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As consumers, payers, and regulatory agencies require evidence regarding health care qualities the demand for process of care measures will grow. Although outcome measures of quality represent the desired end results of health care, validated process of care measures provide an important additional element to quality improvement efforts, as they illuminate exactly which provider actions could be changed to improve patient outcomes. In this essay, we discuss the advantages and disadvantages of process measures of quality, and outline some practical strategies and issues in implementing them.

This paper outlines the steps in developing and implementing process measures of quality. Developing a process measure includes defining the purpose of and audiences for the measures, choosing the clinical area to evaluate, organizing the assessment team, choosing the component of the process to measure, writing the indicator specifications, performing preliminary tests of feasibility, reliability and validity, and determining scoring and analytical specifications. Given the growing evidence in the literature regarding the impact of care, and an evolving understanding of how to develop and implement process of care measures as outlined here, the future should bring the development and implementation of quality indicators that are rigorously developed and that will provide insights into opportunities to improve the quality of care.

Background: The growth of managed health care in the United States has been accompanied by controls on access to specialty physician services. We examined the relationship of physician specialty to treatment and outcomes of patients with asthma in managed care plans., Methods: We conducted a mail survey of adult asthma patients who were enrolled in 12 managed care organizations and had at least 2 contacts for asthma (International Classification of Diseases, Ninth Revision, Clinical Modification code 493.x) during the previous 24 months; we also surveyed their treating physicians. This report concerns 1954 patients and their 1078 corresponding physicians. Treatment indicators included use of corticosteroid inhalers, use of peak flow meters, allergy evaluation, discussion of triggers, and patient self-management knowledge. Outcome measures included canceled activities, hospitalization or emergency department visits, asthma attacks, workdays lost, asthma symptoms, physical and mental health, overall satisfaction with asthma care, and satisfaction with communication with physicians and nurses., Results: Significant differences were noted for patients of specialists and experienced generalists compared with those of generalist physicians. Peak flow meter possession was reported by 41.9% of patients of generalists, 51.7% of patients of experienced generalists, and 53.8% of patients of pulmonologists or allergists. Compared with patients of generalists, outcomes were significantly better for patients of allergists with regard to canceled activities, hospitalizations and emergency department visits for asthma, quality of care ratings, and physical functioning. Patients of pulmonologists were more likely to rate improvement in symptoms as very good or excellent., Conclusions: In a managed health care setting, physicians' specialty training and self-reported expertise in treating asthma were related to better patient-reported care and outcomes.

Objective: To determine whether care for children was more consistent with national asthma guidelines when a specialist rather than a generalist was the usual source of asthma care., Design: Cross-sectional survey., Setting: Two large managed care organizations in the United States., Participants: A total of 260 parents of children with asthma., Interventions: None., Main Outcome Measures: Parent reports of the physician primarily responsible for asthma care (specialist, generalist, or both equally) and whom they would call (specialist or generalist) for questions about asthma care were used to define usual source of care. We assessed consistency of care with 1997 National Asthma Education and Prevention Program guidelines using 11 indicators in 4 domains of asthma care: patient education, control of factors contributing to asthma symptoms, periodic physiologic assessment and monitoring, and proper use of medications., Results: In all 4 domains, care was more likely to be consistent with guidelines when specialists were the usual source of care. These differences remained after adjustment for symptom severity, recent care encounters, and parent demographics. Greatest differences for specialist versus generalist management were for use of controller medications (odds ratio [OR] 6.7; 95% confidence interval [CI]: 1.5-30.4), ever having a pulmonary function test (OR 6.5; 95% CI: 2.4-18.1), and having been told about asthma triggers and how to avoid them (OR 5.9; 95% CI: 1.3-26.2)., Conclusions: In these managed care organizations, asthma care in children was more likely to be consistent with national guidelines when a specialist was the primary provider. Greater use of specialists or altering generalist physicians' care may improve the degree to which the care of children with asthma is consistent with national guidelines.

Background: In the United States, morbidity from asthma disproportionately affects African Americans and women. Although inadequate care contributes to overall asthma morbidity, less is known about differences in asthma care by race and sex., Subjects and Methods: To examine the relationships of race and sex with asthma care, we analyzed responses to questionnaires administered to adults enrolled in 16 managed care organizations participating in the Outcomes Management System Asthma Study between September and December 1993. Indicators of care consistent with National Asthma Education and Prevention Program (1991) recommendations were assessed. Of a random sample of 8640 patients asked to participate, 6612 (77%) completed the survey. This study focused on 5062 (14% African American, 72% women) patients with at least moderate asthma symptom severity., Results: Fewer African Americans than whites reported care consistent with recommendations for medication use (eg, daily inhaled corticosteroid use, 34.9% vs 54.4%; P =.001), self-management education (eg, action plan, 42.0% vs 53.8%; P =.001), avoiding triggers (37.6% vs 53.6%; P =.001), and specialist care (28.3% vs 41.0%; P =.001). Differences in asthma care by sex were smaller and tended to favor women except for daily inhaled corticosteroid use (women vs men: 49.6% vs 58.3%; P =.001) and having specialist care (37.7% vs 43.1%; P =.001). Similar race and sex differences were observed after adjusting for age, education, employment, and symptom frequency., Conclusions: Even among patients with health insurance, disparities in asthma care for African Americans compared with whites exist and may contribute to race disparities in outcomes. Women generally reported better asthma care but may benefit from greater use of inhaled corticosteroids.

