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1. eRAPID electronic patient self-Reporting of Adverse-events: Patient Information and aDvice: a pilot study protocol in pelvic radiotherapy

Author

Patricia Holch, Simon Pini, Ann M. Henry, Susan Davidson, Jacki Routledge, Julia Brown, Kate Absolom, Alexandra Gilbert, Kevin Franks, Claire Hulme, Carolyn Morris, Galina Velikova, and on behalf of the eRAPID radiotherapy work group

Subjects
Cancer, Adverse events, Patient-reported outcome measures (PROMs), Patient-reported outcomes (PROs), Electronic, Electronic health records, Medicine (General), R5-920
Abstract

Abstract Background An estimated 17,000 patients are treated annually in the UK with radical radiotherapy (RT) for pelvic cancer. New treatment approaches in RT have increased survivorship and changed the subjective toxicity profile for patients who experience acute and long-term pelvic-related adverse events (AE). Multi-disciplinary follow-up creates difficulty for monitoring and responding to these events during treatment and beyond. Originally developed for use in systemic oncology therapy eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is an online system for patients to report AEs from home. eRAPID enables patient data to be integrated into the electronic patient records for use in clinical practice, provides patient management advice for mild and moderate AE and advice to contact the hospital for severe AE. The system has now been developed for pelvic RT patients, and we aim to test the intervention in a pilot study with staff and patients to inform a future randomised controlled trial (RCT). Methods Eligible patients are those attending St James’s University hospital cancer centre and The Christie Hospital Manchester undergoing pelvic radiotherapy+/−chemotherapy/hormonotherapy for prostate, lower gastrointestinal and gynaecological cancers. A prospective 1:1 randomised (intervention or usual care) parallel group design with repeated measures and mixed methods will be employed. We aim to recruit 168 patients following recommendations for sample size estimates for pilot studies. Participants using eRAPID will report AE (at least weekly) from home weekly for 6 weeks and 6 weeks post-treatment (12-week total) then at 18 and 24 weeks. Hospital staff will review eRAPID reports and use information during consultations. Notifications will be sent to the relevant clinical team when severe symptoms are reported. We will measure patient-reported outcomes using validated questionnaires (Functional Assessment in Cancer Therapy Scale-General (FACT-G), European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC-QLQ-C30), process of care impact (hospital records of patient contacts and admissions) and economic variables (EQ5D-5L, patient use of resources)). Staff and patient experiences will be explored via semi-structured interviews. Discussion The objectives are to establish feasibility, recruitment, integrity of the system and attrition rates, determine effect sizes and aid selection of the primary outcome measure for a future RCT. We will also refine the intervention by exploring staff and patient views. The overall goal of this complex intervention is to improve the safe delivery of cancer treatments, enhance patient care and standardise documentation of AE within the clinical datasets. Trial registration ClinicalTrials.gov NCT02747264.

Published
2018
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2. Proceedings of Patient Reported Outcome Measure’s (PROMs) Conference Sheffield 2016: advances in patient reported outcomes research

Author

Tim Croudace, John Brazier, Nils Gutacker, Andrew Street, Dan Robotham, Samantha Waterman, Diana Rose, Safarina Satkunanathan, Til Wykes, Nasrin Nasr, Pamela Enderby, Jill Carlton, Donna Rowen, Jackie Elliott, Katherine Stevens, Hasan Basarir, Alex Labeit, Mairead Murphy, Sandra Hollinghurst, Chris Salisbury, Dominic Marley, James Wilson, Amy Barrat, Bibhas Roy, Ines Rombach, Órlaith Burke, Crispin Jenkinson, Alastair Gray, Oliver Rivero-Arias, Ian Porter, Jaheeda Gangannagaripalli, Charlotte Bramwell, Jose M. Valderas, Patricia Holch, Susan Davidson, Jacki Routledge, Ann Henry, Kevin Franks, Alex Gilbert, Kate Absolom, Galina Velikova, Jan R. Boehnke, Andrew Trigg, Ruth Howells, Jeshika Singh, Subhash Pokhrel, Louise Longworth, Caroline Potter, Cheryl Hunter, Laura Kelly, Elizabeth Gibbons, Julian Forder, Angela Coulter, Ray Fitzpatrick, and Michele Peters

Subjects
Computer applications to medicine. Medical informatics, R858-859.7
Abstract

