Biomedical subjects

Morton B Brown

Publications and source records attributed to Morton B Brown.

At least 19 recordsLinked to original sources

PubMed2006

Bowel symptoms in women planning surgery for pelvic organ prolapse.

OBJECTIVE: The objective of the study was to measure associations between bowel symptoms and prolapse. STUDY DESIGN: Baseline data were analyzed from 322 women in the Colpopexy And Urinary Reduction Efforts trial of sacrocolpopexy with or without Burch colposuspension. Women completed the Colorectal-Anal Distress Inventory and Colorectal-Anal Impact Questionnaire and underwent Pelvic Organ Prolapse Quantification. Associations between symptoms and questionnaire scores and Pelvic Organ Prolapse Quantification measures were assessed. RESULTS: Mean age was 61 +/- 10 years. Pelvic Organ Prolapse Quantification stages were II (14%), III (67%), and IV (19%). Colorectal-Anal Distress Inventory symptoms did not increase with prolapse stage. Colorectal-Anal Distress Inventory obstructive subscale scores were higher in stage II women (median 29 [interquartile range 8,92] versus 17 [0,33] and 25 [0,38] for stages III and IV, respectively; adjusted P = .01). The few statistically significant correlations between symptoms and vaginal descent were negative and weak (less than 0.2). CONCLUSION: Bowel symptoms and questionnaire scores do not increase with prolapse stage in women presenting for sacrocolpopexy.

Aged↗

PubMed2006

Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence.

BACKGROUND: We designed this trial to assess whether the addition of standardized Burch colposuspension to abdominal sacrocolpopexy for the treatment of pelvic-organ prolapse decreases postoperative stress urinary incontinence in women without preoperative symptoms of stress incontinence. METHODS: Women who did not report symptoms of stress incontinence and who chose to undergo sacrocolpopexy to treat prolapse were randomly assigned to concomitant Burch colposuspension or to no Burch colposuspension (control) and were evaluated in a blinded fashion three months after the surgery. The primary outcomes included measures of stress incontinence (symptoms, stress testing, or treatment) and measures of urge symptoms. Enrollment was stopped after the first interim analysis because of a significantly lower frequency of stress incontinence in the group that underwent the Burch colposuspension. RESULTS: Of 322 women who underwent randomization, 157 were assigned to Burch colposuspension and 165 to the control group. Three months after surgery, 33.6 percent of the women in the Burch group and 57.4 percent of the controls met one or more of the criteria for stress incontinence (P<0.001) [Corrected]. There was no significant difference between the Burch group and the control group in the frequency of urge incontinence (32.7 percent vs. 38.4 percent, P=0.48). After surgery, women in the control group were more likely to report bothersome symptoms of stress incontinence than those in the Burch group who had stress incontinence (24.5 percent vs. 6.1 percent, P<0.001). CONCLUSIONS: In women without stress incontinence who are undergoing abdominal sacrocolpopexy for prolapse, Burch colposuspension significantly reduced postoperative symptoms of stress incontinence without increasing other lower urinary tract symptoms.

Aged↗

PubMed2006

A discrete-state discrete-time model using indirect observation.

This research was motivated by a desire to model the progression of a chronic disease through various disease stages when data are not available to directly estimate all the transition parameters in the model. This is a common occurrence when time and expense make it unfeasible to follow a single cohort to estimate all the transition parameters. One difficulty of developing a model of chronic disease progression from such data is that the available studies often do not include the transitions of interest. For example, in our model of diabetic nephropathy, many clinical studies did not differentiate between patients without nephropathy and those who had microalbuminuria (a pre-clinical stage of nephropathy). Another difficulty was a lack of data to directly estimate parameters of interest. We consider models which can accommodate such difficulties. In this paper we consider the problem of estimating parameters of a discrete-time Markov process when longitudinal data describing the entire process are not available. First, we present a likelihood approach to estimate parameters of a discrete-time Markov model. Next, we use simulation to investigate the finite-sample behaviour of our approach. Finally, we present two examples: a model of diabetic nephropathy and a model of cardiovascular disease in diabetes.

Albuminuria↗

PubMed2006

The role of endogenous growth hormone-releasing hormone in acromegaly.

