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Biomedical subjects

G A Richwald

Publications and source records attributed to G A Richwald.

At least 19 recordsLinked to original sources

Modeling the impact of treatment options in genital warts: patient-applied versus physician-administered therapies.

With the availability of new patient-applied treatments for genital and perianal warts, medical providers, physician groups, and health systems are reassessing the role of physician-administered therapies. Two key questions are: how cost-effective are physician- versus patient-administered therapies and, given patient preferences for the convenience and privacy associated with the latter therapies, which of the 2 presently available treatments-imiquimod and podofilox-is most appropriate? The purpose of this article is to examine, from the perspective of the health care purchaser, these questions and to undertake a pharmacoeconomic analysis of the direct cost-effectiveness of therapy options, given targets being set for the outcomes of genital warts therapy. The analysis employs a synthetic, decision-modeling framework in which data on sustained clearance and the direct costs of treatment are drawn from both clinical studies and previous studies on the resources used to support treatment. Once targets are set-and it is proposed here that physicians should aim for at least a 50% sustained clearance rate for genital warts--it becomes clear that in cost per sustained clearance terms, imiquimod, as first-line therapy, is the most cost-effective intervention. If we compare imiquimod with podofilox as first-line therapy (with cryotherapy as the second-line option), the cost per sustained clearance for the imiquimod treatment sequence is $1367 compared with the podofilox-initiated sequence of $1508.

Condylomata Acuminata↗

The communicable disease impact of eliminating publicly funded prenatal care for undocumented immigrants.

OBJECTIVES: In 1996, California proposed regulations to eliminate publicly funded prenatal care for undocumented immigrants. Prenatal treatment of sexually transmitted infections (STIs) can prevent STI-related adverse outcomes of pregnancy (AOP). The study assessed the STI-related health and economic impact of the proposed regulations in Los Angeles County (LAC). METHODS: We modeled excess STI-related AOPs and associated costs that would occur in LAC as if the regulations were implemented in 1995. Using attributable fractions in the exposed for five STIs and their associated AOPs, we calculated excess STI-related AOPs and their costs that would result from the regulations and the degree to which excess morbidity would offset gross savings. RESULTS: The model indicates that, depending on regulatory level, 74, 110, or 132 excess AOPs would occur subsequent to the regulations, representing lost prevented morbidity. These excess AOPs would cost $5.1, $7.6, or $9.2 million dollars in direct medical expenses, offsetting anticipated savings by 19.2%, 29.0%, or 34.9%. This analysis does not include other costs of these STIs or costs associated with non-STI-related sequelae of diminished prenatal care, all of which could further offset anticipated savings. CONCLUSIONS: The proposed regulations would likely lead to increased STI-related morbidity and costs, thereby offsetting anticipated savings. Health departments are in a special position to promptly respond to policy issues affecting vulnerable populations. The development of a practical and rational framework for local-level policy assessment can be important for encouraging good scientific approaches that respond to calls for reductions in basic preventive health services.

California↗

Imiquimod.

The imidazoquinoline, imiquimod, is a low molecular weight, synthetic immune response modifier that is used for the treatment of external genital and perianal warts. It is formulated in a 5% vanishing cream as Aldara. This self-applied therapy has shown good efficacy and safety in the treatment of external genital and perianal warts caused by human papillomavirus (HPV) infection. The antiviral mechanism of action of this compound is unlike any other approved antiviral therapy in that it induces the production of antiviral cytokines and cytokines that enhance cellular immunity believed to be necessary for the control or elimination of HPV infection. Imiquimod does not exert its antiviral effects directly on virus-infected cells. Treatment with imiquimod results in resolution of wart tissue and reduction of viral burden. Post-marketing trials using imiquimod demonstrated that patients who experience complete clearance of either new or recalcitrant warts tend to remain clear for longer periods as compared to other treatment modalities. Preclinical data demonstrate in vitro and in vivo that imiquimod directly induces antiviral and immunomodulating cytokines from monocytes, macrophages and dendritic cells. These immunomodulating cytokines have been shown to potentiate Th1 immunity. Self-application, good tolerability, a unique mechanism of action and a relatively high sustained clearance rate combine to make imiquimod a cost-effective first-line therapy for external genital warts and an appropriate second-line therapy when other treatments are unsuccessful. In small-scale studies requiring replication, imiquimod has also been shown to be effective in the treatment of non-HVP-related skin infections and some dermal neoplasias.

