11 research outputs found
The African Medicines Agency: historical perspective of its origins, evolution, institutional structure and future prospects
No full textBackground: The African continent has long faced fragmented regulatory systems, resulting in delayed access to safe, effective, and quality-assured medical products. To address these challenges, the African Medicines Regulatory Harmonisation (AMRH) Programme was launched in 2009 by the African Union, laying the groundwork for the establishment of the African Medicines Agency (AMA). The AMA represents one of the most significant continental developments to harmonize regulatory practices, improve access to quality-assured medical products, and strengthen public health systems across Africa. Objectives: The objectives of this review were to examine the historical development of AMA, its Treaty and proposed institutional framework, as well as operational pilots such as the Continental Listing of Human Medicinal Products implemented by the AMRH since 2023. Methods: A narrative literature review approach was used, sourcing official African Union documents, peer-reviewed publications, and technical reports from African Union Commission, AUDA-NEPAD, WHO, and AMRH stakeholders published between 2005 and 2025. Results: The AMA was formally established by treaty adopted by the AU heads of states and governments in 2019 and entered into force in November 2021. As of June 2025, 31 AU Member States had ratified the Treaty. The agency’s governance and organizational structure include a Conference of State Parties, Governing Board, Secretariat, and Technical Committees. Pilot projects such as the AMRH Continental Listing demonstrated the feasibility of reliance mechanisms, though challenges remain in national legal harmonization, funding, and capacity disparities. Conclusion: The AMA represents a transformative step toward regulatory convergence in Africa. While challenges persist, the Treaty framework and pilot outcomes provide a strong foundation for its operationalisation and the long-term success in improving medical product regulation and public health across the continent
Knowledge protection in indigenous communities: the case of indigenous medical knowledge systems in Zimbabwe
No full textThis study examines the contentious issues relating to the exploitation of indigenous knowledge systems (IKS) within the context of the expanding regime of intellectual property law (IP law). The study focuses specifically on the area of indigenous medical knowledge (IMK) within the geographical context of Zimbabwe as a country case study. The study examines the centrality of knowledge in the global economy and using international political economic theory and practice, demonstrates why it is a key site of struggles between and among nations and various stakeholders. While it considers the narrow issue of the applicability or otherwise of IP law to IKS, this study takes the approach that it is necessary to understand the socio-historical developments that account for the peripheral status of IKS in relation to the dominant western knowledge systems (WKS). A key argument of this study is that the lack of legal protection of IKS is directly connected to their marginal status in social, intellectual, cultural and economic terms arising from the dominance of the predominantly WKS. It is argued that far from being a narrow legalistic debate, the matter of the protection of IKS is a wider socio-cultural, economic and political issue that centres on the power relations between and among people, corporations and states. Through a combination of theoretical and field investigations, the study seeks to explore the factors that account for the marginalisation of IKS generally and IMK systems in particular. The “struggle thesis” demonstrates that from an historical viewpoint knowledge systems are in a state of constant interaction and struggle resulting in problems. The key to resolving the problems is to acknowledge difference and accept the legitimacy and validity of different knowledge systems and to democratise the regime of knowledge protection both nationally and globally. It proposes that solutions lie in not only reconstructing the legal architecture but also in ensuring that the social, economic and political structures are reconstructed to safeguard and nurture the IKS. The study investigates the needs and expectations of the indigenous communities including their rationale for the protection of their knowledge systems. Finally, it also contributes to the development of indigenous research methodologies
Safety, efficacy and pharmacokinetics profile of antimalarial drugs in pregnancy : pharmacoepidemiology studies
No full textBackground: Malaria in pregnancy is an important public health problem in sub Saharan Africa. It is known to be the most common and preventable cause of harmful birth outcomes in malaria endemic areas. It is therefore important for a pregnant woman to be treated with safe and effective antimalarial medication. Drug safety in pregnancy is of a greater concern due to limited safety data available in this vulnerable group. This is because pregnant women are not involved in clinical trials related to drug development process due to safety reasons and hence, most of these medicines come to market with limit information available about their safety in pregnancy. Hence, establishing a drug safety monitoring mechanism would be important to generate safety data when a given medicine is already in the market, especially medications against tropical diseases.
Pregnant women are at increased risk of malaria infection and illness than non-pregnant individuals due to physiological, hormonal and immunological changes that occur in their body after conception. The changes are also responsible for various therapeutic challenges that face this vulnerable group. This explains the presence of significant alteration of antimalarial pharmacokinetic (PK) properties in pregnancy and hence lead to a reduced drug blood concentration, which will ultimately lower antimalarial cure rate. Another factor that affects antimalarial effectiveness in pregnancy is parasite resistance against sulfadoxine-pyrimethamine (SP), a drug that is used for intermittent preventive treatment of malaria in pregnancy (IPTp).
