Multiple Biomarker Testing Tissue Consumption and Completion Rates With Single-gene Tests and Investigational Use of Oncomine Dx Target Test for Advanced Non-Small-cell Lung Cancer: A Single-center Analysis.

INTRODUCTION: First-line targeted therapies have been developed for advanced non-small-cell lung cancer (NSCLC). However, small biopsy samples pose a challenge to testing all relevant biomarkers. The present study characterized clinician-ordered single-gene lung cancer testing and evaluated tissue stewardship and the ability to successfully determine mutation status with single-gene testing or investigational use of the Oncomine Dx Target Test. MATERIALS AND METHODS: Clinician-submitted orders for 3659 single-gene tests (EGFR, ALK, ROS1, BRAF, KRAS, ERBB2, MET, RET, FGFR1) across 1402 samples at a large US-based commercial reference laboratory and 169 investigational Oncomine Dx Target Tests were retrospectively evaluated. The testing success rates and tissue consumption were evaluated by sample type, test type, and number of single-gene tests per sample. RESULTS: The large majority of lung tissue samples submitted for clinical testing were small (70.5% core needle biopsies; 10.0% fine needle aspirations). With single-gene testing, mutation status was successfully reported for ≥ 1 biomarker for 88.4% of the clinical samples. The success rates decreased and tissue consumption increased with testing of additional biomarkers. Investigational Oncomine Dx Target Tests were permitted 1 tissue slide each and demonstrated success rates similar to single-gene testing for ≥ 5 biomarkers on core needle biopsies, ≥ 4 biomarkers on fine needle aspirations, and ≥ 2 biomarkers on surgical resection specimens. CONCLUSION: Tissue stewardship is important to enable successful completion of genetic testing and informed NSCLC treatment decisions. Preliminary assessment of the investigational Oncomine Dx Target Test suggests it could facilitate access to multiple biomarker testing using small tissue samples to support therapy decisions for patients with advanced NSCLC.

Cost-comparison of two trabecular micro-bypass stents versus selective laser trabeculoplasty or medications only for intraocular pressure control for patients with open-angle glaucoma.

AIM: Patients with open-angle glaucoma (OAG) whose intraocular pressure is not adequately controlled by one medication have several treatment options in the US. This analysis evaluated direct costs of unilateral eye treatment with two trabecular micro-bypass stents (two iStents) compared to selective laser trabeculoplasty (SLT) or medications only. MATERIALS AND METHODS: A population-based, annual state-transition, probabilistic, cost-of-care model was used to assess OAG-related costs over 5 years. Patients were modeled to initiate treatment in year zero with two iStents, SLT, or medications only. In years 1-5, patients could remain on initial treatment or move to another treatment option(s), or filtration surgery. Treatment strategy change probabilities were identified by a clinician panel. Direct costs were included for drugs, procedures, and complications. RESULTS: The projected average cumulative cost at 5 years was lower in the two-stent treatment arm ($4,420) compared to the SLT arm ($4,730) or medications-only arm ($6,217). Initial year-zero costs were higher with two iStents ($2,810) than with SLT ($842) or medications only ($996). Average marginal annual costs in years 1-5 were $322 for two iStents, $777 for SLT, and $1,044 for medications only. The cumulative cost differences between two iStents vs SLT or medications only decreased over time, with breakeven by 5 or 3 years post-initiation, respectively. By year 5, cumulative savings with two iStents over SLT or medications only was $309 or $1,797, respectively. LIMITATIONS: This analysis relies on clinical expert panel opinion and would benefit from real-world evidence on use of multiple procedures and treatment switching after two-stent treatment, SLT, or polypharmaceutical initial approaches. CONCLUSIONS: Despite higher costs in year zero, annual costs thereafter were lowest in the two-stent treatment arm. Two-stent treatment may reduce OAG-related health resource use, leading to direct savings, especially over medications only or at longer time horizons.

Transition to a novel advanced integrated vitrectomy platform: comparison of the surgical impact of moving from the Accurus vitrectomy platform to the Constellation Vision System for microincisional vitrectomy surgery.

