Consecutive 6-month Periods Research Articles

Testing an insurance-based monetary incentive program for exercise: RCT design and rationale

Participation in regular physical activity (PA) has numerous health benefits; however, as few as 10% of U.S. adults meet guidelines when device-based assessments of PA are used. The present paper presents the design and rationale for an RCT examining the efficacy of an exercise incentive program currently offered by at least three major US insurance companies, in which participants must attend a YMCA fitness facility at least 50 times within 6 months to receive an incentive. In a factorial design, incentive amount ($200, $100, $0) is crossed with a comparison of the standard gain-framed incentive program and a loss-framed incentive condition in which participants are told their membership fee is being held and will be returned or forfeited depending on their fitness facility attendance. Participants (N = 330) are randomized to gain-framed $100 incentive (n = 55), gain-framed $200 incentive (n = 55), loss-framed $100 incentive (n = 55), loss-framed $200 incentive (n = 55), or control (n = 110). Each participant is enrolled in the same condition for two consecutive 6-month periods for a total of 12 months per participant. The primary outcome is number of visits to the fitness facility over each 6-month period, verified by objective swipe-card data. Secondary outcomes include total moderate-to-vigorous PA (MVPA) over 7-day periods assessed at 3-month intervals through accelerometers (Actigraph wGT3x-BT) and self-report. Habit formation and anticipated regret are putative mediators and household income is a putative moderator of the incentive-based programs. A payer-perspective, within-trial cost-utility analysis will quantify the incremental costs per (a) quality-adjusted life year gained, (b) YMCA attendance, and (c) change in MVPA.

Improving the Prediction of Persistent High Health Care Utilizers: Retrospective Analysis Using Ensemble Methodology.

BackgroundA small proportion of high-need patients persistently use the bulk of health care services and incur disproportionate costs. Population health management (PHM) programs often refer to these patients as persistent high utilizers (PHUs). Accurate PHU prediction enables PHM programs to better align scarce health care resources with high-need PHUs while generally improving outcomes. While prior research in PHU prediction has shown promise, traditional regression methods used in these studies have yielded limited accuracy.ObjectiveWe are seeking to improve PHU predictions with an ensemble approach in a retrospective observational study design using insurance claim records.MethodsWe defined a PHU as a patient with health care costs in the top 20% of all patients for 4 consecutive 6-month periods. We used 2013 claims data to predict PHU status in next 24 months. Our study population included 165,595 patients in the Johns Hopkins Health Care plan, with 8359 (5.1%) patients identified as PHUs in 2014 and 2015. We assessed the performance of several standalone machine learning methods and then an ensemble approach combining multiple models.ResultsThe candidate ensemble with complement naïve Bayes and random forest layers produced increased sensitivity and positive predictive value (PPV; 49.0% and 50.3%, respectively) compared to logistic regression (46.8% and 46.1%, respectively).ConclusionsOur results suggest that ensemble machine learning can improve prediction of care management needs. Improved PPV implies reduced incorrect referral of low-risk patients. With the improved sensitivity/PPV balance of this approach, resources may be directed more efficiently to patients needing them most.

Assessing the Value of Unsupervised Clustering in Predicting Persistent High Health Care Utilizers: Retrospective Analysis of Insurance Claims Data.

