Background: The comparative effectiveness of coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) for patients in whom both procedures are feasible remains poorly understood.

Purpose: To compare the effectiveness of PCI and CABG in patients for whom coronary revascularization is clinically indicated.

Data Sources: MEDLINE, EMBASE, and Cochrane databases (1966–2006); conference proceedings; and bibliographies of retrieved articles. Study Selection: Randomized, controlled trials (RCTs) reported in any language that compared clinical outcomes of PCI with those of CABG, and selected observational studies.

Data Extraction: Information was extracted on study design, sample characteristics, interventions, and clinical outcomes.

Data Synthesis: The authors identified 23 RCTs in which 5019 patients were randomly assigned to PCI and 4944 patients were randomly assigned to CABG. The difference in survival after PCI or CABG was less than 1% over 10 years of follow-up. Survival did not differ between PCI and CABG for patients with diabetes in the 6 trials that reported on this subgroup. Procedure-related strokes were more common after CABG than after PCI (1.2% vs. 0.6%; risk difference, 0.6%; P = 0.002). Angina relief was greater after CABG than after PCI, with risk differences ranging from 5% to 8% at 1 to 5 years (P < 0.001). The absolute rates of angina relief at 5 years were 79% after PCI and 84% after CABG. Repeated revascularization was more common after PCI than after CABG (risk difference, 24% at 1 year and 33% at 5 years; P < 0.001); the absolute rates at 5 years were 46.1% after balloon angioplasty, 40.1% after PCI with stents, and 9.8% after CABG. In the observational studies, the CABG–PCI hazard ratio for death favored PCI among patients with the least severe disease and CABG among those with the most severe disease.

Limitations: The RCTs were conducted in leading centers in selected patients. The authors could not assess whether comparative outcomes vary according to clinical factors, such as extent of coronary disease, ejection fraction, or previous procedures. Only 1 small trial used drug-eluting stents.

Conclusion: Compared with PCI, CABG was more effective in relieving angina and led to fewer repeated revascularizations but had a higher risk for procedural stroke. Survival to 10 years was similar for both procedures.

Background: The comparative effectiveness of coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) for patients in whom both procedures are feasible remains poorly understood.

Purpose: To compare the effectiveness of PCI and CABG in patients for whom coronary revascularization is clinically indicated.

Data Sources: MEDLINE, EMBASE, and Cochrane databases (1966-2006); conference proceedings; and bibliographies of retrieved articles.

Study Selection: Randomized, controlled trials (RCTs) reported in any language that compared clinical outcomes of PCI with those of CABG, and selected observational studies.

Data Extraction: Information was extracted on study design, sample characteristics, interventions, and clinical outcomes.

Data Synthesis: We identified 23 RCTs in which 5019 patients were randomly assigned to PCI and 4944 patients were randomly assigned to CABG. The difference in survival after PCI or CABG was less than 1% over 10 years of follow-up. Survival did not differ between PCI and CABG for patients with diabetes in the 6 trials that reported on this subgroup. Procedural strokes were more common after CABG than after PCI (1.2% vs. 0.6%; risk difference, 0.6%; P = 0.002). Angina relief was greater after CABG than after PCI, with risk differences ranging from 5% to 8% at 1 to 5 years (P 0.001). The absolute rates of angina relief at 5 years were 79% after PCI and 84% after CABG. Repeated revascularization was more common after PCI than after CABG (risk difference, 24% at 1 year and 33% at 5 years; P 0.001); the absolute rates at 5 years were 46.1% after balloon angioplasty, 40.1% after PCI with stents, and 9.8% after CABG. In the observational studies, the CABG-PCI hazard ratio for death favored PCI among patients with the least severe disease and CABG among those with the most severe disease.

Limitations: The RCTs were conducted in leading centers in selected patients. The authors could not assess whether comparative outcomes vary according to clinical factors, such as extent of coronary disease, ejection fraction, or previous procedures. Only 1 small trial used drug-eluting stents.

Conclusion: Compared with PCI, CABG was more effective in relieving angina and led to fewer repeated revascularizations but had a higher risk for procedural stroke. Survival to 10 years was similar for both procedures.