Objective: To evaluate the consistency of pediatric asthma care with the National Asthma Education and Prevention Program Guidelines., Design: Cross-sectional survey at 2 managed care organizations in the United States (winter 1997-1998). The participants were parents of children (n = 318) age 5 to 17 years with asthma. There were no interventions. The outcome measures were indicators of care in 4 domains: (1) periodic physiologic assessment, (2) proper use of medications, (3) patient education, and (4) control of factors contributing to asthma severity., Results: Of 533 eligible patients with asthma, 318 (60%) parents responded; 59% of children were male, 76% were white, and 60% were aged 5 to 10 years. Deficiencies in care were identified in all care domains including, for patients with moderate and severe persistent symptoms, only 55% used long-term control medication daily, 49% had written instructions for handling asthma attacks, 44% had instructions for adjustment of medication before exposures, 56% had undergone allergy testing, and 54% had undergone pulmonary function testing., Conclusions: There are significant opportunities to improve the quality of care for children with asthma enrolled in managed care. A comprehensive approach to improving care may be necessary to address multiple aspects of care where opportunities exist.

Context: Asthma symptoms that occur at night may signal worse asthma control, but the nighttime occurrence may have additional clinical significance. To date, however, there have been few studies of the impact of nocturnal awakening from asthma on children with the disease, including problems with daytime functioning., Objective: To determine if school absenteeism and school performance in children and work absenteeism in their parents are associated with nocturnal awakenings from asthma., Design: Cross-sectional survey during the winter of 1997 through 1998., Setting: Three managed care organizations in the United States., Participants: Parents of 438 children with asthma, aged 5 to 17 years, who were enrolled in managed care organizations., Intervention: None., Main Outcome Measures: Parent's reports of number of days their child missed school and parent missed work and how often the child's education suffered because of asthma in the past 4 weeks., Results: Overall, more than 40% of children had nocturnal awakenings from asthma in the past 4 weeks. Multivariate analyses were performed that adjusted for child age, race, overall symptom severity, and use of reliever medications. Compared with children who did not awaken from asthma, there were greater odds of missed school days in children who awakened 1 to 3 nights (odds ratio [OR], 3.6; 95% confidence interval [CI], 2.1-6.2), 4 to 7 nights (OR, 4.4; 95% CI, 2.0-10.0), and more than 7 nights (OR, 14.7; 95% CI, 5.9-37.0). Similarly, there were greater odds of education suffering in children who awakened 1 to 3 nights (OR, 2.3; 95% CI, 1.4-3.7), 4 to 7 nights (OR, 2.1; 95% CI, 0.9-4.6), and more than 7 nights (OR, 2.3; 95% CI, 1. 0-5.4), and parents missing work in children who awakened 1 to 3 nights (OR, 4.0; 95% CI, 2.2-7.1), 4 to 7 nights (OR, 6.5; 95% CI, 2.7-16), and more than 7 nights (OR, 3.2; 95% CI, 1.3-7.9). Greater overall symptom severity and high use of reliever mediation were also associated with missed school, education suffering, and parent absenteeism., Conclusions: Nighttime awakenings in children with asthma may affect school attendance and performance, as well as work attendance by parents. Nighttime symptoms have independent prognostic value, even when overall asthma symptom severity is accounted for. By addressing whether there are nighttime awakenings in children with asthma, clinicians may be able to tailor the therapeutic regimen to counter these symptoms.