BackgroundA high proportion of health care services are persistently utilized by a small subpopulation of patients. To improve clinical outcomes while reducing costs and utilization, population health management programs often provide targeted interventions to patients who may become persistent high users/utilizers (PHUs). Enhanced prediction and management of PHUs can improve health care system efficiencies and improve the overall quality of patient care.ObjectiveThe aim of this study was to detect key classes of diseases and medications among the study population and to assess the predictive value of these classes in identifying PHUs.MethodsThis study was a retrospective analysis of insurance claims data of patients from the Johns Hopkins Health Care system. We defined a PHU as a patient incurring health care costs in the top 20% of all patients’ costs for 4 consecutive 6-month periods. We used 2013 claims data to predict PHU status in 2014-2015. We applied latent class analysis (LCA), an unsupervised clustering approach, to identify patient subgroups with similar diagnostic and medication patterns to differentiate variations in health care utilization across PHUs. Logistic regression models were then built to predict PHUs in the full population and in select subpopulations. Predictors included LCA membership probabilities, demographic covariates, and health utilization covariates. Predictive powers of the regression models were assessed and compared using standard metrics.ResultsWe identified 164,221 patients with continuous enrollment between 2013 and 2015. The mean study population age was 19.7 years, 55.9% were women, 3.3% had ≥1 hospitalization, and 19.1% had 10+ outpatient visits in 2013. A total of 8359 (5.09%) patients were identified as PHUs in both 2014 and 2015. The LCA performed optimally when assigning patients to four probability disease/medication classes. Given the feedback provided by clinical experts, we further divided the population into four diagnostic groups for sensitivity analysis: acute upper respiratory infection (URI) (n=53,232; 4.6% PHUs), mental health (n=34,456; 12.8% PHUs), otitis media (n=24,992; 4.5% PHUs), and musculoskeletal (n=24,799; 15.5% PHUs). For the regression models predicting PHUs in the full population, the F1-score classification metric was lower using a parsimonious model that included LCA categories (F1=38.62%) compared to that of a complex risk stratification model with a full set of predictors (F1=48.20%). However, the LCA-enabled simple models were comparable to the complex model when predicting PHUs in the mental health and musculoskeletal subpopulations (F1-scores of 48.69% and 48.15%, respectively). F1-scores were lower than that of the complex model when the LCA-enabled models were limited to the otitis media and acute URI subpopulations (45.77% and 43.05%, respectively).ConclusionsOur study illustrates the value of LCA in identifying subgroups of patients with similar patterns of diagnoses and medications. Our results show that LCA-derived classes can simplify predictive models of PHUs without compromising predictive accuracy. Future studies should investigate the value of LCA-derived classes for predicting PHUs in other health care settings.

Use of the World Health Organization Access, Watch, and Reserve Classification to Follow Trends in Prescription of Antibiotic Use in Two Pediatric Intensive Care Units in Rio de Janeiro, Brazil

Abstract Objective The recommended percentage of antibiotic use in pediatric intensive care units (PICUs) using the World Health Organization (WHO) Access, Watch, and Reserve (AWaRE) classification is not known. Methods We have conducted an interrupted time series analysis in two PICUs in Rio de Janeiro, Brazil, over a period of 18 months. The type of antibiotics used was evaluated using the WHO AWaRE classification, and the amount of antibiotic was measured using days of therapy/1,000 patient-days (DOT/1000PD) after implementation of an antimicrobial stewardship program (ASP). The first and last semesters were compared using medians and the Mann–Whitney's test. The trends of antibiotic consumption were performed using time series analysis in three consecutive 6-month periods. Results A total of 2,205 patients were admitted, accounting for 12,490 patient-days. In PICU 1, overall antibiotic consumption (in DOT/1000PD) was 1,322 in the first 6 months of analysis and 1,264.5 in the last 6 months (p = 0.81). In PICU 2, the consumption for the same period was 1,638.5 and 1,344.5, respectively (p = 0.031). In PICU 1, the antibiotics classified in the AWaRE groups were used 33.2, 57.9, and 8.4% of the time, respectively. The remaining 0.5% of antibiotics used were not classified in any of these groups. In PICU 2, the AWaRE groups corresponded to 30.2, 60.5, and 9.3% of all antibiotics used, respectively. There was no use of unclassified antibiotics in this unit. The use of all three groups of WHO AWaRE antibiotics was similar in the first and the last semesters, with the exception of Reserve group in PICU 2 (183.5 × 92, p = 0.031). Conclusion A significant reduction of overall antibiotic use and also in the Reserve group was achieved in one of the PICU units studied. The antibiotics classified in the Watch group were the most used in both units, representing ∼60% of all the antibiotics consumed.

Trends in Wait Time for Colorectal Cancer Screening and Diagnosis 2013-2016.

OBJECTIVES:Colorectal cancer (CRC) screening has increased in the United States during the past 20 years, resulting in an increased demand for colonoscopy. We tested the hypothesis that such increase resulted in longer wait times for colonoscopy and influenced CRC diagnosis.METHODS:A total of 36,623 consecutive colonoscopies performed at the University of Wisconsin from April 8, 2013, until December 31, 2016, were included in the analysis. Wait times for colonoscopy were stratified by consecutive 6-month periods and indications of screening/surveillance vs diagnostic colonoscopy.RESULTS:Despite unchanged number of endoscopists, more colonoscopies were performed in 2015–2016 than in 2013–2014 (20,897 vs 15,726, respectively, P = 0.004). The mean wait time for colonoscopy increased from 68 days in 2013–2014 to 111 days in 2015–2016 (P < 0.0001), with most change affecting screening/surveillance colonoscopy. In 170 patients with a newly diagnosed CRC, the wait time did not significantly change between 2013–2014 and 2015–2016 (21 vs 27 days, respectively, P = 0.2206).DISCUSSION:An increase in screening/surveillance colonoscopies resulted in a substantial rise in the number of procedures between 2013 and 2016. This increase was associated with longer wait times for screening/surveillance but not diagnostic colonoscopy. Longer wait times did not result in later CRC stage at diagnosis.

