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Publications and Products
The Economics of Diabetes Mellitus:
An Annotated Bibliography
TYPES
OF INTERVENTION
Tertiary
Intervention
Foot
Care
107
TITLE:
Benefits of Prevention: The Medicare Therapeutic Shoe Demonstration.
Wooldridge, J.; Handwerger, S. Diabetes Spectrum. 2(6): 390-394.
November-December 1989.
OBJECTIVE:
To describe the Medicare Therapeutic Shoe Demonstration, a congressionally
mandated research initiative into the cost-effectiveness of using Medicare
Part B coverage for therapeutic shoes in patients with diabetes mellitus
who have severe foot disease.
CATEGORY:
Tertiary intervention.
Type of
Study: Randomized clinical trial.
Methodology: Cost-effectiveness analysis.
Perspective: Health care system.
CONCLUSION:
None.
RECOMMENDATION:
None.
ABSTRACT:
In the Medicare Therapeutic Shoe Demonstration, physicians (including
podiatrists) in the demonstration states (California, Florida, and New
York) are to certify the eligibility of patients with diabetes who have
severe foot disease. Patients are to be randomly assigned to receive or
not receive Medicare Part B coverage for therapeutic shoes (n
= 13,700 patients per group). Cost-effectiveness will be determined by
aggregate federal and state costs. If costs for patients who receive the
benefit exceed costs for those who do not, it will not be cost effective.
Unless the shoe benefit is not cost effective, it will become permanent
in 1993. Eligible patients will have a past or present history of callus
formation with peripheral neuropathy, foot ulceration, prior amputation
of a foot in whole or in part, foot deformity with potential for ulceration,
or poor circulation. The legislation limits coverage to one pair of depth-inlay
or custom-molded shoes; an authorized shoe supplier will bill Medicare
directly, with annual deductible and copayment costs the responsibility
of the patient. The demonstration began in August 1989 and will run for
1 to 3 years. 1 table.
108
TITLE:
Cost-Effectiveness of Early Digit Amputation in the Patient With Diabetes.
Benton, G.S.; Kerstein, M.D. Surgery, Gynecology and Obstetrics.
161(6): 523-524. December 1985.
OBJECTIVE:
To assess the cost-effectiveness of early versus delayed amputation of
the osteomyelitic toe in patients with diabetes.
CATEGORY:
Tertiary intervention.
Type of
Study: Patient management.
Methodology: Cost analysis.
Perspective: Health care system.
CONCLUSION:
Early amputation is the preferred approach for managing osteomyelitis
of the toe in patients with diabetes. Oral antibiotic use alone is neither
clinically nor cost effective.
RECOMMENDATION:
Early surgical intervention and rehabilitation would reduce hospitalizations
for foot lesions among patients with diabetes and have beneficial economic
effects.
ABSTRACT:
The authors report the costs of treating 14 men and 8 women with diabetes
who had radiologic confirmation of osteomyelitis of the toe with no systemic
sepsis. Cultures confirmed the diagnosis, with Staphylococcus aureus the
predominant organism. Patients were initially treated with 2 grams/day
of oral cephalosporin. Average length of antibiotic treatment was 108
days for men and 84 days for women. All patients subsequently met minimum
criteria for local amputation: (1) Gangrene and infection was localized,
(2) patient was free of pain, (3) patient had minimal or no rubor of the
toes on dependency, and (4) venous filling was no longer than 20 seconds.
All amputations were through the metatarsal phalangeal region. Time to
complete healing and rehabilitation after surgery was 15 days (range 9
to 31) for men and 13 days (range 8 to 28) for women. Costs were assessed
for antibiotics, local wound care, and mean length of hospitalization
and did not reflect days lost from work. Per-patient and total costs for
antibiotics were $350 and $7,700, respectively. Per-day and total hospitalization
costs were $165 and $2,359, respectively. Postoperative hospitalization
averaged 2.6 days, and daily costs of medicine, operating room, laboratory,
and ancillary services averaged $350. The surgeon's fee averaged $250.
Oral antibiotic therapy was ineffective and therefore an unnecessary cost.
Definitive surgery allows the patient to return to work within 2 weeks
of amputation. 5 references.
