Studying a disease with no home - lessons in trial recruitment from the PATCH II study
Identifieur interne : 005599 ( Main/Exploration ); précédent : 005598; suivant : 005600Studying a disease with no home - lessons in trial recruitment from the PATCH II study
Auteurs : Kim S. Thomas [Royaume-Uni]Source :
- Trials [ 1745-6215 ] ; 2010.
Abstract
Cellulitis is a very common condition that often recurs. The PATCH II study was designed to explore the possibility of preventing future episodes of cellulitis, with resultant cost savings for the NHS. This was the first trial to be undertaken by the UK Dermatology Clinical Trials Network. As such, it was the first to test a recruitment model that involved many busy clinicians each contributing just a few patients.
A double-blind randomised controlled trial comparing prophylactic antibiotics (penicillin V) with placebo tablets, for the prevention of repeat episodes of cellulitis of the leg. Primary outcome was time to subsequent recurrence of cellulitis.
The PATCH II study was closed to recruitment having enrolled 123 participants from a target of 400. Whilst the recruitment period was extended by 12 months, it was not possible to continue beyond this point without additional funds. Many factors contributed to poor recruitment: (i) changes in hospital policy and the introduction of community-based intravenous teams resulted in fewer cellulitis patients being admitted to hospital; ii) those who were admitted were seen by many different specialties, making it difficult for a network of dermatology clinicians to identify suitable participants; and iii) funding for research staff was limited to a trial manager and a trial administrator at the co-ordinating centre. With no dedicated research nurses at the recruiting centres, it was extremely difficult to maintain momentum and interest in the study. Attempts to boost recruitment by providing some financial support for principal investigators to employ local research staff was of limited success.
The model of a network of busy NHS clinicians all recruiting a few patients into large clinical studies requires further testing. It did not work very well for PATCH II, but this was probably because patients were not routinely seen by dermatologists, and recruitment took place prior to research support being available through the Comprehensive Clinical Research Network (CCRN). There is a balance to be struck between asking a lot of centres to recruit just a few patients, and asking a few centres to recruit a lot of patients. Giving modest funds to principal investigators to buy local research nurse time did not work well, probably because too little research time was bought, and it was difficult to separate research tasks from the nurses existing clinical duties. National research infrastructure networks such as the Comprehensive Clinical Research Network will overcome many of the problems encountered in the PATCH II trial.
The trial registration number is ISRCTN03813200.
Url:
DOI: 10.1186/1745-6215-11-22
PubMed: 20196846
PubMed Central: 2838882
Affiliations:
Links toward previous steps (curation, corpus...)
- to stream Pmc, to step Corpus: 004654
- to stream Pmc, to step Curation: 004653
- to stream Pmc, to step Checkpoint: 003207
- to stream Ncbi, to step Merge: 003942
- to stream Ncbi, to step Curation: 003942
- to stream Ncbi, to step Checkpoint: 003942
- to stream Main, to step Merge: 005647
- to stream Main, to step Curation: 005599
Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Studying a disease with no home - lessons in trial recruitment from the PATCH II study</title>
<author><name sortKey="Thomas, Kim S" sort="Thomas, Kim S" uniqKey="Thomas K" first="Kim S" last="Thomas">Kim S. Thomas</name>
<affiliation wicri:level="4"><nlm:aff id="I1">Centre of Evidence Based Dermatology, University of Nottingham, King's Meadow Campus, Nottingham NG7 2NR, UK</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Centre of Evidence Based Dermatology, University of Nottingham, King's Meadow Campus, Nottingham NG7 2NR</wicri:regionArea>
<orgName type="university">Université de Nottingham</orgName>
<placeName><settlement type="city">Nottingham</settlement>
<region type="nation">Angleterre</region>
<region type="région" nuts="1">Nottinghamshire</region>
</placeName>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PMC</idno>
<idno type="pmid">20196846</idno>
