Outcome assessment in dermatology clinical trials and cochrane reviews: call for a dermatology-specific outcome taxonomy.

BACKGROUND: Standardized outcome reporting is crucial for trial evidence synthesis and translation of findings into clinical decision-making. The OMERACT 2.0 Filter and COMET outcome domain taxonomy propose frameworks for consistent reporting of outcomes. There is an absence of a uniform dermatology-specific reporting strategy that uses precise and consistent outcome definitions. OBJECTIVES: Our aim was to map efficacy/effectiveness outcomes assessed in dermatological trials to the OMERACT 2.0 Filter as a starting point for developing an outcome taxonomy in dermatology. METHODS: We critically appraised 10 Cochrane Skin Reviews randomly selected from all 69 Cochrane Skin Reviews published until 01/2015 and the 220 trials included covering a broad spectrum of dermatological conditions and interventions. Efficacy/effectiveness outcomes were mapped to core areas and domains according to the OMERACT 2.0 Filter. The extracted trial outcomes were used for critical appraisal of outcome reporting in dermatology trials and for the preliminary development of a dermatology-specific outcome taxonomy. RESULTS: The allocation of 1086 extracted efficacy/effectiveness outcomes to the OMERACT 2.0 Filter resulted in a hierarchically structured dermatology-specific outcome classification. In 506 outcomes (47%), the outcome concept to be measured was insufficiently described, hindering meaningful evidence synthesis. Although the core areas assessed in different dermatology trials of the same condition overlap considerably, quantitative evidence synthesis usually failed due to imprecise outcome definitions, non-comparable outcome measurement instruments, metrics and reporting. CONCLUSIONS: We present an efficacy/effectiveness outcome classification as a starting point for a dermatology-specific taxonomy to provide trialists and reviewers with the opportunity to better synthesize and compare evidence.

Core outcome sets in dermatology: report from the second meeting of the International Cochrane Skin Group Core Outcome Set Initiative.

Results of clinical trials are the most important information source for generating external clinical evidence. The use of different outcomes across trials, which investigate similar interventions for similar patient groups, significantly limits the interpretation, comparability and clinical application of trial results. Core outcome sets (COSs) aim to overcome this limitation. A COS is an agreed standardized collection of outcomes that should be measured and reported in all clinical trials for a specific clinical condition. The Core Outcome Set Initiative within the Cochrane Skin Group (CSG-COUSIN) supports the development of core outcomes in dermatology. In the second CSG-COUSIN meeting held in 2017, 11 COS development groups working on skin diseases presented their current work. The presentations and discussions identified the following overarching methodological challenges for COS development in dermatology: it is not always easy to define the disease focus of a COS; the optimal method for outcome domain identification and level of detail needed to specify such domains is challenging to many; decision rules within Delphi surveys need to be improved; appropriate ways of patient involvement are not always clear. In addition, there appear to be outcome domains that may be relevant as potential core outcome domains for the majority of skin diseases. The close collaboration between methodologists in the Core Outcome Set Initiative and the international Cochrane Skin Group has major advantages for trialists, systematic reviewers and COS developers.

[What does pain intensity mean from the patient perspective? : A qualitative study on the patient perspective of pain intensity as an outcome parameter in treatment evaluation and on the interpretability of pain intensity measurements]. / Was bedeutet Schmerzintensität aus Sicht der Patienten? : Eine qualitative Studie zur Patientenperspektive auf Schmerzstärke als Konstrukt in der Therapieevaluation und die Interpretierbarkeit der Schmerzstärkemessung.

BACKGROUND: Pain intensity (PI) is a common outcome parameter in effectiveness studies on interdisciplinary multimodal pain therapy (IMPT), despite the fact that IMPT highlights dealing with rather than reducing chronic pain. Moreover, the measurement of pain intensity as a highly subjective experience is problematic. Patient participation is absolutely essential to examine the relevance of PI as a criterion of treatment success as well as to select/develop suitable measurement methods. METHOD: A qualitative multicenter study was conducted using focus groups with 69 patients (18-77 years; 80% female) at four different IMPT centers in Germany to discuss pain intensity as a therapy outcome parameter in IMPT, as well as the interpretability and feasibility of common measurement methods. RESULTS: The discussions emphasized that PI is a relevant, but not the primary, outcome in IMPT for patients. Patients' statements also demonstrate that there are some problems in measuring PI, for instance with regard to pain attacks. CONCLUSIONS: The focus group discussions suggested that, due to the highly subjective nature of PI, as well as (verbal) inaccuracies and a lack of standardization in common instruments, the measurement of pain intensity is a challenging task. These limitations should be taken into account in future studies.

[Development of Arbuscular Mycorrhiza in Highly Responsive and Mycotrophic Host Plant-Black Medick (Medicago lupulina L.)].

The main phases of arbuscular mycorrhiza (AM) development were analyzed in black medick (Medicago lupulina) with Glomus intraradices. Methods of light and transmission electron microscopy were used to investigate AM. The first mycorrhization was identified on the seventh day after sowing. M. lupulina with AM-fungus Glomus intraradices formed Arum type of AM. Roots of black medick at fruiting stage (on the 88th day) were characterized by the development of forceful mycelium. The thickness of mycelium was comparable with the vascular system of root central cylinder. The development of vesicules into intraradical spores was shown. Micelium, arbuscules, and vesicules developed in close vicinity to the division zone of root tip. This might be evidence of an active symbiotic interaction between partners. All stages of fungal development and breeding, including intraradical spores (in inter-cellular matrix of root cortex), were identified in the roots of black medick, which indicated an active utilization of host plant nutrient substrates by the mycosymbiont. Plant cell cytoplasm extension was identified around young arbuscular branches but not for intracellular hyphae. The presence of active symbiosis was confirmed by increased accumulation of phosphorus in M. lupulina root tissues under conditions of G. intraradices inoculation and low phosphorus level in the soil. Thus, black medick cultivar-population can be characterized as an ecologically obligate mycotrophic plant under conditions of low level of available phosphorus in the soil. Specific features of AM development in intensively mycotrophic black medick, starting from the stage of the first true leaf until host plant fruiting, were evaluated. The obtained plant-microbe system is a perspective model object for further ultracytological and molecular genetic studies of the mechanisms controlling arbuscular mycorrhiza symbiotic efficiency, including selection and investigation of new symbiotic plant mutants.

Prejudice toward fat people: the development and validation of the antifat attitudes test.

Although the stigma of obesity in our society is well documented, the measurement of antifat attitudes has been a difficult undertaking. Two studies were conducted to construct and validate the Antifat Attitudes Test (AFAT). In study 1, college students (110 men and 175 women) completed the preliminary 54-item AFAT and specific indices of body image and weight-related concerns. Psychometric and factor analysis revealed a 47-item composite scale and three internally consistent factors that were uncorrelated with social desirability: Social/Character Disparagement, Physical/Romantic Unattractiveness, and Weight Control/Blame. Several body images correlates of antifat prejudice were identified, and men expressed more negative attitudes than women. Study 2 experimentally examined the effects of information about the controllability of weight on the antifat attitudes of 120 participants. Exposure to information on behavioral vs. biogenetic control led to greater blame of persons who are fat for their body size. The implications of the findings and the potential utility of the AFAT are discussed.