CNFUN 24 Month/2 Year CAA Manual - Version 2 April 15, 2019 Page 1 of 21

24-MONTH CORRECTED AGE ASSESSMENT MANUAL

April 2019, Version 2

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TABLE OF CONTENT 1. Introduction to the Canadian Neonatal Follow-Up Network (CNFUN) 3 2. The CIHR Team in Maternal-Infant Care (MiCare Projet) - Birth Cohort April 1, 2009- Sept 30, 2011) 3 3. Post MiCare Cohort (Birth Oct 1, 2011-July 1, 2016) 4 4. Parent Integrated Evidence -based Practice to Improve Quality (“Parent-EPIQ”) 4 5.MacArthur Bates CDI 24 months assessment overview 5 5.1 Prerequisites 5 5.1.1 Ethics approval 5 5.1.2 Consent 5 5.1.3 Inclusion criteria 5 5.1.4 Two years assessment window 5 5.1.5 Responsibility for follow-up 5 5.1.6 Optimizing questionnaire completion 6 5.1.7 MacArthur Bates CDI words and sentences 6 6.Assessment Phase 6 6.1 Questionnaire administration 6 6.2 Identifying and monitoring eligible patients 7

6.3 Families who move to or from your area 7

7.Families with Special Circumstances 8 8. Site questionnaire administration 8 8.1. Site questionnaire administration 9 8.2 Questionnaire tracking and follow-up 9 9. Completing the CDI 10 10 Questionnaire scoring 12 11. Uploading data 16 12. Data handling, analyses and request 17 13. Confidentiality 17 14.Local CNFUN data 17 15. Use of national CNFUN data 17 16. MiCare data 18 17. Data linkages 19 18. CNFUN data analyses 18 19. Obtaining data for publications and presentations 18

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1. Introduction to the Canadian Neonatal Follow-Up Network (CNFUN) The Canadian Neonatal Follow-Up Network (CNFUN) is comprised of neonatal and perinatal follow-up programs in Canada and their multidisciplinary team members. It was developed in liaison with the Canadian Neonatal Network (CNN) to facilitate collaboration in research, integrated data collection and knowledge translation. CNFUN’s mission is to be a network of health care professionals dedicated to improving the care of newborns and children at high risk of adverse outcome as a result of conditions requiring intensive medical care. CNFUN’s goals are to:

- Establish a network of Canadian health care professionals involved in neonatal and perinatal follow-up programs (FUPs).

- Develop a standardized set of assessments done at standardized ages with common definitions.

- Develop a national electronic database of the CNFUN dataset and link it to neonatal and perinatal databases (e.g., CNN, CPN, CAPSNet, etc).

- Use the CNFUN dataset to improve health care by providing accurate up-to-date information for decision making, identifying best practices and facilitating the acquisitions of long-term outcomes data in neonatal, perinatal and early intervention research.

- Be advocates for our patient population by ensuring that the best evidence is translated into practice.

CNFUN involves a standardized assessment done at 18 months corrected age (described in the CNFUN 18 Month Corrected Age Assessment Manual) and the MacArthur Bates CDI questionnaire at 24 months corrected age. This manual outlines all aspects of the 24 months corrected age assessment and data entry. 2. The CIHR Team in Maternal-Infant Care (MiCare) Project (Birth Cohort April 1, 2009- Sept 30, 2011) CIHR funding for the MiCare project provided the first opportunity for CNFUN to realize its goals. CNFUN is one of several national research networks participating in the CIHR Team in Maternal-Infant Care (MiCare) project awarded CIHR funding in 2008. The MiCare research program was designed to improve outcomes and reduce costs through a better understanding of how different practices and risks affect long-term outcomes of preterm infants, and how improved methods of knowledge translation can enhance quality of care.

