Association of Frailty with Healthcare Utilization for Patients over One Year Following Surgical Evaluation.

OBJECTIVE: Characterize the distribution of healthcare utilization associated with pre-operative frailty in the year following evaluation by a surgeon. SUMMARY BACKGROUND DATA: Frailty is associated with increased morbidity, mortality, and costs for surgical patients. However, the total financial burden for frail patients beyond the index surgery and inpatient stay remains unknown. METHODS: Prospective cohort assembled from February 2016 to December 2020 within a multi-hospital integrated healthcare delivery and finance system (IDFS), from patients evaluated with the Risk Analysis Index (RAI) of frailty. Inclusion criteria: age greater than 18, valid RAI, membership in the IDFS Health Plan. Data were stratified by frailty and surgical status. RESULTS: The mean (SD) age was 54.7 (16.1) and 58.2% female of the cohort (n=86,572). For all patients with reimbursement for surgery (n=53,856), frail and very frail patients incurred respective increases of 8% ( P =0.027) and 29% ( P <0.001) on utilization relative to the normal group. Robust patients saw a 52% ( P <0.001) decrease. This pattern was more pronounced in the cohort without surgery (n=32,716). The increase over normal utilization for frail and very frail patients increased to 23% ( P =0.004) and 68% ( P <0.001), respectively. Utilization among robust patients decreased 62% ( P <0.001). Increases among the frail were primarily due to increased inpatient medical and post-acute care services (all P <0.001). CONCLUSIONS: Patient frailty is associated with increased total healthcare utilization, primarily via increased inpatient medical and post-acute care following surgery. Quantifying these frailty-related financial burdens may inform clinical decision making as well as the design of value-based reimbursement strategies.

Prospective assessment of humoral and cellular immune responses to a 3rd COVID-19 mRNA vaccine dose among immunocompromised individuals.

BACKGROUND: Improved COVID-19 prevention is needed for immunocompromised individuals. METHODS: Prospective study of healthcare workers (HCW) and immunocompromised participants with baseline serology following 2 mRNA vaccines and who were retested after dose 3 (D3); multivariable regression was used to identify predictors of serological responses. IFNγ/TNFα T-cell responses were assessed in a subset. RESULTS: 536 participants were included: 492 immunocompromised [(206 solid organ transplant (SOT), 128 autoimmune, 80 hematologic malignancy (HM), 48 solid tumor, 25 HIV], 44 HCW. D3 significantly increased Spike IgG levels among all, but SOT and HM participants had the lowest median antibody levels post-D3 (increase from 0.09 to 0.83 and 0.27 to 1.92, respectively), versus HCW and persons with HIV, autoimmune conditions, and solid tumors (increases from 4.44 to 19.79, 2.9 to 15.75, 3.82 to 16.32, and 4.1 to 25.54, respectively). Seropositivity post-D3 was lowest for SOT (49.0%) and HM (57.8%), versus others (>90% seropositive). Neutralization post-D3 was lowest among SOT and HM. Predictors of lower antibody levels included low baseline levels and shorter intervals between vaccines. T-cell responses against Spike increased significantly among HCW and non-significantly among immunocompromised individuals. CONCLUSIONS: D3 significantly improves serological but not T-cell responses among immunocompromised individuals. SOT and HM patients have suboptimal responses to D3.

Trajectory Analysis of Healthcare Utilization Before and After Major Surgery.

