TY - JOUR
T1 - The NordiNet® International Outcome Study and NovoNet® ANSWER Program®
T2 - Rationale, design, and methodology of two international pharmacoepidemiological registry-based studies monitoring long-term clinical and safety outcomes of growth hormone therapy (Norditropin®)
AU - Höybye, Charlotte
AU - Sävendahl, Lars
AU - Christesen, Henrik Thybo
AU - Lee, Peter
AU - Pedersen, Birgitte Tønnes
AU - Schlumpf, Michael
AU - Germak, John
AU - Ross, Judith
PY - 2013/4/24
Y1 - 2013/4/24
N2 - Objective: Randomized controlled trials have shown that growth hormone (GH) therapy has effects on growth, metabolism, and body composition. GH therapy is prescribed for children with growth failure and adults with GH deficiency. Carefully conducted observational study of GH treatment affords the opportunity to assess long-term treatment outcomes and the clinical factors and variables affecting those outcomes, in patients receiving GH therapy in routine clinical practice. Design: The NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: Web Enabled Research (ANSWER Program®) are two complementary, non-interventional, observational studies that adhere to current guidelines for pharmacoepi-demiological data. Patients: The studies include pediatric and adult patients receiving Norditropin®, as prescribed by their physicians. Measurements: The studies gather long-term data on the safety and effectiveness of real-life treatment with the recombinant human GH, Norditropin®. We describe the origins, aims, objectives, and design methodology of the studies, as well as their governance and validity, strengths, and limitations. Conclusion: The NordiNet® IOS and ANSWER Program® studies will provide valid insights into the effectiveness and safety of GH treatment across a diverse and large patient population treated in accordance with real-world clinical practice and following the Good Pharmacoepide-miological Practice and STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines.
AB - Objective: Randomized controlled trials have shown that growth hormone (GH) therapy has effects on growth, metabolism, and body composition. GH therapy is prescribed for children with growth failure and adults with GH deficiency. Carefully conducted observational study of GH treatment affords the opportunity to assess long-term treatment outcomes and the clinical factors and variables affecting those outcomes, in patients receiving GH therapy in routine clinical practice. Design: The NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: Web Enabled Research (ANSWER Program®) are two complementary, non-interventional, observational studies that adhere to current guidelines for pharmacoepi-demiological data. Patients: The studies include pediatric and adult patients receiving Norditropin®, as prescribed by their physicians. Measurements: The studies gather long-term data on the safety and effectiveness of real-life treatment with the recombinant human GH, Norditropin®. We describe the origins, aims, objectives, and design methodology of the studies, as well as their governance and validity, strengths, and limitations. Conclusion: The NordiNet® IOS and ANSWER Program® studies will provide valid insights into the effectiveness and safety of GH treatment across a diverse and large patient population treated in accordance with real-world clinical practice and following the Good Pharmacoepide-miological Practice and STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines.
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U2 - 10.2147/CLEP.S42602
DO - 10.2147/CLEP.S42602
M3 - Review article
C2 - 23658497
AN - SCOPUS:84877004375
SN - 1179-1349
VL - 5
SP - 119
EP - 127
JO - Clinical Epidemiology
JF - Clinical Epidemiology
IS - 1
ER -