PRACTICAL APPROACH TO THE USE OF OUTCOMES IN ASTHMA: Traveling the Road to Better Asthmatic Care

doi:10.1016/S0889-8561(05)70276-9

Immunology and Allergy Clinics of North America

Volume 16, Issue 4, 1 November 1996, Pages 859-891

https://doi.org/10.1016/S0889-8561(05)70276-9 Get rights and content

“Would you tell me please which way I ought to go from here?” “That depends a good deal on where you want to get to,” said the cat.

LEWIS CARROLL, Alice in Wonderland

Section snippets

BIOLOGIC AND PHYSIOLOGIC ASTHMA OUTCOMES

In the past, biologic and physiologic outcomes have been considered the most precise measure of outcomes in patients with asthma. 5, 116 These outcomes represent the biologic impact of asthma on the target organ, the lung.³¹ This biologic impact of asthma on the lung is assessed by determining lung function. Other biologic activity measures that provide insight into the inflammatory process include eosinophilic cationic protein amounts, allergen skin test reactivity, or serum IgE levels. 21, 36

SYMPTOM ASSESSMENT AS AN OUTCOME TOOL

Symptom assessment in the past has been another outcome tool used in following asthmatic patients. Several instruments have been developed to help objectify a patient's subjective perception of asthma; a patient is able to ascertain frequency and severity of cough, wheezing, sleep quality, and ability to perform aerobic exercise. 16, 17, 58, 60, 61, 69, 102, 135 Response to these outcome questions must be related in some way to the amount and types of medication and therapy prescribed for the

FUNCTIONAL OUTCOMES (BURDEN OF ILLNESS)

Overall functional and health status of the patient represents the effect of asthma on an individual's ability to perform age-appropriate activities under a broad range of circumstances. This aspect of asthma outcomes is a very important reflection of how patients perceive their lives as they relate to asthma. Physiologic, sociologic, and psychological factors are all important in how a person functions, but these three factors vary in how an individual patient's asthma outcomes are affected.

PRACTICAL PROBLEMS WITH INDIVIDUAL PATIENT MONITORING USING GENERIC AND DISEASE-SPECIFIC OUTCOME MEASUREMENT TOOLS

General health outcomes and disease-specific measures in asthma can provide the following positive benefits 44, 45, 64, 74, 78, 89⁹³100, 105, 117, 124 :

1
A complete description of the patient's overall general health state as well as asthma-specific health state.
2
A screen for insipient disease.
3
An assessment of the patient's needs regarding asthma.
4
Physician and patient discussion and agreement about treatment goals.
5
A monitor for asthma progression.
6
A monitor for response to asthma treatment.
7
An

DISEASE STATE MANAGEMENT

The asthma outcome measures (Table 4) can be used to structure the physician-patient interview so that physicians can pinpoint health status changes between visits with individual patients. With these tools, physicians and other health care providers can offer better asthma care. Data derived from these well-tested tools also allow retrospective comparisons of individuals within the asthma populations. These asthma outcome data can be the basis for disease state management of asthma. Harris⁴⁸

PRACTICAL USE OF FUNCTIONAL OUTCOME ASSESSMENT AT THE POINT OF SERVICE

In 1994, the Allergy Department of Dean Clinic strove to develop specific outcome tools that would meet the previously discussed needs. Velocity Healthcare Informatics (VHI) in Minneapolis helped to develop the resulting computer technology. This computerized outcome report reproduced individual patient outcome data in easily reviewed bar graphs, based on the patient's response to a 96-item fill-in-the-dot questionnaire. 19, 61 The result was the “Asthma Report Card” (Fig. 3).

