TY - JOUR
T1 - Enhanced postoperative surveillance versus standard of care to reduce mortality among adult surgical patients in Africa (ASOS-2)
T2 - a cluster-randomised controlled trial
AU - The ASOS-2 Investigators
AU - Biccard, Bruce M.
AU - du Toit, Leon
AU - Lesosky, Maia
AU - Stephens, Tim
AU - Myer, Landon
AU - Prempeh, Agya BA
AU - Vickery, Nicola
AU - Kluyts, Hyla Louise
AU - Torborg, Alexandra
AU - Omigbodun, Akinyinka
AU - Ademuyiwa, Adesoji
AU - Elhadi, Muhammed
AU - Elfagieh, Mohamed
AU - Mbwele, Bernard
AU - Ulisubisya, Mpoki
AU - Mboma, Lazaro
AU - Ashebir, Daniel Z.
AU - Bahta, Mahlet Tesfaye
AU - Hassen, Mohammed
AU - Teferi, Mikiyas
AU - Seman, Yakob
AU - Zoumenou, Eugene
AU - Hewitt-Smith, Adam
AU - Tumukunde, Janat
AU - Munlemvo, Dolly
AU - Morais, Atilio
AU - Basenero, Apollo
AU - Ndarukwa, Pisirai
AU - Ouerdraogo, Nazinigouba
AU - Chaibou, Maman Sani
AU - Zarouf, Mohyeddine
AU - El Adib, Ahmed Rhassane
AU - Gobin, Veekash
AU - Sanogo, Zimogo
AU - Coulibaly, Youssouf
AU - Ngumi, Zipporah
AU - Fadalla, Tarig
AU - Iradukunda, Cynthia
AU - Barendegere, Vénérand
AU - Smalle, Isaac O.
AU - Bittaye, Mustapha
AU - Samateh, Ahmadou Lamin
AU - Elfiky, Mahmoud
AU - Fawzy, Maher
AU - Mulwafu, Wakisa
AU - Msosa, Vanessa
AU - Lopes, Lygia
AU - Antwi-Kusi, Akwasi
AU - Sama, Hamza D.
AU - Forget, Patrice
AU - van Straaten, Dawid
AU - Pearse, Rupert M.
AU - Puchert, Marichen
AU - Rolt, Lucy
AU - Schwebler, Kris
AU - Kabambi, Freddy
AU - Mabotja, Tebogo
AU - Cobas, Leandys
AU - Freitas, Albino
AU - Antunes, Maria
AU - Cabo, Bartolomeu
AU - Paulo, Domingos
AU - Camongua, Carlos
AU - Avognon, Yvette
AU - Marcos, Osseni
AU - Kintomonho, Raymond
AU - Demahou, Onesime
AU - Hounsa, Gisèle
AU - Chobli, Hugues
AU - Fassinou, Elie
AU - Zoglobossou, Aurore
AU - Tchaou, Blaise
AU - Tchegnonsi, Charles
AU - Amadji, Fifame
AU - Bossa, Francine
AU - Ahounou, Ernest
AU - Alao, Djima
AU - Odérémi, Roushdane
AU - Montairou, Afissatou
AU - Gbehade, Oswald
AU - Tobome, Romaric
AU - Boukari, Adam
AU - Bakantieba, Patrick
AU - Sambo, Arouna
AU - Lionelle, Fanou
AU - Gilbert, Nounagnon
AU - Attinon, Julien
AU - Klikpezo, Roger
AU - Dadjo, Aumar
AU - Fanou, Dénis
AU - Hounkpe, Gilberte
AU - Fafana, Bachabi
AU - Nguilu, Néné
AU - Dossou-Yovo, Bodourin
AU - Segla, Chantal
AU - Toko, Mohamed
AU - Gnele-Dedewanou, Evelyne
AU - Noukounwoui, Michel
AU - Yado, Ethienne
AU - Gouroubéra, Timothé
AU - Adjignon, Valéry
AU - Mewanou, Serge
AU - Tchomgang, Aïcha
AU - Agossou, Urielle
AU - Soton, Fernand
AU - Azanlin, Charbel
AU - Zomahoun, Lidwine
AU - Kabore, Rawéléguinbasba Armel Flavien
AU - Savadogo, Salam
AU - Sanou, Fatou Fleur Rosine
AU - Belém, Farid
AU - Hien, Victoria
AU - Bougouma, Cheik Tidiane Hafid W.
