Innovative care, medical research, and the ethics of informed consent.
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Consent Forms↗
Biomedical subjects
Alexa B Kimball
Publications and source records attributed to Alexa B Kimball.
Reporting of ethical review of clinical research submitted to the Journal of the American Academy of Dermatology.
BACKGROUND: In recent years there has been an increasing focus on human subject protection and on documentation of ethical review in published clinical research. The JAAD clearly states in its instructions to authors, which adhere to the guidelines set forth by the International Committee of Medical Journal Editors, "studies involving live human subjects must have been approved by the author's Institutional Review Board or its equivalent." OBJECTIVE: To determine what proportion of prospective studies on human subjects submitted to the clinical trials and therapeutics section lacked mention of review by an ethics board and to determine the outcome of these manuscripts. METHODS: We reviewed 150 prospective studies submitted from July 1, 2004 to January 16, 2006 to a single associate editor, who receives the majority of reports requiring ethics board review. RESULTS: Of 150 prospective studies, 36% (n = 54) had no mention of ethics review or consent, whereas 15% (n = 22) mentioned consent but not ethics review. Forty-two papers were returned asking for ethics information, and of these, 48% were resubmitted with confirmation of ethics review, 22% were withdrawn, 12% were never resubmitted, 12% responded that ethical review was not obtained, and 7% were clarified as exempt from review. Of the 150 papers, 45% were from US authors and 55% were from international authors. Sixty-seven percent of US papers and 35% of international papers included ethics board information (P <or= .001). Of the remaining authors who did not initially provide information on ethics review, 25% of US and 53% of international authors were able to provide documentation of ethics board review when asked. Of international authors asked for ethics information, 67% of European authors provided confirmation of ethical review, as compared with 48% of non-European authors. LIMITATIONS: It is not possible to know with certainty whether each study not citing ethics review actually did not undergo review by an ethics board. Additionally, other editors may have handled some studies requiring ethics review. CONCLUSIONS: One half of authors submitting papers on prospective clinical studies to the JAAD did not provide evidence of ethical review on initial submission. The reason for omission was likely oversight in half of the cases, but in others ethics review and approval were likely not obtained. International authors were more likely to omit mention of ethics review, but, although sample size was too small for statistical analysis, international authors were more often able to provide it when asked, suggesting oversight or misunderstanding as a reason for omission. Furthermore, ethics review may be more standard in the European Union, as European authors were more likely to be able to provide the information when asked, although small sample size precluded statistical analysis.
Dermatology↗
IL-23 stimulates epidermal hyperplasia via TNF and IL-20R2-dependent mechanisms with implications for psoriasis pathogenesis.
Aberrant cytokine expression has been proposed as an underlying cause of psoriasis, although it is unclear which cytokines play critical roles. Interleukin (IL)-23 is expressed in human psoriasis and may be a master regulator cytokine. Direct intradermal administration of IL-23 in mouse skin, but not IL-12, initiates a tumor necrosis factor-dependent, but IL-17A-independent, cascade of events resulting in erythema, mixed dermal infiltrate, and epidermal hyperplasia associated with parakeratosis. IL-23 induced IL-19 and IL-24 expression in mouse skin, and both genes were also elevated in human psoriasis. IL-23-dependent epidermal hyperplasia was observed in IL-19-/- and IL-24-/- mice, but was inhibited in IL-20R2-/- mice. These data implicate IL-23 in the pathogenesis of psoriasis and support IL-20R2 as a novel therapeutic target.
Animals↗
Few Medicaid and uninsured patients are accessing dermatologists.
Uninsured patients and those receiving Medicaid make up a smaller fraction of dermatology practices (5%) than would be predicted by their prevalence in the population (27%). We illustrate the ways in which insurance acceptance patterns and practice composition vary by the age, gender, practice type, and geographic location of the dermatologist.
Adult↗
Determining the relative importance of patient motivations for nonadherence to topical corticosteroid therapy in psoriasis.
BACKGROUND: Medication nonadherence is a significant problem in psoriasis. Although previous research has aimed to quantify the prevalence of nonadherence in topical medication users, patient motivations for intentional nonadherence are not fully understood. OBJECTIVE: Our purpose was to determine the relative importance of factors contributing to nonadherence in topical corticosteroid users with psoriasis. METHODS: A survey was distributed to psoriasis patients visiting an outpatient clinic. RESULTS: Among the 53 persons surveyed, medication nonadherence was 40%. Frustration with medication efficacy, inconvenience, and fear of side effects were the most important reasons patients deviated from usage instructions. Subjects who did not receive instructions on topical treatment duration used corticosteroids longer (>8 weeks) than subjects who were instructed (P < .05). LIMITATIONS: A relatively small sample size prevented trends in demographic predictors of adherence from reaching statistical significance. The patient self-report format has the potential to introduce recall bias. CONCLUSIONS: Factors contributing to intentional nonadherence, including dissatisfaction with efficacy, inconvenience, and fear of side effects, are the most important patient-identified barriers to appropriate use of topical steroids in psoriasis. Clear patient instructions on the intended steroid treatment duration may reduce adverse effects from overuse.
