Skip to main content
main-content
Top

Tip

Swipe om te navigeren naar een ander artikel

01-11-2011 | Brief Communication | Uitgave 9/2011 Open Access

Quality of Life Research 9/2011

Examining the ability to detect change using the TRIM-Diabetes and TRIM-Diabetes Device measures

Tijdschrift:
Quality of Life Research > Uitgave 9/2011
Auteurs:
Meryl Brod, Torsten Christensen, Mette Hammer, Anne K. Busk, Donald M. Bushnell

Abstract

Purpose

Responsiveness is defined as the ability of an instrument to accurately detect change when it has occurred and is an essential psychometric property of a patient-reported outcomes (PRO) measure to understand and interpret study findings. This study examined the responsiveness of 2 Treatment Related Impact Measures (TRIMs): The TRIM-Diabetes (TRIM-D) and TRIM-Diabetes Device (TRIM-DD) as well as confirmed their measurement models in a randomized controlled trial (RCT) design.

Methods

The data were collected in a multi-center, randomized, open-label (2 × 12 week), cross-over study of two prefilled pens in subjects with type 1 or type 2 diabetes, age 18 or older. Internal and external responsiveness were examined. To confirm the measurement model identified in the previous study, the Bentler comparative fit index (CFI) and internal consistency for the RCT sample scores were examined and compared.

Results

Based on a priori criteria, tests of responsiveness were confirmed with patients having significant improvements over time ranging from 2.7 (Psychological Health) to 11.1 (Treatment Burden) (P < 0.01) (effect sizes ranging from 0.2 to 0.8). The previous measurement model factor structure was confirmed (CFI ranging from 0.8 to 1.0), and internal consistency of the TRIMs was similar to the developmental findings.

Conclusions

The total score as well as all domain scores of the TRIMs was significantly responsive over time, thus acceptable internal and external responsiveness of TRIM-D and TRIM-DD are concluded. To date, all validation evidence supports the use of these two measures in future clinical trials.

Onze productaanbevelingen

BSL Podotherapeut Totaal

Binnen de bundel kunt u gebruik maken van boeken, tijdschriften, e-learnings, web-tv's en uitlegvideo's. BSL Podotherapeut Totaal is overal toegankelijk; via uw PC, tablet of smartphone.

Literatuur
Over dit artikel

Andere artikelen Uitgave 9/2011

Quality of Life Research 9/2011 Naar de uitgave