Conference Material > Slide Presentation
Ansbro E, Masri S, Prieto-Merino D, Bahous SA, Molfino L, et al.
MSF Scientific Days International 2022. 2022 May 11; DOI:10.57740/mzsh-8t29
Journal Article > ResearchFull Text
J Am Heart Assoc. 2021 June 15; Volume 10 (Issue 12); e019994.; DOI:10.1161/JAHA.120.019994
Siender M, Bibangambah P, Kim JH, Lankowski A, Chang JL, et al.
J Am Heart Assoc. 2021 June 15; Volume 10 (Issue 12); e019994.; DOI:10.1161/JAHA.120.019994
BACKGROUND
Although ≈70% of the world's population of people living with HIV resides in sub-Saharan Africa, there are minimal prospective data on the contributions of HIV infection to atherosclerosis in the region.
METHODS AND RESULTS
We conducted a prospective observational cohort study of people living with HIV on antiretroviral therapy >40 years of age in rural Uganda, along with population-based comparators not infected with HIV. We collected data on cardiovascular disease risk factors and carotid ultrasound measurements annually. We fitted linear mixed effects models, adjusted for cardiovascular disease risk factors, to estimate the association between HIV serostatus and progression of carotid intima media thickness (cIMT). We enrolled 155 people living with HIV and 154 individuals not infected with HIV and collected cIMT images at 1045 visits during a median of 4 annual visits per participant (interquartile range 3-4, range 1-5). Age (median 50.9 years) and sex (49% female) were similar by HIV serostatus. At enrollment, there was no difference in mean cIMT by HIV serostatus (0.665 versus 0.680 mm, P=0.15). In multivariable models, increasing age, blood pressure, and non-high-density lipoprotein cholesterol were associated with greater cIMT (P<0.05), however change in cIMT per year was also no different by HIV serostatus (0.004 mm/year for HIV negative [95% CI, 0.001-0.007 mm], 0.006 mm/year for people living with HIV [95% CI, 0.003-0.008 mm], HIV×time interaction P=0.25).
CONCLUSIONS
In rural Uganda, treated HIV infection was not associated with faster cIMT progression. These results do not support classification of treated HIV infection as a risk factor for subclinical atherosclerosis progression in rural sub-Saharan Africa.
REGISTRATION
https://www.ClinicalTrials.gov; Unique identifier: NCT02445079.
Although ≈70% of the world's population of people living with HIV resides in sub-Saharan Africa, there are minimal prospective data on the contributions of HIV infection to atherosclerosis in the region.
METHODS AND RESULTS
We conducted a prospective observational cohort study of people living with HIV on antiretroviral therapy >40 years of age in rural Uganda, along with population-based comparators not infected with HIV. We collected data on cardiovascular disease risk factors and carotid ultrasound measurements annually. We fitted linear mixed effects models, adjusted for cardiovascular disease risk factors, to estimate the association between HIV serostatus and progression of carotid intima media thickness (cIMT). We enrolled 155 people living with HIV and 154 individuals not infected with HIV and collected cIMT images at 1045 visits during a median of 4 annual visits per participant (interquartile range 3-4, range 1-5). Age (median 50.9 years) and sex (49% female) were similar by HIV serostatus. At enrollment, there was no difference in mean cIMT by HIV serostatus (0.665 versus 0.680 mm, P=0.15). In multivariable models, increasing age, blood pressure, and non-high-density lipoprotein cholesterol were associated with greater cIMT (P<0.05), however change in cIMT per year was also no different by HIV serostatus (0.004 mm/year for HIV negative [95% CI, 0.001-0.007 mm], 0.006 mm/year for people living with HIV [95% CI, 0.003-0.008 mm], HIV×time interaction P=0.25).
CONCLUSIONS
In rural Uganda, treated HIV infection was not associated with faster cIMT progression. These results do not support classification of treated HIV infection as a risk factor for subclinical atherosclerosis progression in rural sub-Saharan Africa.
REGISTRATION
https://www.ClinicalTrials.gov; Unique identifier: NCT02445079.
