Expected Health Benefits of SGLT-2 Inhibitors and GLP-1 Receptor Agonists in Older Adults.

Background. Older and sicker adults with type 2 diabetes (T2D) were underrepresented in randomized trials of glucagon-like peptide 1 receptor-agonist (GLP1RA) and sodium-glucose cotransporter 2 inhibitors (SGLT2I), and thus, health benefits are uncertain in this population. Objective. To assess the impact of age, health status, and life expectancy in older adults with T2D on health benefits of GLP1RA and SGLT2I. Design. We used the United Kingdom Prospective Diabetes Study (UKPDS) model to simulate lifetime health outcomes. We calibrated the UKPDS model to improve mortality prediction in older adults using a common geriatric prognostic index. Participants. National Health and Nutrition Examination Survey 2013-2018 participants 65 y and older with T2D, eligible for GLP1RA or SGLT2I according to American Diabetes Association guidelines. Interventions. GLP1RA or SGLT2I use versus no additional medication. Main Measures. Lifetime complications and weighted life-years (LYs) and quality-adjusted life-years (QALYs) across overall treatment arms and life expectancies. Key Results. The overall older adult population was predicted to experience significant health benefits from GLP1RA (+0.29 LY [95% confidence interval: 0.27, 0.31], +0.15 QALYs [0.14, 0.16]) and SGLT2I (+0.26 LY [0.24, 0.28], +0.13 QALYs [0.12, 0.14]) as compared with no added medication. However, expected benefits declined in subgroups with shorter life expectancies. Participants with <4 y of life expectancy had minimal gains of <0.05 LY and <0.03 QALYs from added medication. Accounting for injection-related disutility, GLP1RA use reduced QALYs (-0.03 QALYs [-0.04, -0.02]). Conclusions. While GLP1RA and SGLT2I have substantial health benefits for many older adults with type 2 diabetes, benefits are not clinically significant in patients with <4 y of life expectancy. Life expectancy and patient preferences are important considerations when prescribing newer diabetes medications. Highlights: On average, older adults benefit significantly from SGLT2I and GLP1RA use. However, the benefits of these drugs are not clinically significant among older patients with life expectancy less than 4 y.There is potential harm in injectable GLP1RA use in the oldest categories of adults with type 2 diabetes.Heterogeneity in life expectancy and patient preferences for injectable versus oral medications are important to consider when prescribing newer diabetes medications.

Revisiting the Time Needed to Provide Adult Primary Care.

BACKGROUND: Many patients do not receive guideline-recommended preventive, chronic disease, and acute care. One potential explanation is insufficient time for primary care providers (PCPs) to provide care. OBJECTIVE: To quantify the time needed to provide 2020 preventive care, chronic disease care, and acute care for a nationally representative adult patient panel by a PCP alone, and by a PCP as part of a team-based care model. DESIGN: Simulation study applying preventive and chronic disease care guidelines to hypothetical patient panels. PARTICIPANTS: Hypothetical panels of 2500 patients, representative of the adult US population based on the 2017-2018 National Health and Nutrition Examination Survey. MAIN MEASURES: The mean time required for a PCP to provide guideline-recommended preventive, chronic disease and acute care to the hypothetical patient panels. Estimates were also calculated for visit documentation time and electronic inbox management time. Times were re-estimated in the setting of team-based care. KEY RESULTS: PCPs were estimated to require 26.7 h/day, comprising of 14.1 h/day for preventive care, 7.2 h/day for chronic disease care, 2.2 h/day for acute care, and 3.2 h/day for documentation and inbox management. With team-based care, PCPs were estimated to require 9.3 h per day (2.0 h/day for preventive care and 3.6 h/day for chronic disease care, 1.1 h/day for acute care, and 2.6 h/day for documentation and inbox management). CONCLUSIONS: PCPs do not have enough time to provide the guideline-recommended primary care. With team-based care the time requirements would decrease by over half, but still be excessive.

First-Line Therapy for Type 2 Diabetes With Sodium-Glucose Cotransporter-2 Inhibitors and Glucagon-Like Peptide-1 Receptor Agonists : A Cost-Effectiveness Study.

