Analysis and Reporting of Randomized Trials in Cleft Palate Surgery: Learning from the Timing of Primary Surgery (TOPS) Trial

被引：0
作者：
Fell, Matthew [1 ,2 ,8 ]
Phippen, Ginette [2 ]
van Eeden, Stephanie [3 ]
Chong, David [4 ]
Swan, Marc C. [2 ]
van Eeden, Simon [5 ]
Carlin, John B. [6 ,7 ]
机构：
[1] Univ Bristol, Cleft Collect, Bristol, England
[2] Oxford Univ Hosp NHS Fdn Trust, Salisbury NHS Fdn Trust, Spires Cleft Ctr, Oxford, Oxon, England
[3] Newcastle Univ, Sch Educ Commun & Language Sci, Newcastle Upon Tyne, Northumberland, England
[4] Royal Childrens Hosp, Plast & Maxillofacial Surg, Melbourne, Vic, Australia
[5] Alder Hey Childrens & Aintree Univ Hosp, Liverpool, Merseyside, England
[6] Murdoch Childrens Res Inst, Melbourne, Vic, Australia
[7] Univ Melbourne, Melbourne Sch Populat & Global Hlth, Melbourne, Vic, Australia
[8] Oxford Univ Hosp NHS Fdn Trust, Spires Cleft Ctr, Oxford, England
来源：
CLEFT PALATE CRANIOFACIAL JOURNAL | 2024年
关键词：
assessment; cleft palate; evidence-based practice; OUTCOME MEASURES; SPEECH; LIP; 5-YEAR-OLDS; STANDARDS; COHORT; CARE;
D O I：
10.1177/10556656241253949
中图分类号：
R78 [口腔科学];
学科分类号：
1003 ;
摘要：
The Timing of Primary Surgery (TOPS) trial was published August 2023 in the New England Journal of Medicine and is a milestone achievement for a study focused on cleft palate. Due to the complexity of outcome reporting in cleft and the rarity of such comparative trials, TOPS presents a useful opportunity to critically review the design, analysis and reporting strategies utilised. This perspective article focused on the inclusion of participants, the choice of the primary outcome measure and the analysis of ordinal data within the trial. Considerations for future comparative studies in cleft care are discussed.
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页数：7
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共 44 条
  • [1] A Standard Set of Outcome Measures for the Comprehensive Appraisal of Cleft Care
    Allori, Alexander C.
    Kelley, Thomas
    Meara, John G.
    Albert, Asteria
    Bonanthaya, Krishnamurthy
    Chapman, Kathy
    Cunningham, Michael
    Daskalogiannakis, John
    de Gier, Henriette
    Heggie, Andrew A.
    Hernandez, Cristina
    Jackson, Oksana
    Jones, Yin
    Kangesu, Loshan
    Koudstaal, Maarten J.
    Kuchhal, Rajiv
    Lohmander, Anette
    Long, Ross E., Jr.
    Magee, Leanne
    Monson, Laura
    Rose, Elizabeth
    Sitzman, Thomas J.
    Taylor, Jesse A.
    Thorburn, Guy
    van Eeden, Simon
    Williams, Chris
    Wirthlin, John O.
    Wong, Karen W.
    [J]. CLEFT PALATE CRANIOFACIAL JOURNAL, 2017, 54 (05) : 540 - 554
  • [2] Auslander A., 2022, Cleft Palate Craniofac J, V59, pS47
  • [3] Benchmarking Speech, Velopharyngeal Function Outcomes and Surgical Characteristics Following the Sommerlad Protocol and Palate Repair Technique
    Baillie, Lauren
    Sell, Debbie
    [J]. CLEFT PALATE-CRANIOFACIAL JOURNAL, 2020, 57 (10) : 1197 - 1215
  • [4] A Cross-Sectional Cohort Study of Speech in Five-Year-Olds With Cleft Palate ± Lip to Support Development of National Audit Standards BENCHMARKING SPEECH STANDARDS IN THE UNITED KINGDOM
    Britton, Lorraine
    Albery, Liz
    Bowden, Melanie
    Harding-Bell, Anne
    Phippen, Ginette
    Sell, Debbie
    [J]. CLEFT PALATE-CRANIOFACIAL JOURNAL, 2014, 51 (04) : 431 - 451
  • [5] Estimands: bringing clarity and focus to research questions in clinical trials
    Clark, Timothy Peter
    Kahan, Brennan C.
