © 2018. Published by Elsevier B.V.)

Background: Vitamin D insufficiency is a risk factor for multiple sclerosis (MS), and patients do not always show the expected response to vitamin D supplementation., Objective: We aimed to determine if vitamin D supplementation leads to a similar increase in serum 25-hydroxyvitamin-D (25(OH)D) levels in patients with MS and healthy controls (HCs)., Methods: Participants in this open-label study were female, white, aged 18-60 years, had 25(OH)D levels ⩽ 75 nmol/l at screening, and had relapsing-remitting MS (RRMS) or were HCs. Participants received 5000 IU/day of vitamin D3 for 90 days. Utilizing generalized estimating equations we examined the relationship between the primary outcome (serum 25(OH)D level) and the primary (MS versus HC status) and secondary predictors., Results: For this study 27 MS patients and 30 HCs were enrolled. There was no significant difference in baseline 25(OH)D level or demographics except for higher body mass index (BMI) in the MS group (25.3 vs. 23.6 kg/m(2), p=0.035). In total, 24 MS subjects and 29 HCs completed the study. In a multivariate model accounting for BMI, medication adherence, and oral contraceptive use, MS patients had a 16.7 nmol/l (95%CI: 4.2, 29.2, p=0.008) lower increase in 25(OH)D levels compared with HCs., Conclusions: Patients with MS had a lower increase in 25(OH)D levels with supplementation, even after accounting for putative confounders., (© The Author(s), 2015.)

Purpose: To explore the potential association between reduced corneal sensation and/or conjunctival bacterial colonization and postoperative trichiasis and eyelid contour abnormalities after corrective eyelid surgery among participants with a history of trachomatous trichiasis., Methods: As an ancillary study to the Partnership for Rapid Elimination of Trachoma (PRET) Surgery Trial in southern Tanzania, we collected data on 580 PRET participants who had undergone trichiasis surgery 1 year earlier and 200 age-group-matched individuals without trichiasis. Assessments included eyelid status evaluation (presence and severity of postoperative trichiasis and/or eyelid contour abnormality), corneal sensitivity by Cochet-Bonnet aesthesiometer, a questionnaire on symptoms of ocular irritation, and conjunctival microbiology. We divided PRET participants based on their eyelid status and compared results across PRET groups and versus normals., Results: PRET participants had reduced corneal sensitivity compared with age-matched normals (mean sensitivity ranged from 2.8 to 3.8 cm in PRET participants vs. 5.9 cm in normals), and increasing severity of postoperative trichiasis was associated in a stepwise fashion with reduced corneal sensitivity (mean = 3.5 cm for mild and 2.6 cm for severe postoperative trichiasis). Conjunctival colonization with pathogenic bacteria was also associated with more severe postoperative trichiasis (Cochran-Armitage trend test P = 0.001) and with reduced corneal sensitivity (trend test P < 0.0001). Symptoms of ocular irritation were not associated with previous trichiasis surgery, postoperative trichiasis, or eyelid contour abnormality., Conclusions: These findings indicate that reduced corneal sensitivity accompanies trachomatous trichiasis and suggest that reduced corneal sensitivity may play an important role in the harboring of pathogenic bacteria on the ocular surface.

Aim: To determine the risk factors for acute endophthalmitis after cataract extraction in a tertiary care centre in India., Methods: We performed a nested case control study within a retrospective cohort. The surgical records of all patients with clinically diagnosed endophthalmitis within one month after cataract surgery, performed between January 2006 and December 2009, were reviewed. These were compared with randomly selected age and gender-matched controls, from patients having routine cataract surgery within ±1wk of the endophthalmitis case. Univariable and multivariable analysis were performed to identify risk factors for endophthalmitis., Results: Of the total 33 856 cataract surgeries performed during this period, there were 57 cases of postoperative acute endophthalmitis that met our study criteria. Thus, the overall incidence of endophthalmitis in our cohort was 1.6 per 1000 cataract extractions performed. Mean age of cases was 55.9y (SD: 10.9y) and for controls was 55.6y (SD: 9.8y). Thirty-five cases (61.4%) and 133 controls (59.6%) were males. Median time of onset of endophthalmitis was 4d (IQR 2-9d; range: 1-30d). Thirty-nine cases (68.4%) presented within 7d and 27 cases (47.4%) were culture positive. Two hundred and twenty-three age and gender matched controls were selected. In multivariate analysis, endophthalmitis was associated with posterior capsular rupture (PCR) during surgery (OR 6.98, 95%CI: 2.22-21.98), phacoemulsification via scleral incision with a foldable intraocular lens (IOL) implantation (OR 3.02, 95%CI: 1.13-8.04) and ocular co-morbidity (OR 2.32, 95%CI: 1.11-4.87)., Conclusion: PCR, presence of ocular co-morbidity, and phacoemulsification via scleral incision with foldable-IOL were found to be independent risk factors for acute endophthalmitis.

Purpose: Endophthalmitis is a rare but sight-threatening infection after cataract surgery. Roughly one third of eyes remain blind after treatment. We report United States population-based data on microbiological investigations and treatment patterns plus risk factors for poor outcomes., Design: Retrospective cohort study., Participants: Medicare beneficiaries from 5 states in whom endophthalmitis developed within 6 weeks after cataract surgery in 2003 and 2004., Methods: We identified endophthalmitis cases occurring after cataract surgery using Medicare billing claims. We contacted treating physicians and requested they complete a questionnaire on clinical and microbiological data and submit relevant medical records. Two independent observers reviewed materials to confirm that cases met a standardized definition., Main Outcome Measures: Positive culture results, vitrectomy status, microbiology spectrum, and final visual acuity., Results: In total, 615 cases met our case definition. Initial visual acuity was counting fingers or worse for 72%. Among 502 cases with known culture results, 291 (58%) had culture positive results. Twelve percent had positive results for streptococci. More than 99% of cases were treated with intravitreal vancomycin. Vitrectomy was performed in 279 cases (45%), including 201 cases with initial acuity better than light perception. Rates of vitrectomy varied across states, with California having the highest rate and Michigan having the lowest (56% and 19% of cases, respectively). Overall, 43% of individuals achieved visual acuity of 20/40 or better. Poor initial acuity (adjusted odds ratio [OR], 1.08; 95% confidence interval [CI], 1.04-1.12 per 0.10 logarithm of the minimum angle of resolution units), older age at diagnosis (OR, 1.22; 95% CI, 1.03-1.45 per 5-year increase), and more virulent organisms were important predictors of poor final visual acuity. Cases with streptococci infection were 10 times more likely to have poor final acuity than coagulase-negative staphylococci cases (adjusted OR, 11.28; 95% CI, 3.63-35.03). Vitrectomy was not predictive of final visual acuity (adjusted OR, 1.26; 95% CI, 0.78-2.04)., Conclusions: Population-based data on the microbiology of acute postoperative endophthalmitis in the United States after cataract surgery are consistent with prior reports. Vitrectomy usage is higher than that recommended from the Endophthalmitis Vitrectomy Study, with no evidence of increased benefit., (Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare short-term outcomes of repeat penetrating keratoplasty (PK) to those of Boston type 1 keratoprosthesis (KPro). Our hypothesis was that visual outcomes were superior for KPro compared to PK., Methods: This is a retrospective, nonrandomized, intermediate-term case series. Consecutive adults with one or more failed PKs who underwent either PK or KPro between January 2008 and December 2010 were included. Demographics, indication for the initial PK, comorbidities, concomitant procedures, and complications were considered. Only one procedure in each eye was included. All KPro procedures were retained in the analyses., Results: Fifty-three patients underwent PK and 27 received KPro. Mean follow-up was 19.5 months in the PK group and 16.5 months in the KPro group. KPro eyes had worse mean preoperative vision (hand motions vs counting fingers, P=.01) and more comorbidities. In the postoperative period, 35% of PK eyes and 45% of KPro eyes attained best-ever visual acuity of 20/70. Forty-seven percent of PK eyes vs 40% of KPro eyes were able to retain this visual acuity. Two-year rate of failure to retain visual acuity better than the baseline was higher for PK eyes, though not at a statistically significant level (hazard ratio [HR]=1.67; 95% CI, 0.78-3.60; P=.19). Two-year cumulative rate of graft failure (loss of clarity for PK and removal/replacement for KPro) was higher for PK eyes (HR=3.23; 95% CI, 1.12-9.28; P=.03). Retinal detachment, endophthalmitis, and glaucoma rates were similar (P=.6 for all)., Conclusions: These results demonstrate less frequent graft failure, greater visual improvement, and greater likelihood of maintaining the visual improvement in KPro eyes vs PK.

