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OBJECTIVE: Care remains suboptimal for a substantial proportion of the more than 17 million patients in the United States with diabetes. This review examines strategies for improving the quality of care for adult type 2 diabetic patients, through changes in provider behavior and modifications to the organization of care. SEARCH STRATEGY AND
INCLUSION CRITERIA: The researchers searched the MEDLINE® database, the Cochrane Collaboration's Effective Practice and Organisation of Care (EPOC) registry, article bibliographies, and relevant journals for experimental evaluations of quality improvement (QI) interventions involving outpatient care for adults with type 2 diabetes mellitus. The investigators included randomized or quasi-randomized controlled trials, controlled before-after studies, and interrupted time series in which at least one reported outcome involved changes in serum hemoglobin A1c or a measure of provider adherence to a recommended process of care.
DATA COLLECTION AND ANALYSIS: Two reviewers independently abstracted relevant data, including classifying the components of each QI intervention as provider education, provider reminders, facilitated relay of clinical information, patient education, promotion of self-management, patient reminders, audit and feedback, organizational change, or financial incentives. Certain categories were further subdivided into major subtypes (e.g., professional meetings for provider education and disease management for organizational change). The investigators also assessed the impact of clinical information systems as a mediator for interventions of all types. They compared different QI strategies in terms of the median effects achieved for glycemic control and for a generalized measure of clinician adherence. In addition, linear regression analyses were performed using methodologic features and QI types as predictors, taking into account baseline groups differences and study size.
MAIN RESULTS: Fifty-eight articles reporting a total of 66 trials met the established inclusion criteria. The most common interventions employed were organizational change in 40 trials, patient education in 28 trials, and provider education in 24 trials. Fifty-two trials involved interventions employing more than one QI strategy, with a median of 2 strategies per trial and a maximum of 5. The included trials reported a median absolute reduction in HbA1c of 0.48% (interquartile range: 0.20%, 1.38%), and a median improvement in clinician adherence of 4.9% (interquartile range: 3.8%, 15.0%). Trials in the lower 2 quartiles of sample size reported substantially larger effect sizes, as did non-randomized trials, strongly suggesting the presence of publication bias, with publication of smaller non-randomized trials occurring more often when reported improvements are large. Multifaceted trials reported a median reduction in HbA1c of 0.60% (interquartile range: 0.30%, 1.40%), compared to a median reduction of 0.0% (interquartile range: -0.08%, 0.16%) for trials of a single intervention (p=0.01). The benefit of employing more than one QI strategy appeared to persist among larger, randomized trials, but the small numbers of studies limits the reliability of this impression. The investigators did not find any specific type of QI strategy to confer unambiguous benefit. Provider education and disease management were the only strategies to approach statistical significance, compared with interventions absent these strategies.
CONCLUSION: The authors' analysis of quality improvement strategies for diabetes care showed no particular type of QI to have an advantage over others, but suggested that employing at least two strategies provides a greater chance of success than single-faceted interventions, in terms of improving glycemic control or provider adherence. These conclusions are limited by probable publication bias favoring smaller trials and non-randomized trials, and the confounding presence of multiple QI strategies in a given intervention, as well as important patient and provider factors, and organizational characteristics.

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AHRQ Technical Reviews and Summaries
Authors
Douglas K. Owens
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Kernicterus, thought to be due to severe hyperbilirubinemia, is an uncommon disorder with tragic consequences, especially when it affects healthy term and near-term infants. Early identification, prevention and treatment of severe hyperbilirubinemia should make kernicterus a preventable disease. However, national epidemiologic data are needed to monitor any preventive strategies. Recommendations are provided to obtain prospective data on the prevalence and incidence of severe hyperbilirubinemia and associate mortality and neurologic injury using standardized definitions, explore the clinical characteristics and root causes of kernicterus in children identified in the Kernicterus Pilot Registry, identify and test an indicator for population surveillance, validating systems-based approaches to the management of newborn jaundice, and explore the feasibility of using biologic or genetic markers to identify infants at risk for hyperbilirubinemia. Increased knowledge about the incidence and consequences of severe hyperbilirubinemia is essential to the planning, implementation and assessment of interventions to ensure that infants discharged as healthy from their birth hospitals have a safer transition to home, avoiding morbidity due to hyperbilirubinemia and other disorders.At a recent NIHCD-sponsored conference, key questions were raised about kernicterus and the need for additional strategies for its prevention. These questions and an approach to their answers form the basis of this report.

