| Summary: | <p>Abstract</p> <p>Purpose</p> <p>Diabetes is a debilitating illness requiring lifelong management. Treatments can be varied in terms of mode of administration as well as type of agent. Unfortunately, most patient reported outcome measures currently available to assess the impact of treatment are specific to diabetes type, treatment modality or delivery systems and are designed to be either a HRQoL or treatment satisfaction measure. To address these gaps, the Treatment Related Impact Measure-Diabetes and Device measures were developed. This paper presents the item development and validation of the TRIM Diabetes/Device.</p> <p>Methods</p> <p>Patient interviews were conducted to collect the patient perspective and ensure high content validity. Interviews were hand coded and qualitatively analyzed to identify common themes. A conceptual model of the impact of diabetes medication was developed and preliminary items for the TRIM-Diabetes/Device were generated and cognitively debriefed. Validation data was collected via an on-line survey and analyzed according to an a priori statistical analysis plan to validate the overall score as well as each domain. Item level criteria were used to reduce the preliminary item pool. Next, factor analysis to identify structural domains was performed. Reliability and validity testing was then performed.</p> <p>Results</p> <p>One hundred and five patients were interviewed in focus groups, individual interviews and for cognitive debriefing. Five hundred seven patients participated in the validation study. Factor analysis identified seven domains: Treatment Burden, Daily Life; Diabetes Management; Psychological Health; Compliance and Device Function and Bother. Internal consistency reliability coefficients of the TRIM-Diabetes/Device ranged from 0.80 and 0.94. Test-retest reliability of the TRIM-Diabetes/Device ranged from 0.71 to 0.89. All convergent and known groups validity hypotheses were met for the TRIM-Diabetes/Device total scores and sub-scales.</p> <p>Conclusion</p> <p>Validation is an ongoing and iterative process. These findings are the first step in that process and have shown that both the TRIM-Diabetes and the TRIM-Diabetes Device have acceptable psychometric properties. Future research is needed to continue the validation process and examine responsiveness and the validity of the TRIM-Diabetes/Device in a clinical trial population.</p>
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