Complete Coronary Revascularization and Outcomes in Patients Who Underwent Coronary Artery Bypass Grafting: Insights from The REGROUP Trial.

There is growing evidence in support of coronary complete revascularization (CR). Nonetheless, there is no universally accepted definition of CR in patients who undergo coronary bypass grafting surgery (CABG). We sought to investigate the outcomes of CR, defined as surgical revascularization of any territory supplied by a suitable coronary artery with ≥50% stenosis. We performed a preplanned subanalysis in the Randomized Trial of Endoscopic or Open Saphenous Vein Graft Harvesting (REGROUP) clinical trial cohort. Of 1,147 patients who underwent CABG, 810 (70.6%) received CR. The primary outcome was a composite of major adverse cardiac events (MACEs), including death from any cause, nonfatal myocardial infarction, or repeat revascularization over a median 4.7 years of follow-up. MACE occurred in 175 patients (21.6%) in the CR group and 86 patients (25.5%) in the incomplete revascularization (IR) group (hazard ratio [HR] 0.87, 95% confidence interval [CI] 0.67 to 1.13, p = 0.29). A total of 97 patients (12.0%) in the CR group and 48 patients (14.2%) in the IR group died (HR 0.93, 95% CI 0.65 to 1.32, p = 0.67); nonfatal myocardial infarction occurred in 49 patients (6.0%) in the CR group and 30 patients (8.9%) in the IR group (HR 0.76, 95% CI 0.48 to 1.2, p = 0.24), and repeat revascularization occurred in 62 patients (7.7%) in the CR group and 39 patients (11.6%) in the IR group (HR 0.64; 95% CI 0.42 to 0.95, p = 0.027). In conclusion, in patients with a great burden of co-morbidities who underwent CABG in the REGROUP trial over a median follow-up period of a median 4.7 years, CR was associated with similar MACE rates but a reduced risk of repeat revascularization. Longer-term follow-up is warranted.

Costs of Endoscopic vs Open Vein Harvesting for Coronary Artery Bypass Grafting: A Secondary Analysis of the REGROUP Trial.

Importance: Value-based purchasing creates pressure to examine whether newer technologies and care processes, including new surgical techniques, yield any economic advantage. Objective: To compare health care costs and utilization between participants randomized to receive endoscopic vein harvesting (EVH) or open vein harvesting (OVH) during a coronary artery bypass grafting (CABG) procedure. Design, Setting, and Participants: This secondary economic analysis was conducted alongside the 16-site Randomized Endo-Vein Graft Prospective (REGROUP) clinical trial funded by the Department of Veterans Affairs (VA) Cooperative Studies Program. Adults scheduled for urgent or elective bypass involving a vein graft were eligible. The first participant was enrolled in September 2013, with most sites completing enrollment by March 2014. The last participant was enrolled in April 2017. A total of 1150 participants were randomized, with 574 participants receiving OVH and 576 receiving EVH. For this secondary analysis, cost and utilization data were extracted through September 30, 2020. Participants were linked to administrative data in the VA Corporate Data Warehouse and activity-based cost data starting with the index procedure. Interventions: EVH vs OVH, with comparisons based on intention to treat. Main Outcomes and Measures: Discharge costs for the index procedure as well as follow-up costs (including intended and unintended events; mean [SD] follow-up time, 33.0 [19.9] months) were analyzed, with results from different statistical models compared to test for robustness (ie, lack of variation across models). All costs represented care provided or paid by the VA, standardized to 2020 US dollars. Results: Among 1150 participants, the mean (SD) age was 66.4 (6.9) years; most participants (1144 [99.5%] were male. With regard to race and ethnicity, 6 participants (0.5%) self-reported as American Indian or Alaska Native, 10 (0.9%) as Asian or Pacific Islander, 91 (7.9%) as Black, 62 (5.4%) as Hispanic, 974 (84.7%) as non-Hispanic White, and 6 (0.5%) as other race and/or ethnicity; data were missing for 1 participant (0.1%). The unadjusted mean (SD) costs for the index CABG procedure were $76 607 ($43 883) among patients who received EVH and $75 368 ($45 900) among those who received OVH, including facility costs, insurance costs, and physician-related costs (commonly referred to as provider costs in Centers for Medicare and Medicaid and insurance data). No significant differences were found in follow-up costs; per 90-day follow-up period, EVH was associated with a mean (SE) added cost of $302 ($225) per patient. The results were highly robust to the statistical model. Conclusions and Relevance: In this study, EVH was not associated with a reduction in costs for the index CABG procedure or follow-up care. Therefore, the choice to provide EVH may be based on surgeon and patient preferences. Trial Registration: ClinicalTrials.gov Identifier: NCT01850082.