The objectives of the thesis were to assess the magnitude of drugs exposure during pregnancy in relation to pregnancy outcomes, to describe the feasibility of establishing active pharmacovigilance system in developing countries using Health Demographic Surveillance System (HDSS) platform, to determine safety of artemether-lumefantrine (AL) exposure in first trimester of pregnancy, to evaluate pharmacokinetics and pharmacodynamics properties of artemether-lumefantrine in pregnant and non-pregnant women, and to determine the effectiveness of IPTp-SP in prevention of placental malaria, maternal anaemia and low birth weight in areas with different malaria transmission intensity.
Method: Three different study designs were used independently to respond to different specific objectives of this thesis; (i) a longitudinal follow up study was conducted to generate artemether/lumefantrine (AL) safety data in first trimester secondary to its inadvertent exposure in two Health Demographic Surveillance System (HDSS) areas in Tanzania. Pregnant women with gestational age ? 20 weeks were enrolled and followed up on monthly bases until delivery. Drugs exposures during the entire pregnancy period were also recorded. The latter was used to document the feasibility of establishing active pharmacovigilance system using HDSS platform in one of the studied HDSS area. (ii) To determine AL PK, a prospective study involving pregnant in second and third trimester and non-pregnant women, both with uncomplicated P falciparum malaria. Plasma samples were collected at pre-defined dates for bioassay to determine drug level. Participants were followed up on pre-defined schedule visits until day 42. Inter- and intra-individual variability was assessed and covariated effects quantified using a nonlinear mixed-effect modeling approach (NONMEM®). (iii) Another prospective study enrolling pregnant women to assess the effectiveness of IPTp in two areas with different malaria transmission intensity. Pregnant women were recruited in the labor ward and structured questionnaire was used for interview. Placental parasitaemia was screened by using both light microscope and real-time quantitative PCR.
Findings
Pharmacovigilance system
91% (994 of 1089) of pregnant women who were piloted to assess feasibility of establishing active PV system completed the follow up until delivery. 98% of pregnant women reported to have taken at least one medication during pregnancy, mainly drugs provided in the antenatal program. Other most reported drugs were analgesics (24%), antibiotics (17%) and antimalarials (15%), excluding IPTp. Iron and folate supplementations were associated with decreased risk of miscarriage/stillbirth (OR 0.1; 0.08 – 0.3).
AL safety
82% (1783 of 2167) of pregnant women who used and not used antimalarial drugs in first trimester were followed until delivery and recorded their pregnancy outcome. 319 (17.9%) used antimalarial drugs in first trimester and AL was the most frequent antimalarial used [53.9% (172 of 319)]. Others were 24.4 % quinine, 20.7% SP and 3.4% amodiaquine. Quinine exposure in first trimester was associated with increased risk of miscarriage/stillbirth (OR 2.5; 1.3 – 5.1) and premature birth (OR 2.6; 1.3 – 5.3). AL, SP and amodiaquine exposure were found not to be harmful.
PK analysis
33 pregnant women and 22 non-pregnant women with malaria were treated with AL (80/480mg) twice daily for 3 days. Lumefantrine (LF) bioavailability and metabolism rate into desmethyl-lumefantrine were respectively 34% lower and 78% higher in pregnant than in non-pregnant patients. Overall PCR uncorrected therapeutic failure was 18% in pregnant and 5% in non-pregnant women (OR 4.0; p value 0.22). A higher median day 7 LF concentration was associated with adequate clinical and parasitological response.
Effectiveness of IPTp
350 pregnant women were recruited and screened for placental parasitaemia (175 each from high and low malaria transmission areas). Prevalence of placenta parasitaemia was 16.6% in high transmission area and 2.3% in low transmission area. One or more doses of IPTp in high transmission area had 80% impact against placental malaria (OR 0.2; CI 0.06 – 0.7; p=0.015) and 60% in low transmission (OR 0.4; CI 0.04 – 4.5; p=0.478). Primigravida and residing in high transmission area were significant risk factors for placental malaria (OR 2.4; CI 1.1 – 5.0) and (OR 9.4; CI 3.2 – 27.7), respectively. The numbers needed to treat (NNT) was 4 (CI 2 – 4) women in high transmission area and 33 (CI 20 – 50) low transmission area to prevent one placental malaria. IPTp use was not statistically significant associated with decreased risk of maternal anaemia or low birth weight, regardless are of transmission intensity.
