Reliability and validity of the Advanced Basal Cell Carcinoma Index (aBCCdex).

BACKGROUND: Patient-reported outcome (PRO) questionnaires were recently developed specifically for use with patients with advanced basal cell carcinoma (aBCC) and basal cell carcinoma naevus syndrome (BCCNS). OBJECTIVES: To evaluate the measurement properties of PRO questionnaires for use in patients with aBCC or BCCNS. METHODS: In total 129 patients from 10 clinical sites in the U.S.A. and the BCCNS Support Network completed the two newly developed questionnaires multiple times over 3 months. Patients also completed the Skindex-16 and the 12-Item Short-Form Health Survey as collateral measures. Psychometric properties of the questionnaires were evaluated, including internal consistency and test-retest reliability, construct and known-groups validity, and responsiveness. RESULTS: Based on the results of exploratory factor analysis and clinical input, the two newly developed questionnaires were combined into a single questionnaire, called the aBCCdex, which is relevant for patients with both aBCC and BCCNS. The internal consistency reliability was acceptable, and all aBCCdex scale scores correlated significantly with conceptually similar scales. When divided into groups that differed based on scores from collateral measures, aBCCdex scale scores differentiated between groups (known-groups validity) and were responsive to change. CONCLUSIONS: The aBCCdex is a brief and comprehensive questionnaire appropriate for use with patients with aBCC and BCCNS. Its reliability and validity have been confirmed. Further research is necessary to estimate the minimally important difference in a larger patient population.

A multicentre, cross-sectional study on quality of life in patients with cutaneous lupus erythematosus.

BACKGROUND: A study at the University of Pennsylvania (UPenn) Medical Center demonstrated that quality of life in patients with cutaneous lupus erythematosus (CLE) is negatively impacted. Whether patients with CLE in other geographic locations have similar quality of life is unknown. OBJECTIVES: We sought to compare quality of life indicators between patients with CLE at the University of Texas Southwestern (UTSW) Medical Center at Dallas and those at UPenn. METHODS: Patients with CLE (total n=248) at UTSW (n=91) and UPenn (n=157) completed the Skindex-29 +3 and Short Form-36 (SF-36) surveys related to quality of life. Additional information, including demographics, presence of systemic lupus erythematosus (SLE) and disease severity, was collected from UTSW patients with CLE. RESULTS: Most Skindex-29 + 3 and SF-36 subdomain scores between UTSW and UPenn patients with CLE were similar. However, UTSW patients with CLE were significantly more affected in the functioning and lupus-specific Skindex-29 + 3 domains, and physical functioning, role-physical and general health SF-36 subscales than UPenn patients with CLE (P<0·05). Factors related to poor quality of life in UTSW patients with CLE include sex, income, education, presence of SLE, and skin disease activity. CONCLUSIONS: Most quality of life indicators were similar between the two CLE populations. Differences in psychosocial behaviour, and a larger proportion of patients with SLE and females in the UTSW group likely attributed to differences in a minority of Skindex-29+3 and SF-36 subdomains. Capturing data from CLE populations in different locations provides a more thorough picture of the quality of life that patients with CLE experience on a daily basis with special attention to quality of life issues in select patients with CLE.

A cost analysis of topical drug regimens for dermatophyte infections.

OBJECTIVE: To examine the extra cost of using higher-priced drugs as initial therapy for dermatophyte infections, because the many available effective drugs vary considerably in cost. DESIGN: Cost analysis from the purchaser's perspective, comparing two prototypical regimens to treat tinea pedis: one in which all patients initially receive a lower-priced drug and those with unresponsive infections receive a higher-priced drug at a follow-up office visit, and one in which all patients receive the higher-priced drug from the outset. The reference drug was miconazole, an imidazole available without a prescription, for which reported overall efficacy rates are 70% to 100%. MAIN OUTCOME MEASURES: The threshold efficacy rate (the efficacy rate of miconazole below which it is always less expensive to use a specific higher-priced drug first) and the extra cost (of beginning therapy with a higher-priced drug). RESULTS: Assuming the Medicare-approved charge for a follow-up visit ($21.98), it is less expensive to begin therapy with a prescription drug only if the efficacy rate of miconazole is less than 55%; this threshold efficacy rate varied from 26% (for a $0 total cost of the follow-up visit) to 79% (for an $89 total cost of the follow-up visit). If the efficacy rate of miconazole is 70%, the extra cost per patient for all patients to receive the least expensive prescription antifungal drug instead of miconazole first was $15.23 and $8.64 if total visit costs were $0 and $21.98; miconazole remained the less expensive alternative as long as the total cost of the follow-up visit was less than $50.76. CONCLUSION: For reported efficacy rates and standard costs of a follow-up office visit, using miconazole first and then treating only those patients with unresponsive infections with a higher-priced prescription drug is less expensive than treating all patients with the higher-priced drug.