The purpose of this study was to assess the extent to which patients undergoing flexible bronchoscopy (FOB) experience pain and to identify patient factors and process of care factors that are associated with pain. We conducted a prospective cohort study on 481 patients undergoing FOB. Overall control of pain during FOB was the primary outcome. The mean age of the patients was 48 yr, 50% were male, and 32% required supplemental oxygen prior to FOB. Pain control was excellent in 36% of patients, but 10% considered it to be fair or poor. Patient factors associated with excellent pain control were excellent health (versus poor health, OR = 6.25 [95% CI, 2.28-16.67]), more education (college education versus high school education, OR = 1.72 [95% CI, 1.05-2.86]), and not having asthma (OR = 2.86 [95% CI, 1.09-7.14]). Process of care factors associated with excellent pain control were not being bothered by scope insertion (versus bothered, OR = 3.65 [95% CI, 1.99-6.98]), no memory of FOB (versus some memory, OR = 2.33 [95% CI, 1.24-4.44]), and higher ratings of information about the procedure (per 1-point increase on a 12-point scale, OR = 1.57 [95% CI, 1.41-1.78]). This is the first large-scale, prospective study to evaluate patient and process of care factors that influence pain control during FOB. It demonstrated that there are patient characteristics and process of care factors that need to be considered when evaluating pain during bronchoscopy. Improved preparation of patients with lower education, inferior health status, and asthma may lead to decreased pain during FOB. Bronchoscopists may be able to reduce pain during FOB by identifying methods to decrease pain on scope insertion, by improving the information provided to patients, and by achieving greater levels of amnesia during FOB.

Study Objectives: To determine the extent to which on-site cytopathology assessment improves diagnostic yield when sampling lung nodules or masses and/or hilar or mediastinal lymphadenopathy by fiberoptic bronchoscopy (FOB)., Design: Prospective cohort study., Setting: Two teaching hospitals in Baltimore, MD., Patients: Consecutive adult patients (>/= 18 years) undergoing FOB for evaluation of lung nodules or masses and/or hilar or mediastinal lymphadenopathy., Intervention: Prospective collection of data on patient factors and details of the procedure on standardized report forms., Measurements and Results: The primary outcome measure was a new diagnosis obtained by FOB. On-site assessment was used in 81 of 204 cases (40%), and overall diagnostic yield was 62%. Yield was greater when on-site cytopathology assessment was used, in unadjusted analysis (81% vs 50%, p < 0.001) and in a multivariate model (odds ratio, 4.5; 95% confidence interval, 2.1 to 10.0). Other significant predictors of a new diagnosis included older patient age, higher dose of narcotic used during FOB, and shorter procedure time., Conclusions: We conclude that diagnostic yield was greater when on-site cytopathology was used to assist FOB evaluation of intrathoracic adenopathy and/or lung nodules or masses. Increasing the use of on-site cytopathology assessment may improve the quality of FOB services.

The c-myc oncogene is frequently amplified in cells grown from lung tumors and has been linked to the malignancy of these cancers. In support of this, c-myc transfection enhances the in vitro proliferation and soft agar cloning of human small cell lung cancer (SCLC) cells. In this study, we surprisingly found that c-myc expression suppressed the formation of tumors by SCLC cells in athymic nude mice. c-myc expression down-regulated the protein and transcript for vascular endothelial growth factor (VEGF) in these SCLC cells, as well as VEGF transcript in rat fibroblasts manipulated for c-myc expression and in liver cells of c-myc-transgenic mice. Finally, bivariate and multivariate analyses demonstrated that the probability of tumor formation from lung cancer cell lines was negatively correlated with the relative expression of c-Myc, positively correlated with the relative expression of VEGF, and that the latent time to tumor formation was increased by the expression of c-Myc and decreased by the expression of VEGF. We hypothesize that, for lung cancer cells, c-Myc suppresses the formation of tumors in vivo by down-regulating VEGF, and that the amplification of c-myc seen in cells grown from lung tumors with a poor prognosis is an artifact of selection for growth in vitro.

Background: Overuse of inhaled beta-agonists and underuse of inhaled corticosteroids by patients with asthma may have adverse consequences. This study was performed to identify factors associated with misuse of these types of asthma medication., Methods: We examined baseline data from a longitudinal survey of adult patients with asthma. The setting was a consortium of 15 national managed care organizations serving 11 large employers. Baseline surveys were completed by 6612 health plan enrollees at least 18 years old who had had at least 2 visits with a diagnostic code for asthma in the preceding 2 years. The main outcome measures were the overuse of inhaled beta-agonists and the underuse of inhaled corticosteroids. Independent variables were patient and process of care factors., Results: Among patients with moderate or severe asthma, 16% of users of inhaled beta-agonists reported overuse (>8 puffs per day on days of use), and 64% of users of inhaled corticosteroids reported underuse (use on < or =4 days/wk or < or =4 puffs per day). Overuse of inhaled beta-agonists was most strongly associated with concomitant treatment with inhaled corticosteroids or anticholinergic agents, increased asthma symptom severity, problems in obtaining asthma medication, and male sex. Underuse of inhaled corticosteroids was associated with nonwhite race, younger age (18 to 34 years), lower use of inhaled beta-agonist, lower symptom severity, and not possessing a peak flow meter. Rates of misuse of medication also varied by speciality of the patient's provider (generalist, allergist, or pulmonologist)., Conclusions: Overuse of inhaled beta-agonists may be caused by symptom severity, while underusers of corticosteroids may interrupt use as symptoms abate. This study demonstrated an important opportunity to improve medication use among patients with asthma.

