Rafael Alfonso-Cristancho

Effectiveness of biologic therapies for rheumatoid arthritis: an indirect comparisons approach.

Study Objective. To compare the efficacy of biologic disease‐modifying antirheumatic drugs (DMARDs) versus placebo with or without methotrexate, in treating rheumatoid arthritis.

Ninety-day costs of video-assisted thoracic surgery versus open lobectomy for lung cancer.

BACKGROUND Complications after pulmonary resection lead to higher costs of care. Video-assisted thoracoscopic surgery (VATS) for lobectomy is associated with fewer complications, but lower inpatient costs for VATS have not been uniformly demonstrated. Because some complications occur after discharge, we compared 90-day costs of VATS lobectomy versus open lobectomy and explored whether differential health care use after discharge might account for any observed differences in costs. METHODS A cohort study (2007-2011) of patients with lung cancer who had undergone resection was conducted using MarketScan-a nationally representative sample of persons with employer-provided health insurance. Total costs reflect payments made for inpatient, outpatient, and pharmacy claims up to 90 days after discharge. RESULTS Among 9,962 patients, 31% underwent VATS lobectomy. Compared with thoracotomy, VATS was associated with lower rates of prolonged length of stay (PLOS) (3.0% versus 7.2%; p<0.001), 90-day emergency department (ED) use (22% versus 24%; p=0.005), and 90-day readmission (10% versus 12%; p=0.026). Risk-adjusted 90-day costs were

Examining the BMI-mortality relationship using fractional polynomials

3,476 lower for VATS lobectomy (p=0.001). Differential rates of PLOS appeared to explain this cost difference. After adjustment for PLOS, costs were

Ketorolac Use and Postoperative Complications in Gastrointestinal Surgery.

1,276 lower for VATS, but this difference was not significant (p=0.125). In the fully adjusted model, PLOS was associated with the highest cost differential (+

Economic consequences of sequencing biologics in rheumatoid arthritis: a systematic review

50,820; p<0.001). CONCLUSIONS VATS lobectomy is associated with lower 90-day costs--a relationship that appears to be mediated by lower rates of PLOS. Although VATS may lead to lower rates of PLOS among patients undergoing lobectomy, observational studies cannot verify this assertion. Strategies that reduce PLOS will likely result in cost-savings that can increase the value of thoracic surgical care.

Need for Multicriteria Evaluation of Generic Drug Policies

BackgroundMany previous studies estimating the relationship between body mass index (BMI) and mortality impose assumptions regarding the functional form for BMI and result in conflicting findings. This study investigated a flexible data driven modelling approach to determine the nonlinear and asymmetric functional form for BMI used to examine the relationship between mortality and obesity. This approach was then compared against other commonly used regression models.MethodsThis study used data from the National Health Interview Survey, between 1997 and 2000. Respondents were linked to the National Death Index with mortality follow-up through 2005. We estimated 5-year all-cause mortality for adults over age 18 using the logistic regression model adjusting for BMI, age and smoking status. All analyses were stratified by sex. The multivariable fractional polynomials (MFP) procedure was employed to determine the best fitting functional form for BMI and evaluated against the model that includes linear and quadratic terms for BMI and the model that groups BMI into standard weight status categories using a deviance difference test. Estimated BMI-mortality curves across models were then compared graphically.ResultsThe best fitting adjustment model contained the powers -1 and -2 for BMI. The relationship between 5-year mortality and BMI when estimated using the MFP approach exhibited a J-shaped pattern for women and a U-shaped pattern for men. A deviance difference test showed a statistically significant improvement in model fit compared to other BMI functions. We found important differences between the MFP model and other commonly used models with regard to the shape and nadir of the BMI-mortality curve and mortality estimates.ConclusionsThe MFP approach provides a robust alternative to categorization or conventional linear-quadratic models for BMI, which limit the number of curve shapes. The approach is potentially useful in estimating the relationship between the full spectrum of BMI values and other health outcomes, or costs.