CONTEXT: Some indirect evidence suggests hypothalamic control of GH secretion in acromegaly. OBJECTIVE: The objective of the study is to examine whether GH secretion in acromegaly is dependent on endogenous GHRH. PATIENTS AND STUDY DESIGN: We studied eight patients with untreated acromegaly due to a GH-producing pituitary tumor. All patients received an iv infusion of normal saline for 24 h and GHRH-antagonist (GHRH-ant) at 50 microg/kg x h for 7 d. GH was measured every 10 min for 24 h during the normal saline infusion and on the last day of the GHRH-ant infusion. A group of nine different patients with untreated acromegaly served as the control group and underwent blood sampling for GH every 10 min for two 24-h periods to assess the day-to-day variability of GH secretion. SETTING: The study was set in a university referral center. MAIN OUTCOME MEASURE: Twenty-four-hour mean GH was the main outcome measured. RESULTS: In six of eight subjects treated with GHRH-ant, 24-h mean GH decreased by 5.8-30.0% during iv GHRH-ant and, in three subjects, the change in the 24-h mean GH was greater than the upper limit of the 95% confidence interval of the spontaneous day-to-day variability of the mean GH in patients with acromegaly. Based on the binomial distribution, the probability of this magnitude of change to occur in three of eight subjects by chance alone is 0.0008. CONCLUSION: In some patients with acromegaly due to a pituitary adenoma, GH secretion is under partial control by endogenous GHRH.

Acromegaly↗

PubMed2006

A likelihood approach to analyzing clinical trial data when treatments favor different outcomes.

It is increasingly common in clinical trials to design studies for which more than one primary outcome exists. Methods that exist for more than one outcome are generally concerned with identifying one of two situations: (1) improvement in all outcomes from one treatment, as compared to the other treatment(s); or (2) improvement in a single efficacy endpoint, without an excess of toxicity. In contrast, the Colpopexy and Urinary Reduction Effort (CARE) Study is a randomized clinical trial comparing two treatments that presents a slightly different scenario. In this study, there are two outcomes, and it was anticipated by the investigators that each treatment may favor a different outcome. Few statistical methods exist to address the specific challenges encountered by this design. We designed a method to address the specific analytic issues raised in the planning of the CARE study. We developed a likelihood ratio approach to test whether or not a treatment difference exists at the end of the study by considering both the absolute treatment differences and the direction of the differences with respect to the treatments. This method involves simultaneously testing each component of a composite null hypothesis, while maintaining an overall type I error rate. A simulation study is performed to evaluate the operating characteristics of this test, in which we find that our joint likelihood-ratio test has a power as high as, or higher than, other commonly used methods for multiple outcomes, while maintaining a nominal type I error rate.

Female↗

PubMed2006

A multicenter study of the outcome of biliary atresia in the United States, 1997 to 2000.

OBJECTIVE: To determine the prognostic factors and optimal approaches to the diagnosis and management of biliary atresia, the leading indication for liver transplantation in children. STUDY DESIGN: A retrospective study was performed of all children who underwent hepatoportoenterostomy (HPE) for biliary atresia between 1997 and 2000 at 9 centers in the United States. Outcome at age 24 months was correlated with demographic and clinical parameters. RESULTS: A total of 104 children underwent HPE; 25% had congenital anomalies, and outcome was worse in those with biliary atresia splenic malformation syndrome. Diagnostic and clinical approaches varied, although specific approaches did not appear to correlate with outcome. The average age at referral was 53 days, and the average age at HPE was 61 days. At age 24 months, 58 children were alive with their native liver, 42 had undergone liver transplantation (37 alive, 5 dead), and 4 had died without undergoing transplantation. Kaplan-Meier analysis of survival without liver transplantation revealed markedly improved survival in children with total bilirubin level<2 mg/dL at 3 months after HPE (84% vs 16%; P<.0001). CONCLUSIONS: Outcome in the study centers was equivalent to that reported in other countries. Total bilirubin in early follow-up after HPE was highly predictive of outcome. Efforts to improve bile flow after HPE may lead to improved outcome in children with biliary atresia.

