Clinical trial size and efficacy.
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Bias↗
Biomedical subjects
A B Fleischer
Publications and source records attributed to A B Fleischer.
The SAPASI is valid and responsive to psoriasis disease severity changes in a multi-center clinical trial.
We developed a structured Psoriasis Area Severity Index (PASI)-like instrument, the Self-administered PASI (SAPASI), that allows subjects to assess accurately the severity of their psoriasis. The major limitation of our previous SAPASI validity studies is that all were performed in a single academic center, raising questions about the generalizability of the instrument. We administered the SAPASI to 182 subjects in a 12-week, multicenter, double-blind clinical trial of topical tazarotene for psoriasis. On the same day, investigators blind to the SAPASI rating determined the degree of erythema, induration, scale, body surface area (BSA) affected, and overall lesion severity of the subjects' psoriasis. Using these data, we calculated an investigator PASI-Equivalent. Correlation analysis shows that for both initial and final assessments of psoriasis severity, the SAPASI score reflects the PASI-Equivalent score in a significant way (p = .0001), although the correlation is a modest one (r = 0.3 to 0.5). Significant (p = .0001), modest correlations were found between the subjects' reported BSAs and the investigators' reported BSAs. To assess responsiveness, the proportional changes of the SAPASI and PASI-Equivalent were found to be modestly significantly correlated (r = 0.2, p = .04). The results of this study support the general validity of the SAPASI and demonstrate that the SAPASI can detect changes in disease severity in a clinical trial. Significant correlations were also observed between SAPASI components and their investigator-reported counterparts in this multicenter trial. To the best of our knowledge, the current study represents the first multicenter validity study performed on a psoriasis severity instrument, and clearly demonstrates the value of this instrument in assessing the psoriasis severity in a population.
Adult↗
Tobacco smoking contributes little to facial wrinkling.
BACKGROUND: The potential detrimental effects of tobacco smoking have been widely cited. Tobacco smoking has been linked with facial wrinkling, but some previous studies have failed to take into account a number of potential confounders or were unblinded and thus subjective to bias. OBJECTIVE: This study was designed to determine if there was increased facial wrinkling in smokers directly associated with tobacco usage after controlling for solar risk behavior. SUBJECTS: Eighty-two smokers (> 10 cigarettes per day) and 118 non-smokers (< 100 lifetime cigarettes) were recruited. Caucasian participants completed a questionnaire designed to assess demographic variables and other suspected factors related to wrinkling. METHODS: Three dermatologists, blinded to demographic information, reviewed three photographs of each subject and rated the wrinkling on a 100 mm visual analog scale. Stepwise linear regression was performed on all variables which attained a P < 0.1 level of independent significance. RESULTS: Overall the model accounted for 75.4% (P = 0.0001) of the variance in wrinkling, and predictive variables (P < or = 0.02) included age (partial R2 = 0.69), smoking pack years (R2 = 0.04), hours of outdoor work (R2 = 0.008), freckling (R2 = 0.007), and eye color (R2 = 0.004). A second model was created excluding age which accounted for 37.8% of the variance. The predictive variables in the second model (P < 0.08) included education (partial R2 = 0.08), smoking pack years (R2 = 0.05), hours of outdoor work (R2 = 0.03), weight change (R2 = 0.02), female sex (R2 = 0.02), hours of lifetime sun (R2 = 0.03), tanning bed use (R2 = 0.01), and sunscreen use (R2 = 0.02). CONCLUSIONS: Smoking may significantly contribute to facial wrinkling, but accounts for only 6% of the explained variance. If there is a role for tobacco smoking in causing wrinkling, this role is a minor one.
Adult↗
Is prior authorization of topical tretinoin for acne cost effective?
OBJECTIVE: To determine whether prior authorization of topical tretinoin for acne is in the best interest of health insurers and, if so, to determine the optimal prior authorization age for topical tretinoin. STUDY DESIGN: A retrospective, cross-sectional study of data from the National Ambulatory Medical Care Survey was performed. PATIENTS AND METHODS: We performed a sensitivity analysis using published data on the age distribution for topical tretinoin prescriptions for acne and nonacne indications to estimate the cost of topical tretinoin and the cost of performing prior authorizations as a function of the prior authorization age. RESULTS: A prior authorization age of 25 for topical tretinoin is not cost effective for health insurers. If prior authorization is required, an age threshold of 35 or older is most cost effective. The total cost of topical tretinoin (the sum of the drug costs plus the prior authorization costs) changes little with changes in the prior authorization age; if the prior authorization age is set too low, total costs increase (because the number of prior authorizations increase). CONCLUSIONS: Prior authorization for topical tretinoin is of no great benefit to insurers. As the prior authorization age decreases, the cost of requiring prior authorization increases. Eliminating prior authorization altogether would result in at most a small increase in costs and would be balanced by the benefits to both patients and physicians.
