P25/059 Clinical Trial Database

Description

Anonymized Clinical Trial Dataset: Evaluating Outpatient Hysteroscopic Systems (Protocol P25/059) This dataset contains de-identified patient-level clinical and operative data from a prospective, parallel-group, randomized controlled trial (Protocol P25/059) designed to evaluate the clinical performance, patient tolerability, and operator feasibility of different hysteroscopic systems in an outpatient office setting. The dataset includes baseline demographic characteristics (such as age, parity, menopausal status, and clinical indications) and intraoperative performance metrics- including total procedure duration, patient-reported pain scores (Visual Analog Scale), operator-rated technical difficulty (Visual Analog Scale), and visual quality assessments. All data have been fully anonymized and de-identified to protect patient privacy in compliance with General Data Protection Regulation (GDPR) standards

Steps to reproduce

Steps to reproduce 1. Data Import: Import the raw dataset (Excel format) into standard statistical software (e.g., SPSS, R, or Python/Pandas). 2. Population Stratification: Stratify the study population into two cohorts based on Body Mass Index (BMI) thresholds: non-obese (BMI < 30 kg/m²) and obese (BMI >/= 30 kg/m²). 3. Descriptive Statistics: Calculate descriptive statistics for baseline demographic characteristics across the two randomized groups (Reference vs. Study). Categorical variables should be analyzed using frequencies and percentages, while continuous variables (e.g., Age) should be evaluated using means and standard deviations. 4. Outcome Analysis: Compare the continuous primary and secondary outcomes (Procedure Duration, VAS Pain, VAS Difficulty, and VAS Visual Quality) between the Reference and Study groups within each BMI stratum. 5. Statistical Testing: Use the independent Student’s t-test for normally distributed continuous data and the Mann-Whitney U test for non-normally distributed or ordinal variables (such as VAS scores). Categorical variables can be compared using the Chi-square test or Fisher's exact test as appropriate. A P-value < 0.05 is considered statistically significant.

Institutions

• Azienda Usl Toscana Centro

  Tuscany, Pistoia

Categories

Licence