PURPOSE: To examine the relationships between baseline risk factors and sustained decrease of visual field (SDVF) and sustained decrease of visual acuity (SDVA).
DESIGN: Cohort study of participants ...in the Advanced Glaucoma Intervention Study (AGIS).
METHODS: This multicenter study enrolled patients between 1988 and 1992 and followed them until 2001; 789 eyes of 591 patients with advanced glaucoma were randomly assigned to one of two surgical sequences, argon laser trabeculoplasty (ALT)-trabeculectomy-trabeculectomy (ATT) or trabeculectomy-ALT-trabeculectomy (TAT). This report is based on data from 747 eyes. Eyes were offered the next intervention in the sequence upon failure of the previous intervention. Failure was based on recurrent intraocular pressure elevation, visual field defect, and disk rim criteria. Study visits occurred every 6 months; potential follow-up ranged from 8 to 13 years. For each intervention sequence, Cox multiple regression analyses were used to examine the baseline characteristics for association with two vision outcomes: SDVF and SDVA. The magnitude of the association is measured by the hazard ratio (HR), where HR for binary variables is the relative change in the hazard (or risk) of the outcome in eyes with the factor divided by the hazard in eyes without the factor, and HR for continuous variables is the relative change in the hazard (or risk) of the outcome in eyes with a unit increase in the factor.
RESULTS: Characteristics associated with increased SDVF risk in the ATT sequence are: less baseline visual field defect (hazard ratio HR = 0.86,
P < .001, 95% CI = 0.82–0.90), male gender (HR = 2.23,
P < .001, 1.54–3.23), and worse baseline visual acuity (HR = 0.96,
P = .001, 0.94–0.98); in the TAT sequence: less baseline visual field defect (HR = 0.93,
P = .001, 0.89–0.97) and diabetes (HR = 1.87,
P = .007, 1.18–2.97). Characteristics associated with increased SDVA risk in both treatment sequences are better baseline acuity (ATT: HR = 1.05,
P < .001, 1.02–1.09; TAT: HR = 1.06,
P < .001, 1.03–1.08), older age (ATT: HR = 1.05,
P = .001, 1.02–1.08; TAT: HR = 1.04,
P = .002, 1.01–1.06), and less formal education (ATT: HR = 1.92,
P = .001, 1.29–2.88; TAT: HR = 1.77,
P = .002, 1.22–2.54).
CONCLUSIONS: For SDVF, risk factors were better baseline visual field in both treatment sequences, male gender, and worse baseline visual acuity in the ATT sequence, and diabetes in the TAT sequence. For SDVA, risk factors in both treatment sequences were better baseline visual acuity, older age, and less formal education.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
PURPOSE: To investigate the association of pre-intervention and post-intervention patient and eye characteristics with failure of argon laser trabeculoplasty (ALT) and trabeculectomy.
DESIGN: Cohort ...study of participants in the Advanced Glaucoma Intervention Study.
METHODS: This multicenter study took place between 1988 and 2001. Between 1988 and 1992, 789 eyes of 591 patients aged 35 to 80 years with advanced glaucoma were randomized into one of two surgical treatment sequences: argon laser trabeculoplasty (ALT)-trabeculectomy-trabeculectomy or trabeculectomy-ALT-trabeculectomy. Upon study-defined failure (based on maximum medications, sustained intraocular pressure (IOP) elevation, visual field defect, and disk rim deterioration) of each intervention, patients were offered the subsequent intervention. Potential follow-up was 8 to 13 years. This report is based on data from 779 eyes that had at least 3 months of follow-up. The main outcome measures are failure of ALT and trabeculectomy, whether as first or second interventions. Effect size is measured by the hazard ratio (HR) and its corresponding 95% confidence interval (CI) obtained from Cox multiple regression analysis, where HR corresponds to the coefficient of change in risk associated with a unit increase in a factor. For binary factors, this corresponds to the change in risk in eyes with the factor relative to the risk in eyes without the factor.
