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To address the goals of this study, a qualitative research strategy was developed to deal with exploratory, comprehensive, and descriptive concerns [26]. An inductive enquiry consistent with a grounded-theory approach [27] was used in accordance with qualitative guidelines [28–30]. Face-to-face semi-structured interviews were conducted with physicians and women with PMO. A focus group was also organized to further probe the data collected in individual interviews: projective and associative techniques were used to discuss potential issues related to PMO and its treatment [31].
The study included 37 women with PMO and 18 physicians. To be eligible for the study, the women had to have been diagnosed with PMO by a bone density test and to have received a long-term prescription for an anti-osteoporotic treatment. The guiding principle of our sampling procedure was to favor diversity. Women were purposively sampled to ensure this diversity according to age (21 participants between 50 and 69 and 16 aged 70 or over), symptoms (16 fractures, 7 hip fractures), and self-reported compliance (19 women declaring to be adherent) [S1 Table]. A focus group of 4 women without fracture, age 50 to 69, who declared medical compliance, was formed to gain a deeper understanding of why some younger asymptomatic interviewees were compliant even though their condition might seem to impede medical adherence. Individuals with other forms of osteoporosis were excluded in order to clearly circumscribe the results to PMO. The physician sample included 18 persons with public, private, and mixed practices, from the 3 main medical specialties (8 general practitioners [GP], 5 gynecologists [G] and 5 rheumatologists [R]) involved in the management of osteoporosis in France. All the physicians interviewed confirmed that they had women suffering from PMO in their patient base.
Multiple recruitment strategies were used to maximize the diversity of participants. We used the patient lists of 2 doctors of the research team (CR, KB) to recruit 15 women and 3 physicians. The other participants (22 women and 15 physicians) were recruited through various networks: those of the first participants, of the 2 research team sociologists [SA, LH]) of 1 private nurse, and of 2 professional recruiters in 2 distinct regions, using flyers and direct contact. Interested women either contacted the sociologists in charge of the study or agreeded to be phoned with further information to set an appointment for an interview. Written informed consent was obtained from all the women who participated in the study. All physicians gave oral informed consent.
The study protocol was approved by the ethics committee Comité de Protection des Personnes Ile de France III of Tarnier–Cochin Hospital, Paris. All patients received written information presenting the aims, methodology, funding, and institutional affiliation of the researchers, as well as the potential risks and benefits of the study. They gave written informed consent to participate in the study. The study also conformed to the regulations concerning the use of private personal data, and was approved by the French agencies that certify research and enforce the Freedom of Information Act, namely the Comité Consultatif sur le Traitement de l’Information en matière de Recherche dans le domaine de la Santé and the Commission Nationale de l’Informatique et des Libertés. The research was conducted according to the Declaration of Helsinki principles.
Interview and focus group protocols: The interviews followed semi-structured guides with opportunity for open-ended discussion. As analysis progressed, interviewers could thus pursue new topics when they arose, elicit specific information, and remain open to unexpected topics in the follow-up questions. They could also review the interviews conducted and adjust their guides. The patient and physician protocols covered the same topics, allowing viewpoint crossing and data comparison for the issues discussed. The protocol for women with PMO comprised: general views, personal experiences, attitudes towards treatment and decision-making processes, outcomes, and expectations. It combined a thematic structure (views of PMO, its impact in daily life and subsequent adjustments, therapeutic journey, treatment, and expectations) with chronological sequences to examine in detail the therapeutic journey as well as the patient-physician relationship. The physician protocol covered doctors' views on osteoporosis, its management (from diagnosis to therapeutic decision-making processes), patient-physician interactions, and physicians’ expectations. The protocols included representations, reported practices related to PMO, and expectations.
The women were interviewed between March and July 2014. The interviews lasted 1 hour 40 minutes on average (ranging from 1 hour to 2 hours 51 minutes). The interviews took place in participants’ homes (25) or at sociologists’ offices, depending on the women’s preferences. The focus group lasted 3 hours and was conducted at Cochin Hospital (Paris, France) in May 2014. The physician interviews were conducted between December 2013 and March 2014. They took place in the doctors’ offices (15), hospitals (1), or homes (2) and lasted 1 hour 5 minutes on average (ranging from 1 hour to 1 hour 30 minutes). The interviewers ensured that all aspects of the study were sufficiently explained during the interviews and before the focus group. The interviews and the focus group were audio-recorded with permission. They were transcribed verbatim and the audio recordings were erased within 15 days. All interviews were conducted with a commitment to respecting the anonymity of respondents.
The sociologists used inductive thematic analysis to identify and analyze themes and subthemes in the data. They read a preliminary series of interviews and developed a preliminary list of coding categories. As the fieldwork and the analysis progressed, they refined the list (by expanding, detailing, splicing, or linking codes) and modified it as new insights about the data were found. The sociologists discussed the coding frame, fine-tuning the bases of the coding categories. This list provided a content analysis grid to code the entire data. Sessions of peer debriefing with osteoporosis specialists (KB, CR, SP) were held to ensure a high level of inter-researcher consistency.
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