Feasibility study to inform the design of a UK multi-centre randomised controlled trial of prophylactic antibiotics for the prevention of recurrent cellulitis of the leg
Identifieur interne : 001C18 ( Pmc/Curation ); précédent : 001C17; suivant : 001C19Feasibility study to inform the design of a UK multi-centre randomised controlled trial of prophylactic antibiotics for the prevention of recurrent cellulitis of the leg
Auteurs : Kim S. Thomas [Royaume-Uni] ; Neil H. Cox [Royaume-Uni] ; Boki Sp Savelyich [Royaume-Uni] ; Debbie Shipley [Royaume-Uni] ; Sarah Meredith [Royaume-Uni] ; Andrew Nunn [Royaume-Uni] ; Nick Reynolds [Royaume-Uni] ; Hywel C. Williams [Royaume-Uni]Source :
- Trials [ 1745-6215 ] ; 2007.
Abstract
This paper describes the results of a feasibility study for a randomised controlled trial (RCT).
Twenty-nine members of the UK Dermatology Clinical Trials Network (UK DCTN) expressed an interest in recruiting for this study. Of these, 17 obtained full ethics and Research & Development (R&D) approval, and 15 successfully recruited patients into the study. A total of 70 participants with a diagnosis of cellulitis of the leg were enrolled over a 5-month period. These participants were largely recruited from medical admissions wards, although some were identified from dermatology, orthopaedic, geriatric and general surgery wards. Data were collected on patient demographics, clinical features and willingness to take part in a future RCT.
Despite being a relatively common condition, cellulitis patients were difficult to locate through our network of UK DCTN clinicians. This was largely because patients were rarely seen by dermatologists, and admissions were not co-ordinated centrally. In addition, the impact of the proposed exclusion criteria was high; only 26 (37%) of those enrolled in the study fulfilled all of the inclusion criteria for the subsequent RCT, and were willing to be randomised to treatment.
Of the 70 participants identified during the study as having cellulitis of the leg (as confirmed by a dermatologist), only 59 (84%) had all 3 of the defining features of: i) erythema, ii) oedema, and iii) warmth with acute pain/tenderness upon examination.
Twenty-two (32%) patients experienced a previous episode of cellulitis within the last 3 years. The median time to recurrence (estimated as the time since the most recent previous attack) was 205 days (95% CI 102 to 308).
Service users were generally supportive of the trial, although several expressed concerns about taking antibiotics for lengthy periods, and felt that multiple morbidity/old age would limit entry into a 3-year study.
This pilot study has been crucial in highlighting some key issues for the conduct of a future RCT. As a result of these findings, changes have been made to i) the planned recruitment strategy, ii) the proposed inclusion criteria and ii) the definition of cellulitis for use in the future trial.
Url:
DOI: 10.1186/1745-6215-8-3
PubMed: 17257411
PubMed Central: 1797057
Links toward previous steps (curation, corpus...)
- to stream Pmc, to step Corpus: Pour aller vers cette notice dans l'étape Curation :001C19
Links to Exploration step
PMC:1797057Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Feasibility study to inform the design of a UK multi-centre randomised controlled trial of prophylactic antibiotics for the prevention of recurrent cellulitis of the leg</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="1"><nlm:aff id="I1">Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Centre of Evidence Based Dermatology, University of Nottingham, Nottingham</wicri:regionArea></affiliation></author><author><name sortKey="Cox, Neil H" sort="Cox, Neil H" uniqKey="Cox N" first="Neil H" last="Cox">Neil H. Cox</name><affiliation wicri:level="1"><nlm:aff id="I2">Department of Dermatology, Cumberland Infirmary, Carlisle, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Dermatology, Cumberland Infirmary, Carlisle</wicri:regionArea></affiliation></author><author><name sortKey="Savelyich, Boki Sp" sort="Savelyich, Boki Sp" uniqKey="Savelyich B" first="Boki Sp" last="Savelyich">Boki Sp Savelyich</name><affiliation wicri:level="1"><nlm:aff id="I1">Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Centre of Evidence Based Dermatology, University of Nottingham, Nottingham</wicri:regionArea></affiliation></author><author><name sortKey="Shipley, Debbie" sort="Shipley, Debbie" uniqKey="Shipley D" first="Debbie" last="Shipley">Debbie Shipley</name><affiliation wicri:level="1"><nlm:aff id="I3">Department of Dermatology, Bristol Royal Infirmary, Bristol, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Dermatology, Bristol Royal Infirmary, Bristol</wicri:regionArea></affiliation></author><author><name sortKey="Meredith, Sarah" sort="Meredith, Sarah" uniqKey="Meredith S" first="Sarah" last="Meredith">Sarah Meredith</name><affiliation wicri:level="1"><nlm:aff