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1. Protocol for direct reporting of awareness in maternity patients (DREAMY): a prospective, multicentre cohort study of accidental awareness during general anaesthesia

Author

P.M. Odor, S. Bampoe, D.N. Lucas, S.R. Moonesinghe, J. Andrade, J.J. Pandit, Alicja A'Court, Dina Abdel-Gadir, Ayman Abdu, Caroline Abisogun, Zainab Aboud, Judith Abrams, Andrea Ackerman, Christine Adamso, Rachel Addison, Adedayo Adeyeye, Rachel Adler, Maame Aduse-Poku, Siddharth Adyanthaya, Najmiah Ahmad, Dabeeruddeen Ahmed, Atif Ahmed, Bucky Akindele, Olubukola Akindele, Sonia Akrimi, Samar Al-Rawi, Yousif Ali, Jo Allam, Alisha Allana, Kellie Allen, Orlanda Allen, Natasha Amaradasa, Lareina Amarasekara, Freda Amoakwa-adu, Padmanabhan Anandageetha, Suresh Anandakrishnan, Rathai Anandanadesan, Michelle Anderson, Simon Apps, Audrey Aquilina, Gill Arbane, Alice Arch, Sarah Armstrong, Rita Arya, Gloria Ashiru, Keri Ashpole, Claire Atkinson, Francesca Atkinson, Elizabeth Auer, Ben Avery, Maite Babio-Galan, Hareth Bader, George Badham, Subha Bagchi, Sarah Bailey, Yolanda Baird, Cristina Balaka, Melissa Baldwin, Paul Balfour, Shreya Bali, Samantha Banks, Philip Barclay, Lucy Barnes, Thomas Barnes, Niraj Barot, Stephen Barrett, Venetia Barrett, Kate Barrett, Louise Bates, Katherine Batte, Beki Baytug, Mona Behravesh, Suzanne Bell, Raul Benloch, Richard Bentley, Jennifer Berg, Charlotte Berwick, Richard Berwick, Rashmi Bhadange, Sanjoy Bhattacharyya, Egidija Bielskute, Sian Birch, Scott Bird, Ruth Bird, William Birts, Becky Black, Tatyana Blagova, Holly Blake, Oliver Blightman, Susara Blunden, Richard Bolton, Caroline Borkett-Jones, John Boselli, Manuella Bowen, Ruth Bowen, James Bowye, Henry Boyle, Zameen Brar, Jo Bray, Samantha Brayshaw, Catherine Bressington, Alison Brewer, Naomi Brice, Laura Bridge, James Briscoe, Sonia Brocklesby, Harry Brown, Sarah Brown, Derek Brunnen, Keshavareddy Burijintichenna, Sara Burnard, Agnieszka Burtt, Victoria Buswell, Hannah Bykar, Matthew Cairney, Clare Calvert, Laura Camarasa, Natasha Campbell, Frederick Campbell-Jones, Jane Cantliffe, William Carrol, Joanna Carvalho, Catherine Cashell, Sarah Cassie, Kadu Cassim, Marika Chandler, Rachel Chapman, Robert Charles, Ping Chen, Deanne Cheyne, Kiran Chima, Floju Chin, Radu Chirvasuta, Martin Shao Chong, Sadia Choudhury, Priyakam Chowdhury, Tracey Christmas, Shilpa Chughwani, Sarah Ciechanowicz, Emma Clarey, Rob Coe, Jolyon Cohen, Nicholas Coker, Karen Collins, Lauren Collis, Jasna Comar, Marianne Conroy, Kathy Constantin, Jeremy Corfe, Elaine Coulborn, Vanessa Cowie, Rachel Crone, James Cronin, Jennifer Crooks, Nicola Crowther, Elizabeth Crowther, Carina Cruz, Alexa Curtis, Sarah Curtis, Sam Curtis, Adrian Dabrowicz, Nick Daines, Viral Dalal, Peter Dannatt, Dinesh Das, Jennifer Dash, Katherine Davidson, Sarah Davies, Yvette Davis, James Dawson, Jonathan Dean, Caroline Dean, Jane Denman, Neel Desai, Preeti Dewan, Sarah Dimont, Clare Donovan, Mano