USTRALIAN EW EALAND NEONATAL ETWORK Research Data Request Form · PDF fileHome gavage feeding...
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ANZNN Research Data Request Form – Updated August 2015 1 AUSTRALIAN & NEW ZEALAND NEONATAL NETWORK Research Data Request Form Part A: PROPOSED USE OF DATA Please email completed form to [email protected] and attach research protocol and ethics approval letter for research at your hospital. Project details Project title: Primary author: Institution: Secondary author(s): ANZNN member: Yes No Date of request: Contact person: Contact email: Cohort year(s) requested: Cohort requested: (eg. gestation, level of care) Proposed use of data Please indicate at least one: Audit Benchmarking Oral presentation: Within-unit presentation External presentation Publication: Peer review journal Textbook Other (please specify) Proposed publication format: (if applicable) Declaration I confirm that I have read and will comply with the “Principles of data release” I confirm that I have read and will comply with the “Conditions of use and release of data” ANZNN office use only ANZNN file number: Date approved: Date data released:
Transcript of USTRALIAN EW EALAND NEONATAL ETWORK Research Data Request Form · PDF fileHome gavage feeding...
ANZNN Research Data Request Form – Updated August 2015 1
AUSTRALIAN & NEW ZEALAND NEONATAL NETWORK
Research Data Request Form
Part A: PROPOSED USE OF DATA
Please email completed form to [email protected] and attach research protocol and ethics approval letter for research at your hospital.
Project details
Project title:
Primary author:
Institution:
Secondary author(s):
ANZNN member: Yes No Date of request:
Contact person:
Contact email:
Cohort year(s) requested:
Cohort requested: (eg. gestation, level of care)
Proposed use of data
Please indicate at least one:
Audit
Benchmarking
Oral presentation: Within-unit presentation External presentation
Publication: Peer review journal Textbook
Other (please specify)
Proposed publication format: (if applicable)
Declaration
I confirm that I have read and will comply with the “Principles of data release”
I confirm that I have read and will comply with the “Conditions of use and release of data”
ANZNN office use only
ANZNN file number:
Date approved: Date data released:
ANZNN Research Data Request Form – Updated August 2015 2
Part B: ANZNN DATA VARIABLE LIST - neonatal
Indicate the data variables for request. Please refer to the current ANZNN Data Dictionary for definitions of data variables. Neonatal data is currently available for births up to and including 2013. Some data variables may not be available for all of your requested cohort years. The definitions of some data variables may have changed from previous years. Actual dates and times will not be provided.
Data variable ANZNN label Infant year of birth from which data is available
Maternal data
Maternal age MoAge 1995
Previous preterm birth (y/n) Prevprem 1995
Previous perinatal death (y/n) PrevPnd 1995
Assisted conception in this pregnancy AssistConc 1995
Ethnicity of mother Ethnicity 1995
Indigenous status of mother Indig 2001
Source of referral to registration hospital ReferSource 1995
Presenting antenatal problem PresentingProb 1995
Antenatal complications (y/n) Other_prob 1995
Prolonged rupture of membranes (y/n) PROM 1995 – 2011
Preterm labour (y/n) PTL 1995
Hypertension in pregnancy (y/n) PET 1995
Antepartum haemorrhage (y/n) APH 1995
Suspected intrauterine growth restriction (y/n) IUGR 1995
Foetal compromise (y/n) F_distress 1995
Other antenatal complications (y/n) Other 1995
Antenatal diagnosis of foetal malformation (y/n) ANDiag_ 1998
Rupture of membranes: in days before birth in hours before birth (please select one only)
ROMDate/ ROMTime
2006
Systemic antibiotics given to mother within 48 hours of birth (y/n)
MomAntib 2006
Antenatal corticosteroids for foetal lung enhancement(y/n)
Steroids 1995
MgSO4 given to mother within 6 hours of birth MgSO4 2012
Baby and birth
Birth plurality Plurality 1995
Birth order BrthOrd 1995
Year of birth DOB 1995
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Data variable ANZNN label Infant year of birth from which data is available
Age at admission: in days in hours (from 1995) (from 2006) (please select one only)
DOA/ DOATime
Baby's gender SEX 1995
Infant birth weight (g) Wght 1995
Gestational age in completed weeks Gest 1995
Gestational age in weeks + days Gest/Gestdays 2011
Place of birth (level of unit) PlBrth 1995
Hospital of birth Actual hospital names will not be provided under normal circumstances. Please provide written justification if required.
