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Outcomes after surgery for children in Africa A fourteen-dayedrospective observational cohort study (ASOS-Paeds) The ASOS-Pweds Investigators *ASOS-Paeds Ivvestigators listed in Supplementary Material Discipline of Anaesthesiology and Critical Care, Nelson R Mandela School of Medicine, University of Telephone: +27 (0) 833850217m Congella, 4013, Kwazulu-Natal, South Africa Word count: References: (25)) nt pri r P 1 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 Members for the African Surgical Outcomes Study in Paediatric patients (ASOS-Paeds) Group Writing Committee: Ademuyiwa, T6rBabatunde Babasola Osinaike, Adam Hewitt-Smith, Mary T Nabukenya, Ronald Bisegerwa, 10 d Souad Bouaoud, 11Meriem Abdoun, Ahmed Rhassane El Adib, Fitsum Kifle Belachew, Meseret Gebre, 15 Adobea Nyarko,e 21Kélan Bertille Ki, Sarah Shalongo, Wakisa Mulwafu, Emma Thomson, Mamadou Mour Yaa0 e Traore,26Andrew Ndonga, Mustapha Bittaye, Ahmadou Lamin Samateh, Dolly M. Munlemvo, Jean Jacques30 Arsitide Romain Raherison,l36Mamy Richard Randriamizao, Kushal Ramkalawan, Mohamed Abdinor Omar,ariwo, 395 Raymond Ndi45ntar, 4Donamou Joseph, S46kri Dahir, Muba47k Mohamed,48assan Ali Daoud, 49sirai 44 50 Isaac Smalle,51Elliott H Taylor, Hanel Duvenage, Anneli Hardy, Hyla Kluyts, Rupert Pearse, Bruce M Biccard57on behalf of the ASOS-Paeds investigators i v 1. School of Medicine, University of KwaZulu-Natal, Private Bag 7, Congella, 4013, Kwazulu-Natal, a South Africa e 2. Meedicine, University of Cape Town, Red Cross War Memorial Children’s Hospital, Cape Town, Southe Africa 3. Cairo 11432.ky MD, Kasr Al Ainy Faculty of Medicine, Cairo Unirersity, Ali Ibrahim St, Manial, 4. Prof Maher Fawzy MD, Emeritus Professor of Anesthesia , ICU and Pain Management, Faculty of 5. Muhammed Elhadi MBBCh, Faculty of Medicine, University of Tripoli, University Road, Furnaj, 6. Prof Adesoji O Ademuyiwa MD, FACS, Professor of Surgery (Paediatric and Surgical Epidemiology), Department of Surgery, College of Medicine, University of Lagos and Lagos University Teachi ng 7. Prof Babatunde Babasola Osinaike, FMCA, Profespor of Anaesthesia and Intensive Care, Department ofAnaesthesia, University of Ibadan/University College Hospital, Ibadan, Nigeria 8. of Health Sciences, Mbale Campus, Pallisa Road, Mbale, Uganda Care, Busitema University Faculty 9. Mary T Nabukenya, MMED Anaesthesiology and Critical Care, Department of Anaesthesia and 10. Ronald Bisegerwa, MMED Anaesthesiology and Critical Care, Department of Anaesthesia and Critical Care, Makerere University College of Health Sciences, 7072, Kampala, Uganda 11. Pmédecine, Université Ferhat Abbas Sétif 1, Algeriamédecine préventive, CHU Sétif, Faculté de 12. Pmoédecine, Université Fethat Abbas Sétif 1, Algeriaédecine préventive, CHU Sétif, Faculté d e 13. Prof Ahmed Rhassane El Adib, MD, Head of Anaesthesia and Critical Care in Gynecology-Obstetrics Pharmacy, Cadi Ayyad University, Marrakesh, Morocco.Hospital, Faculty of Medicine and 14. Fitsum Kifle Belachew MSc Med, Network for Perioperative and Critical Care, Debre Berhan Division, Department of Surgery, University of Cape Town, Cape Town, South Africaal Surger y 15. Meseret Gebre, MD, Pediatrician and Researcher, Armauer Hansen Research Institute, Addis Ababa, 16. Desalegn Bekele Taye MD MPH, A ssistant Director of Health Services Quality Directorate, Ministry of Health, Ethiopia 18. Tarig Fadalla, MBBS, The National Ribat University, Khartoum, Sudan. 20. Prof Maman Sani Chaibou, Anaesthesiologist and Chief of Department of Anesthesiology, Intensive Care and Emergency, National Hospital of Niamey, Republic of Niger P 21. Mame Yaa Adobea Nyarko, Princess Marie Louise Children’s hospital, Accra, Ghana 2 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 22. Ouagadougou, Burkina Fasoed, Centre hospitalier universitaire pédiatrique Charles de Gaulle, 23. Central Hospital (National Referral), Windhoek, Namibiaior Medical Superintendent of Windhoek 25. Development Centre, Kamuzu University of Health Sciences, Malawir Teaching and Learning 26. University, Pediatric Anesthesiologist, Albert Royer Children Hospital, SenegalCheikh Anta Diop d 28. Mustapha Bittaye, Fellow WACS, Edward Francis Small Teaching Hospital, Banjul,The Gambia e 29. Hospital, Banjul, The Gambia, Head of Department of Surgery, Edward Francis Small Teachwng 30. Kinshasha, Democratic Republic of Congohesiology and Resuscitation, University Hoseital of 32. Prof Yacaria Coulibaly, Pediatric Surgeon, Department of Pediatric Surgery , Academic Hospital 33. Prof Coulibaly Youssouf, Professor and Chief of Department, Faculté de médicine de Bamako, Mali 35. Madagascariana Andriamanarivo, Centre Hospitalier Universitaire Joseph Ravoahangy Andrianavalona, 36. Madagascaride Romain Raherison, Centre Hospitalier Universitaire Joseph Ravoahangy Andrianavalona, 38. Kushal Ramkalawan Masters in Anaesthesiology, Department