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4. Potassium Supplementation and Prevention of Atrial Fibrillation After Cardiac Surgery: The TIGHT K Randomized Clinical Trial.

Author

O'Brien, Benjamin, Campbell, Niall G., Allen, Elizabeth, Jamal, Zahra, Sturgess, Joanna, Sanders, Julie, Opondo, Charles, Roberts, Neil, Aron, Jonathan, Maccaroni, Maria Rita, Gould, Richard, Kirmani, Bilal H., Gibbison, Ben, Kunst, Gudrun, Zarbock, Alexander, Kleine-Brüggeney, Maren, Stoppe, Christian, Pearce, Keith, Hughes, Mark, and Van Dyck, Laura

Subjects
CORONARY artery bypass, HOSPITAL admission & discharge, MEDICAL care costs, ATRIAL fibrillation, CARDIAC surgery
Abstract

Key Points: Question: When trying to prevent atrial fibrillation after cardiac surgery (AFACS), is supplementing potassium only when its serum concentration falls below 3.6 mEq/L noninferior to supplementation when serum potassium concentration falls below 4.5 mEq/L? Findings: In the first 5 days after coronary artery bypass graft (CABG) surgery, patients who only received supplementation when serum potassium concentration dropped below 3.6 mEq/L (n = 830) did not have an increased incidence of new-onset AFACS compared with those who only received supplementation when serum potassium concentration dropped below 4.5 mEq/L (n = 837). There was no difference between the groups for other dysrhythmias or clinical outcomes. Meaning: The widespread practice of seeking to maintain high-normal serum potassium concentration after CABG surgery can be abandoned. This will reduce health care costs and decrease patient risk from an unnecessary intervention. IMPORTANCE: Supplementing potassium in an effort to maintain high-normal serum concentrations is a widespread strategy used to prevent atrial fibrillation after cardiac surgery (AFACS), but is not evidence-based, carries risks, and is costly. OBJECTIVE: To determine whether a lower serum potassium concentration trigger for supplementation is noninferior to a high-normal trigger. DESIGN, SETTING, AND PARTICIPANTS: This open-label, noninferiority, randomized clinical trial was conducted at 23 cardiac surgical centers in the United Kingdom and Germany. Between October 20, 2020, and November 16, 2023, patients with no history of atrial dysrhythmias scheduled for isolated coronary artery bypass grafting (CABG) surgery were enrolled. The last study patient was discharged from the hospital on December 11, 2023. INTERVENTIONS: Patients were randomly assigned to a strategy of tight or relaxed potassium control (only supplementing if serum potassium concentration fell below 4.5 mEq/L or 3.6 mEq/L, respectively). Patients wore an ambulatory heart rhythm monitor, which was analyzed by a core laboratory masked to treatment assignment. MAIN OUTCOMES AND MEASURES: The prespecified primary end point was clinically detected and electrocardiographically confirmed new-onset AFACS in the first 120 hours after CABG surgery or until hospital discharge, whichever occurred first. All primary outcome events were validated by an event validation committee, which was masked to treatment assignment. Noninferiority of relaxed potassium control was defined as a risk difference for new-onset AFACS with associated upper bound of a 1-sided 97.5% CI of less than 10%. Secondary outcomes included other heart rhythm–related events, clinical outcomes, and cost related to the intervention. RESULTS: A total of 1690 patients (mean age, 65 years; 256 [15%] females) were randomized. The primary end point occurred in 26.2% of patients (n = 219) in the tight group and 27.8% of patients (n = 231) in the relaxed group, which is a risk difference of 1.7% (95% CI, −2.6% to 5.9%). There was no difference between the groups in the incidence of at least 1 AFACS episode detected by any means or by ambulatory heart rhythm monitor alone, non-AFACS dysrhythmias, in-patient mortality, or length of stay. Per-patient cost for purchasing and administering potassium was significantly lower in the relaxed group (mean difference, $111.89 [95% CI, $103.60-$120.19]; P <.001). CONCLUSIONS AND RELEVANCE: For AFACS prophylaxis, supplementation only when serum potassium concentration fell below 3.6 mEq/L was noninferior to the current widespread practice of supplementing potassium to maintain a serum potassium concentration greater than or equal to 4.5 mEq/L. The lower threshold of supplementation was not associated with any increase in dysrhythmias or adverse clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04053816 This randomized clinical trial examines whether a lower serum potassium concentration trigger for supplementation is noninferior to a high-normal trigger for the prevention of atrial fibrillation after cardiac surgery. [ABSTRACT FROM AUTHOR]

Published
2024
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7. A Randomised tRial of Expedited transfer to a cardiac arrest centre for non-ST elevation ventricular fibrillation out-of-hospital cardiac arrest: The ARREST pilot randomised trial

Author

Patterson, Tiffany, Perkins, Gavin D., Joseph, Jubin, Wilson, Karen, Van Dyck, Laura, Robertson, Steven, Nguyen, Hanna, McConkey, Hannah, Whitbread, Mark, Fothergill, Rachael, Nevett, Joanne, Dalby, Miles, Rakhit, Roby, MacCarthy, Philip, Perera, Divaka, Nolan, Jerry P., and Redwood, Simon R.

Published
2017
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13. Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT): a randomised, double-blind, controlled trial

Author

Richards, Toby, Baikady, Ravishankar Rao, Clevenger, Ben, Butcher, Anna, Abeysiri, Sandy, Chau, Marisa, Macdougall, Iain C, Murphy, Gavin, Swinson, Rebecca, Collier, Tim, Van Dyck, Laura, Browne, John, Bradbury, Andrew, Dodd, Matthew, Evans, Richard, Brealey, David, Anker, Stefan D, and Klein, Andrew

