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How context can impact clinical trials : a multi-country qualitative case study comparison of diagnostic biomarker test interventions
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Haenssgen, Marco Johannes, Charoenboon, Nutcha, Do, Nga T. T., Althaus, Thomas, Khine Zaw, Yuzana, Wertheim, Heiman F. L. and Lubell, Yoel (2019) How context can impact clinical trials : a multi-country qualitative case study comparison of diagnostic biomarker test interventions. Trials, 20 . 111. doi:10.1186/s13063-019-3215-9
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Official URL: https://doi.org/10.1186/s13063-019-3215-9
Abstract
Background
Context matters for the successful implementation of medical interventions, but its role remains surprisingly understudied. Against the backdrop of antimicrobial resistance, a global health priority, we investigated the introduction of a rapid diagnostic biomarker test (C-reactive protein, or CRP) to guide antibiotic prescriptions in outpatient settings and asked, “Which factors account for cross-country variations in the effectiveness of CRP biomarker test interventions?”
Methods
We conducted a cross-case comparison of CRP point-of-care test trials across Yangon (Myanmar), Chiang Rai (Thailand), and Hanoi (Vietnam). Cross-sectional qualitative data were originally collected as part of each clinical trial to broaden their evidence base and help explain their respective results. We synthesised these data and developed a large qualitative data set comprising 130 interview and focus group participants (healthcare workers and patients) and nearly one million words worth of transcripts and interview notes. Inductive thematic analysis was used to identify contextual factors and compare them across the three case studies. As clinical trial outcomes, we considered patients’ and healthcare workers’ adherence to the biomarker test results, and patient exclusion to gauge the potential “impact” of CRP point-of-care testing on the population level.
Results
We identified three principal domains of contextual influences on intervention effectiveness. First, perceived risks from infectious diseases influenced the adherence of the clinical users (nurses, doctors). Second, the health system context related to all three intervention outcomes (via the health policy and antibiotic policy environment, and via health system structures and the ensuing utilisation patterns). Third, the demand-side context influenced the patient adherence to CRP point-of-care tests and exclusion from the intervention through variations in local healthcare-seeking behaviours, popular conceptions of illness and medicine, and the resulting utilisation of the health system.
Conclusions
Our study underscored the importance of contextual variation for the interpretation of clinical trial findings. Further research should investigate the range and magnitude of contextual effects on trial outcomes through meta-analyses of large sets of clinical trials. For this to be possible, clinical trials should collect qualitative and quantitative contextual information for instance on their disease, health system, and demand-side environment.
Trial registration: ClinicalTrials.gov Identifiers NCT02758821 and NCT01918579.
| Item Type: | Journal Article | ||||||||||||||||||||||||
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| Subjects: | R Medicine > R Medicine (General) | ||||||||||||||||||||||||
| Divisions: | Faculty of Arts > School for Cross-faculty Studies Faculty of Arts > School for Cross-faculty Studies > Global Sustainable Development |
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| Library of Congress Subject Headings (LCSH): | Clinical trials, Biochemical markers, Drug resistance in microorganisms | ||||||||||||||||||||||||
| Journal or Publication Title: | Trials | ||||||||||||||||||||||||
| Publisher: | Biomed Central | ||||||||||||||||||||||||
| ISSN: | 1745-6215 | ||||||||||||||||||||||||
| Official Date: | 8 February 2019 | ||||||||||||||||||||||||
| Dates: |
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| Date of first compliant deposit: | 19 January 2019 | ||||||||||||||||||||||||
| Volume: | 20 | ||||||||||||||||||||||||
| Article Number: | 111 | ||||||||||||||||||||||||
| DOI: | 10.1186/s13063-019-3215-9 | ||||||||||||||||||||||||
| Status: | Peer Reviewed | ||||||||||||||||||||||||
| Publication Status: | Published | ||||||||||||||||||||||||
| Access rights to Published version: | Open Access | ||||||||||||||||||||||||
| RIOXX Funder/Project Grant: |
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