Validation of a Crisis Standards of Care Model for Prioritization of Limited Resources During the Coronavirus Disease 2019 Crisis in an Urban, Safety-Net, Academic Medical Center.

OBJECTIVES: The coronavirus disease 2019 pandemic has overwhelmed healthcare resources even in wealthy nations, necessitating rationing of limited resources without previously established crisis standards of care protocols. In Massachusetts, triage guidelines were designed based on acute illness and chronic life-limiting conditions. In this study, we sought to retrospectively validate this protocol to cohorts of critically ill patients from our hospital. DESIGN: We applied our hospital-adopted guidelines, which defined severe and major chronic conditions as those associated with a greater than 50% likelihood of 1- and 5-year mortality, respectively, to a critically ill patient population. We investigated mortality for the same intervals. SETTING: An urban safety-net hospital ICU. PATIENTS: All adults hospitalized during April of 2015 and April 2019 identified through a clinical database search. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Of 365 admitted patients, 15.89% had one or more defined chronic life-limiting conditions. These patients had higher 1-year (46.55% vs 13.68%; p < 0.01) and 5-year (50.00% vs 17.22%; p < 0.01) mortality rates than those without underlying conditions. Irrespective of classification of disease severity, patients with metastatic cancer, congestive heart failure, end-stage renal disease, and neurodegenerative disease had greater than 50% 1-year mortality, whereas patients with chronic lung disease and cirrhosis had less than 50% 1-year mortality. Observed 1- and 5-year mortality for cirrhosis, heart failure, and metastatic cancer were more variable when subdivided into severe and major categories. CONCLUSIONS: Patients with major and severe chronic medical conditions overall had 46.55% and 50.00% mortality at 1 and 5 years, respectively. However, mortality varied between conditions. Our findings appear to support a crisis standards protocol which focuses on acute illness severity and only considers underlying conditions carrying a greater than 50% predicted likelihood of 1-year mortality. Modifications to the chronic lung disease, congestive heart failure, and cirrhosis criteria should be refined if they are to be included in future models.

Prognostic Assessment of Right Ventricular Systolic Dysfunction on Post-Transcatheter Aortic Valve Replacement Short-Term Outcomes: Systematic Review and Meta-Analysis.

Background Right ventricular systolic dysfunction (RVSD) is a known risk factor for adverse outcome in surgical aortic valve replacement. Transcatheter aortic valve replacement (TAVR), on the other hand, has been shown to be either beneficial or have no effect on right ventricular systolic function. However, the prognostic significance of RVSD on TAVR has not been clearly determined. We conducted a systematic review and meta-analysis to define the impact of RVSD on outcomes in terms of 1-year mortality in patients with severe aortic stenosis undergoing TAVR. Methods and Results An extensive literature review was performed, with an aim to identify clinical studies that focused on the prognosis and short-term mortality of patients with severe symptomatic aortic stenosis who underwent TAVR. A total of 3166 patients from 8 selected studies were included. RVSD, as assessed with tricuspid annular plane systolic excursion, fractional area change or ejection fraction, was found to be a predictor of adverse procedural outcome after TAVR (hazard ratio, 1.31; 95% CI, 1.1-1.55; P=0.002). Overall, we found that RVSD did affect post-TAVR prognosis in 1-year mortality rate. Conclusions Patients with severe, symptomatic aortic stenosis and concomitant severe RVSD have a poor 1-year post-TAVR prognosis when compared with patients without RVSD. Right ventricular dilation and severe tricuspid regurgitation were associated with increased 1-year morality post-TAVR and should be considered as independent risk factors. Further evaluations of long-term morbidity, mortality, as well as sustained improvement in functional class and symptoms need to be conducted to determine the long-term effects.

Accessing a new medication in Germany: a novel approach to assess a health insurance-related barrier.