Purpose: While quality of life surveys have been conducted in trachomatous trichiasis (TT) surgery populations, little is known about patients' perceptions of the surgical experience and outcomes., Methods: We interviewed a subset of Partnership for the Rapid Elimination of Trachoma (PRET) surgery trial participants 24 months after surgery. Questions focused on current ocular symptoms, perceived daily functioning, physical appearance, and overall perception of surgery. We stratified participants based on surgical outcomes: normal upper eyelid, postoperative TT, or eyelid contour abnormality (ECA) in one or both eyelids. We compared responses between sexes and surgical outcome groups using contingency tables and Fisher's exact tests., Results: A total of 483 individuals participated and 86% were very satisfied with surgery results; 96% reported ocular symptom improvement. Participants with moderate to severe ECA or postoperative TT were more likely to report current ocular problems than those with normal eyelids (46% and 58% vs 34%, respectively; p = 0.01 for each comparison). The most common symptom among participants with moderate to severe postoperative TT was feeling lashes touching (blurred vision was the most common among participants with moderate to severe ECA). Overall, 83% stated surgery improved daily life; participants with ECA were less likely to report improvement than others (p = 0.002). Participants who had moderate or severe postoperative TT were least likely to state that they would undergo repeat surgery (80%), followed by participants with ECA (86%)., Conclusions: Postoperative TT and ECA both reduced satisfaction with surgery, but appeared to influence different aspects of life. Improving surgical outcomes both by reducing recurrence rates and limiting ECAs are essential.

Purpose: To evaluate the effects of 0.3 mg or 0.5 mg of ranibizumab in eyes with macular telangiectasia type 2 without subretinal neovascularization., Methods: Ten eyes were randomized to either 0.3 mg or 0.5 mg ranibizumab group in 1 eye only. Study eye received ranibizumab at baseline and at Months 1 and 2. Injections at Months 3, 4, and 5 were at investigator's discretion. Participants were followed monthly through 6 months with best-corrected visual acuity, fluorescein angiography, and optical coherence tomography., Results: For study eyes at baseline, median best-corrected visual acuity letter score was 60 (20/64 Snellen equivalent) and central subfield retinal thickness was 181.5 μm. Median number of injections was six. Median change in best-corrected visual acuity at Month 3 was 4 letters (range: -5 to 9 letters) at both doses in the study eye and 3 letters (range: -10 to 5 letters) in the untreated fellow eye. At Month 3, retinal leakage decreased 0.87 disk area and 0.76 disk area for 0.3 mg and 0.5 mg ranibizumab, respectively. Median change in central subfield retinal thickness was 1 μm and -11 µm for 0.3 mg and 0.5 mg ranibizumab, respectively., Conclusion: Ranibizumab (0.3 mg or 0.5 mg) decreases leakage secondary to macular telangiectasia type 2, but accompanying improvements in best-corrected visual acuity appear similar to improvements in the untreated fellow eye where retinal thickness is relatively unchanged.

Importance: Laser trabeculoplasty (LTP) is routinely used to treat open-angle glaucoma; hence, understanding variations in its use over time and region is important., Objective: To determine trends over time and the regional variation in the performance of LTP., Design, Setting, and Participants: Database analysis of a 5% random sample of all Medicare beneficiaries 65 years or older with continuous Part B (medical insurance) coverage and no enrollment in a health maintenance organization for each year from 2002 through 2009., Interventions: We counted unique claims with a Current Procedural Terminology code of 65855 (LTP) submitted by ophthalmologists, optometrists, ambulatory surgery centers, or outpatient hospitals by region for each year. We examined trends over time and regional variation in LTP rates in 9 large geographic regions., Main Outcomes and Measures: Rate of LTP per 10,000 Medicare beneficiary person-years and per 10,000 diagnosed open-angle glaucoma (OAG) person-years., Results: The LTP rates per 10,000 Medicare beneficiary person-years were 36.3, 60.1, and 53.5 for 2002, 2006, and 2009, respectively. The 65.6% increase between 2002 and 2006 and the 11.0% decrease between 2006 and 2009 were statistically significant (tests for linear trend, P = .009 and P < .001, respectively). Similarly, the LTP rate among Medicare beneficiaries with OAG increased from 507.9 per 10,000 person-years in 2002 to 824.3 per 10,000 person-years in 2006 (62.3% increase; P = .009) and then decreased to 741 per 10,000 person-years by 2009 (10.1% decrease; P = .004). The rates per 10,000 OAG person-years differed significantly by region, ranging from 314 in the East South-Central region to 607 in the East North-Central region in 2002 (93.2% higher; P < .001). A similar range of variation was observed in subsequent years., Conclusions and Relevance: The rate of LTP for Medicare patients with OAG peaked in 2006 and then decreased through 2009. Nearly twice as many LTP procedures per Medicare beneficiary were performed in some regions compared with others throughout the period.