http://www.cnfun.ca/LinkClick.aspx?fileticket=nnGsvTzVSSU%3d&tabid=74

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CNFUN’s role in MiCare was to establish a standardized set of health and neurodevelopmental assessments at 18 and 36 month corrected age to be offered to all children born preterm (< 29 weeks gestation) in Canada. The CNFUN database was linked using a participant unique identifier with those of the other participating networks such as the Canadian Neonatal Network (CNN) to create the MiCare database. This allowed us to link population-based sociodemographic, clinical practice, outcomes and resources use data for high-risk pregnancies and infants through the entire period from pregnancy to childbirth, infancy and developmental follow-up. This unique, integrated database enabled studies on how the interactions between determinants, mechanisms and processes of care affect pregnancy and infant outcomes over the short- and long-term. 3. Post MiCare Cohort (Birth Oct 1, 2011-July 1, 2016) Funding to support CNFUN sites complete and upload 18 month in-patient assessments and 3 year questionnaires was available for births up to Sept 30, 2011. Afterwards, CNFUN sites were encouraged to continue to participate and enter data. 4. Parent Integrated Evidence -based Practice to Improve Quality (“Parent-EPIQ”) Current funding is from the CIHR SPOR grant “CHILD-BRIGHT” (Child Health Initiatives Limiting Disability- Brain Research Improving Growth and Health Trajectories) for the “Parent-EPIQ” project. As part of the MiCare study, CNFUN evaluated neurodevelopmental outcomes, including hearing, vision, cerebral palsy, its severity (measured using the Gross Motor Classification System (GMFCS)) and developmental status (measured using the Bayley Scales of Infant and Toddler Development (Bayley-III)) and categorized children as having a “neurodevelopmental impairment” (NDI) or a “significant NDI (sNDI) and found that 46% have a NDI and almost 15% of infants have a significant NDI. We also identified the variations across the world in definitions of sNDI and the need to standardize definitions of NDI and sNDI. The overall aim of Parent-EPIQ is to engage parents to co-create definitions of NDI and guide EPIQ initiatives to improve developmental outcomes within the Follow-Up Program infrastructure.

Specific aims are: 1. To define outcomes that are meaningful to parents of very preterm children (< 29 weeks

GA) at CNFUN visits at 18-21 corrected age. 2. To implement Parent EPIQ interventions to improve cognitive and language abilities in a

preterm population at 12 intervention sites. 3. Evaluate whether CNFUN measured outcomes across Canada are improving using annual

benchmarked reports for Parent-EPIQ intervention and non-intervention sites. As part of the Parent-EPIQ study a 2 year language assessment using the MacArthur Bates Communicative Development Inventory was added to the CNFUN assessment and database.

http://www.canadianneonatalnetwork.org/

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5.MacArthur Bates CDI 24 months assessment overview A questionnaire will be used for the 24 month/2 Year corrected age assessment (24 CAA). The MacArthur Bates Communicative Development Inventory Words and Sentences questionnaire is a parent reporting instrument which can capture information about a child’s early language, including vocabulary comprehension, production, and grammar. The questionnaire asks parents to document their child’s production and use or words, and also analyses their early phase grammar, including utterances of word forms and complexity of multi-word utterances. 5.1 Prerequisites 5.1.1Ethics approval Each participating site must have ongoing ethics approval from their local Institutional Review Board (IRB or REB). A copy of the approval and annual renewal should be forwarded to the CNFUN coordinator and/or the MiCare office. Templates of the protocol consent form, and other recruiting aids are available by contacting the CNFUN National Coordinator. 5.1.2 Consent The 2-year MacArthur Bates is designed to be emailed as a fillable pdf to parents, or mailed to parents with a cover letter. The cover letter explains consent and informs parents that consent is implied if they complete and return the questionnaire. A sample cover letter can be used as a template and is available through the CNFUN National Coordinator. 5.1.3 Inclusion criteria

