Implementation research: a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya.

BACKGROUND: Self-monitoring of glucose is an essential component of type 1 diabetes (T1D) management. In recent years, continuous glucose monitoring (CGM) has provided an alternative to daily fingerstick testing for the optimisation of insulin dosing and general glucose management in people with T1D. While studies have been conducted to evaluate the impact of CGM on clinical outcomes in the US, Europe and Australia, there are limited data available for low- and middle-income countries (LMICs) and further empirical evidence is needed to inform policy decision around their use in these countries. METHODS: This trial was designed as a pragmatic, parallel-group, open-label, multicentre, three-arm, randomised (1:1:1) controlled trial of continuous or periodic CGM device use versus standard of care in people with T1D in South Africa and Kenya. The primary objective of this trial will be to assess the impact of continuous or periodic CGM device use on glycaemic control as measured by change from baseline glycosylated haemoglobin (HbA1c). Additional assessments will include clinical outcomes (glucose variation, time in/below/above range), safety (adverse events, hospitalisations), quality of life (EQ-5D, T1D distress score, Glucose Monitoring Satisfaction Survey for T1D), and health economic measures (incremental cost-effectiveness ratios, quality adjusted life years). DISCUSSION: This trial aims to address the substantial evidence gap on the impact of CGM device use on clinical outcomes in LMICs, specifically South Africa and Kenya. The trial results will provide evidence to inform policy and treatment decisions in these countries. TRIAL REGISTRATION: NCT05944731 (Kenya), July 6, 2023; NCT05944718 (South Africa), July 13, 2023.

Community health volunteers' performance in rural areas of Yemen: a community-based satisfaction survey.

Objectives: Many developing countries utilize the services of community health volunteers (CHVs) to enhance healthcare services in underserved regions. Evaluating client satisfaction with CHVs' performance is crucial for ensuring the effective utilization of their services. This study aims to assess clients' satisfaction with the provision of basic reproductive health services by CHVs in the governorates of Ibb and Al Mahweet, Yemen. Materials and Methods: A cross-sectional study was conducted, collecting data via structured questionnaires administered by trained data collectors to clients of CHVs. A total of 510 households were interviewed, with 255 from each governorate, distributed across 30 clusters (villages). Each governorate comprised 15 clusters in 12 districts (six districts in Ibb and five in Al Mahweet, excluding one district for security reasons). Within each cluster, 17 households were randomly selected for interviews. Descriptive analysis was performed using the SPSS version 22. Results: The majority of the clients were female (84.7%), most were aged 20-39 years (55.7%), and more than half of them had received at least primary education (54.2%). The study findings indicate that a significant proportion of respondents were highly satisfied with CHVs' performance (93%). Almost all respondents confirmed that CHVs resided in their villages (94%) and were easily accessible for consultation (99%). Most of the respondents (97%) expressed trust in the CHVs, stating that they were helpful to all villagers and treated them well. Additionally, nearly all the respondents reported easy access to services (98.6%), although a considerable percentage experienced a gap of three months or more since their last interaction with a CHV (39.1%). Conclusion: The CHVs contribute to the well-being of the rural populations in Yemen by delivering satisfactory services, particularly regarding family planning. However, ensuring the sustainability of the CHV programs remains a challenge, which requires attention from the program managers and decision makers in the Yemeni healthcare sector.

Co-creation process of an intervention to implement a multiparameter point-of-care testing device in a primary healthcare setting for non-communicable diseases in Peru.

