Keywords
maternal directed - preterm - NICU - physiological parameters - outcome - neonate
- behavior
Introduction
The most frequent cause of death in children under the age of five is prematurity.
In India, prematurity is a major health concern, with an estimated 3.5 million preterm
neonates born each year.[1] According to the United Nations Inter-Agency Group for Child Mortality Estimation
(UN IGME) report from 2021, the neonatal mortality rate globally is 17 per 1,000 live
births aiming for a neonatal mortality rate of 12 or lower per 1,000 live births by
2030.[2] Small-for-gestational-age babies are a significant burden in low-and middle-income
nations, with a concentration in south Asia. To improve survival rates, and lower
disability rates, it is urgently necessary to provide effective therapies for infants
who are born too small or too soon.[1]
Preterm infants are subjected to stressors in the neonatal intensive care unit (NICU),
such as invasive hospital procedures, intense light, and noise from medical equipment.[3] The sounds of the mother's speech or heartbeat and tactile or vestibular stimulation
from her movements provide integrated multimodal stimulation to the fetus.[4] The environment's genetic and epigenetic effects, endogenous brain activity, sleep,
external events that activate the sense organs, and the physical, chemical, sensory,
and social/emotional settings all affect how the brain develops.[5]
The newborn's most crucial responsibility is to adapt to and settle in their new environment,
which is very different from their mother's womb. Modern medical technology has improved
the chances of survival for preterm infants. However, there are common long-term morbidities.
In addition to denying infants the fetal sensory stimulation necessary for their proper
development, premature infants are at higher risk of complications such as respiratory
distress,[6] learning difficulties, cognitive, sensory, and neurological impairment.[7]
[8]
Early detection of premature babies with potential developmental or mental health
issues is important to start interventions immediately since impairments could later
emerge.[9] They could need specialized attention in the neonatal critical care unit to help
them survive and thrive. Preterm newborns may exhibit positive physiologic and behavioral
responses to beneficial NICU interventions.[10] Globally, preterm newborns are more likely to survive thanks to technological and
scientific advances that have an impact on their nursing and medical care. Developmental
care entails modifying the newborn intensive care unit to lower stress and enhance
the preterm neonate's optimal brain and behavioral development. Developmental care
is to help each neonate become as stable, structured, and competent as possible by
carefully managing them and responding to their cues.[11]
Multisensory stimulation is a well-known strategy to address the issues related to
preterm birth-related problems, such as physiological parameters and neuromotor development.
The optimum developmental result for the newborn depends on early intervention. Coronavirus
disease 2019 (COVID-19) guidelines have limited access to the mothers to NICU and
thus limited opportunities for participation in newborn care. Encouragement of mothers
in newborn care is vital to facilitate mother-newborn bonding and increase the confidence
of mothers in caring for their preemies. Maternal-directed interventions such as skin-to-skin
contact, initiating eye to eye contact, singing lullaby, breastfeeding, and emotional
support can be beneficial for both the mother and the baby. This study aimed to involve
maternal participation in sensory stimulation of their NICU preemies and evaluate
its effectiveness on neonatal outcomes.
Materials and Procedures
Research Plan and Participants: A pilot, quasi-experimental study was conducted among the 31 mother preterm newborn
dyads in the study and control group from 21/12/2021 to 15/04/2022. Preterm newborns
admitted in the premature unit NICU of a tertiary care hospital who met the inclusion
criteria after 2 days of stabilization, between 30 to 36 weeks of gestation, weighing
between 1 to 2.5kg, and medically stable were selected for the study along with their
mothers having no major complications associated with delivery using a purposive sampling
technique. The sample size for the main study (from which the pilot sample size was
obtained) was calculated by using the formula based on findings of similar research
conducted previously[12] with a 0.05 level of significance for the two trials and 0.10 power. A total sample
size of 68 each in the experimental and control group was obtained for the main study.
However, the authors increased the sample size to 31 each in the pilot study to have
a more representative sample size.
The sample in the comparison group received routine care in contrast to the mothers
in the trial arm who received training to provide ATVV (Auditory, Tactile, Vestibular,
and Visual) stimulation to their preterm newborn in NICU. To avoid selection bias,
the sample for the experimental group was chosen last after the data collection was
finished on the sample for the control group. The institutional ethical committee
approved the study's conduct and informed consent from the participants was received.
The mother in the experimental group was trained to give ATVV stimulation once the
mother was comfortable adhering to the stimulation process. Initially, information
was given about the procedure using visual aids followed by a demonstration of the
procedure using the doll and a return demonstration was taken to ensure that the mother
understood the process. The mother was guided to give ATVV stimulation to their preterms
in the NICU in the presence of the investigator and after ascertaining the correctness
of the procedure, the mother was encouraged to independently carry out the procedure
to their preterm neonates.