PURPOSE: Knowledge of the existence, position, and magnitude of barriers to equitable healthcare is an important consideration in shaping healthcare policies. METHODS: The authors developed a novel three-dimensional person-time-related hurdle model and followed a cohort of 7358 statutorily (SHI) and 457 privately health insured (PHI) patients with migraine headaches at 377 primary-care practices (MediPlus, IMS Health) in the second to fourth year of the HealthCare Structural Reform Act in Germany. RESULTS: For SHI compared with PHI migraine patients, there was a hurdle to receiving sumatriptan at all (2.4-fold lower hazard, 95% confidence interval, 1.8-3.2). Among patients who received sumatriptan, frequency and intensity of use differed only minimally between SHI and PHI patients. CONCLUSIONS: These findings have implications for healthcare researchers and healthcare policies. The framework extends traditional hurdle models and can serve as a model for quantifying barriers to receipt of services under different funding policies.

Quantifying delay in access to new medical treatment: an application of risk advancement period methodology.

BACKGROUND: We present a novel application of the concept of risk or rate advancement to compute the extent of delay in adoption of an effective new drug in 2 German health insurance systems. METHODS: We identified individuals with migraines, age 18 to 65 years, in 371 primary care practices in Germany in 1994 (MediPlus, IMS Health database). These included 8173 persons covered under the statutory health insurance system and 503 persons covered by private health insurance. We derived risk and population risk advancement periods for sumatriptan compared with nonserotoninergic acute migraine therapy using multiplicative risk regression and generalized estimating equations, adjusted for patient, physician, and practice cofactors. RESULTS: For patients at the mean age of the cohort, 43 years of age, sumatriptan was prescribed 1.2 (95% confidence interval [CI] = 0.3-2.0) years later among those in the statutory health insurance system compared with those who had private insurance. The lag increased by 0.6 (-0.1 to 1.3) years for every 10 years of patient age. In the age-mix of our sample, access to the health benefits of sumatriptan therapy lagged nearly 1.5 years behind in the statutory health insurance system and for Germany as a whole. CONCLUSIONS: Migraine patients' access to sumatriptan therapy lagged substantially in the statutory health insurance system and in the country as a whole. Risk advancement periods provide a useful methodology for communicating major healthcare issues in a meaningful way to society and policymakers.

The disparity in access to new medication by type of health insurance: lessons from Germany.

BACKGROUND: Drug provision within the German statutory health insurance system has undergone several reforms, including the introduction of drug macrobudgets in 1993. OBJECTIVE: The objective of this study was to investigate the extent to which statutorily (SHI) and fully privately (PHI) health-insured patients were provided with new medication recommended by professional bodies in an equitable fashion using the example of migraine patients. RESEARCH DESIGN: We conducted a retrospective cohort study. SETTING: A total of 367 primary-care practices (MediPlus, IMS Health) in Germany in the second year of the HealthCare Structural Reform Act were studied. SUBJECTS: Subjected consisted of 7703 SHI and 470 PHI migraineurs (International Classification of Diseases, 10th edition G43) aged 18 to 65 years at their first migraine prescription visit in 1994. OUTCOME MEASURE: We compared prescription of oral or subcutaneous serotonin 5HT1B/1D receptor agonist sumatriptan with nonserotoninergic migraine therapy. RESULTS: In multiplicative risk regression with variance estimation accounting for clustering of patients within practices, PHI patients were 2.3 times (95% confidence interval [CI], 1.6-3.3) more likely to receive sumatriptan than their SHI counterparts at the mean age of the cohorts (43 years) adjusted for incident versus prevalent migraine treatment, the gender of the patient, the age, gender, and primary care specialist group of the physician, and the type and the community size class of the practice. This disparity widened by 38% (95% CI, 1-88%) every 10 years of patient age. CONCLUSION: Even though virtually everyone in Germany has health insurance and drug coverage, use of new and recommended migraine medicines was less common among those with SHI compared with their privately insured counterparts. Systematic studies of access to health care recommended by professional bodies will be critically important to ensure delivery of high-quality health care for all patients.