Administration, Topical↗
Striae and pelvic relaxation: two disorders of connective tissue with a strong association.
Pelvic relaxation, a weakening of pelvic support structures, is an under-reported condition that affects a multitude of women. In the United States alone, more than 338,000 procedures for prolapse are performed annually. Decreased collagen content has been noted in the tissues of women affected by this condition. Interestingly, biopsy specimens of women with striae also show a diminution of collagen. Using self-reported anonymous data, we compared the prevalence of striae in women with and without pelvic relaxation to see if an association between these two disorders of connective tissue existed. More than half the women with prolapse (54.7%) (n = 41) reported striae, whereas only 25.0% of women in the non-prolapse group (n = 8) reported striae (P < 0.01). Multivariate logistic regression analysis confirmed striae as a significant risk factor for the development of clinical prolapse (odds ratio 3.12, P < 0.05). There appears to be a strong association between the presence of striae and the development of pelvic relaxation, which is unrelated to conventionally cited risk factors, such as age, weight, number of pregnancies, or postmenopausal status.
Adult↗
Controlled nail trephination for subungual hematoma.
An injury to a finger or toe can result in a collection of blood under the nail plate that if unrelieved can cause extreme discomfort due to pressure. In this case, a 47-year-old man developed a subungual hematoma of the right thumb due to a crush injury. Controlled nail trephination was performed using a uniquely designed drill that penetrated the nail plate without breaching the nail bed. The subungual hematoma was successfully drained, and there was a substantial relief in pain over the subsequent 8 hours. This technique appears to be a quick and convenient method of evacuating subungual hematomas with minimal discomfort and minimal risk.
Drainage↗
Rising educational debt levels in recent dermatology trainees and effects on career choices.
BACKGROUND: Educational debt levels are outpacing inflation. OBJECTIVE: To determine whether debt levels influence career choices of graduating dermatology residents. METHODS: Anonymous surveys of graduating dermatology residents. RESULTS: The presence of debt was associated negatively with pursuing fellowship training in 1999 and 2004 (P < .05) but did not affect choices about entering solo practice or job dissatisfaction levels. LIMITATIONS: This study relies on self-reported data, and some surveys were incomplete. CONCLUSION: Debt levels do not appear to significantly influence the career choices of dermatology residents.
Adult↗
Accessibility to air travel correlates strongly with increasing melanoma incidence.
As the cost of air travel has decreased substantially in the USA and Europe over the past few decades, leisure travel to vacation destinations during the winter months has expanded significantly. This trend has probably increased the incidence of significant ultraviolet radiation exposure and sunburn in a broader population who could not previously afford this kind of travel. The purpose of this study was to analyse the correlation between increasing accessibility to air travel and melanoma incidence. This ecological study surveyed air travel patterns and melanoma incidence over the past three decades. Melanoma age-adjusted incidence was obtained from the United States Surveillance, Epidemiology, and End Results 9 Registry Database, 1975-2000, and the Cancer Registry of Norway, 1965-2000. United States mean inflation-adjusted airfare prices for four airports linked to leisure destinations (Miami, Los Angeles, San Diego, Phoenix) were compared with melanoma incidence. Parallel analyses were performed using annual domestic passenger-kilometres and melanoma incidence in Norway. Declining United States leisure-specific airfares corresponded strongly with increasing melanoma incidence (r = 0.96, r = 0.92, P < 0.001). Modelling a 5-year time lag between airfare and melanoma diagnosis strengthened the association (r = 0.98, r = 0.96, P < 0.001). Longer time lags could not be modelled due to data limitations. Data from Norway similarly showed that increasing air passenger mileage corresponded strongly with increasing melanoma incidence. Although correlation does not equate to causality, the very strong relationship between increasing access to air travel and melanoma incidence suggests that changes in recreational patterns may be contributing significantly to the public health problem of melanoma.
Aircraft↗
Medical versus surgical dermatology: how much training do residents receive?
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Dermatology↗
How low should you go: novel device for nail trephination.
BACKGROUND: The most commonly used treatment for subungual hematomas is nail trephination, a technique that is not standardized and that poorly controls for trephination depth. OBJECTIVE: The objective was to test the safety and tolerance of a new device for nail trephination that uses innovative "mesoscission" or microcutting technology to create holes of specific depths in the nail plate without penetrating the nail bed. MATERIALS AND METHODS: Fourteen adult subjects with healthy toenails had five holes drilled in a random single-blind fashion at different test settings into their right great toenail with this device and were assessed for pain and pressure tolerance as well as perioperative and postoperative complications. RESULTS: Nail trephination with this device in this small pilot study was controlled and well tolerated. LIMITATIONS: The study population was small (n = 14) and the follow-up evaluation relied on patient self-report, which is not always reliable. The follow-up period was only 1 week and did not allow for evaluation of permanent nail plate deformity. CONCLUSION: Mesoscission may be a controlled and practical alternative to traditional nail trephining methods.