BACKGROUND: Point-of-care testing (POCT) devices are diagnostic tools that can provide quick and accurate results within minutes, making them suitable for diagnosing non-communicable diseases (NCDs). However, these devices are not widely implemented in healthcare systems and for this reason is relevant to understand the implementation process. AIM: To describe the process and define a strategy to implement a multiparameter POCT device for diagnosing and managing NCDs in one region of Peru. METHODS: A descriptive and non-experimental study, using the participatory methodologies of co-creation process. It was conducted in one region of Peru (Tumbes) to design an intervention for implementing a multiparameter POCT device. Two co-creation sessions were conducted involving five groups: community members, primary healthcare workers, these groups in both rural and urban settings, and regional decision-makers. These sessions included activities to understand patient journeys in receiving care for NCDs, identify facilitators and barriers to POCT devices usage, and define an implementation strategy for POCT devices in both rural and urban settings of Tumbes. The research team analysed the data and summarized key topics for discussion after each session. RESULTS: A total of 78 participants were enrolled across the five groups. Among community members: 22.2% had only diabetes, 24.1% had only hypertension, and 18.5% had both diagnoses. In the patient journey, community members mentioned that it took at least three days to receive a diagnosis and treatment for an NCD. Most of the participants agreed that the POCT devices would be beneficial for their communities, but they also identified some concerns. The strategy for POCT devices implementation included healthcare workers training, POCT devices must be placed in the laboratory area and must be able to perform tests for glucose, glycated haemoglobin, cholesterol, and creatinine. Advertising about POCT devices should be displayed at the healthcare centres and the municipality using billboards and flyers. CONCLUSIONS: The co-creation process was useful to develop strategies for the implementation of multiparameter POCT devices for NCDs, involving the participation of different groups of stakeholders guided by moderators in both, rural and urban, settings in Peru.

Benefits of Usability Evaluation in the Development Process of Diabetes Technologies Using the Example of a Continuous Glucose Monitoring System Prototype.

BACKGROUND: Usability engineering analyzes the interaction between the intended users and a device. Its implementation is mandatory for manufacturers to obtain regulatory approval for the European market. The aim of this evaluation was assessing the role of usability testing in the development process. For this purpose, a continuous glucose monitoring (CGM) device under development was investigated to determine whether it could be used safely and effectively by the intended users. METHODS: Conduct of the usability testing was based on the international standard IEC 62366-1. Medical device use of CGM-experienced and non-experienced users (n = 15 each) was observed without initial training in use scenarios containing 18 tasks. The success rate of task completion was determined and the System Usability Scale (SUS) score was calculated from a questionnaire. A prototype of the FiberSense CGM System (EyeSense GmbH, Großostheim, Germany), comprising of a single-use sensor and a reusable detector, was investigated. RESULTS: Most use errors made by both user groups were related to ease of handling of the reusable detectors. The SUS scores achieved in this study were below the pre-defined SUS score acceptance criterion of ≥68. The most frequently mentioned reason for use errors was an incomprehensible and non-chronological instructions for use (IFU). CONCLUSIONS: The evaluation provides valuable insights on how to improve usability of the prototype device and demonstrates the value of conducting structured usability testing prior to product finalization. The results reflected areas for improvement of the user interface, mainly by restructuring the IFU, provision of an additional leaflet, and device training prior to use.

User requirements for non-invasive and minimally invasive glucose self-monitoring devices in low-income and middle-income countries: a qualitative study in Kyrgyzstan, Mali, Peru and Tanzania.

AIMS: Development of non-invasive and minimally invasive glucose monitoring devices (NI-MI-GMDs) generally takes place in high-income countries (HICs), with HIC's attributes guiding product characteristics. However, people living with diabetes (PLWD) in low-income and middle-income countries (LMICs) encounter different challenges to those in HICs. This study aimed to define requirements for NI-MI-GMDs in LMICs to inform a target product profile to guide development and selection of suitable devices. METHODS: This was a multiple-methods, exploratory, qualitative study conducted in Kyrgyzstan, Mali, Peru and Tanzania. Interviews and group discussions/activities were conducted with healthcare workers (HCWs), adults living with type 1 (PLWD1) or type 2 diabetes (PLWD2), adolescents living with diabetes and caregivers. RESULTS: Among 383 informants (90 HCW, 100 PLWD1, 92 PLWD2, 24 adolescents, 77 caregivers), a range of differing user requirements were reported, including preferences for area of glucose measurement, device attachment, data display, alert type and temperature sensitivity. Willingness to pay varied across countries; common requirements included ease of use, a range of guiding functions, the possibility to attach to a body part of choice and a cost lower than or equal to current glucose self-monitoring. CONCLUSIONS: Ease-of-use and affordability were consistently prioritised, with broad functionality required for alarms, measurements and attachment possibilities. Perspectives of PLWD are crucial in developing a target product profile to inform characteristics of NI-MI-GMDs in LMICs. Stakeholders must consider these requirements to guide development and selection of NI-MI-GMDs at country level, so that devices are fit for purpose and encourage frequent glucose monitoring among PLWD in these settings.

