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- W3113362733 abstract "The SAMPL guidelines for standardizing the reporting of statistical methodology were published in 2013 and are endorsed by the EQUATOR network. This literature review aimed to evaluate consistency with the SAMPL guidelines in research articles reporting real-world (RW) data and statistical analyses in two therapeutic areas: hematological oncology (HO) and multiple sclerosis (MS). Published RW articles in three top-tier clinical journals in each therapeutic area were identified in EMBASE using a published search strategy based on ISPOR recommendations. 2009/2014/2019 were selected as windows to explore longitudinal change in consistency before and after introduction of SAMPL guidelines. The statistics section of each article was scored (yes/no/not applicable) for the presence of the 14 SAMPL guideline elements. The final score for each article (range 0–1) was the proportion of the number of elements with answer ‘yes’, of the total elements applicable to that article. Nonparametric Kruskal-Wallis test was used to compare scores between years (P<0.05 for significance). 193 articles were included in the analysis (2009, 39; 2014, 65; 2019, 89). The mean score of all articles was 0.58; it showed a numerical, non-statistically-significant increase over time (2009, 0.53 [HO 0.56, MS 0.51]; 2014, 0.55 [HO 0.61, MS 0.50]; 2019, 0.62 [HO 0.66, MS 0.58]; P=0.067). Most frequently reported elements were descriptions of ‘main methods for primary objectives’ (91.7% [177/193]) and ‘methods used for each analysis’ (83.4% [161/193]). Less frequently reported elements included ‘specification of one- or two-tailed test’ (24.9% [48/193]) and ‘conformation to data assumptions of the test’ (25.8% [40/155]). Frequent deficiencies were identified in reporting of statistical procedures in RW publications, with no significant improvement after introduction of the SAMPL guidelines. A checklist of essential elements based on SAMPL guidelines would be a valuable tool for statisticians, authors, reviewers, and journals to improve transparency/reproducibility of statistical methodology in peer-reviewed publications." @default.
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- W3113362733 date "2020-12-01" @default.
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- W3113362733 title "PMU77 Low Consistency with the Statistical Analyses and Methods in the Published Literature (SAMPL) Statistical Reporting Guidelines in Peer-Reviewed Real-World Publications in Hematological Oncology and Multiple Sclerosis" @default.
- W3113362733 doi "https://doi.org/10.1016/j.jval.2020.08.1289" @default.
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