109
TITLE:
Diabetic Foot Care: Financial Implications and Practice Guidelines. Reiber,
G. Diabetes Care. 15(Supplement 1): S29-S31. March 1992.
OBJECTIVE:
To examine the financial implications of foot care in patients with diabetes
and to review the implementation of practice guidelines for diabetic foot
care.
CATEGORY:
Tertiary intervention.
Type of
Study: Patient management.
Methodology: Review of studies.
Perspective: Health care system.
CONCLUSION:
Diabetic foot problems result in significant morbidity and mortality in
the United States. Foot care guidelines are emerging, but their role in
reducing foot problems in diabetes is not well defined.
RECOMMENDATION:
Studies should be conducted to address the impact of current guidelines
for foot care, the cost-effectiveness of both preventive and therapeutic
measures, and modes of delivering patient education and foot care.
ABSTRACT:
The author examines the available data on the impact of foot problems
in patients with diabetes and the status of practice guidelines. Although
the actual cost of diabetic foot problems in the United States is under
debate, the current data show that diabetic foot problems result in significant
morbidity and mortality. A 1986 study estimated that chronic skin ulcers
alone accounted for $150 million of the $11.6 billion direct costs of
type 2 diabetes in the United States. California hospital discharge data
showed an average cost of $20,085 and length of stay of 19.3 days for
nontraumatic diabetic amputation in 1987. In fiscal year 1987, Medicare
reported 31,120 bills submitted for reimbursement of lower-extremity amputation,
with reimbursements averaging $12,230 and length of stay averaging 18.7
days. Average cumulative cost of care for 106 patients (diabetes status
unknown) treated at a New England medical center for limb-threatening
ischemia was $40,769 for a lower-extremity bypass (average follow-up:
2.2 years) and $40,563 for amputation (average follow-up: 1.8
years). Foot care guidelines for persons with diabetes from several sources
are reviewed. The author concludes that these guidelines should be viewed
by providers as recommended minimum practice guidelines that should be
modified and adapted according to patient pathology, comorbidity, and
ability. 20 references.
110
TITLE:
Diabetic Foot Ulcers in a Multidisciplinary Setting: An Economic Analysis
of Primary Healing and Healing with Amputation. Apelqvist, J.; Ragnarson-Tennvall,
G.; Persson, U.; Larsson, J. Journal of Internal Medicine. 235(5):
463-471. May 1994.
OBJECTIVE:
To perform a cost analysis of healing with and without amputation in patients
with diabetes who had foot ulcers.
CATEGORY:
Tertiary intervention.
Type of
Study: Prospective.
Methodology: Cost analysis.
Perspective: Health care system.
CONCLUSION:
The findings indicate a potential cost savings from preventive, multidisciplinary
foot care. Treatment for healing without amputation in a multidisciplinary
system was associated with relatively low costs, while amputation was
costly, due mainly to multiple and prolonged hospitalization.
RECOMMENDATION:
Early and aggressive intervention in the management of foot ulcers is
important in keeping treatment costs low. Costs increase dramatically
with the severity of the lesion, impaired peripheral circulation, and
wound-healing time.
ABSTRACT:
A total of 314 consecutively presenting patients with diabetes who had
foot ulcers were included in a prospective study. Forty patients died
before healing occurred; the remaining 274 were included in a retrospective
economic analysis. In this group, 197 patients (72 percent) healed without
amputation, and 77 (28 percent) healed after amputation. All patients
were treated by a combined foot care team (diabetologist, orthopedic surgeon,
diabetes nurse, podiatrist, orthotist) both as inpatients and outpatients
and were followed up by the same team until final outcome. Data from the
prospective study and from patient records were used to estimate direct
costs for inpatient care, antibiotics, surgery, outpatient care, staff
attendance, drugs and material for ulcer dressings, and orthopedic appliances.
Indirect costs (e.g., loss of production) were not calculated. Costs were
calculated in Swedish Krona (SEK) in 1990 prices (SEK 6.0 = about $1 U.S.).