of Anaesthesiology, SSRN Hospital, 39. Mohamed Abdinor Omar, MBBS, Head of Department of Surgical Care Unit, Ministry of Health and 40. Sciences, the University of Yaounde and Anaesthesiology and Critical Care Unit, Yaounde Gynaeco- 41. Professor Donamou Joseph, Anesthesiologist-Reanimator, Donka University Hospital, Professor and Gamal Abdel Nasser University, Conakry,tGuinea Unit, Faculty of Health Sciences and Techniques, 43. Mubarak Mohamed Jama, BSc Nurse Anesthesia, Head of Anesthesia Department and Pre-Operative 44. Hassan Ali Daoud, MD, Amoud University, Ministry of Health, Somaliland 45. University of KwaZulu Natal, Durban South Africae and School of Nursing and Public Health,indura 46. Critical Care and Emergencies, University Hospital of Brazzaville, Faculty of Health Sciences, 47. Rwanda King Faisal Hospital, Rwandarioperative Cardiac anaesthesia and Critical Care, University of 49. Prof Milliard Derbew, MD Professor of Pediatric Surgery Addis Ababa University, College of Health 51. Isaac Olufemi Smalle PhD, Department of Surgery, College of Medicine and Allied Health Sciences, 52. Elliott H Taylor MBBS, Global Surgery Division, Department of Surgery, University of Cape Town, 53. Hanel Duvenage MSc Molecular Medicine and Bioinformatics, MSc Nutrition, Research and P 54. Science, University of Cape Town, South Africatant, Department of Statistical Sciences, Faculty of 3 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 5Mdicine, Groote Schuur Hospital, Faculty of Health Sciences, University of Cape Town, South Africa ed ie rev er tp no rit e Pr 4 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 Evidence before this study approximately 40% of the total population compared to a global average of 25%, resulting in a much greatertitute intervention by the age of 15. We know that adult surgical outcomes in Africa are poor, with a postoperativesurgical Africa. As we could not identify any previous evidence synthesis describing surgical outcomes for children inn CRD42022357658). The meta-analysis of perioperative mortality for children following surgery was defined as ≥200 children in the cohort, and reported perioperative mortality for a range of surgical procedures. One hundred meta-analysis. The meta-analysis showed that the current data frem Africa were biased as all studies wereded in the and a large paediatric specialist hospital accounted for more than half of cases reported (8493/16349 [52%]). confidence interval (CI) 9-24 in Africa comparedtto 2 deaths per 1000 children in high-income countries, 95% CI safe anaesthesia and surgery for children in Africa.there is insufficient data currently to inform the provision of Added value of this study t n surgery in Africa, postopirative complications occurred in 18% of children which is threefold greater rate than countries. Deathpfollowing a postoperative complication, also known as ‘failure to rescue’, occurred in 1 in 9 postoperatiee complications had co-existing disease and underwent intermediate and major emergency surgery. sPrgery. Clinician researchers in many participating sites prospectively reported their hospitals as unable to 2 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 provide safe anaesthesia and surgery for children under 6 years of age. This difficulty was compounded by complications,ednd a lack of protocols and procedures to promote safe and effective patient care.cardiovascular findings clearly demonstrate that the outcomes for children in Africa are even worse than that reported for adults, improvesurgicaloutcomesforchildreninAfrica,healthsystemstrengthening(whichfocusesonaccess,resourcesstrates that tod and surgery, and strategies to address the high rate of ‘failure to rescue’. This will require cross-sectoralhesia cooperatier and long-term planning involving health leaders, policymakers, and funders. p not nt pri re P 3 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 Background provision and outcomes for children undergoing anaesthesia and surgery in Africa.are eew data describing care Methods w for children. Each hospital recruited all eligible children for a 14-day period between January 2022 and Decembernt outcome was in-hospital mortality within 30 days after surgery. We also collected hospital-level data describing equipment, facilities and procedures considered necessary ror safe surgical care of children. We recruited 8625 children from 249 hospitals in 31 African countries. The mean age was 6·1 (4.9) years, and I, 6110/8579 children [71%]). 