Public health and clinical implications of high hemoglobin A1c levels and weight in younger adult Native American people with diabetes.

BACKGROUND: Type 2 diabetes mellitus is a major public health issue for Native American people. Because glycemic levels are predictive of diabetes outcome, understanding determinants of high hemoglobin A(1c) (HbA(1c)) levels may provide targets for prevention efforts. OBJECTIVES: To investigate determinants of high HbA(1c) levels in Native American people. METHODS: We conducted a population-based, cross-sectional study of 206 participants with diabetes from 8 Native American communities in New Mexico. We used linear regression to assess the relationship of HbA(1c) level with age, body mass index (BMI), treatment type, duration of diabetes, physical activity, and diet. RESULTS: Age, dietary pattern, and treatment type were determinants of HbA(1c) levels. Participants younger than 55 years had the highest adjusted HbA(1c) levels at 9.5% and those 65 years and older had the lowest levels at 7.8%. According to a participant's dietary intake, HbA(1c) levels were highest for those who consumed the most fat and sugar, and high consumption of fat and sugar affected HbA(1c) levels most among those younger than 55 years. Participants treated with insulin had the highest hemoglobin A(1c) levels. Physical activity was not associated with HbA(1c) level. CONCLUSIONS: We found an increasing severity of diabetes among younger people. To avoid increased morbidity and mortality in the future, young Native American adults with diabetes need vigorous therapy to maintain tight glucose control. Arch Intern Med. 2000;160:3471-3476.

Challenges to participating in a lifestyle intervention program: the Native American Diabetes Project.

PURPOSE: This paper describes the factors that American Indian teachers in the Native American Diabetes Project (NADP) reported affected participation in the NADP lifestyle education sessions. METHODS: A postsession exit interview was conducted with each of the 7 mentors (teachers) of the NADP sessions. Interview questions addressed general perceptions of the sessions, factors that kept participants from coming to the sessions, and attitudes toward diabetes and persons with diabetes. Interviews were transcribed and responses reflecting factors related to participation were marked and organized into topic areas. RESULTS: Mentors reported a range of factors that affected participation in the sessions, such as conflicts with community activities and beliefs/attitudes about diabetes. The latter factor includes program knowledge, recruitment methods, attitudes toward the program, and beliefs about diabetes. CONCLUSIONS: Asking community members what factors they believe affect participation is an important component of increasing participation in community-based programs. Community members can provide a valuable personal perspective of actual and potential conflicts in the community.

Communicating through stories: experience of the Native American Diabetes Project.

Stories appear to provide an indirect way of confronting the inherent conflict between the concepts of disease and wellness and assisting in the transition to a new concept of living well with the disease. This new concept may engender feelings of acceptance and hope that can facilitate application of knowledge and behavior change. In addition, culturally appropriate stories allow people to draw from their own personal beliefs and values to interpret and apply new information to their own lives. A good story takes listeners on a collective journey with many paths; each path is uniquely suited to the needs of the individual, with wisdom gained that is uniquely suited to their own life.

Participant satisfaction with a culturally appropriate diabetes education program: the Native American Diabetes Project.

PURPOSE: The purpose of this paper is to report on participant satisfaction with the Native American Diabetes Project diabetes education program. METHODS: A questionnaire was designed to measure satisfaction among participants in the diabetes education program, which consisted of five sessions designed according to the Transtheoretical Model of Change and Social Action Theory with input from community members. Eight pueblo communities participated in the program. Sessions were taught by community mentors in three sites in New Mexico. One site taught sessions in a one-on-one format, and two sites taught sessions in a group format. RESULTS: The results showed that participant satisfaction did not vary based on session delivery type or by session site. Overall, participants responded positively to sessions designed according to Social Action Theory and with cultural competency. Retention rates for the sessions were 81% for group sessions and 91% for one-one-one sessions. CONCLUSIONS: Using a strong theoretical framework and community input to design diabetes education sessions may be important factors in participant satisfaction and retention in diabetes lifestyle education sessions.

Knowledge, attitudes and behaviors related to physical activity among Native Americans with diabetes.