OBJECTIVE: To characterize patterns of healthcare utilization before and after surgery and determine any association with pre-operative frailty. SUMMARY BACKGROUND DATA: Frail patients experience worse post-operative outcomes and increased costs during the surgical encounter. Evidence is comparatively lacking for longer-term effects of frailty on post-operative healthcare utilization. METHODS: Retrospective, longitudinal cohort analysis of adult patients undergoing any elective surgical procedure following pre-operative frailty assessment with the Risk Analysis Index (RAI) from 02/2016-12/2020 at a large integrated healthcare delivery and financing system. Group-based trajectory modeling of claims data estimated distinct clusters of patients with discrete utilization trajectories. Multivariable regression predicted membership in trajectories of interest using preoperative characteristics, including frailty. RESULTS: Among 29,067 surgical encounters, four distinct utilization trajectories emerged in longitudinal data from the 12 months before and after surgery. All cases exhibited a surge in utilization during the surgical month, after which most patients returned to "low" [25,473 (87.6%)], "medium" [1,403 (4.8%)], or "high" [528 (1.8%)] baseline utilization states established before surgery. The fourth trajectory identified 1,663 (5.7%) cases where surgery occasioned a transition from "low" utilization before surgery to "high" utilization afterward. RAI score alone did not effectively predict membership in this transition group, but a multivariable model with other preoperative variables was effective (c=0.859, max re-scaled R-squared 0.264). CONCLUSIONS AND RELEVANCE: Surgery occasions the transition from low to high healthcare utilization for a substantial subgroup of surgical patients. Multivariable modeling may effectively discriminate this utilization trajectory, suggesting an opportunity to tailor care processes for these patients.

Coaching to Bedside Shift Report and Its Correlation to Hospital Consumer Assessment of Healthcare Providers and Systems and Value-Based Purchasing Dimension Scores: A Multihospital Implementation Study.

OBJECTIVE: The objective of this multihospital study was to investigate how the intervention of coaching to bedside shift report (BSR) correlates with Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) outcomes and relates to Centers for Medicare and Medicaid Services (CMS) Hospital Value-Based Purchasing (VBP) Program points over a 4-year period (2017-2020) for an acute care hospital health system. BACKGROUND: Hospital leaders' responsibilities include intertwined areas of patient experience and fiscal accountability. Coaching to BSR is reported to have numerous benefits to the patient's experience. Published studies completed with hospital systems evaluating the intervention of coaching to BSR and how it correlated to patient experience and VBP are limited. METHODS: Coaching to BSR was implemented at 16 adult acute care hospitals. Patient-reported BSR rates were collected in tandem with HCAHPS for 4 years. Statistical correlations were assessed between patient-reported BSR and HCAHPS and consequential effect on VBP dimension scores. RESULTS: Coaching to BSR had a significant impact on top- and bottom-box "rate the hospital" HCAHPS scores at a system and hospital level. Value-based purchasing points and percentages increased over 2017-2020, potentially leading to lower CMS penalty claims over the period the BSR was implemented. CONCLUSIONS: Coaching is a key factor when creating a favorable patient experience. The implementation and sustainability of coaching to BSR may result in improved patient experience ratings and increase VBP point accumulation to hospital systems.

Prospective Evaluation of Coronavirus Disease 2019 (COVID-19) Vaccine Responses Across a Broad Spectrum of Immunocompromising Conditions: the COVID-19 Vaccination in the Immunocompromised Study (COVICS).

BACKGROUND: We studied humoral responses after coronavirus disease 2019 (COVID-19) vaccination across varying causes of immunodeficiency. METHODS: Prospective study of fully vaccinated immunocompromised adults (solid organ transplant [SOT], hematologic malignancy, solid cancers, autoimmune conditions, human immunodeficiency virus [HIV]) versus nonimmunocompromised healthcare workers (HCWs). The primary outcome was the proportion with a reactive test (seropositive) for immunoglobulin G to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) receptor-binding domain. Secondary outcomes were comparisons of antibody levels and their correlation with pseudovirus neutralization titers. Stepwise logistic regression was used to identify factors associated with seropositivity. RESULTS: A total of 1271 participants enrolled: 1099 immunocompromised and 172 HCW. Compared with HCW (92.4% seropositive), seropositivity was lower among participants with SOT (30.7%), hematological malignancies (50.0%), autoimmune conditions (79.1%), solid tumors (78.7%), and HIV (79.8%) (P < .01). Factors associated with poor seropositivity included age, greater immunosuppression, time since vaccination, anti-CD20 monoclonal antibodies, and vaccination with BNT162b2 (Pfizer) or adenovirus vector vaccines versus messenger RNA (mRNA)-1273 (Moderna). mRNA-1273 was associated with higher antibody levels than BNT162b2 or adenovirus vector vaccines after adjusting for time since vaccination, age, and underlying condition. Antibody levels were strongly correlated with pseudovirus neutralization titers (Spearman r = 0.89, P < .0001), but in seropositive participants with intermediate antibody levels, neutralization titers were significantly lower in immunocompromised individuals versus HCW. CONCLUSIONS: Antibody responses to COVID-19 vaccines were lowest among SOT and anti-CD20 monoclonal recipients, and recipients of vaccines other than mRNA-1273. Among those with intermediate antibody levels, pseudovirus neutralization titers were lower in immunocompromised patients than HCWs. Additional SARS-CoV-2 preventive approaches are needed for immunocompromised persons, which may need to be tailored to the cause of immunodeficiency.