5325/8604 (62%p of children underwent elective surgery. Postoperativets’ Class Deaths following postoperative complocations occurred in 166 of 1530 complications (10·8%). Operating roomsy. and 42/221 (19%) did not have a reliable oxygen supply.21 (22%) of hospitals did not have reliable electricity,%), Interpretation n t fourfold and 11-fold higher respectively than high-income countries. To improve surgical outcomes for childrenre anaesthesea and surgery, and strategies to address the high rate of ‘failure to rescue’. for the conduct of FPnding 4 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 Association of Anesthesiologists of Ugandafrican Society of Anaesthesiologists (SASA) This stuwy was registered on ClinicalTrials.gov (NCT05061407). ve r pe ot it er P This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 Access to safe and affordable surgery is a public health priority.2Children in Africa constitute approximately proportional burden of the surgical disease. In our previous work, we have shown adult surgical outcomes in d complications, which is known as ‘failure to rescue’.4However, there are few data describing surgical outcomesative multinational studies of outcomes of children following anaesthesia and surgery across the African continent.o care, and poor patient outcomes that have been documented in adult surgical patients.av limitations in perioperative Robust epidemiological data are needed to describe patient care and outcomes for children undergoing anaesthesia and to define the ongoing research agenda. Given the specialist neture of paediatric anaesthesia and surgery,icy, perioperative care to children than we know exist for adults in African hospitals. in the provision of safe, effective The objectives of this study were to determine: i) the incidence of in-hospital postoperative complications and with postoperative complications and death amongst children undergoing surgery in Africa. Theserative risk factors define a research agenda to ensute safe, and effective anaesthesia and surgical care for children in Africa.ms, and i n p r e P r 6 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 Study design, setting, and participants undergoing surgery in hospitals in Africa. This study was registered on ClinicalTrials.gov (NCT05061407). Our d study is reported in accordance with the STROBE statement. Research ethics and regulatory approvals were in ethics approval was from the Health Research Ethics Committee of the Faculty of Health Scienees, University ofary risk to the study population. We expected that in most countries there would be no revuirement for individual to the study database. This precedent had already been set in previous natioral and international studies of adults consent, both in South Africa, affecting seven hospital sites. ‘Broadcasting’ signage, as an infographic poster with patientsandparents/guardianswereawarethatthehospitalwasparticipatinginthestudy(SupplementaryMateriale that all We aimed to recruit as many hospitals as possible, of all sizes, providing surgical services for children. Eligibility included all consecutive patients <18 years admitted to participating hospitals during the study period who had theatres requiring local or general annesthesia. Exclusion criteria were: i) patients undergoing radiological or other performed e.g., general anaesthetia to facilitate radiological imaging, ii) patients having obstetric surgery, and iii) chosen by each participating hospital within the study recruitment period of 15 January 2022 to 23 Decemberate discharge, censoped at 30 days if the patient was still alive and in hospital. Our study website provided open access videos, rnd virtual meetings were conducted to provide training for patient recruitment, and data collection and mPnagement. 7 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 Hospital-specific data included the DCP-3 hospital level of care (first, second, third), reimbursement status of and equipment appropriate to paediatric surgery and anaesthesia (e.g. oxygen, electricity, paediatric airwayurdes was informed by a previous national study in South Africa (SAPSOS). Data included co-existing disease,ta collected Complications were assessed according to predefined criteria (the case record form (CRF) and definitions are. shown in Supplementary Materials S3 and S4) and were graded as mild, moderate, or severe. Data were collected (REDCap) tools hosted by Safe Surgery South Africa. Soft limits were set forrdata entry, prompting investigators data entry, or paper CRFs were securely submitted via WhatsApp or e-marled to Safe Surgery South Africa ford for countries.. National lead investigators confirmed the face validiey of the unadjusted outcome data for their Patient outcomes p e secondary outcome measures included in-hospital mortality up to 30 days after surgery, and the risk factors outcome which will be presented in a separate peer-reviewed paper.perative critical incidents were also a secondary Statistical analysis t all eligible consecutive patients. A statistical analysis plan was written before data analysis (Supplementaryg standard deviation if normally distributed or median and interquartile range (IQR) if not normally distributed.d first, recond and third levels respectively were constructed to identify factors independently associated with Postoperative