OBJECTIVE: Native Americans (NA) have higher diabetes morbidity and mortality compared to other ethnic groups. Although exercise plays an important role in diabetes management, little is known about exercise among Native Americans with diabetes. Our goal was to describe knowledge, attitudes and behaviors related to exercise in Native American participants in New Mexico. DESIGN: Bilingual community members administered a questionnaire to assess knowledge, stage of change (a measure of exercise readiness), and physical activity behavior. Hemoglobin A1c (HbA1c) was measured by DCA 2000 analyzer. Height and weight were measured to calculate body mass index (BMI). Average random blood glucose (RBS) levels and diabetes duration were assessed through chart audit. SETTING: Questionnaires were completed in offices in or near the communities. PARTICIPANTS: 514 Native Americans with diabetes were identified as potential participants, 40% (142 women, 64 men) participated. RESULTS: 37% of participants knew exercise lowers blood sugar. 82% reported they were in the preparation, action, or maintenance stage of change for exercise behavior. Seventy seven percent of this population did not meet the Surgeon General's recommendation for accumulating 30 minutes of leisure time endurance exercise on most days of the week. However, 67% of participants fell within the "high activity" category for all moderate and vigorous activities. Average age, BMI and HbA1c were 58.5 yrs., 30.5 kg/m2, 8.6%, respectively. CONCLUSIONS: Interventions to increase physical activity awareness and participation could improve diabetes management and overall health for Native Americans. When evaluating physical activity, researchers need to consider usual activities of daily living and leisure time activities specific to that population. Failure to do so would be ethnocentric and could lead to inappropriate conclusions.

Adaptation of the Dartmouth COOP Charts for use among American Indian people with diabetes.

OBJECTIVE: To adapt the Dartmouth COOP Charts for use among American Indians with diabetes and to evaluate the operating characteristics of the adapted charts because measures of health status have not been evaluated for use among American Indians with diabetes. RESEARCH DESIGN AND METHODS: American Indian adults participated in focus group conferences to adapt and review the Dartmouth COOP Charts for use in American Indian communities. American Indian participants with diabetes were interviewed and administered the adapted charts. The operating characteristics of the charts were evaluated by measuring internal and external consistency, reliability, and acceptability. RESULTS: Some of the wording and pictures were considered to be offensive and culturally inappropriate in American Indian communities. The adapted charts showed internal consistency in a comparison of interchart variables. CONCLUSIONS: The adapted Dartmouth COOP Charts are more culturally acceptable than the original charts and appear to measure constructs adequately.

Temporal trends in diabetes mortality among American Indians and Hispanics in New Mexico: birth cohort and period effects.

Rates of diabetes mortality are disproportionately high among ethnic minorities in the United States. To describe ethnic trends and cohort effects in diabetes mortality in New Mexico, the authors examined the trends in mortality rates for non-Hispanic whites. Hispanics, and American Indians in the state during the period 1958-1994. Age-specific rates were examined graphically to qualitatively describe the contribution of calendar period and birth cohort effects to changes in the rates. The authors also fit age-period-cohort models to these data. Age-adjusted diabetes mortality rates for American Indians and Hispanics surpassed rates for non-Hispanic whites for all but the earliest two time periods. In the 1993-1994 period, the age-adjusted mortality rate for American Indians was 3.8 times higher for men and 5.6 times higher for women than for their non-Hispanic white counterparts. Rates for American Indian men and women increased sharply over the 37-year period, by 565% and 1,105%, respectively. Mortality rates increased among Hispanics over the period of study but less rapidly than did rates among American Indians. Graphical analyses of age-specific rates were consistent with birth cohort effects among both American Indians and Hispanics and also with a period effect among American Indians. Results from age-period-cohort models indicate a birth cohort effect starting with the 1912 cohort in American Indians and the 1902 cohort in Hispanics. A period effect was present during the 1960s in American Indians. American Indians have experienced an epidemic rise in diabetes mortality in New Mexico; if current trends continue, diabetes may become the leading cause of mortality among American Indians in the state.

Evaluation of cryopreserved homografts in the right ventricular outflow tract after the Ross procedure: intermediate-term follow up.