Costs related to treatment in years 2 and 3 after diagnosis were discounted
by 5 percent to 1990 values. The average direct cost for healing with
amputation was SEK 344,000; for patients who healed without amputation,
SEK 51,000. Costs for inpatient care accounted for 82 percent of the total
average costs for patients with amputation and 37 percent for those who
healed without amputation. Topical treatment of ulcers in the outpatient
setting comprised 13 percent of the total average cost for patients who
underwent amputation; for those who healed without amputation, it made
up 45 percent. Costs for medical visits (45 minutes for the first visit,
20 minutes for subsequent visits), antibiotics, and orthopedic appliances
were low in relation to total costs. Inpatient stay for those who healed
with amputation averaged 76 days; for major amputation, 84 days. The authors
state that treating patients with diabetes who have foot ulcers in a multidisciplinary
system is associated with a high probability of healing without amputation.
4 tables, 29 references.
111
TITLE:
Evaluation of the Costs to Medicare of Covering Therapeutic Shoes for
Diabetic Patients. Wooldridge, J.; Moreno, L. Diabetes Care. 17(6):
541547. June 1994.
OBJECTIVE:
To evaluate the cost to Medicare of a therapeutic shoe benefit for Medicare
Part B beneficiaries with severe diabetic foot disease.
CATEGORY:
Tertiary intervention.
Type of
Study: Randomized clinical trial.
Methodology: Cost-effectiveness analysis.
Perspective: Health care system.
CONCLUSION:
There is no strong evidence that expanding Medicare Part B to cover therapeutic
shoes for beneficiaries with severe diabetic foot disease will increase
total Medicare costs. The demonstration indicated that lowering the cost
of therapeutic shoes through a Medicare benefit would substantially increase
ownership and use of such shoes.
RECOMMENDATION:
A more orderly approach would have been to determine the conditions for
clinical effectiveness of the shoes before assessing their effect on Medicare
costs.
ABSTRACT:
Congress mandated a demonstration of a therapeutic shoe benefit for Medicare
Part B beneficiaries with diabetes. The benefit would be made permanent
if it could not be shown that the benefit was not cost effective. The
authors implemented a 3year demonstration in New York, Florida, and California
in which they sought to enroll 27,500 eligible beneficiaries; only 4,373
applied. Participants were randomly assigned to either a treatment group
that received the extra therapeutic shoe coverage or a control group that
received standard Medicare coverage. The authors evaluated the Medicare
payments and service use for a 12-month period of 3,428 participants (1,711
in the treatment group; 1,717 in the control group) who applied by August
25, 1991, and were randomized by September 30, 1991. Data were collected
from the Health Care Financing Administration, the demonstration's enrollment
form, and a telephone survey of beneficiaries. A onetailed test of statistical
significance assessed the null hypothesis that Medicare payments for the
treatment group were # to payments for the control group. Results indicated
that cost differences between groups were not statistically significant,
although Medicare payments for all services among the treatment group
in the first year of the demonstration were 3.8 percent higher ($451)
than those for the control group. The lower extremity amputation rate
during this period also did not differ significantly (2.6 percent for
the treatment group, 1.8 percent for controls). Similarly, during this
year, Medicare payments for foot care services were 14.6 percent ($318)
higher among the treatment group, but this was also a statistically insignificant
difference. At the beginning of the demonstration, 32 percent of both
the treatment and control groups owned therapeutic shoes; almost 3 years
later, 85 percent of the treatment group used them, versus 55 percent
of controls — this difference was statistically significant. 2
tables, 14 references.
112
TITLE:
Foot Infections in Diabetic Patients: Decision and Cost-Effectiveness
Analyses. Eckman, M.H.; Greenfield, S.; Mackey, W.C.; Wong, J.B.; Kaplan,
S.; Sullivan, L.; Dukes, K.; Pauker, S.G. Journal of the American Medical
Association (JAMA). 273(9): 712-720. March 1, 1995.
OBJECTIVE:
To examine the cost-effectiveness of approaches to the diagnosis and treatment
of foot infections and suspected osteomyelitis in patients with type 2
diabetes.
CATEGORY:
Tertiary intervention.
Type of
Study: Markov modeling.
Methodology: Cost-effectiveness analysis.
Perspective: Health care system.
