Abstract
Background: As a pragmatic randomised timing-of-birth trial, WILL adapted its trial procedures in response to the COVID-19 pandemic. These are reviewed here to inform post-pandemic trial methodology. Methods: The trial (internal pilot) paused in March 2020, re-opened in July 2020, and is currently recruiting in 37 UK NHS consultant-led maternity units. We evaluated pandemic adaptations made to WILL processes and surveyed sites for their views of these changes (20 sites, videoconference). Results: Despite 88% of sites favouring an electronic investigator site file (ISF), information technology requirements and clinical trial unit (CTU) operating procedures mandated the ongoing use of paper ISFs; site start-up delays resulted from restricted access to the CTU. Site initiation visits (SIVs) were conducted remotely; 50% of sites preferred remote SIVs and 44% felt that it was trial-dependent, while few preferred SIVs in-person as standard procedure. The Central team felt remote SIVs provided scheduling and attendance flexibility (for sites and trial staff), the option of recording discussions for missing or future staff, improved efficiency by having multiple sites attend, and time and cost savings; the negative impact on rapport-building and interaction was partially mitigated over time with more familiarity with technology and new ways-of-working. Two methods of remote consent were developed and used by 30/37 sites and for 54/156 recruits. Most (86%) sites using remote consenting felt it improved recruitment. For remote data monitoring (5 sites), advantages were primarily for the monitor (e.g. flexibility, no time constraints, reduced cost), and disadvantages primarily for the sites (e.g. document and access preparation, attendance at a follow-up meeting), but 81% of sites desired having the option of remote monitoring post-pandemic. Conclusions: COVID adaptations to WILL trial processes improved the flexibility of trial delivery, for Central and site staff, and participants. Flexibility to use these strategies should be retained post-pandemic. Trial registration: ISRCTN77258279. Registered on 05 December 2018.
Original language | English |
---|---|
Article number | 884 |
Number of pages | 10 |
Journal | Trials |
Volume | 23 |
Issue number | 1 |
DOIs | |
Publication status | Published - 21 Nov 2022 |
Externally published | Yes |
Keywords
- COVID
- Pregnancy
- Remote consent
- Timing of birth
- Trial management
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In: Trials, Vol. 23, No. 1, 884, 21.11.2022.
Research output: Contribution to journal › Article › Research › peer-review
TY - JOUR
T1 - WILL (When to Induce Labour to Limit risk in pregnancy hypertension)
T2 - a multicentre randomised controlled trial — adaptations to deliver a timing-of-birth trial during the COVID-19 international pandemic
AU - Magee, Laura A.
AU - Tohill, Sue
AU - Kirkham, Katie
