Evaluation of a Data Collection Tool in Clinical Research: Comparison Between the Data Collected by Patient Diary and Data From Medical Administrative Databases

Withdrawn

• Conditions: Health Insurance Database; Case Report Form; Declaration Bias

• Registration Number: NCT02893059
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The main objective of this study is to estimate the reporting bias of patients in terms of prescripted drug and care consumption by comparing data collected in a patient diary and database of health insurance .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-08
• Study Start: 2020-12-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-14
• Last Update Posted: 2021-06-18
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• incident and prevalent cases of patients with type I or type II diabetes. arthritis:
• incident and prevalent cases of rheumatoid arthritis patients defined according to the ACR-EULAR criteria 2010 (Aletaha D et al, 2010).

Renal failure :

• incident and prevalent cases of patients with kidney disease stage 3 or 4, transplanted or not.

Prostate cancer :

• Incident cases of patients with prostate cancer regardless of the stage at diagnosis (positive prostate biopsy).

Breast cancer :

• Incident cases of patients with breast cancer regardless of the stage at diagnosis (biopsy positive breast).

Colorectal cancer :

• Incident cases of patients with colorectal cancer regardless of the stage at diagnosis (colonoscopy and polyp biopsy positive).

Exclusion Criteria

• The subject participates in an experimental study of research affecting the therapeutic management of the patient.

• The subject is exclusion period determined by a previous study.
• The subject is under judicial protection, guardianship or curatorship.
• It is not possible to give informed about information
• The subject does not read French and is not autonomous filling a questionnaire.
• The patient has psychiatric disorders.
• The subject is an emergency.
• Monitoring between patient visits than 6 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comparison of data collected in a patient diary and data stored in the database of health insurance	6 month