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Biomedical subjects

Larry R Muenz

Publications and source records attributed to Larry R Muenz.

11 recordsLinked to original sources

Laying the foundation for Connect to Protect: a multi-site community mobilization intervention to reduce HIV/AIDS incidence and prevalence among urban youth.

Despite the considerable resources that have been dedicated to HIV prevention interventions and services over the past decade, HIV incidence among young people in the United States remains alarmingly high. One reason is that the majority of prevention efforts continue to focus solely on modifying individual behavior, even though public health research strongly suggests that changes to a community's structural elements, such as their programs, practices, and laws or policies, may result in more effective and sustainable outcomes. Connect to Protect is a multi-city community mobilization intervention that focuses on altering or creating community structural elements in ways that will ultimately reduce youth HIV incidence and prevalence. The project, which spans 6 years, is sponsored by the Adolescent Medicine Trials Network for HIV/AIDS Interventions at multiple urban clinical research sites. This paper provides an overview of the study's three phases and describes key factors in setting a firm foundation for the initiation and execution of this type of undertaking. Connect to Protect's community mobilization approach to achieving structural change represents a relatively new and broad direction in HIV prevention research. To optimize opportunities for its success, time and resources must be initially placed into laying the groundwork. This includes activities such as building a strong overarching study infrastructure to ensure protocol tasks can be met across sites; tapping into local site and community expertise and knowledge; forming collaborative relationships between sites and community organizations and members; and fostering community input on and support for changes at a structural level. Failing to take steps such as these may lead to insurmountable implementation problems for an intervention of this kind.

Adolescent↗

Follow-up of 89 asymptomatic patients with adrenoleukodystrophy treated with Lorenzo's oil.

OBJECTIVES: To identify asymptomatic boys with X-linked adrenoleukodystrophy who have a normal magnetic resonance image (MRI), and to assess the effect of 4:1 glyceryl trioleate-glyceryl trierucate (Lorenzo's oil) on disease progression. METHOD: Eighty-nine boys (mean +/- SD baseline age, 4.7 +/- 4.1 years; range, 0.2-15 years) were identified by a plasma very long-chain fatty acids assay used to screen at-risk boys. All were treated with Lorenzo's oil and moderate fat restriction. Plasma fatty acids and clinical status were followed for 6.9 +/- 2.7 years. Changes in plasma hexacosanoic acid levels were assessed by measuring the length-adjusted area under the curve, and a proportional hazards model was used to evaluate association with the development of abnormal MRI results and neurological abnormalities. RESULTS: Of the 89 boys, 24% developed MRI abnormalities and 11% developed both neurological and MRI abnormalities. Abnormalities occurred only in the 64 patients who were aged 7 years or younger at the time therapy was started. There was significant association between the development of MRI abnormalities and a plasma hexacosanoic acid increase. (For a 0.1-microg/mL increase in the length-adjusted area under the curve for the hexacosanoic acid level, the hazard ratio for incident MRI abnormalities in the whole group was 1.36; P = .01; 95% confidence interval, 1.07-1.72.) Results for patients aged 7 years or younger were similar (P = .04). CONCLUSIONS: In this single-arm study, hexacosanoic acid reduction by Lorenzo's oil was associated with reduced risk of developing MRI abnormalities. We recommend Lorenzo's oil therapy in asymptomatic boys with X-linked adrenoleukodystophy who have normal brain MRI results.

Adrenoleukodystrophy↗

Longitudinal antiretroviral adherence among adolescents infected with human immunodeficiency virus.

OBJECTIVES: To longitudinally follow a cohort of adolescents with human immunodeficiency virus (HIV) and to investigate long-term antiretroviral therapy adherence and factors associated with adherence. DESIGN, SETTING, AND PATIENTS: Adolescents infected with HIV (N = 231; mean age, 18.4 years; 72.7% female; 74.9% African American) from 13 cities throughout the United States were assessed at 3-month intervals. MAIN OUTCOME MEASURES: Self-reported adherence measures were validated by comparison with HIV-1 RNA viral load, and behavioral factors that may be associated with antiretroviral therapy adherence were assessed. RESULTS: At the initial visit, approximately 69% of the adolescents reported being adherent to antiretroviral therapy. Adolescents in the later HIV disease stage were less likely to be adherent compared with those in the earlier disease stage. Less alcohol use and being in school were associated with adherence by adolescents on weekends and over the preceding month. Longitudinal adherence was investigated among 65 subjects initially adherent with available information for at least 4 consecutive visits. The median time to nonadherence was 12 months, and failure to maintain adherence was significantly associated with younger age and depression. Among adolescents who attained an undetectable viral load, only about 50% maintained an undetectable viral load for the year. CONCLUSIONS: These findings indicate an urgent need for better interventions to assist adolescents with HIV in adhering to their medication regimens. Adolescents with advanced disease are likely to need more intervention. New treatments recently found effective for adolescent depression may assist in improving adherence for a majority of adolescents with HIV.