CONCLUSION:
Noninvasive testing procedures add significant expense to the treatment
of patients with type 2 diabetes in whom pedal osteomyelitis is suspected
but may result in little improvement in health outcomes.
RECOMMENDATION:
For patients with no signs of systemic infection who have adequate perfusion,
surgical debridement followed by a 10-week course of culture-guided oral
antibiotics may be as effective as and less costly than other strategies.
ABSTRACT:
The authors performed a decision and cost-effectiveness analysis of strategies
for the diagnosis and treatment of patients with type 2 diabetes who have
foot infections and suspected osteomyelitis. Data were drawn from English-language
literature by using MEDLINE searches and the bibliographies of selected
articles. The base case scenario specified a 56-year-old man with type
2 diabetes for 7 years. Five interventions were assessed following hospitalization
for surgical debridement and intravenous antibiotic therapy: (1) treatment
for presumed soft-tissue infection, (2) culture-guided empiric treatment
for presumed osteomyelitis, (3) 71 combinations of diagnostic tests prior
to antibiotic therapy, (4) 71 combinations of tests prior to amputation,
and (5) immediate amputation. A Markov state transition model was constructed
to analyze decision trees and perform sensitivity analyses. Main outcomes
were quality-adjusted life expectancy and average costs (in 1993 dollars).
A long course of culture-guided antibiotic therapy was the least expensive
strategy, with an average lifetime cost of approximately $30,880; immediate
amputation was the most expensive, costing $46,900. Noninvasive testing
to select patients for long-term antibiotic therapy cost from $31,000
to $33,750. Sensitivity analysis showed that roentgenography followed
by magnetic resonance imaging cost an average of $120 more than empiric
therapy, either with no discounting or with cost-discounting of 5
percent, but resulted in no gain in quality-adjusted life expectancy.
Results show that noninvasive testing adds expense to the treatment of
patients with type 2 diabetes in whom pedal osteomyelitis is suspected
but may result in little improvement in health outcomes. A 10-week course
of empiric antibiotic therapy may be as effective as and less costly than
other strategies. 2 figures, 5 tables, 83 references.
113
TITLE:
long-term Costs for Foot Ulcers in Diabetic Patients in a Multidisciplinary
Setting. Apelqvist, J.; Ragnarson-Tennvall, G.; Larsson, J.; Persson,
U. Foot and Ankle International. 16(7): 388394. July 1995.
OBJECTIVE:
To analyze long-term costs for prevention, treatment, home care, and social
services in patients with diabetes and foot ulcers.
CATEGORY:
Tertiary intervention.
Type of
Study: Prospective.
Methodology: Cost analysis.
Perspective: Health care system.
CONCLUSION:
The expected average annual costs per patient during the first 3 years
after healing ranged from $5,200 to $11,200 for primarily healed patients
and from $14,000 to $32,000 for patients healed with amputation. These
findings indicate the potential cost savings of preventive foot care.
RECOMMENDATION:
When estimating the costs for diabetic foot ulcers, a short-term perspective
is not sufficient. long-term costs are high and are due mainly to the
need for increased home care and social services as well as to costs for
recurrent ulcers and new amputations.
ABSTRACT:
A total of 314 consecutively presenting patients with diabetes and foot
ulcers were followed to a final outcome; those who healed were followed
for an additional 3 years. Primary healing occurred in 197 patients (72
percent); healing after amputation, in 77 patients (28 percent). The 40
patients who died before healing were excluded from a retrospective economic
analysis (n = 274) of costs during 3 years after healing. All patients
were treated and followed, both as inpatients and outpatients, by a foot
care team consisting of a diabetologist, an orthopedic surgeon, an orthotist,
a podiatrist, and a diabetes nurse. Those who healed primarily were further
divided according to the presence (n = 56) or absence (n = 141) of critical
ischemia. Healing with amputation was divided according to minor (n =
27) or major (n = 50) amputation. Inpatient, outpatient, home care, and
social service costs were determined for a period of 3 years after healing
of the initial ulcer and were calculated in Swedish Krona in 1990 prices.
