We compared the effectiveness and cost-effectiveness of population-based recall (Pop-recall) versus practice-based recall (PCP-recall) at increasing immunizations among preschool children.
This cluster-randomized trial involved children aged 19 to 35 months needing immunizations in 8 rural and 6 urban Colorado counties. In Pop-recall counties, recall was conducted centrally using the Colorado Immunization Information System (CIIS). In PCP-recall counties, practices were invited to attend webinar training using CIIS and offered financial support for mailings. The percentage of up-to-date (UTD) and vaccine documentation were compared 6 months after recall. A mixed-effects model assessed the association between intervention and whether a child became UTD.
Ten of 195 practices (5%) implemented recall in PCP-recall counties. Among children needing immunizations, 18.7% became UTD in Pop-recall versus 12.8% in PCP-recall counties (P < .001); 31.8% had documented receipt of 1 or more vaccines in Pop-recall versus 22.6% in PCP-recall counties (P < .001). Relative risk estimates from multivariable modeling were 1.23 (95% confidence interval [CI] = 1.10, 1.37) for becoming UTD and 1.26 (95% CI = 1.15, 1.38) for receipt of any vaccine. Costs for Pop-recall versus PCP-recall were $215 versus $1981 per practice and $17 versus $62 per child brought UTD.
Population-based recall conducted centrally was more effective and cost-effective at increasing immunization rates in preschool children.
Antibiotic overuse in the primary care setting is common. Our objective was to evaluate the effect of a clinical pathway-based intervention on antibiotic use.
Eight primary care clinics were randomized to receive clinical pathways for upper respiratory infection, acute bronchitis, acute rhinosinusitis, pharyngitis, acute otitis media, urinary tract infection, skin infections, and pneumonia and patient education materials (study group) versus no intervention (control group). Generalized linear mixed effects models were used to assess trends in antibiotic prescriptions for non-pneumonia acute respiratory infections and broad-spectrum antibiotic use for all eight conditions during a 2-year baseline and 1-year intervention period.
In the study group, antibiotic prescriptions for non-pneumonia acute respiratory infections decreased from 42.7% of cases at baseline to 37.9% during the intervention period (11.2% relative reduction) (p <.0001) and from 39.8% to 38.7%, respectively, in the control group (2.8% relative reduction) (p=0.25). Overall use of broad-spectrum antibiotics in the study group decreased from 26.4% to 22.6% of cases, respectively, (14.4% relative reduction) (p <.0001) and from 20.0% to 19.4%, respectively, in the control group (3.0% relative reduction) (p=0.35). There were significant differences in the trends of prescriptions for acute respiratory infections (p<.0001) and broad-spectrum antibiotic use (p=0.001) between the study and control groups during the intervention period, with greater declines in the study group.
This intervention was associated with declining antibiotic prescriptions for non-pneumonia acute respiratory infections and use of broad-spectrum antibiotics over the first year. Evaluation of the impact over a longer study period is warranted.
Clinical pathways; guidelines; antimicrobial stewardship; antibiotic prescribing; primary care; acute respiratory infection
Acculturation to U.S. society among minority patients may influence health outcomes beyond race and ethnicity alone. In particular, those who are foreign-born and who do not speak English as their primary language may have greater challenges interacting with the health care system and thus be at greater risk for adverse outcomes.
Methods and Results
We studied patients hospitalized with a principal discharge diagnosis of HF between January 2000 and December 2007 in an integrated delivery system that cares for minority patients. Individuals were defined as having low acculturation if their primary language was not English and their country of birth was outside of the U.S. Multivariable logistic regression and Cox proportional hazards regression were used to determine the independent risk of 30-day rehospitalization and 1-year mortality, respectively. Candidate adjustment variables included demographics (age, gender, race/ethnicity), coexisting illnesses, laboratory values, left ventricular systolic function, and characteristics of the index admission. Of 1,268 patients, 30% (n=379) were Black, 39% (n=498) Hispanic, and 27% (n= 348) White. Eighteen percent (n=228) had low acculturation. After adjustment, low acculturation was associated with a higher risk of readmission at 30 days (OR 1.70; 95% CI 1.07-2.68) but not 1-year all-cause mortality (HR 0.69; 95% CI 0.42-1.14).
