The role of cost-effectiveness analysis and health insurance in diabetes care.

The theme of World Diabetes Day for 1999 is 'The Costs of Diabetes'. This theme was chosen quite purposely to reflect the broad nature in which diabetes affects individuals, families, and society. For the theme can highlight the importance of diabetes from a medical, social, or economic perspective. This presentation addresses two issues, cost-effectiveness analysis and financial barriers to care, that pertain to the economic viewpoint. Economically, the costs of diabetes are varied. They include items that one can easily recognize, such as the expenditures related to medical treatment for diabetes (direct costs) or the earnings lost to individuals prematurely disabled or dying young (indirect costs). Other less well known costs exists as well. These include the opportunity costs to individuals with diabetes who forego other 'opportunities in life' because they made a decision to devote their financial or time resources to diabetes care. They also include costs to society, such as the impact of using existing resources in diabetes care unwisely, or having inappropriate priorities. Cost-effectiveness analyses in diabetes care address this last point. Health insurance issues highlight one aspect of opportunity costs in diabetes care.

Fetal deaths related to maternal injury.

CONTEXT: Maternal and fetal trauma is an important cause of adverse fetal outcomes. However, systematic exclusion from US injury surveillance programs of even the most severe outcome, fetal/neonatal death, has led to a lack of understanding about frequency, causes, and prevention. OBJECTIVE: To determine the rate of traumatic fetal deaths reported in state fetal death registries and the types of trauma and physiologic diagnoses associated with these deaths. DESIGN AND SETTING: Retrospective descriptive study of fetal death certificates from 1995 through 1997 obtained from 16 states, which accounted for 55% of US live births and approximately 15 000 fetal death registrations per year. MAIN OUTCOME MEASURE: Rate of fetal injury deaths, based on fetal death certificates coded with an underlying cause of death due to maternal injury at 20 weeks' gestation or later, by cause. RESULTS: During the 3-year study period, 240 traumatic fetal injury deaths were identified (3.7 fetal deaths per 100 000 live births). Motor vehicle crashes were the leading trauma mechanism (82% of cases; 2.3 fetal deaths per 100 000 live births), followed by firearm injuries (6% of cases) and falls (3% of cases). In 3 states, reported crash-related fetal deaths exceeded that of crash-related infant deaths. Placental injury was mentioned in 100 cases (42%) and maternal death was noted in 27 cases (11%). A peak rate of 9.3 fetal deaths per 100 000 live births was observed among 15- to 19-year-old women. CONCLUSIONS: Motor vehicle crashes are the leading cause of fetal deaths related to maternal trauma. Improved tracking of traumatic fetal injury deaths is important to stimulate and guide research and efforts to reduce the risks to women and fetuses from injury during pregnancy.

The association of diabetes specialist care with health care practices and glycemic control in patients with type 1 diabetes: a cross-sectional analysis from the Pittsburgh epidemiology of diabetes complications study.

OBJECTIVE: To determine whether diabetes care characteristics and glycemic control differ by use of specialist care in a representative cohort of patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: Health care, sociodemographic characteristics, and glycemic control were compared between participants in the Pittsburgh Epidemiology of Diabetes Complications Study who reported receiving specialist care (n = 212) and those who did not (n = 217). Specialist care was defined as having received care from an endocrinologist or diabetologist or diabetes clinic attendance during the last year. RESULTS: Patients who reported receiving specialist care were more likely to be female, to have an education level beyond high school, to have an annual household income >$20,000, and to have health insurance. Additionally, patients receiving specialist care were more likely to have received diabetes education during the previous 3 years, to have knowledge of HbAlc testing and to have received that test during the previous 6 months, to have knowledge of the Diabetes Control and Complications Trial results, to self-monitor blood glucose, and to inject insulin more than twice daily. A lower HbA1 level was associated with specialist care versus generalist care (9.7 vs. 10.3%; P = 0.0006) as were higher education and income levels. Multivariate analyses suggest that the lower HbA1 levels observed in patients receiving specialist care were restricted to patients with an annual income >$20,000. CONCLUSIONS: Specialist care was associated with higher levels of participation in diabetes self-care practices and a lower HbA1 level. Future efforts should research and address the failure of patients with low incomes to benefit from specialist care.

