South African cardiovascular risk stratification guideline for non-cardiac surgery.

Executive summary The South African (SA) guidelines for cardiac patients for non-cardiac surgery were developed to address the need for cardiac risk assessment and risk stratification for elective non-cardiac surgical patients in SA, and more broadly in Africa.The guidelines were developed by updating the Canadian Cardiovascular Society Guidelines on Perioperative Cardiac Risk Assessment and Management for Patients Who Undergo Non-cardiac Surgery, with a search of literature from African countries and recent publications. The updated proposed guidelines were then evaluated in a Delphi consensus process by SA anaesthesia and vascular surgical experts. The recommendations in these guidelines are:1. We suggest that elective non-cardiac surgical patients who are 45 years and older with either a history of coronary artery disease, congestive cardiac failure, stroke or transient ischaemic attack, or vascular surgical patients 18 years or older with peripheral vascular disease require further preoperative risk stratification as their predicted 30-day major adverse cardiac event (MACE) risk exceeds 5% (conditional recommendation: moderate-quality evidence).2. We do not recommend routine non-invasive testing for cardiovascular risk stratification prior to elective non-cardiac surgery in adults (strong recommendation: low-to-moderate-quality evidence).3. We recommend that elective non-cardiac surgical patients who are 45 years and older with a history of coronary artery disease, or stroke or transient ischaemic attack, or congestive cardiac failure or vascular surgical patients 18 years or older with peripheral vascular disease should have preoperative natriuretic peptide (NP) screening (strong recommendation: high-quality evidence).4. We recommend daily postoperative troponin measurements for 48 - 72 hours for non-cardiac surgical patients who are 45 years and older with a history of coronary artery disease, or stroke or transient ischaemic attack, or congestive cardiac failure or vascular surgical patients 18 years or older with peripheral vascular disease, i.e. (i) a baseline risk >5% for MACE 30 days after elective surgery (if no preoperative NP screening), or (ii) an elevated B-type natriuretic peptide (BNP)/N-terminal-prohormone B-type natriuretic peptide (NT-proBNP) measurement before elective surgery (defined as BNP >99 pg/mL or a NT-proBNP >300 pg/mL) (conditional recommendation: moderate-quality evidence).Additional recommendations are given for the management of myocardial injury after non-cardiac surgery (MINS) and medications for comorbidities.

Towards the quantification of perioperative cardiovascular risk in the African context: A sub-analysis of the South African Surgical Outcomes Study and the African Surgical Outcomes Study.

BACKGROUND: The burden of cardiovascular disease in patients requiring non-cardiac surgery in Africa is not known. These patients are at increased risk for postoperative cardiovascular complications. OBJECTIVES: In this sub-study, to use data on comorbidities and surgical outcomes from two large observational studies, the South African Surgical Outcomes Study (SASOS) and the African Surgical Outcomes Study (ASOS), to investigate the prevalence of cardiovascular disease in elective surgical patients and the risk of postoperative cardiovascular complications in this population. METHODS: SASOS and ASOS were both prospective, observational cohort studies that collected data over 1 week in each participating centre. The primary outcome was in-hospital postoperative complications, which included prespecified and defined cardiovascular complications. We defined the cardiovascular disease burden of patients aged ≥45 years presenting for surgery (main objective), determined the relative risk of developing postoperative cardiovascular complications (secondary objective) and assessed the utility of the Revised Cardiac Risk Index (RCRI) for preoperative cardiovascular risk stratification of elective, non-cardiac surgical patients in Africa (third objective). RESULTS: The primary outcome analysis of 3 045 patients showed that patients with major cardiac complications were significantly older, with a higher prevalence of hypertension, coronary artery disease or congestive cardiac failure, and had undergone major surgery. In-hospital mortality for the cohort was 1.2%. CONCLUSIONS: The substantial burden of cardiovascular disease in patients presenting for non-cardiac surgery in Africa is shown in the principal findings of this study. The RCRI has moderate discrimination for major cardiac complications and major adverse cardiac events in African patients undergoing non-cardiac surgery.

