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.

Background: Thrombolytic therapy is controversial in patients with submassive pulmonary embolism.

Methods: We performed a cost-effectiveness analysis to compare health effects and costs of treatment with alteplase plus heparin sodium vs heparin alone in hemodynamically stable patients with pulmonary embolism and right ventricular dysfunction by developing a Markov model and using data from clinical trials and administrative sources.

Results: Based on data from a recent randomized trial, we assumed that the risk of clinical deterioration requiring treatment escalation was almost 3 times higher in patients who received heparin alone (23.2% vs 7.6%) but that the risk of death was equal in the 2 cohorts (2.7%). Based on registry data, we assumed that the risk of intracranial hemorrhage was approximately 3 times higher in patients who received alteplase plus heparin (1.2% vs 0.4%). Under these and other assumptions, thrombolysis resulted in marginally higher total lifetime health care costs ($43,900 vs $43,300) and was slightly less effective (10.52 vs 10.57 quality-adjusted life-years) than treatment with heparin alone. Thrombolysis was more effective and cost less than $50,000 per quality-adjusted life-year gained when we assumed that the baseline risk of death in the heparin group was 3 times the base-case value (8.1%) and that alteplase reduced the relative risk of death by at least 10%.

Conclusions: Available data do not support the routine use of thrombolysis to treat patients with submassive pulmonary embolism. However, thrombolysis may prove to be cost-effective in selected subgroups of hemodynamically stable patients in whom the risk of death is higher.

Background: Health-related quality of life is decreased in patients with GERD and Barrett's esophagus (BE).

Objective: To determine whether time-tradeoff (TTO) values would differ in patients with BE when patients were asked to trade away the potential risk of esophageal adenocarcinoma rather than chronic heartburn symptoms.

Design: A prospective clinical trial.

Patients: Subjects with biopsy-proven BE.

Interventions: Custom-designed computer program to elicit health-state utility values, quality of life in reflux and dyspepsia (QOLRAD), and Medical Outcomes Survey short form-36 surveys.

Main Outcome Measurements: TTO utility values for the annual cancer-risk–associated current health state and for hypothetical scenarios of dysplasia and esophageal cancer.

Results: We studied 60 patients in the cancer-risk cohort (57 men, 92% veteran; mean age [standard deviation; SD], 65 years [11 years], mean GERD duration 17 years [12 years]). The heartburn cohort included 40 patients with GERD and BE with TTO values derived for GERD symptoms. The mean (SD) utility for nondysplastic BE was 0.91 (0.13) compared with 0.90 (0.12) for the heartburn cohort (P = .7). The mean utility values were significantly lower for scenarios of low-grade dysplasia (0.85 [0.12], P = .02) and high-grade dysplasia (0.77 [0.14], P < .005). The mean TTO was 0.67 (0.19) for the scenario of esophageal cancer. There was no correlation between the utility scores and the disease-specific survey scores.

Aim: This study compared matched samples of substance use disorder (SUD) patients in Swiss and United States (US) residential treatment programs and examined the relationship of program characteristics to patients' substance use and psychosocial functioning at a 1-year follow-up.

Design and Setting: The study used a prospective, naturalistic design and a sample of 10 public programs in the German-speaking part of Switzerland and 15 US public treatment programs.

Participants: A total of 358 male patients in Swiss programs were matched on age, marital status and education with 358 male patients in US programs. A total of 160 Swiss and 329 US patient care staff members also participated.

Measurement: Patients completed comparable inventories at admission, discharge and 1-year follow-up to assess their substance use and psychological functioning and receipt of continuing care. Staff members reported on program characteristics and their beliefs about substance use.

Findings: Compared to Swiss patients, US patients had more severe substance use and psychological problems at intake and although they did not differ on abstinence and remission at follow-up, had somewhat poorer outcomes in other areas of functioning. Swiss programs were longer and included more individual treatment sessions; US programs included more group sessions and were more oriented toward a disease model of treatment. Overall, length of program, treatment intensity and 12-step orientation were associated with better 1-year outcomes for patients in both Swiss and US programs.

Conclusions: The sample of Swiss and US programs studied here differed in patient and treatment characteristics; however, in general, there were comparable associations between program characteristics and patients' 1-year outcomes. These findings suggest that associations between treatment processes and patients' outcomes may generalize from one cultural context to another.

Context: Child psychosocial issues and maternal depression are underidentified and undertreated, but we know surprisingly little about the barriers to identification and treatment of these problems by primary care pediatricians.

Objectives: The purpose of this work was to determine whether (1) perceived barriers to care for children's psychosocial issues and maternal depression aggregate into patient, physician, and organizational domains, (2) barrier domains are distinct for mothers and children, and (3) physician, patient, and practice/organizational characteristics are associated with different barrier domains for children and mothers.

Methods: We conducted a cross-sectional survey of the 50,818 US nonretired members of the American Academy of Pediatrics. Of a random sample of 1600 members, 832 (745 nontrainee members) responded. This was a mailed 8-page survey with no patients and no intervention. We measured physician assessment of barriers to providing psychosocial care for children's psychosocial problems and maternal depression.