Disabilities due to injury in the military.

INTRODUCTION: Disability is a major health and economic issue in the Armed Forces associated with increased use of medical care, the loss of active duty time, and substantial compensation costs. METHODS: The role of injuries in physical disability from the early 1980s to 1994 was assessed by reviewing administrative data from the U.S. Army Physical Disability Agency, the Naval Disability Evaluation Board, and the Air Force Physical Disability Division. Information on the number of disability cases reviewed in 1994, the leading causes of disability, and the disposition of each case were examined most closely. Also, information from the Department of Defense on the cost of compensating disability cases was reviewed. RESULTS: Disability generally appears to be significant across the services, ranging from 10 to 30 events per 1000 personnel per year depending on the service. Evidence from the data reviewed indicates that 30% to 50% of disability cases may be due to injury. The leading conditions that bring about board reviews and lifetime compensation appear to be lower back and knee conditions, both commonly thought to be due to injuries. Total direct costs of compensation reached $1. 5 billion for fiscal year 1990. CONCLUSIONS: While current disability data systems are maintained for administrative and not research purposes, the information available may be valuable for injury surveillance and research and suggests that injury-related disability is a major health and economic burden for the Armed Forces.

Design of the PID Evaluation and Clinical Health (PEACH) Study.

This paper describes the PID Evaluation and Clinical Health Study (PEACH), a multicenter, randomized clinical trial designed to compare treatment with outpatient and inpatient antimicrobial regimens among women with pelvic inflammatory disease (PID). PEACH is the first trial to evaluate the effectiveness and cost-effectiveness of currently recommended antibiotic combinations in preventing infertility, ectopic pregnancy, chronic pelvic pain, recurrent PID, and other health outcomes. It is also the largest prospective study of PID ever conducted in North America. We describe the PEACH study's specific aims, study organization, patient selection criteria, conditions for exclusion, data collected upon entry, randomization and treatment, adherence measures, follow-up activities, quality-of-life measures, outcomes, and statistical analyses. In the first 11 months of enrollment (March 1996-January 1997), 312 women were randomized. Of eligible women, 59% consented to enroll. Participating women are primarily black (72%) and young (mean age 24 years). After a median of 5.5 months of follow-up, we were in contact with 95% of study participants. The PEACH study will provide a rationale for selecting between inpatient and outpatient antibiotic treatment, the two most common treatment strategies, for PID.

Victimization from physical violence in Pennsylvania: prevalence and health care use.

OBJECTIVES: To determine the prevalence of interpersonal physical violence (IPV) among Pennsylvania adults, to identify the personal characteristics of the victims, and to determine their health care use for resulting injuries. METHODS: Population-based data describing physical violence were obtained through a statewide telephone survey of 3,620 Pennsylvania adults selected from households by random-digit dialing in 1994. The prevalence and 95% confidence interval (95% CI) of victimization from IPV along with ED or other medical care facility use for IPV-related injuries were computed by several personal characteristics. Logistic regression was used to compare victims of IPV and their levels of health care use. RESULTS: The prevalence of reported victimization from IPV was 5.6% (95% CI = 4.9, 6.3). Significantly more victimization was reported by males, persons aged 18-29 years, those employed, and unmarried persons. The proportion of victims who reported to have gone to an ED or other medical care facility for IPV-related injury treatment was 12.9%. Significantly more persons with annual household incomes < $20,000 reported health care use for injuries resulting from IPV than did those with incomes of > or = $20,000 (OR = 3.98; 95% CI = 1.27, 12.48). Health care use for injuries was not found to be related to gender, age, race, employment, or marital status. CONCLUSIONS: This population-based study of health care use for IPV-related injuries found that victims of physical violence in Pennsylvania were not only young and unmarried men, but also employed. Health care use for resulting injuries was greater among persons with lower incomes.

