Dataset Information

Paediatric pharmacovigilance: use of pharmacovigilance data mining algorithms for signal detection in a safety dataset of a paediatric clinical study conducted in seven African countries.

ABSTRACT: Pharmacovigilance programmes monitor and help ensuring the safe use of medicines which is critical to the success of public health programmes. The commonest method used for discovering previously unknown safety risks is spontaneous notifications. In this study we examine the use of data mining algorithms to identify signals from adverse events reported in a phase IIIb/IV clinical trial evaluating the efficacy and safety of several Artemisinin-based combination therapies (ACTs) for treatment of uncomplicated malaria in African children.We used paediatric safety data from a multi-site, multi-country clinical study conducted in seven African countries (Burkina Faso, Gabon, Nigeria, Rwanda, Uganda, Zambia, and Mozambique). Each site compared three out of four ACTs, namely amodiaquine-artesunate (ASAQ), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL) or chlorproguanil/dapsone and artesunate (CD+A). We examine two pharmacovigilance signal detection methods, namely proportional reporting ratio and Bayesian Confidence Propagation Neural Network on the clinical safety dataset.Among the 4,116 children (6-59 months old) enrolled and followed up for 28 days post treatment, a total of 6,238 adverse events were reported resulting into 346 drug-event combinations. Nine signals were generated both by proportional reporting ratio and Bayesian Confidence Propagation Neural Network. A review of the manufacturer package leaflets, an online Multi-Drug Symptom/Interaction Checker (DoubleCheckMD) and further by therapeutic area experts reduced the number of signals to five. The ranking of some drug-adverse reaction pairs on the basis of their signal index differed between the two methods.Our two data mining methods were equally able to generate suspected signals using the pooled safety data from a phase IIIb/IV clinical trial. This analysis demonstrated the possibility of utilising clinical studies safety data for key pharmacovigilance activities like signal detection and evaluation. This approach can be applied to complement the spontaneous reporting systems which are limited by under reporting.

SUBMITTER: Kajungu DK

PROVIDER: S-EPMC4006882 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Publications

Paediatric pharmacovigilance: use of pharmacovigilance data mining algorithms for signal detection in a safety dataset of a paediatric clinical study conducted in seven African countries.

Kajungu Dan K DK Erhart Annette A Talisuna Ambrose Otau AO Bassat Quique Q Karema Corine C Nabasumba Carolyn C Nambozi Michael M Tinto Halidou H Kremsner Peter P Meremikwu Martin M D'Alessandro Umberto U Speybroeck Niko N

PloS one 20140501 5

<h4>Background</h4>Pharmacovigilance programmes monitor and help ensuring the safe use of medicines which is critical to the success of public health programmes. The commonest method used for discovering previously unknown safety risks is spontaneous notifications. In this study we examine the use of data mining algorithms to identify signals from adverse events reported in a phase IIIb/IV clinical trial evaluating the efficacy and safety of several Artemisinin-based combination therapies (ACTs) ...[more]

PMID: 24787710

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Project description:ObjectivesTo determine the extent of provider communication, predictors of good communication and the association between provider communication and patient outcomes, such as patient satisfaction, in seven sub-Saharan African countries.DesignCross-sectional, multicountry study.SettingData from recent Service Provision Assessment (SPA) surveys from seven countries in sub-Saharan Africa. SPA surveys include assessment of facility inputs and processes as well as interviews with caretakers of sick children. These data included 3898 facilities and 4627 providers.Participants16?352 caregivers visiting the facility for their sick children.Primary and secondary outcome measuresWe developed an index of four recommended provider communication items for a sick child assessment based on WHO guidelines. We assessed potential predictors of provider communication and considered whether better provider communication was associated with intent to return to the facility for care.ResultsThe average score of the composite indicator of provider communication was low, at 35% (SD 26.9). Fifty-four per cent of caregivers reported that they were told the child's diagnosis, and only 10% reported that they were counselled on feeding for the child. Caregivers' educational attainment and provider preservice education and training in integrated management of childhood illness were associated with better communication. Private facilities and facilities with better infrastructure received higher communication scores. Caretakers reporting better communication were significantly more likely to state intent to return to the facility (relative risk: 1.19, 95%?CI 1.16 to 1.22).ConclusionsThere are major deficiencies in communication during sick child visits. These are associated with lower provider education as well as less well-equipped facilities. Poor communication, in turn, is linked to lower satisfaction and intention to return to facility among caregivers of sick children. Countries should test strategies for enhancing quality of communication in their efforts to improve health outcomes and patient experience.

Project description:Industrial mining projects can play an important role in global sustainable development if associated health risks are minimised and opportunities maximised. While a broad body of evidence from quantitative studies exists that establishes the interlinkages between mining operations and effects on public health, little research has been conducted investigating health impacts from the perspective of affected communities. This is particularly true in sub-Saharan Africa, where about a third of the remaining global mineral resources are endowed and health-related indicators for sustainable development are lagging behind. In this multi-country qualitative study, we explore community perceptions regarding impacts of industrial mining on their health and well-being. In nine study sites in Burkina Faso, Mozambique and Tanzania, we conducted 83 participatory focus group discussions with a total of 791 participants (385 men, 406 women). Our findings reveal a broad range of perceived impacts on environmental, economic and social determinants of health, with secondary health implications related to morbidity, mortality and well-being. Overall, perceived negative impacts prevailed, mainly related to environmental pollution, change in livelihoods or social disruption. Perceived positive impacts on health and well-being were related to interventions implemented by the mines such as new or improved water sources, health care facilities, roads and schools. The consistency of these findings across countries and study sites suggests a structural problem and indicates a pressing need to address health by acting on the wider determinants of health in mining regions. Participatory health impact assessment should be strengthened in host countries to foster strategic interventions, include marginalised population groups, and protect and promote the health of local communities. By including community perspectives on health before and during project implementation, policymakers can take advantage of economic opportunities while avoiding the pitfalls, bringing their communities closer to achieving good health and well-being goals by 2030 and beyond.

Dataset Information

Paediatric pharmacovigilance: use of pharmacovigilance data mining algorithms for signal detection in a safety dataset of a paediatric clinical study conducted in seven African countries.

Publications

Paediatric pharmacovigilance: use of pharmacovigilance data mining algorithms for signal detection in a safety dataset of a paediatric clinical study conducted in seven African countries.

Similar Datasets

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