All babies born at less than 29 weeks gestation (i.e., 28+6 weeks or less) who were admitted to a Canadian level-III NICU are eligible. 5.1.4 Two years assessment window The goal is for the questionnaires to be completed by parents / legal guardians within a 3 months window: 21 months - 27 months corrected age. The questionnaire can be completed up to 29 months 29 days corrected age. CNFUN recommends sending out the questionnaire packages 1.5- 2 months before the child reaches 24 months corrected age. Some families will need reminders and repeat mailing of the questionnaires. 5.1.5 Responsibility for follow-up

http://www.cnfun.ca/contactus.aspx

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The Follow-Up Program responsible for tracking patients and follow-up assessments and administered the 18 month corrected age assessment is responsible for the 2 year MacArthur Bates CDI. This responsibility can be transferred to another CNFUN clinic if a family moves out of their catchment area. 5.1.6 Optimizing questionnaire completion It is difficult to get a high completion rate for questionnaires but low follow-up rates severely limit the ability to interpret the study results. All attempts should be made to assess each eligible child between 21 months - 27 months corrected age. Parents or guardians should be contacted at least twice via telephone, mail and/or email before they are considered lost to follow-up. It is preferable to have a completed questionnaire outside the age window rather than having no data at all. The questionnaire is valid until 30 months. The MacArthur Bates CDI is a clinical assessment tool, which may benefit families and their health care provider, especially since delayed language is common (about one third) in our preterm population. Reducing the burden and providing families with support is important to consider when interacting with families. Follow-up staffs are encouraged to speak with the family over the phone to answer any questions they might have. The reminder phone calls that sites will make are a great opportunity to check-in with families and ask if they have any questions or need any guidance to complete the questionnaires. Sites are reminded that family participation is voluntary, as is the completion of the questionnaires. 5.1.7 MacArthur Bates CDI words and sentences

Sites will receive instructions to download the MacArthur Bates CDI Words and Sentences English form from the coordinating center in Vancouver. The French form can be downloaded from: https://eoa.umontreal.ca/agora-des-professionnels/ressources/inventaires-macarthur-bates-imbdc/ .The online scoring program and manual for the English form can be downloaded from: https://mb-cdi.stanford.edu/scoringdb_p.htm . The online scoring program for the French form will be distributed to sites. 6.Assessment Phase 6.1 Questionnaire administration The questionnaire can be administered by emailing the pdf copy (English, French and Spanish only) of the form, or by mailing it to families. The benefit of the emailed form is that families can complete it on the computer and can email it back to the sites. The process for this is outlined in detail under Site Questionnaire Administration and summarized in Appendix A.

https://eoa.umontreal.ca/agora-des-professionnels/ressources/inventaires-macarthur-bates-imbdc/https://eoa.umontreal.ca/agora-des-professionnels/ressources/inventaires-macarthur-bates-imbdc/https://mb-cdi.stanford.edu/scoringdb_p.htm

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For clinics that see patients at 2 years (or within the window), an effective means to optimize questionnaire completion is to mail the questionnaires out before the visit, for example with a written clinic appointment letter, and request that they return the questionnaires at the clinic visit. Families can also complete the questionnaires at the clinic visit. 6.2 Identifying and monitoring eligible patients It is crucial that every family with an eligible infant is tracked and offered the opportunity to be a part of the study, regardless of their geographic location, language spoken, or whether their child has complex medical issues and/or is followed by another program or service.

- If your clinic has other scheduled follow-up visits with the family, verify contact information at each visit and remind them about the 24 month questionnaire.

- Please ensure that a process is in place to include eligible babies referred from other sites. Maintain contact with the family at periodic but regular intervals.

6.3 Families who move to or from your area

There may be situations where you need to transfer CNFUN follow-up from one clinic to another. For example, a family may move to another region or there may be a follow-up clinic in a more convenient location. Try to identify these families as early as possible. Let the family know that follow-up is important, and that their child can be followed at CNFUN FUP closest to their new location. If a family is moving out of your area, you should:

Obtain contact information for the new FUP.

Send the CNN patient identifier and the CNFUN patient identifier (if one was generated) to the new follow-up clinic. Once the accepting FUP has confirmed that they will be following the child for CNFUN, the original site can remove the child from their follow-up list.

Some families may move out of your area without notice and may be difficult to track. Try websites such as Canada 411.ca (http://www.canada411.ca) or Canpages (http://www.canpages.ca.ca) that contain free searchable databases of public phone listings across Canada. Remember to search by both the mother and father’s last name.

