Morbidity after surgical management of cervical cancer in low and middle income countries: A systematic review and meta-analysis

Objective: To investigate morbidity for patients after the primary surgical management of cervical cancer in low and middle-income countries (LMIC). Methods: The Pubmed, Cochrane, the Cochrane Central Register of Controlled Trials, Embase, LILACS and CINAHL were searched for published studies from 1st Jan 2000 to 30th June 2017 reporting outcomes of surgical management of cervical cancer in LMIC. Randomeffects meta-analytical models were used to calculate pooled estimates of surgical complications including blood transfusions, ureteric, bladder, bowel, vascular and nerve injury, fistulae and thromboembolic events. Secondary outcomes included five-year progression free (PFS) and overall survival (OS). Findings: Data were available for 46 studies, including 10,847 patients from 11 middle income countries. Pooled estimates were: blood transfusion 29% (95%CI 0.19–0.41, P = 0.00, I 2 = 97.81), nerve injury 1% (95%CI 0.00–0.03, I 2 77.80, P = 0.00), bowel injury, 0.5% (95%CI 0.01–0.01, I 2 = 0.00, P = 0.77), bladder injury 1% (95%CI 0.01–0.02, P = 0.10, I 2 = 32.2), ureteric injury 1% (95%CI 0.01–0.01, I 2 0.00, P = 0.64), vascular injury 2% (95% CI 0.01– 0.03, I 2 60.22, P = 0.00), fistula 2% (95%CI 0.01–0.03, I 2 = 77.32, P = 0.00,), pulmonary embolism 0.4% (95%CI 0.00–0.01, I 2 26.69, P = 0.25), and infection 8% (95%CI 0.04–0.12, 2 95.72, P = 0.00). 5-year PFS was 83% for laparotomy, 84% for laparoscopy and OS was 85% for laparotomy cases and 80% for laparoscopy. Conclusion: This is the first systematic review and meta-analysis of surgical morbidity in cervical cancer in LMIC, which highlights the limitations of the current data and provides a benchmark for future health services research and policy implementation

Causes of perinatal mortality and associated maternal complications in a South African province : challenges in predicting poor outcomes

BACKGROUND: Reviews of perinatal deaths are mostly facility based. Given the number of women who, globally, deliver outside of facilities, this data may be biased against total population data. We aimed to analyse population based perinatal mortality data from a LMIC setting (Mpumalanga, South Africa) to determine the causes of perinatal death and the rate of maternal complications in the setting of a perinatal death. METHODS : A secondary analysis of the South African Perinatal Problems Identification Program (PPIP) database for the Province of Mpumalanga was undertaken for the period October 2013 to January 2014, inclusive. Data on each individual late perinatal death was reviewed. We examined the frequencies of maternal and fetal or neonatal characteristics in late fetal deaths and analysed the relationships between maternal condition and fetal and/or neonatal outcomes. IBM SPSS Statistics 22.0 was used for data analysis. RESULTS : There were 23503 births and 687 late perinatal deaths (stillbirths of ≥ 1000gr or ≥ 28 weeks gestation and early neonatal deaths up to day 7 of neonatal life) in the study period. The rate of maternal complication in macerated stillbirths, fresh stillbirths and early neonatal deaths was 50.4%, 50.7% and 25.8% respectively. Mothers in the other late perinatal deaths were healthy. Maternal hypertension and obstetric haemorrhage were more likely in stillbirths (p = <0.01 for both conditions), whereas ENNDs were more likely to have a healthy mother (p < 0.01). The main causes of neonatal death were related to immaturity (48.7%) and hypoxia (40.6%). 173 (25.2%) of all late perinatal deaths had a birth weight less than the 10th centile for gestational age. CONCLUSION : A significant proportion of women have no recognisable obstetric or medical condition at the time of a late perinatal death; we may be limited in our ability to predict poor perinatal outcome if emphasis is put on detecting maternal complications prior to a perinatal death. Intrapartum care and hypertensive disease remain high priority areas for addressing perinatal mortality. Consideration needs to be given to novel ways of detecting growth restriction in a LMIC setting.http://www.biomedcentral.com/bmcpregnancychildbirtham201

What is needed for taking emergency obstetric and neonatal programmes to scale?