Purpose: To estimate payments for glaucoma care among Medicare beneficiaries from 2002 to 2009., Design: Database study., Participants: Data from a 5% random sample of Medicare billing information from 2002 to 2009., Methods: Medicare beneficiaries, aged 65 years or older, with both Parts A and B fee-for-service (FFS) enrollment comprised the annual denominator. For each year, we included those with a defined glaucoma diagnostic code linked to a glaucoma visit, diagnostic test, or laser/surgical procedure. Open-angle, angle-closure, and other glaucoma were categorized separately. Claims were classified into glaucoma care, other eye care, and other medical care., Main Outcome Measures: Cost of glaucoma care in the Medicare Fee-for-Service Population., Results: In 2009, total glaucoma payments by Medicare were $37.4 million for this subset, for an overall estimated cost of $748 million, or 0.4% of an estimated cost of $192 billion for all Medicare FFS payments. Office visits comprised approximately one half, diagnostic testing was approximately one-third, and surgical and laser procedures were approximately 10% of glaucoma-related costs. Coded open-angle glaucoma (OAG) and OAG suspects accounted for 87.5% of glaucoma costs, whereas cost per person was highest in "other glaucoma." In 2009, <3% of patients with OAG underwent incisional surgery and approximately 5% had laser trabeculoplasty. Laser iridotomy was the highest cost category among patients with angle-closure glaucoma, whereas office visits was the highest cost category among the "other glaucoma" group. The total cost of nonglaucoma eye care for patients with glaucoma was 67% higher than their glaucoma care costs; these were chiefly costs for cataract surgery and treatment of retinal diseases. From 2002 to 2009, FFS glaucoma care costs calculated in 2009 dollars were stable and cost per person per year in 2009 dollars decreased from $242 to $228 (P = 0.01 by test for linear trend)., Conclusions: Annual glaucoma care costs per person decreased in constant dollars from 2002 to 2009. Cataract and retinal eye care for patients with glaucoma substantially exceeded the cost of their glaucoma care each year. Visit payments represented the largest category of costs., (Copyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Half of high-risk, uninsured/underinsured individuals identified through vision screening as needing eye exams do not attend. Patients who attended vision screening and were referred for an exam but did not attend that exam were contacted and asked whether they were interested in receiving a free complete eye exam at an offsite center within three blocks of the clinic. Those who agreed were asked why they did not attend their original appointment and what would make it easier to attend. Primary reasons for missing appointments included forgetting (34%), lacking transportation (36%), and scheduling conflicts (26%). Nearly one quarter (24%) stated they could not afford transportation. Findings demonstrate transportation is a key barrier to eye care services. Current eye care delivery can be improved by addressing barriers to attendance in this context. Alternative delivery models should be examined to identify methods for better reaching underserved target populations.

Purpose: To evaluate which components of a vision screening process are most effective in identifying individuals who need eye care services., Methods: Subjects visiting a free health clinic were screened using visual acuity and a questionnaire. Persons who failed screening were referred for a professional eye examination., Results: A total of 1380 of 3004 screened persons (46%) screened positive on question(s) or distance visual acuity; 81% of screened positives were referred for an eye exam, <50% of the positives attended the examination, and one-third had ≥1 problem requiring intervention or monitoring. The most common problem was distance refractive error that, once corrected, improved vision by two or more lines, followed by glaucoma or glaucoma suspect (8.9%), visually significant cataract (7.2%), and diabetic retinopathy (2.5%). Ninety-four subjects who screened negative ("normal") were examined; nearly half of these had 2+ lines of visual acuity improvement with refraction (from 20/40 or 20/32 to 20/20). Sensitivity for detecting specific eye conditions varied substantially, ranging from 0-83% for individual screening questions. Time since last exam and distance acuity <20/50 were the most sensitive questions for visually significant cataract; however, their specificity was low. No combination of questions and acuity testing had both high sensitivity and specificity., Conclusions: Vision problems requiring intervention were common among this relatively young population, but no combination of screening questions and vision testing proved effective for screening. More than half of those who screened positive never showed for an examination, indicating that on-site eye exams might be more effective.

Objective: To determine whether a new surgical clamp reduces unfavorable postoperative outcomes., Methods: Patients with trachomatous trichiasis (TT) were randomized to surgery with standard bilamellar tarsal rotation (BLTR) instrumentation or the TT clamp and were followed up for 2 years., Main Outcome Measures: Postoperative TT, pyogenic granuloma formation, and eyelid contour abnormalities, combined and individually., Results: A total of 1917 participants who had surgery (3345 eyes) were enrolled. Rates of at least 1 unfavorable outcome were similar for the participants who underwent surgery with the TT clamp and those who underwent surgery with standard BLTR (60.9% vs 63.0%, respectively; adjusted odds ratio [AOR] = 0.88; 95% CI, 0.66-1.18). Granuloma was less common in the TT clamp arm than in the standard BLTR arm (16.8% vs 22.4%, respectively; AOR = 0.67; 95% CI, 0.46-0.97). There was a trend toward increased postoperative TT in the TT clamp arm compared with the standard BLTR arm (43.2% vs 36.6%, respectively; AOR = 1.36; 95% CI, 0.96-1.93). The TT clamp decreased the risk of mild eyelid contour abnormalities compared with standard BLTR (9.1% vs 13.3%, respectively; AOR = 0.64; 95% CI, 0.42-0.97) and showed a trend for a decrease in moderate abnormalities (5.3% vs 7.8%, respectively; AOR = 0.63; 95% CI, 0.39-1.01)., Conclusions: Overall, rates of unfavorable outcomes were similar between groups. Although our results are similar to other programmatic settings, such high rates of unfavorable outcomes are unacceptable; future research is needed to identify ways to improve TT surgery outcomes., Application to Clinical Practice: A new clamp for TT surgery appears to offer protection against granuloma formation and some eyelid contour abnormalities, but it does not reduce postoperative TT., Trial Registration: clinicaltrials.gov Identifier: NCT00886015.

Purpose: To present descriptive epidemiology of cataract surgery among Medicare recipients in the United States., Setting: Cataract surgery performed on Medicare beneficiaries in 2003 and 2004., Methods: Medicare claims data were used to identify all cataract surgery claims for procedures performed in the United States in 2003-2004. Standard assumptions were used to limit the claims to actual cataract surgery procedures performed. Summary statistics were created to determine the number of procedures performed for each outcome of interest: cataract surgery rates by age, sex, race and state; surgical volume by facility type and surgeon characteristics; time interval between first- and second-eye cataract surgery., Results: The national cataract surgery rate for 2003-2004 was 61.8 per 1000 Medicare beneficiary person-years. The rate was significantly higher for females and for those aged 75-84 years. After adjustment for age and sex, blacks had approximately a 30% lower rate of surgery than whites. While only 5% of cataract surgeons performed more than 500 cataract surgeries annually, these surgeons performed 26% of the total cataract surgeries. Increasing surgical volume was found to be highly correlated with use of ambulatory surgical centers and reduced time interval between first- and second-eye surgery in the same patient., Conclusions: The epidemiology of cataract surgery in the United States Medicare population documents substantial variation in surgical rates by race, sex, age, and by certain provider characteristics.