Acne Vulgaris↗
Significance-prevalence index number: a reinterpretation and enhancement of data from the North American contact dermatitis group.
BACKGROUND: The North American Contact Dermatitis Group (NACDG) periodically reports allergen reaction rates and clinical significance. These results are not formally interpreted combining both components into one index. OBJECTIVE: The purpose of this study is to introduce the Significance-Prevalence Index Number (SPIN), which is a parameter that assesses the relative importance of different allergens. METHODS: Data was collected from published studies reported by NACDG from 1984 through 1996. The SPIN for each tested allergen was calculated as the product of the proportion of the population allergic by the weighted clinician-assessed likelihood of relevance of the reaction. RESULTS: In the studies done in 1992 through 1996, fragrance mix, quaternium-15, balsam Peru, formaldehyde, thiuram mix, nickel sulfate, neomycin, bacitracin, carba mix, and paraphenylenediamine were the 10 leading allergens in clinical importance as measured by SPIN. Our SPIN calculations suggest that ethylenediamine and benzocaine have markedly decreased in clinical importance over the past decade, whereas methylchloroisothiazolinone/methylisothiazolinone has become a leading allergen. A number of allergens demonstrate high to intermediate SPIN, yet are not included in the T.R.U.E. test. These clinically important allergens include bacitracin, diazolidinyl urea, glyceryl thioglycate, ethyleneurea melamine-formaldehyde, and imidazolidinyl urea. CONCLUSION: SPIN allows clinicians to incorporate both the allergenicity and the relevance of the allergen into one measure.
Allergens↗
Most common dermatologic problems identified by internists, 1990-1994.
BACKGROUND: Internists in all settings see many patients with skin conditions. Thus, their education in dermatology is important. Information on which areas of dermatology are most commonly seen in internal medicine practices is necessary for designing effective educational programs on skin disease. OBJECTIVE: To determine what types of dermatologic problems internists most commonly diagnose. METHODS: National Ambulatory Medical Care Survey data from 1990 to 1994 were analyzed for dermatologic diagnoses. Physicians specializing in internal medicine and all its subspecialties were compared with dermatologists and with other physicians. RESULTS: The most common skin disorders diagnosed by internists were dermatitis (15.8% of all diagnoses) and bacterial skin infections (14.0% of all diagnoses). Combined, bacterial, fungal, and viral infections included 28.3% of the most common dermatologic diagnoses made by internists. The top 10 most common diagnoses accounted for 57.9% of all skin-related diagnoses and the top 20 most common diagnoses accounted for 72.8%. Internists were more likely to see patients for bacterial skin infections, herpes infection, exanthem, urticaria, and insect bites while dermatologists more commonly saw patients for actinic and seborrheic keratoses, warts, benign and malignant skin tumors, and psoriasis. CONCLUSIONS: The most common dermatologic diseases diagnosed by internists differ considerably from those diagnosed by dermatologists. Because dermatologists do much of the dermatology teaching of internal medicine residents, it is important to recognize these differences to place emphasis on the proper areas of study. Some common or serious skin conditions not often diagnosed by internists such as psoriasis and melanoma also deserve attention in internal medicine training programs.
Adolescent↗
Dermatologists meet the primary care standard for first contact management of skin disease.
BACKGROUND: It has been suggested that first contact for skin disease should be the domain of primary care providers because they provide comprehensive services beyond those offered by dermatologists. OBJECTIVE: The purpose of this study was to test the hypothesis that dermatologists do not meet the standards for providing primary care to which generalists are held. METHODS: National Ambulatory Medical Care Survey data from the year 1995 were used to determine the frequency at which counseling and preventive examinations were performed at visits to primary care providers and dermatologists. RESULTS: Counseling and preventive examinations were performed at a minority of visits for skin disease. No counseling was reported at 91% of the visits to primary care providers and at 94% of visits to dermatologists. Preventive examinations other than blood pressure were done at 4.7% of the visits to primary care providers and at 1.5% of visits to dermatologists. CONCLUSION: The standard of primary care for skin disease, as set by the generalist, is attention to the skin disease and not comprehensive medical care. Dermatologists are best able to meet this standard.
Adolescent↗
Papular dermatitis (subacute prurigo, "itchy red bump" disease): pilot study of phototherapy.
