Influenza: Diabetes as a risk factor for severe related-outcomes and the effectiveness of vaccination in diabetic population. A meta-analysis of observational studies

Aims: In order to better define the need for influenza vaccination in people with diabetes (DM), we collected all available evidence on the effect of DM as a risk factor for complications of both seasonal and pandemic influenza, and on the specific effectiveness of vaccines in patients with DM. Data synthesis: Two distinct systematic searches on MEDLINE, Cochrane, ClinicalTrials.gov and Embase databases were performed, one for each metanalysis, collecting all observational studies and randomized clinical trials performed on humans up to May 31st, 2022. We retrieved 34 observational studies comparing risk for influenza complications in people with or without diabetes, and 13 observational studies assessing vaccine effectiveness on preventing such complications. Mortality for influenza and hospitalization for influenza and pneumonia resulted significantly higher in individuals with versus without DM, both when unadjusted and adjusted data are analyzed. In diabetic individuals vaccinated for influenza overall hospitalization, hospitalization for influenza or pneumonia and overall mortality are significantly lower in comparison with not vaccinated DM subjects, both when unadjusted and adjusted data were analyzed. Conclusion: This systematic review and meta-analysis shows that: 1) influenza is associated with more severe complications in diabetic versus not diabetic individuals and 2) influenza vaccination is effective in preventing clinically relevant outcomes in adults with DM with a NNT (number needed to treat) of 60, 319, and 250 for all-cause hospitalization, specific hospitalization, and all-cause mortality, respectively. The identification of diabetic patients as the target of vaccination campaigns for influenza appears to be justified by available clinical evidence

Effects of glucagon-like peptide-1 receptor agonists on mortality and cardiovascular events. A comprehensive meta-analysis of randomized controlled trials

Introduction The publication of the results of LEADER and SUSTAIN-6 trials suggested a possible beneficial effect of the class of GLP-1 receptor agonists on cardiovascular morbidity and mortality. The aim of the present meta-analysis is to collect and synthetize all available evidence on the effect of GLP-1 receptor agonists on cardiovascular events and mortality. Methods A Medline search for GLP-1 receptor agonists (exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, or semaglutide) was performed, collecting all randomized clinical trials with a duration > 11 weeks, enrolling patients with type 2 diabetes, and comparing a GLP-1 receptor agonist with placebo or any other non-GLP-1 receptor agonist drug. The principal outcome of this analysis was the effect of GLP-1 receptor agonists on all-cause and cardiovascular mortality, overall (fatal plus nonfatal) myocardial infarction, stroke, and heart failure. Results Out of 113 trials fulfilling inclusion criteria (mean duration 41.7 ± 38.2 weeks), 32, 25, 48, 43 and 32 reported at least one event for all-cause and cardiovascular mortality, overall (fatal plus nonfatal) myocardial infarction, stroke, and heart failure, respectively. In GLP-1 receptor agonist-treated patients, all-cause mortality, cardiovascular mortality, and myocardial infarction were significantly lower than in comparators (MH-OR [95% CI] 0.88 [0.79–0.97], p = 0.015, 0.84 [0.74–0.96], p = 0.009, and 0.90 [0.80–1.00], p = 0.050, respectively), whereas no beneficial effect was observed for stroke and heart failure (MH-OR [95% CI] 0.90 [0.81–1.00]. p = 0.059. 0.89 [0.76–1.04]. p = 0.15. and 0.92 [0.81–1.06]. p = 0.25. respectively). Conclusions Overall, the agents of this class appear to reduce all-cause mortality, cardiovascular mortality, and the incidence of myocardial infarction at mid-term follow up

