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.

OBJECTIVE: Late-night salivary cortisol (LNSC) is reportedly highly accurate for the diagnosis of Cushing's syndrome (CS). However, diagnostic thresholds for abnormal results are based on healthy, young populations and limited data are available on its use in elderly populations with chronic medical conditions. The purpose of this study was to evaluate LNSC levels in elderly male veterans with and without diabetes.

DESIGN: Prospective evaluation of LNSC levels in male veterans.

PATIENTS: One hundred and fifty-four participants with type 2 diabetes and 52 participants without diabetes. MEASUREMENTS: Participants underwent outpatient LNSC (2300 h) testing. Participants with elevated LNSC (> or = 4.3 nmol/l) underwent secondary testing, including 24-h urine free cortisol (24UFC, > 60 microg/day) and dexamethasone suppression testing (DST, serum cortisol > 50 nmol/l). Participants with positive secondary testing had a morning ACTH level analysed and either pituitary or adrenal imaging performed.

RESULTS: One hundred and forty-one diabetics and 46 controls (mean age 61 years) returned samples (91% overall). Average LNSC levels (nmol/l) in diabetics were significantly higher than in nondiabetics [median (interquartile range): 2.6 (1.8-4.1) vs. 1.6 (1.0-2.0)] and in those aged > or = 60 compared to 60 [2.7 (2.0-4.3) vs. 1.9 (1.4-2.9)] (P 0.001 for both). Thirty-one participants required secondary testing. Seventy-nine per cent of participants who underwent secondary testing had normal 24UFC and DST. No cases of CS have been diagnosed to date. Increasing age [odds ratio (OR) 2.0 per decade], current diabetes mellitus (OR 4.4), and elevated blood pressure (OR 1.3 per 10 mmHg increase in systolic blood pressure) were associated with abnormal LNSC results (P 0.05 for each).

CONCLUSIONS: LNSC has been shown to be sensitive and specific in diagnosing CS in certain high-risk populations, primarily the young and middle-aged. The development of age- and comorbidity-adjusted thresholds may be warranted for LNSC testing in elderly subjects and in those with significant comorbidity.

People with stigmatized illnesses often avoid seeking health care and education. The internet may be a useful health education and outreach tool for this group. This study examined patterns of internet use for health information among those with and without stigmatized illnesses.

A national survey of internet users in the USA was conducted. Respondents who self-reported a stigmatized condition - defined as anxiety, depression, herpes, or urinary incontinence - were compared to respondents who reported having at least one other chronic illness, such as cancer, heart problems, diabetes, and back pain. The analytical sample consisted of 7014 respondents. Cross-sectional associations between stigmatized illness and frequency of internet use for information about health care, use of the internet for communication about health, changes in health care utilization after internet use, and satisfaction with the internet were determined.

After controlling for a number of potential confounders, those with stigmatized illnesses were significantly more likely to have used the internet for health information, to have communicated with clinicians about their condition using the internet, and to have increased utilization of health care based on information found on the internet, than those with non-stigmatized conditions. Length of time spent online, frequency of internet use, satisfaction with health information found on the internet, and discussion of internet findings with health care providers did not significantly differ between the two groups.

Results from this survey suggest that the internet may be a valuable health communication and education tool for populations who are affected by stigmatized illnesses.

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.

Objective: Hyperinsulinemia/insulin resistance is a risk factor for future type 2 diabetes. Fasting insulin and blood lipids serve as direct indicators of subsequent risk and as biochemical markers of metabolically significant adiposity. We examined the feasibility of obtaining fasting blood samples and report correlates of these biochemical markers in an understudied population sample.

Research Methods and Procedures: Fasting samples were requested from African-American girls, 8.00 to 10.99 years of age, for insulin, glucose, and lipid concentrations. Indices of insulin sensitivity and secretion were calculated and correlated with anthropometric, dietary, physical activity, and body composition data.

Results: Samples were obtained from 119 of 210 (57%) girls, varying from 5% to 86% across the four field centers. Glucose ranged from 71 to 104 mg/dL. Eleven percent had insulin concentrations >20 mU/liter. One girl had a triglyceride concentration >130 mg/dL. Thirteen percent had total cholesterol >200 mg/dL, whereas all subjects had high-density lipoprotein (HDL)-cholesterol of > or =35 mg/dL. Fourteen percent had low-density lipoprotein levels >130 mg/dL. Insulin concentrations showed consistently strong associations with measures of body weight (rs = 0.54 to 0.67); glucose, HDL, and LDL showed weaker correlations (rs = -0.11 to 0.22). Insulin concentration was highly correlated with indices of both insulin secretion and resistance (rs = 0.99).

Discussion: Fasting blood samples in young African-American girls were obtained with reasonable cooperation in three of the four field centers involved in this community-based study. Fasting insulin, glucose, LDL, and HDL concentrations may help evaluate future diabetes and cardiovascular risk in children of this age.

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.

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.