Brief Title
Combining Registry Data in Haemophilia: TARGET H
Official Title
An Observational Pilot sTudy to Assess the Feasibility of Combining Data From Patient Registries in Countries With Developing Health Care Systems to EvaluaTe Haemophilia Management
Brief Summary
This is an investigator-initiated, multinational, retrospective, non-interventional pilot study conducted in five haemophilia treatment centres from different geographical regions that maintain a local (Algeria, Malaysia) or national (India, Iran, South Africa) haemophilia registry. Data from a randomly selected sample of patients from national or local registries are anonymously collated and analysed.The aims are to determine the feasibility of combining data from national and local registries in countries with developing healthcare systems and to assess how existing registries implemented current recommendations for data collection in terms of available fields and their completion.
Detailed Description
The study is conducted in five haemophilia treatment centres (HTCs) from different geographical regions (Algeria, India, Iran, Malaysia and South Africa) that maintain a local or national haemophilia registry. Data will be collected from 20 randomly selected, active patient records from each participating registry/country. In countries with national registries, data from local registries will not be permitted for inclusion to allow adequate assessment of the possibility of registry harmonisation across various regions. Participating centres will report data as available in the data source without seeking additional information to fill source data gaps at the time of data collection. In addition, each investigator will complete a basic questionnaire on feasibility parameters to confirm the source and accuracy of the data, as well as challenges experienced during data collection. Analysed parameters will be grouped into three categories: sociodemographic, disease, and treatment and disease outcome parameters. Feasibility assessment will be performed for all study variables and the percentage availability of each study variable recorded in the participating registries wii be determined, as well as the proportion of missing data for existing variables.
Study Type
Observational
Primary Outcome
Haemophilia registry data
Condition
Haemophilia
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
100
Start Date
May 2015
Completion Date
September 30, 2015
Primary Completion Date
September 2015
Eligibility Criteria
Inclusion Criteria: - male - diagnosis of haemophilia A or B - with or without inhibitors - no other inherited bleeding disorder - active patient record - willing and able to provide written consent Exclusion Criteria: - unwilling or unable to provide written consent
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
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Administrative Informations
NCT ID
NCT03264014
Organization ID
UP TARGET H
Responsible Party
Principal Investigator
Study Sponsor
University of Pretoria
Collaborators
Novo Nordisk A/S
Study Sponsor
, ,
Verification Date
August 2017