Adolescent↗

Dose sparing with intradermal injection of influenza vaccine.

BACKGROUND: The loss of half the U.S. supply of influenza vaccine due to contamination has created a critical shortage. Dose-sparing strategies that use intradermal delivery of vaccines may be one approach to consider. METHODS: We conducted a randomized, open-label trial outside the influenza season in 100 healthy adults 18 to 40 years of age to compare the immunogenicity and safety of intradermal immunization with influenza vaccine with standard intramuscular immunization. Subjects were randomly assigned to receive either a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microg of hemagglutinin per strain, by means of a prefilled syringe or a single intradermal dose of 0.1 ml, containing at least 3 microg of hemagglutinin per strain, by means of a fine-gauge needle; both injections were in the deltoid region. Changes in the hemagglutination-inhibition (HAI) antibody titer were assessed by comparing geometric mean titers and fold increases relative to baseline values and by comparing changes in the seroconversion and seroprotection rates. Local and systemic adverse events were assessed after both types of vaccination. RESULTS: Subjects who received an intradermal injection with one fifth the standard dose of influenza vaccine had increases in the geometric mean HAI titer by a factor of 15.2 for the H1N1 strain in the vaccine, 19.0 for the H3N2 strain, and 12.4 for the B strain on day 21, as compared with respective increases by a factor of 14.9, 7.1, and 15.3 for the intramuscular injection of the standard dose. Seroconversion and seroprotection rates were similar in the two groups on day 21, ranging from 66 to 82 percent and 84 to 100 percent, respectively. Local reactions were significantly more frequent among recipients of intradermal injections than among recipients of intramuscular injections, but such reactions were mild and transient. CONCLUSIONS: In this study of young adults, intradermal administration of one fifth the standard intramuscular dose of an influenza vaccine elicited immunogenicity that was similar to or better than that elicited by intramuscular injection. Intradermal administration could be used to expand the supplies of influenza vaccine, but further studies are needed before this strategy can be recommended for routine use.

Adolescent↗

Treatment of hyperphosphatemia in hemodialysis patients: The Calcium Acetate Renagel Evaluation (CARE Study).

BACKGROUND: Hyperphosphatemia underlies development of hyperparathyroidism, osteodystrophy, extraosseous calcification, and is associated with increased mortality in hemodialysis patients. METHODS: To determine whether calcium acetate or sevelamer hydrochloride best achieves recently recommended treatment goals of phosphorus </=5.5 mg/dL and Ca x P product </=55 mg(2)/dL(2), we conducted an 8-week randomized, double-blind study in 100 hemodialysis patients. RESULTS: Comparisons of time-averaged concentrations (weeks 1 to 8) demonstrated that calcium acetate recipients had lower serum phosphorus (1.08 mg/dL difference, P= 0.0006), higher serum calcium (0.63 mg/dL difference, P < 0.0001), and lower Ca x P (6.1 mg(2)/dL(2) difference, P= 0.022) than sevelamer recipients. At each week, calcium acetate recipients were 20% to 24% more likely to attain goal phosphorus [odds ratio (OR) 2.37, 95% CI 1.28-4.37, P= 0.0058], and 15% to 20% more likely to attain goal Ca x P (OR 2.16, 95% CI 1.20-3.86, P= 0.0097). Transient hypercalcemia occurred in 8 of 48 (16.7%) calcium acetate recipients, all of whom received concomitant intravenous vitamin D. By regression analysis hypercalcemia was more likely with calcium acetate (OR 6.1, 95% CI 2.8-13.3, P < 0.0001). Week 8 intact PTH levels were not significantly different. Serum bicarbonate levels were significantly lower with sevelamer hydrochloride treatment (P < 0.0001). CONCLUSION: Calcium acetate controls serum phosphorus and calcium-phosphate product more effectively than sevelamer hydrochloride. Cost-benefit analysis indicates that in the absence of hypercalcemia, calcium acetate should remain the treatment of choice for hyperphosphatemia in hemodialysis patients.

Acetates↗

Barriers to HAART adherence among human immunodeficiency virus-infected adolescents.

