| |
|
| Appendix II Table. Input variables, quality of data, and sourcesa |
|
| Input variable |
Base-case estimate (range)
|
Quality of evidenceb |
Source |
|
| Epidemiology (%) |
|
Vaccine effectiveness
|
75 (20-90)
|
I |
2 |
|
Skin-test sensitivity
|
70 (50-80)
|
II-2 |
3-5 |
|
Skin-test specificity
|
90 (70-97)
|
II-2 |
4,6,7 |
|
Annual infection rate
|
2 (0.25-3)
|
II-3 |
5,8-16 |
|
Annual emigration among vaccinees
out of highly endemic region
|
0.5 (0-4.2)
|
II-2, III |
c |
|
Symptomatic primary pulmonary
disease after infection
|
40
|
II-2 |
18 |
|
Diagnosed symptomatic primary
pulmonary disease
|
10 (5-15)
|
III |
d |
|
Death from primary pulmonary
disease, given diagnosis
|
0.5 (0-26)
|
II-2 |
19-22 |
|
Chronic pulmonary disease after
diagnosed primary infection
|
5 (1-10)
|
III |
23-26 |
|
Death from chronic pulmonary
disease
|
5 (0-20)
|
III |
24e |
|
Dissemination after infection
|
0.38(0.25-0.55)
|
II-2 |
17 |
|
Meningitis, given dissemination
|
33 (23-44)
|
II-2 |
21,26 |
|
Death from meningeal dissemination
|
7 (5-40)
|
II-2, III |
27d,e |
|
Moderate disability after meningeal
dissemination
|
50 (40-60) |
III |
27d,e |
|
Severe disability after meningeal
dissemination
|
17 (10-30) |
III |
27d,e |
|
Annual meningeal dissemination
relapse rate, on treatment
|
2 (0-5) |
I, II-2 |
28-30 |
|
Death from nonmeningeal
dissemination
|
2 (0-10) |
III |
e |
|
Moderate disability after
nonmeningeal dissemination
|
33 (20-50) |
III |
d,e |
|
Annual nonmeningeal dissemination
relapse rate, On treatment
|
2 (0-5) |
I, II-2, III |
4c |
|
Off treatment
|
50 (35-65)
|
I, II-2, III |
31-34c |
|
Mild vaccine side effects
|
25 (10-40)
|
II-2 |
35 |
|
Vaccine anaphylaxis, x 10-4
|
1.67 (0.1-10)
|
II-2 |
35 |
| |
| Direct medical costs ($) |
|
Three doses of vaccine
|
180 (100-400)
|
III |
36,37 |
|
Skin test
|
12 (9-15)
|
III |
38 |
|
Home care, per month
|
2,450 (1,840-3,060)
|
II-2 |
39 |
|
Diagnosed pulmonary disease
|
2,090 (1,570-2,610)
|
II-2, III |
40 |
|
Incident meningeal dissemination
|
9,510 (7,130-11,890)
|
II-2 |
40 |
|
Medication and follow-up after
Coccidioides immitis meningitis,f per
month
|
1,510 (1,130-1,890)
|
II-2 |
41e,g |
|
Incident nonmeningeal
dissemination
|
6,950 (5,210-8,690)
|
II-2 |
40 |
|
Medication and follow-up for
chronic pulmonary infection and
nonmeningeal dissemination,f per
month
|
530 (290-790)
|
II-2 |
41e,g |
|
Inpatient vaccine anaphylaxis
treatment
|
2,180 (1,640-2,730)
|
II-2 |
40 |
| |
|
Time costsh
|
|
Average wage ($ per hour)
|
12 (9-15)
|
II-2 |
d |
|
Average clinic visit (hours)
|
1.25 (0.5-2)
|
III |
Assumed |
|
Lost work due to undiagnosed
primary pulmonary disease (days)
|
5 (0-10)
|
III |
Assumed |
|
For parents of sick children (days)
|
3 (0-5)
|
III |
Assumed |
| |
| Utilities |
|
Well
|
0.94 to 0.70i
|
II-2 |
42 |
|
Diagnosed primary pulmonary
infection
|
0.90 (0.85-0.95)
|
III |
d |
|
Chronic pulmonary infection (proxy,
pulmonary tuberculosis)
|
0.57 (0.29-0.84)
|
II-2, III |
42 |
|
Meningeal dissemination (proxy,
paraplegia)
|
0.40 (0.21-0.52)
|
II-2, III |
42 |
|
Nonmeningeal dissemination (proxy,
orthopedic impairment)
|
0.59 (0.34-0.84)