<idno type="pmc">2838882</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2838882</idno>
<idno type="RBID">PMC:2838882</idno>
<idno type="doi">10.1186/1745-6215-11-22</idno>
<date when="2010">2010</date>
<idno type="wicri:Area/Pmc/Corpus">004654</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">004654</idno>
<idno type="wicri:Area/Pmc/Curation">004653</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">004653</idno>
<idno type="wicri:Area/Pmc/Checkpoint">003207</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">003207</idno>
<idno type="wicri:Area/Ncbi/Merge">003942</idno>
<idno type="wicri:Area/Ncbi/Curation">003942</idno>
<idno type="wicri:Area/Ncbi/Checkpoint">003942</idno>
<idno type="wicri:Area/Main/Merge">005647</idno>
<idno type="wicri:Area/Main/Curation">005599</idno>
<idno type="wicri:Area/Main/Exploration">005599</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Studying a disease with no home - lessons in trial recruitment from the PATCH II study</title>
<author><name sortKey="Thomas, Kim S" sort="Thomas, Kim S" uniqKey="Thomas K" first="Kim S" last="Thomas">Kim S. Thomas</name>
<affiliation wicri:level="4"><nlm:aff id="I1">Centre of Evidence Based Dermatology, University of Nottingham, King's Meadow Campus, Nottingham NG7 2NR, UK</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Centre of Evidence Based Dermatology, University of Nottingham, King's Meadow Campus, Nottingham NG7 2NR</wicri:regionArea>
<orgName type="university">Université de Nottingham</orgName>
<placeName><settlement type="city">Nottingham</settlement>
<region type="nation">Angleterre</region>
<region type="région" nuts="1">Nottinghamshire</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">Trials</title>
<idno type="eISSN">1745-6215</idno>
<imprint><date when="2010">2010</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>Cellulitis is a very common condition that often recurs. The PATCH II study was designed to explore the possibility of preventing future episodes of cellulitis, with resultant cost savings for the NHS. This was the first trial to be undertaken by the UK Dermatology Clinical Trials Network. As such, it was the first to test a recruitment model that involved many busy clinicians each contributing just a few patients.</p>
</sec>
<sec><title>Methods</title>
<p>A double-blind randomised controlled trial comparing prophylactic antibiotics (penicillin V) with placebo tablets, for the prevention of repeat episodes of cellulitis of the leg. Primary outcome was time to subsequent recurrence of cellulitis.</p>
</sec>
<sec><title>Results</title>
<p>The PATCH II study was closed to recruitment having enrolled 123 participants from a target of 400. Whilst the recruitment period was extended by 12 months, it was not possible to continue beyond this point without additional funds. Many factors contributed to poor recruitment: (i) changes in hospital policy and the introduction of community-based intravenous teams resulted in fewer cellulitis patients being admitted to hospital; ii) those who were admitted were seen by many different specialties, making it difficult for a network of dermatology clinicians to identify suitable participants; and iii) funding for research staff was limited to a trial manager and a trial administrator at the co-ordinating centre. With no dedicated research nurses at the recruiting centres, it was extremely difficult to maintain momentum and interest in the study. Attempts to boost recruitment by providing some financial support for principal investigators to employ local research staff was of limited success.</p>
</sec>
<sec><title>Discussion</title>
<p>The model of a network of busy NHS clinicians all recruiting a few patients into large clinical studies requires further testing. It did not work very well for PATCH II, but this was probably because patients were not routinely seen by dermatologists, and recruitment took place prior to research support being available through the Comprehensive Clinical Research Network (CCRN). There is a balance to be struck between asking a lot of centres to recruit just a few patients, and asking a few centres to recruit a lot of patients. Giving modest funds to principal investigators to buy local research nurse time did not work well, probably because too little research time was bought, and it was difficult to separate research tasks from the nurses existing clinical duties. National research infrastructure networks such as the Comprehensive Clinical Research Network will overcome many of the problems encountered in the PATCH II trial.</p>