Relationship between hyponatremia at hospital admission and cardiopulmonary profile at follow-up in patients with SARS-CoV-2 (COVID-19) infection

Purpose: Hyponatremia occurs in about 30% of patients with pneumonia, including those with SARS-CoV-2 (COVID-19) infection. Hyponatremia predicts a worse outcome in several pathologic conditions and in COVID-19 has been associated with a higher risk of non-invasive ventilation, ICU transfer and death. The main objective of this study was to determine whether early hyponatremia is also a predictor of long-term sequelae at follow-up. Methods: In this observational study, we collected 6-month follow-up data from 189 laboratory-confirmed COVID-19 patients previously admitted to a University Hospital. About 25% of the patients (n = 47) had hyponatremia at the time of hospital admission. Results: Serum [Na+] was significantly increased in the whole group of 189 patients at 6 months, compared to the value at hospital admission (141.4 ± 2.2 vs 137 ± 3.5 mEq/L, p < 0.001). In addition, IL-6 levels decreased and the PaO2/FiO2 increased. Accordingly, pulmonary involvement, evaluated at the chest X-ray by the RALE score, decreased. However, in patients with hyponatremia at hospital admission, higher levels of LDH, fibrinogen, troponin T and NT-ProBNP were detected at follow-up, compared to patients with normonatremia at admission. In addition, hyponatremia at admission was associated with worse echocardiography parameters related to right ventricular function, together with a higher RALE score. Conclusion: These results suggest that early hyponatremia in COVID-19 patients is associated with the presence of laboratory and imaging parameters indicating a greater pulmonary and right-sided heart involvement at follow-up

Hot spots policing of small geographic areas effects on crime

Background In recent years, crime scholars and practitioners have pointed to the potential benefits of focusing crime prevention efforts on crime places. A number of studies suggest that there is significant clustering of crime in small places, or “hot spots,” that generate half of all criminal events. Researchers have argued that many crime problems can be reduced more efficiently if police officers focused their attention to these deviant places. The appeal of focusing limited resources on a small number of high-activity crime places is straightforward. If crime can be prevented at these hot spots, then citywide crime totals could be reduced. Objectives To assess the effects of focused police crime prevention interventions at crime hot spots. The review also examined whether focused police actions at specific locations result in crime displacement (i.e., crime moving around the corner) or diffusion (i.e., crime reduction in surrounding areas) of crime control benefits. Search Methods A keyword search was performed on 15 abstract databases. Bibliographies of past narrative and empirical reviews of literature that examined the effectiveness of police crime control programs were reviewed and forward searches for works that cited seminal hot spots policing studies were performed. Bibliographies of past completed Campbell systematic reviews of police crime prevention efforts were reviewed and hand searches of leading journals in the field were completed. Experts in the field were consulted and relevant citations were