Establishing a South African national framework for COVID-19 surgical prioritisation.

BACKGROUND: Since the start of the COVID-19 pandemic, surgical operations have been drastically reduced in South Africa (SA). Guidelines on surgical prioritisation during COVID-19 have been published, but are specific to high-income countries. There is a pressing need for context-specific guidelines and a validated tool for prioritising surgical cases during the COVID-19 pandemic. In March 2020, the South African National Surgical Obstetric Anaesthesia Plan Task Team was asked by the National Department of Health to establish a national framework for COVID-19 surgical prioritisation. OBJECTIVES: To develop a national framework for COVID-19 surgical prioritisation, including a set of recommendations and a risk calculatorfor operative care. METHODS: The surgical prioritisation framework was developed in three stages: (i) a literature review of international, national and local recommendations on COVID-19 and surgical care was conducted; (ii) a set of recommendations was drawn up based on the available literature and through consensus of the COVID-19 Task Team; and (iii) a COVID-19 surgical risk calculator was developed and evaluated. RESULTS: A total of 30 documents were identified from which recommendations around prioritisation of surgical care were used to draw up six recommendations for preoperative COVID-19 screening and testing as well as the use of appropriate personal protective equipment. Ninety-nine perioperative practitioners from eight SA provinces evaluated the COVID-19 surgical risk calculator, which had high acceptability and a high level of concordance (81%) with current clinical practice. CONCLUSIONS: This national framework on COVID-19 surgical prioritisation can help hospital teams make ethical, equitable and personalised decisions whether to proceed with or delay surgical operations during this unprecedented epidemic.

Factors associated with mortality in patients with COVID-19 admitted to intensive care: a systematic review and meta-analysis.

Identification of high-risk patients admitted to intensive care with COVID-19 may inform management strategies. The objective of this meta-analysis was to determine factors associated with mortality among adults with COVID-19 admitted to intensive care by searching databases for studies published between 1 January 2020 and 6 December 2020. Observational studies of COVID-19 adults admitted to critical care were included. Studies of mixed cohorts and intensive care cohorts restricted to a specific patient sub-group were excluded. Dichotomous variables were reported with pooled OR and 95%CI, and continuous variables with pooled standardised mean difference (SMD) and 95%CI. Fifty-eight studies (44,305 patients) were included in the review. Increasing age (SMD 0.65, 95%CI 0.53-0.77); smoking (OR 1.40, 95%CI 1.03-1.90); hypertension (OR 1.54, 95%CI 1.29-1.85); diabetes (OR 1.41, 95%CI 1.22-1.63); cardiovascular disease (OR 1.91, 95%CI 1.52-2.38); respiratory disease (OR 1.75, 95%CI 1.33-2.31); renal disease (OR 2.39, 95%CI 1.68-3.40); and malignancy (OR 1.81, 95%CI 1.30-2.52) were associated with mortality. A higher sequential organ failure assessment score (SMD 0.86, 95%CI 0.63-1.10) and acute physiology and chronic health evaluation-2 score (SMD 0.89, 95%CI 0.65-1.13); a lower PaO2 :FI O2 (SMD -0.44, 95%CI -0.62 to -0.26) and the need for mechanical ventilation at admission (OR 2.53, 95%CI 1.90-3.37) were associated with mortality. Higher white cell counts (SMD 0.37, 95%CI 0.22-0.51); neutrophils (SMD 0.42, 95%CI 0.19-0.64); D-dimers (SMD 0.56, 95%CI 0.43-0.69); ferritin (SMD 0.32, 95%CI 0.19-0.45); lower platelet (SMD -0.22, 95%CI -0.35 to -0.10); and lymphocyte counts (SMD -0.37, 95%CI -0.54 to -0.19) were all associated with mortality. In conclusion, increasing age, pre-existing comorbidities, severity of illness based on validated scoring systems, and the host response to the disease were associated with mortality; while male sex and increasing BMI were not. These factors have prognostic relevance for patients admitted to intensive care with COVID-19.

