{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T12:22:32Z","timestamp":1782476552335,"version":"3.54.5"},"reference-count":29,"publisher":"BMJ","issue":"2","funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment Programme","doi-asserted-by":"publisher","award":["HTA 06\/78\/03"],"award-info":[{"award-number":["HTA 06\/78\/03"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2016,11,15]]},"published-print":{"date-parts":[[2017,2]]},"abstract":"<jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>Insight into healthcare professionals\u2019 views and experiences of the use of ciclosporin and infliximab as salvage therapies for acute ulcerative colitis (UC) and how this may affect participation in a comparison trial is lacking. The study aimed to capture views and opinions of healthcare professionals about the two drugs within the CONSTRUCT trial.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Design<\/jats:title>\n                  <jats:p>An interview-based qualitative study using Framework Analysis embedded within an open-label, pragmatic randomised trial.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Setting<\/jats:title>\n                  <jats:p>National Health Service Health Boards and Trusts, including large teaching and district hospitals in England, Scotland and Wales.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Participants<\/jats:title>\n                  <jats:p>Principal Investigators (PIs) for trial sites (who were all consultant gastroenterologists) and nurses responsible for administering and monitoring the salvage therapy drugs across trial sites. 15 PIs and 8 nurses recruited from a range of sites stratified by site recruitment rates were interviewed.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Interviews revealed that professionals made judgements regarding the salvage therapies largely based on experience of giving the two drugs and perceptions of effectiveness and adverse side effects. A clear preference for infliximab among nurses was revealed, largely based on experiences of administration and drug handling, with some doctors strongly favouring infliximab based on experience of prescribing the drug as well as patient views and the existing evidence base. Most doctors were more equivocal, and all were prepared to suspend preferences and wait for evidence of effectiveness and safety from the CONSTRUCT trial. PIs also questioned guidelines around drug use and restrictions placed on personal autonomy in delivering best patient care.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Findings highlight healthcare professionals\u2019 preference for the salvage treatment, infliximab in treating steroid-resistant UC, largely based on resource intensive nursing requirements of intravenous administration of ciclosporin. Not all doctors expressed this preference, being more equivocal, and all professionals were content to suspend preferences within the CONSTRUCT trial and recognised the importance of establishing relative effectiveness and safety.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/www.isrctn.com\/ISRCTN22663589\" ext-link-type=\"uri\">ISRCTN 22663589<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2016-014512","type":"journal-article","created":{"date-parts":[[2017,3,28]],"date-time":"2017-03-28T20:29:22Z","timestamp":1490732962000},"page":"e014512","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":18,"title":["Healthcare professionals\u2019 views of the use and administration of two salvage therapy drugs for acute ulcerative colitis: a nested qualitative study within the CONSTRUCT trial"],"prefix":"10.1136","volume":"7","author":[{"given":"Clare","family":"Clement","sequence":"first","affiliation":[{"name":"School of Social and Community Medicine, University of Bristol, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frances","family":"Rapport","sequence":"additional","affiliation":[{"name":"Centre for Healthcare Resilience and Implementation Science, Macquarie University, Sydney, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Seagrove","sequence":"additional","affiliation":[{"name":"Swansea University Medical School, Swansea University, Swansea, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laith","family":"Alrubaiy","sequence":"additional","affiliation":[{"name":"Swansea University Medical School, Swansea University, Swansea, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Williams","sequence":"additional","affiliation":[{"name":"Swansea University Medical School, Swansea University, Swansea, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2017,2,22]]},"reference":[{"key":"2025101814274356000_7.2.e014512.1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.2000.00886.x"},{"key":"2025101814274356000_7.2.e014512.2","doi-asserted-by":"publisher","DOI":"10.1016\/j.crohns.2010.02.001"},{"key":"2025101814274356000_7.2.e014512.3","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2004.02056.x"},{"key":"2025101814274356000_7.2.e014512.4","doi-asserted-by":"crossref","first-page":"1005","DOI":"10.1016\/0016-5085(85)90201-X","article-title":"Intensive intravenous treatment of ulcerative