Costs related to treatment in years 2 and 3 were discounted by 5 percent
to equal 1990 values. The expected total present value costs per patient
during 3 years of observation for primarily healed patients were $26,700
(U.S. dollars) for those with critical ischemia and $16,100 for those
without critical ischemia. These calculations account for the probability
of surviving the first and second year of observation. The corresponding
figures were $43,100 and $63,100 following minor and major amputation,
respectively. The highest costs for inpatient care were found during the
first year of follow-up for patients who had undergone major amputations
($11,900). Similarly, the estimated annual extra costs for social service
and home care were higher among patients who healed with major amputation
than in other groups. 1 figure, 3 tables, 29 references, 1 appendix.
114
TITLE:
Medicare Therapeutic Shoe Demonstration: Report to Congress. Health Care
Financing Administration, Baltimore, Maryland. 1990. 85 pp.
OBJECTIVE:
To provide a report to Congress on the cost-effectiveness of providing
a Medicare Part B benefit for therapeutic shoes.
CATEGORY:
Tertiary intervention.
Type of
Study: Randomized clinical trial.
Methodology: Cost-effectiveness analysis.
Perspective: Health care system.
CONCLUSION:
It is too early to tell whether the benefit will be cost effective; a
demonstration to determine cost-effectiveness is ongoing.
RECOMMENDATION:
None.
ABSTRACT:
The Omnibus Reconciliation Act of 1987 mandated a demonstration project
in which Medicare Part B coverage would be provided for therapeutic shoes.
An evaluation was also required to determine whether the benefit would
be cost effective and should be introduced as a regular benefit. To be
eligible for the demonstration, Medicare beneficiaries with diabetes had
to have one or more of five conditions (previous amputation, deformity
with potential for ulceration, callus formation or history of callus formation
with peripheral neuropathy, a history of foot ulceration, poor circulation)
in one or both feet. A priori, to be cost effective the cost to Medicare
of therapeutic shoes had to be less than the savings resulting from reduced
use of other Medicare-covered services attributable to the program. In
the evaluation, costs to Medicare of a group receiving the experimental
benefit are being compared with costs for a similar group not receiving
the benefit. The authors note that these are insufficient data at this
point to indicate whether the benefit is cost effective, and that the
demonstration project is ongoing. Thus, they provide background on the
demonstration project, present the clinical arguments on coverage, give
a legislative history, describe how the demonstration was implemented,
and discuss what is known about the population at risk and how their characteristics
affect the likelihood that the benefit will be cost effective. In the
demonstration project, physicians must certify the eligibility of beneficiaries
who meet the clinical criteria and prescribe the therapeutic shoes, which
must be provided by suppliers authorized by the Health Care Financing
Administration. Early enrollment has been below expectations, and, in
the first 4 months, very few primary care practitioners certified patient
eligibility or prescribed therapeutic shoes. Plans are under way to increase
participation during early 1990 in cooperation with the clinical community.
2 figures, 11 tables, 10 references.
115
TITLE:
Medicare Therapeutic Shoes Demonstration: Was the Demonstration Cost Effective?
Final Comprehensive Report, Volume I. Wooldridge, J.; Bergeron,
J.; Moreno, L.; Thornton, C. Mathematica Policy Research, Inc., Princeton,
NJ, June 30, 1993. 261 pp.
OBJECTIVE:
To evaluate the cost-effectiveness of the Medicare Therapeutic Shoe Demonstration.
CATEGORY:
Tertiary intervention.
Type of
Study: Randomized clinical trial.
Methodology: Cost-effectiveness analysis.
Perspective: Health care system.
CONCLUSION:
The hypothesis that the shoe benefit was cost effective could not be rejected
statistically. However, because enrollment in the program was below the
target level, the authors lacked sufficient precision in their estimates
to be sure that if the benefit was not cost effective, they would have
correctly identified it as such. (Medicare added a therapeutic shoe benefit
[Part B] in May 1993 as a result of the demonstration findings.)
RECOMMENDATION:
The authors recommend several changes in the benefit (e.g., provide Medicare
coverage for shoe repair) and its procedures as well as regulatory changes.