A prospective observational study of preoperative natriuretic peptide testing in adult non-cardiac surgical patients in hospitals in Western Cape Province, South Africa.

BACKGROUND: International guidelines recommend risk stratification to identify high-risk non-cardiac surgical patients. It is also recommended that all patients aged ≥45 years with significant cardiovascular disease should have preoperative natriuretic peptide (NP) testing. Abnormal preoperative B-type NPs have a strong association with postoperative cardiac complications. In South African hospitals, it is not known how many patients with significant cardiovascular disease scheduled for intermediate- to high-risk surgery will have raised NPs. OBJECTIVES: To determine the prevalence of abnormal (raised) NPs in non-cardiac surgical patients with cardiac clinical risk factors. A secondary objective was to develop a model to identify surgical patients who may benefit from preoperative NP screening. METHODS: The inclusion criteria were patients aged ≥45 years presenting for elective, non-obstetric, intermediate- to high-risk non-cardiac surgery with at least one of the following cardiovascular risk factors: a history of ischaemic heart disease or peripheral vascular disease (coronary equivalent); a history of stroke or transient ischaemic attack; a history of congestive cardiac failure; diabetes mellitus currently on an oral hypoglycaemic agent or insulin; and serum creatinine level >175 µmol/L (>2.0 mg/dL). Blood samples for N-terminal-prohormone B-type NP (NT-proBNP) were collected before induction of anaesthesia. The preoperative prognostic threshold for abnormal (raised) NT-proBNP was ≥300 pg/mL. A generalised linear mixed model was used to determine the association between the risk factors and an abnormal NT-proBNP level. RESULTS: Of 172 patients, 63 (37%) had an elevated preoperative NT-proBNP level. The comorbidities independently associated with elevated preoperative NT-proBNP were coronary artery disease or peripheral vascular disease, congestive cardiac failure, and a creatinine level >175 µmol/L CONCLUSIONS: We strongly recommend that non-cardiac surgical patients aged ≥45 years undergoing intermediate- or high-risk noncardiac surgery with a history of coronary artery disease/peripheral vascular disease, congestive cardiac failure or elevated creatinine have preoperative NP testing as part of risk stratification.

A prospective study of paediatric preoperative fasting times at Red Cross War Memorial Children's Hospital, Cape Town, South Africa.

BACKGROUND: Fasting for liquids and solids is recommended prior to procedures requiring anaesthesia, to reduce the risk of pulmonary aspiration. Children often experience excessive fasting, which is associated with negative physiological and behavioural consequences, and patient discomfort. The duration of preoperative fasting in children in South Africa (SA) is unknown. OBJECTIVES: To determine compliance with fasting guidelines and fasting times of children prior to elective procedures performed under anaesthesia at a paediatric hospital in Cape Town, SA. The primary focus was fasting for clear liquid. We also intended to identify the most common reasons for prolonged clear liquid fasting. METHODS: Over a 7-week period, we prospectively captured fasting times of consecutive patients undergoing elective surgical, medical and radiological procedures at Red Cross War Memorial Children's Hospital. Measurement outcomes were defined as the period from the last clear liquid, milk or solid feed to the start of anaesthesia. For analysis of compliance with preoperative fasting guidelines, institutional preoperative fasting target limits were established based on the standard 6-4-2-hour guideline. RESULTS: The study included 721 elective paediatric cases. The mean (standard deviation (SD)) fasting time for clear liquids (n=585) was 8.0 (4.8) hours, with an adherence rate of 25.5% (95% confidence interval 22 - 29) to the institutional target of 2 - 4 hours. The mean (SD) fasting times for breastmilk (n=92), formula milk (n=116) and solid feeds (n=560) were 7.1 (2.8), 8.8 (2.8) and 13.9 (3.6) hours, respectively. The factors associated with clear liquid fasting >4 hours were inadequate fasting instructions, poor adherence to fasting orders, procedural delays and fasting to promote theatre flexibility. CONCLUSIONS: This study demonstrates that children in an SA hospital experience excessive fasting times prior to elective procedures. To reduce fasting durations and improve the quality of perioperative care, quality improvement interventions are required to create an adaptable fasting system that allows individualised fasting. Improving preoperative fasting times in children is the responsibility of all healthcare professionals in the multidisciplinary management team.