colitis","volume":"89","author":"J\u00e4rnerot","year":"2016","journal-title":"Gastroenterology"},{"key":"2025101814274356000_7.2.e014512.5","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39345.714039.55"},{"key":"2025101814274356000_7.2.e014512.6","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2006.03131.x"},{"key":"2025101814274356000_7.2.e014512.7","doi-asserted-by":"publisher","DOI":"10.1016\/S0210-5705(05)71523-5"},{"key":"2025101814274356000_7.2.e014512.8","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2014-005091"},{"key":"2025101814274356000_7.2.e014512.9","doi-asserted-by":"crossref","first-page":"1","DOI":"10.3310\/hta20440","article-title":"Comparison Of iNfliximab and ciclosporin in Steroid Resistant Ulcerative Colitis: pragmatic randomised Trial and economic evaluation (CONSTRUCT)","volume":"20","author":"Williams","year":"2016","journal-title":"Heal Technol Assess"},{"key":"2025101814274356000_7.2.e014512.10","doi-asserted-by":"crossref","first-page":"1","DOI":"10.3310\/hta9350","article-title":"Conceptual framework and systematic review of the effects of participants\u2019 and professionals\u2019 preferences in randomised controlled trials","volume":"9","author":"King","year":"2005","journal-title":"Health Technol Assess"},{"key":"2025101814274356000_7.2.e014512.11","first-page":"1","article-title":"Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study\u2014a mixed methods study","volume":"18","author":"O'Cathain","year":"2014","journal-title":"Heal Technol Assess"},{"key":"2025101814274356000_7.2.e014512.12","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keh237"},{"key":"2025101814274356000_7.2.e014512.13","unstructured":"Silverman S . Qualitative research: theory, method and practice. 4th edn. Sage Publications , 2014."},{"key":"2025101814274356000_7.2.e014512.14","unstructured":"Denzin N. , Lincoln Y . The sage handbook of qualitative research. Sage Publications , 2005."},{"key":"2025101814274356000_7.2.e014512.15","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-14-54"},{"key":"2025101814274356000_7.2.e014512.16","doi-asserted-by":"publisher","DOI":"10.1177\/0141076898091S3508"},{"key":"2025101814274356000_7.2.e014512.17","unstructured":"Ritchie J , Kewis J , McNaughton Nicholls C , et al . Qualitative research practice. 2nd edn London: Sage Publications , 2003."},{"key":"2025101814274356000_7.2.e014512.18","unstructured":"Ryan G , Bernard H . Data analysis and management methods. In: Denzin NK , Lincoln YS, eds . Handbook of qualitative research. 2nd edn. Newbury Park CA: Sage, 2000:769\u2013902."},{"key":"2025101814274356000_7.2.e014512.19","doi-asserted-by":"crossref","first-page":"59","DOI":"10.1177\/1525822X05279903","article-title":"How many interviews are enough?: an experiment with data saturation and variability","volume":"18","author":"Guest","year":"2006","journal-title":"F Methods"},{"key":"2025101814274356000_7.2.e014512.20","doi-asserted-by":"crossref","unstructured":"Hennink MM , Kaiser BN , Marconi VC . Code saturation versus meaning saturation: how many interviews are enough? Qual Health Res 2016. doi:10.1177\/1049732316665344. [Epub ahead of print 25 Sep 2016]","DOI":"10.1177\/1049732316665344"},{"key":"2025101814274356000_7.2.e014512.21","unstructured":"National Institute for Healthcare and Excellence (NICE). Infliximab for subacute manifestation of ulcerative colitis. NICE Technology Appraisal Guidance TA140, 2008."},{"key":"2025101814274356000_7.2.e014512.22","doi-asserted-by":"publisher","DOI":"10.1093\/fampra\/20.1.61"},{"key":"2025101814274356000_7.2.e014512.23","unstructured":"Royal College of Physicians. Hospital workforce: fit for the future?. 2013. http:\/\/www.rcplondon.ac.uk\/projects\/hospital-workforce-fit-future."},{"key":"2025101814274356000_7.2.e014512.24","doi-asserted-by":"publisher","DOI":"10.1097\/MEG.0b013e328326cacb"},{"key":"2025101814274356000_7.2.e014512.25","doi-asserted-by":"publisher","DOI":"10.1097\/01.MIB.0000440983.86659.81"},{"key":"2025101814274356000_7.2.e014512.26","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v18.i43.6240"},{"key":"2025101814274356000_7.2.e014512.27","doi-asserted-by":"crossref","first-page":"681","DOI":"10.1155\/1997\/183841","article-title":"Health-related concerns of people who receive psychological support for inflammatory bowel disease","volume":"11","author":"Maunder","year":"1997","journal-title":"Can J Gastroenterol Hepatol"},{"key":"2025101814274356000_7.2.e014512.28","doi-asserted-by":"publisher","DOI":"10.1097\/00006842-199111000-00010"},{"key":"2025101814274356000_7.2.e014512.29","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1016\/S2468-1253(16)30003-6","article-title":"Infliximab versus ciclosporin for steroid-resistant acute severe ulcerative colitis (CONSTRUCT): a mixed methods, open-label, pragmatic randomised trial","volume":"1","author":"Williams","year":"2016","journal-title":"Lancet Gastroenterol Hepatol"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2016-014512","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T21:27:50Z","timestamp":1760822870000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2016-014512"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,2]]},"references-count":29,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2017,2,22]]},"published-print":{"date-parts":[[2017,2]]}},"alternative-id":["10.1136\/bmjopen-2016-014512"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2016-014512","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,2]]}}}