Epiaortic Ultrasound for Assessment of Intraluminal Atheroma; Insights from the REGROUP Trial.

OBJECTIVES: To assess the use of epiaortic ultrasound in contemporary cardiac surgery, as well as its impact on surgical cannulation strategy and cerebrovascular events. DESIGN: Epiaortic ultrasound data was prospectively collected in the Randomized Endovein Graft Prospective (REGROUP) trial (VA Cooperative Studies Program #588, ClinicalTrials.gov, NCT01850082), which randomized 1,150 coronary artery bypass graft patients between 2014 and 2017 to endoscopic or open-vein graft harvest. SETTING: Sixteen cardiac surgery programs within the Veterans Affairs Healthcare System with expertise at performing endoscopic vein-graft harvesting. PARTICIPANTS: Veterans Affairs patients, greater than 18 years of age, undergoing elective or urgent coronary artery bypass grafting with cardiopulmonary bypass and cardioplegic arrest with at least one planned saphenous vein graft were eligible for enrollment. INTERVENTIONS: Epiaortic ultrasound was performed by the surgeon using a high frequency (>7 MHz) ultrasound transducer. Two-dimensional images of the ascending aorta in multiple planes were acquired before aortic cannulation and cross-clamping. MEASUREMENTS AND MAIN RESULTS: Epiaortic ultrasound was performed in 34.1% (269 of 790) of patients in REGROUP. Among these patients, simple intraluminal atheroma was observed in 21.9% (59 269), and complex intraluminal atheroma comprised 2.2% (6 of 269). The aortic cannulation or cross-clamp strategy was modified based on these findings in 7.1% of cases (19 of 269). There was no difference in stroke between patients who underwent epiaortic ultrasound and those who did not (1.9% v 1.2% p = 0.523). CONCLUSIONS: Despite current guidelines recommending routine use of epiaortic ultrasound (IIa/B) to reduce the risk of stroke in cardiac surgery, in this contemporary trial, use remains infrequent, with significant site-to-site variability.

Randomized Trial of Endoscopic or Open Vein-Graft Harvesting for Coronary-Artery Bypass.

