Hepatitis C virus (HCV) infection has been associated with reduced bone mineral density, but its association with fracture rates is unknown, particularly in the setting of human immunodeficiency virus (HIV) coinfection. Our objectives were to determine whether persons with HCV infection alone are at increased risk for hip fracture compared to uninfected individuals and to examine if the risk of hip fracture is higher among HCV/HIV-coinfected persons compared to those with HCV alone, those with HIV alone, and those uninfected with either virus. We conducted a cohort study in 36,950 HCV/HIV-coinfected, 276,901HCV-monoinfected, 95,827 HIV-monoinfected, and 3,110,904 HCV/HIV-uninfected persons within the U.S. Medicaid populations of California, Florida, New York, Ohio, and Pennsylvania (1999–2005). Incidence rates of hip fracture were lowest among uninfected persons (1.29 events/1000 person-years), increased with the presence of either HIV infection (1.95 events/1000 person-years) or HCV infection (2.69 events/1000 person-years), and were highest among HCV/HIV-coinfected individuals (3.06 events/1000 person-years). HCV/HIV coinfection was associated with an increased relative hazard (adjusted hazard ratio [95% confidence interval]) of hip fracture compared to HCV-monoinfected (1.38 [1.25–1.53]), HIV-monoinfected (females: 1.76 [1.44–2.16]; males: 1.36 [1.20–1.55]), and uninfected persons (females: 2.65 [2.21–3.17]; males: 2.20 [1.97–2.47]). HCV monoinfection was associated with an increased risk of hip fracture compared to uninfected individuals, and the relative increase was highest in the youngest age groups (females, 18–39 years: 3.56 [2.93–4.32]; males, 18–39 years: 2.40 [2.02–2.84]).
Among Medicaid enrollees, HCV/HIV coinfection was associated with increased rates of hip fracture compared to HCV-monoinfected, HIV-monoinfected, and HCV/HIV-uninfected persons. HCV-monoinfected patients had an increased risk of hip fracture compared to uninfected individuals.
Hepatitis C virus; HCV; HIV; fracture; coinfection
Endocan is a proteoglycan expressed by endothelial cells in the lung which may inhibit leukocyte recruitment and thus prevent the development of acute lung injury (ALI). We tested the association of serum endocan levels with subsequent development of ALI after major trauma.
Materials and Methods
Single-center nested case control study within a prospective cohort study of major trauma patients. Using an ELISA test, we measured endocan levels from admission serum in 24 controls (no ALI) and 24 cases (ALI within 5 days of trauma). Multivariable logistic regression was used to test the association of admission serum endocan levels with subsequent ALI.
Patients who developed ALI had lower levels of endocan on admission (mean 3.5 ± 1.4 ng/mL vs. 4.9 ± 2.6 ng/mL in controls, p=0.02). For each 1-unit increase in serum endocan level, the odds ratio for ALI development decreased (0.69, 95% confidence interval (CI): 0.49, 0.97, p=0.03). Lower endocan levels remained associated with a higher incidence of ALI after adjustment for age and illness severity.
Lower levels of serum endocan on admission are associated with subsequent development of ALI in trauma patients. These observations may be explained by endocan-mediated blockade of leukocyte recruitment in the lung.
Trauma; acute respiratory distress syndrome; acute lung injury; biomarkers; endothelium
Acute kidney injury (AKI) is a common source of morbidity after trauma. We sought to determine novel risk factors for AKI, by Acute Kidney Injury Network (AKIN) criteria, in critically ill trauma patients.
Materials and Methods
Prospective cohort study of 400 patients admitted to the ICU of a level one trauma center, followed for development of AKI over five days.
AKI developed in 147/400 (36.8%) patients. In multivariable regression analysis, independent risk factors for AKI included African American race (OR 1.86; 95% CI 1.08,3.18; p=0.024), body mass index ≥30 (OR 4.72 versus normal BMI, 95% CI 2.59, 8.61, p<0.001), diabetes mellitus (OR 3.26; 95% CI 1.30,8.20; p=0.012), abdominal Abbreviated Injury Scale score ≥4 (OR 3.78; 95% CI 1.79,7.96; p<0.001), and unmatched packed red blood cells administered during resuscitation (OR 1.13 per unit; 95% CI 1.04,1.23; p=0.004). AKIN stages 1, 2, and 3 were associated with hospital mortality rates of 9.8%, 13.7%, and 30.4%, respectively, compared with 3.8% for those without AKI (p<0.001).
