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.

Implementing a Discharge Follow-up Phone Call Program Reduces Readmission Rates in an Integrated Health System.

ABSTRACT: In this study, we sought to determine the effect of implementing a large-scale discharge follow-up phone call program on hospital readmission rates. Previous work has shown that patients with unaddressed concerns during discharge have significantly higher rates of care complications and hospital readmissions. This study is an observational quality improvement project completed from April 17, 2020 to January 31, 2022 at 22 hospitals in a large, integrated academic health system. A nurse-led scripted discharge follow-up phone call program was implemented to contact all patients discharged from inpatient care within 72 hours of discharge. Readmission rates were tracked before and after project implementation. Over a 21-month span, 137,515 phone calls were placed, and 57.92% of patients were successfully contacted within 7 days of discharge. The 7-day readmission rate for contacted patients was 2.91% compared with 4.73% for noncontacted patients. The 30-day readmission rate for contacted patients was 11.00% compared with 12.17% for noncontacted patients. We have found that discharge follow-up phone calls targeting patients decreases risk of readmission, which improves overall patient outcomes.

Healthcare-associated infections during the coronavirus disease 2019 (COVID-19) pandemic and the modulating effect of centralized surveillance.

We analyzed efficacy of a centralized surveillance infection prevention (CSIP) program in a healthcare system on healthcare-associated infection (HAI) rates amid the coronavirus disease 2019 (COVID-19) pandemic. HAI rates were variable in CSIP and non-CSIP facilities. Central-line-associated bloodstream infection (CLABSI), C. difficile infection (CSI), and surgical-site infection (SSI) rates were negatively correlated with COVID-19 intensity in CSIP facilities.

Development and implementation of a centralized surveillance infection prevention program in a multi-facility health system: A quality improvement project.

Objective: To develop, implement, and evaluate the effectiveness of a unique centralized surveillance infection prevention (CSIP) program. Design: Observational quality improvement project. Setting: An integrated academic healthcare system. Intervention: The CSIP program comprises senior infection preventionists who are responsible for healthcare-associated infection (HAI) surveillance and reporting, allowing local infection preventionists (LIPs) a greater portion of their time to non-surveillance patient safety activities. Four CSIP team members accrued HAI responsibilities at 8 facilities. Methods: We evaluated the effectiveness of the CSIP program using 4 measures: recovery of LIP time, efficiency of surveillance activities by LIPs and CSIP staff, surveys characterizing LIP perception of their effectiveness in HAI reduction, and nursing leaders' perception of LIP effectiveness. Results: The amount of time spent by LIP teams on HAI surveillance was highly variable, while CSIP time commitment and efficiency was steady. Post-CSIP implementation, 76.9% of LIPs agreed that they spend adequate time on inpatient units, compared to 15.4% pre-CSIP; LIPs also reported more time to allot to non-surveillance activities. Nursing leaders reported greater satisfaction with LIP involvement with HAI reduction practices. Conclusion: CSIP programs are a little-reported strategy to ease burden on LIPs with reallocation of HAI surveillance. The analyses presented here will aid health systems in anticipating the benefit of CSIP programs.

Institution of Standardized Consultation Criteria to Increase Early Palliative Care Utilization in Older Patients With Acute Leukemia.

PURPOSE: Older patients with acute leukemia (AL) have a high symptom burden and poor prognosis. Although integration of palliative care (PC) with oncologic care has been shown to improve quality-of-life and end-of-life care in patients with AL, the malignant hematologists at our tertiary care hospital make limited use of PC services and do so late in the disease course. Using the Plan-Do-Study-Act (PDSA) methodology, we aimed to increase early PC utilization by older patients with newly diagnosed AL. METHODS: We instituted the following standardized criteria to trigger inpatient PC consultation: (1) age 70 years and older and (2) new AL diagnosis within 8 weeks. PC consultations were tracked during sequential PDSA cycles in 2021 and compared with baseline rates in 2019. We also assessed the frequency of subsequent PC encounters in patients who received a triggered inpatient PC consult. RESULTS: The baseline PC consultation rate before our intervention was 55%. This increased to 77% and 80% during PDSA cycles 1 and 2, respectively. The median time from diagnosis to first PC consult decreased from 49 days to 7 days. Among patients who received a triggered PC consult, 43% had no subsequent inpatient or outpatient PC encounter after discharge. CONCLUSION: Although standardized PC consultation criteria led to earlier PC consultation in older patients with AL, it did not result in sustained PC follow-up throughout the disease trajectory. Future PDSA cycles will focus on identifying strategies to maintain the integration of PC with oncologic care over time, particularly in the ambulatory setting.