Results: Pediatricians frequently endorse the lack of time to treat mental health problems (77.0%) and long waiting periods to see mental health providers (74.0%) as the most important barriers to the identification and treatment of children's psychosocial problems. For maternal depression, pediatricians most often endorsed lack of training in treatment (74.5%) and lack of time to treat (64.3%) as important barriers. Pediatricians' reports of barriers clustered into physician and organizational domains. Physician domains were distinct for children and mothers, but organizational domains were not. Several physician and practice characteristics are significantly associated with the 4 barrier scales, and different characteristics (eg, sociodemographic, attitudinal, and practice features) were related to each barrier area.

Conclusions: Pediatricians endorse a wide range of barriers with respect to the diagnosis and treatment of children's mental health problems and maternal depression. The specificity of factors relating to various barrier areas suggests that overcoming barriers to the identification and treatment of child mental health problems and maternal depression in primary care pediatrics is likely to require a multifaceted approach that spans organizational, physician, and patient issues. In addition, comprehensive interventions will likely require social marketing approaches designed to engage diverse audiences of clinicians and their patients to participate.

Objective: To determine the effects of quality improvement strategies on promoting adherence to interventions for prevention of selected (surgical site infections (SSI), central line-associated bloodstream infections (CLABSI), ventilator-associated pneumonia (VAP), and catheterassociated urinary tract infections (CAUTI)) healthcare-associated infections (HAIs), and on HAI rates.

Data Sources: MEDLINE® and Cochrane Collaboration's Effective Practice and Organisation of Care registry. We also reviewed the reference lists of systematic reviews and included studies, and contacted experts.

Search Strategy and Inclusion Criteria: We included randomized and quasi-randomized controlled trials, controlled before-after studies, interrupted time series, and simple before-after studies that reported either HAI rates or rates of adherence to target preventive quality improvement (QI) interventions for any of the four target HAIs. QI strategies were classified as clinician education, patient education, audit and feedback, clinician reminders, organizational change (including revision of professional roles, staffing changes, and total quality management/continuous quality improvement), and financial or regulatory incentives. We targeted hand hygiene as a preventive intervention for all HAIs. The target preventive interventions specific to SSI were appropriate perioperative antibiotic prophylaxis (including appropriate antibiotic selection, timing, and duration), perioperative glucose control, and decreasing shaving of the operative site. For CLABSI, we targeted adherence to maximal sterile barrier precautions, use of chlorhexidine for skin antisepsis, and avoidance of femoral catheterization. For VAP, we targeted semirecumbent patient positioning and daily assessment of readiness for ventilator weaning. For CAUTI, we targeted reduction in unnecessary catheter use and adherence to aseptic catheter insertion and catheter care. Our primary outcomes were the rate of HAI (defined as infections per 100 cases for SSI and infections per 1,000 device-days for CLABSI, VAP, and CAUTI) and the rate of adherence to preventive interventions (defined as the percentage of patients at risk who received the preventive intervention). Secondary outcomes included effects on costs and adverse effects associated with the interventions.

Data Collection and Analysis: Two reviewers independently abstracted data. Due to heterogeneity in study populations, QI strategies, preventive interventions, and outcomes, no formal quantitative analysis was attempted. We assessed study quality based on prespecified criteria for internal and external validity.

Main Results: Sixty-four studies met all inclusion criteria; 28 studies addressed prevention of SSI, 19 CLABSI prevention, 12 VAP prevention, and 10 CAUTI prevention. Three studies targeted prevention of multiple HAIs. The study methodologic quality was generally poor, as 52 of 64 included studies were simple before-after studies, and most of these (33 of 52) reported data at only one time point before and after the intervention. The majority of included studies reported infection rates, but did not report rate of adherence to preventive interventions. Baseline HAI rates were generally above the median rates reported by the Centers for Disease Control and Prevention's National Nosocomial Infection Surveillance System (NNIS).

• Studies addressing surgical site infections: The majority of studies targeted provision of appropriate antibiotic prophylaxis (22 of 28 studies), using combinations of educational interventions, audit and feedback, and clinician reminders. Sixteen of these studies reported data on adherence to appropriate antibiotic prophylaxis guidelines. Clinician reminders were effective at improving appropriate prophylaxis in two controlled studies; educational interventions with audit and feedback were effective in three multicenter studies (two interrupted time series and one simple before-after study.) No QI strategies were clearly effective at reducing SSI rates or improving adherence to other targeted preventive interventions.
• Studies addressing central line-associated bloodstream infection: Active educational interventions for clinicians appeared effective at reducing CLABSI rates, based on two controlled before-after studies, one interrupted time series, and four simple before-after studies of relatively good methodologic quality. Two of these studies combined education with an explicit checklist for adherence to insertion site practices and allowed nurses to stop the procedure if the checklist was not followed, a strategy worthy of future study.
• Studies addressing ventilator-associated pneumonia: Active educational interventions (including use of Web-based and video tutorials) appeared to reduce VAP rates, based on evidence from two simple before-after studies. Conclusions in this area are especially limited as we did not identify any controlled studies.
• Studies addressing catheter-associated urinary tract infection: Printed or computer-based reminders to physicians, coupled with an "automatic stop order", appear to be effective at reducing the duration of urethral catheterization (based on two controlled studies and three simple before-after studies.)

