Inadequate reporting of trials compromises the applicability of systematic reviews
Background: Uncertainty about the applicability of controlled trial findings is an increasing concern for clinicians and policy decision makers. This study aimed to determine whether information reported in studies included in systematic reviews was adequate enough to assess their applicability. Met...
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| Veröffentlicht in: | International journal of technology assessment in health care 2009-07, Vol.25 (3), p.323-330 |
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| container_title | International journal of technology assessment in health care |
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| creator | Gartlehner, Gerald Thieda, Patricia Hansen, Richard A. Morgan, Laura C. Shumate, Janelle A. Nissman, Daniel B. |
| description | Background: Uncertainty about the applicability of controlled trial findings is an increasing concern for clinicians and policy decision makers. This study aimed to determine whether information reported in studies included in systematic reviews was adequate enough to assess their applicability. Methods: We used the databases of four recently conducted systematic reviews on the comparative efficacy and safety of second-generation antidepressants, inhaled corticosteroids, Alzheimer's drugs, and targeted immune modulators. We developed and pilot-tested a questionnaire to assess the adequacy of reporting with respect to seven previously validated criteria of study design that distinguish explanatory from pragmatic studies. For each of the 137 included studies, two reviewers independently assessed the adequacy of reporting. Results: Overall, only 12 percent of the included studies provided sufficient information to reliably distinguish explanatory from pragmatic studies. The areas with the greatest lack of reporting were the setting of the study, methods of adverse event assessment, and sample size considerations to determine a minimally important difference from a patient perspective. Conclusions: Substantial shortcomings in reporting exist in aspects of study design important to determine whether a study is applicable to specific populations of interest. |
| doi_str_mv | 10.1017/S0266462309990122 |
| format | Article |
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This study aimed to determine whether information reported in studies included in systematic reviews was adequate enough to assess their applicability. Methods: We used the databases of four recently conducted systematic reviews on the comparative efficacy and safety of second-generation antidepressants, inhaled corticosteroids, Alzheimer's drugs, and targeted immune modulators. We developed and pilot-tested a questionnaire to assess the adequacy of reporting with respect to seven previously validated criteria of study design that distinguish explanatory from pragmatic studies. For each of the 137 included studies, two reviewers independently assessed the adequacy of reporting. Results: Overall, only 12 percent of the included studies provided sufficient information to reliably distinguish explanatory from pragmatic studies. The areas with the greatest lack of reporting were the setting of the study, methods of adverse event assessment, and sample size considerations to determine a minimally important difference from a patient perspective. Conclusions: Substantial shortcomings in reporting exist in aspects of study design important to determine whether a study is applicable to specific populations of interest.</description><identifier>ISSN: 0266-4623</identifier><identifier>EISSN: 1471-6348</identifier><identifier>DOI: 10.1017/S0266462309990122</identifier><identifier>PMID: 19619351</identifier><language>eng</language><publisher>New York, USA: Cambridge University Press</publisher><subject>Alzheimer's disease ; Antidepressants ; Arthritis ; Bias ; Bibliographic data bases ; Clinical Trials as Topic ; Documentation - standards ; Drug therapy ; Effectiveness ; Efficacy ; Explanatory studies ; Health care policy ; Hypertension ; Internal validity ; Methods study ; Pragmatic studies ; Publishing ; Questionnaires ; Regulatory approval ; Steroids ; Surveys and Questionnaires ; Systematic reviews</subject><ispartof>International journal of technology assessment in health care, 2009-07, Vol.25 (3), p.323-330</ispartof><rights>Copyright © Cambridge University Press 2009</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c470t-f3b9db06e5886a60ed87c27db099d244171430dbb4d362837b4dc45b12500793</citedby><cites>FETCH-LOGICAL-c470t-f3b9db06e5886a60ed87c27db099d244171430dbb4d362837b4dc45b12500793</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.cambridge.org/core/product/identifier/S0266462309990122/type/journal_article$$EHTML$$P50$$Gcambridge$$H</linktohtml><link.rule.ids>164,314,780,784,27923,27924,55627</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19619351$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gartlehner, Gerald</creatorcontrib><creatorcontrib>Thieda, Patricia</creatorcontrib><creatorcontrib>Hansen, Richard A.