id="I4">MRC Clinical Trials Unit, London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>MRC Clinical Trials Unit, London</wicri:regionArea></affiliation></author><author><name sortKey="Nunn, Andrew" sort="Nunn, Andrew" uniqKey="Nunn A" first="Andrew" last="Nunn">Andrew Nunn</name><affiliation wicri:level="1"><nlm:aff id="I4">MRC Clinical Trials Unit, London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>MRC Clinical Trials Unit, London</wicri:regionArea></affiliation></author><author><name sortKey="Reynolds, Nick" sort="Reynolds, Nick" uniqKey="Reynolds N" first="Nick" last="Reynolds">Nick Reynolds</name><affiliation wicri:level="1"><nlm:aff id="I5">Department of Dermatology, University of Newcastle, Newcastle, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Dermatology, University of Newcastle, Newcastle</wicri:regionArea></affiliation></author><author><name sortKey="Williams, Hywel C" sort="Williams, Hywel C" uniqKey="Williams H" first="Hywel C" last="Williams">Hywel C. Williams</name><affiliation wicri:level="1"><nlm:aff id="I1">Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Centre of Evidence Based Dermatology, University of Nottingham, Nottingham</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">17257411</idno><idno type="pmc">1797057</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1797057</idno><idno type="RBID">PMC:1797057</idno><idno type="doi">10.1186/1745-6215-8-3</idno><date when="2007">2007</date><idno type="wicri:Area/Pmc/Corpus">001C19</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001C19</idno><idno type="wicri:Area/Pmc/Curation">001C18</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">001C18</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Feasibility study to inform the design of a UK multi-centre randomised controlled trial of prophylactic antibiotics for the prevention of recurrent cellulitis of the leg</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="1"><nlm:aff id="I1">Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Centre of Evidence Based Dermatology, University of Nottingham, Nottingham</wicri:regionArea></affiliation></author><author><name sortKey="Cox, Neil H" sort="Cox, Neil H" uniqKey="Cox N" first="Neil H" last="Cox">Neil H. Cox</name><affiliation wicri:level="1"><nlm:aff id="I2">Department of Dermatology, Cumberland Infirmary, Carlisle, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Dermatology, Cumberland Infirmary, Carlisle</wicri:regionArea></affiliation></author><author><name sortKey="Savelyich, Boki Sp" sort="Savelyich, Boki Sp" uniqKey="Savelyich B" first="Boki Sp" last="Savelyich">Boki Sp Savelyich</name><affiliation wicri:level="1"><nlm:aff id="I1">Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Centre of Evidence Based Dermatology, University of Nottingham, Nottingham</wicri:regionArea></affiliation></author><author><name sortKey="Shipley, Debbie" sort="Shipley, Debbie" uniqKey="Shipley D" first="Debbie" last="Shipley">Debbie Shipley</name><affiliation wicri:level="1"><nlm:aff id="I3">Department of Dermatology, Bristol Royal Infirmary, Bristol, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Dermatology, Bristol Royal Infirmary, Bristol</wicri:regionArea></affiliation></author><author><name sortKey="Meredith, Sarah" sort="Meredith, Sarah" uniqKey="Meredith S" first="Sarah" last="Meredith">Sarah Meredith</name><affiliation wicri:level="1"><nlm:aff id="I4">MRC Clinical Trials Unit, London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>MRC Clinical Trials Unit, London</wicri:regionArea></affiliation></author><author><name sortKey="Nunn, Andrew" sort="Nunn, Andrew" uniqKey="Nunn A" first="Andrew" last="Nunn">Andrew Nunn</name><affiliation wicri:level="1"><nlm:aff id="I4">MRC Clinical Trials Unit, London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>MRC Clinical Trials Unit, London</wicri:regionArea></affiliation></author><author><name sortKey="Reynolds, Nick" sort="Reynolds, Nick" uniqKey="Reynolds N" first="Nick" last="Reynolds">Nick Reynolds</name><affiliation wicri:level="1"><nlm:aff id="I5">Department of Dermatology, University of Newcastle, Newcastle, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Dermatology, University of Newcastle, Newcastle</wicri:regionArea></affiliation></author><author><name sortKey="Williams, Hywel C" sort="Williams, Hywel C" uniqKey="Williams H" first="Hywel C" last="Williams">Hywel C. Williams</name><affiliation wicri:level="1"><nlm:aff id="I1">Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Centre of Evidence Based Dermatology, University of Nottingham, Nottingham</wicri:regionArea></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2007">2007</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>This paper describes the results of a feasibility study for a randomised controlled trial (RCT).