obtained. Selection Criteria To be eligible for this review, interventions used to control crime hot spots were limited to police-led prevention efforts. Suitable police-led crime prevention efforts included traditional tactics such as directed patrol and heightened levels of traffic enforcement as well as alternative strategies such as aggressive disorder enforcement and problem-oriented policing. Studies that used randomized controlled experimental or quasiexperimental designs were selected. The units of analysis were limited to crime hot spots or high-activity crime “places” rather than larger areas such as neighborhoods. The control group in each study received routine levels of traditional police crime prevention tactics. Data Collection and Analysis Sixty-five studies containing 78 tests of hot spots policing interventions were identified and full narratives of these studies were reported. Twenty-seven of the selected studies used randomized experimental designs and 38 used quasiexperimental designs. A formal meta-analysis was conducted to determine the crime prevention effects in the eligible studies. Random effects models were used to calculate mean effect sizes. Results Sixty-two of 78 tests of hot spots policing interventions reported noteworthy crime and disorder reductions. The meta-analysis of key reported outcome measures revealed a small statistically significant mean effect size favoring the effects of hot spots policing in reducing crime outcomes at treatment places relative to control places. The effect was smaller for randomized designs but still statistically significant and positive. When displacement and diffusion effects were measured, a diffusion of crime prevention benefits was associated with hot spots policing. Authors\u27 Conclusions The extant evaluation research suggests that hot spots policing is an effective crime prevention strategy. The research also suggests that focusing police efforts on high-activity crime places does not inevitably lead to crime displacement; rather, crime control benefits may diffuse into the areas immediately surrounding the targeted locations

DETERMINANTS OF 6-MONTH MORTALITY IN SURVIVORS OF MYOCARDIAL-INFARCTION AFTER THROMBOLYSIS - RESULTS OF THE GISSI-2 DATA-BASE

none647Background. Current knowledge of risk assessment in survivors of myocardial infarction is largely based on data gathered before the advent of thrombolysis. It must be determined whether and to what extent available information and proposed criteria of prognostication are applicable in the thrombolytic era. Methods and Results. We reassessed risk prediction in the 10 219 survivors of myocardial infarction with follow-up data available (ie, 98% of the total) who had been enrolled in the GISSI-2 trial, relying on a set of prespecified variables. The 3.5% 6-month all-cause mortality rate of these patients compared with the higher value of 4.6% found in the corresponding GISSI-1 cohort, originally allocated to streptokinase therapy, indicates a 24% reduction in postdischarge 6-month mortality. On multivariate analysis (Cox model), the following variables were predictors of 6-month all-cause mortality: ineligibility for exercise test for both cardiac (relative risk [RR], 3.30; 95% confidence interval [CI], 2.36-4.62) and noncardiac reasons (RR, 3.28; 95% CI, 2.23-4.72), early left ventricular failure (RR, 2.41; 95% Cl, 1.87-3.09), echocardiographic evidence of recovery phase left ventricular dysfunction (RR, 2.30; 95% CI, 1.78-2.98), advanced (more than 70 years) age (RR, 1.81; 95% Cl, 1.43 -2.30), electrical instability (ie, frequent and/or complex ventricular arrhythmias) (RR, 1.70; 95% Cl, 