Prediction of Recruitment Potential of Participating Centers in Clinical Trials by Standardized Translation of Selection Criteria and Queries From DRG Database

Multicenter Clinical Study Clinical Trial

— Pred-Inclus  

Official title:

Prediction of Recruitment Potential of Participating Centers in Clinical Trials by Standardized Translation of Selection Criteria and Queries From the French DRG Database (PMSI)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03019068
• Other study ID #: NI14011
• Secondary ID: PREPS-14-0607
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Philippe AEGERTER, MD, PhD
• Phone: + 33 1 49 09 58 86
• Email: philippe.aegerter[@]apr.aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This retrospective study aims to assess, on a large number of clinical trials (CT), the usefulness of converting CT eligibility criteria into standardized queries performed on commonly available data, i.e. Diagnosis Related Groups (DRG) databases in order to estimate the potential recruitment of clinical trials centers.

Efficacy of this Clinical Trial Recruitment Support Systems (CTRSS) will be checked against thorough examination of patient files.

Primary objective is to estimate the precision of the prediction system, i.e. ratio of numbers of eligible patient files / numbers of candidate patient files.

As secondary objectives, the study aims:

• to measure the recall rate or sensitivity of the system: ratio of number of candidates patient files / number of recruited patients;

• to measure the ability of coding: proportion of codable criteria (inclusion criteria or non inclusion criteria) into normalized language;

• to measure the time required for coding criteria and the time required to execute the queries on the national DRG database;

• to evaluate the reliability of coding process by an independent coding of a random sample of 30 protocols;

• to analyse influence of characteristics of the clinical study (design, disease, ...) and of the investigation site (volume, teaching status, ...) on the precision and sensitivity of the prediction system.

Description:

The study will be performed on a large sample (near 100) of multicenter terminated clinical studies with public funding covering therapeutic, diagnostic or prognostic studies. Selection (inclusion, non inclusion) criteria of each CT will be translated into a normalized description using ICD10 and french nomenclature of medical or surgical procedures (CCAM, Classification Commune des Actes Médicaux), these very nomenclatures being used in the french DRG system. Then a dedicated program will query the French DRG national database called PMSI (Programme de Médicalisation des Systèmes d'Information).

For each CT and for each center, the query will select "candidate" patients whose eligibility will be checked by thorough examination of the whole patient file by dedicated data extractors. In addition, already recruited patients will be compared to the prediction of the system.

Collected data span the period between 2010 and 2014, as well as with the medical files.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Multicenter trials.

• Trials that have been completed between 2012 and 2014.

• Sponsors and principal investigators of trials belonging to the public hospital system of the region of Paris (Ile de France).

Exclusion Criteria:

• Trials in the domain of rare diseases.

• Trials involving children.

Related Conditions & MeSH terms

• Multicenter Clinical Study

Locations

Country	Name	City	State
France	Department of Public Health - Hôpital Ambroise Paré	Boulogne-Billancourt	Hauts-de-Seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ability of coding	Proportion of selection criteria which codable into normalized language (ICD10, CCAM); Gain of precision and sensitivity, according to each criterion.	throughout the study: 3 years
Other	Resources required	Average amount of time required to coding, overall time required and time required according to each medical domain; Time required to query the DRF database.	throughout the study: 3 years
Other	Reliability of coding of protocols	Independent translation of a random sample of 30 protocols by 2 physicians, giving 2 queries on the DRG database; then; Calculation of agreement (kappa coefficient) between candidates patients files selected by each query; Assessment of reliability of the data extraction from the whole patient files between the two data extractors.	throughout the study: 3 years
Other	Influence of characteristics of trial and characteristics of site	Development of an regression model analyzing the precision and sensitivity of system, according to the complexity of protocol (design), disease, characteristics of the center (volume, clinical specialization, attractiveness, clinical research activity estimated by a publication score (SIGAPS));	throughout the study: 3 years
Primary	Precision	Precision = Ratio of number of eligible patient files / number of candidate patient files.; The precision will be calculated globally and according to medical domain and aim (therapeutic, diagnostic and prognostic) of modelized clinical studies.	throughout the study: 3 years
Secondary	Sensitivity of system	Ratio of number of candidate patient files / number of already recruited patients.	throughout the study: 3 years