Clinical evidence continuous medical education: a randomised educational trial of an open access e-learning program for transferring evidence-based information – ICEKUBE (Italian Clinical Evidence Knowledge Utilization Behaviour Evaluation) – study protocol

<p>Abstract</p> <p>Background</p> <p>In an effort to ensure that all physicians have access to valid and reliable evidence on drug effectiveness, the Italian Drug Agency sponsored a free-access e-learning system, based on <it>Clinical Evidence</it>, called ECCE. Doctors have access to an electronic version and related clinical vignettes. Correct answers to the interactive vignettes provide Continuing Medical Education credits. The aims of this trial are to establish whether the e-learning program (ECCE) increases physicians' basic knowledge about common clinical scenarios, and whether ECCE is superior to the passive diffusion of information through the printed version of <it>Clinical Evidence</it>.</p> <p>Design</p> <p>All Italian doctors naïve to ECCE will be randomised to three groups. Group one will have access to ECCE for <it>Clinical Evidence </it>chapters and vignettes lot A and will provide control data for <it>Clinical Evidence </it>chapters and vignettes lot B; group two vice versa; group three will receive the concise printed version of <it>Clinical Evidence</it>. There are in fact two designs: a before and after pragmatic trial utilising a two by two incomplete block design (group one versus group two) and a classical design (group one and two versus group three). The primary outcome will be the retention of <it>Clinical Evidence </it>contents assessed from the scores for clinical vignettes selected from ECCE at least six months after the intervention. To avoid test-retest effects, we will randomly select vignettes out of lot A and lot B, avoiding repetitions. In order to preserve the comparability of lots, we will select vignettes with similar, optimal psychometric characteristics.</p> <p>Trial registration</p> <p>ISRCTN27453314</p

Once in a Blue Moon … Rare Adnexal Tumor: From the Clinical and Videodermoscopical Aspects to the Mohs Surgery and the Histological Diagnosis

The adnexal tumours are a very heterogeneous group of lesions, more and more studied in the literature. The squamoid eccrine ductal carcinoma (SEDC) is a rare malignant variant that combines ductal structures with squamous differentiation.We report a case of dermoscopic and histological diagnosis of SEDC, treated with Mohs Surgery and with no recurrence of a tumour after 12 months of follow up

Informing women about hormone replacement therapy: the consensus conference statement

Background: The risks/benefits balance of hormone replacement therapy is controversial. Information can influence consumers' knowledge and behavior; research findings about hormone replacement therapy are uncertain and the messages provided by the media are of poor quality and incomplete, preventing a fully informed decision making process. We therefore felt that an explicit, rigorous and structured assessment of the information needs on this issue was urgent and we opted for the organisation of a national consensus conference (CC) to assess the current status of the quality of information on hormone replacement therapy (HRT) and re-visit recent research findings on its risks/ benefits. Methods: We chose a structured approach based on the traditional CC method combined with a structured preparatory work supervised by an organising committee (OC) and a scientific board (SB). The OC and SB chose the members of the CC's jury and appointed three multidisciplinary working groups (MWG) which were asked to review clinical issues and different aspects of the quality of information. Before the CC, the three MWGs carried out: A literature review on the risk/benefit profile of HRT and two surveys on the quality of information on lay press and booklets targeted to women. A population survey on women's knowledge, attitude and practice was also carried out. The jury received the documents in advance, listened the presentations during the two-day meeting of the CCs, met immediately after in a closed-door meeting and prepared the final document. Participants were researchers, clinicians, journalists as well as consumers' representatives. Results: Key messages in the CC's deliberation were: a) women need to be fully informed about the transient nature of menopausal symptoms, about HRT risks and benefits and about the availability of non-pharmacological interventions; b) HRT is not recommended to prevent menopausal symptoms; c) the term "HRT" is misleading and "post menopausal hormone therapy" should be the preferred definition. Conclusion: This CC led to the identification of specific information drawbacks. Women are exposed to messages that are often partial, non evidence-based nor transparently developed. The structured and participative methodology of this CC allowed a multidisciplinary perspective and a substantial lay people input

A European multi-language initiative to make the general population aware of independent clinical research: the European Communication on Research Awareness Need project