Zoledronic acid ameliorates the effects of secondary osteoporosis in rheumatoid arthritis patients

BackgroundSecondary osteoporosis may occur in patients with rheumatoid arthritis (RA), causing irreversible joint damage and disability. Bisphosphonates, the recently developed bone resorption inhibitors, have demonstrated significant therapeutic effects on senile and postmenopausal osteoporosis. This study evaluated the efficacy and safety of zoledronic acid (ZOL), with or without methotrexate (MTX), for the prevention and treatment of bone destruction in RA patients.MethodsWe recruited 66 RA patients with symptoms of secondary osteoporosis. They were randomized into three treatment groups—combined treatment with MTX and ZOL, ZOL monotherapy, or MTX monotherapy—in two consecutive 6-month periods. The participants were followed for 12 months. At the end of each treatment period, improvement in disease activity, bone destruction, and fracture risk were evaluated.ResultsCombined treatment with ZOL and MTX had significantly better clinical efficacy compared with either ZOL or MTX monotherapy (P < 0.05). The combination significantly improved the lumbar spine and hip BMD and reduced FRAX scores, suggesting that ZOL combined with MTX reduces bone loss and risk of hip fracture in RA patients with secondary osteoporosis.ConclusionZOL has a synergistic effect when combined with MTX, inhibiting RA disease activity, reducing fracture risk, and improving quality of life in RA patients with secondary osteoporosis.Trial registrationChinese Clinical Trial Registry, ChiCTR1800019290. Registered 3 November 2018–Retrospective registered, http://www.chictr.org.cn/showproj.aspx?proj = 31758

Cost-Effectiveness Analysis of Integrated Care in Management of Advanced Chronic Obstructive Pulmonary Disease (COPD).

BackgroundChronic obstructive pulmonary disease (COPD) is a common disease that occurs all over the world. Models of care, initially accessed from the clinical point of view, must also be evaluated in terms of their economic effectiveness, as health care systems are limited. The Integrated Care Model (ICM) is a procedure dedicated to patients suffering from advanced COPD that offers home-oriented support from a multidisciplinary team. The main aim of the present study was to evaluate the cost-effectiveness of the ICM.Material/MethodsWe included 44 patients in the study (31 males, 13 females) with an average age 72 years (Me=71). Costs of care were estimated based on data received from public payer records and included general costs, COPD-related costs, and exacerbation-related costs. To evaluate cost-effectiveness, cost-effectiveness analysis (CEA) was used. The incremental cost-effectiveness ratio (ICER) was calculated based on changes in health care resources utilization and the value of costs observed in 2 consecutive 6-month periods before and after introducing ICM.ResultsCosts of care of all types decreased after introducing ICM. Demand for ambulatory visits changed significantly (p=0.037) together with a substantial decrease in the number of emergency department appointments and hospitalizations (p=0.033). ICER was more profitable for integrated care than for standard care when assessing costs of avoiding negative parameters such as hospitalizations (−227 EUR), exacerbations-related hospitalizations (−312 EUR), or emergency procedures (−119 EUR).ConclusionsICM is a procedure that meets the criteria of cost-effectiveness. It allows for avoiding negative parameters such as unplanned hospitalizations with higher economic effectiveness than the standard type of care used in managing COPD.

High-intensity cannabis use is associated with retention in opioid agonist treatment: a longitudinal analysis.

