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1. Stakeholders’ perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study

Author

Matthew Peak, Michael Griksaitis, Clare Fowler, Simon Gates, Christopher Lamb, Elizabeth Deja, Rachel Agbeko, John Pappachan, Helen Parker, Jennifer Preston, Ahmed Osman, Paula Williamson, Paul S McNamara, David Armstrong, Tracy Moitt, Ramesh Kumar, John Alexander, Kevin P Morris, Roger Parslow, Steve Cunningham, Craig Knott, Chloe Donohue, Catrin Barker, Julie Richardson, Ashley Jones, Stephanie Clarke, Malcolm G Semple, Richard Levin, James Weitz, Natasha Roberts, Vanessa Compton, Kentigern Thorburn, PHILIP MILNER, Howard W Clark, Bessie Cipriano, Nosheen Khalid, Nicolene Plaatjies, Avishay Sarfatti, Mark Terris, Santosh Sundararajan, Edgar Brincat, Natasha Thorn, Ramiya Kirupananthan, Peter J Davis, Samantha Owen, Pavanasam Ramesh, Sarah Fox, Laura Price, Hannah Clarke, Charlotte Thompson, Wendy Browne, Christine Mackerness, Laura Rad, Grace Williamson, Simone Paulson, Laura O'Malley, Zoe Oliver, Evette Allen, Clare van Miert, Ashley Best, Jens Madsen, Anne Dawson, Colin Summers, Blessing Osaghae, Madhuri Panchal, Anthony Postle, Peter Jirasek, Dawn Jones, Michael Mander, Laura Rimmer, Paul C Ritson, Chris Simons, Afeda Mohamed Ali, Cara Alexander, Hannah Child, Natalie Milburn, Holly Parkin, Harriet Payne, Carly Tooke, Helen Winmill, Katherine Baptiste, Sophie Coles, Sarah-Jayne Eames, Christina Linton, Helen Marley, Sarah Mogan, Alvin Schadenberg, John Stiven, Rob Claydon, Anna Stancombe, Kate Teeley, Kathryn Reeves, Emily Scriven, Raghu N Ramaiah, Rekha Patel, Patrick E Davies, Lindsay Crate, Kirsten Beadon, Rachel McMinnis, Frances Sinfield, Hilary Callaghan, Vicki Linton, Jeremy Lyons, Clara Nelson, Tsz-YanMilly Lo, Jackie McCormick, Andrea Wood, Ross Marscheider, Stephen D Playfor, Bernadette C Gavin, Dave J Morgan, Lara T Bunni, Claire F Jennings, Rebecca Marshall, Emma K Riley, Lorena Caruana, Amber Cook, Tracey Curtis, Nichola Etherington, Jenni McCorkell, Christie Mellish, Jenny Pond, Catherine Postlethwaite, Nicola McClelland, Holly Minchin, Joanne Tomlinson, Simona Lampariello, Tara Murray, Olivia Nugent, Samantha Reed, Christa Ronan, and Salman Siddiqi

Subjects
Medicine
Abstract

Objectives The Bronchiolitis Endotracheal Surfactant Study (BESS) is a randomised controlled trial to determine the efficacy of endo-tracheal surfactant therapy for critically ill infants with bronchiolitis. To explore acceptability of BESS, including approach to consent within a limited time frame, we explored parent and staff experiences of trial involvement in the first two bronchiolitis seasons to inform subsequent trial conduct.Design A mixed-method embedded study involving a site staff survey, questionnaires and interviews with parents approached about BESS.Setting Fourteen UK paediatric intensive care units.Participants Of the 179 parents of children approached to take part in BESS, 75 parents (of 69 children) took part in the embedded study. Of these, 55/69 (78%) completed a questionnaire, and 15/69 (21%) were interviewed. Thirty-eight staff completed a questionnaire.Results Parents and staff found the trial acceptable. All constructs of the Adapted Theoretical Framework of Acceptability were met. Parents viewed surfactant as being low risk and hoped their child’s participation would help others in the future. Although parents supported research without prior consent in studies of time critical interventions, they believed there was sufficient time to consider this trial. Parents recommended that prospective informed consent should continue to be sought for BESS. Many felt that the time between the consent process and intervention being administered took too long and should be ‘streamlined’ to avoid delays in administration of trial interventions. Staff described how the training and trial processes worked well, yet patients were missed due to lack of staff to deliver the intervention, particularly at weekends.Conclusion Parents and staff supported BESS trial and highlighted aspects of the protocol, which should be refined, including a streamlined informed consent process. Findings will be useful to inform proportionate approaches to consent in future paediatric trials where there is a short timeframe for consent discussions.Trial registration number ISRCTN11746266.

