Epidemiology and management of primary spontaneous pneumothorax: a systematic review.

Primary spontaneous pneumothorax (PSP) is one of the most common thoracic diseases affecting adolescents and young adults. Despite the high incidence of PSP and the availability of several international guidelines for its diagnosis and treatment, a significant behavioural heterogeneity can be found among those management recommendations. A working group of the Italian Society of Thoracic Surgery summarized the best evidence available on PSP management with the methodological tool of a systematic review assessing the quality of previously published guidelines with the Appraisal of Guidelines for Research and Evaluation (AGREE) II. Concerning PSP physiopathology, the literature seems to be equally divided between those who support the hypothesis of a direct correlation between changes in atmospheric pressure and temperature and the incidence of PSP, so it is not currently possible to confirm or reject this theory with reasonable certainty. Regarding the choice between conservative treatment and chest drainage in the first episode, there is no evidence on whether one option is superior to the other. Video-assisted thoracic surgery represents the most common and preferred surgical approach. A primary surgical approach to patients with their first PSP seems to guarantee a lower recurrence rate than that of a primary approach consisting of a chest drainage positioning; conversely, the percentage of futile surgical interventions that would entail this aggressive attitude must be carefully evaluated. Surgical pleurodesis is recommended and frequently performed to limit recurrences; talc poudrage offers

Radiological informed consent in cardiovascular imaging: towards the medico-legal perfect storm?

Use of radiation for medical examinations and tests is the largest manmade source of radiation exposure. No one can doubt the immense clinical and scientific benefits of imaging to the modern practice of medicine. Every radiological and nuclear medicine examination confers a definite (albeit low) long-term risk of cancer, but patients undergoing such examinations often receive no or inaccurate information about radiological dose exposure and corresponding risk directly related to the radiological dose received. Too detailed information on radiological dose and risk may result in undue anxiety, but information "economical with the truth" may violate basic patients' rights well embedded in ethics (Oviedo convention 1997) and law (97/43 Euratom Directive 1997). Informed consent is a procedure needed to establish a respectful and ethical relation between doctors and patients. Nevertheless, in an "ideal" consent process, the principle of patient autonomy in current radiological practice might be reinforced by making it mandatory to obtain explicit and transparent informed consent form for radiological examination with high exposure (≥ 500 chest x-rays). The form may spell-out the type of examination, the exposure in effective dose (mSv), derived from reference values in guidelines or – better – from actual values from their department. The dose equivalent might be also expressed in number of chest radiographs and the risk of cancer as number of extra cases in the exposed population, derived from most recent and authorative guidelines (e.g., BEIR VII Committee, release 2006). Common sense, deontological code, patients'rights, medical imaging guidelines, Euratom law, all coherently and concordantly encourage and recommend a justified, optimized, responsible and informed use of testing with ionizing radiation. Although the idea of informed consent for radiation dose does not seem to be on the immediate radar screen at least in the US, the current practice clashes against these guidelines and laws

Diffusion of complementary evolving pharmaceutical innovations: The case of Abacavir and its pharmacogenetic companion diagnostic in Italy

Innovation is increasingly important in the delivery of efficient healthcare; however, the pathways through which medical innovation reach clinical practice are fraught with uncertainty. Further scientific investigation and technological development are normal in medical innovation even when drugs, diagnostics or medical procedures are already adopted. Diffusion studies rarely admit such possibilities as a fundamental element of their conceptual frameworks. This paper explores the diffusion process of an antiretroviral drug (Abacavir) and the introduction of its companion pharmacogenetic test into clinical practice in Italy. This is a landmark case of translational medicine where the principles of pharmacogenetics made an important - applied - contribution to medical innovation shifting the focus away from the diffusion of a complete technology (the drug) towards that of a dynamic technology (Abacavir + developing companion diagnostics). We adopt the historical method to analyse the sequence of events. Key findings show that the diffusion process of a dynamic technology does not fit in the widely accepted S-shaped model for a complete technology. The diffusion phase presents complex interactions amongst the stakeholders involved, each operating on the basis of their own competences within the environment and the regulatory system; the analysis of the diffusion process should proceed through the correct identification of the dynamic technology – the therapy – and cannot be de-coupled from scientific discovery and technological development

Patients in long-term maintenance therapy for drug use in Italy: analysis of some parameters of social integration and serological status for infectious diseases in a cohort of 1091 patients

BACKGROUND: Heroin addiction often severely disrupts normal social functioning. The aims of this multi-centre study of heroin users in long-term replacement treatment were: i) to provide information on aspects of social condition such as employment, educational background, living status, partner status and any history of drug addiction for partners, comparing these data with that of the general population; ii) to assess the prevalence of hepatitis, syphilis and HIV, because serological status could be a reflection of the social conditions of patients undergoing replacement treatment for drug addiction; iii) to analyse possible relationships between social conditions and serological status. METHODS: A cross-sectional study was carried out in sixteen National Health Service Drug Addiction Units in northern Italy. The data were collected from February 1, 2002 to August 31, 2002. Recruitment eligibility was: maintenance treatment with methadone or buprenorphine, treatment for the previous six months, and at least 18 years of age. In the centres involved in the study no specific criteria or regulations were established concerning the duration of replacement therapy. Participants underwent a face-to-face interview. RESULTS: The conditions of 1091 drug treatment patients were evaluated. The mean duration of drug use was 14.5 years. Duration was shorter in females, in subjects with a higher educational background, and in stable relationships. Most (68%) had completed middle school (11–14 years of age). Seventy-nine percent were employed and 16% were unemployed. Fifty percent lived with their parents, 34% with a partner and 14% alone. Males lived more frequently with their parents (55%), and females more frequently with a partner (60%). Sixty-seven percent of male patients with a stable relationship had a partner who had never used heroin. HCV prevalence was 72%, HBV antibodies were detected in 42% of patients, while 30% had been vaccinated; 12.5% of subjects were HIV positive and 1.5% were positive for TPHA. CONCLUSION: A significant percentage of heroin users in treatment for opiate addiction in the cohort study have characteristics which indicate reasonable integration within broader society. We posit that the combination of effective treatment and a setting of economic prosperity may enhance the social integration of patients with a history of heroin use