Doraiswami, Kate Doughty, Jamie Douglass, Michelle Dower, Samantha Downing, Wendy Duberry, Emily Duckham, Lucy Dudgeon, Stephanie Dukes, Leigh Dunn, Venkat Duraiswamy, Anthony O' Dwyer, Kristyn Dyer, Suresh Eapen, Mark Earl, Sally Eason, Kylie-Ellen Edwards, Zara Edwards, Osinachi Egole, John Ekpa, Olivia El-Amin, Kariem El-Boghdadly, Okba Elbasir, James Eldridge, Laura Elgie, Matt Ellington, Katharine Elliott, Justine Elliott, Mohamed Elmi, Ramy Elnoumeir, Eunice Emeakaraoha, Matt Evans, Mary Everett, Philippa Fabb, Hadia Farooq, Rohan Farrimond, Fiona Faulds, Erik Fawcett, Andrew Feneley, Dinushi Fernando, Janis Ferns, Claire Finlay, Simon Fitzgerald, Doireann O'Flaherty, Mark Fleet, Lydia Fletcher, Vanessa Fludder, Terri Follet, Jane Forbes, Mark Forth, Greg Foster, John Francis, Kate Fraser, Lauren Friedman, Luca Fruggeri, Laura Fulton, Sam Funnell, Amit Gadre, Ajay Gandhi, Harriet Gardiner, Zoe Garner, Gráinne Garvey, Tom Gately, Richard George, Siobhan Gillespie, Stephanie Glover, Jennifer Goddard, Ben Goodman, Tarikere Gopal, George Graham, David Green, Denise Griffin, Jessica Griffith, Stephanie Grigsby, Julie Grindey, Huw Griffiths, Jonathan Groome, Christine Grother, Gabrielle Grounds, Alice Groves, Abhik Guha, Amila Gunawardhana, Aman Gupta, Rekha Gupta, James Gutsell, Richard Haddon, Dina Hadi, Nicola Hadjipavlou, Henry Hammerbeck, Laura Hammon, Sarah Hammond, Hampesh Hampanna, Holly Hancock, Hemantha Handapangoda, Yumna Haroon-Mowahed, Dawn Harpham, Grant Harris, Abigail Harrison, Divya Harshan, Andrew Hartopp, Eoin Harty, Nick Haslam, Gemma Hawkins, Edith Hawkins, Sarah Hawksey, Carole Hays, Tracy Hazelton, Andrew Heavyside, Chibuzo Hemeson, Katrina Henderson, Oliver Henry, Lara Herbert, Nikki Higgins, James Hilton, Claire Hindmoor, Rachael Hitchcock, Laura Hobbs, Michele Homsy, Cassandra Honeywell, Nazima Hoque, Kirsty House, Ryan Howle, Amanda Tiller, Matthew Huniak, Jeremy Hunte, Tauqeer Husain, Coralie Huson, Catriona Hussain, Tawhida Hussain, Zainab Hussein, Jeremy Hyams, Eleanor Hyde, Marina Iaverdino, Alex Ignacka, Erin Innes, Stefanos Ioannidis, Rehana Iqbal, Fahja Ismail, Jenny Jackson, Michael Jackson, Guy Jackson, Robyn Jacobs, Poonam Jadhav, Aisha Jalaly, Lorraine James, Monica James, Surekha Jani, Chandran Jeganathan, Claire Joannides, Robert Johnson, Thosa Johnson, Carolyn Johnston, Reeanne Jones, Tom Jones, Miran Kadr, Rasmeet Kainth, Jenna Kane, Rafiq Kanji, Sunil Kannanparambil, Girish Kar, Theanalli Kasianandan, Husam Kaskos, Lisa Kavanagh, Richard Kaye, Leith Kelliher, Serena Kelliot, Jemma Kelly, Jenna Kelly, Carol Kenyon, Laura Kessack, Samuel Kestner, Mohammed Khaku, Sophia Khaleeq, Pervaz Khan, Sabeen Khan, Usamah Kidwai, Christopher King, Helen King, Elizabeth Kingston, Waisun Kok, Rebekka Konig, Zheyna Konstantinova, Priya Krishnan, Justin Kua, Kavitha Kuntumalla, Emira Kursumovic, Krzysztof Kurzatkowski, Hariprasad Kuttambakam, Katherine Lane, Sophie Lane, Andrew Langton, Hamad Latif, Norlan Lau, Shyam Laxman, Helen