Randomized controlled trials in neurosurgery—how good are we?
Summary Background The strongest evidence in medical clinical literature is represented by randomized controlled trials (RCTs). This study was designed to evaluate neurosurgically relevant RCTs published recently by neurosurgeons. Method A literature search in MEDLINE and EMBASE included all clinica...
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| Veröffentlicht in: | Acta neurochirurgica 2009-05, Vol.151 (5), p.519-527 |
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| creator | Schöller, K. Licht, S. Tonn, J.-C. Uhl, E. |
| description | Summary
Background
The strongest evidence in medical clinical literature is represented by randomized controlled trials (RCTs). This study was designed to evaluate neurosurgically relevant RCTs published recently by neurosurgeons.
Method
A literature search in MEDLINE and EMBASE included all clinical studies published up to 30 June 2006. RCTs with neurosurgical relevance published by at least one author with affiliation to a neurosurgical department were selected. The number and characteristics of individual trials were recorded, and the quality of the trials with regard to study design, quality of reporting, and relevance for clinical practice was assessed by two different investigators using a modification of the Scottish Intercollegiate Guidelines Network methodology checklist. Changes of RCT quality over time as well as factors influencing the quality were analyzed.
Findings
From the initial search results (MEDLINE n = 3,860, EMBASE n = 3,113 articles), 159 RCTs published by neurosurgeons were extracted for final evaluation. Of the RCTs, 62% have been published since 1995; 52% came from the USA, UK, and Germany. The median RCT sample size was 78 patients and the median follow-up 35.7 weeks. Fifty-two percent of all RCTs were of good, 37% of moderate, and 11% of bad quality, with an improvement over time. RCTs with financial funding and RCTs with a sample size of >78 patients were of significantly better quality. There were no major differences in the rating of the studies between the two investigators.
Conclusions
Only a fraction of neurosurgically relevant literature consists of RCTs, but the quality is satisfying and has significantly improved over the last years. An adequate sample size and sufficient financial support seem to be of substantial importance with regard to the quality of the study. Our data also show that by using a standardized checklist, the quality of trials can be reliably assessed by observers of different experience and educational levels. |
| doi_str_mv | 10.1007/s00701-009-0280-y |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_754555370</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>754555370</sourcerecordid><originalsourceid>FETCH-LOGICAL-c467t-a490cb5254ddaa1e50af51506c5a13e3e9bb34159a8108466740ef35a66c8ac03</originalsourceid><addsrcrecordid>eNp9kc1Kw0AUhQdRbK0-gBsJLnQVvfObZFWk-AcFQXQ9TJJJTUkzdaah1JUP4RP6JN7SQkHQzZ073O-eYc4h5JTCFQVIrgMWoDFAFgNLIV7tkT5kgsVYYB97wKliKu2RoxCmeGOJ4IekRzPOE5WKPhk-m7Z0s_rDllHh2oV3TYPtwtemCVHdRq3tvAudn1i_-v78enPLaOJcGRlvo6UdHpODCkl7sj0H5PXu9mX0EI-f7h9HN-O4ECpZxEZkUOSSSVGWxlArwVSSSlCFNJRbbrM854LKzKQUUqFUIsBWXBqlitQUwAfkcqM79-69s2GhZ3UobNOY1rou6EQKKSVP1uTFv6RKGOWUMgTPf4FT1_kWf6EZR-syBilCdAMV6ELwttJzX8-MX2kKeh2C3oSgkdfrEPQKd862wl0-s-VuY-s6AmwDBBy16Ozu5b9VfwDfEpG-</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>230009208</pqid></control><display><type>article</type><title>Randomized controlled trials in neurosurgery—how good are we?</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Schöller, K. ; Licht, S. ; Tonn, J.-C. ; Uhl, E.</creator><creatorcontrib>Schöller, K. ; Licht, S. ; Tonn, J.-C. ; Uhl, E.</creatorcontrib><description>Summary
Background
The strongest evidence in medical clinical literature is represented by randomized controlled trials (RCTs). This study was designed to evaluate neurosurgically relevant RCTs published recently by neurosurgeons.
Method
A literature search in MEDLINE and EMBASE included all clinical studies published up to 30 June 2006. RCTs with neurosurgical relevance published by at least one author with affiliation to a neurosurgical department were selected. The number and characteristics of individual trials were recorded, and the quality of the trials with regard to study design, quality of reporting, and relevance for clinical practice was assessed by two different investigators using a modification of the Scottish Intercollegiate Guidelines Network methodology checklist. Changes of RCT quality over time as well as factors influencing the quality were analyzed.
Findings
From the initial search results (MEDLINE n = 3,860, EMBASE n = 3,113 articles), 159 RCTs published by neurosurgeons were extracted for final evaluation. Of the RCTs, 62% have been published since 1995; 52% came from the USA, UK, and Germany. The median RCT sample size was 78 patients and the median follow-up 35.7 weeks. Fifty-two percent of all RCTs were of good, 37% of moderate, and 11% of bad quality, with an improvement over time. RCTs with financial funding and RCTs with a sample size of >78 patients were of significantly better quality. There were no major differences in the rating of the studies between the two investigators.
