Participants

generally felt that a severity response format would be more appropriate. Following completion of the first-stage cognitive debriefing interviews, the research team decided to focus the content of OPAQ-PF on physical function as a measure of the impact of osteoporosis, concentrating on the domains of mobility (walking, carrying, and climbing), physical positions (bending, reaching, picking up, standing, and sitting), and transfers (getting in and out of bed, chairs, and vehicles, and on and off the toilet). This led to the removal of items addressing fear of falling, HMPL-504 mouse independence, and symptoms. As a result, the instrument generated at the end of the first stage of phase 2 had 16 items in three domains (mobility, physical positions, and transfers) and included a five-point scale that was used throughout the questionnaire: ‘no difficulty’; ‘a little difficulty’; ‘some difficulty’; ‘a lot of difficulty’; and ‘severe difficulty’. This instrument was used in the second stage of phase 2. Second stage: patient demographics Demographic data for the 18 participants (eight in diversity BYL719 group 1, five in group 2, and five in group 3) recruited for this stage of the study are shown in Table 1. As in the first stage, this cohort was predominantly white (83 %), with a mean (±SD) age of 70.0 ± 9.2 years and a mean disease duration of 6.0 ± 4.1 years.

Twelve of the 18 patients had sustained a total of 16 fractures. The predominant fracture site in this cohort was the hip (n = 5). The remaining fractures were distributed among spine (n = 3), wrist (n = 1), ankle (n = 1), distal forearm (n = 1), humerus (n = 2), ribs (n = 1), pelvis (n = 1), and foot/toe (n = 1). Comorbid conditions included osteoarthritis, inflammatory arthritis, rheumatoid arthritis, diabetes, hypercholesterolemia, asthma, chronic obstructive pulmonary disease, hypertension, and restless legs syndrome. Second stage: concept elicitation In the second stage of phase 2, saturation was achieved after the 13th concept elicitation interview. Concept elicitation data supporting the Progesterone final version of OPAQ-PF are summarized in Table 2. First- and second-stage interview data are presented

together. The results demonstrate widespread support for all items in the domains of mobility, physical positions, and transfers. Second stage: cognitive debriefing Cognitive debriefing results obtained in the first stage of phase 2 reflect participants’ thoughts regarding the design of the questionnaire, the language used, its applicability, the ease with which the instructions could be interpreted, response options, and the recall period. The questionnaire underwent further iterative modifications during the second stage of phase 2 as a result of participants’ feedback. These modifications included removing one item, re-wording of items, and the addition of examples for clarification. As in the first stage of phase 2, all modifications were tracked in an item-tracking matrix.