Purpose: To determine the prevalence of diagnosed glaucoma in the Medicare population and to assess regional variations and trends., Design: Retrospective, cross-sectional study., Participants: A 5% random sample of Medicare beneficiaries aged ≥ 65 years, excluding those in health maintenance organizations., Methods: All claims with a glaucoma diagnosis code submitted by ophthalmologists, optometrists, or ambulatory surgery centers were used to estimate prevalence of the diagnosis of glaucoma for each year from 2002 to 2008. Regional variation in diagnosed glaucoma was examined in 9 large geographic regions and in 179 smaller subregions, controlling for patient characteristics and provider supply., Main Outcome Measures: The prevalence of diagnosed open-angle glaucoma suspect (OAG-s), open-angle glaucoma (OAG), angle-closure glaucoma suspect (ACG-s), and angle-closure glaucoma (ACG), trends over time, and regional variations in prevalence., Results: The overall prevalence increased from 10.4% in 2002 to 11.9% by 2008, largely owing to increase in diagnosed OAG-s (from 3.2% to 4.5%; P<0.001). The relative prevalence of diagnosed OAG compared with diagnosed ACG was 32:1. In 2008, multivariable models showed that the New England and Mid-Atlantic regions had 1.7 times more diagnosed OAG-s than the reference region (East South Central; New England: odds ratio [OR], 1.66; 95% confidence interval [CI], 1.58-1.75; Mid-Atlantic: OR, 1.66; 95% CI, 1.59-1.73). The odds of diagnosed OAG was 36% higher in New England (OR, 1.36; 95% CI, 1.30-1.42) and 31% higher in the Mid-Atlantic (OR, 1.31; 95% CI, 1.26-1.36) than in the reference region. The New England and Mid-Atlantic regions had the highest odds of diagnosed ACG-s and the Mid-Atlantic region had the highest odds of diagnosed ACG. Among 179 subregions, the New York area had high diagnosis rates of all glaucoma types., Conclusions: The relative prevalence of diagnosed ACG compared with diagnosed OAG was lower than expected from population-based data, possibly owing to failure to perform gonioscopy. Substantial regional differences in diagnosed rates existed for all types of glaucoma, even after adjusting for patient characteristics and provider concentration, suggesting possible overdiagnosis in some areas and/or underdiagnosis in other areas. Regionally higher diagnosis rates in the New York area deserve further study., (Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Objective: To estimate endophthalmitis incidence after cataract surgery nationally and at the state level in 2003 and 2004 and to explore risk factors., Design: Analysis of Medicare beneficiary claims data., Participants: We evaluated billed claims for cataract surgery and endophthalmitis diagnosis and treatment for all Medicare fee-for-service beneficiaries in 2003-2004., Methods: Cataract surgeries were identified by procedure codes and merged with demographic information. Cataract annual surgical volume was calculated for all surgeons. Presumed postoperative endophthalmitis cases were identified by International Classification of Diseases-9 Clinical Modification Codes on claims within 42 days after surgery. Endophthalmitis rates and 95% confidence intervals (CI) were calculated at state and national levels. Logistic regression was used to investigate the association between developing endophthalmitis and surgery location and surgeon factors., Main Outcome Measures: Endophthalmitis incidence and risk factors., Results: We included 4006 cases of presumed endophthalmitis, which occurred after 3 280 966 cataract surgeries. The national rate in 2003 was 1.33 per 1000 surgeries (95% CI, 1.27-1.38) and decreased to 1.11 per 1000 (95% CI, 1.06-1.16) in 2004. Males (relative risk [RR], 1.23; 95% CI, 1.15-1.31), older individuals (RR, 1.53; 95% CI, 1.38-1.69; ≥85 compared with 65-74 years), blacks (RR, 1.17; 95% CI, 1.03-1.33), and Native Americans (RR, 1.72; 95% CI, 1.07-2.77) had increased risk of disease. After adjustment, surgeries by surgeons with low annual volume (RR, 3.80; 95% CI, 3.13-4.61 for 1-50 compared with ≥1001 annual surgeries) and less experience (RR, 1.41; 95% CI, 1.25-1.59 for 1-10 compared with ≥30 years), and surgeries performed in 2003 (RR, 1.20; 95% CI, 1.13-1.28) had increased endophthalmitis risk., Conclusions: Endophthalmitis rates are lower than previous yearly US estimates, but remain higher than rates reported from a series of studies from Sweden; patient factors or methodologic differences may contribute to differences across countries. Patient age, gender, and race, and surgeon volume and years of experience are important risk factors., (Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To determine the sensitivity of time domain optical coherence tomography (OCT) in detecting conversion to neovascular age-related macular degeneration (AMD) in eyes at high risk for choroidal neovascularization (CNV), compared with detection using fluorescein angiography (FA) as the gold standard., Design: Prospective, multicenter, observational study., Participants: Individuals aged ≥50 years with nonneovascular AMD at high risk of progressing to CNV in the study eye and evidence of neovascular AMD in the fellow eye., Methods: At study entry and every 3 months through 2 years, participants underwent best-corrected visual acuity, supervised Amsler grid testing, preferential hyperacuity perimetry (PHP) testing, stereoscopic digital fundus photographs with FA, and OCT imaging. A central Reading Center graded all images., Main Outcomes Measures: The sensitivity of OCT in detecting conversion to neovascular AMD by 2 years, using FA as the reference standard. Secondary outcomes included comparison of sensitivity, specificity, positive predictive value, and negative predictive value of OCT, PHP, and supervised Amsler grid relative to FA for detecting incident CNV., Results: A total of 98 participants were enrolled; 87 (89%) of these individuals either completed the 24-month visit or exited the study after developing CNV. Fifteen (17%) study eyes had incident CNV confirmed on FA by the Reading Center. The sensitivity of each modality for detecting CNV was: OCT 0.40 (95% confidence interval [CI], 0.16-0.68), supervised Amsler grid 0.42 (95% CI, 0.15-0.72), and PHP 0.50 (95% CI, 0.23-0.77). Treatment for incident CNV was recommended by the study investigator in 13 study eyes. Sensitivity of the testing modalities for detection of CNV in these 13 eyes was 0.69 (95% CI, 0.39-0.91) for OCT, 0.50 (95% CI, 0.19-0.81) for supervised Amsler grid, and 0.70 (95% CI, 0.35-0.93) for PHP. Specificity of the OCT was higher than that of the Amsler grid and PHP., Conclusions: Time-domain OCT, supervised Amsler grid, and PHP have low to moderate sensitivity for detection of new-onset CNV compared with FA. Optical coherence tomography has greater specificity than Amsler grid or PHP. Among fellow eyes of individuals with unilateral CNV, FA remains the best method to detect new-onset CNV., (Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Background: Surgical technique, including suture placement and tension, is believed to contribute to the outcome of bilamellar tarsal rotation surgery for trachomatous trichiasis. However, the immediate post-operative appearance that minimizes the chance of recurrence and other adverse outcomes has not been investigated., Methodology/principal Findings: To explore whether the degree of correction immediately after surgery is predictive of surgical outcome at the 6-week post-operative visit, photographs taken immediately after surgery were used to predict surgical outcomes, including the severity of eyelid contour abnormality and trichiasis recurrence. Both eyelid contour abnormalities and recurrence were accurately predicted from the immediate post-operative photographs by an experienced oculoplastic surgeon 85% and 70% of the time, respectively. Participants with a "slight over-correction" that resulted in no eyelid contour abnormality and no recurrence were used to identify immediate post-operative contours that lead to a successful surgical outcome., Conclusions/significance: The immediate post-operative eyelid contour is an important indicator of post-operative success of BLTR surgery. Based upon our findings, we developed a Surgery Photocard. This card illustrates some examples of immediate post-surgical appearances, which led to a successful outcome, as well as sub-optimal appearances, which led to poor surgical outcomes. The card also provides suggestions for improving the appearance by adjusting the suture placement or tension based upon standard oculoplastic principles.