We also explored the association between the number of antihypertensives and systolic, diastolic, and pulse pressure. After 15 months, 41% of participants met blood pressure targets. CKD was not associated with control (adjusted odds ratio: 1.04; 95% CI: 0.93 to 1.15). However, CKD was associated with higher odds of use of ≥3 medications among nondiabetic subjects (odds ratio: 1.46; 95% CI: 1.25 to 1.71) and diabetic subjects (odds ratio: 1.40; 95% CI: 1.17 to 1.66). A significant interaction was observed between CKD and the number of antihypertensives as determinants of diastolic and pulse pressures. Among non-CKD participants, a greater number of antihypertensives (0 compared with 4) was associated with wider pulse pressure ({Delta}5.2 mm Hg; P<0.001), mainly because of higher systolic pressures ({Delta}3.6 mm Hg; P=0.001).

Among participants with CKD, although greater numbers of antihypertensives were associated with even wider pulse pressures ({Delta}8.3 mm Hg; P<0.001), this was primarily because of lower diastolic pressures ({Delta}4.8 mm Hg; P<0.01). Among participants with CKD, greater use of antihypertensives was associated with lower diastolic pressures. Given recent evidence suggesting adverse effects of diastolic hypotension, these results suggest potential risks in patients with CKD from aggressive attempts to control systolic blood pressure.

CONTEXT: Quality problems and spiraling costs have resulted in widespread interest in solutions that improve the effectiveness and efficiency of the health care system. Care coordination has been identified by the Institute of Medicine as one of the key strategies for potentially accomplishing these improvements.

OBJECTIVES: The objectives of this project were to develop a working definition of care coordination, apply it to a review of systematic reviews, and identify theoretical frameworks that might predict or explain how care coordination mechanisms are influenced by factors in the health care setting and how they relate to patient outcomes and health care costs.

DATA SOURCES AND REVIEW METHODS: We used literature databases, Internet searches, and personal contacts to assemble background information on ongoing care coordination programs; potential definitions; conceptual frameworks and related empirical evidence; and care coordination measures. We also conducted literature searches through September 30, 2006 of MEDLINE®, and November 15, 2006 for CINAHL®, Cochrane database of systematic reviews, American College of Physicians Journal Club, Database of Abstracts of Reviews of Effects, PsychInfo, Sociological Abstracts, and Social Services Abstracts to identify systematic reviews of care coordination interventions. We excluded systematic reviews with a narrow focus, namely those conducted solely in the inpatient setting, or where the only two participants involved in care were the patient and a health care provider.

RESULTS: We identified numerous ongoing programs in the private and public sector, most of which have not yet been evaluated. We identified over 40 definitions of care coordination and related terminology, and developed a working definition drawing together common elements: Care coordination is the deliberate organization of patient care activities between two or more participants (including the patient) involved in a patient's care to facilitate the appropriate delivery of health care services. Organizing care involves the marshalling of personnel and other resources needed to carry out all required patient care activities, and is often managed by the exchange of information among participants responsible for different aspects of care. We used this definition to develop our inclusion/exclusion criteria for selecting potentially relevant systematic reviews. Our literature search yielded 4,730 publications, of which 75 systematic reviews evaluating care coordination interventions, either fully or as a part of the review, met inclusion criteria. From these, we identified 20 different coordination interventions (e.g., multidisciplinary teams, case management, disease management) covering 12 clinical populations (e.g., mental health, heart disease, diabetes) and conducted in multiple settings (e.g., outpatient, community, home). Finally, we identified four conceptual frameworks (Andersen's behavioral framework, Donabedian's structure-process-outcome framework, Nadler/Tushman and others' Organizational design framework with Wagner's Chronic Care Model provided as an example of such design, and Gittell's Relational coordination framework) with potential applicability to studying care coordination by assessing baseline characteristics of the environment, specific coordination mechanism alternatives, and outcomes. The strongest evidence shows benefit of care coordination interventions for patients who have congestive heart failure, diabetes mellitus, severe mental illness, a recent stroke, or depression, though evidence about key intervention components is lacking.

CONCLUSIONS: Care coordination interventions represent a wide range of approaches at the service delivery and systems level. Their effectiveness is most likely dependent upon appropriate matching between intervention and care coordination problem, though more conceptual, empirical and experimental research is required to explore this hypothesis.

Context: Quality problems and spiraling costs have resulted in widespread interest in solutions that improve the effectiveness and efficiency of the health care system. Care coordination has been identified by the Institute of Medicine as one of the key strategies for potentially accomplishing these improvements.

Objectives: The objectives of this project were to develop a working definition of care coordination, apply it to a review of systematic reviews, and identify theoretical frameworks that might predict or explain how care coordination mechanisms are influenced by factors in the health care setting and how they relate to patient outcomes and health care costs.