Abnormalities, Multiple↗

PubMed2006

Fecal and urinary incontinence in primiparous women.

OBJECTIVE: To prospectively investigate the relationship between anal sphincter tears and postpartum fecal and urinary incontinence. METHODS: The Childbirth and Pelvic Symptoms study was a prospective cohort study performed by the Pelvic Floor Disorders Network to estimate the prevalence of postpartum fecal and urinary incontinence in primiparous women: 407 with clinically recognized anal sphincter tears during vaginal delivery, 390 without recognized sphincter tears (vaginal controls), and 124 delivered by cesarean before labor. Women were recruited postpartum while hospitalized and interviewed by telephone 6 weeks and 6 months postpartum. We assessed fecal and urinary incontinence symptoms using the Fecal Incontinence Severity Index and the Medical, Epidemiological, and Social Aspects of Aging Questionnaire, respectively. Odds ratios were adjusted for age, race, and clinical site. RESULTS: Compared with the vaginal control group, women in the sphincter tear cohort reported more fecal incontinence (6 weeks, 26.6% versus 11.2%; adjusted odds ratio [AOR] 2.8, 95% confidence interval [CI] 1.8-4.3; 6 months, 17.0% versus 8.2%; AOR 1.9, 95% CI 1.2-3.2), more fecal urgency and flatal incontinence, and greater fecal incontinence severity at both times. Urinary incontinence prevalence did not differ between the sphincter tear and vaginal control groups. Six months postpartum, 22.9% of women delivered by cesarean reported urinary incontinence, whereas 7.6% reported fecal incontinence. CONCLUSION: Women with clinically recognized anal sphincter tears are more than twice as likely to report postpartum fecal incontinence than women without sphincter tears. Cesarean delivery before labor is not entirely protective against pelvic floor disorders. LEVEL OF EVIDENCE: II-3.

Adult↗

PubMed2006

Perinatal and early childhood outcomes of twins versus triplets.

The purpose of this prospective cohort study of twins and triplets was to evaluate perinatal and early childhood outcomes through 18 months of age. The study population included 141 twin pregnancies (282 twin children) and 8 triplet pregnancies (24 triplet children) recruited between May, 1996 and June, 2001. Mothers of triplets versus twins were significantly more likely to have infertility treatments, to be overweight or obese before conception, to be admitted antenatally, and to deliver by cesarean section. Length of gestation for triplets was significantly shorter (-2.31 weeks, p < .0001), and more likely to be less than 35 weeks (Adjusted Odds Ratio [AOR] 9.38, 95% confidence interval [CI] 3.22-27.29). Average birthweight for triplets was significantly lighter (-495 grams, p < .0001), and more likely to be low birthweight (AOR 11.38, 95% CI 3.11-41.61). Triplets were also more likely to be admitted to neonatal intensive care (AOR 7.97, 95% CI 2.13-29.77), to require mechanical ventilation (AOR 5.67, 95% CI 2.05-15.65), to develop respiratory distress syndrome (AOR 12.50, 95% CI 3.89-40.20), or a major morbidity (retinopathy of prematurity, necrotizing enterocolitis, ventilator support, or grade III or IV intraventricular hemorrhage, AOR 5.67, 95% CI 2.05-15.65). Weight, length, and head circumference was significantly smaller at birth for triplets compared to twins, and these differences remained through 18 months of age, along with lower mental developmental scores at the oldest age. Compared to twins, triplets have greater neonatal morbidity, and through 18 months of age lower mental and motor scores, slower postnatal growth and more residual stunting, particularly of length and head circumference.

Chi-Square Distribution↗

PubMed2006

The changing risk of infant mortality by gestation, plurality, and race: 1989-1991 versus 1999-2001.