1.32-2.19), late left ventricular failure (RR, 1.54; 95% Cl, 1.17-2.03), previous myocardial infarction (RR, 1.47; 95% CI, 1.14-1.89), and a history of treated hypertension (RR, 1.32; 95% Cl, 1.05-1.65). Early post-myocardial infarction angina, a positive exercise test, female sex, history of angina, history of insulin-dependent diabetes, and anterior site of myocardial infarction were not risk predictors. On further multivariate analysis, performed on 8315 patients with the echocardiographic indicator of left ventricular dysfunction available, only previous myocardial infarction was not retained as an independent risk predictor. Conclusions. A decline in 6-month mortality of myocardial infarction survivors, seen within 6 hours of symptom onset, has been observed in recent years. Ineligibility for exercise test, early left ventricular failure, and recovery-phase left ventricular dysfunction are the most powerful (RR, >2) predictors of 6-month mortality among patients recovering from myocardial infarction after thrombolysis. Qualitative variables reflecting residual myocardial ischemia do not appear to be risk predictors. The lack of an independent adverse influence of early post-myocardial infarction angina on 6-month survival represents a major difference between this study and those of the prethrombolytic era.noneVOLPI A; DEVITA C; FRANZOSI MG; GERACI E; MAGGIONI AP; MAURI F; NEGRI E; SANTORO E; TAVAZZI L; TOGNONI G; FERUGLIO GA; LOTTO A; ROVELLI F; SOLINAS P; TAVAZZI L; TOGNONI G; BRUNO M; CAPPELLO T; COPPINI A; FINCATI F; MANTOVANI G; PANGRAZZI J; POGNA M; TURAZZA FM; ANSELMI M; BARBONAGLIA L; BIGI R; CAVALLI A; FRIGERIO M; GIORDANO A; GUALTIEROTTI C; TORTA D; CAROLA R; GIORDANO F; BARLOTTI R; LOPARCO G; VIGLINO GL; RUGGERI G; GIAMUNDO L; DANESI A; PACIARONI E; GAMBINI C; URBANO G; PURCARO A; FRANCESCONI M; FIGLIOLIA S; CANNONE M; ANTOLINI R; DEVOTI G; CRISTALLINI P; PORCIELLO PI; TEONI P; BURALI A; ZUCCONELLI V; DEMATTEIS C; IERVOGLINI A; SCATASTA M; AMABILI S; CARATTI CA; ZOLA G; FERRAGUTO P; SALICI G; CENTARO A; ROTIROTI D; GENOVESE M; GINEVRINO P; DAMATO N; ALTAMURA CM; COLONNA L; CASTELLANETA G; BOVENZI F; MESSINA D; GALANTINO A; CAMPOREALE N; CUCCHINI F; CAMPOSTELLA L; MALACRIDA R; GENONI M; PELLEGRINI P; BRIDDA A; RIGGI L; ACONE L; MOSCATIELLO G; BRUNO A; INVERNIZZI G; TESPILI M; GUAGLIUMI G; CASARI A; ALBANO T; TOMASSINI B; TORTA D; DIBIASE G; SCARAMUZZINO G; RUGGERO S; BRACCHETTI D; DECASTRO U; FULVI M; BRAITO E; ERLICHER A; OBERLECHNER W; GAGLIARDI RS; BIGHIGNOLI L; BONIZZATO G; RIZZI GM; SCAZZINA L; PERRINI A; STRANEO G; STRANEO U; SCIRE A; VERRIENTI A; GUADALUPI M; STORELLI A; ZUCCA L; DABUSTI M; ALBONICO B; DEPETRA V; TABACCHI GC; SCERVINO R; MEREU D; MAXIA P; BIANCO A; CRABU E; MANGIAMELI S; CENTAMORE G; MALFITANO D; AMICO C; VANCHERI F; SANTOPUOLI G; BALDINI F; PANTALEONI A; CONTESSOTTO F; TERLIZZI R; MERIGHI A; TURCHI E; TEGLIO V; PIGNATTI F; PEZZANA A; GOZZOLINO G; GIGLIO M; PETTINATI G; IEVA M; CIRICUGNO S; CORREALE E; ROMANO S; DIFUCCIA A; CASTELLANO B; NATALE A; CERNETTI C; CELEGON L; CANDELPERGHER G; ARIENZO F; RUSSO F; DEVIVO L; MAY L; ACHILLI G; BLASI A; SORRENTINO F; DATO A; GALLONE P; PALUMBO C; DELLAMONICA R; PAGANO L; ALBERTI A; ORSELLI L; DEPONTI C; PARMIGIANI ML; FERRARI M; ACITO P; BUSI F; DELLAVITTORIA G; BELLET C; BORTOLINI F; ROSSI A; CORONA C; BONDI S; NICCOLINI D; GAMBERI G; ARCURI G; MAIOLINO P; CARROZZA A; DELIO U; CAPRETTI G; MARINONI C; GUASCONI C; SONNINO S; PAGLIEI M; FERRARI G; LOMBARDI R; AGNELLI D; DERINALDIS G; CALCAGNILE A; SIGNORELLI S; BENDINELLI S; LUSETTI L; MOLLAIOLI M; COSMI F; PLASTINA F; VENNERI N; FERACO E; CATELLI P; POLUZZI C; DISTANTE S; BIANCHI C; COPPETTI