Recruitment to multicentre trials—lessons from UKCTOCS: descriptive study
Objective To describe the factors that contributed to successful recruitment of more than 200 000 women to the UK Collaborative Trial of Ovarian Cancer Screening, one of the largest ever randomised controlled trials.Design Descriptive study.Setting 13 NHS trusts in England, Wales, and Northern Irela...
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| Veröffentlicht in: | BMJ 2008-11, Vol.337 (7681), p.1283-1286 |
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| creator | Menon, Usha Gentry-Maharaj, Aleksandra Ryan, Andy Sharma, Aarti Burnell, Matthew Hallett, Rachel Lewis, Sara Lopez, Alberto Godfrey, Keith Oram, David Herod, Jonathan Williamson, Karin Seif, Mourad Scott, Ian Mould, Tim Woolas, Robert Murdoch, John Dobbs, Stephen Amso, Nazar Leeson, Simon Cruickshank, Derek McGuire, Ali Campbell, Stuart Fallowfield, Lesley Skates, Steve Parmar, Mahesh Jacobs, Ian |
| description | Objective To describe the factors that contributed to successful recruitment of more than 200 000 women to the UK Collaborative Trial of Ovarian Cancer Screening, one of the largest ever randomised controlled trials.Design Descriptive study.Setting 13 NHS trusts in England, Wales, and Northern Ireland.Participants Postmenopausal women aged 50-74; exclusion criteria included ovarian malignancy, bilateral oophorectomy, increased risk of familial ovarian cancer, active non-ovarian malignancy, and participation in other ovarian cancer screening trials.Main outcome measures Achievement of target recruitment, acceptance rates of invitation, and recruitment rates.Results The trial was set up in 13 centres with 27 adjoining local health authorities. The coordinating centre team was led by one of the senior investigators, who was closely involved in planning and day to day trial management. Of 1 243 282 women invited, 23.2% (288 955) replied that they were eligible and would like to participate. Of those sent appointments, 73.6% (205 090) attended for recruitment. The acceptance rate varied from 19% to 33% between trial centres. Measures to ensure target recruitment included named coordinating centre staff supporting and monitoring each centre, prompt identification and resolution of logistic problems, varying the volume of invitations by centre, using local non-attendance rates to determine the size of recruitment clinics, and organising large ad hoc clinics supported by coordinating centre staff. The trial randomised 202 638 women in 4.3 years.Conclusions Planning and trial management are as important as trial design and require equal attention from senior investigators. Successful recruitment needs constant monitoring by a committed proactive management team that is willing to explore individual solutions for different centres and use central resources to improve local recruitment. Automation of trial processes with web based trial management systems is crucial in large multicentre randomised controlled trials. Recruitment can be further enhanced by using information videos and group discussions.Trial registration Current Controlled Trials ISRCTN22488978. |
| doi_str_mv | 10.1136/bmj.a2079 |
| format | Article |
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The coordinating centre team was led by one of the senior investigators, who was closely involved in planning and day to day trial management. Of 1 243 282 women invited, 23.2% (288 955) replied that they were eligible and would like to participate. Of those sent appointments, 73.6% (205 090) attended for recruitment. The acceptance rate varied from 19% to 33% between trial centres. Measures to ensure target recruitment included named coordinating centre staff supporting and monitoring each centre, prompt identification and resolution of logistic problems, varying the volume of invitations by centre, using local non-attendance rates to determine the size of recruitment clinics, and organising large ad hoc clinics supported by coordinating centre staff. The trial randomised 202 638 women in 4.3 years.Conclusions Planning and trial management are as important as trial design and require equal attention from senior investigators. Successful recruitment needs constant monitoring by a committed proactive management team that is willing to explore individual solutions for different centres and use central resources to improve local recruitment. Automation of trial processes with web based trial management systems is crucial in large multicentre randomised controlled trials. Recruitment can be further enhanced by using information videos and group discussions.Trial registration Current Controlled Trials ISRCTN22488978.