AU - Evans, Ruth
AU - Gkini, Eleni
AU - Moakes, Catherine
AU - Stubbs, Clive
AU - Thornton, Jim
AU - von Dadelszen, Peter
AU - Brocklehurst, Peter
AU - Chappell, Lucy
AU - Dorling, Jon
AU - Green, Marcus
AU - Hardy, Pollyanna
AU - Hutcheon, Jennifer
AU - Moakes, Catherine
AU - Mol, Ben
AU - Morris, Katie
AU - Riley, Paul
AU - Roberts, Tracy
AU - Scott, Janet
AU - Singer, Joel
AU - Unstead-Joss, Ruth
AU - Wade, Julie
AU - Draycott, Tim
AU - MacLennan, Graeme
AU - MacKillop, Lucy
AU - Mannix, Paul
AU - Elbourne, Diana
AU - Groen, Henk
AU - Murdoch, Edile
AU - Stock, Sarah
AU - Bhuiya, Sumita
AU - Nallapeta, Soumendra
AU - Dooks, Emma
AU - Packham, Sophie
AU - Whitehouse, Diane
AU - O’Hara, Chloe
AU - Weston, Connie
AU - Mellers, Diane
AU - Brittain, Lesley
AU - Adams, Phern
AU - Shakespeare, Rebecca
AU - Kakara, Sudeepthi
AU - Wright, Janet
AU - Mighell, Amal
AU - Syson, Jennifer
AU - Swettenham, Kari
AU - Eedle, Jenny
AU - Seraj, Shaila
AU - Bray, Maryanne
AU - Jones, Bethan
AU - Bertorelli, Claire
AU - Ritter, Hannah
AU - Keeping, Vikki
AU - Cresswell, Janet
AU - Kelly-Baxter, Mary
AU - Yeoh, Li Shan
AU - Bhansali, Shailly Sahu
AU - More, Vandana
AU - Ajay, Bini
AU - Upson, Geraldine
AU - Hake, Danielle
AU - Opoku, Diana
AU - Wayman, Emma
AU - Cwiek, Natalia
AU - Tregellas, Stacy
AU - Lee, Nikki
AU - Margarit, Lavinia
AU - Pike, Joelle
AU - Jones, Kate
AU - Wheeler-Davies, Sophie Mae
AU - Ali, Meena
AU - Rajkumar, Indhuja
AU - Habibi, Ruth
AU - Davies, Sarah
AU - Kumar, Anangsha
AU - Salian, Harinakshi
AU - Smith, Trudy
AU - Meneni, Deepika
AU - Alexander, Hazel
AU - Harwood, Helen
AU - Hebbron, Kerry
AU - Whitecross, Lynn
AU - Hodgers, Mary
AU - Mahadasu, Shilpa
AU - Kametas, Nick
AU - Sana, Yasmin
AU - Martin, Hayley
AU - Jarman, Rebecca
AU - Webster, Sophie
AU - Rajeswary, Jyothi
AU - Gill, Mandy
AU - Bambridge, Gabrielle
AU - Bradley, Isabel
AU - Sexton, Kristina
AU - Oshodi, Lola
AU - Wiesender, Cornelia
AU - Dodd, Claire
AU - Modi, Rupa
AU - Cowlishaw, Beverley
AU - Mulheron, Gina
AU - Kierzenkowska, Magdalena
AU - Patterson, Molly
AU - Amos, Patricia
AU - Bates, Sharon Marie
AU - Raper, Sharon
AU - Agarwal, Umber
AU - Cockerill, Ruth
AU - Mahdi, Amy
AU - Cunningham, Caroline
AU - Dower, Michelle
AU - Andrews, Sian
AU - Holt, Siobhan
AU - Williams, Carly
AU - Castling, Zora
AU - Watkins, Linda
AU - Churchill, David
AU - McKenzie, Ellmina
AU - Icke, Julie
AU - Devison, Laura
AU - Raheja, Vinita
AU - Ayuk, Angela
AU - Reynolds, Jessica
AU - Wyton, Julie
AU - Duffy, Stacey
AU - Walker, Kate
AU - Cantliffe, Jane
AU - Hussain, Catriona
AU - Smith, Carys
AU - Anderson, Harriet
AU - Hodgen, Lesley
AU - Brackley, Karen
AU - Martin, Nicki
AU - Walbridge, Fiona
AU - Hampton, Rhea
AU - Jones, Nia
AU - Bose, Patrick
AU - Young, Catherine
AU - Lee, Fidelma
AU - Peart, Rebecca
AU - Tanton, Emma
AU - Rhead, Kat
AU - Fiedler, Kristin
AU - Bowen, Ruth
AU - Mathen, Stephy
