76
N. Engel et al.
The devices that lend themselves to such POC testing are often thought to be
simple, cheap, and rapid (Mabey et al. 2012), work without access to laboratories,
fridges, gloves, biosafety, continuous power supply, or trained staff and meet what
the World Health Organization defined as ASSURED criteria (Affordable, sensitive,
specific, user-friendly, rapid and robust, equipment free, and delivered). However, the
availability of relatively cheap, simple, and rapid tests that can be conducted outside
laboratories does not automatically ensure the POC continuum. We know that f.i.
malaria rapid tests are often not used or the results not acted upon (Chandler et al.
2012). Similarly, TB tests deployed at POC might require additional infrastructural,
financial, and operational support, exhausting resources at the clinic (Clouse et al.
2012), and HIV rapid testing is at times hampered by poor linkages to care (Kranzer
et al. 2010). In order to understand the new roles and challenges that medical devices
such as POC tests encounter, we need to study diagnostic practices at the POC and
how devices are integrated into workflow and patient pathways.
This chapter reviews results from a qualitative research project on barriers to POC
testing in South Africa and India. In this project, we aimed at understanding where
POC testing is happening and what the main barriers are. Using a framework that envisions POC testing as programs, rather than just tests, across five settings (home, community, peripheral laboratory, clinic, and hospital) (Pant Pai et al. 2012), we examined
diagnostic practices across major diseases and actors in homes, clinics, communities,
hospitals, and laboratories in South Africa and India. Detailed results per country
have been published (Engel et al. 2015a, b, c). Here, we review selected results, discuss them comparatively, and reflect on the implications for medical device design.
7.1.1 Qualitative Project on Barriers to POC Testing
Data for this project was collected in semi-structured interviews (N 101 in South
Africa, N 8 in India) and focus group discussions (N 7 in South Africa, N 13
in India) with doctors, nurses, community health workers, patients, laboratory technicians, policymakers, hospital managers, and diagnostic manufacturers between
September 2012 and June 2013 in Durban, Cape Town, and Eastern Cape (South
Africa) and Bangalore and Tumkur district (India). Participants were purposively
sampled to represent the settings of hospitals, peripheral labs, clinics, communities,
and homes in both the public/private sector and rural/urban setting. In the context
of conducting interviews and FGDs, we visited labs, clinics, and testing facilities.
These three data sources allowed us to triangulate data. The interviews specifically
examined diagnostic steps for each major disease occurring in the setting (such as
HIV, TB, diabetes, diarrhoeal diseases and hypertension in South Africa and HIV,
TB, malaria, hepatitis, syphilis, diabetes, typhoid, and dengue in India) in great detail
from ordering a test to acting on a result, including available material and capacities,
turnaround times, and referral processes. Additionally, we explored during interviews
the challenges that participants encountered when diagnosing, understanding of
N. Engel et al.
The devices that lend themselves to such POC testing are often thought to be
simple, cheap, and rapid (Mabey et al. 2012), work without access to laboratories,
fridges, gloves, biosafety, continuous power supply, or trained staff and meet what
the World Health Organization defined as ASSURED criteria (Affordable, sensitive,
specific, user-friendly, rapid and robust, equipment free, and delivered). However, the
availability of relatively cheap, simple, and rapid tests that can be conducted outside
laboratories does not automatically ensure the POC continuum. We know that f.i.
malaria rapid tests are often not used or the results not acted upon (Chandler et al.
2012). Similarly, TB tests deployed at POC might require additional infrastructural,
financial, and operational support, exhausting resources at the clinic (Clouse et al.
2012), and HIV rapid testing is at times hampered by poor linkages to care (Kranzer
et al. 2010). In order to understand the new roles and challenges that medical devices
such as POC tests encounter, we need to study diagnostic practices at the POC and
how devices are integrated into workflow and patient pathways.
This chapter reviews results from a qualitative research project on barriers to POC
testing in South Africa and India. In this project, we aimed at understanding where
POC testing is happening and what the main barriers are. Using a framework that envisions POC testing as programs, rather than just tests, across five settings (home, community, peripheral laboratory, clinic, and hospital) (Pant Pai et al. 2012), we examined
diagnostic practices across major diseases and actors in homes, clinics, communities,
hospitals, and laboratories in South Africa and India. Detailed results per country
have been published (Engel et al. 2015a, b, c). Here, we review selected results, discuss them comparatively, and reflect on the implications for medical device design.
7.1.1 Qualitative Project on Barriers to POC Testing
Data for this project was collected in semi-structured interviews (N 101 in South
Africa, N 8 in India) and focus group discussions (N 7 in South Africa, N 13
in India) with doctors, nurses, community health workers, patients, laboratory technicians, policymakers, hospital managers, and diagnostic manufacturers between
September 2012 and June 2013 in Durban, Cape Town, and Eastern Cape (South
Africa) and Bangalore and Tumkur district (India). Participants were purposively
sampled to represent the settings of hospitals, peripheral labs, clinics, communities,
and homes in both the public/private sector and rural/urban setting. In the context
of conducting interviews and FGDs, we visited labs, clinics, and testing facilities.
These three data sources allowed us to triangulate data. The interviews specifically
examined diagnostic steps for each major disease occurring in the setting (such as
HIV, TB, diabetes, diarrhoeal diseases and hypertension in South Africa and HIV,
TB, malaria, hepatitis, syphilis, diabetes, typhoid, and dengue in India) in great detail
from ordering a test to acting on a result, including available material and capacities,
turnaround times, and referral processes. Additionally, we explored during interviews
the challenges that participants encountered when diagnosing, understanding of