Method of Anesthesia and Perioperative Risk Factors, Maternal Anesthesia Complications, and Neonatal Mortality Following Cesarean Delivery in Africa: A Substudy of a 7-Day Prospective Observational Cohort Study.

BACKGROUND: The African Surgical Outcomes Study (ASOS) found that maternal mortality following cesarean delivery in Africa is 50 times higher than in high-income countries, and associated with obstetric hemorrhage and anesthesia complications. Mothers who died were more likely to receive general anesthesia (GA). The associations between GA versus spinal anesthesia (SA) and preoperative risk factors, maternal anesthesia complications, and neonatal outcomes following cesarean delivery in Africa are unknown. METHODS: This is a secondary explanatory analysis of 3792 patients undergoing cesarean delivery in ASOS, a prospective observational cohort study, across 22 African countries. The primary aim was to estimate the association between preoperative risk factors and the outcome of the method of anesthesia delivered. Secondary aims were to estimate the association between the method of anesthesia and the outcomes (1) maternal intraoperative hypotension, (2) severe maternal anesthesia complications, and (3) neonatal mortality. Generalized linear mixed models adjusting for obstetric gravidity and gestation, American Society of Anesthesiologists (ASA) category, urgency of surgery, maternal comorbidities, fetal distress, and level of anesthesia provider were used. RESULTS: Of 3709 patients, SA was performed in 2968 (80%) and GA in 741 (20%). Preoperative factors independently associated with GA for cesarean delivery were gestational age (adjusted odds ratio [aOR], 1.093; 95% confidence interval [CI], 1.052-1.135), ASA categories III (aOR, 11.84; 95% CI, 2.93-46.31) and IV (aOR, 11.48; 95% CI, 2.93-44.93), eclampsia (aOR, 3.92; 95% CI, 2.18-7.06), placental abruption (aOR, 6.23; 95% CI, 3.36-11.54), and ruptured uterus (aOR, 3.61; 95% CI, 1.36-9.63). SA was administered to 48 of 94 (51.1%) patients with eclampsia, 12 of 28 (42.9%) with cardiac disease, 14 of 19 (73.7%) with preoperative sepsis, 48 of 76 (63.2%) with antepartum hemorrhage, 30 of 55 (54.5%) with placenta previa, 33 of 78 (42.3%) with placental abruption, and 12 of 29 (41.4%) with a ruptured uterus. The composite maternal outcome "all anesthesia complications" was more frequent in GA than SA (9/741 [1.2%] vs 3/2968 [0.1%], P < .001). The unadjusted neonatal mortality was higher with GA than SA (65/662 [9.8%] vs 73/2669 [2.7%], P < .001). The adjusted analyses demonstrated no association between method of anesthesia and (1) intraoperative maternal hypotension and (2) neonatal mortality. CONCLUSIONS: Analysis of patients undergoing anesthesia for cesarean delivery in Africa indicated patients more likely to receive GA. Anesthesia complications and neonatal mortality were more frequent following GA. SA was often administered to high-risk patients, including those with eclampsia or obstetric hemorrhage. Training in the principles of selection of method of anesthesia, and the skills of safe GA and neonatal resuscitation, is recommended.

A randomised controlled trial comparing quality of recovery between desflurane and isoflurane inhalation anaesthesia in patients undergoing ophthalmological surgery at a tertiary hospital in South Africa (DIQoR trial).

Background: The patient's experience of their postoperative recovery is an important perioperative outcome, with the 15-item quality of recovery scale (QoR-15) recommended as a standardised outcomes measure. Desflurane has a faster emergence from anaesthesia compared with other volatile anaesthetics, but it is uncertain whether this translates to better subjective quality of recovery. The hypothesis for this study is that patients receiving desflurane for maintenance of anaesthesia would have better postoperative quality of recovery than patients receiving isoflurane. Methods: Male and female adult patients undergoing ophthalmological surgery under general anaesthesia were randomly allocated to receive desflurane or isoflurane for maintenance of anaesthesia. The primary outcome was to compare postoperative QoR-15 scores. Secondary outcomes included comparing preoperative QoR-15 scores, volatile agent consumption, and time spent in the recovery room. Results: Data from 164 patients were analysed (80 desflurane, 84 isoflurane). Median (Q1, Q3) postoperative QoR-15 scores were not significantly different (desflurane: 145 [141, 148], isoflurane: 144 [139, 147], 95% confidence interval 0-3, P=0.176, minimal clinically important difference=8). Median (Q1, Q3) volatile agent consumption was 15.4 (12.5, 19.3) ml hr-1 in the desflurane group, and 7.4 (5.9, 9.7) ml hr-1 in the isoflurane group. Median (Q1, Q3) time spent in the recovery room was significantly shorter in the desflurane group (desflurane: 18 [13, 23]; isoflurane: 25 [19, 32], 95% confidence interval -10 to 5, P<0.001). Conclusions: This study found no difference in quality of recovery between patients who received desflurane or isoflurane for maintenance of general anaesthesia during ophthalmological surgery. A shorter time in the recovery room was not associated with improved QoR-15 scores. Clinical trial registration: NCT04188314.

