Name : M.

Agung Prasetya Adnyana Yoga

NIU : 21/475855/PKU/19330
Country : Indonesia
Assignment : Point and Interval Biostatistic Assignment

1. In the Figure 1, please examine the number of subjects enrolled and analyzed for each type of
intervention. What is your comment regarding the results of randomization of this study?
How did investigators try demonstrate that high drop-out did not suggest any bias? Read
table 1 for your justification. Why?
- Regarding from this article, there is 482 women referred were screened for eligibility but the
total number of subject enrolled in this study only 230 and the number of subject declined to
participated is 225. And we used 230 sample to participated and have willingness to join in this
study.
- The intervention for all subject in this article, woman’s are allocated to the dietary intervention
received a HUMBA Handbook with information about healthy nutritious foods, recipes,
unhealthy drinks, managing cravings and ways to be more physically active. Then, they received
4 homebased education sessions by a community professional health workers. This included
behavior change techniques to promote healthy eating and setting SMARTER goals (specific,
measurable, action-oriented, realistic, timed, evaluated, and reviewed). While, subsequent
intervention visits, community health workers plotted the woman’s weight on a personal
pregnancy weight gain chart and provided feedback and positive reinforcement for goals
achieved. A dietitian developed an operation manual and provided oversight. Dietary
intervention visits were aimed to be completed before the 26 until 28 weeks HUMBA study 75-g
oral glucose tolerance test (OGTT). Women in the dietary intervention also received
motivational text messages 3 times weekly from randomization until birth. Content of the
messages was designed to complement dietary education with some worded as if from the baby
to the mother, eg, “Mum, remember to read food labels.” Women could elect to stop receiving
texts at any time. Women allocated to probiotics group received capsules containing
Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 (minimum dose 6.5 109 colony
forming units. Women in the placebo group received identical capsules containing
microcrystalline cellulose and dextrose anhydrate. Women were instructed to take 1 capsule
(probiotic or placebo) daily until birth. All participants continued routine antenatal care.
This is assessment or intervention for participant in this study

No Intervention for Woman Pregnancy

1 Primary Assesment (Excessive weight gain)
Secondary Assesment
2 Weight change baseline to 36 weeks
3 GDM (Gestasional Diabetes Mellitus)
4 Fasting Glucose (1 hours glucose OGTT, 2 hours glucose OGTT)
5 Hba1c measurement
6 EPDS (Edinburgh Post Natal Depression Scale) 36 Weeks
7 Blood Pressure measurement to evaluate Pregnancy Induce Hypertension
8 Mode of birth ( unassist vaginal birth, operative vaginal birth (total cesarean
deliveries, emergencies cesarean deliveries), stillbirth)

No Intervention for liveborn infants

1 Birthweight measurement (gram)
2 Gestational age
3 NICU Admission
4 Composite Morbidity
5 Birth size measurement (head circumference, length, chest circumference, abdominal
circumferences, left arm circumferences )
6 Birth size with z scores (birthweight, head circumferences, length, and SGA (Small
For Gestasional Age) < 10 TH customized, n(%).

Comparison between woman who consented or decline to participate

No Variables Consented N = 230 Declined = 225 P values

1 Maternal age , years 28.8 (5.7) 27.9 (5.7) .10
2 Weight , kg 107.1 (17.9) 105.9 (18.5) .51
3 Height, cm 166.2 (6.2) 166.6 (5.6) .42
4 BMI, kg/m2 38.8 (6.1 38.0 (5.7) .22
5 Ethnicity .60

Why in this study didn’t have any bias while there is 225 participant declined or in this study
have a high drop out ?
- Because they are considering about the number of loss to follow up, while in this study
allow to consider 10% loss to follow up and the researcher considering about the
minimum sample size in this study to keep their research have a valid data and to prevent
 bias data. Most statisticians agree that the minimum sample size to get any kind of
meaningful result is 100 but the total sample size in this study still above more than 100
or 230 sample.

- The best way to avoid selection bias is to use randomization. Randomizing selection of
beneficiaries into treatment and control groups, for example, ensures that the two groups
are comparable in terms of observable and unobservable characteristics. In this study of
course use randomization technique to prevent any selection bias too. While in this study
we divided into 2 group and we were choosed the sample with randomization technique
between two group ( group control and intervention control)

2. Examine Table 1 on the comparison between women who consented or declined to

participate. Please comment regarding the results of randomization on this study. Do you
think the investigators have already conducted a proper randomization? How they did it?