Abstract

BACKGROUND: Preoperative anaemia affects a high proportion of patients undergoing major elective surgery and is associated with poor outcomes. We aimed to test the hypothesis that intravenous iron given to anaemic patients before major open elective abdominal surgery would correct anaemia, reduce the need for blood transfusions, and improve patient outcomes. METHODS: In a double-blind, parallel-group randomised trial, we recruited adult participants identified with anaemia at preoperative hospital visits before elective major open abdominal surgery at 46 UK tertiary care centres. Anaemia was defined as haemoglobin less than 130 g/L for men and 120 g/L for women. We randomly allocated participants (1:1) via a secure web-based service to receive intravenous iron or placebo 10-42 days before surgery. Intravenous iron was administered as a single 1000 mg dose of ferric carboxymaltose in 100 mL normal saline, and placebo was 100 mL normal saline, both given as an infusion over 15 min. Unblinded study personnel prepared and administered the study drug; participants and other clinical and research staff were blinded to treatment allocation. Coprimary endpoints were risk of the composite outcome of blood transfusion or death, and number of blood transfusions from randomisation to 30 days postoperatively. The primary analysis included all randomly assigned patients with data available for the primary endpoints; safety analysis included all randomly assigned patients according to the treatment received. This study is registered, ISRCTN67322816, and is closed to new participants. FINDINGS: Of 487 participants randomly assigned to placebo (n=243) or intravenous iron (n=244) between Jan 6, 2014, and Sept 28, 2018, complete data for the primary endpoints were available for 474 (97%) individuals. Death or blood transfusion occurred in 67 (28%) of the 237 patients in the placebo group and 69 (29%) of the 237 patients in the intravenous iron group (risk ratio 1·03, 95% CI 0·78-1·37; p=0·84). There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group (rate ratio 0·98, 95% CI 0·68-1·43; p=0·93). There were no significant differences between the two groups for any of the prespecified safety endpoints. INTERPRETATION: Preoperative intravenous iron was not superior to placebo to reduce need for blood transfusion when administered to patients with anaemia 10-42 days before elective major abdominal surgery. FUNDING: UK National Institute of Health Research Health Technology Assessment Program.

Published
2020

14. Human neurons from Christianson syndrome iPSCs reveal mutation-specific responses to rescue strategies

Author

Lizarraga, Sofia B., primary, Ma, Li, additional, Maguire, Abbie M., additional, van Dyck, Laura I., additional, Wu, Qing, additional, Ouyang, Qing, additional, Kavanaugh, Brian C., additional, Nagda, Dipal, additional, Livi, Liane L., additional, Pescosolido, Matthew F., additional, Schmidt, Michael, additional, Alabi, Shanique, additional, Cowen, Mara H., additional, Brito-Vargas, Paul, additional, Hoffman-Kim, Diane, additional, Gamsiz Uzun, Ece D., additional, Schlessinger, Avner, additional, Jones, Richard N., additional, and Morrow, Eric M., additional

Published
2021
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15. A school-based social-marketing intervention to promote sexual health in English secondary schools: the Positive Choices pilot cluster RCT

Author

Ponsford, Ruth, primary, Bragg, Sara, additional, Allen, Elizabeth, additional, Tilouche, Nerissa, additional, Meiksin, Rebecca, additional, Emmerson, Lucy, additional, Van Dyck, Laura, additional, Opondo, Charles, additional, Morris, Steve, additional, Sturgess, Joanna, additional, Brocklehurst, Elizabeth, additional, Hadley, Alison, additional, Melendez-Torres, GJ, additional, Elbourne, Diana, additional, Young, Honor, additional, Lohan, Maria, additional, Mercer, Catherine, additional, Campbell, Rona, additional, and Bonell, Chris, additional

Published
2021
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20. Irbesartan in Marfan syndrome (AIMS): a double-blind, placebo-controlled randomised trial

