Evaluation of reporting quality for observational studies using routinely collected health data in pharmacovigilance. 2018

Xiaolu Nie, and Ying Zhang, and Zehao Wu, and Lulu Jia, and Xiaoling Wang, and Sinéad M Langan, and Eric I Benchimol, and Xiaoxia Peng
a Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital , Capital Medical University, National Center for Children's Health , Beijing , China.

OBJECTIVE To appraise the reporting quality of studies which concerned linezolid-related thrombocytopenia referring to REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement. METHODS Medline, Embase, Cochrane library and clinicaltrial.gov were searched for observational studies concerning linezolid-related thrombocytopenia using routinely collected health data from 2000 to 2017. Two reviewers screened potential eligible articles and extracted data independently. Finally, reporting quality assessment was performed by two senior researchers using RECORD statement. RESULTS Of 25 included studies, 11 (44.0%) mentioned the type of data in the title and/or abstract. In 38 items derived from RECORD statement, the median number of items reported in the included studies was 22 (inter-quartile range 18-27). Inadequate reporting issues were discovered in the following aspects: validation studies of the codes or algorithms, study size estimation, quantitative variables, subgroup statistical methods, missing data, follow-up/matching or sampling strategy, sensitivity analysis and cleaning methods, funding and role of funders and accessibility of protocol, raw data. CONCLUSIONS This study provides the evidence that the reporting quality of post-marketing safety evaluation studies conducted using routinely collected health data was often insufficient. Future stakeholders are encouraged to endorse the RECORD guidelines in pharmacovigilance.

UI MeSH Term Description Entries
D011358 Product Surveillance, Postmarketing Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale. Drug Surveillance, Postmarketing,Evaluation Studies, Postmarketing,Postmarketing Product Surveillance,Product Surveillance, Post-Marketing,Drug Surveillances, Postmarketing,Evaluation Study, Postmarketing,Post-Marketing Product Surveillance,Post-Marketing Product Surveillances,Postmarketing Drug Surveillance,Postmarketing Drug Surveillances,Postmarketing Evaluation Studies,Postmarketing Evaluation Study,Postmarketing Product Surveillances,Product Surveillance, Post Marketing,Product Surveillances, Post-Marketing,Product Surveillances, Postmarketing,Studies, Postmarketing Evaluation,Study, Postmarketing Evaluation,Surveillance, Post-Marketing Product,Surveillance, Postmarketing Drug,Surveillance, Postmarketing Product,Surveillances, Post-Marketing Product,Surveillances, Postmarketing Drug,Surveillances, Postmarketing Product
D003625 Data Collection Systematic gathering of data for a particular purpose from various sources, including questionnaires, interviews, observation, existing records, and electronic devices. The process is usually preliminary to statistical analysis of the data. Data Collection Methods,Dual Data Collection,Collection Method, Data,Collection Methods, Data,Collection, Data,Collection, Dual Data,Data Collection Method,Method, Data Collection,Methods, Data Collection
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000069349 Linezolid An oxazolidinone and acetamide derived ANTI-BACTERIAL AGENT and PROTEIN SYNTHESIS INHIBITOR that is used in the treatment of GRAM-POSITIVE BACTERIAL INFECTIONS of the skin and respiratory tract. Linezolide,N-((3-(3-fluoro-4-morpholinylphenyl)-2-oxo-5-oxazolidinyl)methyl)acetamide,PNU-100766,U 100766,U-100766,Zyvox,100766, U,PNU 100766,PNU100766,U100766
D013921 Thrombocytopenia A subnormal level of BLOOD PLATELETS. Thrombopenia,Thrombocytopenias,Thrombopenias
D058028 Research Report Detailed account or statement or formal record of data resulting from empirical inquiry. Report,Field Report,Investigative Report,Progress Report,Reports,Summary Report,Field Reports,Investigative Reports,Progress Reports,Report, Field,Report, Investigative,Report, Progress,Report, Summary,Reports, Field,Reports, Investigative,Reports, Progress,Reports, Summary,Research Reports,Summary Reports
D060735 Pharmacovigilance The detection of long and short term side effects of conventional and traditional medicines through research, data mining, monitoring, and evaluation of healthcare information obtained from healthcare providers and patients. Pharmacovigilances
D064887 Observational Studies as Topic Works about clinical studies in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study). Natural Experiment as Topic,Natural Experiments as Topic,Naturalistic Observation Studies as Topic,Naturalistic Observation Study as Topic,Observational Study as Topic

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