Patients with HF who are foreign-born and do not speak English as their primary language have a greater risk of rehospitalization, independent of clinical factors and race/ethnicity. Future studies should evaluate whether culturally concordant interventions focusing on such patients may improve outcomes for this patient population.
heart failure; readmission; survival; risk factors; health disparities
Chronic kidney disease (CKD) and end stage renal disease (ESRD) are steadily increasing in prevalence in the United States. While there is reasonable evidence that specific activities can be implemented by primary care physicians (PCPs) to delay CKD progression and reduce mortality, CKD is under-recognized and undertreated in primary care offices, and PCPs are generally not familiar with treatment guidelines. The current study addresses the question of whether the facilitated TRANSLATE model compared to computer decision support (CDS) alone will lead to improved evidence-based care for CKD in primary care offices.
This protocol consists of a cluster randomized controlled trial (CRCT) followed by a process and cost analysis. Only practices providing ambulatory primary care as their principal function, located in non-hospital settings, employing at least one primary care physician, with a minimum of 2,000 patients seen in the prior year, are eligible. The intervention will occur at the cluster level and consists of providing CKD-specific CDS versus CKD-specific CDS plus practice facilitation for all elements of the TRANSLATE model. Patient-level data will be collected from each participating practice to examine adherence to guideline-concordant care, progression of CKD and all-cause mortality. Patients are considered to meet stage three CKD criteria if at least two consecutive estimated glomerular filtration rate (eGFR) measurements at least three months apart fall below 60 ml/min. The process evaluation (cluster level) will determine through qualitative methods the fidelity of the facilitated TRANSLATE program and find the challenges and enablers of the implementation process. The cost-effectiveness analysis will compare the benefit of the intervention of CDS alone against the intervention of CDS plus TRANSLATE (practice facilitation) in relationship to overall cost per quality adjusted years of life.
This study has three major innovations. First, this study adapts the TRANSLATE method, proven effective in diabetes care, to CKD. Second, we are creating a generalizable CDS specific to the Kidney Disease Outcome Quality Initiative (KDOQI) guidelines for CKD. Additionally, this study will evaluate the effects of CDS versus CDS with facilitation and answer key questions regarding the cost-effectiveness of a facilitated model for improving CKD outcomes. The study is testing virtual facilitation and Academic detailing making the findings generalizable to any area of the country.
Registered as NCT01767883 on clinicaltrials.gov NCT01767883
Chronic kidney disease; Practice based research networks; Practice facilitation; Academic detailing; Computer decision support
The authors describe the implementation of a depression care management (DCM) program at Colorado Access, a public sector health plan, and describe the program's clinical and system outcomes for members with chronic medical conditions. High medical risk, high cost Medicaid health plan members were identified and systematically screened for depression. A total of 370 members enrolled in the DCM program. Longitudinal analyses revealed significantly reduced depression severity scores at 3, 6, and 12 months after intervention as compared to baseline depression scores. At 12 months, 56% of enrollees in the DCM program had either a 50% reduction in PHQ-9 scores or a PHQ-9 score < 10. Longitudinal economic analyses comparing 12 months before and after intervention revealed a significant but modest increase in ER visits, outpatient office visits, and overall medical and pharmacy costs when adjusted for months enrolled in DCM. Limitations and recommendations for the integrated depression care management are discussed.
Fundoplication is a common pediatric surgery, but little data comparing the laparoscopic approach with the open approach have been published.
To compare infection rates, complication rates, length of stay, and cost for laparoscopic fundoplication versus open fundoplication among pediatric patients and to examine trends in utilization of laparoscopic fundoplication.
We used the Pediatric Health Information System database to conduct a retrospective study of children (aged <19 years) admitted for a fundoplication between 2005 and 2008. Descriptive characteristics for those undergoing a laparoscopic and open fundoplication were compared. Multivariate regression with random effects specified at the hospital level was used to model the association between laparoscopic fundoplication and the outcomes.