Journal Article > CommentaryFull Text
Lancet Infect Dis. 2021 February 12; Volume 21; DOI:10.1016/S1473-3099(20)30836-7
Hewison CCH, Guglielmetti L
Lancet Infect Dis. 2021 February 12; Volume 21; DOI:10.1016/S1473-3099(20)30836-7
We are not alone in welcoming the study by Kelly E Dooley and colleagues 1 that sheds light on the QT prolonging effects of the combination of bedaquiline and delamanid, two key drugs for the treatment of multidrug-resistant or rifampicin-resistant tuberculosis. Clinicians treating multidrug-resistant or rifampicin-resistant tuberculosis worldwide only recently started losing sleep over the fear of QT interval prolongation, a well-known adverse event of many drugs. A heart rate-corrected QT interval (QTc) of 500 ms or more increases the risk of potentially fatal ventricular arrhythmias, including torsade de pointes. 2 Despite the frequent, long-term use of QT interval-prolonging drugs, including moxifloxacin, which is used as a positive control in thorough QT studies, 3 ECG monitoring became routine during multidrug or rifampicin-resistant tuberculosis treatment only after the first phase 2 trials showed QT prolongation during treatment with bedaquiline and delamanid. These concerns initially led WHO to formulate conservative recommendations regarding their use in combination. 4 Many of these fears have since been dispelled by increasing evidence. 5 , 6 , 7 In particular, WHO guidelines, based on a review of data done in 2019 including the results of the study by Dooley and colleagues, showed no additional safety concerns related to this combination. 8
Journal Article > EditorialFull Text
Glob Heart. 2019 December 31; Volume 15 (Issue 1); 57.; DOI:10.5334/gh.860
Webster R, Murphy A, Bygrave H, Ansbro É, Grobbee DE, et al.
Glob Heart. 2019 December 31; 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.
Journal Article > ResearchFull Text
BMJ Open. 2023 January 25; 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. 2023 January 25; 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 > ResearchAbstract
Cardiol Young. 2021 March 8; DOI:10.1017/S1047951121000834
Muhame RM, Dragulescu A, Nadimpalli A, Martinez D, Bottineau MC, et al.
Cardiol Young. 2021 March 8; DOI:10.1017/S1047951121000834
Background: In resource limited settings, children with cardiac disease present late, have poor outcomes and access to paediatric cardiology programmes is limited. Cardiac point of care ultrasound was introduced at several Médecins Sans Frontières sites to facilitate cardiopulmonary assessment. We describe the spectrum of disease, case management and outcomes of cases reviewed over the Telemedicine platform.
Methods: Previously ultrasound naïve, remotely placed clinical teams received ultrasound training on focussed image acquisition. The Médecins Sans Frontières Telemedicine platform was utilised for remote case and imaging review to diagnose congenital and acquired heart disease and guide management supported by a remotely situated paediatric cardiologist.
Results: Two-hundred thirty-three cases were reviewed between 2016 and 2018. Of 191 who underwent focussed cardiac ultrasound, diagnoses included atrial and ventricular septal defects 11%, atrioventricular septal defects 7%, Tetralogy of Fallot 9%, cardiomyopathy/myocarditis 8%, rheumatic heart disease 8%, isolated pericardiac effusion 6%, complex congenital heart disease 4% and multiple other diagnoses in 15%. In 17%, there was no identifiable abnormality while 15% had inadequate imaging to make a diagnosis. Cardiologist involvement led to management changes in 75% of cases with a diagnosis. Mortality in the entire group was disproportionately higher among neonates (38%, 11/29) and infants (20%, 16/81). There was good agreement on independent review of selected cases between two independent paediatric cardiologists.
Conclusion: Cardiac point of care ultrasound performed by remote clinical teams facilitated diagnosis and influenced management in cases reviewed over a Telemedicine platform. This is a feasible method to support clinical care in resource limited settings.
Methods: Previously ultrasound naïve, remotely placed clinical teams received ultrasound training on focussed image acquisition. The Médecins Sans Frontières Telemedicine platform was utilised for remote case and imaging review to diagnose congenital and acquired heart disease and guide management supported by a remotely situated paediatric cardiologist.
Results: Two-hundred thirty-three cases were reviewed between 2016 and 2018. Of 191 who underwent focussed cardiac ultrasound, diagnoses included atrial and ventricular septal defects 11%, atrioventricular septal defects 7%, Tetralogy of Fallot 9%, cardiomyopathy/myocarditis 8%, rheumatic heart disease 8%, isolated pericardiac effusion 6%, complex congenital heart disease 4% and multiple other diagnoses in 15%. In 17%, there was no identifiable abnormality while 15% had inadequate imaging to make a diagnosis. Cardiologist involvement led to management changes in 75% of cases with a diagnosis. Mortality in the entire group was disproportionately higher among neonates (38%, 11/29) and infants (20%, 16/81). There was good agreement on independent review of selected cases between two independent paediatric cardiologists.