Purpose: To report visual outcomes and risk factors for poor outcomes of cataract surgery in three Integrated Tribal Development Agency (ITDA) areas of Andhra Pradesh, India., Methods and Results: Using validated Rapid Assessment of Avoidable Blindness (RAAB) methodology, a population based cross-sectional study, was conducted in three ITDA areas. A two-stage sampling procedure was used to select 7281 participants aged 50 years and above. Vision assessment using a tumbling E chart and standard ocular examinations were completed. Visual outcomes and risk factors for poor outcomes were assessed among subjects undergoing cataract surgery (1548 eyes of 1124 subjects). Mean age at surgery was 67±8 years; Among the operated eyes, presenting visual acuity (PVA) and best corrected visual acuity (BCVA) worse than 6/18 was seen in 492 (31.8%; 95% CI, 29.5-34.2%) and 298 eyes (19.3%; 95% CI, 17.3-21.3%), respectively. Similarly, PVA and BCVA worse than 6/60 was seen in 219 (14.1%; 95% CI, 12.4-16%) and 147 eyes (9.5%; 95% CI, 8.1-11.1%), respectively. When either eye was taken into consideration, the PVA and BCVA worse than 6/18 was seen in 323 (20.1%; 95% CI, 18.9-23%) and 144 subjects (9.3%; 95% CI, 7.9-10.9%), respectively. PVA and BCVA worse than 6/60 was seen in 74 (4.8%; 95% CI, 3.8-6%) and 49 subjects (3.2%; 95% CI, 2.4-4.2%), respectively. Posterior capsular opacification was seen in 51 of 1316 pseudophakic eyes (3.9%; 95% CI, 2.9-5.1%). In multivariable analysis among pseudophakic subjects with PVA worse than 6/18, increasing age (p = 0.002) and undergoing free surgery (p = 0.05) were independent risk factors. Undergoing surgery before 2005 (p = 0.05) and being illiterate (p = 0.05) were independent risk factors for BCVA worse than 6/18., Conclusions: There are changing trends with improved outcomes in cataract surgery among these tribal populations of India. However, post-operative refractive error correction remains an issue, especially for those undergoing free surgeries.

Background: Clear definitions of outcomes following trichiasis surgery are critical for planning program evaluations and for identifying ways to improve trichiasis surgery. Eyelid contour abnormality is an important adverse outcome of surgery; however, no standard method has been described to categorize eyelid contour abnormalities., Methodology/principal Findings: A classification system for eyelid contour abnormalities following surgery for trachomatous trichiasis was developed. To determine whether the grading was reproducible using the classification system, six-week postoperative photographs were reviewed by two senior graders to characterize severity of contour abnormalities. Sample photographs defining each contour abnormality category were compiled and used to train four new graders. All six graders independently graded a Standardization Set of 75 eyelids, which included a roughly equal distribution across the severity scale, and weighted kappa scores were calculated. Two hundred forty six-week postoperative photographs from an ongoing clinical trial were randomly selected for evaluating agreement across graders. Two months after initial grading, one grader regraded a subset of the 240 photographs to measure longer-term intra-observer agreement. The weighted kappa for agreement between the two senior graders was 0.80 (95% CI: 0.71-0.89). Among the Standardization Set, agreement between the senior graders and the 4 new graders showed weighted kappa scores ranging from 0.60-0.80. Among 240 eyes comprising the clinical trial dataset, agreement ranged from weighted kappa 0.70-0.71. Longer-term intra-observer agreement was weighted kappa 0.86 (95% CI: 0.80-0.92)., Conclusions/significance: The standard eyelid contour grading system we developed reproducibly delineates differing levels of contour abnormality. This grading system could be useful both for helping to evaluate trichiasis surgery outcomes in clinical trials and for evaluating trichiasis surgery programs.

Purpose: To evaluate the physical functioning of Ethiopian trichiasis surgery patients before and 6 months after surgery., Design: Nested cohort study., Methods: This study was nested within the Surgery for Trichiasis, Antibiotics to Prevent Recurrence (STAR) clinical trial conducted in Ethiopia. Demographic information, ocular examinations, and physical functioning assessments were collected before and 6 months after surgery. A single score for patients' physical functioning was constructed using Rasch analysis. A multivariate linear regression model was used to determine if change in physical functioning was associated with change in visual acuity., Results: Of the 438 participants, 411 (93.8%) had both baseline and follow-up questionnaires. Physical functioning scores at baseline ranged from -6.32 (great difficulty) to +6.01 (no difficulty). The percentage of participants reporting no difficulty in physical functioning increased by 32.6%; the proportion of participants in the mild/no visual impairment category increased by 8.6%. A multivariate linear regression model showed that for every line of vision gained, physical functioning improves significantly (0.09 units; 95% CI: 0.02-0.16)., Conclusions: Surgery to correct trichiasis appears to improve patients' physical functioning as measured at 6 months. More effort in promoting trichiasis surgery is essential, not only to prevent corneal blindness, but also to enable improved functioning in daily life., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Objective: To determine whether year of residency is associated with intraoperative phacoemulsification complication rates., Design: Retrospective cohort study., Participants: One attending physician supervised 691 resident-performed phacoemulsification procedures on 492 patients. Second- and third-year residents performed 228 and 463 cases, respectively., Methods: All resident-performed phacoemulsification procedures performed between October 2003 and June 2008 and supervised by one attending surgeon (SR) were considered for this study. Data were collected on the residency year of the physician performing the surgery, preoperative risk indicators, and intraoperative complications, including anterior and posterior capsular tears with or without vitreous loss, zonular dialysis or dehiscence, burns, nuclear fragment loss, and Descemet's membrane tear. Cases were classified as difficult if they had 1 or more preoperative risk indicators including: pseudoexfoliation; proliferative diabetic retinopathy; prior vitrectomy; a 4+ dense, white, or brunescent cataract; current Flomax (Boehringer-Ingelheim, Ingelheim, Germany) use, pre-existing zonular dialysis; and intraoperative use of Trypan blue, iris hooks, or pupil dilator. Intraoperative complications are presented as rate per 100 surgeries (95% confidence intervals [CIs])., Main Outcome Measures: Intraoperative complication rates and case difficulty., Results: Fifty-three patients experienced at least 1 complication, with 25 cases experiencing multiple complications. Intraoperative complication rates were similar among second- and third-year resident groups (7.9% vs. 7.6%; P = 0.88). Similarly, vitreous loss rates among second- and third-year residents were comparable (4.8% vs. 3.0%; P = 0.27). Risk indicators were more common among third-year cases (24.6% vs. 15.8%; P = 0.008). Having 1 or more risk indicators increased the odds of an intraoperative complication (odds ratio [OR], 3.09; 95% CI, 1.73-5.49). After controlling for risk indicators, second-year resident surgeries still had a similar risk of intraoperative complications as third-year resident surgeries (OR, 1.15; 95% CI, 0.6-2.19)., Conclusions: The year of residency did not significantly influence intraoperative complication rates, even after controlling for differences in case difficulty., (Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To determine the safety and effect of ranibizumab on predominantly hemorrhagic choroidal neovascular lesions due to age-related macular degeneration., Methods: Seven subjects with predominantly hemorrhagic choroidal neovascular lesions were treated with intravitreal injections of ranibizumab at baseline, Month 1, and Month 2. Additional monthly injections were given through Month 11 at the discretion of the examiner for a potential maximum of 12 injections., Results: At 12 months, the median visual acuity letter score was 30 (Snellen equivalent: 20/250), with a median change from baseline to last follow-up of +7 letters. Three of 7 subjects (43%) gained 2 or more lines of vision, while no subject lost 2 or more lines. The median change in OCT central subfield thickness from baseline to Month 12 was -109 microm, with a mean of -120 +/- 158 microm. Two eyes had retinal pigment epithelial tears. No ocular adverse events or systemic adverse events were reported related to the usage of ranibizumab., Conclusion: With no subject losing 2 or more lines of visual acuity over 12 months and no new safety concerns identified, these predominantly hemorrhagic lesions treated with ranibizumab appeared to have a better visual acuity outcome than the natural history controls of the submacular surgery trials. While the study is limited by few cases enrolled, the results suggest that ranibizumab is able to penetrate through the subretinal hemorrhage to affect the underlying hemorrhagic choroidal neovascular lesion and the natural history.

