Adaptation of the By-Band randomized clinical trial to By-Band-Sleeve to include a new intervention and maintain relevance of the study to practice
<strong>Background</strong> Recruitment into surgical RCTs can be threatened if new interventions available outside the trial compete with those being evaluated. Adapting the trial to include the new intervention may overcome this issue, yet this is not often done in surgery. This paper...
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Journal article |
| Language: | English |
| Published: |
Wiley
2017
|
| _version_ | 1826305901751959552 |
|---|---|
| author | Rogers, CA Reeves, BC Byrne, J Donovan, JL Mazza, G Paramasivan, S Andrews, RC Wordsworth, S Thompson, J Blazeby, JM Welbourn, R By-Band-Sleeve Study Investigators |
| author_facet | Rogers, CA Reeves, BC Byrne, J Donovan, JL Mazza, G Paramasivan, S Andrews, RC Wordsworth, S Thompson, J Blazeby, JM Welbourn, R By-Band-Sleeve Study Investigators |
| author_sort | Rogers, CA |
| collection | OXFORD |
| description | <strong>Background</strong> Recruitment into surgical RCTs can be threatened if new interventions available outside the trial compete with those being evaluated. Adapting the trial to include the new intervention may overcome this issue, yet this is not often done in surgery. This paper describes the challenges, rationale and methods for adapting an RCT to include a new intervention. <strong>Methods</strong> The By‐Band study was designed in the UK in 2009–2010 to compare the effectiveness of laparoscopic adjustable gastric band and Roux‐en‐Y gastric bypass for severe obesity. It contained a pilot phase to establish whether recruitment was possible, and the grant proposal specified that an adaptation to include sleeve gastrectomy would be considered if practice changed and recruitment was successful. Information on changing obesity surgery practice, updated evidence and expert opinion about trial design were used to inform the adaptation. <strong>Results</strong> The pilot phase recruited over 13 months in 2013–2014 and randomized 80 patients (79 anticipated). During this time, major changes in obesity practice in the UK were observed, with gastric band reducing from 32·6 to 15·8 per cent and sleeve gastrectomy increasing from 9·0 to 28·1 per cent. The evidence base had not changed markedly. The British Obesity and Metabolic Surgery Society and study oversight committees supported an adaptation to include sleeve gastrectomy, and a proposal to do so was approved by the funder. <strong>Conclusion</strong> Adaptation of a two‐group surgical RCT can allow evaluation of a third procedure and maintain relevance of the RCT to practice. It also optimizes the use of existing trial infrastructure to answer an additional important research question. Registration number: ISRCTN00786323 (http://www.isrctn.com/). |
| first_indexed | 2024-03-07T06:39:51Z |
| format | Journal article |
| id | oxford-uuid:f8e23726-7273-45b6-a2ac-a920f81b3bee |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T06:39:51Z |
| publishDate | 2017 |
| publisher | Wiley |
| record_format | dspace |
| spelling | oxford-uuid:f8e23726-7273-45b6-a2ac-a920f81b3bee2022-03-27T12:54:00ZAdaptation of the By-Band randomized clinical trial to By-Band-Sleeve to include a new intervention and maintain relevance of the study to practiceJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:f8e23726-7273-45b6-a2ac-a920f81b3beeEnglishSymplectic Elements at OxfordWiley2017Rogers, CAReeves, BCByrne, JDonovan, JLMazza, GParamasivan, SAndrews, RCWordsworth, SThompson, JBlazeby, JMWelbourn, RBy-Band-Sleeve Study Investigators<strong>Background</strong> Recruitment into surgical RCTs can be threatened if new interventions available outside the trial compete with those being evaluated. Adapting the trial to include the new intervention may overcome this issue, yet this is not often done in surgery. This paper describes the challenges, rationale and methods for adapting an RCT to include a new intervention. <strong>Methods</strong> The By‐Band study was designed in the UK in 2009–2010 to compare the effectiveness of laparoscopic adjustable gastric band and Roux‐en‐Y gastric bypass for severe obesity. It contained a