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Randomized controlled clinical trials remain the best method for minimizing bias when evaluating dermatological treatments. Many dermatologic clinical trials have suffered from small sample sizes, selective reporting of outcomes, publication bias, poor reporting, and heterogeneous outcomes that have hampered comparability-deficiencies that can be overcome by adopting good trial planning and reporting practice encouraged by this journal. Although a profusion of explanatory placebo-controlled studies have contributed little to decision making in the clinical setting, some comparative effectiveness trials such as the use of topical corticosteroids for pemphigoid may have played a pivotal role in improving the well-being of dermatological patients. Systematic reviews (SRs) of clinical trials strive to organize the entire body of evidence while minimizing bias so that policy makers and guideline developers can base their recommendations on the appropriate strength and level of evidence. In dermatology, SRs, such as those undertaken by the Cochrane Collaboration, have produced clear clinical messages despite conflicting individual studies, and also play a key role in identifying research gaps. Future challenges include optimizing the use of research resources, adopting methodological developments in health technology assessment, and prospective registration and complete reporting of all study results. [ABSTRACT FROM AUTHOR]

The article reflects the opinion of the author on the importance of systematic reviews in clinical dermatology in research and publication. Significant reviews are crucial in medical researches, since it can save both lives and resources. Moreover, the author stated that proper application of metaanalysis in published and unpublished researches could create a more precise estimate of treatment effect to make small but clinically important effects become apparent among conflicting singular trial.

The article provides information on the scientific concepts underlying pragmatic clinical trials in dermatology. It discusses the objectives of pragmatic clinical trials and its comparison to explanatory clinical trials, limitations of pragmatic clinical trials, and the use of the Pragmatic-Explanatory Continuum Indicator Summary tool.

The author discusses the significance of democratizing randomized clinical trials (RCTs) in the field of dermatology in Great Britain. He explains that RCTs are essential in assessing the efficacy of skin disease treatment but its usefulness is limited in the quality of design and reporting and the clinical question that the trials address. He cites that the challenges can be addressed by forming a network of like-minded people such as the UK Dermatology Clinical Trials Network (UK DCTN).

Cleverly using records obtained from the 2003 National Survey of Children's Health (NSCH), Shaw et al. provide a pioneering glimpse into the burden of eczema across the United States. Using parental reports of a doctor's diagnosis of eczema in the past 12 months, the authors show that eczema affects around 9-18% of children age 17 and under. The study confirms reported associations such as living in metropolitan areas, higher household education level, and black ethnicity. Novel findings include the demonstration of higher eczema prevalence along the East Coast. The study correlates well with previous reports and may help point to environmental factors that contribute to the development of eczema. [ABSTRACT FROM AUTHOR]

The author reflects on the report which discusses conflicts of interests (COI) in dermatology. He stresses that the author of the report misunderstood two crucial point of the issue by making obscure differences between a circumstance and a behavior. He argues that a COI simply means that a set of conditions is operating that could have a marked influence on behavior, and for the audience to make a judgment on whether such conflicts are relevant that could have resulted in a specific behavior.

The article reports that the International Committee of Medical Journal Editors (ICMJE) is a group of the world's leading medical journals whose participants meet annually to improve standards in manuscripts submitted to biomedical journals. In September 2004, the ICMJE announced a tough new stance on registering clinical trials. All trials that start enrolling participants after July 1, 2005 must register their trial in a suitable publicly accessible register before that date in order to be considered for subsequent publication in those journals.

The article focuses on a scientific look at seasonality of symptom severity in atopic dermatitis (AD). Several papers on AD list a long number of factors that may exacerbate AD, such as stress, heat, irritants, dry skin, infections, allergens, and sweating. Yet, the basis for many of these has not been studied scientifically. Indeed, the objective study of flare factors for AD flares remains one of the major research gaps in the understanding of AD. This is perhaps surprising given that exploration of possible exacerbating or relieving features is such a common discussion point during consultations with many patients and families with AD.

