Association of diabetes-related kidney disease with cardiovascular and non-cardiovascular outcomes: a retrospective cohort study.

BACKGROUND: Diabetes-related kidney disease is associated with end-stage renal disease and mortality, but opportunities remain to quantify its association with cardiovascular and non-cardiovascular morbidity outcomes. METHODS: We used the Truven Health MarketScan Commercial Claims and Encounters Database, 2010-2014, which includes specific health services records for employees and their dependents from a selection of large employers, health plans, and government and public organizations. We used administrative claims data to quantify the association between diabetes-related kidney disease and end-stage renal disease, myocardial infarction, congestive heart failure, stroke, and infections. Cox proportional hazard regression models were used to estimate adjusted hazard ratios of developing complications. RESULTS: Among 2.2 million patients with diabetes, 7.1% had diabetes-related kidney disease: 13.5%, stage 1-2; 33.8%, stage 3; 13.2% stages 4-5; 39.5%, unknown stage. In multivariable Cox proportional hazard models adjusted for demographic characteristics, baseline comorbid conditions, and total hospital days during the baseline period, hazard ratios for each outcome increased with greater diabetes-related kidney disease severity (stage 1-2 vs. stage 4-5) compared with no diabetes-related kidney disease: myocardial infarction, 1.2 (95% confidence interval 1.1-1.4) and 3.1 (2.9-3.4); congestive heart failure, 1.7 (1.6-1.9) and 5.6 (5.3-5.8); stroke, 1.3 (1.2-1.5) and 2.3 (2.1-2.5); infection, 1.4 (1.3-1.5) and 2.9 (2.8-3.0). Among patients with stage 4-5 disease, 36-month cumulative incidence was nearly 22.8% for congestive heart failure, and 25.8% for infections. CONCLUSIONS: Diabetes-related kidney disease appears to be formally diagnosed at a more advanced stage than might be expected, given clinical practice guidelines. Risks of cardiovascular and non-cardiovascular outcomes are high.

How are Companion Diagnostics Considered in Economic Evaluations of Oncology Treatments? A Review of Health Technology Assessments.

BACKGROUND: Companion diagnostic (CDx) testing is increasingly used to identify eligible patients for targeted treatments. Guidance on how CDx testing should be incorporated into cost-effectiveness models (CEM) is limited. This review evaluated how health technology assessment bodies and research organizations considered CDx in CEMs of targeted therapies in oncology and whether this ultimately impacted their decisions or time from regulatory approval to recommendations. METHODS: An exhaustive list of approved CDx tests in oncology was compiled. For corresponding indications and treatments, NICE appraisals published between 2016 and 2019 were identified. Then, assessments for the same treatments issued from 11 other agencies were reviewed. Data extracted included background and CDx information, CDx's role in the CEM, and recommendations. RESULTS: Twenty-seven NICE appraisals were identified; 15 considered CDx testing in the CEM, while 12 did not, mainly because testing had already been established for the comparators within the same class or in clinical practice from a prior treatment line. Both testing costs and mutation prevalence drove CDx testing costs per patient. The cross-comparison of assessments showed that CDx test characteristics were inconsistently reported. Time from regulatory approval to recommendations was not impacted by CDx cost inclusion in CEMs. CONCLUSION: CDx testing was included in cost-effectiveness models whenever mutation testing was required solely for patients receiving targeted treatment; cost per patient was based on test costs and mutation prevalence. It is unclear if expanded reliance on CDx testing will impact future assessments of targeted therapies. A future update is warranted to track trends over time.

Lifetime benefits of early detection and treatment of diabetic kidney disease.

