ESGO Database: Validation of the ESGO Quality Indicators in Advanced Ovarian Cancer Surgery

Validation of the ESGO Quality Indicators in Advanced Ovarian Cancer Surgery

the Pilot Study of the ESGO Consortium of Accredited Centres

Study information

This research project is an international retrospective multi-centre study performed by the ESGO Consortium of accredited centres. The main aim of the study is to assess the prognostic impact of ten published ESGO quality indicators (Querleu et al., IJGC 2016;  Fotopoulou/Concin et al., IJGC 2020) for advanced ovarian cancer surgery.

Study Synopsis
Data2

Patient information

As part of the project, ESGO collects and registers data from women treated for advanced ovarian cancer at centres participating in this study. By keeping strict personal data protection measures, ESGO ensures transparent data processing and provides clear information to patients in compliance with all respective data protection regulations in place, in particular, EU Regulation 2016/679 (GDPR).

 

In view of the scientific research purposes, public interest in the field of public health, and ESGO’s legitimate interests in carrying out this research project, processing of personal data in the context of this retrospective study does not require the collection of patients' individual consent. General information about this study is publicly available at the centres participating in this study and on the ESGO website.

General Patient Information Sheet

Any patient, however, may refuse to allow the inclusion of their data in this study. If you are a patient who objects to participation in this study, please contact your treating gynaecologist at your hospital. You can also object by filling in this objection form and emailing it to database@esgo.org. In such cases, your personal data will not be included in this retrospective study.

 

In cases in which a centre’s local regulations require explicit individual consent of patients for inclusion of patient data in the study, ESGO will provide that centre with an Individual Patient Consent Form upon request (database@esgo.org).

REDCap: Data upload

Once the participating ESGO-accredited centre has obtained approval from the local Ethics Committee and completed signature processes of the Framework Agreement and the Study Commitment Letter, the entry of clinical data into the ESGO Database can start.

REDCap account creation

ESGO will create your individual REDCap access.

Please reach out to us at database@esgo.org and provide the names and email addresses of all individuals responsible for data entry or otherwise requiring access from your centre.

Entry of centre-level data

Please refer to the instructions provided below for guidance on how to enter centre-level data.

PDF instructions how to enter centre-level data

Video tutorial how to enter centre-level data:

Entry of patient-level data

There are two ways to enter patient data.

  1. Case by case (one patient’s data at a time): the data of each patient is directly entered into the REDCap system, one patient at a time (similar to an eCRF).
PDF instructions how to enter individual patient data case by case

Video tutorial how to enter individual patient data case by case:

  1. Spreadsheet (bulk data for many patients uploaded at once): This option is only recommended for high-volume centres (e.g. ESGO centres of excellence for advanced ovarian cancer surgery). All participating centres have been supplied with a spread sheet file template containing all clinical parameters that are collected in the frame of this research project. The completed file (in the format of a CSV file) can be directly uploaded to the REDCap system so that all patient data from the file are uploaded together.
PDF instructions how to bulk enter patient data

Data entry - Recording Missing Data

PDF instructions on recording missing data

If you encounter any issues or problems, please contact ESGO via database@esgo.org.

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