Fifty-six percent of 7083 fundoplication admissions had laparoscopic fundoplication. Median length of stay was 4 days for laparoscopic and 10 days for open fundoplication. The median cost of laparoscopic fundoplication was $13 003 versus $22 487 for open fundoplication. Laparoscopic fundoplication was associated with a 24% and 51% reduction in the adjusted odds of infection and surgical complications, respectively. The proportion of fundoplications performed laparoscopically increased from 51% in 2005 to 63% in 2008 (P < .001), but there was no increase in the overall fundoplication rate.
In a large study of children's hospitals, laparoscopic fundoplication was associated with improved outcomes compared with the open procedure, even after adjustment for patient severity. Laparoscopic fundoplication has become the most common form of antireflux surgery in children over 1 year of age, but this has not been associated with an increase in the overall utilization of the fundoplication procedure. These data have important implications for clinical practice and surgical training.
fundoplication; laparoscopic fundoplication; open fundoplication; neurologic impairment; surgical outcomes
Previous studies have identified behavioral phenotypes that predispose genetically vulnerable youth to a later onset of bipolar I or II disorder, but few studies have examined whether early psychosocial intervention can reduce risk of syndromal conversion. In a one-year open trial, we tested a version of family-focused treatment adapted for youth at high risk for bipolar disorder (FFT-HR).
A referred sample of 13 children (mean 13.4 ± 2.69 years; 4 boys, 9 girls) who had a parent with bipolar I or II disorder participated at one of two outpatient specialty clinics. Youth met DSM-IV criteria for major depressive disorder (n = 8), cyclothymic disorder (n = 1), or bipolar disorder not otherwise specified (n = 4), with active mood symptoms in the past month. Participants were offered FFT-HR (12 sessions in four months) with their parents, plus psychotropic medications as needed. Independent evaluators assessed depressive symptoms, hypomanic symptoms, and global functioning at baseline and then every four months for one year, with retrospective severity and impairment ratings made for each week of the follow-up interval.
Families were mostly adherent to the treatment protocol (85% retention), and therapists administered the FFT-HR manual with high levels of fidelity. Youth showed significant improvements in depression, hypomania, and psychosocial functioning scores on the Adolescent Longitudinal Interval Follow-up Evaluation. They also showed significant improvements in Young Mania Rating Scale and Children’s Depression Rating Scale scores.
FFT-HR is a promising intervention for youth at high risk for BD. Larger-scale randomized trials that follow youth into young adulthood will be necessary to determine whether early psychosocial intervention can reduce the probability of developing bipolar I or II disorder among genetically vulnerable youth.
early intervention; family therapy; high risk; pediatric; prevention; psychoeducation
Much has been written about how the medical home model can enhance patient-centeredness, care continuity, and follow-up, but few comprehensive aids or resources exist to help practices accomplish these aims. The complexity of primary care can overwhelm those concerned with quality improvement.
The RE-AIM planning and evaluation model was used to develop a multimedia, multiple-health behavior tool with psychosocial assessment and feedback features to facilitate and guide patient-centered communication, care, and follow-up related to prevention and self-management of the most common adult chronic illnesses seen in primary care.
The Connection to Health Patient Self-Management System, a web-based patient assessment and support resource, was developed using the RE-AIM factors of reach (e.g., allowing input and output via choice of different modalities), effectiveness (e.g., using evidence-based intervention strategies), adoption (e.g., assistance in integrating the system into practice workflows and permitting customization of the website and feedback materials by practice teams), implementation (e.g., identifying and targeting actionable priority behavioral and psychosocial issues for patients and teams), and maintenance/sustainability (e.g., integration with current National Committee for Quality Assurance recommendations and clinical pathways of care). Connection to Health can work on a variety of input and output platforms, and assesses and provides feedback on multiple health behaviors and multiple chronic conditions frequently managed in adult primary care. As such, it should help to make patient-healthcare team encounters more informed and patient-centered. Formative research with clinicians indicated that the program addressed a number of practical concerns and they appreciated the flexibility and how the Connection to Health program could be customized to their office.
