Comparison of Bayesian and frequentist approaches in clinical outcomes between hospitals

Many public health agencies and researchers are interested in comparing hospital outcomes, for example, morbidity, mortality, and hospitalization across areas and hospitals. However, since there is variation of rates in clinical trials among hospitals because of several biases, we are interested in controlling for the bias and assessing real differences in clinical practices. In this study, we compared the variations between hospitals in rates of severe Intraventricular Haemorrhage (IVH) infant using Frequentist statistical approach vs. Bayesian hierarchical model through simulation study. The template data set for simulation study was included the number of severe IVH infants of 24 intensive care units in Australian and New Zealand Neonatal Network from 1995 to 1997 in severe IVH rate in preterm babies. We evaluated the rates of severe IVH for 24 hospitals with two hierarchical models in Bayesian approach comparing their performances with the shrunken rates in Frequentist method. Gamma-Poisson (BGP) and Beta-Binomial (BBB) were introduced into Bayesian model and the shrunken estimator of Gamma-Poisson (FGP) hierarchical model using maximum likelihood method were calculated as Frequentist approach. To simulate data, the total number of infants in each hospital was kept and we analyzed the simulated data for both Bayesian and Frequentist models with two true parameters for severe IVH rate. One was the observed rate and the other was the expected severe IVH rate by adjusting for five predictors variables for the template data. The bias in the rate of severe IVH infant estimated by both models showed that Bayesian models gave less variable estimates than Frequentist model. We also discussed and compared the results from three models to examine the variation in rate of severe IVH by 20th centile rates and avoidable number of severe IVH cases. ^

Clinical trials, informed consent, & emergency medicine: A systematic literature review

Background: In the United States, the Food and Drug Administration (FDA) regulates clinical trials. These regulations address good clinical practices as well as human subject protection (FDA, 2012). One of the most important legal and ethical concerns in clinical trials is informed consent. 21 CFR 50 governs human subjects research. Part 50.24 provides an emergency research exception to the informed consent requirement. Research was conducted to determine the appropriateness of this exception, whether the benefit justifies the exception, and its public health significance.^ Methods: A systematic literature review was conducted and articles were identified from peer-reviewed journals.^ Results: There is some variance in opinions regarding the appropriateness of the exception, but the literature reviewed found the study results of these trials justified the waiver.^ Conclusion: The exception to the informed consent requirement is likely appropriate and justified in emergency research when implemented within the specified guidelines.^

The population health performance of medical students at two medical schools

Public Health and medicine are complimentary disciplines dedicated to the health and well-being of humankind. Worldwide, medical school accreditation bodies require the inclusion of population health in medical education. In 2003, the Institutes of Medicine (IOM) recommended that all medical students receive basic public health training in population-based prevention. The purpose of this study was to (1) examine the public health clinical performance of third-year medical students at two independent medical schools, (2) compare the public health clinical practice performance of the schools, and (3) identify underlying predictors of high and low public health clinical performance at one of the medical schools. ^ This study is unique in its analysis and report of observed medical student public health clinical practices. The cohort consisted of 751 third-year medical students who completed a required clinical performance exam using trained standardized patients. Medical student performance scores on 24 consensus public health items derived from nine patient cases were analyzed.^ The analysis showed nearly identical results for both medical schools at the 60%, 65%, and 70% pass rate. Students performed poorly on items associated with prevention, behavioral science, and surveillance. Factors associated with high student performance included being from an underrepresented minority, matching to a primary care residency, and high class ranking. A review of medical school curriculum at both schools revealed a lack of training in four public health domains. Nationally, 32% of medical students reported inadequate training in public health in the year 2006.^ These findings suggest more dedicated teaching time for public health domains is needed at the medical schools represented in this study. Finally, more research is needed to assess attainment of public health knowledge and skills for medical students nationwide if we are to meet the recommendations of the IOM. ^