AU - Ouattara, Sie Ahmed
AU - Kabore, Mariam Bambara
AU - Nazinigouba, Ouedraogo
AU - Bonkoungou, Papougnezambo
AU - Lankoandé, Martin
AU - Traoré, Mireille
AU - Sawadogo, Patrick
AU - Wenmenga, Inès
AU - Kinda, Boureima
AU - Simporé, André
AU - Sapo, Christian
AU - Traore, Salah Idriss
AU - Dipama, Haoua
AU - Kaboré, Lydie WR
AU - Napon, Salifou
AU - Kaboré, Télesphore G.
AU - Louré, Arouna
AU - Tondé, Pélagie PP
AU - Zoundi, Christian
AU - Sanou, Harouna
AU - Ndikumana, Remy
AU - Nsengiyumva, Carlos
AU - Sund, Gregory
AU - Niyukuri, Alliance
AU - Kwizera, Axel
AU - Niyondiko, Jean Claude
AU - Kilembe, Adolphe Manzanza
AU - Ilunga, Jean Pierre Mwema
AU - Sarah, Nehema Hailemariam
AU - Makeya, Gabriel Mubobo
AU - Mwepu, Idesbald Mwebe
AU - Likongo, Ted Botawaosenge
AU - Mvwala, Richard Kapela
AU - Mubunda, Raphael Nzau Kapend
AU - Mukuna, Noellie Kanka
AU - Pembe, Julie Djondo
AU - Ndaye, Nicolas Lumuanga
AU - Amisi, Eric Bibonge
AU - Madika, Mike Ilunga
AU - Lungela, Joe Kembo
AU - Mayemba, Didier Ndonda
AU - Diyoyo, Philomene Mamba
AU - Ngalala, Alex Mbo
AU - Mukenga, Martin Mamba
AU - Kabuni, Patricia Tito
AU - Mpoto, Dany Bolimo
AU - Mole, Herve Inesnku
AU - Keby, Louise
AU - Buti, Oria Andavo
AU - Phaka, Anselme
AU - Mayenge, Belinda
AU - Kalongo, Jean Jeacques Kabuley
AU - Mawisa, Timothe Kemfuni
AU - Ngwizani, Rodrigue Tondo
AU - Leya, Kuyala
AU - Sanduku, Dieudonne Kisile
AU - Mawisa, Timothe Nkemfuni
AU - Mfumu, Coco Nseke
AU - Bolenge, Mbuta
AU - Kabuce, Desire Kinzenzengu
AU - Kintieti, Patrick
AU - Mbuluku, Amelia
AU - Mahuwa, Vicky
AU - Mabiala, Tharcice Khonde
AU - Ngoy, Guilain
AU - Boloko, Patrick
AU - Mvwama, Nono Mazangama
AU - Kengbanda, Jose
AU - Mushimbonga, Pitchou
AU - Kuhapala, Blaise
AU - Marcel, Nzosani
AU - Guylain, Kienze
AU - Mboma, Gerard
AU - Sagboze, Sandra Zalambo
AU - Manika, Michel Muteya
AU - Kigayi, Jean Pierre Mumbere
AU - Cishugi, Roger Mukanire
AU - Mugisho, Placide Buhendwa
AU - Baguma, Roger
AU - Kongolo, Moïse
AU - Mbayabu, Michel Mandungu
AU - Muamba, Crispin Mukendi
AU - Kapinga, Edmond Banema
AU - Kapinga, Vasco Ngolela
AU - Nsumpi, Guylain Tshimanga
AU - Odia, Patrick Kanda
AU - Bingidimi, Salomon
N1 - Publisher Copyright:
© 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
PY - 2021/10
Y1 - 2021/10
N2 - Background: Risk of mortality following surgery in patients across Africa is twice as high as the global average. Most of these deaths occur on hospital wards after the surgery itself. We aimed to assess whether enhanced postoperative surveillance of adult surgical patients at high risk of postoperative morbidity or mortality in Africa could reduce 30-day in-hospital mortality. Methods: We did a two-arm, open-label, cluster-randomised trial of hospitals (clusters) across Africa. Hospitals were eligible if they provided surgery with an overnight postoperative admission. Hospitals were randomly assigned through minimisation in recruitment blocks (1:1) to provide patients with either a package of enhanced postoperative surveillance interventions (admitting the patient to higher care ward, increasing the frequency of postoperative nursing observations, assigning the patient to a bed in view of the nursing station, allowing family members to stay in the ward, and placing a postoperative surveillance guide at the bedside) for those at high risk (ie, with African Surgical Outcomes Study Surgical Risk Calculator scores ≥10) and usual care for those at low risk (intervention group), or for all patients to receive usual postoperative care (control group). Health-care providers and participants were not masked, but data assessors were. The primary outcome was 30-day in-hospital mortality of patients at low and high risk, measured at the participant level. All analyses were done as allocated (by cluster) in all patients with available data. This trial is registered with ClinicalTrials.gov, NCT03853824. Findings: Between May 3, 2019, and July 27, 2020, 594 eligible hospitals indicated a desire to participate across 33 African countries; 332 (56%) were able to recruit participants and were included in analyses. We allocated 160 hospitals (13 275 patients) to provide enhanced postoperative surveillance and 172 hospitals (15 617 patients) to provide standard care. The mean age of participants was 37·1 years (SD 15·5) and 20 039 (69·4%) of 28 892 patients were women. 