This primary care practice tool based on an implementation science model has the potential to guide patients to more healthful behaviors and improved self-management of chronic conditions, while fostering effective and efficient communication between patients and their healthcare team. RE-AIM and similar models can help clinicians and media developers create practical products more likely to be widely adopted, feasible in busy medical practices, and able to produce public health impact.
Latinos in the United States have a higher prevalence of type 2 diabetes than non-Latino whites, even after controlling for adiposity. Decreased adiponectin is associated with insulin resistance and predicts T2DM, and therefore may mediate this ethnic difference. We compared total and high-molecular-weight (HMW) adiponectin in Latino versus white individuals, identified factors associated with adiponectin in each ethnic group, and measured the contribution of adiponectin to ethnic differences in insulin resistance.
We utilized cross-sectional data from subjects in the Latinos Using Cardio Health Actions to reduce Risk study. Participants were Latino (n = 119) and non-Latino white (n = 60) men and women with hypertension and at least one other risk factor for CVD (age 61 ± 10 yrs, 49% with T2DM), seen at an integrated community health and hospital system in Denver, Colorado. Total and HMW adiponectin was measured by RIA and ELISA respectively. Fasting glucose and insulin were used to calculate the homeostasis model insulin resistance index (HOMA-IR). Variables independently associated with adiponectin levels were identified by linear regression analyses. Adiponectin's contribution to ethnic differences in insulin resistance was assessed in multivariate linear regression models of Latino ethnicity, with logHOMA-IR as a dependent variable, adjusting for possible confounders including age, gender, adiposity, and renal function.
Mean adiponectin levels were lower in Latino than white patients (beta estimates: -4.5 (-6.4, -2.5), p < 0.001 and -1.6 (-2.7, -0.5), p < 0.005 for total and HMW adiponectin), independent of age, gender, BMI/waist circumference, thiazolidinedione use, diabetes status, and renal function. An expected negative association between adiponectin and waist circumference was seen among women and non-Latino white men, but no relationship between these two variables was observed among Latino men. Ethnic differences in logHOMA-IR were no longer observed after controlling for adiponectin levels.
Among patients with CVD risk, total and HMW adiponectin is lower in Latinos, independent of adiposity and other known regulators of adiponectin. Ethnic differences in adiponectin regulation may exist and future research in this area is warranted. Adiponectin levels accounted for the observed variability in insulin resistance, suggesting a contribution of decreased adiponectin to insulin resistance in Latino populations.
Risk factors for cardiovascular disease (CVD) derived from the Framingham study are widely used to guide preventive efforts. It remains unclear whether these risk factors predict CVD death in racial/ethnic minorities as well as they do in the predominately white Framingham cohorts.
Methods and Results
Using linked data from the National Health and Nutrition Examination Survey III (1988-1994) and the National Death Index, we developed Cox proportional-hazard models that predicted time to cardiovascular death separately for non-Hispanic white (NHW), non-Hispanic black (NHB) and Mexican American (MA) participants aged 40-80 with no previous CVD. We compared calibration and discrimination for the three racial/ethnic models. We also plotted predicted 10-year CVD mortality by age for the three racial/ethnic groups while holding other risk factors constant. 3437 NHW, 1854 NHB and 1834 MA subjects met inclusion criteria. Goodness of fit chi-square tests demonstrated adequate calibration for the three models (NHW, p=0.49; NHB, p=0.47; MA, p=0.55 and areas under the receiver operating characteristic curves demonstrated similar discrimination (c-statistics-NHW=0.8126; NHB=0.7679; and MA=0.7854). Older age was more strongly associated with CVD mortality in NHWs (HR-3.37, 95%CI-2.80, 4.05) than NHBs (HR-2.29, 95%CI-1.91, 2.75) and was intermediate in MAs (HR-2.46, 95%CI-1.95, 3.11). Predicted 10-year mortality was highest for NHBs across all age ranges and was higher for MAs than NHWs until late in the seventh decade.
