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Objective: To describe methods to approach application of data standards to integrate social determinants of health (SDoH) into EHRs through evaluation of a case of clinical decision support for pediatric asthma., Materials and Methods: We identified a list of environmental factors important for managing pediatric asthma. We identified and integrated data from local outdoor air quality monitors with elements available from the clinic's EHR and self-reported indoor air quality questionnaire data. We assessed existing SDoH frameworks, assessment tools, and terminologies to identify representative data standards for these environmental SDoH measures., Results: We found many-to-many relationships between the multiple framework domains, the environmental exposure measures collected, and existing standards. The majority of concepts did not accurately align with environmental exposure measurements. We propose an ontology-driven information framework methodology to apply standards for SDoH measurements to support measuring, managing, and computing SDoH data., Discussion: To support methods of integrating SDoH data in the EHR via an ontology-driven information framework, a common SDoH ecosystem should be developed descriptively and prescriptively integrating framework domains, assessment tools, and standard ontologies to support future data sharing, aggregation, and interoperability. A hierarchical object-oriented information model should be adopted to manage SDoH to extend beyond patient-centered orientation of EHRs to orient to households and communities., Conclusion: SDoH data pose unique challenges and opportunities in collecting, measuring, and managing health information. Future work is needed to define data standards for implementing SDoH in a hierarchical, object-oriented information model representing multiple units of orientation including individuals, households, and communities., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Patient-perceived global ratings of change are often used as anchors of health-related quality of life (HRQoL) since they are easy for clinicians to interpret and incorporate the patient's perception of change as a means to capture clinical significance. Although this approach may be preferred, the validity of the anchor-based approach is currently under scrutiny., Objective: To estimate the explained variation in single-item domain-specific global ratings of change (GRCs) that is accounted for by time 1 (T1) and time 2 (T2) domain-specific summary change scores from the Short-Form 36, V2 (SF-36) Health Survey in asthma primary care patients., Methods: The baseline and first follow-up enrollment data to be evaluated in this investigation were part of a larger longitudinal HRQoL study conducted from August 2000-December 2002, in which the 356 asthma patients from Midwestern primary care facilities completed telephone interviews for every two consecutive months for a year on multiple HRQoL measures, including the SF-36 and domain-specific GRCs. A structural equation modeling technique was employed to ascertain the explained variability in patient-reported GRCs for each SF-36 domain that is accounted for by the summary change scores at the two time-points for four SF-36 domains (bodily pain, general health perception, mental health, and physical functioning). The model was estimated by the maximum likelihood method with the Satorra-Bentler correction for ordinal variables using equal threshold asymptotic covariance matrices., Results: Multicollinearity between T1 and T2 latent constructs clouded interpretation of the standardized structural coefficients leading to GRCs. Correlations, however, revealed that all four domain-specific GRCs were more strongly related to T2- than T1-domain summary scores, indicating that patients were not equally relying on T1 and T2 to generate the GRCs. Furthermore, T1-domain summary scores were not of equal magnitude and opposite sign as compared to T2 scores., Conclusions: In this study, there is insufficient evidence to establish SF-36 domain-specific GRC validity in asthma primary care patients. Therefore, it is recommended to reassess validity before using domain-specific SF-36 GRCs to classify clinically important change over time.

Background: Patient-perceived change in health-related quality of life (HRQoL) domains has often been classified using a 15-point patient transition rating scale. However, traditional change levels of trivial ( - 1, 0, or 1), minimal (2, 3 or - 2, - 3), moderate (4, 5 or - 4, - 5) and large (6, 7 or - 6, - 7) on this scale have been arbitrarily defined and originally assumed that change related to an improvement was the same as that for a decline., Objective: To compare traditional and Rasch partial credit model-derived cut points and the mean changes for each change categorization when assessing clinically important change in asthma-specific HRQoL., Methods: Our sample included 396 asthmatic outpatients who completed bimonthly telephone interviews on the Asthma Quality of Life Questionnaire and transition rating items over 1 year of participation. We employed item response theory in a novel approach to identify cut points on domain-specific HRQoL change data and transition ratings. After determining natural cut points for minimal, moderate, and large differences on the transition rating anchor, we calculated mean changes under change categorizations for both improvements and declines for the two transition rating classification approaches., Results: Although traditional and Rasch categorizations for small, moderate, and large changes slightly differed and displayed a lack of symmetry between improvements and declines, nearly all mean changes between classification approaches were comparable., Conclusions: In this study, traditional transition rating cut points remain suitable to assess HRQoL clinical significance in outpatients with asthma.