30-day in-hospital mortality occurred in 169 (1·3%) of 12 970 patients with mortality data in the intervention group and in 193 (1·3%) of 15 242 patients with mortality data in the control group (relative risk 0·96, 95% CI 0·69–1·33; p=0·79). 45 (0·2%) of 22 031 patients at low risk and 309 (5·6%) of 5500 patients at high risk died. No harms associated with either intervention were reported. Interpretation: This intervention package did not decrease 30-day in-hospital mortality among surgical patients in Africa at high risk of postoperative morbidity or mortality. Further research is needed to develop interventions that prevent death from surgical complications in resource-limited hospitals across Africa. Funding: Bill & Melinda Gates Foundation and the World Federation of Societies of Anaesthesiologists. Translations: For the Arabic, French and Portuguese translations of the abstract see Supplementary Materials section.
AB - Background: Risk of mortality following surgery in patients across Africa is twice as high as the global average. Most of these deaths occur on hospital wards after the surgery itself. We aimed to assess whether enhanced postoperative surveillance of adult surgical patients at high risk of postoperative morbidity or mortality in Africa could reduce 30-day in-hospital mortality. Methods: We did a two-arm, open-label, cluster-randomised trial of hospitals (clusters) across Africa. Hospitals were eligible if they provided surgery with an overnight postoperative admission. Hospitals were randomly assigned through minimisation in recruitment blocks (1:1) to provide patients with either a package of enhanced postoperative surveillance interventions (admitting the patient to higher care ward, increasing the frequency of postoperative nursing observations, assigning the patient to a bed in view of the nursing station, allowing family members to stay in the ward, and placing a postoperative surveillance guide at the bedside) for those at high risk (ie, with African Surgical Outcomes Study Surgical Risk Calculator scores ≥10) and usual care for those at low risk (intervention group), or for all patients to receive usual postoperative care (control group). Health-care providers and participants were not masked, but data assessors were. The primary outcome was 30-day in-hospital mortality of patients at low and high risk, measured at the participant level. All analyses were done as allocated (by cluster) in all patients with available data. This trial is registered with ClinicalTrials.gov, NCT03853824. Findings: Between May 3, 2019, and July 27, 2020, 594 eligible hospitals indicated a desire to participate across 33 African countries; 332 (56%) were able to recruit participants and were included in analyses. We allocated 160 hospitals (13 275 patients) to provide enhanced postoperative surveillance and 172 hospitals (15 617 patients) to provide standard care. The mean age of participants was 37·1 years (SD 15·5) and 20 039 (69·4%) of 28 892 patients were women. 30-day in-hospital mortality occurred in 169 (1·3%) of 12 970 patients with mortality data in the intervention group and in 193 (1·3%) of 15 242 patients with mortality data in the control group (relative risk 0·96, 95% CI 0·69–1·33; p=0·79). 45 (0·2%) of 22 031 patients at low risk and 309 (5·6%) of 5500 patients at high risk died. No harms associated with either intervention were reported. Interpretation: This intervention package did not decrease 30-day in-hospital mortality among surgical patients in Africa at high risk of postoperative morbidity or mortality. Further research is needed to develop interventions that prevent death from surgical complications in resource-limited hospitals across Africa. Funding: Bill & Melinda Gates Foundation and the World Federation of Societies of Anaesthesiologists. Translations: For the Arabic, French and Portuguese translations of the abstract see Supplementary Materials section.
UR - http://www.scopus.com/inward/record.url?scp=85113385710&partnerID=8YFLogxK
U2 - 10.1016/S2214-109X(21)00291-6
DO - 10.1016/S2214-109X(21)00291-6
M3 - Article
C2 - 34418380
AN - SCOPUS:85113385710
SN - 2214-109X
VL - 9
SP - e1391-e1401
JO - The Lancet Global Health
JF - The Lancet Global Health
IS - 10
ER -