Determining the Minimum Dataset for Surgical Patients in Africa: A Delphi Study.

BACKGROUND: It is often difficult for clinicians in African low- and middle-income countries middle-income countries to access useful aggregated data to identify areas for quality improvement. The aim of this Delphi study was to develop a standardised perioperative dataset for use in a registry. METHODS: A Delphi method was followed to achieve consensus on the data points to include in a minimum perioperative dataset. The study consisted of two electronic surveys, followed by an online discussion and a final electronic survey (four Rounds). RESULTS: Forty-one members of the African Perioperative Research Group participated in the process. Forty data points were deemed important and feasible to include in a minimum dataset for electronic capturing during the perioperative workflow by clinicians. A smaller dataset consisting of eight variables to define risk-adjusted perioperative mortality rate was also described. CONCLUSIONS: The minimum perioperative dataset can be used in a collaborative effort to establish a resource accessible to African clinicians in improving quality of care.

Guidelines for Perioperative Care in Elective Abdominal and Pelvic Surgery at Primary and Secondary Hospitals in Low-Middle-Income Countries (LMIC's): Enhanced Recovery After Surgery (ERAS) Society Recommendation.

BACKGROUND: This is the first Enhanced Recovery After Surgery (ERAS®) Society guideline for primary and secondary hospitals in low-middle-income countries (LMIC's) for elective abdominal and gynecologic care. METHODS: The ERAS LMIC Guidelines group was established by the ERAS® Society in collaboration with different representatives of perioperative care from LMIC's. The group consisted of seven members from the ERAS® Society and eight members from LMIC's. An updated systematic literature search and evaluation of evidence from previous ERAS® guidelines was performed by the leading authors of the Colorectal (2018) and Gynecologic (2019) surgery guidelines (Gustafsson et al in World J Surg 43:6592-695, Nelson et al in Int J Gynecol Cancer 29(4):651-668). Meta-analyses randomized controlled trials (RCTs), prospective and retrospective cohort studies from both HIC's and LMIC's were considered for each perioperative item. The members in the LMIC group then applied the current evidence and adapted the recommendations for each intervention as well as identifying possible new items relevant to LMIC's. The Grading of Recommendations, Assessment, Development and Evaluation system (GRADE) methodology was used to determine the quality of the published evidence. The strength of the recommendations was based on importance of the problem, quality of evidence, balance between desirable and undesirable effects, acceptability to key stakeholders, cost of implementation and specifically the feasibility of implementing in LMIC's and determined through discussions and consensus. RESULTS: In addition to previously described ERAS® Society interventions, the following items were included, revised or discussed: the Surgical Safety Checklist (SSC), preoperative routine human immunodeficiency virus (HIV) testing in countries with a high prevalence of HIV/AIDS (CD4 and viral load for those patients that are HIV positive), delirium screening and prevention, COVID 19 screening, VTE prophylaxis, immuno-nutrition, prehabilitation, minimally invasive surgery (MIS) and a standardized postoperative monitoring guideline. CONCLUSIONS: These guidelines are seen as a starting point to address the urgent need to improve perioperative care and to effect data-driven, evidence-based care in LMIC's.

Postoperative Outcomes Associated With Procedural Sedation Conducted by Physician and Nonphysician Anesthesia Providers: Findings From the Prospective, Observational African Surgical Outcomes Study.

