Round One: Teleconference
Four of the eight panel members attended a group teleconference and three members were interviewed individually by SP. The panel agreed to participating in online questionnaires rather than interviews to increase flexibility in participation for future rounds. The panel recommended qualitative feedback be included as well as the rating of items.
Birth Outcomes
Round One: Teleconference
Birth outcomes discussed as important included birth weight, small for gestational age, head circumference Apgar score, delivery at less than 37 weeks gestation, stillbirth, Neonatal Intensive Care Unit (NICU) admissions and sex. Panel members considered it essential to limit women’s burden to answer surveys straight after birth by using discharge summaries or data linkage.
Round Two: Questionnaire
Seven measures at birth (birth weight, gestational age, Apgar score, NICU admissions, sex length, head circumference) were presented for consensus. Three items reached consensus and four progressed to round three (Table 1). The panel suggested an additional seven outcomes in qualitative responses including substance use in pregnancy, cord blood gas values, labor type (induction, spontaneous), birth type (caesarean, vaginal), health of the mother, number people living in home, educational attainments of the mother and place of residence. Seven members (>80%) indicated the best mode of data collection to be hospital discharge summary.
Round Three: Questionnaire
Twelve items were presented for consensus (Table 1). All 12 items in round 3 reached consensus (Table 1). A total of 15 items were accepted as essential items to collect. (see Additional file 1 for data extraction form).
Table 1: Consensus for birth outcomes
Items
|
Round 2
n =8
|
Round 3
n = 8
|
Consensus
|
Gestational age
|
7
|
-
|
ü
|
Birth weight
|
7
|
-
|
ü
|
NICU admissions
|
7
|
-
|
ü
|
Length
|
6
|
7
|
ü
|
Head circumference
|
4
|
8
|
ü
|
Sex
|
5
|
8
|
ü
|
Apgar score
|
5
|
8
|
ü
|
Substance use in pregnancy
|
-
|
8
|
ü
|
Cord blood gas values
|
-
|
8
|
ü
|
Labour (induction, spontaneous)
|
-
|
8
|
ü
|
Birth type (caesarean, vaginal)
|
-
|
8
|
ü
|
Health of mother
|
-
|
8
|
ü
|
Number people living in home
|
-
|
8
|
ü
|
Education
|
-
|
8
|
ü
|
Place of residence
|
-
|
8
|
ü
|
Total:
|
7
|
12
|
15
|
Data collection from one to 6 months of age for respiratory symptoms and health service utilisation
Round One: Teleconference
Panels members were asked to consider the best mode of data collection from the mothers of the infants from one to 6 months of age. Options discussed included phone call, face-to-face, text message, online diary using phone application or weblink. The panel recommended phone calls or face to face (with use of text message to organise time/venue). The panel advised that women were unlikely to use a mobile phone application to report data. The panel recommended gaining feedback from Indigenous women on their preference for the modality of data collection i.e. phone call, face-to-face, email, mobile phone application. Options discussed for personnel to collect data included an on-site research facilitator (a volunteer for the service who would be aiding the main trial) or other female health worker with a trusted relationship with the woman. The panel members advised additional information would be required to form a decision on the inclusion of respiratory items and requested input from Respiratory Paediatrician (JM) as required to support decision making.
Round Two: Questionnaire
Forty-eight items were presented in total for consideration. Five items were presented on how data should be collected (frequency, number of survey questions, modality, personnel to collect data and reimbursement amount) (Table 2). Two items reached consensus, 1) frequency of data to be collect monthly rather than fortnightly and 2) modality of collection for women to choose their preference. Three items progressed to round three (number of survey questions, personnel to collect data, reimbursement amount). Forty-three items were presented on acute respiratory symptoms, health care utilisation, exposure to tobacco smoke and breastfeeding status. Of the 43 items, one item reached consensus (exposure to tobacco smoke). Twenty-eight items progressed to round three and 16 items were omitted (Table 3).
