Abstract
BackgroundThe use of prescription anti-obesity medication (AOM) is becoming increasingly common as treatment options grow and become more accessible. However, AOM may not be without a wide range of potentially negative impacts on patient functioning and well being. The Treatment Related Impact Measure (TRIM-Weight) is an obesity treatment-specific patient reported outcomes (PRO) measure designed to assess the key impacts of prescription anti-obesity medication. This paper will present the validation findings for the TRIM-Weight.MethodsThe online validation battery survey was administered in four countries (the U.S., U.K., Australia, and Canada). Eligible subjects were over age eighteen, currently taking a prescription AOM and were currently or had been obese during their life. Validation analyses were conducted according to an a priori statistical analysis plan. Item level psychometric and conceptual criteria were used to refine and reduce the preliminary item pool and factor analysis to identify structural domains was performed. Reliability and validity testing was then performed and the minimally importance difference (MID) explored.ResultsTwo hundred and eight subjects completed the survey. Twenty-one of the 43 items were dropped and a five-factor structure was achieved: Daily Life, Weight Management, Treatment Burden, Experience of Side Effects, and Psychological Health. A-priori criteria for internal consistency and test-retest coefficients for the total score and all five subscales were met. All pre-specified hypotheses for convergent and known group validity were also met with the exception of the domain of Daily Life (proven in an ad hoc analysis) as well as the 1/2 standard deviation threshold for the MID.ConclusionThe development and validation of the TRIM-Weight has been conducted according to well-defined principles for the creation of a PRO measure. Based on the evidence to date, the TRIM-Weight can be considered a brief, conceptually sound, valid and reliable PRO measure.
Highlights
The use of prescription anti-obesity medication (AOM) to treat obesity is becoming increasingly common as treatment options grow and become more accessible
AOM has been associated with a wide range of potentially negative impacts on patient functioning and well being
The impact of AOM is far less well understood than the impact of obesity on Health Related Quality of Life (HRQoL)
Summary
The use of prescription anti-obesity medication (AOM) to treat obesity is becoming increasingly common as treatment options grow and become more accessible. Treatment satisfaction may be correlated with patient compliance [3,4,5], impaired self-management [6], health care decisions [7], and use of health care services [8] It is associated with improvements in treatment efficacy outcomes [9], and patients who are satisfied with their treatments are more likely to maintain positive physical and psychological health [10]. Assessing treatment satisfaction can help the physician distinguish among treatment regimes with equal efficacy or impact on HRQoL [11], as well as identify treatments that patients find more acceptable [10], potentially resulting in greater compliance and thereby efficacy. The use of prescription anti-obesity medication (AOM) is becoming increasingly common as treatment options grow and become more accessible. This paper will present the validation findings for the TRIM-Weight
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