Fears around leaving infectious diseases untreated and
poorly enforced antibiotic supply controls could hamper efforts to reduce the
use of antibiotics in low to middle income countries, according to a new study
from the University of Warwick.
Published in the journal Trials and led
by Dr Marco J Haenssgen, Assistant Professor in
Global Sustainable Development, the study demonstrates that contextual factors,
such as local health policies, influence the results of clinical trials of
medical interventions. The landmark study is one of the most detailed qualitative
analyses of the context of clinical trials in antimicrobial resistance ever
conducted. It calls for the routine collection of social data alongside
clinical trials to help tailor the local appropriateness of clinical
interventions and help researchers interpret their findings.
By better recording these contextual influences, the researchers argue that
interdisciplinary research collaborations between the social and medical
sciences can help tackle global challenges such as drug resistance more effectively.
The study analyses clinical trials in Myanmar, Thailand, and Vietnam with a
total of 4446 participants, that aimed to test the effectiveness of a
five-minute finger-prick blood test to reduce antibiotic prescriptions for
fever patients in primary healthcare. The test measured C-reactive protein
levels in the participants’ blood, helping healthcare workers such as nurses
and doctors to decide whether the cause of the febrile illness was likely to be
bacterial, in which case an antibiotic could be prescribed.
The research by Dr Haenssgen’s team complemented these trials and identified
differences in adherence to the results of the test in patients and clinicians,
both across and within the sites – in some clinics, physicians prescribed
antibiotics despite a negative test result in as much as 71% of cases. They
then determined the reasons for the disparities through the analysis of nearly
one million words of qualitative material from 130 interview and group
discussion participants across the three countries.
They found that if antibiotics were over-abundant or if healthcare workers were
worried about deadly infectious diseases, they were less likely to follow the
guidance provided by the biomarker test. Similarly, if long and dangerous
journeys prevented patients from follow-up visits to primary health centres or
if they struggled to understand the purpose of the test, then patients may be
more likely to ignore the results and buy antibiotics without prescriptions
from local grocery stores and pharmacies – making the intervention seemingly
The study further argues that such clinical trials could also exclude different
parts of the relevant target population, as some people struggle with accessing
healthcare and others might not consume antibiotics for fevers but, for
instance, open wounds and other conditions for which the biomarker test is not
currently being used.
MJ, et al. How context can impact clinical trials: a multi-country qualitative
case study comparison of diagnostic biomarker test interventions. Trials.
Published 9 January 2019. https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3215-9