The study of bleeding disorders has been hampered by the lack of criteria strictly defining the clinical severity and relevance of bleeding symptoms. This represents a major hurdle, since the quality of etiologic, prognostic and therapeutical studies heavily depends on a precise definition of the outcome of interest, as related to patients’ bleeding manifestations, their treatment and bleeding risk. Furthermore, given the low incidence and prevalence of some bleeding disorders, it would be of the utmost importance to pool high-quality clinical data together by developing large databases of patients with bleeding disorders. This would allow data sharing for a more precise description of the various bleeding disorders and for investigating genotype/genotype and genotype/environmental interactions to identify factors that can affect an individual's risk of bleeding.
The ISTH Bleeding Assessment Tool (ISTH-BAT) is a consensus-based, publicly available tool designed to evaluate the severity of bleeding symptoms, primarily in patients with congenital disorders of hemostasis (see Rodeghiero et al, JTH 2010:8: 2063–2065). The tool includes a standardized questionnaire and a 0-4 bleeding score for each symptom that is used to compute an overall bleeding score.
Based on the ISTH-BAT, a web-based instrument has been developed at the Rockefeller University, NY, USA, named Bleeding Assessment Tool Repository (BAT-R). The database is designed to collect and store data regarding bleeding symptoms in humans, providing a user-friendly, web-accessible platform, encouraging uniformity in the standardization and collection of bleeding histories.
The main aim of the Standing Committee is to promote the use of the ISTH-BAT, in order to develop a large database of bleeding symptoms in well-defined cohorts of patients with a bleeding disorder. Data-sharing among clinical and basic researchers will improve the identification of etiologic and prognostic factors of bleeding. The Standing Committee will therefore coordinate and oversee the use of the BAT-R as an online phenotypic and laboratory database of bleeding symptoms collected by investigators throughout the world. These investigators, while maintaining the control of their own data for their original projects, should be willing to share (upon their formal permission) their data with other investigators for collective or secondary projects. For this purpose, it is vital that researchers promote studies allowing data sharing of de-identified phenotypic and laboratory data into a common database. This will enhance the statistical power and provide important genotype-phenotype-environment correlations that cannot be obtained from single-site studies.The system allows a hierarchy of credentials, in order to explore the data according to the different levels of permission, as detailed below.
Therefore, the ISTH-SSC strongly encourages investigators to use the BAT-R for all studies collecting data on bleeding symptoms. Benefits include:
- Immediate availability of the ISTH bleeding questionnaire
- Automated computation of the ISTH Bleeding Score based on bleeding phenotype
- Ability to support several studies by a single investigator at the same time. Thus, an investigator may store data separately for several different studies he/she may be conducting
- Storage of each patient bleeding phenotype in a secure web platform
- Easy data download in Microsoft Excel™ format
- Completely free
- Assistance by the Standing Committee for formal procedures.
I want to start a new project using the BAT-R to store phenotypic data. What should I do?
In order to use the BAT-R for a new project, the study Principal Investigator (PI) should send to the Standing Committee Chairman (firstname.lastname@example.org) all the following documents:
- A brief outline of the project, including the names, sites and e-mail contacts of all sub-investigators (if any) designed to enter/access data of the BAT-R
- A statement that an IRB or equivalent ethics comiittee has approved the study, including an explicit consent by the enrolled patients to use their anonymized data in collaborative studies approved by the ISTH-BAT Standing Committee
- The Agreement letter with the Rockefeller University (click here to download). Leave blank the field "approved by the ISTH-BAT Standing Committee on ______” . By signing this form, the PIs agrees to share the study data for future studies that will be endorsed by the ISTH-BAT Standing Committee.
Upon receipt of the above mentioned documents, the Standing Committee will rapidly review the study proposals and notify the PI about approval / rejection of the study. If approved, the Agreement letter will be forwarded directly by the ISTH-BAT Standing Committee to the Rockefeller University, which will provide the PI and sub-investigators credentials to access the database. Please note that sub-investigators will have to sign a waiver when they first log into the system.
I want to use data already present in the BAT-R database for a new project. What should I do?
In order to utilize data already present in the BAT-R for a new project, the study Principal Investigator (PI) should send to the Standing Committee Chairman (email@example.com) the following documents:
- A brief outline of the project, including the name of the study or studies (and PI or PIs) that the investigator wants to analyze
- The Agreement letter with the Rockefeller University (click here to download). Leave blank the field "approved by the ISTH-BAT Standing Committee on ______” .
Upon receipt of the above mentioned documents, the Standing Committee will rapidly review the project proposals. If the project is approved, the Standing Committee will:
- ask permission of the PI of each study requested
- provide the PI with the list of studies whose PIs have given permission to share their data with the proposed project.
If PIs of the studies requested for inclusion agree to the use of the data from their studies, the Agreement letter will be forwarded directly by the ISTH-BAT Standing Committee to the Rockefeller University, which will contact the PI to provide the requested data.
A database of all studies submitted to the ISTH-BAT will be maintained.