Cannabis use is common among people on opioid agonist treatment (OAT), causing concern for some care providers. However, there is limited and conflicting evidence on the impact of cannabis use on OAT outcomes. Given the critical role of retention in OAT in reducing opioid-related morbidity and mortality, we aimed to estimate the association of at least daily cannabis use on the likelihood of retention in treatment among people initiating OAT. As a secondary aim we tested the impacts of less frequent cannabis use. Data were drawn from two community-recruited prospective cohorts of people who use illicit drugs (PWUD). Participants were followed for a median of 81months (interquartile range=37-130). Vancouver, Canada. This study comprised a total of 820 PWUD (57.8% men, 59.4% of Caucasian ethnicity, 32.2% HIV-positive) initiating OAT between December 1996 and May 2016. The proportion of women was higher among HIV-negative participants, with no other significant differences. The primary outcome was retention in OAT, defined as remaining in OAT (methadone or buprenorphine/naloxone-based) for two consecutive 6-month follow-up periods. The primary explanatory variable was cannabis use (at least daily versus less than daily) during the same 6-month period. Confounders assessed included: socio-demographic characteristics, substance use patterns and social-structural exposures. In adjusted analysis, at least daily cannabis use was positively associated with retention in OAT [adjusted odds ratio (aOR)=1.21, 95% confidence interval (CI)=1.04-1.41]. Our secondary analysis showed that compared with non-cannabis users, at least daily users had increased odds of retention in OAT (aOR=1.20, 95% CI=1.02-1.43), but not less than daily users (aOR=1.00, 95% CI=0.87-1.14). Among people who use illicit drugs initiating opioid agonist treatment in Vancouver, at least daily cannabis use was associated with approximately 21% greater odds of retention in treatment compared with less than daily consumption.

Safety of Oats in Children with Celiac Disease: A Double-Blind, Randomized, Placebo-Controlled Trial

To evaluate the long-term validity and safety of pure oats in the treatment of children with celiac disease. This noninferiority clinical trial used a double-blind, placebo-controlled, crossover design extended over 15 months. Three hundred six children with a biopsy-proven diagnosis of celiac disease on a gluten-free diet for ≥2 years were randomly assigned to eat specifically prepared gluten-free food containing an age-dependent amount (15-40 g) of either placebo or purified nonreactive varieties of oats for 2 consecutive 6-month periods separated by washout standard gluten-free diet for 3 months. Clinical (body mass index, Gastrointestinal Symptoms Rating Scale score), serologic (IgA antitransglutaminase antibodies, and IgA anti-avenin antibodies), and intestinal permeability data were measured at baseline, and after 6, 9, and 15 months. Direct treatment effect was evaluated by a nonparametric approach using medians (95% CI) as summary statistic. After the exclusion of 129 patients who dropped out, the cohort included 177 children (79 in the oats-placebo and 98 in the placebo-oats group; median, 0.004; 95% CI, -0.0002 to 0.0089). Direct treatment effect was not statistically significant for clinical, serologic, and intestinal permeability variables (body mass index: median, -0.5; 95% CI, -0.12 to 0.00; Gastrointestinal Symptoms Rating Scale score: median, 0; 95% CI, -2.5 to 0.00; IgA antitransglutaminase antibodies: median, -0.02; 95% CI, -0.25 to 0.23; IgA anti-avenin antibodies: median, -0.0002; 95% CI, -0.0007 to 0.0003; intestinal permeability test: median, 0.004; 95% CI, -0.0002 to 0.0089). Pure nonreactive oat products are a safe dietary choice in the treatment of children with celiac disease. ClinicalTrials.gov: NCT00808301.

Is high indoor radon concentration correlated with specific activity of radium in nearby soil? A study in Kosovo and Metohija.

This paper presents indoor radon concentrations and specific activities of natural radionuclides measured in soils of Kosovo and Metohija. The measurements of radon concentration were performed during two consecutive 6-month periods in two rooms of 63 houses using CR-39 detectors. The annual radon concentration ranged from 30 to 810Bqm-3 with the average value of 128Bqm-3. Almost 15% of the houses had radon concentration higher than 200Bqm-3. The difference between radon concentrations measured in the two 6-month periods was analyzed, showing, as expected, a slightly higher radon concentration in the "winter period" than in the "summer period". The variation between different rooms of the same houses was also analyzed, showing that 20% of the dwellings had a significantly higher radon concentration (>100Bqm-3) in one room compared to the other (the coefficient of variation ranged up to 96%). The specific activities of natural radionuclides in the nearby soil were determined by gamma spectrometry. The estimated average value (and standard deviation) of 226Ra, 232Th, and 40K specific activities were 32 (13), 35 (16), and 582 (159)Bqkg-1, respectively. The correlation between indoor 222Rn and 226Ra content in soil was investigated. Only a weak correlation was found (Spearman's rho=0.220) indicating that other factors might affect diffusion and accumulation of radon indoors, as confirmed also by the high variability between the rooms of the same houses.

