Praziquantel-related visual disorders among recipients in mass drug administration campaigns in schistosomiasis endemic settings: Systematic review and meta-analysis protocol.

BACKGROUND: Hundreds of millions of doses of Praziquantel (PZQ) have been administered to persons with and without schistosomiasis living in schistosomiasis endemic settings, through the mass drug administration (MDA) strategy which started in the early 2000s. A recent publication suggested high risk of PZQ-related visual disorders, raising public health concerns. We aim to systematically synthesize evidence on the magnitude of PZQ-related visual disorders. METHODS: We will search PubMed, Google Scholar, CINAHL, SCOPUS, CENTRAL and LILACS from 1977 (when the first human clinical trials on PZQ started) to 31st May 2024, with no language restrictions. The key search terms will include "Praziquantel", "PZQ", "visual disorder", "adverse events", "side effects", "blurry vision" and "visual impairment" together with alternative terms and synonyms. All the countries endemic for schistosomiasis will be included as search terms. We will also search HINARI, Africa Journals Online, Thesis Databases and Preprint Repositories. Where necessary, we will contact expert researchers working in the field of schistosomiasis, UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), pharmaceutical industries, country-specific Food and Drug Authorities (FDAs) and the European Medicines Agency databases. We will search Conference Proceedings and reference lists of relevant studies for additional studies. At least two authors will independently select studies, extract data and assess risk of bias in the included studies. Any disagreements or discrepancies will be resolved through discussion between the reviewers. Heterogeneity will be explored graphically, and statistically using the I2-statistic. We will conduct random-effects meta-analysis when heterogeneity is appreciable, and express dichotomous outcomes (visual adverse events including excessive lacrimation, blurry vision and visual impairments) as risk ratio (RR) or Odds Ratio (OR) with their 95% confidence interval (CI). We will perform subgroup analysis to assess the impact of heterogeneity, and sensitivity analyses to test the robustness of the effect estimates. The overall level of evidence will be assessed using GRADE. EXPECTED OUTCOMES: The present review expects to identify and categorize visual disorders occurring after administration of PZQ, alone or in combination with other drugs. By synthesizing the data from multiple studies, the review aims to present a quantitative assessment of the risk or odds of experiencing a visual disorder in different populations after ingesting PZQ. The review will also generate insights into whether PZQ in combination with other drugs are associated with increased odds of visual disorders and whether the occurrence of visual disorders correlates with dosage or treatment duration. Policymakers, public health experts and stakeholders could rely on the review findings to deliver context-sensitive preventive chemotherapy programs by adjusting drug combinations or dosing schedules to reduce risk of visual adverse effects in populations treated with PZQ. The review aims to identify gaps in the current evidence regarding visual disorders following PZQ administration in schistosomiasis endemic settings which can serve as the basis for future research on important but unanswered questions. DISSEMINATION AND PROTOCOL REGISTRATION: The findings of this study will be disseminated through stakeholder forums, conferences, and peer-review publications. The review protocol has been registered in the International Prospective Register for Systematic Reviews (PROSPERO)- CRD42023417963.

Completion of three-dose hepatitis B vaccination cycle and associated factors among health care workers in the Greater Accra Region of Ghana.

BACKGROUND: Despite the availability of a safe and effective vaccine coupled with the awareness of the potential risk of Healthcare Workers acquiring Hepatitis B Virus infection, some HCWs never get vaccinated. Generally, hepatitis B vaccination coverage globally is below the expected level as adherence has remained poor in various healthcare settings, especially in developing countries. The objective of this study was to assess the completion of a three-dose Hepatitis B virus vaccination cycle and associated factors among healthcare workers in the Greater Accra Region of Ghana. METHODS AND MATERIALS: An analytical cross-sectional study was conducted and included 363 healthcare workers selected using probability sampling procedures. The participants were recruited from five facilities within the Greater Accra Region in the first half of 2018. A pretested questionnaire was used to collect data which was analyzed using SPSS version 21. The proportion of healthcare workers receiving the recommended 3 doses of the hepatitis vaccine was computed. The multivariable analysis procedure identified the factors associated with adherence to the receipt of three doses of the hepatitis B vaccine. Odds ratios were estimated with corresponding confidence intervals with the level of significance set at 0.05. RESULTS: A total of 340 sample units were included in the analysis. Most of the participants (252/340, 74.1%) were females, mainly nurses/midwives (162/340, 47.6%) with a mean age of 34.5 (SD ±7.7). A high proportion of the participants (82.7%) have tertiary/post-tertiary level education and ever participated in at least one training workshop on the prevention of blood-borne infections (80.6%). Overall vaccination uptake was 60.9% (207/340) (95% CI = 55.7%-66.1%). Complete vaccination coverage (three doses) was 46.8% (159/340). High-risk perception (AOR = 4.0; 95% CI = 1.3-12.5), and previous training in infection prevention (AOR = 2.8; 95% CI = 1.1-7.5) were significantly associated with adherence to receipt of three doses of hepatitis B vaccine. CONCLUSION: Adherence to three-dose hepatitis B vaccination cycles is not universal among the healthcare workers in the Greater Accra Region. Receipt of the three-dose regimen is significantly associated with high-risk perception and attendance of training in infectious disease prevention. Interventions to increase risk perception and training in the prevention of blood-borne infections could improve adherence to complete/full vaccination protocol among healthcare workers who are at constant risk of exposure to the hepatitis B virus.

