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®)

Charlotte Höybye, Lars Sävendahl, Henrik Thybo Christesen, Peter Lee, Birgitte Tønnes Pedersen, Michael Schlumpf, John Germak, Judith Ross

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

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 pharmacoepidemiological 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 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.

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 Pharmacoepidemiological Practice and STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines.

OriginalsprogEngelsk
TidsskriftClinical Epidemiology
Vol/bind5
Sider (fra-til)119-27
Antal sider9
ISSN1179-1349
DOI
StatusUdgivet - 2013

Fingeraftryk

Human Growth Hormone
Registries
Outcome Assessment (Health Care)
Safety
Guidelines
Growth
Epidemiology
Randomized Controlled Trials
Pediatrics
Physicians
Research
Population

Citer dette

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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.DESIGN: The NordiNet{\circledR} International Outcome Study (IOS) and the American Norditropin{\circledR} Studies: Web Enabled Research (ANSWER Program{\circledR}) are two complementary, non-interventional, observational studies that adhere to current guidelines for pharmacoepidemiological data.PATIENTS: The studies include pediatric and adult patients receiving Norditropin{\circledR}, as prescribed by their physicians.MEASUREMENTS: The studies gather long-term data on the safety and effectiveness of reallife treatment with the recombinant human GH, Norditropin{\circledR}. 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{\circledR} IOS and ANSWER Program{\circledR} 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.",
author = "Charlotte H{\"o}ybye and Lars S{\"a}vendahl and Christesen, {Henrik Thybo} and Peter Lee and Pedersen, {Birgitte T{\o}nnes} and Michael Schlumpf and John Germak and Judith Ross",
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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®). / Höybye, Charlotte; Sävendahl, Lars; Christesen, Henrik Thybo; Lee, Peter; Pedersen, Birgitte Tønnes; Schlumpf, Michael; Germak, John; Ross, Judith.

I: Clinical Epidemiology, Bind 5, 2013, s. 119-27.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

Y1 - 2013

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 pharmacoepidemiological 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 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.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 Pharmacoepidemiological 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 pharmacoepidemiological 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 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.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 Pharmacoepidemiological Practice and STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines.

U2 - 10.2147/CLEP.S42602

DO - 10.2147/CLEP.S42602

M3 - Journal article

VL - 5

SP - 119

EP - 127

JO - Clinical Epidemiology

JF - Clinical Epidemiology

SN - 1179-1349

ER -