OBJECTIVE: Our aim was to quantify contemporary infant mortality risks and to evaluate the change by plurality, gestation, and race during the most recent decade. PATIENTS AND METHODS: The study population included live births of 20 to 43 weeks' gestation from the 1989-1991 and 1999-2001 US Birth Cohort Linked Birth/Infant Death Data Sets, including 11,317,895 and 11,181,095 live births and 89,823 and 67,129 infant deaths, respectively. Adjusted odds ratios and 95% confidence intervals were calculated to evaluate the change in risk by plurality and gestation and to compare the change with that for singletons. RESULTS: Overall, the infant mortality risk decreased significantly for singletons, twins, and triplets but nonsignificantly for quadruplets and quintuplets. Compared with singletons, significantly greater reductions were experienced by twins overall and at <37 weeks and triplets at <29 weeks. The largest reduction was for triplets at 20 to 24 weeks and for quadruplets and quintuplets at 25 to 28 weeks. For white infants, significant reductions were achieved overall for singletons, twins, and triplets and at every gestation. For black infants, significant reductions occurred for singletons overall and at every gestation, for twins at <37 weeks, and for triplets at 25 to 28 weeks. Compared with white infants, black infants had significantly lower risks before and higher risks after 33 weeks, although between 1989-1991 and 1999-2001 this survival advantage at earlier ages diminished, and the risk at later gestations increased. CONCLUSIONS: The improvements in survival were greater for multiples versus singletons and for white versus black infants. Within each plurality, at each gestation the racial disparity in mortality has widened.

Adult↗

PubMed2005

A multicentered comparison of measurements obtained with microtip and external water pressure transducers.

This study compared simultaneous intravesical pressure readings obtained with catheter-mounted microtip transducers and external water pressure transducer catheters during filling cystometry. Women undergoing multichannel urodynamic testing were randomly assigned to one of three groups: two microtip catheters, two external water pressure transducer catheters, or one of each type. Intravesical pressure was measured simultaneously for each transducer combination in each subject for minimal and maximal Valsalva effort and minimal, moderate, and maximal cough effort at two sequential bladder volumes (150 and 300 ml). Paired t tests were used to compare the means of the intravesical pressure obtained by the two types of catheters. The largest mean differences were observed when comparing microtip and water pressure transducers. Correlations of maximum pressure were consistently high between two microtip transducers and two water pressure transducers but lower for the microtip-water combination. Excellent reproducibility was demonstrated with transducers of similar types for intravesical pressures recorded during Valsalva and cough in women without prolapse. However, considerable variability was seen in pressures recorded by different transducers, particularly dependent on the water catheter manufacturer, indicating that intravesical pressure recordings from microtip and water-based systems are not interchangeable.

Adult↗

PubMed2005

The cost of twin pregnancy: maternal and neonatal factors.

OBJECTIVE: The purpose of this study was to evaluate factors affecting birth charges in twin pregnancies. STUDY DESIGN: Clinical and financial data were obtained on 1486 twin pregnancies delivered between 1995 to 2002 at medical centers in Maryland, Florida, Michigan, and South Carolina. Maternal and neonatal length of stay (LOS) and charges were modeled by gestational age and other risk factors using a general linear model. RESULTS: Maternal and infant birth admission LOS and charges increased significantly with a decline in gestational age. Maternal LOS and charges were also significantly increased by cesarean delivery and preeclampsia. Newborn LOS and charges increased significantly by monochorionicity and slowed growth between 20 to 28 weeks. For mother and infants, the shortest LOS and lowest birth charges were at 37 to 38 weeks. CONCLUSION: These findings reflect the substantial maternal and neonatal morbidity associated with twin pregnancies, and demonstrate that 37 to 38 weeks is their optimal gestation.

Adolescent↗

PubMed2005

Dissection of hypothalamic-pituitary-adrenal axis pathology in 1-month-abstinent alcohol-dependent men, part 2: response to ovine corticotropin-releasing factor and naloxone.