The Global Burden of Disease (GBD) Study 2010 estimated the GBD attributable to 15 categories of skin disease from 1990 to 2010 for 187 countries. For each of the following diseases, we performed systematic literature reviews and analyzed resulting data: eczema, psoriasis, acne vulgaris, pruritus, alopecia areata, decubitus ulcer, urticaria, scabies, fungal skin diseases, impetigo, abscess, and other bacterial skin diseases, cellulitis, viral warts, molluscum contagiosum, and non-melanoma skin cancer. We used disability estimates to determine nonfatal burden. Three skin conditions, fungal skin diseases, other skin and subcutaneous diseases, and acne were in the top 10 most prevalent diseases worldwide in 2010, and eight fell into the top 50; these additional five skin problems were pruritus, eczema, impetigo, scabies, and molluscum contagiosum. Collectively, skin conditions ranged from the 2nd to 11th leading cause of years lived with disability at the country level. At the global level, skin conditions were the fourth leading cause of nonfatal disease burden. Using more data than has been used previously, the burden due to these diseases is enormous in both high- and low-income countries. These results argue strongly to include skin disease prevention and treatment in future global health strategies as a matter of urgency. [ABSTRACT FROM AUTHOR]

We assessed completeness of trial registration and the extent of outcome-reporting bias in published randomized controlled trials (RCTs) of eczema (atopic dermatitis) treatments by surveying all relevant RCTs published from January 2007 to July 2011 located in a database called the Global Resource of Eczema Trials (GREAT). The GREAT database is compiled by searching six bibliographic databases, including EMBASE and MEDLINE. Out of 109 identified RCTs, only 37 (34%) had been registered on an approved trial register. Only 18 out of 109 trials (17%) had been registered 'properly' in terms of submitting the registration before the trial end date and nominating a primary outcome. The proportion of 'any registered' and 'properly registered' RCTs increased from 19% and 10% in 2007 to 57% and 36% in 2011, respectively. Assessment of selective outcome-reporting bias was difficult even among the properly registered trials owing to unclear primary outcome description especially with regard to timing. Only 5 out of the 109 trials (5%) provided enough information for us to be confident that the outcomes reported in the published trial were consistent with the original registration. Adequate trial registration and description of primary outcomes for eczema RCTs is currently poor. [ABSTRACT FROM AUTHOR]

A response by Jochen Schmitt, Carsten Flohr, and Hywel C. Williams to a letter to the editor on their article "Core outcome domains for controlled trials and clinical recordkeeping in eczema: international multiperspective Delphi consensus process" in an issue in 2011 is presented.

A letter to the editor in response to the article "The Nature of Clinical Evidence: Floating Currencies Rather than Gold Standards," by J. Rees in the previously published issue is presented.

Core outcome sets (COSs) are consensus-derived minimum sets of outcomes to be assessed in a specific situation. COSs are being increasingly developed to limit outcome-reporting bias, allow comparisons across trials, and strengthen clinical decision making. Despite the increasing interest in outcomes research, methods to develop COSs have not yet been standardized. The aim of this paper is to present the Harmonizing Outcomes Measures for Eczema (HOME) roadmap for the development and implementation of COSs, which was developed on the basis of our experience in the standardization of outcome measurements for atopic eczema. Following the establishment of a panel representing all relevant stakeholders and a research team experienced in outcomes research, the scope and setting of the core set should be defined. The next steps are the definition of a core set of outcome domains such as symptoms or quality of life, followed by the identification or development and validation of appropriate outcome measurement instruments to measure these core domains. Finally, the consented COS needs to be disseminated, implemented, and reviewed. We believe that the HOME roadmap is a useful methodological framework to develop COSs in dermatology, with the ultimate goal of better decision making and promoting patient-centered health care. [ABSTRACT FROM AUTHOR]

There is wide variation in the use of outcome measures for eczema. We performed a three-stage web-based international Delphi exercise to develop consensus-based sets of core outcome domains for eczema for 'controlled trials' and 'clinical recordkeeping'. A total of 57 individuals from four stakeholder groups (consumers, clinical experts, regulatory agency representatives, and journal editors) representing 13 countries were asked to rate the importance of 19 outcome domains for eczema and to choose which domains should be included in two core sets of outcomes. Forty-six individuals (81%) participated. Participants received standardized feedback, including the group median, interquartile range, and previous responses, and the assessment was repeated in two subsequent rounds. We defined consensus a priori if at least 60% of the members of at least three stakeholder groups, including consumers, recommended domain inclusion in the core set. Consensus was achieved for inclusion of symptoms, physician-assessed clinical signs, and a measurement for long-term control of flares in the core set of outcome domains for eczema trials. We recommend including these three core outcomes in future eczema trials in order to enhance clinical interpretability and to enable meta-analyses across different studies. For recordkeeping, consensus was reached to regularly monitor eczema symptoms in clinical practice. Future work is needed to select which existing or new scales should be used to measure the domains identified as relevant for the core set. [ABSTRACT FROM AUTHOR]