Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing.

BACKGROUND: International guidelines recommend the use of appropriate informed consent procedures in low literacy research settings because written information is not known to guarantee comprehension of study information. OBJECTIVES: This study developed and evaluated a multimedia informed consent tool for people with low literacy in an area where a malaria treatment trial was being planned in The Gambia. METHODS: We developed the informed consent document of the malaria treatment trial into a multimedia tool integrating video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the multimedia tool were assessed using quantitative and qualitative methods. In two separate visits, the participants' comprehension of the study information was measured by using a validated digitised audio questionnaire. RESULTS: The majority of participants (70%) reported that the multimedia tool was clear and easy to understand. Participants had high scores on the domains of adverse events/risk, voluntary participation, study procedures while lowest scores were recorded on the question items on randomisation. The differences in mean scores for participants' 'recall' and 'understanding' between first and second visits were statistically significant (F (1,41)=25.38, p<0.00001 and (F (1, 41) = 31.61, p<0.00001 respectively. CONCLUSIONS: Our locally developed multimedia tool was acceptable and easy to administer among low literacy participants in The Gambia. It also proved to be effective in delivering and sustaining comprehension of study information across a diverse group of participants. Additional research is needed to compare the tool to the traditional consent interview, both in The Gambia and in other sub-Saharan settings

A multimedia consent tool for research participants in the Gambia: a randomized controlled trial.

OBJECTIVE: To assess the effectiveness of a multimedia informed consent tool for adults participating in a clinical trial in the Gambia. METHODS: Adults eligible for inclusion in a malaria treatment trial (n = 311) were randomized to receive information needed for informed consent using either a multimedia tool (intervention arm) or a standard procedure (control arm). A computerized, audio questionnaire was used to assess participants' comprehension of informed consent. This was done immediately after consent had been obtained (at day 0) and at subsequent follow-up visits (days 7, 14, 21 and 28). The acceptability and ease of use of the multimedia tool were assessed in focus groups. FINDINGS: On day 0, the median comprehension score in the intervention arm was 64% compared with 40% in the control arm (P = 0.042). The difference remained significant at all follow-up visits. Poorer comprehension was independently associated with female sex (odds ratio, OR: 0.29; 95% confidence interval, CI: 0.12-0.70) and residing in Jahaly rather than Basse province (OR: 0.33; 95% CI: 0.13-0.82). There was no significant independent association with educational level. The risk that a participant's comprehension score would drop to half of the initial value was lower in the intervention arm (hazard ratio 0.22, 95% CI: 0.16-0.31). Overall, 70% (42/60) of focus group participants from the intervention arm found the multimedia tool clear and easy to understand. CONCLUSION: A multimedia informed consent tool significantly improved comprehension and retention of consent information by research participants with low levels of literacy

An adapted instrument to assess informed consent comprehension among youth and parents in rural western Kenya: a validation study.

OBJECTIVE: To adapt and validate a questionnaire originally developed in a research setting for assessment of comprehension of consent information in a different cultural and linguistic research setting. DESIGN: The adaptation process involved development and customisation of a questionnaire for each of the three study groups, modelled closely on the previously validated questionnaire. The three adapted draft questionnaires were further reviewed by two bioethicists and the developer of the original questionnaire for face and content validity. The revised questionnaire was subsequently programmed into an audio computerised format, with translations and back translations in three widely spoken languages by the study participants: Luo, Swahili and English. SETTING: The questionnaire was validated among adolescents, their parents and young adults living in Siaya County, a rural region of western Kenya. PARTICIPANTS: Twenty-five-item adapted questionnaires consisting of close-ended, multiple-choice and open-ended questions were administered to 235 participants consisting of 107 adolescents, 92 parents and 36 young adults. Test-retest was conducted 2-4 weeks after first questionnaire administration among 74 adolescents, young adults and parents. OUTCOME MEASURE: Primary outcome measures included ceiling/floor analysis to identify questions with extremes in responses and item-level correlation to determine the test-retest relationships. Given the data format, tetrachoric correlations were conducted for dichotomous items and polychoric correlations for ordinal items. The qualitative validation assessment included face and content validity evaluation of the adapted instrument by technical experts. RESULTS: Ceiling/floor analysis showed eight question items for which >80% of one or more groups responded correctly, while for nine questions, including all seven open-ended questions,<20% responded correctly. Majority of the question items had moderate to strong test-retest correlation estimates indicating temporal stability. CONCLUSIONS: Our study demonstrates that cross-cultural adaptation and validation of an informed consent comprehension questionnaire is feasible. However, further research is needed to develop a tool which can estimate a quantifiable threshold of comprehension thereby serving as an objective indicator of the need for interventions to improve comprehension

COVID-19 vaccination implementation in 52 African countries: trajectory and implications for future pandemic preparedness.

