Establishing a global regulatory floor for children's decisions about participation in clinical research.

BACKGROUND: Enrolling children in clinical trials typically requires parental or guardian permission and, when appropriate, child assent. Aligning requirements across jurisdictions would facilitate multisite pediatric trials. Guidance from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is the best candidate for a global standard but would benefit from additional specification. METHODS: Ethical analysis of ICH guidance for permission and assent for pediatric trials, with recommendations for clarification. RESULTS: ICH guidance regarding permission and assent would be enhanced by additional detail in the following areas: (1) what information should be provided to parents, guardians, and children considering a trial, and how that information should be provided; (2) the definition of "assent," the criteria for when assent should be required, and the need to include children in discussions even when assent is not mandated; (3) criteria for requiring children's signatures indicating agreement; (4) greater specificity regarding children's right to decline or withdraw; and (5) clarification of when children's wish to decline or withdraw from participation may be overridden and of what the overriding process should entail. CONCLUSION: ICH guidance provides a global standard for decision making regarding children's participation in trials. Several clarifications would facilitate the conduct of multinational pediatric research. IMPACT: Enrolling children in clinical trials requires the permission of a parent/guardian ± the assent of the minor. Differing global regulatory requirements for enrolling children complicate the conduct of multicenter and multinational trials. The authors identify points of ambiguity and/or contradiction in the International Council for Harmonization guidelines and offer recommendations for a common ethical platform for conducting global pediatric research.

The barriers and facilitators of implementing a national laboratory-based AMR surveillance system in Cambodia: key informants' perspectives and assessments of microbiology laboratories.

Background: Collecting data on antimicrobial resistance (AMR) is an essential approach for defining the scope of the AMR problem, developing evidence-based interventions and detecting new and emerging resistances. Our study aimed to identify key factors influencing the implementation of a laboratory-based AMR surveillance system in Cambodia. This will add additional insights to the development of a sustainable and effective national AMR surveillance system in Cambodia and other low- and middle-income countries. Methods: Key informants with a role in governing or contributing data to the laboratory-based surveillance system were interviewed. Emerging themes were identified using the framework analysis method. Laboratories contributing to the AMR surveillance system were assessed on their capacity to conduct quality testing and report data. The laboratory assessment tool (LAT), developed by the World Health Organisation (WHO), was adapted for assessment of a diagnostic microbiology laboratory covering quality management, financial and human resources, data management, microbiology testing performance and surveillance capacity. Results: Key informants identified inadequate access to laboratory supplies, an unsustainable financing system, limited capacity to collect representative data and a weak workforce to be the main barriers to implementing an effective surveillance system. Consistent engagement between microbiology staff and clinicians were reported to be a key factor in generating more representative data for the surveillance system. The laboratory assessments identified issues with quality assurance and data analysis which may reduce the quality of data being sent to the surveillance system and limit the facility-level utilisation of aggregated data. A weak surveillance network and poor guidance for outbreak response were also identified, which can reduce the laboratories' opportunities in detecting critical or emerging resistance occurring in the community or outside of the hospital's geographical coverage. Conclusion: This study identified two primary concerns: ensuring a sustainable and quality functioning of microbiology services at public healthcare facilities and overcoming sampling bias at sentinel sites. These issues hinder Cambodia's national AMR surveillance system from generating reliable evidence to incorporate into public health measures or clinical interventions. These findings suggest that more investments need to be made into microbiology diagnostics and to reform current surveillance strategies for enhanced sampling of AMR cases at hospitals.

Process evaluation of the scale-up of integrated diabetes and hypertension care in Belgium, Cambodia and Slovenia (the SCUBY Project): a study protocol.

INTRODUCTION: Integrated care interventions for type 2 diabetes (T2D) and hypertension (HT) are effective, yet challenges exist with regard to their implementation and scale-up. The 'SCale-Up diaBetes and hYpertension care' (SCUBY) Project aims to facilitate the scale-up of integrated care for T2D and HT through the co-creation and implementation of contextualised scale-up roadmaps in Belgium, Cambodia and Slovenia. We hereby describe the plan for the process and scale-up evaluation of the SCUBY Project. The specific goals of the process and scale-up evaluation are to (1) analyse how, and to what extent, the roadmap has been implemented, (2) assess how the differing contexts can influence the implementation process of the scale-up strategies and (3) assess the progress of the scale-up. METHODS AND ANALYSIS: A comprehensive framework was developed to include process and scale-up evaluation embedded in implementation science theory. Key implementation outcomes include acceptability, feasibility, relevance, adaptation, adoption and cost of roadmap activities. A diverse range of predominantly qualitative tools-including a policy dialogue reporting form, a stakeholder follow-up interview and survey, project diaries and policy mapping-were developed to assess how stakeholders perceive the scale-up implementation process and adaptations to the roadmap. The role of context is considered relevant, and barriers and facilitators to scale-up will be continuously assessed. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Institutional Review Board (ref. 1323/19) at the Institute of Tropical Medicine (Antwerp, Belgium). The SCUBY Project presents a comprehensive framework to guide the process and scale-up evaluation of complex interventions in different health systems. We describe how implementation outcomes, mechanisms of impact and scale-up outcomes can be a basis to monitor adaptations through a co-creation process and to guide other scale-up interventions making use of knowledge translation and co-creation activities.