|
II-2, III |
42 |
|
Severe disability after meningitis
(proxy, hemiplegia)
|
0.27 (0.10-0.38)
|
II-2, III |
42 |
|
Moderate disability after meningitis
(proxy, sciatica)
|
0.72 (0.52-0.92)
|
II-2, III |
42 |
|
Moderate disability after
nonmeningeal dissemination (proxy, arthritis)
|
0.69 (0.51-0.92)
|
II-2, III |
42 |
|
Chronic azole treatment (proxy,
warfarin treatment)
|
0.98 (0.92-1.0)
|
II-2, III |
43 |
|
Dead
|
0
|
III |
Assumed |
|
Vaccine side effect quality-of-life
decrement (days)
|
0.1 (0-0.2)
|
III |
Assumed |
| |
| Other variables (%) |
|
Discount rate
|
3 (0-5)
|
III |
44 |
|
aThe base-case estimate represents our best estimate for each value. All costs are in 2000 U.S. dollars.
bThe quality rating is derived from the U.S. Preventive Services Task Force Guide to Clinical Preventive Services (1). Source of evidence: I: at least one
properly randomized controlled trial; II-1: well-designed controlled trial without randomization; II-2: well-designed cohort or case-control analytic
studies; II-3: multiple time series with or without intervention; III: opinions of respected authorities; descriptive studies and case reports; or reports of
expert committees (1).
cInternal Revenue Service, unpub. data.
dJohn Galgiani, pers. comm.
eHans Einstein, pers. comm.
fWe assumed that meningitis patients were treated with 800 mg of daily
fluconazole, and chronic pulmonary and nonmeningeal dissemination patients
with either 400 mg fluconazole or 400 mg ketoconazole daily (Royce Johnson, pers. comm., 1999). A 50:50 distribution of fluconazole and ketoconazole
use represents our base case; the upper end of the range assumes all nonmeningeal dissemination patients receive fluconazole in follow-up, whereas the
lower end assumes they receive the less expensive ketoconazole.
gRon Talbot, pers. comm.
hBased on a weighted adjusted gross income of $24,105 from taxpayers in the 10 highly endemic counties (Internal Revenue Service,
unpub. data).
iMean HALex scores for healthy persons, by age group (when men and women had differing mean scores, we chose the higher of the two scores):
<5=0.94; 5-17=0.93; 18-24= 0.92; 25-34=0.91; 35-44=0.90; 45-54=0.87; 55-64=0.81; 65-74=0.78; >75=0.70 (43).
|
|
| |
|
References
- U.S. Preventive Services Task Force. Guide to clinical preventive services. 2nd ed. Alexandria (VA): International Medical Publishing; 1996.
- Szmuness W, Stevens CE, Harley EJ, Zang EA, Oleszko WR, William DC, et al.
Hepatitis B vaccine: demonstration of efficacy in a controlled clinical
trial in a high risk population in the United States. N Engl J Med 1980;303:833-41.
- Stevens DA, Levine HB, Deresinski SC, Ten Eyck DR, Restrepo MA. Epidemiological and clinical skin testing studies with spherulin. In: Ajello L,
editor. Coccidioidomycosis: Current clinical and diagnostic status. Vol. 1. Miami: Symposia Specialists; 1977. p. 107-14.
- Lebowitz MD, Johnson WM, Kaltenborn W. Coccidioidin skin test reactivity and cross-reactivity with histoplasmin in a Tucson population. In: Ajello L,
editor. Coccidioidomycosis: Current clinical and diagnostic status. Vol. 1. Miami: Symposia Specialists; 1977. p. 45-61.
