The design of test items for the new instrument was based on a generalized conceptual framework of treatment satisfaction. The initial formation of the conceptual framework was grounded in a thorough review of the scientific literature that dealt with the core TS-M domains across a diversity of therapeutic areas. Subsequently, the draft conceptual framework was more fully elaborated using qualitative data from patient focus group interviews. Focus group participants (n = 30) were recruited to take part in one of three, two-hour sessions conducted in Los Angeles, Chicago, and Boston. Participants consisted of patients with at least one the following illness conditions: asthma, arthritis, cancer, cardiovascular disease, depression/anxiety, diabetes, infectious disease, migraine, and psoriasis. The focus group discussions were guided by a trained interviewer who, in accordance with established qualitative research procedures [61 ], focused on aspects of the treatment satisfaction framework, outlined in a discussion guide [62 ,63 ].
Over the course of the three focus group sessions, the discussion guide and conceptual framework on which it was based, were evolved through integration of the patients' perspectives from each preceding group. In this way the guide was iteratively refined to reflect the participants' perspectives. Once the framework was fully elaborated, the domains of TS-M included; (1) side effects, (2) symptom relief, (3) convenience, (4) effectiveness, (5) impact on daily life, and (6) tolerability/acceptability. Fifty-five draft TS-M items were designed to measure aspects of the conceptual framework and its domains. Further details of the qualitative methods and results can be found in a sister manuscript describing the development of the TS-M conceptual framework.
Over the course of the three focus group sessions, the discussion guide and conceptual framework on which it was based, were evolved through integration of the patients' perspectives from each preceding group. In this way the guide was iteratively refined to reflect the participants' perspectives. Once the framework was fully elaborated, the domains of TS-M included; (1) side effects, (2) symptom relief, (3) convenience, (4) effectiveness, (5) impact on daily life, and (6) tolerability/acceptability. Fifty-five draft TS-M items were designed to measure aspects of the conceptual framework and its domains. Further details of the qualitative methods and results can be found in a sister manuscript describing the development of the TS-M conceptual framework.