Assessment of the effectiveness of ultraviolet-C disinfection on transmission of hospital-acquired pathogens from prior room occupants.

Objective: To evaluate the effectiveness of ultraviolet-C (UV-C) disinfection as an adjunct to standard chlorine-based disinfectant terminal room cleaning in reducing transmission of hospital-acquired multidrug-resistant organisms (MDROs) from a prior room occupant. Design: A retrospective cohort study was conducted to compare rates of MDRO transmission by UV-C status from January 1, 2016, through December 31, 2018. Setting: Acute-care, single-patient hospital rooms at 6 hospitals within an academic healthcare system in Pennsylvania. Methods: Transmission of hospital-acquired MDRO infection was assessed in patients subsequently assigned to a single-patient room of a source occupant with carriage of 1 or more MDROs on or during admission. Acquisition of 5 pathogens was compared between exposed patients in rooms with standard-of-care chlorine-based disinfectant terminal cleaning with or without adjunct UV-C disinfection. Logistic regression analysis was used to estimate the adjusted risk of pathogen transfer with adjunctive use of UV-C disinfection. Results: In total, 33,771 exposed patient admissions were evaluated; the source occupants carried 46,688 unique pathogens. Prior to the 33,771 patient admissions, 5,802 rooms (17.2%) were treated with adjunct UV-C disinfection. After adjustment for covariates, exposed patients in rooms treated with adjunct UV-C were at comparable risk of transfer of any pathogen (odds ratio, 1.06; 95% CI, 0.84-1.32; P = .64). Conclusion: Our analysis does not support the use of UV-C in addition to post-discharge cleaning with chlorine-based disinfectant to lower the risk of prior room occupant pathogen transfer.

Preprocedural SARS-CoV-2 Testing to Sustain Medically Needed Health Care Delivery During the COVID-19 Pandemic: A Prospective Observational Study.

BACKGROUND: We implemented a preprocedural severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) screening initiative designed to sustain health care during a time when the extent of SARS-CoV-2 infection was unknown. METHODS: This was a prospective study of patients undergoing procedures at 3 academic hospitals in Pittsburgh, Pennsylvania (April 21-June 11), and 19 community hospitals across Middle/Western Pennsylvania and Southwestern New York (May 1-June 11). Patients at academic hospitals underwent symptom screening ≤7 days preprocedure, then SARS-CoV-2 nasopharyngeal polymerase chain reaction (PCR) testing 1-4 days preprocedure. A subset also underwent day-of-procedure testing. Community hospital patients underwent testing per local protocols. We report SARS-CoV-2 PCR positivity rates, impact, and barriers to testing encountered through June 11. PCR positivity rates of optional preprocedural SARS-CoV-2 testing for 2 consecutive periods following the screening initiative are also reported. RESULTS: Of 5881 eligible academic hospital patients, 2415 (41.1%) were tested (April 21-June 11). Lack of interest, distance, self-isolation, and nursing home/incarceration status were barriers. There were 11 PCR-positive patients (10 asymptomatic) among 10 539 patients tested (0.10%; 95% CI, 0.05%-0.19%): 3/2415 (0.12%; 95% CI, 0.02%-0.36%) and 8/8124 (0.10%; 95% CI, 0.04%-0.19%) at academic and community hospitals, respectively. Procedures were performed as scheduled in 40% (4/10) of asymptomatic PCR-positive patients. Positivity increased during subsequent coronavirus disease 2019 (COVID-19) surges: 54/34 948 (0.15%; 95% CI, 0.12%-0.20%) and 101/24 741 (0.41%; 95% CI, 0.33%-0.50%) PCR-positive patients from June 12-September 10 and September 11-December 15, respectively (P < .0001). CONCLUSIONS: Implementing preprocedural PCR testing was complex and revealed low infection rates (0.24% overall), which increased during COVID-19 surges. Additional studies are needed to define the COVID-19 prevalence threshold at which universal preprocedural screening is warranted.