Table of contents S1 Using computerized adaptive testing Tim Croudace S2 Well-being: what is it, how does it compare to health and what are the implications of using it to inform health policy John Brazier O1 “Am I going to get better?”—Using PROMs to inform patients about the likely benefit of surgery Nils Gutacker, Andrew Street O2 Identifying Patient Reported Outcome Measures for an electronic Personal Health Record Dan Robotham, Samantha Waterman, Diana Rose, Safarina Satkunanathan, Til Wykes O3 Examining the change process over time qualitatively: transformative learning and response shift Nasrin Nasr, Pamela Enderby O4 Developing a PROM to evaluate self-management in diabetes (HASMID): giving patients a voice Jill Carlton, Donna Rowen, Jackie Elliott, John Brazier, Katherine Stevens, Hasan Basarir, Alex Labeit O5 Development of the Primary Care Outcomes Questionnaire (PCOQ) Mairead Murphy, Sandra Hollinghurst, Chris Salisbury O6 Developing the PKEX score- a multimodal assessment tool for patients with shoulder problems Dominic Marley, James Wilson, Amy Barrat, Bibhas Roy O7 Applying multiple imputation to multi-item patient reported outcome measures: advantages and disadvantages of imputing at the item, sub-scale or score level Ines Rombach, Órlaith Burke, Crispin Jenkinson, Alastair Gray, Oliver Rivero-Arias O8 Integrating Patient Reported Outcome Measures (PROMs) into routine primary care for patients with multimorbidity: a feasibility study Ian Porter, Jaheeda Gangannagaripalli, Charlotte Bramwell, Jose M. Valderas O9 eRAPID: electronic self-report and management of adverse-events for pelvic radiotherapy (RT) patients Patricia Holch, Susan Davidson, Jacki Routledge, Ann Henry, Kevin Franks, Alex Gilbert, Kate Absolom & Galina Velikova O10 Patient reported outcomes (PROMs) based recommendation in clinical guidance for the management of chronic conditions in the United Kingdom Ian Porter, Jose M.Valderas O11 Cross-sectional and longitudinal parameter shifts in epidemiological data: measurement invariance and response shifts in cohort and survey data describing the UK’s Quality of Life Jan R. Boehnke O12 Patient-reported outcomes within health technology decision making: current status and implications for future policy Andrew Trigg, Ruth Howells O13 Can social care needs and well-being be explained by the EQ-5D? Analysis of Health Survey for England dataset Jeshika Singh, Subhash Pokhrel, Louise Longworth O14 Where patients and policy meet: exploring individual-level use of the Long-Term Conditions Questionnaire (LTCQ) Caroline Potter, Cheryl Hunter, Laura Kelly, Elizabeth Gibbons, Julian Forder, Angela Coulter, Ray Fitzpatrick, Michele Peters

Published
2016
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3. eRAPID electronic patient self-Reporting of Adverse-events: Patient Information and aDvice: a pilot study protocol in pelvic radiotherapy

Author

Alexandra Gilbert, Claire Hulme, Ann Henry, Galina Velikova, Kate Absolom, Kevin Franks, Jacki Routledge, Simon Pini, Patricia Holch, Julia Brown, Carolyn Morris, and Susan E Davidson

Subjects
medicine.medical_specialty, Medicine (miscellaneous), Intervention, law.invention, 03 medical and health sciences, Study Protocol, 0302 clinical medicine, Quality of life (healthcare), Randomized controlled trial, law, Survivorship curve, Intervention (counseling), Self-management, Electronic, Medicine, Electronic health records, 030212 general & internal medicine, Adverse effect, Cancer, Internet, lcsh:R5-920, Radiotherapy, business.industry, Repeated measures design, Chemoradiotherapy, Patient-reported outcome measures (PROMs), Patient-reported outcomes (PROs), 030220 oncology & carcinogenesis, Adverse events, Emergency medicine, business, lcsh:Medicine (General)
Abstract

Background An estimated 17,000 patients are treated annually in the UK with radical radiotherapy (RT) for pelvic cancer. New treatment approaches in RT have increased survivorship and changed the subjective toxicity profile for patients who experience acute and long-term pelvic-related adverse events (AE). Multi-disciplinary follow-up creates difficulty for monitoring and responding to these events during treatment and beyond. Originally developed for use in systemic oncology therapy eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is an online system for patients to report AEs from home. eRAPID enables patient data to be integrated into the electronic patient records for use in clinical practice, provides patient management advice for mild and moderate AE and advice to contact the hospital for severe AE. The system has now been developed for pelvic RT patients, and we aim to test the intervention in a pilot study with staff and patients to inform a future randomised controlled trial (RCT). Methods Eligible patients are those attending St James’s University hospital cancer centre and The Christie Hospital Manchester undergoing pelvic radiotherapy+/−chemotherapy/hormonotherapy for prostate, lower gastrointestinal and gynaecological cancers. A prospective 1:1 randomised (intervention or usual care) parallel group design with repeated measures and mixed methods will be employed. We aim to recruit 168 patients following recommendations for sample size estimates for pilot studies. Participants using eRAPID will report AE (at least weekly) from home weekly for 6 weeks and 6 weeks post-treatment (12-week total) then at 18 and 24 weeks. Hospital staff will review eRAPID reports and use information during consultations. Notifications will be sent to the relevant clinical team when severe symptoms are reported. We will measure patient-reported outcomes using validated questionnaires (Functional Assessment in Cancer Therapy Scale-General (FACT-G), European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC-QLQ-C30), process of care impact (hospital records of patient contacts and admissions) and economic variables (EQ5D-5L, patient use of resources)). Staff and patient experiences will be explored via semi-structured interviews. Discussion The objectives are to establish feasibility, recruitment, integrity of the system and attrition rates, determine effect sizes and aid selection of the primary outcome measure for a future RCT. We will also refine the intervention by exploring staff and patient views. The overall goal of this complex intervention is to improve the safe delivery of cancer treatments, enhance patient care and standardise documentation of AE within the clinical datasets. Trial registration ClinicalTrials.gov NCT02747264. Electronic supplementary material The online version of this article (10.1186/s40814-018-0304-6) contains supplementary material, which is available to authorized users.