</p></sec><sec sec-type="methods"><title>Methods</title><p>Twenty-nine members of the UK Dermatology Clinical Trials Network (UK DCTN) expressed an interest in recruiting for this study. Of these, 17 obtained full ethics and Research & Development (R&D) approval, and 15 successfully recruited patients into the study. A total of 70 participants with a diagnosis of cellulitis of the leg were enrolled over a 5-month period. These participants were largely recruited from medical admissions wards, although some were identified from dermatology, orthopaedic, geriatric and general surgery wards. Data were collected on patient demographics, clinical features and willingness to take part in a future RCT.</p></sec><sec><title>Results</title><p>Despite being a relatively common condition, cellulitis patients were difficult to locate through our network of UK DCTN clinicians. This was largely because patients were rarely seen by dermatologists, and admissions were not co-ordinated centrally. In addition, the impact of the proposed exclusion criteria was high; only 26 (37%) of those enrolled in the study fulfilled all of the inclusion criteria for the subsequent RCT, and were willing to be randomised to treatment.</p><p>Of the 70 participants identified during the study as having cellulitis of the leg (as confirmed by a dermatologist), only 59 (84%) had all 3 of the defining features of: i) erythema, ii) oedema, and iii) warmth with acute pain/tenderness upon examination.</p><p>Twenty-two (32%) patients experienced a previous episode of cellulitis within the last 3 years. The median time to recurrence (estimated as the time since the most recent previous attack) was 205 days (95% CI 102 to 308).</p><p>Service users were generally supportive of the trial, although several expressed concerns about taking antibiotics for lengthy periods, and felt that multiple morbidity/old age would limit entry into a 3-year study.</p></sec><sec><title>Conclusion</title><p>This pilot study has been crucial in highlighting some key issues for the conduct of a future RCT. As a result of these findings, changes have been made to i) the planned recruitment strategy, ii) the proposed inclusion criteria and ii) the definition of cellulitis for use in the future trial.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Trials</journal-id><journal-title>Trials</journal-title><issn pub-type="epub">1745-6215</issn><publisher><publisher-name>BioMed Central</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">17257411</article-id><article-id pub-id-type="pmc">1797057</article-id><article-id pub-id-type="publisher-id">1745-6215-8-3</article-id><article-id pub-id-type="doi">10.1186/1745-6215-8-3</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research</subject></subj-group></article-categories><title-group><article-title>Feasibility study to inform the design of a UK multi-centre randomised controlled trial of prophylactic antibiotics for the prevention of recurrent cellulitis of the leg</article-title></title-group><contrib-group><contrib id="A1" corresp="yes" contrib-type="author"><name><surname>Thomas</surname><given-names>Kim S</given-names></name><xref ref-type="aff" rid="I1">1</xref><email>kim.thomas@nottingham.ac.uk</email></contrib><contrib id="A2" contrib-type="author"><name><surname>Cox</surname><given-names>Neil H</given-names></name><xref ref-type="aff" rid="I2">2</xref><email>neil.cox@ncumbria-acute.nhs.uk</email></contrib><contrib id="A3" contrib-type="author"><name><surname>Savelyich</surname><given-names>Boki SP</given-names></name><xref ref-type="aff" rid="I1">1</xref><email>boki-savelyich@nottingham.ac.uk</email></contrib><contrib id="A4" contrib-type="author"><name><surname>Shipley</surname><given-names>Debbie</given-names></name><xref ref-type="aff" rid="I3">3</xref><email>debbie.shipley@ubht.swest.nhs.uk</email></contrib><contrib id="A5" contrib-type="author"><name><surname>Meredith</surname><given-names>Sarah</given-names></name><xref ref-type="aff" rid="I4">4</xref><email>sm@ctu.mrc.ac.uk</email></contrib><contrib id="A6" contrib-type="author"><name><surname>Nunn</surname><given-names>Andrew</given-names></name><xref ref-type="aff" rid="I4">4</xref><email>andrew.nunn@ctu.mrc.ac.uk</email></contrib><contrib id="A7" contrib-type="author"><name><surname>Reynolds</surname><given-names>Nick</given-names></name><xref ref-type="aff" rid="I5">5</xref><email>n.j.reynolds@ncl.ac.uk</email></contrib><contrib id="A8" contrib-type="author"><name><surname>Williams</surname><given-names>Hywel C</given-names></name><xref ref-type="aff" rid="I1">1</xref><email>hywel.williams@nottingham.ac.uk</email></contrib><contrib id="A9" contrib-type="author"><collab>on behalf of the UK Dermatology Clinical Trials Network (UK DCTN)</collab><xref ref-type="aff" rid="I1">1</xref><email>joanne.chalmers@nottingham.ac.uk</email></contrib></contrib-group><aff id="I1"><label>1</label>Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK</aff><aff