Adult↗
Co-occurrence and comorbidities in patients with immune-mediated inflammatory disorders: an exploration using US healthcare claims data, 2001-2002.
OBJECTIVE: Research in immune-mediated inflammatory disorders (IMIDs) suggests that several diseases share disruptions in key cytokines. A common pathogenesis may present as similar patterns of disease co-occurrence and comorbidity, which could be observed through the analysis of healthcare claims datasets. METHODS: Adult patients continuously enrolled from 2001-2002 were identified in two US healthcare datasets containing medical and drug claims from health plans and self-insured employers. Patients with treatment records indicating an IMID were selected (e.g., rheumatoid arthritis, psoriasis, Crohn's disease); controls for each disorder were matched 3:1 based on age, gender, region, and previous insurance coverage. IMID cohorts and comorbidities were identified using International Classification of Diseases, 9th revision codes. Prevalence relative risk was used to assess co-occurrence and comorbidity rates in IMID cohorts and controls. Medical and drug utilization patterns were also explored. RESULTS: Findings were similar across the two datasets. IMID patients represented about 4% of the population; specific IMID prevalence matched the epidemiology literature. Patients with at least one IMID had a higher risk for another IMID when compared to controls. The risk for infectious, renal, liver, and ulcerative comorbidities was also elevated. Selected drug utilization patterns confirmed comorbidity findings. IMID patients used more healthcare resources compared to controls; findings were robust under sensitivity analyses. CONCLUSIONS: IMID patients were generally more likely than controls to have another IMID, supporting the concept that the diseases are related. These patients also had higher comorbidity rates. Findings may be limited by the nature of claims datasets and the confounding effect of current treatments. Prospective studies are needed to determine whether IMIDs have a common pathogenesis.
Adult↗
Metronidazole in the treatment of rosacea: do formulation, dosing, and concentration matter?
BACKGROUND: Topical metronidazole is commonly used in the management of rosacea. No consensus on the optimal formulation, concentration, or dosing regimen exists. PURPOSE: To assess the relative efficacy of metronidazole cream, gel, and lotion at concentrations of 0.75% and 1%, in dosing regimens of once and twice daily. METHODS: A meta-analysis of published metronidazole efficacy rates was performed. RESULTS: In non-weighted analysis, the mean efficacy was 28.2% (95% confidence interval [CI], 22.0%-34.4%) for the cream, 38.4% (95% CI, 18.4%-58.4%) for the gel, and 35% for the lotion. Confidence intervals for QD versus BID dosing and 0.75% versus 1% concentrations also overlapped. In weighted analysis, the mean reduction was 31.3% for the cream, 22.1% for the gel, and 35% for the lotion. CONCLUSIONS: Metronidazole cream, gel, and lotion vehicles have similar efficacies. There were no substantial differences between concentrations of 0.75% and 1%, or between once daily and twice daily regimens.
Administration, Cutaneous↗
Double-blinded, placebo-controlled trial of green tea extracts in the clinical and histologic appearance of photoaging skin.
BACKGROUND: Green tea extracts have gained popularity as ingredients in topical skin care preparations to treat aging skin. Green tea polyphenolic compounds have significant antioxidant and anti-inflammatory activities, and studies suggest that these extracts help mediate ultraviolet radiation damage. OBJECTIVE: To evaluate the effects of a combination regimen of topical and oral green tea supplementation on the clinical and histologic characteristics of photoaging. METHODS: Forty women with moderate photoaging were randomized to either a combination regimen of 10% green tea cream and 300 mg twice-daily green tea oral supplementation or a placebo regimen for 8 weeks. RESULTS: No significant differences in clinical grading were found between the green tea-treated and placebo groups, other than higher subjective scores of irritation in the green tea-treated group. Histologic grading of skin biopsies did show significant improvement in the elastic tissue content of treated specimens (p<.05). CONCLUSION: Participants treated with a combination regimen of topical and oral green tea showed histologic improvement in elastic tissue content. Green tea polyphenols have been postulated to protect human skin from the cutaneous signs of photoaging, but clinically significant changes could not be detected. Longer supplementation may be required for clinically observable improvements.
Administration, Oral↗
Clobetasol propionate foam in the treatment of psoriasis.