Scaling up an emergency obstetric and neonatal care (EmONC) programme entails reaching a larger number of people in a potentially broader geographical area.Multiple strategies requiring simultaneous attention should be deployed. This paper provides a framework for understanding the implementation, scale-up and sustainability of such programmes. We reviewed the existing literature and drew on our experience in scaling up the Essential Steps in the Management of Obstetric Emergencies (ESMOE) programme in South Africa.We explore the non-linear change process and conditions to be met for taking an existing EmONC programme to scale. Important concepts cutting across all components of a programme are equity, quality and leadership. Conditions to be met include appropriate awareness across the board and a policy environment that leads to the following: commitment, health systems-strengthening actions, allocation of resources (human, financial and capital/material), dissemination and training, supportive supervision and monitoring and evaluation.Medical Research Council of South Africa,the University of Pretoria and the School of Women's and Infants' Health at the University of Western Australia.http://www.elsevier.com/locate/bpobgyn2016-11-30hb201

Attitudes towards the implementation of universal umbilical artery lactate analysis in a South African district hospital

BACKGROUND : Of the 5.54 million stillbirths and neonatal deaths occurring globally each year, a significant amount of these occur in the setting of inadequate intrapartum care. The introduction of universal umbilical artery lactate (UA) measurements in this setting may improve outcomes by providing an objective measurement of quality of care and stimulating case reflection, audit, and practice change. It is important that consideration is given to the barriers and facilitators to implementing this tool outside of a research setting. METHODS : During the period 16/11/2014 -13/01/2015, we conducted a training course in cardiotocograph (CTG) interpretation, fetal physiology, and the sampling and analysing of UA lactate, with a pre and post questionnaire aimed at assessing the barriers and facilitators to the introduction of universal UA lactate in a district hospital in the Eastern Cape, South Africa. RESULTS : Thirty-five pre-training questionnaires available (overall response rate 95 %) and 22 post training questionnaires (response rate 63 %) were available for analysis. Prior to training, the majority gave positive responses (strongly agree or agree) that measuring UA lactate assists neonatal care, is protective for staff medicolegally, and improves opportunities for audit and teaching of maternity practice (n = 33, 30, 32; 94.4 %, 85.7 %, 91.4 % respectively). Respondents remained positive about the benefits post training. An increased workload on medical or midwifery staff was less likely to be seen as barrier following training (71 vs. 38.9 % positive response, p = 0.038). A higher rate of respondents felt that expense and lack of equipment were likely to be barriers after completing training, although this wasn’t significant. There was a trend towards lack of time and expertise being less likely to be seen as barriers post training. CONCLUSION : The majority of participants providing intrapartum care in this setting are positive about the role of universal UA lactate analysis and the potential benefits it provides. Training aids in overcoming some of the perceived barriers to implementation of universal UA lactate analysis.Emma Allanson is a PhD candidate funded by the University of Western Australia with an Australian post-graduate award, and an Athelstan and Amy Saw Medical top-up scholarship, and by the Women and Infants Research Foundation with a Gordon King doctor of philosophy scholarship.http://www.biomedcentral.com/bmcpregnancychildbirtham2016Obstetrics and Gynaecolog

Impact of maternal HIV on umbilical cord lactate measurement at delivery in a South African labor ward

OBJECTIVE : To assess umbilical artery lactate levels and perinatal outcomes among women with and without HIV infection. METHODS : The present prospective cohort study recruited women planning to undergo vaginal delivery at Kalafong Hospital, South Africa, between March 3 and November 12, 2014. Umbilical artery lactate levels were measured and perinatal outcome data were recorded. Outcome analyses were stratified by maternal HIV status, and a subgroup analysis was performed where women with a CD4 count below 350 × 106 cells/L were compared with women without HIV. RESULTS : In total, 936 women with singleton fetuses were enrolled. Maternal HIV status was available for 897 (95.8%) participants, of whom 202 (21.6%) had HIV infections. Overall, 186 (92.1%) women with HIV infections received prophylaxis or treatment. There was no difference between participants with and without HIV infections in the preterm delivery rate (P=0.770), mode of delivery (P=0.354), neonatal resuscitation rate (P=0.717), 1‐ or 5‐minute Apgar scores below 7 (P=0.353), or the rate of having an umbilical artery lactate level above 5.45 mmol/L (P=0.301). Similarly, there were no differences in outcomes in the subgroup analysis of women with a CD4 count below 350 × 106 cells/L. CONCLUSION : Umbilical artery lactate levels and perinatal outcomes were found to be comparable between patients with and without HIV infections in a South African setting.University of Western Australia; Women and Infants Research Foundationhttp://wileyonlinelibrary.com/journal/ijgo2019-06-01hj2018Obstetrics and Gynaecolog