S; ZAMPAGLIONE G; GATTO C; ZURLO R; USLENGHI E; MARGARIA F; MILANESE U; LOMANTO B; ZIACCHI V; RIVA D; BERTOCCHI P; TIRELLA G; DAULERIO M; SAURO G; BINI A; MAZZONI V; POGGI P; MARESTA A; JACOPI F; PATRONCINI A; PUPITA F; GAGGI S; FRAUSINI G; ANTONIOLI GE; MALACARNE C; CODECA L; CAPPATO R; ANDREOLI L; VARACCA S; BUIO E; FAZZINI PF; PUCCI P; SARRO F; VERGASSOLA R; BARCHIELLI M; DEMATTEIS D; CARRONE M; BRUNOZZI LT; MENICONI L; LIBERATI R; RADOGNA M; TALLONE M; CONTE R; IERI A; ZIPOLI A; SANSONI M; CANZIANI R; GUIDALI P; CRISTALLO E; MARIELLO F; MUZIO L; BENVENUTO MR; BALDINI MR; VECCHIO C; CHIARELLA F; FALCIDIENO M; CECCHI A; GIULIANO G; SEU V; PERUGINI P; TOSELLI A; BASSO F; CORTI E; ROSSI P; DELFINO R; CAPONNETTO S; GNECCO G; GHIGLIOTTI G; PENNESI A; LOMBARDI G; RUGGIERI A; BERTOLO L; SLOMP L; LANZETTA T; MAZZARONE L; CRESTI A; BELLODI G; ZUARINI AM; VENERI L; PARCHI C; GIOVANELLI N; NEGRONI S; DETHOMATIS M; BARGHINI A; MARINO E; RICCI D; LEMME P; DIGIACOMO U; AQUARO G; RONZANI G; OTTELLO B; VONTI V; MORETTI S; PALERMO R; MARSILI P; SIDERI F; RAGAZZINI G; GRAMENZI S; BATTISTINI S; DIODATO T; VALERIO A; TUCCI C; DEPASQUALE B; GELFO PG; BERTULLA A; BOLLINI R; DEMARCHI E; BACCA F; DEGIORGI V; LOCATELLI V; SAVOIA MT; FERRACINI C; BARBARESI F; COTOGNI A; FRANCO G; ROMANO S; PASSONI F; DURBANO M; MORETTI G; PEROTTI S; CAPRETTI M; DELBENE P; CASCONE M; BALDINI U; ORLANDI M; ODDONE A; CAIZZI V; MASINI G; LAZZARI M; BALLERINI B; BOZZI L; MOCETTI T; BERTOLINI A; PASOTTI E; SANGUINETTI M; MANTOVANI R; TOGNOLI T; MAGGI A; TUSA M; CAMERONI E; GUERRA GP; REGGIANI A; REDAELLI S; GIUSTI S; TANTALO L; RIZZI A; DIGIOVANNI N; GUZZO V; GABRIELE M; COLOMBO G; ALBERZONI A; SALVIOLI G; GALFETTI F; DOVICO E; BELLUZZI F; GOLA E; CASELLATO F; LECCHI G; CONSOLO F; SACCA CB; CONSOLO A; PICCOLO E; GASPARINI G; DEVITA C; ALBERTI A; MASSA D; BELLI C; DOSSENA MG; CORSINI C; SANNA GP; AZZOLLINI M; TRUAZZA F; LOTTO A; NADOR F; DEMARTINI M; BOZZI G; SEREGNI R; PASTINE I; MORPURGO M; CASAZZA F; REGALIA F; MAGGIOLINI S; RIGO R; PANCALDI S; POZZETTI D; PASCOTTO P; FRANCESCHI L; DAINESE F; MELINI L; CAPPELLI C; BERNARDI C; PALMIERI M; BORGIONI L; ZILIO G; SANDRI R; ALITTO F; MASARO G; VALAGUSSA F; SCHIAVINA R; RAVESI D; DANIELLO L; PIANTADOSI FR; BARRA P; ROMEO D; MININNI N; SEVERINO S; MOSTACCI M; CASTELLARI M; BANDA D; ROLANDI R; VILLA WD; CARBONE V; ALLEGRI M; FASCIOLO L; PITTALIS M; MUREDDU V; SORO F; DELEDDA MG; MARRAS E; MARCHI SM; DELUCA C; MANETTA M; VOLTA SD; SPERANDEO V; DONZELLI M; VITRANO MG; GERACI E; PITROLO F; LAMONICA S; BELLANCA G; MESSINA G; MIRTO U; RAINERI A; TRAINA M; DIBENEDETTO A; RIBAUDO E; DIFRANCESCO M; RONCHITELLI R; CARONE M; DIGREGORIO D; DIPAOLO G; PASQUALE M; COREA L; COCCHIERI M; ALUNNI G; PAPI L; CHIRIATTI G; LUPETTI M; GAZZOLA U; ARRUZZOLI S; VILLANI GQ; MELLINI M; MADRUZZA L; PIAZZA R; MICHELI G; FRANCHINI C; BECHI S; MARTINES C; MARCHESE D; GABBIA G; BIGALLI A; CIUTI M; CABANI E; DELCITERNA F; ALFIERI A; CHITI M; LONGHINI J; CODELUPPI P; NEGRELLI M; ZANUTTINI D; NICOLOSI GL; MARTIN G; PETRELLA A; BARDAZZI L; BIANCO GA; CELLAMARE G; GIANNELLI F; LICITRA G; LICITRA R; LETTICA GV; TUMIOTTO G; BELLANTI G; BOSI S; CASALI G; MONDUCCI I; BARONE A; PARENTI F; HEYMAN J; COZZI E; BALDACCI G; BACCOS D; BRIGHI F; DESANCTIS A; BOCK R; PALMIERI M; ROSSI F; AMATI P; SEMPRINI P; NARDELLI A; BOTTERO G; VARTOLO C; MILAZZOTTO F; DICROCE G; DIMARIO F; ANGRISANI G; AZZOLINI P; NEJA CP; MANZOLI U; ROSSI E; TRANI C; MASINI V; SEBASTIANI F; TOPAI M; BORGIA MC; LUCIANI C; FERRI F; DEPAOLA D; CAPURSO S; TUGNOLI F; VETTA C; ALTIERI T; BORZI M; VISCOMI A; STRIANO U; SALITURI S; ZONZIN P; FIORENCIS R; BADIN A; RAVERA B; BALDI C; SILVESTRI