Performance Assessment of Three Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes.

BACKGROUND: FIND, the global alliance for diagnostics, identified the nonmarket-approved continuous glucose monitoring (CGM) system, FiberSense system (FBS), as a potential device for use in low- and middle-income countries. Together with two market-approved, factory-calibrated CGM systems, namely, the FreeStyle Libre 2 (FL2) and the GlucoRx AiDEX (ADX), the FBS was subjected to a clinical performance evaluation. METHODS: Thirty adult participants with type 1 diabetes were enrolled. The study was mainly conducted at home, with three in-clinic sessions conducted over the study period of 28 days. Comparator measurements were collected from capillary samples, using a high-quality blood glucose monitoring system. RESULTS: Data from 31, 70, and 78 sensors of FBS, FL2, and ADX, respectively, were included in the performance analysis. The mean absolute relative differences between CGM and comparator data for FBS, FL2, and ADX were 14.7%, 9.2%, and 21.9%, and relative biases were -2.1%, -2.5%, and -18.5%, respectively. Analysis of individual sensor accuracy revealed low, moderate, and high sensor-to-sensor variability for FBS, FL2, and ADX, respectively. Sensor survival probabilities until the end of sensor life were 47.2% for FBS (28 days), 71.3% for FL2 (14 days), and 48.4% for ADX (14 days). CONCLUSIONS: The results of FBS were encouraging enough to conduct further performance and usability evaluations in a low- and middle-income country. The results of FL2 mainly agreed with existing studies, whereas ADX showed substantial deviations from previously reported results.

Knowledge, Implementation, and Gaps of Gender-Based Violence Management Guidelines among Health Care Workers.

(1) Background: Gender-based violence (GBV) is widespread globally and has a myriad of adverse effects but is vastly under-reported. Health care workers are among the first responders in GBV. The objective of this study was to assess the knowledge of health workers with regard to GBV and related management guidelines and implementation. (2) Methods: The study employed a descriptive, sequential mix-method study, beginning with the quantitative part, followed by the qualitative component. Qualitative analysis was conducted using a content framework approach. (3) Results: More than two-thirds (71.79%) of health workers were found to be generally knowledgeable about gender-based violence; however, only 36.9% had good knowledge about gender-based violence management guidelines for gender-based violence and the mean value for all the items was less than 3 which indicates poor knowledge of the management guideline. Additionally, only 36.8% found the gender-based violence management guidelines useful and practical in clinical care for gender-based violence cases. (4) Conclusions: The finding of this study revealed that knowledge of gender-based violence management guideline was not adequate among health workers and rarely used during management of GBV cases. This calls for continuous training and specific refresher courses, including on-site practical sessions, professionals' mentorship, and supervision.

Facilitators and barriers of the implementation of point-of-care devices for cardiometabolic diseases: a scoping review.

BACKGROUND: Point-of-care testing (POCT) devices may facilitate the delivery of rapid and timely results, providing a clinically important advantage in patient management. The challenges and constraints in the implementation process, considering different levels of actors have not been much explored. This scoping review aimed to assess literature pertaining to implementation facilitators and barriers of POCT devices for the diagnosis or monitoring of cardiometabolic diseases. METHODS: A scoping review of the literature was conducted. The inclusion criteria were studies on the inception, planning, or implementation of interventions with POCT devices for the diagnosis or monitoring of cardiometabolic diseases defined as dyslipidemia, cardiovascular diseases, type 2 diabetes, and chronic kidney disease. We searched MEDLINE, Embase, and Global Health databases using the OVID searching engine until May 2022. The Consolidated Framework of Implementation Research (CFIR) was used to classify implementation barriers and facilitators in five constructs. Also, patient, healthcare professional (HCP), and organization level was used. RESULTS: Twenty studies met the eligibility criteria for data extraction. All studies except two were conducted in high-income countries. Some findings are: 1) Intervention: the most widely recognized facilitator was the quick turnaround time with which results are obtained. 2) Outer setting: at the organizational level, the lack of clear regulatory and accreditation mechanisms has hindered the adoption and sustainability of the use of POCT. 3) Inner setting: for HCP, performing POCT during the consultation was both a facilitator and a barrier in terms of time, personnel, and service delivery. 4) Individuals: the implementation of POCT may generate stress and discomfort in some HCP in terms of training and new responsibilities. 5) Process: for patients, it is highly appreciated that obtaining the sample was simple and more comfortable if venipuncture was not used. CONCLUSION: This scoping review has described the facilitators and barriers of implementing a POCT device for cardiometabolic conditions using the CFIR. The information can be used to design better strategies to implement these devices and benefit more populations that have low access to cardiometabolic tests.

