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Publications and Products
The Economics of Diabetes Mellitus:
An Annotated Bibliography
TYPES
OF INTERVENTION
Secondary
Intervention
Screening
and Diagnosis for Type 2 Diabetes
3
TITLE:
Comparison of glycosylated Hemoglobin and Fasting Plasma Glucose with
Two-Hour Post-Load Plasma Glucose in the Detection of Diabetes Mellitus.
Simon, D.; Coignet, M.C.; Thibult, N.; Senan, C.; Eschwege, E. American
Journal of Epidemiology. 122(4): 589-593. October 1985.
OBJECTIVE:
To compare the use of a glycosylated hemoglobin (HbA1C) test
alone with a combination of that test and a plasma glucose measurement
in a diabetes screening program.
CATEGORY:
Secondary intervention.
Type of
Study: Patient screening.
Methodology: Statistical analysis.
Perspective: Health care system.
CONCLUSION:
Using the combination of an HbA1C measurement and a fasting
plasma glucose measurement increases the specificity and predictive value
of a positive diagnosis of diabetes over that obtained by glycosylated
hemoglobin alone.
RECOMMENDATION:
Longitudinal surveys should be performed to assess the validity of HbA1C
as a measurement tool for diabetes screening.
ABSTRACT:
From September 15, 1981, to April 1, 1984, 333 outpatients were recruited
from the screening diabetes center of the Hôtel-Dieu Hospital in
Paris. Patients filled out a questionnaire; underwent a physical exam;
had blood drawn for fasting plasma glucose, HbA1C, cholesterol,
and triglyceride measurements; and took an oral glucose tolerance test
with a 75-g glucose load. With 2-hour plasma glucose values as a reference,
sensitivities of the fasting plasma glucose measurement, HbA1C,
and a combination of fasting plasma glucose and glycosylated hemoglobin
were, respectively, 52 percent, 60 percent, and 40 percent; the specificities
were 98.7 percent, 90.9 percent, and 99.4 percent; and the predictive
values for a positive diagnosis were 76.5 percent, 34.9 percent, and 83.3
percent. Taking into account the economic and psychosociologic implications
of a diagnosis of diabetes, it is better for a screening test for asymptomatic
diabetes to have a high degree of specificity and a high predictive value
for a positive diagnosis than to have good sensitivity but poor specificity.
As an oral glucose tolerance test is time-consuming for patients and nurses,
measurements of HbA1C by chromatography and of fasting plasma
glucose appear to be less expensive (about 5 versus 10 U.S. dollars).
Longitudinal surveys are needed to assess the validity of HbA1C
as a tool for diabetes screening. 1 table, 32 references.
4
TITLE:
Comparison of Screening Tests for Non-Insulin-Dependent Diabetes Mellitus.
Hanson, R.L.; Nelson, R.G.; McCance, D.R.; Beart, J.A.; Charles, M.A.;
Pettitt, D.J.; Knowler, W.C. Archives of Internal Medicine. 153(18):
2133-2140. September 27, 1993.
OBJECTIVE:
To compare four screening tests for type 2 diabetes.
CATEGORY:
Secondary intervention.
Type of
Study: Population screening.
Methodology: Statistical analysis.
Perspective: Health care system.
CONCLUSION:
Fasting plasma glucose was the best test for screening, but glycated hemoglobin
and quantitative urine glucose also provided high specificity with sensitivities
approximately 80 percent or higher.
RECOMMENDATION:
The choice of a particular screening test should depend on assay cost,
convenience, and availability.