Malaria vaccine-related adverse events among children under 5 in sub-Saharan Africa: systematic review and meta-analysis protocol.

INTRODUCTION: The RTS,S vaccine has been approved for use in children under 5 living in moderate to high malaria transmission areas. However, clinically important adverse events have been reported in countries in sub-Saharan Africa. This systematic review aims to assess the frequency, severity and clinical importance of vaccine-related adverse events. METHODS AND ANALYSIS: This systematic review protocol has been prepared following robust methods and reported in line with the Preferred Reporting Items for Systematic reviews and Meta-Analyses for protocols guidelines. We will search PubMed, CINAHL, LILACS, Google Scholar, SCOPUS, WEB OF SCIENCE, Cochrane library, HINARI, African Journals Online, Trip Pro and TOXNET from 2000 to 30 September 2023, without language restrictions. We will also search conference proceedings, dissertations, World Bank Open Knowledge Repository, and WHO, PATH, UNICEF, Food and Drugs Authorities and European Medicines Agency databases, preprint repositories and reference lists of relevant studies for additional studies. Experts in the field will be contacted for unpublished or published studies missed by our searches. At least two reviewers will independently select studies and extract data using pretested tools and assess risk of bias in the included studies using the Cochrane risk of bias tool. Any disagreements will be resolved through discussion between the reviewers. Heterogeneity will be explored graphically, and statistically using the I2 statistic. We will conduct random-effects meta-analysis when heterogeneity is appreciable, and express dichotomous outcomes (serious adverse events, cerebral malaria and febrile convulsion) as risk ratio (RR) with their 95% CI. We will perform subgroup analysis to assess the impact of heterogeneity and sensitivity analyses to test the robustness of the effect estimates. The overall level of evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation. ETHICS AND DISSEMINATION: Ethical approval is not required for a systematic review. The findings of this study will be disseminated through stakeholder forums, conferences and peer-review publications. PROSPERO REGISTRATION NUMBER: CRD42021275155.

Psychosocial interventions and their effectiveness on quality of life among elderly persons living with HIV in Africa South of the Sahara: Systematic review and meta -analysis protocol.

BACKGROUND: The number of elderly people living with HIV (EPLHIV) has increased significantly as a result of antiretroviral treatment (ART) and this has brought about a variety of psychosocial challenges that have an impact on their quality of life (QoL). Various psychosocial interventions have been tried or implemented in Sub-Saharan Africa (SSA) to improve QoL of EPLHIV. However, there is paucity of data on the types and effectiveness of these interventions. This systematic review, therefore, aims to explore available psychosocial interventions in SSA and their effectiveness in improving the QoL of EPLHIV. METHODS: We will search PubMed, PsycINFO, LILACS, Cochrane Library, Google Scholar, HINARI, Africa Journals Online, Scopus and Web of Science to retrieve publications on psychosocial interventions implemented to improve QoL of EPLHIV from inception of the identified databases to 31st December 2023 without language restrictions. Also, supplementary sources such as conference proceedings, preprint repositories, databases of dissertations, as well as WHO and governmental databases can be explored for additional studies. For unpublished studies, trial registries and experts would be contacted, and reference lists of retrieved papers will be manually searched. Retrieved studies will be deduplicated using Mendeley and exported to Rayyan. At least two reviewers will independently select studies, extract data and assess the quality of the included studies using validated tools. Dichotomous outcomes data will be assessed and reported as odds ratio (OR) or risk ratio (RR) and for continuous outcomes, mean difference (MD) will be used; all reported with their 95% confidence interval (CI). Heterogeneity will be explored graphically by inspecting the overlapping of CIs and assessed quantitatively using the I2 statistic. EXPECTED OUTCOMES: This systematic review will be the first to rigorously identify psychosocial intervention on QoL of EPLHIV in SSA and assess their effectiveness with the aim to provide regional and country- specific data that will inform the selection and implementation of appropriate and socially acceptable policies across countries in SSA. Key findings of the review are expected to contribute critical evidence on availability, types and effectiveness of psychosocial interventions for improving quality of life of vulnerable elderly persons in SSA living with HIV. Furthermore, the review will explore any variation and possible correlates of psychosocial interventions by age, sex, CD4 count (if available), setting and geographic location within SSA that will provide healthcare professionals with reliable evidence, with the ultimate goal of inspiring countries in SSA to adopt innovative interventions to improve HIV care. TRIAL REGISTRATION: Systematic review registration: The systematic review protocol has been registered in the International Prospective Register for Systematic Reviews (PROSPERO), with registration ID CRD42021278218.