</sec>
<sec><title>Trial Registration</title>
<p>The trial registration number is ISRCTN03813200.</p>
</sec>
</div>
</front>
<back><div1 type="bibliography"><listBibl><biblStruct></biblStruct>
<biblStruct><analytic><author><name sortKey="Thomas, Ks" uniqKey="Thomas K">KS Thomas</name>
</author>
<author><name sortKey="Cox, Nh" uniqKey="Cox N">NH Cox</name>
</author>
<author><name sortKey="Savelyich, Bs" uniqKey="Savelyich B">BS Savelyich</name>
</author>
<author><name sortKey="Shipley, D" uniqKey="Shipley D">D Shipley</name>
</author>
<author><name sortKey="Meredith, S" uniqKey="Meredith S">S Meredith</name>
</author>
<author><name sortKey="Nunn, A" uniqKey="Nunn A">A Nunn</name>
</author>
<author><name sortKey="Reynolds, N" uniqKey="Reynolds N">N Reynolds</name>
</author>
<author><name sortKey="Williams, Hc" uniqKey="Williams H">HC Williams</name>
</author>
</analytic>
</biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct><analytic><author><name sortKey="Depledge, J" uniqKey="Depledge J">J Depledge</name>
</author>
<author><name sortKey="Gracie, F" uniqKey="Gracie F">F Gracie</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Corwin, P" uniqKey="Corwin P">P Corwin</name>
</author>
<author><name sortKey="Toop, L" uniqKey="Toop L">L Toop</name>
</author>
<author><name sortKey="Mcgeoch, G" uniqKey="Mcgeoch G">G McGeoch</name>
</author>
<author><name sortKey="Than, M" uniqKey="Than M">M Than</name>
</author>
<author><name sortKey="Wynn Thomas, S" uniqKey="Wynn Thomas S">S Wynn-Thomas</name>
</author>
<author><name sortKey="Wells, Ej" uniqKey="Wells E">EJ Wells</name>
</author>
<author><name sortKey="Dawson, R" uniqKey="Dawson R">R Dawson</name>
</author>
<author><name sortKey="Abernethy, P" uniqKey="Abernethy P">P Abernethy</name>
</author>
<author><name sortKey="Pithie, A" uniqKey="Pithie A">A Pithie</name>
</author>
<author><name sortKey="Chambers, S" uniqKey="Chambers S">S Chambers</name>
</author>
<author><name sortKey="Fletcher, L" uniqKey="Fletcher L">L Fletcher</name>
</author>
<author><name sortKey="Richards, D" uniqKey="Richards D">D Richards</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Gillan, Mg" uniqKey="Gillan M">MG Gillan</name>
</author>
<author><name sortKey="Ross, S" uniqKey="Ross S">S Ross</name>
</author>
<author><name sortKey="Gilbert, Fj" uniqKey="Gilbert F">FJ Gilbert</name>
</author>
<author><name sortKey="Grant, Am" uniqKey="Grant A">AM Grant</name>
</author>
<author><name sortKey="O Dwyer, Pj" uniqKey="O Dwyer P">PJ O'Dwyer</name>
</author>
</analytic>
</biblStruct>
<biblStruct></biblStruct>
<biblStruct><analytic><author><name sortKey="Brealey, Sd" uniqKey="Brealey S">SD Brealey</name>
</author>
<author><name sortKey="Atwell, C" uniqKey="Atwell C">C Atwell</name>
</author>
<author><name sortKey="Bryan, S" uniqKey="Bryan S">S Bryan</name>
</author>
<author><name sortKey="Coulton, S" uniqKey="Coulton S">S Coulton</name>
</author>
<author><name sortKey="Cox, H" uniqKey="Cox H">H Cox</name>
</author>
<author><name sortKey="Cross, B" uniqKey="Cross B">B Cross</name>
</author>
<author><name sortKey="Fylan, F" uniqKey="Fylan F">F Fylan</name>
</author>
<author><name sortKey="Garratt, A" uniqKey="Garratt A">A Garratt</name>
</author>
<author><name sortKey="Gilbert, Fj" uniqKey="Gilbert F">FJ Gilbert</name>
</author>
<author><name sortKey="Gillan, Mg" uniqKey="Gillan M">MG Gillan</name>
</author>
<author><name sortKey="Hendry, M" uniqKey="Hendry M">M Hendry</name>
</author>
<author><name sortKey="Hood, K" uniqKey="Hood K">K Hood</name>
</author>
<author><name sortKey="Houston, H" uniqKey="Houston H">H Houston</name>
</author>
<author><name sortKey="King, D" uniqKey="King D">D King</name>
</author>
<author><name sortKey="Morton, V" uniqKey="Morton V">V Morton</name>
</author>
<author><name sortKey="Orchard, J" uniqKey="Orchard J">J Orchard</name>
</author>
<author><name sortKey="Robling, M" uniqKey="Robling M">M Robling</name>
</author>
<author><name sortKey="Russell, It" uniqKey="Russell I">IT Russell</name>
</author>
<author><name sortKey="Torgerson, D" uniqKey="Torgerson D">D Torgerson</name>
</author>
<author><name sortKey="Wadsworth, V" uniqKey="Wadsworth V">V Wadsworth</name>
</author>
<author><name sortKey="Wilkinson, C" uniqKey="Wilkinson C">C Wilkinson</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Macdonald, Am" uniqKey="Macdonald A">AM MacDonald</name>