This Asthma Report

PATIENT SATISFACTION

Patient satisfaction as an outcome variable is important to physicians but is more important to patients themselves.¹¹⁵ Higher patient satisfaction has been shown to lead to improvement in patient compliance and adherence to recommendations, thus leading to a better asthma outcome.¹⁰³ Managed care organizations strive to attract patients and to encourage re-enrollment. Improving patient satisfaction is a productive way to facilitate those goals. Currently, many managed care organizations have

ECONOMIC COST OUTCOMES IN ASTHMA

Physicians need cost information about patients in order to make decisions about which type of care would be of the most clinical value. Costs will not change until physicians become more aware of the following major forms of economic valuation: cost-effectiveness, cost-benefit, and cost-utility. Cost-effectiveness is the costs as compared with the clinical efforts produced in ordinary circumstances. Cost-benefit is costs as compared with a particular benefit to society. Cost-utility is the

ESTABLISHING KNOWLEDGE FROM OUTCOMES FOR IMPROVEMENT

Two types of studies establish the clinical information that is used to treat asthma. The first type of study, the traditional randomized clinical trial, is the most important tool in establishing efficacy studies. The patient population is homogeneous, tightly controlled, but difficult to generalize to other patient populations. Although these types of studies are important, information about asthma treatment should be grounded on sound evidence. Proper designs and statistics are necessary.

THE FUTURE OF ASTHMA OUTCOMES—GUIDELINES AND BEYOND

Guidelines are consensus statements developed to assist practitioners and patients in making decisions about appropriate health care for asthma (Table 7). Although the development process for asthma guidelines varies, the processes have included (1) formulating the scope of the clinical problem, (2) identifying and assessing pertinent scientific data in an unbiased manner, (3) integrating the data and deciding which of the multiple outcomes are most important, and (4) determining if the

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Cited by (15)