Burden of mental health problems among pregnant and postpartum women in sub-Saharan Africa: systematic review and meta-analysis protocol.

INTRODUCTION: Pregnancy and postpartum-related mental health problems pose serious public health threat to the society, but worryingly, neglected in sub-Saharan Africa (SSA). This review will assess the burden and distribution of maternal mental health (MMH) problems in SSA, with the aim to inform the implementation of context sensitive interventions and policies. METHODS AND ANALYSIS: All relevant databases, grey literature and non-database sources will be searched. PubMed, LILAC, CINAHL, SCOPUS and PsycINFO, Google Scholar, African Index Medicus, HINARI, African Journals Online and IMSEAR will be searched from inception to 31 May 2023, without language restriction. The reference lists of articles will be reviewed, and experts contacted for additional studies missed by our searches. Study selection, data extraction and risk of bias assessment will be done independently by at least two reviewers and any discrepancies will be resolved through discussion between the reviewers. Binary outcomes (prevalence and incidence) of MMH problems will be assessed using pooled proportions, OR or risk ratio and mean difference for continuous outcomes; all will be presented with their 95% CIs. Heterogeneity will be investigated graphically for overlapping CIs and statistically using the I2 statistic and where necessary subgroup analyses will be performed. Random-effects model meta-analysis will be conducted when heterogeneity is appreciable, otherwise fixed-effect model will be used. The overall level of evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation. ETHICS AND DISSEMINATION: Although no ethical clearance or exemption is needed for a systematic review, this review is part of a larger study on maternal mental health which has received ethical clearance from the Ethics Review Committee of the Ghana Health Service (GHS-ERC 012/03/20). Findings of this study will be disseminated through stakeholder forums, conferences and peer review publications. PROSPERO REGISTRATION NUMBER: CRD42021269528.

Malaria and typhoid fever among patients presenting with febrile illnesses in Ga West Municipality, Ghana.

BACKGROUND: Clinicians in areas where malaria and typhoid fever are co-endemic often treat infected patients irrationally, which may lead to the emergence of drug resistance and extra cost to patients. This study determined the proportion of febrile conditions attributable to either malaria and/or typhoid fever and the susceptibility patterns of Salmonella spp. isolates to commonly used antimicrobial agents in Ghana. METHODS: One hundred and fifty-seven (157) febrile patients attending the Ga West Municipal Hospital, Ghana, from February to May 2017 were sampled. Blood samples were collected for cultivation of pathogenic bacteria and the susceptibility of the Salmonella isolates to antimicrobial agents was performed using the Kirby-Bauer disk diffusion method with antibiotic discs on Müller Hinton agar plates. For each sample, conventional Widal test for the detection of Salmonella spp was done as well as blood film preparation for detection of Plasmodium spp. Data on the socio-demographic and clinical characteristics of the study participants were collected using an android technology software kobo-collect by interview. RESULTS: Of the total number of patients aged 2-37 years (median age = 6 years, IQR 3-11), 82 (52.2%) were females. The proportion of febrile patients with falciparum malaria was 57/157 (36.3%), while Salmonella typhi O and H antigens were detected in 23/157 (14.6%) of the samples. The detection rate of Salmonella spp in febrile patients was 10/157 (6.4%). Malaria and typhoid fever coinfection using Widal test and blood culture was 9 (5.7%) and 3 (1.9%), respectively. The isolates were highly susceptible to cefotaxime, ceftriaxone, ciprofloxacin, and amikacin but resistant to ampicillin, tetracycline, co-trimoxazole, gentamicin, cefuroxime, chloramphenicol, and meropenem. CONCLUSION: Plasmodium falciparum and Salmonella spp coinfections were only up to 1.9%, while malaria and typhoid fever, individually, were responsible for 36.3% and 6.4%, respectively. Treatment of febrile conditions must be based on laboratory findings in order not to expose patients to unnecessary side effects of antibiotics and reduce the emergence and spread of drug resistance against antibiotics.

Implementation of Medicines Pricing Policies in Ghana: The Interplay of Policy Content, Actors' Participation, and Context.