Published
2024
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2. Measuring the success of programmes of care for people living with dementia: a protocol for consensus building with consumers to develop a set of Core Outcome Measures for Improving Care (COM-IC)

Author

Thomas Morris, Susan E Kurrle, Susanna Dodd, Paula Williamson, Leon Flicker, Len Gray, Osvaldo P Almeida, Tracy Comans, John Quinn, Kim Nguyen, Judy A Lowthian, Dominic Trépel, Alyssa Welch, Anna Kearney, Colm Cunningham, Jack Nunn, Danelle Kenny, Glenys Petrie, Tiet-Hanh Dao-Tran, and Asmita Manchha

Subjects
Medicine
Abstract

Introduction The Core Outcome Measures for Improving Care (COM-IC) project aims to deliver practical recommendations on the selection and implementation of a suite of core outcomes to measure the effectiveness of interventions for dementia care.Methods and analysis COM-IC embeds a participatory action approach to using the Alignment–Harmonisation–Results framework for measuring dementia care in Australia. Using this framework, suitable core outcome measures will be identified, analysed, implemented and audited. The methods for analysing each stage will be codesigned with stakeholders, through the conduit of a Stakeholder Reference Group including people living with dementia, formal and informal carers, aged care industry representatives, researchers, clinicians and policy actors. The codesigned evaluation methods consider two key factors: feasibility and acceptability. These considerations will be tested during a 6-month feasibility study embedded in aged care industry partner organisations.Ethics and dissemination COM-IC has received ethical approval from The University of Queensland (HREC 2021/HE001932). Results will be disseminated through networks established over the project, and in accordance with both the publication schedule and requests from the Stakeholder Reference Group. Full access to publications and reports will be made available through UQ eSpace (https://espace.library.uq.edu.au/), an open access repository hosted by The University of Queensland.

Published
2023
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4. Realising the full potential of data-enabled trials in the UK: a call for action

Author

Andrea Cipriani, Steve Goodacre, Jennifer K Quint, Catherine Hewitt, Ian Roberts, John Norrie, Aziz Sheikh, Michael King, Irwin Nazareth, Alan Watkins, Frank Sullivan, Derek Stewart, Nick Freemantle, Liam Smeeth, Jane Daniels, Tobias Dreischulte, Brooke Jackson, Michael Donnelly, Martin Landray, Martin Gulliford, Mark Edwards, Paula R Williamson, David A Harrison, Adam Streeter, Jennifer Logue, Paula Williamson, Louise Bowman, Marion Campbell, Martin C Gulliford, Jamie Soames, Dheeraj Rai, Stephanie MacNeill, Marion Bennie, Jo Rycroft-Malone, Matthew R Sydes, Andrew Farmer, Hywel C Williams, Martyn Lewis, Elizabeth Williamson, Xavier Griffin, Colin McCowan, John Wilding, Jennifer Quint, Agnieszka Michael, Murali Shyamsundar, Tom Denwood, Deborah Ashby, Jacqui Nuttall, Kate Williams, Doreen Tembo, David Harrison, Andrew Morris, Laura Gray, Fiona Lobban, Claire Snowdon, Martin Gibson, Rhoswyn Walker, Will Whiteley, Nick Mills, Juliet Tizzard, Emer Brady, Guillermo Lopez Campos, Catrin Tudur Smith, Yolanda Barbachano, Steph Garfield-Birkbeck, Will Navaie, Martin O'Kane, Jonathan Sheffield, Paula Walker, Rhoswyn R Walker, Janet Valentine, Susan Beatty, Helen Bodmer, Paul Brocklehurst, Steph Garfield‑Birkbeck, Doug Gould, Thomas Hiemstra, Anna Higgins, Julia Hippisley‑Cox, Sasha Korniak, Marion Mafham, Kathleen Meeley, Chris Newby, Martin O’Kane, Mike Robling, Jo Rycroft‑Malone, Matthew Sydes, and Hwyel Williams

