Development of a Minimum Dataset for the Monitoring of Recombinant Human Growth Hormone Therapy in Children with Growth Hormone Deficiency: A GloBE-Reg Initiative
Authors' conclusion
In summary, this exercise performed through the GloBE-Reg initiative provides a recommendation of the MDS requirement, collected through real-world data, for the monitoring of safety and effectiveness of rhGH in children with GHD, both for the current daily preparations and the newer long-acting GH.
Study context
- Population
- Data fields for monitoring children with growth hormone deficiency (GHD) on recombinant human growth hormone (rhGH) therapy; 12 clinical experts from 7 international endocrine organisations, 2 patient representatives, representatives from 2 pharmaceutical companies219 items graded
- Outcome
- Minimum dataset (MDS): data fields with 70% consensus on importance, provided <50% deemed the item difficult to collect
Methodological detailsexpert grading exercise, international, expert panel with patient and industry representatives, Undertaken by the growth hormone (GH) scientific study group in GloBE-Reg, a common registry platform for long-term safety and effectiveness studies
- Expert grading exercise
- International
- Expert panel with patient and industry representatives
- Undertaken by the GH scientific study group in GloBE-Reg, a common registry platform for long-term safety and effectiveness studies
Recommendations
As reported in the abstract
Items qualifying for the MDS
- Items compiled
- 246
- Items removed due to redundancies
- 27
- Items graded
- 219
- Items with ≥70% consensus as important
- 111
- Items deemed easy to collect
- 69
- Items meeting both criteria for the minimum dataset (MDS)
- 63
- Final MDS recommendation (after discussion of anomalies)
- 43 items
- To be completed once
- 20
- Every 6 months
- 14
- Every 12 months
- 9
Original publication
Development of a Minimum Dataset for the Monitoring of Recombinant Human Growth Hormone Therapy in Children with Growth Hormone Deficiency: A GloBE-Reg Initiative. Horm Res Paediatr. Published 13 September 2023. doi:10.
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