Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia: a double-blind, randomised, placebo-controlled trial.

RATIONALE: Pulse glucocorticoid therapy is used in hyperinflammation related to coronavirus disease 2019 (COVID-19). We evaluated the efficacy and safety of pulse intravenous methylprednisolone in addition to standard treatment in COVID-19 pneumonia. METHODS: In this multicentre, randomised, double-blind, placebo-controlled trial, 304 hospitalised patients with COVID-19 pneumonia were randomised to receive 1 g of methylprednisolone intravenously for three consecutive days or placebo in addition to standard dexamethasone. The primary outcome was the duration of patient hospitalisation, calculated as the time interval between randomisation and hospital discharge without the need for supplementary oxygen. The key secondary outcomes were survival free from invasive ventilation with orotracheal intubation and overall survival. RESULTS: Overall, 112 (75.4%) out of 151 patients in the pulse methylprednisolone arm and 111 (75.2%) of 150 in the placebo arm were discharged from hospital without oxygen within 30 days from randomisation. Median time to discharge was similar in both groups (15 days, 95% CI 13.0-17.0 days and 16 days, 95% CI 13.8-18.2 days, respectively; hazard ratio (HR) 0.92, 95% CI 0.71-1.20; p=0.528). No significant differences between pulse methylprednisolone and placebo arms were observed in terms of admission to intensive care unit with orotracheal intubation or death (20.0% versus 16.1%; HR 1.26, 95% CI 0.74-2.16; p=0.176) or overall mortality (10.0% versus 12.2%; HR 0.83, 95% CI 0.42-1.64; p=0.584). Serious adverse events occurred with similar frequency in the two groups. CONCLUSIONS: Methylprenisolone pulse therapy added to dexamethasone was not of benefit in patients with COVID-19 pneumonia.

A focused ethnography in the context of a European cancer research hospital accreditation program.

BACKGROUND: A quality accreditation program (AP) is designed to guarantee predefined quality standards of healthcare organizations. Evidence of the impact of quality standards remains scarce and somewhat challenging to document. This study aimed to investigate the accreditation of a cancer research hospital (Italy), promoted by the Organization of European Cancer Institutes (OECI), by focusing on the individual, group, and organizational experiences resulting from the OECI AP. METHODS: A focused ethnography study was carried out to analyze the relevance of participation in the accreditation process. Twenty-nine key informants were involved in four focus group meetings, and twelve semistructured interviews were conducted with professionals and managers. Inductive qualitative content analysis was applied to examine all transcripts. RESULTS: Four main categories emerged: a) OECI AP as an opportunity to foster diversity within professional roles; b) OECI AP as a possibility for change; c) perceived barriers; and d) OECI AP-solicited expectations. CONCLUSIONS: The accreditation process is an opportunity for improving the quality and variety of care services for cancer patients through promoting an interdisciplinary approach to care provision. Perceiving accreditation as an opportunity is a prerequisite for overcoming the barriers that professionals involved in the process may report. Critical to a positive change is sharing the values and the framework, which are at the basis of accreditation programs. Improving the information-sharing process among managers and professionals may limit the risk of unmet expectations and prevent demotivation by future accreditation programs. Finally, we found that positive changes are more likely to happen when an accreditation process is considered an activity whose results depend on managers' and professionals' joint work.

The experience of accreditation of the Reggio Emilia Research Hospital with the OECI model.