F; ALLEMANO P; REYNAUD S; SANSON A; MILANI L; DESIMONE MV; RUSSO A; VILLELLA A; GRAZINI M; AMIDEI S; ANSELMI L; PICCANICOLINO R; MASCELLI G; TAGLIAMONTE A; MESSINA V; TEDESCHI C; BOSSI M; BISIOLI M; TACCHI G; PAGNI G; VIVALDI F; IBBA GV; SANNIA L; PEDRAZZINI F; BAGNI E; FABII S; ALVINO A; ANTONIELLI E; DORONZO B; MARTINENGO E; BECCHI G; SALMOIRAGHI A; DIGIOVANNA F; CARAMANNO G; CAPORICCI D; BRUN M; GIANI P; FERRARIO G; PECI P; RONCONI G; SKOUSE D; BIANCHI C; GIUSTINIANI S; CUCCHI GF; TAVASCI E; SILVERII A; MARCELLINI G; SPECA G; STANISCIA D; CIMINO A; SERAFINI N; DEBONIS P; CERRUTI P; BAZZUCCHI M; DALPRA F; SPEROTTO C; MOLE GD; BARBANO G; POMARI F; GASCHINO G; PARIGI A; GANDOLFO N; RONDONI F; BRUSCA A; DILEO M; GOLZIO PG; ABRATE M; SCLAVO MG; ROCCI R; POGGIO G; GIANI S; CUZZUCREA D; BRASCHI GB; SCIACCA R; SAMMARTANO A; FURLANELLO F; BRAITO G; CUZZATO V; TOTIS O; FAURETTO F; LEO F; GALATI A; PALMA P; CAMERINI F; MORGERA T; BARBIERI L; FERUGLIO GA; SLAVICK GA; FRESCO C; CUDA A; SARNICOLA P; ARZILLO P; BINAGHI G; MACCHI G; CALVERI G; DIMARCO G; LEVANTESI G; PANERAI C; CATURELLI G; FACCHIN L; SARTORE G; ZARDINI P; MARINO P; CARBONIERI E; NAVA S; MAZZINI C; NAVA R; SERRA N; SASSARA M; NICROSINI F; GANDOLFI P; BERGOGNONI G; BALLESTRA AM; VIOLO CVOLPI A; DEVITA C; FRANZOSI MG; GERACI E; MAGGIONI AP; MAURI F; NEGRI E; SANTORO E; TAVAZZI L; TOGNONI G; FERUGLIO GA; LOTTO A; ROVELLI F; SOLINAS P; TAVAZZI L; TOGNONI G; BRUNO M; CAPPELLO T; COPPINI A; FINCATI F; MANTOVANI G; PANGRAZZI J; POGNA M; TURAZZA FM; ANSELMI M; BARBONAGLIA L; BIGI R; CAVALLI A; FRIGERIO M; GIORDANO A; GUALTIEROTTI C; TORTA D; CAROLA R; GIORDANO F; BARLOTTI R; LOPARCO G; VIGLINO GL; RUGGERI G; GIAMUNDO L; DANESI A; PACIARONI E; GAMBINI C; URBANO G; PURCARO A; FRANCESCONI M; FIGLIOLIA S; CANNONE M; ANTOLINI R; DEVOTI G; CRISTALLINI P; PORCIELLO PI; TEONI P; BURALI A; ZUCCONELLI V; DEMATTEIS C; IERVOGLINI A; SCATASTA M; AMABILI S; CARATTI CA; ZOLA G; FERRAGUTO P; SALICI G; CENTARO A; ROTIROTI D; GENOVESE M; GINEVRINO P; DAMATO N; ALTAMURA CM; COLONNA L; CASTELLANETA G; BOVENZI F; MESSINA D; GALANTINO A; CAMPOREALE N; CUCCHINI F; CAMPOSTELLA L; MALACRIDA R; GENONI M; PELLEGRINI P; BRIDDA A; RIGGI L; ACONE L; MOSCATIELLO G; BRUNO A; INVERNIZZI G; TESPILI M; GUAGLIUMI G; CASARI A; ALBANO T; TOMASSINI B; TORTA D; DIBIASE G; SCARAMUZZINO G; RUGGERO S; BRACCHETTI D; DECASTRO U; FULVI M; BRAITO E; ERLICHER A; OBERLECHNER W; GAGLIARDI RS; BIGHIGNOLI L; BONIZZATO G; RIZZI GM; SCAZZINA L; PERRINI A; STRANEO G; STRANEO U; SCIRE A; VERRIENTI A; GUADALUPI M; STORELLI A; ZUCCA L; DABUSTI M; ALBONICO B; DEPETRA V; TABACCHI GC; SCERVINO R; MEREU D; MAXIA P; BIANCO A; CRABU E; MANGIAMELI S; CENTAMORE G; MALFITANO D; AMICO C; VANCHERI F; SANTOPUOLI G; BALDINI F; PANTALEONI A; CONTESSOTTO F; TERLIZZI R; MERIGHI A; TURCHI E; TEGLIO V; PIGNATTI F; PEZZANA A; GOZZOLINO G; GIGLIO M; PETTINATI G; IEVA M; CIRICUGNO S; CORREALE E; ROMANO S; DIFUCCIA A; CASTELLANO B; NATALE A; CERNETTI C; CELEGON L; CANDELPERGHER G; ARIENZO F; RUSSO F; DEVIVO L; MAY L; ACHILLI G; BLASI A; SORRENTINO F; DATO A; GALLONE P; PALUMBO C; DELLAMONICA R; PAGANO L; ALBERTI A; ORSELLI L; DEPONTI C; PARMIGIANI ML; FERRARI M; ACITO P; BUSI F; DELLAVITTORIA G; BELLET C; BORTOLINI F; ROSSI A; CORONA C; BONDI S; NICCOLINI D; GAMBERI G; ARCURI G; MAIOLINO P; CARROZZA A; DELIO U; CAPRETTI G; MARINONI C; GUASCONI C; SONNINO S; PAGLIEI M; FERRARI G; LOMBARDI R; AGNELLI D; DERINALDIS G; CALCAGNILE A; SIGNORELLI S; BENDINELLI S; LUSETTI L; MOLLAIOLI M; COSMI F; PLASTINA F; VENNERI N; FERACO E; CATELLI P; POLUZZI C; DISTANTE S; BIANCHI C; COPPETTI S; ZAMPAGLIONE G; GATTO C; ZURLO R; USLENGHI E; MARGARIA F; MILANESE U; LOMANTO