"Teens talk healthy weight": A video technology project

Purpose. The purpose of this study was to investigate the impact of a motivational weight management DVD on knowledge of obesity related diseases, readiness, motivation, and self-efficacy to lose weight, connectedness to their care provider, and patients return to clinic. Design. A randomized control trial was conducted in which 40 overweight/obese adolescents and their parents/caregivers were randomly assigned to standard care alone or standard care plus DVD. Subjects completed a set of pre- and post-questionnaire measures. A group of 22 patients was also formed as a historical control group in order to account for the potential effect of extra attention given to subjects prospectively enrolled. Methods. The adolescents and their parent/caregiver were placed into a patient room. Consent was obtained and a set of written pre-questionnaires were given to both the parent and the adolescent. Standard care was provided to all patients by the Registered Dietitian and physician; the DVD was shown in addition to standard care among the intervention group. A set of post-questionnaires were given and compensation was provided. Analysis. Groups were compared to determine equivalence at baseline. Analysis of covariance was used to evaluate changes over time, while controlling for pre-test scores and race/ethnicity. Results. Parents who viewed the DVD experienced greater changes in correct knowledge as compared to parents who did not view the DVD. Conclusion. Our study found only one substantial benefit of the DVD beyond standard clinical practices. This is an important area for change as it increased awareness of obesity as a serious disease and has future clinical implications.^

Provider perceptions of physical activity counseling: A systematic review

Background: Although the health benefits of physical activity are well-established, the evidence regarding the efficacy of physical activity counseling by primary care providers is inconclusive. Healthy People 2020 recommends that physicians provide counseling on physical activity to their patients; however, few providers adhere to these guidelines. The primary objective of this review is to systematically summarize and evaluate primary care providers' perceptions and attitudes about physical activity counseling. ^ Methods: A systematic literature search of relevant articles was conducted between January and May 2011 using four databases: MEDLINE (1948 to the present), PsycInfo (1806 to the present), CINAHL Plus with Full Text (1981 to the present), and the Cochrane Library. Studies were included if 1) the study population consisted of primary care providers and, 2) the study evaluated providers' attitudes and perceptions pertaining to physical activity counseling. Both quantitative and studies were considered. ^ Results: Most primary care providers agree that physical activity counseling is important and that they have a role in promoting physical activity to their patients. Providers are uncertain about the effectiveness of counseling, feel only marginally comfortable providing more than general advice about physical activity, and cite major barriers to counseling such as lack of time, lack of training, and lack of reimbursement for their counseling efforts. The evidence in this review suggests that beyond these barriers, providers are more likely to counsel their patients about physical activity if they are active themselves, or if they feel that their patients' condition, such as cardiovascular disease or obesity, would strongly benefit from a lifestyle change. ^ Conclusion: While major barriers to physical activity counseling, such as lack of time for counseling and lack of counseling knowledge still exist, primary care providers are receptive to the idea of acting as physical activity promoters in their clinical practices. However, the barriers encountered need to be addressed on multiple levels (e.g. individual, organizational), and additional training is needed in order for providers to effectively promote the physical activity of their patients.^

Relationship between Clostridium difficile toxin type and clinical features, severity and outcome in patients with C. difficile diarrhea (CDAD)

Background. Clostridium difficile infection is one of the major causes of antibiotic associated diarrhea and colitis in the United States. Currently, there is a dearth of literature on the risk factors and outcomes differences between the patients with infection due to the hypervirulent strain vs. the non-hypervirulent strains. The objective of this study was to determine the relationship between C. difficile toxin type and clinical features, severity and outcome in patients with C. difficile diarrhea. ^ Methods. The case group included 37 patients who had infections due to hypervirulent strain (tcdC deletion) and the control group included 55 patients with other toxin types (toxin A, B, binary toxin). A univariate analysis was performed followed by a multivariable logistic regression analysis to assess the differences between cases and controls. ^ Results. In the multivariate analyses, we found out that being a male was a protective factor for developing the infection due to the hypervirulent strain [OR 0.33; 95% CI 0.12-0.90]. Also, the hypervirulent group has worse clinical and economic outcomes, although the differences were small and nonsignificant. ^ Conclusions. There may likely be no predictive risk factor for acquiring infection due to the hypervirulent strain and the acquisition may be more linked to the infection control practices of the individual hospitals or location of patients. Hence, better infection control practices may prove helpful in decreasing the overall disease burden and thus improve patient outcomes. ^

An exploratory study of screening practices and barriers for postpartum depression in Texas