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Journal of Perinatology
Authors
Ciaran S. Phibbs
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Background: Improving asthma knowledge and self-management is a common focus of asthma educational programs, but most programs have had little influence on morbidity outcomes. We developed a novel multiple-component intervention that included the use of an asthma education video game intended to promote adoption of asthma self-management behaviors and appropriate asthma care.

Objective: To determine the effectiveness of an asthma education video game in reducing morbidity among high-risk, school-aged children with asthma.

Methods: We enrolled 119 children aged 5 to 12 years from low-income, urban areas in and around San Francisco, CA, and San Jose, CA. Children with moderate-to-severe asthma and parental reports of significant asthma health care utilization were randomized to participate in the disease management intervention or to receive their usual care (control group). Patients were evaluated for clinical and quality-of-life outcomes at weeks 8, 32, and 52 of the study.

Results: Compared with controls, the intervention group had significant improvements in the physical domain (P = .04 and P = .01 at 32 and 52 weeks, respectively) and social activity domain (P = .02 and P = .05 at 32 and 52 weeks, respectively) of asthma quality of life on the Child Health Survey for Asthma and child (P = .02 at 8 weeks) and parent (P = .04 and .004 at 32 and 52 weeks, respectively) asthma self-management knowledge. There were no significant differences between groups on clinical outcome variables.

Conclusions: A multicomponent educational, behavioral, and medical intervention targeted at high-risk, inner-city children with asthma can improve asthma knowledge and quality of life.

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Annals of Allergy, Asthma & Immunology
Authors
Thomas N. Robinson
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STUDY OBJECTIVES: Patients with pulmonary arterial hypertension (PAH) often present with dyspnea and severe functional limitations, but their health-related quality of life (HRQOL) has not been studied extensively. This study describes HRQOL in a cohort of patients with PAH.

DESIGN: Cross-sectional study.

SETTING: A tertiary care, university hospital-based, pulmonary hypertension (PH) clinic.

PARTICIPANTS: We studied HRQOL in 53 patients with PAH (mean age, 47 years; median duration of disease, 559 days). Eighty-three percent were women, 53% received epoprostenol, and 72% reported moderate-to-severe functional limitations with a New York Heart Association class 3 or 4 at enrollment.

MEASUREMENTS AND RESULTS: We examined HRQOL by administering the Nottingham Health Profile, Congestive Heart Failure Questionnaire, and Hospital Anxiety and Depression Scale. We used the Visual Analog Scale and standard gamble (SG) techniques to measure preferences for current health (utilities). Compared with population norms, participants reported moderate-to-severe impairment in multiple domains of HRQOL, including physical mobility, emotional reaction, pain, energy, sleep, and social isolation. Mean SG utilities were 0.71, suggesting that, on average, participants were willing to accept a 29% risk of death in order to be cured of PH.

CONCLUSIONS: PAH is a devastating condition that affects predominately young women in the prime of their life. Understanding HRQOL and preferences are important in the care and management of these patients. Compared with population norms, patients with PAH have substantial functional and emotional limitations that adversely affect their HRQOL.

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Journal Publisher
Medinfo
Authors
Mary K. Goldstein
Mark A. Musen
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Objective:

Care remains suboptimal for a substantial proportion of the more than 17 million

patients in the United States with diabetes. This review examines strategies for improving the quality of care for adult type 2 diabetic patients, through changes in provider behavior and modifications to the organization of care.

Search Strategy and Inclusion Criteria: The researchers searched the MEDLINE® database, the Cochrane Collaboration's Effective Practice and Organisation of Care (EPOC) registry, article bibliographies, and relevant journals for experimental evaluations of quality improvement (QI) interventions involving outpatient care for adults with type 2 diabetes mellitus. The investigators included randomized or quasi-randomized controlled trials, controlled before/after studies, and interrupted time series in which at least one reported outcome involved changes in serum hemoglobin A1c or a measure of provider adherence to a recommended process of care.