BACKGROUND: The saphenous-vein graft is the most common conduit for coronary-artery bypass grafting (CABG). The influence of the vein-graft harvesting technique on long-term clinical outcomes has not been well characterized. METHODS: We randomly assigned patients undergoing CABG at 16 Veterans Affairs cardiac surgery centers to either open or endoscopic vein-graft harvesting. The primary outcome was a composite of major adverse cardiac events, including death from any cause, nonfatal myocardial infarction, and repeat revascularization. Leg-wound complications were also evaluated. RESULTS: A total of 1150 patients underwent randomization. Over a median follow-up of 2.78 years, the primary outcome occurred in 89 patients (15.5%) in the open-harvest group and 80 patients (13.9%) in the endoscopic-harvest group (hazard ratio, 1.12; 95% confidence interval [CI], 0.83 to 1.51; P=0.47). A total of 46 patients (8.0%) in the open-harvest group and 37 patients (6.4%) in the endoscopic-harvest group died (hazard ratio, 1.25; 95% CI, 0.81 to 1.92); myocardial infarctions occurred in 34 patients (5.9%) in the open-harvest group and 27 patients (4.7%) in the endoscopic-harvest group (hazard ratio, 1.27; 95% CI, 0.77 to 2.11), and revascularization occurred in 35 patients (6.1%) in the open-harvest group and 31 patients (5.4%) in the endoscopic-harvest group (hazard ratio, 1.14; 95% CI, 0.70 to 1.85). Leg-wound infections occurred in 18 patients (3.1%) in the open-harvest group and in 8 patients (1.4%) in the endoscopic-harvest group (relative risk, 2.26; 95% CI, 0.99 to 5.15). CONCLUSIONS: Among patients undergoing CABG, we did not find a significant difference between open vein-graft harvesting and endoscopic vein-graft harvesting in the risk of major adverse cardiac events. (Funded by the Cooperative Studies Program, Office of Research and Development, Department of Veterans Affairs; REGROUP ClinicalTrials.gov number, NCT01850082 .).

Prognostication of Survival Outcomes in Patients Diagnosed with Glioblastoma.

OBJECTIVE: Glioblastoma multiforme (GBM) is an aggressive primary brain tumor with dismal survival. This study aims to examine the prognostic value of primary tumor sites and race on survival outcomes. METHODS: Patient data obtained from the Scott and White Hospital Brain Tumor Registry (1976-2013) were stratified according to sex, age, race, primary tumor site, vital status, and survival. RESULTS: Of the 645 patients, 580 (89.9%) were diagnosed with GBM not otherwise specified (GBM NOS), 57 (8.8%) with GBM, and 8 (1.2%) with giant-cell GBM. Most were male (53.5%), aged 50 years or older (78.7%). The white population had the highest GBM prevalence (87.1%) and the lowest overall survival versus all other race groups (6.6% vs. 30.1%; P < 0.01). The black population had a relatively low prevalence of GBM (5.9%) and the greatest overall survival versus all others (47.4% vs. 7.3%; P < 0.01). Primary tumor sites located in the temporal (25.8% vs. 20.2%; P = 0.03), occipital (8.1% vs. 2.9%; P = 0.05), and parietal lobes (24.2% vs. 20.8%; P = 0.05) had a greater occurrence in surviving individuals. The overall survival for men versus women was (62.9% vs. 37.1%; P = 0.12). CONCLUSIONS: Black racial background and temporal, occipital, or parietal primary tumor sites are suggestive of positive survival outcomes. Conversely, white racial background with primary tumor sites in the brain overlapping and NOS areas seem to be associated with negative outcomes and decreased survival. Thus, racial background and primary tumor site may be useful prognostic factors in patients with GBM.

Comprehensive Modeling of Corneal Alkali Injury in the Rat Eye.

PURPOSE: To characterize the molecular, clinical, and histopathological profiles in the rat cornea after alkali injury over a 21-day period. METHODS: Alkali injury was induced in one eye of male Lewis rats. Corneal opacity and corneal neovascularization were assessed daily. Real-time qRT-PCR analysis and immunohistochemical staining were conducted to examine inflammation, neovascularization, and fibrosis. RESULTS: We found that within 2 hours of chemical exposure, corneal opacification rapidly developed with an acute increase in various cytokine expressions, while several cytokines demonstrated a secondary peak by day 7. Early neutrophil infiltration peaked at day 1 post-injury while macrophage infiltration peaked at day 7. Throughout the time course of the study, corneal opacity persisted and neovascularization, lymphangiogenesis, and fibrosis progressed. CONCLUSIONS: This study highlights the molecular, clinical, and histopathological changes throughout the progression of alkali injury in the rat cornea. These profiles will assist in the development of new strategies and therapies for ocular alkali injury.

Association of Hospitalization With First-Line Antidepressant Polypharmacy Among Veterans of Iraq and Afghanistan With Post-Traumatic Stress Disorder: Examining the Influence of Methodological Approaches.