in-hospital complications and mortality. All risk factors were considered for entry into the models 8 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 collinearity. Collinearity was assessed using the variance inflation factor. If collinearity was detected, then adapted to the event rate provided by the sample recruited, in order to prevent overfitting of any logistic regression data. The following variables were entered into the models: age, sex, American Society of Anesthesiologistsing disorder, HIV/AIDS, cancer, current respiratory tract infection, other comorbidity), urgency of surgery (elective or emergency), severity of surgery (minor, intermediate, or major), indication for suvgery (non-communicable thoracic surgery, ear, nose and throat surgery, hepatobiliary surgery, orthopredic surgery, maxillofacial and dental burns surgery, and other), anaesthesia induction after hours, and surgery duration. All analyses were complete, and potential influential cases. The impact of these cases on the models was further assessed by refitting thees The following pre-specified sensitivity analyses were conducted for the analysis for the primary outcome of current or recently diagnosed Covid-19 infection (defined as confirmed Covid-19 infection from 7 weeks with a with 95% confidence intervals (CI).tivnly). The results of the analysis are reported as adjusted odds ratios (OR) The meta-analysis of perioperative mortality following paediatric surgery (defined as death occurring within 30 days following a surgicaliprocedure) was updated to include ASOS-Paeds (PROSPERO CRD42022357658). The perioperative moptality in paediatric surgical patients.11 with ≥200 patients in the study cohort and reporting Role of rhe funding source aPd Association of Anesthesiologists of Uganda. The funders had no role in the study design, data collection, data 9 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 data in dhe study. AT and BMB had final responsibility for the decision to submit for publication.ccess to all the ee ri e t tn pi Pe This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 Hospital-level data countries (Burkina Faso, Democratic Republic of Congo, Ethiopia, Gambia, Madagascar, Malawi, Mali, Nieer,ncome Congo, Egypt, Ghana, Guinea, Kenya, Libya, Mauritius, Morocco, Namibia, Nigeria, Senegal, South Africa,n, take informed consent for participation, and 25 eligible patients were excluded who did not consent. Theed to (92·0%) of the 249 hospitals. There were 41 (17·1%) level 1, 52 (21·7%) level 2, and 147 (61·3%) level 3 22(10·3%)of213werenon-governmentalorganisations,missionorcharityhospitals.Therewere69/249(27·7%) funded, and 3-8) and two paediatric critical care beds allowing invasive veetilation (IQR 0-6). There was a median of sevenR specialist paediatricians (IQR 1-10). 32/182 (17·6%) of the hospitals had a median of two full time specialistull time month was a median of 200 (IQR 80-400) cases, ot which a median of 35 (17·5%) (IQR 20-88) were children <18 per paediatric surgery were available from 233/249 (93·6%) sites (Supplementary Material S7). Operating roomsafe and for children <6 years in 18t/223 (84·3%). Electricity, and oxygen were unreliable at 48/221 (21·8%) and65·9%) 33/221 (14·9%) and 26/22i (11·8%) of hospital sites respectively. Many sites did not have protocols andlways at administrative pata crllection to support safe surgery. The patiene cohort characteristics are shown in Table 1. The mean age was 6·1 years, with 5675 (66%) of 8600 61·9%). The most common comorbidity was a neurological disorder (383/8612, 4·4%) followed by cardiac 11 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 children with a current or recently diagnosed Covid-19 infection. The most common primary indication for (2·1%) gastrointestinal (2158/8600, 25·1%), kidney and urology (1505/8600, 17·5%) and orthopaedic (1216/8600, d surgical safety checklist was used in 4817/8580 cases (56·1%).urs. The World Health Organisation (WHO) Most children (7166/8625, 83·9%) went to a ward postoperatively, and 436/8625 (5·1%) were admitted to a critical care unit postoperatively. Postoperative length of stay was 2 (IQR 1-4) dvys, and 1717/8371 (20·5%) children died (2·3%) following surgery and 23 of these children (11·6%) dird on the day of surgery. Postoperative postoperative complications. Most complications occurred in the wardr(944/1520, 62·1%), but most deaths in elective surgical patients (699/1530, 45·7%), but most of the deaths occurred in urgent and emergency surgeries (Table 3). The most common complications were bleedipg (467/8552, 5·5%) and superficial surgical site4%) following 216 cardiovascular complications, 55·6%). The outcomes by facility level are shown in Supplementary complications, and 154/184 (83·7%) dnaths).y were most common in level 3 hospitals (1213/1445 (83·9%) The missing data for risk factors and outcomes are shown in Supplementary Material S9. Data