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"Early Access" refers to a software release strategy wherein consumers can acquire an incomplete version of the software and contribute to the development process by providing feedback. It has developed into a prevalent preference in the industry, embraced by a growing number of studios that decide to co-develop their upcoming games together with their customer base. Although the strategy is widely used, the perception of what the “Early Access” term practically translates to is fragmented: the operations and practices encompassed under the label differ from one studio to another, generating ambiguity around the term and lacking a clear, common understanding of the principles, variations, and frameworks that can be employed to implement this strategy. This research aims to build clarity around the model, understanding its key elements, common methods, and processes. We aim to provide insights into success factors and explore their dynamics from both the developers' and community perspectives of the process. We performed an exploratory study, based on the findings from a qualitative analysis of insights gathered from 13 semi-structured interviews with developers, community managers, and practitioners within the industry. The analysis followed the GIOIA methodology, which enabled us to unfold the intricate array of insights and structure the information into six main aggregate dimensions of the core elements of Early Access, which were then compared to the results of a literature review of articles related to fields that share similar dynamics with Early Access practices. The result is an extensive analysis of the Early Access methodology, as well as a set of principles and key factors for a successful approach to the model. The conclusion incorporates the pillars of the Early Access model, decoding its ambiguous definition, and presenting the variables that generate the variation of Early Access implementations, and their interdependencies. Furthermore, we analysed t, "Early Access" hänvisar till en mjukvarulanseringsstrategi där konsumenter kan skaffa sig en ofullständig version av mjukvaran och bidra till utvecklingsprocessen genom att ge feedback. Det har blivit en framträdande preferens inom branschen, ett växande antal spelutvecklare väljer att samutveckla sina kommande spel tillsammans med sin kundbas. Även om strategin är allmänt använd, är uppfattningen om vad termen "Early Access" praktiskt översätts till fragmenterad: de operationer och metoder som omfattas under etiketten skiljer sig från en studio till en annan, vilket skapar otydlighet kring termen och saknar en klar, gemensam förståelse för de principer, variationer och ramverk som kan användas för att implementera denna strategi. Denna forskning syftar till att skapa klarhet kring modellen, förstå dess viktigaste element, vanliga metoder och processer. Vi syftar till att ge insikter om framgångsfaktorer och utforska deras dynamik från både utvecklarnas och gemenskapens,en grupp av engagerade konsumenter, perspektiv på processen. Vi genomförde en forskningsstudie, baserad på resultaten från en kvalitativ analys av insikter som samlats in från 13 semistrukturerade intervjuer med utvecklare, community managers och experter inom branschen. Analysen följde GIOIA-metodologin. Detta gjorde det möjligt för oss att avveckla den intrikata uppsättningen av insikter och strukturera informationen i sex huvudaggregerade dimensioner av de centrala elementen i "Early Access". Dessa dimensioner jämfördes sedan med resultaten från en litteraturöversikt av artiklar som beskriver dynamiken och praxis som delar samma principer för Early Access” metoder. Resultatet är en omfattande analys av ”Early Access” metodologi, liksom en uppsättning av principer och nyckelfaktorer för en framgångsrik applicering av modellen. Slutsatsen sammanfattar de grundläggande principerna “Early Access”-modellen, klargör dess tvetydiga definition och identifierar variablerna som skapar variationen i implemen

The complexity of treatment after solid organ transplantation has been related to non-adherence to therapy prescriptions and to reduced graft survival. The aim of this study was to evaluate the middle-term effects of the conversion from Prograf (TAC), to extended-release tacrolimus (Advagraf) (ADV) in stable kidney transplant recipients.

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Introduction. Metabolic syndrome (MS) is an important cardiovascular risk factor. The aim of this study was to evaluate the incidence of MS in an Italian kidney transplant recipient population and its relationship to the incidence of major adverse cardiovascular events (MACE) after renal transplantation. Methods. The prevalence of MS was evaluated according to the National Cholesterol Education Program Adult Treatment Panel III criteria among adult recipients who underwent a renal transplant between January 1997 and December 2007. In this period, we prospectively recorded the incidence of MACE to be related to the presence of MS. Results. We included 425 kidney transplant recipients in the study including 62% males and an overall median age 46 years (interquartile range = 36-54). The prevalence of MS was 41.2% at 6 months after transplantation and 46.6% at 5 years. During the follow-up (median = 5.1 years), 32 patients (7.5%) experienced at least one MACE. The detection of MS at 6 months after transplantation was significantly associated with an increased risk of MACE occurrence (MS IRR = 2.2 P = .05). Conclusions. Our findings indicated that MS was largely present in the transplant population confirming that as in the general population, it was a significant risk factor for the occurrence of severe cardiovascular disease. Early identification and treatment of patients with MS may improve long-term patient survival.