BACKGROUND AND AIMS OF THE STUDY: The Ross procedure involves replacing a transplanted pulmonary valve with a cryopreserved homograft in order to re-establish right ventricle-pulmonary artery continuity. This study reviews mid-term results of such surgery in children and young adults. METHODS: Since November 1986, 114 patients have undergone the Ross procedure at the Children's Hospital of Oklahoma using cryopreserved pulmonary homografts (n = 113) and aortic homograft (n = 1) to reconstruct the right ventricular outflow tract. Graft size ranged from 16 to 32 mm. Ninety-three patients (mean age at implant 10.4 years (range: 0.8-22 years) have had complete mean follow up of 3.2 years (range: 5 months to 8.4 years) after surgery. Homograft evaluation included clinical reports and comparison of early post-implant and latest echocardiography. Measurements of homograft valve annulus and peak instantaneous Doppler gradient were compared; quality of valve leaflets, location of obstruction, and the degree of pulmonary regurgitation were assessed. RESULTS: Compared with early postoperative data, mean homograft annulus size decreased by 15% (p < 0.0001); in 88% of patients, the decrease ranged from one to nine millimeter. Peak Doppler gradient increased significantly (from 10 to 17 mmHg, p < 0.0001); 25% of patients developed gradients > 25 mmHg, and four had gradients > 50 mmHg. Significant obstruction developed most often at the supravalvular level or in the homograft conduit itself. This usually occurred within one year of implant, and was associated with calcification and contracture of the homograft wall. Significant pulmonary regurgitation developed in 19 cases (20%), but was more than mild in only three. Leaflet integrity was maintained except in those who developed severe stenosis or regurgitation. Two patients have undergone re-operation for homograft stenosis 2.8 and 5.4 years respectively after the Ross procedure; one has developed recurrent severe stenosis in the homograft four months later. CONCLUSIONS: After the Ross procedure: (i) Pulmonary homografts undergo significant annular reduction in most patients, though this is usually not associated with the development of significant obstruction. (ii) Peak Doppler gradients across the homograft increase in most patients, though only 4% develop more than mild obstruction. (iii) Mild pulmonary regurgitation is common (20%); moderate or severe regurgitation is rare and usually develops in concert with severe stenosis. (iv) Severe homograft valve degeneration usually occurs within one year of implant, and may reflect an immune-mediated response.

Rapid HbA1c testing in a community setting.

OBJECTIVE: To determine whether the DCA 2000 analyzer provides valid and reliable HbA1c results when used under field conditions and operated by nonmedical personnel. This study was part of a community diabetes education program, the Native American Diabetes Project, in which HbA1c was measured as an indicator of average glycemic control. RESEARCH DESIGN AND METHODS: Two study samples were taken, the first in the spring of 1994 and the second in the spring of 1995. Seven community members in 1994 and six new community members in 1995 were trained over 2 days, using standard protocol, to operate the DCA 2000 HbA1c analyzer and to collect two capillary blood samples from participants in the Native American Diabetes Project. Duplicate DCA 2000 HbA1c measurements performed by the community workers were compared with measurements from a high-performance liquid chromatography (HPLC) system. Validity and reliability measures were calculated. RESULTS: Of the participants, 43 were studied in 1994 and 14 in 1995. Comparison of the mean DCA 2000 results with those of HPLC showed high validity, with the absolute relative difference between the mean DCA 2000 and the external reference of HPLC (magnitude of mean DCA 2000-HPLC magnitude of /HPLC) as 4.0 and 2.0% for 1994 and 1995, respectively. The Pearson correlation coefficients (r) between these two measures were 0.968 and 0.996 for 1994 and 1995, respectively. While the 1994 data appeared to have less validity for values > 10%, they included only one value with a 60-min warm-up of the DCA analyzer. The 1995 data, all collected after a 60-min warm-up, had good correlation throughout the range of values. The within-run reliability was excellent, with an intraclass correlation coefficient of reliability of 0.959 and 0.975 for paired samples, for 1994 and 1995 respectively. The mean coefficient of variation for these paired measures was 3.0% in 1994 and 2.8% in 1995. Both validity and reliability were improved by changing the warm-up period of the DCA 2000 analyzer from 5 to 60 min. All correlation coefficients were statistically significant (P < 0.0001). CONCLUSIONS: The DCA 2000 gave valid and reliable HbA1c results when operated in a community setting by nonmedical personnel. Extending the warm-up period of the device to 60 min slightly improved the validity and reliability of the test.

A comparative assessment of vancomycin-associated nephrotoxicity in the young versus the elderly hospitalized patient.

