Evaluating the impact of malaria rapid diagnostic tests on patient-important outcomes in sub-Saharan Africa: a systematic review of study methods to guide effective implementation.

OBJECTIVE: To perform critical methodological assessments on designs, outcomes, quality and implementation limitations of studies evaluating the impact of malaria rapid diagnostic tests (mRDTs) on patient-important outcomes in sub-Saharan Africa. DESIGN: A systematic review of study methods. DATA SOURCES: MEDLINE, EMBASE, Cochrane Library, African Index Medicus and clinical trial registries were searched up to May 2022. ELIGIBILITY CRITERIA: Primary quantitative studies that compared mRDTs to alternative diagnostic tests for malaria on patient-important outcomes within sub-Sahara Africa. DATA EXTRACTION AND SYNTHESIS: Studies were sought by an information specialist and two independent reviewers screened for eligible records and extracted data using a predesigned form using Covidence. Methodological quality was assessed using the National Institutes of Health tools. Descriptive statistics and thematic analysis guided by the Supporting the Use of Research Evidence framework were used for analysis. Findings were presented narratively, graphically and by quality ratings. RESULTS: Our search yielded 4717 studies, of which we included 24 quantitative studies; (15, 62.5%) experimental, (5, 20.8%) quasi-experimental and (4, 16.7%) observational studies. Most studies (17, 70.8%) were conducted within government-owned facilities. Of the 24 included studies, (21, 87.5%) measured the therapeutic impact of mRDTs. Prescription patterns were the most reported outcome (20, 83.3%). Only (13, 54.2%) of all studies reported statistically significant findings, in which (11, 45.8%) demonstrated mRDTs' potential to reduce over-prescription of antimalarials. Most studies (17, 70.8%) were of good methodological quality; however, reporting sample size justification needs improvement. Implementation limitations reported were mostly about health system constraints, the unacceptability of the test by the patients and low trust among health providers. CONCLUSION: Impact evaluations of mRDTs in sub-Saharan Africa are mostly randomised trials measuring mRDTs' effect on therapeutic outcomes in real-life settings. Though their methodological quality remains good, process evaluations can be incorporated to assess how contextual concerns influence their interpretation and implementation. PROSPERO REGISTRATION NUMBER: CRD42018083816.

Policy uptake and implementation of the RTS,S/AS01 malaria vaccine in sub-Saharan African countries: status 2 years following the WHO recommendation.

In October 2021, the WHO recommended the world's first malaria vaccine-RTS,S/AS01-to prevent malaria in children living in areas with moderate-to-high transmission in sub-Saharan Africa (SSA). A second malaria vaccine, R21/Matrix-M, was recommended for use in October 2023 and added to the WHO list of prequalified vaccines in December 2023. This study analysis assessed the country status of implementation and delivery strategies for RTS,S/AS01 by searching websites for national malaria policies, guidelines and related documents. Direct contact with individuals working in malaria programmes was made to obtain documents not publicly available. 10 countries had documents with information relating to malaria vaccine implementation, 7 referencing RTS,S/AS01 and 3 (Burkina Faso, Kenya and Nigeria) referencing RTS,S/AS01 and R21/Matrix-M. Five other countries reported plans for malaria vaccine roll-out without specifying which vaccine. Ghana, Kenya and Malawi, which piloted RTS,S/AS01, have now integrated the vaccine into routine immunisation services. Cameroon and Burkina Faso are the first countries outside the pilot countries to incorporate the vaccine into national immunisation services. Uganda plans a phased RTS,S/AS01 introduction, while Guinea plans to first pilot RTS,S/AS01 in five districts. The RTS,S/AS01 schedule varied by country, with the first dose administered at 5 or 6 months in all countries but the fourth dose at either 18, 22 or 24 months. SSA countries have shown widespread interest in rolling out the malaria vaccine, the Global Alliance for Vaccines and Immunization having approved financial support for 20 of 30 countries which applied as of March 2024. Limited availability of RTS,S/AS01 means that some approved countries will not receive the required doses. Vaccine availability and equity must be addressed even as R21/Matrix-M becomes available.

Quality assessment of clinical practice guidelines in Kenya using the AGREE II tool: a methodological review.

OBJECTIVE: To assess the quality of available and accessible national Clinical Practice Guidelines (CPGs) in Kenya using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool. METHODS: We searched the websites of the Kenyan Ministry of Health, professional associations and contacted experts in relevant organisations. Our scope was guidelines on maternal, neonatal, nutritional disorders, injuries, communicable and non-communicable diseases in Kenya published in the last 5 years until 30 June 2022. Study selection and data extraction were done by three independent reviewers with disagreements resolved via discussion or with a senior reviewer. We conducted a quality assessment using the online English version of AGREE II tool across six domains. Descriptive statistics were analysed using Stata software V.17. The primary outcome was the methodological quality of the included CPGs assessed by the AGREE II tool score. RESULTS: We retrieved 95 CPGs and included 24 in the analysis after screening for eligibility. The CPGs scored best in clarity of presentation and least in the rigour of development. In descending order, the appraisal scores (mean and CI) per domain were as follows: Clarity of presentation 82.96% (95% CI 78.35% to 87.57%) with all guidelines scoring above 50%. Scope and purpose 61.75% (95% CI 54.19% to 69.31%) with seven guidelines scoring less than 50%. Stakeholder involvement 45.25% (95% CI 40.01% to 50.49%) with 16 CPGs scoring less than 50%. Applicability domain 19.88% (95% CI 13.32% to 26.43%) with only one CPG scoring above 50%. Editorial independence 6.92% (95% CI 3.47% to 10.37%) with no CPG scoring above 50% and rigour of development 3% (95% CI 0.61% to 5.39%) with no CPG scoring at least 50%. CONCLUSION: Our findings suggest that the quality of CPGs in Kenya is limited mainly by the rigour of development, editorial independence, applicability and stakeholder involvement. Training initiatives on evidence-based methodology among guideline developers are needed to improve the overall quality of CPGs for better patient care.