AKI in critically ill trauma patients is associated with substantial mortality. The findings of African American race, obesity, and blood product administration as independent risk factors for AKI deserve further study to elucidate underlying mechanisms.
acute kidney injury; trauma; critical illness; race; obesity; transfusion; epidemiology; risk factors
Packed Red Blood Cell (PRBC) transfusion is associated with Acute Lung Injury (ALI) development after trauma, but this risk may not be constant through time after trauma. We hypothesized the relationship between PRBC delivery and ALI risk varies through time after injury.
Data were collected prospectively from 1999–2006. Inclusion criteria: age > 13 years, SICU admission, and injury severity score (ISS) ≥ 16. Exclusion criteria included discharge/death within 24 hours of admission. Patients were followed prospectively for ALI development for 5 days after trauma. Discrete time models were fit to test the association of timing of PRBC delivery with development of ALI while controlling for patient demographics, resuscitation variables, ISS, and APACHE III scores.
At total of 602 patients were included. Median age was 33 years, 77% were male, and 50% were African American. Using a discrete time-survival model, the relation between transfusion and ALI development was found to vary by transfusion time-window (p<0.0001). The major effect of PRBC delivery on ALI risk occurred in the first 24 hours after trauma; this finding persisted in multivariable modeling (adjusted OR = 1.07 per unit; 95%CI 1.02–1.11, p<0.001). Cumulative incidence of ALI approached 50% in patients receiving ≥ 6u PRBC in the first 24 hours.
The association between PRBC transfusion and ALI development in trauma patients is time-dependent, with PRBC delivery in the first 24 hours after injury driving the overall relation. Each PRBC unit during this time period increases odds of subsequent ALI development by 7%.
To estimate the frequency of pregnancy testing among adolescent emergency department (ED) patients and to determine factors associated with testing.
This was a retrospective cross-sectional study using the National Hospital Ambulatory Medical Care Survey (NHAMCS) from 2005-2009 of ED visits by females ages 14 to 21 years. We estimated the frequency of pregnancy testing among all visits, those for potential reproductive health complaints, and those associated with exposure to potentially teratogenic radiation. Multivariable logistic regression modeling was performed to calculate adjusted probabilities and odds ratios with 95% confidence intervals to evaluate factors associated with pregnancy testing by patient characteristics.
We identified 11,531 visits, representing an estimated 41.0 million female adolescent ED visits. Of these, 20.9% (95% CI 19.3%, 22.5%) included pregnancy testing. Among visits for potential reproductive health complaints and those associated with exposure to potentially teratogenic radiation, 44.5% (95% CI 41.3%, 47.8%) and 36.7% (95% CI 32.5%, 40.9%), respectively, included pregnancy testing. Among the entire study population, we found statistically significant differences in pregnancy by testing (p<0.001 for all) by age, race/ethnicity, hospital admission, and geographic region.
A minority of female adolescent ED visits included pregnancy testing even if patients presented with potential reproductive health complaints or received exposure to ionizing radiation. Small but statistically significant differences in pregnancy testing rates were noted based on age, race/ethnicity, ED disposition, and geographic region. Future studies should focus on designing quality improvement interventions to increase pregnancy testing in adolescent ED patients, especially among those in whom pregnancy complications or the risk of potentially teratogenic radiation exposure is higher.
Early transition from intravenous to oral antimicrobial therapy for acute osteomyelitis in children has been suggested as a safe and effective alternative to traditional prolonged intravenous therapy via central venous catheter, but no studies have directly compared these two treatment modalities. We sought to compare the effectiveness of early transition from intravenous to oral antimicrobial therapy vs. prolonged intravenous antimicrobial therapy for the treatment of children with acute osteomyelitis.
We conducted a retrospective cohort study of children ages 2 months to 17 years diagnosed with acute osteomyelitis between 2000 and 2005 at 29 free-standing children’s hospitals in the United States to confirm the extent of variation in use of early transition to oral therapy. We used a propensity scores to adjust for potential differences between children treated with prolonged intravenous therapy, and logistic regression to model the association of outcome (treatment failure rates within 6 months of diagnosis and difference in the mode of therapy within hospitals and across hospitals.