ABSTRACT:
The authors compared the sensitivity of measuring quantitative urine glucose,
dipstick urine glucose, fasting plasma glucose, and glycated hemoglobin
to screen for diabetes in Pima Indians, a tribe at high risk for type
2 diabetes. Fasting plasma glucose concentrations and glycated hemoglobin
(HbA1 or HbA1C) were compared in 2,092 fasting participants;
glycated hemoglobin, quantitative glycosuria, and dipstick glycosuria
were compared in 237 nonfasting participants. Among nonfasting participants,
at specificities of 98 or 99 percent, sensitivities for detecting diabetes
were 80.6 percent for quantitative glycosuria, 64.3 percent for dipstick
glycosuria, and 92.9 percent for HbA1. For detecting diabetes
with severe hyperglycemia, sensitivities for the 3 tests ranged from 85.0
percent (HbA1) to 96.0 percent (quantitative glycosuria), with
similar specificities. Among fasting participants, at a specificity of
98.3 percent the sensitivity of fasting plasma glucose was 88.0 percent;
at similar specificities, HbA1 had a sensitivity of 78.8 percent
and HbA1C, 80.3 percent. For detecting diabetes with severe
hyperglycemia, all 3 tests had a sensitivity of 94.6 percent or greater
with specificity of 98 percent. The slightly higher sensitivity of fasting
plasma glucose (versus glycated hemoglobin) is probably of minimal significance
because fasting plasma glucose is a less convenient test. glycosuria assays
have limited ability to detect diabetes with moderate hyperglycemia, but
they reliably detect severe hyperglycemia. 4 figures, 4 tables, 41 references.
5
TITLE:
Effectiveness of glycosylated Hemoglobin, Fasting Plasma Glucose, and
a Single Post Load Plasma Glucose Level in Population Screening for Glucose
Intolerance. Modan, M.; Halkin, H.; Karasik, A.; Lusky, A. American
Journal of Epidemiology. 119(3): 431-444. March 1984.
OBJECTIVE:
To determine which of the following methods is the most effective screening
test for glucose intolerance (impaired glucose tolerance and type 2 diabetes):
glycosylated hemoglobin, fasting plasma glucose, combination of fasting
plasma glucose and glycosylated hemoglobin, plasma glucose 1-hour post
oral glucose load, and plasma glucose 2-hour post oral glucose load.
CATEGORY:
Secondary intervention.
Type of
Study: Population screening.
Methodology: Statistical analysis.
Perspective: Health care system.
CONCLUSION:
The most effective screening methods were the 1- and 2-hour post oral
glucose loads. The 1-hour post oral glucose load worked better for detecting
glucose intolerance, and the 2-hour post oral glucose load was better
for detecting diabetes.
RECOMMENDATION:
For clinical diagnosis, a two-stage screening using a fasting or random
blood glucose test and an oral glucose load may be adequate, but for epidemiologic
studies a full oral glucose tolerance test that includes a fasting test
and two post-load levels is preferred.
ABSTRACT:
The study population included a sample group of 2,040 people, aged 40-70
years, who were participating in the Israel Study of Glucose Intolerance,
Obesity and Hypertension. Members of the sample group who were not known
to have diabetes underwent a glucose tolerance test based on a fasting
test and 1-hour and 2-hour post oral glucose loads. In 1,058 participants,
glycosylated hemoglobin was also measured. Results showed that glycosylated
hemoglobin alone is inefficient and inferior to a fasting plasma glucose
test to determine glucose intolerance. Although glycosylated hemoglobin
increased with glucose intolerance, there was considerable overlap in
the distributions between newly identified patients with diabetes and
patients with normal tolerance. The combination of the glycosylated hemoglobin
test with the fasting plasma glucose test did not perform any better than
the fasting test alone. However, testing fasting plasma glucose is not
a satisfactory screening method because of its low specificities at adequate
sensitivity levels compared with the 1- and 2-hour post glucose load tests.
Of these tests, the 2-hour post glucose load level is more reliable when
screening for diabetes alone, and the 1-hour post glucose load is more
effective in screening for impaired glucose tolerance. Adding a fasting
test to the 1- and 2-hour post glucose load tests raised the cost less
than 5 percent, and the risk analysis showed that the venipunctures needed
for the tests were not associated with any problems in patients. If a
distinction is desired between impaired glucose tolerance and diabetes,
a two-stage screening is indicated. In this method, everyone gets a 1-hour
post load and the positive subgroup is retested by a full oral glucose
tolerance test. For purposes of epidemiologic screening, a full oral glucose
tolerance test is preferred over any "shortcut" method. 1 figure,
6 tables, 28 references.
6
TITLE:
The glycosylated Hemoglobin as a Diagnostic and Monitoring Tool for Diabetes:
Evidence from Claims Data (abstract). Altan, A.E.; Carlson, A.M.; Nettles,
A. AHSR FHSR Annual Meeting Abstract Book. 1996; 13:11.
OBJECTIVE:
To investigate how often the glycosylated hemoglobin (HbAlc) test is used
to diagnose type 2 diabetes and the extent to which it is used to monitor
diabetes control.
