Project description:BACKGROUND:Every year, an estimated 2.6 million stillbirths occur worldwide, with up to 98% occurring in low- and middle-income countries (LMIC). There is a paucity of primary data on cause of stillbirth from LMIC, and particularly from sub-Saharan Africa to inform effective interventions. This study aimed to identify the cause of stillbirths in low- and middle-income settings and compare methods of assessment. METHODS:This was a prospective, observational study in 12 hospitals in Kenya, Malawi, Sierra Leone and Zimbabwe. Stillbirths (28 weeks or more) were reviewed to assign the cause of death by healthcare providers, an expert panel and by using computer-based algorithms. Agreement between the three methods was compared using Kappa (κ) analysis. Cause of stillbirth and level of agreement between the methods used to assign cause of death. RESULTS:One thousand five hundred sixty-three stillbirths were studied. The stillbirth rate (per 1000 births) was 20.3 in Malawi, 34.7 in Zimbabwe, 38.8 in Kenya and 118.1 in Sierra Leone. Half (50.7%) of all stillbirths occurred during the intrapartum period. Cause of death (range) overall varied by method of assessment and included: asphyxia (18.5-37.4%), placental disorders (8.4-15.1%), maternal hypertensive disorders (5.1-13.6%), infections (4.3-9.0%), cord problems (3.3-6.5%), and ruptured uterus due to obstructed labour (2.6-6.1%). Cause of stillbirth was unknown in 17.9-26.0% of cases. Moderate agreement was observed for cause of stillbirth as assigned by the expert panel and by hospital-based healthcare providers who conducted perinatal death review (κ = 0.69; p < 0.0005). There was only minimal agreement between expert panel review or healthcare provider review and computer-based algorithms (κ = 0.34; 0.31 respectively p < 0.0005). CONCLUSIONS:For the majority of stillbirths, an underlying likely cause of death could be determined despite limited diagnostic capacity. In these settings, more diagnostic information is, however, needed to establish a more specific cause of death for the majority of stillbirths. Existing computer-based algorithms used to assign cause of death require revision.

Project description:BackgroundThe trial protocol is the most important document for clinical trials and describes not only the design and methodology of a study, but also all practical aspects. The suitability of the protocol has a direct impact on the execution and results of the trial. However, suitability is rarely addressed in trial practice and research. The aim of our study was to investigate protocol suitability and to identify suitability-enhancing measures for trials in sub-Saharan Africa.MethodsWe used an exploratory mixed methods design. First, we interviewed 36 trial staff at different organisational levels in Ghana, Burkina Faso and Senegal. Second, we conducted an online survey among trial staff in sub-Saharan Africa to investigate trial protocol suitability based on the main themes distilled from the interviews.ResultsProtocol suitability surfaced as a prominent topic in interviews with trial staff, critiqued for its lack of clarity, implementability and adaptation to trial participants as well as to the workforce and infrastructure available. Both qualitative and quantitative investigations identified local site staff involvement in protocol development as the most helpful mean of increasing protocol suitability. Careful assessment of the local context, capacity and cultures, and ensuring that staff understand the protocol were also cited as helpful measures.ConclusionsOur data suggests that protocol suitability can be increased by discussing and reviewing the protocol with trial staff in advance. Involving operationally experienced staff would be most useful. For multicentre trials, we suggest that at least one trial staff member from each of the sites with the highest expected recruitment rates be involved in developing the protocol. Carefully assessing the context prior to study start is indispensable to ensuring protocol suitability and should particularly focus on the workforce and infrastructure available, as well as the needs and availability of trial participants. To allow for protocol suitability enhancing measures, planners must allocate enough time for trial preparation and solicit feedback and information on context at an early stage. Such prospective planning would increase implementability, efficiency and quality of trials in the long run.

