How context can impact clinical trials: a multi-country qualitative case study comparison of diagnostic biomarker test interventions

Table 2 Qualitative sample characteristics

	Case study
	Chiang Rai (Thailand)	Yangon (Myanmar)	Hanoi (Vietnam)
Timing of data collection	August 2016, May 2017	December 2016 –January 2017	June – December 2015
Healthcare worker sample
Sample size	21 HCWs (16 female/5 male)	12 HCWs (6 female/6 male)	12 HCWs (10 female/2 male)
Sampling strategy	Census (all participating HCWs)	Purposive sample (at least 1 from each site)^a	Purposive sample (at least 1 from each site)^b
Semi-structured interviews	21 SSIs	12 SSIs	2 SSIs
Focus group discussions	None	None	1 FGD (10 participants)
Patient sample
Sample size	37 Patients^c (control and treatment; 24 female/13 male, average age 42 years)	21 Patients^c (control and treatment; 13 female/8 male, average age 37 years)	27 Patients^c (treatment group only; 23 female/4 male, average age 49 years)
Sampling strategy	Purposive sample (maximum variation)^d	Purposive sample (maximum variation)^d	Random sample with information saturation^e
Semi-structured interviews	25 SSIs (incl. 2 interviews with 2 participants)	11 SSIs (incl. 1 interview with 2 participants)	9 SSIs
Focus group discussions	3 FGDs (3 male, 4 female; 3 female guardians)	2 FGDs (4 male, 5 female; mixed adult/guardian)	3 FGDs (5/6/7 participants; male/female/guardian)

Source: Authors
“Guardian” is defined as an interview participant who signed consent for a child participating in the clinical trial, or non-trial respondent who was responsible for care of a child. However, guardians reported on their own health behaviour as well as their children’s.
HCW healthcare worker, SSI semi-structured interview, FDG focus group discussion
^aRespondents within sites selected on basis of availability
^bRespondents within sites comprising main study doctors who enrolled more than 80% of the centre’s total sample. At least one such doctor per site would participate in the focus group discussion. In two sites, there were two such doctors; one would participate in the focus group discussion and one each would participate in a semi-structured interview
^cIncluding patients and guardians of patients who were children
^dMaximum variation across the following variables: patients’ study groups (pre-intervention/control/treatment group), antibiotic prescription (yes/no), sex (male/female), age (guardian of a child below 18 years/18–49/50+), education (below/above primary education)
^eSaturation criterion: no new themes arose from two consecutive focus group discussions/semi-structured interviews

ISSN: 1745-6215