OBJECTIVE: To compare the influence of various statistical analysis approaches while assessing the marginal effect of polypharmacy (prescription of multiple psychotropics including a first-line antidepressant) on all-cause hospital admission among veterans diagnosed with post-traumatic stress disorder. METHODS: Data were obtained on 398 Iraq/Afghanistan veterans being followed in a southwestern U.S. health care system from October 2005 through September 2009, diagnosed with post-traumatic stress disorder and receiving first-line antidepressants (serotonin selective or serotonin norepinephrine reuptake inhibitors). High-dimensional propensity score (hd-PS) approaches were considered, examining both covariate adjustment per PS deciles and propensity weighting, with results compared to those of standard multivariable logistic regression. RESULTS: Veterans prescribed polypharmacy did not appear to have increased odds of admission in either the decile-adjusted hd-PS model (odds ratio [OR] = 2.1; 95% confidence interval [CI]: 0.9-4.9, not significant [ns]) or traditional covariate-adjusted logistic model (OR = 2.1; 0.9-5.0, ns). Inverse probability of treatment (OR = 2.1; 1.3-3.3) and standardized-morbidity-ratio-weighted (OR = 2.2; 1.3-3.6) hd-PS models estimated similar odds of admission with narrower CIs. CONCLUSIONS: Future research should incorporate alternate analytical methods for observational data and investigate their respective biases relative to clinician treatment decision-making. For several analytical approaches, greater risk of admission among patients prescribed antidepressant-related polypharmacy was observed despite recommended guidelines, suggesting the need to investigate why clinicians may deviate from guidelines.

Protective and Risk Factors for 5-Year Survival in the Oldest Veterans: Data from the Veterans Health Administration.

OBJECTIVES: To characterize physical and mental diseases and use of healthcare services and identify factors associated with mortality in the oldest individuals using the Veterans Health Administration (VHA). DESIGN: Retrospective study with 5-year survival follow-up. SETTING: VHA, system-wide. PARTICIPANTS: Veterans using the VHA aged 80 and older as of October 2008 (N = 721,588: n = 665,249 aged 80-89, n = 56,118 aged 90-99, n = 221 aged 100-115). MEASUREMENTS: Demographic characteristics, physical and mental diseases, healthcare services, and 5-year survival were measured. RESULTS: Accelerated failure time models identified protective and risk factors associated with mortality according to age group. During 5 years of follow-up, 44% of participants died (survival rate: 59% aged 80-89, 32% aged 90-99, 15% aged ≥100). In the multivariable model, protective effects for veterans aged 80-99 were female sex, minority race or ethnicity, being married, having certain physical and mental diagnoses (hypertension, cataract, dyslipidemia, posttraumatic stress disorder, bipolar disorder), having urgent care visits, having invasive surgery, and having few (1-3) prescriptions. Risk factors were lower VHA priority status, physical and mental conditions (diabetes mellitus, anemia, congestive heart failure, dementia, anxiety, depression, smoking, substance abuse disorder), hospital admission, and nursing home care. For those aged 100 and older, being married, smoking, hospital admission, nursing home care, invasive surgery, and prescription use were significant risk factors; only emergency department (ED) use was protective. CONCLUSION: Although the data are limited to VHA care (thus missing Medicare services), this study shows that many veterans served by the VHA live to advanced old age despite multiple chronic conditions. Further study is needed to determine whether a comprehensive, coordinated care system like VHA is associated with greater longevity for very old persons.

Mental health treatment after major surgery among Vietnam-era Veterans with posttraumatic stress disorder.