ABSTRACT:
The Medicare Therapeutic Shoe Demonstration (conducted from August 1989
to October 1992) enrolled 4,373 Medicare beneficiaries with diabetes and
severe foot disease. Enrollees were randomly assigned to a benefit group
(who received Medicare Part B coverage for therapeutic shoes) or a control
group (no coverage). The authors refer to two earlier reports on the demonstration:
the first (1990) found no evidence that the program was cost saving; the
second (1993) found no statistical basis to conclude that costs had increased.
In the present report, the authors summarize a more comprehensive evaluation
of whether providing the benefit was cost effective (Congress had mandated
that the shoe benefit be enacted nationally unless it was shown not to
be cost effective). For this report, a null hypothesis was tested to see
whether it could be rejected: that under the demonstration, costs were
lower than or equal to what they would have been without the intervention.
For evaluation purposes, the shoe benefit would not be cost effective
if the net cost to Medicare of providing the shoes significantly exceeded
zero (i.e., the gross cost of covering the shoes significantly exceeded
savings from reduced use of Medicare services that might result if the
shoes helped to prevent new foot problems). The authors state that their
approach assured a low probability of asserting that costs increased because
of the program if they really did not. However, they state that their
approach also carried the risk of not concluding that costs truly increased
under the new benefit if the increase in cost was small. For the benefit
group's first year in the demonstration, the authors found no statistically
significant differences from the control group in terms of Medicare payments
for all services, for Medicare Part A or Part B services only, or for
all foot care services, although in each instance the figure for the treatment
group was higher. Hospital admissions for the two groups were also indistinguishable
statistical. 6 figures, 44 tables, 38 references.
116
TITLE:
Osteomyelitis in Feet of Diabetics: Clinical Accuracy, Surgical Utility,
and Cost-Effectiveness of MR Imaging. Morrison, W.B.; Schweitzer, M.E.;
Wapner, K.L.; Hecht, P.J.; Gannon, F.H.; Behm, W.R. Radiology.
196(2): 557564. August 1995.
OBJECTIVE:
To evaluate the sensitivity, specificity, clinical utility, and Cost-effectiveness
of magnetic resonance imaging (MRI) in the diagnosis of osteomyelitis
of the foot in patients with diabetes.
CATEGORY:
Tertiary intervention.
Type of
Study: Patient management.
Methodology: Cost analysis.
Perspective: Health care system.
CONCLUSION:
MRI has good sensitivity and specificity for diagnosing osteomyelitis
in the feet of patients with diabetes, is competitively priced compared
with other imaging methods, and is clinically useful in accurately delineating
the extent of osteomyelitis so that limited surgical resection may be
achieved.
RECOMMENDATION:
Although the common perception of MRI is that it is a high-tech, high-cost
modality, in the inpatient setting it may be the best and most cost-effective
method of diagnosis.
ABSTRACT:
The authors prospectively evaluated 62 MRI studies of the foot in
59 patients to detect the presence and extent of osteomyelitis. The population
was divided into patients with diabetes (study group, n = 27 feet) and
patients without diabetes (control group, n = 35 feet). MRI was performed
with a 1.5T unit and an extremity coil; two orthogonal planes were imaged
in each study. Contrast enhancement was used in 53 of the 62 studies.
Biopsy (n = 41 feet) and clinical follow-up (n = 62 feet) were used to
establish the diagnosis, select treatment, and determine outcome. Patients
were followed up for an average of 6 months after treatment. A subgroup
of 13 patients who underwent footsparing resection procedures was
followed up for an average of 9 months; in every case, there was no recurrent
infection at the surgical margin. Good sensitivity (82 percent) and specificity
(80 percent) were obtained with MRI in diagnosing osteomyelitis in diabetic
feet despite a high frequency of neuropathic osteoarthropathy (33 percent)
and peripheral vascular disease (19 percent), both of which can complicate
image interpretation. Sensitivity and specificity were higher in the control
group (89 percent and 94 percent, respectively), but the differences were
not statistically significant. Cost analysis revealed that contrast-enhanced
MRI is competitively priced compared with the combination of two scintigraphic
methods, one involving three-phase bone scanning and the other, white
blood cell scanning. The overall cost of diagnosis, surgical procedures,
and hospitalization was slightly lower with contrast-enhanced MRI than
with the optimal (combined) scintigraphic method. 5 figures, 2 tables,
52 references.