Clinical Utility of the Risk Analysis Index as a Prospective Frailty Screening Tool within a Multi-practice, Multi-hospital Integrated Healthcare System.

OBJECTIVE: The goal of this project was to first address barriers to implementation of the Risk Analysis Index (RAI) within a large, multi-hospital, integrated healthcare delivery system, and to subsequently demonstrate its utility for identifying at-risk surgical patients. BACKGROUND: Prior studies demonstrate the validity of the RAI for evaluating preoperative frailty, but they have not demonstrated the feasibility of its implementation within routine clinical practice. METHODS: Implementation of the RAI as a frailty screening instrument began as a quality improvement initiative at the University of Pittsburgh Medical Center in July 2016. RAI scores were collected within a REDCap survey instrument integrated into the outpatient electronic health record and then linked to information from additional clinical datasets. NSQIP-eligible procedures were queried within 90 days following the RAI, and the association between RAI and postoperative mortality was evaluated using logistic regression and Cox proportional hazards models. Secondary outcomes such as inpatient length of stay and readmissions were also assessed. RESULTS: RAI assessments were completed on 36,261 unique patients presenting to surgical clinics across five hospitals from July 1 to December 31, 2016, and 8,172 of these underwent NSQIP-eligible surgical procedures. The mean RAI score was 23.6 (SD 11.2), the overall 30-day and 180-day mortality after surgery was 0.7% and 2.6%, respectively, and the median time required to collect the RAI was 33 [IQR 23-53] seconds. Overall clinic compliance with the recommendation for RAI assessment increased from 58% in the first month of the study period to 84% in the sixth and final month. RAI score was significantly associated with risk of death (HR=1.099 [95% C.I.: 1.091 - 1.106], p < 0.001). At an RAI cutoff of ≥37, the positive predictive values for 30- and 90-day readmission were 14.8% and 26.2%, respectively, and negative predictive values were 91.6% and 86.4%, respectively. CONCLUSIONS: The RAI frailty screening tool can be efficiently implemented within multi-specialty, multi-hospital healthcare systems. In the context of our findings and given the value of the RAI in predicting adverse postoperative outcomes, health systems should consider implementing frailty screening within surgical clinics.

Association Between Use of Rehabilitation in the Acute Care Hospital and Hospital Readmission or Mortality in Patients With Stroke.

OBJECTIVE: To examine the association between the number of physical and occupational therapist visits received in the acute care hospital and the risk of hospital readmission or death. DESIGN: Retrospective cohort study of electronic health records and administrative claims data collected for 2.25 years (January 1, 2016-March 30, 2018). SETTING: Twelve acute care hospitals in a large health care system in western Pennsylvania. PARTICIPANTS: Adults (N=8279) discharged with a primary stroke diagnosis. INTERVENTIONS: The exposure was number of physical and occupational therapist visits during the acute care stay. MAIN OUTCOME MEASURES: Generalized linear mixed models were estimated to examine the relationship between therapy use and 30- and 7-day hospital readmission or death (outcome), controlling for patient demographic and clinical characteristics. RESULTS: The 30- and 7-day readmission or death rates were 16.0% and 5.7%, respectively. The number of therapist visits was inversely related to the risk of 30-day readmission or death. Relative to no therapist visits, the odds of readmission or death were 0.70 (95% confidence interval [CI], 0.54-0.90) for individuals who received 1-2 visits, 0.59 (95% CI, 0.43-0.81) for 3-5 visits, and 0.57 (95% CI, 0.39-0.81) for >5 visits. A similar pattern was seen for the 7-day outcome, with slightly larger effect sizes. Effects were also greater in individuals with more mobility limitations on admission and for those discharged to a postacute care facility vs home. CONCLUSIONS: There was an inverse relationship between the number of therapist visits and risk for readmission or death for patients with stroke discharged from an acute care hospital. Effects differed by time to the event (30d vs 7d), discharge location, and mobility limitations on admission.

