Reporting of study design in titles and abstracts of articles published in clinically oriented dermatology journals.

BACKGROUND: Dermatologists may have difficulty in identifying the types of study design used in published articles, hindering their ability to appraise the literature critically. OBJECTIVES: To assess the frequency with which titles or abstracts of articles published in clinically oriented dermatology journals reported the type of study design using standard key words, including 'randomized control trial', 'nonrandomized control trial', 'double-blind', 'placebo control', 'crossover trial', 'before-after trial', 'gold standard', 'blinded or masked comparison', 'cohort', 'inception cohort', 'validation cohort', 'validation sample', 'survey', 'case series', 'cost-effectiveness analysis', 'cost-benefit analysis', 'cost-utility analysis', 'cross-sectional study' and 'case-control'. METHODS: A cross-sectional study analysed articles published between December 2004 and November 2005 in the 'Epidemiology and Health Services Research' and 'Therapeutics' sections of the British Journal of Dermatology (BJD), in the 'Studies' section of the Archives of Dermatology (Arch Dermatol) and in the 'Reports' section of the Journal of the American Academy of Dermatology (JAAD). RESULTS: In the BJD, 15 of 37 articles (40.5%, 95% confidence interval, CI 24.8-57.9%) included at least one standard key word in the title or abstract, compared with 43 of 87 articles (49.4%, 95% CI 38.5-60.4%) in the Arch Dermatol and 19 of 93 articles (20.4%, 95% CI 12.8-30.1%) in the JAAD (P < 0.001). CONCLUSIONS: Most articles in the three journals did not report the study design used in the title or abstract. A consistent and clear indication of the design used in studies may better enable editors, reviewers and readers to assess critically articles published in clinically oriented dermatology journals.

Characteristics and completeness of clinical trial registrations in psoriasis and atopic dermatitis.

BACKGROUND: Controversy over the failure to publish results of clinical trials linking antidepressant treatment to suicidal behaviour in adolescents has increased interest in clinical trial registration. OBJECTIVE: To assess numbers, characteristics and completeness of registrations of trials for psoriasis and atopic dermatitis registered at two web-based trial registries: ClinicalTrials.gov and isrctn.org. METHODS: In this cross-sectional study we identified trials by searching ClinicalTrials.gov and isrctn.org on 18 January 2006 for trials registered up to 31 December 2005. We included only trials of therapeutic interventions for atopic dermatitis or psoriasis. We ascertained the date of submission of registration, the funding source of the trial, and whether a registration listed the specific name of the intervention studied, the specific outcome measure used (e.g. "Psoriasis Area and Severity Index"), the criterion used to gauge success on the outcome measure (e.g. > or = 75% decrease), and the time at which the outcome would be assessed (e.g. at 12 weeks). RESULTS: There were 156 registered trials, including 128 (82%) at ClinicalTrials.gov [36 (23%) in atopic dermatitis, 92 (59%) in psoriasis] and 28 (18%) at isrctn.org [23 (15%) in atopic dermatitis, 5 (3%) in psoriasis]. Pharmaceutical companies funded 87 trials (56%), federal or governmental agencies 28 (18%), universities or organizations 21 (13%), and a combination of funders 20 (13%). Of atopic dermatitis trials (13 of 36) and (24 of 92) of psoriasis trials at ClinicalTrials.gov were registered in September 2005. The specific name of the intervention studied was listed in 150 registrations (96%), 89 (57%) listed the specific measure used, 69 (44%) listed the criteria to gauge success and 62 (40%) listed the time of assessment. CONCLUSIONS: While trial registrations in atopic dermatitis and psoriasis are increasing, more complete information in these registrations may increase their value for dermatologists and their patients.

Food and Drug Administration surveillance of dermatology-related and nondermatology-related prescription drug advertising in the USA, 2000-2003.

