Validity of randomized clinical trials in Gastroenterology from 1964–2000
The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in Gastroenterology as original articles from 1964 to 2000. The methodological quality (randomization and bl...
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| Veröffentlicht in: | Gastroenterology (New York, N.Y. 1943) N.Y. 1943), 2002-04, Vol.122 (4), p.1157-1160 |
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| container_title | Gastroenterology (New York, N.Y. 1943) |
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| creator | Kjaergard, Lise L. Frederiksen, Sarah L. Gluud, Christian |
| description | The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in Gastroenterology as original articles from 1964 to 2000.
The methodological quality (randomization and blinding), sample size, publication year, and disease area were extracted from each trial. Changes during the study period were analyzed by analysis of variance with adjustments for potential confounders.
Forty-two percent of all trials reported adequate generation of the allocation sequence, 39% reported adequate allocation concealment, and 62% were double blind. The reported methodological quality improved significantly in the mid-1990s. Conclusions: The present study shows a positive development, but the reported methodological quality of trials can still be improved. |
| doi_str_mv | 10.1053/gast.2002.32390 |
| format | Article |
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The methodological quality (randomization and blinding), sample size, publication year, and disease area were extracted from each trial. Changes during the study period were analyzed by analysis of variance with adjustments for potential confounders.
Forty-two percent of all trials reported adequate generation of the allocation sequence, 39% reported adequate allocation concealment, and 62% were double blind. The reported methodological quality improved significantly in the mid-1990s. Conclusions: The present study shows a positive development, but the reported methodological quality of trials can still be improved.</description><identifier>ISSN: 0016-5085</identifier><identifier>EISSN: 1528-0012</identifier><identifier>DOI: 10.1053/gast.2002.32390</identifier><identifier>PMID: 11910365</identifier><identifier>CODEN: GASTAB</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Biological and medical sciences ; Clinical trial. Drug monitoring ; Gastroenterology ; General pharmacology ; Humans ; Medical sciences ; Pharmacology. Drug treatments ; Randomized Controlled Trials as Topic - standards ; Reproducibility of Results</subject><ispartof>Gastroenterology (New York, N.Y. 1943), 2002-04, Vol.122 (4), p.1157-1160</ispartof><rights>2002 American Gastroenterological Association</rights><rights>2002 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c439t-37418a52fd04e1370083c53a6ae3d57bdc812db46847a388a1d4d65e69d0430c3</citedby><cites>FETCH-LOGICAL-c439t-37418a52fd04e1370083c53a6ae3d57bdc812db46847a388a1d4d65e69d0430c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1053/gast.2002.32390$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=13590656$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11910365$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kjaergard, Lise L.</creatorcontrib><creatorcontrib>Frederiksen, Sarah L.</creatorcontrib><creatorcontrib>Gluud, Christian</creatorcontrib><title>Validity of randomized clinical trials in Gastroenterology from 1964–2000</title><title>Gastroenterology (New York, N.Y. 1943)</title><addtitle>Gastroenterology</addtitle><description>The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in Gastroenterology as original articles from 1964 to 2000.
The methodological quality (randomization and blinding), sample size, publication year, and disease area were extracted from each trial. Changes during the study period were analyzed by analysis of variance with adjustments for potential confounders.