Author

Mullen, Michael, primary, Jin, Xu Yu, additional, Child, Anne, additional, Stuart, A Graham, additional, Dodd, Matthew, additional, Aragon-Martin, José Antonio, additional, Gaze, David, additional, Kiotsekoglou, Anatoli, additional, Yuan, Li, additional, Hu, Jiangting, additional, Foley, Claire, additional, Van Dyck, Laura, additional, Knight, Rosemary, additional, Clayton, Tim, additional, Swan, Lorna, additional, Thomson, John D R, additional, Erdem, Guliz, additional, Crossman, David, additional, Flather, Marcus, additional, Dean, John, additional, Was, Bartosz, additional, Gow, Heather, additional, Murray, Jane, additional, D'Allessandro, Mariella, additional, Christie, Michael, additional, Cooper, Patricia, additional, Booth, Philip, additional, Burns, Sharon, additional, Paterson, Yvonne, additional, Chikermane, Ashish, additional, Assing, Anthony, additional, Cotter, Catherine, additional, Atkins, Gillian, additional, Williamson, Helen, additional, Barclay, Justin, additional, Jennison, Alan, additional, Henderson, Alex, additional, McSkeane, Anna, additional, Fairlamb, Helen, additional, Kelly, Julie, additional, Kelsall, Nicola, additional, Prentice, Scott, additional, O'Sullivan, John, additional, Head-Baister, Alison, additional, Phillipson, Angela, additional, Johnson, Anna, additional, Crossland, D, additional, Oliver, Jack, additional, Davison, Jade, additional, Wake, Jill, additional, Quinn, Louise, additional, Foreman, Maureen, additional, Wealleans, Vera, additional, Walker, Niki, additional, Duncan, Alexis, additional, Tibbs, Evelyn, additional, Kelly, Ruth, additional, Khambadkone, Sachin, additional, Zotti, Bridget, additional, Brady, Cassie, additional, Cervi, Elena, additional, Field, Ella, additional, Szepezvary, Eszter, additional, Mantey, Florence, additional, Riley, Gillian, additional, Titmus, Heather, additional, Bo, Ilaria, additional, Kaski, Juan Pablo, additional, Green, Loren, additional, Jones, Nigel, additional, Banks, Rebecca, additional, Kiesewetter, Christopher, additional, Mathur, Sujeev, additional, Frigiola, Alessandra, additional, Savis, Alex, additional, Belfield, Holly, additional, Guzman, Josephine, additional, Harris, Julia, additional, Wilson, Karen, additional, Peacock, Kelly, additional, Gibson, Kirsty, additional, Wellman, Paul, additional, Simpson, John, additional, Kabir, Saleha, additional, Mushemi, Sitali, additional, Stewart, Michael, additional, Atkinson, Bev, additional, Richardson, Cath, additional, Leng, Elaine, additional, Brennan, Paul, additional, Nixon, Annabel, additional, Spencer, Collette, additional, Oliver, James, additional, Forster, Jan, additional, Turner, Louise, additional, Bainbridge, Samantha, additional, Choy, Anna Maria, additional, Dawson, Adelle, additional, Kiddie, Gwen, additional, Kerr, Heather, additional, Mordi, Ify, additional, Duff, Jackie, additional, Dunlop, Jacqueline, additional, Berg, Jonathan, additional, Armory, Pauline, additional, Freeman, Leisa, additional, Anwar, Amir, additional, Graham, Charles, additional, London, Clare, additional, Healey, Gail, additional, Gallagher, Ian, additional, Ilsley, Mary, additional, Ahmed, Rizwan, additional, Wood, Sheila, additional, Wheeldon, Nigel, additional, Mason, Cecilia, additional, Nassim, Farook, additional, Middle, Janet, additional, Adams, Justin, additional, Angelini, Karen, additional, Housley, Kay, additional, Ryalls, Kim, additional, Agyemang, Michael, additional, Walker, Rachel, additional, Batigan, Robina, additional, Bennett, Tina, additional, Clift, Paul, additional, Alvior, Amor Mia, additional, Nilsson, Annette, additional, Green, Carole, additional, Crook, Charlotte, additional, Palmer, Connie Becani, additional, Dwenger, Elizabeth, additional, Doherty, Phillipa, additional, Igbokwe, Rebecca, additional, Sharif, Saba, additional, MacDonald, Sonia, additional, West, Cathy, additional, Kirby, Kevin, additional, Naqvi, Nitha, additional, Welch, Sophie, additional, Warsama, Suad, additional, Li, Wei, additional, Farzad, Zohreh, additional, Smith, Ben, additional, Murday, Victoria, additional, Murtagh, Eamonn, additional, Adams, Emma, additional, Armour, Lesley, additional, Lilley, Stuart, additional, Pandya, Bejal, additional, Richards, Amy, additional, Andiapen, Mervyn, additional, Macrae, Rebecca, additional, Tome, Maite, additional, Hutchinson, Carmel, additional, Angulo, Kameka, additional, Kauppayamootoo, Rooba, additional, Gati, Sabiha, additional, Cruddas, Elizabeth, additional, Newman, William G, additional, Breen, Catherine, additional, Kumar, Dhavendra, additional, Wilson, Dirk G, additional, Farrugia, Adele, additional, Fraser, Alan, additional, Sumers, Jayne, additional, Powell, Jessie, additional, Edwards, Julie, additional, Hale, Terese, additional, Boult, Zoe, additional, Carroll, Aisling, additional, Veldtman, Gruschen, additional, Ho, Andrew, additional, Black, David, additional, Fletcher, Lisa, additional, Mapstone, Sue, additional, Bharucha, Tara, additional, Marsh, Gary, additional, Jones, Joanne, additional, Sheehan, Karen, additional, Selway, Kathleen, additional, Stevenson, Kirsty, additional, Nelson, Martin, additional, Fairweather, Rebecca, additional, Curtis, Stephanie, additional, Simpson, Sue, additional, Denvir, Martin, additional, White, Audrey, additional, Steven, Jill, additional, Munro, Joanna, additional, Lam, Wayne, additional, Toff, William, additional, Petrou, Mario, additional, Silcocks, Paul, additional, and MacAllister, Raymond, additional

Published
2019
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21. Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial

Author

Hausenloy, Derek J, primary, Kharbanda, Rajesh K, additional, Møller, Ulla Kristine, additional, Ramlall, Manish, additional, Aarøe, Jens, additional, Butler, Robert, additional, Bulluck, Heerajnarain, additional, Clayton, Tim, additional, Dana, Ali, additional, Dodd, Matthew, additional, Engstrom, Thomas, additional, Evans, Richard, additional, Lassen, Jens Flensted, additional, Christensen, Erika Frischknecht, additional, Garcia-Ruiz, José Manuel, additional, Gorog, Diana A, additional, Hjort, Jakob, additional, Houghton, Richard F, additional, Ibanez, Borja, additional, Knight, Rosemary, additional, Lippert, Freddy K, additional, Lønborg, Jacob T, additional, Maeng, Michael, additional, Milasinovic, Dejan, additional, More, Ranjit, additional, Nicholas, Jennifer M, additional, Jensen, Lisette Okkels, additional, Perkins, Alexander, additional, Radovanovic, Nebojsa, additional, Rakhit, Roby D, additional, Ravkilde, Jan, additional, Ryding, Alisdair D, additional, Schmidt, Michael R, additional, Riddervold, Ingunn Skogstad, additional, Sørensen, Henrik Toft, additional, Stankovic, Goran, additional, Varma, Madhusudhan, additional, Webb, Ian, additional, Terkelsen, Christian Juhl, additional, Greenwood, John P, additional, Yellon, Derek M, additional, Bøtker, Hans Erik, additional, Junker, Anders, additional, Kaltoft, Anne, additional, Madsen, Morten, additional, Christiansen, Evald Høj, additional, Jakobsen, Lars, additional, Carstensen, Steen, additional, Kristensen, Steen Dalby, additional, Thim, Troels, additional, Pedersen, Karin Møller, additional, Korsgaard, Mette Tidemand, additional, Iversen, Allan, additional, Jørgensen, Erik, additional, Joshi, Francis, additional, Pedersen, Frants, additional, Tilsted, Hans Henrik, additional, Alzuhairi, Karam, additional, Saunamäki, Kari, additional, Holmvang, Lene, additional, Ahlehof, Ole, additional, Sørensen, Rikke, additional, Helqvist, Steffen, additional, Mark, Bettina Løjmand, additional, Villadsen, Anton Boel, additional, Raungaard, Bent, additional, Thuesen, Leif, additional, Christiansen, Martin Kirk, additional, Freeman, Philip, additional, Jensen, Svend Eggert, additional, Skov, Charlotte Schmidt, additional, Aziz, Ahmed, additional, Hansen, Henrik Steen, additional, Ellert, Julia, additional, Veien, Karsten, additional, Pedersen, Knud Erik, additional, Hansen, Knud Nørregård, additional, Ahlehoff, Ole, additional, Cappelen, Helle, additional, Wittrock, Daniel, additional, Hansen, Poul Anders, additional, Ankersen, Jens Peter, additional, Hedegaard, Kim Witting, additional, Kempel, John, additional, Kaus, Henning, additional, Erntgaard, Dennis, additional, Pedersen, Danny Mejsner, additional, Giebner, Matthias, additional, Hansen, Troels Martin Hansen, additional, Radosavljevic-Radovanovic, Mina, additional, Prodanovic, Maja, additional, Savic, Lidija, additional, Pejic, Marijana, additional, Matic, Dragan, additional, Uscumlic, Ana, additional, Subotic, Ida, additional, Lasica, Ratko, additional, Vukcevic, Vladan, additional, Suárez, Alfonso, additional, Samaniego, Beatriz, additional, Morís, César, additional, Segovia, Eduardo, additional, Hernández, Ernesto, additional, Lozano, Iñigo, additional, Pascual, Isaac, additional, Vegas-Valle, Jose M., additional, Rozado, José, additional, Rondán, Juan, additional, Avanzas, Pablo, additional, del Valle, Raquel, additional, Padrón, Remigio, additional, García-Castro, Alfonso, additional, Arango, Amalia, additional, Medina-Cameán, Ana B., additional, Fente, Ana I., additional, Muriel-Velasco, Ana, additional, Pomar-Amillo, Ángeles, additional, Roza, César L., additional, Martínez-Fernández, César M., additional, Buelga-Díaz, Covadonga, additional, Fernández-Gonzalo, David, additional, Fernández, Elena, additional, Díaz-González, Eloy, additional, Martinez-González, Eugenio, additional, Iglesias-Llaca, Fernando, additional, Viribay, Fernando M., additional, Fernández-Mallo, Francisco J., additional, Hermosa, Francisco J., additional, Martínez-Bastida, Ginés, additional, Goitia-Martín, Javier, additional, Vega-Fernández, José L., additional, Tresguerres, Jose M., additional, Rodil-Díaz, Juan A., additional, Villar-Fernández, Lara, additional, Alberdi, Lucía, additional, Abella-Ovalle, Luis, additional, de la Roz, Manuel, additional, Fernández-Carral, Marcos Fernández-Carral, additional, Naves, María C., additional, Peláez, María C., additional, Fuentes, María D., additional, García-Alonso, María, additional, Villanueva, María J., additional, Vinagrero, María S., additional, Vázquez-Suárez, María, additional, Martínez-Valle, Marta, additional, Nonide, Marta, additional, Pozo-López, Mónica, additional, Bernardo-Alba, Pablo, additional, Galván-Núñez, Pablo, additional, Martínez-Pérez, Polácido J., additional, Castro, Rafael, additional, Suárez-Coto, Raquel, additional, Suárez-Noriega, Raquel, additional, Guinea, Rocío, additional, Quintana, Rosa B., additional, de Cima, Sara, additional, Hedrera, Segundo A., additional, Laca, Sonia I., additional, Llorente-Álvarez, Susana, additional, Pascual, Susana, additional, Cimas, Teodorna, additional, Mathur, Anthony, additional, McFarlane-Henry, Eleanor, additional, Leonard, Gerry, additional, Veerapen, Jessry, additional, Westwood, Mark, additional, Colicchia, Martina, additional, Prossora, Mary, additional, Andiapen, Mervyn, additional, Mohiddin, Saidi, additional, Lenzi, Valentina, additional, Chong, Jun, additional, Francis, Rohin, additional, Pine, Amy, additional, Jamieson-Leadbitter, Caroline, additional, Neal, Debbie, additional, Din, J., additional, McLeod, Jane, additional, Roberts, Josh, additional, Polokova, Karin, additional, Longman, Kristel, additional, Penney, Lucy, additional, Lakeman, Nicki, additional, Wells, Nicki, additional, Hopper, Oliver, additional, Coward, Paul, additional, O'Kane, Peter, additional, Harkins, Ruth, additional, Guyatt, Samantha, additional, Kennard, Sarah, additional, Orr, Sarah, additional, Horler, Stephanie, additional, Morris, Steve, additional, Walvin, Tom, additional, Snow, Tom, additional, Cunnington, Michael, additional, Burd, Amanda, additional, Gowing, Anne, additional, Krishnamurthy, Arvindra, additional, Harland, Charlotte, additional, Norfolk, Derek, additional, Johnstone, Donna, additional, Newman, Hannah, additional, Reed, Helen, additional, O'Neill, James, additional, Greenwood, John, additional, Cuxton, Josephine, additional, Corrigan, Julie, additional, Somers, Kathryn, additional, Anderson, Michelle, additional, Burtonwood, Natalie, additional, Bijsterveld, Petra, additional, Brogan, Richard, additional, Ryan, Tony, additional, Kodoth, Vivek, additional, Khan, Arif, additional, Sebastian, Deepti, additional, Gorog, Diana, additional, Boyle, Georgina, additional, Shepherd, Lucy, additional, Hamid, Mahmood, additional, Farag, Mohamed, additional, Spinthakis, Nicholas, additional, Waitrak, Paulina, additional, De Sousa, Phillipa, additional, Bhatti, Rishma, additional, Oliver, Victoria, additional, Walshe, Siobhan, additional, Odedra, Toral, additional, Gue, Ying, additional, Kanji, Rahim, additional, Ryding, Alisdair, additional, Ratcliffe, Amanda, additional, Merrick, Angela, additional, Horwood, Carol, additional, Sarti, Charlotte, additional, Maart, Clint, additional, Moore, Donna, additional, Dockerty, Francesca, additional, Baucutt, Karen, additional, Pitcher, Louise, additional, Ilsley, Mary, additional, Clarke, Millie, additional, Germon, Rachel, additional, Gomes, Sara, additional, Clare, Thomas, additional, Nair, Sunil, additional, Staines, Jocasta, additional, Nicholson, Susan, additional, Watkinson, Oliver, additional, Gallagher, Ian, additional, Nelthorpe, Faye, additional, Musselwhite, Janine, additional, Grosser, Konrad, additional, Stimson, Leah, additional, Eaton, Michelle, additional, Heppell, Richard, additional, Turney, Sharon, additional, Horner, Victoria, additional, Schumacher, Natasha, additional, Moon, Angela, additional, Mota, Paula, additional, O'Donnell, Joshua, additional, Panicker, Abeesh