BACKGROUND: Guidelines recommend sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP1) receptor agonists as second-line therapy for patients with type 2 diabetes. Expanding their use as first-line therapy has been proposed but the clinical benefits may not outweigh their costs. OBJECTIVE: To evaluate the lifetime cost-effectiveness of a strategy of first-line SGLT2 inhibitors or GLP1 receptor agonists. DESIGN: Individual-level Monte Carlo-based Markov model. DATA SOURCES: Randomized trials, Centers for Disease Control and Prevention databases, RED BOOK, and the National Health and Nutrition Examination Survey. TARGET POPULATION: Drug-naive U.S. patients with type 2 diabetes. TIME HORIZON: Lifetime. PERSPECTIVE: Health care sector. INTERVENTION: First-line SGLT2 inhibitors or GLP1 receptor agonists. OUTCOME MEASURES: Life expectancy, lifetime costs, incremental cost-effectiveness ratios (ICERs). RESULTS OF BASE-CASE ANALYSIS: First-line SGLT2 inhibitors and GLP1 receptor agonists had lower lifetime rates of congestive heart failure, ischemic heart disease, myocardial infarction, and stroke compared with metformin. First-line SGLT2 inhibitors cost $43 000 more and added 1.8 quality-adjusted months versus first-line metformin ($478 000 per quality-adjusted life-year [QALY]). First-line injectable GLP1 receptor agonists cost more and reduced QALYs compared with metformin. RESULTS OF SENSITIVITY ANALYSIS: By removing injection disutility, first-line GLP1 receptor agonists were no longer dominated (ICER, $327 000 per QALY). Oral GLP1 receptor agonists were not cost-effective (ICER, $823 000 per QALY). To be cost-effective at under $150 000 per QALY, costs for SGLT2 inhibitors would need to be under $5 per day and under $6 per day for oral GLP1 receptor agonists. LIMITATION: U.S. population and costs not generalizable internationally. CONCLUSION: As first-line agents, SGLT2 inhibitors and GLP1 receptor agonists would improve type 2 diabetes outcomes, but their costs would need to fall by at least 70% to be cost-effective. PRIMARY FUNDING SOURCE: American Diabetes Association.

Development and Validation of a Decision Analytical Model for Posttreatment Surveillance for Patients With Oropharyngeal Carcinoma.

Importance: Clinical practice regarding posttreatment radiologic surveillance for patients with oropharyngeal carcinoma (OPC) is neither adapted to individual patient risk nor fully evidence based. Objectives: To construct a microsimulation model for posttreatment OPC progression and use it to optimize surveillance strategies while accounting for both tumor stage and human papillomavirus (HPV) status. Design, Setting, and Participants: In this decision analytical modeling study, a Markov model of 3-year posttreatment patient trajectories was created. The training data source was the American College of Surgeon's National Cancer Database from 2010 to 2015. The external validation data set was the 2016 International Collaboration on Oropharyngeal Cancer Network for Staging (ICON-S) study. Training data comprised 2159 patients with OPC treated with primary radiotherapy who had known HPV status and disease staging information. Patients with American Joint Committee on Cancer, 7th edition stage III to IVB disease and those with clinical metastases during the time of primary treatment were included. Data were analyzed from August 1 to October 31, 2020. Main Outcomes and Measures: Main outcomes included disease stage and HPV status, specific disease transition probabilities, and latency of surveillance regimens, defined as time between recurrence incidence and disease discovery. Results: Training data consisted of 2159 total patients (1708 men [79.1%]; median age, 59.6 years [range, 40-90 years]; 401 with stage III disease, 1415 with stage IVA disease, and 343 with stage IVB disease). Cohorts predominantly had HPV-negative disease (1606 [74.4%]). With model-optimized regimens, recurrent disease was discovered a mean of 0.6 months (95% CI, 0.5-0.8 months) earlier than with a standard surveillance regimen based on current clinical guidelines. Recurrent disease was discovered using the optimized regimens without significant reduction in sensitivity. Compared with strategies based on reimbursement guidelines, the model-optimized regimens found disease a mean of 1.8 months (95% CI, 1.3-2.3 months) earlier. Conclusions and Relevance: Optimized, risk-stratified surveillance regimens consistently outperformed nonoptimized strategies. These gains were obtained without requiring any additional imaging studies. This approach to risk-stratified surveillance optimization is generalizable to a broad range of tumor types and risk factors.

