Journal Article > ResearchFull Text
BMJ Open. 25 January 2023; Volume 13 (Issue 1); e063668.; DOI:10.1136/bmjopen-2022-063668
Ansbro É, Masri S, Prieto-Merino D, Willis R, Aoun Bahous S, et al.
BMJ Open. 25 January 2023; Volume 13 (Issue 1); e063668.; DOI:10.1136/bmjopen-2022-063668
OBJECTIVES
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.
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.
Journal Article > ResearchFull Text
BMC Health Serv Res. 4 June 2022; Volume 22 (Issue 1); 744.; DOI:10.1186/s12913-022-08040-z
Murphy A, Willis R, Ansbro É, Masri S, Kabbara N, et al.
BMC Health Serv Res. 4 June 2022; Volume 22 (Issue 1); 744.; DOI:10.1186/s12913-022-08040-z
BACKGROUND
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.
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.
Conference Material > Slide Presentation
Ansbro E, Masri S, Prieto-Merino D, Bahous SA, Molfino L, et al.
MSF Scientific Days International 2022. 11 May 2022; DOI:10.57740/mzsh-8t29
Conference Material > Abstract
Oza S, Harris P, Ansbro E, Perel P, Frieden M, et al.
MSF Scientific Days International 2020: Research. 20 May 2020
INTRODUCTION
Globally, hypertension is responsible for approximately half of all heart disease and stroke deaths. Over 75% of these deaths occur in low- and middle-income countries. However globally, hypertension awareness, treatment, and control remain low (39%, 29%, and 10%, respectively). Reasons for poor control are multifactorial, and include patient-specific factors such as poor adherence, often associated with high pill-burden regimens. Health system factors are also important and may include the use of complex algorithms, leading to clinical inertia amongst healthcare workers. Fixed-dose combination (FDC) medications may be one way of reducing pill burden and simplifying clinical algorithms. To understand the use of multiple drug classes in the management of hypertension we analysed antihypertensive prescribing patterns and blood pressure (BP) control in cohorts from MSF treatment programmes in Jordan and Zimbabwe to determine the proportion of patients who may benefit from a FDC (those currently treated with more than two drug classes) and the potential extent of clinical inertia.
METHODS
We used routine, retrospective data from two cohorts of adult patients with hypertension; one from Jordan, a semi-urban clinic managed by doctors (using data from October 2016 to December 2018) and one from Zimbabwe, a rural setting managed by nurses (data from May 2016 to July 2019). We carried out descriptive analyses of prescribing patterns and their relationship with BP control.
Ethics
This study was approved by the ethics committees of Jordan and Zimbabwe and the MSF Ethics Review Board.
RESULTS
We analysed data from 3305 and 3957 hypertensive patients from Jordan and Zimbabwe respectively; with median ages in Jordan 61 (interquartile range, IQR, 53-69) and in Zimbabwe 63 (IQR 53-70); the majority were female (62.7% and 80.4% respectively). Retention and BP control at 12 months were 95% and 77% (Jordan) and 59% and 42.3% (Zimbabwe). The proportion of patients on two, three, or four-five antihypertensive drug classes at baseline were 42%, 19%, 4% in Jordan and 46%, 7%, <1% in Zimbabwe. At 12 months follow-up, proportions were 40%, 28%, 11% in Jordan and 46%, 17%, 1% in Zimbabwe. Proportions with controlled BP at 12 months on two, three, or four-five drug classes were 71%, 64% and 55% in Jordan, and 40%, 27%, 25% in Zimbabwe. No medication change for uncontrolled BP was made at the next visit for 1,843 (79.3%) of 2,325 visits in Jordan, and 4,763 (63.5%) of 7,497 visits in Zimbabwe. This included 545 (28.6%) and 2,549 (53.5%) visits with uncontrolled stage two or three hypertension respectively.