Published
2018

4. Postoperative continuous positive airway pressure to prevent pneumonia, re-intubation, and death after major abdominal surgery (PRISM): a multicentre, open-label, randomised, phase 3 trial

Author

Rupert Pearse, Marco Ranieri, Tom Abbott, Mari-Liis Pakats, Edoardo Piervincenzi, Akshaykumar Patel, Brennan Kahan, Andrew Rhodes, Priyanthi Dias, Russell Hewson, Ib Jammer, Michelle Chew, Cesar Aldecoa, Reitze Rodseth, Bruce Biccard, Tim Stephens, Sara Payne, David Hepworth, Soeren Pischke, Joerund Asvall, John Hausken, Shaman Jhanji, Martin Rooms, Neil Flint, Dawn Hales, Tamas Szakmany, Andrew Leitch, Savino Spadaro, Davide Chiumello, Paul Johnston, Joyce Yeung, Guglielmo Tellan, Tonny Veenith, Josep Macmillan, Pierpaolo Terragni, Caroline Sander, Vidya Kasipandian, Tahania Ahmad, Aaron Lee, Marcello Tammaro, Danny McAuley, Simon Skene, Ravinder Vohra, Matt Wilson, Mark Edwards, Ewen Griffiths, Naomi Pritchard, Claudia Filippini, Tor Aasmundstad, Einar Aksnes, Lise-Merete Alpers, Andreas Barratt-Due, Anita Dahl, Linda Feldt, Elisa Figari, Eva Flåten, Karen Granheim, Minna Hagring, Håkon Haugaa, Gisle Kjoesen, Inge Klaevahaugen, Harald Lenz, Marianne Myhre, Hilde Orrem, Emily Stitt, Tor Inge Toennessen, Samuel Al-Kadhimi, Robert Anker, Mihaela Balint, Lauren Barraclough, Ethel Black, Matt Clayton, Leonora Conneely, Zara Edwards, Alex Eeles, Matthew Evans, Michelle Gerstman, Nicole Greenshields, Eleanor Harvey, Aoife Hegarty, Natalie Hester, Jenna Hutchinson, Ramanathan Kasivisvanathan, Helen Lawrence, Veronica Marsh, Laura Matthews, Francesca Mazzola, Jamie McCanny, Ben Morrison, Michelle O'Mahony, Ching Ling Pang, David Parkinson, Katrina Pirie, Ravishankar Rao Baikady, Louisa Shovel, Lorna Smith, Kate Tatham, Peter Thomas, Sophie Uren, Susanna Walker, Alasdair Wills, Prematie Andreou, Alex Howson, Jasmin Kaur, Adam Lewszuk, Esther Molina, Nirmalabaye Ramsamy, Emma Roberts, Vanessa Amaral, Salma Begum, Soliana Bekele, Richard Cashmore, Carmen Correia, Steven Dunkley, Maria Fernandez, Alexander Fowler, Amaia Garcia, Maria Della Giovampaola, Kathryn Greaves, Bethan Griffiths, Ryan Haines, Richard Haslop, Ying Hu, Sarah Hui, Marta Januszewska, Vasi Manon, Tim Martin, Shaun May, Annamaria Minicozzi, Edyta Niebrzegowska, Monica Oliveira, Katherine Pates, Filipa Santos, Tasnin Shahid, Paolo Simili, Alastair Somerville, Emily Subhedar, Ruzena Uddin, Sophie Walker, Yize Wan, Jan Whalley, Parjam Zolfaghari, Una Gunter, Gemma Hodkinson, Gwenllian Howe, Valentina Baratozzi, Giulia Casotto, Giulia Darai, Erica Ferrari, Giovanni Mistraletti, Valentina Palmaverdi, Stefano Furlani, Paolo Priani, Riccardo Ragazzi, Marco Salmaso, Marco Verri, Carlo Volta, Chris Nutt, Emma McKay, Orla O'Neill, Jaimin Patel, Katie Atterbury, Sarah Ballinger, Natalie Carling, Kaytie Ellis, Jo Gresty, Teresa Melody, Jade Monk, Chloe Norman, Eleanor Reeves, Julia Sampson, Peter Sutton, Marie Thomas, Amy Bamford, Colin Bergin, Ronald Carrera, Lauren Cooper, Liesl Despy, Karen Ellis, Emma Fellows, Stephanie Goundry, Samantha Harkett, Peter Ip, Tracy Mason, Christopher McGhee, Aisling McLaughlin, Aoife Neal, Martin Pope, Stephanie Porter, Hazel Smith, Catherine Snelson, Elaine Spruce, Ylenia Vigo, Arlo Whitehouse, Tony Whitehouse, Maria Donatiello, Sergio Gazzanelli, Mario Mezzapesa, Martina Savino, Giacomo Settesoldi, Gudrun Kunst, Sian Birch, Louise Greig, Harriet Noble, Evita Pappa, Bethany Penhaligon, Andrea Cossu, Leda Floris, Davide Piredda, Alberto Racca, Olof Brattstrom, Bente Heggelund, Magnus Flodberg, Sandra Månsson, Mamoona Ahmed, Jonathan