- Dodge RR, Lebowitz MD, Barbee R, Burrows B. Estimates of C. immitis infection by skin test reactivity in an endemic community. Am J Public Health
1985;75:863-5.
- Levine HB, Gonzalez-Ochoa A, Ten Eyck DR. Dermal sensitivity to Coccidioides immitis. A comparison of responses elicited in man by spherulin and
coccidioidin. Am Rev Respir Dis 1973;107:379-86.
- Levine HB, Restrepon A, Eyck DR, Stevens DA. Spherulin and
coccidioidin: cross-reactions in dermal sensitivity to histoplasmin and
paracoccidioidin.
Am J Epidemiol 1975;101:512-6.
- Gifford M, Buss W, Douds R. Annual report of the Kern County Health Department for the fiscal year July 1, 1936 to June 30, 1937.
- Edwards PQ, Palmer CE. Prevalence of sensitivity to coccidioidin, with special reference to specific and nonspecific reactions to coccidioidin and to
histoplasmin. Diseases of the Chest 1957;31:35-60.
- Hugenhotz PG. Skin test survey at Williams Air Force Base, Arizona. In: Symposium on Coccidioidomycosis, Phoenix, AZ. Washington: U.S.
Government Printing Office; 1957.
- Maddy KT. The geographic distribution of Coccidioides immitis and possible ecologic implications. Arizona Medicine 1958;15:178.
- Klotz AL, Biddle M. Coccidioidin skin test survey of San Fernando Valley State college students over a five year period. In: The Second Symposium on
Coccidioidomycosis. Phoenix (AZ): University of Arizona Press; 1965.
- Doto I. Coccidioidin,
histoplasmin, and tuberculin sensitivity among school children in Maricopa Co., Arizona. Am J Epidemiol 1972;95:464.
- Catanzaro A. Coccidioidin sensitivity in San Diego schools. Sabouraudia 1979;17:85-9.
- Fredrich BE. A skin test survey of valley fever in Tijuana, Mexico. Soc Sci Med 1989;29:1217-27.
- Larwood T. Coccidioidin skin testing in Kern County, California: decrease in infection rate over 58 years. Clin Infect Dis 2000;30:612-3.
- Smith CE, Beard RR. Varieties of coccidiodal infection in relation to the epidemiology and control of diseases. Am J Public Health 1946;36:1394-402.
- Bayer AS. Fungal pneumonias; pulmonary coccidioidal syndromes (Part 1). Primary and progressive primary coccidioidal pneumonias --diagnostic,
therapeutic, and prognostic considerations. Chest 1981;79:575-83.
- Arsura E, Caldwell J, Johnson R, Einstein H, Welch G, Talbot R, et al. Coccidioidomycosis epidemic of 1991: epidemiologic features. In: 5th
International Conference on Coccidioidomycosis. Stanford (CA) University: National Foundation for Infectious Diseases; 1994.
- Arsura EL. The association of age and mortality in coccidioidomycosis letter. J Am Geriatr Soc 1997;45:532-3.
- Johnson RH, Caldwell JW, Welch G, Einstein HE. The great coccidioidomycosis epidemic: clinical features. In: Coccidioidomycosis: 5th International
Conference. Stanford (CA) University: National Foundation for Infectious Diseases; 1994.
- Sarosi GA, Parker JD, Doto IL, Tosh FE. Chronic pulmonary
coccidioidomycosis. N Engl J Med 1970;283:325-9.
- Bayer AS. Fungal pneumonias: pulmonary coccidioidal syndromes (Part 2).
Miliary, nodular, and cavitary pulmonary coccidioidomycosis;
chemotherapeutic and surgical considerations. Chest 1981;79:686-91.
- Einstein HE, Johnson RH. Coccidioidomycosis: new aspects of epidemiology and therapy. Clin Infect Dis 1993;16:349-54.
- Galgiani JN. Coccidioidomycosis. In: Remington JS, Swartz MN, editors. Curr Clin Top Infect Dis 1997:188-204.
