New ethical considerations in vaccine trials.

Known and novel pathogens continue to afflict the world's population, and we deploy existing and new vaccines - the best type of weapon we've got - against them. One consequence is that we are accumulating steadily more experience of both the scientific and the ethical requirements of conducting vaccine trials in people. Good science is itself an ethical requirement, as it is meaningless to apply ethical principles to a scientifically flawed product or plan. Bad science can only be bad ethics. And we have learned that ethical principles are a necessity when we apply the benefits of science to the improving of human health. Recent epidemics have provided opportunities to expand our understanding of this field and of the many components of it that we recognize to be necessary to the ethical assessment of vaccines

A medical career in Malawi – personal reflections

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Acute bacterial meningitis in children admitted to the Queen Elizabeth Central Hospital Blantyre, Malawi in 1996-97.

In order to design appropriate interventioos, we collected clinical and demographic data prospectively on all children aged one day to 14 years admitted with a diagnosis of bacterial meningitis (BM) from April 1st 1996 to March 31st 1997 to the Queen Elizabeth Central Hospital (QECH), Blantyre Malawi. During the study period 267 children (2.7% of all paediatric admissions) were found to have BM; 83% were under 5 years of age, 61 % under one year and 23% under one month. The most common causative organisms in the post neonatal period (n = 206) were Streptococcus pneumoniae (27%), Haemophilus influenzae type b (Hib) 21 %, and Salmonella typhimurium (6%). In the neonatal group «I month, n = 61) the most common causes were Streptococcus agalactiae (23%), S. typhimurium (15%), S. pneumoniae (11. 5%) and other gram negative rods (11.5%). Nineteen of 21 salmonella infections were in children under one year of age and all S. agalactiae were in infants under three months. There was delay on presentation: the average length of fever was 4.6 days, 39.5% had convulsed prior to arrival and 57% had an altered level of consciousness. An initial diagnosis of malaria had probably contributed to the delay in 22.5% , (42 of 186 tested). Forty eight percent were < 80% weight for age, with 18% < 60 % weight for age. The overall mortality was 40%. The outcome was worst in salmonella infections, particularly neonatal salmonella BM with a case fatality rate (CFR) of 89% (8 of 9 cases). Coma on presentation worsened prognosis (mortality 64% if Blantyre Coma Score <3, 26% if > 3). Fifteen percent of survivors had sequelae on discharge. Twenty percent of Hib isolates were resistant to chloramphenicol, but all salmonellae were sensitive. Five percent of S. pneumoniae were resistant to penicillin and 8% to chloramphenicol. Earlier access to adequate health care and awareness of BM in a malaria endemic area would reduce mortality and morbidity. Vaccination against Hib infection would have reduced death by 18 (17%) and prevented sequelae in 7

Presentation of child sexual abuse cases to Queen Elizabeth Central Hospital following the establishment of an HIV post-exposure prophylaxis programme

AimsTo review child sexual abuse cases and their management presenting to Queen Elizabeth Central Hospital (QECH), Blantyre, since the introduction of an HIV post-exposure prophylaxis (PEP) programme. MethodsDemographic and medical data was collected from all children presenting to Queen Elizabeth Central Hospital, Blantyre, Malawi between January 2005 and February 2007 with alleged child sexual abuse (CSA).ResultsBetween January 2005 and February 2007, 217 children presented with alleged CSA. This is an average of 3 more per month since the previous year. The results of the physical examination in 60% (130/217) of the cases showed signs of trauma. 63% (137/217) of the cases presented within 72 hours of defilement. Overall in 42% (92/217) of childrena one month course of HIV PEP was indicated and given. In 58% (125/217) HIV PEP was not indicated in view of normal examination, presentation too late (>72 hrs after abuse), multiple abuse episodes in the last 6 months, HIV test positive or HIV test refused. In 66% (144/217) of assessed children antibiotic treatment was given for the preventionand/ or treatment of sexually transmitted infections (STIs).ConclusionsThe introduction of an HIV PEP programme for victims of CSA has lead to increased numbers presenting and being treated. In conclusion it is likely that a significant number of children have been prevented from acquiring HIV and other STIs following CSA. The key area where our service needsto be improved is in establishing documented follow up of all cases to monitor medication compliance, side effects and rates of HIV seroconversion following CSA

Commentary (The Lancet) Bednets and malaria in Africa

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Case Report - A 6 year-old boy was referred from a district hospital with congestive cardiac failure

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Paediatric Wandering Spleens in Malawi

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Evaluation of 'TRY': an algorithm for neonatal continuous positive airways pressure in low-income settings

BACKGROUND: Non-invasive respiratory support using bubble continuous positive airway pressure (bCPAP) is useful in treating babies with respiratory distress syndrome. Despite its proven clinical and cost-effectiveness, implementation is hampered by the inappropriate administration of bCPAP in low-resource settings. A clinical algorithm-'TRY' (based on Tone: good; Respiratory distress; Yes, heart rate above 100 beats/min)-has been developed to correctly identify which newborns would benefit most from bCPAP in a teaching hospital in Malawi. OBJECTIVE: To evaluate the reliability, sensitivity and specificity of TRY when employed by nurses in a Malawian district hospital. METHODS: Nursing staff in a Malawian district hospital baby unit were asked, over a 2-month period, to complete TRY assessments for every newly admitted baby with the following inclusion criteria: clinical evidence of respiratory distress and/or birth weight less than 1.3 kg. A visiting paediatrician, blinded to nurses' assessments, concurrently assessed each baby, providing both a TRY assessment and a clinical decision regarding the need for CPAP administration. Inter-rater reliability was calculated comparing nursing and paediatrician TRY assessment outcomes. Sensitivity and specificity were estimated comparing nurse TRY assessments against the paediatrician's clinical decision. RESULTS: Two hundred and eighty-seven infants were admitted during the study period; 145 (51%) of these met the inclusion criteria, and of these 57 (39%) received joint assessments. The inter-rater reliability was high (kappa 0.822). Sensitivity and specificity were 92% and 96%, respectively. CONCLUSIONS: District hospital nurses, using the TRY-CPAP algorithm, reliably identified babies that might benefit from bCPAP and thus improved its effective implementation

Profile: The Kilifi Health and Demographic Surveillance System (KHDSS).

The Kilifi Health and Demographic Surveillance System (KHDSS), located on the Indian Ocean coast of Kenya, was established in 2000 as a record of births, pregnancies, migration events and deaths and is maintained by 4-monthly household visits. The study area was selected to capture the majority of patients admitted to Kilifi District Hospital. The KHDSS has 260 000 residents and the hospital admits 4400 paediatric patients and 3400 adult patients per year. At the hospital, morbidity events are linked in real time by a computer search of the population register. Linked surveillance was extended to KHDSS vaccine clinics in 2008. KHDSS data have been used to define the incidence of hospital presentation with childhood infectious diseases (e.g. rotavirus diarrhoea, pneumococcal disease), to test the association between genetic risk factors (e.g. thalassaemia and sickle cell disease) and infectious diseases, to define the community prevalence of chronic diseases (e.g. epilepsy), to evaluate access to health care and to calculate the operational effectiveness of major public health interventions (e.g. conjugate Haemophilus influenzae type b vaccine). Rapport with residents is maintained through an active programme of community engagement. A system of collaborative engagement exists for sharing data on survival, morbidity, socio-economic status and vaccine coverage