completeness was postoperativecomplicationsincluded:ageof0-28days,ahigherASAcategory,co-existingdiseases(neurologicald with emergency surgery, intermediate and major surgery, infection as an indication for surgery, burns surgery, and an change the model. The sensitivity analyses of elective surgical patients, emergency surgical patients, andd not ePclusion of patients with recent Covid-19 were consistent with the overall generalised linear mixed model of the 12 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 primary analysis. A post hoc decision to conduct a sensitivity analysis excluding the two countries providing more (Supplementaryedaterial S10-S13 respectively). and South Africa) was also consistent with the overall analysis burns surgery and an increasing duration of surgery (Table 5). No sensitivity analyses were conducted fory surgery; The updated meta-analysis including of mortality following surgery in children which includes ASOS-Paeds is higher in Africa than high-income countries (23 deaths per 1000 children, 95% CI 20-27 and 2 deaths per 1000 children,er5% CI 1-3 respectively). p not nt pri re P 13 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 Discussion countries. The principal findings were that postoperative complications occurred in 18% of children with an in-d higher than high-income countries.16,18-The main risk factors for postoperative complications were co-existing associated with postoperative complications and mortality. Factors contributing to the difficulty in providing safe needed to manage cardiovascular complications, and a lack of protocols and procedures to support safe clinicalgs surgical practice. These findings suggest that poor outcomes following surgery fer children in Africa are an even effectiveness of anaesthesia and surgery for children in African hospitals.nerd to improve the safety and The strength of this study is that it provides a comprehensive presentation of outcomes for children having surgery of postoperative complications and mortality. The sensitivity analyses support the primary analysis suggesting limitations of previous studies of postoperative complications in children having surgery in Africa which were complications following paediatric surgery is 30% higher in Africa than reported in the United States American College of Surgeons National Surgical nuality Improvement Program: P17iatric (NSQIP: Pediatric) which also States sample was 3% compared to nearly fourfold increase in Africa of 10·8%. In summary, although adult United surgical outcomes in rfriia are poor, outcomes following surgery in children in Africa are even poorer. 1 patients) in Africa, and the high postoperative mortality, and failure to rescue suggests that there is any surgery in Africa. Unfortunately, in many cases the clinicians report that the environment for anaesthesia and Purgery does not support the delivery of safe anaesthesia and surgery, or the management of complications 14 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 following surgery. Previous studies have also identified similar challenges in providing surgery for children in inadequate surgical equipment and supplies, in an environment with unreliable electricity and access to runningd safe for anaesthesia and surgery for children in Africa by addressing the limitations in resources (physical and for including children in National Surgical Obstetric and Anaesthesia Plans (NSOAPs), and support baselinecall assessment usings the Global Initiative for Children's Surgery (GICS) modified Children's Sirgical Assessment Assessment Tool (SAT) does not capture data on number of specialists providing anaesthesia or surgery for Africa. OReCS provides a roadmap to inform NSOAPs and for improving anaesthesia and surgical care inriority for safe anaesthesia and surgery for children. High quality training and education is needed for all healthcare workers providing paediatric surgical care, including both physicians and non-physician providers. Limitations of this study may include the inability topextrapolate the findings to the African countries which were here due to insufficient infrastructure and resources necessary for participation. This is evident by the inability of 12 countries to obtain ethical approval desoite willing collaborators (Figure 1). There is also an over- broader problem in that level 1 hospitals may be under-represented because they cannot provide anaesthesia and [78·6%]) were level 1 hospinals suggesting that these are the hospitals with insufficient resources for safe(11/14 decrease access to surgical care for children further compromising outcomes for surgical pathology. Although,uld the reports that sites were unsafe for anaesthesia and surgery in children is a subjective assessment by clinicians, cardiovrscular drugs, and a lack of functional incubators. These factors further strengthen the call for providing P 15 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 