BACKGROUND: Pituitary and adrenal responsiveness is suppressed in abstinent alcohol-dependent individuals. To clarify the specific organizational disruption in hypothalamic-pituitary-adrenal functioning during early abstinence, the authors separately assessed each level of the stress-response axis. In this second of a two-part study, ovine corticotropin-releasing factor (oCRH) was used to stimulate the pituitary corticotrophs, and naloxone was used to activate the axis at the hypothalamic level. In addition, pulsatile characteristics of corticotropin and cortisol were assessed over a 12-hr period (0800 to 2000 hr). METHODS: Eleven abstinent alcohol-dependent men and 10 healthy comparison participants were assessed. All participants were between the ages of 30 and 50 years, and alcohol-dependent patients were abstinent from 4 to 6 weeks. Basal concentrations of corticotropin and cortisol were obtained every 10 min from 0800 to 2000 hr and subjected to pulsatile analysis. Plasma corticotropin and cortisol concentrations were then obtained every 5 to 10 min after low-dose, intravenously administered doses of oCRH (0.4 microg/kg) or naloxone (0.125 mg/kg). Medications were administered at 2000 hr and the two challenge studies were separated by 48 hr. RESULTS: Pulsatile analysis revealed that the mean corticotropin amplitude was increased in alcohol-dependent patients relative to controls (p <0.05). Other pulsatile characteristics of corticotropin and all cortisol pulsatile measures were not significantly different between the two groups. The integrated cortisol response to oCRH was significantly lower in alcohol-dependent patients compared with controls (p <0.01), but the integrated corticotropin response was not significantly different. In contrast, neither the corticotropin nor the cortisol response to naloxone was significantly different between groups. CONCLUSIONS: Adrenocorticoid hyposensitivity persists after oCRH infusion for at least 1 month after cessation of drinking, whereas hyporesponsiveness of the pituitary corticotrophs to CRH seems to resolve with continued abstinence. The authors suggest that adrenocortical hyporesponsiveness during prolonged abstinence may impact relapse risk.

Adrenocorticotropic Hormone↗

PubMed2005

Dissection of hypothalamic-pituitary-adrenal axis pathology in 1-month-abstinent alcohol-dependent men, part 1: adrenocortical and pituitary glucocorticoid responsiveness.

BACKGROUND: Long-term ingestion of alcohol produces marked alterations in hypothalamic-pituitary-adrenal axis activity. The authors engaged in a series of studies to determine the distinct role of the hypothalamus and the pituitary and adrenal glands in the disturbances observed in abstinent alcohol-dependent subjects. In this first of a two-part study, the authors report on (1) the basal secretory profile of corticotropin and cortisol from 2000 to 0800 hrs, (2) adrenocortical sensitivity in both the presence and absence of endogenous pituitary activation, and (3) pituitary glucocorticoid sensitivity to dexamethasone. METHODS: Eleven male, 4 to 6 weeks abstinent, alcohol-only-dependent subjects and 10 age-matched male healthy controls were studied. Basal circulating concentrations of corticotropin and cortisol were obtained from 2000 to 0800 hr. A submaximal dose of cosyntropin (0.01 microg/kg), a corticotropin analogue was then administered to assess adrenocortical sensitivity. In a separate session, cosyntropin was administered following high-dose dexamethasone (8 mg iv) to assess adrenocortical sensitivity in the relative absence of endogenous corticotropin. In addition, the corticotropin response to dexamethasone was measured to determine pituitary glucocorticoid responsiveness. RESULTS: Cortisol, but not corticotropin, pulse amplitude (p < 0.05) and mean concentration (p= 0.05) was significantly lower in alcohol-dependent subjects compared with controls. The cortisol response to cosyntropin was lower in alcohol-dependent subjects following endogenous corticotropin suppression by high-dose dexamethasone (p <0.04) but not without dexamethasone pretreatment. Mean corticotropin (p <0.004) and cortisol (p <0.05) concentrations in response to dexamethasone were attenuated in the patients compared to controls. Basal concentrations of 11-deoxycortisol, the precursor to cortisol, were also decreased in alcohol-dependent subjects (p <0.05). CONCLUSION: Attenuated basal and stimulated adrenocortical concentrations in abstinent alcohol-dependent men are coupled with a nonhomeostatic increase in pituitary glucocorticoid inhibition. A decrease in stress-axis responsivity in alcohol dependence may have implications for treatment outcome.

Adrenal Cortex↗

PubMed2005

Gender mix in twins and fetal growth, length of gestation and adult cancer risk.