Study Objective: To determine whether recipients of lung transplants have a higher risk of bleeding from fiberoptic bronchoscopy (FOB) than other patients who undergo the procedure., Design: Prospective cohort study., Setting: Bronchoscopy services of Johns Hopkins Hospital, a tertiary referral center and Johns Hopkins Bayview Medical Center, a community hospital., Patients: All adult patients (18 years) who underwent FOB between July 1, 1996 and June 30, 1997 by the full-time pulmonary medicine staff were included. A total of 720 procedures were performed, including 38 in lung transplant recipients., Measurements: Bleeding was assessed by reviewing physician reports of bloody drainage after the procedure and whether the procedure was terminated early for bleeding. Patient reports of hemoptysis were assessed using questionnaires administered pre- and post-FOB. Predictor variables included patient demographics, bleeding parameters (platelets, prothrombin time, and activated partial thromboplastin time), immunosuppressive medications, aspirin use, use of transbronchial biopsy, and the time length of the procedure., Results: Lung transplant recipients were significantly more likely to have used aspirin prior to FOB (18.4 vs 7.2%, p < 0.05) and to undergo transbronchial biopsy (64.9 vs 26.8%, p < 0.001). Lung transplant patients were more likely to have new or worsened hemoptysis (53.8 vs 24.6%, p < 0.001), to have > 25 mL of blood loss (44.5 vs 17.5%, p < 0.001) and to have the procedure terminated early for bleeding (5.4 vs 1.0%, p < 0.05). In multivariate analysis, predictors of new or worsened hemoptysis included lung transplant, longer procedure time, and older patient age. Independent predictors of greater blood loss included lung transplant, performance of transbronchial biopsy, longer procedure time, and older patient age., Conclusions: Lung transplant recipients are at higher risk of bleeding from bronchoscopy than are other patients. This propensity to bleed is independent of coagulation parameters, platelet count, immunosuppressive medication use, aspirin use, or performance of transbronchial biopsy. The higher risk of bleeding should be considered when assessing the risks and benefits of bronchoscopy in lung transplant recipients.

Study Objective: To apply the principles of quality improvement to measure the frequency and severity of symptoms that result from fiberoptic bronchoscopy (FOB), and to identify opportunities to improve FOB practice by identifying factors about patients and the process of care that predict these symptoms., Design: Concurrent longitudinal cohort study., Patients: Four hundred ninety-three adult patients who underwent FOB., Measurements and Results: Patients completed questionnaires just prior to FOB and again at 48 h postprocedure. Patients were asked to rate the severity of nose pain, throat pain, swallowing pain, and chest pain, and the frequency of coughing, hemoptysis, phlegm, shortness of breath, wheezing, difficulty swallowing, fever, and chills. Symptom severity was reported on a four-point ordinal scale., Findings: Significant worsening was found for nose pain, throat pain, swallowing pain, and hemoptysis. Shorter patients experienced more throat pain and hemoptysis, and longer procedure time predicted nose pain and hemoptysis., Conclusions: Bronchoscopy causes nose pain, throat pain, swallowing pain, and hemoptysis to a larger extent than previously has been recognized. There are opportunities to improve the patient experience with bronchoscopy by using smaller bronchoscopes in shorter patients, shortening the procedure length, and reanesthetizing the nares in longer procedures.

Expenditure and utilization patterns of aged Medicare beneficiaries with chronic obstructive respiratory disease (COPD) (n = 42,472) were compared with all Medicare beneficiaries (n = 1,221,615) using a 5% nationally representative sample of aged Medicare beneficiaries participating in the fee-for-service program in 1992. Per capita expenditures for an aged Medicare beneficiary with COPD were 2.4 times the per capita expenditures for all Medicare beneficiaries. The most expensive 10% of Medicare beneficiaries with COPD accounted for nearly half of total expenditures for this population. Higher comorbidity, as measured by the Deyo-adapted Charlson index, was associated with higher expenditures. For Medicare Part B claims, internal medicine accounted for the largest portion of physician expenditures (14%). Per capita expenditures for pulmonologists were 7.5 times higher for beneficiaries with COPD compared with all Medicare beneficiaries. Results from this study suggest that there is a subgroup of individuals with COPD who are likely to be very expensive during the year. Additional analytic studies are needed to more specifically identify characteristics associated with these individuals. As more Medicare beneficiaries enroll in managed care and as physicians are increasingly being paid on a capitated basis this information will be useful to physicians as they monitor the care provided to patients and assess the financial risks they accept under capitation.