Framingham risk factors predict CVD mortality equally well in NHWs, NHBs and MAs, but the strength of the association between individual risk factors and CVD mortality differs by race and ethnicity. When other risk factors are held constant, minority individuals are at higher risk of CVD mortality at younger ages than NHWs.
Risk factors; cardiovascular diseases; prevention; epidemiology
Few studies have addressed the physical and mental health effects of caring for a family member with bipolar disorder. This study examined whether caregivers’ health is associated with changes in suicidal ideation and depressive symptoms among bipolar patients observed over one year.
Patients (N = 500) participating in the Systematic Treatment Enhancement Program for Bipolar Disorder and their primary caregivers (N = 500, including 188 parental and 182 spousal caregivers) were evaluated for up to one year as part of a naturalistic observational study. Caregivers’ perceptions of their own physical health were evaluated using the general health scale from the Medical Outcomes Study 36-item Short-Form Health Survey. Caregivers’ depression was evaluated using the Center for Epidemiological Studies of Depression Scale.
Caregivers of patients who had increasing suicidal ideation over time reported worsening health over time compared to caregivers of patients whose suicidal ideation decreased or stayed the same. Caregivers of patients who had more suicidal ideation and depressive symptoms reported more depressed mood over a one-year reporting period than caregivers of patients with less suicidal ideation or depression. The pattern of findings was consistent across parent caregivers and spousal caregivers.
Caregivers, rightly concerned about patients becoming suicidal or depressed, may try to care for the patient at the expense of their own health and well-being. Treatments that focus on the health of caregivers must be developed and tested.
bipolar disorders; caregivers; mental disorders; mood disorders; suicide
Early growth monitoring may not identify infants at-risk for later growth faltering because it is difficult for the provider to recognize how large of a negative shift might be problematic.
The aim of this study was to determine whether a slowing in early weight-for-age could be used to identify children at increased risk of later growth faltering.
Longitudinal data for infants aged birth to two years were analyzed for 1978 healthy, term infants born between 1999-2001. Logistic regression techniques were used to determine whether a negative change in weight-for-age, across well-child visit intervals, can identify infants at risk for growth faltering.
The period prevalence of underweight was 24%. The odds ratio (OR) for infants with a negative shift in z-scores ≥ -0.85 between four and six months was 2.4 (95% CI 1.5, 3.9) compared to those without this shift, holding birth weight constant. Sensitivity analyses revealed the model was significant when either the 2000 CDC growth charts (p<.0001) or the 2006 WHO growth charts (p<.0001) were used as the reference, although the prevalence of underweight was lower (14.7%) when the 2006 WHO growth charts were the reference.
The findings support the hypothesis that a downward shift in weight-for-age of this magnitude during early infancy when well-child visits are most frequent can be used to identify children at-risk of later poor growth.
Early Intervention; Failure-to-thrive; Growth; Infant; Weight; Sensitivity
Although many studies have identified patient characteristics or chronic diseases associated with medication adherence, the clinical utility of such predictors has rarely been assessed. We attempted to develop clinical prediction rules for adherence with antihypertensive medications in two health care delivery systems.
Methods and Results
Retrospective cohort studies of hypertension registries in an inner-city health care delivery system (N = 17176) and a health maintenance organization (N = 94297) in Denver, Colorado. Adherence was defined by acquisition of 80% or more of antihypertensive medications.
A multivariable model in the inner-city system found that adherent patients (36.3% of the total) were more likely than non-adherent patients to be older, white, married, and acculturated in US society, to have diabetes or cerebrovascular disease, not to abuse alcohol or controlled substances, and to be prescribed less than three antihypertensive medications. Although statistically significant, all multivariate odds ratios were 1.7 or less, and the model did not accurately discriminate adherent from non-adherent patients (C-statistic = 0.606). In the health maintenance organization, where 72.1% of patients were adherent, significant but weak associations existed between adherence and older age, white race, the lack of alcohol abuse, and fewer antihypertensive medications. The multivariate model again failed to accurately discriminate adherent from non-adherent individuals (C-statistic = 0.576).
