OBJECTIVE While metformin is generally accepted as the first-line agent in treatment of type 2 diabetes, there are insufficient evidence and extensive debate about the best second-line agent. We aimed to assess the benefits and harms of four commonly used antihyperglycemia treatment regimens considering clinical effectiveness, quality of life, and cost. RESEARCH DESIGN AND METHODS We developed and validated a new population-based glycemic control Markov model that simulates natural variation in HbA1c progression. The model was calibrated using a U.S. data set of privately insured individuals diagnosed with type 2 diabetes. We compared treatment intensification of metformin monotherapy with sulfonylurea, dipeptidyl peptidase-4 inhibitor, glucagon-like peptide-1 receptor agonist, or insulin. Outcome measures included life-years (LYs), quality-adjusted life-years (QALYs), mean time to insulin dependence, and expected medication cost per QALY from diagnosis to first diabetes complication (ischemic heart disease, myocardial infarction, congestive heart failure, stroke, blindness, renal failure, amputation) or death. RESULTS According to our model, all regimens resulted in similar LYs and QALYs regardless of glycemic control goal, but the regimen with sulfonylurea incurred significantly lower cost per QALY and resulted in the longest time to insulin dependence. An HbA1c goal of 7% (53 mmol/mol) produced higher QALYs compared with a goal of 8% (64 mmol/mol) for all regimens. CONCLUSIONS Use of sulfonylurea as second-line therapy for type 2 diabetes generated glycemic control and QALYs comparable with those associated with other agents but at lower cost. A model that incorporates HbA1c and diabetes complications can serve as a useful clinical decision tool for selection of treatment options.
Association of type of renal surgery and access to robotic technology for kidney cancer: results from a population‐based cohort
Objective To evaluate the relationship between partial nephrectomy ( PN ) and hospital availability of robot‐assisted surgery from a population‐based cohort in the USA . Methods After merging the Nationwide Inpatient Sample ( NIS ) and the A merican Hospital Association survey from 2006 to 2008, we identified 21 179 patients who underwent either PN or radical nephrectomy ( RN ) for renal cell carcinoma ( RCC ). The primary outcome assessed was the type of nephrectomy performed. Multivariable logistic regression identified the patient and hospital characteristics associated with receipt of PN . Results We identified 4832 (22.8%) and 16 347 (77.2%) patients who were treated for RCC with PN and RN , respectively. On multivariable analysis, patients were more likely to receive PN at academic centres (odds ratio [ OR ] 2.77; P < 0.001), urban centres ( OR 3.66; P < 0.001) and A merican College of Surgeons ( ACOS )‐designated cancer centres ( OR : 1.10; P < 0.05) compared with non‐academic, rural and non‐ ACOS ‐designated cancer centre hospitals, respectively. Robot‐assisted surgery availability at a hospital was also associated with a higher adjusted odds of PN compared with centres without that availability ( OR 1.28; P < 0.001). Conclusions Although academic and urban locations are establi s hed factors that affect the receipt of PN for RCC , the availability of robot‐assisted surgery at a hospital was also independently associated with higher use of PN . Our results are informative in identifying other key hospital characteristics which may facilitate greater adoption of PN .
Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
Chronic conditions are the most important cause of morbidity, mortality and health expense in the USA. Comparative effectiveness research (CER) seeks to provide evidence supporting the relative value of alternative courses of action. This research often concludes with estimates of the likelihood of desirable and undesirable outcomes associated with each option. Patients with chronic conditions should engage with their clinicians in deciding which of these options best fits their goals and context. In practicing shared decision-making (SDM), clinicians and patients should make use of CER to inform their deliberations. In these ways, SDM and CER are interrelated. SDM translates CER into patient-centered practice, while CER provides the backbone evidence about options and outcomes in SDM interventions. In this review, we explore the potential for a SDM–CER synergy in improving healthcare for patients with chronic conditions.