id="I2"><label>2</label>Department of Dermatology, Cumberland Infirmary, Carlisle, UK</aff><aff id="I3"><label>3</label>Department of Dermatology, Bristol Royal Infirmary, Bristol, UK</aff><aff id="I4"><label>4</label>MRC Clinical Trials Unit, London, UK</aff><aff id="I5"><label>5</label>Department of Dermatology, University of Newcastle, Newcastle, UK</aff><pub-date pub-type="collection"><year>2007</year></pub-date><pub-date pub-type="epub"><day>26</day><month>1</month><year>2007</year></pub-date><volume>8</volume><fpage>3</fpage><lpage>3</lpage><ext-link ext-link-type="uri" xlink:href="http://www.trialsjournal.com/content/8/1/3"></ext-link><history><date date-type="received"><day>18</day><month>8</month><year>2006</year></date><date date-type="accepted"><day>26</day><month>1</month><year>2007</year></date></history><permissions><copyright-statement>Copyright © 2007 Thomas et al; licensee BioMed Central Ltd.</copyright-statement><copyright-year>2007</copyright-year><copyright-holder>Thomas et al; licensee BioMed Central Ltd.</copyright-holder><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/2.0"><p>This is an Open Access article distributed under the terms of the Creative Commons Attribution License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/2.0"></ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</p><pmc-comment>
Thomas
S
Kim
kim.thomas@nottingham.ac.uk
Feasibility study to inform the design of a UK multi-centre randomised controlled trial of prophylactic antibiotics for the prevention of recurrent cellulitis of the leg
2007 Trials 8(1): 3-. (2007) 1745-6215(2007)8:1<3> urn:ISSN:1745-6215
</license></permissions><abstract><sec><title>Background</title><p>This paper describes the results of a feasibility study for a randomised controlled trial (RCT).</p></sec><sec sec-type="methods"><title>Methods</title><p>Twenty-nine members of the UK Dermatology Clinical Trials Network (UK DCTN) expressed an interest in recruiting for this study. Of these, 17 obtained full ethics and Research & Development (R&D) approval, and 15 successfully recruited patients into the study. A total of 70 participants with a diagnosis of cellulitis of the leg were enrolled over a 5-month period. These participants were largely recruited from medical admissions wards, although some were identified from dermatology, orthopaedic, geriatric and general surgery wards. Data were collected on patient demographics, clinical features and willingness to take part in a future RCT.</p></sec><sec><title>Results</title><p>Despite being a relatively common condition, cellulitis patients were difficult to locate through our network of UK DCTN clinicians. This was largely because patients were rarely seen by dermatologists, and admissions were not co-ordinated centrally. In addition, the impact of the proposed exclusion criteria was high; only 26 (37%) of those enrolled in the study fulfilled all of the inclusion criteria for the subsequent RCT, and were willing to be randomised to treatment.</p><p>Of the 70 participants identified during the study as having cellulitis of the leg (as confirmed by a dermatologist), only 59 (84%) had all 3 of the defining features of: i) erythema, ii) oedema, and iii) warmth with acute pain/tenderness upon examination.</p><p>Twenty-two (32%) patients experienced a previous episode of cellulitis within the last 3 years. The median time to recurrence (estimated as the time since the most recent previous attack) was 205 days (95% CI 102 to 308).</p><p>Service users were generally supportive of the trial, although several expressed concerns about taking antibiotics for lengthy periods, and felt that multiple morbidity/old age would limit entry into a 3-year study.</p></sec><sec><title>Conclusion</title><p>This pilot study has been crucial in highlighting some key issues for the conduct of a future RCT. As a result of these findings, changes have been made to i) the planned recruitment strategy, ii) the proposed inclusion criteria and ii) the definition of cellulitis for use in the future trial.</p></sec></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Sante/explor/LymphedemaV1/Data/Pmc/Curation
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001C18 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Pmc/Curation/biblio.hfd -nk 001C18 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Sante
|area= LymphedemaV1
|flux= Pmc
|étape= Curation
|type= RBID
|clé= PMC:1797057
|texte= Feasibility study to inform the design of a UK multi-centre randomised controlled trial of prophylactic antibiotics for the prevention of recurrent cellulitis of the leg
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Pmc/Curation/RBID.i -Sk "pubmed:17257411" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Pmc/Curation/biblio.hfd \
| NlmPubMed2Wicri -a LymphedemaV1
| This area was generated with Dilib version V0.6.31. |  |