Risks to healthcare workers following tracheal intubation of patients with COVID-19: a prospective international multicentre cohort study.

Healthcare workers involved in aerosol-generating procedures, such as tracheal intubation, may be at elevated risk of acquiring COVID-19. However, the magnitude of this risk is unknown. We conducted a prospective international multicentre cohort study recruiting healthcare workers participating in tracheal intubation of patients with suspected or confirmed COVID-19. Information on tracheal intubation episodes, personal protective equipment use and subsequent provider health status was collected via self-reporting. The primary endpoint was the incidence of laboratory-confirmed COVID-19 diagnosis or new symptoms requiring self-isolation or hospitalisation after a tracheal intubation episode. Cox regression analysis examined associations between the primary endpoint and healthcare worker characteristics, procedure-related factors and personal protective equipment use. Between 23 March and 2 June 2020, 1718 healthcare workers from 503 hospitals in 17 countries reported 5148 tracheal intubation episodes. The overall incidence of the primary endpoint was 10.7% over a median (IQR [range]) follow-up of 32 (18-48 [0-116]) days. The cumulative incidence within 7, 14 and 21 days of the first tracheal intubation episode was 3.6%, 6.1% and 8.5%, respectively. The risk of the primary endpoint varied by country and was higher in women, but was not associated with other factors. Around 1 in 10 healthcare workers involved in tracheal intubation of patients with suspected or confirmed COVID-19 subsequently reported a COVID-19 outcome. This has human resource implications for institutional capacity to deliver essential healthcare services, and wider societal implications for COVID-19 transmission.

Towards high-quality peri-operative care: a global perspective.

Article 25 of the United Nations' Universal Declaration of Human Rights enshrines the right to health and well-being for every individual. However, universal access to high-quality healthcare remains the purview of a handful of wealthy nations. This is no more apparent than in peri-operative care, where an estimated five billion individuals lack access to safe, affordable and timely surgical care. Delivery of surgery and anaesthesia in low-resource environments presents unique challenges that, when unaddressed, result in limited access to low-quality care. Current peri-operative research and clinical guidance often fail to acknowledge these system-level deficits and therefore have limited applicability in low-resource settings. In this manuscript, the authors priority-set the need for equitable access to high-quality peri-operative care and analyse the system-level contributors to excess peri-operative mortality rates, a key marker of quality of care. To provide examples of how research and investment may close the equity gap, a modified Delphi method was adopted to curate and appraise interventions which may, with subsequent research and evaluation, begin to address the barriers to high-quality peri-operative care in low- and middle-income countries.

Priorities for peri-operative research in Africa.

Deaths following surgery are the third largest contributor to deaths globally, and in Africa are twice the global average. There is a need for a peri-operative research agenda to ensure co-ordinated, collaborative research efforts across Africa in order to decrease peri-operative mortality. The objective was to determine the top 10 research priorities for peri-operative research in Africa. A Delphi technique was used to establish consensus on the top research priorities. The top 10 research priorities identified were (1) Develop training standards for peri-operative healthcare providers (surgical, anaesthesia and nursing) in Africa; (2) Develop minimum provision of care standards for peri-operative healthcare providers (surgical, anaesthesia and nursing) in Africa; (3) Early identification and management of mothers at risk from peripartum haemorrhage in the peri-operative period; (4) The role of communication and teamwork between surgical, anaesthetic, nursing and other teams involved in peri-operative care; (5) A facility audit/African World Health Organization situational analysis tool audit to assess emergency and essential surgical care, which includes anaesthetic equipment available and level of training and knowledge of peri-operative healthcare providers (surgeons, anaesthetists and nurses); (6) Establishing evidence-based practice guidelines for peri-operative physicians in Africa; (7) Economic analysis of strategies to finance access to surgery in Africa; (8) Establishment of a minimum dataset surgical registry; (9) A quality improvement programme to improve implementation of the surgical safety checklist; and (10) Peri-operative outcomes associated with emergency surgery. These peri-operative research priorities provide the structure for an intermediate-term research agenda to improve peri-operative outcomes across Africa.