Purpose. To evaluate the prevalence of Postpartum Depression (PPD) screening among practicing obstetrician-gynecologists in Texas, and to identify factors and barriers associated with routine depression screening practices.^ Subjects. One hundred and eighty-nine fellows and junior fellows of the Texas Association of Obstetricians & Gynecologists (District XI).^ Methods. A survey questionnaire was developed and sent to 2,028 obstetriciangynecologists, asking about their current screening practices related to PPD. The survey questions were related to the physician's demographics, the patient population, screening practices, barriers to screening, and perceptions about resources in the community. Responses were analyzed to determine associations between these factors and the physician's screening practices. ^ Results. The respondents (n=189) constituted 9.3% of the surveyed population, thus the findings cannot be considered representative of all practicing Ob-Gyns in Texas. However, the following trends were observed. Of the respondents, 85.4% reported routinely screening for PPD, while 14.6% did not. However, of those that screened, only 20.2% used the Edinburgh Postnatal Depression Scale and 7.6% screened with the Postpartum Depression Screening Scale, both validated screening tools. The majority (77.2%) reported using an informal patient interview to screen. For those who did not routinely screen, inadequate training and inadequate resources to screen for PPD were the top two barriers. Physician's age was associated with routine screening practice, as older physicians were less likely to screen routinely. Primary insurance coverage of the patient population was also associated with screening practice; physicians with Medicaid and uninsured patients were less likely to screen routinely. Lastly, physicians that believed that adequate resources existed in their communities for the treatment of PPD were more likely to screen than those that did not.^ Conclusions. The present study is the first attempt at assessing Postpartum Depression screening practices and barriers in Texas. Although the response rate was low, the findings related to informal screening methods and inadequate training indicated that education and training with regards to PPD screening and validated screening tools among Ob-Gyns stand to be improved. Connecting physicians to psychiatric resources may also improve screening rates. This first look at screening practices in Texas serves as a platform for future research in order to gain definitive insight into the diagnosis and treatment of PPD, and ultimately design interventions to improve detection rates and treatment.^

Clinical and economic outcomes of serious postoperative infections following resection of common respiratory and gastrointestinal solid tumors

Unlike infections occurring during periods of chemotherapy-induced neutropenia, postoperative infections in patients with solid malignancy remain largely understudied. The purpose of this population-based study was to evaluate the clinical and economic burden, as well as the relationship of hospital surgical volume and outcomes associated with serious postoperative infection (SPI) – i.e., bacteremia/sepsis, pneumonia, and wound infection – following resection of common solid tumors.^ From the Texas Discharge Data Research File, we identified all Texas residents who underwent resection of cancer of the lung, esophagus, stomach, pancreas, colon, or rectum between 2002 and 2006. From their billing records, we identified ICD-9 codes indicating SPI and also subsequent SPI-related readmissions occurring within 30 days of surgery. Random-effects logistic regression was used to calculate the impact of SPI on mortality, as well as the association between surgical volume and SPI, adjusting for case-mix, hospital characteristics, and clustering of multiple surgical admissions within the same patient and patients within the same hospital. Excess bed days and costs were calculated by subtracting values for patients without infections from those with infections computed using multilevel mixed-effects generalized linear model by fitting a gamma distribution to the data using log link.^ Serious postoperative infection occurred following 9.4% of the 37,582 eligible tumor resections and was independently associated with an 11-fold increase in the odds of in-hospital mortality (95% Confidence Interval [95% CI], 6.7-18.5, P < 0.001). Patients with SPI required 6.3 additional hospital days (95% CI, 6.1 - 6.5) at an incremental cost of $16,396 (95% CI, $15,927–$16,875). There was a significant trend toward lower overall rates of SPI with higher surgical volume (P=0.037). ^ Due to the substantial morbidity, mortality, and excess costs associated with SPI following solid tumor resections and given that, under current reimbursement practices, most of this heavy burden is borne by acute care providers, it is imperative for hospitals to identify more effective prophylactic measures, so that these potentially preventable infections and their associated expenditures can be averted. Additional volume-outcomes research is also needed to identify infection prevention processes that can be transferred from higher- to lower-volume providers.^

A review of economic analysis in the vaccination program; decision making and governance: Adivisory Committee on Immunization Practices (ACIP)