Although certain socio-demographic characteristics or clinical diagnoses are statistically associated with adherence to refills of antihypertensive medications, a combination of these characteristics is not sufficiently accurate to allow clinicians to predict whether their patients will be adherent with treatment.
drugs; hypertension; prevention
Pneumococcal vaccine (PPV) is recommended for adults ≥65 years and those with chronic illness, but there are potential advantages of universal vaccination of adults age 50–64 years.
To assess reported (1) recommendations and administration practices of general internists for PPV, (2) barriers to vaccination, and (3) willingness to expand vaccination to all adults ≥50 years.
National survey of general internists representative of the American College of Physicians.
Response rate was 74% (N = 326). Although 99% reported giving PPV, less than 20% used a computerized database to identify eligible patients by age or diagnoses and only 6% recalled patients. Major barriers included acute problems taking precedence over preventive care (39%), difficulty determining vaccination history (30%), not thinking of it/not a priority (20%), and inadequate reimbursement for vaccine (19%). If ACIP expanded recommendations, 60% would definitely and 37% would probably institute this change.
Most general internists reported giving PPV, but delivery was hindered by competing demands, lack of systems to identify patients needing vaccination, and reimbursement issues. Barriers might be decreased by a policy of universal vaccination of adults ≥50 years, and the majority of physicians reported they would follow such a recommendation if it were made.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-008-0800-0) contains supplementary material, which is available to authorized users.
immunization delivery; pneumococcal vaccine; pneumococcus; pneumonia
Efforts to improve primary care depression treatment have assessed strategies across heterogeneous groups of patients, but few have examined clinician-level influences on depression treatment.
To examine clinician characteristics that affect depression treatment in primary care settings, using multilevel ordinal regression modeling to disentangle patient- from clinician-level effects.
Secondary analysis from the Quality Improvement in Depression Study dataset.
The participants were 1,023 primary care patients with depression who reported on treatment in the 6-month follow-up and whose clinicians (n = 158) had at least 4 patients in the study.
Primary outcome variable was depression treatment intensity, derived from assessment of concordance with AHCPR depression treatment guidelines based on patient-reported data on their treatment. Primary independent variable was clinical practice burden for treating depression, derived from patient- and clinician-reported composite measures tested for significant association with clinician-reported practice burden.
Clinicians who treat patients with more chronic medical comorbidities perceive less burden from treating depressed patients in their practice (Spearman’s rho = −.30, p < .05). Clinicians who treat patients with more chronic medical comorbidities also provide greater intensity of depression treatment (adjusted OR = 1.44, p = .02), even after adjusting for the effects of patient-level chronic medical comorbidities (adjusted OR = 0.95, p = .45).
Clinicians who provide more chronic care also provide greater depression treatment intensity, suggesting that clinicians who care for complex patients can integrate depression care into their practice. Targeting interventions to these clinicians to enhance their ability to provide guideline-concordant depression care is a worthwhile endeavor and deserves further investigation.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-008-0738-2) contains supplementary material, which is available to authorized users.
depression; comorbidity; multilevel modeling
Left ventricular hypertrophy is a major independent risk factor for cardiovascular mortality. The contribution of left ventricular hypertrophy to racial and ethnic differences in cardiovascular mortality is poorly understood.
We used data from the Third National Health and Nutrition Examination Survey and from the National Death Index to compare mortality for those with an electrocardiographic (ECG) diagnosis of left ventricular hypertrophy to those without left ventricular hypertrophy separately for whites, African Americans, and Latinos. We used Cox proportional hazards regression to control for other known prognostic factors.
ECG left ventricular hypertrophy was significantly associated with ten-year cardiovascular mortality in all three racial/ethnic groups, both unadjusted and adjusted for other known prognostic factors. The hazard ratio for this association was significantly greater for African Americans (2.31, 95% CI 1.55–3.42) than for whites and Latinos (1.32, 95% CI 1.14–1.76 and 2.11, 95% CI 1.35–3.30 respectively) independent of systolic blood pressure.