A multicentre cross-sectional descriptive study evaluating the cardiovascular risk profile of preoperatively identified patients with hypertension.

BACKGROUND: The prevalence of hypertension in adults in South Africa (SA) is 35%. Hypertension is the most important modifiable risk factor for cardiovascular (CV) and chronic kidney disease (CKD) in sub-Saharan Africa. However, 49% of people are unaware of their blood pressure status. Screening for hypertension prior to surgery provides a unique opportunity to diagnose and treat affected individuals. Furthermore, assessing overall CV risk identifies patients at highest risk for complications, and improves the utilisation of scarce resources. OBJECTIVES: To evaluate the CV risk profile of hypertensive patients in the adult population of the Western Cape Province presenting for elective non-cardiac, non-obstetric surgery. METHODS: This report documents the CV risk profile of patients recruited to the HASS-2 study (Hypertension and Surgery Study 2), which was undertaken in seven Western Cape hospitals. Patients were screened for hypertension and pharmacological treatment was initiated or adjusted in patients with stages 1 and 2 disease. Stage 3 patients were referred to a physician. In the present substudy, patients with stages 1 and 2 hypertension were assessed for associated CV risk factors, the presence of target organ damage, and documented CV or kidney disease; they received an overall risk stratification according to the 2018 European Society of Cardiology and the European Society of Hypertension Guidelines. RESULTS: Sixty-one patients with stage 1 and 12 with stage 2 hypertension were analysed. Established CV disease was present in 13.7% of the study population, and CKD (eGFR <60 mL/min) in 10.8%. Seventy-one percent of the study group had a raised body mass index, and 55.9% underlying metabolic syndrome. Prediabetes and diabetes were present in 16.1% and 14.5%, respectively. According to the 2018 European guidelines, 34.7% were at moderate, 33.3% at high and 16.7% at very high risk for a CV event in the following 10 years. CONCLUSIONS: The perioperative period is a critical time during which surgeons, nurses and anaesthetists can influence patients' CV risk of adverse events. This involves appropriate screening, education and treatment. In this study population, nearly 9 out of 10 elective surgical patients with stage 1 or 2 hypertension had CV risk factors placing them at moderate to very high risk. The simultaneous assessment of these additional CV risk parameters, in addition to diagnosis and management of hypertension, may further decrease the health and financial burden in resource-limited facilities in SA, and improve CV outcomes.

Risk factors and interventions associated with mortality or survival in adult COVID-19 patients admitted to critical care: a systematic review and meta-analysis

Patients with confirmed COVID-19 admitted to intensive care units have a high mortality rate, which appears to be associated with increasing age, male sex, smoking history, hypertension and diabetes mellitus. Methods: A systematic review to determine risk factors and interventions associated with mortality/survival in adult patients admitted to an intensive care unit (ICU) with confirmed COVID-19/SARS-CoV-2 infection. The protocol was registered with PROSPERO (CRD42020181185).Results: The search identified 483 abstracts between 1 January and 7 April 2020, of which nine studies were included in the final review. Only one study was of low bias. Advanced age (odds ratio [OR] 11.99, 95% confidence interval [CI] 5.35­18.62) and a history of hypertension were associated with mortality (OR 4.17, 95% CI 2.90­5.99). Sex was not associated with mortality. There was insufficient data to assess the association between other comorbidities, laboratory results or critical care risk indices and mortality.The critical care interventions of mechanical ventilation (OR 6.25, 95% CI 0.75­51.93), prone positioning during ventilation (OR 2.06, 95% CI 0.20­21.72), and extracorporeal membrane oxygenation (ECMO) (OR 8.00, 95% CI 0.69, 92.33) were not associated with mortality. The sample size was insufficient to conclusively determine the association between these interventions and ICUmortality. The need for inotropes or vasopressors was associated with mortality (OR 6.36, 95% CI 1.89­21.36). Conclusion: The studies provided little granular data to inform risk stratification or prognostication of patients requiring intensive