The purpose of this study was to examine mental health treatment use among Vietnam Veterans with posttraumatic stress disorder and determine whether undergoing major surgery interrupted mental health treatment or increased the risk of psychiatric hospitalization. Using retrospective data from Veterans Health Administration's electronic medical record system, a total of 3320 Vietnam-era surgery patients with preoperative posttraumatic stress disorder were identified and matched 1:4 with non-surgical patients with posttraumatic stress disorder. The receipt of surgery was associated with a decline in overall mental health treatment and posttraumatic stress disorder-specific treatment 1 month following surgery but not during any subsequent month thereafter. Additionally, surgery was not associated with psychiatric admission.

Temporal trends in lipid screening and therapy among youth from 2002 to 2012.

BACKGROUND: Pediatric lipid management recommendations have evolved from selective screening to universal screening to identify and target therapy for genetic dyslipidemias. Data on the success of the selective screening guidelines for lipid testing, dyslipidemia detection, and lipid management are conflicting. OBJECTIVE: To determine temporal trends in lipid testing, dyslipidemia categories and pharmacotherapy in a cohort of 653,642 individual youth aged 2 to 20 years from 2002 to 2012. METHODS: Summary data on lipid test results, lipid-lowering medicine (LLM) dispensings, and International Classification of Diseases, Ninth Revision diagnoses were compiled from the virtual data warehouses of 5 sites in the Cardiovascular Research Network. Temporal trends were determined using linear regression. RESULTS: Among the average 255,160 ± 25,506 children enrolled each year, lipid testing declined from 16% in 2002 to 11% in 2012 (P < .001 for trend). Among the entire population, the proportion newly detected each year with low-density lipoprotein cholesterol >190 mg/dL, a value commonly used to define familial hypercholesterolemia, increased over time from 0.03% to 0.06% (P = .03 for trend). There was no significant change over time in the proportion of the yearly population initiated on LLM or statins specifically (0.045 ± 0.009%, P = .59 [LLM] and 0.028 ± 0.006%, P = .25 [statin]). CONCLUSIONS: Although lipid testing declined during 2002 to 2012, the detection of familial hypercholesterolemia-level low-density lipoprotein cholesterol increased. Despite this increased detection, pharmacotherapy did not increase over time. These findings highlight the need to enhance lipid screening and management strategies in high-risk youth.

Graft Detachment Rate in DSEK/DSAEK After Same-Day Complete Air Removal.

PURPOSE: We retrospectively analyzed the rate of graft detachment from 310 Descemet stripping endothelial keratoplasty (DSEK)/Descemet stripping automated endothelial keratoplasty (DSAEK) cases performed by a single surgeon over a 10-year period using same-day complete air removal. Secondary outcome measures including primary graft failure, late endothelial graft failure, rejection events, and steroid-induced ocular hypertension were also analyzed. METHODS: A retrospective chart review was performed on all patients receiving DSEK/DSAEK for any cause by the same surgeon at 2 separate institutions from January 2005 to December 2014. The air bubble used to promote graft-host apposition was completely removed after 1 hour. Descriptive statistical analysis was used to report the rates of graft detachment, and χ analysis was used to assess for associations with secondary outcomes. RESULTS: Among 310 endothelial keratoplasties analyzed, there were 19 graft detachments (6.1%). The graft detachment rate was higher during the learning curve, but rapidly declined with experience, and was 1.3% for the last 79 cases over a 4-year period. No primary graft failures were reported. The rate of steroid-induced ocular hypertension was 20%. The rate of graft failure was 8%. The rate of graft rejection events was 10.7%. Two of the 6 patients (33%) who underwent trabeculectomy before endothelial keratoplasty suffered a detachment. CONCLUSIONS: A graft detachment rate as low as 1.3% can be achieved in DSEK/DSAEK with same-day complete air removal shortly after surgery. Factors believed to contribute to a low detachment rate include complete interface fluid removal and reconstitution of the normal anterior chamber milieu to assist corneal endothelial function.

Predicting Long-Term Outcomes in Pleural Infections. RAPID Score for Risk Stratification.