Purpose: The purpose of this study was to evaluate the cost effectiveness of pegaptanib sodium and ranibizumab injections compared with photodynamic therapy (PDT) with verteporfin for the treatment of choroidal neovascularization secondary to age-related macular degeneration., Methods: The analyses were performed using outcomes data from the pivotal trials for each treatment and the medicare reimbursable costs for each treatment and associated medical procedures. A multistate transition model with 3-month cycles was created to compare incremental medical costs associated with pegaptanib or ranibizumab versus PDT for patients with starting vision of 20/40, 20/80, and 20/200 Snellen equivalent., Results: Two-year medical treatment costs ranged from $3,100 to $54,100 depending on treatment and lesion type. Photodynamic therapy was less costly and more effective than pegaptanib for predominantly classic and minimally classic lesions. Ranibizumab was not only more effective but also more costly than PDT for all lesion types., Conclusion: Compared with PDT, pegaptanib is inferior in both cost and effectiveness, whereas ranibizumab has a greater effectiveness. Because ranibizumab does not meet 1 of the common thresholds for being considered cost effective (<$50,000 per quality-adjusted life year), there is rationale to seek other therapies that are more cost effective.

Purpose: To evaluate the performance of a questionnaire, the Refractive Status and Vision Profile (RSVP), in the assessment of patient outcomes following refractive surgery., Setting: Patients recruited from 5 refractive surgery practices., Methods: The RSVP was self-administered by patients before and 2 to 6 months after bilateral refractive surgery. Information on uncorrected visual acuity (UCVA), refractive error, and self-reported satisfaction with vision was also collected. Changes in total RSVP scores and in the scores of RSVP subscales (concern, functioning, driving, symptoms, optical problems, glare, and trouble with corrective lenses) were assessed. The relationship between change in the RSVP and subscale scores was assessed in relation to change in traditional clinical measures. The responsiveness of the RSVP to clinically meaningful changes in patients' vision was measured by calculating its effect size., Results: One hundred seventy-six patients completed baseline and postoperative RSVPs and had bilateral refractive surgery. Postoperatively, 92.0% of patients had a UCVA of 20/40 or better in at least 1 eye. Fifteen percent had some worsening in the total RSVP score, and there was substantial variation in the proportion of patients who had worsening in particular subscale scores, ranging from 7.0% who reported worsening in trouble with corrective lenses to 41.5% who reported worsening in driving. Change in satisfaction with vision following surgery was correlated with change in the overall RSVP and subscale scores but not with change in refractive error. A significant worsening in 3 or more RSVP subscales was independently associated with an almost 6-fold (odds ratio 5.84, 95% confidence interval: 1.88,18.13) likelihood of patient report of dissatisfaction with vision, after adjusting for age, sex, preoperative refractive error, and postoperative UCVA. Low scores (ie, minimal dysfunction) on 2 of the RSVP subscales (physical functioning and optical problems) at baseline were predictive of poor postoperative patient outcomes. The RSVP was very sensitive to the intervention of refractive surgery (effect size of 1.2 to 1.4)., Conclusions: The RSVP was able to detect clinically relevant changes in functional status and quality of life after refractive surgery. Change in the RSVP score was correlated with change in patient report of satisfaction and was predictive of postoperative patient satisfaction. The RSVP provides a valuable new metric to assess outcomes of refractive surgery.

Purpose: There is increased recognition that a rigorous approach to functional assessment should complement the assessment of clinical status. The authors compare the reliability, validity, and responsiveness to clinical change of a visual function index (VF-14) in non-U.S. and in U.S. patients with cataracts., Design: An observational longitudinal study was performed., Participants: One thousand four hundred seven first eye cataract surgery patients were recruited in four international sites: Manitoba (Canada), Denmark, Barcelona (Spain), and the United States., Intervention: Patients were evaluated before cataract surgery and at a 4-month postoperative follow-up visit. Patients completed the preoperative interview and the clinical examination (766 in the United States, 152 in Manitoba, 291 in Denmark, and 198 in Barcelona), and 91.3% of those (1284) also completed the 4-month postoperative follow-up interview and were evaluated postoperatively by an ophthalmologist., Main Outcome Measures: The authors used the following measures: the visual function index (VF-14), the Sickness Impact Profile (SIP), global measures of patients' trouble and satisfaction with vision, and best-corrected visual acuity (VA) in each eye., Results: The VF-14 showed a high internal consistency reliability level in all sites (Cronbach's alpha coefficients > or = 0.84). Correlation of preoperative visual function index scores with the Vision-Related SIP was strong (r = -0.68 in non-U.S. and r = -0.57 in U.S. patients) and with VA in the eye with better vision was moderate (r = 0.40 and r = 0.27, respectively), the pattern of relationships being very similar among U.S. and non-U.S. patients. In patients with only first-eye surgery who reported that their initial trouble with vision had improved, the amount of change in visual function as assessed by the VF-14 (effect size) was large (1.01 for the non-U.S. patients and 1.17 for the U.S. patients)., Conclusions: The non-U.S. versions of the visual function index (VF-14) analyzed are as reliable, valid, and responsive to clinical change as the original U.S. version. These versions are appropriate for international studies of cataract patients outcomes and possibly in routine clinical practice.