This study evaluated the effect of gender mix (the gender combinations of twin pairs) on fetal growth and length of gestation, and reviewed the literature on the long-term effects of this altered fetal milieu on cancer risk. In singletons, it is well established that females weigh less than males at all gestations, averaging 125-135 g less at full term. This gender difference is generally believed to be the result of the effect of androgens on fetal growth. The gender difference in fetal growth is greater before the third trimester and less towards term, with males growing not only more, but also earlier than females. Plurality is a known risk factor for reduced fetal growth and birthweight. Compared with singletons, the mean birthweight percentiles of twins fall substantially (by 10% or more) below the singleton 10th percentile by 28 weeks, below the singleton 50th percentile by 30 weeks, and below the singleton 90th percentile by 34 weeks. In unlike-gender twin pairs, it has been reported that the female prolongs gestation for her brother, resulting in a higher birthweight for the male twin than that of like-gender male twins. Other researchers have demonstrated that females in unlike-gender pairs had higher birthweights than females in like-gender pairs. Analyses from our consortium on 2491 twin pregnancies with known chorionicity showed longer gestations and faster rates of fetal growth in both males and females in unlike-gender pairs compared with like-gender male or female pairs, although these differences were not statistically significant. The post-natal effects for females growing in an androgenic-anabolic environment include increased sensation-seeking behaviour and aggression, lowered visual acuity, more masculine attitudes and masculinising effects of the auditory system and craniofacial growth. In contrast, there is no evidence to suggest that there might be a similar feminising effect on males from unlike-gender pairs. This hormonal exposure in utero may influence adult body size and susceptability to breast cancer.

Adult↗

PubMed2005

The Hispanic paradox in twin pregnancies.

The objective of this study was to compare length of gestation, fetal growth, and birthweight by race/ethnicity and pregravid weight groups in twin pregnancies. Three thousand and thirty-six twin pregnancies of 28 weeks or more gestation were divided by race/ethnicity (White, Black and Hispanic), and pregravid body mass index (BMI) groups (less than 25.0 vs. 25.0 or more). Outcomes were modeled using multiple regression, controlling for confounders, with White non-Hispanic women as the reference group. Hispanic women had the highest average birthweight and the longest gestation, as well as the lowest proportions of low birthweight, very low birthweight, preterm and early preterm births of the 3 race/ethnicity groups. In the multivariate analyses, Hispanic women had significantly longer gestations (by 7.8 days) and faster rates of fetal growth midgestation (20 to 28 weeks, by 17.4 g/week) and late gestation (after 28 weeks, by 5.3 g/week), whereas Black women had significantly slower rates of fetal growth (by 5.7 g/week and by 4.5 g/week, respectively). These findings in twins reflect the racial and ethnic disparities previously shown in singletons, including the Hispanic paradox of longer gestations and higher rates of fetal growth.

Birth Weight↗

PubMed2005

Use of cholecystokinin-octapeptide for the prevention of parenteral nutrition-associated cholestasis.

OBJECTIVE: To determine whether cholecystokinin-octapeptide (CCK-OP) would prevent or ameliorate parenteral nutrition-associated cholestasis (PNAC) among high-risk neonates treated with total parenteral nutrition. STUDY DESIGN: This was a multicenter, double-blind, randomized, controlled trial conducted between 1996 and 2001. PATIENTS: Neonates at risk for the development of PNAC included very low birth weight neonates and those with major surgical conditions involving the gastrointestinal tract. SETTING: Tertiary care hospitals. INTERVENTION: Patients were randomized to receive CCK-OP (0.04 mug/kg per dose, twice daily) or placebo. Eligible infants were all <30 days of age. Patients were enrolled within 2 weeks after birth or within 7 days after surgery. OUTCOME MEASURES: The primary outcome measure was conjugated bilirubin (CB) levels, which were measured weekly. Secondary outcome measures included incidence of sepsis, times to achieve 50% and 100% of energy intake through the enteral route, number of ICU and hospital days, mortality rate, and incidences of biliary sludge and cholelithiasis. RESULTS: A total of 243 neonates were enrolled in the study. CCK-OP administration did not significantly affect CB levels (1.76 +/- 3.14 and 1.93 +/- 3.31 mg/dL for CCK-OP and placebo groups, respectively; mean +/- SD). Secondary outcome measures also were not significantly affected by the study drug. CONCLUSIONS: Use of CCK-OP failed to reduce significantly the incidence of PNAC or levels of CB. CCK-OP had no effect on other secondary measures and should not be recommended for the prevention of PNAC.

