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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