Data Sources and Review Methods: We used literature databases, Internet searches, and personal contacts to assemble background information on ongoing care coordination programs; potential definitions; conceptual frameworks and related empirical evidence; and care coordination measures. We also conducted literature searches through September 30, 2006, of MEDLINE®, and November 15, 2006, for CINAHL®, Cochrane database of systematic reviews, American College of Physicians Journal Club, Database of Abstracts of Reviews of Effects, PsychInfo, Sociological Abstracts, and Social Services Abstracts to identify systematic reviews of care coordination interventions. We excluded systematic reviews with a narrow focus, namely those conducted solely in the inpatient setting, or where the only two participants involved in care were the patient and a health care provider.

Results: We identified numerous ongoing programs in the private and public sector, most of which have not yet been evaluated. We identified over 40 definitions of care coordination and related terminology, and developed a working definition drawing together common elements:

Care coordination is the deliberate organization of patient care activities between two or more participants (including the patient) involved in a patient's care to facilitate the appropriate delivery of health care services. Organizing care involves the marshalling of personnel and other resources needed to carry out all required patient care activities, and is often managed by the exchange of information among participants responsible for different aspects of care.

We used this definition to develop our inclusion/exclusion criteria for selecting potentially relevant systematic reviews. Our literature search yielded 4,730 publications, of which 75 systematic reviews evaluating care coordination interventions, either fully or as a part of the review, met inclusion criteria. From these, we identified 20 different coordination interventions (e.g., multidisciplinary teams, case management, disease management) covering 12 clinical populations (e.g., mental health, heart disease, diabetes) and conducted in multiple settings (e.g., outpatient, community, home). Finally, we identified four conceptual frameworks (Andersen's behavioral framework, Donabedian's structure-process-outcome framework, Nadler/Tushman and others' Organizational design framework with Wagner's Chronic Care Model provided as an example of such design, and Gittell's Relational coordination framework) with potential applicability to studying care coordination by assessing baseline characteristics of the environment, specific coordination mechanism alternatives, and outcomes.

The strongest evidence shows benefit of care coordination interventions for patients who have congestive heart failure, diabetes mellitus, severe mental illness, a recent stroke, or depression, though evidence about key intervention components is lacking.

Conclusions: Care coordination interventions represent a wide range of approaches at the service delivery and systems level. Their effectiveness is most likely dependent upon appropriate matching between intervention and care coordination problem, though more conceptual, empirical and experimental research is required to explore this hypothesis.

Background

Human growth hormone (GH) is widely used as an antiaging therapy, although its use for this purpose has not been approved by the U.S. Food and Drug Administration and its distribution as an antiaging agent is illegal in the United States.

Purpose

To evaluate the safety and efficacy of GH therapy in the healthy elderly.

Data Sources

The authors searched MEDLINE and EMBASE databases for English-language studies published through 21 November 2005 by using such terms as growth hormone and aging.

Study Selection

The authors included randomized, controlled trials that compared GH therapy with no GH therapy or GH and lifestyle interventions (exercise with or without diet) with lifestyle interventions alone. Included trials provided GH for 2 weeks or more to community-dwelling participants with a mean age of 50 years or more and a body mass index of 35 kg/m2 or less. The authors excluded studies that evaluated GH as treatment for a specific illness.

Data Extraction

Two authors independently reviewed articles and abstracted data.

Data Synthesis

31 articles describing 18 unique study populations met the inclusion criteria. A total of 220 participants who received GH (107 person-years) completed their respective studies. Study participants were elderly (mean age, 69 years [SD, 6]) and overweight (mean body mass index, 28 kg/m^2 [SD, 2]). Initial daily GH dose (mean, 14 µg per kg of body weight [SD, 7]) and treatment duration (mean, 27 weeks [SD, 16]) varied. In participants treated with GH compared with those not treated with GH, overall fat mass decreased (change in fat mass, -2.1g [95% CI, -2.8 to -1.35] and overall lean body mass increased (change in lean body mass, 2.1 kg [CI, 1.3 to 2.9]) (P 0.001), and their weight did not change significantly (change in weight, 0.1 kg [CI, -0.7 to 0.8]; P = 0.87). Total cholesterol levels decreased (change in cholesterol, -0.29 mmol/L [-11.21 mg/dL]; P = 0.006), although not significantly after adjustment for body composition changes. Other outcomes, including bone density and other serum lipid levels, did not change. Persons treated with GH were significantly more likely to experience soft tissue edema, arthralgias, carpal tunnel syndrome, and gynecomastia and were somewhat more likely to experience the onset of diabetes mellitus and impaired fasting glucose.