AU - Sarwar, Zainab
AU - Rishton, Chloe
AU - Scott, Chloe
AU - Farey, Jane
AU - Verasingam, Nisha
AU - Rich, Mel
AU - Moreton, Annette
AU - Bressington, Catherine
AU - Pullen, Jennifer
AU - Burnard, Sara
AU - Duberry, Wendy
AU - Dey, Madhuchanda
AU - Jones, Sharon
AU - Bird, Pauline
AU - Ullal, Aarti
AU - Walton, Eileen
AU - Price, Ashleigh
AU - Scollen, Janet
AU - Ormonde, Judith
AU - Herdman, Kirsten
AU - Hewitt, Lesley
AU - Rowland, Lucy
AU - Singh, Mandeep
AU - Raajkumar, Sundararajah
AU - Saji, Beena
AU - Khalil, Asma
AU - Perry, Alice
AU - Marler, Emily
AU - Imuzeze, Ijeoma
AU - Robinson, Sophie
AU - Nelson, Jonathan
AU - McNamara, Kathryn
AU - Craig, Carina
AU - Endersby, Del
AU - Wagstaff, Jayne
AU - Robinson, Kate
AU - Barnes, Hannah
AU - Gavin, Jane
AU - Myers, Jenny
AU - Stanbury, Kate
AU - Hughes, Christine
AU - Vinayakarao, Latha
AU - Melson, Louise
AU - Grigsby, Stephanie
AU - Blunden, Susara
AU - Griffin, Melanie
AU - Newell, Sarah
AU - Thompson, Katharine Jane
AU - Smart, Brittany
AU - Payne, Elizabeth
AU - Pitchford, Marie
AU - Khan, Rahila
AU - Stone, Sophia
AU - Elgarhy, Ahmed
AU - Meadows, Emma
AU - Flynn-Batham, Marian
AU - Passmore, Nikky
AU - Cannons, Vivienne
AU - Symington, Declan
AU - Lewin, Alice
AU - Tarft, Hayley
AU - Hunt, Jessamine
AU - Vowles, Zoe
AU - Slaney, Maria
AU - Woodcock, Rachel
AU - Van der Meer, Alex
AU - Benn, Tracey
AU - Davies, Ru
AU - Boyd, Sophie
AU - Waring, Gareth
AU - Riches, Jill
AU - Fenn, Andrea
AU - Kimber, Aly
AU - Harrop, Susan
AU - Stott, Daniel
AU - Tetteh, Amos
AU - Casagrandi, Davide
AU - Bourke, Miriam
AU - Vaikousi, Eirini
AU - Sarquis, Rita
AU - Folorunsho, Morenike
AU - Newth, Olivia
AU - Weist, Sarah
AU - Acheampong, Yaa
AU - Ravikumar, Vidhya
AU - Yorke, Jemma
AU - Atkinson, Vicki
AU - Wood, Shelly
AU - Mengistu, Tigist
AU - Chadwick, Robert
AU - Haden, Helen
AU - Richardson, Lisa
AU - Girling, Joanna
AU - Barker, Amy
AU - Day, Andrea
AU - Palmer, Elaine
AU - Page, Louise
AU - Nwandison, Millicent
AU - Osakwe, Osaeloke
AU - de Rosnay, Philippe
AU - Usman, Sana
AU - Barnes, Susan
AU - Ryan, Grace
AU - the WILL Trial Study Group
N1 - Funding Information: The WILL Trial Study Group for providing feedback and support to the paper. This study is funded by the National Institute for Health Research (NIHR) [Health Technology Assessment programme (16/167/123)]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. WILL Trial Study Group From Clinical Investigator, Co-investigator and Trial Management Groups Laura A. Magee (Chief Investigator), Peter Brocklehurst, Lucy Chappell, Jon Dorling, Ruth Evans, Eleni Gkini, Marcus Green, Pollyanna Hardy, Jennifer Hutcheon, Katie Kirkham, Catherine Moakes, Ben Mol, Katie Morris, Paul Riley, Tracy Roberts, Janet Scott, Joel Singer, Clive Stubbs, Jim Thornton, Sue Tohill, Ruth Unstead-Joss, Peter von Dadelszen, Julie Wade. Publisher Copyright: © 2022, The Author(s).