ATVV stimulation was given by the mothers in the experimental group to their preterm
neonates for a total of 12 minutes daily for 10 days. Auditory stimulation included live humming of lullabies throughout the stimulation. After initiating auditory
stimulation for 3 minutes, tactile stimulation was given for 3 minutes with warm palms; infant's body is stroked moderately in a
sequence of the head, face, chest, upper limbs, abdomen, and lower limbs in a supine
position. Following tactile stimulation after a gap of 30 seconds, vestibular stimulation is initiated with slow and steady rocking for 3 minutes. After a gap of 30 seconds,
tactile stimulation is repeated for 3 minutes continuing with auditory stimulation.
Visual stimulation including eye-to-eye contact was encouraged throughout the stimulation process. During
signs of overstimulation, the mother was advised to pause the stimulation for 15 seconds
and then continue. The mothers in the control group received a pamphlet explaining
the process of ATVV stimulation after the baby was discharged from the NICU.
Measurement: The neonatal outcomes were measured before the intervention as well as 3, 5, 7, and
10 days afterward. Neonatal outcomes measured were (a) physiological indicators (heart,
breathing rate, temperature, and oxygen levels in blood) measured using a calibrated
multiparameter monitor; (b) the weight of the newborn was measured after changing
the diaper using a calibrated weighing machine; (c) behavioral assessment tool for
preterm infants was used to assess the behavior of preterm newborn after the mother–newborn
interaction in NICU. This tool was used in the Indian setting and permission to use
this tool was obtained from the author. No modifications in the tool were done. Two
components make up the tool. The autonomic/visceral system has four categories including
color, respiration, visceral signs, and neurophysiological responses. The maximum
total score for this component is 8. A score of more than 5 to 8 for all the four
domains in the subsystem is considered to show “Normal behavioral response” and the
scores obtained of 2 to 4 show suspected abnormal behavioral responses and scores
of less than 1 show definite abnormal behavioral responses. The component of the state
and attention-interaction system consists of three domains: alertness, orientation
to an auditory stimulus, and state control. It has a point system scoring, that is,
from zero to two for both components. The total score is 6, and scores more than 4
to 6 are considered as “normal behavioral response,” a score between 2 and 4 shows
suspected abnormal behavioral response, and scores of less than 1 show “definite abnormal
behavioral response.”[13]
The content validity of the tools was ascertained by submitting them to 11 subject
experts. The content validity index for baseline characteristics of mother and newborn
is 0.98; physiological parameters are 1 as well as preterm behavioral assessment tool
is also equal to 1. The intraclass correlation coefficients were used to examine the
inter-rater reliability of the behavioral assessment tool for preterm infants. Two
independent observers' raw scores for the two subsystems, namely the autonomic and
state and attention-interaction systems and their domains in the tool, were calculated
using SPSS (Ver. 15.0), South East Asia, Bangalore. The autonomic subsystem's “r”
value was 0.96, while the state and attention–interaction subsystem's “r” value was
0.92, indicating good reliability for both of the tool's subsystem.
Data Analysis: SPSS version 23 package was used for data analysis. The data were analyzed using
percentages, the frequency for univariate data, standard deviations, and mean in cases
of continuous data. The chi-squared test was used to examine categorical variables.
Parametric tests utilized the independent t-test. For nonparametric testing comparing independent groups, the Kendall tau-b correlation
coefficient was utilized. According to the skewed distribution, one-way analysis of
variance (ANOVA) with Bonferroni posthoc was adopted to compare more than two separate
groups. Statistical significance was denoted by a p-value less than 0.05
Results
Characteristics of Mother as well as Preterm Newborn
The characteristic data of 31 mothers and preterm newborns in the groups of treatment
and control are described in the below text.
According to the information presented in [Table 1], there was not any scientifically significant distinction between the two groups
concerning the age of the mothers, the gestational age, or the birth weight of the
neonates. The majority of the mothers were primi, homemakers, were from joint families,
had a male child, mode of delivery was lower segment cesarean section and were graduated.
The occupation of the mother varied significantly across the groups of intervention
and control.
Table 1
Demographic characteristics of the mother and preterm newborn, n = 31 + 31
Variable
|
Intervention arm
n = 31
|
Control arm
|
t-Value
|
p-Value
|
X2 Value
|
Age of mother[a]
|
27.52 ± 3.129
|
27.36 ± 4
|
0.177
|
0.86
|
–
|
Gestational age[a]
|
30.81 ± 1.45
|
30.68 ± 1.51
|
0.343
|
0.73
|
Birth weight[a]
|
1.60 ± 0.45
|
1.77 ± 0.61
|
1.245
|
0.218
|
No. of deliveries (%)
|
1
|
23 (74.2)
|
22 (71)
|
–
|
0.6
|
1.022
|
2
|
8 (25.8)
|
8 (25.8)
|
3
|
0
|
1 (3.2)
|
Occupation (%)
|
Homemaker
|
21 (67.7)
|
17 (54.8)
|
–
|
0.008b
|
9.684
|
Professional
|
5 (16.1)
|
0
|
Salaried
|
5 (16.1)
|
14(45.2)
|
Type of family (%)
|
Nuclear
|
9 (29)
|
10 (32.3)
|
–
|
0.783
|
0.076
|
Joint
|
22 (71)
|
21 (67.7)
|
Gender of newborn (%)
|
Male
|
15 (48.4)
|
20 (64.5)
|
–
|
0.2
|
1.64
|
Female
|
16 (51.6)
|
11 (35.5)
|
Mode of delivery (%)
|
Normal vaginal
|
18 (58.1)
|
11 (39.3)
|
–
|
0.15
|
2.07
|
LSCS
|
13 (41.9)
|
17 (60.7)
|
Education (%)
|
SSLC
|
7 (22.6)
|
4 (12.9)
|
–
|
0.35
|
3.285
|
PUC
|
6 (19.4)
|
12(38.7)
|
Graduate
|
16 (51.6)
|
14(45.2)
|
Postgraduate
|
2 (6.5)
|
1(3.2)
|
Abbreviations: LSCS, lower segment cesarean section; PUC, preuniversity course; SSLC,
secondary school leaving certificate.
