Studying a disease with no home--lessons in trial recruitment from the PATCH II study.

Hdl Handle:
http://hdl.handle.net/10147/128377
Title:
Studying a disease with no home--lessons in trial recruitment from the PATCH II study.
Authors:
Thomas, Kim S
Affiliation:
Centre of Evidence Based Dermatology, University of Nottingham, King's Meadow Campus, Nottingham NG7 2NR, UK. kim.thomas@nottingham.ac.uk.
Citation:
Studying a disease with no home--lessons in trial recruitment from the PATCH II study. 2010, 11:22 Trials
Journal:
Trials
Issue Date:
2010
URI:
http://hdl.handle.net/10147/128377
DOI:
10.1186/1745-6215-11-22
PubMed ID:
20196846
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.
Item Type:
Article
Language:
en
MeSH:
Anti-Bacterial Agents; Cellulitis; Cooperative Behavior; Double-Blind Method; Great Britain; Humans; Interinstitutional Relations; Leg; Patient Selection; Penicillin V; Recurrence; Research Support as Topic; Time Factors; Treatment Outcome
ISSN:
1745-6215

Full metadata record

DC FieldValue Language
dc.contributor.authorThomas, Kim Sen
dc.date.accessioned2011-04-19T14:55:34Z-
dc.date.available2011-04-19T14:55:34Z-
dc.date.issued2010-
dc.identifier.citationStudying a disease with no home--lessons in trial recruitment from the PATCH II study. 2010, 11:22 Trialsen
dc.identifier.issn1745-6215-
dc.identifier.pmid20196846-
dc.identifier.doi10.1186/1745-6215-11-22-
dc.identifier.urihttp://hdl.handle.net/10147/128377-
dc.description.abstractCellulitis 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.-
dc.description.abstractA 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.-
dc.description.abstractThe 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.-
dc.description.abstractThe 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.-
dc.description.abstractThe trial registration number is ISRCTN03813200.-
dc.language.isoenen
dc.subject.meshAnti-Bacterial Agents-
dc.subject.meshCellulitis-
dc.subject.meshCooperative Behavior-
dc.subject.meshDouble-Blind Method-
dc.subject.meshGreat Britain-
dc.subject.meshHumans-
dc.subject.meshInterinstitutional Relations-
dc.subject.meshLeg-
dc.subject.meshPatient Selection-
dc.subject.meshPenicillin V-
dc.subject.meshRecurrence-
dc.subject.meshResearch Support as Topic-
dc.subject.meshTime Factors-
dc.subject.meshTreatment Outcome-
dc.titleStudying a disease with no home--lessons in trial recruitment from the PATCH II study.en
dc.typeArticleen
dc.contributor.departmentCentre of Evidence Based Dermatology, University of Nottingham, King's Meadow Campus, Nottingham NG7 2NR, UK. kim.thomas@nottingham.ac.uk.en
dc.identifier.journalTrialsen
dc.description.provinceMunster-

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