OBJECTIVES: To investigate the barriers to highly active antiretrovial therapy (HAART) adherence among human immunodeficiency virus (HIV)-infected adolescents and to explore the association of barriers and nonadherence. DESIGN: Structured interviews were conducted to determine the barriers associated with adherence; principal component factor analysis was performed on scores of the 19 barrier variables. SETTING: Human immunodeficiency virus-infected adolescents were recruited from 13 US cities into the REACH (Reaching for Excellence in Adolescent Care and Health) Project, the first large-scale disease progression study of HIV-positive adolescents infected through sexual behavior or injection drug use. PATIENTS: Human immunodeficiency virus-infected adolescents in the REACH cohort who were prescribed HAART (N = 114) were included in the analyses. MAIN OUTCOME MEASURES: The main outcome measures were self-report of adherence and barriers to adherence and viral load (HIV-1 RNA level in plasma). RESULTS: Viral load was significantly associated with self-report of adherence to HAART (P =.02). Only 28.3% of adolescents reported taking all of their prescribed antiretroviral medications in the previous month. Factor analysis of the barriers to adherence indicates there are 2 factors accounting for the largest proportion of the variance: (1) medication-related adverse effects (both physical and psychological) and (2) complications in day-to-day routines. CONCLUSIONS: Adherence was tied closely with daily routine, which supports the assumption that working closely with adolescents to improve their organizational skills may be necessary to improve adherence. Patient-level intervention, provider-level intervention, and health care system modification may all be necessary to improve HIV-infected adolescents' adherence to HAART.

Adolescent↗

The relationship between educational attainment and relapse among alcohol-dependent men and women: a prospective study.

BACKGROUND: We investigated the relationship between educational attainment and drinking outcomes after discharge from inpatient treatment for alcohol dependence. METHODS: Between 1993 and 1996, we consecutively recruited 41 women and 60 men hospitalized for alcohol dependence and followed them up monthly for 1 year. We conducted structured interviews during hospitalization and at monthly intervals after discharge for 1 year. We examined the relationship between educational attainment before treatment and postdischarge drinking outcomes, including time to relapse. RESULTS: After covariate adjustment, educational level was a significant predictor of drinking outcomes. CONCLUSIONS: Lower levels of educational attainment before entry into treatment predicted shorter times to first drink and relapse in both women and men. The association of educational attainment and treatment outcome for alcohol dependence warrants further investigation.

Achievement↗

Cholecystokinin cholescintigraphy: methodology and normal values using a lactose-free fatty-meal food supplement.

UNLABELLED: The purpose of this investigation was to evaluate the use of a commercially available lactose-free fatty-meal food supplement, as an alternative to sincalide cholescintigraphy, to develop a standard methodology, and to determine normal gallbladder ejection fractions (GBEFs) for this supplement. METHODS: Twenty healthy volunteers all had negative medical histories for hepatobiliary and gallbladder disease, had no personal or family history of hepatobiliary disease, and were not taking any medication known to affect gallbladder emptying. All were prescreened with a complete blood cell count, comprehensive metabolic profile, gallbladder and liver ultrasonography, and conventional cholescintigraphy. Three of the 20 subjects were eliminated from the final analysis because of an abnormality in one of the above studies. RESULTS: After gallbladder filling on conventional cholescintigraphy, the subjects ingested the supplement and an additional 60-min study was acquired. GBEFs were calculated and ranged from 33% to 95% (mean +/- SD, 62.6% +/- 21.3%). Statistical analysis determined the lower range of normal to be 32.6%. Maximal gallbladder emptying occurred between 55 and 60 min. CONCLUSION: A standard methodology and normal GBEFs (> or =33%) were established for supplement-stimulated cholescintigraphy.

Administration, Oral↗

History of abuse and drinking outcomes following inpatient alcohol treatment: a prospective study.

Little is known about the impact of sexual or physical abuse history on response to alcohol treatment. This prospective study investigated the relationships between sexual and physical abuse histories, participants' characteristics, and response to inpatient alcohol treatment. Forty-one women and 59 men were assessed monthly for 1 year following hospitalization for alcohol dependence. Survival analyses showed that sexual abuse history was associated with shorter times to first drink and relapse. Physical abuse history was not associated with poorer drinking outcomes. Although women were more likely than men to have a history of sexual abuse, no gender differences were found in drinking outcomes. Poorer drinking outcomes were found among participants who at baseline were not married, had less than a college education, were not employed full time, or carried a diagnosis of depression or other psychiatric disorder. When adjusted for these characteristics, the associations between sexual abuse history and times to first drink and relapse were no longer statistically significant. While sexual abuse history is a clinically meaningful predictor of return to drinking we note the importance of considering patients' background and clinical characteristics in examining the impact of sexual abuse history on drinking outcomes following treatment.