Allen, Paula Bell, Roman Genetu, Julia Glennon, Janice Hanley, Katy Jenner, Summayyah Jogi, Parisa Mahjoob, Clare McGovern, Anthony Murphy, Roonak Nazari, Jacki Routledge, Trishna Uttamlal, Sinead Ward, Giorgio Iotti, Raffaella Picchioni, Silvia Poma, Paolo Navalesi, Andrea Bruni, Brunella De Leonardis, Eugenio Garofalo, Panna Patel, Carol McArthur, Karen Burns, Steven Peters, Giuseppe Foti, Serena Calcinati, Alice Grassi, Silvia Villa, John Berridge, Muthuraj Kanakaraj, Hazel Cahill, Greg Forshaw, Andy Gibson, Lia Grainger, Kate Howard, Katherine James, Zoe Murphy, Helen Sweeting, Rebecca Tait, Danielle Wilcock, David Yates, Sean Cope, Ashley Allan, Rebecca Betts, Sarah Cornell, Julie Sheriff, Lindsey Woods, Giacomo Grasselli, Matteo Brioni, Luigi Castagna, Richard von Rahden, Zane Farina, Samantha Green, Simphiwe Gumede, Chantal Rajah, Arisha Ramkillawan, Susan Moug, David Alcorn, Carol Dalton, Natalie Dickinson, Jennifer Edwards, Steven Henderson, Erin McIlveen, Richard Ramsaran, Joanne Bell, Lorna Fleming, Kathleen Monks, Jane Parker, Sean Stamper, Jo Stokes-Denson, Elisa Elías, Yessica Guerra, Jesus Rico-Feijoo, Carlos Kidel, Helder Filipe, Gretchelle Asis, Yvonne Gleeson, Alice Harvey, Christine Jackson, Margaret McNeil, Sara Mingo, Glykeria Pakou, Manuel Pinto, Stephen Wright, Maite Babio-Galan, David Buckley, Verity Calder, Ahmad Chishti, Joseph Cosgrove, Katherine Cullen, Leigh Dunn, Matthew Faulds, Jonathan Fortune, Matthew Gardner, Abigail Harrison, Carole Hays, Gerry Jones, Caroline Macfie, Iain Mccullagh, Ian Nesbitt, Suzanne O'Neil, Catherine Phoenix, Girish Rangaswamy, Craig Samson, Carmen Scott, Tara Shrestha, Rita Singh, Graham Soulsby, Jon Walton, Kimberley Zwiggelaar, Ceri Lynch, Heidi Clarke, Bethan Deacon, Helen Ivatt, Leanne Jones, Ahmed Latif, Shaun Oram, Chris Perman, Lisa Roche, Rowan Duys, Margot Flint, Kamal Bhagwan, Ettienne Coetzee, Ivan Joubert, Felipe Montoya-Pelaez, Pradeep Navsaria, Guy Picken, Owen Porrill, Grant Strathie, Thembinkosi Zungu, Sireesha Aluri, Simon Chau, Deborah Cooper, Mishell Cunningham, Allison Daniels, Susan Hope, Alice Nicholson, Laura Walker, Antonino Giarratano, Giuseppe Accurso, Santi Raineri, Giuseppe Tricoli, Richard Innes, Patricia Doble, Joanne Hutter, Corinne Pawley, Moira Tait, Mark Hamilton, Edward Andrade, Veronica Barnes, Claire Dalton, Carlos Delgado, Sarah Farnell-Ward, Helen Farrah, Geraldine Gray, Luisa Howlett, Gipsy Joseph, Monika Krupa, Susannah Leaver, Joao Macedo, Karen Maher, Johannes Mellinghoff, Rachel Oguntimehin, Joel Pereira, Frances Robinson, Christine Ryan, Nirav Shah, Paula Shirley, Alexandra Torborg, Thuli Biyase, Leanne Drummond, Belinda Kusel, Mbalenhle Mbuyisa, Sivuyisiwe Solala, Jenna Taylor, Adanma Ezihe-Ejiofor, Maame Aduse-Poku, Gary Colville, Louise Davies, Soo Kang, Alex Phillips, Justin Kirk-Bayley, Leigh Kelliher, Paula Carvelli, Gokce Daysal, Matthew Dickinson, Nancileigh Doyle, Christina Hughes, Laura Montague, Elizabeth Potter, Armorel Salberg, Sheena Sibug, Sinduja Sivarajan, Milo Thomson, Nichola Wakeford, Monica Rocco, Daniela Alampi, Daniel Conway, Richard Clark, Jashmin Maria, Fiona Pomeroy, Tanviha Quraishi, Abigail Williams, Srikanth Chukkambotla, Caroline Aherne, Donna Harrison-Briggs, Jill Fitchett, Stephen Duberley, Andrea Zanoni, Daniela Cardinale, Claudia Righi, Mark Blunt, Tracy Fuller, Ruth Hodgson, Melissa Rosbergen, Andrew Brennan, Louise Akeroyd, Victoria Boardman, Christopher Bull, Mike Carrick, Ian Chadderton, Sarah Cooper, Sarah Goellner, Laura Graham, Carl Ilyas, James King, Muhammad Laklouk, Tom