Table 2: Frequency, number of questions, mode, personnel to collect data and reimbursement
Items
|
Round 2
n = 8
|
Results 3
n = 8
|
Consensus
|
Frequency of data collection:
Fortnightly
Monthly
|
0
7
|
-
7
|
ü
|
Number of questions:
1 to 5
6 to 10
11 to 15
16 to 20
|
0
4
1
2
|
-
5*
1
2
|
ü
|
Modality:
Phone call
Survey
Phone app
Email
Women’s preference
Women randomised to different modality
|
3
2
2
1
7
1
|
-
-
-
-
7
-
|
ü
|
Who should collect data:
Research facilitator (based on site, Indigenous or non-Indigenous)
Indigenous researcher (based at research institution)
Non Indigenous researcher (based at research institution)
Research facilitator, if not possible, Indigenous researcher
Unsure
|
6
5
2
-
1
|
2
3
-
3*
-
|
ü
|
Reimbursement to mother, amount per survey:
$15 voucher
Baby bundle (value of $15)
$10 voucher
$5 voucher
Research site to choose either $15 or $ baby bundle
|
3
3
1
0
-
|
1
2
-
-
5*
|
.
ü
|
* Rule enacted, highest frequency accepted if consensus not achieved in Round 3
Table 3: Consensus for outcomes for acute respiratory symptoms, health care utilisation, and exposure to tobacco and breastfeeding status from 1 to 6 months of age
Item
|
Round 2
n = 8
|
Round 3
n = 8
|
Consensus
|
Has your baby had wheeze or whistle in the past 4 weeks?
|
4
|
7
|
ü
|
Has your baby had a moist or wet cough in the past 4 weeks?
|
6
|
7
|
|
Has your baby had a dry cough in the past 4 weeks?
|
6
|
7
|
|
Has your baby had shortness of breath in the past 4 weeks?
|
4
|
7*
|
|
Has your baby had an earache in the past 4 weeks?
|
4
|
7*
|
|
Has your baby had a runny nose in the past 4 weeks?
|
4
|
7*
|
|
Does your baby have a cough today?
|
6
|
5*
|
ü
|
Have you been worried about your baby's health for any reason in the past 4 weeks?
|
5
|
7*
|
ü
|
If yes, what have you been worried about?
|
4
|
8*
|
ü
|
Has your baby been hospitalised in the past 4 weeks?
|
6
|
7*
|
ü
|
If yes, what were the reasons your baby went to hospital?
|
5
|
7*
|
ü
|
If yes, how many days was your baby hospitalised?
|
6
|
7*
|
ü
|
Has your baby been to see a doctor at any time in the past 4 weeks?
|
5
|
7*
|
ü
|
If yes, what were the reasons?
|
5
|
7
|
ü
|
Has your baby been given medications in the past 4 weeks?
|
6
|
7*
|
ü
|
Has exposure to tobacco smoke changed?
|
7
|
-
|
ü
|
Has breastfeeding changed in the past 4 weeks?
|
6
|
8*
|
ü
|
Any out of pocket expenses to care for your baby’s sickness?
|
4
|
3
|
û
|
Has your baby had any feeding difficulties in the past 4 weeks?
|
4
|
3
|
û
|
Has your baby had a fever/temp/feel hot in the past 4 weeks?
|
2
|
-
|
û
|
Has your baby had chills in the past 4 weeks?
|
1
|
-
|
û
|
Has your baby vomited in the past 4 weeks?
|
1
|
-
|
û
|
Has your baby had diarrhea in the past 4 weeks?
|
1
|
-
|
û
|
Has your baby had irritability in the past 4 weeks?
|
0
|
-
|
û
|
Has your baby had increased tiredness in the past 4 weeks?
|
0
|
-
|
û
|
Has your baby had unsettled sleep in the past 4 weeks?
|
0
|
-
|
û
|
Has your baby had fast breathing in the past 4 weeks?
|
4
|
0
|
û
|
How many days has your baby had the cough for?
|
6
|
6
|
û
|
Are you worried about your baby's cough becoming worse?
|
5
|
1
|
û
|
What is your baby's cough like in daytime?
|
5
|
0
|
û
|
What is your baby's cough like in night time?
|
5
|
0
|
û
|
Total number of days the baby was in hospital.
|
3
|
-
|
û
|
Anything else that affects your family getting health care for your baby?