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.

Remote monitoring for heart failure: Assessing the risks of readmission and mortality.

Study objective: Remote monitoring (RM) can help patients with heart failure (HF) remain free of hospitalization. Our objective was to implement a patient-centered RM program that ensured timely clinical response, which would be associated with reduced mortality. Design: This was a retrospective, observational, propensity-matched study. Setting: A large regional health system between 9/1/2016-1/31/2018. Participants: Patients admitted with acute HF exacerbation were matched on key variables. Up to two comparison patients were selected for each RM user. Interventions: We used an algorithmic approach to assess daily physiologic data, assess symptoms, provide patient education, encourage patient self-management, and triage medical problems. Main outcome measures: We assessed all-cause mortality using Kaplan-Meier and log rank analysis. We used Cox proportional hazards to compare risk of death. Results: Our cohort of 680 RM users and 1198 comparisons were similar across baseline characteristics except age (74.7 years versus 76.6 years, p < 0.001, respectively). Having one or more admissions in the preceding 120 days was more prevalent in the RM group (35.9% versus 29.8%, p = 0.013). The 30- and 90-day all-cause readmission rates were each higher among the RM users compared with the comparison patients (p = 0.013 and p < 0.001 for 30 and 90 days, respectively). Mortality was lower in the RM group at 30 and 90 days post-discharge (p < 0.001). Conclusions: RM that responds to biometric data and encourages patient self-management can be used in a large hospital system and is associated with decreased all-cause mortality. Our findings underscore RM technology as a method to improve HF care.

Validation of Asthma Control Assessment Among Urban Adolescents Using the Asthma Control and Communication Instrument.

BACKGROUND: The National Institutes of Health guidelines recommend questionnaires to assess asthma control, but there are few self-reported asthma morbidity surveys validated among urban, African American, Hispanic, and/or poor adolescents. The Asthma Control and Communication Instrument (ACCI) is a 12-item self-reported questionnaire previously validated among a diverse adult population, but not among adolescents. OBJECTIVE: To assess the ability of the ACCI to accurately describe asthma control in an urban adolescent population. METHODS: Between November 13, 2014, and March 2, 2017, we collected information using the ACCI, the Asthma Control Test, the Pediatric Asthma Quality of Life Questionnaire, and lung function among adolescents enrolled in a school-based asthma intervention study. The ACCI measure of asthma control was validated by evaluating accuracy (on the basis of receiver operating characteristic curve), internal reliability, and concurrent and discriminative validity. RESULTS: We collected information on 280 adolescents (mean age, 13.4 years; 56% males; and 51% African American). ACCI control showed good internal reliability and strong concurrent and discriminative validity with the Asthma Control Test and the Pediatric Asthma Quality of Life Questionnaire. The accuracy of the ACCI in classifying adolescents with uncontrolled asthma was good (area under the curve, 0.83; 95% CI, 0.79-0.88). CONCLUSION: The ACCI, a clinical tool developed to assist communication about asthma control, has demonstrated strong construct validity as a self-reported questionnaire within an urban, African American, and Hispanic sample of adolescents. It has the potential to assist in the assessment of asthma control in urban, minority, and/or poor adolescents.

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.

Feasibility of Picture-Based Asthma Medication Plans in Urban Pediatric Outpatient Clinics.

