2 Minute Medicine Rewind October 20 – October 27, 2014

In this section, we highlight the key high-impact studies, updates, and analyses published in medicine during the past week.

Four Month Moxifloxacin-Based Regimens for Drug Sensitive Tuberculosis

Shortening the duration of tuberculosis treatment would help in enhancing adherence, reducing side effects, and lowering the costs of treatment. Fluoroquinolones have been showing promising activity again mycobacteria, and this study investigated whether substituting a fluoroquinolone into a current tuberculosis treatment regimen might allow for a shorter duration course of treatment. This randomized, double-blind, placebo-controlled phase 3 trial randomized 1,931 newly diagnosed and previously untreated tuberculosis patients into three groups to test the non-inferiority of two proposed moxifloxacin-containing regimes as compared with a control regimen by examining treatment failures or relapses within 18 months following the randomization. The first (control) group received isoniazid, rifampin, pyrazinamide, and ethambutol for 8 weeks, followed by 18 weeks of isoniazid and rifampin. In the second (isoniazid) group, ethambutol was replaced with moxifloxacin for 17 weeks, followed by 9 weeks of placebo. In the third (ethambutol) group, isoniazid was replaced with moxifloxacin for 17 weeks, followed by 9 weeks of placebo. This study demonstrated that ethambutol and isoniazid groups experienced a faster decline in bacterial loads as compared to the control group: the hazard ratios for the time to culture negativity for ethambutol and isoniazid groups, as compared to the control group, ranged from 1.17 to 1.25. However, favorable outcome was seen in fewer patients in the isoniazid group (85%) and the ethambutol group (80%) compared to the control group (92%), with the differences between experimental and control group statistically significant. Therefore, this study did not demonstrate non-inferiority of the two moxifloxacin based regiments that would allow shortening of the current tuberculosis treatment options.

Association Between Hospital Conversions to For-Profit Status and Clinical and Economic Outcomes

Although there have been debates regarding the effects of hospitals switching from nonprofit or public hospitals to for profit institutions, little data has been collected to date on the results of such hospital conversions. This retrospective cohort analysis involved 237 converting hospital and 631 matched control hospitals, with 1,843,764 Medicare fee-for service beneficiaries at converting hospitals and 4,828,138 patients at the control hospitals. The study examined the financial performance measures, quality process measures, mortality rates, Medicare volume, and patient population changes in the converted hospitals as compared to the control hospitals. In this study, hospitals that converted to for profit status were more likely to be small or medium sized institutions, less likely to be teaching hospitals, and more likely to be located in the south and in an urban or suburban location. Hospital that converted to for profit status improved their ratios of net income to net revenue plus other income by 2.2% as compared to 0.4% improvement observed in control hospitals (difference in differences of 1.8, 95% CI: 0.5% to 3.1% p = 0.007). Both converting hospitals and control hospitals improved their process quality metrics, but the difference in differences between the two groups was not statistically significant. The changes in mortality rates for Medicare patients between the two groups were also not statistically significant. Similarly, over this time period, the changes in the annual Medicare volume, disproportionate share hospital index, the proportion of patents with Medicaid, or the proportion of black or Hispanic patients were also not statistically different between the two groups of hospitals. Therefore, this study concluded that hospital conversion to for profit status appears to be associated with improved financial margins for the hospital, but does not appear to be associated with significant changes in mortality rates or the proportion of poor or minority patients that the hospital serves.

Total Expenditures per Patient in Hospital-Owned and Physician-Owned Physician Organizations in California