RESULTS: Pre-intervention factors associated with failure of ALT are younger age (HR = 0.98, CI = 0.96–0.99,
P = .009) and higher IOP (1.11, 1.08–1.15,
P < .001). Pre-intervention factors associated with failure of trabeculectomy are younger age (HR = 0.97, CI = 0.95–0.99,
P = .005) and higher IOP (1.04, 1.01–1.06,
P = .002), as well as diabetes (2.86, 1.88–4.36,
P < .001) and any postoperative complication (1.99, 1.35–2.93,
P < .001). Individual postoperative complications significantly associated with increased risk of failure of trabeculectomy are elevated IOP (3.4, 1.9–6.1,
P < .001) and marked inflammation (2.4, 1.3–4.6,
P = .006).
CONCLUSIONS: In this study, ALT failure was associated with younger age and higher pre-intervention IOP. Trabeculectomy failure was associated with younger age, higher pre-intervention IOP, diabetes, and one or more postoperative complications, particularly elevated IOP and marked inflammation.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract
Introduction
Knowledge of the contemporary epidemiology of hepatitis B virus (HBV) infection among military personnel can inform potential Department of Defense (DoD) screening policy and ...infection and disease control strategies.
Materials and Methods
HBV infection status at accession and following deployment was determined by evaluating reposed serum from 10,000 service members recently deployed to combat operations in Iraq and Afghanistan in the period from 2007 to 2010. A cost model was developed from the perspective of the Department of Defense for a program to integrate HBV infection screening of applicants for military service into the existing screening program of screening new accessions for vaccine-preventable infections.
Results
The prevalence of chronic HBV infection at accession was 2.3/1,000 (95% CI: 1.4, 3.2); most cases (16/21, 76%) identified after deployment were present at accession. There were 110 military service-related HBV infections identified. Screening accessions who are identified as HBV susceptible with HBV surface antigen followed by HBV surface antigen neutralization for confirmation offered no cost advantage over not screening and resulted in a net annual increase in cost of $5.78 million. However, screening would exclude as many as 514 HBV cases each year from accession.
Conclusions
Screening for HBV infection at service entry would potentially reduce chronic HBV infection in the force, decrease the threat of transfusion-transmitted HBV infection in the battlefield blood supply, and lead to earlier diagnosis and linkage to care; however, applicant screening is not cost saving. Service-related incident infections indicate a durable threat, the need for improved laboratory-based surveillance tools, and mandate review of immunization policy and practice.
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DOBA, IZUM, KILJ, NUK, ODKLJ, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK, VSZLJ
To determine the least worsening of a visual field (VF) and the least number of confirming tests needed to identify progression of glaucomatous VF defects.
Cohort study of participants in a clinical ...trial.
Seven hundred fifty-two eyes of 565 patients with advanced glaucoma.
Visual field tests were quantified with the Advanced Glaucoma Intervention Study (AGIS) VF defect score and the Humphrey Field Analyzer mean deviation (MD). Follow-up was 8 to 13 years.
Two measures based on the AGIS VF defect score: (1) sustained decrease of VF (SDVF), a worsening from baseline by 2 (alternatively, 3 or 4) or more units and sustained for 2 (alternatively, 3) consecutive 6-month visits and (2) after the occurrence of SDVF, the average percent of eyes with worsening by 2 (alternatively, 3 or 4) or more units from baseline. Two similar measures based on MD.
Based on the original AGIS criteria for SDVF (a worsening of 4 units in the AGIS score sustained during 3 consecutive 6-month visits), 31% of eyes had an SDVF. The percent of eyes with a sustained event increases by approximately 10% when either the minimum number of units of field loss or the minimum number of 6-month visits during which the loss is sustained decreases by 1. During 3 years of follow-up after a sustained event, a worsening of at least 2 units was found in 72% of eyes that had a 2-visit sustained event. The same worsening was found in 84% of eyes that had a 3-visit sustained event. Through the next 10 years after a sustained event, based on worsening of 2, 3, or 4 units at 2 or 3 consecutive tests, the loss reoccurred, on average, in >/=75% of study eyes. Results for MD are similar.
In patients with advanced glaucoma, a single confirmatory test 6 months after a VF worsening indicates with at least 72% probability a persistent defect when the worsening is defined by at least 2 units of AGIS score or by at least 2 decibels of MD. When the number of confirmatory tests is increased from 1 to 2, the percentage of eyes that show a persistent defect increases from 72% to 84%.