A multicentre prospective observational study of the prevalence of preoperative anaemia and iron deficiency in adult elective surgical patients in hospitals in Western Cape Province, South Africa.

BACKGROUND: Preoperative anaemia has been shown to be an independent risk factor for postoperative morbidity and mortality. Iron deficiency is the leading cause of anaemia globally. There are limited data describing the burden of perioperative anaemia and the relative contribution of iron deficiency in South Africa (SA). OBJECTIVES: To determine the prevalence and severity of preoperative anaemia in adults presenting for elective surgery in Western Cape Province, SA, and to investigate the contribution of iron deficiency as a cause of the anaemia. For this purpose, an investigative protocol from a recent consensus statement on the management of perioperative anaemia was applied. METHODS: We performed a prospective, observational study in adult patients presenting for elective non-cardiac, non-obstetric surgery over a 5-day period at six Western Cape government-funded hospitals. The World Health Organization patient classification was applied, and patients with anaemia were investigated for iron deficiency. RESULTS: The prevalence of preoperative anaemia was 28% (105/375; 95% confidence interval (CI) 23.5 - 32.5); 55/105 patients (52%) had moderate and 11/105 (11%) severe anaemia. Iron deficiency was the cause of anaemia in 37% (32/87; 95% CI 26.6 - 46.9), but only 9% of iron-deficient patients received iron supplementation prior to surgery. CONCLUSIONS: Preoperative anaemia was common in this study, and more than half of the affected patients had moderate to severe anaemia. Iron deficiency was responsible for almost 40% of cases. Iron supplementation was under-utilised in the preoperative period as a means of increasing haemoglobin. The introduction of system-wide policies would empower perioperative physicians to mitigate the risk associated with preoperative anaemia in the Western Cape.

A multicentre prospective observational study of the prevalence and glycaemic control of diabetes mellitus in adult non-cardiac elective surgical patients in hospitals in Western Cape Province, South Africa.

BACKGROUND: Diabetes mellitus (DM) is a common condition. The high burden of undiagnosed DM and a lack of large population studies make accurate prevalence estimations difficult, especially in the surgical environment. Furthermore, poorly controlled DM is associated with an increased risk of perioperative complications and mortality. OBJECTIVES: The primary objective was to establish the prevalence of DM in elective adult non-cardiac, non-obstetric surgical patients in hospitals in Western Cape Province, South Africa. The secondary objectives were to assess the glycaemic control and compliance with treatment of known diabetics. METHODS: A 5-day multicentre, prospective observational study was performed at six government-funded hospitals in the Western Cape. Screening for DM was done using finger-prick capillary blood glucose (CBG) testing. Patients found to have a CBG ≥6.5 mmol/L had their glycated haemoglobin (HbA1c) level measured. DM was diagnosed based on the Society for Endocrinology, Metabolism and Diabetes of South Africa (SEMDSA) diagnostic criteria. Patients known to have DM had their HbA1cmeasured and completed a Morisky Medication Adherence Scale (MMAS-4) questionnaire to assess glycaemic control and compliance with treatment. RESULTS: Of the 379 participants, 61 were known diabetics (16.2%; 95% confidence interval (CI) 12.4 - 19.8). After exclusion of 8 patients with incomplete results, a new diagnosis of DM was made in 5/310 patients (1.6%; 95% CI 0.2 - 3.0). The overall prevalence of DM was 17.8% (66/371; 95% CI 13.9 - 21.7). HbA1c results were available for 57 (93.4%) of the 61 known diabetics. Of these, 27 (47.4%; 95% CI 34.4 - 60.3) had an HbA1c level ≥8.5% and 14 (24.6%; 95% CI 13.4 - 35.8) had a level ≤7%. Based on positive responses to two or more questions on the MMAS-4 questionnaire, 12/60 participants (20.0%) were deemed non-compliant. CONCLUSIONS: There is a low rate of undiagnosed DM in our elective surgical population, but in a high proportion of patients with DM the condition is poorly controlled. Poorly controlled DM is known to increase postoperative complications and is likely to increase the burden of perioperative care. Resources should be focused on improvement of long-term glycaemic control in patients presenting for elective surgery.