Journal Article↗

Etiology of genital ulcers and prevalence of human immunodeficiency virus coinfection in 10 US cities. The Genital Ulcer Disease Surveillance Group.

To determine the etiology of genital ulcers and to assess the prevalence of human immunodeficiency virus (HIV) infection in ulcer patients in 10 US cities, ulcer and serum specimens were collected from approximately 50 ulcer patients at a sexually transmitted disease clinic in each city. Ulcer specimens were tested using a multiplex polymerase chain reaction assay to detect Haemophilus ducreyi, Treponema pallidum, and herpes simplex virus (HSV); sera were tested for antibody to HIV. H. ducreyi was detected in ulcer specimens from patients in Memphis (20% of specimens) and Chicago (12%). T. pallidum was detected in ulcer specimens from every city except Los Angeles (median, 9% of specimens; range, 0%-46%). HSV was detected in >/=50% of specimens from all cities except Memphis (42%). HIV seroprevalence in ulcer patients was 6% (range by city, 0%-18%). These data suggest that chancroid is prevalent in some US cities and that persons with genital ulcers should be a focus of HIV prevention activities.

Female↗

External genital warts: report of the American Medical Association Consensus Conference. AMA Expert Panel on External Genital Warts.

A consensus process was undertaken to describe and evaluate current information and practice regarding the diagnosis, treatment, and evaluation of patients with external genital warts (EGWs) and their sex partners. This process developed a number of key statements that were based on strong evidence in the literature or reasonable suppositions and opinions of experts. Key statements included the following. In most cases, EGWs can be diagnosed clinically by visual inspection. No one treatment is ideal for all patients or all warts. Women with EGWs and female sex partners of men with EGWs are at increased risk for human papillomavirus-related cervical disease and, like all women, should be screened for cervical cancer. The diagnosis of EGWs in children requires a sexual abuse evaluation. Clinicians who treat EGWs have a responsibility to counsel patients and to provide information about the infectivity, diagnosis, treatment, and natural history of EGWs and general information about sexual health and other sexually transmitted diseases.

Adolescent↗

Comparisons of cost and accuracy of DNA probe test and culture for the detection of Neisseria gonorrhoeae in patients attending public sexually transmitted disease clinics in Los Angeles County.

BACKGROUND: Strict handling and transport requirements for the successful use of culture in the detection of Neisseria gonorrhoeae warrant investigation of accurate and cost-effective test alternatives such as the Gen-Probe PACE 2 DNA probe assay (Gen-Probe, Inc., San Diego, CA). STUDY DESIGN: The Gen-Probe PACE 2 DNA probe assay for N. gonorrhoeae was compared with conventional culture methods in the principal Los Angeles County (LAC) Department of Health Services (DHS) Public Health Laboratory and three of its branch laboratories. Urethral and endocervical samples were collected from 1,566 patients (921 males; 645 females) attending six LAC DHS sexually transmitted disease clinics. Cost analysis was performed comparing material and labor costs of the two test methods. RESULTS: The overall prevalence based on culture was 11.8% (15.7% for males; 6.4% for females). Nine samples were culture positive, Gen-Probe negative and four samples were culture negative, Gen-Probe positive and remained discordant after discrepant analysis. The sensitivity and specificity were 94.6% and 99.7%, respectively, for the PACE 2 assay compared with culture. The positive and negative predictive values were 97.8% and 99.3%, respectively. No statistically significant difference was found between the two tests. A cost analysis found an average cost of $3.11/test for culture and $3.85/test for PACE 2, given the approximate 12% disease prevalence in this population. CONCLUSIONS: Gen-Probe's PACE 2 assay may provide an acceptable, cost-effective alternative to culture, especially among high-risk males.