Sadasiva, additional, Musa, Anntoniette, additional, Tapp, Luke, additional, Krishnamoorthy, Suresh, additional, Ansell, Valerie, additional, Ali, Danish, additional, Hyndman, Samantha, additional, Banerjee, Prithwish, additional, Been, Martin, additional, Mackenzie, Ailie, additional, McGregor, Andrew, additional, Hildick-Smith, David, additional, Champney, Felicity, additional, Ingoldby, Fiona, additional, Keate, Kirstie, additional, Bennett, Lorraine, additional, Skipper, Nicola, additional, Gregory, Sally, additional, Harfield, Scott, additional, Mudd, Alexandra, additional, Wragg, Christopher, additional, Barmby, David, additional, Grech, Ever, additional, Hall, Ian, additional, Middle, Janet, additional, Barker, Joann, additional, Fofie, Joyce, additional, Gunn, Julian, additional, Housley, Kay, additional, Cockayne, Laura, additional, Weatherlley, Louise, additional, Theodorou, Nana, additional, Wheeldon, Nigel, additional, Fati, Pene, additional, Storey, Robert F., additional, Richardson, James, additional, Iqbal,, Javid, additional, Adam, Zul, additional, Brett, Sarah, additional, Agyemang, Michael, additional, Tawiah, Cecilia, additional, Hogrefe, Kai, additional, Raju, Prashanth, additional, Braybrook, Christine, additional, Gracey, Jay, additional, Waldron, Molly, additional, Holloway, Rachael, additional, Burunsuzoglu, Senem, additional, Sidgwick, Sian, additional, Hetherington, Simon, additional, Beirnes, Charmaine, additional, Fernandez, Olga, additional, Lazar, Nicoleta, additional, Knighton, Abigail, additional, Rai, Amrit, additional, Hoare, Amy, additional, Breeze, Jonathan, additional, Martin, Katherine, additional, Andrews, Michelle, additional, Patale, Sheetal, additional, Bennett, Amy, additional, Smallwood, Andrew, additional, Radford, Elizabeth, additional, Cotton, James, additional, Martins, Joe, additional, Wallace, Lauren, additional, Milgate, Sarah, additional, Munir, Shahzad, additional, Metherell, Stella, additional, Cottam, Victoria, additional, Massey, Ian, additional, Copestick, Jane, additional, Delaney, Jane, additional, Wain, Jill, additional, Sandhu, Kully, additional, Emery, Lisa, additional, Hall, Charlotte, additional, Bucciarelli-Ducci, Chiara, additional, Besana, Rissa, additional, Hussein, Jodie, additional, Bell, Sheila, additional, Gill, Abby, additional, Bales, Emily, additional, Polwarth, Gary, additional, East, Clare, additional, Smith, Ian, additional, Oliveira, Joana, additional, Victor, Saji, additional, Woods, Sarah, additional, Hoole, Stephen, additional, Ramos, Angelo, additional, Sevillano, Annaliza, additional, Nicholson, Anne, additional, Solieri, Ashley, additional, Redman, Emily, additional, Byrne, Jean, additional, Joyce, Joan, additional, Riches, Joanne, additional, Davies, John, additional, Allen, Kezia, additional, Saclot, Louie, additional, Ocampo, Madelaine, additional, Vertue, Mark, additional, Christmas, Natasha, additional, Koothoor, Raiji, additional, Gamma, Reto, additional, Alvares, Wilson, additional, Pepper, Stacey, additional, Kobson, Barbara, additional, Reeve, Christy, additional, Malik, Iqbal, additional, Chester, Emma, additional, Saunders, Heidi, additional, Mojela, Idah, additional, Smee, Joanna, additional, Davies, Justin, additional, Davies, Nina, additional, Clifford, Piers, additional, Dias, Priyanthi, additional, Kaur, Ramandeep, additional, Moreira, Silvia, additional, Ahmad, Yousif, additional, Tomlinson, Lucy, additional, Pengelley, Clare, additional, Bidle, Amanda, additional, Spence, Sharon, additional, Al-Lamee, Rasha, additional, Phuyal, Urmila, additional, Abbass, Hakam, additional, Bose, Tuhina, additional, Elliott, Rebecca, additional, Foundun, Aboo, additional, Chung, Alan, additional, Freestone, Beth, additional, Lee, Dr Kaeng, additional, Elshiekh, Dr Mohamed, additional, Pulikal, George, additional, Bhatre, Gurbir, additional, Douglas, James, additional, Kaeng, Lee, additional, Pitt, Mike, additional, Watkins, Richard, additional, Gill, Simrat, additional, Hartley, Amy, additional, Lucking, Andrew, additional, Moreby, Berni, additional, Darby, Damaris, additional, Corps, Ellie, additional, Parsons, Georgina, additional, De Mance, Gianluigi, additional, Fahrai, Gregor, additional, Turner, Jenny, additional, Langrish, Jeremy, additional, Gaughran, Lisa, additional, Wolyrum, Mathias, additional, Azkhalil, Mohammed, additional, Bates, Rachel, additional, Given, Rachel, additional, Kharbanda, Rajesh, additional, Douthwaite, Rebecca, additional, Lloyd, Steph, additional, Neubauer, Stephen, additional, Barker, Deborah, additional, Suttling, Anne, additional, Turner, Charlotte, additional, Smith, Clare, additional, Longbottom, Colin, additional, Ross, David, additional, Cunliffe, Denise, additional, Cox, Emily, additional, Whitehead, Helena, additional, Hudson, Karen, additional, Jones, Leslie, additional, Drew, Martin, additional, Chant, Nicholas, additional, Haworth, Peter, additional, Capel, Robert, additional, Austin, Rosalynn, additional, Howe, Serena, additional, Smith, Trevor, additional, Hobson, Alex, additional, Strike, Philip, additional, Griffiths, Huw, additional, Anantharam, Brijesh, additional, Jack, Pearse, additional, Thornton, Emma, additional, Hodgson, Adrian, additional, Jennison, Alan, additional, McSkeane, Anna, additional, Smith, Bethany, additional, Shaw, Caroline, additional, Leathers, Chris, additional, Armstrong, Elissa, additional, Carruthers, Gayle, additional, Simpson, Holly, additional, Smith, Jan, additional, Hodierne, Jeremy, additional, Kelly, Julie, additional, Barclay, Justin, additional, Scott, Kerry, additional, Gregson, Lisa, additional, Buchanan, Louise, additional, McCormick, Louise, additional, Kelsall, Nicci, additional, Mcarthy, Rachel, additional, Taylor, Rebecca, additional, Thompson, Rebecca, additional, Shelton, Rhidian, additional, Moore, Roger, additional, Tomlinson, Sharon, additional, Thambi, Sunil, additional, Cooper, Theresa, additional, Oakes, Trevor, additional, Deen, Zakhira, additional, Relph, Chris, additional, prentice, Scott, additional, Hall, Lorna, additional, Dillon, Angela, additional, Meadows, Deborah, additional, Frank, Emma, additional, Markham-Jones, Helene, additional, Thomas, Isobel, additional, Gale, Joanne, additional, Denman, Joanne, additional, O'Connor, John, additional, Hindle, Julia, additional, Jackson-Lawrence, Karen, additional, Warner, Karen, additional, Lee, Kelvin, additional, Upton, Robert, additional, Elston, Ruth, additional, Lee, Sandra, additional, Venugopal, Vinod, additional, Finch, Amanda, additional, Fleming, Catherine, additional, Whiteside, Charlene, additional, Pemberton, Chris, additional, Wilkinson, Conor, additional, Sebastian, Deepa, additional, Riedel, Ella, additional, Giuffrida, Gaia, additional, Burnett, Gillian, additional, Spickett, Helen, additional, Glen, James, additional, Brown, Janette, additional, Thornborough, Lauren, additional, Pedley, Lauren, additional, Morgan, Maureen, additional, Waddington, Natalia, additional, Brennan, Oliver, additional, Brady, Rebecca, additional, Preston, Stephen, additional, Loder, Chris, additional, Vlad, Ionela, additional, Laurence, Julia, additional, Smit, Angelique, additional, Dimond, Kirsty, additional, Hayes, Michelle, additional, Paddy, Loveth, additional, Crause, Jacolene, additional, Amed, Nadifa, additional, Kaur-Babooa, Priya, additional, Rakhit, Roby, additional, Kotecha, Tushar, additional, Fayed, Hossam, additional, Pavlidis, Antonis, additional, Prendergast, Bernard, additional, Clapp, Brian, additional, Perara, Divaka, additional, Atkinson, Emma, additional, Ellis, Howard, additional, Wilson, Karen, additional, Gibson, Kirsty, additional, Smith, Megan, additional, Khawaja, Muhammed Zeeshan, additional, Sanchez-Vidal, Ruth, additional, Redwood, Simon, additional, Jones, Sophie, additional, Tipping, Aoife, additional, Oommen, Anu, additional, Hendry, Cara, additional, Fath-Orboubadi, DR Fazin, additional, Phillips, Hannah, additional, Kolakaluri, Laurel, additional, Sherwood, Martin, additional, Mackie, Sarah, additional, Aleti, Shilpa, additional, Charles, Thabitha, additional, Roy, Liby, additional, Henderson, Rob, additional, Stables, Rod, additional, Marber, Michael, additional, Berry, Alan, additional, Redington, Andrew, additional, Thygesen, Kristian, additional, Andersen, Henning Rud, additional, Berry, Colin, additional, Copas, Andrew, additional, Meade, Tom, additional, Kelbæk, Henning, additional, Bueno, Hector, additional, von Weitzel-Mudersbach, Paul, additional, Andersen, Grethe, additional, Ludman, Andrew, additional, Cruden, Nick, additional, Topic, Dragan, additional, Mehmedbegovic, Zlatko, additional, de la Hera Galarza, Jesus Maria, additional, Robertson, Steven, additional, Van Dyck, Laura, additional, Chu, Rebecca, additional, Astarci, Josenir, additional, Jamal, Zahra, additional, Hetherington, Daniel, additional, and Collier, Lucy, additional