BACKGROUND: The ECRAN (European Communication on Research Awareness Needs) project was initiated in 2012, with support from the European Commission, to improve public knowledge about the importance of independent, multinational, clinical trials in Europe. METHODS: Participants in the ECRAN consortium included clinicians and methodologists directly involved in clinical trials; researchers working in partnership with the public and patients; representatives of patients; and experts in science communication. We searched for, and evaluated, relevant existing materials and developed additional materials and tools, making them freely available under a Creative Commons licence. RESULTS: The principal communication materials developed were: 1. A website ( http://ecranproject.eu ) in six languages, including a Media centre section to help journalists to disseminate information about the ECRAN project 2. An animated film about clinical trials, dubbed in the 23 official languages of the European Community, and an interactive tutorial 3. An inventory of resources, available in 23 languages, searchable by topic, author, and media type 4. Two educational games for young people, developed in six languages 5. Testing Treatments interactive in a dozen languages, including five official European Community languages 6. An interactive tutorial slide presentation testing viewers' knowledge about clinical trials CONCLUSIONS: Over a 2-year project, our multidisciplinary and multinational consortium was able to produce, and make freely available in many languages, new materials to promote public knowledge about the importance of independent and international clinical trials. Sustained funding for the ECRAN information platform could help to promote successful recruitment to independent clinical trials supported through the European Clinical Research Infrastructure Network

Natural History of Malignant Bone Disease in Renal Cancer: Final Results of an Italian Bone Metastasis Survey

Abstract Background: Bone metastasis represents an increasing clinical problem in advanced renal cell carcinoma (RCC) as diseaserelated survival improves. There are few data on the natural history of bone disease in RCC

Compassionate use programs in Italy: ethical guidelines

BACKGROUND: This article proposes a retrospective analysis of a compassionate use (CU), using a case study of request for Avelumab for a patient suffering from Merkel Cell Carcinoma. The study is the result of a discussion within a Provincial Ethics Committee (EC) following the finding of a high number of requests for CU program. The primary objective of the study is to illustrate the specific ethical and clinical profiles that emerge from the compassionate use program (CUP) issue. The secondary goals are: a) to promote a moral reflection among physicians who require approval for the CUP and b) provide the basis for recommendations on how to request CUP. MAIN BODY: The instruments for carrying out the analysis of the case study and the discussion are as follows: Analysis of the audio-recording of the EC meeting regarding the selected Case study. In-depth discussion of topics that emerged during the meeting by means of administration of 5 semi-structured interviews with 2 doctors involved in the case (proposing physician and palliative physician) and with 3 components of the EC who played a major role in the EC internal discussion. CONCLUSIONS: In an exploration of emerging clinical and ethical issues, four primary themes arise: 1. efficacy, safety of the treatment and patient's quality of life; 2. clear, realistic, adequate communication; 3. right to hope; 4. simultaneous Palliative Care approach. The results of ethical analysis carried out concern two areas: 1) ethical profiles relating to the use of CUP; 2) the role of the EC concerning the compassionate use of drugs and the need to provide recommendations on how to request CUP. With the aim of implementing these conclusions, the provincial EC of Reggio Emilia chose to steer the request for drugs for compassionate use through recommendations for good clinical and ethical practice based on the following assumptions: 1) the "simultaneous care" approach must be preferred. Secondly, 2) the EC's assessment must be part of the decision-making process that the care team conducts before proposing compassionate use to the patient

Nevo epidermico verrucoso e carcinomi basocellulari multipli: una rara associazione

Il nevo epidermico verrucoso è una lesione cutanea amartomatosa localizzata o diffusa, spesso congenita, costituita quasi esclusivamente da cheratinociti. Si compone di numerose papule di colorito rosato o lievemente pigmentate che confluiscono in placche e, con il tempo, si caratterizzano per la comparsa di nuovi elementi, per il colorito piu' scuro e per la superficie cheratosica. Puo' interessare qualsiasi area corporea, estendendosi lungo le linee di Blaschko. Il nostro caso è quello di una donna caucasica di 71 anni con nevo epidermico verrucoso presente dalla nascita, localizzato all'arto inferiore sinistro ed esteso dalla coscia al primo dito del piede. La paziente riferiva la comparsa nell'ambito del preesistente nevo di numerose lesioni papulo-nodulari, di colorito rosato, alcune pigmentate, con caratteristiche clinico-dermatoscopiche di carcinomi basocellulari. Abbiamo eseguito exeresi delle lesioni di dimensioni maggiori, in due sedute chirurgiche. L'esame istopatologico ha confermato la diagnosi di carcinomi-basocellulari. L'insorgenza di tumori epiteliali nel contesto di un nevo epidermico verrucoso è un evento molto raro e rimane ancora da chiarire se possa trattarsi di due lesioni clonali o rappresenti semplicemente la collisione di due tumori indipendenti. La tendenza all'ulcerazione e la potenziale aggressività dei carcinomi basocellulari raccomandano un trattamento di radicalità

Un curioso caso di alopecia.

Il caso di alopecia presentato non confortava, all’obiettività clinica, la diagnosi istopatologica di “forma inveterata di lupus”. Abbiamo eseguito revisione del vetrino in collaborazione con i colleghi dell’Anatomia Patologica, orientandoci così verso una diagnosi di alopecia areata. Tre infiltrazioni intralesionali di corticosteroide1-3 a lento rilascio portavano, infatti, ad una risoluzione quasi completa dell’alopecia