B; ZIACCHI V; RIVA D; BERTOCCHI P; TIRELLA G; DAULERIO M; SAURO G; BINI A; MAZZONI V; POGGI P; MARESTA A; JACOPI F; PATRONCINI A; PUPITA F; GAGGI S; FRAUSINI G; ANTONIOLI GE; MALACARNE C; CODECA L; CAPPATO R; ANDREOLI L; VARACCA S; BUIO E; FAZZINI PF; PUCCI P; SARRO F; VERGASSOLA R; BARCHIELLI M; DEMATTEIS D; CARRONE M; BRUNOZZI LT; MENICONI L; LIBERATI R; RADOGNA M; TALLONE M; CONTE R; IERI A; ZIPOLI A; SANSONI M; CANZIANI R; GUIDALI P; CRISTALLO E; MARIELLO F; MUZIO L; BENVENUTO MR; BALDINI MR; VECCHIO C; CHIARELLA F; FALCIDIENO M; CECCHI A; GIULIANO G; SEU V; PERUGINI P; TOSELLI A; BASSO F; CORTI E; ROSSI P; DELFINO R; CAPONNETTO S; GNECCO G; GHIGLIOTTI G; PENNESI A; LOMBARDI G; RUGGIERI A; BERTOLO L; SLOMP L; LANZETTA T; MAZZARONE L; CRESTI A; BELLODI G; ZUARINI AM; VENERI L; PARCHI C; GIOVANELLI N; NEGRONI S; DETHOMATIS M; BARGHINI A; MARINO E; RICCI D; LEMME P; DIGIACOMO U; AQUARO G; RONZANI G; OTTELLO B; VONTI V; MORETTI S; PALERMO R; MARSILI P; SIDERI F; RAGAZZINI G; GRAMENZI S; BATTISTINI S; DIODATO T; VALERIO A; TUCCI C; DEPASQUALE B; GELFO PG; BERTULLA A; BOLLINI R; DEMARCHI E; BACCA F; DEGIORGI V; LOCATELLI V; SAVOIA MT; FERRACINI C; BARBARESI F; COTOGNI A; FRANCO G; ROMANO S; PASSONI F; DURBANO M; MORETTI G; PEROTTI S; CAPRETTI M; DELBENE P; CASCONE M; BALDINI U; ORLANDI M; ODDONE A; CAIZZI V; MASINI G; LAZZARI M; BALLERINI B; BOZZI L; MOCETTI T; BERTOLINI A; PASOTTI E; SANGUINETTI M; MANTOVANI R; TOGNOLI T; MAGGI A; TUSA M; CAMERONI E; GUERRA GP; REGGIANI A; REDAELLI S; GIUSTI S; TANTALO L; RIZZI A; DIGIOVANNI N; GUZZO V; GABRIELE M; COLOMBO G; ALBERZONI A; SALVIOLI G; GALFETTI F; DOVICO E; BELLUZZI F; GOLA E; CASELLATO F; LECCHI G; CONSOLO F; SACCA CB; CONSOLO A; PICCOLO E; GASPARINI G; DEVITA C; ALBERTI A; MASSA D; BELLI C; DOSSENA MG; CORSINI C; SANNA GP; AZZOLLINI M; TRUAZZA F; LOTTO A; NADOR F; DEMARTINI M; BOZZI G; SEREGNI R; PASTINE I; MORPURGO M; CASAZZA F; REGALIA F; MAGGIOLINI S; RIGO R; PANCALDI S; POZZETTI D; PASCOTTO P; FRANCESCHI L; DAINESE F; MELINI L; CAPPELLI C; BERNARDI C; PALMIERI M; BORGIONI L; ZILIO G; SANDRI R; ALITTO F; MASARO G; VALAGUSSA F; SCHIAVINA R; RAVESI D; DANIELLO L; PIANTADOSI FR; BARRA P; ROMEO D; MININNI N; SEVERINO S; MOSTACCI M; CASTELLARI M; BANDA D; ROLANDI R; VILLA WD; CARBONE V; ALLEGRI M; FASCIOLO L; PITTALIS M; MUREDDU V; SORO F; DELEDDA MG; MARRAS E; MARCHI SM; DELUCA C; MANETTA M; VOLTA SD; SPERANDEO V; DONZELLI M; VITRANO MG; GERACI E; PITROLO F; LAMONICA S; BELLANCA G; MESSINA G; MIRTO U; RAINERI A; TRAINA M; DIBENEDETTO A; RIBAUDO E; DIFRANCESCO M; RONCHITELLI R; CARONE M; DIGREGORIO D; DIPAOLO G; PASQUALE M; COREA L; COCCHIERI M; ALUNNI G; PAPI L; CHIRIATTI G; LUPETTI M; GAZZOLA U; ARRUZZOLI S; VILLANI GQ; MELLINI M; MADRUZZA L; PIAZZA R; MICHELI G; FRANCHINI C; BECHI S; MARTINES C; MARCHESE D; GABBIA G; BIGALLI A; CIUTI M; CABANI E; DELCITERNA F; ALFIERI A; CHITI M; LONGHINI J; CODELUPPI P; NEGRELLI M; ZANUTTINI D; NICOLOSI GL; MARTIN G; PETRELLA A; BARDAZZI L; BIANCO GA; CELLAMARE G; GIANNELLI F; LICITRA G; LICITRA R; LETTICA GV; TUMIOTTO G; BELLANTI G; BOSI S; CASALI G; MONDUCCI I; BARONE A; PARENTI F; HEYMAN J; COZZI E; BALDACCI G; BACCOS D; BRIGHI F; DESANCTIS A; BOCK R; PALMIERI M; ROSSI F; AMATI P; SEMPRINI P; NARDELLI A; BOTTERO G; VARTOLO C; MILAZZOTTO F; DICROCE G; DIMARIO F; ANGRISANI G; AZZOLINI P; NEJA CP; MANZOLI U; ROSSI E; TRANI C; MASINI V; SEBASTIANI F; TOPAI M; BORGIA MC; LUCIANI C; FERRI F; DEPAOLA D; CAPURSO S; TUGNOLI F; VETTA C; ALTIERI T; BORZI M; VISCOMI A; STRIANO U; SALITURI S; ZONZIN P; FIORENCIS R; BADIN A; RAVERA B; BALDI C; SILVESTRI F; ALLEMANO P; REYNAUD S; SANSON A; MILANI L; DESIMONE MV; RUSSO A; VILLELLA A; GRAZINI