Lawton, Christopher Macrow, Michael Munro, Adam Neep, Martin Northey, Victoria Peacock, Kate Pye, Lydia Radley, James Sira, Beth Smithson, Stuart Syddall, David Tooth, Thomas White, Sindre Hoel, Elin Aakre, Monica Bakke, Tone Hoivik, Arystarch Makowski, Harry Alcock, Sean Cardoso, Samantha Coetzee, Mary Everett, Mohamed Ibrahim, Christina Kouridaki, Vongayi Ogbeide, Elisabetta Bertellini, Valentina Bertolotti, Antonio Buono, Maria Fanigliulo, Ram Kumar, Nicole Richards, Alisha Allana, Samantha Bacciarelli, Helen Barker, Jessica De Bois, Isabel Bradley, Jennifer Crooks, Peter Daum, Alex Feben, Lizzie Gannon, Sarah Kipling, Andrew Peetamsingh, Charlotte Quamina, Sahiba Sethi, Harry Sivadhas, Kathryn Sollesta, Andrew Swain, Evalyn Tan, Joan Willis, Maggie Zou, Julius Cranshaw, Nina Barratt, Katie Bowman, Debbie Branney, Maria Letts, Sally Pitts, Christopher Day, Sarah Benyon, Sara Eddy, Adam Green, Anna Grice, Sinéad Kelly, Daisy Mackle, Victor Mariano, Linda Park, Pauline Sibley, William Spencer, Elena Bignami, Valentina Bellini, Francesco Forfori, Maria Curci, Alessandra Leo, Matthew Jackson, Jennifer Awolesi, Sheila Hodgkinson, Alissa Kent, Dee Leonard, Claire Stapleton, Clare Tibke, Farhad Alexander-Sefre, Lorraine Campey, Kathryn Hall, Jennifer Spimpolo, Malin Nilsson, Helen Didriksson, Emma Hamilton, Mandy Carnahan, Chris Mowatt, Jo Stickley, Antonio Corcione, Giuseppe Rossi, Hege Fladby, Nina Andersen, Gunhild Bjoernå, Mads Reite, Linda Roertveit, Philipp Seidel, Glenn Arnold, Melissa Benavente, Anjalee Chattersingh, Nyasha Chironga, Gillian Hornzee, Joyce Kibaru, Ihtisham Malik, Laura McLeavy, Byiravey Pathmanathan, Florence Prior, Rhea Strudwick, Marios Vezyrgiannis, Aneeta Sinha, Sheeba Babu, Bisanth Batuwitage, Zoe Daly, Katharine Ellinor, Elizabeth Hawes, Ann Holmes, Karen Hudson, Jeremy Nightingale, Alison Le Poidevin, Lindsey Roberts, Agnieszka Kubisz-Pudelko, Joanna Allison, Lucy Pippard, Vincent Hamlyn, Angie Organ, Thaventhran Prabhahar, Hayley Bridger, Lee Dvorkin, Vitul Manhas, Rachel Vincent, Shondipon Laha, Terri-Louise Cromie, Donna Doyle, Rachel Howarth, Mark Verlander, Ailsa Watt, Alexandra Williams, Massimo Antonelli, Salvatore Cutuli, Luca Montini, Juan Graterol, Benita Adams, Sarah Bean, Karen Burt, Fiona Hammonds, Suyogi Jigajinni, Laura Fulton, Stephen Kinghorn, Jost Mullenheim, Kirsty Baillie, Martyn Cain, Kerry Colling, Carol Hannaway, Ruggero Corso, Morena Calli, Carlos Ferrando, Esther Romero, Pablo Jorge-Monjas, María Soria-García, José Gómez-Herreras, Rita Rodríguez-Jiménez, Blanca De Prada-Martín, Pearse, Rupert, Ranieri, Marco, Abbott, Tom, Pakats, Mari-Lii, Piervincenzi, Edoardo, Patel, Akshaykumar, Kahan, Brennan, Rhodes, Andrew, Dias, Priyanthi, Hewson, Russell, Jammer, Ib, Chew, Michelle, Aldecoa, Cesar, Rodseth, Reitze, Biccard, Bruce, Stephens, Tim, Payne, Sara, Hepworth, David, Pischke, Soeren, Asvall, Joerund, Hausken, John, Jhanji, Shaman, Rooms, Martin, Flint, Neil, Hales, Dawn, Szakmany, Tama, Leitch, Andrew, Spadaro, Savino, Chiumello, Davide, Johnston, Paul, Yeung, Joyce, Tellan, Guglielmo, Veenith, Tonny, Macmillan, Josep, Terragni, Pierpaolo, Sander, Caroline, Kasipandian, Vidya, Ahmad, Tahania, Lee, Aaron, Tammaro, Marcello, McAuley, Danny, Skene, Simon, Vohra, Ravinder, Wilson, Matt, Edwards, Mark, Griffiths, Ewen, Pritchard, Naomi, Filippini, Claudia, Aasmundstad, Tor, Aksnes, Einar, Alpers, Lise-Merete, Barratt-Due, Andrea, Dahl, Anita, Feldt, Linda, Figari, Elisa, Flåten, Eva, Granheim, Karen, Hagring, Minna, Haugaa, Håkon, Kjoesen, Gisle, Klaevahaugen, Inge, Lenz, Harald, Myhre, Marianne, Orrem, Hilde, Stitt, Emily, Toennessen, Tor