Subjects
Medicine
Abstract

Rationale Clinical trials are the gold standard for testing interventions. COVID-19 has further raised their public profile and emphasised the need to deliver better, faster, more efficient trials for patient benefit. Considerable overlap exists between data required for trials and data already collected routinely in electronic healthcare records (EHRs). Opportunities exist to use these in innovative ways to decrease duplication of effort and speed trial recruitment, conduct and follow-up.Approach The National Institute of Health Research (NIHR), Health Data Research UK and Clinical Practice Research Datalink co-organised a national workshop to accelerate the agenda for ‘data-enabled clinical trials’. Showcasing successful examples and imagining future possibilities, the plenary talks, panel discussions, group discussions and case studies covered: design/feasibility; recruitment; conduct/follow-up; collecting benefits/harms; and analysis/interpretation.Reflection Some notable studies have successfully accessed and used EHR to identify potential recruits, support randomised trials, deliver interventions and supplement/replace trial-specific follow-up. Some outcome measures are already reliably collected; others, like safety, need detailed work to meet regulatory reporting requirements. There is a clear need for system interoperability and a ‘route map’ to identify and access the necessary datasets. Researchers running regulatory-facing trials must carefully consider how data quality and integrity would be assessed. An experience-sharing forum could stimulate wider adoption of EHR-based methods in trial design and execution.Discussion EHR offer opportunities to better plan clinical trials, assess patients and capture data more efficiently, reducing research waste and increasing focus on each trial’s specific challenges. The short-term emphasis should be on facilitating patient recruitment and for postmarketing authorisation trials where research-relevant outcome measures are readily collectable. Sharing of case studies is encouraged. The workshop directly informed NIHR’s funding call for ambitious data-enabled trials at scale. There is the opportunity for the UK to build upon existing data science capabilities to identify, recruit and monitor patients in trials at scale.

Published
2021
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5. Circulating sex hormone binding globulin levels are modified with intensive lifestyle intervention, but their changes did not independently predict diabetes risk in the Diabetes Prevention Program