ECG left ventricular hypertrophy contributes more to the risk of cardiovascular mortality in African Americans than it does in Whites. Using regression of ECG left ventricular hypertrophy as a goal of therapy might be a means to reduce racial differences in cardiovascular mortality; prospective validation is required.
left ventricular hypertrophy; electrocardiography; cardiovascular risk assessment; racial/ethnic differences
Family interventions have been found to hasten episode recovery and delay recurrences among adults with bipolar disorder.
To examine the benefits of family-focused treatment for adolescents (FFT-A) and pharmacotherapy in the 2-year course of adolescent bipolar disorder.
Two-site outpatient randomized controlled trial with 2-year follow-up.
A referred sample of 58 adolescents (mean [SD] age, 14.5[1.6] years) with bipolar I (n=38), II (n=6), or not otherwise specified disorder (n=14) with a mood episode in the prior 3 months.
Patients were randomly assigned to FFT-A and protocol pharmacotherapy (n=30) or enhanced care (EC) and protocol pharmacotherapy (n=28). The FFT-A consisted of 21 sessions in 9 months of psychoeducation, communication training, and problem-solving skills training. The EC consisted of 3 family sessions focused on relapse prevention.
Main Outcome Measures
Independent “blind” evaluators assessed patients every 3 to 6 months for 2 years. Outcomes included time to recovery from the index episode, time to recurrence, weeks in episode or remission, and mood symptom severity scores.
Analyses were by intent to treat. Rates of 2-year study completion did not differ across the FFT-A (60.0%) and EC conditions (64.3%). Although there were no group differences in rates of recovery from the index episode, patients in FFT-A recovered from their baseline depressive symptoms faster than patients in EC (hazard ratio,1.85; 95% confidence interval, 1.04-3.29; P=.04). The groups did not differ in time to recurrence of depression or mania, but patients in FFT-A spent fewer weeks in depressive episodes and had a more favorable trajectory of depression symptoms for 2 years.
Family-focused therapy is effective in combination with pharmacotherapy in stabilizing bipolar depressive symptoms among adolescents. To establish full recovery, FFT-A may need to be supplemented with systematic care interventions effective for mania symptoms.
clinicaltrials.gov Identifier NCT00571402.
Electrocardiographic criteria for the diagnosis of left ventricular hypertrophy in current use were defined using autopsy results or echocardiography; criteria defined using mortality might be more clinically meaningful.
Using data from NHANES III, we selected electrocardiographic measures that best differentiated those surviving at five years from those who did not. We identified voltage thresholds using regression techniques, and then compared survival for subjects above and below the thresholds.
Cornell voltage, Cornell product, and Novacode estimate of left ventricular mass index were discriminative for mortality and had identifiable thresholds present in their relationships with mortality. Independent of systolic blood pressure, there were significant associations with five-year mortality for Novacode index above threshold; hazard ratios were 1.58 for women and 1.27 for men, and for five-year cardiovascular mortality were 1.78 for women and 2.34 for men.
Electrocardiographic criteria for left ventricular hypertrophy validated against mortality might be clinically useful.
Family interventions have been found to hasten episode recovery and delay recurrences among adults with bipolar disorder.
To examine the benefits of family-focused therapy for adolescents (FFT-A) and pharmacotherapy in the 2-year course of adolescent bipolar disorder.
Design and setting
Two-site outpatient randomized controlled trial with 2-year follow-up.
A referred sample of 58 adolescents (14.5 ± 1.6 yrs) with bipolar I (n = 38), II (n = 6), or not otherwise specified disorder (n = 14) with a mood episode in the prior 3 months.
Patients were randomly assigned to FFT-A and protocol pharmacotherapy (n = 30) or enhanced care (EC) and protocol pharmacotherapy (n = 28). FFT-A consisted of 21 sessions in 9 months of psychoeducation, communication training, and problem-solving skills training. EC consisted of 3 family sessions focused on relapse prevention.
Main Outcome Measures
Independent “blind” evaluators assessed patients every 3-6 months over 2 years. Outcomes included time to recovery from the index episode, time to recurrence, weeks in episode/remission, and mood symptom severity scores.