The incidence of vancomycin-associated nephrotoxicity was determined in a younger (age < 60 y) versus elderly (age > or = 60 y) hospitalized adult population to identify associated drug- and nondrug-related risk factors. Nephrotoxicity was defined as an acute increase in serum creatinine of > or = 44.2 mumol/L if baseline serum creatinine was < or = 221 mumol/L or an increase in serum creatinine of > or = 88.4 mumol/L if baseline serum creatinine > 221 mumol/L. A total of 289 patients, 141 younger (mean age, +/- S.D. 37.9 +/- 12.4 y) and 148 elderly (73.6 +/- 8.5 years), was retrospectively reviewed. Nephrotoxicity occurred in 7.8% younger vs 18.9% elderly patients (P = 0.003). Using multivariate logistic regression models for the pooled patient population, concurrent loop diuretic use was significantly associated with vancomycin-associated nephrotoxicity (relative risk (R.R.) = 5.06); for the younger population, only concurrent amphotericin B use was significantly associated with vancomycin-associated nephrotoxicity (R.R. = 6.65); and for the elderly population, only concurrent loop diuretic use was significantly associated with vancomycin-associated nephrotoxicity (R.R. = 9.70). These data suggest that elderly patients are at significantly greater risk of vancomycin-associated nephrotoxicity than are younger patients. However, because age was not a significant risk factor for nephrotoxicity in comparing the pooled vancomycin-associated nephrotoxicity group compared to the non-nephrotoxicity group, the differences observed between age groups probably reflect differences in risk factor prevalence.

Bayesian forecasting of serum vancomycin concentrations with non-steady-state sampling strategies.

The application of three non-steady-state sampling strategies and the fitting of either three or five pharmacokinetic parameter estimates by a two-compartment Bayesian forecasting program was evaluated retrospectively in 27 adult patients with stable renal function. Sampling strategies included a single midpoint concentration, a set of peak and trough concentrations, and three serial vancomycin concentrations. The most precise and least-bias predictions of steady-state peak vancomycin concentrations were observed by using population-based parameter estimates [mean prediction error (ME) = -0.40 and mean absolute error = 5.77]. The addition of non-steady-state feedback concentration(s) did not provide additional information for predictions of future steady-state peak concentrations. The least-bias prediction of steady-state trough vancomycin concentrations was seen when a single midpoint non-steady-state concentration was used (ME = 0.92 and -0.17 for five and three fitted parameter estimates, respectively). The MEs of serial and peak and trough feedback strategies were similar in magnitude to those obtained using population parameters, but in opposite directions (underprediction vs. overprediction, respectively). The fitting of only three parameters produced results similar to those using five parameters. The results from this study confirm our previous evaluation that non-steady-state concentrations provide very minimal information to Bayesian forecasting of future steady-state concentrations.

A retrospective analysis of long-term use of nondepolarizing neuromuscular blocking agents in the intensive care unit, and guidelines for drug selection.

Nondepolarizing neuromuscular blocking agents (NNMBAs) are frequently administered to patients in the intensive care unit (ICU). We conducted a retrospective study of patients in intensive care who received infusions (> 48 hrs) of commonly used NNMBAs. The goals were to describe NNMBA use in our ICUs, determine patient characteristics, and assess the cost of the individual drugs. We found that atracurium was prescribed for 68% of study patients; 68% of the patients did not have renal, hepatic, or cardiovascular disease; dosages of NNMBAs varied; a statistically significant increase in dosage requirements over time occurred with atracurium; assessment of neuromuscular blockade was 100% subjective; and 41% and 17% of patients receiving atracurium and vecuronium, respectively, experienced prolonged neuromuscular weakness documented subjectively. As a result of this study, guidelines for agent selection were developed to facilitate cost effective use of NNMBA in our ICUs. Using these guidelines would potentially significantly decrease drug expenditures in this setting.

Clostridium difficile colonization in residents of long-term care facilities: prevalence and risk factors.