Author

Mike Reidy, Christine Lee, Michael Brändle, Sherita Hill Golden, Samuel Dagogo-Jack, David Kessler, Elizabeth Barrett-Connor, Steve Jones, Ling Chen, Judith Wylie-Rosett, Ping Zhang, Paula Williamson, Carlos Lorenzo, Leigh Perreault, Dana Dabelea, Santica Marcovina, Rachel Williams, Marie Smith, Carmen Pal, Patricia Katz, William H. Herman, Sharon L Edelstein, Yong Ma, Vanita R Aroda, Costas A Christophi, Catherine Kim, Sherita H Golden, Edward Horton, Kieren J Mather, George A. Bray, Kishore Gadde, Iris W. Culbert, Jennifer Arceneaux, Annie Chatellier, Amber Dragg, Catherine M. Champagne, Crystal Duncan, Barbara Eberhardt, Frank Greenway, Fonda G. Guillory, April A. Herbert, Michael L. Jeffirs, Betty M. Kennedy, Erma Levy, Monica Lockett, Jennifer C. Lovejoy, Laura H. Morris, Lee E. Melancon, Donna H. Ryan, Deborah A. Sanford, Kenneth G. Smith, Lisa L. Smith, Julia A. St, Richard T. Tulley Amant, Paula C. Vicknair, Donald Williamson, Jeffery J. Zachwieja, Kenneth S. Polonsky, Janet Tobian, David A. Ehrmann, Margaret J. Matulik, Bart Clark, Kirsten Czech, Catherine DeSandre, Ruthanne Hilbrich, Wylie McNabb, Ann R. Semenske, Jose F. Caro, Kevin Furlong, Barry J. Goldstein, Pamela G. Watson, Kellie A. Smith, Jewel Mendoza, Wendi Wildman, Renee Liberoni, John Spandorfer, Constance Pepe, Richard P. Donahue, Ronald B. Goldberg, Ronald Prineas, Jeanette Calles, Juliet Ojito, Patricia Rowe, Paul Cassanova-Romero, Sumaya Castillo-Florez, Hermes J. Florez, Anna Giannella, Lascelles Kirby, Carmen Larreal, Olga Lara, Valerie McLymont, Jadell Mendez, Arlette Perry, Patrice Saab, Beth Veciana, Steven M. Haffner, Helen P. Hazuda, Maria G. Montez, Kathy Hattaway, Arlene Martinez, Tatiana Walker, Richard F. Hamman, Patricia V. Nash, Sheila C. Steinke, Lisa Testaverde, Denise R. Anderson, Larry B. Ballonoff, Alexis Bouffard, Brian Bucca, B. Ned Calonge, Lynne Delve, Martha Farago, James O. Hill, Shelley R. Hoyer, Tonya Jenkins, Bonnie T. Jortberg, Dione Lenz, Marsha Miller, David W. Price, Judith G. Regensteiner, Helen Seagle, Carissa M. Smith, Brent VanDorsten, Edward S. Horton, Kathleen E. Lawton, Catherine S. Poirier, Kati Swift, Ronald A. Arky, Marybeth Bryant, Jacqueline P. Burke, Enrique Caballero, Karen M. Callaphan, Barbara Fargnoli, Therese Franklin, Om P. Ganda, Ashley Guidi, Mathew Guido, Sharon D. Jackson, Alan M. Jacobsen, Lori Lambert, Sarah Ledbury, Margaret Kocal, Lyn M. Kula, Maureen A. Malloy, Maryanne Nicosia, Cathryn F. Oldmixon, Jocelyn Pan, Marizel Quitingon, Stacy Rubtchinsky, Jessica Sansoucy, Dana Schweizer, Ellen W. Seely, Donald Simonson, Fannie Smith, Caren G. Solomon, Jeanne Spellman, James Warram, Steven E. Kahn, Brenda K. Montgomery, Wilfred Fujimoto, Robert H. Knopp, Edward W. Lipkin, Michelle Marr, Ivy Morgan-Taggart, Anne Murillo, Dace Trence, Lonnese Taylor, April Thomas, Elaine C. Tsai, Abbas E. Kitabchi, Mary E. Murphy, Laura Taylor, Jennifer Dolgoff, William B. Applegate, Michael Bryer-Ash, Debra Clark, Sandra L. Frieson, Uzoma Ibebuogu, Raed Imseis, Helen Lambeth, Lynne