Conclusion:
Overall medicine use in pregnancy period is very high, including AL exposure in first trimester albeit this drug is not the first line treatment for malaria in early pregnancy. AL use in first trimester was safer as opposed to quinine, the first line drug which was associated with adverse pregnancy outcomes. We therefore recommend to consider other options than quinine for standard antimalarial drug in first trimester, and AL could be the best one.
HDSS platforms represent a reliable and feasible support to build on a pharmacovigilance system to assess safety of drugs in pregnancy since it has proved to be feasible. We recommend that pharmaceutical companies and other global financial bodies should invest more on the establishment of active pharmacovigilance system in pregnancy in tropical developing countries. The latter will boost safety data pool of newly marketed medicines and anti-infective agents for treating different illnesses in pregnancy.
LF bioavailability is significantly lowered in pregnant women due to altered PK properties as opposed to non-pregnant women in the same area. This may be responsible for therapeutic failure among pregnant women secondary to the observed low post-treatment prophylaxis. We recommend to evaluate a modified treatment regimen of malaria in pregnancy. ---------- Muhtasari
Utangulizi: Ugonjwa wa malaria kwa mama mjamzito ni tatizo kuu kwenye afya ya jamii hasa Africa kusini mwa jangwa la Sahara. Malaria ni miongoni mwa magonjwa yanayoweza kuzuilika. Ugonjwa huu unasababisha mazara makubwa sana kwa mtoto mchanga tokea akiwa tumboni kwa mama yake hasa sehemu zenye malaria kwa kiwango cha juu. Hivyo basi ni vema mama mjamzito atibiwe na dawa salama na zenye uwezo mkubwa wa kuangamiza vidudu vya malaria. Usalama wa dawa kwa mama mjamzito ni kitu chenye changamoto kubwa kutokana na uhaba wa takwimu muhimu za usalama wa dawa za malaria kwa wajawazito. Sababu kuu inatokana na mama wajawazito kutohusishwa kwenye majaribio ya dawa kipindi cha za mwanzoni pale ambapo dawa husika bado hazijapewa kibali cha kuingia sokoni kwa sababu ya kuhofia usalama wa kiafya hasa kwa mtoto aliyopo tumboni. Hilo linapelekea kwa dawa nyingi kuingia sokoni zikiwa na upungufu wa taarifa muhimu juu ya usalama wake kwa mama mjamzito. Kwa sababu hiyo, ni muhimu kuwa na mfumo wa kipekee wa kumfuatilia mama mjamzito pale atakapotumia dawa ambazo zipo tayari sokoni ili kuboresha taarifa za kiusalama kiafya kutokana na matumizi yake kipindi cha ujauzito.
Mama mjamzito anahatari kubwa ya kuambukizwa ugonjwa wa malaria pamoja na kuuguwa kuliko mama ambaye hana ujauzito. Hili linatokana na mabadiliko kipindi cha ujauzito ambayo yanasababishwa na kupunguwa kwa kinga ya mwili na mabadiliko ya homoni mwilini mwake. Mabadiliko haya yanachangia pia kuathiri ufanisi wa dawa mwilini kwake kupambana na vijidudu vya malaria na hivyo kupunguza uwezo wa uponyaji. Usugu wa dawa dhidi ya vijidudu vya malaria, kwa mfano dawa ya SP huchangia pia kuathiri uwezo wa kumponya mgonjwa wa malaria.
Dhumini kuu la utafiti huu ni (i) kujuwa wingi wa dawa anazotumia mama mjamzito ukilinganisha na matokeo ya mimba yake, (ii) kuonyesha uwezekano wa kuwa na mfumo pekee wa kudhibitisha matumizi ya dawa ambao utaweza kufuatilia usalama na matumizi ya dawa kwa ujumla kwa mama mjamzito, kwenye nchi inayoendelea kwa kutumia mfumo wa HDSS (Health Demographic Surveillance System), (iii) kuhakiki usalama wa matumizi ya dawa mseto (ALU) ya malaria kipindi cha mimba changa, (iv) kutathimini unyambulisho wa dawa ya mseto mwilini mwa mgonjwa sambamba na kulinganisha ufanisi wake wa kuangamiza vijidudu vya malaria, na (v) kutathimini ufanisi wa dawa ya SP ambayo mama mjamzito anapatiwa kliniki kama inasaidia kuangamiza vijidudu vya malari kwenye kondo la uzazi, kuzuia upungufu wa damu kwa mama na mtoto kutozaliwa na kilo pungufu kwenye maeneo yenye viwango tofauti vya maambukizo ya malaria.