Impact of a drug utilization review program on high‐risk use of prescription controlled substances
Established hospital palliative care consult services (PCCS) have been associated with reduced costs and length of stay, decreased symptom burden, and increased satisfaction with care. Using a retrospective case–control design, we analyzed administrative data of patients seen by PCCS while hospitalized at the Rochester, Minnesota Mayo Clinic hospitals from 2003 to 2008. The PCCS patients were matched to 3:1. A total of 1477 patients seen by the PCCS were matched with 4431 patients not seen. Costs for patients seen and discharged alive were US$35 449 (95% confidence interval [CI] US$34 157-US$36 686) compared to US$37 447 (95% CI US$36 734-US$38 126), without PCCS consultation. Costs for PCCS patients that died during hospitalization were US$54 940 (95% CI US$51 483-US$58 576) and non-PCCS patients were US$79 660 (95% CI US$76 614-US$83 398).
Population‐based trends in urinary diversion among patients undergoing radical cystectomy for bladder cancer
What's known on the subject? and What does the study add? Variations in the type of urinary diversion exist for patients undergoing radical cystectomy. Although its use has been increasing from 2001 to 2008, patients who are older, female, and primary insured by Medicaid are less likely to receive continent diversions. Furthermore, patients treated surgically at high‐volume and teaching hospitals are more likely to receive continent diversions. Objective To describe the contemporary trends in urinary diversion among patients undergoing radical cystectomy ( RC ) for bladder cancer; and elucidate whether socioeconomic disparities persist in the type of diversion performed in the USA from a population‐based cohort. Patients and Methods Using the Nationwide Inpatient Sample, we identified patients who underwent RC for bladder cancer between 2001 and 2008. Multivariable regression models were used to identify patient and hospital covariates associated with continent urinary diversion and enumerate predicted probabilities for statistically significant variables over time. Results Overall, 55 635 (92%) patients undergoing RC for bladder cancer received incontinent urinary diversion, while 4552 (8%) patients received continent diversion from 2001 to 2008. Receipt of continent urinary diversion increased from 6.6% in 2001–2002 to 9.4% in 2007–2008 ( P < 0.001 for trend). Patients who were older (odds ratio [ OR ] 0.93; P < 0.001), female ( OR 0.52; P < 0.001) and insured by Medicaid ( OR 0.54; P = 0.002) were less likely to receive continent urinary diversion. However, patients treated at teaching ( OR 2.14; P < 0.001) and high‐volume hospitals ( OR 2.39; P = 0.04) had higher odds of continent urinary diversion. Predicted probabilities of continent diversion remained lower for female patients, Medicaid insurance status, and non‐teaching and medium/low‐volume hospitals over time. Conclusions In this nationally representative sample of hospitals from 2001 to 2008, the use of continent diversion in RC gradually increased. Although variations in urinary diversion exist by hospital teaching status, case volume, patient gender and primary health insurance, increased attention in expanding the use of continent diversions may help reduce these disparities for patients undergoing RC for bladder cancer.
Dissemination and implementation of comparative effectiveness evidence: key informant interviews with Clinical and Translational Science Award institutions
Aim: To identify ongoing practices and opportunities for improving national comparative effectiveness research (CER) translation through dissemination and implementation (D&I) via NIH-funded Clinical and Translational Science Award (CTSA) institutions. Materials & methods: Key informant interviews were conducted with 18 CTSA grantees sampled to represent a range of D&I efforts. Results & conclusions: The institutional representatives endorsed fostering CER translation nationally via the CTSA Consortium. However, five themes emerged from the interviews as barriers to CER D&I: lack of institutional awareness, insufficient capacity, lack of established D&I methods, confusion among stakeholders about what CER actually is and limited funding opportunities. Interviewees offered two key recommendations to improve CER translation: development of a centralized clearing house to facilitate the diffusion of CER D&I resources and methods across CTSA institutions; and formalization of the national CTSA network to leverage existing community engagement relationships and resources for the purpose of adapting and disseminating robust CER evidence locally with providers, patients and healthcare systems.