Purpose: Previous analyses of Medicare claims data, as well as clinical series, have suggested that performance of neodymium:YAG (Nd:YAG) laser posterior capsulotomy after extracapsular cataract surgery increases significantly the risk of retinal detachment. However, methodologic problems with previous research limit the strength of conclusions that can be drawn from these earlier studies. This study was designed to resolve those methodological limitations while using a population-based approach for assessment of the independent association between the performance of Nd:YAG laser posterior capsulotomy and pseudophakic retinal detachment., Methods: A nested case-control study was conducted. Medicare beneficiaries who had undergone extracapsular cataract extraction from 1988 to 1990 were identified from a 5% sample of Medicare claims data. Within this cohort, people who were diagnosed or treated for retinal detachment during the years 1988 through 1991 (cases) were identified from Medicare records. Four controls were matched to each case of retinal detachment using an incidence density design. Providers of the patients' cataract and retinal surgery were contacted and asked to provide clinical data for all cases and controls that they had treated., Results: Seven hundred six cases of retinal detachment were originally identified from Medicare records. After exclusions due to ineligibility, a total of 291 cases and 870 matched controls were available for analysis. Conditional logistic regression models showed that a number of factors were associated independently with an excess risk of retinal detachment after cataract surgery. These included Nd:YAG laser capsulotomy (odds ratio [OR] = 3.8; 95% confidence interval [CI], 2.4-5.9), a history of retinal detachment (OR = 2.7; 95% CI, 1.2-6.1), a history of lattice degeneration (OR = 6.6; 95% CI, 1.6-27.1), axial length (OR = 1.21/mm; 95% CI, 1.03-1.43), refractive error (OR = 0.92/diopter; 95% CI, 0.88-0.95), and a history of ocular trauma after cataract surgery (OR = 6.1; 95% CI, 4.3-28.2)., Conclusion: Performance of Nd:YAG laser posterior capsulotomy is associated with a significantly elevated risk of retinal detachment in patients who have undergone extracapsular cataract extraction. Other independent risk factors for retinal detachment include axial length, myopia, posterior capsular rupture during surgery, history of retinal detachment or lattice degeneration, and ocular trauma after cataract surgery.

Objectives: To assess the test-retest reliability and responsiveness of the VF-14, which is an index of functional impairment in patient with cataracts., Design: Observational longitudinal study. Patients were enrolled prior to undergoing their first cataract surgery between July 15 and December 15, 1991, and they were followed up for 1 year after surgery., Setting: Patients were recruited from 72 ophthalmologists' practices in three US cities., Patients: Five hundred fifty-two patients who had undergone a surgical procedure in only one eye by the 4-month postoperative follow-up (responsiveness analyses) and a subset of these (n = 426) who had not subsequently undergone surgery for the second eye by the 12-month postoperative follow-up (reproducibility analyses)., Main Outcome Measures: Two health status measures (the VF-14 and the Sickness Impact Profile, two global measures of a patient's trouble and satisfaction with his or her vision, and best corrected visual acuity in each eye., Results: The VF-14 is highly reproducible, with an intraclass correlation coefficient of .79 when patient-rated criteria are used to define stable patients. The intraclass correlation coefficient was lower (.57 to .71) when various measures of visual acuity were used to define stable patients. The VF-14 is also about three times more responsive to a change in vision than the Sickness Impact Profile, which is a generic health status measure (effect size of approximately 1.00 vs 0.30). Estimates of the responsiveness of the VF-14 and the Sickness Impact Profile were not associated with preoperative visual acuity in the operated on or better eye. Responsiveness of the VF-14, however, was higher in patients with greater self-rated trouble with vision preoperatively., Conclusions: The VF-14 was reproducible in stable patients during an 8-month period, and it was more responsive to clinically significant changes in vision than was a generic health status measure (ie, the Sickness Impact Profile).

Objective: To describe the relationship between patients' preoperative expectations regarding the outcome of cataract surgery and actual postoperative experience., Methods: A longitudinal study of 772 patients undergoing first eye cataract surgery recruited from 75 ophthalmology practices in three metropolitan areas was conducted. Prior to surgery and approximately 4 months after surgery, a detailed interview was conducted that included general and vision-specific health status measures (including the Visual Function 12-Item Scale [VF-12]), patient-reported level of trouble and satisfaction with vision, and questions addressing patients' preoperative expectations regarding the outcomes of surgery. In addition, detailed clinical data were collected preoperatively and postoperatively. A total of 552 patients had only single eye cataract surgery by 4 months postoperatively and are included in this analysis., Results: Patients' preoperative expectations regarding the impact of cataract surgery were very high and were unrelated to their demographic or ocular characteristics. The preoperative VF-12 score, however, was positively correlated with expected postoperative VF-12 score (Spearman correlation, .45, P < .001). Only 61% of patients achieved or surpassed their expected level of postoperative functioning. The difference between expected and actual postoperative VF-12 scores was not associated with patients' demographic characteristics or provider-related variables. Older patients (> 75 years) and patients with ocular comorbidity had a larger difference between expected and actual postoperative functioning than younger patients and those without ocular comorbidity., Conclusion: Expectations regarding visual functioning after cataract surgery are very high, and in most cases such expectations are fulfilled. In selected cases, more comprehensive counseling may reduce the discrepancy between expectations and actual outcomes of cataract surgery.

Because registered nurses are assuming expanded roles in hospital management, the appropriate educational preparation for these roles has become a widely debated issue. A national survey of hospital CEOs and CNOs was conducted to assess their personal preferences for management education for nurses and to gather information about their hospitals' policies and practices in hiring nurses for management positions at various levels within the hospital (from unit-level management to executive level). Both CEOs and CNOs preferred the joint MSN/MBA degree option as the best model for graduate management education for nurses, and they perceived greater demand in the future for hospital nurses with graduate management degrees. However, hospital policies and practices with regard to degree requirements and preferences for nurses hired in management positions at all levels varied widely.

Purpose: To identify preoperative patient characteristics associated with a lack of improvement on one or more measures 4 months after cataract surgery., Methods: The authors collected preoperative and 4-month postoperative information on 552 patients undergoing first-eye cataract surgery from the practices of 72 ophthalmologists in three cities. The principal outcomes assessed were (1) Snellen visual acuity, (2) a cataract-related symptom score (possible range: 0, 0 of 6 symptoms present or bothersome, to 18, all 6 symptoms very bothersome), and (3) a measure of functional impairment in patients with cataract--the VF-14 score (possible range: 0, inability to perform any of the applicable activities, to 100, no difficulty performing any of the applicable activities). Multiple logistic regression was used to assess the association between preoperative patient characteristics and failure to improve on one or more outcome measures. Multiple linear regression was used to estimate the adjusted rate of lack of improvement in one or more outcome measures for one group of patients compared with another., Results: Although 91 patients (16.5%) failed to improve on one or more of the outcome measures assessed, only 2 (0.4%) failed to improve on all three measures. The 91 patients who did not improve on at least one measure were approximately one sixth as likely to be satisfied with their vision postoperatively as the 461 patients who improved on all three outcome measures. Preoperative age of 75 years of age or older, VF-14 score of 90 or higher, cataract symptom score of 3 or lower, and ocular comorbidity (glaucoma, diabetic retinopathy, or age-related macular degeneration) were associated independently with increased likelihood of not improving on one or more measure (odds ratio: 3.57, 2.10, 3.29, and 2.16, respectively). The mean adjusted rate of failure to improve on at least one of the outcome measures ranged from 20.5% to 26.5% for patients with these preoperative characteristics compared with 8.8% to 13.8% for those patients without them. The preoperative level of Snellen visual acuity was not associated with the likelihood of not improving on one or more of the outcomes assessed., Conclusions: The authors conclude that specific preoperative characteristics (age, comorbidity, cataract symptom score, and VF-14 score) are independent predictors of patient outcome after cataract surgery.