M; AMIDEI S; ANSELMI L; PICCANICOLINO R; MASCELLI G; TAGLIAMONTE A; MESSINA V; TEDESCHI C; BOSSI M; BISIOLI M; TACCHI G; PAGNI G; VIVALDI F; IBBA GV; SANNIA L; PEDRAZZINI F; BAGNI E; FABII S; ALVINO A; ANTONIELLI E; DORONZO B; MARTINENGO E; BECCHI G; SALMOIRAGHI A; DIGIOVANNA F; CARAMANNO G; CAPORICCI D; BRUN M; GIANI P; FERRARIO G; PECI P; RONCONI G; SKOUSE D; BIANCHI C; GIUSTINIANI S; CUCCHI GF; TAVASCI E; SILVERII A; MARCELLINI G; SPECA G; STANISCIA D; CIMINO A; SERAFINI N; DEBONIS P; CERRUTI P; BAZZUCCHI M; DALPRA F; SPEROTTO C; MOLE GD; BARBANO G; POMARI F; GASCHINO G; PARIGI A; GANDOLFO N; RONDONI F; BRUSCA A; DILEO M; GOLZIO PG; ABRATE M; SCLAVO MG; ROCCI R; POGGIO G; GIANI S; CUZZUCREA D; BRASCHI GB; SCIACCA R; SAMMARTANO A; FURLANELLO F; BRAITO G; CUZZATO V; TOTIS O; FAURETTO F; LEO F; GALATI A; PALMA P; CAMERINI F; MORGERA T; BARBIERI L; FERUGLIO GA; SLAVICK GA; FRESCO C; CUDA A; SARNICOLA P; ARZILLO P; BINAGHI G; MACCHI G; CALVERI G; DIMARCO G; LEVANTESI G; PANERAI C; CATURELLI G; FACCHIN L; SARTORE G; ZARDINI P; MARINO P; CARBONIERI E; NAVA S; MAZZINI C; NAVA R; SERRA N; SASSARA M; NICROSINI F; GANDOLFI P; BERGOGNONI G; BALLESTRA AM; VIOLO

Transformation of Australian Community Pharmacies Into Good Clinical Practice Compliant Trial Pharmacies for HIV Pre-Exposure Prophylaxis

Background: In Australia, clinical trial drugs are conventionally dispensed through clinical trial pharmacies only, while community pharmacies dispense drugs approved by Australia's regulatory body. A large HIV pre-exposure prophylaxis study aimed to deliver clinical trial drug through community pharmacies to improve convenience and mimic real world prescribing. This paper describes the process of making community trials compliant with good clinical practice and reports outcomes of delivering clinical trial drug through community pharmacies. Methods: Eight community and four clinical trial pharmacies across three Australian states were approached to participate. A good clinical practice checklist was generated and pharmacies underwent a number of changes to meet clinical trial pharmacy requirements prior to study opening. Changes were made to community pharmacies to make them compliant with good clinical trial practice including; staff training, structural changes, and implementing monitoring of study drug and prescribing practices. Study drug was ordered through standard clinical trial processes and dispensed from study pharmacies by accredited pharmacists. Throughout the trial, record logs for training, prescriber signature and delegation, temperature, participant, and drug accountability were maintained at each pharmacy. The study team monitored each log and delivered on-site training to correct protocol variations. Results: Each pharmacy that was approached agreed to participate. All community pharmacies achieved good clinical practice compliance prior to dispensing study drug. Over the course of the study, 20,152 dispensations of study drug occurred, 83% of these occurred at community pharmacies. Only 2.0% of dispensations had an error, and errors were predominantly minor. On five occasions a pharmacist who was not accredited dispensed study drug. Conclusions: Community based pharmacies can undergo training and modifications to achieve good clinical practice compliance and dispense clinical trial study drug. Community based pharmacies recorded few variations from study protocol. Community based pharmacies offer a useful alternative to clinical trial pharmacies to increase convenience for study participants and expanded use of these pharmacies should be considered for large clinical trials, including HIV prevention trials