High prevalence of spin was found in pharmacovigilance studies using disproportionality analyses to detect safety signals: a meta-epidemiological study
•Spin is common in publications of pharmacovigilance disproportionality analyses.•Only 19%of articles did not show any type of spin.•Over-interpretation of the results is the most frequent type of spin. To systematically review and appraise misinterpretation of pharmacovigilance disproportionality a...
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| Veröffentlicht in: | Journal of clinical epidemiology 2021-10, Vol.138, p.73-79 |
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| container_title | Journal of clinical epidemiology |
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| creator | Mouffak, Amelle Lepelley, Marion Revol, Bruno Bernardeau, Claire Salvo, Francesco Pariente, Antoine Roustit, Matthieu Cracowski, Jean-Luc Khouri, Charles |
| description | •Spin is common in publications of pharmacovigilance disproportionality analyses.•Only 19%of articles did not show any type of spin.•Over-interpretation of the results is the most frequent type of spin.
To systematically review and appraise misinterpretation of pharmacovigilance disproportionality analysis results in published studies.
We randomly selected 100 studies that performed disproportionality analyses and indexed in Medline identified during a systematic literature search. Titles, abstracts and main texts (results, discussion and conclusion) were evaluated for spin independently by two reviewers. Spin in pharmacovigilance studies was classified according to three main categories: inappropriate interpretation, inappropriate extrapolations and misleading reporting.
Of the 100 studies evaluated, we found that 63%, 56% and 51% had at least one type of spin in their abstract, main text or conclusion respectively, and 40% used causal language to interpret their results in the abstract or conclusion. Spin in titles and results were exclusively represented by inappropriate interpretations of findings (12% and 21% respectively), with terms such as “risk of” or “risks associated with” or results erroneously presented as regular Odds Ratios. Spin in discussion sections mostly concerned inappropriate interpretations (38%)and misleading reporting (12%). Misleading reporting, notably failing to acknowledge the limitations of disproportionality analyses, was the most frequent type of spin in abstracts (55%) and conclusion sections (37%).
We found that spin is frequent in publications of pharmacovigilance disproportionality analyses, notably in abstracts. This consisted notably in an over-interpretation of the results suggesting a proven causative link between a drug use and the risk of an event. |
| doi_str_mv | 10.1016/j.jclinepi.2021.06.022 |
| format | Article |
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To systematically review and appraise misinterpretation of pharmacovigilance disproportionality analysis results in published studies.
We randomly selected 100 studies that performed disproportionality analyses and indexed in Medline identified during a systematic literature search. Titles, abstracts and main texts (results, discussion and conclusion) were evaluated for spin independently by two reviewers. Spin in pharmacovigilance studies was classified according to three main categories: inappropriate interpretation, inappropriate extrapolations and misleading reporting.
Of the 100 studies evaluated, we found that 63%, 56% and 51% had at least one type of spin in their abstract, main text or conclusion respectively, and 40% used causal language to interpret their results in the abstract or conclusion. Spin in titles and results were exclusively represented by inappropriate interpretations of findings (12% and 21% respectively), with terms such as “risk of” or “risks associated with” or results erroneously presented as regular Odds Ratios. Spin in discussion sections mostly concerned inappropriate interpretations (38%)and misleading reporting (12%). Misleading reporting, notably failing to acknowledge the limitations of disproportionality analyses, was the most frequent type of spin in abstracts (55%) and conclusion sections (37%).
We found that spin is frequent in publications of pharmacovigilance disproportionality analyses, notably in abstracts. This consisted notably in an over-interpretation of the results suggesting a proven causative link between a drug use and the risk of an event.</description><identifier>ISSN: 0895-4356</identifier><identifier>ISSN: 1878-5921</identifier><identifier>EISSN: 1878-5921</identifier><identifier>DOI: 10.1016/j.jclinepi.2021.06.022</identifier><identifier>PMID: 34186195</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adverse Drug Reaction Reporting Systems - statistics & numerical data ; Biomedical Research - standards ; Clinical medicine ; Conflicts of interest ; Data Accuracy ; Disproportionality analyses ; Drug-Related Side Effects and Adverse Reactions - epidemiology ; Epidemiologic Studies ; Epidemiology ; Evaluation ; Humans ; Hypotheses ; Impact factors ; Odds Ratio ; Pharmacology ; Pharmacovigilance ; Prevalence ; Product safety ; Publication Bias - statistics & numerical data ; Reporting ; Signal detection ; Spin</subject><ispartof>Journal of clinical epidemiology, 2021-10, Vol.138, p.73-79</ispartof><rights>2021</rights><rights>Copyright © 2021. Published by Elsevier Inc.</rights><rights>Copyright Elsevier Limited Oct 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c444t-b7c39f504923e9054ef6ee82f9a687ce6d281b6a02f4106789b7779e8ecdddbd3</citedby><cites>FETCH-LOGICAL-c444t-b7c39f504923e9054ef6ee82f9a687ce6d281b6a02f4106789b7779e8ecdddbd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2593603556?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64387,64389,72469</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34186195$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mouffak, Amelle</creatorcontrib><creatorcontrib>Lepelley, Marion</creatorcontrib><creatorcontrib>Revol, Bruno</creatorcontrib><creatorcontrib>Bernardeau, Claire</creatorcontrib><creatorcontrib>Salvo, Francesco</creatorcontrib><creatorcontrib>Pariente, Antoine</creatorcontrib><creatorcontrib>Roustit, Matthieu</creatorcontrib><creatorcontrib>Cracowski, Jean-Luc</creatorcontrib><creatorcontrib>Khouri, Charles</creatorcontrib><title>High prevalence of spin was found in pharmacovigilance studies using disproportionality analyses to detect safety signals: a meta-epidemiological study</title><title>Journal of clinical epidemiology</title><addtitle>J Clin Epidemiol</addtitle><description>•Spin is common in publications of pharmacovigilance disproportionality analyses.•Only 19%of articles did not show any type of spin.•Over-interpretation of the results is the most frequent type of spin.