Clinical Decision Support for In-Hospital AKI.

AKI carries a significant mortality and morbidity risk. Use of a clinical decision support system (CDSS) might improve outcomes. We conducted a multicenter, sequential period analysis of 528,108 patients without ESRD before admission, from October of 2012 to September of 2015, to determine whether use of a CDSS reduces hospital length of stay and in-hospital mortality for patients with AKI. We compared patients treated 12 months before (181,696) and 24 months after (346,412) implementation of the CDSS. Coprimary outcomes were hospital mortality and length of stay adjusted by demographics and comorbidities. AKI was diagnosed in 64,512 patients (12.2%). Crude mortality rate fell from 10.2% before to 9.4% after CDSS implementation (odds ratio, 0.91; 95% confidence interval [95% CI], 0.86 to 0.96; P=0.001) for patients with AKI but did not change in patients without AKI (from 1.5% to 1.4%). Mean hospital duration decreased from 9.3 to 9.0 days (P<0.001) for patients with AKI, with no change for patients without AKI. In multivariate mixed-effects models, the adjusted odds ratio (95% CI) was 0.76 (0.70 to 0.83) for mortality and 0.66 (0.61 to 0.72) for dialysis (P<0.001). Change in adjusted hospital length of stay was also significant (incidence rate ratio, 0.91; 95% CI, 0.89 to 0.92), decreasing from 7.2 to 6.0 days for patients with AKI. Results were robust to sensitivity analyses and were sustained for the duration of follow-up. Hence, implementation of a CDSS for AKI resulted in a small but sustained decrease in hospital mortality, dialysis use, and length of stay.

Implementation and Impact of a Maternal-Fetal Medicine Telemedicine Program.

OBJECTIVE: The increase in maternal morbidity has resulted in higher need for maternal-fetal medicine (MFM) subspecialty care. To meet the rising demand, particularly in rural areas, the use of MFM telemedicine services has increased. This study describes the structure, implementation, and patient and child health outcomes associated with a large health system's MFM telemedicine program. STUDY DESIGN: Observational electronic health record data are used to compare maternal and childbirth outcomes between patients receiving care via telemedicine or in-person visits through regression analysis. Average patient time and resources saved are calculated, and patient satisfaction scores are reported. RESULTS: The telemedicine patients experienced similar outcomes to the in-person group, indicating that MFM telemedicine can serve as an effective substitute for in-person care. MFM telemedicine patients saved $90.28 per consult in travel and work-related expenses. An overwhelming majority of MFM telemedicine patients were satisfied with their visit and indicated that they would be interested in receiving care via telemedicine in the future. CONCLUSION: The results indicate that the patients may benefit financially and experience similar outcomes when telemedicine programs are appropriately designed to eliminate access barriers and provide high-quality care.

Hospital Nurses' Work Activity in a Technology-Rich Environment: A Triangulated Quality Improvement Assessment.

The aim of this project was to describe hospital nurses' work activity through observations, nurses' perceptions of time spent on tasks, and electronic health record time stamps. Nurses' attitudes toward technology and patients' perceptions and satisfaction with nurses' time at the bedside were also examined. Activities most frequently observed included documenting in and reviewing the electronic health record. Nurses' perceptions of time differed significantly from observations, and most patients rated their satisfaction with nursing time as excellent or good.

Predicting future emergency department visits and hospitalizations for asthma using the Pediatric Asthma Control and Communication Instrument - Emergency Department version (PACCI-ED).