</creatorcontrib><creatorcontrib>Morgan, Laura C.</creatorcontrib><creatorcontrib>Shumate, Janelle A.</creatorcontrib><creatorcontrib>Nissman, Daniel B.</creatorcontrib><title>Inadequate reporting of trials compromises the applicability of systematic reviews</title><title>International journal of technology assessment in health care</title><addtitle>Int J Technol Assess Health Care</addtitle><description>Background: Uncertainty about the applicability of controlled trial findings is an increasing concern for clinicians and policy decision makers. This study aimed to determine whether information reported in studies included in systematic reviews was adequate enough to assess their applicability. Methods: We used the databases of four recently conducted systematic reviews on the comparative efficacy and safety of second-generation antidepressants, inhaled corticosteroids, Alzheimer's drugs, and targeted immune modulators. We developed and pilot-tested a questionnaire to assess the adequacy of reporting with respect to seven previously validated criteria of study design that distinguish explanatory from pragmatic studies. For each of the 137 included studies, two reviewers independently assessed the adequacy of reporting. Results: Overall, only 12 percent of the included studies provided sufficient information to reliably distinguish explanatory from pragmatic studies. The areas with the greatest lack of reporting were the setting of the study, methods of adverse event assessment, and sample size considerations to determine a minimally important difference from a patient perspective. Conclusions: Substantial shortcomings in reporting exist in aspects of study design important to determine whether a study is applicable to specific populations of interest.</description><subject>Alzheimer's disease</subject><subject>Antidepressants</subject><subject>Arthritis</subject><subject>Bias</subject><subject>Bibliographic data bases</subject><subject>Clinical Trials as Topic</subject><subject>Documentation - standards</subject><subject>Drug therapy</subject><subject>Effectiveness</subject><subject>Efficacy</subject><subject>Explanatory studies</subject><subject>Health care policy</subject><subject>Hypertension</subject><subject>Internal validity</subject><subject>Methods study</subject><subject>Pragmatic studies</subject><subject>Publishing</subject><subject>Questionnaires</subject><subject>Regulatory approval</subject><subject>Steroids</subject><subject>Surveys and Questionnaires</subject><subject>Systematic reviews</subject><issn>0266-4623</issn><issn>1471-6348</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNqFkc1O3DAUha2Kqgy0D9ANiliwS3uv7djxEvE3SFOqtiy6s5zEA4ZkkrEdYN6-Hs2oSCDEypbPd67O9SHkK8I3BJTf_wAVggvKQCkFSOkHMkEuMReMlztkspbztb5L9kK4A8BEwieyi0qgYgVOyO_LhWnscjTRZt4OvY9ucZP18yx6Z9qQ1X03-L5zwYYs3trMDEPralO51sXVmgurEG1noquT_8HZx_CZfJwnq_2yPffJ9fnZ9ck0n_28uDw5nuU1lxDzOatUU4GwRVkKI8A2paypTE9KNZRzlMgZNFXFGyZoyWS61LyokBYAUrF9crQZm_ItRxuiTilr27ZmYfsxaCELKErg74KMS6EEl--CFKSEBCfw8AV4149-kZbVFIEVDAEShBuo9n0I3s714F1n_Eoj6HV9-lV9yXOwHTxWnW2eHdu-EpBvAJd-_em_bvx92pfJQouLX3o2nZ5e4V-pfySebUOYrvKuubHPUd-O8Q9-a7Jq</recordid><startdate>20090701</startdate><enddate>20090701</enddate><creator>Gartlehner, Gerald</creator><creator>Thieda, Patricia</creator><creator>Hansen, Richard A.</creator><creator>Morgan, Laura C.</creator><creator>Shumate, Janelle A.</creator><creator>Nissman, Daniel B.</creator><general>Cambridge University Press</general><scope>BSCLL</scope><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>7RV</scope><scope>7T5</scope><scope>7U5</scope><scope>7WY</scope><scope>7WZ</scope><scope>7X7</scope><scope>7XB</scope><scope>87Z</scope><scope>88C</scope><scope>88E</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8FL</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>BEZIV</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FRNLG</scope><scope>FYUFA</scope><scope>F~G</scope><scope>GHDGH</scope><scope>H94</scope><scope>K60</scope><scope>K6~</scope><scope>K9.</scope><scope>KB0</scope><scope>L.-</scope><scope>L7M</scope><scope>M0C</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQBIZ</scope><scope>PQBZA</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7T2</scope><scope>7U2</scope><scope>C1K</scope><scope>7X8</scope></search><sort><creationdate>20090701</creationdate><title>Inadequate reporting of trials compromises the applicability of systematic reviews</title><author>Gartlehner, Gerald ; Thieda, Patricia ; Hansen, Richard A. ; Morgan, Laura C. ; Shumate, Janelle A. ; Nissman, Daniel B.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c470t-f3b9db06e5886a60ed87c27db099d244171430dbb4d362837b4dc45b12500793</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Alzheimer's disease</topic><topic>Antidepressants</topic><topic>Arthritis</topic><topic>Bias</topic><topic>Bibliographic data bases</topic><topic>Clinical Trials as Topic</topic><topic>Documentation - standards</topic><topic>Drug therapy</topic><topic>Effectiveness</topic><topic>Efficacy</topic><topic>Explanatory studies</topic><topic>Health care policy</topic><topic>Hypertension</topic><topic>Internal validity</topic><topic>Methods study</topic><topic>Pragmatic studies</topic><topic>Publishing</topic><topic>Questionnaires</topic><topic>Regulatory approval</topic><topic>Steroids</topic><topic>Surveys and Questionnaires</topic><topic>Systematic reviews</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gartlehner, Gerald</creatorcontrib><creatorcontrib>Thieda, Patricia</creatorcontrib><creatorcontrib>Hansen, Richard A.