PRIMeR is the first U.S.-based ancillary study of MRD assessment by multiparameter flow cytometry (MFC). Patients were enrolled on a national 3-arm RCT (BMT CTN 0702, STAMiNA trial, ...ClinicalTrials.gov Identifier: NCT01109004) comparing 1) tandem auto-HCT, 2) single auto-HCT and 3) single auto-HCT, 4 cycles of lenalidomide, bortezomib, dexamethasone consolidation (auto+RVD); all 3 treatment arms included continuous lenalidomide maintenance until MM progression. STAMiNA opened to accrual before PRIMeR initiated, therefore 437 of 758 patients enrolled in STAMiNA provided consent and at least one analyzable sample for MRD by MFC to PRIMeR. Disease responses and progressions were adjudicated by an independent review committee. All analyses of treatment arm were performed using intent-to-treat. The MFC panel included 10 monoclonal antibodies (CD38, CD138, CD45, CD56, CD19, CD20, CD27, CD28, kappa, lambda) measured via 3 tubes of 6 colors each with a target of analyzing 2.5 × 105-1.5 × 106 events, depending on sample quality and quantity, yielding a sensitivity of 10−5 to 10−6. All samples were interpreted by two experienced flow cytometrists who were blinded to treatment arm and other patient, disease and treatment characteristics. MRD was assessed at Baseline/pre-AutoHCT (BL), Pre-maintenance (PM), and 1 year (Y1) post AutoHCT with the primary endpoint of MRD negative at Y1. At a median follow-up of 38 months, there was no significant difference in PFS or OS by treatment arm in the subset of PRIMeR patients. Univariate analysis demonstrated that being MRD negative at PM and Y1 was associated with better PFS, and at Y1, patients who were MRD negative also had longer OS (Table 1, Figures). Multivariate analysis of time to progression or death, adjusting for disease risk, demonstrated hazard ratios (HR) in MRD negative patients compared to MRD positive patients at BL, PM and Y1 were 0.66 (p=0.07), 0.48 (0<0.001) and 0.22 (p<0.001) respectively. Corresponding HRs for overall mortality were 0.81 (p=0.50), 0.77 (p=0.52) and 0.10 (0<0.001). The proportion of MRD negative patients at Y1 was highest (odds ratio 1.2) among patients randomized to the tandem AutoHCT arm (Table 2). This is the first prospective U.S. cooperative group multi-center trial to demonstrate the prognostic value of MRD by MFC at PM and Y1 for PFS and OS with modern therapy including lenalidomide maintenance after AutoHCT. MRD status is prognostic for PFS at all measured timepoints, and for OS at Y1. Despite better outcomes, patients with MRD negative MM at Y1 year still experienced disease progression (23% vs. 56% at 38 months after Auto HCT) despite continuous lenalidomide maintenance. As MM is an incurable disease, MRD status may be a useful surrogate to direct further therapy which needs to be evaluated along with other clinical factors to predict long term PFS and OS. Additional analyses with longer follow-up are ongoing.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Emergency Department (ED) staff are vulnerable to occupational exposure to infectious blood and body fluids (BBF). Universal precautions are often ignored in the ED setting. Identification of body ...locations at high risk of BBF exposure may allow development of site specific protective garments that minimize risk and inconvenience. All permanent staff (92) in a 58,000 visit public university hospital ED with potential for BBF exposure were surveyed. Respondents estimated the number of BBF contacts sustained during the past year, describing their most recent contact in detail. Seventy-eight of 91 (85%) responded, reporting average rates of 54.1 intact skin, 1.5 nonintact skin, and .87 mucous membrane BBF contacts per full-time employee per year. Of the most recent incidents, 94% involved blood, 22% involved vomit or urine, and 11% involved saliva. Eighty-eight percent of BBF contacts were to unprotected skin or mucous membranes, either when no barrier was worn or at the gap between gloves and sleeves. Most (66%) were distal to the elbow; 13% involved the face. Use of long gloves or another continuous protective barrier from the fingers to the elbow, in addition to increased use of face masks or shields, would markedly reduce the rate of ED BBF contacts with a minimum of inconvenience.
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