</description><edition>International edition</edition><identifier>ISSN: 0959-8138</identifier><identifier>ISSN: 0959-8146</identifier><identifier>EISSN: 1468-5833</identifier><identifier>EISSN: 1756-1833</identifier><identifier>DOI: 10.1136/bmj.a2079</identifier><identifier>PMID: 19008269</identifier><identifier>CODEN: BMJOAE</identifier><language>eng</language><publisher>London: British Medical Journal Publishing Group</publisher><subject>Aged ; Biological and medical sciences ; Cancer screening ; Clinical trials ; Collaboration ; Experimentation ; Female ; General aspects ; Group discussion ; Hospital units ; Humans ; Mass Screening - mortality ; Media coverage ; Medical sciences ; Medical screening ; Middle Aged ; Multicenter Studies as Topic - methods ; Online recruitment ; Ovarian cancer ; Ovarian Neoplasms - mortality ; Ovarian Neoplasms - prevention & control ; Patient Acceptance of Health Care - statistics & numerical data ; Patient Selection ; Primary care ; Primary health care ; Professional recruitment ; Randomized Controlled Trials as Topic - methods ; Recruitment ; Research Design ; Staffing ; Ultrasonic imaging ; United Kingdom ; Web browsers ; Womens health ; Womens health services</subject><ispartof>BMJ, 2008-11, Vol.337 (7681), p.1283-1286</ispartof><rights>Menon et al 2008</rights><rights>Copyright 2008 BMJ Publishing Group Ltd.</rights><rights>2008 INIST-CNRS</rights><rights>Copyright BMJ Publishing Group LTD Nov 13, 2008</rights><rights>Copyright BMJ Publishing Group Nov 29, 2008</rights><rights>Menon et al 2008 2008 Menon et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b547t-c82ab3960b87119b756841070956e93d8c35f8ecdd17d1ac4ab25ec8e0886db13</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://bmj.com/content/337/bmj.a2079.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttp://bmj.com/content/337/bmj.a2079.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>114,115,230,314,776,780,799,881,3183,23552,27903,27904,30978,57995,58228,77346,77377</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20853828$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19008269$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Menon, Usha</creatorcontrib><creatorcontrib>Gentry-Maharaj, Aleksandra</creatorcontrib><creatorcontrib>Ryan, Andy</creatorcontrib><creatorcontrib>Sharma, Aarti</creatorcontrib><creatorcontrib>Burnell, Matthew</creatorcontrib><creatorcontrib>Hallett, Rachel</creatorcontrib><creatorcontrib>Lewis, Sara</creatorcontrib><creatorcontrib>Lopez, Alberto</creatorcontrib><creatorcontrib>Godfrey, Keith</creatorcontrib><creatorcontrib>Oram, David</creatorcontrib><creatorcontrib>Herod, Jonathan</creatorcontrib><creatorcontrib>Williamson, Karin</creatorcontrib><creatorcontrib>Seif, Mourad</creatorcontrib><creatorcontrib>Scott, Ian</creatorcontrib><creatorcontrib>Mould, Tim</creatorcontrib><creatorcontrib>Woolas, Robert</creatorcontrib><creatorcontrib>Murdoch, John</creatorcontrib><creatorcontrib>Dobbs, Stephen</creatorcontrib><creatorcontrib>Amso, Nazar</creatorcontrib><creatorcontrib>Leeson, Simon</creatorcontrib><creatorcontrib>Cruickshank, Derek</creatorcontrib><creatorcontrib>McGuire, Ali</creatorcontrib><creatorcontrib>Campbell, Stuart</creatorcontrib><creatorcontrib>Fallowfield, Lesley</creatorcontrib><creatorcontrib>Skates, Steve</creatorcontrib><creatorcontrib>Parmar, Mahesh</creatorcontrib><creatorcontrib>Jacobs, Ian</creatorcontrib><title>Recruitment to multicentre trials—lessons from UKCTOCS: descriptive study</title><title>BMJ</title><addtitle>BMJ</addtitle><description>Objective To describe the factors that contributed to successful recruitment of more than 200 000 women to the UK Collaborative Trial of Ovarian Cancer Screening, one of the largest ever randomised controlled trials.Design Descriptive study.Setting 13 NHS trusts in England, Wales, and Northern Ireland.Participants Postmenopausal women aged 50-74; exclusion criteria included ovarian malignancy, bilateral oophorectomy, increased risk of familial ovarian cancer, active non-ovarian malignancy, and participation in other ovarian cancer screening trials.Main outcome measures Achievement of target recruitment, acceptance rates of invitation, and recruitment rates.Results The trial was set up in 13 centres with 27 adjoining local health authorities. The coordinating centre team was led by one of the senior investigators, who was closely involved