Adult↗

Combined magnetic fields accelerate and increase spine fusion: a double-blind, randomized, placebo controlled study.

STUDY DESIGN: The clinical study conducted was a prospective, randomized, double-blind, placebo-controlled trial. OBJECTIVES: The purpose of this study was to evaluate the effect of combined magnetic fields on the healing of primary noninstrumented posterolateral lumbar spine fusion. SUMMARY OF BACKGROUND DATA: Combined magnetic fields, a new type of biophysical stimulus, have been shown to act by stimulating endogenous production of growth factors that regulate the healing process. This is the first placebo-controlled study to assess the effect of an electromagnetic stimulus on primary noninstrumented posterolateral lumbar spine fusion surgery as well as the first evaluation of combined magnetic fields as an adjunctive stimulus to lumbar spine fusion. METHODS: This multicenter investigational study was conducted at 10 clinical sites under an Investigational Device Exemption from the United States Food and Drug Administration. Eligible patients had one-level or two-level fusions (between L3 and S1) without instrumentation, either with autograft alone or in combination with allograft. The combined magnetic field device used a single posterior coil, centered over the fusion site, with one 30-minute treatment per day for 9 months. Randomization was stratified by site and number of levels fused. Evaluation was performed 3, 6, and 9 months after surgery and 3 months after the end of treatment. The primary endpoint was assessment of fusion at 9 months, based on radiographic evaluation by a blinded panel consisting of the treating physician, a musculoskeletal radiologist, and a spine surgeon. RESULTS: Of 243 enrolled patients, 201 were available for evaluation. Among all patients with active devices, 64% healed at 9 months compared with 43% of patients with placebo devices: a significant difference (P = 0.003 by Fisher's exact test). Stratification by gender showed fusion in 67% of women with active devices, compared with 35% of those with placebo devices (P = 0.001 by Fisher's exact test). By contrast, there was not a statistically significant effect of the active device in this male study population. In the overall population of 201 patients, repeated measures analyses of fusion outcomes (by generalized estimating equations) showed a main effect of treatment, favoring the active treatment (P = 0.030). In a model with main effect and a time by treatment interaction, the latter was significant (P = 0.024), indicating acceleration of healing. Performed in the full sample of 243 patients, results of the intent-to-treat analysis were qualitatively the same as in the evaluable sample of 201 patients. DISCUSSION: This investigational study demonstrates that combined magnetic field treatment of 30 min/d increases the probability of successful spine fusion, and statistical analysis using the generalized estimating equations model suggests an acceleration of the healing process. This is the first randomized clinical trial of noninstrumented primary posterolateral lumbar spine fusion, with evaluation by a blinded, unbiased panel. This is the first double-blind study performed to date assessing noninstrumented fusion outcome with extremely critical radiographic criteria. The lower overall fusion rates in this study are attributed to the high-risk patient group with an average age of 57 years, the use of noninstrumented technique with posterolateral fusion only, and the reliance on extremely critical radiographic and clinical criteria and blinded panel for fusion assessment without surgical confirmation. CONCLUSIONS: In conclusion, the adjunctive use of the combined magnetic field device was statistically beneficial in the overall patient population, as has been shown in previous studies of adjunctive bone growth stimulation for spine fusion. For the first time, stratification of fusion success data by gender demonstrated that the female study population responded positively to the adjunctive combined magnetic field treatment, with no statistically significant effect observed in the male study population. Adjunctive use of the combined magnetic field device significantly increased the 9-month success of radiographic spinal fusion and showed an acceleration of the healing process.

Adult↗

Hypertension Intervention Pooling Project.

Data from 12 independently designed and conducted randomized trials of behavioral interventions for hypertension, consisting principally of variants of relaxation and biofeedback therapies, were aggregated to assess current progress of research in this area. Meta-analytical methods revealed a statistically significant decrease in diastolic blood pressure for nonmedicated patients at the end of intervention. No significant improvement was detected in medicated patients, but potential differential effectiveness of prescribed medications and differences in compliance among patients prohibits separation of changes due to behavioral treatments alone. The need to devise criteria for selection of patients, and to establish the most appropriate patient-treatment match is emphasized.

Behavior Therapy↗