117
TITLE:
Preventing Diabetic Foot Disease: Lessons From the Medicare Therapeutic
Shoe Demonstration. Wooldridge, J.; Bergeron, J.; Thornton, C. American
Journal of Public Health. 86(7): 935-938. July 1996.
OBJECTIVE:
To determine why few at-risk patients with diabetes purchased and used
therapeutic shoes in the Medicare demonstration program (1989 to 1992).
CATEGORY:
Tertiary intervention.
Type of
Study: Randomized clinical trial.
Methodology: Cost-effectiveness analysis.
Perspective: Health care system.
CONCLUSION:
Physicians may not recognize the importance of special foot care for patients
with diabetes. Only 6 percent of physicians who were notified about the
Medicare demonstration ever enrolled any patients.
RECOMMENDATION:
Internists and general and family physicians need to receive continuing
education on preventive care for foot problems in patients with diabetes.
Frequent reminders to physicians about the Medicare shoe benefit might
increase the number of participating physicians. A legislative change
to allow podiatrists to certify eligibility in the national program would
facilitate access.
ABSTRACT:
Patients with diabetes often have amputations because of foot ulcers from
impaired peripheral sensation, circulatory problems, and poorly controlled
blood sugar levels. In May 1993, Medicare added coverage of therapeutic
shoes for beneficiaries with diabetes at risk for foot disease after an
evaluation did not show that this benefit increased Medicare costs. The
patient's physician certified patient eligibility, a physician prescribed
the shoes, and an authorized shoe supplier fit and furnished the shoes.
The evaluation took place in California, Florida, and New York from August
1989 to October 1992, with few beneficiaries applying in the first 6 months
despite a publicity campaign in which 43,000 Medicare beneficiaries who
had a relatively recent admission for a diabetes-related foot problem
and 56,000 physicians or podiatrists as well as clinics were notified.
A second campaign, targeted at physicians, was mounted in response. Enrollment
after 37 months totaled 4,373 beneficiaries, far below the target of 27,500.
Of this group, 2,183 were randomly assigned to the treatment (coverage)
group, 2,190 to the control group (no coverage). Three years after the
evaluation began, 85 percent of the treatment group and 55 percent of
the control group owned therapeutic shoes. Despite the promise of Medicare
coverage, only 71 percent of the treatment group bought therapeutic shoes
through the demonstration. Podiatrists enrolled nearly half of the eligible
participants; internists and orthopedic surgeons were the next most frequent
enrollers. Pedorthists supplied 29 percent of the shoes; podiatrists,
23 percent; and prosthetists, 22 percent. Only 2 percent of the 43,000
Medicare beneficiaries who were notified of the demonstration subsequently
enrolled. Podiatrists reported that many patients resist wearing custom-molded
shoes. 2 tables, 8 references.
118
TITLE:
A Prospective Evaluation of Transcutaneous Oxygen Measurements in the
Management of Diabetic Foot Problems. Ballard, J.L.; Eke, C.C.; Bunt,
T.J.; Killeen, J.D. Journal of Vascular Surgery. 22(4): 485-492.
October 1995.
OBJECTIVE:
To determine whether lower extremity transcutaneous measurements of the
partial pressure of oxygen can accurately predict the severity of foot
ischemia and be used to select appropriate treatment for patients with
diabetes and tissue necrosis or ischemic pain at rest.
CATEGORY:
Tertiary intervention.
Type of
Study: Patient management.
Methodology: Statistical analysis.
Perspective: Health care system.
CONCLUSION:
Mapping of lower-extremity transcutaneous partial pressure of oxygen is
an accurate, noninvasive, and relatively inexpensive method to prospectively
select appropriate treatment for patients with diabetes and limb-threatening
ischemia, and it may obviate the need for arteriography to determine the
severity of foot ischemia.
RECOMMENDATION:
An absolute transmetatarsal level for the partial pressure of oxygen of
30 mm Hg or greater appears to be an accurate cutoff point for the selection
of conservative or operative treatment for almost all diabetic foot problems.
However, the conservative management scheme requires diligent patient
follow-up. A higher threshold (40 mm Hg) may be required to manage calcaneal
gangrene or some very severe nonhealing ulcerations.