Background: We evaluated how well physicians' global estimates of disease severity correspond to more specific physician-rated disease variables as well as patients' self-rated health and other patient variables., Methods: We analyzed baseline data from 1662 primary care patients with chronic cardiac or pulmonary disease who were enrolled in a longitudinal study of health-related quality of life (HRQoL). Each patient's primary physician rated overall disease severity, estimated the two-year risk of hospitalization and mortality, and reported the use of disease-specific medications, tests, and subspecialty referrals. Patient variables included sociodemographic characteristics, psychosocial factors, self-rated health, and both generic and disease-specific HRQoL., Results: Physicians rated 40% of their patients "about average", 30% "worse", and 30% "better" than the typical patient seen with the specific target disorder. The physician's global estimate of disease severity was strongly associated (P < 0.001) with each of the five more specific elements of physician-rated disease severity, but only marginally associated with patient self-rated health. Multivariable regression identified a set of patient variables that explained 16.4% of the variance in physician-rated disease severity., Conclusion: Physicians' global ratings may provide disease severity and prognostic information unique from and complementary to patient self-rated health and HRQoL measures. The elements influencing physician-rated disease severity and its predictive validity for clinical outcomes warrant prospective investigation.

Background: Change in health-related quality of life (HRQoL) is an important outcome in asthma treatment. Patient and provider consensus on how to determine thresholds for identifying important improvements and declines, however, has not been achieved., Objective: To search for consensus in clinically important difference (CID) thresholds for HRQoL change from 3 points of view: (1) an expert panel of physicians who treat patients with asthma and measure the HRQoL of their patients, (2) asthmatic patients, and (3) the primary care physicians (PCPs) of these asthmatic patients., Methods: The expert panel used Delphi and consensus methods to agree on CID levels for the Asthma Quality of Life Questionnaire and the Medical Outcomes Study 36-Item Short-Form Health Survey, version 2.0. A total of 396 patients attending midwestern primary care clinic sites completed these interviews bimonthly for 1 year. The 46 PCPs treating these patients completed baseline assessments on each patient's asthma and then evaluated the change in each patient's condition at subsequent office visits during the next year., Results: The patient-perceived estimates were consistent with results of previous studies but were notably lower than those derived from the expert panel and the PCPs. The Short-Form Health Survey generally did not provide sufficient sensitivity to detect important changes., Conclusions: Although consensus on the interpretation of change in HRQoL measures was not achieved, this evidence-based approach demonstrates the value of patient and physician perspectives and the need for improved dialogue and understanding to optimize the HRQoL of patients with asthma.

Objective: Translation of evidence-based guidelines into clinical practice has been inconsistent. We performed a randomized, controlled trial of guideline-based care suggestions delivered to physicians when writing orders on computer workstations., Study Setting: Inner-city academic general internal medicine practice., Study Design: Randomized, controlled trial of 246 physicians (25 percent faculty general internists, 75 percent internal medicine residents) and 20 outpatient pharmacists. We enrolled 706 of their primary care patients with asthma or chronic obstructive pulmonary disease. Care suggestions concerning drugs and monitoring were delivered to a random half of the physicians and pharmacists when writing orders or filling prescriptions using computer workstations. A 2 x 2 factorial randomization of practice sessions and pharmacists resulted in four groups of patients: physician intervention, pharmacist intervention, both interventions, and controls. DATA EXTRACTION/COLLECTION METHODS: Adherence to the guidelines and clinical activity was assessed using patients' electronic medical records. Health-related quality of life, medication adherence, and satisfaction with care were assessed using telephone questionnaires., Principal Findings: During their year in the study, patients made an average of five scheduled primary care visits. There were no differences between groups in adherence to the care suggestions, generic or condition-specific quality of life, satisfaction with physicians or pharmacists, medication compliance, emergency department visits, or hospitalizations. Physicians receiving the intervention had significantly higher total health care costs. Physician attitudes toward guidelines were mixed., Conclusions: Care suggestions shown to physicians and pharmacists on computer workstations had no effect on the delivery or outcomes of care for patients with reactive airways disease.

Objective: On the eight scales of the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36), Version 2, we compared the clinically important difference (CID) thresholds for change over time developed by three separate expert panels of physicians with experience in quality of life assessment among patients with chronic obstructive pulmonary disease (COPD), asthma, and heart disease., Study Design: We used a modified Delphi technique combined with a face-to-face panel meeting within each disease to organize and conduct the consensus process among the expert panelists, who were familiar with the assessment and evaluations of health-related quality of life (HRQL) measures among patients with the panel-specific disease., Principal Findings: Each of the expert panels first determined the magnitude of the smallest numerically possible change on each SF-36 scale, referred to as a state change, and then built their CIDs from this metric. All three panels attained consensus on the scale changes that constituted small, moderate, and large clinically important SF-36 change scores. The CIDs established by the heart disease panel were generally greater than the CIDs agreed on by the asthma and COPD panels., Conclusions: These panel-derived thresholds reflect possible differences in disease management among the represented panel-specific diseases, and are all greater than the minimal CID thresholds previously developed for the SF-36 scales among patients with arthritis. If confirmed among patients with the relevant diseases and those patients' physicians, these disease-specific CIDs could assist both researchers and practicing clinicians in the use and interpretation of HRQL changes over time.