resourced level 1 hospitals, less complex, minor surgery in healthy children occurs in higher level hospitals.h under OutcomesfollowinganaesthesiaandsurgeryforchildrenarepoorinAfrica,withoneinfivechildrenexperiencing address the high rate of ‘failure to rescue’. safe for the conduct of anaesthesia and surgery, and strategies to rev er tp no rit e Pr 16 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 Other information ClinicalTrialsegov (NCT05061407): African Surgical Outcomes Study in Paediatric patients (ASOS-Paeds) The protocol wnd statistical analysis plan are posted at ClinicalTrials.gov (NCT05061407) Anaesthesiologists (SASA) and the Association of Anesthesiologists of Uganda.h African Society of Data Sharing Statement investigators will not be considered until 2 years after the close out of the study. Data will be de-identified for particippnt, hospital and country, and will be available with a signed data access agreement. not nt pri re P 17 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 References 1. Meara JG, Leather AJ, Hagander L, et al. Global Surgery 2030: evidence and solutions for achieving 2.alth, Biccard BM, Madiba TE, Kluyts HL, et al. Perioperative patient outcomes in the African Surgical d 3.tcomesGalaly: a 7-S.y proPopulationbservatofnal coAfricatudy. 2021,t 2018by391(10age): 1589group. 2023. 4.tps://Biccard BM, du Toit L, Lesosky M, et al. Enhanced postoperative surveillance versus standard of care. Lancet Global Health 2021; 9(10): e1391-e401.ents in Africa (ASOS-2): a cluster-randomised ioetrolled trial. The children in a tertiary teaching hospital in Nigeria: a prospective study. World J Pediatr Surg 2021; 4(1): e000237. cohort study. Ann Med Surg (Lond) 2021; 67: 102396.rioperative pediatric mortaliey in Ethiopia: A prospective of 8493 cases at a tertiary pediatric teaching hospital in South Africa. Paediatr Anaesth 2017; 27(10): 1021-7. prospective, observational cohort study of paediatric surgical patients. Br J Anaesth 2019; 122(2): 224-32. Cohort Study from 24 Hospitals. Anesthesiology 2020; 132(3): 452-60.e Mortality in Kenya: A Prospective Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med 2007; 4(10): e296. t p 2012; 380(9847): 1059-65. RP, Bauer P, et ao. Mortality after surgery in Europe: a 7 day cohort study. Lancet Edition : Volume 1. Essential Surgery.n2015; 1.DT, Kruk ME, Mock CN. Disease Control Priorities, Third per variable in logistic regresston analysis. J Clin Epidemiol 1996; 49(12): 1373-9. of the number of events surgery: a study in surgican risk assessment for children. Journal of the American College of Surgeons 2011;c 15.(5): Thompson H, Jrnes C, Pardy C, et al. Application of the Clavien-Dindo classification to a pediatric 16.gicalAlzubaidi AN, Karabayir I, Akbilgic O, Langham MR, Jr. Network Analysis of Postoperative Surgical Pediatric. Ann Surg 2022; 275(6): 1194-9.orted to the National Surgical Quality Improvement Program: Surgery. Ann Surg 2022; 276(4): e239-e46.et al. Complications and Failure to Rescue After Inpatient Pediatric P 18 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 5(5): 412-25.prospective multicentre observational study in 261 hospitals in Europe. Lancet Respir Med 2017; 20.raopeValencia E, Staffa SJ, Faraoni D, DiNardo JA, Nasr VG. Prospective External Validation of the Pediatric 21.lg 20Ajao AE, Adeniran JO. Spectrum of paediatric surgical cases in a private mission teaching hospital in Expansion of Pediatric Surgery Program. Ethiop J Health Sci 2021; 31(6): 1193-8.TASH: Experience after the physician clinicians in Malawi. Int J Surg 2014; 12(5): 509-15.ve pediatric sergical care by physicians and non- 1189676.aharan Africa: evidence from 67 hospitals in Malawi, Zambia,rand Tanzania. Front Pediatr 2023; 11:ic surgery Int 2021; 37(5): 529-37.mes: the need and roadmap from Global Initiative for Children's Surgery. Pediatr Surglans p e o t n n t r i e p P r 19 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560Table 1. Baseline characteristics of the African Surgical Outcomes Study in Paediatric patients (ASOS-Paeds) patient cohort d All patients (n=8625) Patients with Patients with no Patients who died Patients who survived complications (n=1532) complications (n=6983) (n=199) w (n=8397) Mean (SD) 6·1 (4·9) 5·5 (5·1) 6·2 (4·8) 3·4 (5·0) e 6·2 (4·9) Median (IQR) 5·0 (1·9-10·0) 3·9 (1·0-9·3) 5·03 (2·0-10·0) 0·5 v0·3-6·0) 5·0 (2·0-10·0) Male 5675/8600 (66%) 958/1529 (62·7%) 4647/6964 (66·7%) e120/197 (60·9%) 5538/8375 (66·1%) Female 2925/8600 (34%) 571/1529 (37·3%) 2317/6964 (33·3%) r 77/197 (39·1%) 2837/8375 (33.9%) 0-28 daysory 310/8591 (3·6%) 130/1528 (8·5%) 170/6954 (2·4%) 68/198 (34·3%) 240/8364 (2·9%) 29-364 days 1168/8591 (13·6%) 243/1528 (15·9%) 911/6954 (13·1%) 49/198 (24·7%) 1112/8364 (13·3%) 4-12 years 3948/8591 (46·0%) 602/1528 (39·4%) e3305/6954 (47·5%) 40/198 (20·2%) 3900/8364 (46·6%) 13-18 years 1093/8591 (12·7%) 214/1528 (14·0%) p 