Driving patterns and medical conditions in older women.

OBJECTIVES: To describe driving patterns (e.g., driving frequency) in older women drivers and to evaluate the impact of medical conditions and comorbidity on driving patterns. DESIGN: Cross-sectional examination of the association between medical conditions and driving patterns. SETTING: Population-based cohort from the Pittsburgh Center of the Study of Osteoporotic Fractures (SOF). PARTICIPANTS: A total of 1768 women aged 71 years or older. MAIN MEASUREMENTS: Driving information was obtained through a driving questionnaire, including driving status, weekly mileage, longest trip in the past year, etc. Data for demographics, lifestyle behavior, and medical conditions were collected through the SOF study. RESULTS: Among the participants, 1103 (62.3%) were current drivers, 337 (19.1%) had stopped driving, and 329 (18.6%) had never driven in their lifetime. The proportion reporting driving cessation and decline in driving amount increased with age. The prevalence of most medical conditions was higher among former drivers than in current or never drivers. Even after controlling for age and other demographic variables, fractures, heart disease, diabetes, self-reported poor vision or hearing, as well as comorbidity were found to be associated independently with decreased driving amount, including driving cessation, decline in mileage, and avoiding long trips. CONCLUSION: Both individual medical conditions and comorbidity influence driving patterns in older drivers. Because it is common for older people to have several medical conditions simultaneously, comorbidity might be a more comprehensive measure of medical impact on driving.

The cost-effectiveness of intensive therapy for diabetes mellitus.

Although persons with diabetes constitute only 3.1% of the US population, costs for their care account for 11.9% of total US health care expenditures. Approximately half of the expenditures for medical care for diabetes are for treatment of the metabolic condition and half for the treatment of chronic complications. Intensive therapy for persons with diabetes uses more resources and is more expensive than conventional therapy. On the other hand, intensive therapy is associated with a lower incidence of costly chronic complications. Formal economic analyses have demonstrated that intensive therapy is cost-effective for the treatment of diabetes. In IDDM, intensive therapy costs approximately $20,000 per QALY gained; in NIDDM, it costs approximately $16,000 per QALY gained. From an economic perspective, intensive therapy for persons with diabetes compares favorably with pharmacologic therapy for high-risk individuals with hypertension and hypercholesterolemia. Health policy should foster the use of such therapy for persons with diabetes mellitus.

Health insurance and the financial impact of IDDM in families with a child with IDDM.

OBJECTIVE: To examine the health insurance experience and out-of-pocket health care costs of families with a child with IDDM. RESEARCH DESIGN AND METHODS: A case-control study of 197 families with a child with IDDM and 142 control families with no diabetic children was conducted. IDDM-affected families were identified from the Allegheny County IDDM Registry. Brothers and sisters of the parents in the IDDM-affected families were asked to participate as control subjects. Health insurance coverage and the money that families spent on health care services and supplies not reimbursed by insurance (out-of-pocket costs) were assessed by questionnaire. RESULTS: No difference was found between the IDDM-affected and control families in the percentages with or without insurance. Families with low household incomes ($10,000-$19,999) were at the greatest risk for having no insurance. While coverage provided by private plans was similar between the IDDM-affected and control families, many families had no reimbursement for insulin (10%), syringes (10%), or blood testing strips (30%). Out-of-pocket expenses were 56% higher in the IDDM-affected families than in the control families. Seventeen percent of the IDDM-affected families had expenses over 10% of their household income. This particularly affected families with low household incomes. Pre-existing illness clauses and insurance denial affected only a small proportion of the case families. CONCLUSIONS: These data illustrate that most families with a child with IDDM have health insurance, yet still incur larger out-of-pocket health care costs than do families without the presence of diabetes. IDDM-affected families likely face a number of economic decisions regarding health insurance and the use of health care.

