Objectives: Coverage decisions are decisions by third party payers about whether and how much to pay for technologies or services, and under what conditions. Given their complexity, a systematic and transparent approach is needed. The DECIDE (Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence) Project, a GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group initiative funded by the European Union, has developed GRADE Evidence to Decision (EtD) framework for different types of decisions, including coverage ones. Methods: We used an iterative approach, including brainstorming to generate ideas, consultation with stakeholders, user testing, and pilot testing of the framework. Results: The general structure of the EtD includes formulation of the question, an assessment using twelve criteria, and conclusions. Criteria that are relevant for coverage decisions are similar to those for clinical recommendations from a population perspective. Important differences between the two include the decision-making processes, accountability, and the nature of the judgments that need to be made for some criteria. Although cost-effectiveness is a key consideration when making coverage decisions, it may not be the determining factor. Strength of recommendation is not directly linked to the type of coverage decisions, but when there are important uncertainties, it may be possible to cover an intervention for a subgroup, in the context of research, with price negotiation, or with restrictions. Conclusions: The EtD provides a systematic and transparent approach for making coverage decisions. It helps ensure consideration of key criteria that determine whether a technology or service should be covered and that judgments are informed by the best available evidence. Coverage decisions are decisions by third party payers (public or private health insurers) about whether and how much to pay for drugs, tests, devices, or services and under what conditions. These decisions are made at national, regional, or local levels, depending on the type of interventions and the way health services are paid for in a country. Often, committees or panels that may include policy makers, managers, clinicians, from the Italian Ministry of Health ( Keywords: GRADE, Coverage decisions

Background: Direct admission to Coronary Care Unit (CCU) on hospital arrival can be considered as a good proxy for adequate management in patients with acute myocardial infarction (AMI), as it has been associated with better prognosis. We analyzed a cohort of patients with AMI hospitalized in Rome (Italy) in 1997-2000 to assess the proportion directly admitted to CCU and to investigate the effect of patient characteristics such as gender, age, illness severity on admission, and socio-economic status (SES) on CCU admission practices.

A total of 213 subjects from a community in Italy of immigrants from Somalia and other NE African countries were enrolled in this study to evaluate the prevalence of HAV, HBV, HCV and HDV infections and to assess their possible risk factors. Of the subjects, 45 per cent (96) were female and 24 per cent (52) were under 12 years old. The age range was from 1 to 67 years and the mean age was 24 years. Eighty-three per cent (177 subjects) were born in Somalia, 10 per cent (21 subjects) in Ethiopia, and the rest in Djibouti, Egypt or Saudi Arabia. The 213 subjects were administered a questionnaire which covered socio-demographic characteristics and risk factors resulting from Western medical practice, traditional medicine, personal behaviour and living conditions. Blood was drawn from 209 subjects to ascertain the presence of HbsAg, HBeAg, anti-HAV, anti-HBc, anti-HBs, anti-HCV and anti-HDV. The results of this study show an HAV prevalence of 96 per cent (an 87.5 per cent prevalence in children under 12), and an HBV prevalence of 32 per cent (a 3.3 per cent prevalence of HBsAg carriers). No subject under 11 was HBV positive and no woman tested positive for HBeAg, confirming the extreme unlikelihood of vertical transmission of HBV. The prevalence of HBV is closely correlated with age (ranging from 2 per cent in those under 12 to 59 per cent in subjects over 39).(ABSTRACT TRUNCATED AT 250 WORDS)

The objective of this study was to assess hospital bed occupancy both by planned and unplanned cases, and to assess how supply and demand affect bed occupancy. Data was obtained from the Lazio Hospital Information System (HIS) dataset on all hospital discharges from July 1998 to June 2001. Using Diagnosis Related Groups (DRG) as the reason for hospital stay, admissions were classified into four categories: 'planned stay', 'presumed planned stay', 'presumed unplanned stay', and 'unplanned stay'. Time series analysis of daily bed occupancy by category of stay was performed. Generalized Additive Models (GAMs) were used to asses the effect of weekdays and holidays on bed occupancy. Fluctuations in daily occupancy were observed in all categories of stay-in general, bed occupancy decreased over weekends, on national holidays, and during the major holiday season of August. In comparison with unplanned stays, the largest fluctuations were observed for planned stays while presumed planned and unplanned stays showed lesser fluctuations. It is possible to distinguish planned and unplanned hospital stays by using DRG grouping. Cyclic rigidities in the supply of services rather than the availability of beds or demand for beds seem to dictate hospital use in Roma so that restrictions in services hamper any reallocation of beds for 'planned stay' when demand for 'unplanned stay' beds declines.

Chlamydia-positive genitourinary infections are common causes of male and female infertility. Semen abnormalities are often associated with Chlamydia infections. A large population of male patients, admitted to our clinic for genitourinary infection, were examined for genitourinary pathogens, including Chlamydia, and for semen abnormalities. There were higher abnormalities semen in Chlamydiainfected patients than either non-Chlamydia-infected or healthy controls. Chlamydia therapy by antimicrobial agents improved semen characteristics. Chlamydia infection contributes to seminal fluid abnormalities and probably to male infertility. A search for chlamydial infection is warranted whenever semen abnormalities are noted. An antimicrobial therapy improves semen quality when effective in eradicating Chlamydia.

Background and Relevance: Intracranial atherosclerosis is responsible for 70,000 ischemic strokes each year in the USA. Noninvasive testingsuch as transcranial Doppler ultrasound (TCD) and magnetic resonance angiography (MRA) to identify intracranial atherosclerosis is in widespread use, but has not been rigorously validated against the gold standard, catheter angiography. The recently NIH-funded Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial will compare warfarin with aspirin for stroke prevention in patients with intracranial atherosclerosis. WASID requires performance of angiography along with TCD and MRA, providing an opportunity to critically evaluate these noninvasive tests. Main Objective: The purpose of the Stroke Outcomes and Neuroimaging of Intracranial Atherosclerosis (SONIA) study is to develop the noninvasive diagnosis of intracranial atherosclerosis. The primary aim of SONIA is to define velocity values on TCD and anatomic abnormalities on MRA that identify severe (50–99%) intracranial stenosis of large, proximal arteries seen on catheter angiography. SONIA will define the criteria, or ‘cutpoints’, for an abnormal TCD or MRA and show that they perform with a reliable positive predictive value (PPV). Study Design: SONIA will be conducted in collaboration with WASID. Study-wide cutpoints defining positive TCD and MRA have been developed and reviewed by the site investigators of WASID. Hard copy angiography, TCD and MRA generated in WASID will be centrally read in SONIA. TCD and MRA cutpoints seek to achieve a target PPV of 80% for the identification of severe intracranial stenosis on angiography. Conclusions: Central readings will be used to validate the cutpoints and to develop measures of negative predictive value, and inter- and intra-observer variability. Sensitivity and specificity will be determined after adjustment for verification bias and employed in receiver-operator characteristic analyses. SONIA will use these techniques to develop TCD and MRA cutpoints that minimize the clinical consequences of test errors occurring in the noninvasive evaluation of patients with suspected intracranial atherosclerosis.

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Hospital specialty wards react poorly and single handedly to a minor and predictable burden. Any winter bed crisis in the Lazio region is probably the result of defective management of available beds more than excess in demand.