Adult↗

The association between Chlamydia trachomatis and ectopic pregnancy. A matched-pair, case-control study.

We performed a case-control study of the association of past exposure to Chlamydia trachomatis and ectopic pregnancy with 306 case patients with an ectopic pregnancy and 266 pregnant patients who served as controls. The geometric mean antichlamydial antibody titer among cases was 75 +/- 10.2 vs 13 +/- 11.0 among controls. The matched-pair odds ratio for ectopic pregnancy and IgG titer of 1:64 or greater to C trachomatis was 3.0 (95% confidence interval, 2.1 to 4.4). Adjusting for age at first intercourse, total lifetime partners, douching, history of infertility, and parity yielded a relative risk of 2.4 (95% confidence interval, 1.5 to 3.3). Current douching remained an independent risk factor after controlling for chlamydial exposure, with an adjusted relative risk of 2.1 (95% confidence interval, 1.3 to 3.5). The population attributable fraction for chlamydial infection was 0.47 and that for douching was 0.45. The results stress the need for control of C trachomatis infections and for further study of specific douching behaviors as risk factors for ectopic pregnancy.

Adult↗

Condom sales at public universities in California: implications for campus AIDS prevention.

Public health officials have called for increased use of condoms to protect Americans from sexually acquiring human immunodeficiency virus (HIV) infection. To investigate the availability of condoms for sale on college campuses, we asked student union directors and bookstore managers from all 28 public universities in California, with a combined enrollment of half a million students, to complete a detailed questionnaire in August and September 1987. Two thirds of the campuses reported having condoms for sale in either their bookstores or convenience stores; one third said condoms were available in the men's and women's restrooms in their student unions. On most campuses, sales were instituted in the past year in response to the AIDS (acquired immune deficiency syndrome) epidemic. However, very few campuses provided AIDS education at the point of sale, and condoms were not easily available outside of store hours. Respondents felt that the most important obstacles to increasing the distribution of condoms on campus included concern about presenting a negative image of the university and the low priority assigned to this issue by the university administration and others on campus. This study suggests that although condom availability has improved in the past year, the opportunity exists at most California public universities to increase the distribution of condoms and improve associated AIDS-related health education efforts.

Acquired Immunodeficiency Syndrome↗

Feminism and regulation collide: the Food and Drug Administration's approval of the cervical cap.

In May 1988, the Prentif Cavity Rim cervical cap, a barrier method of contraception, was approved by the Food and Drug Administration (FDA) for contraceptive purposes in the United States. This paper describes some of the events leading to the approval of the cervical cap as a contraceptive. Of major interest is the unprecedented involvement of the feminist health movement in clinic-based research, policy making, and distribution of the cervical cap. The recall of the Vimule cervical cap, the use of lay health workers in fitting an experimental device, and the feminist providers' response to the FDA's regulation of the cervical cap are detailed.

Contraceptive Devices, Female↗

Effectiveness of the cavity-rim cervical cap: results of a large clinical study.

From 1981-1988, 3433 women were fitted with a cavity-rim cervical cap in a Food and Drug Administration-approved study. The estimated first-year pregnancy risk was 11.3% (95% confidence limits 10.0-12.8), with risks of 8.3 and 3.8% for user and method failures, respectively. Women who were younger, less educated, and more sexually active, and who intended to have children in the future, had higher pregnancy risks. "Near-perfect" users, ie, individuals who wore the cap for a maximum of 72 hours, used spermicide 100% of the time, and did not report unprotected sexual intercourse, had half the first-year pregnancy risk of others (6.1 versus 11.9%). There were no serious medical or gynecologic complications associated with cap use, although over 20% of users reported problems with cap dislodgment during or after intercourse, cap malodor, or partner discomfort.

