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Summary: A patient oriented hospital information system (ARIANE) was inaugurated at the Sherbrooke University hospital (CHUS) in 1990 and a clinical data warehouse (CDW) completed 2004. The CDW is updated from ARIANE every 24h and includes ICD discharge diagnosis data, visit DRG and SNOMED encoding. The data is encrypted on storage. Data is accessed according to institutional approval. To facilitate data access two levels of tool have been made accessible using a web-browser. The first level consists of a ‘dashboard’ that has a defined design and enables a set of pre-determined dynamic queries about a patient population. This level can be operated with minimal training. The second level uses a convivial database query tool, which requires some prior training. Two prototype dashboards have been designed and evaluated for acceptability. The first for the emergency department enables analysis of patient occupancy. The second for the biochemistry department enables quality assurance evaluation. In most cases worldwide the clinical data warehouse is only beginning to be exploited, often impeded by lack of connection between different enterprise databases. Our CDW is expected rapidly to create a culture change so that clinical practice can be continuously evaluated using compiled data readily available from the electronic health record/hospital information system. [Copyright &y& Elsevier]

Abstract: Objectives: : Total testosterone (TT) is frequently prescribed with an SHBG and/or free or bioavailable testosterone measurement. Our objective was to identify a TT range for which subsequent SHBG measurement/calculation adds no additional clinical information. Design and methods: : Study data were composed of 3955 sets of TT, SHBG and calculated bioavailable testosterone (cBAT) results from unscreened ambulatory male subjects, aged 18-99. Results: : 90% of mismatches between TT and cBAT were observed with TT levels between 6.5 and 13.0 nmol/L, with only slight age variation and no important change with albumin level. SHBG measurement restricted to male patients with TT between 6.5 and 13.0 nmol/L should enable reagent cost savings of over 55%. Conclusion: : We suggest that a TT level below 6.5 nmol/L or above 13.0 nmol/L provides sufficient useful information for ruling out hypogonadism in ambulatory adult males. This strategy of BAT testing should lead to significant time and cost savings. [Copyright &y& Elsevier]

In the phase II/III RELATIVITY-047 trial, a novel fixed-dose combination (FDC) of nivolumab plus relatlimab (NIVO + RELA; a programmed death-1 and a lymphocyte-activation gene 3 inhibitor, respectively) significantly improved progression-free survival (PFS) versus NIVO in patients with previously untreated unresectable or metastatic melanoma (median follow-up, 13.2 months) with stable health-related quality of life (HRQoL), although grade three or four treatment-related adverse events (TRAEs) were more frequent with the combination. Updated HRQoL results (median follow-up, 19.3 months) are presented. Patients were randomised to receive intravenous NIVO + RELA (480 mg and 160 mg, respectively) or NIVO (480 mg) every 4 weeks. HRQoL was assessed using the Functional Assessment of Cancer Treatment-Melanoma (FACT-M) and EQ-5D-3L questionnaires at baseline, before dosing at each treatment cycle, and at follow-up (posttreatment) visits. Consistent with the initial analysis, HRQoL remained stable with NIVO + RELA on treatment and was similar to that with NIVO. Mean changes from baseline did not exceed clinically meaningful thresholds. HRQoL results were consistent across instruments and scales/subscales. Despite an increased rate of grade three or four TRAEs with NIVO + RELA versus NIVO, the proportion of patients reporting that they were bothered 'quite a bit' or 'very much' by TRAEs was low and comparable between treatments. Results from the RELATIVITY-047 trial show that the PFS benefit with NIVO + RELA FDC over NIVO was obtained with stable patient-reported HRQoL, supporting NIVO + RELA as a first-line treatment option for patients with advanced melanoma. • Nivolumab plus relatlimab (NIVO + RELA) improves PFS versus nivolumab in melanoma, with added toxicity. • In RELATIVITY-047, quality of life (QoL) was stable/similar with both treatments. • Results were consistent across all QoL instruments and subscales. • QoL results suggest that the two treatments had similar overall tolerability. • These results support NIVO + RELA as a first-line option for melanoma. [ABSTRACT FROM AUTHOR]

Nivolumab (an anti–programmed death-1 antibody) is an adjuvant standard of care for patients with high-risk resected melanoma, although a watch-and-wait strategy remains an option. In the absence of head-to-head evidence, an indirect treatment comparison (ITC) of adjuvant nivolumab versus placebo, the proxy for a watch-and-wait strategy, was conducted in patients with high-risk resected melanoma. An ITC using the Bucher method compared nivolumab with placebo using intention-to-treat population data from the phase III CheckMate 238 (nivolumab vs ipilimumab; minimum follow-up, 4 years; NCT02388906) and European Organisation for Research and Treatment of Cancer (EORTC) 18071 (ipilimumab vs placebo; minimum follow-up, ≈4.5 years; NCT00636168) trials. The end-points were recurrence-free survival (RFS), distant metastasis-free survival (DMFS) and overall survival (OS). To account for cross-trial differences in staging and subsequent therapy, additional analyses examined patients with stage IIIB/IIIC disease and adjusted post-recurrence survival in EORTC 18071, respectively. Nivolumab versus placebo was associated with clinically meaningful improvements in RFS (hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.42–0.68) and OS (HR, 0.63; 95% CI, 0.45–0.89). Nivolumab versus placebo was also associated with clinically meaningful improvements in RFS (HR, 0.53; 95% CI, 0.40–0.69), DMFS (HR, 0.62; 95% CI, 0.46–0.83) and OS (HR, 0.67; 95% CI, 0.47–0.97) in patients with stage IIIB/IIIC disease and in OS (HR, 0.65; 95% CI, 0.46–0.92) in the overall population after adjusting post-recurrence survival in EORTC 18071. This ITC shows that adjuvant nivolumab provides clinically meaningful improvements in RFS, DMFS and OS versus a watch-and-wait strategy in high-risk resected melanoma. • Nivolumab is an adjuvant treatment for patients with high-risk resected melanoma. • This indirect treatment comparison (ITC) compared adjuvant nivolumab with placebo. • Placebo was the proxy for a watch-and-wait strategy. • Data used in the ITC were from two phase III trials. • Adjuvant nivolumab improved efficacy versus placebo in high-risk resected melanoma. [ABSTRACT FROM AUTHOR]

Recent changes in the adjuvant treatment of melanoma have raised interest in confirming relapse-free survival (RFS) as a surrogate for overall survival (OS). We explore this issue with the meta-analytic framework, using individual patient data from the European Organisation for Research and Treatment of Cancer (EORTC) 18071 trial of ipilimumab and published results from other adjuvant trials. The individual patient data analysis results at a median follow-up of 5.3 years showed a strong association between RFS and OS at the patient level (ρ = 0.84; 95% confidence interval [CI]: 0.82–0.87) and a moderate association at the trial level (R2 = 0.59; 95% CI: 0.08–1.00). The trial-level association previously observed in interferon-based trials appeared to be maintained when the EORTC 18071 results were added to a regression analysis using published results from other trials. More data from adjuvant trials are required to confirm the strength of association between RFS and OS in this setting. • We explored relapse-free survival (RFS) as a surrogate for overall survival (OS). • We used data from the European Organisation for Research and Treatment of Cancer 18071 trial and published results from other trials. • We found a strong association between RFS and OS at the patient level. • We found a moderate association between RFS and OS at the trial level. • Our results are promising and require confirmation with a larger number of trials. [ABSTRACT FROM AUTHOR]