BACKGROUND: Implementing medicines pricing policy effectively is important for ensuring equitable access to essential medicines and ultimately achieving universal health coverage. However, published analyses of policy implementations are scarce from low- and middleincome countries. This paper contributes to bridging this knowledge gap by reporting analysis of implementation of two medicines pricing policies in Ghana: value-added tax (VAT) exemptions and framework contracting (FC) for selected medicines. We analysed implications of actor involvements, contexts, and contents on the implementation of these policies, and the interplay between these. This paper should be of interest, and relevance, to policy designers, implementers, the private sector and policy analysts. METHODS: Data were collected through document reviews (n=18), in-depth interviews (n=30), focus groups (n=2) and consultative meetings (n=6) with purposefully identified policy actors. Data were analysed thematically, guided by the four components of the health policy triangle framework. RESULTS: The nature and complexity of policy contents determined duration and degree of formality of implementation processes. For instance, in the FC policy, negotiating medicines prices and standardizing the tendering processes lengthened implementation. Highly varied stakeholder participation created avenues for decision-making and promoted inclusiveness, but also raised the need to manage different agendas and interests. Key contextual enablers and constraints to implementation included high political support and currency depreciation, respectively. The interrelatedness of policy content, actors, and context influenced the timeliness of policy implementations and achievement of intended outcomes, and suggest five attributes of effective policy implementation: (1) policy nature and complexity, (2) inclusiveness, (3) organizational feasibility, (4) economic feasibility, and (5) political will and leadership. CONCLUSION: Varied contextual factors, active participation of stakeholders, nature, and complexity of policy content, and structures have all influenced the implementation of medicines pricing policies in Ghana.

Implementation of medicines pricing policies in sub-Saharan Africa: systematic review.

BACKGROUND: High medicine prices contribute to increasing cost of healthcare worldwide. Many patients with limited resources in sub-Saharan Africa (SSA) are confronted with out-of-pocket charges, constraining their access to medicines. Different medicine pricing policies are implemented to improve affordability and availability; however, evidence on the experiences of implementations of these policies in SSA settings appears limited. Therefore, to bridge this knowledge gap, we reviewed published evidence and answered the question: what are the key determinants of implementation of medicines pricing policies in SSA countries? METHODS: We identified policies and examined implementation processes, key actors involved, contextual influences on and impact of these policies. We searched five databases and grey literature; screening was done in two stages following clear inclusion criteria. A structured template guided the data extraction, and data analysis followed thematic narrative synthesis. The review followed best practices and reported using PRISMA guidelines. RESULTS: Of the 5595 studies identified, 31 met the inclusion criteria. The results showed thirteen pricing policies were implemented across SSA between 2003 and 2020. These were in four domains: targeted public subsides, regulatory frameworks and direct price control, generic medicine policies and purchasing policies. Main actors involved were government, wholesalers, manufacturers, retailers, professional bodies, community members and private and public health facilities. Key contextual barriers to implementation were limited awareness about policies, lack of regulatory capacity and lack of price transparency in external reference pricing process. Key facilitators were favourable policy environment on essential medicines, strong political will and international support. Evidence on effectiveness of these policies on reducing prices of, and improving access to, medicines was mixed. Reductions in prices were reported occasionally, and implementation of medicine pricing policy sometimes led to improved availability and affordability to essential medicines. CONCLUSIONS: Implementation of medicine pricing policies in SSA shows some mixed evidence of improved availability and affordability to essential medicines. It is important to understand country-specific experiences, diversity of policy actors and contextual barriers and facilitators to policy implementation. Our study suggests three policy implications, for SSA and potentially other low-resource settings: avoiding a 'one-size-fits-all' approach, engaging both private and public sector policy actors in policy implementation and continuously monitoring implementation and effects of policies. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020178166.

Challenges with adherence to the 'test, treat, and track' malaria case management guideline among prescribers in Ghana.

BACKGROUND: Despite several efforts at addressing the barriers to adherence to the WHO-supported test, treat and track (T3) malaria case management guideline in Ghana, adherence remains a challenge. This study explored the challenges of prescribers regarding adherence to the T3 guideline. METHODS: This was an explorative study using key informant interviews amongst prescribers comprising medical doctors, physician assistants, nurses and a health extension worker from 16 health facilities in six districts in Ghana. The data was analysed using Nvivo 10 and organized into thematic areas. RESULTS: Prescribers lauded the guideline on testing and treatment as it ensures the quality of malaria case management, but irregular supply of malaria rapid diagnostic test kits (RDT), mistrust of laboratory tests, and the reluctance of prescribers to change from presumptive treatment were key barriers to testing. Patients with malaria test negative results if not treated, revisiting the facility with severe malaria, the experience of prescribers, lack of regular training and supervision for old and new staff and the inability of prescribers to investigate non-malaria fever hindered adherence to results-based treatment. CONCLUSION: As malaria remains a significant cause of morbidity and mortality in Ghana, this study provides insights on gaps in adherence to the testing and treatment of malaria. While the diagnostic capacity for malaria case management is a challenge, the lack of training resulting in the inability of some prescribers to investigate non-malaria fever hinders adherence to the malaria case management guideline. Therefore, there is a need to train new prescribers, laboratory personnel, and other staff involved in malaria diagnosis and treatment on the malaria case management guideline before they assume duty. Equipping laboratory personnel and prescribers with the knowledge to investigate non-malaria fevers could improve adherence to the guideline for improved patient care.