Yes, they have already conducted a proper randomization because Eligible women were
allocated randomly by the research midwife using a web-based randomization program
(http://randomize.net) using random permuted blocks of 4-8 participants, stratified by BMI
(30 to < 35 or >35 kg.m2), to dietary intervention and probiotic or placebo capsules or routine
dietary advice and probiotic or placebo capsules. Participants, researchers, and data analysts
were blinded to probiotic and placebo allocation. Participants in the dietary intervention
could not be blinded but researchers collecting and analyzing outcome data were unaware of
the dietary treatment allocation.
This is a a graphic that I put from journal, whil the researcher applied randomized control
trial between group control and group intervention, fro group intervention we want to do
intervention about allocated dieteray intervention and allocated probiotic capusles and other
than we want to compare with maternal woman allocated to routine dietary advice and
allocated with placebo capsules .

Consented and Randomised

n = 230

Allocation
Allocated to Routine Dietary
Allocated to Dietary Intervention Advice
n = 116 n = 114

Analysis

Maternal Primary Outcome Maternal Primary Outcome

- Evaluated (n =107) - Evaluated (n =110)
- Not Evaluated (n=9) - Not Evaluated (n=4)
Neonatal Primary Outcome Neonatal Priamary Outcome
- Evaluated (n =111) - Evaluated (n =111)
 Consented and randomized
n = 230

Allocation
Allocated to probiotic Allocated to placebo
capsules capsules
(n=115) (n=115)

Analysis

Maternal Primary Outcome Maternal Primary Outcome

- Evaluated (n =108) - Evaluated (n =109)
- Not Evaluated (n=7) - Not Evaluated (n=6)
Neonatal Priamary Outcome Neonatal Priamary Outcome
- Evaluated (n =110) - Evaluated (n =112)
- Not Evaluated (n=5) - Not Evaluated (n=3)

3. Please refer to Table 1. Create similar table but change the standard deviations to 90%
confidence intervals instead.
Table 1. Comparison between women who consented or declined to participate with 95% CI

No Variables Consented N = Declined N = 225 P values

230
1 Maternal age , years 28.8 (5.7) 27.9 (5.7) .10
2 Weight , kg 107.1 (17.9) 105.9 (18.5) .51
3 Height, cm 166.2 (6.2) 166.6 (5.6) .42
4 BMI, kg/m2 38.8 (6.1 38.0 (5.7) .22
5 Ethnicity .60
New Zealand Maori 52(22.6) 33(14.7)
Cook Island Maori 28 (12.2) 18(8.0)
Samoan 46(20.0) 74 (32.9)
Tongan 27 (11.7) 53(23.6)
Other Pacific Island 13(5.7) 4(1.8)
Indian 13 (5.7) 9(4.0)
Other 9(3.9) 7(3.1)

Table 1. Comparison between women who consented or declined to participate with 90% CI

No Variables Consented Confident Declined Confident interval

N = 230 interval (90%) N = 225 (90%)
1 Maternal age , 28.8(0.37) 28.17 – 29.4 27.9 (0.38) 27.27 – 28.52
years
2 Weight , kg 107.1 (1.18) 105.1- 109.04 105.9 103.8-107.9
(1.23)
 3 Height, cm 166.2 165.9-166.8 166.6 165.9-167.21
(0.408) (0.373)
4 BMI, kg/m2 38.8 (0.402) 38.15-39.4 38 (0.38) 37.3-38.62
5 Ethnicity
New Zealand 52(1.49) 49.53-54.4 33(0.98) 31.3-34.61
Maori
Cook Island 28(0.8) 26.67-29.32 18(0.53) 17.1-18.8
Maori
Samoan 27 (0.77) 25.7-28.2 53(1.5) 50.4-55.5
Tongan 13 (0.37) 12.37-13.6 4(0.12) 3.80-4.19
Other Pacific 42(1.2) 40.0-43.99 27(0.8) 25.67-28.3
Island
Indian 13(0.37) 12.3-13.6 9(0.26) 8.5-9.4
Other 9(0.25) 8.57-9.4 7(0.206) 6.6-7.3

4. Write your reading for 90% confidence intervals in a plain language so that non-statistician
can understand the meaning.