To systematically review and appraise misinterpretation of pharmacovigilance disproportionality analysis results in published studies.
We randomly selected 100 studies that performed disproportionality analyses and indexed in Medline identified during a systematic literature search. Titles, abstracts and main texts (results, discussion and conclusion) were evaluated for spin independently by two reviewers. Spin in pharmacovigilance studies was classified according to three main categories: inappropriate interpretation, inappropriate extrapolations and misleading reporting.
Of the 100 studies evaluated, we found that 63%, 56% and 51% had at least one type of spin in their abstract, main text or conclusion respectively, and 40% used causal language to interpret their results in the abstract or conclusion. Spin in titles and results were exclusively represented by inappropriate interpretations of findings (12% and 21% respectively), with terms such as “risk of” or “risks associated with” or results erroneously presented as regular Odds Ratios. Spin in discussion sections mostly concerned inappropriate interpretations (38%)and misleading reporting (12%). Misleading reporting, notably failing to acknowledge the limitations of disproportionality analyses, was the most frequent type of spin in abstracts (55%) and conclusion sections (37%).
We found that spin is frequent in publications of pharmacovigilance disproportionality analyses, notably in abstracts. This consisted notably in an over-interpretation of the results suggesting a proven causative link between a drug use and the risk of an event.</description><subject>Adverse Drug Reaction Reporting Systems - statistics & numerical data</subject><subject>Biomedical Research - standards</subject><subject>Clinical medicine</subject><subject>Conflicts of interest</subject><subject>Data Accuracy</subject><subject>Disproportionality analyses</subject><subject>Drug-Related Side Effects and Adverse Reactions - epidemiology</subject><subject>Epidemiologic Studies</subject><subject>Epidemiology</subject><subject>Evaluation</subject><subject>Humans</subject><subject>Hypotheses</subject><subject>Impact factors</subject><subject>Odds Ratio</subject><subject>Pharmacology</subject><subject>Pharmacovigilance</subject><subject>Prevalence</subject><subject>Product safety</subject><subject>Publication Bias - statistics & numerical data</subject><subject>Reporting</subject><subject>Signal detection</subject><subject>Spin</subject><issn>0895-4356</issn><issn>1878-5921</issn><issn>1878-5921</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkcFu1TAQRS0Eoo_CL1SW2LBJsB3HjlmBKmiRKrGBteXYk9RREgc7eeh9Cb-L09eyYMNqZM2Z67lzEbqipKSEivdDOdjRz7D4khFGSyJKwtgzdKCNbIpaMfocHUij6oJXtbhAr1IaCKGSyPoluqg4bQRV9QH9vvX9PV4iHM0IswUcOpwWP-NfJuEubLPD-bHcmzgZG46-96PZsbRuzkPCW_Jzj51PSwxLiKsPsxn9esIm11PKxBqwgxXsipPpIHeS73MvfcAGT7CaIntwMPkwht5bMz5In16jF12G4M1jvUQ_vnz-fn1b3H27-Xr96a6wnPO1aKWtVFcTrlgFitQcOgHQsE4Z0UgLwrGGtsIQ1nFKhGxUK6VU0IB1zrWuukTvzrp5_58bpFVPPlkYs0sIW9Ks5kJJSRTP6Nt_0CFscbeSKVUJUtW1yJQ4UzaGlCJ0eol-MvGkKdF7dHrQT9HpPTpNhM7R5cGrR_mtncD9HXvKKgMfzwDkexw9RJ2s3zNzPubzahf8__74A8STsbI</recordid><startdate>202110</startdate><enddate>202110</enddate><creator>Mouffak, Amelle</creator><creator>Lepelley, Marion</creator><creator>Revol, Bruno</creator><creator>Bernardeau, Claire</creator><creator>Salvo, Francesco</creator><creator>Pariente, Antoine</creator><creator>Roustit, Matthieu</creator><creator>Cracowski, Jean-Luc</creator><creator>Khouri, Charles</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7QP</scope><scope>7RV</scope><scope>7T2</scope><scope>7T7</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>202110</creationdate><title>High prevalence of spin was found in pharmacovigilance studies using disproportionality analyses to detect safety signals: a meta-epidemiological study</title><author>Mouffak, Amelle ; Lepelley, Marion ; Revol, Bruno ; Bernardeau, Claire ; Salvo, Francesco ; Pariente, Antoine ; Roustit, Matthieu ; Cracowski, Jean-Luc ; Khouri, Charles</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c444t-b7c39f504923e9054ef6ee82f9a687ce6d281b6a02f4106789b7779e8ecdddbd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adverse Drug Reaction Reporting Systems - statistics & numerical data</topic><topic>Biomedical Research - standards</topic><topic>Clinical medicine</topic><topic>Conflicts of interest</topic><topic>Data Accuracy</topic><topic>Disproportionality analyses</topic><topic>Drug-Related Side Effects and Adverse Reactions - epidemiology</topic><topic>Epidemiologic