Contribution of child health interventions to under-five mortality decline in Ghana: A modeling study using lives saved and missed opportunity tools.

BACKGROUND: Increased coverage of interventions have been advocated to reduce under-five mortality. However, Ghana failed to achieve the Millennium Development Goal on child survival in 2015 despite improved coverage levels of some child health interventions. Therefore, there is the need to determine which interventions contributed the most to mortality reduction and those that can further rapidly reduce mortality to inform the prioritization of the scale-up of interventions. MATERIALS AND METHODS: Deterministic mathematical modeling was done using Lives Saved and Missed Opportunity Tools. Secondary data was used, and the period of the evaluation was between 2008 and 2014. Some of the interventions assessed were complementary feeding, skilled delivery, and rotavirus vaccine. RESULTS: A total of 48,084 lives were saved from changes in coverage of interventions and a reduction in the prevalence of stunting and wasting. Reduction in wasting prevalence saved 10,372(21.6%) lives, insecticide-treated net/indoor residual spraying 6,437(13.4%) lives saved, reduction in stunting 4,315(9%) lives saved and artemisinin-based combination therapy (ACTs) 4,325(9.0%) lives saved. If coverage levels of interventions in 2014 were scaled up to 90% in 2015, among neonates, full supportive care for prematurity (5,435 lives saved), full supportive care for neonatal sepsis/pneumonia (3,002 lives saved), and assisted vaginal delivery (2,163 lives saved), would have saved the most lives among neonates, while ACTs (4,925 lives saved), oral rehydration salts (ORS) (2,056 lives saved), and antibiotics for the treatment of pneumonia (1,805 lives saved) would have made the most impact on lives saved among children 1-59 months. Lastly, if all the interventions were at 100% coverage in 2014, the under-five mortality rate would have been 40.1 deaths per 1,000 live births in 2014. DISCUSSION: The state of the package of interventions will likely not lead to rapid mortality reduction. Coverage and quality of childbirth-related interventions should be increased. Additionally, avenues to further reduce stunting and wasting, including increased breastfeeding and complementary feeding, will be beneficial.

Clinical characteristics of external bacterial ocular and periocular infections and their antimicrobial treatment patterns among a Ghanaian ophthalmic population.

Empirical antimicrobial therapy is linked to a surge in antimicrobial resistant infections. However, an insight on the bacteria etiology of ocular infections is essential in the appropriation of choice of antimicrobial among clinicians, yet there remains a dearth of data from Ghana. We investigated the bacteria etiology of external ocular and periocular infections and antimicrobial treatment patterns among a Ghanaian ophthalmic population. A multicenter study design with purposive sampling approach was employed. Patients demographics and clinical data were collated using a pretested structure questionnaire. Cornea specimens and conjunctival swabs were obtained for bacterial isolation following standard protocols. About 95% (98/103) of ocular samples were positive for bacteria culture. The proportion of Gram-negative bacteria was 58.2%, and the predominant bacteria species were Pseudomonas aeruginosa 38.8% and Staphylococcus aureus 27.6%. Conjunctivitis 40.0% and keratitis 75.0% were mostly caused by Pseudomonas aeruginosa. The routinely administered antimicrobial therapy were polymyxin B 41.2%, neomycin 35.1% and ciprofloxacin 31.6%. Participants demographic and clinical characteristics were unrelated with positive bacteria culture (p > 0.05). Our results showed a markedly high burden of ocular bacterial infections and variations in etiology. Bacterial infection-control and antimicrobial agent management programs should be urgently institutionalized to prevent the emergence of resistant infections.

Review of 2022 WHO guidelines on the control and elimination of schistosomiasis.

Schistosomiasis is a helminthiasis infecting approximately 250 million people worldwide. In 2001, the World Health Assembly (WHA) 54.19 resolution defined a new global strategy for control of schistosomiasis through preventive chemotherapy programmes. This resolution culminated in the 2006 WHO guidelines that recommended empirical treatment by mass drug administration with praziquantel, predominately to school-aged children in endemic settings at regular intervals. Since then, school-based and community-based preventive chemotherapy programmes have been scaled-up, reducing schistosomiasis-associated morbidity. Over the past 15 years, new scientific evidence-combined with a more ambitious goal of eliminating schistosomiasis and an increase in the global donated supply of praziquantel-has highlighted the need to update public health guidance worldwide. In February, 2022, WHO published new guidelines with six recommendations to update the global public health strategy against schistosomiasis, including expansion of preventive chemotherapy eligibility from the predominant group of school-aged children to all age groups (2 years and older), lowering the prevalence threshold for annual preventive chemotherapy, and increasing the frequency of treatment. This Review, written by the 2018-2022 Schistosomiasis Guidelines Development Group and its international partners, presents a summary of the new WHO guideline recommendations for schistosomiasis along with their historical context, supporting evidence, implications for public health implementation, and future research needs.