C. Lichtermann, Hooman Oktaei, Harriet Ricks, Lily M.K. Rutledge, Amy R. Sherman, Clara M. Smith, Judith E. Soberman, Beverly Williams-Cleaves, Boyd E. Metzger, Mark E. Molitch, Mariana K. Johnson, Daphne T. Adelman, Catherine Behrends, Michelle Cook, Marian Fitzgibbon, Mimi M. Giles, Deloris Heard, Cheryl K.H. Johnson, Diane Larsen, Anne Lowe, Megan Lyman, David McPherson, Samsam C. Penn, Thomas Pitts, Renee Reinhart, Susan Roston, Pamela A. Schinleber, David M. Nathan, Charles McKitrick, Heather Turgeon, Mary Larkin, Kathy Abbott, Ellen Anderson, Laurie Bissett, Kristy Bondi, Enrico Cagliero, Jose C. Florez, Kali D’Anna, Linda Delahanty, Valerie Goldman, Peter Lou, Alexandra Poulos, Elyse Raymond, Christine Stevens, Beverly Tseng, Jerrold M. Olefsky, Mary Lou Carrion-Petersen, Madeline Beltran, Lauren N. Claravall, Jonalle M. Dowden, Steven V. Edelman, Robert R. Henry, Javiva Horne, Marycie Lamkin, Simona Szerdi Janesch, Diana Leos, Sunder Mudaliar, William Polonsky, Jean Smith, Jennifer Torio-Hurley, Karen Vejvoda, F. Xavier Pi-Sunyer, Jane E. Lee, David B. Allison, Nnenna Agharanya, Nancy J. Aronoff, Maria Baldo, Jill P. Crandall, Sandra T. Foo, Susan Hagamen, Jose A. Luchsinger, Kathy Parkes, Mary Beth Pena, Ellen S. Rooney, Gretchen E.H. Van Wye, Kristine A. Viscovich, David G. Marrero, Kieren J. Mather, Melvin J. Prince, Susie M. Kelly, Marcia A. Jackson, Gina McAtee, Paula Putenney, Ronald T. Ackermann, Carolyn M. Cantrell, Yolanda F. Dotson, Edwin S. Fineberg, Megan Fultz, John C. Guare, Angela Hadden, James M. Ignaut, Marion S. Kirkman, Erin O’Kelly Phillips, Beverly D. Porter, Paris J. Roach, Nancy D. Rowland, Madelyn L. Wheeler, Vanita Aroda, Robert E. Ratner, Gretchen Youssef, Sue Shapiro, Catherine Bavido-Arrage, Geraldine Boggs, Marjorie Bronsord, Ernestine Brown, Wayman W. Cheatham, Susan Cola, Cindy Evans, Peggy Gibbs, Tracy Kellum, Renee Wiggins, Milvia Lagarda, Lilia Leon, Claresa Levatan, Milajurine Lindsay, Asha K. Nair, Maureen Passaro, Angela Silverman, Gabriel Uwaifo, Debra Wells-Thayer, Mohammed F. Saad, Karol Watson, Maria Budget, Sujata Jinagouda, Medhat Botrous, Khan Akbar, Claudia Conzues, Perpetua Magpuri, Kathy Ngo, Amer Rassam, Debra Waters, Kathy Xapthalamous, Julio V. Santiago, Neil H. White, Angela L. Brown, Samia Das, Prajakta Khare-Ranade, Tamara Stich, Ana Santiago, Edwin Fisher, Emma Hurt, Tracy Jones, Michelle Kerr, Lucy Ryder, Cormarie Wernimont, Christopher D. Saudek, Vanessa Bradley, Emily Sullivan, Tracy Whittington, Caroline Abbas, Adrienne Allen, Frederick L. Brancati, Sharon Cappelli, Jeanne M. Clark, Jeanne B. Charleston, Janice Freel, Katherine Horak, Alicia Greene, Dawn Jiggetts, Deloris Johnson, Hope Joseph, Kimberly Loman, Henry Mosley, John Reusing, Richard R. Rubin, Alafia Samuels, Thomas Shields, Shawne Stephens, Kerry J. Stewart, LeeLana Thomas, Evonne Utsey, David S. Schade, Karwyn S. Adams, Janene L. Canady, Carolyn Johannes, Claire Hemphill, Penny Hyde, Leslie F. Atler, Patrick J. Boyle, Mark R. Burge, Lisa Chai, Kathleen Colleran, Ysela Gonzales, Doris