Bilirubin↗

PubMed2005

A computer simulation model of diabetes progression, quality of life, and cost.

OBJECTIVE: To develop and validate a comprehensive computer simulation model to assess the impact of screening, prevention, and treatment strategies on type 2 diabetes and its complications, comorbidities, quality of life, and cost. RESEARCH DESIGN AND METHODS: The incidence of type 2 diabetes and its complications and comorbidities were derived from population-based epidemiologic studies and randomized, controlled clinical trials. Health utility scores were derived for patients with type 2 diabetes using the Quality of Well Being-Self-Administered. Direct medical costs were derived for managed care patients with type 2 diabetes using paid insurance claims. Monte Carlo techniques were used to implement a semi-Markov model. Performance of the model was assessed using baseline and 4- and 10-year follow-up data from the older-onset diabetic population studied in the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR). RESULTS: Applying the model to the baseline WESDR population with type 2 diabetes, we predicted mortality to be 51% at 10 years. The prevalences of stroke and myocardial infarction were predicted to be 18 and 19% at 10 years. The prevalences of nonproliferative diabetic retinopathy, proliferative retinopathy, and macular edema were predicted to be 45, 16, and 18%, respectively; the prevalences of microalbuminuria, proteinuria, and end-stage renal disease were predicted to be 19, 39, and 3%, respectively; and the prevalences of clinical neuropathy and amputation were predicted to be 52 and 5%, respectively, at 10 years. Over 10 years, average undiscounted total direct medical costs were estimated to be USD $53,000 per person. Among survivors, the average utility score was estimated to be 0.56 at 10 years. CONCLUSIONS: Our computer simulation model accurately predicted survival and the cardiovascular, microvascular, and neuropathic complications observed in the WESDR cohort with type 2 diabetes over 10 years. The model can be used to predict the progression of diabetes and its complications, comorbidities, quality of life, and cost and to assess the relative effectiveness, cost-effectiveness, and cost-utility of alternative strategies for the prevention and treatment of type 2 diabetes.

Computer Simulation↗

PubMed2005

A clinical trial of continuous subcutaneous insulin infusion versus multiple daily injections in older adults with type 2 diabetes.

OBJECTIVE: To compare the efficacy and safety of continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) in older adults with insulin-treated type 2 diabetes and to assess treatment satisfaction and quality of life. RESEARCH DESIGN AND METHODS: Adults (n = 107) > or =60 years of age (mean age 66 years) with insulin-treated type 2 diabetes (mean duration 16 years, BMI 32 kg/m(2), and HbA(1C) [A1C] 8.2%) were randomized to CSII (using insulin lispro) or MDI (using insulin lispro and insulin glargine) in a two-center, 12-month, prospective, randomized, controlled clinical trial. Efficacy was assessed with A1C, safety by frequency of hypoglycemia, and treatment satisfaction and quality of life with the Diabetes Quality of Life Clinical Trial Questionnaire and the 36-item short-form health survey, version 2. RESULTS: Forty-eight CSII subjects (91%) and 50 MDI subjects (93%) completed the study. Mean A1C fell by 1.7 +/- 1.0% in the CSII group to 6.6% and by 1.6 +/- 1.2% in the MDI group to 6.4%. The difference in A1C between treatment groups was not statistically significant (P = 0.20). Eighty-one percent of CSII subjects and 90% of MDI subjects experienced at least one episode of minor (self-treated) hypoglycemia (P = 0.17), and three CSII and six MDI subjects experienced severe hypoglycemia (P = 0.49). Rates of severe hypoglycemia were similarly low in the two groups (CSII 0.08 and MDI 0.23 events per person-year, P = 0.61). Weight gain did not differ between groups (P = 0.70). Treatment satisfaction improved significantly with both CSII and MDI (P < 0.0001), and the difference between groups was not statistically significant (P = 0.58). CONCLUSIONS: In older subjects with insulin-treated type 2 diabetes, both CSII and MDI achieved excellent glycemic control with good safety and patient satisfaction.

Diabetes Mellitus, Type 2↗