Health hazards due to the exposure to radon in schools of the Cappadocia region

This study presents the results of a survey of radon concentrations in schools (kindergartens, primary schools, secondary schools, high schools, colleges, and one faculty) located in the province of Nevsehir which is the center of the Cappadocia region. Radon measurements covered two consecutive 6-month periods in the ground floor classrooms inside the school buildings and they were performed using a continuous active radon detector (AlphaGUARD PQ2000 PRO). Data distribution is well fitted by a log-normal curve. The arithmetic average value of the radon concentrations measured in summer and winter was found as 75 ? 12 Bqm-3 and 67 ? 10 Bqm-3, respectively. From the measured results, the effective doses from radon exposures in summer and winter were estimated as 0.27 and 0.40 mSv and 0.24 and 0.36 mSv for students and teachers, respectively. The results showed that radon concentration measured in schools does not pose significant health hazards for students and teachers.

Target Joint Status in Patients with Hemophilia a during 18 Consecutive Months of Prophylaxis with a Pegylated Full-Length Recombinant Factor VIII with Extended Half-Life

Introduction and Objective: Patients with severe hemophilia A repeatedly bleed into joints and subsequently develop target joints and arthropathy. BAX 855, a polyethylene glycol pegylated, full-length, recombinant factor VIII built on ADVATE, demonstrates an extended half-life, efficacy, and safety for prophylaxis and the treatment of bleeding in patients with severe hemophilia A. Target joint status was evaluated in an ad-hocanalysis of integrated efficacy data from previously treated adolescent and adult patients who participated in the pivotal (completed) and continuation (ongoing) studies.Methods: The number of target joints, defined as a single joint with ≥3 spontaneous bleeding episodes in any consecutive 6-month period, were analyzed over 3 consecutive 6-month periods in patients who received twice weekly BAX 855 prophylaxis at 40-50 IU/kg.Results: After approximately 6 months of twice weekly prophylaxis during the pivotal study, 101 adolescent and adult patients continued treatment in the continuation study, 51 of whom were treated with twice weekly prophylaxis for 18 consecutive months. At screening 29.4% (15/51) of these patients had no target joints, 19.6% (10) had 1 target joint, 21.6% (11) had 2, and the remaining 29.4% (15) had 3 or more. After the first 6-month treatment period, the percent of patients with no target joints increased to 66.7% (34 patients), including 19 patients in whom 1 or more target joints had resolved and 15 patients who remained target joint-free from screening. Of note, for the 15 patients with 3 or more target joints at screening, all of their target joints resolved after the first 6 months of treatment with BAX 855. This trend was maintained after the second 6-month treatment period. After the third 6-month period of twice weekly prophylaxis, the percent of patients with no target joints further increased to 82.4% (42), which included the 15 patients who remained target joint-free from screening. Nine patients had 1 or more unresolved target joint after 18 months of twice weekly prophylaxis, and in 6 of these patients, 1 to 3 other target joints had resolved. Overall, there were 89 target joints at screening which reduced to 14 after 18 months of twice weekly prophylaxis. Of those, 10 target joints changed status (eg, were present, resolved, and then re-appeared) and only 4 target joints (in 4 patients) persisted as unresolved through each of the 3 consecutive 6-month treatment periods.Conclusions: These results demonstrate the efficacy of continuous twice weekly prophylaxis with BAX 855 for preventing and resolving the majority of target joints. DisclosuresEngl:Shire, formerly Baxalta and Baxter: Employment, Equity Ownership. Patrone:Shire, formerly Baxalta and Baxter: Employment, Equity Ownership. Abbuehl:Shire, formerly Baxalta and Baxter: Employment, Equity Ownership.