Powers, engagements and resultant influences over the design and implementation of medicine pricing policies in Ghana.

INTRODUCTION: Universal availability and affordability of essential medicines are determined by effective design and implementation of relevant policies, typically involving multiple stakeholders. This paper examined stakeholder engagements, powers and resultant influences over design and implementation of four medicines pricing policies in Ghana: Health Commodity Supply Chain Master Plan, framework contracting for high demand medicines, Value Added Tax (VAT) exemptions for selected essential medicines, and ring-fencing medicines for local manufacturing. METHODS: Data were collected using reviews of policy documentation (n=16), consultative meetings with key policy actors (n=5) and in-depth interviews (n=29) with purposefully identified national-level policymakers, public and private health professionals including members of the National Medicine Pricing Committee, pharmaceutical wholesalers and importers. Data were analysed using thematic framework. RESULTS: A total of 46 stakeholders were identified, including representatives from the Ministry of Health, other government agencies, development partners, pharmaceutical industry and professional bodies. The Ministry of Health coordinated policy processes, utilising its bureaucratic mandate and exerted high influences over each policy. Most stakeholders were highly engaged in policy processes. Whereas some led or coproduced the policies in the design stage and participated in policy implementation, others were consulted for their inputs, views and opinions. Stakeholder powers reflected their expertise, bureaucratic mandates and through participation in national level consultation meetings, influences policy contents and implementation. A wider range of stakeholders were involved in the VAT exemption policies, reflecting their multisectoral nature. A minority of stakeholders, such as service providers were not engaged despite their interest in medicines pricing, and consequently did not influence policies. CONCLUSIONS: Stakeholder powers were central to their engagements in, and resultant influences over medicine pricing policy processes. Effective leadership is important for inclusive and participatory policymaking, and one should be cognisant of the nature of policy issues and approaches to policy design and implementation.

Spontaneous reporting of adverse drug reaction among health professionals in Ghana.

BACKGROUND: Spontaneous reporting of adverse drug reactions (ADR) is an effective means of ensuring postmarketing surveillance of drugs, and health professionals play a cardinal role through voluntary reporting of ADR. However, the pharmacovigilance system in Ghana is plagued with under-reporting issues, which is of public health concern. METHOD: A questionnaire-based cross-sectional study involving 268 health professionals at Kpone-Katamanso District was carried out. Data on spontaneous reporting of ADR, demographics of participants, knowledge, and attitudes of professionals towards reporting and factors that may influence ADR reporting were collected. Logistic regression models were used to examine the association of the independent variables with spontaneous reporting of ADR. RESULT: Overall, 77.6% (208) of the 268 respondents had observed ADR; however, only 17.3% of the respondents had ever reported an ADR to the Ghana FDA. Health professionals who had average knowledge on spontaneous reporting of ADR were 51.9%, while 30.3% had good knowledge of spontaneous reporting of ADR. After adjustment on potential confounding variables (Knowledge, Feedback from FDA, Uncertainty about cause of ADR, Severity of ADR), Age (AOR = 2.26, 95%CI = 1.25-4.10), Fear of Legal Consequences (AOR = 0.15, 95%CI = 0.41-0.51), Time Constraint (AOR = 0.3, 95%CI = 0.10-0.91), Pharmacovigilance training (AOR = 18.78, 95%CI = 5.46-64.59) and Unavailability of Reporting form (AOR = 0.28, 95%CI = 0.09-0.88) were found to be significantly associated spontaneous reporting of ADR. CONCLUSION: The proportion of health professionals in the Kpone- Katamanso District who spontaneously reported observed ADR was low though they had average knowledge about ADR reporting. This underscores the need for a policy to be implemented that makes spontaneous reporting of adverse drug reaction mandatory for health professionals.

Determinants of blood glucose control among people with Type 2 diabetes in a regional hospital in Ghana.