The Advisory Committee on Immunization Practices (ACIP) develops written recommendations for the routine administration of vaccines to children and adults in the U.S. civilian population. The ACIP is the only entity in the federal government that makes such recommendations. ACIP elaborates on selection of its members and rules out concerns regarding its integrity, but fails to provide information about the importance of economic analysis in vaccine selection. ACIP recommendations can have large health and economic consequences. Emphasis on economic evaluation in health is a likely response to severe pressures of the federal and state health budget. This study describes the economic aspects considered by the ACIP while sanctioning a vaccine, and reviews the economic evaluations (our economic data) provided for vaccine deliberations. A five year study period from 2004 to 2009 is adopted. Publicly available data from ACIP web database is used. Drummond et al. (2005) checklist serves as a guide to assess the quality of economic evaluations presented. Drummond et al.'s checklist is a comprehensive hence it is unrealistic to expect every ACIP deliberation to meet all of their criteria. For practical purposes we have selected seven criteria that we judge to be significant criteria provided by Drummond et al. Twenty-four data points were obtained in a five year period. Our results show that out of the total twenty-four data point‘s (economic evaluations) only five data points received a score of six; that is six items on the list of seven were met. None of the data points received a perfect score of seven. Seven of the twenty-four data points received a score of five. A minimum of a two score was received by only one of the economic analyses. The type of economic evaluation along with the model criteria and ICER/QALY criteria met at 0.875 (87.5%). These three criteria were met at the highest rate among the seven criteria studied. Our study findings demonstrate that the perspective criteria met at 0.583 (58.3%) followed by source and sensitivity analysis criteria both tied at 0.541 (54.1%). The discount factor was met at 0.250 (25.0%).^ Economic analysis is not a novel concept to the ACIP. It has been practiced and presented at these meetings on a regular basis for more than five years. ACIP‘s stated goal is to utilize good quality epidemiologic, clinical and economic analyses to help policy makers choose among alternatives presented and thus achieve a better informed decision. As seen in our study the economic analyses over the years are inconsistent. The large variability coupled with lack of a standardized format may compromise the utility of the economic information for decision-making. While making recommendations, the ACIP takes into account all available information about a vaccine. Thus it is vital that standardized high quality economic information is provided at the ACIP meetings. Our study may provide a call for the ACIP to further investigate deficiencies within the system and thereby to improve economic evaluation data presented. ^

Implementation of active surveillance cultures and associated infection control practices for the reduction of methicillin resistant Staphylococcus aureus in the healthcare setting: An interrupted time series analysis

OBJECTIVE. To determine the effectiveness of active surveillance cultures and associated infection control practices on the incidence of methicillin resistant Staphylococcus aureus (MRSA) in the acute care setting. DESIGN. A historical analysis of existing clinical data utilizing an interrupted time series design. ^ SETTING AND PARTICIPANTS. Patients admitted to a 260-bed tertiary care facility in Houston, TX between January 2005 through December 2010. ^ INTERVENTION. Infection control practices, including enhanced barrier precautions, compulsive hand hygiene, disinfection and environmental cleaning, and executive ownership and education, were simultaneously introduced during a 5-month intervention implementation period culminating with the implementation of active surveillance screening. Beginning June 2007, all high risk patients were cultured for MRSA nasal carriage within 48 hours of admission. Segmented Poisson regression was used to test the significance of the difference in incidence of healthcare-associated MRSA during the 29-month pre-intervention period compared to the 43-month post-intervention period. ^ RESULTS. A total of 9,957 of 11,095 high-risk patients (89.7%) were screened for MRSA carriage during the intervention period. Active surveillance cultures identified 1,330 MRSA-positive patients (13.4%) contributing to an admission prevalence of 17.5% in high-risk patients. The mean rate of healthcare-associated MRSA infection and colonization decreased from 1.1 per 1,000 patient-days in the pre-intervention period to 0.36 per 1,000 patient-days in the post-intervention period (P<0.001). The effect of the intervention in association with the percentage of S. aureus isolates susceptible to oxicillin were shown to be statistically significantly associated with the incidence of MRSA infection and colonization (IRR = 0.50, 95% CI = 0.31-0.80 and IRR = 0.004, 95% CI = 0.00003-0.40, respectively). ^ CONCLUSIONS. It can be concluded that aggressively targeting patients at high risk for colonization of MRSA with active surveillance cultures and associated infection control practices as part of a multifaceted, hospital-wide intervention is effective in reducing the incidence of healthcare-associated MRSA.^