Adult↗

Lack of in vitro efficacy of oral forms of certain cephalosporins, erythromycin, and oxacillin against Pasteurella multocida.

The in vitro susceptibility of human isolates of Pasteurella multocida to oral antimicrobial agents from our current study and from a review of the literature suggests that dicloxacillin (oxacillin), erythromycin, clindamycin, cephalexin, cefaclor, and cefadroxil should not be used for empiric therapy of animal bite wounds. Agents that were consistently active against P. multocida were penicillin, ampicillin, amoxicillin-clavulanic acid, tetracycline, minocycline, chloramphenicol, trimethoprim-sulfamethoxazole, and cefuroxime. Possible reasons for the confusion regarding the activity of oral cephalosporins are addressed.

Animals↗

Human and animal bite wounds.

Bite wounds account for 1 percent of emergency department visits. Most bites occur on the hands. Human bites cause serious injury more often than animal bites do. Pasteurella multocida is found in about 25 percent of dog bites and a higher percentage of cat bites. Alpha-hemolytic streptococci are the most frequent isolates from human bite wounds. Anaerobic bacteria are commonly found in all types of infected bites.

Anti-Bacterial Agents↗

Aztreonam in human serum and breast milk.

Serum and milk concentrations of aztreonam were studied in 12 lactating, healthy subjects over the 8 h period after the administration of a single intramuscular or intravenous 1 g dose. Milk concentrations of aztreonam were found to be much lower than serum concentrations at all time points after both routes of injection. Peak milk concentrations of aztreonam averaged less than 1% of peak serum concentrations. Times to peak concentrations averaged 6 and 10 times longer in milk than in serum after intramuscular and intravenous injections, respectively. The low milk levels, as well as the previously determined poor oral absorption of aztreonam, suggest a low risk of untoward effects in the nursing infant.

Adult↗

The effects of marijuana use during pregnancy. II. A study in a low-risk home-delivery population.

Results from a previous epidemiologic study indicate that marijuana use near term may elevate risk of abnormal progress of labor and meconium staining. We conducted a study of the association of self-reported marijuana use and perinatal problems in a series of 313 women enrolled in a home-birth center. The 41 marijuana users were similar to non-users with respect to most potentially confounding factors, but users had lower mean income and exhibited more tobacco and alcohol use during pregnancy than non-users. Users experienced slightly elevated rates of dysfunctional labor (43% vs. 35% in non-users), precipitate labor (13% vs. 8%) and meconium staining (17% vs. 13%); differences with respect to most other outcomes were smaller or nonexistent. The observed differences were smaller in both relative and absolute terms than those reported by the earlier study, and were little changed upon adjustment for potentially confounding factors (including alcohol use, cigarette use, parity and income). After accounting for statistical variation, the results appear consistent with the earlier findings but further research is recommended.

Adult↗

Are condom instructions readable? Results of a readability study.

The use of condoms has assumed a central position in the current strategy to prevent sexual transmission of the human immunodeficiency virus. The effectiveness of condoms in disease prophylaxis is dependent, to a degree, on their correct use. Condom manufacturers routinely include information on condom use either printed on the actual package or in an enclosed package insert. With the use of three readability formulas, the reading grade level was determined for 14 different sets of instructions included with 25 brands of condoms manufactured by 7 domestic and 1 overseas manufacturer. The readability formulas, when applied to instructions for condom use, estimated that, conservatively, 8 of the 14 instructions required at least reading at the level of a high school graduate and none required less than a 10th grade level. Clearly written instructions and simple concepts could assist current and future condom users in the correct use of condoms and improve the effectiveness of condoms in the prevention of AIDS and other sexually transmitted diseases.

Achievement↗