Longer-term Benefits and Risks of Sodium-Glucose Cotransporter-2 Inhibitors in Type 2 Diabetes: a Systematic Review and Meta-analysis.

BACKGROUND: Sodium-glucose cotransporter-2 inhibitors (SGLT2Is) are a recent class of medication approved for the treatment of type 2 diabetes (T2D). Previous meta-analyses have quantified the benefits and harms of SGLT2Is; however, these analyses have been limited to specific outcomes and comparisons and included trials of short duration. We comprehensively reviewed the longer-term benefits and harms of SGLT2Is compared to placebo or other anti-hyperglycemic medications. METHODS: We searched PubMed, Scopus, and clinicaltrials.gov from inception to July 2019 for randomized controlled trials of minimum 52 weeks' duration that enrolled adults with T2D, compared an SGLT2I to either placebo or other anti-hyperglycemic medications, and reported at least one outcome of interest including cardiovascular risk factors, microvascular and macrovascular complications, mortality, and adverse events. We conducted random effects meta-analyses to provide summary estimates using weighted mean differences (MD) and pooled relative risks (RR). The study was registered a priori with PROSPERO (CRD42018090506). RESULTS: Fifty articles describing 39 trials (vs. placebo, n = 28; vs. other anti-hyperglycemic medication, n = 12; vs. both, n = 1) and 112,128 patients were included in our analyses. Compared to placebo, SGLT2Is reduced cardiovascular risk factors (e.g., hemoglobin A1c, MD - 0.55%, 95% CI - 0.62, - 0.49), macrovascular outcomes (e.g., hospitalization for heart failure, RR 0.70, 95% CI 0.62, 0.78), and mortality (RR 0.87, 95% CI 0.80, 0.94). Compared to other anti-hyperglycemic medications, SGLT2Is reduced cardiovascular risk factors, but insufficient data existed for other outcomes. About a fourfold increased risk of genital yeast infections for both genders was observed for comparisons vs. placebo and other anti-hyperglycemic medications. DISCUSSION: We found that SGLT2Is led to durable reductions in cardiovascular risk factors compared to both placebo and other anti-hyperglycemic medications. Reductions in macrovascular complications and mortality were only observed in comparisons with placebo, although trials comparing SGLT2Is vs. other anti-hyperglycemic medications were not designed to assess longer-term outcomes.

The Longer-Term Benefits and Harms of Glucagon-Like Peptide-1 Receptor Agonists: a Systematic Review and Meta-Analysis.

BACKGROUND: Previous meta-analyses of the benefits and harms of glucagon-like peptide-1 receptor agonists (GLP1RAs) have been limited to specific outcomes and comparisons and often included short-term results. We aimed to estimate the longer-term effects of GLP1RAs on cardiovascular risk factors, microvascular and macrovascular complications, mortality, and adverse events in patients with type 2 diabetes, compared to placebo and other anti-hyperglycemic medications. METHODS: We searched PubMed, Scopus, and clinicaltrials.gov (inception-July 2019) for randomized controlled trials ≥ 52 weeks' duration that compared a GLP1RA to placebo or other anti-hyperglycemic medication and included at least one outcome of interest. Outcomes included cardiovascular risk factors, microvascular and macrovascular complications, all-cause mortality, and treatment-related adverse events. We performed random effects meta-analyses to give summary estimates using weighted mean differences (MD) and pooled relative risks (RR). Risk of bias was assessed using the Cochrane Collaboration risk of bias in randomized trials tool. Quality of evidence was summarized using the Grading of Recommendations, Assessment, Development, and Evaluation approach. The study was registered a priori with PROSPERO (CRD42018090506). RESULTS: Forty-five trials with a mean duration of 1.7 years comprising 71,517 patients were included. Compared to placebo, GLP1RAs reduced cardiovascular risk factors, microvascular complications (including renal events, RR 0.85, 0.80-0.90), macrovascular complications (including stroke, RR 0.86, 0.78-0.95), and mortality (RR 0.89, 0.84-0.94). Compared to other anti-hyperglycemic medications, GLP1RAs only reduced cardiovascular risk factors. Increased gastrointestinal events causing treatment discontinuation were observed in both comparisons. DISCUSSION: GLP1RAs reduced cardiovascular risk factors and increased gastrointestinal events compared to placebo and other anti-hyperglycemic medications. GLP1RAs also reduced MACE, stroke, renal events, and mortality in comparisons with placebo; however, analyses were inconclusive for comparisons with other anti-hyperglycemic medications. Given the high costs of GLP1RAs, the lack of long-term evidence comparing GLP1RAs to other anti-hyperglycemic medications has significant policy and clinical practice implications.