Laycock, Rachel Lee, Silvia Leonardi, Karen Light, Heidi Lightfoot, Shuang Liu, Sanduni Liyanage, Jessica Lowe, Nuala Lucas, Miyoba Lungu, Marianne Lunn, Heather Lynes, Kishore Machavarapu, Matthew Mackenzie, Jonathan Major, Victoria Male, Zain Malik, Katarina Manso, Myrna Maquinana, Katarzyna Marciniak, Lizzie Maronge, Chris Marsh, Carmela Martella, Nicki Martin, Nicole Martins, Jaspreet Marway, Louisa Mason, Lucy Mason, Nadia Masood, James Masters, Matthew Maton-Howarth, Francesca Mazzola, Tamsin McAllister, Rachel McCarthy, Claire McCormick, Sharon McCready, Steffan McDougall, Lorna Mcewan, Jon McGarry, Helen McKevitt, Stephanie Mckinley, Anna Mckskeane, Eloise McMaster, Martina McMonagle, Helen McNamara, Hannah McPhee, Laura McRae, Dee Mead, Emma Meadows, Madhur Mehta, Joanne Meikle, Yavor Metodiev, Chloe Michael, Victoria Millar, Sarah Miller, Gregg Miller, Sezanne Milne, Kostas Miltsios, Lucia Misquita, Simone Misquita, Manasi Mittal, Mohamed Mohamed, Katherine Powell Monaghan, Joanna Monk, Alexandra Monkhouse, David Monks, Laura Montague, Angela Moon, Jennifer Moran, Annette Moreton, Endaf Morgan, Oliver Morgan, Danny Morland, Monica Morosan, Kimberley Morris, Andrea Morris, Clare Moser, Manulella Mount, Carol Muir, McDonald Mupudzi, Mayur Murali, Iona Murdoch, Heather Murray, Theresa Murray, Karen Murrell, Girish Narasimha Murthy, Diana Neeley, Hannah Nei, Kerry Neil, Tara Nejim, Mark Nel, Anne Nicholson, Angela Nicklin, Catherine Nolan, Tracey Nolan, Eveliina Nurmi, Bridie O'Neill, Christie Oakes, Neil Oakes, Maria Ochoa-Ferraro, Nike Odeleye, Katy Oliver, Mark Oliver, Julie Onslow, Desire Onwochei, Thomas Oommen, Tim Orr, Osato Osagie, Hannah Osborn, Jennie Overend, Hazel Owston, Emma Pack, Pulak Padhi, Prabvathy Palani, Rajesh Pandey, Dhruti Pandya, Navjot Panesar, Con Papageorgiou, Georgios Papanastasiou, Costas Papoutsos, Suji Pararajasingham, James Parry, Hasita Patel, Jaishel Patel, Jiten Patel, Kaumudi Patel, Kiran Patel, Mitul Patel, Reshma Patel, Ruchira Patel, Nimisha Patel, Sangeeta Pathak, Fiona Pearson, Viktorija Peciulene, Beth Peers, Benjamin Peirce, Stacey Pepper, Jasmina Perinpanayagam, Hollie Perry, Nadya Petrova, Trudie Phillips, Sioned Phillips, Leonidas Phylactides, Felicity Pilkington, James Plumb, Evangelia Poimenidi, Anna Sau Kuk Poon, Thomas Potter, Una Poultney, Lucy Powell, Andrew Prenter, Katie Preston, Anna Price, Naomi Pritchard, Jenny Pullen, Manishi Purohit, Charlotte Quamina, Jibran Qureshi, Zahra Rajput, Stephen Ramage, Tamilselvi Ramanathan, Upeka Ranasinghe, Kalum Ranatunga, Abby Rand, Seema Randive, Desikan Rangarajan, Chandana Rao, Sambasiva Rao Pelluri, Antony Ratnasingham, Jamil Razzaque, Anuvidya Reddy, Katie Redington, Emma Reel, Peter Remeta, Francesca Ricco, Anna Riccoboni, Polly Rice, Mel Rich, Nicole Richards, Joanne Riches, Simon Ripoll, Fleur Roberts, Kitty Roberts, Kay Robins, Susie Robinson, Samantha Roche, Maria Rojo, Milena Carmela Romano, Hilary Rosser, Lindsay Roughley, Catriona Routley, Christine