Introduction. The half-life of everolimus is approximately 28 hours, but everolimus is generally administered twice a day. The aim of this prospective, single-center, exploratory study was to compare the efficacy and safety of a once a day everolimus (OD) with the standard twice a day administration regimen (BID) as immunosuppressive therapy in renal transplantation. Methods. Forty-one de novo renal transplant recipients prospectively assigned to OD (n = 21) or BID (n = 20) treatment were followed for 1 year. In the OD group, everolimus was orally administered targeting a trough blood level of 2 to 5 ng/mL. In the BID group, everolimus was given twice a day targeting a trough blood level of 3 to 12 ng/mL. All patients also received induction with basiliximab and low-dose calcineurin inhibitor immunosuppression. Results. At 1 year follow-up patient and graft survivals were 100%. The intention-to-treat analysis showed similar renal function between the two regimens: serum creatinine values for OD 1.54 +/- 0.6 versus BID 1.48 +/- 0.53 mg/dL (P = NS). Also the occurrence of acute rejection episodes was not significantly different: 4.8% in the OD versus 15% in the BID group, (P = NS). The median trough blood levels were significantly lower among the OD group: OD 4.5 versus BID 7.2 ng/mL (P < .001). Discussion. This study demonstrated that once a day administration of everolimus achieved excellent patient and graft survival and good renal function without an increased incidence of acute rejection episodes.

Objective. This study investigated whether switching from the twice-daily (Prograf; TAC) to the once-daily formulation of tacrolimus with extended release (Advagraf; XL) affected quality of life, anxiety, and transplant benefit perception after allogeneic kidney transplantation. Methods. After local Institutional Review Board approval, 78 adult patients prescribed twice-daily tacrolimus for >= 1 year after kidney transplantation were asked to participate in this study. All patients were evaluated at T0 (before the switch), and the 49 who accepted the change were reassessed after 6 months (T1). The following tests were used: (State and Trait Anxiety Inventories Y1 and Y2, (Psychologic General Well-Being Index), and modified Transplant Effect Questionnaire for posttransplantation symptoms. Blood samples for laboratory profiles and determinations of drug concentrations were obtained throughout the study period. Results. There were no significant differences between the psychologic variables at TO among patients who switched from TAC to XL (n = 49) versus those who did not participate (n = 29). Eight of the 49 patients who accepted the drug conversion were reswitched to TAC because of adverse events. At T1, the remaining switched patients (n = 41) showed an increase in the disclosure of having undergone transplantation (P < .05) versus nonswitched patients; whereas reswitched patients (n = 8) showed less positivity and well-being (P < .05) compared with those who remained in the switched regimen. Conclusion. The findings suggested increased disclosure of having undergone transplantation among patients who decided to switch from TAC to XL.

Background. The aim of this study was to investigate whether pretransplant psychological variables included in the CBA 2.0 Primary Scale-fear, personality, obsessive-compulsive symptoms, state and trait anxiety, psychological reactions, and depression-could predict graft rejection among patients undergoing kidney transplantation. Methods. After ethical committee approval we enrolled 33 consecutive adult patients undergoing kidney transplantation. The inclusion criteria were a stable clinical situation in an out-of-hospital setting; Italian language literacy; a minimum of secondary school-level education, and written informed consent. We excluded patients with a psychotic disturbance, neurocognitive deficit, dementia, serious mental delay (IQ <50), current alcohol or drug abuse, recent ideation or attempted suicide or nonadherence to the therapeutic protocol. Acute and/or chronic graft rejection was diagnosed according to clinical and histopathologic criteria. CBA-2,0 "Primary Scale" series of questionnaires were handed out to patients at the time of the examinations to discrem eligibility for transplantation. Analyses of variance were performed to compare psychological scores among patients with versus without graft rejection. Logistic regression analyses of psychological variables were performed to detect possible predictors for graft rejection. The results of the analysis showed that higher psychoticism scores were able to predict graft rejection (P < .05). Results. The findings of this study suggest that it is mandatory to preoperatively plan an holistic treatment including psychological intervention mainly focused on psychoticism.

INTRODUCTION: The half-life of everolimus is approximately 28 hours, but everolimus is normally administered twice a day. The aim of this prospective, single-center, exploratory study was to compare the efficacy and safety of a once a day (OD) everolimus regimen versus the standard twice a day regimen (BID) for immunosuppressive therapy in renal transplantation. METHODS: Forty de novo renal transplant recipients prospectively assigned to OD (n = 21) or BID (n = 19) were followed for 6 months. In the OD group, everolimus was given orally once a day to target a trough blood level of 2-6 ng/mL. In the BID, group everolimus was given twice a day to target a trough blood level of 3-12 ng/mL. All patients also received induction treatment with basiliximab and low-dose calcineurin inhibitors. RESULTS: At 6 months follow-up, patient and graft survivals were 100%; renal function and acute rejection rates were similar between the 2 regimens. Patients in the OD group showed significantly lower cholesterol and triglyceride levels compared with those in the BID group, namely, total cholesterol level, OD 212 +/- 54 versus BID 249 +/- 59 mg/dL (P < .05), and serum triglycerides, OD 162 +/- 72 versus BID 245 +/- 133 mg/dL (P < .02). DISCUSSION: This study showed that OD administration of everolimus provided excellent patient and graft survivals and good renal function without an increased incidence of acute rejection episodes. The lipid profile was significantly better among patients receiving everolimus OD. These findings suggested that everolimus can be safely administered once a day.