PBTH 1995
Presentation at birth Present_n 1995
Method of birth Delivery 1995
Apgar score at 1 minute Apg1 1995
Apgar score at 5 minutes Apg5 1995
Intubated at resuscitation (y/n) Intubated 1995
Presence of congenital anomaly (y/n) Anom 1995
Congenital anomalies, specify Anomdesc 1995
Temperature on admission Temp 1995
Worst base excess Worst_BE 1995
Therapeutic hypothermia (y/n) hypotherm 2007
Age at initiation of therapeutic hypothermia: in days in hours (please select one only)
StartCoolDate/ StartCoolTime
2012
Age at cessation of therapeutic hypothermia: in days in hours (please select one only)
CeaseCoolDate/ CeaseCoolTime
2012
Principal reason for non-completion of full 72 hours of therapeutic hypothermia
Hypothermceased 2012
Respiratory
Main respiratory diagnosis Resp 1995
Exogenous surfactant Surf 1995
Age when surfactant first given: in days in hours (please select one only)
Surfdate/ SurfTime
2006
Air leak requiring drainage ALLeak 1995
Age at first drainage of pulmonary air leak: in days in hours (please select one only)
ALDate/ ALTime
2007
Nitric oxide (y/n) NO_ 1996
Extracorporeal membrane oxygenation (ECMO) (y/n) ECMO_ 1996
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Data variable ANZNN label Infant year of birth from which data is available
Ventilatory support
Age at first intubation for ongoing mechanicalventilation: in days in hours (please select one only)
MVDate/ MVTime
2007
Hours of intermittent positive pressure ventilation IPPVhrs 1997 – 2012
Hours of invasive ventilatory support (via ETT) IPPVhrs 2013
Age at commencement of nasal CPAP: in days in hours (please select one only)
StartCPAPDate/ StartCPAPTime
2007
Age at final cessation of nasal CPAP: in days in hours (please select one only)
CeaseCPAPDate/ CeaseCPAPTime
2007
Duration of continuous positive airways pressure: in days in hours (1995 – 2001) (from 2002)
CPAP/CPAPhrs
Hours of nasal CPAP nCPAPhrs 2013
Hours of nasal/non-invasive ventilation NVenthrs 2013
Nasal high flow (y/n) HiFlo 2009
Minimum nasal high flow MinHiFlo 2009
Maximum nasal high flow MaxHiFlo 2009
Age at commencement of nasal high flow: in days in hours (please select one only)
StartHiFloDate/ StartHiFloTime
2009
Age at final cessation of nasal high flow: in days in hours (please select one only)
CeaseHiFloDate/ CeaseHiFloTime
2009
Hours of nasal high flow HiFlohrs 2009
High frequency ventilation (y/n) HFOV 1996
Age at initiation of high frequency ventilation: in days in hours (please select one only)
HFOVDate/ HFOVTime
2007
Hours of high frequency ventilation HFOVhrs 2007
Age (in days) at final oxygen therapy LastO2 1995 – 2010
Age (in days) at final added respiratory support (oxygen therapy or airway support)
LastRespSupp 2011
Chronic lung disease (y/n) O2_36wk_ 1999
Post-natal steroids for chronic lung disease (y/n) SystCSCLD 2013
Home oxygen therapy (y/n) HmeO2 1995
Necrotising enterocolitis and infection
Proven necrotising enterocolitis (y/n) NEC_ 1995
Spontaneous intestinal perforation (y/n) SIP 2013
ANZNN Research Data Request Form – Updated August 2015 5
Data variable ANZNN label Infant year of birth from which data is available
Proven bacterial, fungal or viral systemic infection yes/no number of episodes
Infn/Infection_/ Name_Inf
1995
Early onset bacterial or fungal sepsis (<48 hours) yes/no (from 2002) number of episodes (from 2006)
Early infection/ Infection_Type
Name of organism identified by blood or CSF culture of early onset sepsis
Name_Einf/ Name_Inf
2006
Late onset bacterial or fungal sepsis (≥48 hours) yes/no number of episodes
Late infection/ Infection_Type
2002
Name of organism identified by blood or CSF culture of late onset sepsis
Name_Linf/ Name_Inf
2006
Age (in days) at collection of positive blood or CSF culture for each episode of late onset sepsis
Date_Linf/ Date_Inf
2006
Nosocomial viral infection yes/no number of episodes
Lviralinf/ Infection_Type
2012
Name of virus identified as cause of nosocomial infection
Name_Lviralinf/ Name_Inf
2012
Age (in days) at onset of each episode nosocomial viral infection
Date_Lviralinf/ Date_Inf
2012
Surgery
Neonatal major surgery (y/n) Surgery_ 1995
ICD-10 code for each episode of major Neonatal surgery
Surg_code 2007
Age (in days) at each major neonatal surgery DateSurg 2007
Nutrition, feeding and immunisation
Parenteral nutrition (y/n) PNS 2012
Age at initiation of parenteral nutrition: in days in hours (please select one only)
StartPNSDate/ StartPNSTime
2012
Age at cessation of parenteral nutrition: in days in hours (please select one only)