Conclusion: Cardiac point of care ultrasound performed by remote clinical teams facilitated diagnosis and influenced management in cases reviewed over a Telemedicine platform. This is a feasible method to support clinical care in resource limited settings.
Journal Article > ResearchFull Text
J Acquir Immune Defic Syndr. 2018 April 11; Volume 78 (Issue 4); 458-464.; DOI:10.1097/QAI.0000000000001696
Muiru AN, Bibangambah P, Hemphill LC, Sentongo R, Kim JH, et al.
J Acquir Immune Defic Syndr. 2018 April 11; Volume 78 (Issue 4); 458-464.; DOI:10.1097/QAI.0000000000001696
BACKGROUND
The utility and validity of cardiovascular diseases (CVD) risk scores are not well studied in sub-Saharan Africa. We compared and correlated CVD risk scores with carotid intima media thickness (c-IMT) among HIV-infected and uninfected people in Uganda.
METHODS
We first calculated CVD risk using the (1) Framingham laboratory-based score; (2) Framingham nonlaboratory score (FRS-BMI); (3) Reynolds risk score; (4) American College of Cardiology and American Heart Association score; and (5) the Data collection on Adverse Effects of Anti-HIV Drugs score. We then compared absolute risk scores and risk categories across each score using Pearson correlation and kappa statistics, respectively. Finally, we fit linear regression models to estimate the strength of association between each risk score and c-IMT.
RESULTS
Of 205 participants, half were females and median age was 49 years [interquartile range (IQR) 46-53]. Median CD4 count was 430 cells/mm (IQR 334-546), with median 7 years of antiretroviral therapy exposure (IQR 6.4-7.5). HIV-uninfected participants had a higher median systolic blood pressure (121 vs. 110 mm Hg), prevalent current smokers (18% vs. 4%, P = 0.001), higher median CVD risk scores (P < 0.003), and greater c-IMT (0.68 vs. 0.63, P = 0.003). Overall, FRS-BMI was highly correlated with other risk scores (all rho >0.80). In linear regression models, we found significant correlations between increasing CVD risk and higher c-IMT (P < 0.01 in all models).
CONCLUSIONS
In this cross-sectional study from Uganda, the FRS-BMI correlated well with standard risk scores and c-IMT. HIV-uninfected individuals had higher risk scores than HIV-infected individuals, and the difference seemed to be driven by modifiable factors.
The utility and validity of cardiovascular diseases (CVD) risk scores are not well studied in sub-Saharan Africa. We compared and correlated CVD risk scores with carotid intima media thickness (c-IMT) among HIV-infected and uninfected people in Uganda.
METHODS
We first calculated CVD risk using the (1) Framingham laboratory-based score; (2) Framingham nonlaboratory score (FRS-BMI); (3) Reynolds risk score; (4) American College of Cardiology and American Heart Association score; and (5) the Data collection on Adverse Effects of Anti-HIV Drugs score. We then compared absolute risk scores and risk categories across each score using Pearson correlation and kappa statistics, respectively. Finally, we fit linear regression models to estimate the strength of association between each risk score and c-IMT.
RESULTS
Of 205 participants, half were females and median age was 49 years [interquartile range (IQR) 46-53]. Median CD4 count was 430 cells/mm (IQR 334-546), with median 7 years of antiretroviral therapy exposure (IQR 6.4-7.5). HIV-uninfected participants had a higher median systolic blood pressure (121 vs. 110 mm Hg), prevalent current smokers (18% vs. 4%, P = 0.001), higher median CVD risk scores (P < 0.003), and greater c-IMT (0.68 vs. 0.63, P = 0.003). Overall, FRS-BMI was highly correlated with other risk scores (all rho >0.80). In linear regression models, we found significant correlations between increasing CVD risk and higher c-IMT (P < 0.01 in all models).
CONCLUSIONS
In this cross-sectional study from Uganda, the FRS-BMI correlated well with standard risk scores and c-IMT. HIV-uninfected individuals had higher risk scores than HIV-infected individuals, and the difference seemed to be driven by modifiable factors.
Conference Material > Abstract
Ansbro E, Masri S, Prieto-Merino D, Bahous SA, Molfino L, et al.
MSF Scientific Days International 2022. 2022 May 11; 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. 2021 October 9; 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. 2021 October 9; 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.
Journal Article > LetterSubscription Only
N Engl J Med. 2018 January 4; Volume 378 (Issue 1); e2(3).; DOI:10.1056/NEJMc1714503
Rossi G
N Engl J Med. 2018 January 4; Volume 378 (Issue 1); e2(3).; DOI:10.1056/NEJMc1714503