Methodolojia: Njia tatu tofauti zilitumika kupata majibu husika ya malengo ya utafiti huu; (i) Kufuatilia mama wajawazito tokea kipindi cha mwanzo cha ujauzito wao hadi wanapojifungua na kurekodi taarifa za matumizi ya dawa (ikiwemo dawa mseto) na matokeo ya ujauzito. Zoezi hili lilifanyika kwenye vituo vya HDSS huko Rufiji na Kigoma mjini. (ii) Unyambulisho wa ufanisi wa dawa mseto uliwahusisha wanawake ambao ni wajawazito (wenye umri wa mimba kuanzia wiki 13 na kuendelea) na wale wasio wajawazito lakini wote wakiwa wametambulika hawana malaria kali. Walipewa dawa mseto na kutolewa damu kwa kipindi tofauti tofauti ndani ya siku 42 za kuwafuatilia ili kupima kiwango cha dawa kwenye damu na kuhakiki vijidudu vya malaria vinavyo angamia. (iii) Kuhakiki ufanisi wa SP kama kinga ya malaria kwa mama mjamzito (IPTp) ilihusisha kuwatambua akina mama wajawazito wakiwa kwenye hospitali mbili tofauti ambazo zipo kwenye maeneo yanye viwango tofauti vya uambukizaji wa malaria. Utambuzi wa akinamama hawa ulikuwa muda mfupi kabla hawajajifungua na ulihusisha kukusanya damu toka kwenye kondo la uzazi mara tu baada ya kujifungua na kupima kama kuna maambukizi ya vijidudu vya malaria.
Matokea: (i) Mfumo wa ukusanyaji taarifa ya matumizi ya dawa kipindi chote cha ujauzito. Asilimia 90 (994/1089) ya mama wajawazito waliweza kufuatiliwa mpaka walipo jifunguwa. Jumla ya 98% waliripoti kutumia walau aina moja ya dawa kipindi cha ujauzito, hasa zikiwa dawa zinazotolewa kwenye mpango maalumu wa mama na mtoto. Dawa nyingi zikiwa ni dawa za kuzuia maumivu (24%), antibayotiki (17%) na dawa za kutibu malaria (15%). Imeonekana dawa za kuongeza wingi wa dama zinahusiana na kupunguza hatari ya mimba kuharibika na mtoto kuzaliwa njiti.
(ii) Usalama wa dawa mseto: Jumla ya mama wajawazito 1783 kati ya 2167 (82%) waliyotumia na ambao hawajatumia dawa za malaria kipindi cha miezi mitatu ya mwanzo ya ujauzito walifuatiliwa na kurekodi matokeo yao ya ujauzito wao. 319 (17.9%) walitumia dawa za malaria kipindi hicho cha mwanzo cha ujauzito na kati ya hawa 53.9% walitumia dawa mseto. Wengine walitumia quinine (24.4%), SP (20.7%) na amodiaquine (3.4%). Matumizi ya quinine kipindi cha miezi mitatu ya mwanzo ya mimba yalihusishwa na kuharibika kwa mimba na kuzaa mtoto njiti. Dawa ya mseto, SP na amodiaquine zilionyesha kutokuwa na mathara yeyote.
(iii) Unyambulisho wa ufanisi ya dawa mseto: Utafiti huu ulihusisha wajawazito 33 na wanawake wasio wajawazito 22 waliyo na malaria na kutibiwa na dozi kamili ya dawa mseto mara mbili kutwa kwa siku 3. Sehemu ya dawa ya mseto ilionekana kuwa pungufu kwa wajawazito ukilinganisha na wale wasiyo wajawazito. Kwenye kipindi cha kuwafuatiliya wagonjwa (ndani ya siku 42), 18% ya wajawazito na 5% ya wasiyo wajawazito waligundulika kuwa bado wana vijidudu vya malaria. Kuwa na kiwango kikubwa cha dawa ya mseto kwenye mzunguko wa damu ulihusishwa na kupona malaria kwa ufasaha.
(iv) Ufanisi wa SP kama kinga ya malaria kwa mama mjamzito. Jumla ya mama wajawazito 350 walihusiswa kwenye utafiti huu, 175 toka kila sehemu yenye malaria ya kwa kiwango cha juu na pia toka kwenye sehemu ya malaria kwa kiwango cha chini. Maambukizo ya malaria kwenye kondo la uzazi ilikuwa 16.6% kwenye eneo la malaria cha kiwango cha juu na 2.3% kwenye eneo lenye malaria kwa kiwango cha chini. Matumizi ya SP yalionyesha uwezekano wa kuzuia maambukizi ya kondo la uzazi hasa eneo lenye malaria ya juu. Kuwa na ujauzito wa kwanza na kuishi eneo lenye malaria ya juu ni kiambata hatarishi cha kupata maambukizo ya kondo la uzazi
Hitimisho: Kwa ujumla matumizi ya dawa kipindi cha ujauzito yapo kwenye kiwangu cha juu, ikiwemo matumizi ya dawa mseto kwenye kipindi cha mimba changa, japokuwa dawa hii siyo chaguo la kwanza kwenye tiba ya malaria kwenye kipindi hichi. Dawa mseto imeonekana kuwa salama zaidi kuliko quinine hivyo ni bora kuanza kufikiria jinsi itakavyoweza kupendekezwa kwa matumizi kipindi cha mimba changa.