CeasePNSDate/ CeasePNSTime
2012
Hours of parenteral nutrition PNShrs 2012
Home gavage feeding (y/n) Hmegavage 2012
Immunisation status (y/n) Immunised 2003 – 2006
Age (in days) at usual two month immunisation DateImmun 2007
Early breast milk feeding (y/n) Bmonset 2003
Breast milk feeding at discharge (y/n) Bmdischarge 2003
Age (in days) when full enteral feeds achieved Datefullfeed 2007 – 2010
Age (in days) at which baby regained birth weight DateBWtg 2007
ANZNN Research Data Request Form – Updated August 2015 6
Data variable ANZNN label Infant year of birth from which data is available
Intraventricular haemorrhage and cranial ultrasound
Maximum grade of intraventricular haemorrhage (IVH) IVH 1995
Age (in days) at late head ultrasound USd6wk 1995
Ventricle size Ventricles 1995
Ventricular index VI6wk 1999
Cerebral cystic formations Cysts 1995
Eye examination
Baby meets local criteria for eye examination (y/n) ROPeligibleExam 2001
Retinopathy of prematurity ROP 1995
ROP followed until retinal full vascularisation (y/n) Retmaturity 2007
Surgical therapy for retinopathy of prematurity (y/n) ROPRx 1995
Medical (VEGF inhibition) therapy for retinopathy of prematurity (y/n)
ROP_VEGF 2012
Discharge information
Died (y/n) Died_ 1995
Age (in days) at death DiedDate 1995
Post mortem (y/n) Autopsy_ 1995
Immediate cause of death Cause_Death 1995
Death due to congenital malformation (y/n) CongAbnmDeath 1997
Transferred to another hospital (y/n) T_fer_ 1995
Age (in days) at transfer to another hospital T_ferDate 1995
Level of first transfer unit receiving baby NursLevel 1995
Age (in days) at discharge HomeDate 1995
Comments
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Part C: ANZNN DATA VARIABLE LIST – 2 to 3 year follow-up
Indicate the data variables for request. Please refer to the current ANZNN Follow-up Data Dictionary for definitions of data variables. 2 to 3 year follow-up data is currently only available for ANZNN registrants born in 2009–2010 who survived to discharge to home and were born at less than 28 completed weeks gestation or weighed less than 1,000 grams at birth. Actual dates will not be provided.
Data variable ANZNN label Infant year of birth from which data is available
Outcome data
Corrected age (in days) at assessment DateOfAssess 2009
Outcome at 2 to 3 years Outcm2or3 2009
Outcome for follow-up at 2 to 3 years Outcmfup 2009
Weight (kg) Weight 2009
Type of stature measurement StatureType 2009
Stature (cm) Stature 2009
Head circumference HC 2009
Hearing aid Hearaid 2009
Cochlear implant (y/n) CochImplt 2009
Blind (y/n) Blind 2009
Respiratory support at time of follow-up assessment RespSprt 2009
Gastrointestinal feeding at time of follow-up assessment
GITfeed 2009
Cerebral palsy CP 2009
Gross Motor Function Classification System (GMFCS) for cerebral palsy
GMFCS 2009
Bayley Scales of Infant and Toddler Development
Bayley Scales of Infant and Toddler Development - third edition (y/n)
BayleyDevTest 2009
Bayley cognitive scale, composite score CognComp 2009
Bayley language scale, receptive communication scaled score
ResScale 2009
Bayley language scale, expressive communication scaled score
ExpScale 2009
Bayley language sum, composite score LangSumComp 2009
Bayley motor scale, fine motor scaled score FinMotScale 2009
Bayley motor scale, gross motor scaled score GrossMotScale 2009
Bayley motor sum, composite score MotSumComp 2009
ANZNN Research Data Request Form – Updated August 2015 8
Data variable ANZNN label Infant year of birth from which data is available
Griffiths Mental Development Scales
Griffiths Mental Development Scales (GMDS) (y/n) GMDS 2009
GMDS locomotor subscale quotient LocoSubQuo 2009
GMDS personal/social subscale quotient PerSocSubQuo 2009
GMDS language subscale quotient LangSubQuo 2009
GMDS eye and hand coordination subscale quotient EyeHandSubQuo 2009
GMDS performance subscale quotient PerformSubQuo 2009
GMDS practical reasoning subscale quotient PracReasSubQuo 2009
GMDS general quotient GQ 2009
Other developmental tests
Other developmental tests administered (y/n) OtherDevTests 2009
Age (in days) at other developmental test DateTest 2009
Name of other developmental test administered NameTest 2009
Subscales of other developmental tests OthSubscales 2009
Score of other developmental tests OthScore 2009
Level of development (months) as determined by other developmental tests
OthlevDevlp 2009
Other major disabilities
Other major disabilities, excluding congenital anomalies (y/n)