Limitations

Some important outcomes were infrequently or heterogeneously measured and could not be synthesized. Most included studies had small sample sizes.

Conclusions

The literature published on randomized, controlled trials evaluating GH therapy in the healthy elderly is limited but suggests that it is associated with small changes in body composition and increased rates of adverse events. On the basis of this evidence, GH cannot be recommended as an antiaging therapy.

Context:

There have been numerous reports of interventions designed to improve the care of patients with diabetes, but the effectiveness of such interventions is unclear.

Objective:

To assess the impact on glycemic control of 11 distinct strategies for quality improvement (QI) in adults with type 2 diabetes.

Data Sources and Study Selection:

MEDLINE (1966-April 2006) and the Cochrane Collaboration's Effective Practice and Organisation of Care Group database, which covers multiple bibliographic databases. Eligible studies included randomized or quasi-randomized controlled trials and controlled before-after studies that evaluated a QI intervention targeting some aspect of clinician behavior or organizational change and reported changes in glycosylated hemoglobin (HbA1c) values.

Data Extraction:

Postintervention difference in HbA1c values were estimated using a meta-regression model that included baseline glycemic control and other key intervention and study features as predictors.

Data Synthesis:

Fifty randomized controlled trials, 3 quasi-randomized trials, and 13 controlled before-after trials met all inclusion criteria. Across these 66 trials, interventions reduced HbA1c values by a mean of 0.42% (95% confidence interval [CI], 0.29%-0.54%) over a median of 13 months of follow-up. Trials with fewer patients than the median for all included trials reported significantly greater effects than did larger trials (0.61% vs 0.27%, P = .004), strongly suggesting publication bias. Trials with mean baseline HbA1c values of 8.0% or greater also reported significantly larger effects (0.54% vs 0.20%, P = .005). Adjusting for these effects, 2 of the 11 categories of QI strategies were associated with reductions in HbA1c values of at least 0.50%: team changes (0.67%; 95% CI, 0.43%-0.91%; n = 26 trials) and case management (0.52%; 95% CI, 0.31%-0.73%; n = 26 trials); these also represented the only 2 strategies conferring significant incremental reductions in HbA1c values. Interventions involving team changes reduced values by 0.33% more (95% CI, 0.12%-0.54%; P = .004) than those without this strategy, and those involving case management reduced values by 0.22% more (95% CI, 0.00%-0.44%; P = .04) than those without case management. Interventions in which nurse or pharmacist case managers could make medication adjustments without awaiting physician authorization reduced values by 0.80% (95% CI, 0.51%-1.10%), vs only 0.32% (95% CI, 0.14%-0.49%) for all other interventions (P = .002).

Conclusions:

Most QI strategies produced small to modest improvements in glycemic control. Team changes and case management showed more robust improvements, especially for interventions in which case managers could adjust medications without awaiting physician approval. Estimates of the effectiveness of other specific QI strategies may have been limited by difficulty in classifying complex interventions, insufficient numbers of studies, and publication bias.

Background:

Emerging evidence indicates that patients with mental health conditions (MHCs) may receive less intensive medical care. Diabetes serves as a useful condition in which to test for MHC-related disparities in care. We examined whether quality measures for diabetes care are worse for patients with or without MHCs.

Methods:

This national, cross-sectional study included 313 586 noninstitutionalized Veterans Health Administration patients with diabetes (identified from diagnostic codes and prescriptions) whose Veterans Health Administration facility transmitted laboratory data to a central database; 76 799 (25%) had MHCs (based on diagnostic codes for depressed mood, anxiety, psychosis, manic symptoms, substance use disorders, personality disorders, and other categories). National data from Veterans Health Administration records, Medicare claims, and a national survey were linked to characterize 1999 diabetes care.

Results:

Failure to meet diabetes performance measures was more common in patients with MHCs: unadjusted odds ratio (95% confidence interval) was 1.24 (1.22-1.27) for no hemoglobin A1c testing, 1.25 (1.23-1.28) for no low-density lipoprotein cholesterol testing, 1.05 (1.03-1.07) for no eye examination, 1.32 (1.30-1.35) for poor glycemic control, and 1.17 (1.15-1.20) for poor lipemic control. Disparities persisted after case mix adjustment and were more pronounced with specific MHCs (psychotic, manic, substance use, and personality disorders). The percentage not meeting diabetes care standards increased with increasing number of MHCs.

Conclusion:

Patients with mental illness merit special attention in national diabetes quality improvement efforts.