Employment patterns among parents of children with insulin-dependent diabetes mellitus (IDDM).

OBJECTIVE: To examine the influence of diabetes on the employment patterns of parents of children living with diabetes. STUDY DESIGN: A case-control study of 197 families with an IDDM child and 142 control families without IDDM children was conducted. Case families were identified from a population-based diabetes registry. Brothers and sisters of the parents in the IDDM families were asked to participate as controls. Employment rates, absenteeism related to child care, and changes in work status were assessed by means of a questionnaire. Surveys were obtained from 85% of the families (172 case; 118 control). RESULTS: No difference was found between the IDDM and control families in the overall rate of employment and changes in work patterns. However, IDDM families were more likely to report absences from work related to child care (58% vs. 45%, P < 0.05). This impact was greatest for the working mothers. The greatest impact of IDDM on employment may be faced by single parents, who reported lower rates of employment and higher rates of absenteeism and changes in work patterns. CONCLUSIONS: Families face decisions regarding employment and the appropriate level of care for children with diabetes. These data illustrate that most families with an IDDM child have employment experiences similar to those of families without diabetic children. Larger sample sizes of single parent families are necessary to confirm these findings.

Efficiency and accuracy of disease monitoring systems: application of capture-recapture methods to injury monitoring.

Capture-recapture methods were employed to determine the most accurate and efficient approaches to monitor adolescent injuries. Multiple sources were used to ascertain cases of adolescent injuries that occurred between September 1 and December 31, 1991, in a single school district in metropolitan Pittsburgh, Pennsylvania. Eliminating the duplicate cases between the sources revealed 144 verified injuries; 127 (88.2%) were identified by student monthly recalls, 33 (22.9%) by daily attendance records, 58 (40.3%) by medical excuses, and 72 (50.0%) by a 4-month student recall. Capture-recapture analyses were undertaken to assess potential dependencies between the sources, to estimate the degree of underascertainment in the population, and to evaluate the efficiency of the individual sources and the combinations between them. It was estimated that 91% of the cases in the population were ascertained when all four methods of case finding were utilized. Furthermore, the analysis indicated that accurate injury estimates could be achieved using combinations of only two or three of the sources. An analysis of the efficiency of the methods of ascertainment revealed a trade-off between effort (the number of hours needed to identify cases) and the precision (coefficient of variation) of the injury estimates. Capture-recapture analysis not only provided an approach to evaluate and adjust for undercount but also offered a formal means to evaluate the most efficient combination of the sources to maximize completeness while minimizing effort. The use of these techniques has the potential to evaluate and improve injury surveillance as well as other disease monitoring systems.

Epidemiology of type II diabetes: an international perspective.

Non-insulin-dependent diabetes mellitus (NIDDM, type II diabetes) is present in nearly all of the countries of the world, and represents a significant disease burden in most developed countries. Type II diabetes is fairly common among Caucasoid populations in the United States and Europe and, more importantly, among Native Americans, Pacific Island populations, persons of Asian Indian origin, Hispanics and African Americans. Our current understanding is that type II diabetes probably results from an interaction of genetic and environmental factors. While a genetic link is most likely a precursor to type II diabetes, a number of lifestyle behaviours, including obesity, lack of physical activity, and diet, also influence the development of the disease. Lifestyle changes and westernization that accompany economic development in developing countries have been followed in the past by substantial increases in the prevalence of type II diabetes. Thus, further increases in type II diabetes might be expected in the Third World as the economic advancement of these countries continues.

Establishment of accurate incidence rates for head and spinal cord injuries in developing and developed countries: a capture-recapture approach.

Prevention of head and spinal cord injuries is defined as a reduction in the incidence of these disabilities. Accurate incidence data are fundamental to any prevention program. The current approaches toward determining incidence rates for head and spinal cord injuries are summarized. Previous research has focused on passive surveillance systems and population-based registries. An alternative system for monitoring the incidence of head injuries is discussed that uses a surveillance methodology called capture-recapture. This method employs multiple population-based sources to identify cases and uses the cases that overlap between the sources to estimate the degree of undercount in the population. This estimate in turn is used to produce an ascertainment-corrected incidence estimate. Through the use of methods such as capture-recapture, accurate monitoring of the incidence of head and spinal injuries across developing and developed countries is indeed feasible.