in planning and day to day trial management. Of 1 243 282 women invited, 23.2% (288 955) replied that they were eligible and would like to participate. Of those sent appointments, 73.6% (205 090) attended for recruitment. The acceptance rate varied from 19% to 33% between trial centres. Measures to ensure target recruitment included named coordinating centre staff supporting and monitoring each centre, prompt identification and resolution of logistic problems, varying the volume of invitations by centre, using local non-attendance rates to determine the size of recruitment clinics, and organising large ad hoc clinics supported by coordinating centre staff. The trial randomised 202 638 women in 4.3 years.Conclusions Planning and trial management are as important as trial design and require equal attention from senior investigators. Successful recruitment needs constant monitoring by a committed proactive management team that is willing to explore individual solutions for different centres and use central resources to improve local recruitment. Automation of trial processes with web based trial management systems is crucial in large multicentre randomised controlled trials. Recruitment can be further enhanced by using information videos and group discussions.Trial registration Current Controlled Trials ISRCTN22488978.</description><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Cancer screening</subject><subject>Clinical trials</subject><subject>Collaboration</subject><subject>Experimentation</subject><subject>Female</subject><subject>General aspects</subject><subject>Group discussion</subject><subject>Hospital units</subject><subject>Humans</subject><subject>Mass Screening - mortality</subject><subject>Media coverage</subject><subject>Medical sciences</subject><subject>Medical screening</subject><subject>Middle Aged</subject><subject>Multicenter Studies as Topic - methods</subject><subject>Online recruitment</subject><subject>Ovarian cancer</subject><subject>Ovarian Neoplasms - mortality</subject><subject>Ovarian Neoplasms - prevention & control</subject><subject>Patient Acceptance of Health Care - statistics & numerical data</subject><subject>Patient Selection</subject><subject>Primary care</subject><subject>Primary health care</subject><subject>Professional recruitment</subject><subject>Randomized Controlled Trials as Topic - methods</subject><subject>Recruitment</subject><subject>Research Design</subject><subject>Staffing</subject><subject>Ultrasonic imaging</subject><subject>United Kingdom</subject><subject>Web browsers</subject><subject>Womens health</subject><subject>Womens health services</subject><issn>0959-8138</issn><issn>0959-8146</issn><issn>1468-5833</issn><issn>1756-1833</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><sourceid>7QJ</sourceid><recordid>eNp1kc1u1DAYRS0EoqOhCx4AFPEnsUix4_iPBRIEpqCWVoKWBRvLcTzgIYkH26nojofgCXkSnMloKEhdWdY9_nQ-XwDuIniAEKbP6m51oArIxA0wQyXlOeEY3wQzKIjIOcJ8D-yHsIIQFphxQcltsIcEhLygYgaOPhjtBxs708csuqwb2mh1uniTRW9VG37__NWaEFwfsqV3XXZ-VJ2dVh-fZ40J2tt1tBcmC3FoLu-AW8v0wOxvzzk4X7w5q97mx6eH76qXx3lNShZzzQtVY0FhzRlComaE8hJBloSpEbjhGpMlN7ppEGuQ0qWqC2I0N5Bz2tQIz8GLae56qDvTbGxVK9fedspfSqes_Dfp7Vf5xV3IYvwaUaYBT7YDvPs-mBBlZ4M2bat644YgqWCcIEQS-OA_cOUG36flZAFLWHDMR52H10GIMQ4xpWSknk6U9i4Eb5Y7XwTlWKRMRcpNkYm9f3XBv-S2tgQ83gIqaNUuveq1DTuugJxgnuzm4N7ErUJ0_kqetis3UvmU2xDNj12u_DdJGWZEnnyq5Mn7RXm4-PxKvk78o4kfXa_3_wPoy8rr</recordid><startdate>20081113</startdate><enddate>20081113</enddate><creator>Menon, Usha</creator><creator>Gentry-Maharaj, Aleksandra</creator><creator>Ryan, Andy</creator><creator>Sharma, Aarti</creator><creator>Burnell, Matthew</creator><creator>Hallett, Rachel</creator><creator>Lewis, Sara</creator><creator>Lopez, Alberto</creator><creator>Godfrey, Keith</creator><creator>Oram, David</creator><creator>Herod, Jonathan</creator><creator>Williamson, Karin</creator><creator>Seif, Mourad</creator><creator>Scott, Ian</creator><creator>Mould, Tim</creator><creator>Woolas, Robert</creator><creator>Murdoch, John</creator><creator>Dobbs, Stephen</creator><creator>Amso, Nazar</creator><creator>Leeson, Simon</creator><creator>Cruickshank, Derek</creator><creator>McGuire, Ali</creator><creator>Campbell, Stuart</creator><creator>Fallowfield, Lesley</creator><creator>Skates, Steve</creator><creator>Parmar, Mahesh</creator><creator>Jacobs, Ian</creator><general>British Medical Journal Publishing Group</general><general>British Medical Association</general><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><general>BMJ Publishing Group