Objective: To investigate peak expiratory flow rate (PEFR) and quality of life scores for their ability to predict exacerbations of asthma., Participants and Methods: We identified adults who received oral or inhaled asthma medications from 36 community drugstores. We administered the McMaster Asthma Quality of Life Questionnaire (AQLQ) and measured PEFR, defining "red zone" (highest risk) as a PEFR < 50% of each patient's expected value based on gender, age, and height. We identified asthma exacerbations (breathing-related emergency department visits and hospitalizations) within 4 and 12 months after enrollment and used proportional hazards regression to assess the ability of PEFR and AQLQ scores to predict exacerbations, controlling for clinical and demographic factors., Results: A red zone PEFR was a significant univariable predictor of exacerbations within 12 months (hazard ratio [HR], 1.8; 95% confidence interval [CI], 1.1 to 3.0; P =.027). However, neither a red zone PEFR, the raw PEFR, or percent of predicted maximal PEFR were significantly predictive when controlling for AQLQ scores, clinical characteristics, or demographic data (P >.2). However, the 4 subscales of the AQLQ were each significant univariable and multivariable predictors of asthma exacerbations. For example, the overall AQLQ scale had a multivariable HR of 0.63 (95% CI, 0.46 to 0.87; P =.005) for exacerbations occurring within 4 months and 0.66 (95% CI, 0.54 to 0.82; P <.001) within 12 months., Conclusions: PEFR added no predictive information to that contained in AQLQ scores and clinical and demographic data. These results support the National Institutes of Health asthma guidelines' recommendation for routinely assessing symptoms but not PEFR.

Background: Standards for change in health-related quality of life (HRQoL) measures used among asthmatic patients have been established by considering only patient preferences to determine important differences and may not reflect an informed clinical evaluation of change., Objective: To establish clinically important difference (CID) standards through the consensus of an expert physician panel for the Juniper Asthma Quality of Life Questionnaire (AQLQ) and Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36, version 2) when used to measure HRQoL among asthmatic patients., Methods: We organized an 8-person panel of physicians familiar with measuring HRQoL among asthmatic patients with the AQLQ and the SF-36. This expert panel participated in 2 rounds of a modified Delphi process before attending an in-person consensus meeting to establish the CID standards for small, moderate, and large changes in the AQLQ and the SF-36. After the consensus meeting, the panel used an iterative improvement process to cooperatively complete their final report., Results: The expert panel's thresholds for detecting CIDs in the domains of the AQLQ were much higher than previously established levels using patient-perceived changes. CIDs for asthma were also ascertained on the scales of the SF-36, version 2, which were markedly greater than previously cited cross-sectional differences between patient groups., Conclusions: The CID standards established by this expert panel elucidate a potential distinction between patient and physician perspectives of important HRQoL changes. The many stakeholders of HRQoL difference standards should consider this distinction when adopting standards to evaluate patient change.

Context: It is not known whether patient outcomes are enhanced by effective pharmacist-patient interactions., Objective: To assess the effectiveness of a pharmaceutical care program for patients with asthma or chronic obstructive pulmonary disease (COPD)., Design, Setting, and Participants: Randomized controlled trial conducted at 36 community drugstores in Indianapolis, Ind. We enrolled 1113 participants with active COPD or asthma from July 1998 to December 1999. Outcomes were assessed in 947 (85.1%) participants at 6 months and 898 (80.7%) at 12 months., Interventions: The pharmaceutical care program (n = 447) provided pharmacists with recent patient-specific clinical data (peak expiratory flow rates [PEFRs], emergency department [ED] visits, hospitalizations, and medication compliance), training, customized patient educational materials, and resources to facilitate program implementation. The PEFR monitoring control group (n = 363) received a peak flow meter, instructions about its use, and monthly calls to elicit PEFRs. However, PEFR data were not provided to the pharmacist. Patients in the usual care group (n = 303) received neither peak flow meters nor instructions in their use; during monthly telephone interviews, PEFR rates were not elicited. Pharmacists in both control groups had a training session but received no components of the pharmaceutical care intervention., Main Outcome Measures: Peak expiratory flow rates, breathing-related ED or hospital visits, health-related quality of life (HRQOL), medication compliance, and patient satisfaction., Results: At 12 months, patients receiving pharmaceutical care had significantly higher peak flow rates than the usual care group (P =.02) but not than PEFR monitoring controls (P =.28). There were no significant between-group differences in medication compliance or HRQOL. Asthma patients receiving pharmaceutical care had significantly more breathing-related ED or hospital visits than the usual care group (odds ratio, 2.16; 95% confidence interval, 1.76-2.63; P<.001). Patients receiving pharmaceutical care were more satisfied with their pharmacist than the usual care group (P =.03) and the PEFR monitoring group (P =.001) and were more satisfied with their health care than the usual care group at 6 months only (P =.01). Despite ample opportunities to implement the program, pharmacists accessed patient-specific data only about half of the time and documented actions about half of the time that records were accessed., Conclusions: This pharmaceutical care program increased patients' PEFRs compared with usual care but provided little benefit compared with peak flow monitoring alone. Pharmaceutical care increased patient satisfaction but also increased the amount of breathing-related medical care sought.