Rowley, Pallab Rudra, Robin Russell, Christine Ryan, Chloe Saad, Abtin Sadeghi, Armorel Salberg, Matt Samuel, Rebecca Samuels, Suresh Sanapala, Seliat Sanusi, Sarbpreet Sarao, Sathyabhama Sathyabhama, Zoe Saunders, Bernadetta Sawarzynska-ryszka, Panagiota Sceales, Penny Sceales, Natasha Schumacher, Nuala Schwartz, Claudia Sellers, Heather Sellers, Jessica Sellick, Soumen Sen, Dhaneesha Senaratne, Sarah Senbeto, Dineth Seneviratna, Thunga Setty, Raj Shah, Sonia Shah, James Shambly, Saju Sharafudeen. Imran Sharieff, Laurence Sharifi, Lisa Sharpe, Michael Shaw, Ian Sheldrake, Priya Shinde, Adam Shonfeld. Jonathon Short, Julian Siah, Sheena Sibug. Omar Siddique, Sara Siew, Matthew Simpson, Georgina Singleton, Kathryn Sinha, Aneeta Sinha, Matthew Sinnott, Harry Sivadhas, Sivanth Sivakumar, Boopathi Sivarajan, Sinduja Sivarajan, Chris Skeoch, Samuel Slade, Paul Slater, Camilla Smith, Carys Smith, Christopher Smith, James Smith, Lorraine Smith, Annika Smith, Edward Smith, Ruth Smith, Sue Smith, Tim Smith, Helen Smithers, Sue Smolen, Claire Smyth, Toni Snel, Carol Snipe, Sam Soltanifar, Nilesh Sonawane, Andal Soundararaja, Emily Spence, Mark Spiliopoulos, Chhavi Srivastava, Karen Stacey, Helena Stafford, Nikki Staines, Richard Stead, Emma Stevens, Alex Stilwell, Gary Stocks, Aaron Stokes, Christopher Stone, Ben Straughan, Vanitha Subbarathnam, Srinath Sudunagunta, Pervez Sultan, Puvan Suppiah, Priyanka Surve, Angus Sutherland, Rob Swanton, Claire Swarbrick, Amy Swinson, Eleni Syrrakou, Shahrzad Tadbiri, Preetam Tamhane, Perumal Tamilselvan, Andrew Tan, Shamil Tanna, Hayley Tarft, Laura Tarry, Ian Taylor, Suzanne Taylor, Julie Tebbot, Svetlana Theron, Megan Thomas, Sarah Todd, Hermione Tolliday, Charlotte Topham, Nicholas Tovell, Martyn Traves, Dawn Trodd, Aseem Tufchi, Katie Turley, Marc Turnbull, Chris Turnbull, Oliver Turner, William Turner, Sharon Turney, Eleanor Tyagi, David Uncles, Vanessa Unsworth, Pradnya Vadnere, Rama Varadan, Vik Vasishta, Andrew Veal, Lalitha Vedham, Jessica Venkaya, Miriam Verghese, Icel Veronica, Dinesh Vidanagamage, Rachel Vincent, Vinodhan Vyapury, Harris Wain, Fiona Walbridge, Elaine Walker, Pete Walsh, Eleanor Walshe, Michelle Walters, Yize Wan, Cherry Wang, Kavita Wankhade, Gareth Waters, Christopher Watts, Alex Webber, Tom Wedgwood, Michael Wee, Susan Wellstead, Alison White, Michael Whitear, Lucy Whitefield, Sarah Wilkinson, Lauren Williams, Rhys Williams, Dawn Wilson, Samantha Wilson, Katie Wimble, Elaine Winkley, Luke Winslow, Paul Winwright, Karolina Wloch, Gideon Wong, Hannah Wong, Jan Man Wong, Tim Wood, Sarah Wray, Ian Wrench, James Wu, Kynn Wynn, Yeng Yap, Chia Kuan Yeow, Emily Young, Alex Yusaf, Saeed Uz Zafar, Darius Zeinali, Sheldon Zhang, Sarvesh Zope, Liana Zucco, Sibtain Anwar, Nadia Blunt, John Cronin, Vimal Grover, Kate Grailey, Martin Grey, David Highton, Phil Hopkins, Harriet Kemp, Queenie Lo, Daniel Martin, Clare Morkane, James O'Carroll, Charles Oliver, Benjamin Post, Anil Visram, and Alex Wickham