Costs of therapy for dermatophyte infections.

The price of drugs is an important consideration in the determination of the therapy's cost effectiveness. In this article the cost of antifungal drugs to several pharmacies (from a wholesaler) is calculated for topical and oral drug regimens to treat three hypothetical patients with dermatophyte infections. Drug costs to pharmacies for the topical treatment of tinea varied greatly--more than 14-fold (for 4-week courses, from $11.14 for miconazole to $156.72 for terbinafine). Costs to pharmacies of oral drugs for tinea also varied considerably, although the degree of difference depended on the regimens used for fluconazole and itraconazole, for which optimal dosages and durations of therapy have not been determined and for which this use is not approved by the Food and Drug Administration. Given the frequency of these infections and the importance of outcomes in addition to clinical cure (such as prevention of relapse), this difference highlights the need for formal studies to compare drug effectiveness in combination with cost.

Physicians' behavior and their interactions with drug companies. A controlled study of physicians who requested additions to a hospital drug formulary.

OBJECTIVE: It is controversial whether physicians' interactions with drug companies affect their behavior. To test the null hypothesis, that such interactions are not associated with physician behavior, we studied one behavior: requesting that a drug be added to a hospital formulary. DESIGN: Nested case-control study. SETTING: University hospital. PARTICIPANTS: Full-time attending physicians. Case physicians were all 40 physicians who requested a formulary addition from January 1989 through October 1990. Control physicians were 80 randomly selected physicians who had not made requests. MAIN EXPOSURE MEASURE: Physician interactions with drug companies, as determined by survey of physicians (response rate, 88% [105/120]). RESULTS: Physicians who had requested that drugs be added to the formulary interacted with drug companies more often than other physicians; for example, they were more likely to have accepted money from companies to attend or speak at educational symposia or to perform research (odds ratio [OR], 5.1; 95% confidence interval [CI], 2.0 to 13.2). Furthermore, physicians were more likely than other physicians to have requested that drugs manufactured by specific companies be added to the formulary if they had met with pharmaceutical representatives from those companies (OR, 13.2; 95% CI, 4.8 to 36.3) or had accepted money from those companies (OR, 19.2; 95% CI, 2.3 to 156.9). These associations were consistent in multivariable analyses controlling for potentially confounding factors. Moreover, physicians were more likely to have requested formulary additions made by the companies whose pharmaceutical representatives they had met (OR, 4.9; 95% CI, 3.2 to 7.4) or from whom they had accepted money (OR, 1.7; 95% CI, 1.0 to 2.7) than they were to have requested drugs made by other companies. CONCLUSION: Requests by physicians that drugs be added to a hospital formulary were strongly and specifically associated with the physicians' interactions with the companies manufacturing the drugs.

Doctors, drug companies and gifts.

This paper by Chren and Landefeld was originally presented at the Miriam Hospital on March 21, 1991, as the 1991 Lichtman Oration, an annual meeting devoted to ethical problems in medicine honoring Herbert C. Lichtman, MD, former physician-in-chief at the hospital. Because of the importance of this paper, and its controversial character, the Journal has asked a number of practicing physicians and other concerned persons to offer their opinions on this paper. These commentaries will then be published in a subsequent issue of the Journal, along with reactions by our readers.

Doctors, drug companies, and gifts.

Doctors often accept gifts from drug companies. We analyze this practice and conclude that accepting a gift has complex practical and ethical repercussions. Gifts cost patients money, and they may change society's perception of the profession as serving the best interest of patients. Also, accepting a gift establishes a relationship between the physician and the drug company that obliges a response from the physician. Accepting gifts and the resulting relationship have ethical implications as well. First, the use of patients' money to pay for gifts can be unjust. Second, the fiduciary relationship between physician and patient may be threatened if prescribing practices are affected (as intended by the drug company). Third, physicians' characters may be altered by a practice that fosters self-interest at patients' expense. We discuss the need for guidelines for the profession to help physicians promote their patients' well-being.

KIE: The authors analyze the complex practical and ethical issues surrounding the phenomenon of gift giving by drug companies to physicians. They consider the ethical implications of the practice, pointing out that whenever a doctor accepts a gift from a pharmaceutical firm or its representative, an implicit relationship between the recipient and the giver is established. Inherent in this relationship is an obligation to respond to the gift; this obligation may conflict with the physician's obligations toward patients, and even may affect the physician's character. Chren, et al. propose that American medical organizations adopt statements about the issues raised by drug company gifts, and conclude with a discussion of five items these statements might cover.