Use of continuous glucose monitors in low- and middle-income countries: A scoping review.

AIMS: The use of continuous glucose monitors (CGMs) has been shown to have positive impact on diabetes management for people with type 1 diabetes (T1DM), type 2 diabetes (T2DM) and gestational diabetes (GDM) in high-income countries. However, as useful as CGMs are, the experience in low- and middle-income countries (LMICs) is limited and has not been summarized. METHODS: A scoping review of the scientific literature was conducted. Medline, Embase, Global Health and Scopus were used to seek original research conducted in LMICs. The search results were screened by two reviewers independently. We included studies assessing health outcomes following the use of CGMs at the individual level (e.g. glycaemic control or complications) and at the health system level (e.g. barriers, facilitators and cost-effectiveness) in English, Portuguese, Spanish and French. Results were summarized narratively. RESULTS: From 4772 records found in database search, 27 reports were included; most of them from China (n = 7), Colombia (n = 5) and India (n = 4). Thirteen reports studied T1DM, five T2DM, seven both T1DM and T2DM and two GDM. Seven reports presented results of experimental studies (five randomized trials and two quasi-experimental); two on cost-effective analysis and the remaining 18 were observational. Studies showed that CGMs improved surrogate glycaemic outcomes (HbA1c reduction), hard endpoints (lower hospitalization rates and diabetes complications) and patient-oriented outcomes (quality of life). However, several caveats were identified: mostly observational studies, few participants in trials, short follow-up and focused on surrogate outcomes. CONCLUSIONS: The scoping review identified that studies about CGMs in LMICs have several limitations. Stronger study designs, appropriate sample sizes and the inclusion of patient-important outcomes should be considered to inform the evidence about CGMs for the management of people with diabetes in LMICs.

Knowledge, Experience and Perception of Gender-Based Violence Health Services: A Mixed Methods Study on Adolescent Girls and Young Women in Tanzania.

Many adolescent girls and young women (AGYW) experience gender-based violence (GBV) in Tanzania and only few seek GBV health services following violence. The objectives of our study are (1) to evaluate knowledge of gender-based violence among AGYW, (2) to explore their perceptions of and experiences with GBV health service quality and (3) to evaluate access to comprehensive GBV services. This study employed an explanatory, sequential mixed methods design in two districts of Dar es Salaam, Tanzania (Kinondoni and Temeke). A quantitative cross-sectional survey among AGYW (n = 403) between 15-24 years old was performed to assess their knowledge of GBV as well as perceptions of and experiences with GBV health services. The quantitative data was complemented by 20 semi-structured in-depth interviews with participants. Out of 403 study participants, more than three quarters (77.9%) had moderate to good knowledge of how GBV is defined and what constitutes gender-based violence. However, few participants (30.7%, n = 124) demonstrated knowledge of GBV health services offered at local health facilities. For example, only 10.7% (n = 43) of participants reported knowledge of forensic evidence collection. Additionally, of 374 participants (93% of total participants) who reported to have received GBV education sessions, only 66% accessed GBV health services (n = 247) and about half of these (52.7%, n = 130) were satisfied with these services. The study indicated that-despite good knowledge about what constituted GBV-knowledge about the roles and availability of GBV health services was limited and utilization of GBV health services remained low. Coordinated actions need to be strengthened to reach AGYW who remain unaware of GBV health services offered at health facilities by improving GBV service quality, bettering interventions aimed at reducing GBV among AGYW in Tanzania, and scaling-up integrated service models, such as GBV one-stop centers.