Kupitia HDSS imeonyesha inaweza kusaidia kuwa na mfumo wa uhakika na kuaminika wa kukusanya taarifa muhimu za matumizi ya dawa kwa mama mjamzito kwenye nchi masikini. Hivyo ni bora makampuni ya dawa, wafadhili kwa kushirikiana na taasisi za afya ndani na nje ya nchi wafikirie jinsi ya kufadhili mfumo huu ili kusaidia kuboresha takwimu za usalama wa dawa kwa mama wajawazito.
Imethibitika kuwa dawa mseto inapunguwa kwa kiasi kikubwa mwilini mwa mwanamke mjamzito ukilinganisha na mwanamke asiyo mjamzito. Hili huenda ikapelekea mama mjamzito kutopona kwa ufasaa na kupungukiwa uwezekano wa kukabiliyana na maambukizo mapya ya malaria kipindi cha usoni hasa baada ya kumaliza dozi ya malaria. Hivyo tunapendekeza kupitiwa upya dozi ya malaria inayotumika sasa na mama mjamzito na kushauri upatikanaji wa dozi mpya kwa hili kundi la wajawazito
Assessing malaria attributed mortality in west and southern Africa
No full textMalaria has persistently remained a serious health and socio-economic problem in developing nations particularly in Sub-Saharan Africa (SSA). There are approximately 500 million cases of malaria each year and close to one million deaths occurring mainly among children under five years. Developing countries spend a reasonable proportion of their gross domestic product (GDP) on malaria which in the end hinders their levels of development.
World Health Organizations (WHO) and partners through the Roll Back Malaria initiative (RBM) have targeted vector control, health promotion and case management (using rapid diagnostic tests and treatment with Artemisinin combination therapy) in order reduce malaria morbidity and mortality cases. Since 2002, funds for promoting malaria control activities have increased exponentially in SSA. Major donors include presidential malaria initiative (PMI) and Global fund to fight AIDS, tuberculosis and malaria (GFATM). Countries which have scaled up the recommended malaria control strategies such as insecticides-treat net (ITN) and treatment of confirmed cases have reported a decline in both morbidity and mortality especially among children. However, these statistics are based on health facilities data and yet in most developing countries many deaths occur at home and are never recorded due to inefficient vital registration systems. Monitoring the progress of such interventions requires reliable sources of data on both the transmission and infection outcome.
In malaria endemic areas, people acquire natural immunity during the early years of their life after getting exposed to repeated infections. This is observed from the reductions in the number of severe malaria-related morbidity and mortality cases especially in children >5 years. Due to the current undertakings that are aimed at reducing malaria exposure, there are concerns about shifting the disease burden to older children but the required to data to monitor this are not readily available in SSA. Low income countries have resorted to health and demographic surveillance systems (HDSS) to monitor routinely population changes and health outcomes within a defined geographical area.
In 2000, the INDEPTH, a network of HDSS integrated the Malaria Transmission Intensity and Mortality Burden Across Africa (MTIMBA) project into selected sites’ routine activities in order to assess the transmission-malaria mortality relationship taking into account the current interventions. Mortality data and other demographic characteristics were extracted from routinely collected HDSS databases. The entomological data were collected every fortnight from randomly sampled compounds over the 3 years MTIMBA period.
The MTIMBA project generated large geostatistical data that are correlated in space and time. Furthermore, the project captured longitudinal mosquito data that were characterized by many zeros especially during the dry periods. The zeros are due empty traps from a compound or when all the captured mosquitoes are not infectious. Appropriate data analysis therefore should apply models that account for spatial-temporal correlation and the excess zeros in order to avoid over or underestimation of parameters. Zero-inflated geostatistical models account for spatial-temporal correlation by introducing location-specific and time interval random effects which creates more parameters to estimate. Bayesian models implemented via Markov chain Monte Carlo simulation (MCMC) addresses fit of highly parameterized models.
This work applied zero-inflated Bayesian models to estimate malaria attributable mortality across all age-groups using large, correlated and sparse data collected from Navrongo and Manhiça HDSS between 2001 and 2004. The contributions of this thesis were (i) the description of the HDSS data characteristics and relevant methods for analysis; (ii) the spatially explicit estimates of malaria transmission intensity at monthly intervals; and (iii) the relationship between all-cause mortality and malaria transmission intensity across all age categories.