Of the 1969 children who met inclusion criteria, 1021 received prolonged intravenous therapy and 948 received oral therapy. Use of prolonged intravenous therapy varied significantly across hospitals (10% to 95%, P<0.001). The treatment failure rate was 5% (54 of 1021) in the prolonged intravenous therapy group and 4% (38 of 948) in the oral therapy group. There was no significant association between treatment failure and the mode of antimicrobial therapy (adjusted odds ratio=0.77, 95% confidence interval=0.49 to 1.22). Thirty-five children (3.4%) in the prolonged intravenous therapy group were readmitted for a catheter-associated complication.
Treatment of acute osteomyelitis with early transition to oral therapy is not associated with a higher risk of treatment failures and avoids the risks of prolonged intravenous therapy through central venous catheters.
Osteomyelitis; therapy; children
We aimed to identify combinations of biomarkers to enhance the definition of PGD for translational research.
Biomarkers reflecting lung epithelial injury (sRAGE and SP-D), coagulation cascade (PAI-1 and Protein C), and cell adhesion (ICAM-1) were measured in the plasma of 315 subjects derived from the LTOG cohort at 6 and 24 hours after transplantation. We assessed biomarker utility in two ways: first, we tested the discrimination of grade 3 PGD within 72 hours; second, we tested the predictive utility of plasma biomarkers for 90-day mortality.
86/315 subjects (27%) developed PGD. 23 subjects (8%) died within 90 days of transplantation, of which 16 (70%) had PGD. Biomarkers measured at 24 hours had greater discrimination than at 6 hours. Individually, sRAGE (AUC 0.71) and PAI-1 (AUC 0.73) had the best discrimination of PGD. The combinations of sRAGE with PAI-1 (AUC 0.75), PAI-1 with ICAM-1 (AUC 0.75), and PAI-1 with SP-D (AUC 0.76) had the best discrimination. Combinations of greater than 2 biomarkers did not significantly enhance discrimination of PGD. ICAM-1 with PAI-1 (AUC 0.72) and ICAM-1 with sRAGE (AUC of 0.72) had the best prediction for 90-day mortality. The addition of ICAM-1, PAI-1, or sRAGE to the concurrent clinical PGD grade significantly improved prediction of 90-day mortality (p<0.001 each).
Measurement of the combination of a marker of impaired fibrinolysis with an epithelial injury or cell adhesion marker had the best discrimination for PGD and prediction for early mortality, and may provide an alternative outcome useful in future research.
Primary Graft Dysfunction; Lung transplantation; Biomarkers; Acute Lung Injury
The authors sought to clarify the relationship between evidence-based medicine and access to drug coverage. They concluded that a structured approach to improving clarity, consistency, and transparency was lacking.
Establishing a better understanding of the relationship between evidence evaluation and formulary decision-making has important implications for patients, payers, and providers. The goal of our study was to develop and test a structured approach to evidence evaluation to increase clarity, consistency, and transparency in formulary decision-making.
The study comprised three phases. First, an expert panel identified key constructs to formulary decision-making and created an evidence-assessment tool. Second, with the use of a balanced incomplete block design, the tool was validated by a large group of decision-makers. Third, the tool was pilot-tested in a real-world P&T committee environment.
An expert panel identified key factors associated with formulary access by rating the level of access that they would give a drug in various hypothetical scenarios. These findings were used to formulate an evidence-assessment tool that was externally validated by surveying a larger sample of decision-makers. Last, the tool was pilot-tested in a real-world environment where P&T committees used it to review new drugs.
Survey responses indicated that a structured approach in the formulary decision-making process could yield greater clarity, consistency, and transparency in decision-making; however, pilot-testing of the structured tool in a real-world P&T committee environment highlighted some of the limitations of our structured approach.
Although a structured approach to formulary decision-making is beneficial for patients, health care providers, and other stakeholders, this benefit was not realized in a real-world environment. A method to improve clarity, consistency, and transparency is still needed.
evidence; decision-making; formulary; access
Few data exist on risk factors for candidemia in pediatric intensive care unit (PICU) patients who are at high risk of mortality from infection. We conducted a population-based case-control study to determine risk factors and predictors for candidemia in the PICU.