CONCLUSION
Most patients with hypertension required more than two antihypertensive medications, but a significant proportion persisted with uncontrolled BP. No additional class of antihypertensive was given in the majority of visits by patients with uncontrolled BP, suggesting possible clinical inertia by healthcare workers. Despite recent inclusion of FDC’s in MSF guidelines and WHO’s Essential Medicines List, their lack of inclusion in national guidelines, and procurement challenges, have hindered MSF’s implementation of FDC’s. Demonstrating feasibility of FDC use in MSF pilot projects could play an important role in furthering uptake.
Conflicts of Interest
None declared.
Globally, hypertension is responsible for approximately half of all heart disease and stroke deaths. Over 75% of these deaths occur in low- and middle-income countries. However globally, hypertension awareness, treatment, and control remain low (39%, 29%, and 10%, respectively). Reasons for poor control are multifactorial, and include patient-specific factors such as poor adherence, often associated with high pill-burden regimens. Health system factors are also important and may include the use of complex algorithms, leading to clinical inertia amongst healthcare workers. Fixed-dose combination (FDC) medications may be one way of reducing pill burden and simplifying clinical algorithms. To understand the use of multiple drug classes in the management of hypertension we analysed antihypertensive prescribing patterns and blood pressure (BP) control in cohorts from MSF treatment programmes in Jordan and Zimbabwe to determine the proportion of patients who may benefit from a FDC (those currently treated with more than two drug classes) and the potential extent of clinical inertia.
METHODS
We used routine, retrospective data from two cohorts of adult patients with hypertension; one from Jordan, a semi-urban clinic managed by doctors (using data from October 2016 to December 2018) and one from Zimbabwe, a rural setting managed by nurses (data from May 2016 to July 2019). We carried out descriptive analyses of prescribing patterns and their relationship with BP control.
Ethics
This study was approved by the ethics committees of Jordan and Zimbabwe and the MSF Ethics Review Board.
RESULTS
We analysed data from 3305 and 3957 hypertensive patients from Jordan and Zimbabwe respectively; with median ages in Jordan 61 (interquartile range, IQR, 53-69) and in Zimbabwe 63 (IQR 53-70); the majority were female (62.7% and 80.4% respectively). Retention and BP control at 12 months were 95% and 77% (Jordan) and 59% and 42.3% (Zimbabwe). The proportion of patients on two, three, or four-five antihypertensive drug classes at baseline were 42%, 19%, 4% in Jordan and 46%, 7%, <1% in Zimbabwe. At 12 months follow-up, proportions were 40%, 28%, 11% in Jordan and 46%, 17%, 1% in Zimbabwe. Proportions with controlled BP at 12 months on two, three, or four-five drug classes were 71%, 64% and 55% in Jordan, and 40%, 27%, 25% in Zimbabwe. No medication change for uncontrolled BP was made at the next visit for 1,843 (79.3%) of 2,325 visits in Jordan, and 4,763 (63.5%) of 7,497 visits in Zimbabwe. This included 545 (28.6%) and 2,549 (53.5%) visits with uncontrolled stage two or three hypertension respectively.
CONCLUSION
Most patients with hypertension required more than two antihypertensive medications, but a significant proportion persisted with uncontrolled BP. No additional class of antihypertensive was given in the majority of visits by patients with uncontrolled BP, suggesting possible clinical inertia by healthcare workers. Despite recent inclusion of FDC’s in MSF guidelines and WHO’s Essential Medicines List, their lack of inclusion in national guidelines, and procurement challenges, have hindered MSF’s implementation of FDC’s. Demonstrating feasibility of FDC use in MSF pilot projects could play an important role in furthering uptake.
Conflicts of Interest
None declared.
Journal Article > ResearchFull Text
BMJ Open. 24 November 2019; Volume 9 (Issue 11); DOI:10.1136/bmjopen-2019-030176
Ansbro É, Biringanine M, Caleo GNC, Prieto-Merino D, Sadique Z, et al.