The Productivity Requirements of Implementing a Medical Scribe Program.

BACKGROUND: Economic analyses of medical scribes have been limited to individual, specialty-specific clinics. OBJECTIVE: To determine the number of additional patient visits various specialties would need to recover the costs of implementing scribes in their practice at 1 year. DESIGN: Modeling study based on 2015 data from the Centers for Medicare & Medicaid Services (CMS) and National Ambulatory Medical Care Survey. Scribe costs were based on literature review and a third-party contractor model. Revenue was calculated from direct visit billing, CPT (Current Procedural Terminology) billing, and data from the National Ambulatory Medical Care Survey. DATA SOURCES: 2015 data from CMS and the National Ambulatory Medical Care Survey. TARGET POPULATION: Health care providers. TIME HORIZON: 1 year. PERSPECTIVE: Office-based clinic. OUTCOME MEASURES: The number of additional patient visits a physician must have to recover the costs of a scribe program at 1 year. RESULTS OF BASE-CASE ANALYSIS: An average of 1.34 additional new patient visits per day (295 per year) were required to recover scribe costs (range, 0.89 [cardiology] to 1.80 [orthopedic surgery] new patient visits per day). For returning patients, an average of 2.15 additional visits per day (472 per year) were required (range, 1.65 [cardiology] to 2.78 [orthopedic surgery] returning visits per day). The addition of 2 new patient (or 3 returning) visits per day was profitable for all specialties. RESULTS OF SENSITIVITY ANALYSIS: Results were not sensitive to most inputs, with the exception of hourly scribe cost and inclusion of CPT revenue. LIMITATION: Use of Medicare data and failure to account for indirect costs, downstream revenue, or changes in documentation quality. CONCLUSION: For all specialties, modest increases in productivity due to scribes may allow physicians to see more patients and offset scribe costs, making scribe programs revenue-neutral. PRIMARY FUNDING SOURCE: University of Chicago Medicine's Center for Healthcare Delivery Science and Innovation and the Bucksbaum Institute.

The Impact of Biomarker Screening and Cascade Genetic Testing on the Cost-Effectiveness of MODY Genetic Testing.

OBJECTIVE: In the U.S., genetic testing for maturity-onset diabetes of the young (MODY) is frequently delayed because of difficulty with insurance coverage. Understanding the economic implications of clinical genetic testing is imperative to advance precision medicine for diabetes. The objective of this article is to assess the cost-effectiveness of genetic testing, preceded by biomarker screening and followed by cascade genetic testing of first-degree relatives, for subtypes of MODY in U.S. pediatric patients with diabetes. RESEARCH DESIGN AND METHODS: We used simulation models of distinct forms of diabetes to forecast the clinical and economic consequences of a systematic genetic testing strategy compared with usual care over a 30-year time horizon. In the genetic testing arm, patients with MODY received treatment changes (sulfonylureas for HNF1A- and HNF4A-MODY associated with a 1.0% reduction in HbA1c; no treatment for GCK-MODY). Study outcomes included costs, life expectancy (LE), and quality-adjusted life years (QALY). RESULTS: The strategy of biomarker screening and genetic testing was cost-saving as it increased average quality of life (+0.0052 QALY) and decreased costs (-$191) per simulated patient relative to the control arm. Adding cascade genetic testing increased quality-of-life benefits (+0.0081 QALY) and lowered costs further (-$735). CONCLUSIONS: A combined strategy of biomarker screening and genetic testing for MODY in the U.S. pediatric diabetes population is cost-saving compared with usual care, and the addition of cascade genetic testing accentuates the strategy's benefits. Widespread implementation of this strategy could improve the lives of patients with MODY while saving the health system money, illustrating the potential population health benefits of personalized medicine.

