Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07379593
Brief Summary:
The study aims to validate both the predictive capacity and the clinical usability of the Clinical Decision Support System (CDSS) developed within the PREPARE project (European Union Grant Agreement 101080288 PREPARE HORIZON-HLTH-2022-TOOL-12-01) for the management of idiopathic scoliosis (IS). This will be achieved through simulation-based studies.
Detailed Description:
Study Population:
Three participant groups will be included:
* Patients under 18 years who have undergone rehabilitative treatment for idiopathic scoliosis at ISICO's main center in Milan.
* Parents of the included patients.
* Specialist physicians in rehabilitation involved in scoliosis management at ISICO.
All participants must have adequate cognitive and language abilities to take part in discussions and complete questionnaires.
Sample Size:
Part I: Involves the 8 ISICO physicians performing clinical visits.
The main outcome measure is the variation in treatment decisions before and after exposure to the CDSS.
With α = 0.05, power = 80%, and expected effect size (Cohen's d = 0.3), the minimum required sample size is 175 clinical cases.
Parts II-III (Focus Groups):
6-12 patients
6-12 parents
6-10 physicians These group sizes align with qualitative research standards to ensure thematic saturation.
Safety Evaluation:
Adverse events will be monitored, recorded, and assessed by the Data Safety Monitoring Committee (DSMC).
Statistical and Analytical Plan:
Quantitative analysis will evaluate:
The frequency, nature, and motivations behind changes in treatment plans after using CDSS recommendations.
Correlations between CDSS suggestions and clinicians' treatment decisions.
Qualitative analysis will interpret data from focus group discussions to identify patterns, trends, and associations between CDSS recommendations, clinical choices, and possible alternative decisions had the CDSS been applied.
Study:
NCT07379593
Study Brief:
Protocol Section:
NCT07379593