title: The NordiNet® International Outcome Study and NovoNet® ANSWER Program®: rationale, design, and methodology of two international pharmacoepidemiological registry-based studies monitoring long-term clinical and safety outcomes of growth hormone therapy (Norditropin®).
abstract: 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.
  
  
  METHODS
  The NordiNet® International Outcome Study (IOS) and the American Norditropin®
  
  
  METHODS
  Web Enabled Research (ANSWER Program®) are two complementary, non-interventional, observational studies that adhere to current guidelines for pharmacoepidemiological data.
  
  
  METHODS
  The studies include pediatric and adult patients receiving Norditropin®, as prescribed by their physicians.
  
  
  METHODS
  The studies gather long-term data on the safety and effectiveness of reallife 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.
  
  
  CONCLUSIONS
  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 Pharmacoepidemiological Practice and STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines.
authors: Department of Molecular Medicine and Surgery, Karolinska Institute and Department of Endocrinology, Metabolism and Diabetes, Stockholm, Sweden.
authors: Charlotte
authors: C
authors: Höybye
authors: Lars
authors: L
authors: Sävendahl
authors: Henrik Thybo
authors: HT
authors: Christesen
authors: Peter
authors: P
authors: Lee
authors: Birgitte Tønnes
authors: BT
authors: Pedersen
authors: Michael
authors: M
authors: Schlumpf
authors: John
authors: J
authors: Germak
authors: Judith
authors: J
authors: Ross
keywords: growth hormone replacement therapy; pharmacoepidemiology; survey; treatment outcome
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