OBJECTIVE: To determine the period prevalence of Clostridium difficile disease and asymptomatic carriage in the residents of long-term care facilities (LTCF) and to characterize the risk factors for colonization or associated disease. DESIGN: Period prevalence survey. SETTING: Two long-term care facilities in St. Paul, MN. PARTICIPANTS: Specimens were collected from 225 LTCF residents. MEASUREMENTS: The dependent variable was the culture result for C. difficile, which was isolated and identified using selective culture media and a commercial anaerobe identification kit. Tissue culture assay was used to detect the ability of each C. difficile isolate to produce toxin. Independent variables (including gender, age, race, current medical diagnoses, severity of underlying disease, case mix, current clinical symptoms, current medications, antibiotic use within 4 weeks prior to specimen procurement, and other pertinent history) were obtained from the current medical record of each participant. RESULTS: Of 225 stool cultures that were obtained, 16 (7.1%) were positive for C. difficile. None of the residents with a positive culture was symptomatic. History of nosocomial infection and the use of antibiotics in general, cephalosporins, trimethoprim/sulfamethoxazole (TMP/SMX), and histamine-2 blockers were significantly associated with positive C. difficile culture (P < or = 0.05) by univariate analyses. Trends towards significance (0.05 < 0.10) were noted for narcotic use, previous hospitalization, LTCF, and non-insulin-dependent diabetes mellitus. Logistic regression analysis revealed significant, independent predictors of positive culture: antibiotic use in general (P = 0.028; relative risk = 3.31), histamine-2 antagonist use (P = 0.038; relative risk = 3.27), cephalosporin use (P = 0.038; relative risk = 4.66), and TMP/SMX use (P = 0.007; relative risk = 8.45). CONCLUSIONS: The use of antibiotics, particularly cephalosporins and TMP/SMX, is a significant risk factor for asymptomatic carriage of C. difficile in long-term care facilities. The use of H-2 blockers was also a significant risk factor for carriage; however, this finding has not been reported previously and should be confirmed by independent studies. These medications should be used judiciously in the LTCF population. When diarrheal diseases are encountered in LTCF residents, a high index of suspicion for C. difficile infection should be maintained and the appropriate diagnostic and therapeutic measures taken.

Elimination of quinolone antibiotic carryover through use of antibiotic-removal beads.

To prove the utility of antibiotic-removal beads in separating antibiotics from bacterial samples, Escherichia coli ATCC 25922 was exposed to five separate quinolones before and after each was exposed to antibiotic-removal beads. Plates treated with antibiotic solutions that were exposed to beads demonstrated antibiotic removal, and plates treated with antibiotic solutions that were not exposed to beads demonstrated antibiotic carryover. After exposure to beads, fluoroquinolone concentrations decreased from 5 micrograms/ml to 0.14 micrograms/ml (ciprofloxacin), 0.04 micrograms/ml (temafloxacin), < 0.01 microgram/ml (ofloxacin), < 0.01 microgram/ml (sparfloxacin), and 0.02 micrograms/ml (clinafloxacin). These data indicate that antibiotic carryover can be successfully circumvented through the use of antibiotic-removal beads.

Effect of obesity on vancomycin pharmacokinetic parameters as determined by using a Bayesian forecasting technique.

Few data exist concerning the effect of obesity on the pharmacokinetic parameters of vancomycin. The purpose of this investigation was to assess the effect of obesity on vancomycin pharmacokinetic parameters in 95 nonobese and 135 obese adult patients (age range, 18 to 92 years) receiving vancomycin. All subjects had normal renal function as defined by a creatinine concentration in serum of < or = 1.5 mg/dl (mean estimated creatinine clearance +/- 1 standard deviation, 76 +/- 34; range, 23 to 215 ml/min). Vancomycin concentrations in serum were determined by the fluorescence polarization immunoassay. All data for vancomycin concentration in serum versus time for each course of therapy were fitted by using a two-compartment Bayesian forecasting program. Subjects were stratified into nine groups on the basis of the percent difference between actual body weight (ABW) and lean body weight (LBW) (> -10%, -10 to 0%, > 0 to 10%, > 10 to 20%, > 20 to 30%, > 30 to 40%, > 40 to 50%, > 50 to 60%, > 60%). Analysis of variance with post hoc Scheffe's testing revealed that statistically significant differences occurred in terminal disposition half-life (t1/2 beta) between the extremes of modestly obese (group 4) and morbidly obese (group 9, P < 0.05) patients. Similar analysis with distribution volume (V) identified significant differences in patients at or near their LBW (groups 2 to 4) and patients who were morbidly obese (groups 8 and 9, P < 0.05). Multiple regression models for the pharmacokinetic parameters V, t1/2beta, and vancomycin total body clearance were developed to assess the joint predictive power of LBW, ABW, and percent over LBW, controlling for the effects of age, initial creatinine concentration in serum, initial creatinine clearance, and gender. In the final model for V, both ABW and percent over LBW were independent and significant predictors. For total body clearance, only ABW was significant and predictive. Percent over LBW was a significant and independent predictor of t1/2beta. LBW is not predictive of these pharmacokinetic parameters and should not be used for initial dosing. On the basis of these data, ABW appears to be superior to LBW for calculating initial dose requirements for vancomycin.