Laurence Le Cleach

Poor Reporting of Quality of Life Outcomes in Dermatology Randomized Controlled Clinical Trials

Background: Because many dermatological diseases are chronic but not life-threatening, consideration of their impact on health-related quality of life (QOL) seems essential. Objective: To analyze the use of QOL as an evaluation endpoint in randomized clinical trials concerning skin diseases. Methods: Studies identified by computerized search of 3 bibliographical databases were selected, and their data on QOL as an evaluation endpoint were collected and analyzed. Results: Among the 67 studies retained, 87% did not adequately describe the questionnaires; 75% did not address handling of missing data; 95% did not calculate the number of subjects needed to obtain the desired statistical power; 95% did not disclose before-and-after results as means of overall scores and each dimension. Conclusion: Our analysis highlighted methodological weaknesses in the use of QOL questionnaire and poor reporting of QOL outcomes in randomized clinical trials.

Bed bug infestation

#### Summary points Bed bugs are bloodfeeding insects that seem to be resurging in developed countries,1 possibly due to international travel and changes in pest control practices.2 Diagnosis of bed bug infestation relies on clinical manifestations of bites and direct observation of the arthropod, which is rarely recognised by those who are bitten.3 Evidence is lacking on the bed bug’s capacity to transmit disease, management of eradication, and the economic impact of infestations. This summary of the available evidence on the diagnosis and management of bed bug infestation aims to help general practitioners identify the clinical signs of bed bug bites and help patients identify and manage infestations. #### Sources and selection criteria We focused on articles published since October 2008 to update Goddard and colleagues’ systematic review.2 We searched PubMed and Embase databases until July 2012, using the search terms “bedbugs [Mesh] OR bed bugs OR bed bug OR Cimex”. We also manually searched textbooks, newspapers, and websites, mainly those listed by the Centers for Disease Control and Prevention (www.cdc.gov/nceh/ehs/topics/bedbugs.htm). Our selection criteria were case reports on more than five patients, and results related to humans in the field of prevention and elimination of bed bugs or clinical manifestations of their bites. The two main species of bed bugs are Cimex lectularius and Cimex hemipterus , which are found in tropical zones and temperate areas, respectively. They are brown, wingless, flat, 2-5 mm …

Is Topical Monotherapy Effective for Localized Pyoderma Gangrenosum

In May 2008, a 32-year-old woman was seen with a painful infiltrated erythematous lesion 11 cm in diameter, studded with purulent necrotic pits, on the anterior right shin (Figure, A). It had started as an erythematous infiltrated lesion 3 months previously and had been stable for 1 month. Pyoderma gangrenosum was diagnosed based on the clinical appearance, negative findings on bacterial culture, and histologic examination of a skin biopsy specimen. No systemic underlying disease was found during investigations, including a colonoscopy. There is little evidence on the efficacy of PG treatment because there is only 1 randomized controlled trial to date comparing the effects of infliximab vs placebo. Systemic corticosteroids and cyclosporine are usually recommended as first-line treatments. Given the stability of this solitary lesion, we decided to consider the option of topical monotherapy for our patient. The objective of this article was to determine from the available evidence whether a topical agent would be an effective and safe treatment in this setting. Literature Search

Research Techniques Made Simple: Workflow for Searching Databases to Reduce Evidence Selection Bias in Systematic Reviews

Clinical trials and basic science studies without statistically significant results are less likely to be published than studies with statistically significant results. Systematic reviews and meta-analyses that omit unpublished data are at high risk of distorted conclusions. Here, we describe methods to search beyond bibliographical databases to reduce evidence selection bias in systematic reviews. Unpublished studies may be identified by searching conference proceedings. Moreover, clinical trial registries-databases of planned and ongoing trials-and regulatory agency websites such as the European Medicine Agency (EMA) and the United States Food and Drug Administration (FDA) may provide summaries of efficacy and safety data. Primary and secondary outcomes are prespecified in trial registries, thus allowing the assessment of outcome reporting bias by comparison with the trial report. The sources of trial data and documents are still evolving, with ongoing initiatives promoting broader access to clinical study reports and individual patient data. There is currently no established methodology to ensure that the multiple sources of information are incorporated. Nonetheless, systematic reviews must adapt to these improvements and cover the new sources in their search strategies.

Designing Randomized-Controlled Trials to Improve Head-Louse Treatment: Systematic Review Using a Vignette-Based Method

Head-louse infestation remains a public health problem. Despite published randomized-controlled trials, no consensus-based clinical practice guidelines for its management emerged because of the heterogeneity of trial methodologies. Our study was undertaken to attempt to find an optimal trial framework: minimizing the risk of bias, while taking feasibility into account. To do so, we used the vignette-based method. A systematic review first identified trials on head-louse infestation; 49 were selected and their methodological constraints assessed. Methodological features were extracted and combined by arborescence to generate a broad spectrum of potential designs, called vignettes, yielding 357 vignettes. A panel of 48 experts then rated one-on-one comparisons of those vignettes to obtain a ranking of the designs. Methodological items retained for vignette generation were income level of the population, types of treatments compared, randomization unit, blinding, treatment-administration site, diagnosis method and criteria, and primary outcome measure. The expert panel selected vignettes with cluster randomization, centralized treatment administration, and blinding of the outcome assessor. The vignette method identified optimal designs to standardize future head-louse treatment trials, thereby obtaining valid conclusions and comparable data from future trials, and appears to be a reliable way to generate evidence-based guidelines.

Comparative Effectiveness of Cryotherapy and Salicylic Acid for Plantar Warts

Laurence Le Cleach, MD; Ludovic Trinquart, MCS; Dominique Penso-Assathiany, MD; Olivier Chosidow, MD, PhD; Department of Dermatology, Hopital Henri-Mondor, Assistance Publique–Hopitaux de Paris, Creteil (Drs Le Cleach, Penso-Assathiany, and Chosidow), Centre Cochrane Francais, Hotel-Dieu, Paris (Drs Le Cleach and Chosidow and Mr Trinquart), French Satellite of the Cochrane Skin Group, Creteil (Drs Le Cleach and Chosidow), and Universite Paris-Est-Creteil, Val de Marne (Dr Chosidow), France

Safety of Topical Corticosteroid Use During Pregnancy

Benedicte Lebrun-Vignes, MD; Laurence Le Cleach, MD; Bruno Giraudeau, PhD; Olivier Chosidow, MD, PhD; Pharmacovigilance Center, Department of Pharmacology, Hopital Pitie-Salpetriere (Dr Lebrun-Vignes), and French Cochrane Center, Hopital Hotel-Dieu (Dr Le Cleach), Assistance Publique–Hopitaux de Paris (APHP), Paris; Department of Dermatology, Hopital Henri-Mondor, APHP (Drs Le Cleach and Chosidow), and Universite Paris–Est Creteil Val de Marne (Dr Chosidow), Creteil; and Institut National de la Sante et de la Recherche Medicale Centre d’Investigation Clinique 202 and Universite Francois Rabelais Tours, Centre Hospitalier Regional et Universitaire de Tours, Tours (Dr Giraudeau), France