Subjects
Adult, One year follow up, Trial protocol, Guidelines as Topic, Anesthesia, General, Intraoperative Awareness, Cohort Studies, Interviews as Topic, 03 medical and health sciences, 0302 clinical medicine, 030202 anesthesiology, Anesthesia, Obstetrical, Humans, Medicine, General anaesthesia, Prospective Studies, 030219 obstetrics & reproductive medicine, business.industry, Obstetrics and Gynecology, medicine.disease, United Kingdom, Anesthesiology and Pain Medicine, Accidental, Cohort, Structured interview, Female, Medical emergency, business, Surgical patients, Cohort study
Abstract

Background Accidental awareness during general anaesthesia (AAGA) is a complex and rare outcome to investigate in surgical patient populations, particularly obstetric patients. We report the protocol of the Direct Reporting of Awareness in Maternity patients (DREAMY) study, illustrating how the research was designed to address practical and methodological challenges for investigating AAGA in an obstetric cohort. Methods This is the trial protocol of a prospective, multicentre cohort study of patients undergoing obstetric surgery under general anaesthesia. Accidental awareness during general anaesthesia will be detected using three repetitions of standardised direct questioning over 30 days, with responses indicating memories during general anaesthesia verified using structured interviews. Reports will be adjudicated, then classified, in accordance with pre-defined and pre-validated structures, including the Michigan Awareness Classification tool. Quantitative data will be collected on general anaesthesia conduct for all participants. This descriptive study is being conducted in England and aims to recruit a minimum of 2015 patients. Results The DREAMY study was prospectively registered (ClinicalTrials.gov Identifier: NCT03100396) and ethical approval granted. Participant recruitment began in May 2017 and one year follow up concluded in August 2019. Publication of the results is anticipated in 2020. Conclusions The DREAMY study will provide data on incidence, experience and implications of AAGA for obstetric patients, using a robust methodology that will reliably detect and translate subjective AAGA reports into objective outcomes. In addition, the study is expected to improve vigilance for AAGA in participating hospitals and encourage adoption of recommendations for support of patients experiencing AAGA.

Published
2020
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2. The clinical and cost-effectiveness of total versus partial knee replacement in patients with medial compartment osteoarthritis (TOPKAT): 5-year outcomes of a randomised controlled trial