Cost-effectiveness of Shared Telemedicine Appointments in Young Adults With T1D: CoYoT1 Trial.

OBJECTIVE: Young adults with type 1 diabetes (T1D) often struggle to achieve glycemic control and maintain routine clinic visits. We aimed to evaluate the societal cost-effectiveness of the Colorado young adults with T1D (CoYoT1) Clinic, an innovative care model of shared medical appointments through home telehealth. RESEARCH DESIGN AND METHODS: Patients self-selected into the CoYoT1 (N = 42) or usual care (N = 39) groups. RESULTS: Within the trial, we found no significant differences in 9-month quality-adjusted life; however, the control group had a larger decline from baseline in utility than the CoYoT1 group, indicating a quality of life (QoL) benefit of the intervention (difference in difference mean ± SD: 0.04 ± 0.09; P = 0.03). There was no significant difference in total costs. The CoYoT1 group had more study-related visits but fewer nonstudy office visits and hospitalizations. CONCLUSIONS: The CoYoT1 care model may help young adults with T1D maintain a higher QoL with no increase in costs.

Cost-effectiveness of Initiating an Insulin Pump in T1D Adults Using Continuous Glucose Monitoring Compared with Multiple Daily Insulin Injections: The DIAMOND Randomized Trial.

BACKGROUND: The economic impact of both continuous glucose monitoring (CGM) and insulin pumps (continuous subcutaneous insulin infusion [CSII]) in type 1 diabetes (T1D) have been evaluated separately. However, the cost-effectiveness of adding CSII to existing CGM users has not yet been assessed. OBJECTIVE: The aim of this study was to evaluate the societal cost-effectiveness of CSII versus continuing multiple daily injections (MDI) in adults with T1D already using CGM. METHODS: In the second phase of the DIAMOND trial, 75 adults using CGM were randomized to either CGM+CSII or CGM+MDI (control) and surveyed at baseline and 28 weeks. We performed within-trial and lifetime cost-effectiveness analyses (CEAs) and estimated lifetime costs and quality-adjusted life-years (QALYs) via a modified Sheffield T1D model. RESULTS: Within the trial, the CGM+CSII group had a significant reduction in quality of life from baseline (-0.02 ± 0.05 difference in difference [DiD]) compared with controls. Total per-person 28-week costs were $8,272 (CGM+CSII) versus $5,623 (CGM+MDI); the difference in costs was primarily attributable to pump use ($2,644). Pump users reduced insulin intake (-12.8 units DiD) but increased the use of daily number of test strips (+1.2 DiD). Pump users also increased time with glucose in range of 70 to 180 mg/dL but had a higher HbA1c (+0.13 DiD) and more nonsevere hypoglycemic events. In the lifetime CEA, CGM+CSII would increase total costs by $112,045 DiD, decrease QALYs by 0.71, and decrease life expectancy by 0.48 years. CONCLUSIONS: Based on this single trial, initiating an insulin pump in adults with T1D already using CGM was associated with higher costs and reduced quality of life. Additional evidence regarding the clinical effects of adopting combinations of new technologies from trials and real-world populations is needed to confirm these findings.

Cost-effectiveness of Continuous Glucose Monitoring for Adults With Type 1 Diabetes Compared With Self-Monitoring of Blood Glucose: The DIAMOND Randomized Trial.