Data Collection and Analysis:

Two reviewers independently abstracted relevant data, including classifying the components of each QI intervention as provider education, provider reminders, facilitated relay of clinical information, patient education, promotion of self management,patient reminders, audit and feedback, organizational change, or financial incentives. Certain categories were further subdivided into major subtypes (e.g., professional meetings for provider education and disease management for organizational change). The investigators also assessed the impact of clinical information systems as a mediator for interventions of all types. They compared different QI strategies in terms of the median effects achieved for glycemic control and for a generalized measure of clinician adherence. In addition, linear regression analyses were performed using methodologic features and QI types as predictors, taking into account baseline groups differences and study size.

Main Results:

Fifty-eight articles reporting a total of 66 trials met the established inclusion criteria. The most common interventions employed were organizational change in 40 trials, patient education in 28 trials, and provider education in 24 trials. Fifty-two trials involved interventions employing more than one QI strategy, with a median of 2 strategies per trial and a maximum of 5. The included trials reported a median absolute reduction in HbA1c of 0.48% interquartile range: 0.20%, 1.38%), and a median improvement in clinician adherence of 4.9% (interquartile range: 3.8%, 15.0%). Trials in the lower 2 quartiles of sample size reported substantially larger effect sizes, as did non-randomized trials, strongly suggesting the presence of publication bias, with publication of smaller non-randomized trials occurring more often when reported improvements are large. Multifaceted trials reported a median reduction in HbA1c of 0.60% (interquartile range: 0.30%, 1.40%), compared to a median reduction of 0.0% (interquartile range: -0.08%, 0.16%) for trials of a single intervention (p=0.01). The benefit of employing more than one QI strategy appeared to persist among larger, randomized trials, but the small numbers of studies limits the reliability of this impression. The investigators did not find any specific type of QI strategy to confer unambiguous benefit. Provider education and disease management were the only strategies to approach statistical significance, compared with interventions absent these strategies.

Conclusion:

The authors' analysis of quality improvement strategies for diabetes care showed no particular type of QI to have an advantage over others, but suggested that employing at least two strategies provides a greater chance of success than single-faceted interventions, in terms of improving glycemic control or provider adherence. These conclusions are limited by probable publication bias favoring smaller trials and non-randomized trials, and the confounding presence of multiple QI strategies in a given intervention, as well as important patient and provider factors, and organizational characteristics.

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Working Papers
Publication Date
Journal Publisher
Stanford-UCSF Evidence-based Practice Center, for the Agency for Healthcare Research and Quality
Authors
Douglas K. Owens
Number
AHRQ Publication No. 04-0051-2
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STUDY OBJECTIVES: Patients with pulmonary arterial hypertension (PAH) often present with dyspnea and severe functional limitations, but their health-related quality of life (HRQOL) has not been studied extensively. This study describes HRQOL in a cohort of patients with PAH.

DESIGN: Cross-sectional study.

SETTING: A tertiary care, university hospital-based, pulmonary hypertension (PH) clinic.

PARTICIPANTS: We studied HRQOL in 53 patients with PAH (mean age, 47 years; median duration of disease, 559 days). Eighty-three percent were women, 53% received epoprostenol, and 72% reported moderate-to-severe functional limitations with a New York Heart Association class 3 or 4 at enrollment.

MEASUREMENTS AND RESULTS: We examined HRQOL by administering the Nottingham Health Profile, Congestive Heart Failure Questionnaire, and Hospital Anxiety and Depression Scale. We used the Visual Analog Scale and standard gamble (SG) techniques to measure preferences for current health (utilities). Compared with population norms, participants reported moderate-to-severe impairment in multiple domains of HRQOL, including physical mobility, emotional reaction, pain, energy, sleep, and social isolation. Mean SG utilities were 0.71, suggesting that, on average, participants were willing to accept a 29% risk of death in order to be cured of PH.

CONCLUSIONS: PAH is a devastating condition that affects predominately young women in the prime of their life. Understanding HRQOL and preferences are important in the care and management of these patients. Compared with population norms, patients with PAH have substantial functional and emotional limitations that adversely affect their HRQOL.