The effect of text message support on diabetes self-management in developing countries - A randomised trial.

OBJECTIVE: mHealth interventions have the potential to facilitate self-management. This TEXT4DSM study implemented a mobile phone intervention in existing diabetes programmes in three low- and middle-income countries (Democratic Republic of Congo, Cambodia, and the Philippines). RESEARCH DESIGN AND METHODS: Sub-studies with a similar randomised controlled trial design were conducted in three different countries. Each sub-study included 480 adults with diabetes. Subjects were randomised to receive either routine care or routine care plus text message self-management support. The primary outcome was the difference in the proportion of subjects with well-controlled diabetes after 2 years. RESULTS: Baseline and 2-year HbA1c measurements were available for 781 individuals. After 2 years, the proportion of subjects with controlled HbA1c was 2.8% higher in the intervention group than in the control group (difference not statistically significant). In the logistic regression model, the odds ratio for having controlled diabetes after the intervention was 1.1, after adjusting for baseline HbA1c level, sex, receiving insulin treatment, and participating in the routine programme. The HbA1c dynamics over time differed between programmes; the number of people with controlled diabetes tended to increase in DR Congo and decrease in Cambodia. CONCLUSION: This study was the first to test the same mHealth intervention in different countries. The finding that text messages did not show an additional effect on diabetes control implied that expectations about mHealth should be cautious. The degree of coverage, the quality of the routine programme, and the progression of disease can interfere with the expected impact. Trial registration: ISRCTN registry (86247213).

Adapting chronic care models for diabetes care delivery in low-and-middle-income countries: A review.

A contextual review of models for chronic care was done to develop a context-adapted chronic care model-based service delivery model for chronic conditions including diabetes. The Philippines was used as the setting of a low-to-middle-income country. A context-based narrative review of existing models for chronic care was conducted. A situational analysis was done at the grassroots level, involving the leaders and members of the community, the patients, the local health system and the healthcare providers. A second analysis making use of certain organizational theories was done to explore on improving feasibility and acceptability of organizing care for chronic conditions. The analyses indicated that care for chronic conditions may be introduced, considering the needs of people with diabetes in particular and the community in general as recipients of care, and the issues and factors that may affect the healthcare workers and the health system as providers of this care. The context-adapted chronic care model-based service delivery model was constructed accordingly. Key features are: incorporation of chronic care in the health system's services; assimilation of chronic care delivery with the other responsibilities of the healthcare workers but with redistribution of certain tasks; and ensuring that the recipients of care experience the whole spectrum of basic chronic care that includes education and promotion in the general population, risk identification, screening, counseling including self-care development, and clinical management of the chronic condition and any co-morbidities, regardless of level of control of the condition. This way, low-to-middle income countries can introduce and improve care for chronic conditions without entailing much additional demand on their limited resources.

Knowledge, attitudes and perceptions of people with type 2 diabetes as related to self-management practices: Results of a cross-sectional study conducted in Luzon, Philippines.

OBJECTIVE: This study measured factors that could be associated with self-management practices of people with type 2 diabetes from two different health systems in the Philippines in terms of diabetes knowledge, attitudes, perceptions of support and self-efficacy, and obesity/adiposity. METHODS: Knowledge, attitudes, perceptions, obesity/adiposity measures, adherence to medications, diabetes diet, and exercise and the number of diabetes consultations of people with type 2 diabetes utilizing services of two different health systems were collected. Analysis of variance was used to determine differences in knowledge, attitudes, perceptions, obesity/adiposity, and demographic characteristics according to: proper/under-utilization of services; adherence/non-adherence to medications, diet and exercise; high/low perceived self-efficacy; and the health systems. Logistic regression was done to identify any associations with obesity/adiposity, self-management practices, and perceived self-efficacy. RESULTS: There were 549 respondents. Differences in knowledge, attitudes, perceptions, and some demographic characteristics between the two health systems and between those with high/low self-efficacy perceptions were significant. Perceived self-efficacy was significantly associated with all four self-management practices. CONCLUSIONS/INTERPRETATIONS: People consulting at the health service with a more supportive system had better perceived self-efficacy and self-care behavior. Higher knowledge, attitude, and perception scores were noted among those with better self-efficacy perceptions, which was associated with better self-care behavior.