Picture-based Asthma Action Plans show promise for overcoming parental literacy barriers and improving child asthma outcomes, but it is uncertain how parents respond to pictures of specific medications, which may be particularly important for improving disease self-management. Thus, we assessed parent attitudes toward an asthma-related picture-based medication plan (PBMP) in an urban academic pediatric clinic and examined attitudes by literacy level. Surveys were administered to a convenience sample of parents of children presenting to an urban pediatric pulmonary clinic for asthma consultation between March and August 2011. The Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF) was administered to parents. Parents indicated their level of agreement with 9 statements on the potential usefulness of the PBMP: (1) before being shown a PBMP; and (2) after seeing the doctor. McNemar's tests showed that the proportion of high-literate parents (≥9th grade reading level) who endorsed the potential benefits of the PBMP after the clinical encounter was significantly higher than before the clinical encounter. A high proportion of low-literate parents (<9th grade reading level) consistently endorsed the PBMP before and after the clinical encounter. Among a diverse sample seen in an urban asthma clinic, parents of all literacy levels endorse PBMPs as useful, especially after using them in clinical encounters.

Racial Disparities in Asthma Morbidity Among Pediatric Patients Seeking Asthma Specialist Care.

OBJECTIVE: To elucidate whether there may be a higher morbidity threshold for African American versus white children to be referred to or seek asthma specialist care. METHODS: Secondary analysis of registry data captured from children presenting for an initial routine outpatient asthma consultation. Parents completed standard survey instruments, and spirometry was conducted when deemed appropriate by the provider. RESULTS: Wilcoxon rank sum tests revealed that African American patients had been hospitalized twice as often and admitted to the intensive care unit or intubated significantly more than 1½ times more frequently than their white patient counterparts. t tests indicated African American patients' forced expiratory volume in 1 second (FEV1) percentage predicted was significantly worse than that of whites, but there was no significant difference for FEV1/forced vital capacity ratio. t tests suggested that African American patients had statistically worse asthma control than did white patients at the time of initial presentation to the pulmonologist, but there was no difference in the distribution of asthma severity categories. Multivariate regression models indicated that racial differences in parent education did not explain the disparities in asthma morbidity. CONCLUSIONS: African American patients had significantly worse asthma morbidity than their white counterparts, including higher rates of hospitalization and intensive care unit admission and poorer lung functioning. Given that receipt of asthma specialist care can improve those outcomes that are disparately experienced by African American children, methods of increasing their access to and use of asthma specialist care need to be developed.

Validation of parental reports of asthma trajectory, burden, and risk by using the pediatric asthma control and communication instrument.

BACKGROUND: Despite a growing interest, few pediatric asthma questionnaires assess multiple dimensions of asthma morbidity, as recommended by national asthma guidelines, or use patient-reported outcomes. OBJECTIVE: To evaluate a questionnaire that measures multiple dimensions of parent-reported asthma morbidity (Direction, Bother, and Risk). METHODS: We administered the Pediatric Asthma Control and Communication Instrument (PACCI) and assessed asthma control (PACCI Control), quality of life, and lung function among children who presented for routine asthma care. The PACCI was evaluated for discriminative validity. RESULTS: A total of 317 children participated (mean age, 8.2 years; 58% boys; 44% African American). As parent-reported PACCI Direction changed from "better" to "worse," we observed poorer asthma control (P < .001), mean Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ) scores (P < .001), and FEV1% (P = .025). Linear regression showed that, for each change in PACCI Direction, the mean PACQLQ score decreased by -0.6 (95% CI, -0.8 to -0.4). As parent-reported PACCI Bother changed from "not bothered" to "very bothered," we observed poorer asthma control (P < .001) and lower mean PACQLQ scores (P < .001). Linear regression showed that, for each change in PACCI Bother category, the mean PACQLQ score decreased by -1.1 (95% CI, -1.3 to -0.9). Any reported PACCI Risk event (emergency department visit, hospitalization, or use of an oral corticosteroid) was associated with poorer asthma control (P < .05) and PACQLQ scores (P < .01). CONCLUSIONS: PACCI Direction, Bother, and Risk are valid measures of parent-reported outcomes and show good discriminative validity. The PACCI is a simple clinical tool to assess multiple dimensions of parent-reported asthma morbidity, in addition to risk and control.