The developing world of pre-operative optimisation: a systematic review of Cochrane reviews.

Pre-operative optimisation is a heterogenous group of interventions aimed at improving peri-operative outcomes. To understand the evidence for pre-operative optimisation in the developing world, we systematically reviewed Cochrane reviews on the topic according to the Human Developmental Index (HDI) of the country where patient recruitment occurred. We used summary statistics and cartograms to describe the HDI, year of publication, timing of pre-operative intervention and risk of bias associated with each included trial. We assessed the impact of multinational trials on the risk of bias introduced by countries of differing HDI. Four-hundred and nine trials representing 51 countries and 89,389 randomly allocated participants were summarised in this review. Four-hundred and nineteen out of 451 (93%) trial populations (i.e. a group of study participants from one country) were from high and very high HDI countries. The median (IQR [range]) HDI of countries were 0.862 (0.806-0.892 [0.445-0.949]). Three of the 409 included trials were multinational, representing 32 countries and 37,736 out of 89,389 (42.2%) included participants. Africa was the least represented continent, with only 4 included trials and 566 participants, of which 62.3% were from one multinational trial. The overall risk of bias was high or unclear in 381 out of 409 (93%) trials. Inclusion of multinational trials decreased the proportion of trial populations introducing high or unclear risk of bias by 9.4% (95%CI 5.1-13.7; p < 0.0001). Half of the world's population live in low- and middle-HDI countries. This population is poorly represented in systematically reviewed evidence on pre-operative optimisation. Multinational trials increase the knowledge contribution from low- and middle-HDI countries and decrease risk of bias in systematic reviews.

The African Surgical OutcomeS-2 (ASOS-2) Pilot Trial, a mixed-methods implementation study

Background: The African Surgical Outcomes Study (ASOS) showed that surgical patients in Africa have a mortality twice the global average. The working hypothesis is that patients die as a result of failure to rescue following complications in the postoperative period. The African Surgical OutcomeS-2 (ASOS-2) Trial plans to test the efficacy of increased postoperative surveillance in high risk patients for decreasing perioperative morbidity and mortality. This pilot trial aimed i) to evaluate the adequacy of data produced by the data collection strategies of the ASOS-2 Trial, ii) to evaluate the fidelity of implementation of the increased postoperative surveillance intervention, and iii) to understand the acceptability, appropriateness and feasibility of the intervention and the trial processes. Methods: The ASOS-2 Pilot Trial was a mixed-methods (quantitative-qualitative) implementation study focusing on the intervention arm of the proposed ASOS-2 Trial. The intervention is increased postoperative surveillance for high-risk surgical patients. The intervention protocol was implemented at all sites for a seven-day period. A post pilot trial survey was used to collect data on the implementation outcomes. Results: 803 patients were recruited from 16 hospitals in eight African countries. The sampling and data collection strategies provided 98% complete data collection. Seventy-three percent of respondents believed that they truly provided increased postoperative surveillance to high risk patients. In reality 83/125 (66%) of high-risk patients received some form of increased postoperative surveillance. However, the individual components of the increased postoperative surveillance intervention were implemented in less than 50% of high-risk patients (excepting increasing nursing observations). The components most frequently unavailable were the ability to provide care in a higher care ward (32.1%) and assigning the patient to a bed in view of the nurses' station (28.4%). Failure to comply with available components of the intervention ranged from 27.5% to 54.3%. The post pilot survey had a response rate of 30/40 (75%). In Likert scale questions about acceptability, appropriateness, and feasibility of the ASOS-2 intervention, 63% to 87% of respondents indicated agreement. Respondents reported barriers related to resources, trial processes, teamwork and communication as reasons for disagreement. Conclusions: The proposed ASOS-2 Trial appears to be appropriate, acceptable and feasible in Africa. This pilot trial provides support for the proposed ASOS-2 Trial. It emphasises the need for establishing trial site teams which address the needs of all stakeholders during the trial. A concerted effort must be made to help participating hospitals to increase compliance with all the components of the proposed intervention of 'increased postoperative surveillance' during the ASOS-2 Trial