Although many physician practices are now being acquired by the hospitals and multi-hospital systems, the financial outcomes of such mergers have not yet been firmly established. This study attempted to elucidate whether total expenditures per patient are higher in the physician organizations owned by hospital systems as compared to the practices owned by the participating physicians themselves. The study examined data on total expenditures for the care provided to 4.5 million patients covered by HMO insurance plans in California between 2009 and 2012, and compared the total annual expenditures per patient (as determined by insurance payments and including payments to practicing physicians, hospitals, clinical laboratories, and pharmaceutical manufacturers for office visits, inpatient and outpatient procedures, diagnostics tests, and pharmaceuticals). The total expenditures were also adjusted for patient illness burden, geographic input costs, and organizational characteristics. The patients were cared for by 158 organizations, including 118 physician owned practices, 19 local hospital owned practices, and 21 multihospital owned practices. The physician owned organizations had mean expenditures of $3,066 per patient (95% CI: 2,892 to 3,240), local hospital owned organizations had mean expenditures of 4,312 per patient (95% CI: 3,768 to 4,857) and multi hospital owned practices had mean expenditures of 4,776 per patient (95% CI: 4,349 to 5,202). When adjusted for patient severity and other factors, local hospital owned practices had 10.3% (95% CI: 1.7% to 19.7%) higher expenditures compared to physician owned practices. Organizations owned by multihospital systems had 19.8% (95% CI: 13.9% to 26%) higher expenditures compared to physician owned organizations. Therefore, with analysis of practices in this study, practices owned by practicing physicians incurred overall lower expenditures compared to the practices owned by local hospital or multi-hospital organizations.

Genetic and Environmental Risk Assessment and Colorectal Cancer Screening in an Average-Risk Population

Adherence to chronic screening programs, including the colorectal cancer screening, remains a significant problem. The use of individualized genetic and environmental risk assessments (GERA) for colorectal cancer susceptibility has been thought to possibly improve adherence to colorectal screening guidelines by stratifying patients into high and average risk groups based on their individual genetic markers and other factors. In this randomized controlled study, 783 patients at an average risk of colon cancer who have not previously been compliant with the colorectal screening protocols, were randomly assigned to the usual care group or the GERA group, where patients were informed whether their individualized risk of colon cancer is average or elevated based on the methylenetetrahydrofolatereductase polymorphisms and serum folate levels. Patient’s compliance with colorectal screening within 6 months of study entry was assessed. Unfortunately, the overall screening rates for colorectal cancer did not differ significantly between the usual care group (35.7% of patients screened) and the GERA group (33.1% of patients screened). The odds ratio for screening for the GERA group versus the usual care group was 0.88 (95% CI: 0.64 to 1.22). Interestingly, within the GERA group, the rates of screening did not differ significantly between average risk (38.1% of patients screened) and elevated risk (26.9% of patients screened) patients. The odds ratio for screening in elevated versus average risk patients was found to be 0.75 (95% CI :0.39 to 1.42). Therefore, this study was unable to show that in average risk patients, personalized genetic and environmental risk assessment models are effective in improving adherence to the colorectal screening protocols.

Effectiveness of maternal pertussis vaccination in England: an observational study

In reaction to a recent rise in pertussis outbreaks and a particularly devastating effect of the disease on patients younger than 3 months, a new pertussis vaccination program aimed at pregnant women has been introduced across England in October 2012. This study attempted to analyze the effectiveness of this vaccination program. According to the new program, all women between 28 and 38 weeks of pregnancy were offered the pertussis immunization. Although the safety and efficacy of the vaccine in pregnancy has previously been demonstrated, the effectiveness of maternal immunization program has not yet been studied. To assess the efficacy of the vaccine, the study compared cases of pertussis between January and September 2013, at which time point all babies younger than 3 months were born to mothers eligible for the pregnancy vaccination program, with equivalent periods in 2012 and 2011, prior to the initiation of the vaccine program. The vaccine effectiveness was calculated as one minus the odds of maternal vaccination in cases divided by the odds of vaccination in the population. According to this study, the greatest proportional fall between 2013 and 2012 was in the age group of infants younger than 3 months of age, with decline in confirmed cases from 328 cases in 2012 to 72 cases in 2013( -78%, 95% CI -72 to -83) and with decline in hospital admissions from 440 in 2012 to 140 in 2013 (-68%, 95% CI -61 to -74). The incidence of pertussis remained highest in infants younger than 3 months during this time period. There was also a decline in the number of cases observed for infants younger than 3 months between 2011 and 2013, and this was the only age group where the number of cases in 2011 outnumbered the number of cases in 2013. Vaccine effectiveness was also estimated based on 82 confirmed cases in infants born after Oct 1, 2012 – in infants younger than 3 months of age, effectiveness was 91% (95% CI: 84% to 95%), consistent with high vaccine effectiveness.

Image: PD/CDC

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