AIMS: To assess the determinants of glycaemic control among patients with Type 2 diabetes mellitus (T2DM) presenting at the Greater Accra Regional Hospital, Ghana. METHODS: The study employed semi-structured questionnaires and review of clinical records of patients 16 years and above with Type 2 Diabetes. RESULTS: The mean age of participants was 56.6 ± 13.8 years, with majority (71.6%) being females. A total of 161 (59.4%) of patients had poor glycaemic control (HbA1c ≥8.1%; 95% CI: 53.6 to 65.3%). Poor glycaemic control was significantly associated with high body mass index of the patient (AOR 13.22; 95% CI: 1.95 to 89.80), having only elementary education (AOR 5.22, 95% CI 2.12-12.86, p<0.0001) and being on insulin therapy (AOR 2.88; 95% CI: 1.05 to 7.88). On the other hand, seldom coffee intake (AOR: 0.27; 95% CI: 0.11 to 0.64), high physical activity (AOR 1.57, 95% CI 1.06-2.35, p = 0.025) and having a cardiovascular disease (AOR: 0.15; 95% CI: 0.05 to 0.46) appeared to positively influence glycaemic control. Self-monitoring of blood glucose and diet interventions did not appear to influence glycaemic control. CONCLUSIONS: The study results showing that a high proportion of patients attending the Diabetes Clinic with uncontrolled diabetes has serious implications for the management of T2DM diabetes as it suggests that current hospital-based treatment measures are less effective. Comprehensive management of T2DM targeting all the key factors identified in this study and incorporating a multispectral collaborative effort based on holistic approach, combined with non-pharmacological components are strongly warranted.

Are maternal and child health initiatives helping to reduce under-five mortality in Ghana? Results of a quasi-experimental study using coarsened exact matching.

BACKGROUND: Despite a 53 % decline in under-five mortality (U5M) worldwide during the period of the Millennium Development Goals (MDGs), U5M remains a challenge. Under-five mortality decline in Ghana is slow and not parallel with the level of coverage of child health interventions. The interventions promoted to improve child survival include early initiation of breastfeeding, clean postnatal care, and skilled delivery. This study sought to assess the effectiveness of these interventions on U5M in Ghana. METHODS: A quasi-experimental study was conducted using secondary data of the 2008 and 2014 Ghana Demographic and Health Surveys. Coarsened Exact Matching and logistic regression were done. The interventions assessed were iron intake, early initiation of breastfeeding, clean postnatal care, hygienic disposal of stool, antenatal care visits, skilled delivery, intermittent preventive treatment of malaria in pregnancy, and tetanus toxoid vaccine. RESULTS: There were 2,045 children under-five years and 40 (1.9 %) deaths in 2008. In 2014, the total number of children under-five years was 4,053, while deaths were 53(1.2 %). In 2014, children less than one month old formed 1.6 % of all children under-five years, but 47.8 % of those who died. Mothers who attended four or more antenatal care visits were 78.2 % in 2008 and 87.0 % in 2014. Coverage levels of improved sanitation and water connection in the home were among the lowest, with 11.6 % for improved sanitation and 7.3 % for water connection in the home in 2014. Fifty-eight (58), 1.4 %, of children received all the eight (8) interventions in 2014, and none of those who received all these interventions died. After controlling for potential confounders, clean postnatal care was associated with a 66% reduction in the average odds of death (aOR = 0.34, 95 %CI:0.14-0.82), while early initiation of breastfeeding was associated with a 62 % reduction in the average odds of death (aOR = 0.38, 95 % CI: 0.21-0.69). CONCLUSIONS: Two (clean postnatal care and early initiation of breastfeeding) out of eight interventions were associated with a reduction in the average odds of death. Thus, a further decline in under-five mortality in Ghana will require an increase in the coverage levels of these two high-impact interventions.

COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines' Side Effects.

BACKGROUND: Coronavirus disease (COVID-19) vaccine-related side effects have a determinant role in the public decision regarding vaccination. Therefore, this study has been designed to actively monitor the safety and effectiveness of COVID-19 vaccines globally. METHODS: A multi-country, three-phase study including a cross-sectional survey to test for the short-term side effects of COVID-19 vaccines among target population groups. In the second phase, we will monitor the booster doses' side effects, while in the third phase, the long-term safety and effectiveness will be investigated. A validated, self-administered questionnaire will be used to collect data from the target population; Results: The study protocol has been registered at ClinicalTrials.gov, with the identifier NCT04834869. CONCLUSIONS: CoVaST is the first independent study aiming to monitor the side effects of COVID-19 vaccines following booster doses, and the long-term safety and effectiveness of said vaccines.

Burden of malaria in children under five and caregivers' health-seeking behaviour for malaria-related symptoms in artisanal mining communities in Ghana.