</creatorcontrib><creatorcontrib>Morgan, Laura C.</creatorcontrib><creatorcontrib>Shumate, Janelle A.</creatorcontrib><creatorcontrib>Nissman, Daniel B.</creatorcontrib><collection>Istex</collection><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>Nursing & Allied Health Database</collection><collection>Immunology Abstracts</collection><collection>Solid State and Superconductivity Abstracts</collection><collection>ABI/INFORM Collection</collection><collection>ABI/INFORM Global (PDF only)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ABI/INFORM Global (Alumni Edition)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</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>ABI/INFORM Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>Business Premium Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Business Premium Collection (Alumni)</collection><collection>Health Research Premium Collection</collection><collection>ABI/INFORM Global (Corporate)</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Business Collection (Alumni Edition)</collection><collection>ProQuest Business Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ABI/INFORM Professional Advanced</collection><collection>Advanced Technologies Database with Aerospace</collection><collection>ABI/INFORM Global</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Business</collection><collection>ProQuest One Business (Alumni)</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>Health and Safety Science Abstracts (Full archive)</collection><collection>Safety Science and Risk</collection><collection>Environmental Sciences and Pollution Management</collection><collection>MEDLINE - Academic</collection><jtitle>International journal of technology assessment in health care</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gartlehner, Gerald</au><au>Thieda, Patricia</au><au>Hansen, Richard A.</au><au>Morgan, Laura C.</au><au>Shumate, Janelle A.</au><au>Nissman, Daniel B.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Inadequate reporting of trials compromises the applicability of systematic reviews</atitle><jtitle>International journal of technology assessment in health care</jtitle><addtitle>Int J Technol Assess Health Care</addtitle><date>2009-07-01</date><risdate>2009</risdate><volume>25</volume><issue>3</issue><spage>323</spage><epage>330</epage><pages>323-330</pages><issn>0266-4623</issn><eissn>1471-6348</eissn><abstract>Background: Uncertainty about the applicability of controlled trial findings is an increasing concern for clinicians and policy decision makers. This study aimed to determine whether information reported in studies included in systematic reviews was adequate enough to assess their applicability. Methods: We used the databases of four recently conducted systematic reviews on the comparative efficacy and safety of second-generation antidepressants, inhaled corticosteroids, Alzheimer's drugs, and targeted immune modulators. We developed and pilot-tested a questionnaire to assess the adequacy of reporting with respect to seven previously validated criteria of study design that distinguish explanatory from pragmatic studies. For each of the 137 included studies, two reviewers independently assessed the adequacy of reporting. Results: Overall, only 12 percent of the included studies provided sufficient information to reliably distinguish explanatory from pragmatic studies. The areas with the greatest lack of reporting were the setting of the study, methods of adverse event assessment, and sample size considerations to determine a minimally important difference from a patient perspective. Conclusions: Substantial shortcomings in reporting exist in aspects of study design important to determine whether a study is applicable to specific populations of interest.</abstract><cop>New York, USA</cop><pub>Cambridge University Press</pub><pmid>19619351</pmid><doi>10.1017/S0266462309990122</doi><tpages>8</tpages></addata></record> |
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| ispartof | International journal of technology assessment in health care, 2009-07, Vol.25 (3), p.323-330 |
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| source | MEDLINE; Cambridge University Press Journals Complete |
| subjects | Alzheimer's disease Antidepressants Arthritis Bias Bibliographic data bases Clinical Trials as Topic Documentation - standards Drug therapy Effectiveness Efficacy Explanatory studies Health care policy Hypertension Internal validity Methods study Pragmatic studies Publishing Questionnaires Regulatory approval Steroids Surveys and Questionnaires Systematic reviews |
| title | Inadequate reporting of trials compromises the applicability of systematic reviews |
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