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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.
Predictors of post-spinal hypotension in elderly patients; a prospective observational study in the Durban Metropole
Aims and objective: To evaluate the pre-spinal risk factors for hypotension associated with spinal anaesthesia in elderly surgical patients. Summary of background data: Hypotension is associated with morbidity and mortality following noncardiac surgery. Reducing the incidence of hypotension associated with spinal anaesthesia may be associated with improved postoperative outcomes. Methods: This was a prospective, observational study, using convenience sampling. All patients over 55 years of age scheduled to receive spinal anaesthesia for lower limb surgery were eligible. Exclusion criteria included the need for resuscitation and/or the need for vasopressors prior to anaesthesia and surgery, and patients who declined spinal anaesthesia. The dosage of spinal anaesthesia and the use of intraoperative sedation were left to the attending anaesthesiologist. The primary outcome was hypotension, which was defined as a decrease in the systolic blood pressure by 25% from the baseline, or a systolic blood pressure below 100 mmHg. The following pre-spinal risk factors were assessed in a multivariable logistic regression for their association with spinal hypotension: age, American Society of Anaesthesiologists-Physical September 2019 Status, sex, dose of local anaesthetic, isobaric bupivacaine or bupivacaine with dextrose, baseline blood pressure, baseline heart rate and fluid preloading prior to spinal anaesthesia. Results: Three hundred and eighty-nine patients were recruited. The primary outcome of spinal hypotension was independently associated with female sex (odds ratio [OR] 1.97, 95% confidence interval [CI] 1.19–3.28), increasing dosage of bupivacaine (OR 1.14, CI 1.01–1.29), and the use of isobaric bupivacaine (OR 1.50, CI 0.95–2.36). Conclusion: Spinal hypotension was associated with female sex, increasing dosage of bupivacaine, and the use of isobaric bupivacaine.
Effects of accelerated versus standard care surgery on the risk of acute kidney injury in patients with a hip fracture: a substudy protocol of the hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) international randomised controlled trial
IntroductionInflammation, dehydration, hypotension and bleeding may all contribute to the development of acute kidney injury (AKI). Accelerated surgery after a hip fracture can decrease the exposure time to such contributors and may reduce the risk of AKI.Methods and analysisHip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) is a multicentre, international, parallel-group randomised controlled trial (RCT). Patients who suffer a hip fracture are randomly allocated to either accelerated medical assessment and surgical repair with a goal of surgery within 6 hours of diagnosis or standard care where a repair typically occurs 24 to 48 hours after diagnosis. The primary outcome of this substudy is the development of AKI within 7 days of randomisation. We anticipate at least 1998 patients will participate in this substudy.Ethics and disseminationWe obtained ethics approval for additional serum creatinine recordings in consecutive patients enrolled at 70 participating centres. All patients provide consent before randomisation. We anticipate reporting substudy results by 2021.Trial registration numberNCT02027896; Pre-results.
Rationale and design of the HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial: a protocol for an international randomised controlled trial evaluating early surgery for hip fracture patients
IntroductionAnnually, millions of adults suffer hip fractures. The mortality rate post a hip fracture is 7%–10% at 30 days and 10%–20% at 90 days. Observational data suggest that early surgery can improve these outcomes in hip fracture patients. We designed a clinical trial—HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) to determine the effect of accelerated surgery compared with standard care on the 90-day risk of all-cause mortality and major perioperative complications.Methods and analysisHIP ATTACK is a multicentre, international, parallel group randomised controlled trial (RCT) that will include patients ≥45 years of age and diagnosed with a hip fracture from a low-energy mechanism requiring surgery. Patients are randomised to accelerated medical assessment and surgical repair (goal within 6 h) or standard care. The co-primary outcomes are (1) all-cause mortality and (2) a composite of major perioperative complications (ie, mortality and non-fatal myocardial infarction, pulmonary embolism, pneumonia, sepsis, stroke, and life-threatening and major bleeding) at 90 days after randomisation. All patients will be followed up for a period of 1 year. We will enrol 3000 patients.Ethics and disseminationAll centres had ethics approval before randomising patients. Written informed consent is required for all patients before randomisation. HIP ATTACK is the first large international trial designed to examine whether accelerated surgery can improve outcomes in patients with a hip fracture. The dissemination plan includes publishing the results in a policy-influencing journal, conference presentations, engagement of influential medical organisations, and providing public awareness through multimedia resources.Trial registration numberNCT02027896; Pre-results.
The developing world of pre‐operative optimisation: a systematic review of Cochrane reviews
SummaryPre‐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.
Prospective observational cohort study on grading the severity of postoperative complications in global surgery research
AbstractBackgroundThe Clavien–Dindo classification is perhaps the most widely used approach for reporting postoperative complications in clinical trials. This system classifies complication severity by the treatment provided. However, it is unclear whether the Clavien–Dindo system can be used internationally in studies across differing healthcare systems in high- (HICs) and low- and middle-income countries (LMICs).MethodsThis was a secondary analysis of the International Surgical Outcomes Study (ISOS), a prospective observational cohort study of elective surgery in adults. Data collection occurred over a 7-day period. Severity of complications was graded using Clavien–Dindo and the simpler ISOS grading (mild, moderate or severe, based on guided investigator judgement). Severity grading was compared using the intraclass correlation coefficient (ICC). Data are presented as frequencies and ICC values (with 95 per cent c.i.). The analysis was stratified by income status of the country, comparing HICs with LMICs.ResultsA total of 44 814 patients were recruited from 474 hospitals in 27 countries (19 HICs and 8 LMICs). Some 7508 patients (16·8 per cent) experienced at least one postoperative complication, equivalent to 11 664 complications in total. Using the ISOS classification, 5504 of 11 664 complications (47·2 per cent) were graded as mild, 4244 (36·4 per cent) as moderate and 1916 (16·4 per cent) as severe. Using Clavien–Dindo, 6781 of 11 664 complications (58·1 per cent) were graded as I or II, 1740 (14·9 per cent) as III, 2408 (20·6 per cent) as IV and 735 (6·3 per cent) as V. Agreement between classification systems was poor overall (ICC 0·41, 95 per cent c.i. 0·20 to 0·55), and in LMICs (ICC 0·23, 0·05 to 0·38) and HICs (ICC 0·46, 0·25 to 0·59).ConclusionCaution is recommended when using a treatment approach to grade complications in global surgery studies, as this may introduce bias unintentionally.