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Reliability of the North Star Ambulatory Assessment in a multicentric setting
E S Mazzone1, S Messina, G Vasco
1Department of Paediatric Neurology, Catholic University, Rome, Italy.
Insights
The North Star Ambulatory Assessment (NSAA) is suitable for clinical trials in Duchenne Muscular Dystrophy. Adequate training is crucial for achieving reliable results in multicenter studies.
Area of Science:
- Neurology
- Clinical Trials
- Musculoskeletal Disorders
Background:
- Duchenne Muscular Dystrophy (DMD) requires reliable outcome measures for clinical trials.
- The North Star Ambulatory Assessment (NSAA) is designed for ambulant children with DMD.
Purpose of the Study:
- To assess the suitability of the NSAA as an outcome measure in multicenter clinical trials.
- To determine the training required for good interobserver reliability with the NSAA in a multicenter setting.
Main Methods:
- Thirteen Italian centers participated.
- Examiners received initial training via videos and examples.
- Interobserver reliability was assessed after the first training session.
- A second training session involved video review and discussion.
- Reliability was reassessed after the second training session and again after one month.
Main Results:
- Initial assessment showed poor interobserver reliability (<.5).
- Following a second training session, interobserver reliability improved significantly to .995.
- High intra-observer reliability (.95) was maintained over one month.
Conclusions:
- The NSAA is easily administered and takes approximately 10 minutes.
- The NSAA is a viable outcome measure for multicenter trials.
- Effective, targeted training is essential for achieving reliable NSAA scores in multicenter settings.
Abstract:
The aim of this study was to investigate the suitability of the North Star Ambulatory Assessment as a possible outcome measure in multicentric clinical trials. More specifically we wished to investigate the level of training needed for achieving a good interobserver reliability in a multicentric setting. The scale was specifically designed for ambulant children with Duchenne Muscular Dystrophy and includes 17 items that are relevant for this cohort. Thirteen Italian centers participated in the study. In the first phase of the study we provided two training videos and an example of the scale performed on a child. After the first session of training, all the 13 examiners were asked to send a video with an assessment performed in their centre and to score all the videos collected. There were no difficulties in performing the items and in obtaining adequate videos with a hand held camera but the results showed a poor interobserver reliability (<.5). After a second training session with review and discussion of the videos previously scored, the same examiners were asked to score three new videos. The results of this session had an excellent interobserver reliability (.995). The level of agreement was maintained even when the same videos were rescored after a month, showing a significant intra-observer reliability (.95). Our results suggest that the NSAA is a test that can be easily performed, completed in 10 min and can be used in a multicentric setting, providing that adequate training is administered.
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