CATEGORY:
Secondary intervention.
Type of
Study: Patient management.
Methodology: Claims review.
Perspective: Health care system.
CONCLUSION:
The HbAlc test may be misused as a diagnostic tool for type 2 diabetes
and underused as a tool to monitor diabetes control.
RECOMMENDATION:
None.
ABSTRACT:
The investigators examined claims records of 81,039 persons enrolled in
three 1993 managed care plans located in large metropolitan areas in the
western, midwestern, or eastern United States. The researchers identified
individuals with diagnosed diabetes (both insulin-treated and noninsulin-treated);
those who had received the oral glucose tolerance test, the recognized
diagnostic test for diabetes; and those who had received the HbAlc test.
Among enrollees identified as not having diabetes (n = 70,068), 1,141
received an HbAlc test; of these persons, 4 percent (44 enrollees) also
were given an oral glucose tolerance test. Of the 10,970 persons identified
as having diabetes, 40 percent had had at least one HbAlc test during
the year.
7
TITLE:
Immunization to Prevent Insulin-Dependent Diabetes Mellitus? The Economics
of Genetic Screening and Vaccination for Diabetes. England, W.L.; Roberts,
S.D. Annals of Internal Medicine. 94(3): 395-400. March 1981.
OBJECTIVE:
To determine the relative value of several strategies for preventing diabetes
through the use of vaccine.
CATEGORY:
Secondary intervention.
Type of
Study: Epidemiological cohort model.
Methodology: Cost-benefit analysis.
Perspective: Health care system.
CONCLUSION:
Vaccinating all children at age 3 was preferable, both economically and
for disease prevention, to strategies that involved histocompatibility
leukocyte antigen (HLA) screening prior to vaccination or to no vaccination
at all.
RECOMMENDATION:
Health programs and technologies need to be analyzed (e.g., for cost and
risk) before they become available.
ABSTRACT:
Numerous studies have shown an association between type 1 diabetes and
viral infections, which suggests that vaccination for diabetes may be
possible. The principal assumption behind the present paper is that viruses
are involved in precipitating diabetes and that a vaccine for them can
be developed. The author calculated an incidence rate for new cases of
diabetes and program costs for 12 approaches to vaccination, 10 involving
screening — the other 2 were vaccinating everyone and vaccinating
no one. A decision tree analysis framework was used: the cost analysis
considered the direct cost of diabetes, vaccine production and immunization,
screening for predisposition to diabetes (measures evaluated included
eight types of HLA tests, the Lewis negative erythrocyte phenotype, and
the presence of diabetes in a parent or sibling), and side effects. The
investigators used data based on published sources if possible; when data
were inadequate or not available, a sensitivity analysis was performed.
Only direct costs were tabulated. The analysis presupposed that any vaccinations
would take place at age 3 (the most cost-effective age for all policies);
incidence rates are the projected results after 27 years of vaccinating.
Vaccinating everyone would reduce incidence by 29 percent and decrease
the nondiscounted annual cost of diabetes by 18 percent; this policy was
preferred to the other 11 on the basis of both incidence and cost. These
results were, however, heavily influenced by the cost and efficacy of
the vaccine, cost and probability of a vaccine reaction, cost and probability
of diabetes, and the discount rate. A decision to vaccinate everyone was
preferred to other alternatives for a wide range of vaccine characteristics.
7 tables, 51 references.
8
TITLE:
Multiple Biochemical Blood Testing as a Case-Finding Tool in Ambulatory
Medical Patients. Ruttimann, S.; Dreifuss, M.; Clemencon, D.; di Gallo,
A.; Dubach, U.C. The American Journal of Medicine. 94(2): 141-148.
February 1993.
OBJECTIVE:
To prospectively assess the yield, disadvantages, and charges associated
with routine biomedical testing in a medical outpatient clinic.
CATEGORY:
Secondary intervention.
Type of
Study: Patient management.
Methodology: Cost-analysis.
Perspective: Health care system.
CONCLUSION:
Routine biochemical testing in the university teaching setting was useful
in identifying new diagnoses, but the number of newly discovered disorders
that required new medical management was small.
