BACKGROUND
Humanitarian crises bring unique, and potentially growing challenges to people with type 1 diabetes (T1D). We aimed to determine, in youth with T1D (mean age (± 1SD) 0–17.9 years) within and coming from humanitarian crises settings (HCS), the reported prevalence that meet international consensus targets for glycaemic, blood pressure and lipid management, and incidence of severe hypoglycaemia or diabetic ketoacidosis.
METHODS
A narrative review of quantitative data was conducted, using a systematic process. MEDLINE (Ovid), Global Health, Web of Science, Scopus, Embase, CINAHL, APA PsycINFO, Cochrane trials, and the reference lists of eligible records were searched (January 2014-February 2024); ten records covering ten separate studies were retrieved.
RESULTS
Glycaemic management was consistently suboptimal in HCS. However, among individuals coming from HCS, glycaemia varied. Across both groups, data relating to blood pressure, lipids, severe hypoglycaemia or diabetic ketoacidosis were either unavailable or limited.
CONCLUSION
Findings expose the dearth of data relating to defined youth with T1D within and coming from HCS, leaving the status of this population largely uncharacterised. With limited data indicating suboptimal T1D management, there is a pressing need for the development of a consensus guideline on, and core indicators relating to such youth within and coming from HCS, plus monitoring systems and outcome data.
AIMS
Most glucose self-monitoring devices have been developed with high-income countries in mind. We developed a target product profile (TPP) for new glucose self-monitoring technologies for users in low- and middle-income countries (LMICs).
METHODS
A draft TPP including 39 characteristics was developed by an expert group including diabetes specialists, device specialists, and people with diabetes, incorporating findings from qualitative research in LMICs. Each characteristic had minimal and optimal requirements for two use cases, frequent and sporadic use. Characteristics requiring refinement were identified via online survey. Characteristics with agreement level <90% for any requirement were reviewed by the expert group and amended as appropriate.
RESULTS
One characteristic (shelf life) had agreement <75% (both requirements for both use cases). Characteristics with agreement ≥75% and <90% for the frequent use case included infrastructure level, measurement cycle, duration of use before replacement, interchangeability, and calibration (both requirements), and activity log and price per month to end payer (minimal requirement). Intended use (both requirements), accuracy, and price per month to end payer (optimal requirement) had agreement ≥75% and <90% for the sporadic use case.
CONCLUSIONS
This TPP will inform developers on requirements for glucose self-monitoring technologies for LMICs, and support decision-makers in evaluating existing devices.
This pre–post implementation study evaluated the introduction of fixed dose combination (FDC) medications for atherosclerotic cardiovascular disease (ASCVD) secondary prevention into routine care in a humanitarian setting.
SETTING
Two Médecins sans Frontières (MSF) primary care clinics serving Syrian refugee and host populations in north Lebanon.
PARTICIPANTS
Consenting patients ≥18 years with existing ASCVD requiring secondary prevention medication were eligible for study enrolment. Those with FDC contraindication(s) or planning to move were excluded. Of 521 enrolled patients, 460 (88.3%) were retained at 6 months, and 418 (80.2%) switched to FDC. Of these, 84% remained on FDC (n=351), 8.1% (n=34) discontinued and 7.9% (n=33) were lost to follow-up by month 12.
INTERVENTIONS
Eligible patients, enrolled February–May 2019, were switched to Trinomia FDC (atorvastatin 20 mg, aspirin 100 mg, ramipril 2.5/5/10 mg) after 6 months’ usual care. During the study, the COVID-19 pandemic, an economic crisis and clinic closures occurred.
OUTCOME MEASURES
Descriptive and regression analyses compared key outcomes at 6 and 12 months: medication adherence, non-high density lipoprotein cholesterol (non-HDL-C) and systolic blood pressure (SBP) control. We performed per-protocol, intention-to-treat and secondary analyses of non-switchers.
RESULTS
Among 385 switchers remaining at 12 months, total adherence improved 23%, from 63% (95% CI 58 to 68) at month 6, to 86% (95% CI 82 to 90) at month 12; mean non-HDL-C levels dropped 0.28 mmol/L (95% CI −0.38 to −0.18; p<0.0001), from 2.39 (95% CI 2.26 to 2.51) to 2.11 mmol/L (95% CI 2.00 to 2.22); mean SBP dropped 2.89 mm Hg (95% CI −4.49 to −1.28; p=0.0005) from 132.7 (95% CI 130.8 to 134.6) to 129.7 mm Hg (95% CI 127.9 to 131.5). Non-switchers had smaller improvements in adherence and clinical outcomes.
CONCLUSION
Implementing an ASCVD secondary prevention FDC improved adherence and CVD risk factors in MSF clinics in Lebanon, with potential for wider implementation by humanitarian actors and host health systems.