OBJECTIVE: Emergency departments (EDs) are potential settings for interventions to improve asthma outcomes. Screening tools can identify children at risk of future morbidity. Our objective was to determine the predictive validity of the Pediatric Asthma Control and Communication Instrument - Emergency Department version (PACCI-ED) for future asthma-related ED visits and hospitalizations. METHODS: This was a retrospective cohort study of 108 children 1-17 years old who visited an ED for asthma and completed the PACCI-ED. The PACCI-ED queries parents about prior 12-month ED visits, hospitalizations, steroid use, perceived asthma morbidity and burden, and asthma control (over prior 1-2 weeks). The primary outcome was subsequent ED visits and hospitalizations within 1 year of enrollment. Poisson regression was used to model PACCI-ED questions for future ED visits controlling for age and socioeconomic status. RESULTS: Reported ED visits predicted future ED visits (adjusted incidence rate ratio (aIRR) 3.1, 95% confidence interval (CI): 1.3-7.2) but not future hospitalizations. Reported hospitalizations predicted future ED visits (aIRR 3.3; 95% CI 1.7-6.3) and hospitalizations (aIRR 6.4; 95% CI 2.3-17.6). The remaining PACCI-ED questions did not predict future ED visits or hospitalizations. CONCLUSIONS: The PACCI-ED risk domain was the only domain that predicted future asthma ED visits and hospitalizations. Questions about previous ED visits and hospitalizations are the most effective questions when screening children with asthma in EDs for the risk of future health-care use.

Association Between Adherence to the Mediterranean Diet and Asthma in Peruvian Children.

PURPOSE: Adherence to a Mediterranean diet pattern may be associated with lower asthma prevalence in children. We sought to corroborate these findings in Peruvian children. METHODS: This case-control study included children of ages 9-19 years living in Lima, Peru. A food frequency questionnaire (FFQ) was completed and diet pattern was analyzed using a modified Mediterranean diet score (MDS). Primary analysis investigated the relationship between MDS and asthma status. Maternal education, age, sex, and body mass index category were included in multivariate model. Secondary outcomes included asthma control, forced expiratory volume in 1 s (FEV1), allergic rhinitis, and atopic status. RESULTS: 287 participants with asthma and 96 controls without asthma completed a FFQ. Mean age was 13.5 years. According to the asthma control test (ACT), 86 % of those with asthma were controlled (score >19). MDS scores ranged 6-18 (median 15). In adjusted analysis, being above the median MDS scores was associated with decreased odds of asthma [OR = 0.55, 95 % CI (0.33, 0.92), p = 0.02]. Among children whose mothers completed secondary education, being above the median MDS significantly decreased the odds of asthma [OR = 0.31, 95 % CI (0.14, 0.71), p < 0.01], whereas among those whose mothers did not complete secondary education there was no protective effect [OR = 0.86, 95 % CI (0.43, 1.7), p = 0.66]. There was no association between MDS scores and asthma control, FEV1, allergic rhinitis, or atopic status. CONCLUSION: Adherence to the Mediterranean diet was inversely associated with having asthma among children in Lima, Peru. This effect was strongest among children with better educated mothers.

Effectiveness of motivational interviewing to reduce head start children's secondhand smoke exposure. a randomized clinical trial.

RATIONALE: Secondhand smoke exposure (SHSe) is a significant modifiable risk for respiratory health in children. Although SHSe is declining overall, it has increased for low-income and minority populations. Implementation of effective SHSe interventions within community organizations has the potential for significant public health impact. OBJECTIVES: To evaluate the effectiveness of motivational interviewing (MI) delivered in the context of a SHS education reduction initiative within Head Start to reduce preschool children's SHSe. METHODS: A total of 350 children enrolled in Baltimore City Head Start whose caregivers reported a smoker living in the home were recruited. Caregivers were randomized to MI + education or education alone. Assessments were conducted at baseline, 3, 6, and 12 months. MEASUREMENTS AND MAIN RESULTS: The primary outcome measure was household air nicotine levels measured by passive dosimeters. Secondary outcomes included child salivary cotinine, self-report of home smoking ban (HSB), and smoking status. Participants in the MI + education group had significantly lower air nicotine levels (0.29 vs. 0.40 mg), 17% increase in prevalence of caregiver-reported HSBs, and a 13% decrease in caregiver smokers compared with education-alone group (all P values < 0.05). Although group differences in salivary cotinine were not significant, among all families who reported having an HSB, salivary cotinine and air nicotine levels declined in both groups (P < 0.05). CONCLUSIONS: MI may be effective in community settings to reduce child SHSe. More research is needed to identify ways to tailor interventions to directly impact child SHSe and to engage more families to make behavioral change. Clinical trial registered with www.clinicaltrials.gov (NCT 00927264).