RECOMMENDATION:
Reducing the number of routine biomedical tests to three — cholesterol,
glucose, and alanine aminotransferase measurements — to detect disorders
that need treatment may be preferable to ordering large biochemical profiles.
ABSTRACT:
The authors assessed the utility of routine biochemical tests in finding
new disorders that changed medical management. Patients (n = 493) attending
the medical outpatient clinic of the University Hospital in Basel, Switzerland,
for the first time during 1989 underwent a 23-test biochemical screen.
To differentiate clinically indicated from routine tests, resident physicians
were instructed to order only tests required to monitor known or suspected
medical conditions, even though the complete profile was performed. Patient
charges were $40 for the biochemical profile and $17.60 for each additional
visit caused exclusively by abnormal routine tests; charges were counted
until diagnosis or patient discharge. Ninety percent of the tests were
considered routine; 11.4 percent of these routine tests were abnormal.
Four hundred thirty of the 493 patients had new abnormalities diagnosed
on the routine tests; further tests were ordered for 10.9 percent of these
patients, additional visits were required for 1.4 percent, and new diagnoses
were reached for 11.1 percent. A change in management occurred in 5.8
percent (n = 25) of these patients; in all but 4 of these cases the newly
detected disorder was hypercholesterolemia, alcoholic liver disease, or
diabetes mellitus. These 21 cases could have been detected with cholesterol,
glucose, and alanine aminotransferase tests alone. Total charges for all
tests were $20,938; total charges for tests considered clinically indicated
were $8,256. Additional charges per patient for the detection of the new
diagnoses averaged $25.72. Using only the tests relevant to the new diagnoses,
per-patient charges would have been reduced 30 percent. Biochemical screening
in this setting is feasible and results in acceptable amounts of further
testing and additional patient laboratory costs. Prospective studies should
be developed to test the utility of reducing screening to cholesterol,
glucose, and alanine aminotransferase tests only. 4 tables, 41 references.
9
TITLE:
Screening for Diabetes Mellitus in General Practice Using a Reflectance
Meter System: The Islington Diabetes Survey. Forrest, R.D.; Jackson, C.A.;
Yudkin, J.S. Diabetes Research. 6(3): 119-122. November 1987.
OBJECTIVE:
To assess the accuracy of a reflectance meter system in screening for
diabetes mellitus in a community-based screening program; to compare the
results obtained with the laboratory assessment of blood glucose; and
to estimate the costs of screening for diabetes mellitus with this system.
CATEGORY:
Secondary intervention.
Type of
Study: Population screening.
Methodology: Cost-effectiveness analysis.
Perspective: Health care system.
CONCLUSION:
The reflectance meter system accurately estimated the prevalence of diabetes
mellitus in the study population. Blood glucose concentrations obtained
with the reflectance meter were higher than those of the laboratory assay,
and confirmatory glucose tolerance tests were needed in a large number
of misclassified patients. However, total costs of screening, even with
the additional confirmatory glucose tolerance tests, were still significantly
lower for the reflectance meter assay.
RECOMMENDATION:
The glucose reflectance meter system, along with confirmatory glucose
tolerance tests, can provide an acceptable, lower-cost alternative to
the autoanalyzer glucose-oxidase method of blood glucose assay for community-based
screening for diabetes mellitus.
ABSTRACT:
The authors assessed the accuracy and costs of a reflectance meter system
for screening for diabetes mellitus and compared the results obtained
with laboratory assessment of blood glucose. As a component of the Islington
Diabetes Survey, 1,084 randomly selected persons over age 40 were screened
with an oral glucose tolerance test after an overnight fast. Two-hour
blood glucose was measured using an automated glucose-oxidase method.