Author

David J Beard, Loretta J Davies, Jonathan A Cook, Graeme MacLennan, Andrew Price, Seamus Kent, Jemma Hudson, Andrew Carr, Jose Leal, Helen Campbell, Ray Fitzpatrick, Nigel Arden, David Murray, Marion K Campbell, Karen Barker, Gordon Murray, Hamish Simpson, Donna Dodwell, Simon Donell, Jonathan Waite, David Beard, Cushla Cooper, Loretta Davies, Helen Doll, Jonathan Cook, Marion Campbell, Gordon Fernie, Alison McDonald, Anne Duncan, Mayret Castillo, Francesco Fusco, Akiko Greshon, Kay Holland, Jiyang Li, Elena Rabaiotti, Sandra Regan, Victoria Stalker, Mark Forrest, Gladys McPherson, Charles Boachie, Diana Collins, Janice Cruden, Sophie Halpin, Beverley Smith, David Torgerson, Chris Maher, Peter Brownson, Mark Mullins Mullins, Jane Blazeby, Ruth Jenkins, Mark Lewis, Witek Mintowt-Czyz, Beverland Beverland, Leeann Bryce, Julie Catney, Ian Dobie, Emer Doran, Seamus O'Brien, Fazal Ali, Heather Cripps, Amanda Whileman, Phil Williams, Julie Toms, Ellen Brown, Gillian Horner, Andrew Jennings, Glynis Rose, Frances Bamford, Wendy Goddard, Hans Marynissen, Haleh Peel, Lyndsey Richards, Amanda Bell, Sunny Deo, Sarah Grayland, David Hollinghurst, Suzannah Pegler, Venkat Satish, Claire Woodruffe, Nick London, David Duffy, Caroline Bennett, James Featherstone, Joss Cook, Kim Dearnley, Nagarajan Muthukumar, Laura Onuoha, Sarah Wilson, Sandhu Banher, Eunice Emeakaroha, Jamie Horohan, Sunil Jain, Susan Thompson, Sarah Buckley, Aaron Ng, Ajit Shetty, Karen Simeson, Julian Flynn, Meryl Newsom, Cheryl Padilla-Harris, Oliver Pearce, James Bidwell, Alison Innes, Winifred Culley, Bill Ledingham, Janis Stephen, Rachel Bray, Hywel Davies, Debbie Delgado, Jonathan Eldridge, Leigh Morrison, James Murray, Andrew Porteous, James Robinson, Matt Dawson, Raj Dharmarajan, David Elson, Will Hage, Nicci Kelsall, Mike Orr, Jackie Grosvenor, SS Maheswaran, Claire McCue, Hemanth Venkatesh, Michelle Wild, Deborah Wilson, Chris Dodd, William Jackson, Pam Lovegrove, Jennifer Piper, Neil Bradbury, Lucy Clark, Stefanie Duncan, Genevieve Simpson, Allister Trezies, Vikram Desai, Cheryl Heeley, Kramer Guy, Rosalyn Jackson, Alan Hall, Gordon Higgins, Michael Hockings, David Isaac, Pauline Mercer, Lindsey Barber, Helen Cochrane, Janette Curtis, Julie Grindey, David Johnson, Phil Turner, David Houlihan-Burne, Briony Hill, Ron Langstaff, Mariam Nasseri, Mark Bowditch, Chris Martin, Steven Pryke, Bally Purewal, Chris Servant, Sheeba Suresh, Claire Tricker, Robert Ashford, Manjit Attwal, Jeanette Bunga, Urjit Chatterji, Susan Cockburn, Colin Esler, Steven Godsiff, Tim Green, Christina Haines, Subash Tandon, Racquel Carpio, Sarah Griffiths, Natalie Grocott, Ian dos Remedios, David Barrett, Phil Chapman-Sheath, Caroline Grabau, Jane Moghul, William Tice, Catherine Trevithick, Rajiv Deshmukh, Mandy Howes, Kimberley Netherton, Dipak Raj, Nikki Travis, Mohammad Maqsood, Rebecca Norton, Farzana Rashid, Alison Raynor, Mark Rowsell, and Karen Warner

Subjects
Male, Reoperation, medicine.medical_specialty, Cost effectiveness, medicine.medical_treatment, Cost-Benefit Analysis, Operative Time, UNICOMPARTMENTAL ARTHROPLASTY, Knee replacement, Osteoarthritis, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Surveys and Questionnaires, Clinical endpoint, Medicine, Humans, 030212 general & internal medicine, Arthroplasty, Replacement, Knee, Aged, Pain, Postoperative, business.industry, General Medicine, Health Care Costs, Length of Stay, Middle Aged, Osteoarthritis, Knee, medicine.disease, Arthroplasty, REVISION, 3. Good health, Quality-adjusted life year, Editorial Commentary, Treatment Outcome, Physical therapy, OXFORD HIP, Female, Quality-Adjusted Life Years, ARTHRITIS, business, Oxford knee score, Follow-Up Studies
Abstract