Inge, Al-Kadhimi, Samuel, Anker, Robert, Balint, Mihaela, Barraclough, Lauren, Black, Ethel, Clayton, Matt, Conneely, Leonora, Edwards, Zara, Eeles, Alex, Evans, Matthew, Gerstman, Michelle, Greenshields, Nicole, Harvey, Eleanor, Hegarty, Aoife, Hester, Natalie, Hutchinson, Jenna, Kasivisvanathan, Ramanathan, Lawrence, Helen, Marsh, Veronica, Matthews, Laura, Mazzola, Francesca, McCanny, Jamie, Morrison, Ben, O'Mahony, Michelle, Pang, Ching Ling, Parkinson, David, Pirie, Katrina, Rao Baikady, Ravishankar, Shovel, Louisa, Smith, Lorna, Tatham, Kate, Thomas, Peter, Uren, Sophie, Walker, Susanna, Wills, Alasdair, Andreou, Prematie, Howson, Alex, Kaur, Jasmin, Lewszuk, Adam, Molina, Esther, Ramsamy, Nirmalabaye, Roberts, Emma, Amaral, Vanessa, Begum, Salma, Bekele, Soliana, Cashmore, Richard, Correia, Carmen, Dunkley, Steven, Fernandez, Maria, Fowler, Alexander, Garcia, Amaia, Della Giovampaola, Maria, Greaves, Kathryn, Griffiths, Bethan, Haines, Ryan, Haslop, Richard, Hu, Ying, Hui, Sarah, Januszewska, Marta, Manon, Vasi, Martin, Tim, May, Shaun, Minicozzi, Annamaria, Niebrzegowska, Edyta, Oliveira, Monica, Pates, Katherine, Santos, Filipa, Shahid, Tasnin, Simili, Paolo, Somerville, Alastair, Subhedar, Emily, Uddin, Ruzena, Walker, Sophie, Wan, Yize, Whalley, Jan, Zolfaghari, Parjam, Gunter, Una, Hodkinson, Gemma, Howe, Gwenllian, Baratozzi, Valentina, Casotto, Giulia, Darai, Giulia, Ferrari, Erica, Mistraletti, Giovanni, Palmaverdi, Valentina, Furlani, Stefano, Priani, Paolo, Ragazzi, Riccardo, Salmaso, Marco, Verri, Marco, Volta, Carlo, Nutt, Chri, McKay, Emma, O'Neill, Orla, Patel, Jaimin, Atterbury, Katie, Ballinger, Sarah, Carling, Natalie, Ellis, Kaytie, Gresty, Jo, Melody, Teresa, Monk, Jade, Norman, Chloe, Reeves, Eleanor, Sampson, Julia, Sutton, Peter, Thomas, Marie, Bamford, Amy, Bergin, Colin, Carrera, Ronald, Cooper, Lauren, Despy, Liesl, Ellis, Karen, Fellows, Emma, Goundry, Stephanie, Harkett, Samantha, Ip, Peter, Mason, Tracy, McGhee, Christopher, McLaughlin, Aisling, Neal, Aoife, Pope, Martin, Porter, Stephanie, Smith, Hazel, Snelson, Catherine, Spruce, Elaine, Vigo, Ylenia, Whitehouse, Arlo, Whitehouse, Tony, Donatiello, Maria, Gazzanelli, Sergio, Mezzapesa, Mario, Savino, Martina, Settesoldi, Giacomo, Kunst, Gudrun, Birch, Sian, Greig, Louise, Noble, Harriet, Pappa, Evita, Penhaligon, Bethany, Cossu, Andrea, Floris, Leda, Piredda, Davide, Racca, Alberto, Brattstrom, Olof, Heggelund, Bente, Flodberg, Magnu, Månsson, Sandra, Ahmed, Mamoona, Allen, Jonathan, Bell, Paula, Genetu, Roman, Glennon, Julia, Hanley, Janice, Jenner, Katy, Jogi, Summayyah, Mahjoob, Parisa, McGovern, Clare, Murphy, Anthony, Nazari, Roonak, Routledge, Jacki, Uttamlal, Trishna, Ward, Sinead, Iotti, Giorgio, Picchioni, Raffaella, Poma, Silvia, Navalesi, Paolo, Bruni, Andrea, De Leonardis, Brunella, Garofalo, Eugenio, Patel, Panna, McArthur, Carol, Burns, Karen, Peters, Steven, Foti, Giuseppe, Calcinati, Serena, Grassi, Alice, Villa, Silvia, Berridge, John, Kanakaraj, Muthuraj, Cahill, Hazel, Forshaw, Greg, Gibson, Andy, Grainger, Lia, Howard, Kate, James, Katherine, Murphy, Zoe, Sweeting, Helen, Tait, Rebecca, Wilcock, Danielle, Yates, David, Cope, Sean, Allan, Ashley, Betts, Rebecca, Cornell, Sarah, Sheriff, Julie, Woods, Lindsey, Grasselli, Giacomo, Brioni, Matteo, Castagna, Luigi, von