|
4
|
3
|
û
|
If yes, how many times has the baby been to the doctor?
|
3
|
-
|
û
|
Total number of days baby was in hospital
|
3
|
-
|
û
|
Amount of time spent from work/home to get health care for baby?
|
3
|
-
|
û
|
How many hours per week have been spent getting health care for your baby?
|
1
|
-
|
û
|
Has your baby been given antibiotics in the past 4 weeks?
|
6
|
1
|
û
|
What is the name of the hospital?
|
0
|
-
|
û
|
Has any person in the baby's household had a respiratory illness?
|
2
|
-
|
û
|
Has your baby seen any other health professional?
|
5
|
4
|
û
|
How many times has your baby been to see the health professional?
|
3
|
5
|
û
|
Reason (s) baby seen by other health professional
|
3
|
7
|
û
|
Total
|
43
|
28
|
17
|
* Rule of combining ‘very essential’ and ‘somewhat essential’ enacted
Round Three: Questionnaire
Thirty-one items were presented in total. Of the three items presented on how data should be collected, number of questions was 5 to 10, site to choose personnel to collect data and site to choose $15 gift card or $15 baby bundle. Of the 28 measures to be collected presented in round three, 17 were accepted (see Additional file 2 for final version of monthly survey)Five items reached consensus by achieving a response frequency of ≥80 % and twelve items reached consensus through enacting the rule to combine votes for ‘very essential’ and ‘somewhat essential’. Items accepted include seven acute respiratory symptoms, two general health items, six items on health care utilisation, one item on exposure to tobacco smoke and one item on breastfeeding status. Additional recommendations from the panel were to provide families and health providers with education on detecting and managing chronic cough, and to ensure adequate follow up of infants with chronic cough.
Measures for respiratory illness and development for 6 months old infants
Round One: Teleconference
Five measures were discussed, 1) 50-item parent report respiratory symptom screening questionnaire (36), 2) 18-item respiratory screening questionnaire adapted into Creole (37), 3) a clinical assessment form developed for the purpose of the larger study, 4) Ages and Stages Questionnaire (ASQ) (38) and 5) an adapted version of ASQ for remote Indigenous communities, ASQ-TRAK (39)). Participants were not aware of any other suitable measures or existing surveys.
Round Two: Questionnaire
Of the five assessments tools, none reached consensus for use in the existing form. Qualitative feedback from the panel recommended a shorter length questionnaire. The questionnaire adapted into Creole language from the Torres Strait was not considered suitable for most Indigenous women. Participants recommended specific language changes or inclusion of definitions for words such as 'posset', 'wheeze' and, 'rattles/ruttles'. Minor feedback was received on the clinical assessment form including a recommendation to ask more broadly about a child’s respiratory health and then use prompts for specific respiratory conditions, e.g. bronchitis.
Five of eight participants indicated it was important to collect developmental outcomes at six months and five of eight indicated that the ASQ and ASQ TRAK were suitable tools. Key feedback on how the data should be collected included: a health professional should complete it with the woman and infant, the health professional must be familiar with working in Indigenous communities, and the questionnaire should be completed prior to a clinical assessment and the results provided to the clinical assessor.
Feedback from Indigenous women:
Overall feedback from the Indigenous women indicated a preference for the 50-item questionnaire compared to the 18-item questionnaire adapted into Creole. There was an overwhelming consensus to shorten the length and clarify certain terms, such as ‘posset’ and ‘rattly breathing’. Similar to the Indigenous panel, women advised that the Creole language was only suitable for Indigenous people who speak Torres Strait Creole. Women also recommended a simpler layout, particularly if surveys are to be parent completed.
Round Three
Based on the feedback gathered from participants, several changes were made to the 6 months of age questionnaires presented in round three. The 50-item questionnaire was reduced to 33- items (see Additional file 3). The clinical assessment form was reduced to one page and included growth parameters, immunisations, respiratory illnesses since birth, other significant illness since birth, and current medications. The clinical assessment form (see Additional file 4) was recommended to be completed with information extracted from the clinical notes and parent report. A consensus from participants, 8/8 (100%), was achieved for use of the three assessment tools in their amended form.