Conclusions
Only a fraction of neurosurgically relevant literature consists of RCTs, but the quality is satisfying and has significantly improved over the last years. An adequate sample size and sufficient financial support seem to be of substantial importance with regard to the quality of the study. Our data also show that by using a standardized checklist, the quality of trials can be reliably assessed by observers of different experience and educational levels.</description><identifier>ISSN: 0001-6268</identifier><identifier>EISSN: 0942-0940</identifier><identifier>DOI: 10.1007/s00701-009-0280-y</identifier><identifier>PMID: 19337684</identifier><language>eng</language><publisher>Vienna: Springer Vienna</publisher><subject>Evidence-Based Medicine ; Humans ; Interventional Radiology ; Medicine ; Medicine & Public Health ; Minimally Invasive Surgery ; Neurology ; Neuroradiology ; Neurosurgery ; Neurosurgery - methods ; Neurosurgical Concepts ; Quality Control ; Randomized Controlled Trials as Topic - classification ; Randomized Controlled Trials as Topic - standards ; Research Design ; Surgical Orthopedics</subject><ispartof>Acta neurochirurgica, 2009-05, Vol.151 (5), p.519-527</ispartof><rights>Springer-Verlag 2009</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c467t-a490cb5254ddaa1e50af51506c5a13e3e9bb34159a8108466740ef35a66c8ac03</citedby><cites>FETCH-LOGICAL-c467t-a490cb5254ddaa1e50af51506c5a13e3e9bb34159a8108466740ef35a66c8ac03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00701-009-0280-y$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00701-009-0280-y$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,778,782,27907,27908,41471,42540,51302</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19337684$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Schöller, K.</creatorcontrib><creatorcontrib>Licht, S.</creatorcontrib><creatorcontrib>Tonn, J.-C.</creatorcontrib><creatorcontrib>Uhl, E.</creatorcontrib><title>Randomized controlled trials in neurosurgery—how good are we?</title><title>Acta neurochirurgica</title><addtitle>Acta Neurochir</addtitle><addtitle>Acta Neurochir (Wien)</addtitle><description>Summary
Background
The strongest evidence in medical clinical literature is represented by randomized controlled trials (RCTs). This study was designed to evaluate neurosurgically relevant RCTs published recently by neurosurgeons.
Method
A literature search in MEDLINE and EMBASE included all clinical studies published up to 30 June 2006. RCTs with neurosurgical relevance published by at least one author with affiliation to a neurosurgical department were selected. The number and characteristics of individual trials were recorded, and the quality of the trials with regard to study design, quality of reporting, and relevance for clinical practice was assessed by two different investigators using a modification of the Scottish Intercollegiate Guidelines Network methodology checklist. Changes of RCT quality over time as well as factors influencing the quality were analyzed.
Findings
From the initial search results (MEDLINE n = 3,860, EMBASE n = 3,113 articles), 159 RCTs published by neurosurgeons were extracted for final evaluation. Of the RCTs, 62% have been published since 1995; 52% came from the USA, UK, and Germany. The median RCT sample size was 78 patients and the median follow-up 35.7 weeks. Fifty-two percent of all RCTs were of good, 37% of moderate, and 11% of bad quality, with an improvement over time. RCTs with financial funding and RCTs with a sample size of >78 patients were of significantly better quality. There were no major differences in the rating of the studies between the two investigators.
Conclusions
Only a fraction of neurosurgically relevant literature consists of RCTs, but the quality is satisfying and has significantly improved over the last years. An adequate sample size and sufficient financial support seem to be of substantial importance with regard to the quality of the study. Our data also show that by using a standardized checklist, the quality of trials can be reliably assessed by observers of different experience and educational levels.</description><subject>Evidence-Based Medicine</subject><subject>Humans</subject><subject>Interventional Radiology</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Minimally Invasive Surgery</subject><subject>Neurology</subject><subject>Neuroradiology</subject><subject>Neurosurgery</subject><subject>Neurosurgery - methods</subject><subject>Neurosurgical Concepts</subject><subject>Quality Control</subject><subject>Randomized Controlled Trials as Topic - classification</subject><subject>Randomized Controlled Trials as Topic - standards</subject><subject>Research Design</subject><subject>Surgical Orthopedics</subject><issn>0001-6268</issn><issn>0942-0940</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><recordid>eNp9kc1Kw0AUhQdRbK0-gBsJLnQVvfObZFWk-AcFQXQ9TJJJTUkzdaah1JUP4RP6JN7SQkHQzZ073O-eYc4h5JTCFQVIrgMWoDFAFgNLIV7tkT5kgsVYYB97wKliKu2RoxCmeGOJ4IekRzPOE5WKPhk-m7Z0s_rDllHh2oV3TYPtwtemCVHdRq3tvAudn1i_-v78enPLaOJcGRlvo6UdHpODCkl7sj0H5PXu9mX0EI-f7h9HN-O4ECpZxEZkUOSSSVGWxlArwVSSSlCFNJRbbrM854LKzKQUUqFUIsBWXBqlitQUwAfkcqM79-69s2GhZ3UobNOY1rou6EQKKSVP1uTFv6RKGOWUMgTPf4FT1_kWf6EZR-syBilCdAMV6ELwttJzX8-MX2kKeh2C3oSgkdfrEPQKd862wl0-s-VuY-s6AmwDBBy16Ozu5b9VfwDfEpG-</recordid><startdate>20090501</startdate><enddate>20090501</enddate><creator>Schöller, K.