Ltd</general><scope>9YT</scope><scope>ACMMV</scope><scope>BSCLL</scope><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>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88I</scope><scope>8AF</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ASE</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FPQ</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K6X</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M2O</scope><scope>M2P</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7QJ</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20081113</creationdate><title>Recruitment to multicentre trials—lessons from UKCTOCS: descriptive study</title><author>Menon, Usha ; Gentry-Maharaj, Aleksandra ; Ryan, Andy ; Sharma, Aarti ; Burnell, Matthew ; Hallett, Rachel ; Lewis, Sara ; Lopez, Alberto ; Godfrey, Keith ; Oram, David ; Herod, Jonathan ; Williamson, Karin ; Seif, Mourad ; Scott, Ian ; Mould, Tim ; Woolas, Robert ; Murdoch, John ; Dobbs, Stephen ; Amso, Nazar ; Leeson, Simon ; Cruickshank, Derek ; McGuire, Ali ; Campbell, Stuart ; Fallowfield, Lesley ; Skates, Steve ; Parmar, Mahesh ; Jacobs, Ian</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b547t-c82ab3960b87119b756841070956e93d8c35f8ecdd17d1ac4ab25ec8e0886db13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>Cancer screening</topic><topic>Clinical trials</topic><topic>Collaboration</topic><topic>Experimentation</topic><topic>Female</topic><topic>General aspects</topic><topic>Group discussion</topic><topic>Hospital units</topic><topic>Humans</topic><topic>Mass Screening - mortality</topic><topic>Media coverage</topic><topic>Medical sciences</topic><topic>Medical screening</topic><topic>Middle Aged</topic><topic>Multicenter Studies as Topic - methods</topic><topic>Online recruitment</topic><topic>Ovarian cancer</topic><topic>Ovarian Neoplasms - mortality</topic><topic>Ovarian Neoplasms - prevention & control</topic><topic>Patient Acceptance of Health Care - statistics & numerical data</topic><topic>Patient Selection</topic><topic>Primary care</topic><topic>Primary health care</topic><topic>Professional recruitment</topic><topic>Randomized Controlled Trials as Topic - methods</topic><topic>Recruitment</topic><topic>Research Design</topic><topic>Staffing</topic><topic>Ultrasonic imaging</topic><topic>United Kingdom</topic><topic>Web browsers</topic><topic>Womens health</topic><topic>Womens health services</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Menon, Usha</creatorcontrib><creatorcontrib>Gentry-Maharaj, Aleksandra</creatorcontrib><creatorcontrib>Ryan, Andy</creatorcontrib><creatorcontrib>Sharma, Aarti</creatorcontrib><creatorcontrib>Burnell, Matthew</creatorcontrib><creatorcontrib>Hallett, Rachel</creatorcontrib><creatorcontrib>Lewis, Sara</creatorcontrib><creatorcontrib>Lopez, Alberto</creatorcontrib><creatorcontrib>Godfrey, Keith</creatorcontrib><creatorcontrib>Oram, David</creatorcontrib><creatorcontrib>Herod, Jonathan</creatorcontrib><creatorcontrib>Williamson, Karin</creatorcontrib><creatorcontrib>Seif, Mourad</creatorcontrib><creatorcontrib>Scott, Ian</creatorcontrib><creatorcontrib>Mould, Tim</creatorcontrib><creatorcontrib>Woolas, Robert</creatorcontrib><creatorcontrib>Murdoch, John</creatorcontrib><creatorcontrib>Dobbs, Stephen</creatorcontrib><creatorcontrib>Amso, Nazar</creatorcontrib><creatorcontrib>Leeson, Simon</creatorcontrib><creatorcontrib>Cruickshank, Derek</creatorcontrib><creatorcontrib>McGuire, Ali</creatorcontrib><creatorcontrib>Campbell, Stuart</creatorcontrib><creatorcontrib>Fallowfield, Lesley</creatorcontrib><creatorcontrib>Skates, Steve</creatorcontrib><creatorcontrib>Parmar, Mahesh</creatorcontrib><creatorcontrib>Jacobs, Ian</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>Istex</collection><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>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</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>British Nursing Index</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>British Nursing Index (BNI) (1985 to Present)</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>SciTech Premium Collection</collection><collection>British Nursing Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</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 China</collection><collection>ProQuest Central Basic</collection><collection>Applied Social Sciences Index & Abstracts (ASSIA)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Menon, Usha</au><au>Gentry-Maharaj, Aleksandra</au><au>Ryan, Andy</au><au>Sharma, Aarti</au><au>Burnell, Matthew</au><au>Hallett, Rachel</au><au>Lewis, Sara</au><au>Lopez, Alberto</au><au>Godfrey, Keith</au><au>Oram, David</au><au>Herod, Jonathan</au><au>Williamson, Karin</au><au>Seif, Mourad</au><au>Scott, Ian</au><au>Mould, Tim</au><au>Woolas, Robert</au><au>Murdoch, John</au><au>Dobbs, Stephen</au><au>Amso, Nazar</au><au>Leeson, Simon</au><au>Cruickshank, Derek</au><au>McGuire, Ali</au><au>Campbell, Stuart</au><au>Fallowfield, Lesley</au><au>Skates, Steve</au><au>Parmar, Mahesh</au><au>Jacobs, Ian</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Recruitment to multicentre trials—lessons from UKCTOCS: descriptive study</atitle><jtitle>BMJ</jtitle><addtitle>BMJ</addtitle><date>2008-11-13</date><risdate>2008</risdate><volume>337</volume><issue>7681</issue><spage>1283</spage><epage>1286</epage><pages>1283-1286</pages><issn>0959-8138</issn><issn>0959-8146</issn><eissn>1468-5833</eissn><eissn>1756-1833</eissn><coden>BMJOAE</coden><abstract>Objective To describe the factors that contributed to successful recruitment of more than 200 000 women to the UK Collaborative Trial of Ovarian Cancer Screening, one of the largest ever randomised controlled trials.Design Descriptive study.Setting 13 NHS trusts in England, Wales, and Northern Ireland.Participants Postmenopausal women aged 50-74; exclusion criteria included ovarian malignancy, bilateral oophorectomy, increased risk of familial ovarian cancer, active non-ovarian malignancy, and participation in other ovarian cancer screening trials.Main outcome measures Achievement of target recruitment, acceptance rates of invitation, and recruitment rates.Results The trial was set up in 13 centres with 27 adjoining local health authorities. The coordinating centre team was led by one of the senior investigators, who was closely involved in planning and day to day trial management. Of 1 243 282 women invited, 23.2% (288 955) replied that they were eligible and would like to participate. Of those sent appointments, 73.6% (205 090) attended for recruitment. The acceptance rate varied from 19% to 33% between trial centres. Measures to ensure target recruitment included named coordinating centre staff supporting and monitoring each centre, prompt identification and resolution of logistic problems, varying the volume of invitations by centre, using local non-attendance rates to determine the size of recruitment clinics, and organising large ad hoc clinics supported by coordinating centre staff. The trial randomised 202 638 women in 4.3 years.Conclusions Planning and trial management are as important as trial design and require equal attention from senior investigators. Successful recruitment needs constant monitoring by a committed proactive management team that is willing to explore individual solutions for different centres and use central resources to improve local recruitment. Automation of trial processes with web based trial management systems is crucial in large multicentre randomised controlled trials. Recruitment can be further enhanced by using information videos and group discussions.Trial registration Current Controlled Trials ISRCTN22488978.</abstract><cop>London</cop><pub>British Medical Journal Publishing Group</pub><pmid>19008269</pmid><doi>10.1136/bmj.a2079</doi><tpages>4</tpages><edition>International edition</edition><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0959-8138 |
| ispartof | BMJ, 2008-11, Vol.337 (7681), p.1283-1286 |
| issn | 0959-8138 0959-8146 1468-5833 1756-1833 |
| language | eng |
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| source | Applied Social Sciences Index & Abstracts (ASSIA); Jstor Complete Legacy; MEDLINE; BMJ Journals - NESLi2; Alma/SFX Local Collection |
| subjects | Aged Biological and medical sciences Cancer screening Clinical trials Collaboration Experimentation Female General aspects Group discussion Hospital units Humans Mass Screening - mortality Media coverage Medical sciences Medical screening Middle Aged Multicenter Studies as Topic - methods Online recruitment Ovarian cancer Ovarian Neoplasms - mortality Ovarian Neoplasms - prevention & control Patient Acceptance of Health Care - statistics & numerical data Patient Selection Primary care Primary health care Professional recruitment Randomized Controlled Trials as Topic - methods Recruitment Research Design Staffing Ultrasonic imaging United Kingdom Web browsers Womens health Womens health services |
| title | Recruitment to multicentre trials—lessons from UKCTOCS: descriptive study |
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