A frequent point of drop-out from neonatal follow-up is following the first appointment. Maintain periodic contact with the families at highest risk for not attending:

Employment outside the home or returning to work

Social mobility and frequent address changes; and

If you become aware that an eligible child is moving into your area, you should:

http://www.canada411.ca/http://www.canpages.ca/

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- Verify that the child’s date of birth and location of NICU care meet the inclusion criteria.

- Contact the original clinic to transfer CNN and CNFUN identifiers and contact information.

- Update your patient list and clearly indicate that the patient is now being followed by another site and confirm that the other site has accepted the patient.

6.3Change of address

In circumstances where the family has moved, try contacting the family by telephone, email, or by checking with the family’s most recent medical charts on-site. 7.Families with Special Circumstances Following are some strategies routinely used by Follow-Up Programs across Canada to help recruit families with special circumstances. Language barriers When a family is not fluent in either of the official languages, the MacArthur Bates CDI is available in 40 additional languages, which can be mailed to the family. If your clinic sees a high volume of ESL patients who would benefit from having the questionnaire in an additional language, please contact the coordinating centre to arrange obtaining this. Please note that only the English, French, and Spanish versions currently have the fillable pdf and downloadable scoring tool, and forms in additional languages will need to be mailed out and manually scored. It may be helpful to have a professional interpreter call the family and explain the cover letter to ensure that they understand the purpose of the questionnaire. If the child is attending the Follow-Up Clinic in person, please designate time for the interpreter to assist the family with completing the questionnaire. Other barriers For situations where the families are illiterate, sites will offer to read through the consent form over the phone and, when consent is obtained, offer to administer the questionnaires over the phone or in-person at the clinic. Sites can also ask if the families have any support personnel who can help with completion of the questionnaires. 8. Site questionnaire administration The 24 Month Corrected Age Assessment Timeline outlines assessment planning, questionnaire send-out, questionnaire tracking, and data entry. The following is a detailed breakdown for each of the time points, which spans from 20 months CAA to 28 months CAA (see Appendix A for a summary of the timeline).

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8.2 Questionnaire tracking and follow-up Each site can devise their own system to track contact information, what questionnaires were received in office, and what questionnaires were not received, in addition to using the database for tracking. Sites will make reminder phone calls to families about the questionnaire, according to the 24 CAA Timeline (see appendix A). If the family misplaced any of the questionnaires, or requests another set of questionnaires, send what was requested. 18 Months CNFUN visit Sites should notify parents of the 24 month questionnaire, and ask them for their email (if not already collected) to send the questionnaire. At this time, parents can note whether they would prefer a paper-copy of the questionnaire mailed to them, and if they require the questionnaire in a different language. 20-22 Months corrected age – patient list and questionnaire prep During this stage, sites will consult their patient lists to see which children are approaching 24 months corrected age. Once identified, packages can then be prepared for send-out. All of the questionnaires being sent to families need to have the CNN and CNFUN unique identifiers on the cover page. The date fields will be left blank before mail-out, since this date will be filled in the day the questionnaires are completed. The unique identifier fields will be used for scoring and data entry and so it is important to ensure that the numbers have been properly transcribed onto each of the questionnaire covers. This is especially important in cases where families pull apart the questionnaires packages. When mailing a paper-questionnaire, a return envelope will be stamped and addressed by sites with the site’s mailing address so that families can easily mail back their questionnaires. Lastly, address and stamp the envelope to the participant’s home. 21 Months - questionnaire sends out Sites will send the questionnaire to families. The email or mail-out package will include the following items: -24 CAA Cover Letter -Questionnaire with CNN and CNFUN identifiers -Pre-addressed envelope with postage (if mailing) 21 Months, 2 weeks – first phone call reminder

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After approximately 2 weeks of the initial mail-out, sites will make their first phone call reminder to families. This is a good opportunity to connect with families and answer any questions they have about the questionnaire, their participation, and CNFUN in general. At this point, ask the family if they received the package and review when the questionnaire should be completed. If the questionnaire was not received, confirm the family’s email or mailing address and resend the package. 22 Months – second phone call reminder If the questionnaire was not received or was lost, confirm the email or mailing address with the family and resend the package. This is also an opportune time to answer any questions families may have. 27 Months – end of assessment window Verify that the questionnaire was received in your clinic and that data entry into the CNFUN Database is complete (see section Data and Data Entry). The CFNUN database can be used to track questionnaires on an ongoing basis as they are received in office. 29 Months, 29 days – end of window The MacArthur Bates CDI Words and Sentences is valid up to 30 months. Once parents / legal guardians have returned the questionnaire to the clinic offices, the questionnaire should be reviewed for completeness, scored, and the appropriate information can be entered into the CNFUN database for tracking purposes.