ABSTRACT:
Thirty-four men and 21 women (ages 34 to 87) with diabetes and ischemic
pain at rest or pedal tissue necrosis (representing 66 threatened feet)
were prospectively treated from June 1993 to July 1994. Treatment indications
included nonhealing ulcer (53 percent), gangrene (38 percent), and rest
pain (9 percent). Noninvasive hemodynamic arterial assessment and transcutaneous
mapping of the partial pressure of oxygen for the involved limb were obtained
before treatment was selected. Patients with trans-metatarsal levels of
30 mm Hg or higher received conservative treatment (e.g., local wound
care, debridement, minor foot amputation). If the trans-metatarsal level
was less than 30 mm Hg, arteriography was performed. The endpoints for
determining treatment success or failure were complete wound healing or
relief of ischemic rest pain. Thirty-one of 36 (86 percent) limbs with
an initial transmetatarsal level of 30 mm Hg or higher were treated successfully
with conservative care, including 11 of 15 feet without a palpable pedal
pulse. After revascularization (16 feet) or angioplasty (8 feet), 20 of
24 (83 percent) limbs with initial partial pressure of less than 30 mm
Hg achieved a transmetatarsal level greater than 30 mm Hg. An initial
or postintervention transmetatarsal level of 30 mm Hg or greater was more
accurate (90 percent, p = 0.001) than a palpable pulse (65 percent, p
= 0.009) in predicting ultimate resolution of pedal gangrene, nonhealing
ulceration, or ischemic rest pain. The total cost for transmetatarsal
mapping of a lower extremity was $93.88 per patient, versus $1,052.73
for a diagnostic lower extremity arteriogram. If absence of pedal pulses
had been the indication for arteriography, 45 limbs in this study would
have been subjected to this examination, yet only 31 actually required
it. The authors also found that conservative management is cost effective
compared with revascularization surgery or angioplasty. 3 tables, 17 references.
119
TITLE:
Towards Less Amputations in Diabetic Patients: Incidence, Causes, Cost,
Treatment, and Prevention — A Review. Larsson, J.; Apelqvist, J.
Acta Orthopaedica Scandinavica. 66(2): 181-192. April 1995.
OBJECTIVE:
To discuss the problem of lower extremity amputation in patients with
diabetes, and to analyze possibilities for reducing the number of such
procedures.
CATEGORY:
Tertiary intervention.
Type of
Study: Patient management.
Methodology: Review of studies.
Perspective: Health care system.
CONCLUSION:
A comprehensive system that incorporates regular foot examinations, preventive
foot care, protective footwear, education of patients, a multidisciplinary
approach to foot ulcers, strict amputation criteria, long-term follow-up
after healing, and continuous registration of amputations can reduce major
amputation in patients with diabetes.
RECOMMENDATION:
None.
ABSTRACT:
Foot ulcers are the most common reason for amputation in the patient with
diabetes. The most frequent underlying condition is polyneuropathy with
sensory, motor, and autonomic disturbances. Most often, the foot ulceration
is precipitated by trauma, usually caused by faulty or incorrectly used
footwear. Patients with diabetes with a high probability for an amputation
include those with polyneuropathy and those with vascular disease without
evidence of polyneuropathy. Common indications for amputation in patients
with diabetes are gangrene, infection, and nonhealing ulcer. In 1990,
the estimated cost of an amputation in the United States (hospital treatment
only) was $18,300. When evaluating costs of treatment or other therapeutic
strategies, it is important to include the costs of hospitalization and
rehabilitation along with outpatient treatment costs until healing. The
first step to minimize the risk of amputation is preventing lesions that
may develop into gangrene and/or a deep infection. An important regimen
is regular inspection of feet and footwear of patients with diabetes during
health care visits; however, previous studies have shown this occurs in
only 12 to 15 percent of checkups. Patients should have early access to
a multi-disciplinary team for examination and treatment, both as inpatients
and outpatients. From a long-term perspective, among patients with diabetes,
a minor amputation has a lower risk for a new major amputation. A minor
amputation also has a better rehabilitation potential. 8 tables, 117 references.
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