Applying the international classification of diseases to perinatal mortality data, South Africa

OBJECTIVE : To examine the feasibility of applying the International Classification of Diseases-perinatal mortality (ICD-PM) coding to an existing data set in the classification of perinatal deaths. METHODS : One author, a researcher with a non-clinical public health background, applied the ICD-PM coding system to South Africa’s national perinatal mortality audit system, the Perinatal Problem Identification Program. The database for this study included all perinatal deaths (n = 26 810), defined as either stillbirths (of birth weight > 1000 g and after 28 weeks of gestation) or early neonatal deaths (age 0–7 days), that occurred between 1 October 2013 and 31 December 2016. A clinical obstetrician verified the coding. FINDINGS : The South African classification system does not include the timing of death; however, under the ICD-PM system, deaths could be classified as antepartum (n = 15 619; 58.2%), intrapartum (n = 3725; 14.0%) or neonatal (n = 7466; 27.8%). Further, the South African classification system linked a maternal condition to only 40.3% (10 802/26 810) of all perinatal deaths; this proportion increased to 68.9% (18 467/26 810) under the ICD-PM system. CONCLUSION : The main benefit of using the clinically relevant and user-friendly ICD-PM system was an enhanced understanding of the data, in terms of both timing of death and maternal conditions. We have also demonstrated that it is feasible to convert an existing perinatal mortality classification system to one which is globally comparable and can inform policy-makers internationally.http://www.who.int/bulletin/enam2019Afrikaan

Variation in neurosurgical management of traumatic brain injury

Background: Neurosurgical management of traumatic brain injury (TBI) is challenging, with only low-quality evidence. We aimed to explore differences in neurosurgical strategies for TBI across Europe. Methods: A survey was sent to 68 centers participating in the Collaborative European Neurotrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) study. The questionnaire contained 21 questions, including the decision when to operate (or not) on traumatic acute subdural hematoma (ASDH) and intracerebral hematoma (ICH), and when to perform a decompressive craniectomy (DC) in raised intracranial pressure (ICP). Results: The survey was completed by 68 centers (100%). On average, 10 neurosurgeons work in each trauma center. In all centers, a neurosurgeon was available within 30 min. Forty percent of responders reported a thickness or volume threshold for evacuation of an ASDH. Most responders (78%) decide on a primary DC in evacuating an ASDH during the operation, when swelling is present. For ICH, 3% would perform an evacuation directly to prevent secondary deterioration and 66% only in case of clinical deterioration. Most respondents (91%) reported to consider a DC for refractory high ICP. The reported cut-off ICP for DC in refractory high ICP, however, differed: 60% uses 25 mmHg, 18% 30 mmHg, and 17% 20 mmHg. Treatment strategies varied substantially between regions, specifically for the threshold for ASDH surgery and DC for refractory raised ICP. Also within center variation was present: 31% reported variation within the hospital for inserting an ICP monitor and 43% for evacuating mass lesions. Conclusion: Despite a homogeneous organization, considerable practice variation exists of neurosurgical strategies for TBI in Europe. These results provide an incentive for comparative effectiveness research to determine elements of effective neurosurgical care

Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

SummaryBackground Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatoryactions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19.Methods In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospitalwith COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients wererandomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once perday by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatmentgroups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment andwere twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants andlocal study staff were not masked to the allocated treatment, but all others involved in the trial were masked to theoutcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treatpopulation. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.Findings Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) wereeligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was65·3 years (SD 15·7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomlyallocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall,561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days(rate ratio 0·97, 95% CI 0·87–1·07; p=0·50). No significant difference was seen in duration of hospital stay (median10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days(rate ratio 1·04, 95% CI 0·98–1·10; p=0·19). Among those not on invasive mechanical ventilation at baseline, nosignificant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilationor death (risk ratio 0·95, 95% CI 0·87–1·03; p=0·24).Interpretation In patients admitted to hospital with COVID-19, azithromycin did not improve survival or otherprespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restrictedto patients in whom there is a clear antimicrobial indication