BMJ Open. 24 November 2019; Volume 9 (Issue 11); DOI:10.1136/bmjopen-2019-030176
Journal Article > ResearchFull Text
BMC Health Serv Res. 23 June 2017; Volume 17 (Issue 1); DOI:10.1186/s12913-017-2362-5
Murphy A, Biringanine M, Roberts B, Stringer B, Perel P, et al.
BMC Health Serv Res. 23 June 2017; Volume 17 (Issue 1); DOI:10.1186/s12913-017-2362-5
Evidence is urgently needed from complex emergency settings to support efforts to respond to the increasing burden of diabetes mellitus (DM). We conducted a qualitative study of a new model of DM health care (Integrated Diabetic Clinic within an Outpatient Department [IDC-OPD]) implemented by Médecins Sans Frontières (MSF) in Mweso Hospital in eastern Democratic Republic of Congo (DRC). We aimed to explore patient and provider perspectives on the model in order to identify factors that may support or impede it.
Journal Article > ResearchFull Text
Confl Health. 9 August 2019; Volume 13 (Issue 1); DOI:10.1186/s13031-019-0217-x
Boulle P, Sibourd Baudry A, Ansbro É, Prieto Merino D, Saleh N, et al.
Confl Health. 9 August 2019; Volume 13 (Issue 1); DOI:10.1186/s13031-019-0217-x
We included 514 patients with ASCVD in the cross-sectional study, performed in 2017. Most (61.9%) were male and mean age was 60.4 years (95% CI, 59.6-61.3). Over half (58.8%) underwent revascularization and 26.1% had known cerebrovascular disease. ASCVD risk factors included 51.8% with diabetes and 72.2% with hypertension. While prescription (75.7 to 98.2%) and self-reported adherence rates (78.4 to 93.9%) for individual ASCVD secondary prevention drugs (ACE-inhibitor, statin and antiplatelet) were high, the use of all three was low at 41.3% (CI95%: 37.0-45.6). The 5-year retrospective cohort study (ending April 2017) identified 1286 patients with ASCVD and 16,618 related consultations (comprising 24% of all NCD consultations). Over one third (39.7%) of patients were lost to follow-up, with lower risk among men.
Journal Article > EditorialFull Text
Glob Heart. 31 December 2019; Volume 15 (Issue 1); 57.; DOI:10.5334/gh.860
Webster R, Murphy A, Bygrave H, Ansbro É, Grobbee DE, et al.
Glob Heart. 31 December 2019; Volume 15 (Issue 1); 57.; DOI:10.5334/gh.860
HIGHLIGHTS
-- Despite clinical evidence of its effectiveness in secondary prevention of cardiovascular disease, uptake of fixed dose combination therapy (FDCs) for CVD has been poor.
-- A symposium was held bringing together stakeholders on this issue, including from academia, government and NGOs.
-- The conclusion made was that what is now needed to improve implementation of FDCs is country-specific health systems analyses to design appropriate implementation strategies.
-- Implementation strategies must look beyond listing on the WHO Essential Medicines List to consider approaches to improving FDC availability, accessibility, affordability, and adherence.
-- Strategies might include incorporation of FDCs into the WHO HEARTS technical package, simplified treatment and monitoring algorithms, decentralisation of medicine dispensing and task-sharing for treatment management.
-- Despite clinical evidence of its effectiveness in secondary prevention of cardiovascular disease, uptake of fixed dose combination therapy (FDCs) for CVD has been poor.
-- A symposium was held bringing together stakeholders on this issue, including from academia, government and NGOs.
-- The conclusion made was that what is now needed to improve implementation of FDCs is country-specific health systems analyses to design appropriate implementation strategies.
-- Implementation strategies must look beyond listing on the WHO Essential Medicines List to consider approaches to improving FDC availability, accessibility, affordability, and adherence.
-- Strategies might include incorporation of FDCs into the WHO HEARTS technical package, simplified treatment and monitoring algorithms, decentralisation of medicine dispensing and task-sharing for treatment management.
