Data collection and measurements

The primary study outcomes of the larger C-STOP trial were ascertained at 6 months, and the research team remained blinded to these data. That said, during 1-year follow-up of this population, we identified nurse case-management patients who had started bisphosphonate treatment at any time up to their 1-year data collection. We enrolled 150 patients in the nurse case-management arm of the larger study. Thus, all patients seen in the clinic were potentially eligible, and the only patients seen in the clinic were trial patients. We did not sample patients “randomly” for the purposes of generalizability of the results as conceptualized in quantitative research. Instead, we sampled patients based on their ability to act as key informants (i.e., someone with direct experience with the phenomenon who is able to reflect on and articulate their experience) for the purposes of transferability of the results to similar populations and contexts. At this time, we purposefully sampled patients who had started bisphosphonate treatment (by study treatment algorithm, either generic alendronate or risedronate prescribed weekly [18]) and reported whether they were still persistent with treatment at 1 year (“persisters”) or they had stopped treatment (“stoppers”). We verified all self-reported treatment data independently by using local pharmacy dispensing records.

As the study progressed, we used theoretical sampling, one of the core strategies of grounded theory [22, 24]. Theoretical sampling is responsive to the data in that the researchers sample concepts and not persons [22]. Since the nurse case-manager had met and remained in contact with all trial patients, she helped identify potential patients who could talk directly to our various emerging concepts. For example, we recruited patients diagnosed with either osteopenia or OP as defined strictly by BMD test results to elicit a deeper understanding of perceived severity, when this specific concept emerged from analysis. As well, we re-interviewed several patients as themes and concepts emerged.

A trained researcher conducted qualitative in-person interviews using a semi-structured interview guide (Appendix), which was refined as data analysis progressed. Interviews were conducted in the same location as case-management appointments at a single center and lasted up to 45 min. Interviews were digitally recorded for subsequent analysis and verified for accuracy. The University of Alberta Health Ethics Research Board approved the parent trial and this qualitative sub-study, and all subjects provided written informed consent.