Candida species are the leading cause of invasive fungal infections in hospitalized children and are the third most common isolates recovered from pediatric healthcare-associated bloodstream infection in the US . Few data exist on risk factors for candidemia in pediatric intensive care unit (PICU) patients.
We conducted a population-based case-control study of PICU patients at Children's Hospital of Philadelphia (CHOP) from 1997-2004. Cases were identified using laboratory records, controls were selected from PICU rosters. Controls were matched to cases by incidence density sampling, adjusting for time at risk. Following conditional multivariate analysis, we performed weighted multivariate analysis to determine predicted probabilities for candidemia given certain risk factor combinations.
We identified 101 cases of candidemia(incidence,3.5/1,000 PICU admissions). Factors independently associated with candidemia included presence of a central venous catheter(OR 30.4;CI,7.7,119.5), malignancy(OR 4.0;CI,1.23,13.1), use of vancomycin for >3 days in the prior two weeks(OR 6.2;CI,2.4,16), and receipt of agents with activity against anaerobic organisms for >3 days in the prior two weeks(OR 3.5;CI, 1.5,8.4). Predicted probability of various combinations of the factors above ranged from 10.7%-46%. The 30-day mortality rate was 44% in cases compared to 14% in controls (OR 4.22;CI,2.35,7.60).
To our knowledge, this is the first study to evaluate independent risk factors and to determine a population of children in PICUs at high risk for developing candidemia. Future efforts should focus on validation of these risk factors identified in a different PICU population and development of interventions for prevention of candidemia in critically ill children.
Candidemia; Pediatrics; Risk factors; Intensive Care
Rationale: Cognitive and psychiatric morbidity is common and potentially modifiable after acute lung injury (ALI). However, practical measures of neuropsychological function for use in multicenter trials are lacking.
Objectives: To determine whether a validated telephone-based neuropsychological test battery is feasible in a multicenter trial. To determine the frequency and risk factors for long-term neuropsychological impairment.
Methods: As an adjunct study to the Acute Respiratory Distress Syndrome Clinical Trials Network Fluid and Catheter Treatment Trial, we assessed neuropsychological function at 2 and 12 months post–hospital discharge.
Measurements and Main Results: Of 406 eligible survivors, we approached 261 to participate and 213 consented. We tested 122 subjects at least once, including 102 subjects at 12 months. Memory, verbal fluency, and executive function were impaired in 13% (12 of 92), 16% (15 of 96), and 49% (37 of 76) of long-term survivors. Long-term cognitive impairment was present in 41 of the 75 (55%) survivors who completed cognitive testing. Depression, post-traumatic stress disorder, or anxiety was present in 36% (37 of 102), 39% (40 of 102), and 62% (63 of 102) of long-term survivors. Enrollment in a conservative fluid-management strategy (P = 0.005) was associated with cognitive impairment and lower partial pressure of arterial oxygen during the trial was associated with cognitive (P = 0.02) and psychiatric impairment (P = 0.02).
Conclusions: Neuropsychological function can be assessed by telephone in a multicenter trial. Long-term neuropsychological impairment is common in survivors of ALI. Hypoxemia is a risk factor for long-term neuropsychological impairment. Fluid management strategy is a potential risk factor for long-term cognitive impairment; however, given the select population studied and an unclear mechanism, this finding requires confirmation.
acute respiratory distress syndrome; acute lung injury; cognitive function; critical illness
Background And Objectives
To understand the association between shared decision-making (SDM) and health care expenditures and use among children with special health care needs (CSHCN).
We identified CSHCN <18 years in the 2002–2006 Medical Expenditure Panel Survey by using the CSHCN Screener. Outcomes included health care expenditures (total, out-of-pocket, office-based, inpatient, emergency department [ED], and prescription) and utilization (hospitalization, ED and office visit, and prescription rates). The main exposure was the pattern of SDM over the 2 study years (increasing, decreasing, or unchanged high or low). We assessed the impact of these patterns on the change in expenditures and utilization over the 2 study years.