OBJECTIVES: Diabetic kidney disease (DKD) is a frequent complication of diabetes with potentially devastating consequences that may be prevented or delayed. This study aimed to estimate the health and economic benefit of earlier diagnosis and treatment of DKD. METHODS: Life expectancy and medical spending for people with diabetes were modeled using The Health Economics Medical Innovation Simulation (THEMIS). THEMIS uses data from the Health and Retirement Study to model cohorts of individuals over age 50 to project population-level lifetime health and economic outcomes. DKD status was imputed based on diagnoses and laboratory values in the National Health and Nutrition Examination Survey. We simulated the implementation of a new biomarker identifying people with diabetes at an elevated risk of DKD and DKD patients at risk of rapid progression. RESULTS: Compared to baseline, the prevalence of DKD declined 5.1% with a novel prognostic biomarker test, while the prevalence of diabetes with stage 5 chronic kidney disease declined 3.0%. Consequently, people with diabetes gained 0.2 years in life expectancy, while per-capita annual medical spending fell by 0.3%. The estimated cost was $12,796 per life-year gained and $25,842 per quality-adjusted life-year. CONCLUSIONS: A biomarker test that allows earlier treatment reduces DKD prevalence and slows DKD progression, thereby increasing life expectancy among people with diabetes while raising healthcare spending by less than one percent.

The effects of a stressed inshore urban reef on coral recruitment in Suva Harbour, Fiji.

A relic inshore reef ecosystem adjacent to the Fijian capital of Suva and another remote inshore reef were monitored monthly from July 2014 to July 2015 for coral recruitment, sedimentation rates, coral cover, temperature, and light intensity. Despite a major sewage spill in Suva Harbour in December 2014, the municipal inshore site exposed to constant anthropogenic activity, recorded no significant differences in coral spat abundance (except for the family Poritidae) on artificial substrata compared to the remote inshore site. Total yearly spat abundance was 106 on municipal reef and 132 on remote reef, while average daily sediment trap collection rates (g cm2/day) were significantly higher in the municipal site for the entire duration of monitoring. Total annual particulate organic matter content in sediment was also significantly higher in the municipal site (107.51 g cm2), compared to the remote site (43.37 g cm2). Mean light intensity was significantly lower for the municipal site (69.81 lum/ft2) compared to the remote site (239.26 lum/ft2), with Photosynthetically Active Radiation also lower for the former (800-1,066.66 µmol m-2 s-1) compared to the latter (3,266.66-3,600 µmol m-2 s-1). The lack of significant differences in coral spat recruitment rates suggests that settling larvae may be unable to distinguish between sub-optimal and optimal sites probably as a consequence of interference with coral settlement cues arising from anthropogenic development.

Use of antipsychotic blood levels in clinician decision making: A cross-over study using clinical vignettes of patients with schizophrenia.

The cause of treatment failure of antipsychotic medications is often difficult to determine in patients with schizophrenia. Evaluation of antipsychotic blood levels (ABLs) may aid clinicians in determining the cause of antipsychotic failure. The Clinical Assessment of the Schizophrenia Patient (CASP) was developed to evaluate clinical decision making during outpatient visits. The CASP assesses changes in medications, psychosocial treatments, and acute interventions along with factors influencing clinical decision making. Nine vignettes representative of clinical situations in patients with schizophrenia were created in two versions (one with ABLs, one without ABLs). The CASP was used to evaluate clinical decisions using the vignettes. Thirty-four clinicians participated in the study. In 8 out of 9 vignettes, most clinicians (at least 89.7%) made a different clinical decision with ABLs compared to without ABLs. In assessing the usefulness of ABLs, a majority (60.7%-85.7%, depending on the vignette) of clinicians responded that ABLs changed their clinical decision for 8 vignettes. Most clinicians (79%-93%) responded that they were more confident in their decisions with ABL information. This study demonstrated that ABLs have the potential to influence clinical decision making in the treatment of patients with schizophrenia.

The Value of Diagnostic Testing in Personalized Medicine.

Personalized medicine - the targeting of therapies to individuals on the basis of their biological, clinical, or genetic characteristics - is thought to have the potential to transform health care. While much emphasis has been placed on the value of personalized therapies, less attention has been paid to the value generated by the diagnostic tests that direct patients to those targeted treatments. This paper presents a framework derived from information economics for assessing the value of diagnostics. We demonstrate, via a case study, that the social value of such diagnostics can be very large, both by avoiding unnecessary treatment and by identifying patients who otherwise would not get treated. Despite the potential social benefits, diagnostic development has been discouraged by cost-based, rather than value-based, reimbursement.