Studies</topic><topic>Epidemiology</topic><topic>Evaluation</topic><topic>Humans</topic><topic>Hypotheses</topic><topic>Impact factors</topic><topic>Odds Ratio</topic><topic>Pharmacology</topic><topic>Pharmacovigilance</topic><topic>Prevalence</topic><topic>Product safety</topic><topic>Publication Bias - statistics & numerical data</topic><topic>Reporting</topic><topic>Signal detection</topic><topic>Spin</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mouffak, Amelle</creatorcontrib><creatorcontrib>Lepelley, Marion</creatorcontrib><creatorcontrib>Revol, Bruno</creatorcontrib><creatorcontrib>Bernardeau, Claire</creatorcontrib><creatorcontrib>Salvo, Francesco</creatorcontrib><creatorcontrib>Pariente, Antoine</creatorcontrib><creatorcontrib>Roustit, Matthieu</creatorcontrib><creatorcontrib>Cracowski, Jean-Luc</creatorcontrib><creatorcontrib>Khouri, Charles</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical epidemiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mouffak, Amelle</au><au>Lepelley, Marion</au><au>Revol, Bruno</au><au>Bernardeau, Claire</au><au>Salvo, Francesco</au><au>Pariente, Antoine</au><au>Roustit, Matthieu</au><au>Cracowski, Jean-Luc</au><au>Khouri, Charles</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>High prevalence of spin was found in pharmacovigilance studies using disproportionality analyses to detect safety signals: a meta-epidemiological study</atitle><jtitle>Journal of clinical epidemiology</jtitle><addtitle>J Clin Epidemiol</addtitle><date>2021-10</date><risdate>2021</risdate><volume>138</volume><spage>73</spage><epage>79</epage><pages>73-79</pages><issn>0895-4356</issn><issn>1878-5921</issn><eissn>1878-5921</eissn><abstract>•Spin is common in publications of pharmacovigilance disproportionality analyses.•Only 19%of articles did not show any type of spin.•Over-interpretation of the results is the most frequent type of spin.
To systematically review and appraise misinterpretation of pharmacovigilance disproportionality analysis results in published studies.
We randomly selected 100 studies that performed disproportionality analyses and indexed in Medline identified during a systematic literature search. Titles, abstracts and main texts (results, discussion and conclusion) were evaluated for spin independently by two reviewers. Spin in pharmacovigilance studies was classified according to three main categories: inappropriate interpretation, inappropriate extrapolations and misleading reporting.
Of the 100 studies evaluated, we found that 63%, 56% and 51% had at least one type of spin in their abstract, main text or conclusion respectively, and 40% used causal language to interpret their results in the abstract or conclusion. Spin in titles and results were exclusively represented by inappropriate interpretations of findings (12% and 21% respectively), with terms such as “risk of” or “risks associated with” or results erroneously presented as regular Odds Ratios. Spin in discussion sections mostly concerned inappropriate interpretations (38%)and misleading reporting (12%). Misleading reporting, notably failing to acknowledge the limitations of disproportionality analyses, was the most frequent type of spin in abstracts (55%) and conclusion sections (37%).
We found that spin is frequent in publications of pharmacovigilance disproportionality analyses, notably in abstracts. This consisted notably in an over-interpretation of the results suggesting a proven causative link between a drug use and the risk of an event.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>34186195</pmid><doi>10.1016/j.jclinepi.2021.06.022</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of clinical epidemiology, 2021-10, Vol.138, p.73-79 |
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| language | eng |
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| subjects | Adverse Drug Reaction Reporting Systems - statistics & numerical data Biomedical Research - standards Clinical medicine Conflicts of interest Data Accuracy Disproportionality analyses Drug-Related Side Effects and Adverse Reactions - epidemiology Epidemiologic Studies Epidemiology Evaluation Humans Hypotheses Impact factors Odds Ratio Pharmacology Pharmacovigilance Prevalence Product safety Publication Bias - statistics & numerical data Reporting Signal detection Spin |
| title | High prevalence of spin was found in pharmacovigilance studies using disproportionality analyses to detect safety signals: a meta-epidemiological study |
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