Collecting and reporting adverse events in low-income settings-perspectives from vaccine trials in the Gambia.

BACKGROUND: Despite Africa's significant infectious disease burden, it is underrepresented in global vaccine clinical trials. While this trend is slowly reversing, it is important to recognize and mitigate the challenges that arise when conducting vaccine clinical trials in this environment. These challenges stem from a variety of factors peculiar to the population and may negatively impact adverse event collection and reporting if not properly addressed. METHODS: As a team of clinical researchers working within the MRCG (Medical Research Council Unit The Gambia), we have conducted 12 phase 1 to 3 vaccine trials over the past 10 years. In this article, we discuss the challenges we face and the strategies we have developed to improve the collection and reporting of adverse events in low-income settings. OUTCOME: Healthcare-seeking behaviors in the Gambia are influenced by spiritual and cultural beliefs as well as barriers to accessing orthodox healthcare; participants in trials may resort to non-orthodox care, reducing the accuracy of reported adverse events. To address this, trial eligibility criteria prohibit self-treatment and herbal product use during trials. Instead, round-the-clock care is provided to trial participants, facilitating safety follow-up. Constraints in the healthcare system in the Gambia such as limitations in diagnostic tools limit the specificity of diagnosis when reporting adverse events. To overcome these challenges, the Medical Research Council Unit maintains a Clinical Services Department, offering medical care and diagnostic services to study participants. Sociocultural factors, including low literacy rates and social influences, impact adverse event collection. Solicited adverse events are collected during home visits on paper-based or electronic report forms. Community engagement meetings are held before each study starts to inform community stakeholders about the study and answer any questions they may have. These meetings ensure that influential members of the community understand the purpose of the study and the risks and benefits of participating in the trial. This understanding makes them more likely to support participation within their communities. CONCLUSION: Conducting ethical vaccine clinical trials in resource-limited settings requires strategies to accurately collect and report adverse events. Our experiences from the Gambia offer insights into adverse event collection in these settings.

Assessment of Clinical Information Quality in Digital Health Technologies: International eDelphi Study.

BACKGROUND: Digital health technologies (DHTs), such as electronic health records and prescribing systems, are transforming health care delivery around the world. The quality of information in DHTs is key to the quality and safety of care. We developed a novel clinical information quality (CLIQ) framework to assess the quality of clinical information in DHTs. OBJECTIVE: This study explored clinicians' perspectives on the relevance, definition, and assessment of information quality dimensions in the CLIQ framework. METHODS: We used a systematic and iterative eDelphi approach to engage clinicians who had information governance roles or personal interest in information governance; the clinicians were recruited through purposive and snowball sampling techniques. Data were collected using semistructured online questionnaires until consensus was reached on the information quality dimensions in the CLIQ framework. Responses on the relevance of the dimensions were summarized to inform decisions on retention of the dimensions according to prespecified rules. Thematic analysis of the free-text responses was used to revise definitions and the assessment of dimensions. RESULTS: Thirty-five clinicians from 10 countries participated in the study, which was concluded after the second round. Consensus was reached on all dimensions and categories in the CLIQ framework: informativeness (accuracy, completeness, interpretability, plausibility, provenance, and relevance), availability (accessibility, portability, security, and timeliness), and usability (conformance, consistency, and maintainability). A new dimension, searchability, was introduced in the availability category to account for the ease of finding needed information in the DHTs. Certain dimensions were renamed, and some definitions were rephrased to improve clarity. CONCLUSIONS: The CLIQ framework reached a high expert consensus and clarity of language relating to the information quality dimensions. The framework can be used by health care managers and institutions as a pragmatic tool for identifying and forestalling information quality problems that could compromise patient safety and quality of care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2021-057430.

The ten-year risk of developing cardiovascular disease among public health workers in North-Central Nigeria using Framingham and atherogenic index of plasma risk scores.

BACKGROUND: Estimation of total cardiovascular disease (CVD) risk with the use of risk prediction charts such as the Framingham risk score and Atherogenic index of plasma score is a huge improvement on the practice of identifying and treating each of the risk factors such as high blood pressure and elevated blood cholesterol. The estimation of the total risk highlights that CVD risk factors occur together and thereby predicts who should be treated. There is scarcity of data on the risk scoring of adults in Nigeria including health workers. Therefore, this study was done to estimate the cardiovascular risks of health workers in public health services in north-central Nigeria. METHODS: A cross-sectional survey was performed using validated Framingham risk score calculator and calculation of risk based on the lipid profile of 301 randomly selected health workers in North-central Nigeria. Descriptive analysis was done using frequency counts and percentages while inferential statistics were done using chi square and correlation analyses using statistical Package for Social Sciences (SPSS) version 21.0. The confidence level was 95% and the level of significance was set at 0.05. RESULTS: The 10-year risk of developing CVD was generally low in the health workers. Using Framingham risk score, 98.3% of health workers have low risk, 1.0% have moderate risk and 0.7% have high risk. Among the cadres of health workers, 1.5% of the nurses have moderate risk while 2.5% of the doctors and 3.3% of the CHEWs have high risk of developing CVD in 10 years. Using Atherogenic index of plasma scoring, only 2% of the health workers have high risk, 4.7% have intermediate risk while 93.4% have low risk. Across the cadres, 6.3% of the nurses and 3.3% of the CHEWs have intermediate risk while 2.4% of the nurses and 3.3% of the CHEWs have high risk. These findings were however not statistically significant. CONCLUSIONS: The 10-year risk of developing cardiovascular disease was low in the health workers in this study using both Framingham's risk score and atherogenic index of plasma scores.