INTRODUCTION: To end the COVID-19 pandemic, the WHO set a goal in 2021 to fully vaccinate 70% of the global population by mid-2022. We projected the COVID-19 vaccination trajectory in 52 African countries and compared the projected to the 'actual' or 'observed' coverage as of December 2022. We also estimated the required vaccination speed needed to have attained the WHO 70% coverage target by December 2022. METHODS: We obtained publicly available, country-reported daily COVID-19 vaccination data, covering the initial 9 months following the deployment of vaccines. We used a deterministic compartmental Susceptible-Exposed-Infectious-Recovered-type model and fit the model to the number of COVID-19 cases and vaccination coverage in each African country using a Markov chain Monte Carlo approach within a Bayesian framework. FINDINGS: Only nine of the 52 African countries (Tunisia, Cabo Verde, Lesotho, Mozambique, Rwanda, Seychelles, Morocco, Botswana and Mauritius) were on track to achieve full COVID-19 vaccination coverage rates ranging from 72% to 97% by the end of December 2022, based on their progress after 9 months of vaccine deployment. Of the 52 countries, 26 (50%) achieved 'actual' or 'observed' vaccination coverage rates within ±10 percentage points of their projected vaccination coverage. Among the countries projected to achieve <30% by December 2022, nine of them (Chad, Niger, Nigeria, South Sudan, Tanzania, Somalia, Zambia, Sierra Leone and Côte d'Ivoire) achieved a higher observed coverage than the projected coverage, ranging from 12.3 percentage points in South Sudan to 35.7 percentage points above the projected coverage in Tanzania. Among the 52 countries, 83% (43 out of 52) needed to at least double their vaccination trajectory after 9 months of deployment to reach the 70% target by December 2022. CONCLUSION: Our findings can guide countries in planning strategies for future global health emergencies and learning from each other, especially those that exceeded expectations and made significant progress towards the WHO's 2022 COVID-19 vaccination target despite projected poor coverage rates

Clinical presentations and management of COVID-19 infected children seen in a district health facility in Kambia, northern Sierra Leone.

Studies reporting the clinical presentations of COVID-19 in children in sub-Saharan Africa are few, especially from resource-constrained countries. This case series reports the demographic and clinical characteristics and laboratory findings of confirmed cases of COVID-19 in children seen at a district hospital in Sierra Leone. This is a report of nine COVID-19 paediatric cases managed at a secondary level hospital in Kambia District, Northern Sierra Leone. Each child was detected by contact tracing after an infected adult was identified by the COVID-19 response team. The clinical symptoms at presentation, clinical courses, and treatments instituted and patient outcomes are discussed in the context of the facilities available at a typical West African district hospital. Nine out of 30 individuals with confirmed COVID-19 infection who presented to the hospital from 24 April to 20 September 2020 and who were admitted to the isolation center of the hospital were in the paediatric age group. The mean age (SD) and median (IQR) of the children were 69.0 ± 51.7months and 84.0 (10.5, 108.0) months, respectively; five (55.6%) were males. The children were asymptomatic or only had mild illnesses and none required intranasal oxygen or ventilatory support. In the five symptomatic children, the most common symptoms were fever (40%) and cough (40%). All children had normal haemoglobin, platelet and white blood cell (WBC) count. Four children had a positive malaria test and were treated with a complete course of anti-malaria medications. No child received steroid or had specific anti-COVID-19 treatment. All children stayed in the isolation center for 14 days and were re-tested for COVID-19 two weeks after initial diagnosis. No complications have been reported in any of them since discharge. The proportion of children among COVID-19 infected cases seen in a rural community in Sierra Leone was 30%. Fever was the most common symptom and malaria was confirmed in 40% of the infected children. This has significant implication on the diagnosis of COVID-19 in malaria-endemic settings and on how best to manage children who present with fever during the COVID-19 pandemic

Assessment of Test Anxiety, Student Preferences and Performance on Different Examination Models in Umm AlQura University, Saudi Arabia

Background: Test anxiety is a special kind of anxiety-worry mixed with fear which arises in situations where an individual is being evaluated in an academic context. This anxiety may prevent effective use and communication of the information learned by students for examinations, resulting in poor academic performance. Factors such as examination types and socio-cultural context influence test anxiety in university students. Limited evidence is currently available on the roles played by these factors among nursing students in Saudi Arabia, where strong socio-cultural factors shape university education. Objectives: The study was designed to assess university students’ preferences for various examination types: quizzes, formal exam, Objective Structured Clinical Examination (OSCE), paper based written exam, oral exam, open book exam. The study also determined the association of test anxiety of the students and the results obtained from different examination types. Methods: This descriptive, cross-sectional study was conducted among 135 baccalaureate nursing students at the Umm Al-Qura University, Saudi Arabia. A pre-tested, semi-structured questionnaire was self-administered to the students, covering level of exam fairness, easiness, and the number of study hours required to attend the examinations. The test anxiety level of the students was evaluated using a Westside Test Anxiety Scale. Multivariate analysis of variance was performed to explore the association between test anxiety and socio-demographic characteristics of the students. Results: A total of 135 female nursing students were enrolled into the study. Their ages ranged from 20 to 22 years with mean age of 20.8 ± 0.63. Only 24 (17.8%) of them were married at the time of the study. Fifty-nine participants (43.7%) missed less than three theory lectures while 64 (47.4%) were absent for less than three times in the practical sessions. The most preferred examination type was monthly written examination 43 (31.9%) while 78 (57.8%) students had problematic test anxiety. The most frequent coping mechanisms adopted to manage test anxiety by study participants were psychological support and preparation for the examination (p=0.001 and p=0.031, respectively). No statistically significant association existed between test anxiety and academic performance (p=0.41). However, coping mechanisms such as preparing for the exam and psychological support had a statistically significant relationship with academic performance (p<0.0001 and 0.026, respectively). Conclusion: This study showed that test anxiety and preferences for particular test formats affect the students ability to demonstrate content knowledge. The results suggest the need for school support system to make testing outcomes more equitable for nursing student

Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing

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COVID-19 vaccination implementation in 52 African countries: trajectory and implications for future pandemic preparedness

Introduction To end the COVID-19 pandemic, the WHO set a goal in 2021 to fully vaccinate 70% of the global population by mid-2022. We projected the COVID-19 vaccination trajectory in 52 African countries and compared the projected to the ‘actual’ or ‘observed’ coverage as of December 2022. We also estimated the required vaccination speed needed to have attained the WHO 70% coverage target by December 2022.Methods We obtained publicly available, country-reported daily COVID-19 vaccination data, covering the initial 9 months following the deployment of vaccines. We used a deterministic compartmental Susceptible-Exposed-Infectious-Recovered-type model and fit the model to the number of COVID-19 cases and vaccination coverage in each African country using a Markov chain Monte Carlo approach within a Bayesian framework.Findings Only nine of the 52 African countries (Tunisia, Cabo Verde, Lesotho, Mozambique, Rwanda, Seychelles, Morocco, Botswana and Mauritius) were on track to achieve full COVID-19 vaccination coverage rates ranging from 72% to 97% by the end of December 2022, based on their progress after 9 months of vaccine deployment. Of the 52 countries, 26 (50%) achieved ‘actual’ or ‘observed’ vaccination coverage rates within ±10 percentage points of their projected vaccination coverage. Among the countries projected to achieve &lt;30% by December 2022, nine of them (Chad, Niger, Nigeria, South Sudan, Tanzania, Somalia, Zambia, Sierra Leone and Côte d’Ivoire) achieved a higher observed coverage than the projected coverage, ranging from 12.3 percentage points in South Sudan to 35.7 percentage points above the projected coverage in Tanzania. Among the 52 countries, 83% (43 out of 52) needed to at least double their vaccination trajectory after 9 months of deployment to reach the 70% target by December 2022.Conclusion Our findings can guide countries in planning strategies for future global health emergencies and learning from each other, especially those that exceeded expectations and made significant progress towards the WHO’s 2022 COVID-19 vaccination target despite projected poor coverage rates

What factors are associated with paediatric admissions and their outcomes in a rural hospital in northern Sierra Leone? Insights from a pilot observational study

Introduction: Data on the pattern of admissions and causes of child death are crucial in informing priorities for improving child survival. In many health facilities in sub-Saharan Africa, understanding the pattern of paediatric admissions and their outcomes is constrained by poor documentation of these important features. Methods: We developed and piloted a simple paper-based tool for documentation of basic, standardised patient-level information on causes of admissions, diagnoses, treatments and outcomes in children admitted to a rural hospital in Sierra Leone. The tool contained sections covering basic sociodemographic information about a patient, chief medical complaints, findings from clinical examinations and tests conducted at admission, results from subsequent clinical and laboratory investigations, working/definitive diagnoses, management and treatment outcomes. Results: From 1 August 2019 to 31 July 2021, we used this tool to document the admissions, treatments and clinical outcomes of 1663 children admitted to Kambia district hospital in northern Sierra Leone. The majority of the children (1015, 62%) were aged 12–59 months, were boys (942, 57%), were wasted (516, 31%), stunted (238, 14%) or underweight (537, 32%). Above a half of the children lived more than 1 km distance from the hospital (876/1410, 62%). The highest number of admissions occurred in November 2019 and the lowest in April 2020. Severe malaria was the leading cause of admission. More than 80% of the children were successfully treated and discharged home (1356/1663, 81.5%) while 122/1663 (7.3%) died. Children aged under 5 years who were underweight, and those who presented with danger signs (eg, signs of breathing difficulty, dehydration, head injury or severe infections) had a higher risk of death than children without these features (p&lt;0.01; p=0.03; p=0.011 and p=0.009, respectively). Conclusion: Lack of systematic documentation of medical histories and poor record keeping of hospital admissions and outcomes can be overcome by using a simple tool. Continuous use of the tool with regular audits could improve delivery of paediatric care in resource-limited settings