9. Completing the CDI The CDI: Words and Sentences form has two major parts, each with sub-sections

Part 1: Words Children Use

Vocabulary checklist Classification of whether the child says words in 22 semantic categories (680 items)

How children use words Use of language to refer to the past, the future, and absent objects and people (5 items)

Part 2: Sentences and Grammar

Word endings/Part 1 Question about the child’s use of language to refer to the past, the future, and absent objects and people (4 items)

Word forms A list of irregular plural nouns (5 items) and irregular past tense verbs (20 items)

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Word endings/Part 2 A list of overregularized nouns (14 items) and overregularized verbs (31 items)

Combining A question about whether the child has begun to combine words (1 item)

Examples A request to write examples of the three longest sentences that the parent has heard the child say in the recent past (basis for the mean length of the three longest sentences)

Complexity Sentence pairs that contrast in length and grammatical complexity (37 item pairs); asks the parent to indicate which one sounds most like the way the child currently talks

Time required by parents: approximately 20-40 minutes, depending on their child’s communicative skills. General instructions for parents: There are written instructions provided at the beginning of each section of the inventory – for most parents, these instructions are all that will be necessary. It may be useful to remind parents of the following items:

- Indicate today’s date: this is needed to make sure we can accurately calculate the age of the child

at administration

- Do not mark imitations: it is important that parents realize that they should not probe for

production by testing the child’s ability to imitate a word or sentence; they should only mark words

that the child uses spontaneously, without a direct model.

- Give the child credit for mispronounced or “baby talk” words (e.g. saying “nana” instead of

“banana” or “banky” instead of “blanket”). These words are acceptable substitutes for items listed

on the vocabulary checklist

- Give the child credit for words the child says or understands that have the same meaning as a word

on the CDI

- Take into account words indicating the names of people (e.g. Tati, Oma, Grandma) or words that

are specific to your region or dialect (e.g. owie instead of booboo, sack instead of bag, pop instead

of soda).

- Ask others to help fill out this form (e.g. another parent, nanny, child care providers, etc.)

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10. Questionnaire scoring Score each section according to the following table:

Part 1: Words Children Use

Vocabulary checklist Count the number of responses in each subsection. Do not count items left blank. words produced: sum and record the number of says responses across all 22 categories

How children use words For each of the 5 items, record sometimes and often responses as yes. Record not yet response as no. Count items blank as no

Part 2: Sentences and Grammar

Word endings/Part 1 For each of the 4 items, record sometimes and often responses as yes. Record not yet response as no. Count items blank as no

Word forms For the 5 irregular nouns and 20 irregular verbs, count the number of yes (i.e. selected) responses in each section

Word endings/Part 2 For the 14 overregularized nouns and 31 overregularized verbs, count the number of selected responses across the Noun and Verb sections to obtain a single total score

Combining Record sometimes and often responses as yes. Record not yet response as no. Count items blank as no

Examples Count and record the number of morphemes in each example utterance (maximum of 3 provided by parent) To compute a summary score: Mean length of the three longest sentences [M3L]: sum the number of morphemes in each example; divide by 3. If fewer than 3 provided, divide by number provided. If not yet is marked for combining, score M3L as 1 See scoring the child’s three longest sentences for more details on scoring this section

Complexity Count and record the number of items in which the second (more complex) of the two alternatives (37 maximum) is marked. If both alternatives are chosen,

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score as if the parent chose only the second. Do not count items left blank. If not yet is marked for combining, score complexity as 0.

Scoring the Child’s Three Longest Sentences: Please read through the following exerpts from the CDI manual for important instructions for scoring the three longest sentences.