The Pediatric Asthma Control and Communication Instrument for the Emergency Department (PACCI-ED) improves physician assessment of asthma morbidity in pediatric emergency department patients.

OBJECTIVES: To determine whether the Pediatric Asthma Control and Communication Instrument for the Emergency Department (PACCI-ED), a 12-item questionnaire, can help ED attendings accurately assess a patient's asthma control and morbidity. METHODS: This was a randomized-controlled trial performed at an urban pediatric ED of children aged 1-17 years presenting with an asthma exacerbation. Parents answered PACCI-ED questions about their children's asthma. Attendings were randomized to view responses to the PACCI-ED (intervention group) or to be blinded to the completed PACCI-ED (control group). The two groups were compared on their empirical clinical assessment of: (1) chronic asthma control categories, (2) asthma trajectory (stable, worsening or improving), (3) patient adherence to controller medications, and (4) burden of disease for the patient's family. The validated PACCI algorithm was used as the criterion standard for these four outcomes. Accuracy of clinical assessment was compared between intervention and control groups using chi-squared tests and an intention-to-treat approach. RESULTS: Seventeen ED attendings were enrolled in the study and 77 children visits were included in the analysis. There were no significant differences between the intervention and the control groups for child's gender, age, race, and asthma characteristics. Intervention group attendings were more accurate than control group attendings in assessing the category of chronic asthma control (43% versus 19%; p = 0.03), disease trajectory (72% versus 45%; p = 0.02), and the disease burden for families (74% versus 35%; p = 0.001) over the past 12 months. There was a trend towards more accuracy of intervention versus control attendings for estimating patient adherence to controller medications (72% versus 48%; p = 0.06). CONCLUSIONS: The PACCI-ED improves the assessment of asthma control, trajectory, and burden by ED attendings, and may help assessment of asthma medication adherence and prior asthma exacerbations. The PACCI-ED can be used to improve provider assessment of asthma morbidity during pediatric ED visits for asthma exacerbations, and to identify children who may benefit from interventions to reduce asthma morbidity.

Pediatrician qualifications and asthma management behaviors and their association with patient race/ethnicity.

OBJECTIVE: We sought to understand if pediatrician characteristics and asthma assessment and treatment varied in association with the proportion of African-American and Latino children in the pediatrician's practice. METHODS: We conducted a cross-sectional survey of 500 American Academy of Pediatrics members between November 2005 and May 2006. Standardized vignettes were used to test how different indicators of a patient's asthma status affect pediatrician asthma assessments and recommendations. Linear and logistic regression models were used to examine the association of pediatrician assessments and treatment recommendations for these vignettes, respectively, with the proportion of reported African-American and Latino children seen in their practice. RESULTS: There were 270 respondents (response rate = 54%). Based on pediatrician-reported percentage of minority patients, there were no differences in board certification status, recognition of poorly controlled asthma nor in the likelihood of appropriately increasing long-term controller medications to treat poorly controlled asthma (p > 0.05 for all analyses). CONCLUSIONS: Caring primarily for minority children by AAP pediatricians appears unrelated to training qualifications or in their reported knowledge of how to appropriately assess and treat asthma. Therefore, studies of asthma care disparities should focus on understanding the knowledge-base of non-AAP pediatric providers who care for minority populations and exploring other potential contributory provider-level factors (e.g. communication skills).

The Pediatric Asthma Control and Communication Instrument asthma questionnaire: for use in diverse children of all ages.

