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Table 2 Qualitative study design

From: Protocol: mixed-methods study to evaluate implementation, enforcement, and outcomes of U.S. state laws intended to curb high-risk opioid prescribing

Domain 1: Research team and reflexivity
Personal characteristics
1. 1 Interviewer/facilitator All interviews will be conducted by the same member of the study team
2. Credentials The interviewer will be a masters-level trained research assistant
3. Occupation The interviewer will be employed full-time as a research assistant
4. Gender The interviewer will be female
5. Experience and training The interviewer will have experience participating in qualitative research studies and will be supervised by study co-PIs with extensive training and experience conducting qualitative research
Relationship with participants
6. Relationship established Potential interviewees will be contacted with a standardized recruitment email to introduce the study and the interviewer and to request their participation
7. Participant knowledge of the interviewer The recruitment email will explain the study goals and why the interviewer is interested in conducting this research. This information will be reviewed at the start of each interview
8. Interviewer characteristics The recruitment email will provide information about the research team, including the interviewer. This information will be reviewed at the start of each interview
Domain 2: Study design
Theoretical framework
9. Methodological orientation and theory The qualitative portion of the study will use a content analysis approach
Participant selection
10. Sampling Potential interviewees will be selected based on their legally established responsibilities relative to the state law(s) of interest
11. Method of approach Potential interviewees will be approached with a standardized recruitment email
12. Sample size We anticipate conducting 5 to 10 interviews in each of 18 treatment states
13. Non-participation We will document any reasons provided by those who decline to participate as well as any individuals who do not respond to our recruitment email
Setting
14. Setting of data collection Data will be collected via interviews conducted by telephone
15. Presence of non-participants We anticipate that the interviewer and interviewee will be the only individuals present
16. Description of sample The sample will include key implementation leaders for the law(s) of interest in each of 18 treatment states
Data collection
17. Interview guide The interview guide will be developed by the study team and shared with an advisory board for feedback. It will be pilot-tested and refined before data collection begins
18. Repeat interviews We do not anticipate conducting repeat interviews
19. Audio/visual recording Once permission is granted, interviews will be audio recorded
20. Field notes The interviewer will draft summary notes immediately after concluding each interview
21. Duration We anticipate that interviews will last no more than 30 min
22. Data saturation The study team will convene on a regular basis to review interview data and determine when data saturation is reached
23. Transcripts returned We do not plan on returning transcripts to interviewees. Based on the straightforward nature of our questions and prior research with similar types of interviewees, we do not anticipate that this will be necessary
Domain 3: Analysis and findings
Data analysis
24. Number of data coders We plan to have two coders pilot a sub-sample of transcripts. Once discrepancies are resolved and the codebook is finalized, the full set of transcripts will be coded by one individual
25. Description of the coding tree We plan to develop a coding tree (i.e., codebook) based on a review of the literature, a priori knowledge within the study team, and summary notes from interviews. We will also share a draft codebook with our advisory board for feedback
26. Derivation of themes Themes will be derived once data have been coded. Preliminary themes may be identified based on discussions with the interviewer and review of field notes
27. Software We plan to use NVivo qualitative research software
28. Participant checking A bulleted list of key findings will be shared with participants once data have been coded and analyzed
Reporting
29. Quotations presented Quotations from interviews will be used to present findings, and they will be accompanied by an interviewee identification number
30. Data and findings consistent Our planned use of quotations will allow for assessment of consistency between our data and findings. We will also create supplemental tables with additional quotations to share as much information as possible when presenting our findings
31. Clarity of major themes We plan to use sub-headings listing our major themes to promote clarity when writing up our findings
32. Clarify of minor themes We plan to provide quotations from interviewees who raised minor themes or shared information contrary to findings of our major themes