The research hospital Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) of Reggio Emilia has a unique organization that involves a recently recognized IRCCS in oncology within a preexisting general hospital. The IRCCS of Reggio Emilia joined the "Tailored Accreditation Model for Comprehensive Cancer Centers: Validation through the Applicability of the Experimental OECI-based Model to the Network of Cancer IRCCS of the Alliance Against Cancer" and applied the accreditation & designation (A&D) Organisation of European Cancer Institutes (OECI) model in 2013. Before that accreditation, it had never been accredited according to international accreditation systems concerning cancer. By December 2015, the IRCCS of Reggio Emilia completed the first steps of the A&D OECI process (self-assessment period, peer review visit, implementation of the improvement plan). In December 2014, OECI confirmed the accreditation of our IRCCS and its designation as a Clinical Cancer Center and proposed a revisit at 2 years for upgrading the designation to Comprehensive Cancer Center (CCC). On the whole, the results given by adhesion to the A&D-OECI project are numerous and positive, under different points of view, formal (European accreditation and designation as a Clinical Cancer Center with possible upgrade to CCC) and substantial (involvement of professionals, attention to ongoing improvement, work on the sectors mainly of interest). The balance between the advantages and disadvantages linked to this accreditation model was positive. Following our experience, we conclude that the model was useful also for our kind of IRCCS, with its features useful for investigating all the sectors of the patient care pathway and research and necessity to stimulate change.

Evidence-based guidelines for the management of lower urinary tract symptoms related to uncomplicated benign prostatic hyperplasia in Italy: updated summary.

BACKGROUND AND SCOPE: Despite the high prevalence and huge socio-economic impact of benign prostatic hyperplasia (BPH) in Italy, no national guidelines have been produced so far. This is a summary of the first Italian guidelines on the diagnosis and treatment of lower urinary tract symptoms (LUTS) related to uncomplicated BPH, prepared by a multidisciplinary panel under the auspices of the Italian Association of Urologists and introduced in Italy in 2003. An update compiled by the authors is also included. METHODS: Relevant papers published from 1998 to 2003 (updated to 2006) were identified through a structured literature review and the quality of evidence presented therein was graded according to the Centre for the Evaluation of Effectiveness in Health Administration (CeVEAS) system. Recommendations were based on evidence from the literature, but also on feedback from practitioners and specialists. MAIN FINDINGS/RECOMMENDATIONS: Given the prevalence of BPH, all men aged > or = 50 years of age should be asked about LUTS and informed about disease characteristics and therapeutic options, while sexual function should always be assessed in patients with severe and long-standing LUTS. Initial assessment should include medical history (including drug and co-morbidity history), digital rectal examination, urinalysis, International Prostate Symptom Score-Quality of Life (IPSS-QoL) and a voiding diary, while prostate-specific antigen (PSA) and measurement of prostate volume by suprapubic ultrasonography are indicated in fully informed patients with a life expectancy of > or = 10 years in whom BPH progression could influence treatment choices. QoL considerations should dictate whether to start active treatment. When QoL is not affected by LUTS, watchful waiting is indicated if symptoms are mild, acceptable if they are moderate. When QoL is affected, medical therapy with alpha1-blockers or 5alpha-reductase inhibitors (the latter indicated in patients with increased prostate volume) is appropriate. Combined therapy with alpha1-blockers + 5alpha-reductase inhibitors should only be considered in patients at high risk for progression (prostate volume > 40 mL or PSA > 4 ng/mL), since the incremental cost of combination therapy vs. monotherapy with alpha1-blockers or finasteride is prohibitive. Selection of the type of surgery should be based on the surgeon's experience, the presence of co-morbid conditions and the size of the prostate. Open prostatectomy and transurethral resection of the prostate (TURP) are recommended in patients with acute or chronic retention of urine, and acceptable in obstructed patients with moderate/severe symptoms and worsened QoL. Transurethral incision of the prostate (TUIP) is acceptable when prostate volume is < or = 30 mL. Holmium laser enucleation of the prostate (HoLEP) may be proposed to motivated patients where expert surgeons are available. Transurethral microwave thermotherapy (TUMT) or transurethral needle ablation (TUNA) may be proposed to motivated patients who prefer to avoid surgery and/or do not respond to medical treatment. The possible effects of medical or surgical treatments on sexual function should always be discussed. CONCLUSIONS: These guidelines are intended to provide a framework for health professionals involved in BPH management in order to facilitate decision-making in all areas and at all levels of healthcare.