Project description:Sub-Saharan Africa represents 69% of the total number of individuals living with HIV infection worldwide and 72% of AIDS deaths globally. Pulmonary infection is a common and frequently fatal complication, though little is known regarding the lower airway microbiome composition of this population. Our objectives were to characterize the lower airway microbiome of Ugandan HIV-infected patients with pneumonia, to determine relationships with demographic, clinical, immunological, and microbiological variables and to compare the composition and predicted metagenome of these communities to a comparable cohort of patients in the US (San Francisco). Bronchoalveolar lavage samples from a cohort of 60 Ugandan HIV-infected patients with acute pneumonia were collected. Amplified 16S ribosomal RNA was profiled and aforementioned relationships examined. Ugandan airway microbiome composition and predicted metagenomic function were compared to US HIV-infected pneumonia patients. Among the most common bacterial pulmonary pathogens, Pseudomonas aeruginosa was most prevalent in the Ugandan cohort. Patients with a richer and more diverse airway microbiome exhibited lower bacterial burden, enrichment of members of the Lachnospiraceae and sulfur-reducing bacteria and reduced expression of TNF-alpha and matrix metalloproteinase-9. Compared to San Franciscan patients, Ugandan airway microbiome were significantly richer, and compositionally distinct with predicted metagenomes that encoded a multitude of distinct pathogenic pathways e.g secretion systems. Ugandan pneumonia-associated airway microbiome is compositionally and functionally distinct from those detected in comparable patients in developed countries, a feature which may contribute to adverse outcomes in this population. Please note that the data from the comparable cohort of patients in the USUS data was published as supplemental material of PMID: 22760045 but not submitted to GEO The 'patient_info.txt' contains 12 clinical, 7 immunological and 3 microbiological variables for each patient.

Project description:Sub-Saharan Africa represents 69% of the total number of individuals living with HIV infection worldwide and 72% of AIDS deaths globally. Pulmonary infection is a common and frequently fatal complication, though little is known regarding the lower airway microbiome composition of this population. Our objectives were to characterize the lower airway microbiome of Ugandan HIV-infected patients with pneumonia, to determine relationships with demographic, clinical, immunological, and microbiological variables and to compare the composition and predicted metagenome of these communities to a comparable cohort of patients in the US (San Francisco). Bronchoalveolar lavage samples from a cohort of 60 Ugandan HIV-infected patients with acute pneumonia were collected. Amplified 16S ribosomal RNA was profiled and aforementioned relationships examined. Ugandan airway microbiome composition and predicted metagenomic function were compared to US HIV-infected pneumonia patients. Among the most common bacterial pulmonary pathogens, Pseudomonas aeruginosa was most prevalent in the Ugandan cohort. Patients with a richer and more diverse airway microbiome exhibited lower bacterial burden, enrichment of members of the Lachnospiraceae and sulfur-reducing bacteria and reduced expression of TNF-alpha and matrix metalloproteinase-9. Compared to San Franciscan patients, Ugandan airway microbiome were significantly richer, and compositionally distinct with predicted metagenomes that encoded a multitude of distinct pathogenic pathways e.g secretion systems. Ugandan pneumonia-associated airway microbiome is compositionally and functionally distinct from those detected in comparable patients in developed countries, a feature which may contribute to adverse outcomes in this population. Please note that the data from the comparable cohort of patients in the USUS data was published as supplemental material of PMID: 22760045 but not submitted to GEO The 'patient_info.txt' contains 12 clinical, 7 immunological and 3 microbiological variables for each patient. The G2 PhyloChip microarray platform (commercially available from Second Genome, Inc.) was used to profile bacteria in lower airway samples from 60 subjects

Project description:BackgroundGlobally, pre-eclampsia and eclampsia are major contributors to maternal and perinatal mortality; of which the vast majority of deaths occur in less developed countries. In addition, a disproportionate number of morbidities and mortalities occur due to delayed access to health services. The Community Level Interventions for Pre-eclampsia (CLIP) Trial aims to task-shift to community health workers the identification and emergency management of pre-eclampsia and eclampsia to improve access and timely care. Literature revealed paucity of published feasibility assessments prior to initiating large-scale community-based interventions. Arguably, well-conducted feasibility studies can provide valuable information about the potential success of clinical trials prior to implementation. Failure to fully understand the study context risks the effective implementation of the intervention and limits the likelihood of post-trial scale-up. Therefore, it was imperative to conduct community-level feasibility assessments for a trial of this magnitude.MethodsA mixed methods design guided by normalization process theory was used for this study in Nigeria, Mozambique, Pakistan, and India to explore enabling and impeding factors for the CLIP Trial implementation. Qualitative data were collected through participant observation, document review, focus group discussion and in-depth interviews with diverse groups of community members, key informants at community level, healthcare providers, and policy makers. Quantitative data were collected through health facility assessments, self-administered community health worker surveys, and household demographic and health surveillance.ResultsRefer to CLIP Trial feasibility publications in the current and/or forthcoming supplement.ConclusionsFeasibility assessments for community level interventions, particularly those involving task-shifting across diverse regions, require an appropriate theoretical framework and careful selection of research methods. The use of qualitative and quantitative methods increased the data richness to better understand the community contexts.Trial registrationNCT01911494.

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Understanding the complexities of unexplained stillbirth in sub-Saharan Africa: a mixed-methods study.

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