Among 2858 subjects representing 12 million CSHCN, 15.9% had increasing, 15.2% decreasing, 51.9% unchanged high, and 17.0% unchanged low SDM. At baseline, mean per child total expenditures were $2131. Over the 2 study years, increasing SDM was associated with a decrease of $339 (95% confidence interval: $21, $660) in total health care costs. Rates of hospitalization and ED visits declined by 4.0 (0.1, 7.9) and 11.3 (4.3, 18.3) per 100 CSHCN, and office visits by 1.2 (0.3, 2.0) per child with increasing SDM. Relative to decreasing SDM, increasing SDM was associated with significantly lower total and out-of-pocket costs, and fewer office visits.
We found that increasing SDM was associated with decreased utilization and expenditures for CSHCN. Prospective study is warranted to confirm if fostering SDM reduces the costs of caring for CSHCN for the health system and families.
children with special health care needs; communication; decision-making; health care expenditures
To characterize the effect of corticosteroid exposure on clinical outcomes in children hospitalized with new-onset Henoch-Schönlein purpura (HSP).
PATIENTS AND METHODS
We conducted a retrospective cohort study of children discharged with an International Classification of Diseases, Clinical Modification code of HSP between 2000 and 2007 by using inpatient administrative data from 36 tertiary care children’s hospitals. We used stratified Cox proportional hazards regression models to estimate the relative effect of time-varying corticosteroid exposure on the risks of clinical outcomes that occur during hospitalization for acute HSP.
During the 8-year study period, there were 1895 hospitalizations for new-onset HSP. After multivariable regression modeling adjustment, early corticosteroid exposure significantly reduced the hazard ratios for abdominal surgery (0.39 [95% confidence interval (CI): 0.17– 0.91]), endoscopy (0.27 [95% CI: 0.13– 0.55]), and abdominal imaging (0.50 [95% CI: 0.29 – 0.88]) during hospitalization.
In the hospital setting, early corticosteroid exposure was associated with benefits for several clinically relevant HSP outcomes, specifically those related to the gastrointestinal manifestations of the disease.
cohort; corticosteroids; adolescents; and epidemiology
The influence of community context on the effectiveness of evidence-based maternal and child home visitation programs following implementation is poorly understood. This study compared prenatal smoking cessation between home visitation program recipients and local-area comparison women across 24 implementation sites within one state, while also estimating the independent effect of community smoking norms on smoking cessation behavior.
Retrospective cohort design using propensity score matching of Nurse-Family Partnership (NFP) clients and local-area matched comparison women who smoked cigarettes in the first trimester of pregnancy. Birth certificate data were used to classify smoking status. The main outcome measure was smoking cessation in the third trimester of pregnancy. Multivariable logistic regression analysis examined, over two time periods, the association of NFP exposure and the association of baseline county prenatal smoking rate on prenatal smoking cessation.
The association of NFP participation and prenatal smoking cessation was stronger in a later implementation period (35.5% for NFP clients vs. 27.5% for comparison women, p < 0.001) than in an earlier implementation period (28.4% vs. 25.8%, p = 0.114). Cessation was also negatively associated with county prenatal smoking rate, controlling for NFP program effect, (OR = 0.84 per 5 percentage point change in county smoking rate, p = 0.002).
Following a statewide implementation, program recipients of NFP demonstrated increased smoking cessation compared to comparison women, with a stronger program effect in later years. The significant association of county smoking rate with cessation suggests that community behavioral norms may present a challenge for evidence-based programs as models are translated into diverse communities.
Home visitation; Community context; Implementation; Evaluation; Smoking cessation
We developed an electronic medical record (EMR)-based HPV vaccine decision support intervention targeting clinicians, (immunization alerts, education, and feedback) and families (phone reminders and referral to an educational website). Through telephone surveys completed by 162 parents of adolescent girls, we assessed the acceptability of the family-focused intervention and its effect on information-seeking behavior, communication, and HPV vaccine decision-making. The intervention was acceptable to parents and 46% remembered receiving the reminder call. Parents reported that the call prompted them to seek out information regarding the HPV vaccine, discuss the vaccine with friends and family, and reach a decision. Parents whose adolescent girls attended practices receiving the clinician-focused intervention were more likely to report that their clinician discussed the HPV vaccine at preventive visits. The results of this study demonstrate the acceptability and potential impact on clinical care of a comprehensive decision support system directed at both clinicians and families.