• Use of printed or computer-based reminders with automatic stop orders to reduce unnecessary urethral catheterization.
• Printed or computer-based reminders to improve surgical antibiotic prophylaxis
• Active educational interventions with use of of checklists to improve adherence to central line insertion practices
• Active educational interventions such as tutorials to improve adherence to preventive interventions for ventilator-associated pneumonia.

Background: Accumulating evidence indicates that addiction and psychiatric treatment programs that actively promote self-help group involvement can reduce their patients' health care costs in the first year after treatment, but such initially impressive effects may wane over time. This paper examines whether the positive clinical outcomes and reduced health care costs evident 1 year after treatment among substance-dependent patients who were strongly encouraged to attend 12-step self-help groups were sustained at 2-year follow-up.

Methods: A 2-year quasi-experimental analysis of matched samples of male substance-dependent patients who were treated in either 12-step-based (n=887 patients) or cognitive-behavioral (CB, n=887 patients) treatment programs. The 12-step-based programs placed substantially more emphasis on 12-step concepts, had more staff members "in recovery," had a more spiritually oriented treatment environment, and promoted self-help group involvement much more extensively than did the CB programs. The 2-year follow-up assessed patients' substance use, psychiatric functioning, self-help group affiliation, and mental health care utilization and costs.

Results: As had been the case in the 1-year follow-up of this sample, the only difference in clinical outcomes was a substantially higher abstinence rate among patients treated in 12-step (49.5%) versus CB (37.0%) programs. Twelve-step treatment patients had 50 to 100% higher scores on indices of 12-step self-help group involvement than did patients from CB programs. In contrast, patients from CB programs relied significantly more on outpatient and inpatient mental health services, leading to 30% lower costs in the 12-step treatment programs. This was smaller than the difference in cost identified at 1 year, but still significant ($2,440 per patient, p=0.01).

Conclusions: Promoting self-help group involvement appears to improve posttreatment outcomes while reducing the costs of continuing care. Even cost offsets that somewhat diminish over the long term can yield substantial savings. Actively promoting self-help group involvement may therefore be a useful clinical practice for helping addicted patients recover in a time of constrained fiscal resources.

Objective: To obtain information about health outcomes in neonates in 9 subgroups of the Asian population in the United States.

Design: Cross-sectional comparison of outcomes for births to mothers of Cambodian, Chinese, Filipino, Indian, Japanese, Korean, Laotian, Thai, and Vietnamese origin and for births to non-Hispanic white mothers. Regression models were used to compare neonatal mortality across groups before and after controlling for various risk factors.

Setting: All California births between January 1,1991, and December 31, 2001.

Participants: More than 2.3 million newborn infants.

Main Exposure: Racial and ethnic groups.

Main Outcome Measure: Neonatal mortality (death within 28 days of birth).

Results: The unadjusted mortality rate for births to non-Hispanic white mothers was 2.0 per 1000. The unadjusted mortality rate for births to Chinese and Japanese mothers was significantly lower (Chinese: 1.2 per 1000, P.001; Japanese: 1.2 per 1000, P=.004), and for births to Korean mothers the rate was significantly higher (2.7 per 1000, P=.003). For infants of Chinese mothers, observed risk factors explain the differences observed in unadjusted data. For infants of Cambodian, Japanese, Korean, and Thai mothers, differences persist or widen after risk factors are considered. After risk adjustment, infants of Cambodian, Japanese, and Korean mothers have significantly lower neonatal mortality rates compared with infants born to non-Hispanic white mothers (adjusted odds ratios, 0.58 for infants of Cambodian mothers, 0.67 for infants of Japanese mothers, and 0.69 for infants of Korean mothers; all P.05); infants of Thai mothers have higher neonatal mortality rates (adjusted odds ratio, 1.89; P.05).

Conclusions: There are significant variations in neonatal mortality between subgroups of the Asian American population that are not entirely explained by differences in observable risk factors. Efforts to improve clinical care that treat Asian Americans as a homogeneous group may miss important opportunities for improving infant health in specific subgroups.

Public-private partnerships have become a common approach to health care problems worldwide. Many public-private partnerships were created during the late 1990s, but most were focused on specific diseases such as HIV/AIDS, tuberculosis, and malaria.

Recently there has been enthusiasm for using public-private partnerships to improve the delivery of health and welfare services for a wider range of health problems, especially in developing countries. The success of public-private partnerships in this context appears to be mixed, and few data are available to evaluate their effectiveness.

This analysis provides an overview of the history of health-related public-private partnerships during the past 20 years and describes a research protocol commissioned by the World Health Organization to evaluate the effectiveness of public-private partnerships in a research context.