A cross-sectional study of the differences in diabetes knowledge, attitudes, perceptions and self-care practices as related to assessment of chronic illness care among people with diabetes consulting in a family physician-led hospital-based first line health service and local government health unit-based health centers in the Philippines.

BACKGROUND: The purpose of this study was to investigate differences in diabetes knowledge, attitudes and perceptions (KAP), self-care practices as related to assessment of chronic illness care among people with diabetes consulting in a family physician-led tertiary hospital-based out-patient clinic versus local government health unit-based health centers in the Philippines. METHODS: People with diabetes consulting in the said primary care services were interviewed making use of questionnaires adapted from previously tested and validated KAP questionnaires and the patients' assessment of chronic illness care (PACIC) questionnaire. Adherence to medications, diabetes diet, and exercise and the number of diabetes consultations were asked. Analysis of variance was used to determine differences in KAP, self-care practices, and PACIC and regression analysis was used to determine any associations of the abovementioned variables to the PACIC ratings. RESULTS: A total of 549 respondents were included in the study. Differences in knowledge, attitudes, perceptions, PACIC, utilization of health services, and adherence to medications and exercise were all statistically significant. Ratings for diabetes knowledge, positive attitudes, and the perceptions of support attitudes and the abilities to perform self care, and the proportions of those properly utilizing health services and adhering to medications and exercise were higher while ratings for negative attitudes, perceived support needs, perceived support received and PACIC were lower among those consulting in the family physician-led health service. CONCLUSIONS: Combining family medicine-based approaches with culturally competent diabetes care may improve knowledge, attitudes, perceptions and self-care practices of and collaborative care with people with diabetes.

Integrating chronic care with primary care activities: enriching healthcare staff knowledge and skills and improving glycemic control of a cohort of people with diabetes through the First Line Diabetes Care Project in the Philippines.

BACKGROUND: This study investigated the effects of integrating primary chronic care with current healthcare activities in two local government health units (LGHU) of the Philippines on knowledge and skills of the LGHU staff and clinical outcomes for people with diabetes. DESIGN: Integration was accomplished through health service reorganization, (re)distribution of chronic care tasks, and training of LGHU staff. Levels of the staff's pre- and post-training diabetes knowledge and of their self-assessment of diabetes care-related skills were measured. Primary diabetes care with emphasis on self-care development was provided to a cohort of people with diabetes. Glycosylated hemoglobin (HbA1c) and obesity measures were collected prior to and one year after full project implementation. RESULTS: The training workshop improved diabetes knowledge (p<0.001) and self-assessed skills (p<0.001) of the LGHU staff. Significant reductions in HbA1c (p<0.001), waist-hip ratio (p<0.001) and waist circumference (p=0.011) of the cohort were noted. Although the reduction in HbA1c was somewhat greater among those whose community-based care providers showed improvement in knowledge and self-assessed skills, the difference was not statistically significant. CONCLUSIONS: Primary care for chronic conditions such as diabetes may be integrated with other healthcare activities in health services of low-to-middle-income countries such as the Philippines, utilizing pre-existing human resources for health, and may improve clinical endpoints.

Effects of the First Line Diabetes Care (FiLDCare) self-management education and support project on knowledge, attitudes, perceptions, self-management practices and glycaemic control: a quasi-experimental study conducted in the Northern Philippines.