The ASOS Surgical Risk Calculator: development and validation of a tool for identifying African surgical patients at risk of severe postoperative complications.

BACKGROUND: The African Surgical Outcomes Study (ASOS) showed that surgical patients in Africa have a mortality twice the global average. Existing risk assessment tools are not valid for use in this population because the pattern of risk for poor outcomes differs from high-income countries. The objective of this study was to derive and validate a simple, preoperative risk stratification tool to identify African surgical patients at risk for in-hospital postoperative mortality and severe complications. METHODS: ASOS was a 7-day prospective cohort study of adult patients undergoing surgery in Africa. The ASOS Surgical Risk Calculator was constructed with a multivariable logistic regression model for the outcome of in-hospital mortality and severe postoperative complications. The following preoperative risk factors were entered into the model; age, sex, smoking status, ASA physical status, preoperative chronic comorbid conditions, indication for surgery, urgency, severity, and type of surgery. RESULTS: The model was derived from 8799 patients from 168 African hospitals. The composite outcome of severe postoperative complications and death occurred in 423/8799 (4.8%) patients. The ASOS Surgical Risk Calculator includes the following risk factors: age, ASA physical status, indication for surgery, urgency, severity, and type of surgery. The model showed good discrimination with an area under the receiver operating characteristic curve of 0.805 and good calibration with c-statistic corrected for optimism of 0.784. CONCLUSIONS: This simple preoperative risk calculator could be used to identify high-risk surgical patients in African hospitals and facilitate increased postoperative surveillance. CLINICAL TRIAL REGISTRATION: NCT03044899.

Barriers to clinical research in Africa: a quantitative and qualitative survey of clinical researchers in 27 African countries.

BACKGROUND: There is a need for high quality research to improve perioperative patient care in Africa. The aim of this study was to understand the particular barriers to clinical research in this environment. METHODS: We conducted an electronic survey of African Surgical Outcomes Study (ASOS) investigators, including 29 quantitative Likert scale questions and eight qualitative questions with subsequent thematic analysis. Protocol compliant and non-compliant countries were compared according to WHO statistics for research and development, health workforce data, and world internet statistics. RESULTS: Responses were received from 134/418 of invited researchers in 24/25 (96%) of participating countries, and three non-participating countries. Barriers included lack of a dedicated research team (47.7%), reliable internet access (32.6%), staff skilled in research (31.8%), and team commitment (23.8%). Protocol compliant countries had significantly more physicians per 1000 population (4 vs 0.9, P<0.01), internet penetration (38% vs 28%, P=0.01) and published clinical trials (1461 vs 208, P<0.01) compared with non-compliant countries. Facilitators of research included establishing a research culture (86.9%), simple data collection tools (80%), and ASOS team interaction (77.9%). Most participants are interested in future research (93.8%). Qualitative data reiterated human resource, financial resource, and regulatory barriers. However, the desire to contribute to an African collaboration producing relevant data to improve patient outcomes was expressed strongly by ASOS investigators. CONCLUSIONS: Barriers to successful participation in ASOS related to resource limitations and not motivation of the clinician investigators. Practical solutions to individual barriers may increase the success of multi-centre perioperative research in Africa.