(searched for: doi:10.1186/s12874-020-00942-y)
Published: 12 May 2022
Journal: BMC Medicine
BMC Medicine, Volume 20, pp 1-19; https://doi.org/10.1186/s12916-022-02304-5
Background: Factors contributing to the lack of understanding of research studies include poor reporting practices, such as selective reporting of statistically significant findings or insufficient methodological details. Systematic reviews have shown that prognostic factor studies continue to be poorly reported, even for important aspects, such as the effective sample size. The REMARK reporting guidelines support researchers in reporting key aspects of tumor marker prognostic studies. The REMARK profile was proposed to augment these guidelines to aid in structured reporting with an emphasis on including all aspects of analyses conducted. Methods: A systematic search of prognostic factor studies was conducted, and fifteen studies published in 2015 were selected, three from each of five oncology journals. A paper was eligible for selection if it included survival outcomes and multivariable models were used in the statistical analyses. For each study, we summarized the key information in a REMARK profile consisting of details about the patient population with available variables and follow-up data, and a list of all analyses conducted. Results: Structured profiles allow an easy assessment if reporting of a study only has weaknesses or if it is poor because many relevant details are missing. Studies had incomplete reporting of exclusion of patients, missing information about the number of events, or lacked details about statistical analyses, e.g., subgroup analyses in small populations without any information about the number of events. Profiles exhibit severe weaknesses in the reporting of more than 50% of the studies. The quality of analyses was not assessed, but some profiles exhibit several deficits at a glance. Conclusions: A substantial part of prognostic factor studies is poorly reported and analyzed, with severe consequences for related systematic reviews and meta-analyses. We consider inadequate reporting of single studies as one of the most important reasons that the clinical relevance of most markers is still unclear after years of research and dozens of publications. We conclude that structured reporting is an important step to improve the quality of prognostic marker research and discuss its role in the context of selective reporting, meta-analysis, study registration, predefined statistical analysis plans, and improvement of marker research.
Published: 24 February 2022
Journal: PLOS Computational Biology
PLOS Computational Biology, Volume 18; https://doi.org/10.1371/journal.pcbi.1009819
Published: 1 March 2021
Journal: Pharmacoepidemiology and Drug Safety
Pharmacoepidemiology and Drug Safety, Volume 30, pp 779-786; https://doi.org/10.1002/pds.5207
Baloxavir marboxil is a novel antiviral agent for influenza, introduced into clinical practice in 2018. A concern remains about the variant virus with reduced susceptibility after baloxavir exposure and its clinical consequences such as healthcare-seeking behavior. Using a healthcare database in Japan, we compared the medical resource use following baloxavir and neuraminidase inhibitors (NAIs) treatment among children aged 7-15 years. The study period was from December 2018 to March 2019. The primary endpoint was the composite of hospitalization, laboratory and radiological tests, and antibiotic use over 1-9 days of antiviral treatment. As exploratory analyses, secondary outcomes being each single component of the primary composite were assessed and subgroup analyses comparing baloxavir with each NAI were done. Data from 115 867 prescriptions in 115 238 children were analyzed (median age: 10 years; severe influenza risk in 26%; baloxavir accounting for 43%). Overall, baloxavir use did not increase subsequent medical resource utilization in the composite endpoint (adjusted odds ratio [aOR]: 1.04; 95% confidence interval [CI]: 0.99-1.09; P = .14), as were likelihoods of other secondary outcomes. In the subgroup analysis, baloxavir use was associated with higher medical resource use than oseltamivir (aOR: 1.21; 95% CI: 1.13-1.31; P <.001) and lower resource use than zanamivir (aOR: 0.93; 95% CI 0.86-1.00; P = .40). Based on a single-year experience in Japan, prescribing baloxavir rather than NAIs did not increase medical resource utilization within 9 days of treatment, except in one exploratory comparison with oseltamivir.
Published: 8 July 2020
Journal: Biometrical Journal
Biometrical Journal, Volume 63, pp 226-246; https://doi.org/10.1002/bimj.202000053
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