</creator><creator>Licht, S.</creator><creator>Tonn, J.-C.</creator><creator>Uhl, E.</creator><general>Springer Vienna</general><general>Springer Nature B.V</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>7TK</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope></search><sort><creationdate>20090501</creationdate><title>Randomized controlled trials in neurosurgery—how good are we?</title><author>Schöller, K. ; Licht, S. ; Tonn, J.-C. ; Uhl, E.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c467t-a490cb5254ddaa1e50af51506c5a13e3e9bb34159a8108466740ef35a66c8ac03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Evidence-Based Medicine</topic><topic>Humans</topic><topic>Interventional Radiology</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Minimally Invasive Surgery</topic><topic>Neurology</topic><topic>Neuroradiology</topic><topic>Neurosurgery</topic><topic>Neurosurgery - methods</topic><topic>Neurosurgical Concepts</topic><topic>Quality Control</topic><topic>Randomized Controlled Trials as Topic - classification</topic><topic>Randomized Controlled Trials as Topic - standards</topic><topic>Research Design</topic><topic>Surgical Orthopedics</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Schöller, K.</creatorcontrib><creatorcontrib>Licht, S.</creatorcontrib><creatorcontrib>Tonn, J.-C.</creatorcontrib><creatorcontrib>Uhl, E.</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>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><jtitle>Acta neurochirurgica</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Schöller, K.</au><au>Licht, S.</au><au>Tonn, J.-C.</au><au>Uhl, E.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized controlled trials in neurosurgery—how good are we?</atitle><jtitle>Acta neurochirurgica</jtitle><stitle>Acta Neurochir</stitle><addtitle>Acta Neurochir (Wien)</addtitle><date>2009-05-01</date><risdate>2009</risdate><volume>151</volume><issue>5</issue><spage>519</spage><epage>527</epage><pages>519-527</pages><issn>0001-6268</issn><eissn>0942-0940</eissn><abstract>Summary
Background
The strongest evidence in medical clinical literature is represented by randomized controlled trials (RCTs). This study was designed to evaluate neurosurgically relevant RCTs published recently by neurosurgeons.
Method
A literature search in MEDLINE and EMBASE included all clinical studies published up to 30 June 2006. RCTs with neurosurgical relevance published by at least one author with affiliation to a neurosurgical department were selected. The number and characteristics of individual trials were recorded, and the quality of the trials with regard to study design, quality of reporting, and relevance for clinical practice was assessed by two different investigators using a modification of the Scottish Intercollegiate Guidelines Network methodology checklist. Changes of RCT quality over time as well as factors influencing the quality were analyzed.
Findings
From the initial search results (MEDLINE n = 3,860, EMBASE n = 3,113 articles), 159 RCTs published by neurosurgeons were extracted for final evaluation. Of the RCTs, 62% have been published since 1995; 52% came from the USA, UK, and Germany. The median RCT sample size was 78 patients and the median follow-up 35.7 weeks. Fifty-two percent of all RCTs were of good, 37% of moderate, and 11% of bad quality, with an improvement over time. RCTs with financial funding and RCTs with a sample size of >78 patients were of significantly better quality. There were no major differences in the rating of the studies between the two investigators.
Conclusions
Only a fraction of neurosurgically relevant literature consists of RCTs, but the quality is satisfying and has significantly improved over the last years. An adequate sample size and sufficient financial support seem to be of substantial importance with regard to the quality of the study. Our data also show that by using a standardized checklist, the quality of trials can be reliably assessed by observers of different experience and educational levels.</abstract><cop>Vienna</cop><pub>Springer Vienna</pub><pmid>19337684</pmid><doi>10.1007/s00701-009-0280-y</doi><tpages>9</tpages></addata></record> |
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| ispartof | Acta neurochirurgica, 2009-05, Vol.151 (5), p.519-527 |
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| language | eng |
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| source | MEDLINE; SpringerLink Journals - AutoHoldings |
| subjects | Evidence-Based Medicine Humans Interventional Radiology Medicine Medicine & Public Health Minimally Invasive Surgery Neurology Neuroradiology Neurosurgery Neurosurgery - methods Neurosurgical Concepts Quality Control Randomized Controlled Trials as Topic - classification Randomized Controlled Trials as Topic - standards Research Design Surgical Orthopedics |
| title | Randomized controlled trials in neurosurgery—how good are we? |
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