OBJECTIVE: This study evaluated the societal cost-effectiveness of continuous glucose monitoring (CGM) in patients with type 1 diabetes (T1D) using multiple insulin injections. RESEARCH DESIGN AND METHODS: In the Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes (DIAMOND) trial, 158 patients with T1D and HbA1c ≥7.5% were randomized in a 2:1 ratio to CGM or control. Participants were surveyed at baseline and 6 months. Within-trial and lifetime cost-effectiveness analyses were conducted. A modified Sheffield T1D policy model was used to simulate T1D complications. The main outcome was cost per quality-adjusted life-year (QALY) gained. RESULTS: Within the 6-month trial, the CGM group had similar QALYs to the control group (0.462 ± 0.05 vs. 0.455 ± 0.06 years, P = 0.61). The total 6-month costs were $11,032 (CGM) vs. $7,236 (control). The CGM group experienced reductions in HbA1c (0.60 ± 0.74% difference in difference [DiD]), P < 0.01), the daily rate of nonsevere hypoglycemia events (0.07 DiD, P = 0.013), and daily test strip use (0.55 ± 1.5 DiD, P = 0.04) compared with the control group. In the lifetime analysis, CGM was projected to reduce the risk of T1D complications and increase QALYs by 0.54. The incremental cost-effectiveness ratio (ICER) was $98,108 per QALY for the overall population. By extending sensor use from 7 to 10 days in a real-world scenario, the ICER was reduced to $33,459 per QALY. CONCLUSIONS: For adults with T1D using multiple insulin injections and still experiencing suboptimal glycemic control, CGM is cost-effective at the willingness-to-pay threshold of $100,000 per QALY, with improved glucose control and reductions in nonsevere hypoglycemia.

Individualized Glycemic Control for U.S. Adults With Type 2 Diabetes: A Cost-Effectiveness Analysis.

Background: Intensive glycemic control in type 2 diabetes (glycated hemoglobin [HbA1c] level <7%) is an established, cost-effective standard of care. However, guidelines recommend individualizing goals on the basis of age, comorbidity, diabetes duration, and complications. Objective: To estimate the cost-effectiveness of individualized control versus uniform intensive control (HbA1c level <7%) for the U.S. population with type 2 diabetes. Design: Patient-level Monte Carlo-based Markov model. Data Sources: National Health and Nutrition Examination Survey 2011-2012. Target Population: The approximately 17.3 million persons in the United States with diabetes diagnosed at age 30 years or older. Time Horizon: Lifetime. Perspective: Health care sector. Intervention: Individualized versus uniform intensive glycemic control. Outcome Measures: Average lifetime costs, life-years, and quality-adjusted life-years (QALYs). Results of Base-Case Analysis: Individualized control saved $13 547 per patient compared with uniform intensive control ($105 307 vs. $118 854), primarily due to lower medication costs ($34 521 vs. $48 763). Individualized control decreased life expectancy (20.63 vs. 20.73 years) due to an increase in complications but produced more QALYs (16.68 vs. 16.58) due to fewer hypoglycemic events and fewer medications. Results of Sensitivity Analysis: Individualized control was cost-saving and generated more QALYs compared with uniform intensive control, except in analyses where the disutility associated with receiving diabetes medications was decreased by at least 60%. Limitation: The model did not account for effects of early versus later intensive glycemic control. Conclusion: Health policies and clinical programs that encourage an individualized approach to glycemic control for U.S. adults with type 2 diabetes reduce costs and increase quality of life compared with uniform intensive control. Additional research is needed to confirm the risks and benefits of this strategy. Primary Funding Source: National Institute of Diabetes and Digestive and Kidney Diseases.

Cost-effectiveness Analysis of Vascular Access Referral Policies in CKD.