pilot phase to establish whether recruitment was possible, and the grant proposal specified that an adaptation to include sleeve gastrectomy would be considered if practice changed and recruitment was successful. Information on changing obesity surgery practice, updated evidence and expert opinion about trial design were used to inform the adaptation. <strong>Results</strong> The pilot phase recruited over 13 months in 2013–2014 and randomized 80 patients (79 anticipated). During this time, major changes in obesity practice in the UK were observed, with gastric band reducing from 32·6 to 15·8 per cent and sleeve gastrectomy increasing from 9·0 to 28·1 per cent. The evidence base had not changed markedly. The British Obesity and Metabolic Surgery Society and study oversight committees supported an adaptation to include sleeve gastrectomy, and a proposal to do so was approved by the funder. <strong>Conclusion</strong> Adaptation of a two‐group surgical RCT can allow evaluation of a third procedure and maintain relevance of the RCT to practice. It also optimizes the use of existing trial infrastructure to answer an additional important research question. Registration number: ISRCTN00786323 (http://www.isrctn.com/). |
| spellingShingle | Rogers, CA Reeves, BC Byrne, J Donovan, JL Mazza, G Paramasivan, S Andrews, RC Wordsworth, S Thompson, J Blazeby, JM Welbourn, R By-Band-Sleeve Study Investigators Adaptation of the By-Band randomized clinical trial to By-Band-Sleeve to include a new intervention and maintain relevance of the study to practice |
| title | Adaptation of the By-Band randomized clinical trial to By-Band-Sleeve to include a new intervention and maintain relevance of the study to practice |
| title_full | Adaptation of the By-Band randomized clinical trial to By-Band-Sleeve to include a new intervention and maintain relevance of the study to practice |
| title_fullStr | Adaptation of the By-Band randomized clinical trial to By-Band-Sleeve to include a new intervention and maintain relevance of the study to practice |
| title_full_unstemmed | Adaptation of the By-Band randomized clinical trial to By-Band-Sleeve to include a new intervention and maintain relevance of the study to practice |
| title_short | Adaptation of the By-Band randomized clinical trial to By-Band-Sleeve to include a new intervention and maintain relevance of the study to practice |
| title_sort | adaptation of the by band randomized clinical trial to by band sleeve to include a new intervention and maintain relevance of the study to practice |
| work_keys_str_mv | AT rogersca adaptationofthebybandrandomizedclinicaltrialtobybandsleevetoincludeanewinterventionandmaintainrelevanceofthestudytopractice AT reevesbc adaptationofthebybandrandomizedclinicaltrialtobybandsleevetoincludeanewinterventionandmaintainrelevanceofthestudytopractice AT byrnej adaptationofthebybandrandomizedclinicaltrialtobybandsleevetoincludeanewinterventionandmaintainrelevanceofthestudytopractice AT donovanjl adaptationofthebybandrandomizedclinicaltrialtobybandsleevetoincludeanewinterventionandmaintainrelevanceofthestudytopractice AT mazzag adaptationofthebybandrandomizedclinicaltrialtobybandsleevetoincludeanewinterventionandmaintainrelevanceofthestudytopractice AT paramasivans adaptationofthebybandrandomizedclinicaltrialtobybandsleevetoincludeanewinterventionandmaintainrelevanceofthestudytopractice AT andrewsrc adaptationofthebybandrandomizedclinicaltrialtobybandsleevetoincludeanewinterventionandmaintainrelevanceofthestudytopractice AT wordsworths adaptationofthebybandrandomizedclinicaltrialtobybandsleevetoincludeanewinterventionandmaintainrelevanceofthestudytopractice AT thompsonj adaptationofthebybandrandomizedclinicaltrialtobybandsleevetoincludeanewinterventionandmaintainrelevanceofthestudytopractice AT blazebyjm adaptationofthebybandrandomizedclinicaltrialtobybandsleevetoincludeanewinterventionandmaintainrelevanceofthestudytopractice AT welbournr adaptationofthebybandrandomizedclinicaltrialtobybandsleevetoincludeanewinterventionandmaintainrelevanceofthestudytopractice AT bybandsleevestudyinvestigators adaptationofthebybandrandomizedclinicaltrialtobybandsleevetoincludeanewinterventionandmaintainrelevanceofthestudytopractice |