Rahden, Richard, Farina, Zane, Green, Samantha, Gumede, Simphiwe, Rajah, Chantal, Ramkillawan, Arisha, Moug, Susan, Alcorn, David, Dalton, Carol, Dickinson, Natalie, Edwards, Jennifer, Henderson, Steven, McIlveen, Erin, Ramsaran, Richard, Bell, Joanne, Fleming, Lorna, Monks, Kathleen, Parker, Jane, Stamper, Sean, Stokes-Denson, Jo, Elías, Elisa, Guerra, Yessica, Rico-Feijoo, Jesu, Kidel, Carlo, Filipe, Helder, Asis, Gretchelle, Gleeson, Yvonne, Harvey, Alice, Jackson, Christine, McNeil, Margaret, Mingo, Sara, Pakou, Glykeria, Pinto, Manuel, Wright, Stephen, Babio-Galan, Maite, Buckley, David, Calder, Verity, Chishti, Ahmad, Cosgrove, Joseph, Cullen, Katherine, Dunn, Leigh, Faulds, Matthew, Fortune, Jonathan, Gardner, Matthew, Harrison, Abigail, Hays, Carole, Jones, Gerry, Macfie, Caroline, Mccullagh, Iain, Nesbitt, Ian, O'Neil, Suzanne, Phoenix, Catherine, Rangaswamy, Girish, Samson, Craig, Scott, Carmen, Shrestha, Tara, Singh, Rita, Soulsby, Graham, Walton, Jon, Zwiggelaar, Kimberley, Lynch, Ceri, Clarke, Heidi, Deacon, Bethan, Ivatt, Helen, Jones, Leanne, Latif, Ahmed, Oram, Shaun, Perman, Chri, Roche, Lisa, Duys, Rowan, Flint, Margot, Bhagwan, Kamal, Coetzee, Ettienne, Joubert, Ivan, Montoya-Pelaez, Felipe, Navsaria, Pradeep, Picken, Guy, Porrill, Owen, Strathie, Grant, Zungu, Thembinkosi, Aluri, Sireesha, Chau, Simon, Cooper, Deborah, Cunningham, Mishell, Daniels, Allison, Hope, Susan, Nicholson, Alice, Walker, Laura, Giarratano, Antonino, Accurso, Giuseppe, Raineri, Santi, Tricoli, Giuseppe, Innes, Richard, Doble, Patricia, Hutter, Joanne, Pawley, Corinne, Tait, Moira, Hamilton, Mark, Andrade, Edward, Barnes, Veronica, Dalton, Claire, Delgado, Carlo, Farnell-Ward, Sarah, Farrah, Helen, Gray, Geraldine, Howlett, Luisa, Joseph, Gipsy, Krupa, Monika, Leaver, Susannah, Macedo, Joao, Maher, Karen, Mellinghoff, Johanne, Oguntimehin, Rachel, Pereira, Joel, Robinson, France, Ryan, Christine, Shah, Nirav, Shirley, Paula, Torborg, Alexandra, Biyase, Thuli, Drummond, Leanne, Kusel, Belinda, 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Linda, Sibley, Pauline, Spencer, William, Bignami, Elena, Bellini, Valentina, Forfori, Francesco, Curci, Maria, Leo, Alessandra, Jackson, Matthew, Awolesi, Jennifer, Hodgkinson, Sheila, Kent, Alissa, Leonard, Dee, Stapleton, Claire, Tibke, Clare, Alexander-Sefre, Farhad, Campey, Lorraine, Hall, Kathryn, Spimpolo, Jennifer, Nilsson, Malin, Didriksson, Helen, Hamilton, Emma, Carnahan, Mandy, Mowatt, Chri, Stickley, Jo, Corcione, Antonio, Rossi, Giuseppe, Fladby, Hege, Andersen, Nina, Bjoernå, Gunhild, Reite, Mad, Roertveit, Linda, Seidel, Philipp, Arnold, Glenn, Benavente, Melissa, Chattersingh, Anjalee, Chironga, Nyasha, Hornzee, Gillian, Kibaru, Joyce, Malik, Ihtisham, McLeavy, Laura, Pathmanathan, Byiravey, Prior, Florence, Strudwick, Rhea, Vezyrgiannis, Mario, Sinha, Aneeta, Babu, Sheeba, Batuwitage, Bisanth, Daly, Zoe, Ellinor, Katharine, Hawes, Elizabeth, Holmes, Ann, Hudson, Karen, Nightingale, Jeremy, Le Poidevin, Alison, Roberts, Lindsey, Kubisz-Pudelko, Agnieszka, Allison, Joanna, Pippard, Lucy, Hamlyn, Vincent, Organ, Angie, Prabhahar, Thaventhran, Bridger, Hayley, Dvorkin, Lee, Manhas, Vitul, Vincent, Rachel, Laha, Shondipon, Cromie, Terri-Louise, Doyle, Donna, Howarth, Rachel, Verlander, Mark, Watt, Ailsa, Williams, Alexandra, Antonelli, Massimo, Cutuli, Salvatore, Montini, Luca, Graterol, Juan, Adams, Benita, Bean, Sarah, Burt, Karen, Hammonds, Fiona, Jigajinni, Suyogi, Fulton, Laura, Kinghorn, Stephen, Mullenheim, Jost, Baillie, Kirsty, Cain, Martyn, Colling, Kerry, Hannaway, Carol, Corso, Ruggero, Calli, Morena, Ferrando, Carlo, Romero, Esther, Jorge-Monjas, Pablo, Soria-García, María, Gómez-Herreras, José, Rodríguez-Jiménez, Rita, and De Prada-Martín, Blanca