Effectiveness of Budesonide Administered via Dry-Powder Inhaler Versus Triamcinolone Acetonide Administered via Pressurized Metered-Dose Inhaler for Adults with Persistent Asthma in Managed Care Settings
2004, Clinical Therapeutics
Background: Clinical studies have demonstrated the efficacy and relative safety of inhaled corticosteroids in the treatment of asthma. However, effectiveness and cost-effectiveness comparisons of available inhaled corticosteroids in real-life clinical settings are lacking.
Objective: This study compared the effectiveness and safety of budesonide administered via dry-powder inhaler versus that of triamcinolone acetonide administered via pressurized metered-dose inhaler in the treatment of adult patients with persistent asthma treated in a managed care setting.
Methods: This was a randomized, open-labe, 52-week study of adult patients (aged ≥ 18 years) with persistent asthma enrolled in 25 US health plans. The primary study outcome was mean change from baseline to the end of treatment in symptom-free days. Secondary variables were changes from baseline in number of episode-free days, episode-free days at 52 weeks, forced expiratory volume in 1 second (FEV₁), forced vital capacity, asthma symptom scores, breakthrough bronchdilator use, patient discontinuations, and health-related quality of life. Patients were issued diaries in which to record use of study medication and concomitant asthma medication use, as well as daytime and nightime asthma symptom severity. Patients were assessed at weeks 4, 13, 26, 39, and 52. Safety was assessed based on adverse events and changes in laboratory tests, vital signs, and physical examinations.
Results: A total of 945 patients (344 men, 601 women; mean [SD] age, 46.8 [14] years) were enrolled; 631 received budesonide and 314 received triacinolane acetonide. Improvements in all effectiveness variables were observed with both treatments. The mean increase from baseline in the number of symptom-free days per month assessed at month 12 was 7.74 (95% CI, 6.81–8.66) for patients receiving budesonide and 3.78 (95% CI, 2.47–5.09) for patients receiving triamcinoline acetonide (P < 0.001). The estimated annual mean (SD) number sympton-free days for patients recieving budesonide was 141.1 (125.0) over the treatment phase, compared with 99.3 (112.1) for those receiving triamcinolone acetonide (P < 0.001). Patients receiving budesonide demonstrated significant improvements (compared with those receiving triamcinolone acetonide) in overall quality of life, daytime and nightime asthma symptom severity, breakthrough bronchodilator use, and FEV₁ (all P < 0.001). Safety measures were similar between groups.
Conclusion: In these managed care settings, budesonide inhalation powder administered via dry-powder inhaler was significantly more effective than triamcinolone acetonide administered via pressurized metered-dose inhaler in the treatment of adults with persistent asthma.
Effects of montelukast and beclomethasone on airway function and asthma control
2002, Journal of Allergy and Clinical Immunology
Background: Maintaining asthma control is a major objective of therapy. Traditionally, the effectiveness of asthma therapy has been judged primarily by its effect on airway function rather than on multiaspect asthma control. Objective: An inhaled corticosteroid and a leukotriene receptor antagonist were compared to determine whether they provided equivalent effects, as judged by days of asthma control. Methods: In a randomized, multicenter, double-blind, placebo-controlled, parallel-group study, asthmatic patients (n = 782) with FEV₁ percent predicted values of between 50% and 85% and a weekly average β-agonist use of more than 2 puffs per day were randomized to receive montelukast (10 mg daily), beclomethasone (200 μg twice daily), or placebo treatment for 6 weeks in a double-dummy fashion. We examined the distribution of the primary end point: percentage of days of asthma control. Secondary end points included FEV₁, albuterol use, occurrence of an asthma attack, asthma flare-up, rescue corticosteroid use, sustained asthma control, and adverse experiences. Results: The percentage of days of asthma control was almost identical between the montelukast and beclomethasone groups (98% overlap in the distribution). Montelukast was at least equal to beclomethasone, and both were greater than placebo on the basis of frequency of asthma attacks, asthma flare-ups, and rescue corticosteroid use. Beclomethasone had a greater effect than montelukast and both treatments were better than placebo at improving FEV₁. Conclusions: Montelukast was as effective as beclomethasone, as judged by indices of clinical control other than FEV₁. When evaluating the outcome of montelukast therapy, FEV₁ might underestimate clinical effectiveness. (J Allergy Clin Immunol 2002;110:847-54.)
Evaluation of a short form for measuring health-related quality of life among pediatric asthma patients
2000, Journal of Allergy and Clinical Immunology
Background: This study was undertaken to derive and validate a short form parent-completed questionnaire to measure health-related quality of life (HRQL) in pediatric asthma patients. Objective: The objectives of this study were to (1) use stepwise analysis to derive a shorter questionnaire from the original long-form questionnaire and (2) determine the tradeoff in precision between the long- and short-form surveys. Methods: One hundred eighty-one pediatric asthma patients were enrolled from 4 sites. A parent of each patient completed a general and an asthma-specific questionnaire during routine office visits from June 1995 to January 1997. The questionnaire included the Child Health Questionnaire Parent Form 50, a general HRQL survey, and a 17-item asthma-specific battery assessing daytime symptoms, nighttime symptoms, and functional limitations. All scales were scored from 0 to 100, with higher scores indicating better HRQL. Analysis of variance models were used to derive short-form scales from the 17-item long-form scales, and the final asthma-specific short-form scale structure was confirmed with use of stepwise regression. Scale reliability was assessed with Cronbach’s α. Validity of the short-form questionnaire was assessed by comparing mean scale scores according to the level of asthma severity defined by several clinical criteria. Asthma severity was assessed with use of percent predicted FEV₁, frequency and type of symptoms, parent rating of disease severity, physician rating of disease severity, and resource use (emergency department use and hospitalizations). The relative validity of each of the short-form scales was measured by comparing the proportion of variance explained by each of the short-form scales compared with the respective long-form scales. Results: The 17-item asthma-specific battery was reduced to 8 items, the Integrated Therapeutics Group Child Asthma Short Form. The daytime and nighttime symptom scales for each contain 2 items and the functional limitations scale 4 items. Reliability was greater than 0.70 for each of the short-form scales. The absence of ceiling and floor effects indicates each scale’s ability to detect changes at both low and high levels of functioning. Lower (poorer) mean HRQL scores for severe cases compared with mild cases, for all disease severity indicators, demonstrated clinical validity. Relative validity estimates, comparing the proportion of explained variance of the short-form scales with that of the long-form scales, ranged from 0.85 to 1.20, indicating a similar ability to measure change. Conclusions: This study documents the development of a brief, multidimensional, 8-item questionnaire for measuring HRQL in pediatric asthma patients. The brevity of the questionnaire makes it practical for use in practice settings and to monitor patients. (J Allergy Clin Immunol 2000;105:245-51.)
Guidelines for collaboration among physicians, pharmacists, and managed care organizations to improve asthma outcomes
2014, American Journal of Pharmacy Benefits
Depression, panic-fear, and quality of life in near-fatal asthma patients
2005, Journal of Clinical Psychology in Medical Settings
Symptoms: Monitoring, Perceptions
2005, Monitoring Asthma: Volume 207