Objectives: To establish a link between the minimal important difference (MID) and the standard error of measurement (SEM) for all responsive dimensions of the Asthma Quality of Life Questionnaire (AQLQ)., Methods: Secondary data analysis of baseline and follow-up interview data from 198 outpatients with asthma enrolled in a randomized controlled trial and receiving care at a major urban academic medical center's general medicine clinics. Domain statistics for baseline and follow-up interviews were examined for the AQLQ. The baseline SEM values were compared with established AQLQ MID standards using weighted kappa values., Results: One SEM identified the MID in responsive AQLQ dimensions. Weighted kappa values (0.88-0.93) validated excellent agreement between these two criteria., Conclusion: This is the third study to support using one SEM to identify important individual change in health-related quality of life (HRQoL) measures. However, refinement of the process for determining a measure's clinically meaningful differences is still needed to secure a link between the SEM and the identification of relevant HRQoL change over time.

Objective: To investigate peak expiratory flow rate (PEFR) and quality of life scores for their ability to predict exacerbations of asthma.Participants and Methods: We identified adults who received oral or inhaled asthma medications from 36 community drugstores. We administered the McMaster Asthma Quality of Life Questionnaire (AQLQ) and measured PEFR, defining "red zone" (highest risk) as a PEFR < 50% of each patient's expected value based on gender, age, and height. We identified asthma exacerbations (breathing-related emergency department visits and hospitalizations) within 4 and 12 months after enrollment and used proportional hazards regression to assess the ability of PEFR and AQLQ scores to predict exacerbations, controlling for clinical and demographic factors.Results: A red zone PEFR was a significant univariable predictor of exacerbations within 12 months (hazard ratio [HR], 1.8; 95% confidence interval [CI], 1.1 to 3.0; P =.027). However, neither a red zone PEFR, the raw PEFR, or percent of predicted maximal PEFR were significantly predictive when controlling for AQLQ scores, clinical characteristics, or demographic data (P >.2). However, the 4 subscales of the AQLQ were each significant univariable and multivariable predictors of asthma exacerbations. For example, the overall AQLQ scale had a multivariable HR of 0.63 (95% CI, 0.46 to 0.87; P =.005) for exacerbations occurring within 4 months and 0.66 (95% CI, 0.54 to 0.82; P <.001) within 12 months.Conclusions: PEFR added no predictive information to that contained in AQLQ scores and clinical and demographic data. These results support the National Institutes of Health asthma guidelines' recommendation for routinely assessing symptoms but not PEFR. [ABSTRACT FROM AUTHOR]

To investigate peak expiratory flow rate (PEFR) and quality of life scores for their ability to predict exacerbations of asthma. We identified adults who received oral or inhaled asthma medications from 36 community drugstores. We administered the McMaster Asthma Quality of Life Questionnaire (AQLQ) and measured PEFR, defining “red zone” (highest risk) as a PEFR < 50% of each patient's expected value based on gender, age, and height. We identified asthma exacerbations (breathing-related emergency department visits and hospitalizations) within 4 and 12 months after enrollment and used proportional hazards regression to assess the ability of PEFR and AQLQ scores to predict exacerbations, controlling for clinical and demographic factors. A red zone PEFR was a significant univariable predictor of exacerbations within 12 months (hazard ratio [HR], 1.8; 95% confidence interval [CI], 1.1 to 3.0; P = .027). However, neither a red zone PEFR, the raw PEFR, or percent of predicted maximal PEFR were significantly predictive when controlling for AQLQ scores, clinical characteristics, or demographic data ( P > .2). However, the 4 subscales of the AQLQ were each significant univariable and multivariable predictors of asthma exacerbations. For example, the overall AQLQ scale had a multivariable HR of 0.63 (95% CI, 0.46 to 0.87; P = .005) for exacerbations occurring within 4 months and 0.66 (95% CI, 0.54 to 0.82; P < .001) within 12 months. PEFR added no predictive information to that contained in AQLQ scores and clinical and demographic data. These results support the National Institutes of Health asthma guidelines’ recommendation for routinely assessing symptoms but not PEFR. J GEN INTERN MED 2004;19:237–242. [ABSTRACT FROM AUTHOR]