BACKGROUND: There is an unmet need for essential surgical services in Africa. Limited anesthesia services are a contributing factor. Nonphysician anesthesia providers are utilized to assist with providing anesthesia and procedural sedation to make essential surgeries available. There is a paucity of data on outcomes following procedural sedation for surgery in Africa. We investigated the postoperative outcomes following procedural sedation by nonphysicians and physicians in Africa. We hypothesized that the level of training of the sedation provider may be associated with the incidence of severe postoperative complications and death. METHODS: A secondary analysis of a prospective cohort of inhospital adult surgical patients representing 25 African countries was performed. The primary outcome was a collapsed composite of inhospital severe postoperative complications and death. We assessed the association between receiving procedural sedation conducted by a nonphysician (versus physician) and the composite outcome using logistic regression. We used the inverse probability of treatment weighting propensity score method to adjust for potential confounding variables including patient age, hemoglobin level, American Society of Anesthesiologists (ASA) physiological status, diabetes mellitus, urgency of surgery, severity of surgery, indication for surgery, surgical discipline, seniority of the surgical team, hospital level of specialization, and hospital funding system using public or private funding. All patients who only received procedural sedation for surgery were included. RESULTS: Three hundred thirty-six patients met the inclusion criteria, of which 98 (29.2%) received sedation from a nonphysician provider. The incidence of severe postoperative complications and death was 10 of 98 (10.2%) in the nonphysician group and 5 of 238 (2.1%) in the physician group. The estimated association between procedural sedation conducted by a nonphysician provider and inhospital outcomes was an 8-fold increase in the odds of severe complications and/or death, with an odds ratio (95% confidence interval [CI]) of 8.3 (2.7-25.6). CONCLUSIONS: The modest number of observations in this secondary data analysis suggests that shifting the task of procedural sedation from physicians to nonphysicians to increase access to care may be associated with severe postoperative complications and death in Africa. Research focusing on identifying factors contributing to adverse outcomes associated with procedural sedation is necessary to make this practice safer.

An Evaluation of Severe Anesthetic-Related Critical Incidents and Risks From the South African Paediatric Surgical Outcomes Study: A 14-Day Prospective, Observational Cohort Study of Pediatric Surgical Patients.

BACKGROUND: Severe anesthetic-related critical incident (SARCI) monitoring is an essential component of safe, quality anesthetic care. Predominantly retrospective data from low- and middle-income countries (LMICs) report higher incidence but similar types of SARCI compared to high-income countries (HIC). The aim of our study was to describe the baseline incidence of SARCI in a middle-income country (MIC) and to identify associated risk for SARCI. We hypothesized a higher incidence but similar types of SARCI and risks compared to HICs. METHODS: We performed a 14-day, prospective multicenter observational cohort study of pediatric patients (aged <16 years) undergoing surgery in government-funded hospitals in South Africa, a MIC, to determine perioperative outcomes. This analysis described the incidence and types of SARCI and associated perioperative cardiac arrests (POCAs). We used multivariable logistic regression analysis to identify risk factors independently associated with SARCI, including 7 a priori variables and additional candidate variables based on their univariable performance. RESULTS: Two thousand and twenty-four patients were recruited from May 22 to August 22, 2017, at 43 hospitals. The mean age was 5.9 years (±standard deviation 4.2). A majority of patients during this 14-day period were American Society of Anesthesiologists (ASA) physical status I (66.4%) or presenting for minor surgery (54.9%). A specialist anesthesiologist managed 59% of cases. These patients were found to be significantly younger (P < .001) and had higher ASA physical status (P < .001). A total of 426 SARCI was documented in 322 of 2024 patients, an overall incidence of 15.9% (95% confidence interval [CI], 14.4-17.6). The most common event was respiratory (214 of 426; 50.2%) with an incidence of 8.5% (95% CI, 7.4-9.8). Six children (0.3%; 95% CI, 0.1-0.6) had a POCA, of whom 4 died in hospital. Risks independently associated with a SARCI were age (adjusted odds ratio [aOR] = 0.95; CI, 0.92-0.98; P = .004), increasing ASA physical status (aOR = 1.85, 1,74, and 2.73 for ASA II, ASA III, and ASA IV-V physical status, respectively), urgent/emergent surgery (aOR = 1.35, 95% CI, 1.02-1.78; P = .036), preoperative respiratory infection (aOR = 2.47, 95% CI, 1.64-3.73; P < .001), chronic respiratory comorbidity (aOR = 1.75, 95% CI, 1.10-2.79; P = .018), severity of surgery (intermediate surgery aOR = 1.84, 95% CI, 1.39-2.45; P < .001), and level of hospital (first-level hospitals aOR = 2.81, 95% CI, 1.60-4.93; P < .001). CONCLUSIONS: The incidence of SARCI in South Africa was 3 times greater than in HICs, and an associated POCA was 10 times more common. The risk factors associated with SARCI may assist with targeted interventions to improve safety and to triage children to the optimal level of care.

Development of a Clinical Prediction Model for In-hospital Mortality from the South African Cohort of the African Surgical Outcomes Study.