A. Hernandez-McGinnis, Carolyn King, Sofya Rubinchik, Willette Senter, Jill Crandall, Harry Shamoon, Janet O. Brown, Gilda Trandafirescu, Elsie Adorno, Liane Cox, Helena Duffy, Samuel Engel, Allison Friedler, Angela Goldstein, Crystal J. Howard-Century, Jennifer Lukin, Stacey Kloiber, Nadege Longchamp, Helen Martinez, Dorothy Pompi, Jonathan Scheindlin, Elissa Violino, Elizabeth A. Walker, Elise Zimmerman, Joel Zonszein, Trevor Orchard, Rena R. Wing, Susan Jeffries, Gaye Koenning, M. Kaye Kramer, Susan Barr, Catherine Benchoff, Miriam Boraz, Lisa Clifford, Rebecca Culyba, Marlene Frazier, Ryan Gilligan, Stephanie Guimond, Susan Harrier, Louann Harris, Andrea Kriska, Bonny Rockette-Wagner, Qurashia Manjoo, Monica Mullen, Alicia Noel, Amy Otto, Jessica Pettigrew, Debra Rubinstein, Linda Semler, Cheryl F. Smith, Elizabeth Venditti, Valarie Weinzierl, Katherine V. Williams, Tara Wilson, Richard F. Arakaki, Renee W. Latimer, Narleen K. Baker-Ladao, Mae K. Isonaga, Ralph Beddow, Nina E. Bermudez, Lorna Dias, Jillian Inouye, Marjorie K. Mau, John S. Melish, Kathy Mikami, Pharis Mohideen, Sharon K. Odom, Raynette U. Perry, Robin E. Yamamoto, William C. Knowler, Norman Cooeyate, Mary A. Hoskin, Carol A. Percy, Alvera Enote, Camille Natewa, Kelly J. Acton, Vickie L. Andre, Rosalyn Barber, Shandiin Begay, Peter H. Bennett, Mary Beth Benson, Evelyn C. Bird, Brenda A. Broussard, Brian C. Bucca, Marcella Chavez, Sherron Cook, Jeff Curtis, Tara Dacawyma, Matthew S. Doughty, Roberta Duncan, Charlotte Dodge, Cyndy Edgerton, Jacqueline M. Ghahate, Justin Glass, Martia Glass, Dorothy Gohdes, Wendy Grant, Robert L. Hanson, Ellie Horse, Louise E. Ingraham, Merry Jackson, Priscilla Jay, Roylen S. Kaskalla, Kathleen M. Kobus, Jonathan Krakoff, Jason Kurland, Catherine Manus, Cherie McCabe, Sara Michaels, Tina Morgan, Yolanda Nashboo, Julie A. Nelson, Steven Poirier, Evette Polczynski, Christopher Piromalli, Jeanine Roumain, Debra Rowse, Robert J. Roy, Sandra Sangster, Janet Sewenemewa, Miranda Smart, Darryl Tonemah, Charlton Wilson, Michelle Yazzie, Raymond Bain, Sarah Fowler, Marinella Temprosa, Michael D. Larsen, Tina Brenneman, Sharon L. Edelstein, Solome Abebe, Julie Bamdad, Melanie Barkalow, Joel Bethepu, Tsedenia Bezabeh, Nicole Butler, Jackie Callaghan, Caitlin E. Carter, Costas Christophi, Gregory M. Dwyer, Mary Foulkes, Yuping Gao, Robert Gooding, Adrienne Gottlieb, Kristina L. Grimes, Nisha Grover-Fairchild, Lori Haffner, Heather Hoffman, Kathleen Jablonski, Tara L. Jones, Richard Katz, Preethy Kolinjivadi, John M. Lachin, Pamela Mucik, Robert Orlosky, Qing Pan, Susan Reamer, James Rochon, Alla Sapozhnikova, Hanna Sherif, Charlotte Stimpson, Ashley Hogan Tjaden, Fredricka Walker-Murray, Elizabeth M. Venditti, Andrea M. Kriska, Valerie Weinzierl, Jessica Harting, F. Alan Aldrich, John Albers, Greg Strylewicz, R. Eastman, Judith Fradkin, Sanford Garfield, Edward Gregg, Morton B. Brown, David Altshuler, Liana K. Billings, Maegan Harden, Toni I. Pollin, Alan R. Shuldiner, Paul W. Franks, and Marie-France Hivert