    Phillips, Alan
    White, Ian
    Carpenter, James R.
    [J]. BMJ OPEN, 2022, 12 (01):
  • [6] A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan
    Conroy, Elizabeth J.
    Cooper, Rachael
    Shaw, William
    Persson, Christina
    Willadsen, Elisabeth
    Munro, Kevin J.
    Williamson, Paula R.
    Semb, Gunvor
    Walsh, Tanya
    Gamble, Carrol
    [J]. TRIALS, 2021, 22 (01)
  • [7] Current Surgical Practice for Children Born with a Cleft lip and/or Palate in the United Kingdom
    Fell, Matthew
    Davies, Alex
    Davies, Amy
    Chummun, Shaheel
    Cobb, Alistair R. M.
    Moar, Kanwalraj
    Wren, Yvonne
    [J]. CLEFT PALATE-CRANIOFACIAL JOURNAL, 2022, : 679 - 688
  • [8] Range and Frequency of Congenital Malformations Among Children With Cleft Lip and/or Palate
    Fitzsimons, K. J.
    Hamilton, M. J.
    van der Meulen, J.
    Medina, J.
    Wahedally, M. A. H.
    Park, M. H.
    Russell, C. J. H.
    [J]. CLEFT PALATE CRANIOFACIAL JOURNAL, 2023, 60 (08) : 917 - 927
  • [9] Timing of Primary Surgery for Cleft Palate
    Gamble, Carrol
    Persson, Christina
    Willadsen, Elisabeth
    Albery, Liz
    Andersen, Helene Soegaard
    Antoneli, Melissa Zattoni
    Appelqvist, Malin
    Aukner, Ragnhild
    Bodling, Pia
    Bowden, Melanie
    Brunnegard, Karin
    Cairns, Gillian
    Calladine, Samantha
    Campbell, Linsay
    Clayton-Smith, Jill
    Cooper, Rachael
    Conroy, Elizabeth
    El-Angbawi, Ahmed
    Emborg, Berit Kildegaard
    Wikman, Josefin Enfalt
    Fitzpatrick, Beth
    Fukushiro, Ana Paula
    de Azevedo Bento Goncalves, Cristina Guedes
    Havstam, Christina
    Hvistendahl, Anne Katherine
    Jorgensen, Line Dahl
    Klinto, Kristina
    Kvinnsland, Marit Berntsen
    Larham, Catriona
    Lemvik, Jorunn
    Leturgie, Louise
    Liljerehn, Eva
    Lodge, Natalie
    Lohmander, Anette
    McMahon, Siobhan
    Mehendale, Felicity
    Miguel, Haline Coracine
    Moe, Marianne
    Nielsen, Joan Bogh
    Nyberg, Jill
    Pedersen, Nina-Helen
    Phippen, Ginette
    Alvarez Piazentin-Penna, Silvia Helena
    Patrick, Kathryn
    Pliskin, Lindsay
    Rigby, Lucy
    Semb, Gunvor
    Southby, Lucy
    Sporre, Maria
    Taleman, Ann-Sofie Bjorkman
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2023, 389 (09) : 795 - 807
  • [10] Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina (ORBITA) and coronary stents: A case study in the analysis and reporting of clinical trials
    Gelman, Andrew
    Carlin, John B.
    Nallamothu, Brahmajee K.
    [J]. AMERICAN HEART JOURNAL, 2019, 214 : 54 - 59
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