We confident 90% that the values of the result will fall between the upper and lower limit if
the procedure of research is repeated again in the population. For example we want to
interpretation the variable height in this study. We confident 90% from the height variable in
this study while the result from height value will fall between 165.9 up to 166.8 if the
procedure of research will repeated again in the population or in similar think It also tells us
about how stable the estimate is. A stable estimate is one that would be close to the same
value if the survey were repeated. If repeated samples were taken and the 90% confidence
interval was computed for each sample, 90% of the intervals would contain the population
mean. A 90% confidence interval has a 0.90 probability of containing the population mean.
90% of the population distribution is contained in the confidence interval. For example the
maternal age variable in this study use 90% confidence interval while it means we confidence
90 % the maternal age in this population would contain maternal age in this population
between 28.17up to 29.4.

5. Please pay special attention on the 90% confidence interval of between-group differences for
the each type of baseline variables. What is your comment? What is your conclusion on
randomization after you read this article.

Randomization eliminates accidental bias, including selection bias, and provides a base for
allowing the use of probability theory. Randomization in an experiment means random
assignment of treatments. This way we can eliminate any selection possible biases that may arise
in the experiment. And also randomization in an experiment is important because it minimizes
bias responses. Random allocation is a technique that chooses individuals for treatment groups
and control groups entirely by chance with no regard to the will of researchers or patients'
condition and preference. This allows researchers to control all known and unknown factors that
may affect results in treatment groups and control groups.

Random Sequences
Generation

Simple randomization
Sealing with envelope or
Block randomization
eCRF or Drug Preparation
Stratified random

Procedure
Blinding for patient Double Blind

Blinding for physician

Result asssesment
Triple Blind
Blinding for assesors

Analysis Blinding for analyze or

Total Blind
statistician

Rgearding from this article, participants, researchers, and data analysts were blinded to probiotic
and placebo allocation. Participants in the dietary intervention could not be blinded but
researchers collecting and analyzing outcome data were unaware of the dietary treatment
allocation. Women allocated to probiotics ( include group intervention) received capsules
containing Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 (minimum dose 6.5 x
109 colony forming units). Women in the placebo group received identical capsules containing
microcrystalline cellulose and dextrose anhydrate. Women were instructed to take 1 capsule
(probiotic or placebo) daily until birth. All participants continued routine antenatal care. From
illustration like that we knew while this study have a plan and make a consideration about
randomization technique and were apply blinding aspect between participant and researchers.

APPENDIX
. cii 230 28.8 5.7, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

230 28.8 .3758469 28.17928 29.42072

. cii 225 27.9 5.7, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

225 27.9 .38 27.27236 28.52764

. cii 230 107.1 17.9, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

230 107.1 1.180291 105.1507 109.0493

. cii 225 105.9 18.5, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

225 105.9 1.233333 103.8629 107.9371

. cii 230 166.2 6.2, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

230 166.2 .4088159 165.5248 166.8752

. cii 225 166.6 5.6, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

225 166.6 .3733333 165.9834 167.2166

. cii 230 38.8 6.1, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

230 38.8 .4022221 38.13572 39.46428

. cii 225 38.0 5.7, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

225 38 .38 37.37236 38.62764

. cii 230 52 22.6, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

230 52 1.4902 49.53888 54.46112

. cii 225 33 14.7, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

225 33 .98 31.38135 34.61865

. cii 230 28 12.2, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

230 28 .8044442 26.67143 29.32857

. cii 225 33 14.7, level (90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

225 33 .98 31.38135 34.61865

. cii 230 28 12.2, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

230 28 .8044442 26.67143 29.32857

. cii 225 18 8.0, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

225 18 .5333333 17.1191 18.8809

. cii 230 46 20.0, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

230 46 1.318761 43.82202 48.17798

. cii 225 74 32.9 , level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

225 74 2.193333 70.37731 77.62269

. cii 230 27 11.7, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

230 27 .7714752 25.72588 28.27412

. cii 225 53 23.6, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

225 53 1.573333 50.40135 55.59865

. cii 230 13 5.7, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

230 13 .3758469 12.37928 13.62072

. cii 225 4 1.8,level (90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

225 4 .12 3.801798 4.198202

. cii cii 230 42 18.3, level(90)

cii not found
r(111);

. cii 230 42 18.3, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

230 42 1.206666 40.00715 43.99285

. cii 225 27 12.0,level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

225 27 .8 25.67865 28.32135

. cii 230 13 5.7, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

230 13 .3758469 12.37928 13.62072

. cii 225 9 4.0, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

225 9 .2666667 8.559551 9.440449

. cii 230 9 3.9, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

230 9 .2571584 8.575294 9.424706

. cii 225 7 3.1, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

225 7 .2066667 6.658652 7.341348

. cii 225 18 8.0, level(90)

Variable Obs Mean Std. Err. [90% Conf. Interval]

225 18 .5333333 17.1191 18.8809