Published
2019
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23. Human neurons from Christianson syndrome iPSCs reveal allele-specific responses to rescue strategies

Author

Lizarraga, Sofia B., primary, Maguire, Abbie M., additional, Ma, Li, additional, van Dyck, Laura I., additional, Wu, Qing, additional, Nagda, Dipal, additional, Livi, Liane L., additional, Pescosolido, Matthew F., additional, Schmidt, Michael, additional, Alabi, Shanique, additional, Cowen, Mara H., additional, Brito-Vargas, Paul, additional, Hoffman-Kim, Diane, additional, Gamsiz Uzun, Ece D., additional, Schlessinger, Avner, additional, Jones, Richard N., additional, and Morrow, Eric M., additional

Published
2018
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24. A clinical and economic evaluation of Control of Hyperglycaemia in Paediatric intensive care (CHiP): a randomised controlled trial

Author

Macrae, Duncan, primary, Grieve, Richard, additional, Allen, Elizabeth, additional, Sadique, Zia, additional, Betts, Helen, additional, Morris, Kevin, additional, Pappachan, Vithayathil John, additional, Parslow, Roger, additional, Tasker, Robert C, additional, Baines, Paul, additional, Broadhead, Michael, additional, Duthie, Mark L, additional, Fortune, Peter-Marc, additional, Inwald, David, additional, McMaster, Paddy, additional, Peters, Mark J, additional, Schindler, Margrid, additional, Guerriero, Carla, additional, Piercy, Deborah, additional, Slavik, Zdenek, additional, Snowdon, Claire, additional, Van Dyck, Laura, additional, and Elbourne, Diana, additional

Published
2014
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26. A clinical and economic evaluation of Control of Hyperglycaemia in Paediatric intensive care (CHiP): a randomised controlled trial