Role of community health volunteers in identifying people with elevated blood pressure for diagnosis and monitoring of hypertension in Malawi: a qualitative study.

BACKGROUND: In recent years, there has been greater recognition of the important role of community health volunteers in many countries and their important role informs many health programs. This include health education, provision of services such as screening, monitoring and referral to health facilities. Their roles are better understood in the areas of communicable diseases like HIV infection, Tuberculosis and Malaria however little is known about their role in non-communicable diseases. This study seeks to explore perception of CHVs' functions, tasks, and their fulfilment in identifying people with elevated blood pressure for diagnosis and monitoring of hypertension in Lilongwe, Malawi. METHODS: This was a qualitative naturalistic research design utilizing observation and semi-structured interviews with community health volunteers working in Lilongwe, Malawi. Interviews were carried out with the researcher. Participants were recruited from the ZaMaC project. An interview guide was developed with a category-guided deductive approach. The interviews were recorded through note taking. Data analysis was performed using content analysis approach. RESULTS: Community health volunteers have multiple roles in prevention and monitoring of hypertension. They act as health educators and provide lifestyle counselling. They screened for hypertension and monitored blood pressure and assisted community members to navigate the health system such as linkage to health facilities. These roles were shaped in response to community needs. CONCLUSION: This study indicates the complexities of the roles of community health volunteer in identifying people with elevated BP for diagnosis and monitoring of hypertension. Understanding community health volunteers' roles provides insight into their required competencies in provision of their daily activities as well as required training to fill in their knowledge gaps.

Reorienting Primary Health Care Services for Non-Communicable Diseases: A Comparative Preparedness Assessment of Two Healthcare Networks in Malawi and Zambia.

Despite positive NCD policies in recent years, majority of Sub-Saharan African (SSA) health systems are inadequately prepared to deliver comprehensive first-line care for NCDs. Primary health care (PHC) settings in countries like Malawi and Zambia could be a doorway to effectively manage NCDs by moving away from delivering only episodic care to providing an integrated approach over time. As part of a collaborative health system strengthening project, we assessed and compared the preparedness and operational capacity of two target networks of public PHC settings in Lilongwe (Malawi) and Lusaka (Zambia) to integrate NCD services within routine service delivery. Data was collected and analyzed using validated health facility survey tools. These baseline assessments conducted between August 2018 and March 2019, also included interviews with 20 on-site health personnel and focal persons, who described existing barriers in delivering NCD services. In both countries, policy directives to decentralize disease-specific NCD services to the primary care level were initiated to meet increased demand but lacked operational guidance. In general, the assessed PHC sites were inadequately prepared to integrate NCDs into various service delivery domains, thus requiring further support. In spite of existing multi-faceted limitations, there was motivation among healthcare staff to provide NCD services.

An Overview on Acute Malnutrition and Food Insecurity among Children during the Conflict in Yemen.

BACKGROUND: This study aims to describe malnutrition among children under five and to describe the food insecurity status during the current conflict in Yemen. METHODS: Data were obtained from a Yemeni nutrition surveillance program (pilot phase) targeting 4142 households with 5276 children under five from two governorates (Ibb and Sana'a). RESULTS: Global acute malnutrition was found in 13.3% of overall screened children, while 4.9% had severe acute malnutrition (SAM) and 8.4% had moderate acute malnutrition. One-fifth of the children under six months of age were acutely malnourished, followed by children under two years at 18.5% based on weight-for-height z scores. Significant associations between malnutrition and other diseases included suspected measles at three times higher rates (4.5%, p < 0.00) among SAM cases than other children. Diarrhea, fever, and cough were significantly higher among the SAM group (p < 0.05). Most households depended on market food purchases in the month preceding this survey (84.7%). Household coping mechanisms to secure daily meals included borrowing food to survive, changing types and quality of food, and decreasing the number of meals per day; some families sent their children to live with relatives. CONCLUSION: Malnutrition is a serious public health problem. The humanitarian community needs to adopt alternative strategies to improve food security and the nutrition status in Yemen.