Chapter 2 described the characteristics of the MTIMBA data. These are large geostatistical, temporal, seasonal and zero-inflated data. The mortality and mosquito data were misaligned because they were captured at different compounds and time periods. Zero-inflated Bayesian spatio-temporal models are the state-of-art in handling such data. The rigorous statistical process was demonstrated by modelling sporozoite rate (SR) data from Manhiça HDSS. The analysis of the MTIMBA data was used as an avenue for building SSA capacity through course work, seminars and mentorship. Site-specific analyses are still on-going. However, the project generated data that is relevant for assessing within and between site malaria transmission heterogeneity.
The Navrongo malaria exposure surfaces described in chapter 3 were obtained from zero-inflated geostatistical models fitting separately the binomial SR data and negative binomial count data by mosquito species. All the models included space and time correlation in addition to the Climate, environmental and seasonality covariates. The entomological inoculation rate (EIR) estimates were derived as a product of predicted man biting rate and SR. Observed EIR in this district was >100 infective bites/person/year. Distance to water to bodies, day temperatures and vegetation were the main predictors of mosquito densities for the two species. The EIR maps clearly indicated that the temporal heterogeneity was stronger than the spatial variation in this area. The same situation was also observed from the analyses of the two MTIMBA sites of Rufiji (Tanzania) and Kisumu (Kenya).
Monthly malaria exposure surfaces (chapter 3) were linked to the nearest compounds where mortality was observed as described in chapter 4. Time to death data were split at monthly intervals in order to generate Bernoulli and binomial data that were modelled via logistic regression formulations. Spatio-temporal models were fitted to obtain age-specific mortality risk estimates. The model considered 2 covariates; natural logarithm transformed EIR estimates with their measurement errors and age. ITN variable was only included in neonates, post-neonates and child models. The analysis showed a positive log-linear relationship between all-cause mortality and malaria exposure in all the age groups but the association was only important among children (1-4 years) and people >= 60 years. ITN use showed a protective effect among all the under five children, confirming what was observed in Rufiji and Kisumu HDSS.
The methods used in estimating malaria exposure surfaces and mortality risks in chapters 3 and 4 were extended to Manhiça HDSS (Mozambique) data to describe the mortality-malaria transmission relationship for this area (chapter 5). The spatio-temporal age-specific models considered EIR estimates with their measurement errors (to account for the predictive uncertainty) and age as model covariates.
The distance to the nearest water bodies was the only important common predictor of An. funestus and An. gambiae mosquito densities. Malaria transmission intensity declined consistently in this area. The Model-based results indicated a positive log-linear relationship between all-cause mortality and malaria exposure across all age groups namely; the neonates (0-28 days), post-neonates (1-11months), children (1-4years), young people (5-14 years), adults (15- 59years) and old age (>=60 years).
This work contributes to further understand of malaria-mortality relationships. A positive association between mortality and malaria exposure among the under fives is consistent with what was reported from the MTIMBA sites of Rufiji and Kisumu. Completion of the remaining site-specific analyses followed by a meta-analysis will make a great contribution to malaria epidemiology. Further work however, should consider cohort analysis in order to ascertain whether malaria control interventions have caused a shift in the age of acquired immunity
Organisational levels and organisational charactistics: Oxfam GB and the disability movement in Uganda
No full textIn the past decade, Oxfam has streamlined and restructured its global activities in an attempt to professionalise and strategise. This move has affected the relationship between different Oxfam components and between Oxfam and its partners. A three layered approach, looking at structural elements, ideational elements and organisational learning, is used to pick apart the restructuring and its effects within the Oxfam GB head office, the Oxfam Ugandan Country Office, The National Union of Disabled Persons of Uganda (NUDIPU), and NUDIPU's district branches. The fate of disability issues within this picture reveal the inequalities involved between North and South, and the able bodied and persons with disabilities
Peacemaking in Africa : - a critical analysis of the relationship between the African Union and African sub-regional organizations in recent peacemaking initiatives
No full textThis thesis considers the question of how, in practice, a regional organization comes to take the leading role in managing a peacemaking intervention. More specifically, it considers which criteria, if any, are used in the choice of a lead actor in peacemaking efforts, and how the principles of 'subsidiarity, complementarity and comparative advantage,' as laid out in the Memorandum of Understanding between the AU and the subregional organizations, are being applied in this decision making. The recent example cases of Zimbabwe, Kenya and Cote d'Ivoire are specifically analyzed to show the reality of the working relationship in the present