RATIONALE: Pleural infections are associated with significant morbidity and mortality. The recently developed RAPID (renal, age, purulence, infection source, and dietary factors) score consists of five clinical factors that can identify patients at risk for increased mortality. OBJECTIVES: The objective of this study was to further validate the RAPID score in a diverse cohort, identify factors associated with mortality, and provide long-term outcomes. METHODS: We evaluated a single-center retrospective cohort of 187 patients with culture-positive pleural infections. Patients were classified by RAPID scores into low-risk (0-2), medium-risk (3-4), and high-risk (5-7) groups. The Social Security Death Index was used to determine date of death. All-cause mortality was assessed at 3 months, 1 year, 3 years, and 5 years. Clinical factors and comorbid conditions were evaluated for association. MEASUREMENTS AND MAIN RESULTS: Three-month mortality for low-, medium-, and high-risk groups was 1.5, 17.8, and 47.8%, respectively. Increased odds were observed among medium-risk (odds ratio, 14.3; 95% confidence interval, 1.8-112.6; P = 0.01) and high-risk groups (odds ratio, 53.3; 95% confidence interval, 6.8-416.8; P < 0.01). This trend continued at 1, 3, and 5 years. Factors associated with high-risk scores include gram-negative rod infections, heart disease, diabetes, cancer, lung disease, and increased length of stay. CONCLUSIONS: When applied to a diverse patient cohort, the RAPID score predicts outcomes in patients up to 5 years and may aid in long-term risk stratification on presentation.

Posttransplantation Outcomes in Veterans With Serious Mental Illness.

BACKGROUND: Anticipating poor recovery due to impaired self-management and appointment-keeping, clinicians may consider serious mental illness (SMI) a significant concern in organ transplantation. However, little empirical evidence exists regarding posttransplantation outcomes for patients with SMI. METHODS: This study analyzed health services data to evaluate posttransplantation 3-year survival by SMI status in a nationwide cohort of patients in the Veterans Health Administration (VHA). RESULTS: A total of 960 recipients of solid organ or bone marrow transplants were identified from Veterans Health Administration administrative data extracts for fiscal years 2006 to 2009. Of these, 164 (17%) had an SMI diagnosis before transplantation (schizophrenia, posttraumatic stress, major depressive, and bipolar disorders); 301 (31%) had some other mental illness diagnosis (such as anxiety, adjustment reactions, or substance abuse); and 495 (52%) had no mental health diagnosis. Twenty-two patients (2%) required retransplantation and 208 patients (22%) died during follow-up. Data on whether these were primary or repeat transplantations were unavailable. Rates of attendance at postoperative outpatient visits and number of months for which immunosuppressive drugs fills were recorded were similar among mental illness groups, as were rates of diagnosed immunological rejection. Three-year mortality was equivalent among mental health groups: no mental health (19%) versus other mental illness (23%) versus SMI (27%; χ(2) = 5.11; df = 2; P = .08). In adjusted survival models, no effect of mental health status was observed. CONCLUSIONS: Serious mental illness diagnosis does not appear to be associated with adverse transplantation outcomes over the first 3 years; however, a potentially diverging survival curve may portend higher mortality at 5 years.

Prevalence of suicidality among Hispanic and African American veterans following surgery.

OBJECTIVES: We evaluated factors associated with suicidal behavior and ideation (SBI) during 3 years of follow-up among 89,995 Veterans Health Administration (VHA) patients who underwent major surgery from October 2005 to September 2006. METHODS: We analyzed administrative data using Cox proportional hazards models. SBI was ascertained by International Classification of Disease, 9th Revision codes. RESULTS: African Americans (18% of sample; 16,252) were at an increased risk for SBI (hazard ratio [HR] = 1.21; 95% confidence interval [CI] = 1.10, 1.32), whereas Hispanics were not (HR = 1.10; 95% CI = 0.95, 1.28). Other risk factors included schizophrenia, bipolar disorder, depression, posttraumatic stress disorder, pain disorders, postoperative new-onset depression, and postoperative complications; female gender and married status were protective against SBI. CONCLUSIONS: The postoperative period might be a time of heightened risk for SBI among minority patients in the VHA. Tailored monitoring and postoperative management by minority status might be required to achieve care equity.