Assessment of mitral valve morphology using three-dimensional echocardiography. Feasibility and reference values

ObjectivesTo evaluate the feasibility of real time transthoracic three-dimensional echocardiography (RT3DE) for evaluation of normal canine mitral valves (MVs), and to provide reference values for this technique. AnimalsForty-three cardiologically healthy, not sedated dogs. MethodsTransthoracic RT3DE mitral datasets were acquired during two consecutive 6-month periods. The datasets were analyzed using commercially available software. An MV model was drawn using a semiautomated procedure and MV variables were obtained and calculated. The ratio between annulus height and commissural diameter was used as an index of the annulus' saddle-shaped non-planarity. After evaluation of associations between measured variables and body size, the datasets were used to generate reference intervals. Coefficients of variation (CVs), variance components, and repeatability coefficients were calculated for the evaluation of intra-observer, inter-observer, and day-to-day variability. ResultsDatasets could be analyzed in 34 of 43 (79%) dogs. 68 percent of datasets obtained during the first 6-month period could be analyzed and 90% obtained during the second period could be analyzed. An allometric relationship was identified for most MV variables. The MV annulus appeared elliptical and saddle-shaped. Inter- and intra-observer CVs were less than 20%. Coefficient of variation greater than 20% was calculated for the inter-day variation for some variables. Operator and observer were primarily responsible for the variation of most of the variables. ConclusionsEvaluation of canine mitral valves by transthoracic RT3DE is feasible. Canine MVs of healthy dogs analyzed using RT3DE are elliptical and saddle-shaped. Reference intervals for the measured MV variables are proposed.

Abstract 16450: The Impact of Left Ventricular versus Simultaneous Biventricular Pacing on Structural and Biochemical Reverse Remodeling in Patients With Heart Failure: Insights From the EvAluation of Resynchronization Therapy for Heart Failure (EARTH) Trial

Introduction: Cardiac Resynchronization Therapy (CRT) with simultaneous biventricular pacing (BiVP) is recommended for patients with heart failure and wide QRS, however up to a third of patients do not respond. GREATER-EARTH has demonstrated similar benefits with BiVP or LV pacing (LVP). Herein, we evaluate the effects of these two CRT modes on cardiac remodeling, evaluated by echocardiography and circulating biomarkers. Methods: 121 patients (LVEF≤35% and QRS≥120ms) referred for defibrillator implantation were randomized to BiVP or LVP for consecutive 6-month periods with cross-over. The primary endpoint was the change in LV end-systolic volume (LVESV) between patients with BiVP vs LVP from baseline to 6 months. Secondary endpoints included changes in LVEF, mitral regurgitation, RV and diastolic function. Changes in levels of markers of cardiac remodeling were also compared. Results: Both CRT pacing modes led to remodeling benefits after 6-months of therapy: LVESV decreased from 162±57mL at baseline to 130±63mL with BiVP vs 130±60 mL with LVP (p=0.68 between CRTs), with a positive response (≥15% LVESV reduction) being observed in 49% of patients with BiVP and 33% of LVP, p=0.09. Similarly, RV remodeling (dimension and RV-MPI) was equally improved with both pacing strategies (p=0.69 and p=0.38 respectively, between CRTs). Interestingly, estimated systolic PAP (from 43±14 to 37±10 and 41±14, p=0.008), selected indices of LV diastolic function such as indexed LA volume (p=0.045) and diastolic dysfunction grade (p=0.019), as well as changes in MR grade (p=0.004) were significantly improved only with BiVP. In parallel, there was a non-statistically significant decrease in NT-proBNP, from 2559±3296 to 1554±2092 and 1630±1950 ng/L, with BiVP and LVP respectively (p=0.093) as well as a trend in decreasing PIIINP levels, from 8.3±3.0 to 7.5±2.7 and 7.6±2.3 with BiVP and LVP respectively, p=0.097. Conclusions: In this prospective, multicenter, randomized, double-blind study, both BiVP and LVP resulted in improvements in LV remodelling assessed by echocardiography, while more patients responded to BiVP. BiVP may be superior to LVP to improve multiple aspects of myocardial remodeling and should remain the preferred mode of CRT in patients with advanced HF.

Using Clinical Databases to Verify the Impact of Regulatory Agency Alerts in Japan: Hepatitis B Testing Behavior After an Alert Regarding Risk of Viral Reactivation.