BACKGROUND: Some patients with a subacute or chronic pruritic erythematous papular eruption are refractory to treatment. We previously described a number of these patients with papular dermatitis or subacute prurigo. OBJECTIVE: The purpose of this study was to examine the effectiveness of different types of phototherapy for treatment of papular dermatitis. METHODS: We reviewed the medical records of 11 patients who were diagnosed with papular dermatitis and who underwent phototherapy within the last 5 years. RESULTS: Eleven patients had a total of 17 phototherapy courses: psoralen-UVA (PUVA; 9), UVA/UVB light (3), and UVB alone (5). Within the PUVA treatment group, three of nine patients experienced total clearing, and six of nine patients experienced partial improvement. Although patients in all groups relapsed with time, overall the PUVA-treated patients had the best response rate and the best chance of the condition remaining clear after treatment was stopped. CONCLUSION: PUVA may be an effective treatment for papular dermatitis. The frequency of relapse indicates that maintenance treatments may be necessary for long-term control of the disease.
Aged↗
Nondermatologists are more likely than dermatologists to prescribe antifungal/corticosteroid products: an analysis of office visits for cutaneous fungal infections, 1990-1994.
BACKGROUND: Dermatologists have greater accuracy than nondermatologists for diagnosis of skin disease. However, it is not clear whether this affects medical outcome. OBJECTIVE: We tested the hypothesis that nondermatologists would be more likely than dermatologists to prescribe combination products for the treatment of common fungal skin infections. METHODS: We analyzed office-based physician visits for fungal skin infections recorded in the 1990-1994 National Ambulatory Medical Care Survey. RESULTS: There were 4.1 million visits for cutaneous fungal disease of which 82% were to nondermatologists. Nondermatologists were more likely to prescribe combination agents (34.1%) than dermatologists (4.8%, p=0.001). If the percentage of combination agents used by nondermatologists was reduced to that of dermatologists, an estimated $24.9 million or $10.3 million would be saved if clotrimazole or ketoconazole, respectively, were the substituted drug for the combination agent clotrimazole/betamethasone dipropionate. CONCLUSION: Nondermatologists are more likely to use a more expensive, less effective regimen than are dermatologists, suggesting that dermatologists are more cost-effective than nondermatologists in the treatment of common fungal skin disorders.
Administration, Topical↗
Most topical tretinoin treatment is for acne vulgaris through the age of 44 years: an analysis of the National Ambulatory Medical Care Survey, 1990-1994.
BACKGROUND: Topical tretinoin is effective treatment for both acne and photoaging. This creates a problem for insurers that cover medication costs, because treatment of acne is often covered but treatment of photoaging is not. The age distributions of patients with acne or photoaging are likely to be very different. Therefore, one approach insurers can use is an age cutoff for covering the cost of topical tretinoin therapy. OBJECTIVE: Our purpose was to determine at what age patients are more likely to receive tretinoin for treatment of acne vulgaris versus other conditions to provide a rational basis for insurers to set coverage cutoffs. METHODS: National Ambulatory Medical Care Survey data for the years 1990 to 1994 were analyzed to ascertain the age distribution of acne vulgaris office visits and treatment with topical acne agents including tretinoin. These data were compared to office visits and tretinoin treatment of wrinkles, solar elastosis, and other conditions. RESULTS: The mean age (+/- standard deviation) of patients seen for acne vulgaris was 24.3 +/-11.5 years old. The age distribution of topical tretinoin treatment paralleled the age distribution of acne. Tretinoin treatment of acne and of nonacne conditions were equal at an age of 44. CONCLUSION: The distribution of outpatient visits for acne treatment is skewed toward older patients and persists beyond age 40. A rational age cut-off for coverage of topical tretinoin treatment is 40 years.
Acne Vulgaris↗
Only 33% of visits for skin disease in the US in 1995 were to dermatologists: is decreasing the number of dermatologists the appropriate response?
The National Ambulatory Medical Care Survey conducted in 1995 provides an assessment of ambulatory medical practice including diagnoses, physician specialties, and insurance information. The National Center for Health Statistics collected data from non-federally employed physicians of all specialties using their standardized sampling technique. The database was reviewed for aspects of visits for skin diseases for all patients. The total number of visits for dermatologic disease in 1995 was estimated to be 22.0 million. 21.7% of these were first time visits and 24.3% were referrals. The leading dermatologic diagnoses in 1995 in order of frequency were acne, contact dermatitis, hypertrophic and atrophic conditions of skin, viral warts, malignant neoplasm of skin, benign neoplasm of skin, psoriasis, cellulitis and abscess, disorders of skin and subcutaneous tissue, and localized superficial swelling/mass/lump. Dermatology led all specialties in providing 32. 6% of the dermatologic outpatient care in 1995, followed by general/family medicine (22.7%), internal medicine (12.8%), pediatrics (11.2%), and all other specialties (20.7%). Of the visits to dermatologist in 1995, 3.78% were paid for by Medicaid. This paper presents dermatologic information pertaining to insurance, first time visits, referrals, diagnoses, and physician specialties.
