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®)

References

• HartungDMTouchetteDOverview of clinical research designAm J Health Syst Pharm200966439840819202050
   PubMed Web of Science ®Google Scholar
• MannCJObservational research methods. Research design II: cohort, cross sectional, and case-control studiesEmerg Med J2003201546012533370
   PubMed Web of Science ®Google Scholar
• von ElmEAltmanDGEggerMPocockSJGøtzschePCVandenbrouckeJPSTROBE InitiativeThe Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studiesJ Clin Epidemiol200861434434918313558
   PubMed Web of Science ®Google Scholar
• McNeilJJPiccennaLRonaldsonKIonnides-DemosLLThe value of patient-centred registries in phase IV drug surveillancePharma Med2010245281288
   Google Scholar
• GlasziouPVandenbrouckeJPChalmersIAssessing the quality of researchBMJ20043287430394114703546
   PubMed Web of Science ®Google Scholar
• Growth Hormone Research SocietyConsensus guidelines for the diagnosis and treatment of growth hormone (GH) deficiency in childhood and adolescence: summary statement of the GH Research SocietyJ Clin Endocrinol Metab200085113990399311095419
   PubMed Web of Science ®Google Scholar
• Critical evaluation of the safety of recombinant human growth hormone administration: statement from the Growth Hormone Research SocietyJ Clin Endocrinol Metab20018651868187011344173
   PubMed Web of Science ®Google Scholar
• ClaytonPECuneoRCJuulAMonsonJPShaletSMTauberMEuropean Society of Paediatric EndocrinologyConsensus statement on the management of the GH-treated adolescent in the transition to adult careEur J Endocrinol2005152216517015745921
   PubMed Web of Science ®Google Scholar
• HoKK2007GH Deficiency Consensus Workshop Participants. Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II: a statement of the GH Research Society in association with the European Society for Pediatric Endocrinology, Lawson Wilkins Society, European Society of Endocrinology, Japan Endocrine Society, and Endocrine Society of AustraliaEur J Endocrinol2007157669570018057375
   PubMed Web of Science ®Google Scholar
• GutiérrezLPKoltowska-HäggströmMJönssonPJRegistries as a tool in evidence-based medicine: example of KIMS (Pfizer International Metabolic Database)Pharmacoepidemiol Drug Saf20081719010217957812
   PubMed Web of Science ®Google Scholar
• GharibHCookDMSaengerPHAmerican Association of Clinical Endocrinologists Growth Hormone Task ForceAmerican Association of Clinical Endocrinologists medical guidelines for clinical practice for growth hormone use in adults and children—2003 updateEndocr Pract200391647612917095
   PubMedGoogle Scholar
• MolitchMEGrowth hormone treatment in adults with growth hormone deficiency: the transitionJ Endocrinol Invest201134215015421270511
   PubMed Web of Science ®Google Scholar
• Norditropin® [homepage on the Internet]Princeton, NJNovo Nordisk Inc2012 Available from: http://www.norditropin-us.comAccessed December 27, 2012
   Google Scholar
• Novo Nordisk IncSummary of Product Characteristics [Norditropin® SimpleXx®]BagsværdNovo Nordisk Inc2012 Available from: http://www.novonordisk.com/images/growth_hormone/2012/Norditropin%20SimpleXx-SmPC_August%202012.pdfAccessed December 27, 2012
   Google Scholar
• Novo Nordisk IncSummary of Product Characteristics [Norditropin® NordiFlex®]BagsværdNovo Nordisk Inc2012 Available from: http://www.novonordisk.com/images/growth_hormone/2012/Norditropin%20NordiFlex_SmPC_August%202012.pdfAccessed December 27, 2012
   Google Scholar
• Novo Nordisk IncSummary of Product Characteristics [Norditropin® FlexPro®]BagsværdNovo Nordisk Inc2012 Available from: http://www.novonordisk.com/therapy_areas/growth_hormone/hcp/devices/norditropin-flexpro/pdf/Norditropin%20FlexPro-SmPC_August2012.pdfAccessed December 27, 2012
   Google Scholar
• Novo NordiskObservational prospective study on patients treated with Norditropin®ClinicalTrialsgov [website on the Internet]Bethesda, MDUS National Library of Medicine2009 [updated January 4, 2013] Available from: http://clinicaltrials.gov/ct2/show/NCT00960128 NLM identifier: NCT00960128Accessed February 20, 2013
   Google Scholar
• Novo NordiskAn observational study (Registry) assessing treatment outcomes and safety for children and adults who are prescribed Norditropin® (Human Growth Hormone) (ANSWER)ClinicalTrialsgov [website on the Internet]Bethesda, MDUS National Library of Medicine2009 [updated January 11, 2013] Available from: http://clinicaltrials.gov/ct2/show/NCT01009905NLM identifier: NCT01009905Accessed February 20, 2013
   Google Scholar
• Novo NordiskSafety and efficacy of long-term somatropin treatment in children (GrowthWIN II)ClinicalTrialsgov [website on the Internet]Bethesda, MDUS National Library of Medicine2012 [updated June 26, 2012] Available from: http://clinicaltrials.gov/show/NCT01543867NLM identifier: NCT01543867Accessed December 27, 2012
   Google Scholar
• Novo NordiskSafety and efficacy of long-term somatropin treatment in adults (NordiWIN)ClinicalTrialsgov [website on the Internet]Bethesda, MDUS National Library of Medicine2012 [updated June 26, 2012] Available from: http://clinicaltrials.gov/ct2/show/NCT01543880 NLM identifier: NCT01543880Accessed December 27, 2012
   Google Scholar
• Guidelines for Good Pharmacoepidemiology Practices (GPP) Revised April 2007 Available from: www.pharmacoepi.orgAccessed March 12, 2013
   Google Scholar
• International Classification of Diseases 10th Revision (ICD-10) Available from http://www.cdc.gov/nchs/data/dvs/icd10fct.pdfAccessed March 12, 2013
   Google Scholar
• ThodbergHHvan RijnRRTanakaTMartinDDKreiborgSA paediatric bone index derived by automated radiogrammetryOsteoporos Int20102181391140019937229
   PubMed Web of Science ®Google Scholar
• LeePAGermakJGutRKhutoryanskyNRossJIdentification of factors associated with good response to growth hormone therapy in children with short stature: results from the ANSWER Program®Int J Pediatr Endocrinol20112011621899782
   PubMedGoogle Scholar
• LeePASävendahlLOliverIComparison of response to 2-years’ growth hormone treatment in children with isolated growth hormone deficiency, born small for gestational age, idiopathic short stature, or multiple pituitary hormone deficiency: combined results from two large observational studiesInt J Pediatr Endocrinol2012201212222788856
   PubMedGoogle Scholar
• LeePARossJGermakJAGutREffect of 4 years of growth hormone therapy in children with Noonan syndrome in the American Norditropin Studies: Web-Enabled Research (ANSWER) Program® registryInt J Pediatr Endocrinol2012201211522682146
   PubMedGoogle Scholar
• RossJLeePAGutRGermakJImpact of age and duration of growth hormone therapy in children with Turner syndromeHorm Res Paediatr201176639239922156541
   PubMed Web of Science ®Google Scholar
• SävendahlLBlankensteinOOliverIGender infuences short-term growth hormone treatment response in childrenHorm Res Paediatr201277318819422508317
   PubMed Web of Science ®Google Scholar
• RossJLeePAGutRGermakJFactors influencing the one- and two-year growth response in children treated with growth hormone: analysis from an observational studyInt J Pediatr Endocrinol2010201049465620981140
   PubMedGoogle Scholar