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CDI Scoring Program The CDI scoring program can facilitate the tabulation, percentile calculation, report generation, and data-tracking functions associated with the forms. The English program and user manual can be downloaded from https://mb-cdi.stanford.edu/scoringdb_p.htm . The French program will be distributed to sites by CNFUN, or can be obtained by contacting Margaret Friend (mfriend@sdsu.edu) who has the program available. You will still need to hand-score the sections and then input these into the program. The program will then generate a score report along with percentiles that can then be input into the CNFUN database, Section J (shown below). Additional Notes: CNFUN has a copy of the CDI User’s Guide and Technical Manual. If you require any in-depth information regarding the forms and their development and implementation, please ask and we can send you copies of the relevant sections as you need. Data Entry Data Entry Data entry is located in section J of the CNFUN Database.

Section J: 24-Month Assessment

The score report from the scoring program provides a number of indicators and scores for each completed CDI. You can find an example of the scoring report here (under “See Samples”). The scores that are needed for entry to the CNFUN database include:

Total number of words produced o Percentile rank for this number of words

Is the child combining words? (Yes, No, Incomplete)

Length of child’s three longest sentences mean o Percentile rank for this mean

Sentence complexity score (out of 37)

https://mb-cdi.stanford.edu/scoringdb_p.htmmailto:mfriend@sdsu.eduhttps://mb-cdi.stanford.edu/scoringdb_p.htm

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Section J 24 Month Assessment

J1: Date Date the form was completed

J2a: # of words Total number of words produced

J2b: %ile Percentile rank for total words produced

J3: Combining words

Is the child combining words? Yes No Incomplete

J4a: 3 longest sentences mean

Mean of the length of child’s three longest sentences

J4b: %ile Percentile rank of the child’s three longest sentences mean

J5: Sentence complexity Sentence complexity score out of 37

11. Uploading data Uploading data means sending it electronically to the MiCare coordinating centre. You should upload your data on a regular basis (i.e., at least monthly) to stay up-to-date. The CNFUN Coordinating Center in Vancouver will request an upload every 6 months. Site uploading on a

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regular basis is important for data quality, follow-up status checking, and site payment. See section Data Entry for more instructions. For the purpose of the 24 month assessment, upload data will include the MacArthur Bates CDI. Data uploading can be done whether or not a case has been successfully “validated.” When validation is successful, this simply means that all necessary fields were completed, and when a case fails validation this means that not all fields were completed. CNFUN encourages sites to make every effort to obtain complete data. If a site is experiencing barriers to accessing information, such as CNN information, contact the CNFUN National Coordinator. 12. Data handling, analyses and request 13. Confidentiality

There are several levels of confidentiality that must be maintained. Firstly, the data in the computer represents personal information about patients. To maintain full confidentiality, no personal identifiers information are transmitted to the coordinating center (CC). The CC will be able to identify patients by their CNN unique identifier (UI), but only personnel at the local site will be able to match that number to a specific patient. For data confidentiality and accountability, each abstractor will be issued a user ID and password, only known to him or her to log in to the application. Every record created or updated using a given user ID will be marked in the backend database with that user ID and the created/updated data. The audit trail information can be used for security purposes as well as quality improvement. 14. Local CNFUN data

Any data locally entered into the CNFUN database can be accessed by sites locally, according to their own site and ethics review board guidelines. This includes 24 month CAA information and personal information. Any data that is entered and saved will be available on your local database. After local data is uploaded to the CNFUN database administrator in Toronto, the data is still available locally. Additionally, local CNN data is available to sites and can be obtained from your site’s local CNN abstractor. 15. Use of national CNFUN data Requests for CNFUN data for research projects can be requested from the CNFUN steering committee by active institutional or individual members by contacting the CNFUN National Coordinator. Use of this data is guided by MiCare protocols and will be subject to CNFUN Data Access Policies on data usage and data release.