Author

David Inwald, Paddy McMaster, Peter-Marc Fortune, Carla Guerriero, Helen Betts, Diana Elbourne, Deborah Piercy, Richard Grieve, Roger C Parslow, Mark L Duthie, Claire Snowdon, Zia Sadique, Margrid Schindler, Elizabeth Allen, Robert C. Tasker, Zdenek Slavik, Kevin Morris, Mark J. Peters, Duncan Macrae, Vithayathil John Pappachan, Laura Van Dyck, Paul Baines, Michael Broadhead, Macrae, Duncan, Grieve, Richard, Allen, Elizabeth, Sadique, Zia, Betts, Helen, Morris, Kevin, Pappachan, Vithayathil John, Parslow, Roger, Tasker, Robert C., Baines, Paul, Broadhead, Michael, Duthie, Mark L., Fortune, Peter-Marc, Inwald, David, Mcmaster, Paddy, Peters, Mark J., Schindler, Margrid, Guerriero, Carla, Piercy, Deborah, Slavik, Zdenek, Snowdon, Claire, Van Dyck, Laura, and Elbourne, Diana

Subjects
Male, medicine.medical_specialty, Pediatrics, lcsh:Medical technology, Adolescent, medicine.medical_treatment, Cost-Benefit Analysis, Intensive Care Units, Pediatric, law.invention, Outcome Assessment (Health Care), Randomized controlled trial, law, Intensive care, Diabetes mellitus, Surveys and Questionnaires, Outcome Assessment, Health Care, medicine, Surveys and Questionnaire, Humans, Hypoglycemic Agents, Insulin, Cost-Benefit Analysi, Child, Mechanical ventilation, Hypoglycemic Agent, business.industry, Health Policy, Infant, Health Care Costs, medicine.disease, Confidence interval, Cardiac surgery, Health Care Cost, lcsh:R855-855.5, England, Child, Preschool, Hyperglycemia, Arterial line, Female, business, Human, Research Article
Abstract

Background Early research in adults admitted to intensive care suggested that tight control of blood glucose during acute illness can be associated with reductions in mortality, length of hospital stay and complications such as infection and renal failure. Prior to our study, it was unclear whether or not children could also benefit from tight control of blood glucose during critical illness. Objectives This study aimed to determine if controlling blood glucose using insulin in paediatric intensive care units (PICUs) reduces mortality and morbidity and is cost-effective, whether or not admission follows cardiac surgery. Design Randomised open two-arm parallel group superiority design with central randomisation with minimisation. Analysis was on an intention-to-treat basis. Following random allocation, care givers and outcome assessors were no longer blind to allocation. Setting The setting was 13 English PICUs. Participants Patients who met the following criteria were eligible for inclusion: ≥ 36 weeks corrected gestational age; ≤ 16 years; in the PICU following injury, following major surgery or with critical illness; anticipated treatment > 12 hours; arterial line; mechanical ventilation; and vasoactive drugs. Exclusion criteria were as follows: diabetes mellitus; inborn error of metabolism; treatment withdrawal considered; in the PICU > 5 consecutive days; and already in CHiP (Control of Hyperglycaemia in Paediatric intensive care). Intervention The intervention was tight glycaemic control (TGC): insulin by intravenous infusion titrated to maintain blood glucose between 4.0 and 7.0 mmol/l. Conventional management (CM) This consisted of insulin by intravenous infusion only if blood glucose exceeded 12.0 mmol/l on two samples at least 30 minutes apart; insulin was stopped when blood glucose fell below 10.0 mmol/l. Main outcome measures The primary outcome was the number of days alive and free from mechanical ventilation within 30 days of trial entry (VFD-30). The secondary outcomes comprised clinical and economic outcomes at 30 days and 12 months and lifetime cost-effectiveness, which included costs per quality-adjusted life-year. Results CHiP recruited from May 2008 to September 2011. In total, 19,924 children were screened and 1369 eligible patients were randomised (TGC, 694; CM, 675), 60% of whom were in the cardiac surgery stratum. The randomised groups were comparable at trial entry. More children in the TGC than in the CM arm received insulin (66% vs. 16%). The mean VFD-30 was 23 [mean difference 0.36; 95% confidence interval (CI) –0.42 to 1.14]. The effect did not differ among prespecified subgroups. Hypoglycaemia occurred significantly more often in the TGC than in the CM arm (moderate, 12.5% vs. 3.1%; severe, 7.3% vs. 1.5%). Mean 30-day costs were similar between arms, but mean 12-month costs were lower in the TGC than in CM arm (incremental costs –£3620, 95% CI –£7743 to £502). For the non-cardiac surgery stratum, mean costs were lower in the TGC than in the CM arm (incremental cost –£9865, 95% CI –£18,558 to –£1172), but, in the cardiac surgery stratum, the costs were similar between the arms (incremental cost £133, 95% CI –£3568 to £3833). Lifetime incremental net benefits were positive overall (£3346, 95% CI –£11,203 to £17,894), but close to zero for the cardiac surgery stratum (–£919, 95% CI –£16,661 to £14,823). For the non-cardiac surgery stratum, the incremental net benefits were high (£11,322, 95% CI –£15,791 to £38,615). The probability that TGC is cost-effective is relatively high for the non-cardiac surgery stratum, but, for the cardiac surgery subgroup, the probability that TGC is cost-effective is around 0.5. Sensitivity analyses showed that the results were robust to a range of alternative assumptions. Conclusions CHiP found no differences in the clinical or cost-effectiveness of TGC compared with CM overall, or for prespecified subgroups. A higher proportion of the TGC arm had hypoglycaemia. This study did not provide any evidence to suggest that PICUs should stop providing CM for children admitted to PICUs following cardiac surgery. For the subgroup not admitted for cardiac surgery, TGC reduced average costs at 12 months and is likely to be cost-effective. Further research is required to refine the TGC protocol to minimise the risk of hypoglycaemic episodes and assess the long-term health benefits of TGC. Trial registration Current Controlled Trials ISRCTN61735247. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 26. See the NIHR Journals Library website for further project information.