For 530 persons, blood glucose was also measured using the reflectance
meter system. The reflectance meter system gave an acceptable estimate
of the prevalence of diabetes mellitus, identifying 14 of the 15 cases
found by the glucose-oxidase system, but it did not provide an accurate
estimate of the prevalence of impaired glucose tolerance. (Reflectance
meter values were higher than glucose-oxidase values in 82 percent of
cases.) Costs associated with screening the 530 individuals were calculated
at £1,166.00 for the glucose-oxidase method and £358.75 for
the reflectance meter. Confirmatory glucose tolerance tests were required
in 29 persons on the basis of glucose-oxidase values and in 47 on the
basis of reflectance meter values. Total costs for these confirmatory
tests were estimated at £1,460.90 for patients initially screened
via glucose-oxidase and £857.95 for those screened by the reflectance
meter. Estimated total costs per case of diabetes mellitus identified
were £97.39 for the glucose-oxidase method and £ 61.28 for the
reflectance meter. The authors conclude that the reflectance meter is
an acceptable screening tool for diabetes; it is less costly, it is simpler
and easier to use, and it provides results faster than the glucose-oxidase
method. 2 figures, 1 table, 16 references.
10
TITLE:
Screening for Retinopathy: A Relative Cost-Effectiveness Analysis of Alternative
Modalities and Strategies. Sculpher, M.J.; Buxton, M.J.; Ferguson, B.A.;
Spiegelhalter, D.J.; Kirby, A.J. Health Economics. 1(1): 39-51.
April 1992.
OBJECTIVE:
To assess the relative cost-effectiveness of various screening strategies
for retinopathy associated with diabetes.
CATEGORY:
Secondary intervention.
Type of
Study: Patient screening.
Methodology: Cost-effectiveness analysis.
Perspective: Health care system.
CONCLUSION:
Systematic screening carried out in the general practitioner's office
at the same time as routine diabetes care checks can save considerable
costs over screening that requires additional visits to a hospital or
an optician.
RECOMMENDATION:
None.
ABSTRACT:
The authors used data from a 1985-1988 English study of the cost-effectiveness
of screening for retinopathy to compare various screening options, including
single modalities (either ophthalmoscopy or fundus photography), combined
approaches, and selective screening. The base study was conducted at three
community-based health centers in England; 3,423 patients with diabetes
were screened. The authors defined cost-effectiveness as cost per true-positive
case detected. Total cost per patient for ophthalmoscopy at the general
practitioner's office was £ 20.66; at an optician's office, £
19.31; for fundus photography, this cost was £ 25.46 at the hospital
and £ 14.87 at the general practitioner's office (costs at the general
practitioner's office were less if screening was part of a general checkup).
The sensitivity of these approaches (in the order just listed) was 0.53,
0.48, 0.40, and 0.58; specificity was 0.91, 0.94, 0.96, and 0.97. Combined
approaches (e.g., both ophthalmoscopy and fundus photography at the general
practitioner's office) had higher sensitivity but lower specificity. Expected
cost per true-positive case detected was £ 784 for ophthalmoscopy
(same for general practitioner and optician), £ 1,178 for hospital-based
fundus photography, £ 497 for photography at the general practitioner's
office, £ 734 for both ophthalmoscopy and photography at the general
practitioner's office, and £ 968 for ophthalmoscopy by an optician
combined with photography at a general practice. If screening at the general
practitioner's office was combined with regular follow-up, these costs
dropped to £ 273 for ophthalmoscopy, £ 434 for fundus photography,
£ 419 for ophthalmoscopy plus photography, and £ 914 for photography
at the office combined with ophthalmoscopy on the optician's premises.
Among the selective screening options, directly referring high-risk patients
and not screening those who were low-risk had the lowest cost per true-positive
case ( £ 168) but only 0.25 sensitivity. Directly referring high-risk
patents and providing both ophthalmoscopy and photography at the general
practitioner's office had a sensitivity of 0.85 and a cost per true positive
of £ 679 ( £ 407 if part of a general check-up). 1 figure, 5
tables, 42 references.
11
TITLE:
Targeted Screening for Diabetes in Community Chiropody Clinics. Gill,
G.V.; Lishman, L.; Kaczmarczyk, E.; Tesfaye, S. Quarterly Journal of
Medicine. 89:229-232. 1996.
OBJECTIVE:
To assess the cost-effectiveness of screening for diabetes in adults attending
community podiatry clinics.
CATEGORY:
Secondary intervention.
Type of
Study: Patient screening.
Methodology: Cost analysis.
Perspective: Health care system.
CONCLUSION:
Screening was simple and very cost effective, but the diagnostic yield
was moderate.