BackgroundMeasures of the effectiveness of risk minimization activities are necessary for the appropriate use of drugs, and clinical databases are a low-cost method of quickly producing such results.ObjectiveThe aim of this study was to explore the secondary application of clinical databases in verifying the impact of risk minimization activities; specifically, whether such databases could be used to identify changes in hepatitis B virus testing behavior after an alert from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.MethodsPatient data from December 1, 2010 to November 30, 2012 were extracted from the Medical Data Vision clinical database. The percentages of patients tested for hepatitis B virus DNA (HBV-DNA), hepatitis B surface antigen (HBsAg), and hepatitis B surface antibody (HBsAb)/hepatitis B core antibody (HBcAb) were compared 1 year before (consecutive 6-month periods A and B) and 1 year after (consecutive 6-month periods C and D) a PMDA alert regarding viral reactivation in patients receiving immunosuppressive agents.ResultsData for 9866 patients in the clinical database were analyzed. After the PMDA alert, the percentage of patients tested for HBV-DNA linearly increased in periods A to D: 4.70 % (n = 262/5571), 5.78 % (n = 330/5710), 6.52 % (n = 398/6101), and 7.59 % (n = 479/6315). However, no changes were observed in the rates of HBsAg and HBcAb/HBsAb testing (around 50 and 70 %, respectively). Overall testing rates appeared to differ depending on disease and drug type.ConclusionThese findings suggest that the PMDA alert was effective at recommending HBV-DNA testing. This secondary application of clinical databases may be effective for verifying the impact of risk minimization activities.

Quality of Supervision as an Independent Contributor to an Anesthesiologist's Individual Clinical Value.

Although the clinical (operating room) production of individual anesthesiologists has been measured in multiple related ways (e.g., hours of direct clinical care), the same is not true for the quality of that effort. In our study, we consider the quality of clinical supervision provided by anesthesiologists who are supervising anesthesia residents and nurse anesthetists. The quality of the daily supervision can be measured reliably and validly using the scale developed by de Oliveira Filho et al. If clinical production and supervisory quality were not positively correlated, then it would be important for departments to measure the quality of clinical supervision because, essentially, the clinical value provided by an anesthesiologist would be correlated with, but not necessarily proportional to, their clinical hours. Our department sends daily e-mail requests to anesthesia residents and nurse anesthetists to evaluate the supervision provided by each anesthesiologist with whom they worked the previous day in an operating room setting. We compared anesthesiologists' clinical activity (total operating room hours) and supervision scores obtained during the first (July 1, 2013 to December 31, 2013) and last (July 1, 2014 to December 31, 2014) of 3 consecutive 6-month periods. During the first 6 months, anesthesiologists received no feedback regarding the supervision scores. During the last 6 months, there was feedback to all anesthesiologists regarding their individual supervision scores and comments provided by residents (during the preceding 6 months) and nurse anesthetists (during the preceding 12 months). Anesthesiologists' mean supervision scores were not positively correlated with their total (weekly) hours of clinical activity. For the first 6 months, the correlations were r = -0.18 among scores provided by residents (P = 0.92 for positive correlation, N = 57 anesthesiologists) and r = -0.04 among scores provided by nurse anesthetists (P = 0.70, N = 61). For the last 6 months, the correlations were r = -0.28 (P = 0.98) and r = -0.10 (P = 0.79), respectively. Pairwise by anesthesiologist, the mean supervision scores provided by residents increased by 0.08 ± 0.01 points (P < 0.0001, N = 44). The mean supervision scores provided by nurse anesthetists increased by 0.28 ± 0.02 points (P < 0.0001, N = 49). When anesthesiologists supervise anesthesia residents and nurse anesthetists, the amount of clinical work performed and the quality of the supervision provided do not necessarily follow one another. Thus, faculty supervision scores serve as an independent measure of the contribution of an individual anesthesiologist to the care of the patient. Furthermore, when supervision quality is monitored and feedback is provided to anesthesiologists, quality can increase. The results suggest that anesthesiology department managers should not only be monitoring (and perhaps reporting) the quality of their departments' level of supervision, but also establishing processes so that individual anesthesiologists can learn about the quality of supervision they provide.

Safety and feasibility of an enhanced recovery pathway after a liver resection: prospective cohort study

BackgroundIn contrast to colorectal surgery, enhanced recovery pathways (ERPs) have not yet become standard practice after major upper abdominal surgery. The aim of this study was to assess the feasibility and outcomes after implementation of an ERP after liver a resection. MethodsPatients who underwent a liver resection in two consecutive 6-month periods before (July–December 2013) and after (January–June 2014) implementation of an ERP were included in a prospective study. Patients who underwent live donation, ALPPS (associating liver partition with portal vein ligation for staged hepatectomy) or concomitant procedures were excluded. Peri-operative outcomes were compared between groups, and multivariate analysis of factors influencing the length of hospital stay (LOS) was performed. ResultsTwo hundred and eleven patients (93 pre-ERP and 91 post-ERP patients) underwent a liver resection during the study period. There was no significant difference in the median LOS (P = 0.907) and 30-day readmission rates (P = 0.645) between the groups. Severe (Clavien grade III–V) complications were reduced in ERP patients (13.9% versus 4.3%; P = 0.039). On multivariate analysis, an increased age (< 0.001), open resection (< 0.001) and complications (< 0.001) were associated with an increased LOS. ConclusionEnhanced recovery after a liver resection appears to be safe, feasible and may reduce severe complications. However, the LOS was significantly influenced by patient age, open surgery and post-operative complications, but not by an ERP.