Transplant centers are reluctant to perform heart transplantation in patients with hepatitis C virus (HCV) infection because augmented immunosuppression could potentially increase mortality. However, there have been few studies examining whether HCV infection reduces survival after heart transplantation.
We used data from the the U.S. Scientific Registry of Transplant Recipients to perform a multicenter cohort study evaluating the association between recipient pre-transplant HCV status and survival after heart transplantation. Adults undergoing heart transplantation between January 1, 1993 and December 31, 2007 were eligible to participate.
Among 20,687 heart transplant recipients (443 HCV-positive and 20,244 HCV-negative) at 103 institutions followed for a mean of 5.6 years, mortality was higher among HCV-positive than HCV-negative recipients (177 [40%] vs 6,367 [31.5%]; p = 0.0001). After matching on propensity score, hospital and gender, the hazard ratio (HR) of death for HCV-positive heart transplant recipients was 1.32 (95% confidence interval [CI] 1.08 to 1.61). Mortality rates were higher among HCV-positive heart transplant recipients at 1 year (9.4% vs 8.2%), 5 years (26.3% vs 22.9%), 10 years (53.1% vs 43.4%) and 15 years (74.8% vs 62.3%) post-transplantation. HRs did not vary by gender or overall number of heart transplantations performed at the center.
Pre-transplant HCV positivity is associated with decreased survival after heart transplantation.
heart transplantation; HCV; survival; mortality; outcome; cohort study
Antiviral therapy reduces symptom duration and hospitalization risk among previously healthy and chronically ill children infected with seasonal influenza. The impact of oseltamivir on outcomes of hospitalized children is unknown. The primary objective of this study was to determine whether oseltamivir improves outcomes of critically ill children hospitalized with influenza.
We performed a retrospective cohort study of children admitted to a pediatric intensive care unit with influenza during 6 consecutive winter seasons (2001-2007). We used the Pediatric Health Information System (PHIS) database, which contains resource utilization data from 41 children's hospitals. We matched oseltamivir-treated and oseltamivir-non-treated patients by the probability of oseltamivir exposure using a propensity score we derived from patient and hospital characteristics. We subsequently compared the outcomes of critically ill children treated with oseltamivir within 24 hours of admission with propensity score matched children who were not treated with oseltamivir.
We identified 1,257 children with influenza infection, 264 of whom were treated with oseltamivir within 24 hours of hospital admission. Multivariable analysis of 252 oseltamivir-treated patients and 252 propensity score- matched untreated patients demonstrated that patients treated with oseltamivir experienced a 18% reduction in total hospital days (Time Ratio: 0.82, p=0.02) whereas intensive care unit stay, in-hospital mortality and readmission rates did not differ.
For critically ill children infected with seasonal influenza, treatment with oseltamivir within 24 hours of hospitalization was associated with a shorter duration of hospital stay. Additional study is needed to determine the impact of delayed initiation of oseltamivir on clinical outcomes.
influenza; child; treatment; epidemiology; oseltamivir
The Institute of Medicine has prioritized shared decision making (SDM), yet little is known about the impact of SDM over time on behavioral outcomes for children. This study examined the longitudinal association of SDM with behavioral impairment among children with special health care needs (CSHCN).
CSHCN aged 5-17 years in the 2002-2006 Medical Expenditure Panel Survey were followed for 2 years. The validated Columbia Impairment Scale measured impairment. SDM was measured with 7 items addressing the 4 components of SDM. The main exposures were (1) the mean level of SDM across the 2 study years and (2) the change in SDM over the 2 years. Using linear regression, we measured the association of SDM and behavioral impairment.
Among 2,454 subjects representing 10.2 million CSHCN, SDM increased among 37% of the population, decreased among 36% and remained unchanged among 27%. For CSHCN impaired at baseline, the change in SDM was significant with each 1-point increase in SDM over time associated with a 2-point decrease in impairment (95% CI: 0.5, 3.4), whereas the mean level of SDM was not associated with impairment. In contrast, among those below the impairment threshold, the mean level of SDM was significant with each one point increase in the mean level of SDM associated with a 1.1-point decrease in impairment (0.4, 1.7), but the change was not associated with impairment.