Psoriasis is a common, chronic, distressing skin disorder that frequently affects the scalp, skin, nails and joints. Despite treatment, many patients suffer from unremitting disease and decreased quality of life. Scalp-type psoriasis is particularly difficult to treat. Although topical corticosteroids are the mainstay of therapy for moderate-to-severe disease, patients frequently object to the messiness and unfavourable cosmetic appearance of topical treatments. In this context, foam vehicles, which have the advantage of minimal residue and increased ease of application, have emerged as novel alternatives to traditional creams, ointments and solutions. Clobetasol propionate foam 0.05% (OLUX, Connetics Corporation), a high potency topical steroid, has been shown to alleviate symptoms of several dermatological conditions, including scalp and body psoriasis, improve disease severity and increase quality of life. Dose should be limited to 50 g/week, given the risk of adrenal suppression. Because patient preference is an important determinant of medication efficacy in clinical practice, clobetasol foam is a useful new formulation in the treatment of psoriasis and other skin conditions.
Administration, Topical↗
The psychosocial burden of psoriasis.
BACKGROUND: Skin diseases such as psoriasis can profoundly influence a patient's self-image, self-esteem, and sense of well-being. Psoriasis is a multifactorial inflammatory condition with a disease burden that extends beyond the physical symptoms experienced by patients. Psoriasis affects all aspects of quality of life, including physical, psychologic, social, sexual, and occupational elements. OBJECTIVE: The goal of this article was to review the published literature on the impact of psoriasis on quality of life. METHODS: Relevant studies were identified through a comprehensive search of MEDLINE, EMBASE, and the Derwent Drug File databases of English-language articles published between 1993 and 2005 using the terms psoriasis in combination with quality of life, cost, cost-benefit analysis, economic, employment, days lost, healthcare, hospitalization, managed care, outcomes research, occupation, payers, and psychosocial. The reference lists of identified articles were checked for additional studies that might have been missed in the original searches. RESULTS: Data suggest that social stigmatization, high stress levels, physical limitations, depression, employment problems and other psychosocial co-morbidities experienced by patients with psoriasis are not always proportional to, or predicted by, other measurements of disease severity such as body surface area involvement or plaque severity. CONCLUSION: It is essential to include measures of psychosocial morbidity when assessing psoriasis severity and treatment efficacy because of the substantial role that psychosocial burden plays in patient perception of disease severity, quality of life, and disease course.
Adaptation, Psychological↗
Gender and parenting significantly affect work hours of recent dermatology program graduates.
BACKGROUND: The increased proportion of female physicians over the last 30 years may have important implications for future physician workforce needs. OBJECTIVE: To assess the roles of gender, marital status, and parenting in employment choices. DESIGN, SETTING, AND PARTICIPANTS: Anonymous surveys were distributed to recent dermatology residency graduates taking a board examination review course from 1999 through 2002. MAIN OUTCOME MEASURES: The number of hours respondents saw patients per week and the number of hours they spent in each field of dermatology per week. RESULTS: There were 191 respondents to the survey in 2002, which represented 54% of the 2002 residency graduates. For clarity, this article focuses on the 2002 results except where trends over time become apparent. Of the respondents, 57% were women and 43% were men. Women saw patients a mean of 26 hours per week while men saw patients a mean of 31 hours (P =.01), although women spent more time practicing medical dermatology. Marital status did not significantly affect the number of work hours. Men and women who were not parents worked almost the same number of hours per week, but male parents saw patients a greater number of hours than female parents (34 vs 24; P<.01). Men who were parents spent more hours per week seeing patients than men who were not. In contrast, women who were parents spent fewer hours seeing patients than women who were not.Conclusion Parenting, in combination with gender, greatly influences workforce choices for professionals with young families while gender alone has little impact on those choices.
Adult↗
The dermatology workforce shortage.
BACKGROUND: While many dermatology workforce projections over the past two decades forecasted an impending oversupply, more recent reports have begun to suggest a shortage of dermatologic services. METHODS: Anonymous surveys administered to practicing dermatologists and to recent training graduates were examined for surrogate indicators of the supply and demand for dermatologic services. RESULTS: The mean wait time for new patient appointments with dermatologists was 36 calendar days, but ranged widely based on location (means ranged from 9-120 days by state). About half (49%) of practicing dermatologists feel that they need more dermatologists in their communities, while only 20% describe the local supply as too high. The reported need for medical and general dermatologists is far more acute than for dermatologic subspecialists. Many practices (33%) are looking for new associates, and not surprisingly, most new graduates entering the workforce over the past 4 years (86-93%) do not describe any difficulty finding desirable positions. Fewer than 10% of recent graduates are dissatisfied with their current jobs. CONCLUSION: Based on survey data examining wait times, physician perception, use of physician extenders, searches for new employees, and experience of recent graduates entering the workforce, it appears there is an inadequate supply of dermatologists to meet the demand for services.
Adult↗