Summary Background Late-stage isolated medial knee osteoarthritis can be treated with total knee replacement (TKR) or partial knee replacement (PKR). There is high variation in treatment choice and little robust evidence to guide selection. The Total or Partial Knee Arthroplasty Trial (TOPKAT) therefore aims to assess the clinical effectiveness and cost-effectiveness of TKR versus PKR in patients with medial compartment osteoarthritis of the knee, and this represents an analysis of the main endpoints at 5 years. Methods Our multicentre, pragmatic randomised controlled trial was done at 27 UK sites. We used a combined expertise-based and equipoise-based approach, in which patients with isolated osteoarthritis of the medial compartment of the knee and who satisfied general requirements for a medial PKR were randomly assigned (1:1) to receive PKR or TKR by surgeons who were either expert in and willing to perform both surgeries or by a surgeon with particular expertise in the allocated procedure. The primary endpoint was the Oxford Knee Score (OKS) 5 years after randomisation in all patients assigned to groups. Health-care costs (in UK 2017 prices) and cost-effectiveness were also assessed. This trial is registered with ISRCTN (ISRCTN03013488) and ClinicalTrials.gov ( NCT01352247 ). Findings Between Jan 18, 2010, and Sept 30, 2013, we assessed 962 patients for their eligibility, of whom 431 (45%) patients were excluded (121 [13%] patients did not meet the inclusion criteria and 310 [32%] patients declined to participate) and 528 (55%) patients were randomly assigned to groups. 94% of participants responded to the follow-up survey 5 years after their operation. At the 5-year follow-up, we found no difference in OKS between groups (mean difference 1·04, 95% CI −0·42 to 2·50; p=0·159). In our within-trial cost-effectiveness analysis, we found that PKR was more effective (0·240 additional quality-adjusted life-years, 95% CI 0·046 to 0·434) and less expensive (−£910, 95% CI −1503 to −317) than TKR during the 5 years of follow-up. This finding was a result of slightly better outcomes, lower costs of surgery, and lower follow-up health-care costs with PKR than TKR. Interpretation Both TKR and PKR are effective, offer similar clinical outcomes, and result in a similar incidence of re-operations and complications. Based on our clinical findings, and results regarding the lower costs and better cost-effectiveness with PKR during the 5-year study period, we suggest that PKR should be considered the first choice for patients with late-stage isolated medial compartment osteoarthritis. Funding National Institute for Health Research Health Technology Assessment Programme.

Published
2019
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3. Outcomes after pethidine or diamorphine administration

Author

Elaine Torrance, Joanne Thomas, and Julie Grindey

Subjects
medicine.medical_specialty, business.industry, Obstetrics, Vaginal delivery, First pregnancy, Pethidine, Pain control, Anesthesia, Maternity and Midwifery, Vomiting, Medicine, Case note, Apgar score, medicine.symptom, business, Neonatal resuscitation, medicine.drug
Abstract

Despite the common use of pethidine (PTD) and diamorphine (DMP) in providing pain control during labour, there is little evidence of their effectiveness. In addition, some studies have suggested that PTD is associated with a poor neonatal and maternal outcome. Conversely, DMP has not been reported to have any major adverse neonatal or maternal outcomes. The objective was to compare the effects of intramuscular PTD with DMP on neonatal outcome, maternal vomiting and further administration of pharmacological pain relief during labour. The study involved retrospective case note analysis of 268 women in their first pregnancy giving birth between February 1999 and May 2000: 134 receiving PTD and 134 receiving DMP as the first pharmacological pain relief in labour for a singleton vaginal delivery following an uncomplicated spontaneous labour at term. The following information was collected: neonatal Apgar score at 1 minute; neonatal resuscitation; time to first infant feed; actual and intended method of feeding; maternal vomiting; and further administration of analgesia. There were no significant differences in the two groups in respect of Apgar score of less than 7, neonatal resuscitation and time to initiate first feed. However, those women receiving PTD were significantly less likely to vomit or to require further analgesia than those receiving DMP.

Published
2003
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