Although the change in SDM may be more important for children with behavioral impairment and the mean level over time for those below the impairment threshold, results suggest that both the change in SDM and the mean level may impact behavioral health for CSHCN.
Children with Special Health Care Needs; Communication; Decision-Making
Adherence to hepatitis C virus (HCV) therapy with pegylated interferon and ribavirin has been incompletely examined.
To evaluate the relationship between adherence to HCV therapy and early and sustained virologic response, assess changes in adherence over time, and examine risk factors for non-adherence.
Retrospective cohort study.
National Veterans Affairs Hepatitis C Clinical Case Registry
5,706 HCV-infected patients (genotypes 1, 2, 3, or 4) with at least one prescription for pegylated interferon and ribavirin between 2003 and 2006 and HCV RNA results prior to and after treatment initiation.
Adherence was calculated over 12-week intervals using pharmacy refill data. Endpoints included early virologic response (decrease of ≥2 log10 HCV RNA at 12 weeks) and sustained virologic response (undetectable HCV RNA 24 weeks after end of treatment).
Early virologic response increased with higher levels of ribavirin adherence over the initial 12 weeks of therapy (genotype 1, 4: 25/68 [37%] with the lowest category [≤40% adherence] versus 1,367/2,187 [63%] with the highest category [91–100% adherence], p<0.001; genotype 2, 3: 12/18 [67%] with ≤40% adherence versus 651/713 [91%] with 91–100% adherence, p<0.001). Among genotype 1 and 4 patients, sustained response increased with higher ribavirin adherence over the second, third, and fourth 12-week intervals. Results were similar for interferon adherence. Mean adherence to interferon and ribavirin decreased 3.4% and 6.6% per 12-week interval, respectively (test for trend, p<0.001 for each drug). Patients prescribed growth factors or thyroid medications during treatment had higher mean antiviral adherence.
Observational study without standardized timing for outcomes measurements.
Early and sustained virologic responses increased with higher levels of adherence to interferon and ribavirin. Adherence to both antivirals declined over time, but more so for ribavirin.
Adherence; hepatitis C virus; HCV; antiviral therapy
To identify patterns of shared decision-making (SDM) among a nationally representative sample of US children with attention-deficit/hyperactivity disorder (ADHD) or asthma and determine if demographics, health status, or access to care are associated with SDM.
PATIENTS AND METHODS
We performed a cross-sectional study of the 2002–2006 Medical Expenditure Panel Survey, which represents 2 million children with ADHD and 4 million children with asthma. The outcome, high SDM, was defined by using latent class models based on 7 Medical Expenditure Panel Survey items addressing aspects of SDM. We entered factors potentially associated with SDM into logistic regression models with high SDM as the outcome. Marginal standardization then described the standardized proportion of children’s households with high SDM for each factor.
For both ADHD and asthma, 65% of children’s households had high SDM. Those who reported poor general health for their children were 13% less likely to have high SDM for ADHD (64 vs 77%) and 8% less likely for asthma (62 vs 70%) when adjusting for other factors. Results for behavioral impairment were similar. Respondent demographic characteristics were not associated with SDM. Those with difficulty contacting their clinician by telephone were 26% (ADHD: 55 vs 81%) and 29% (asthma: 48 vs 77%) less likely to have high SDM than those without difficulty.
These findings indicate that households of children who report greater impairment or difficulty contacting their clinician by telephone are less likely to fully participate in SDM. Future research should examine how strategies to foster ongoing communication between families and clinicians affect SDM.
ADHD; asthma; communication; decision-making; telephone care
Primary care offices are critical access points for obesity treatment, but evidence for approaches that can be implemented within these settings is limited. The Think Health! (¡Vive Saludable!) Study was designed to assess the feasibility and effectiveness of a behavioral weight loss program, adapted from the Diabetes Prevention Program, for implementation in routine primary care. Recruitment of clinical sites targeted primary care practices serving African American and Hispanic adults. The randomized design compares (a) a moderate-intensity treatment consisting of primary care provider counseling plus additional counseling by an auxiliary staff member (i.e., lifestyle coach), with (b) a low-intensity, control treatment involving primary care provider counseling only. Treatment and follow up duration are 1 to 2 years. The primary outcome is weight change from baseline at 1 and 2 years post-randomization. Between November 2006 and January 2008, 14 primary care providers (13 physicians; 1 physician assistant) were recruited at five clinical sites. Patients were recruited between October 2007 and November 2008. A total of 412 patients were pre-screened, of whom 284 (68.9%) had baseline assessments and 261 were randomized, with the following characteristics: 65% African American; 16% Hispanic American; 84% female; mean (SD) age of 47.2 (11.7) years; mean (SD) BMI of 37.2(6.4) kg/m2; 43.7% with high blood pressure; and 18.4% with diabetes. This study will provide insights into the potential utility of moderate-intensity lifestyle counseling delivered by motivated primary care clinicians and their staff. The study will have particular relevance to African Americans and women.