The risks of licensing persons with diabetes to drive trucks.

The 1990 Americans with Disabilities Act forbids employers to bar disabled persons from jobs unless employers can show the disabled person cannot perform the tasks. The Federal Highway Administration will not license persons with diabetes mellitus to drive commercial motor vehicles in interstate commerce. These individuals may experience severe hypoglycemia, greatly increasing their risk of losing control of the truck. This prohibition is currently being reexamined. We describe the disease process leading to severe hypoglycemia and its physical manifestations. To quantify the risks of licensing persons with diabetes to use insulin, we first estimate the number of potential insulin-using drivers. We estimate that 1420 insulin-using persons would seek licenses in the United States if they were permitted to do so (920 noninsulin dependent and 500 insulin dependent). Next, we estimate the annual incidence of mild and severe hypoglycemia in these populations. The third step is to estimate the number of hypoglycemic episodes while driving. Estimating the likelihood of a crash due to a mild or severe hypoglycemic episode is the fourth step. We estimate that an additional 42 crashes each year would occur if insulin using persons were licensed to drive commercial motor vehicles in interstate commerce (20 from insulin dependent and 22 from non-insulin dependent drivers).

Should persons with diabetes be licensed to drive trucks?--Risk management.

How should a regulatory agency interpret a risk analysis that concludes there is a small increase in risk? The agency must decide on behalf of society whether the increased risk is large enough to justify banning the risky activity or taking some other step to lessen the risks. In a companion paper (Songer et al.), we conclude that licensing insulin using persons to drive commercial motor vehicles in interstate commerce would result in 42 additional crashes each year. Here we address risk management issues by interpreting the number of additional crashes and the relative risks of the prospective handicapped drivers. Are the number of additional crashes (42) significant? Is the increase in the annual crash risk (from 0.00785 to 0.032 for non-insulin dependent and 0.048 for insulin dependent persons) significant? Are the relative risks significant for all insulin using drivers (4.7)? For drivers with a history of severe hypoglycemic reactions (19.8)? How should society tradeoff risk increases for increases in opportunity for these handicapped persons? We review other social decisions concerning highway safety: Accepting the increasing risks of letting 16 year olds drive, allowing extremely light cars, allowing some unsafe highways, and allowing extremely unsafe driving conditions at some times of day. We conclude that the additional risks from insulin using persons are well within the current accepted range of risks.(ABSTRACT TRUNCATED AT 250 WORDS)

Insulin-dependent diabetes mellitus, physical activity, and death.

The beneficial effect of physical activity in the general population is well known, but, to the authors' knowledge, has not been reported for persons with insulin-dependent diabetes mellitus. In a cohort of 548 diabetes patients followed as part of the Pittsburgh Insulin-dependent Diabetes Mellitus Morbidity and Mortality Study, physical activity was ascertained by survey in 1981, and mortality was ascertained through January 1, 1988. Cases were also compared with non-diabetic sibling controls. Activity level among cases varied inversely with the occurrence of diabetic complications. Overall activity level was inversely related to mortality risk. Sedentary males (< 1,000 kcal/week) were three times more likely to die than active males (> 2,000 kcal/week). A similar, but statistically nonsignificant, relation was seen in females. Cox proportional hazards analysis controlling for potential confounders (age, body mass index, insulin dose, reported diabetes complications, cigarette smoking, and current alcohol drinking) similarly revealed that activity level was inversely associated with mortality risk. Comparison of cases with non-diabetic sibling controls identified similar activity levels for the two groups. The results suggest that activity is not detrimental with regard to mortality, and may in fact provide a beneficial effect in terms of longevity in diabetes patients.