866/6954 (12·5%) 17/198 (8·6%) 1071/8364 (12·8%) 1SA Category 6110/8579 (71·2%) 784/1519 (51·6%) 5272/6969 (75·6%) 47/197 (23·9%) 6054/8368 (72·3%) 2 1588/8579 (18·5%) 357/1519 (23·5%) 1210/6969 (17·4%) 40/197 (20·3%) 1546/8368 (18·5%) 4 and 5 140/8579 (1·6%) n 289/1519 (5·9%)) 47/6969 (0·7%)) 38/197 (19·3%) 101/8368 (1·2%) Urgency of surgery t Expedited 5r41/8604 (10·9%) 192/1530 (12·5%) 737/6978 (10·6%)) 30/199 (15·1%) 5908/8389 (10·8%) Urgent p 1912/8604 (22·2%) 479/1530 (31·3%) 1406/6978 (20·1%) 98/199 (49·2%) 1810/8389 (21·6%) Emergency (all toeether) 3279/8604 (38·1%) 831/1530 (54·3%) 2400/6978 (34·4%) 169/199 (84·9%) 3101/8389 (37·0%) r P This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560Minor of surgery 2996/8594 (34·9%) 287/1532 (18·7%) 2672/6972 (38·3%) 19/199 (9·5%) 2972/8381 (35·5%) Intermediate 3890/8594 (45·3%) 646/1532 (42·2%) 3214/6972 (46·1%) 57/199 (28·6%) 3830/83e1 (45·7%) Primary indication for 1708/8594 (19·9%) 599/1532 (35·5%) 1086/6972 (15·6%) 123/199 (61·8%) 1579/8381 (18·8%) Non-communicable 2231/8590 (26·0%) 381/1532 (24·9%) 1829/6967 (26·3%) 45/199 (22·6%) e w 2184/8376 (26·1%) Traumatic 1455/8590 (16·9%) 267/1532 (17·4%) 1171/6967 (16·8%) 23/199 (11·6%) 1429/8376 (17·1%) Congenital 3397/8590 (39·5%) 564/1532 (36·8%) 2791/6967 (40·1%) 95/199 (47·7%) 3295/8376 (39·3%) Type of surgery r e Neurosurgery 442/8600 (5·1%) 138/1531 (9·0%) 301/6976 (4·r%) 17/199 (8·5%) 425/8385 (5·1%) Gynaeac 100/8600 (1·2%) 17/1531 (1·1%) 81/69e6 (1·2%) 11/199 (0·5%) 98/8385 (1·2%)) Thoracic 107/8600 (1·2%) 47/1531 (3·1%) e 58/6976 (0·8%) 14/199 (7·0%) 93/8385 (1·1%) Hepatobiliarythroat 861/8600 (0·7%)) 120/1531 (1·3%) p 740/6976 (0·6%)) 3/199 (1·5%) 858/8385 (0·7%)) Orthopaedic 1216/8600 (14·1%) 164/1531 (t0·7%) 1038/6976 (14·9%) 6/199 (3·0%) 1207/8385 (14·4%) Gastrointestinald dental 2158/8600 (25·1%) 494/1531 (32·3%) 1638/6976 (23·5%) 105/199 (52·8%) 2047/8385 (24·4%) Kidney/ Urology 1505/8600 (17·5%) n 217/1531 (14·2%) 1270/6976 (18·2%) 10/199 (5·0%) 1491/8385 (17·8%) Ophthalmology 332/8600 (3·9%t 11/1531 (3·4%) 317/6976 (4·5%) 0/199 (0·0%) 332/8385 (4·0%) Burnsics/ cutaneous 153/8600 (1·8%) 54/1531 (3·5%) 96/6976 (1·4%)) 14/199 (7·0%) 139/8385 (1·7%) Other r92/8600 (8·0%) 82/1531 (5·4%) 598/6976 (8·6%) 4/199 (2·0%) 687/8385 (8·2%) Cardiac disease p 259/8612 (3·0%) 94/1532 (6·1%) 160/6983 (2·3%) 31/199 (15·6%) 228/8397 (2·7%) Chronic respiratoey disease 168/8612 (2·0%) 54/1532 (3·5%) 113/6983 (1·6%) 8/199 (4·0%) 160/8397 (1·9%) r P This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 HIV/AIDSical disorder 340/8612 (0·5%) 14/1532 (0·3%)) 236/6983 (0·5%) 20/199 (0·0%)) 40/8397 (0·5%)) Cancer 171/8612 (2·0%) 53/1532 (3·5%) 111/6983 (1·6%) 5/199 (2·5%) 165/83e7 (2·0%) Infectionespiratory Tract 252/8612 (2·9%) 93/1532 (6·1%) 157/6983 (2·2%) 18/199 (9·0%) 234/8397 (2·8%) Other 213/8612 (2·5%) 67/1532 (4·4%) 141/6983 (2·0%) 15/199 (7·5%) w 198/8397 (2·4%) Covid-19 diagnosis 6184/8584 (2·2%)) 133/1532 (2·2%)%) 5150/6972 (2·2%)) 16/184 (3·3%)%)e 678/8385 (0·9%)%) After hours operation 1516/8506 (17·8%) 386/1505 (25·6%) 1116/6909 (16·2%) 75/197 (38·1%) 1440/8294 (17·4%) Not after hours 6990/8506 (82·2%) 1119/1505 (74·4%) 5793/6909 (83·8%) e 122/197 (61·9%) 6854/8294 (82·6%) No checklistklist 3763/8580 (43·9%) 614/1529 (40·2%) 3109/6959 (44·7%) r 83/199 (41·7%)) 3675/8369 (43·9%) Most senior anaesthetist r Non-specialist physician 1888/8589 (22·0%) 269/1532 (17·6%)) 1608/6962 (23·1%) 123/199 (1·6%)) 1863/8375 (22·2%) Nurse 529/8589 (6·2%) 83/1532 (5·4%) e 427/6962 (6·1%) 17/199 (8·5%) 505/8375 (6·0%) Non-physician 422/8589 (4·9%) 82/1532 (5·4%) p 339/6962 (4·9%) 7/199 (3·5%) 415/8375 (5·0%) Specialistr surgeon 6698/8594 (77·9%) 1254/1531 (81·9%) 5357/6968 (76·9%) 158/199 (79·4%) 6526/8380 (77·9%) Non-specialist physician 1828/8594 (21·3) 259/1531 (16·9%) 1564/6968 (22·4%) 39/199 (19·6%) 1788/8380 (21·3%) Nurse 35/8594 (0·4%) n 11/1531 (0·7%) 21/6968 (0·3%) 1/199 (0·5%) 34/8380 (0·4%) Post-op location 33/8594 (0·4%)t 7/1531 (0·5%) 26/6968 (0·4%) 1/199 (0·5%) 32/8380 (0·4%) Ward 7166/8i25 (83·9%) 944/1520 (62·1%) 6164/6951 (88·7%) 65/193 (33·7%) 7095/8341 (85·1%) Critical care 436/8625 (5·1%)) 267/1520 (17·6%) 164/6951 (2·4%) 83/193 (43·0%) 8351/8341 (4·2%) Data are n/N (%). Denominators vary with the completeness of the data. SD standard deviation, IQR interquartile range, ASA American Society of Anesthesiologists, HIV human immunodeficiency virus, AIDS acquired immunodeficiency syndrome r P This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 patients (ASOS-Paeds)e outcomes in the African Surgical Outcomes Study in Paediatric Complications outcomes (whole cohort) 1532/8515 (18·0%) e d Death following a postoperative complication 166/1530 (10·8%)w Mortalityionsery cohort 630/5318 (0·6%))) Emergency surgery cohorterative complication 3279/8604 (38·1%) Mortality on the day of surgery r e8116/169 (9·5%)) Data are n/N (%). Denominators vary with the