RECOMMENDATION:
Screening of a podiatry clinic's population for diabetes cannot be recommended
without knowing what percentage of that population is already known to
have diabetes.
ABSTRACT:
Patients who have known foot problems may have an increased likelihood
of having diabetes. In this study, which was based in Liverpool, England,
all patients aged 40 to 75 years attending community chiropody (podiatry)
clinics who were not previously known to have diabetes were offered postprandial
screening for glycosuria. Patients who reported positive results on the
self-test were brought to the hospital for a glucose tolerance test. Of
1,058 patients who accepted screening, 11 (1.0 percent) reported positive
results; of this group, 4 had diabetes, 2 had impaired glucose tolerance,
and 5 had normal glucose tolerance. The cost for each person screened
was 11 pence; for each person with a positive urine test, £ 2.06;
and for each newly diagnosed patient with diabetes, £ 34.46. No cost
was included for staff time in the coordinating hospital chiropody department
to respond to the participants. The authors indicate that their slightly
disappointing result (0.4 percent new diabetes patients) is probably due
to the very high proportion (17.3 percent) of Liverpool chiropody clinic
patients already known to have type 2 diabetes. According to the authors,
screening of a podiatry clinic's population cannot be recommended without
knowing its proportion of already identified diabetes patients. They also
observe that a major difficulty with screening for type 2 diabetes is
the lack of a sufficiently sensitive and specific test. The authors also
point out that handing out rather than mailing the test strips was cost-saving,
as was having the patients telephone in their results. 1 figure, 2 tables,
15 references.
12
TITLE:
Value of Serum Glucose Assay as Part of the Biochemical Profile in Screening
for Diabetes. Northam, B.E.; Smith, J.H.; Fitzgerald, M.G.; Nattrass,
M.; Wright, A.D. Annals of Clinical Biochemistry. 19(6): 412-415.
November 1982.
OBJECTIVE:
To evaluate a system of identifying patients with previously undetected
diabetes that begins with a screening assay for serum glucose.
CATEGORY:
Secondary intervention.
Type of
Study: Patient screening.
Methodology: Cost analysis.
Perspective: Health care system.
CONCLUSION:
Addition of serum glucose testing for inpatients undergoing other laboratory
evaluations is a useful and cost-effective method of screening for diabetes.
RECOMMENDATION:
None.
ABSTRACT:
The authors report the effectiveness and cost of diabetes screening for
adult inpatients at General Hospital in Birmingham, England, during 3
months in 1980. A serum glucose test was added to the routine biochemical
profiles of 2,050 patients; 453 had values of 10 mmol/L or higher. After
elimination of those known to have diabetes or receiving intravenous glucose,
152 patients underwent capillary blood glucose tests; 71 had elevated
values. Ten of these patients were referred to the diabetes clinic, 42
underwent oral glucose tolerance testing, and 19 were lost because of
illness, death, or discharge. Fifteen patients were found to have normal
glucose tolerance, 11 had impaired glucose tolerance, and for 16, the
glucose tolerance test was in the diabetes range (3 of these 16 patients
were referred to the diabetes clinic). Retesting as outpatients 3 months
later resulted in referral of two of the patients with impaired glucose
tolerance and one with apparent diabetes to the diabetes clinic. In all,
16 patients with previously undetected diabetes were identified. Additional
costs on an annual basis for direct screening were £ 500 for serum
glucose testing (reagent only), £ 320 for 2 blood glucose tests (including
labor for sample collection and analysis), and £ 440 for oral glucose
tolerance testing, for a total of £ 1,260, or £ 20 per case
of diabetes identified (64 cases in a year). If time for staff (other
than the clinical staff) to eliminate patients with diabetes and on intravenous
glucose was added, the total per case would be doubled. The prevalence
of diabetes (0.8 percent of inpatients) may have been underestimated because
of losses to follow-up (30 patients), size of dose of glucose for the
glucose tolerance testing (50 g rather than 75 g), arbitrary selection
of serum glucose concentration required for follow-up, and elimination
of patients receiving intravenous glucose. The true prevalence of diabetes
was probably 0.8 percent to 3.5 percent. This screening method is cost
effective, based on the additional screening cost of only £ 20 per
case of diabetes identified. 1 figure, 2 tables, 8 references.Disease
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