BACKGROUND: The optimal timing of vascular access referral for patients with chronic kidney disease who may need hemodialysis (HD) is a pressing question in nephrology. Current referral policies have not been rigorously compared with respect to costs and benefits and do not consider patient-specific factors such as age. STUDY DESIGN: Monte Carlo simulation model. SETTING & POPULATION: Patients with chronic kidney disease, referred to a multidisciplinary kidney clinic in a universal health care system. MODEL, PERSPECTIVE, & TIMEFRAME: Cost-effectiveness analysis, payer perspective, lifetime horizon. INTERVENTION: The following vascular access referral policies are considered: central venous catheter (CVC) only, arteriovenous fistula (AVF) or graft (AVG) referral upon HD initiation, AVF (or AVG) referral when HD is forecast to begin within 12 (or 3 for AVG) months, AVF (or AVG) referral when estimated glomerular filtration rate is <15 (or <10 for AVG) mL/min/1.73m2. OUTCOMES: Incremental cost-effectiveness ratios (ICERs, in 2014 US dollars per quality-adjusted life-year [QALY] gained). RESULTS: The ICER of AVF (AVG) referral within 12 (3) months of forecasted HD initiation, compared to using only a CVC, is ∼$105k/QALY ($101k/QALY) at a population level (HD costs included). Pre-HD AVF or AVG referral dominates delaying referral until HD initiation. The ICER of pre-HD referral increases with patient age. Results are most sensitive to erythropoietin costs, ongoing HD costs, and patients' utilities for HD. When ongoing HD costs are excluded from the analysis, pre-HD AVF dominates both pre-HD AVG and CVC-only policies. LIMITATIONS: Literature-based estimates for HD, AVF, and AVG utilities are limited. CONCLUSIONS: The cost-effectiveness of vascular access referral is largely driven by the annual costs of HD, erythropoietin costs, and access-specific utilities. Further research is needed in the field of dialysis-related quality of life to inform decision making regarding vascular access referral.

Timing of arteriovenous fistula creation in patients With CKD: a decision analysis.

BACKGROUND: The optimal time for arteriovenous fistula (AVF) referral is uncertain. Improving the timeliness of referral may reduce central venous catheter (CVC) use. STUDY DESIGN: Monte Carlo simulation model. SETTING & POPULATION: Patients with chronic kidney disease (CKD) followed up in a multidisciplinary clinic, overall and stratified by age. MODEL, PERSPECTIVE, & TIMEFRAME: Decision analysis, patient, patient's lifetime. INTERVENTION: AVF referral, using 1 of 2 strategies: refer when hemodialysis is anticipated to begin within a certain time frame or refer when estimated glomerular filtration rate (eGFR) drops below a certain threshold. OUTCOMES: A range of values for each strategy are compared to each other with respect to incident vascular access type (AVF or CVC), percentage of patients with an unnecessary AVF creation, and life expectancy after dialysis therapy initiation. RESULTS: A 15-month referral time frame gave 34% with incident CVCs, 14% with unnecessary AVFs, and a life expectancy of 1,751 days. Time frames of 12-18 months performed similarly. Referral at eGFR of 20 mL/min/1.73 m(2) gave 38% with incident CVCs, 20% with unnecessary AVFs, and life expectancy of 1,742 days. Using an eGFR threshold of 15 mL/min/1.73 m(2), 10% had an unnecessary AVF. Policy performance was affected by CKD progression rate and age. For fast progressors (ΔeGFR = -7mL/min/1.73 m(2) per year), referral at eGFR of 25 mL/min/1.73 m(2) achieved a similar incident CVC percentage (~40%) as referral at 15 mL/min/1.73 m(2) in slower progressors (ΔeGFR = -2.78 mL/min/1.73 m(2) per year). For patients aged 70-80 and 80-90 years, time frames of 15-18 months yielded 16%-22% with unnecessary AVFs (vs 9%-11% in 50- to 60-year-olds); an eGFR threshold strategy of 20 mL/min/1.73 m(2) yielded 24% unnecessary AVFs in 80- to 90-year-olds versus 16% in 50- to 60-year-olds. LIMITATIONS: Our model does not consider patients with nonlinear CKD progression or acute kidney injury. We did not include arteriovenous grafts or consider cost or quality of life. CONCLUSIONS: In general, AVF referral within about 12 months of the estimated time to dialysis performed best among time frame strategies, and referral at eGFR < 15-20 mL/min/1.73 m(2) performed best among threshold strategies. The timing of referral should also be guided by the individual rate of CKD progression. Elderly patients with CKD could be referred later to reduce the risk of creating an AVF that is never used.