- Vincent T, Galgiani John N, Huppert M, Salkin D. The natural history of coccidioidal meningitis: VA-Armed Forces Cooperative Studies, 1955-1958.
Clin Infect Dis 1993;16:247-54.
- Bouza E, Dreyer JS, Hewitt WL, Meyer RD. Coccidioidal meningitis. An analysis of thirty-one cases and review of the literature. Medicine 1981;60:139-72.
- Galgiani JN, Catanzaro A, Cloud GA, Higgs J, Friedman BA, Larsen RA, et al. Fluconazole therapy for coccidioidal meningitis. The NIAID-Mycoses
Study Group. Ann Intern Med 1993;119:28-35.
- Perez JA Jr, Johnson RH, Caldwell JW, Arsura EL, Nemecheck P. Fluconazole therapy in coccidioidal meningitis maintained with intrathecal
amphotericin B. Arch Intern Med 1995;155:1665-8.
- Tucker RM, Denning DW, Dupont B, Stevens DA. Itraconazole therapy for chronic coccidioidal meningitis. Ann Intern Med 1990;112:108-12.
- Catanzaro A, Galgiani JN, Levine BE, Sharkey-Mathis PK, Fierer J, Stevens DA, et al.
Fluconazole in the treatment of chronic pulmonary and
nonmeningeal disseminated coccidioidomycosis. NIAID Mycoses Study Group. Am J Med 1995;98:249-56.
- Galgiani JN, Catanzaro A, Cloud GA, Johnson RH, Williams PL, Mirels LF, et al.
Comparison of oral fluconazole and itraconazole for progressive,
nonmeningeal coccidioidomycosis. A randomized, double-blind trial. Mycoses Study Group. Ann Intern Med 2000;133:676-86.
- Graybill JR, Stevens DA, Galgiani JN, Dismukes WE, Cloud GA. Itraconazole treatment of
coccidioidomycosis. NAIAD Mycoses Study Group. Am J
Med 1990;89:282-90.
- Oldfield EC 3rd, Bone WD, Martin CR, Gray GC, Olson P, Schillaci RF. Prediction of relapse after treatment of
coccidioidomycosis. Clin Infect Dis
1997;25:1205-10.
- Niu MT, Rhodes P, Salive M, Liveley T, Davis DM, Black S, et al. Comparative safety data of two recombinant hepatitis B vaccines in children: data
from the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink
(VSD). J Clin Epidemiol 1998;51:503-10.
- Andre FE. Summary of safety and efficacy data on a yeast derived hepatitis B vaccine. Am J Med 1989;87:14s-20s.
- Assad S. Over a decade of experience with a yeast recombinant hepatitis B vaccine. Vaccine 1999;18:57-67.
- Revised 2000 National Physician Fee Schedule. Baltimore: Health Care Financing Administration; 2000.
- Manton KG, Etallard E. Chapter 6: Program payment and utilization trends for Medicare beneficiaries with disabilities. In: Wiener JM, Clauser SB,
Kenner DL, editors. Persons with disabilities. Washington: The Brookings Institution; 1995. p. 117-62.
- Healthcare Cost and Utilization Project. Nationwide inpatient sample. Rockville (MD): Agency for Healthcare Research and Quality; 1996.
- Wholesale acquisition prices for pharmaceuticals in the United States. Montvale (NJ): Medical Economics; 1999.
- Gold M, Franks P, McCoy K, Fryback DG. Toward consistency in cost-utility analyses: using national measures to create condition-specific values. Med
Care 1998;36:778-92.
- Gage B, Cardinalli A, Owens D. The effect of stroke and stroke prophylaxis with aspirin or warfarin on quality of life. Arch Intern Med 1996;156:1829-36.
- Lipscomb J, Weinstein MC, Torrance GW. Time Preference. In: Gold MR, Siegel JE, Russell LB, Weinstein MC, editors. Cost-effectiveness in health
and medicine. New York: Oxford University Press; 1996. p. 214-35.
|