Um modelo para identificar desperdícios de conhecimento relacionados à performance dos portfólios de projetos
No full textTese (doutorado) - Universidade Federal de Santa Catarina, Centro Tecnológico, Programa de Pós-Graduação em Engenharia de Produção, Florianópolis, 2015.Atualmente vários fatores são determinantes para se fazer uma gestão efetiva dos processos de negócios das empresas. Dentre estes, dois vêm se destacando: capital intelectual e gestão do conhecimento. Entretanto, verifica-se que há uma falta de entendimento e mensuração dos desperdícios de conhecimento, e estes desperdícios podem ocorrer com o capital intelectual, durante a gestão de um portfólio. Desta forma, o objetivo geral desta tese é desenvolver um modelo de identificação dos desperdícios de conhecimento em portfólio de projetos. Para alcançá-lo, foram estabelecidos os seguintes objetivos específicos: identificar junto à literatura os modelos existentes relacionados à mensuração do capital intelectual, determinar os conceitos de desperdícios de conhecimento, analisar a relação existente entre os desperdícios de conhecimento e a performance do portfólio de projetos, medir desperdícios de conhecimento em portfólio de projetos. O procedimento metodológico foi estruturado em três fases: pesquisa e análise da literatura, desenvolvimento metodológico e estudo de campo. A pesquisa e análise da literatura foi realizada com base em buscas sistemáticas e exploratórias da literatura, e buscou identificar os aspectos relacionados à gestão do capital intelectual, bem como dos desperdícios de conhecimento em um ambiente de gestão de portfólio de projetos. Durante a fase de desenvolvimento metodológico, realizou-se um survey, junto a especialistas, a fim de compreender e estruturar desperdício de conhecimento e perda de conhecimento, resultando na validação externa destes constructos. Com base nesta validação e nos elementos teóricos advindos da literatura, foi desenvolvido o modelo conceitual genérico para mensurar desperdícios de conhecimento. Na sequência, buscou-se dar especificidade ao modelo criando indicadores de desperdício de conhecimento relacionados ao objeto de estudo, que é a gestão de portfólio de projetos, resultando num modelo específico autorreflexivo (modelo de mensuração dos desperdícios de conhecimento em portfólio de projetos). O estudo de campo foi realizado no âmbito da cooperação existente entre o PPGEP, e a University of Skövde, School of Business (doutorado sanduíche), com nove empresas suecas intensivas em conhecimento que adotam a gestão de portfólios. Por meio de estudos de caso, utilizando de entrevistas semiestruturadas padronizadas que envolveram gestores de portfólio de projetos, visando não só validar empiricamente o modelo, bem como fazer os devidos ajustes e melhorias do mesmo. Como contribuições desta tese obteve-se: a estruturação e compreensão do que são desperdício de conhecimento, suas dimensões, bem como sua relevância e importância; A estruturação e compreensão do conceito de perda de conhecimento e sua importância; A diferenciação entre ambos os conceitos; O desenvolvimento de um modelo conceitual genérico para mensurar desperdícios de conhecimento, bem como do modelo autorreflexivo específico para gestão de portfólios que permite entender como, quando, onde e de que forma ocorrem os desperdícios de conhecimento em portfólio de projetos, possibilitando uma gestão baseada em evidências e permitindo ações de melhoria contínua do desempenho global.Abstract : Currently several factors are crucial for making company's effective business processes management. Among these, two has been increasing: intellectual capital and knowledge management. However, it appears that there is a lack of understanding and measuring knowledge waste, which can occur with the intellectual capital for the management of a portfolio. Thus, the general objective of this thesis is to develop an identification model of knowledge waste for portfolio management. To achieve this, the following specific objectives were established: identify at the literature existing models related to the measurement of intellectual capital; determine the concepts of knowledge waste; examine the relationship between the knowledge waste and project portfolio performance; measure knowledge waste in project portfolio. The methodological approach was structured in three groups of activities: literature, methodological development and field study. The literature review was based on systematic and exploratory searches of the literature, and sought to identify the aspects related to the management of intellectual capital and knowledge waste in a project portfolio management environment. The literature provided the theoretical elements about intellectual capital, waste knowledge, loss of knowledge, performance and construction of performance indicators. During the methodological development, a survey was conducted among the experts to understand and structure what is waste of knowledge and loss of consciousness, resulting in the external validation of these constructs. Based on this validation and theoretical elements coming from the literature, was developed the generic conceptual model to measure knowledge of waste. Next, was given the specificity to the model creating knowledge waste indicators related to the subject matter, which is the project portfolio management, resulting in a self reflective specific model. The field study was carried out under the existing cooperation between the PPGEP, and the University of Skövde, School of Business (PhD sandwich) with nine Swedish intensive knowledge companies that adopt portfolio management. Through case studies, using standardized semi-structured interviews involving project portfolio managers, aimed not only empirically validate the model and make the necessary adjustments and improvements thereof. As contributions of this thesis were obtained: the structuring and understanding of what is knowledge waste, its dimensions and its relevance and importance; The structuring and understanding the concept of knowledge loss and its importance; The differentiation between the two concepts; The development of a conceptual generic model to measure knowledge waste; And the specific self reflective model for portfolio management that allows to understand how, when, and where knowledge waste occur in project portfolio, enabling evidence-based management allowing actions for continual improvement of overall performance
