Carol J Peden1, Tim Stephens2, Graham Martin3, Brennan C Kahan4, Ann Thomson4, Kate Rivett5, Duncan Wells6, Gerry Richardson7, Sally Kerry4, Julian Bion8, Rupert M Pearse9. 1. Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. 2. William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, London, UK. 3. Health Sciences, University of Leicester, Leicester, UK. 4. Pragmatic Clinical Trials Unit, Barts and The London School of Medicine and Dentistry, London, UK. 5. Patient representative, London, UK. 6. Patient representative, Chalfont St Peter, UK. 7. Centre for Health Economics, University of York, York, UK. 8. Institute of Clinical Sciences, University of Birmingham, Birmingham, UK. 9. William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, London, UK. Electronic address: r.pearse@qmul.ac.uk.
Abstract
BACKGROUND: Emergency abdominal surgery is associated with poor patient outcomes. We studied the effectiveness of a national quality improvement (QI) programme to implement a care pathway to improve survival for these patients. METHODS: We did a stepped-wedge cluster-randomised trial of patients aged 40 years or older undergoing emergency open major abdominal surgery. Eligible UK National Health Service (NHS) hospitals (those that had an emergency general surgical service, a substantial volume of emergency abdominal surgery cases, and contributed data to the National Emergency Laparotomy Audit) were organised into 15 geographical clusters and commenced the QI programme in a random order, based on a computer-generated random sequence, over an 85-week period with one geographical cluster commencing the intervention every 5 weeks from the second to the 16th time period. Patients were masked to the study group, but it was not possible to mask hospital staff or investigators. The primary outcome measure was mortality within 90 days of surgery. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN80682973. FINDINGS: Treatment took place between March 3, 2014, and Oct 19, 2015. 22 754 patients were assessed for elegibility. Of 15 873 eligible patients from 93 NHS hospitals, primary outcome data were analysed for 8482 patients in the usual care group and 7374 in the QI group. Eight patients in the usual care group and nine patients in the QI group were not included in the analysis because of missing primary outcome data. The primary outcome of 90-day mortality occurred in 1210 (16%) patients in the QI group compared with 1393 (16%) patients in the usual care group (HR 1·11, 0·96-1·28). INTERPRETATION: No survival benefit was observed from this QI programme to implement a care pathway for patients undergoing emergency abdominal surgery. Future QI programmes should ensure that teams have both the time and resources needed to improve patient care. FUNDING: National Institute for Health Research Health Services and Delivery Research Programme.
RCT Entities:
BACKGROUND: Emergency abdominal surgery is associated with poor patient outcomes. We studied the effectiveness of a national quality improvement (QI) programme to implement a care pathway to improve survival for these patients. METHODS: We did a stepped-wedge cluster-randomised trial of patients aged 40 years or older undergoing emergency open major abdominal surgery. Eligible UK National Health Service (NHS) hospitals (those that had an emergency general surgical service, a substantial volume of emergency abdominal surgery cases, and contributed data to the National Emergency Laparotomy Audit) were organised into 15 geographical clusters and commenced the QI programme in a random order, based on a computer-generated random sequence, over an 85-week period with one geographical cluster commencing the intervention every 5 weeks from the second to the 16th time period. Patients were masked to the study group, but it was not possible to mask hospital staff or investigators. The primary outcome measure was mortality within 90 days of surgery. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN80682973. FINDINGS: Treatment took place between March 3, 2014, and Oct 19, 2015. 22 754 patients were assessed for elegibility. Of 15 873 eligible patients from 93 NHS hospitals, primary outcome data were analysed for 8482 patients in the usual care group and 7374 in the QI group. Eight patients in the usual care group and nine patients in the QI group were not included in the analysis because of missing primary outcome data. The primary outcome of 90-day mortality occurred in 1210 (16%) patients in the QI group compared with 1393 (16%) patients in the usual care group (HR 1·11, 0·96-1·28). INTERPRETATION: No survival benefit was observed from this QI programme to implement a care pathway for patients undergoing emergency abdominal surgery. Future QI programmes should ensure that teams have both the time and resources needed to improve patient care. FUNDING: National Institute for Health Research Health Services and Delivery Research Programme.
Authors: Ruth E Langley; Fay H Cafferty; Archie Macnair; Sharon B Love; Macey L Murray; Duncan C Gilbert; Mahesh K B Parmar; Tom Denwood; James Carpenter; Matthew R Sydes Journal: Trials Date: 2021-05-10 Impact factor: 2.279
Authors: Karim Asehnoune; Charlene Le Moal; Gilles Lebuffe; Marguerite Le Penndu; Nolwen Chatel Josse; Matthieu Boisson; Thomas Lescot; Marion Faucher; Samir Jaber; Thomas Godet; Marc Leone; Cyrus Motamed; Jean Stephane David; Raphael Cinotti; Younes El Amine; Darius Liutkus; Matthias Garot; Antoine Marc; Anne Le Corre; Alexandre Thomasseau; Alexandra Jobert; Laurent Flet; Fanny Feuillet; Morgane Pere; Emmanuel Futier; Antoine Roquilly Journal: BMJ Date: 2021-06-02