Forty-two percent of all trials reported adequate generation of the allocation sequence, 39% reported adequate allocation concealment, and 62% were double blind. The reported methodological quality improved significantly in the mid-1990s. Conclusions: The present study shows a positive development, but the reported methodological quality of trials can still be improved.</description><subject>Biological and medical sciences</subject><subject>Clinical trial. Drug monitoring</subject><subject>Gastroenterology</subject><subject>General pharmacology</subject><subject>Humans</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><subject>Randomized Controlled Trials as Topic - standards</subject><subject>Reproducibility of Results</subject><issn>0016-5085</issn><issn>1528-0012</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kL1OwzAUhS0EglKY2VAW2FKu49hxRlTxJ5BYgNVy7RtklMTFTpHKxDvwhjwJLq3Uieks3z336CPkhMKEAmcXrzoOkwKgmLCC1bBDRpQXMgegxS4ZpRA5B8kPyGGMbwBQM0n3yQGlNQUm-Ijcv-jWWTcsM99kQffWd-4TbWZa1zuj22wITrcxc312k34Fj_2Awbf-dZk1wXcZrUX58_WdNsAR2WsSi8ebHJPn66un6W3-8HhzN718yE3J6iFnVUml5kVjoUTKKgDJDGdaaGSWVzNrJC3srBSyrDSTUlNbWsFR1OmAgWFjcr7unQf_vsA4qM5Fg22re_SLqCrKGadVmcCLNWiCjzFgo-bBdTosFQW18qdW_tTKn_rzly5ON9WLWYd2y2-EJeBsA-iY9DRJmXFxyzFeg-AicfWawyTiw2FQ0TjsDVoX0AzKevfviF_-7Ysf</recordid><startdate>20020401</startdate><enddate>20020401</enddate><creator>Kjaergard, Lise L.</creator><creator>Frederiksen, Sarah L.</creator><creator>Gluud, Christian</creator><general>Elsevier Inc</general><general>Elsevier</general><scope>IQODW</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>7X8</scope></search><sort><creationdate>20020401</creationdate><title>Validity of randomized clinical trials in Gastroenterology from 1964–2000</title><author>Kjaergard, Lise L. ; Frederiksen, Sarah L. ; Gluud, Christian</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c439t-37418a52fd04e1370083c53a6ae3d57bdc812db46847a388a1d4d65e69d0430c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Biological and medical sciences</topic><topic>Clinical trial. Drug monitoring</topic><topic>Gastroenterology</topic><topic>General pharmacology</topic><topic>Humans</topic><topic>Medical sciences</topic><topic>Pharmacology. Drug treatments</topic><topic>Randomized Controlled Trials as Topic - standards</topic><topic>Reproducibility of Results</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kjaergard, Lise L.</creatorcontrib><creatorcontrib>Frederiksen, Sarah L.</creatorcontrib><creatorcontrib>Gluud, Christian</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Gastroenterology (New York, N.Y. 1943)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kjaergard, Lise L.</au><au>Frederiksen, Sarah L.</au><au>Gluud, Christian</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Validity of randomized clinical trials in Gastroenterology from 1964–2000</atitle><jtitle>Gastroenterology (New York, N.Y. 1943)</jtitle><addtitle>Gastroenterology</addtitle><date>2002-04-01</date><risdate>2002</risdate><volume>122</volume><issue>4</issue><spage>1157</spage><epage>1160</epage><pages>1157-1160</pages><issn>0016-5085</issn><eissn>1528-0012</eissn><coden>GASTAB</coden><abstract>The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in Gastroenterology as original articles from 1964 to 2000.
The methodological quality (randomization and blinding), sample size, publication year, and disease area were extracted from each trial. Changes during the study period were analyzed by analysis of variance with adjustments for potential confounders.
Forty-two percent of all trials reported adequate generation of the allocation sequence, 39% reported adequate allocation concealment, and 62% were double blind. The reported methodological quality improved significantly in the mid-1990s. Conclusions: The present study shows a positive development, but the reported methodological quality of trials can still be improved.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>11910365</pmid><doi>10.1053/gast.2002.32390</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0016-5085 |
| ispartof | Gastroenterology (New York, N.Y. 1943), 2002-04, Vol.122 (4), p.1157-1160 |
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| language | eng |
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| source | MEDLINE; Elsevier ScienceDirect Journals Complete; Alma/SFX Local Collection |
| subjects | Biological and medical sciences Clinical trial. Drug monitoring Gastroenterology General pharmacology Humans Medical sciences Pharmacology. Drug treatments Randomized Controlled Trials as Topic - standards Reproducibility of Results |
| title | Validity of randomized clinical trials in Gastroenterology from 1964–2000 |
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