Analyses were by intent-to-treat. Rates of 2-year study completion did not differ across the FFT-A (60.0%) and EC conditions (64.3%). Although there were no group differences in rates of recovery from the index episode, patients in FFT-A recovered from their baseline depressive symptoms faster than patients in EC (HR = 1.85; 95% CI: 1.04 – 3.29; P = .037). The groups did not differ on time to recurrence of depression or mania, but patients in FFT-A spent fewer weeks in depressive episodes and had a more favorable trajectory of depression symptoms over 2 years.
FFT-A is effective in combination with pharmacotherapy in stabilizing bipolar depressive symptoms among adolescents. To establish full recovery, FFT-A may need to be supplemented with systematic care interventions found effective for mania symptoms.
Electronic disease registries are a critical feature of the chronic disease management programs that are used to improve the care of individuals with chronic illnesses. These registries have been developed primarily in managed care settings; use in safety net institutions—organizations whose mission is to serve the uninsured and underserved—has not been described. We sought to assess the feasibility of developing disease registries from electronic data in a safety net institution, focusing on hypertension because of its importance in minority populations. We compared diagnoses obtained from algorithms utilizing electronic data, including laboratory and pharmacy records, against diagnoses derived from chart review. We found good concordance between diagnoses identified from electronic data and those identified by chart review, suggesting that registries of patients with chronic diseases can be developed outside the setting of closed panel managed care organizations.
Hypertension; safety net; chronic disease; disease registries
Survey results regarding primary care physicians' likelihood of recommending a new vaccine were compared before and after the vaccine was licensed by the Food and Drug Administration for three new vaccines: herpes zoster (HZ), human papillomavirus (HPV) and rotavirus (RV), using physician networks representative of United States physicians. The main purpose of this study was to determine (a) how accurately physicians predict their eventual vaccine recommendations and the barriers they will experience in delivering the new vaccine and (b) whether physicians shift towards more or less strongly recommending a new vaccine from pre- to post-licensure. Responses from 284, 152 and 184 physicians were analyzed for the three vaccines, respectively. For all vaccines, there was a significant association between physicians' pre- and post-licensure recommendations (p<0.05). When responses changed from pre- to post-licensure, physicians tended to recommend a given vaccine more strongly than they had anticipated pre-licensure. Before vaccine availability, physicians tended to predict greater barriers to vaccine delivery than they eventually experienced. Surveys are useful for predicting physician practices, but may provide a slightly pessimistic view of physician adoption of new vaccines. Such data can be helpful in devising strategies to encourage vaccine delivery by physicians.
Depression and brief periods of (hypo)mania are linked to an increased risk of progression to bipolar I or II disorder (BD) in children of bipolar parents. This randomized trial examined the effects of a 4-month family-focused therapy (FFT) program on the 1-year course of mood symptoms in youth at high familial risk for BD, and explored its comparative benefits among youth in families with high vs. low expressed emotion (EE).
Participants were 40 youth (mean 12.3 ± 2.8 years, range 9–17) with BD not otherwise specified, major depressive disorder, or cyclothymic disorder who had a first-degree relative with BD I or II and active mood symptoms (Young Mania Rating Scale [YMRS] > 11 or Child Depression Rating Scale > 29). Participants were randomly allocated to FFT–High Risk version (FFT-HR; 12 sessions of psychoeducation and training in communication and problem-solving skills) or an education control (EC; 1–2 family sessions).
Youth in FFT-HR had more rapid recovery from their initial mood symptoms (hazard ratio = 2.69, p = .047), more weeks in remission, and a more favorable trajectory of YMRS scores over 1 year than youth in EC. The magnitude of treatment effect was greater among youth in high-EE (vs. low-EE) families.
FFT-HR may hasten and help sustain recovery from mood symptoms among youth at high risk for BD. Longer follow-up will be necessary to determine if early family intervention has downstream effects that contribute to the delay or prevention of full manic episodes in vulnerable youth. Clinical trial registration information—Early Family-Focused Treatment for Youth at Risk for Bipolar Disorder; http://www.clinicaltrials.gov/; NCT00943085.
expressed emotion; high risk; early warning signs; psychoeducation; psychosocial intervention