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Journal Articles
Publication Date
Journal Publisher
Chest
Authors
Mary K. Goldstein
Mark A. Hlatky
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Purpose:

Little is known about how well clinicians are aware of their own adherence to clinical guidelines, an important indicator of quality. We compared clinicians' beliefs about their adherence to hypertension guidelines with data on their actual performance.

Methods:

We surveyed 139 primary care clinicians at three Veterans Affairs medical centers, asking them to assess their own adherence to hypertension guidelines. We then extracted data from the centers' clinical databases on guideline-concordant medication use and blood pressure control for patients cared for by these providers during a 6-month period. Data were collected for patients with hypertension and diabetes, hypertension and coronary disease, or hypertension with neither of these comorbid conditions.

Results:

Eighty-six clinicians (62%) completed the survey. Each clinician saw a median of 94 patients with hypertension (mean age, 65 years). Patients were treated with an average of 1.6 antihypertensive medications. Overall, clinicians overestimated the proportion of their patients who were prescribed guideline-concordant medications (75% perceived vs. 67% actual, P 0.001) and who had blood pressure levels 140/90 mm Hg on their last visit (68% perceived vs. 43% actual, P 0.001). Among individual clinicians, there were no significant correlations between perceived and actual guideline adherence (r = 0.18 for medications, r = 0.14 for blood pressure control; P 0.10 for both). Clinicians with relatively low actual guideline performance were most likely to overestimate their adherence to medication recommendations and blood pressure targets.

Conclusion:

Clinicians appear to overestimate their adherence to hypertension guidelines, particularly with regards to the proportion of their patients with controlled blood pressure. This limited awareness may represent a barrier to successful implementation of guidelines, and could be addressed through the use of provider profiles and point-of-service feedback to clinicians.

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American Journal of Medicine
Authors
Mary K. Goldstein
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Human papillomavirus (HPV) has been implicated as the primary etiologic agent of cervical cancer. Potential vaccines against high-risk HPV types are in clinical trials. We evaluated vaccination programs with a vaccine against HPV-16 and HPV-18. We developed disease transmission models that estimated HPV prevalence and infection rates for the population overall, by age group, by level of sexual activity within each age group, and by sex. Data were based on clinical trials and published and unpublished sources. An HPV-16/18 vaccine for 12-year-old girls would reduce cohort cervical cancer cases by 61.8%, with a cost-effectiveness ratio of $14,583 per quality-adjusted life year (QALY). Including male participants in a vaccine rollout would further reduce cervical cancer cases by 2.2% at an incremental cost-effectiveness ratio of $442,039/QALY compared to female-only vaccination. Vaccination against HPV-16 and HPV-18 can be cost-effective, although including male participants in a vaccination program is generally not cost-effective, compared to female-only vaccination.

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Emerging Infectious Diseases
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In 1999, the American College of Physicians (ACP), then the American College of Physicians-American Society of Internal Medicine, and the American College of Cardiology/American Heart Association (ACC/AHA) developed joint guidelines on the management of patients with chronic stable angina. The ACC/AHA then published an updated guideline in 2002, which ACP recognized as a scientifically valid review of the evidence and background paper. This ACP guideline summarizes the recommendations of the 2002 ACC/AHA updated guideline and underscores the recommendations most likely to be important to physicians seeing patients in the primary care setting. This guideline is the second of 2 that provide guidance on the management of patients with chronic stable angina. This document covers treatment and follow-up of symptomatic patients who have not had an acute myocardial infarction or revascularization procedure in the previous 6 months. Sections addressing asymptomatic patients are also included. Asymptomatic refers to patients with known or suspected coronary disease based on a history or electrocardiographic evidence of previous myocardial infarction, coronary angiography, or abnormal results on noninvasive tests. A previous guideline covered diagnosis and risk stratification for symptomatic patients who have not had an acute myocardial infarction or revascularization procedure in the previous 6 months and asymptomatic patients with known or suspected coronary disease based on a history or electrocardiographic evidence of previous myocardial infarction, coronary angiography, or abnormal results on noninvasive tests.

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Journal Articles
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Journal Publisher
Annals of Internal Medicine
Authors
Douglas K. Owens
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