Self-reported and employer-recorded sickness absence in doctors.

Doctors' sickness absence reduces the quality and continuity of patient care and is financially costly. Doctors have lower rates of sickness absence than other healthcare workers. To compare self-reported with recorded sickness absence in doctors in a UK National Health Service hospital trust. A retrospective questionnaire study. The main outcome measures were self-reported and trust-recorded sickness absence episodes of 4 days or more in two consecutive 6-month periods. The response rate was 82% (607/736). Self-reported sickness absence rates were 1.2% compared with a rate of 0.6% from trust-recorded data. There were 38 matched pairs of self-reported (mean duration: 18 days, standard deviation: 22 days) and trust-recorded (mean duration: 10 days, standard deviation: 17 days) sickness absence episodes of 4 days or more in the 12 months studied. A matched pairs t-test determined that the difference between the two means was significant (t = 2.57, P < 0.05). Doctors' sickness absence was significantly under-recorded in this study population.

Long- and short-term indoor radon survey in the Ardea municipality, south Rome

The indoor radon concentration was measured in 16 schools and 6 public departments in the Ardea municipality, using both active and passive detectors. The annual concentration of radon has been determined as the mean of two consecutive 6-month periods of sampling from January 2012 to January 2013. The indoor radon level measured in the monitored buildings ranged from 17 to 918 Bq·m(-3), with a mean value of 154 Bq·m(-3). In addition, the correlation between short-term and long-term measurements was studied. Experimental data demonstrate that the deviation of short-term measurements with respect to polyallyl diglycol carbonate data does not exceed ±40 % in a very extended range of radon concentrations.

Relation between submaximal exercise test to evaluate response to resynchronization therapy and change in quality of life: a substudy of the GREATER-EARTH trial

Purpose: A novel method of evaluating response to cardiac resynchronization therapy (CRT) was introduced in the EARTH trials. This substudy sought to assess the relationship between response to CRT using submaximal treadmill exercise testing, and quality of life (QoL) measures. Methods: The GREATER-EARTH trial was a multicentre, randomized, double-blind crossover trial evaluating left ventricular versus biventricular pacing in patients requiring an implantable cardioverter-defibrillator and CRT (LVEF <35% and QRS duration ≥ 120 msec). A total of 121 patients were randomized to CRT by left ventricular pacing (LV) followed by biventricular pacing (BiV) or vice versa for consecutive 6-month periods. The present analyses were restricted to the first 6-month period to avoid carryover effects. Clinical response to CRT was pre-defined as an increase of ≥20% duration of submaximal treadmill exercise testing at 6 months compared to baseline. QoL was assessed at baseline and 6 months using generic (SF-36, Physical [PCS] and Mental [MCS] components) and disease-specific (Minnesota Living with Heart Failure [LWHF]) questionnaires. The relationship between responder status according to submaximal exercise test and change in QoL scores was assessed using multivariate linear regression. Results: Clinical responders showed significant improvements in QoL scores between baseline and 6 months (decrease in LWHF 15 points [p 0.30). Responder status was the only independent predictor of change in QoL scores; resynchronization mode (LV vs BiV), interaction between mode and responder status, age and sex were not independently associated with changes in QoL. Changes in the duration of submaximal exercise testing showed moderate but significant correlations with changes in LWHF (Spearman's ρ= -0.38; p<0.0001) and PCS scores (ρ=0.46; p<0.0001). An exploratory regression tree analysis showed that using a cut-off value of 55% improvement in duration of submaximal exercise testing instead of 20% to define response provided the best discrimination in terms of QoL score change. Conclusions: Submaximal treadmill exercise testing adequately reflects changes in quality of life after resynchronization therapy. Although this test should be compared to other means of assessing response and refined as to its best cut-off value, it has great potential in patient evaluation following resynchronization therapy.