Development of a Minimum Dataset for the Global Monitoring of the Safety and Efficacy of Growth Hormone Replacement in Adults With Growth Hormone Deficiency (AGHD).

The systematic review identified 35 studies with 6732 participants with AGHD covering a range of outcome categories.

• 35 studies were identified through systematic literature search in PubMed, Science Direct and Cochrane
• Total of 6732 participants with AGHD were included across studies
• Median age of participants was 49 years (range, 22-82 years)
• Studies were sourced from databases to identify outcomes relevant to AGHD monitoring

Cardiovascular outcomes were the most commonly reported outcome category in the identified studies.

• Cardiovascular outcomes were included in 21 out of 35 studies (60%)
• Serum IGF-I was reported in 13 studies (37%)
• IGF-I SDS was reported in 8 studies (23%)
• Adiposity measures were included in 15 studies (44%)
• Psychosocial outcomes were included in 10 studies (29%)

Expert consensus produced a final minimum dataset of 45 items from an initial pool of 190 expert-provided items.

• 17 clinical experts from 10 countries and two patient representatives participated through the GloBE-Reg network
• A total of 190 items were provided by experts
• 86 items (45%) achieved sufficient consensus and alignment with reported outcomes
• The final MDS contains 45 items to be assessed, of which only 43 are manually entered
• Items were graded independently on importance of the data field and ease of data collection in routine clinical practice

The consensus process involved independent grading of data items on two dimensions: importance and ease of collection.

• Participants graded items on importance of the data field
• Participants also graded items on ease of data collection in routine clinical practice
• The grading was conducted independently by participants
• Items achieving sufficient consensus were aligned with outcomes reported in the systematic review literature

The study was conducted under the framework of the Global Registry for Novel Therapies in Rare Bone and Endocrine Conditions (GloBE-Reg).

• GloBE-Reg assembled the 17 clinical experts and two patient representatives
• Experts represented 10 countries
• The registry framework was used to develop items for routine clinical data collection
• The goal was to create consistency and comparability in global studies of AGHD