BACKGROUND: Spending on advertising of prescription medicines in the U.S.A. is increasing by nearly a billion dollars yearly. The Food and Drug Administration (FDA) is legally mandated to regulate pharmaceutical advertising in the U.S.A. Prior studies have documented inaccuracies in pharmaceutical advertisements, in the U.S.A. and the rest of the world. OBJECTIVES: To assess trends in FDA surveillance of dermatology-related prescription drug advertising, and to investigate pharmaceutical companies' responses to FDA regulatory actions. METHODS: We analysed all FDA citations of prescription drug advertisements issued during 2000-2003, and responses from cited companies to our mailed requests for follow-up information. RESULTS: Twenty-four dermatology-related drugs from 21 companies accounted for 30 (15.2%) of the 198 letters sent by the FDA; of these, 18 letters cited advertisements or promotions of these medications for dermatology-related uses. The most common violation cited overall was insufficient communication of risk (32.4% overall, 33.9% dermatology-related). Most FDA letters cited physician-targeted advertising (71.6% overall, 62.1% dermatology-related). The number of dermatology-related letters sent declined by 69.2% from 2000 (n=13) to 2003 (n=4), paralleling the 69.6% decline in the total number of letters sent (n=79 in 2000, n=24 in 2003). Compared with 2000, the FDA took longer to issue citation letters in 2003 for advertisements overall [hazard ratio (HR) 0.47, 95% confidence interval (CI) 0.27-0.72, P=0.001], although this trend was not present for dermatology-related advertisements (HR 1.12, 95% CI 0.39-3.29, P=0.83). Eight of the 16 companies (50%) that received requests from the authors for information replied. Seven of the eight (87.5%) reported complying with FDA requests to discontinue the cited advertisements, while one (12.5%) reported disagreeing with the citation and successfully clarifying the issue with the FDA. CONCLUSIONS: Dermatology-related advertisements accounted for 15.2% of FDA citations of pharmaceutical advertisements between 2000 and 2003. Recent controversy over pharmaceutical advertising may lead to changes in pharmaceutical advertising practices and surveillance of pharmaceutical advertising in the U.S.A.

Neonatal head circumference, neonatal weight, and risk of hayfever, asthma and eczema in a large cohort of adolescents from Sheffield, England.

BACKGROUND: Neonatal physical characteristics, including head circumference and birth weight, have been hypothesized to be markers of in utero thymic development. Greater head circumference and lower birth weight have been linked in previous studies to subsequent development of asthma, and greater birth weight has been associated with subsequent development of eczema. OBJECTIVE: To investigate potential associations between neonatal head circumference and weight and hayfever, asthma and eczema in a cohort of adolescents from Sheffield, England. METHODS: Responses to a questionnaire inquiring about physician-diagnosed hayfever, asthma and eczema among adolescents in Sheffield, England, were linked to previously recorded measurements of weight at birth and at 1 month and head circumference at 1 month. Logistic regression methods were used to relate diagnoses to neonatal measurements and potential confounders. RESULTS: The cohort consisted of 10,809 adolescents, of whom 16.5% reported hayfever, 18.0% asthma, and 16.2% eczema. After adjusting for sex, age at the time of the questionnaire, maternal age and gestational age at birth, number of older and younger siblings, time since birth of next older sibling, neonatal sickness, type of neonatal feeding, and maternal and paternal educational backgrounds, hayfever was the only disease associated with neonatal measurements. Comparing the highest with the lowest fifths of distributions, lifetime prevalence of hayfever was positively associated with neonatal head circumference (adjusted odds ratio 1.23, 95% CI 1.03 to 1.47) and with birth weight (1.17, 0.99 to 1.39). Hayfever was inversely related to the ratio of head circumference to birth weight (0.89, 0.75 to 1.05) and to gestational age. The associations with head circumference and birth weight were not substantially altered by further adjustment for gestational age. CONCLUSION: Greater neonatal head circumference may be associated with an increased risk of hayfever, but the inverse relationship between hayfever prevalence and the ratio of head circumference to birth weight challenges the prior hypothesis that greater head circumference relative to body mass reflects abnormal thymic development in utero, increasing the likelihood of allergic sensitization.