BACKGROUND: National Institutes of Health asthma guidelines recommend questionnaires to assess asthma control, but these questionnaires are not useable across the entire pediatric age spectrum and have not been validated among significant numbers of minority or Spanish-speaking children. OBJECTIVE: We sought to evaluate a questionnaire designed to assess asthma control across a broad age range of minority and Spanish-speaking children cared for in an outpatient setting. METHODS: Between July 1, 2007, and September 30, 2010, we collected information using the Pediatric Asthma Control and Communication Instrument (PACCI), the Asthma Control Test (ACT; or the childhood ACT for children 4-11 years old), the Pediatric Asthma Caregiver Quality of Life Questionnaire, and lung function and clinicians' ratings of asthma status among a population of children presenting for routine asthma specialist care. The PACCI measure of asthma control was validated by evaluating accuracy, internal reliability, and concurrent, discriminative, and known-groups validity. RESULTS: We collected information on 265 English- and 52 Spanish-speaking children (mean age, 8.2 years; 58% male; 44% African American). Across all age groups and in both languages, PACCI control showed good internal reliability and strong concurrent, discriminative, and known-groups validity with ACT and Pediatric Asthma Caregiver Quality of Life Questionnaire scores and clinicians' ratings of asthma control. The accuracy of the PACCI in classifying children with uncontrolled asthma was good (area under the curve, 0.83; 95% CI, 0.79-0.88). CONCLUSIONS: The PACCI accurately measures asthma control in English- and Spanish-speaking children. The PACCI should be useful to clinicians to assess and classify asthma according to National Institutes of Health asthma guidelines.

Asthma in Head Start children: effects of the Breathmobile program and family communication on asthma outcomes.

BACKGROUND: Asthma morbidity and mortality rates are high among young inner-city children. Lack of routine primary care provider visits, poor access to care, and poor patient-physician communication might be contributing factors. OBJECTIVE: This study evaluated the effects of providing Breathmobile services only, a Facilitated Asthma Communication Intervention (FACI) only, or both Breathmobile plus FACI on asthma outcomes relative to standard care. METHODS: Children with asthma (n = 322; mean age, 4 years; 53% male; 97% African American) were recruited from Head Start programs in Baltimore City and randomized into 4 groups. Outcome measures included symptom-free days (SFDs), urgent care use (emergency department visits and hospitalizations), and medication use (courses of oral steroids and proportion taking an asthma controller medication), as reported by caregivers at baseline, 6-month, and 12-month assessments. Generalized estimating equations models were conducted to examine the differential treatment effects of the Breathmobile and FACI compared with standard care. RESULTS: Children in the combined treatment group (Breathmobile plus FACI) had an increase of 1.7 (6.6%) SFDs that was not maintained at 12 months. In intent-to-treat analyses the FACI-only group had an increase in the number of emergency department visits at 6 months, which was not present at 12 months or in the post hoc as-treated analyses. No significant differences were found between the intervention groups compared with those receiving standard care on all other outcome measures. CONCLUSIONS: Other than a slight improvement in SFDs at 6 months in the Breathmobile plus FACI group, the intervention components did not result in any significant improvements in asthma management or asthma morbidity.

Adherence to inhaled corticosteroids: an ancillary study of the Childhood Asthma Management Program clinical trial.

BACKGROUND: Information comparing subjective and objective measurements of adherence to study medications and the effects of adherence on treatment-related differences in asthma clinical trials are limited. OBJECTIVE: We sought to compare subjective and objective measurements of children's adherence to inhaled corticosteroids or placebo and to determine whether adherence to study medications modified treatment-related differences in outcomes. METHODS: In an ancillary study conducted in 3 of 8 Childhood Asthma Management Program Clinical Centers, adherence was assessed by using self-reported and objective data in 5- to 12-year-old children with mild or moderate asthma who were randomly assigned to 200 µg of inhaled budesonide twice per day (n = 84) or placebo (n = 56) for 4 years. The κ statistic was used to evaluate agreement between self-reported adherence (daily diary cards) and objectively measured adherence (number of doses left in study inhalers). Multivariable analyses were used to determine whether adherence to study treatment modified treatment-related differences in outcomes. RESULTS: Adherence of less than 80% was seen in 75% of 140 children when adherence was measured objectively but only in 6% of children when measured by means of self-report. There was poor agreement between objective and subjective measurements of adherence of at least 80% (κ = 0.00; 95% CI, -0.05 to 0.04); self-reported adherence over the 4-year period generally overestimated objectively measured adherence (93.6% vs 60.8%, P < .0001). There was little evidence to indicate that adherence modified treatment-related differences in outcomes. CONCLUSION: Researchers should use objective rather than self-reported adherence data to identify clinical trial participants with low levels of adherence to study treatment.