View all citing articles on Scopus

: Address reprint requests to Don A. Bukstein, MD Dean Clinic 1313 Fish Hatchery Road Madison, WI 53715

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PRACTICAL APPROACH TO THE USE OF OUTCOMES IN ASTHMA: Traveling the Road to Better Asthmatic Care

Section snippets

BIOLOGIC AND PHYSIOLOGIC ASTHMA OUTCOMES

SYMPTOM ASSESSMENT AS AN OUTCOME TOOL

FUNCTIONAL OUTCOMES (BURDEN OF ILLNESS)

PRACTICAL PROBLEMS WITH INDIVIDUAL PATIENT MONITORING USING GENERIC AND DISEASE-SPECIFIC OUTCOME MEASUREMENT TOOLS

DISEASE STATE MANAGEMENT

PRACTICAL USE OF FUNCTIONAL OUTCOME ASSESSMENT AT THE POINT OF SERVICE

PATIENT SATISFACTION

ECONOMIC COST OUTCOMES IN ASTHMA

ESTABLISHING KNOWLEDGE FROM OUTCOMES FOR IMPROVEMENT

THE FUTURE OF ASTHMA OUTCOMES—GUIDELINES AND BEYOND

Chest

J Allergy Clin Immunol

Chest

Chest

Chest

Chest

Lancet

J Clin Epidemiol

J Clin Epidemiol

J Psychosom Res

J Psychosom Res

Chest

J Clin Epidemiol

Chest

J Allergy Clin Immunol

J Chron Dis

J Allergy Clin Immunol

J Allergy Clin Immunol

Action Asthma: The Occurrence and Cost of Asthma

Implementation of local guidelines for cost effective management of hypertension

JAMA

The Medical Outcomes Study Instrument (MOSI): Use of a new health status measure in Britain

Fam Pract

Diurnal variation in peak expiratory flow in asthmatics

Eur J Respir Dis

Asthma outcome measures

Am J Respir Crit Care Med

A randomized trial to improve self management practices of adults with asthma

Arch Intern Med

A new approach to the treatment of asthma

N Engl J Med

Health status measures: An overview and guide for selection

Annu Rev Pub Health

The Sickness Impact Profile: Development and final revision of a health status measure

Med Care

Eleven worthy aims for clinical leadership of health system reform

JAMA

Harvesting knowledge for improvement

JAMA

Relation between respiratory symptoms, pulmonary function and peak flow variability in adults

Thorax

Quality of life in asthma: Internal consistency and validity of the SF-36 questionnaire

Am J Respir Crit Care Med

Overview of adult health status measures fielded in Rand's health insurance study

Med Care

Subjective symptomatology of asthma in an outpatient population

Psychosom Med

Successful treatment of chronic asthma using point-of-service outcomes analysis

Journal of Clinical Outcomes Management

The utility of outcome information at the point of service

Managed Care Quarterly

The course and prognosis of different forms of chronic airways obstruction in a sample from the general population

N Engl J Med

Association of asthma with serum IgE levels and skin-test reactivity to allergens

N Engl J Med

Asthma hospitalization and mortality in New York City

Am J Public Health

Changing physician performance

JAMA

A framework for the continual improvement of health care

Joint Communication Journal of Quality Improvement

Dean Medical Center tracks patient outcomes

Inside Ambulatory Care

Inadequate parental understanding of asthma medications

Ann Allergy

Measuring components of children's health status

Med Care

Shattuck lecture outcome management: A technology of patient experience