Published
2014

28. A school-based social-marketing intervention to promote sexual health in English secondary schools: the Positive Choices pilot cluster RCT

Author

Ponsford R, Bragg S, Allen E, Tilouche N, Meiksin R, Emmerson L, Van Dyck L, Opondo C, Morris S, Sturgess J, Brocklehurst E, Hadley A, Melendez-Torres GJ, Elbourne D, Young H, Lohan M, Mercer C, Campbell R, and Bonell C

Abstract

Background: The UK still has the highest rate of teenage births in western Europe. Teenagers are also the age group most likely to experience unplanned pregnancy, with around half of conceptions in those aged < 18 years ending in abortion. After controlling for prior disadvantage, teenage parenthood is associated with adverse medical and social outcomes for mothers and children, and increases health inequalities. This study evaluates Positive Choices (a new intervention for secondary schools in England) and study methods to assess the value of a Phase III trial., Objectives: To optimise and feasibility-test Positive Choices and then conduct a pilot trial in the south of England assessing whether or not progression to Phase III would be justified in terms of prespecified criteria., Design: Intervention optimisation and feasibility testing; pilot randomised controlled trial., Setting: The south of England: optimisation and feasibility-testing in one secondary school; pilot cluster trial in six other secondary schools (four intervention, two control) varying by local deprivation and educational attainment., Participants: School students in year 8 at baseline, and school staff., Interventions: Schools were randomised (1 : 2) to control or intervention. The intervention comprised staff training, needs survey, school health promotion council, year 9 curriculum, student-led social marketing, parent information and review of school/local sexual health services., Main Outcome Measures: The prespecified criteria for progression to Phase III concerned intervention fidelity of delivery and acceptability; successful randomisation and school retention; survey response rates; and feasible linkage to routine administrative data on pregnancies. The primary health outcome of births was assessed using routine data on births and abortions, and various self-reported secondary sexual health outcomes., Data Sources: The data sources were routine data on births and abortions, baseline and follow-up student surveys, interviews, audio-recordings, observations and logbooks., Results: The intervention was optimised and feasible in the first secondary school, meeting the fidelity targets other than those for curriculum delivery and criteria for progress to the pilot trial. In the pilot trial, randomisation and school retention were successful. Student response rates in the intervention group and control group were 868 (89.4%) and 298 (84.2%), respectively, at baseline, and 863 (89.0%) and 296 (82.0%), respectively, at follow-up. The target of achieving ≥ 70% fidelity of implementation of essential elements in three schools was achieved. Coverage of relationships and sex education topics was much higher in intervention schools than in control schools. The intervention was acceptable to 80% of students. Interviews with staff indicated strong acceptability. Data linkage was feasible, but there were no exact matches for births or abortions in our cohort. Measures performed well. Poor test–retest reliability on some sexual behaviour measures reflected that this was a cohort of developing adolescents. Qualitative research confirmed the appropriateness of the intervention and theory of change, but suggested some refinements., Limitations: The optimisation school underwent repeated changes in leadership, which undermined its participation. Moderator analyses were not conducted as these would be very underpowered., Conclusion: Our findings suggest that this intervention has met prespecified criteria for progression to a Phase III trial., Future Work: Declining prevalence of teenage pregnancy suggests that the primary outcome in a full trial could be replaced by a more comprehensive measure of sexual health. Any future Phase III trial should have a longer lead-in from randomisation to intervention commencement., Trial Registration: Current Controlled Trials ISRCTN12524938., Funding: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research ; Vol. 9, No. 1. See the NIHR Journals Library website for further project information., (Copyright © Queen’s Printer and Controller of HMSO 2021. This work was produced by Ponsford et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.)

Published
2021
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29. Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT): a randomised, double-blind, controlled trial.

Author

Richards T, Baikady RR, Clevenger B, Butcher A, Abeysiri S, Chau M, Macdougall IC, Murphy G, Swinson R, Collier T, Van Dyck L, Browne J, Bradbury A, Dodd M, Evans R, Brealey D, Anker SD, and Klein A

Subjects
Aged, Double-Blind Method, Elective Surgical Procedures, Female, Humans, Male, Treatment Outcome, United Kingdom, Abdomen surgery, Administration, Intravenous, Anemia drug therapy, Iron administration & dosage, Preoperative Care
Abstract

Background: Preoperative anaemia affects a high proportion of patients undergoing major elective surgery and is associated with poor outcomes. We aimed to test the hypothesis that intravenous iron given to anaemic patients before major open elective abdominal surgery would correct anaemia, reduce the need for blood transfusions, and improve patient outcomes., Methods: In a double-blind, parallel-group randomised trial, we recruited adult participants identified with anaemia at preoperative hospital visits before elective major open abdominal surgery at 46 UK tertiary care centres. Anaemia was defined as haemoglobin less than 130 g/L for men and 120 g/L for women. We randomly allocated participants (1:1) via a secure web-based service to receive intravenous iron or placebo 10-42 days before surgery. Intravenous iron was administered as a single 1000 mg dose of ferric carboxymaltose in 100 mL normal saline, and placebo was 100 mL normal saline, both given as an infusion over 15 min. Unblinded study personnel prepared and administered the study drug; participants and other clinical and research staff were blinded to treatment allocation. Coprimary endpoints were risk of the composite outcome of blood transfusion or death, and number of blood transfusions from randomisation to 30 days postoperatively. The primary analysis included all randomly assigned patients with data available for the primary endpoints; safety analysis included all randomly assigned patients according to the treatment received. This study is registered, ISRCTN67322816, and is closed to new participants., Findings: Of 487 participants randomly assigned to placebo (n=243) or intravenous iron (n=244) between Jan 6, 2014, and Sept 28, 2018, complete data for the primary endpoints were available for 474 (97%) individuals. Death or blood transfusion occurred in 67 (28%) of the 237 patients in the placebo group and 69 (29%) of the 237 patients in the intravenous iron group (risk ratio 1·03, 95% CI 0·78-1·37; p=0·84). There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group (rate ratio 0·98, 95% CI 0·68-1·43; p=0·93). There were no significant differences between the two groups for any of the prespecified safety endpoints., Interpretation: Preoperative intravenous iron was not superior to placebo to reduce need for blood transfusion when administered to patients with anaemia 10-42 days before elective major abdominal surgery., Funding: UK National Institute of Health Research Health Technology Assessment Program., (Copyright © 2020 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Published
2020
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