Subjects
Diseases of the endocrine glands. Clinical endocrinology, RC648-665
Abstract

Introduction Sex hormone binding globulin (SHBG) levels are reported to be inversely associated with diabetes risk. It is unknown whether diabetes prevention interventions increase SHBG and whether resultant changes in SHBG affect diabetes risk. The purpose of this analysis was to determine whether intensive lifestyle intervention (ILS) or metformin changed circulating SHBG and if resultant changes influenced diabetes risk in the Diabetes Prevention Program (DPP).Research design and methods This is a secondary analysis from the DPP (1996–2001), a randomized trial of ILS or metformin versus placebo on diabetes risk over a mean follow-up of 3.2 years. The DPP was conducted across 27 academic study centers in the USA. Men, premenopausal and postmenopausal women without hormone use in the DPP were evaluated. The DPP included overweight/obese persons with elevated fasting glucose and impaired glucose tolerance. Main outcomes measures were changes in SHBG levels at 1 year and risk of diabetes over 3 years.Results ILS resulted in significantly higher increases (postmenopausal women: p

Published
2020
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6. Timing Of Primary Surgery for cleft palate (TOPS): protocol for a randomised trial of palate surgery at 6 months versus 12 months of age

Author

Carrol Gamble, Paula Williamson, William Shaw, Gunvor Semb, Anette Lohmander, Christina Persson, Elisabeth Willadsen, Jill Clayton-Smith, Inge Kiemle Trindade, Kevin J Munro, Nicola Harman, Elizabeth J Conroy, and Dieter Weichart

Subjects
Medicine
Abstract

Introduction Cleft palate is among the most common birth abnormalities. The success of primary surgery in the early months of life is crucial for successful feeding, speech, hearing, dental development and facial growth. Over recent decades, age at palatal surgery in infancy has reduced. This has led to palatal closure in one-stage procedures being carried out around the age of 12 months, but in some cases as early as 6 months. The primary objective of the Timing Of Primary Surgery for Cleft Palate (TOPS)trial is to determine whether surgery for cleft palate performed at 6 or 12 months of age is most beneficial for speech outcomes.Methods and analysis Infants with a diagnosis of non-syndromic isolated cleft palate will be randomised to receive standardised primary surgery (Sommerlad technique) for closure of the cleft at either 6 months or 12 months, corrected for gestational age. The primary outcome will be perceived insufficient velopharyngeal function at 5 years of age. Secondary outcomes measured across 12 months, 3 years and 5 years will include growth, safety of the procedure, dentofacial development, speech, hearing level and middle ear function. Video and audio recordings of speech will be collected in a standardised age-appropriate manner and analysed independently by multiple speech and language therapists. The trial aims to recruit and follow-up 300 participants per arm. Data will be analysed according to the intention-to-treat principle using a 5% significance level. All analyses will be prespecified within a full and detailed statistical analysis plan.Ethics and dissemination Ethical approval has been sought in each participating country according to country-specific procedures. Trial results will be presented at conferences, published in peer-reviewed journals and disseminated through relevant patient support groups.Trial registration number NCT00993551; Pre-results.

Published
2019
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7. Feasibility study to examine discrepancy rates in prespecified and reported outcomes in articles submitted to The BMJ

Author

Sara Schroter, Carrol Gamble, Mike Clarke, Paula Williamson, Kerry Dwan, Jamie Kirkham, Jennifer Weston, and Douglas Altman

Subjects
Medicine
Abstract

Objectives Adding, omitting or changing prespecified outcomes can result in bias because it increases the potential for unacknowledged or post hoc revisions of the planned analyses. Journals have adopted initiatives such as requiring the prospective registration of trials and the submission of study protocols to promote the transparency of reporting in clinical trials. The main objective of this feasibility study was to document the frequency and types of outcome discrepancy between prespecified outcomes in the protocol and reported outcomes in trials submitted to The BMJ.Methods A review of all 3156 articles submitted to The BMJ between 1 September 2013 and 30 June 2014. Trial registry entries, protocols and trial reports of randomised controlled trials published by The BMJ and a random sample of those rejected were reviewed. Editorial, peer reviewer comments and author responses were also examined to ascertain any reasons for discrepancies.Results In the study period, The BMJ received 311 trial manuscripts, 21 of which were subsequently published by the journal. In trials published by The BMJ, 27% (89/333) of the prespecified outcomes in the protocol were not reported in the submitted paper and 11% (31/275) of reported outcomes were not prespecified. In the sample of 21 trials rejected by The BMJ, 19% (63/335) of prespecified outcomes went unreported and 14% (45/317) of reported outcomes were not prespecified. None of the reasons provided by published authors were suggestive of outcome reporting bias as the reasons were unrelated to the results.Conclusions Mandating the prospective registration of a trial and requesting that a protocol be uploaded when submitting a trial article to a journal has the potential to promote transparency and safeguard the evidence base against outcome reporting biases as a result of outcome discrepancies. Further guidance is needed with regard to documenting reasons for outcome discrepancies.

Published
2016
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