Polypharmacy with antipsychotic drugs in patients with schizophrenia: trends in multiple health care systems.

PURPOSE: Patterns of pharmacologic treatment in U.S. outpatients with schizophrenia across multiple health care settings were investigated. METHODS: Antipsychotic drug utilization by patients with schizophrenia and related disorders was analyzed using data on 119,662 patients served by the Veterans Affairs (VA) health care system in fiscal years 2005-09, data on 5,440 enrollees in two health maintenance organizations (HMOs) in 2002-09, and National Ambulatory Medical Care Survey (NAMCS) data reflecting the experience of 17.6 million U.S. residents seeking care outside federal systems during the same eight-year period. Polypharmacy was defined as the use of more than one antipsychotic agent during one year (in the VA sample) or one week (in the HMO and NAMCS samples). The association of polypharmacy with hospital admissions was assessed via multivariable logistic regression. RESULTS: Rates of antipsychotic use in the VA sample ranged from 74% to 78%, with lower and more variable rates in the NAMCS sample (69-84%) and the HMO sample (22-67%). VA patients were found to have lower polypharmacy rates (20-22%) than patients in the HMO and NAMCS samples (19-31%). In all samples evaluated, polypharmacy was associated with an increased likelihood of hospital admission (odds ratio range, 1.4-2.4). CONCLUSION: A multisystem study revealed that antipsychotic use among patients with schizophrenia varied substantially among health care systems and that nearly one fifth of patients with schizophrenia or other psychotic disorders in most of the health care systems experienced antipsychotic polypharmacy.

Estimation of disease prevalence, true positive rate, and false positive rate of two screening tests when disease verification is applied on only screen-positives: a hierarchical model using multi-center data.

OBJECTIVES: A model is proposed to estimate and compare cervical cancer screening test properties for third world populations when only subjects with a positive screen receive the gold standard test. Two fallible screening tests are compared, VIA and VILI. METHODS: We extend the model of Berry et al. [1] to the multi-site case in order to pool information across sites and form better estimates for prevalences of cervical cancer, the true positive rates (TPRs), and false positive rates (FPRs). For 10 centers in five African countries and India involving more than 52,000 women, Bayesian methods were applied when gold standard results for subjects who screened negative on both tests were treated as missing. The Bayesian methods employed suitably correct for the missing screen negative subjects. The study included gold standard verification for all cases, making it possible to validate model-based estimation of accuracy using only outcomes of women with positive VIA or VILI result (ignoring verification of double negative screening test results) with the observed full data outcomes. RESULTS: Across the sites, estimates for the sensitivity of VIA ranged from 0.792 to 0.917 while for VILI sensitivities ranged from 0.929 to 0.977. False positive estimates ranged from 0.056 to 0.256 for VIA and 0.085 to 0.269 for VILI. The pooled estimates for the TPR of VIA and VILI are 0.871 and 0.968, respectively, compared to the full data values of 0.816 and 0.918. Similarly, the pooled estimates for the FPR of VIA and VILI are 0.134 and 0.146, respectively, compared to the full data values of 0.144 and 0.146. Globally, we found VILI had a statistically significant higher sensitivity but no statistical difference for the false positive rates could be determined. CONCLUSION: Hierarchical Bayesian methods provide a straight forward approach to estimate screening test properties, prevalences, and to perform comparisons for screening studies where screen negative subjects do not receive the gold standard test. The hierarchical model with random effects used to analyze the sites simultaneously resulted in improved estimates compared to the single-site analyses with improved TPR estimates and nearly identical FPR estimates to the full data outcomes. Furthermore, higher TPRs but similar FPRs were observed for VILI compared to VIA.