OtherDis 2009
ICD-10 code of other major disabilities OtherDisCode 2009
Comments
ANZNN Research Data Request Form – Updated August 2015 9
PRINCIPLES FOR DATA RELEASE
Principles for data release to ANZNN members: 1. The release of de-identified or unit-identified data to ANZNN members for research or service planning will be governed by the rules and regulations of ANZNN. 2. For research projects – written approval from your organisation and an institutional human research ethics committee (HREC) must be submitted to ANZNN together with a research protocol. 3. Once approval is given then a requesting researcher must complete the ANZNN Contract and Confidentiality Agreement. The researcher will be required to provide project status update every 6 months. 4. Release of summary data to ANZNN members for an initial enquiry for research or service planning will be governed by the rules and regulations of ANZNN. Data release will be limited to essential data fields specifically requested. Extraction of appropriate data will be performed by the data manager assisted by the epidemiologist. 5. The National Perinatal Epidemiology and Statistics Unit (NPESU) will be treated as a member of the ANZNN. NB: ANZNN members will not be charged for providing ANZNN data for their research or service planning purposes Principles for data release to non-ANZNN members: 1. The Annual Report or any published data from the annual report can be released to the public when requests are made through and approval is received from the ANZNN Executive Committee, the ANZNN Advisory Council, the ANZNN Data Collection Operation Committee (DCOC) and National Perinatal Epidemiology and Statistics Unit (NPESU). 2. All data release will be in compliance with the ANZNN and NPESU guidelines. 3. Data in addition to data referred to in (1) shall not be released to any external person or authority without all of the following;
Prior written permission from the ANZNN Executive Committee Prior written permission from the ANZNN Advisory Council
NB: The ANZNN will charge a fee representing its costs for preparing the data for any data requests from non-members. Data request procedure: 1. The data request will be reviewed by the data manager initially then presented to the DCOC. 2. Once determined the data request is feasible and not conflicting with other current data requests then permission will be sought from the Advisory Council.
ANZNN Research Data Request Form – Updated August 2015 10
CONDITIONS FOR USE AND RELEASE OF DATA
1. Use of the data would entail agreement by the Advisory Council (Directors, or their nominee, of each contributing NICU) and the data coordinators (Kei Lui (chairperson of the DCOC), Georgina Chambers (director of NPESU and data custodian) and Ross Haslam (chairperson of the ANZNN Executive)). 2. Data will not be published or supplied with any patient identifying information. 3. Data will not be published or supplied with any NICU or State / Territory / nation identifying information without the written approval of all the NICU Directors of the State / Territory or nation concerned. 4. External requests for a hard copy of patient de-identified data will be made in writing to the data custodians. Any requests for data that could potentially identify a unit or state / territory / nation will be referred to the Advisory Council. External requests for patient de-identified data on computer disk will be made in writing to the data custodians, and then referred to the Advisory Council. Requests in writing must be in the form of a one-page research proposal. A confidentiality agreement must be signed by the person(s) requesting data prior to the release of the data. 5. Publication of data in any form must be endorsed in writing by seventy five percent (75%) of the Advisory Council prior to the material being submitted for publication. The mechanism for this will be by prior notification and then endorsement at an Advisory Council meeting, or by faxing each Council member. 6. Data will be released annually in a report provided free to each participating Director. This report will summarise the pooled, de-identified data. This report will be distributed widely after the majority of the Advisory Council agrees on content and form. 7. All published data must acknowledge the ANZNN Advisory Council and Coordinators. 8. Data will also be released to each Director in electronic form with their own unit data identified, and the rest of the data completely de-identified.