PY - 2022/11/21
Y1 - 2022/11/21
N2 - Background: As a pragmatic randomised timing-of-birth trial, WILL adapted its trial procedures in response to the COVID-19 pandemic. These are reviewed here to inform post-pandemic trial methodology. Methods: The trial (internal pilot) paused in March 2020, re-opened in July 2020, and is currently recruiting in 37 UK NHS consultant-led maternity units. We evaluated pandemic adaptations made to WILL processes and surveyed sites for their views of these changes (20 sites, videoconference). Results: Despite 88% of sites favouring an electronic investigator site file (ISF), information technology requirements and clinical trial unit (CTU) operating procedures mandated the ongoing use of paper ISFs; site start-up delays resulted from restricted access to the CTU. Site initiation visits (SIVs) were conducted remotely; 50% of sites preferred remote SIVs and 44% felt that it was trial-dependent, while few preferred SIVs in-person as standard procedure. The Central team felt remote SIVs provided scheduling and attendance flexibility (for sites and trial staff), the option of recording discussions for missing or future staff, improved efficiency by having multiple sites attend, and time and cost savings; the negative impact on rapport-building and interaction was partially mitigated over time with more familiarity with technology and new ways-of-working. Two methods of remote consent were developed and used by 30/37 sites and for 54/156 recruits. Most (86%) sites using remote consenting felt it improved recruitment. For remote data monitoring (5 sites), advantages were primarily for the monitor (e.g. flexibility, no time constraints, reduced cost), and disadvantages primarily for the sites (e.g. document and access preparation, attendance at a follow-up meeting), but 81% of sites desired having the option of remote monitoring post-pandemic. Conclusions: COVID adaptations to WILL trial processes improved the flexibility of trial delivery, for Central and site staff, and participants. Flexibility to use these strategies should be retained post-pandemic. Trial registration: ISRCTN77258279. Registered on 05 December 2018.
AB - Background: As a pragmatic randomised timing-of-birth trial, WILL adapted its trial procedures in response to the COVID-19 pandemic. These are reviewed here to inform post-pandemic trial methodology. Methods: The trial (internal pilot) paused in March 2020, re-opened in July 2020, and is currently recruiting in 37 UK NHS consultant-led maternity units. We evaluated pandemic adaptations made to WILL processes and surveyed sites for their views of these changes (20 sites, videoconference). Results: Despite 88% of sites favouring an electronic investigator site file (ISF), information technology requirements and clinical trial unit (CTU) operating procedures mandated the ongoing use of paper ISFs; site start-up delays resulted from restricted access to the CTU. Site initiation visits (SIVs) were conducted remotely; 50% of sites preferred remote SIVs and 44% felt that it was trial-dependent, while few preferred SIVs in-person as standard procedure. The Central team felt remote SIVs provided scheduling and attendance flexibility (for sites and trial staff), the option of recording discussions for missing or future staff, improved efficiency by having multiple sites attend, and time and cost savings; the negative impact on rapport-building and interaction was partially mitigated over time with more familiarity with technology and new ways-of-working. Two methods of remote consent were developed and used by 30/37 sites and for 54/156 recruits. Most (86%) sites using remote consenting felt it improved recruitment. For remote data monitoring (5 sites), advantages were primarily for the monitor (e.g. flexibility, no time constraints, reduced cost), and disadvantages primarily for the sites (e.g. document and access preparation, attendance at a follow-up meeting), but 81% of sites desired having the option of remote monitoring post-pandemic. Conclusions: COVID adaptations to WILL trial processes improved the flexibility of trial delivery, for Central and site staff, and participants. Flexibility to use these strategies should be retained post-pandemic. Trial registration: ISRCTN77258279. Registered on 05 December 2018.
KW - COVID
KW - Pregnancy
KW - Remote consent
KW - Timing of birth
KW - Trial management
UR - http://www.scopus.com/inward/record.url?scp=85140307279&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06834-4
DO - 10.1186/s13063-022-06834-4
M3 - Article
C2 - 36271441
AN - SCOPUS:85140307279
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 884
ER -