Global Incidence and Risk Factors Associated With Postoperative Urinary Retention Following Elective Inguinal Hernia Repair
No full textImportance: Postoperative urinary retention (POUR) is a well-recognized complication of inguinal hernia repair (IHR). A variable incidence of POUR has previously been reported in this context, and contradictory evidence surrounds potential risk factors. Objective: To ascertain the incidence of, explore risk factors for, and determine the health service outcomes of POUR following elective IHR. Design, Setting, and Participants: The Retention of Urine After Inguinal Hernia Elective Repair (RETAINER I) study, an international, prospective cohort study, recruited participants between March 1 and October 31, 2021. This study was conducted across 209 centers in 32 countries in a consecutive sample of adult patients undergoing elective IHR. Exposure: Open or minimally invasive IHR by any surgical technique, under local, neuraxial regional, or general anesthesia. Main Outcomes and Measures: The primary outcome was the incidence of POUR following elective IHR. Secondary outcomes were perioperative risk factors, management, clinical consequences, and health service outcomes of POUR. A preoperative International Prostate Symptom Score was measured in male patients. Results: In total, 4151 patients (3882 male and 269 female; median [IQR] age, 56 [43-68] years) were studied. Inguinal hernia repair was commenced via an open surgical approach in 82.2% of patients (n = 3414) and minimally invasive surgery in 17.8% (n = 737). The primary form of anesthesia was general in 40.9% of patients (n = 1696), neuraxial regional in 45.8% (n = 1902), and local in 10.7% (n = 446). Postoperative urinary retention occurred in 5.8% of male patients (n = 224), 2.97% of female patients (n = 8), and 9.5% (119 of 1252) of male patients aged 65 years or older. Risk factors for POUR after adjusted analyses included increasing age, anticholinergic medication, history of urinary retention, constipation, out-of-hours surgery, involvement of urinary bladder within the hernia, temporary intraoperative urethral catheterization, and increasing operative duration. Postoperative urinary retention was the primary reason for 27.8% of unplanned day-case surgery admissions (n = 74) and 51.8% of 30-day readmissions (n = 72). Conclusions: The findings of this cohort study suggest that 1 in 17 male patients, 1 in 11 male patients aged 65 years or older, and 1 in 34 female patients may develop POUR following IHR. These findings could inform preoperative patient counseling. In addition, awareness of modifiable risk factors may help to identify patients at increased risk of POUR who may benefit from perioperative risk mitigation strategies.
SARS-CoV-2 vaccination modelling for safe surgery to save lives: data from an international prospective cohort study
No full textBackground Preoperative SARS-CoV-2 vaccination could support safer elective surgery. Vaccine numbers are limited so this study aimed to inform their prioritization by modelling. Methods The primary outcome was the number needed to vaccinate (NNV) to prevent one COVID-19-related death in 1 year. NNVs were based on postoperative SARS-CoV-2 rates and mortality in an international cohort study (surgical patients), and community SARS-CoV-2 incidence and case fatality data (general population). NNV estimates were stratified by age (18-49, 50-69, 70 or more years) and type of surgery. Best- and worst-case scenarios were used to describe uncertainty. Results NNVs were more favourable in surgical patients than the general population. The most favourable NNVs were in patients aged 70 years or more needing cancer surgery (351; best case 196, worst case 816) or non-cancer surgery (733; best case 407, worst case 1664). Both exceeded the NNV in the general population (1840; best case 1196, worst case 3066). NNVs for surgical patients remained favourable at a range of SARS-CoV-2 incidence rates in sensitivity analysis modelling. Globally, prioritizing preoperative vaccination of patients needing elective surgery ahead of the general population could prevent an additional 58 687 (best case 115 007, worst case 20 177) COVID-19-related deaths in 1 year. Conclusion As global roll out of SARS-CoV-2 vaccination proceeds, patients needing elective surgery should be prioritized ahead of the general population. The aim of this study was to inform vaccination prioritization by modelling the impact of vaccination on elective inpatient surgery. The study found that patients aged at least 70 years needing elective surgery should be prioritized alongside other high-risk groups during early vaccination programmes. Once vaccines are rolled out to younger populations, prioritizing surgical patients is advantageous