BACKGROUND: Microincisional vitrectomy surgery (MIVS) is the current standard surgical approach for pars plana vitrectomy. Historically, the most common surgical platform for vitrectomy surgery, since its introduction in 1997, has been the Accurus vitrectomy system. Recent introduction of the next generation of vitrectomy platforms has generated concerns associated with transitioning to new technology in the operating room environment. This study compared, in a matched fashion, surgical use of the Accurus vitrectomy system and the next generation Constellation Vision System to evaluate surgical efficiencies, complications, and user perceptions of this transition. METHODS: Electronic health records were abstracted as a hospital quality assurance activity and included all vitreoretinal surgical procedures at the Bascom Palmer Eye Institute, Anne Bates Leach Eye Hospital, during two discrete 12-month time periods. These two periods reflected dedicated usage of the Accurus (June 2008-May 2009) and Constellation Vision (July 2009-June 2010) systems. Data were limited to a single surgeon and evaluated for operating room (OR) total time usage/day, OR case time/case, and OR surgical time/case. Further analysis evaluated all patients undergoing combined MIVS and clear cornea phacoemulsification/intraocular lens (IOL) implantation during each individual time period to determine the impact of the instrumentation on these parameters. All records were evaluated for intraoperative complications. RESULTS: Five hundred and fourteen eligible patients underwent MIVS during the 2-year study windows, with 281 patients undergoing surgery with the Accurus system and 233 patients undergoing surgery with the Constellation system. Combined MIVS and phacoemulsification with IOL implantation was performed 141 times during this period with the Accurus and 158 times during the second study period with the Constellation. Total number of patients operated per day increased from 7.55 with Accurus to 8.53 with Constellation. Surgical room time decreased from 56 minutes with Accurus to 52 minutes with Constellation, and procedure time decreased from 35 minutes with Accurus to 31 minutes with Constellation (P < 0.004). Combined MIVS/phacoemulsification surgery saw similar declines in surgical room time and procedure time (P < 0.001). Subset analysis of procedures limited by case number per day (eg, four cases/day, five cases/day, six cases/day, and seven or more cases/day) showed similar outcomes with a decrease in surgical room time and procedure time. No increases in surgery-related complications were noted by quality assurance review during these time periods. DISCUSSION: Transitioning to advanced surgical technology is a complex issue for the surgeon, the hospital team, and the hospital administration. This study documents improvement in three significant measures of surgical efficiency: operative number of patients per day, operative room time, and surgical procedure time that reflect the positive impact of the novel, combined, integrated, posterior and anterior, ophthalmologic surgical platform of the Constellation Vision System. These data are imperative to evaluate the impact of transition from one surgical platform to another. During this transition, hospital quality assurance review and surgeon evaluation of operative complications showed no increased concerns for the shift from the Accurus to the Constellation Vision System surgical platform. Further, both operative staff and surgeons felt that the transition to the Constellation was not associated with increases in difficulty with setup, turnover, or use and that the Constellation decreased safety concerns for surgical usage. Ultimately, in this case, new technology benefited the surgeon, the patient, and the hospital.

The economic impact of aspergillosis: analysis of hospital expenditures across patient subgroups.

OBJECTIVE: To measure the impact of invasive aspergillosis infection on US hospital costs and financial performance across different patient populations. METHODS: Hospital discharge data for patients with a primary or secondary diagnosis of aspergillosis were extracted from the 2003 Nationwide Inpatient Sample (NIS) and the fiscal year 2003 (FYO3) Medicare Provider Analysis and Review (MedPAR) file. The data on patient demographics, length of stay (LOS), hospital charges, estimated costs, and reimbursement levels were reported. After controlling for comorbidities, operative procedures, and diagnosis-related group (DRG) assignment, the clinical and economic outcomes were compared for patients with and without aspergillosis. RESULTS: The NIS contains a total of over 38 million projected hospital discharges. From these, 10400 aspergillosis cases were identified across 171 DRGs, resulting in a US incidence rate of 36 per million per year. The mean age of aspergillosis patients was 55.6 years, with 53.4% male and 67.9% Caucasian. The median (mean) LOS per aspergillosis patient was 10 (17.7) days, with a median (mean) total hospital charge (THC) of $44,845 ($96,731). Among the patient subgroups analyzed, the median (mean) THC per patient ranged from $47,252 ($82,946) for HIV to $413,200 ($442,233) for bone marrow transplant (BMT). When compared to the non-aspergillosis patient population, the data showed a significant increase in LOS, THC, and hospital costs. Furthermore, the higher hospital costs associated with aspergillosis patients were not matched by similar increases in reimbursements, resulting in a greater financial loss for hospitals. The mean reimbursement-to-cost ratio for aspergillosis cases across the DRGs analyzed was 0.80. CONCLUSIONS: Aspergillosis affects a wide range of patient groups and has a negative economic impact across many DRGs. Improved prevention, diagnosis, and patient management strategies can help mitigate these effects on hospital financial performance.