The increased demand for health status measures in evaluating medical interventions has increased the importance of clarifying when to use generic versus disease-specific health status measures. The authors compared the performance of a well known generic health status measure, the Sickness Impact Profile (SIP), and a disease-specific measure of functional impairment related to vision (the VF-14) in detecting functional impairment in 426 cataract patients before and at 12 months after first eye cataract surgery. Using analysis of covariance models, the associations were assessed between the SIP and VF-14 and four criterion variables--patient ratings of trouble and satisfaction with their vision and overall health, and best corrected visual acuity--after controlling for patient age and medical comorbidities. Preoperative patient ratings of trouble and satisfaction with vision were significantly associated with VF-14 scores (P < 0.001), but not with SIP scores. Preoperative visual acuity in the better eye was significantly associated with both VF-14 and SIP scores (P < 0.001). Patient general health ratings were significantly associated with SIP scores (P < 0.001), but not with VF-14 scores. Postoperative changes in patient ratings of their vision and in visual acuity were significantly associated with changes in VF-14 scores (P < 0.05), but not with changes in SIP scores. Changes in patient ratings of overall health were significantly associated with changes in SIP scores (P < 0.01), but not with changes in VF-14 scores. In patients undergoing cataract surgery, a disease-specific health status measure is more sensitive to preoperative functional impairment related to vision, and to change in functional impairment after cataract surgery, than is a generic health status measure.

Objective: Patients discharged from a self-managed nursing unit are compared with patients from traditionally managed units on postdischarge outcomes., Data Sources and Study Setting: Primary data were collected on patients discharged from eight nursing units in three clinical areas in one hospital from August through November 1990., Study Design: A case series of eligible patients discharged from four self-managed nursing units (n = 140) are compared with patients from four matched traditionally managed units (n = 138) on postdischarge outcomes: perceived health status, perceived functional status, needs for care, unmet needs for care, unplanned health care visits, and readmissions to the hospital within 31 days of discharge., Data Collection Methods: Patients were interviewed by telephone at approximately two weeks postdischarge, and data from hospital records were merged with interview data., Principal Findings: Bivariate and multiple logistic regression analyses showed no significant effects (either positive or negative) of self-managed units on the postdischarge outcomes studied., Conclusions: Self-managed nursing units, previously shown to improve nurses' work satisfaction and retention, have no impact on patient postdischarge outcomes.

Background: Although ophthalmologists have long recognized that visual acuity alone is an inadequate measure of visual impairment, the need for and outcomes of cataract surgery historically have been assessed in terms of visual acuity., Purpose: To examine the relation among different cataract surgery outcome measures, including a 14-item instrument designed to measure functional impairment caused by cataract (the VF-14), at 4 months after cataract surgery., Methods: The authors performed a longitudinal study of 552 patients undergoing first eye cataract surgery by 1 of 75 ophthalmologists practicing in Columbus, Ohio, St. Louis, Missouri, or Houston, Texas. Patients were interviewed, and clinical data were obtained preoperatively (July 15, 1991-March 14, 1992) and 4 months postoperatively., Results: The percentage of patients judged to be improved at 4 months after cataract surgery varied by the outcome measure used: Snellen visual acuity (96%); VF-14 score (89%); satisfaction with vision (85%); self-reported trouble with vision (80%); and Sickness Impact Profile score (67%). The change in patients' ratings of their trouble with vision and their satisfaction with vision were correlated more strongly with the change in VF-14 score than with the change in visual acuity (operated eye or better eye). The average change in VF-14 score was unrelated to the preoperative visual acuity in the eye undergoing surgery., Conclusion: Estimates of the proportion of patients benefiting from cataract surgery vary with the outcome measure used to measure benefit. Change in VF-14 score, a measure of functional impairment related to vision, may be a better measure of the benefit of cataract surgery than change in visual acuity.

Purpose: To examine associations between surgical technique, patient and surgeon characteristics, and clinical outcomes of cataract surgery., Methods: Seventy-five ophthalmologists were recruited from three cities based on a sampling scheme stratified by surgeon-reported annual volume of cataract surgery. Seven hundred seventy-two patients undergoing first eye cataract surgery were enrolled, with complete preoperative, perioperative, and 4-month postoperative clinical data on 717 patients (93%)., Results: Sixty-five percent of surgery was performed by phacoemulsification and 35% by standard extracapsular (ECCE) techniques. Performance of ECCE was associated with the presence of ocular comorbidity and 21 or more years in practice of the surgeon. Performance of phacoemulsification was associated with annual volume of cataract surgery, wherein high-volume (201-399 patients annually) and very high-volume (> 400 patients annually) surgeons had 3.7 and 3.9 times the likelihood of performing phacoemulsification compared with moderate-volume (51-200 cases annually) surgeons. The rates of intraoperative, perioperative, and 4-month postoperative adverse events and the amount of improvement in visual acuity did not differ either by surgical technique or volume stratum. The reported occurrence of posterior capsular opacification within 4 months of surgery was increased in the presence of cortical opacification, one city, and patients operated on by either high- or very high-volume surgeons., Conclusions: In this cohort, no difference in clinical outcomes, as measured by change in visual acuity or occurrence of postoperative adverse events (except for posterior capsular opacification), can be attributed to performance of phacoemulsification versus ECCE or to the reported annual volume of cataract surgery of the surgeon. Self-reported high and very high annual volume of cataract surgery is associated independently with performance of phacoemulsification and surgeon's report of posterior capsular opacification at 4 months after cataract surgery.

Objective: To describe the development and the performance of a brief questionnaire designed to measure functional impairment caused by cataract (the VF-14)., Design: Observational cross-sectional study. Patients were recruited between July 15 and December 15, 1991., Setting: Patients were recruited from the practices of 70 ophthalmologists, located in Columbus, Ohio (N = 21), St Louis, Mo (N = 26), and Houston, Tex (N = 23)., Patients: Seven hundred sixty-six patients undergoing cataract surgery for the first time., Main Outcome Measures: Preoperative best corrected visual acuity in each eye; scores on the VF-14, a new index of functional impairment in patients with cataract; patient reports of overall trouble and satisfaction with their vision; and scores on the Sickness Impact Profile, a measure of general health status., Results: The VF-14 has high internal consistency (Cronbach's alpha = .85) and correlates more strongly with the overall self-rating of the amount of trouble and satisfaction patients have with their vision than do several measures of visual acuity or the Sickness Impact Profile score. The VF-14 score is moderately correlated with visual acuity in the better eye., Conclusions: The VF-14 is a reliable and valid measure of functional impairment caused by cataract and provides information not conveyed by visual acuity or a general measure of health status.

A number of innovative practice models have been introduced in an effort to resolve the hospital nursing shortage and improve the working conditions and retention of registered nurses. This study examines the effects of a unit-level self-management model (including salaried compensation and gainsharing) in a number of clinical areas at The Johns Hopkins Hospital in Baltimore, Maryland. In comparisons of nurses on self-managed and traditional nursing units, outcomes examined were nurses' perceptions of their work process, nurses' work satisfaction levels, and nurses' retention. The self-management model is found to increase work satisfaction through effects on two work process variables: coordination of care and effective team performance. The model is also associated with higher retention. Nurses on self-managed units work longer hours but earn increased pay; the effects of hours and pay on work satisfaction and retention are discussed.