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_treatment, Population, NO, 03 medical and health sciences, 0302 clinical medicine, CPAP, Abdomen, Settore MED/41 - ANESTESIOLOGIA, Intubation, Intratracheal, medicine, Humans, Intubation, 030212 general & internal medicine, Continuous positive airway pressure, Adverse effect, education, education.field_of_study, Continuous Positive Airway Pressure, business.industry, respiratory complications, continuous positive airway pressure, major abdominal surgery, Pneumonia, Middle Aged, medicine.disease, respiratory tract diseases, Intratracheal, Treatment Outcome, 030228 respiratory system, Respiratory failure, Anesthesia, Vomiting, medicine.symptom, Respiratory Insufficiency, business, Abdominal surgery
Abstract

BackgroundRespiratory complications are an important cause of postoperative morbidity. We aimed to investigate whether continuous positive airway pressure (CPAP) administered immediately after major abdominal surgery could prevent postoperative morbidity.MethodsPRISM was an open-label, randomised, phase 3 trial done at 70 hospitals across six countries. Patients aged 50 years or older who were undergoing elective major open abdominal surgery were randomly assigned (1:1) to receive CPAP within 4 h of the end of surgery or usual postoperative care. Patients were randomly assigned using a computer-generated minimisation algorithm with inbuilt concealment. The primary outcome was a composite of pneumonia, endotracheal re-intubation, or death within 30 days after randomisation, assessed in the intention-to-treat population. Safety was assessed in all patients who received CPAP. The trial is registered with the ISRCTN registry, ISRCTN56012545.FindingsBetween Feb 8, 2016, and Nov 11, 2019, 4806 patients were randomly assigned (2405 to the CPAP group and 2401 to the usual care group), of whom 4793 were included in the primary analysis (2396 in the CPAP group and 2397 in the usual care group). 195 (8·1%) of 2396 patients in the CPAP group and 197 (8·2%) of 2397 patients in the usual care group met the composite primary outcome (adjusted odds ratio 1·01 [95% CI 0·81-1·24]; p=0·95). 200 (8·9%) of 2241 patients in the CPAP group had adverse events. The most common adverse events were claustrophobia (78 [3·5%] of 2241 patients), oronasal dryness (43 [1·9%]), excessive air leak (36 [1·6%]), vomiting (26 [1·2%]), and pain (24 [1·1%]). There were two serious adverse events: one patient had significant hearing loss and one patient had obstruction of their venous catheter caused by a CPAP hood, which resulted in transient haemodynamic instability.InterpretationIn this large clinical effectiveness trial, CPAP did not reduce the incidence of pneumonia, endotracheal re-intubation, or death after major abdominal surgery. Although CPAP has an important role in the treatment of respiratory failure after surgery, routine use of prophylactic post-operative CPAP is not recommended.FundingNational Institute for Health Research, Barts Charity, Intersurgical, Association of Anaesthetists, and Sapienza Università di Roma.

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