Asthma treatment decisions by pediatric residents do not consistently conform to guidelines or improve with level of training.

OBJECTIVE: To compare asthma treatment decisions by pediatric residents to current asthma guidelines and to learn whether treatment decisions vary by postgraduate year in training. METHODS: We conducted a Web-based survey of residents from 10 training programs through the Continuity Research Network of the Academic Pediatric Association (CORNET). Surveys included 6 vignettes of patients receiving low-dose inhaled steroids with guideline- and non-guideline-based indicators of asthma status and 1 stable patient on high-intensity medication. RESULTS: There were 369 resident respondents (65% response rate), 26% postgraduate year (PGY) 1, 38% PGY2, and 36% PGY3+. Seventy-five percent of each resident group reported seeing fewer than 1 asthma patient per continuity clinic session. A majority of residents made appropriate treatment recommendations in 2 of 4 vignettes of guideline-based indicators of asthma status: first, 97% overall stepping up treatment for mild persistent asthma; and second, 52% overall stepping down treatment for a patient with well-controlled asthma on high-intensity medications. Inconsistent with guideline recommendations, 82% of residents overall did not step down treatment for a patient with well-controlled asthma receiving low-intensity therapy; 75% of residents did not step up treatment for a patient with a recent hospitalization for asthma. Of the 3 vignettes evaluating non-guideline-based indicators of asthma status, a majority of residents (60%) stepped up treatment for parental reports of worse asthma, while a minority did so for a parental report of being bothered by their child's asthma (27%) or when wheezing was reported at physical examination (43%). There were no statistically significant differences for any of the comparisons by year in training. CONCLUSIONS: Pediatric residents' management of asthma is consistent with national guidelines in some cases but not in others. There were no differences in the outpatient asthma management decisions between residents by years in training. Educational efforts should be focused on strategies to facilitate pediatric resident adherence to national asthma guideline recommendations for outpatient asthma management.

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.

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.

Perception of airflow obstruction in patients hospitalized for acute asthma.

BACKGROUND: Little is known about the perception of airflow obstruction in patients hospitalized for acute asthma. OBJECTIVES: To evaluate patient perception of airflow obstruction at hospital discharge and at a 2-week follow-up visit and to determine whether symptom control and/or severity of airflow obstruction identified patients at risk for acute asthma after discharge. METHODS: In a prospective cohort study of inner-city adults hospitalized for acute asthma from April 1, 2001, through October 31, 2002, symptom control (Asthma Control Questionnaire) and airflow obstruction (forced expiratory volume in 1 second [FEV1] percentage predicted) were evaluated at discharge and 2 weeks after discharge. We evaluated perception of airflow obstruction (symptom control vs FEV1 percentage predicted) and perception of change in airflow obstruction (change in symptom control vs percentage change in FEV1) between the 2 visits. Acute asthma after discharge was defined as an emergency department visit or hospitalization for asthma within 90 days of discharge. RESULTS: In fifty-one participants, symptom control was not significantly associated with airflow obstruction at hospital discharge (P = .30), indicating poor perception of airflow obstruction. Among the 41 participants (80.4% of those enrolled) who completed the follow-up visit, change in symptom control was not significantly associated with change in airflow obstruction (P = .20), indicating poor perception of change in airflow obstruction. Greater airflow obstruction at follow-up (P = .02) and a smaller improvement in airflow obstruction (P = .03), but not symptom control, were associated with a higher risk of acute asthma after discharge. CONCLUSIONS: Patients hospitalized for acute asthma have poor perception of airflow obstruction and change in airflow obstruction. Objective measurements of lung function should guide treatment decisions after discharge in this population.