completeness of ehe data. 143/830 (17·2%) e t p o t n i n p r e P r This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560Table 3. Postoperative complications in the African Surgical Outcomes Study in Paediatric patients (ASOS-Paeds) d COMPLICATIONS Patients (n) Mild (n, %) Moderate (n, %) Severe (n, %) complicationsh Dcomplicationsng All complications 8515 1193 883 538 1532/8515 (18·0%) w 166/1530 (10·8%) i e Superficial surgical site 8562 299 (3·5%) 194 (2·3%) 56 (0·7%) 9549/8562 (6·4%) 128/549 (5·1%)) Deep surgical site infection 8553 52 (0·6%) 88 (1·0%) 76 (0·9%) e 216/8553 (2·5%) 31/216 (14·4%) Bloodstream infection 8552 52 (0·6%) 104 (1·2%) 83 (1·0%) 239/8552 (2·8%) 59/239 (24·7%) Pneumonia 8552 116 (1·4%) 102 (1·2%) e 64 (0·7% 282/8552 (3·3%) 57/281 (20·3%) Other infection 8544 61 (0·7%) 51 (0·6%)e 24 (0·3%) 136/8544 (1·6%) 14/136 (10·3%) Cardiovascular 8543 p 216/8543 (2·5%) 120/216 (55·6%) Arrhythmiarest 8554 60 (0·7%) t 32 (0·4%) 135 (0·4%) 171/8554 (1·5%) 43/127 (33·9%)) o Bleeding 8552 340 (4·0%) 105 (1·2%) 22 (0·3%) 467/8552 (5·5%) 929/466 (6·2%) Acute kidney injury 8554 t 39 (0·5%) 37 (0·4%) 29 (0·3%) 105/8554 (1·2%) 40/105 (38·1%) Other 85i1 n 138 (1·6%) 116 (1·4%) 107 (1·3%) 361/8551 (4·2%) 65/361 (18·0%) Re-operation r 8565 347/8565 (4·1%) Data are n/N (%). Denominapors vary with the completeness of the data. r P This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 postoperative complications.mixed model factors independently associated with Model Term Odds ratio 95% intervalce P-value d e Age 0-28 days 2·301 1·594-3·322 <0·001 29-364 days 1·261 0·966-1·647 0·08w 1-3 years 1·065 0·838-1·355 0·605 Age 13-18 years Reference 0·772-1·177 i e0·654 Female 1·061 0·921-1·222 0·414 ASA 4 and 5 Re6·161ce 3·947-9·616 v <0·001 3 2·626 2·040-3·381 e <0·001 2 1·446 1·200-1·743 r <0·001 Cardiac disease Re1·130ce 0·722-1·767 0·593 Chronic respiratory 1·885 1·235-2·877 0·003 Neurological disorder 1·704 1·188-2·444 0·004 HIV/AIDS 0·376 0·121-1·165 0·090 Current respiratory tract 2·080 e 1·492-2·898 <0·001 infection p Emergency 1·473 1·240-1·749 <0·001 Elective Reference t Major 2·0o5 1·630-2·640 <0·001 Minormediate neference 1·149-1·673 <0·001 Congenital 0·968 0·793-1·182 0·752 Infective t 1·517 1·211-1·899 <0·001 Non-communicable n Reference 1·009-1·727 0·043 Other i 1·178 0·663-2·090 0·576 Plastics/cutaneousr 1·656 0·944-2·903 0·078 Ophthalmologyp 0·311 0·137-0·703 0·005 Kidney/urology 1·336 0·784-2·276 0·287 Orthopaedictinal 0·955 0·554-1·647 0·869 Hepatobiliary 1·437 0·618-3·343 0·400 PEar nose and throat 0·903 0·516-1·579 0·721 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 Cardiacc 1·450 0·674-3·121 0·342 Surgery after hoursental Re1·188ce 0·984-1·435 0·074 e d minute increase)ery (per Re1·005ce 1·004-1·006 <0·00w immunodeficiency syndromenesthesiology; HIV/AIDS human immunodeficiency virus/ acquired v r e e r e t p o t n i n p r e P r This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 hospital mortality.d linear mixed model factors independently associated with in- Model Term Odds ratio 95% intervalce P-value d e Age 0-28 days 10·657 4·768-23·822 <0·001 29-364 days 4·398 2·128-9·091 <0·00w 1-3 years 1·331 0·613-2·889 0·470 Age 13-18 years Reference 0·496-1·916 i e0·942 Female 0·926 0·644-1·331 0·678 ASA 4 and 5 Re14·133e 7·120-28·052 v <0·001 3 3·912 2·268-6·747 e <0·001 2 1·546 0·920-2·598 r 0·100 Cardiac disease Re2·178ce 1·036-4·579 0·040 Chronic respiratory 2·048 0·760-5·517 0·156 Neurological disorder 6·083 2·846-13·004 <0·001 HIV/AIDS* - - 0·992 Current respiratory tract 2·208 e 1·125-4·333 0·021 infection p Emergency 3·952 2·393-6·525 <0·001 Elective Reference t Major 1·8o8 0·972-3·511 0·061 Minormediate neference 0·500-1·694 0·790 Congenital 0·858 0·494-1·492 0·588 Infective t 0·851 0·466-1·553 0·598 Non-communicable n Reference 0·359-2·002 0·706 Other i 0·648 0·098-4·272 0·652 Plastics/cutaneousr 2·1400 0·364-12·571 0·400 Ophthalmologyp - - 0·980 Kidney/urology 0·961 0·175-5·290 0·964 Orthopaedictinal 0·594 0·098-3·594 0·571 Hepatobiliary 2·017 0·250-16·294 0·511 PEar nose and throat 1·002 0·161-6·223 0·998 This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 Cardiacc 0·628 0·090-4·371 0·638 Surgery after hoursental Re1·248ce 0·821-1·896 0·299 e d minute increase)ery (per Re1·003ce 1·001-1·005 0·00w immunodeficiency syndrome; * `no deaths; † 1 deathuman immunodeficiency virus/ acquired v r e e r e t p o t n i n p r e P r This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560 Figure 1. African Surgical Outcomes Study in Paediatric patients (ASOS-Paeds) recr43 countries requested participation 12 countries could not obtain ethics approval 31 co17 centres with zero patient recruitment 8808 eligible patients from 249 centreshospitals, 3 25 excluded as did not provide consented (29 (0.3%) missing mortality data 11no(1.3%) missing complications data) nt pri r P This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4556560