BACKGROUND: Data on the factors that influence mortality after surgery in South Africa are scarce, and neither these data nor data on risk-adjusted in-hospital mortality after surgery are routinely collected. Predictors related to the context or setting of surgical care delivery may also provide insight into variation in practice. Variation must be addressed when planning for improvement of risk-adjusted outcomes. Our objective was to identify the factors predicting in-hospital mortality after surgery in South Africa from available data. METHODS: A multivariable logistic regression model was developed to identify predictors of 30-day in-hospital mortality in surgical patients in South Africa. Data from the South African contribution to the African Surgical Outcomes Study were used and included 3800 cases from 51 hospitals. A forward stepwise regression technique was then employed to select for possible predictors prior to model specification. Model performance was evaluated by assessing calibration and discrimination. The South African Surgical Outcomes Study cohort was used to validate the model. RESULTS: Variables found to predict 30-day in-hospital mortality were age, American Society of Anesthesiologists Physical Status category, urgent or emergent surgery, major surgery, and gastrointestinal-, head and neck-, thoracic- and neurosurgery. The area under the receiver operating curve or c-statistic was 0.859 (95% confidence interval: 0.827-0.892) for the full model. Calibration, as assessed using a calibration plot, was acceptable. Performance was similar in the validation cohort as compared to the derivation cohort. CONCLUSION: The prediction model did not include factors that can explain how the context of care influences post-operative mortality in South Africa. It does, however, provide a basis for reporting risk-adjusted perioperative mortality rate in the future, and identifies the types of surgery to be prioritised in quality improvement projects at a local or national level.

Maternal and neonatal outcomes after caesarean delivery in the African Surgical Outcomes Study: a 7-day prospective observational cohort study.

BACKGROUND: Maternal and neonatal mortality is high in Africa, but few large, prospective studies have been done to investigate the risk factors associated with these poor maternal and neonatal outcomes. METHODS: A 7-day, international, prospective, observational cohort study was done in patients having caesarean delivery in 183 hospitals across 22 countries in Africa. The inclusion criteria were all consecutive patients (aged ≥18 years) admitted to participating centres having elective and non-elective caesarean delivery during the 7-day study cohort period. To ensure a representative sample, each hospital had to provide data for 90% of the eligible patients during the recruitment week. The primary outcome was in-hospital maternal mortality and complications, which were assessed by local investigators. The study was registered on the South African National Health Research Database, number KZ_2015RP7_22, and on ClinicalTrials.gov, number NCT03044899. FINDINGS: Between February, 2016, and May, 2016, 3792 patients were recruited from hospitals across Africa. 3685 were included in the postoperative complications analysis (107 missing data) and 3684 were included in the maternal mortality analysis (108 missing data). These hospitals had a combined number of specialist surgeons, obstetricians, and anaesthetists totalling 0·7 per 100 000 population (IQR 0·2-2·0). Maternal mortality was 20 (0·5%) of 3684 patients (95% CI 0·3-0·8). Complications occurred in 633 (17·4%) of 3636 mothers (16·2-18·6), which were predominantly severe intraoperative and postoperative bleeding (136 [3·8%] of 3612 mothers). Maternal mortality was independently associated with a preoperative presentation of placenta praevia, placental abruption, ruptured uterus, antepartum haemorrhage (odds ratio 4·47 [95% CI 1·46-13·65]), and perioperative severe obstetric haemorrhage (5·87 [1·99-17·34]) or anaesthesia complications (11·47 (1·20-109·20]). Neonatal mortality was 153 (4·4%) of 3506 infants (95% CI 3·7-5·0). INTERPRETATION: Maternal mortality after caesarean delivery in Africa is 50 times higher than that of high-income countries and is driven by peripartum haemorrhage and anaesthesia complications. Neonatal mortality is double the global average. Early identification and appropriate management of mothers at risk of peripartum haemorrhage might improve maternal and neonatal outcomes in Africa. FUNDING: Medical Research Council of South Africa.

Perioperative patient outcomes in the African Surgical Outcomes Study: a 7-day prospective observational cohort study.