BACKGROUND: Artisanal mining creates enabling breeding ground for the vector of malaria parasites. There is paucity of data on the effects of artisanal mining on malaria. This study assessed burden of malaria and caregivers' health-seeking behaviour for children under five in artisanal mining communities in East Akim District in Ghana. METHODS: A cross-sectional study involving caregivers and their children under five was conducted in three artisanal mining communities in the East Akim District in Ghana. Caregivers were interviewed using a structured questionnaire. Finger prick blood samples were collected and analysed for haemoglobin concentration using a rapid diagnostic test, and thick and thin blood smears were analysed to confirm the presence of malaria parasites. RESULTS: Of the 372 children under 5 years included in the study, 197 (53.1%) were male, with a mean age (± SD) of 23.0 ± 12.7 months. The proportion of children with malaria (Plasmodium falciparum and P. malariae) was 98.1% and 1.9%, respectively, whilst the proportion with anaemia (Hb < 11.0 g/dl) was 39.5% (n = 147). Almost all caregivers were female (98.9%), and 28.6% (n = 106) did not have access to any malaria control information. Caregivers associated malaria infection with mosquito bites (68.3%, n = 254) and poor sanitation (21.2%, n = 79). Malaria in children under five was significantly associated with anaemia (OR 11.07, 95% CI 6.59-18.68, n = 111/160, 69.4%; P < 0.0001), residing close to stagnant water (≤ 25 m) from an artisanal mining site (AOR 2.91, 95% CI 1.47-5.76, P = 0.002) and caregiver age younger than 30 years (OR 0.44, 95% CI 0.208-0.917, n = 162, 43.55%, P = 0.001). CONCLUSIONS: There is a high burden of malaria and anaemia among children under five in artisanal mining communities of the East Akim District, and far higher than in non-artisanal mining sites. Interventions are needed to effectively regulate mining activities in these communities, and strengthen malaria control and health education campaigns to curtail the high malaria burden and improve health-seeking behaviour.

Protocol for a realist synthesis of health systems responsiveness in low-income and middle-income countries.

INTRODUCTION: Health systems responsiveness is a key objective of any health system, yet it is the least studied of all objectives particularly in low-income and middle-income countries. Research on health systems responsiveness highlights its multiple elements, for example, dignity and confidentiality. Little is known, however, about underlying theories of health systems responsiveness, and the mechanisms through which responsiveness works. This realist synthesis contributes to bridging these two knowledge gaps. METHODS AND ANALYSIS: In this realist synthesis, we will use a four-step process, comprising: mapping of theoretical bases, formulation of programme theories, theory refinement and testing of programme theories using literature and empirical data from Ghana and Vietnam. We will include theoretical and conceptual pieces, reviews, empirical studies and grey literature, alongside the primary data. We will explore responsiveness as entailing external and internal interactions within health systems. The search strategy will be purposive and iterative, with continuous screening and refinement of theories. Data extraction will be combined with quality appraisal, using appropriate tools. Each fragment of evidence will be appraised as it is being extracted, for its relevance to the emerging programme theories and methodological rigour. The extracted data pertaining to contexts, mechanisms and outcomes will be synthesised to identify patterns and contradictions. Results will be reported using narrative explanations, following established guidance on realist syntheses. ETHICS AND DISSEMINATION: Ethics approvals for the wider RESPONSE (Improving health systems responsiveness to neglected health needs of vulnerable groups in Ghana and Vietnam) study, of which this review is one part, were obtained from the ethics committees of the following institutions: London School of Hygiene and Tropical Medicine (ref: 22981), University of Leeds, School of Medicine (ref: MREC19-051), Ghana Health Service (ref: GHS-ERC 012/03/20) and Hanoi University of Public Health (ref: 020-149/DD-YTCC).We will disseminate results through academic papers, conference presentations and stakeholder workshops in Ghana and Vietnam. PROSPERO REGISTRATION NUMBER: CRD42020200353. Full record: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020200353.

Implementation of medicines pricing policies in sub-Saharan Africa: protocol for a systematic review.

INTRODUCTION: Ensuring universal availability and accessibility of medicines and supplies is critical for national health systems to equitably address population health needs. In sub-Saharan Africa (SSA), this is a recognised priority with multiple medicines pricing policies enacted. However, medicine prices have remained high, continue to rise and constrain their accessibility. In this systematic review, we aim to identify and analyse experiences of implementation of medicines pricing policies in SSA. Our ambition is for this evidence to contribute to improved implementation of medicines pricing policies in SSA. METHODS AND ANALYSIS: We will search: Medline, Web of Science, Scopus, Global Health, Embase, Cairn.Info International Edition, Erudit and African Index Medicus, the grey literature and reference from related publications. The searches will be limited to literature published from the year 2000 onwards that is, since the start of the Millennium Development Goals.Published peer-reviewed studies of implementation of medicines pricing policies in SSA will be eligible for inclusion. Broader policy analyses and documented experiences of implementation of other health policies will be excluded. The team will collaboratively screen titles and abstracts, then two reviewers will independently screen full texts, extract data and assess quality of the included studies. Disagreements will be resolved by discussion or a third reviewer. Data will be extracted on approaches used for policy implementation, actors involved, evidence used in decision making and key contextual influences on policy implementation. A narrative approach will be used to synthesise the data. Reporting will be informed by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guideline. ETHICS AND DISSEMINATION: No ethics approvals are required for systematic reviews.Results will be disseminated through academic publications, policy briefs and presentations to national policymakers in Ghana and mode widely across countries in SSA. PROSPERO REGISTRATION NUMBER: CRD42020178166.