Dermatology↗
Characteristics of office-based visits for skin cancer. Dermatologists have more experience than other physicians in managing malignant and premalignant skin conditions.
BACKGROUND: Actinic keratoses and skin cancer constitute a major public health problem for predisposed individuals. OBJECTIVE: The purpose of this paper is to determine the characteristics of office-based visits for actinic keratoses and skin cancer in the United States. METHODS: The National Ambulatory Medical Care Survey provided data on office-based physician visits for actinic keratoses and skin cancer in 1993 and 1994. RESULTS: There were 3.7 million visits per year for actinic keratoses, 3.1 million visits per year for nonmelanoma skin cancer (NMSC), and 430,000 visits per year for melanoma. Excisions and destructions of lesions accounted for 90%, 67%, and 62% of procedures for actinic keratoses, NMSC, and melanoma, respectively. Dermatologists (683), plastic surgeons (37), and general and family physicians (11) managed more visits per physician per year than other specialists. CONCLUSION: Dermatologists have significantly more experience managing skin cancer than do other physicians.
Clinical Competence↗
Procedures for skin diseases performed by physicians in 1993 and 1994: analysis of data from the National Ambulatory Medical Care Survey.
BACKGROUND: The provision of ambulatory dermatologic procedural care is not well characterized. OBJECTIVE: Our purpose was to determine the frequency that different cutaneous procedures are performed by different physician specialties and the diagnoses corresponding to these procedures. METHODS: Outpatient dermatologic procedures recorded in the 1993 and 1994 National Ambulatory Medical Care Survey were analyzed. To define dermatologic procedures and diagnoses, the International Classification of Diseases diagnosis and procedure codes were identified that related to the skin and subcutaneous tissues. Sampling weights were applied to achieve the nationally representative estimates. RESULTS: During 1993 and 1994, an estimated 37 million dermatologic procedures were performed. Most were performed by dermatologists (69%) and by family and general practice physicians (15%). A single procedure, "Other local excision or destruction of lesion or tissue of skin and subcutaneous tissue," constituted 65% of all of the dermatologic procedures. UV light treatments, ambulatory microscopic examination of skin specimens, and acne surgical procedures were performed almost exclusively by dermatologists. Most skin biopsies (82%) and excision/destruction procedures (71%) were performed by dermatologists. Actinic keratoses and viral warts accounted for 25% of all cutaneous dermatologic diagnoses treated. CONCLUSION: Dermatologists have far more experience performing skin biopsies and excision/destruction procedures than other physicians. Cost containment efforts that deny coverage for treatment of actinic keratoses and viral warts would affect a significant portion of cutaneous procedures.
Adult↗
Increasing utilization of dermatologists by managed care: an analysis of the National Ambulatory Medical Care Survey, 1990-1994.
Patients with managed care are less likely to see dermatologists for skin problems than are patients with traditional insurance. Through 1992, increase in the demand for treatment of skin problems reduced the effect of managed care on dermatologists. We assessed the continued impact of managed care on visits to dermatologists. Skin disease visits from the National Ambulatory Medical Care Survey were analyzed for the years 1990-1994. We found that demand for treatment of skin problems did not rise between 1992 and 1994, but demand for dermatologists services within the managed care sector more than doubled. In 1994 patients with HMO/prepaid insurance with skin disease were just as likely to see a dermatologist as were patients with commercial insurance. Mean visit duration for skin problems was 19% longer for nondermatologists than for dermatologists (p < 0.001). We conclude that dermatologists are more efficient at treating skin disease than nondermatologists and that utilization of dermatologists within managed care is increasing.
Ambulatory Care↗
The economic impact of psoriasis increases with psoriasis severity.