BACKGROUND: There is a need to increase access to surgical treatments in African countries, but perioperative complications represent a major global health-care burden. There are few studies describing surgical outcomes in Africa. METHODS: We did a 7-day, international, prospective, observational cohort study of patients aged 18 years and older undergoing any inpatient surgery in 25 countries in Africa (the African Surgical Outcomes Study). We aimed to recruit as many hospitals as possible using a convenience sampling survey, and required data from at least ten hospitals per country (or half the surgical centres if there were fewer than ten hospitals) and data for at least 90% of eligible patients from each site. Each country selected one recruitment week between February and May, 2016. The primary outcome was in-hospital postoperative complications, assessed according to predefined criteria and graded as mild, moderate, or severe. Data were presented as median (IQR), mean (SD), or n (%), and compared using t tests. This study is registered on the South African National Health Research Database (KZ_2015RP7_22) and ClinicalTrials.gov (NCT03044899). FINDINGS: We recruited 11 422 patients (median 29 [IQR 10-70]) from 247 hospitals during the national cohort weeks. Hospitals served a median population of 810 000 people (IQR 200 000-2 000 000), with a combined number of specialist surgeons, obstetricians, and anaesthetists totalling 0·7 (0·2-1·9) per 100 000 population. Hospitals did a median of 212 (IQR 65-578) surgical procedures per 100 000 population each year. Patients were younger (mean age 38·5 years [SD 16·1]), with a lower risk profile (American Society of Anesthesiologists median score 1 [IQR 1-2]) than reported in high-income countries. 1253 (11%) patients were infected with HIV, 6504 procedures (57%) were urgent or emergent, and the most common procedure was caesarean delivery (3792 patients, 33%). Postoperative complications occurred in 1977 (18·2%, 95% CI 17·4-18·9]) of 10 885 patients. 239 (2·1%) of 11 193 patients died, 225 (94·1%) after the day of surgery. Infection was the most common complication (1156 [10·2%] of 10 970 patients), of whom 112 (9·7%) died. INTERPRETATION: Despite a low-risk profile and few postoperative complications, patients in Africa were twice as likely to die after surgery when compared with the global average for postoperative deaths. Initiatives to increase access to surgical treatments in Africa therefore should be coupled with improved surveillance for deteriorating physiology in patients who develop postoperative complications, and the resources necessary to achieve this objective. FUNDING: Medical Research Council of South Africa.

Critical care admission of South African (SA) surgical patients: Results of the SA Surgical Outcomes Study.

BACKGROUND: Appropriate critical care admissions are an important component of surgical care. However, there are few data describing postoperative critical care admission in resource-limited low- and middle-income countries. OBJECTIVE: To describe the demographics, organ failures, organ support and outcomes of non-cardiac surgical patients admitted to critical care units in South Africa (SA). METHODS: The SA Surgical Outcomes Study (SASOS) was a 7-day national, multicentre, prospective, observational cohort study of all patients ≥16 years of age undergoing inpatient non-cardiac surgery between 19 and 26 May 2014 at 50 government-funded hospitals. All patients admitted to critical care units during this study were included for analysis. RESULTS: Of the 3 927 SASOS patients, 255 (6.5%) were admitted to critical care units; of these admissions, 144 (56.5%) were planned, and 111 (43.5%) unplanned. The incidence of confirmed or strongly suspected infection at the time of admission was 35.4%, with a significantly higher incidence in unplanned admissions (49.1 v. 24.8%, p<0.001). Unplanned admission cases were more frequently hypovolaemic, had septic shock, and required significantly more inotropic, ventilatory and renal support in the first 48 hours after admission. Overall mortality was 22.4%, with unplanned admissions having a significantly longer critical care length of stay and overall mortality (33.3 v. 13.9%, p<0.001). CONCLUSION: The outcome of patients admitted to public sector critical care units in SA is strongly associated with unplanned admissions. Adequate 'high care-dependency units' for postoperative care of elective surgical patients could potentially decrease the burden on critical care resources in SA by 23%. This study was registered on ClinicalTrials.gov (NCT02141867).

National priorities for perioperative research in South Africa.

BACKGROUND: Perioperative research is currently unco-ordinated in South Africa (SA), with no clear research agenda. OBJECTIVE: To determine the top ten national research priorities for perioperative research in SA. METHODS: A Delphi technique was used to establish consensus on the top ten research priorities. RESULTS: The top ten research priorities were as follows: (i) establishment of a national database of (a) critical care outcomes, and (b) critical care resources; (ii) a randomised controlled trial of preoperative B-type natriuretic peptide-guided medical therapy to decrease major adverse cardiac events following non-cardiac surgery; (iii) a national prospective observational study of the outcomes associated with paediatric surgical cases; (iv) a national observational study of maternal and fetal outcomes following operative delivery in SA; (v) a stepped-wedge trial of an enhanced recovery after surgery programme for (a) surgery, (b) obstetrics, (c) emergency surgery, and (d) trauma surgery; (vi) a stepped-wedge trial of a surgical safety checklist on patient outcomes in SA; (vii) a prospective observational study of perioperative outcomes after surgery in district general hospitals in SA; (viii) short-course interventions to improve anaesthetic skills in rural doctors; (ix) studies of the efficacy of simulation training to improve (a) patient outcomes, (b) team dynamics, and (c) leadership; and (x) development and validation of a risk stratification tool for SA surgery based on the South African Surgical Outcomes Study (SASOS) data. CONCLUSIONS: These research priorities provide the structure for an intermediate-term research agenda.