HI Global Registry 1st Study Report Now Available
The HI Global Registry (HIGR) is the first global patient-powered congenital hyperinsulinism (HI) patient registry. Many years in the making, HIGR launched on October 8, 2018. What follows is an initial report from the HIGR investigators including an introduction to the research project and an early glimpse of data from it. While the first annual report by investigators is not planned until early 2020, the intent of sharing these early findings is to further engage stakeholders in HIGR’s work, better inform the preparation and data analysis of the HIGR annual reporting cycle, and encourage full and robust study participation from all potential study participants. As participation grows, the pool of HI data will become increasingly more significant.
The investigators openly invite comments and questions about the report and welcome ideas for engaging all key HI stakeholders. Broad and robust participation from all members of the HI community will certainly serve to strengthen HIGR. The HIGR team can be contacted at firstname.lastname@example.org.
About the HI Global Registry
Congenital Hyperinsulinism International (CHI) has developed a patient-reported registry called the HI Global Registry with its partners to improve the understanding of HI, and advance research for better treatments and patient care. The registry consists of a series of online surveys that asks the participant questions about the patient’s experience with the disorder over his or her lifetime. The data is stored on a secure cloud-based platform and made anonymous by removing any personal details that can identify the patient. This information is then combined with patient data from around the world to produce research reports that can be studied by disease experts and researchers. The HI Global Registry is open for registration now– click here to visit the registry website.
Patients and their legally authorized representatives will be able to participate in the HI Global Registry by registering online and consenting to participate in the study. After consenting, participants will be directed to take surveys where they will enter their information, which can then be viewed in visual graphs that integrate data from other patients. When registering, they can also select in the contact preferences section to learn more about clinical trials, and be notified by CHI when they meet eligibility criteria for a study. Participants will be able to join the registry from anywhere in the world, and they will be able to choose to withdraw at any time.
The project is sponsored by Congenital Hyperinsulinism International and governed by a group of internationally recognized HI patient advocates and experts, known as the HI Global Registry Steering Committee.
The HI Global Registry is hosted on the IAMRARE™ Platform which was developed and is owned by the National Organization for Rare Disorders (NORD). The IAMRARE™ Platform was created with input from patient, caregiver, and government stakeholders to ensure a safe and user friendly system for study participation.
Together, we will CONNECT THE DOTS to find better treatments and cures for HI.
A. What is the HI Global Registry (HIGR) Participation Graph?
The HIGR graph is a visual summary of the main registry activities that lead to data collection and analysis to achieve the objectives of the study. There are four main stages of activity:
- Registered – when respondents create an online account to participate in the HIGR
- Consented to participate – when respondents accept the terms and conditions of participating in the HIGR
- Surveys started – when respondents complete a portion of the 13 surveys that are relevant to the participant and submit them as final responses.
- All surveys completed – when respondents complete all surveys that are relevant to the participant (patient) and submit them as final responses.
B. What is the relationship between the various stages?
- In order to obtain the necessary data to conduct research that will advance HI knowledge, treatments, and standards of patient care all registry activity stages must be completed.
- A participant’s (patient’s) data can only be integrated with other participants’ data to contribute to the research when their responses are final and surveys are submitted as final.
- Once surveys are submitted as final the data will be de-identified and added to the database, which will increase statistical power for research analysis.
- Research analysis will produce reports and findings to achieve the objectives of the study and share with the patient community and researchers.
C. What is our “target” and its importance?
The target is how many registry participants the study is aiming to recruit to survey the patient population and obtain final submitted data to have the statistical power to achieve HIGR objectives.
D. How can the audience engage with the HIGR Participation graph and support retention of study participation?
HIGR respondents and parties interested in the Registry can engage with the graph by being aware of the level of activity for all stages of participation. In addition, to supporting participation by registering with the study and contributing data, individuals can see the required activity to ensure the study is successful and advance knowledge and research.