No abstract

Fleetwood is an employee of Quantics Consulting. McCool and Glanville are employees of York Health Economics Consortium (YHEC). Quantics and YHEC received funding from F. Hoffmann-La Roche for conducting the systematic review and network meta-analysis reported in this paper. Edwards, Gsteiger, and Daigl are employees of F. Hoffmann-La Roche. Fisher was employed by InterMune UK, a wholly owned Roche subsidiary, until July 2015. He is currently employed by FIECON, which has received funding from F. Hoffmann-La Roche for consulting services. The systematic review and network meta-analysis reported in this paper were conducted by Fleetwood (Quantics Consulting) and McCool and Glanville (YHEC), funded by F. Hoffmann-La Roche. The original network analysis was funded by InterMune. Study concept and design were contributed by Edwards, Gsteiger, and Daigl, along with Fleetwood, McCool, and Glanville. Fleetwood, McCool, and Glanville collected the data, with assistance from Edwards, Gsteiger, and Daigl. Data interpretation was performed by Fleetwood and Fisher, with assistance from the other authors. The manuscript was written by Fleetwood, McCool, and Glanville, with assistance from Edwards, Daigl, and Fisher, and revised by all the authors.

<b><i>Background:</i></b> Most phase 3 clinical trials of systemic therapy for first-line unresectable hepatocellular carcinoma (HCC) have failed, with the exception of SHARP, REFLECT, and IMbrave150. We conducted indirect comparisons of therapies evaluated for first-line HCC treatment. <b><i>Summary:</i></b> We conducted a systematic review and meta-analysis of treatments for adults with locally advanced or metastatic unresectable HCC and no prior systemic treatment, including atezolizu­mab plus bevacizumab, sorafenib, lenvatinib, nivolumab, selective internal radiotherapy (SIRT), transarterial chemoembolization, and placebo or best supportive care. Randomized controlled trials published from January 1, 2007, to March 12, 2020, were retrieved from MEDLINE and Embase. Qualitative assessment of heterogeneity evaluated study designs, populations, and outcomes. Indirect comparisons used generalized linear models with random effects within a Bayesian framework and informative priors. We calculated relative efficacy estimates with 95% credible intervals (CrIs) and Bayesian posterior probability estimates of atezolizumab-bevacizumab being superior to other treatments. Nine clinical studies with a total of 3,897 participants were identified from 8,783 records and used to build the all-trials evidence network. Indirect comparisons suggested an improved overall survival (OS) with atezolizumab-bevacizumab versus lenvatinib (odds ratio, 0.63 [95% CrI 0.39–1.04]; with 97% Bayesian posterior probability of being superior), nivolumab (0.68 [95% CrI 0.41–1.14]; 94%), sorafenib (0.59 [95% CrI 0.39–0.87]; 99%), SIRT (0.51 [95% CrI 0.32–0.82]; 100%), or placebo/best supportive care (0.40 [95% CrI 0.25–0.64]; 100%). <b><i>Key Messages:</i></b> Within the context of indirect comparisons, analyses of OS favored atezolizumab-bevacizumab versus other treatment options for patients with locally advanced or metastatic unresectable HCC.

No abstract

Background. In orthopedics, there is no instrument specifically designed to assess patients' expectations of their final surgery outcome in general trauma populations. We developed the Trauma Expectation Factor Trauma Outcome Measure (TEFTOM) to investigate the fulfilment of patients' expectations one year after surgery as a measure of general trauma surgical outcomes. The aim of this paper was to assess the psychometric characteristics of this new general trauma outcome measure. Methods. The questionnaire was tested in 201 ankle and distal tibia fracture patients scheduled for surgery. Patients were followed up for twelve months. The TEFTOM questionnaire was evaluated for its criterion validity, internal consistency, reproducibility, and responsiveness. Results. TOM showed good criterion validity against the American Academy of Orthopaedic Surgeons Foot and Ankle Scale (Pearson's correlation coefficient = 0.69–0.77). Internal consistency was acceptable for TEF (Cronbach's alpha = 0.65–0.76) and excellent for TOM (Cronbach's alpha = 0.76–0.85). Reproducibility was moderate to very good (intraclass coefficient correlation (ICC) ≥0.67) for TEF and very good (ICC ≥0.92) for TOM. TOM also proved to be responsive to changes in patients' condition over time (Wald test; P < 0.001). Conclusions. TEFTOM is a promising tool for measuring general trauma outcomes in terms of patients' expectation fulfilment that proved to be valid, internally consistent, reproducible, and responsive to change.