A simulation of the comparative long-term effectiveness of liraglutide and glimepiride monotherapies in patients with type 2 diabetes mellitus

OBJECTIVE To study the association between ketorolac use and postoperative complications. BACKGROUND Nonsteroidal anti-inflammatory drugs may impair wound healing and increase the risk of anastomotic leak in colon surgery. Studies to date have been limited by sample size, inability to identify confounding, and a focus limited to colon surgery. METHODS Ketorolac use, reinterventions, emergency department (ED) visits, and readmissions in adults (≥ 18 years) undergoing gastrointestinal (GI) operations was assessed in a nationwide cohort using the MarketScan Database (2008-2012). RESULTS Among 398,752 patients (median age 52, 45% male), 55% underwent colorectal surgery, whereas 45% had noncolorectal GI surgery. Five percent of patients received ketorolac. Adjusting for demographic characteristics, comorbidities, surgery type/indication, and preoperative medications, patients receiving ketorolac had higher odds of reintervention (odds ratio [OR] 1.20, 95% confidence interval [CI] 1.08-1.32), ED visit (OR 1.44, 95% CI 1.37-1.51), and readmission within 30 days (OR 1.11, 95% CI 1.05-1.18) compared to those who did not receive ketorolac. Ketorolac use was associated with readmissions related to anastomotic complications (OR 1.20, 95% CI 1.06-1.36). Evaluating only admissions with ≤ 3 days duration to exclude cases where ketorolac might have been used for complication-related pain relief, the odds of complications associated with ketorolac were even greater. CONCLUSIONS Use of intravenous ketorolac was associated with greater odds of reintervention, ED visit, and readmission in both colorectal and noncolorectal GI surgery. Given this confirmatory evaluation of other reports of a negative association and the large size of this cohort, clinicians should exercise caution when using ketorolac in patients undergoing GI surgery.

Preparing Electronic Clinical Data for Quality Improvement and Comparative Effectiveness Research: The SCOAP CERTAIN Automation and Validation Project.

Abstract Background and objectives: Tumor necrosis factor-alpha (anti-TNF) blocking agents are effective for the treatment of rheumatoid arthritis (RA), with mean response rates of 60–70%. Patients with incomplete response to initial anti-TNF treatment often are switched to other biologic treatments with some success. However, little is known about whether or not switching to anti-TNF or other non-TNF biologic treatments is cost-effective. This study sought to review the economic evidence of sequencing various biologic treatments in RA. Methods: A systematic review was conducted of published and unpublished literature (January 2000 to October 2012) on the cost-effectiveness of sequencing biologic treatments in RA after failure of an initial biologic treatment. It included modeling and other economic studies that assessed cost-effectiveness of one or more sequences of biologics. Studies were excluded that evaluated non-biologic sequencing. Results: This review of the available evidence suggests that there is limited evidentiary support favoring the cost-effectiveness of switching from one anti-TNF agent to another within the anti-TNF category of biologics. This is due, in large part, to the limited clinical evidence base supporting the incremental efficacy of second- and third-line anti-TNF treatments and to variation on how and when to assess non-response to the first-line biologic. When compared to anti-TNF agents, biologic treatments with a different mechanism of action are more cost-effective as second-line agents. Limitations: Not all sequences and patterns of switching, either within or outside of therapeutic class, have been evaluated for clinical benefit and cost-effectiveness, limiting the interpretation of these findings. Conclusions: Switching from one anti-TNF agent to another after first-line treatment failure may not be a cost-effective treatment strategy. However, when non-TNF biologics are included in the sequence they are likely to be more cost-effective than anti-TNF specific cycling sequences.

BMI Trajectories Among the Severely Obese: Results From an Electronic Medical Record Population

Policymakers tend to focus on improving patented drug policies because they are under pressure from patients, physicians, and manufacturers to increase access to novel therapies. The success of pharmaceutical innovation over the last few decades has led to the availability of many off-patent drugs to treat disease areas with the greatest public health need. Therefore, the success of public health programs in improving the health status of the total population is highly dependent on the efficiency of generic drug policies. The objective of this article was to explore factors influencing the true efficiency of generic prescription drug policies in supporting public health initiatives in the developed world. Health care decision makers often assess the efficiency of generic drug policies by the level of price erosion and market share of generics. Drug quality, bioequivalence, in some cases drug formulations, supply reliability, medical adherence and persistence, health outcomes, and nondrug costs, however, are also attributes of success for generic drug policies. Further methodological research is needed to measure and improve the efficiency of generic drug policies. This also requires extension of the evidence base of the impact of generic drugs, partly based on real-world evidence. Multicriteria decision analysis may assist policymakers and researchers to evaluate the true value of generic drugs.

Patients' experience and outcomes after laparoscopic adjustable gastric banding in Washington state

Study Objective. To project and compare long‐term outcomes of morbidity and mortality, and costs of complications of type 2 diabetes mellitus from a randomized controlled trial of patients receiving liraglutide versus glimepiride monotherapy.