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16. MiCare data 17. Data linkages One of the main features of the CNFUN database is its ability to link with the Canadian Neonatal Network (CNN) and other MiCare databases. This will allow analysis of the relationships between neonatal and perinatal variables (including NICU interventions) as well as early childhood outcomes. Data will be linked using the Unique Identifier (UI) issued at the time of initial entry in the CNN database. Each baby only has one UI, even if he or she was transferred between NICUs. Linkage will occur at the MiCare coordinating centre after the data has been entered and uploaded. At times, CNFUN FUPs will have to obtain some data from the CNN database at their local site. Patient information collected at the 18 month assessment will already be available in the CNFUN DB, which can be retrieved locally. For those patients that did not complete the 18 month CAA, sites will need to collect basic information to create a CNFUN record. It is a good idea to identify someone in your FUP to liaise with your site’s CNN Data Abstractor or Site Investigator (or the CNN contacts at the sites from which your program received referrals) and create a process to easily share information. If you don’t know who the CNN Abstractor is at your site, please consult the CNN website or contact the National CNFUN coordinator. The following fields needs to be obtained from the CNN Data Abstractor:

CNN unique identifier (A1)

Date of birth (A3)

Gestational age (A4)

Birth weight (A5)

CNN abstractors can generate a list of patients to be followed for CNFUN, the UI and other data fields listed above as well as demographic information that will be helpful for tracking (i.e., the baby’s name, hospital number, mom’s name, etc). This query must be done at the site – identifying information is not transmitted to the MiCare, CNN or CNFUN coordinating centers. Please contact your CNN abstractor to obtain a copy. General Instructions for data entry and general database use are available in English and in French on the CNFUN website.

http://www.canadianneonatalnetwork.org/portal/CNNHome/AbstractorsPage.aspxhttp://www.cnfun.ca/Resources/DataCollection18monthsCCA.aspxhttp://www.cnfun.ca/Resources/DataCollection18monthsCCA.aspx

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18. CNFUN data analyses Primary data analyses will identify variations in developmental outcomes at 18 and 24 months corrected age. Analyses will compare developmental outcomes across hospitals at 18 months and 24 months separately. Separate analysis will examine whether outcomes at 18 months and 24 months are consistent for the same hospitals. Other subanalyses will be performed subsequently. 19. Obtaining data for publications and presentations

Conditions Researchers wishing to submit a data request application must either be:

An active member of a MiCare network (identified above); or Working with a MiCare network member on the proposed project.

If the proposed data set is pooled together from more than one network, then a member of each network must be on the application. Procedure A researcher who wishes to use patient data from more than one network must make a formal request to the MiCare Steering Committee (SC). Following review of the request by the individual networks involved, the SC will review for approval to use the ‘Pooled MiCare Data’. The MiCare SC will act as an adjudication body to oversee such requests. A brief proposal must be submitted to the MiCare SC for review. The proposal should indicate objectives of the project, how the project will be conducted, plan for analyses, source(s) of funding, and appropriate ethics approvals. The proposal should state the cohort to be included in the dataset and specific variables required. The MiCare SC will review the feasibility of the proposal, and address whether there is sufficient data to carry out the analysis or availability of data. Furthermore, the MiCare SC may request an independent review of the scientific merit of the proposal if this is felt necessary and/or has not yet been done. Researchers will be notified in writing of MiCare’s decision in a timely fashion, usually within 4 weeks of submission. The MiCare SC will outline, in writing, reasons for requests which are denied. Appeals and process Data Sharing

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Data released to another network is subject to the following conditions: A written data use agreement will be required (see Appendix B). A researcher must agree to use the data only for the approved project/request. If a

researcher wishes to use the data in a new project at a later time, a new application must be submitted for review and approval.

A researcher must agree to keep all patient data confidential. Data will only be shared within the network team(s) conducting the analysis. Requests from other individuals for access to the data should be referred to the MiCare Network Directors’ Steering Committee.

Upon study completion, datasets should be returned to the MiCare Research Centre where they will be stored in a secured place for a period of time and any electronic copies will be deleted. All hard documents containing identifiable patient information must be shredded. The researcher in each site is responsible for ensuring information is discarded in accordance with this policy.

Requests involving complex datasets or data requests for non-academic purposes may be subject to a charged fee.

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