OBJECTIVES: To investigate the effects of implementing a context-adapted diabetes self-management education and support (DSME/S) project based on chronic care models in the Philippines, on knowledge, attitudes, self-management practices, adiposity/obesity and glycaemia of people with diabetes. DESIGN: Prospective quasi-experimental before-after study. PARTICIPANTS: 203 people with type 2 diabetes mellitus from two local government units in the Northern Philippines fulfilling set criteria. OUTCOME MEASURES: Context-adapted DSME/S was given to a cohort of people with diabetes by trained pre-existing local government healthcare personnel. Changes in knowledge, attitudes and self-management practices, body mass index, waist circumference, waist-hip ratio (WHR) and glycosylated haemoglobin (HbA1c) were measured 1 year after full project implementation. Non-parametric and parametric descriptive and inferential statistics including logistic regression analysis were done. RESULTS: Complete data were collected from 164 participants. Improvements in glycaemia, waist circumference, WHR, knowledge, some attitudes, adherence to medications and exercise, and an increase in fear of diabetes were significant. Reductions in HbA1c, regardless of level of control, were noted in 60.4%. Significant increase in knowledge (p<0.001), positive attitude (p=0.013), perceived ability to control blood glucose (p=0.004) and adherence to medications (p=0.001) were noted among those whose glycaemia improved. Significant differences between the subgroups whose HbA1c improved and those whose HbA1c deteriorated include male gender (p=0.042), shorter duration of diabetes (p=0.001) and increased perceived ability to control blood glucose (p=0.042). Significant correlates to improved glycaemia were male gender (OR=2.655; p=0.034), duration of diabetes >10 years (OR=0.214; p=0.003) and fear of diabetes (OR=0.490; p=0.048). CONCLUSIONS: Context-adapted DSME/S introduced in resource-constrained settings and making use of established human resources for health may improve knowledge, attitudes, self-management practices and glycaemia of recipients. Further investigations on addressing fear of diabetes and tailoring DSME/S to females with diabetes and those who have had diabetes for a longer period of time may help improve glycaemia.

The effectiveness of text messages support for diabetes self-management: protocol of the TEXT4DSM study in the democratic Republic of Congo, Cambodia and the Philippines.

BACKGROUND: People with diabetes find it difficult to sustain adequate self-management behaviour. Self-Management Support strategies, including the use of mobile technology, have shown potential benefit. This study evaluates the effectiveness of a mobile phone support intervention on top of an existing strategy in three countries, DR Congo, Cambodia and the Philippines to improve health outcomes, access to care and enablement of people with diabetes, with 480 people with diabetes in each country who are randomised to either standard support or to the intervention. DESIGN/METHODS: The study consists of three sub-studies with a similar design in three countries to be independently implemented and analysed. The design is a two-arm Randomised Controlled Trial, in which a total of 480 adults with diabetes participating in an existing DSME programme will be randomly allocated to either usual care in the existing programme or to usual care plus a mobile phone self-management support intervention. Participants in both arms complete assessments at baseline, one year and two years after inclusion.Glycosylated haemoglobin blood pressure, height, weight, waist circumference will be measured. Individual interviews will be conducted to determine the patients' assessment of chronic illness care, degree of self-enablement, and access to care before implementation of the intervention, at intermediate moments and at the end of the study.Analyses of quantitative data including assessment of differences in changes in outcomes between the intervention and usual care group will be done. A probability of <0.05 is considered statistically significant. Outcome indicators will be plotted over time. All data are analysed for confounding and interaction in multivariate regression analyses taking potential clustering effects into account.Differences in outcome measures will be analysed per country and realistic evaluation to assess processes and context factors that influence implementation in order to understand why it works, for whom, under which circumstances. A costing study will be performed. DISCUSSION: The intervention addresses the problem that the greater part of diabetes management takes place without external support and that many challenges, unforeseen problems and questions occur at moments in between scheduled contacts with the support system, by exploiting communication technology. TRIAL REGISTRATION: ISRCTN86247213.

The growing caseload of chronic life-long conditions calls for a move towards full self-management in low-income countries.

BACKGROUND: The growing caseload caused by patients with chronic life-long conditions leads to increased needs for health care providers and rising costs of health services, resulting in a heavy burden on health systems, populations and individuals. The professionalised health care for chronic patients common in high income countries is very labour-intensive and expensive. Moreover, the outcomes are often poor. In low-income countries, the scarce resources and the lack of quality and continuity of health care result in high health care expenditure and very poor health outcomes. The current proposals to improve care for chronic patients in low-income countries are still very much provider-centred.The aim of this paper is to show that present provider-centred models of chronic care are not adequate and to propose 'full self-management' as an alternative for low-income countries, facilitated by expert patient networks and smart phone technology. DISCUSSION: People with chronic life-long conditions need to 'rebalance' their life in order to combine the needs related to their chronic condition with other elements of their life. They have a crucial role in the management of their condition and the opportunity to gain knowledge and expertise in their condition and its management. Therefore, people with chronic life-long conditions should be empowered so that they become the centre of management of their condition. In full self-management, patients become the hub of management of their own care and take full responsibility for their condition, supported by peers, professionals and information and communication tools.We will elaborate on two current trends that can enhance the capacity for self-management and coping: the emergence of peer support and expert-patient networks and the development and distribution of smart phone technology both drastically expand the possibilities for full self-management. CONCLUSION: Present provider-centred models of care for people with chronic life-long conditions are not adequate and we propose 'full self-management' as an alternative for low-income countries, supported by expert networks and smart phone technology.