The outcomes of your clinical trial depend on where you implement it!

What is it about?

Research in medicine often uses experiments ("clinical trials") to find out which interventions work. Because drug resistance is becoming a health problem globally, one kind of intervention being trialled are diagnostic tests to help doctors and nurses decide when to prescribe antibiotics. Three such clinical trials were recently completed in Southeast Asia (Myanmar, Thailand, Vietnam), involving a five-minute finger prick test that informs healthcare workers (doctors and nurses who prescribe antibiotics) whether an illness is unlikely to be caused by a bacterial infection - in which case an antibiotic would not normally be prescribed. However, doctors and nurses as well as patients reacted very differently within and across the three studies. We carried out interviews and focus group discussions as part of the medical research to better understand implementation contexts and processes. The comparison of this qualitative research across the three comparable case studies gave us a unique insight why in some cases healthcare workers ignore the diagnostic test ("non-compliance" of healthcare workers), patients do not follow the healthcare workers' recommendation ("non-compliance" of patients), or why important forms of antibiotic use among patients might be missed by the diagnostic test ("exclusion" of patients). For example, how people thought about illness and antibiotics influenced their compliance with the test results. In Thailand and Myanmar, patients typically did not talk about illness in terms of bacterial infections, nor did they often use the word “antibiotic” (in Thailand, patients call them “anti-inflammatory drugs” and in Myanmar, the colloquial words for antibiotics and pesticides are the same). In Vietnam, patients had a clearer notion of antibiotics and bacterial infections. Contrary to intuition, patients whose understanding of illness and medicine did not align with Western medical concepts tended to put more faith in the diagnostic test. Similarly, patients with less education tend not to question healthcare workers' decisions and appeared more likely to follow the test results - provided they were not so disadvantaged that they could not reach the clinics that offered the test. On the other hand, doctors and nurses appeared less likely to follow the test results when antibiotics were in plentiful supply, when they had nothing else to give to patients in case the test suggested not to prescribe antibiotics, when they were concerned that patients would contract a serious infection soon after the clinic visit without the opportunity to return in time for follow-up, or when they already had a lot of experience with other diagnostic tests (e.g. X-rays) and were therefore not impressed by the novelty of the finger prick test.

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Why is it important?

We understand very little about how local factors like the demand from patients, the cultural understanding of illness, health policies, or the concerns and dilemmas of healthcare workers influence the outcomes of clinical experiments. Our study was the first that systematically compared very similar clinical trials using a wealth of qualitative data, breaking new ground in understanding what affects medical research outcomes - especially in an area as important as drug resistance, which is on top of the global health agenda and which is feared to contribute to 10 million deaths per year by 2050. Our study shows that clinical research should set itself up in such a way that enables the systematic collection of contextual factors in the future. Perhaps at some point we will then be able to develop a "tool kit" that can help researchers, medical practitioners, and policy makers to decide when the local context militates against one medical intervention, favouring another instead.

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