Conference Material > Abstract
Ansbro E, Masri S, Prieto-Merino D, Bahous SA, Molfino L, et al.
MSF Scientific Days International 2022. 11 May 2022; DOI:10.57740/8697-vn33
INTRODUCTION
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.
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.
Journal Article > ResearchFull Text
BMC Cardiovascular Disorders. 9 October 2021; Volume 21; 486.; DOI:10.1186/s12872-021-02298-7
Vetter B, Beran D, Boulle P, Chua AC, de la Tour R, et al.
BMC Cardiovascular Disorders. 9 October 2021; Volume 21; 486.; DOI:10.1186/s12872-021-02298-7
INTRODUCTION
Multi-parameter diagnostic devices can simplify cardiometabolic disease diagnosis. However, existing devices may not be suitable for use in low-resource settings, where the burden of non-communicable diseases is high. Here we describe the development of a target product profile (TPP) for a point-of-care multi-parameter device for detection of biomarkers for cardiovascular disease and metabolic disorders, including diabetes, in primary care settings in low- and middle-income countries (LMICs).
METHODS
A draft TPP developed by an expert group was reviewed through an online survey and semi-structured expert interviews to identify device characteristics requiring refinement. The draft TPP included 41 characteristics with minimal and optimal requirements; characteristics with an agreement level for either requirement of ≤ 85% in either the survey or among interviewees were further discussed by the expert group and amended as appropriate.
RESULT
Twenty people responded to the online survey and 18 experts participated in the interviews. Twenty-two characteristics had an agreement level of ≤ 85% in either the online survey or interviews. The final TPP defines the device as intended to be used for basic diagnosis and management of cardiometabolic disorders (lipids, glucose, HbA1c, and creatinine) as minimal requirement, and offering an expanded test menu for wider cardiometabolic disease management as optimal requirement. To be suitable, the device should be intended for level 1 healthcare settings or lower, used by minimally trained healthcare workers and allow testing using self-contained cartridges or strips without the need for additional reagents. Throughput should be one sample at a time in a single or multi-analyte cartridge, or optimally enable testing of several samples and analytes in parallel with random access.
CONCLUSIONS
This TPP will inform developers of cardiometabolic multi-parameter devices for LMIC settings, and will support decision makers in the evaluation of existing and future devices.
Multi-parameter diagnostic devices can simplify cardiometabolic disease diagnosis. However, existing devices may not be suitable for use in low-resource settings, where the burden of non-communicable diseases is high. Here we describe the development of a target product profile (TPP) for a point-of-care multi-parameter device for detection of biomarkers for cardiovascular disease and metabolic disorders, including diabetes, in primary care settings in low- and middle-income countries (LMICs).
METHODS
A draft TPP developed by an expert group was reviewed through an online survey and semi-structured expert interviews to identify device characteristics requiring refinement. The draft TPP included 41 characteristics with minimal and optimal requirements; characteristics with an agreement level for either requirement of ≤ 85% in either the survey or among interviewees were further discussed by the expert group and amended as appropriate.
RESULT
Twenty people responded to the online survey and 18 experts participated in the interviews. Twenty-two characteristics had an agreement level of ≤ 85% in either the online survey or interviews. The final TPP defines the device as intended to be used for basic diagnosis and management of cardiometabolic disorders (lipids, glucose, HbA1c, and creatinine) as minimal requirement, and offering an expanded test menu for wider cardiometabolic disease management as optimal requirement. To be suitable, the device should be intended for level 1 healthcare settings or lower, used by minimally trained healthcare workers and allow testing using self-contained cartridges or strips without the need for additional reagents. Throughput should be one sample at a time in a single or multi-analyte cartridge, or optimally enable testing of several samples and analytes in parallel with random access.
CONCLUSIONS
This TPP will inform developers of cardiometabolic multi-parameter devices for LMIC settings, and will support decision makers in the evaluation of existing and future devices.