</author>
<author><name sortKey="Knight, Rc" uniqKey="Knight R">RC Knight</name>
</author>
<author><name sortKey="Campbell, Mk" uniqKey="Campbell M">MK Campbell</name>
</author>
<author><name sortKey="Entwistle, Va" uniqKey="Entwistle V">VA Entwistle</name>
</author>
<author><name sortKey="Grant, Am" uniqKey="Grant A">AM Grant</name>
</author>
<author><name sortKey="Cook, Ja" uniqKey="Cook J">JA Cook</name>
</author>
<author><name sortKey="Elbourne, Dr" uniqKey="Elbourne D">DR Elbourne</name>
</author>
<author><name sortKey="Francis, D" uniqKey="Francis D">D Francis</name>
</author>
<author><name sortKey="Garcia, J" uniqKey="Garcia J">J Garcia</name>
</author>
<author><name sortKey="Roberts, I" uniqKey="Roberts I">I Roberts</name>
</author>
<author><name sortKey="Snowdon, C" uniqKey="Snowdon C">C Snowdon</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Carr, A" uniqKey="Carr A">A Carr</name>
</author>
<author><name sortKey="Cooper, C" uniqKey="Cooper C">C Cooper</name>
</author>
</analytic>
</biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct><analytic><author><name sortKey="Menon, U" uniqKey="Menon U">U Menon</name>
</author>
<author><name sortKey="Gentry Maharaj, A" uniqKey="Gentry Maharaj A">A Gentry-Maharaj</name>
</author>
<author><name sortKey="Ryan, A" uniqKey="Ryan A">A Ryan</name>
</author>
<author><name sortKey="Sharma, A" uniqKey="Sharma A">A Sharma</name>
</author>
<author><name sortKey="Burnell, M" uniqKey="Burnell M">M Burnell</name>
</author>
<author><name sortKey="Hallett, R" uniqKey="Hallett R">R Hallett</name>
</author>
<author><name sortKey="Lewis, S" uniqKey="Lewis S">S Lewis</name>
</author>
<author><name sortKey="Lopez, A" uniqKey="Lopez A">A Lopez</name>
</author>
<author><name sortKey="Godfrey, K" uniqKey="Godfrey K">K Godfrey</name>
</author>
<author><name sortKey="Oram, D" uniqKey="Oram D">D Oram</name>
</author>
<author><name sortKey="Herod, J" uniqKey="Herod J">J Herod</name>
</author>
<author><name sortKey="Williamson, K" uniqKey="Williamson K">K Williamson</name>
</author>
<author><name sortKey="Seif, M" uniqKey="Seif M">M Seif</name>
</author>
<author><name sortKey="Scott, I" uniqKey="Scott I">I Scott</name>
</author>
<author><name sortKey="Mould, T" uniqKey="Mould T">T Mould</name>
</author>
<author><name sortKey="Woolas, R" uniqKey="Woolas R">R Woolas</name>
</author>
<author><name sortKey="Murdoch, J" uniqKey="Murdoch J">J Murdoch</name>
</author>
<author><name sortKey="Dobbs, S" uniqKey="Dobbs S">S Dobbs</name>
</author>
<author><name sortKey="Amso, N" uniqKey="Amso N">N Amso</name>
</author>
<author><name sortKey="Leeson, S" uniqKey="Leeson S">S Leeson</name>
</author>
<author><name sortKey="Cruickshank, D" uniqKey="Cruickshank D">D Cruickshank</name>
</author>
<author><name sortKey="Mcguire, A" uniqKey="Mcguire A">A McGuire</name>
</author>
<author><name sortKey="Campbell, S" uniqKey="Campbell S">S Campbell</name>
</author>
<author><name sortKey="Fallowfield, L" uniqKey="Fallowfield L">L Fallowfield</name>
</author>
<author><name sortKey="Skates, S" uniqKey="Skates S">S Skates</name>
</author>
<author><name sortKey="Parmar, M" uniqKey="Parmar M">M Parmar</name>
</author>
<author><name sortKey="Jacobs, I" uniqKey="Jacobs I">I Jacobs</name>
</author>
</analytic>
</biblStruct>
</listBibl>
</div1>
</back>
</TEI>
<affiliations><list><country><li>Royaume-Uni</li>
</country>
<region><li>Angleterre</li>
<li>Nottinghamshire</li>
</region>
<settlement><li>Nottingham</li>
</settlement>
<orgName><li>Université de Nottingham</li>
</orgName>
</list>
<tree><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Thomas, Kim S" sort="Thomas, Kim S" uniqKey="Thomas K" first="Kim S" last="Thomas">Kim S. Thomas</name>
</region>
</country>
</tree>
</affiliations>
</record>
Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Sante/explor/LymphedemaV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 005599 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 005599 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien |wiki= Wicri/Sante |area= LymphedemaV1 |flux= Main |étape= Exploration |type= RBID |clé= PMC:2838882 |texte= Studying a disease with no home - lessons in trial recruitment from the PATCH II study }}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i -Sk "pubmed:20196846" \ | HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd \ | NlmPubMed2Wicri -a LymphedemaV1
This area was generated with Dilib version V0.6.31. |