Obesity; Counseling; Female; Ethnic Groups; Office Visits; Patient Education
To characterize patterns of electronic medical record (EMR) use at pediatric primary care acute visits.
Direct observational study of 529 acute visits with 27 experienced pediatric clinician users.
For each 20 s interval and at each stage of the visit according to the Davis Observation Code, we recorded whether the physician was communicating with the family only, using the computer while communicating, or using the computer without communication. Regression models assessed the impact of clinician, patient and visit characteristics on overall visit length, time spent interacting with families, and time spent using the computer while interacting.
The mean overall visit length was 11:30 (min:sec) with 9:06 spent in the exam room. Clinicians used the EMR during 27% of exam room time and at all stages of the visit (interacting, chatting, and building rapport; history taking; formulation of the diagnosis and treatment plan; and discussing prevention) except the physical exam. Communication with the family accompanied 70% of EMR use. In regression models, computer documentation outside the exam room was associated with visits that were 11% longer (p=0.001), and female clinicians spent more time using the computer while communicating (p=0.003).
The 12 study practices shared one EMR.
Among pediatric clinicians with EMR experience, conversation accompanies most EMR use. Our results suggest that efforts to improve EMR usability and clinician EMR training should focus on use in the context of doctor–patient communication. Further study of the impact of documentation inside versus outside the exam room on productivity is warranted.
This cross-sectional study used Geographic Information System methods to compare sociodemographic and clinical characteristics of children enrolled and not enrolled in a primary care network to determine the suitability of the network to estimate population-based disease rates. We validated the network surveillance system by comparing invasive pneumococcal disease rates between network and nonnetwork children using population-based surveillance data. Among the study population of 130300 children, network children were more likely to be female, Black, non-Hispanic, younger, and receive Medicaid. These differences varied across neighborhoods, however, adjusting for neighborhood characteristics did not significantly change observed differences. Rates of invasive pneumococcal disease were not significantly different between network and non-network children. Significant demographic and clinical differences existed between network and non-network children and varied over small areas. Observed population rates of an infectious disease did not significantly differ suggesting that the network can potentially provide valid disease estimates for the community population.
The purpose of this study was to test the discriminant validity of ISHLT PGD grades in terms of lung injury biomarker profiles and survival.
The study samples consisted of a multicenter prospective cohort study for the biomarker analysis and a 450 patient cohort study for the mortality analyses. PGD was defined according to ISHLT consensus at 24, 48 and 72 hours after transplantation. We compared the changes in plasma markers of acute lung injury between PGD grades using longitudinal data models. To test predictive validity, we compared differences in the 30-day mortality and long-term survival according to PGD grade.
PGD grade 3 demonstrated greater differences between plasma ICAM-1, protein C, and PAI-1 levels than did PGD grades 0-2 at 24, 48, and 72 hours after lung transplantation (p<0.05 for each). Grade 3 had the highest 30-day (test for trend p<0.001) and overall mortality (log rank p<0.001), with PGD grades 1 and 2 demonstrating intermediate risks of mortality. The ability to discriminate both 30 day and overall mortality improved as the time of grading moved away from the time of transplantation (test for trend p<0.001).
The ISHLT grading system has good discriminant validity, based on plasma markers of lung injury and mortality. Grade 3 PGD was associated with the most severely altered plasma biomarker profile and the worst outcomes, regardless of the time point of grading. PGD grade at 48 and 72 hours discriminated mortality better than PGD grade at 24 hours.
Lung Transplantation; complications; Acute lung injury; Primary graft dysfunction; reperfusion injury