We report findings of a qualitative evaluation of fixed-dose combination therapy for patients with established atherosclerotic cardiovascular disease (ASCVD) attending Médecins Sans Frontières (MSF) clinics in Lebanon. Cardiovascular disease is a leading cause of death and disability worldwide, and humanitarian actors are increasingly faced with the challenge of providing care for chronic diseases such as ASCVD in settings where health systems are disrupted. Secondary prevention strategies, involving 3-5 medications, are known to be effective for patients at risk of heart attack or stroke, but supply and adherence are challenging in humanitarian settings. Fixed dose combination therapy, combining two or more medications in one tablet, may be a strategy to address this.
METHODS
The evaluation was nested within a prospective mixed-methods study in which eligible ASCVD patients were followed for 1 year during (i) 6 months of usual care then (ii) 6 months of fixed dose combination (FDC) therapy. After 1 year, we conducted in-depth interviews with a purposive sample of patients, MSF staff and external stakeholders. Interviews focused on acceptability and sustainability of the fixed dose therapy intervention. Interview data were analysed thematically, informed by thea Theoretical Framework of Acceptability. Additional attention was paid to non-typical cases in order to test and strengthen analysis.
RESULTS
Patients and health care providers were positive about the FDC intervention. For patients, acceptability was related to ease of treatment and trust in MSF staff, while, for staff, it was related to perceived improvements in adherence, having a good understanding of the medication and its use, and fitting well with their priorities for patient's wellbeing. External stakeholders were less familiar with FDC therapy. While external clinicals expressed concerns about treatment inflexibility, non-clinician stakeholder interviews suggested that cost-effectiveness would have a major influence on FDC therapy acceptability. Sustainability was tied to the future role of MSF care provision and coherence with the local health system.
CONCLUSIONS
For patients and clinic staff, FDC was an acceptable treatment approach for secondary prevention of ASCVD disease in two MSF clinics in Lebanon. Sustainability is more complex and calls for better alignment of care with public systems.
Cardiovascular disease (CVD) is the leading cause of death and disability globally, including in humanitarian contexts. Fixed-dose combination (FDC) drugs are cost-effective for primary and secondary prevention of CVD. From 2012 until the end of 2020, MSF provided care for CVD patients from Syrian refugee and host populations in primary care clinics in Tripoli, north Lebanon. In this implementation study, we assessed whether FDC use is linked with adherence to CVD medications and treatment simplification in a humanitarian setting.
METHODS
Our prospective, before-and-after cohort study followed CVD patients in MSF clinics in Lebanon during two consecutive six month periods. Eligible patients, enrolled February-May 2019, were switched to Trinomia® FDC (atorvastatin 20mg, aspirin 100 mg, ramipril 2.5/5/10/mg) after six months’ usual care. During the study, the Covid-19 pandemic, an economic crisis, and clinic closures occurred. Descriptive and regression analyses compared key outcomes: medication adherence, non-high density lipoprotein cholesterol (non-HDL-C) levels, and systolic blood pressure (SBP) control, at six and twelve months. We performed intention-to-treat analyses and secondary analyses of non-switchers.
ETHICS
This study was approved by the MSF Ethics Review Board, the LSHTM Research Ethics Committee, and the Lebanese American University’s Institutional Review Board.
RESULTS
Of 521 enrolled patients, 460 (88.3%) were retained at six months and 418 (80.3%) switched to FDC. By month 12, 84% of switched patients remained on FDC (n=351), 8.1% (n=34) discontinued, and 7.9% (n=33) were lost to follow-up. Among the 385 who initially switched and remained in the study at 12 months, total adherence improved by 23% from 63% (95% confidence intervals (CI) 0.58-0.68) at month six to 86% (95% CI 0.82-0.90) at month 12. Mean non-HDL-C levels dropped 0.28 millimoles/litre (mmol/L; 95% CI -0.38 to -0.1; p=0.000) from 2.39 (95% CI 2.26 - 2.51) to 2.11 mmol/L (95% CI 2.00 - 2.22); mean SBP dropped 3.07 mmHg (95% CI -4.76 to -1.38; p= 0004) from 132.7 (95% CI 130.8 - 134.6) to 129.7 mmHg (95% CI 127.9 - 131.5). Among non-switchers, total adherence was lower and improvements in clinical outcomes were less pronounced.
CONCLUSION
Implementing a CVD secondary prevention FDC was associated with better adherence and intermediate clinical outcomes inan MSF primary care clinic in Lebanon. Further operational experience is needed to ascertain how best to integrate and sustain CVD FDC’s in humanitarian operations. MSF could advocate for their broader use with other humanitarian actors and within public health systems of crisis-affected countries.
CONFLICTS OF INTEREST
None declared.