BACKGROUND: Psoriasis treatments are known to be costly, but little is known about the financial impact of psoriasis and the way in which it relates to the severity of the disease. OBJECTIVE: This study was performed to obtain an estimate of the treatment costs faced by patients with psoriasis. METHODS: A total of 578 anonymous mail surveys were distributed to patients with psoriasis; 318 surveys were returned (55%). Psoriasis severity was assessed with the previously validated Self-Administered Psoriasis Area Severity Index (SAPASI). RESULTS: The total and out-of-pocket expenses to care for psoriasis were correlated with psoriasis severity (r = 0.26, p = 0.0001). There were no sex (p = 0.9) or racial (p = 0.4) differences in total expenditures. Severity was correlated with how bothersome to the patient was the cost of treatment (r = 0.30, p = 0.0001), the time required for treatment (r = 0.38, p = 0.0001), and the time lost from work (r = 0.23, p = 0.0001). Lower quality of life at work and in money matters also correlated with severity of psoriasis. Higher family income was associated with less time spent caring for psoriasis and less interference with work around the home. CONCLUSION: As expected, the expenses caring for psoriasis are greater for patients with more severe disease. These costs and other financial implications are associated with lower quality of life for patients with more severe psoriasis.
Absenteeism↗
Adult pityriasis rubra pilaris: a 10-year case series.
BACKGROUND: Pityriasis rubra pilaris (PRP) often has a devastating impact on the lives of patients. Descriptions of its histopathologic features are not uniform. Finding a successful therapy can be challenging. OBJECTIVE: Our purpose was to examine the histopathologic features and response of patients to our standard therapy of an oral retinoid and concomitant or later addition of low-dose weekly methotrexate. METHODS: A retrospective chart review was done on 24 patients with PRP seen from March 1986 to March 1996. Biopsy specimens from 19 patients were reexamined. Telephone follow-up was conducted to determine maintenance of remission. RESULTS: All patients had the adult acquired form of PRP. Biopsy specimens from nine patients were characterized by prototypical findings of PRP, while the others included both typical and other features. Twenty-two patients were treated with either isotretinoin, 40 mg twice daily, or etretinate, 25 to 75 mg/day. Six patients with more disabling involvement had low-dose weekly methotrexate ranging from 5 to 30 mg started concurrently. Five patients had weekly methotrexate added at a later time. Seventeen patients showed 25% to 75% response after 16 weeks of therapy. All patients whose skin cleared maintained their remission. CONCLUSION: Initial oral retinoid plus concurrent or later low-dose weekly methotrexate resulted in 25% to 75% improvement of PRP in 17 of 24 patients after 16 weeks of therapy. Some of the atypical features seen in biopsy specimens emphasize the importance of clinical and histopathologic correlation in establishing the diagnosis.
Administration, Oral↗
Commercial tanning bed treatment is an effective psoriasis treatment: results from an uncontrolled clinical trial.
Phototherapy is highly effective in the therapy of psoriasis, but patient access to phototherapeutic facilities is not universal. Commercial tanning facilities are universal, but their efficacy in psoriasis treatment is unestablished. Our purpose was to conduct a study to assess the effect of a commercial tanning unit outfitted with nonprescription lamps on psoriasis. We conducted a 6-wk open study of 20 adult patients with stable psoriasis vulgaris. Clinical response was defined as a decrease in the Psoriasis Area Severity Index (PASI) or the Self-Administered PASI (SAPASI) by > or = 10%. There were 16 men and 4 women who participated with a mean (+/-SD) age of 43.0 +/- 14.8 y. Initial and final health-related quality of life information collected included the following instruments: the Brief Symptom Inventory (BSI), the Psoriasis-Related Stressor Scale (PRSS), and the Psoriasis Disability Scale (PDS). Side effects of tanning therapy were closely monitored. Fifteen subjects completed the entire 6-wk trial, and exit data on all subjects were used for analysis. The mean number of tanning sessions was 19 +/- 7.6 with a median of 19 and range of 3 to 29. Analysis of all 20 enrolled subjects found that 16 (80%) showed clinical response as measured by PASI, whereas 17 (85%) showed SAPASI response. Initial and final PASI scores decreased (p = 0.0001) from 7.96 +/- 1.77 to 5.04 +/- 2.5, and SAPASI scores also decreased (p = 0.02) from 11.8 +/- 4.4 to 7.9 +/- 7.7. When controlled for age and sex, a dose-response relationship was demonstrated with the PASI and SAPASI (p < 0.02). Decreases in the mean BSI and PRSS scales were demonstrated (p < 0.02), confirming the clinical significance of the reductions in disease severity scores. Episodes of mild burning occurred in 7 of 20 (35%) participants. Three subjects reported itching after one or two tanning sessions. This study showed that a tested commercial nonprescription tanning unit improved both psoriasis severity and health-related quality of life. Commercial tanning bed treatments may be a useful approach in patients unable to obtain office-based ultraviolet treatments.
Adult↗