a Mean ± standard deviation; bHighly significant.
The effectiveness of the maternal-directed intervention on neonatal outcomes is measured
in terms of physiological parameters described in [Table 2.] Preterm infant behavioral assessment is described in [Tables 3] and [4].
Table 2
Comparison of temperature in Celsius, heart and respiratory rate per minute, and blood
oxygen level in percentage of the preterm newborn, n = 31 + 31
Period
|
Physiological parameter
|
Intervention arm
Mean ± SD
|
Control arm
Mean ± SD
|
t-Value
|
p-Value
|
Pretest
|
Temperature
|
36.039 ± 0.533
|
36.090 ± 0.591
|
0.381
|
0.719
|
Heart rate
|
152.850 ± 13.923
|
152.000 ± 14.708
|
0.152
|
0.853
|
Respiratory rate
|
58.871 ± 10.847
|
57.125 ± 10.409
|
0.656
|
0.514
|
Oxygen saturation
|
91.097 ± 4.331
|
92.903 ± 2.773
|
1.956
|
0.055
|
3rd day
|
Temperature
|
36.116 ± 0.469
|
36.203 ± 0.399
|
0.788
|
0.434
|
Heart rate
|
150.380 ± 9.327
|
152.450 ± 8.147
|
0.931
|
0.356
|
Respiratory rate
|
57.097 ± 10.143
|
56.321 ± 10.921
|
0.289
|
0.773
|
Oxygen saturation
|
93.710 ± 2.224
|
93.645 ± 2.058
|
1.719
|
0.091
|
5th day
|
Temperature
|
36.287 ± 0.533
|
36.326 ± 0.565
|
0.278
|
0.782
|
Heart rate
|
148.124 ± 7.857
|
151.152 ± 6.202
|
1.684
|
0.097
|
Respiratory rate
|
54.290 ± 6.929
|
56.126 ± 8.089
|
0.594
|
0.555
|
Oxygen saturation
|
95.774 ± 1.910
|
94.806 ± 1.778
|
0.069
|
0.945
|
7th day
|
Temperature
|
36.435 ± 0.376
|
36.339 ± 0.397
|
0.985
|
0.329
|
Heart rate
|
146.251 ± 7.762
|
150.845 ± 9.299
|
2.117
|
0.039[a]
|
Respiratory rate
|
51.287 ± 6.820
|
55.189 ± 6.925
|
2.178
|
0.0334[a]
|
Oxygen saturation
|
96.161 ± 1.828
|
94.355 ± 2.484
|
1.456
|
0.151
|
10th day
|
Temperature
|
36.471 ± 0.304
|
36.342 ± 0.362
|
1.520
|
0.134
|
Heart rate
|
144.615 ± 9.233
|
150.129 ± 8.940
|
2.889
|
0.009b
|
Respiratory rate
|
50.190 ± 5.229
|
55.092 ± 8.520
|
2.619
|
0.01b
|
Oxygen saturation
|
96.548 ± 2.158
|
94.484 ± 2.293
|
0.114
|
0.048[a]
|
Abbreviation: SD, standard deviation.
a Significant; bHighly significant.
Table 3
Grading of preterm infant behavior
Period
|
Normal behavioral response
|
Suspected abnormal behavioral response
|
Definite abnormal behavioral response
|
Frequency
|
Percentage
|
Frequency
|
Percentage
|
Frequency
|
Percentage
|
Intervention group: Autonomic/ visceral system
|
Pretest
|
15
|
48.4
|
13
|
41.9
|
3
|
9.7
|
3rd day
|
21
|
67.7
|
10
|
32.3
|
0
|
0
|
5th day
|
24
|
77.4
|
7
|
22.6
|
0
|
0
|
7th day
|
30
|
96.8
|
1
|
3.2
|
0
|
0
|
10th day
|
31
|
100
|
0
|
0
|
0
|
0
|
Control group
|
Pretest
|
14
|
45.2
|
14
|
45.2
|
3
|
9.6
|
3rd day
|
16
|
51.6
|
13
|
41.9
|
2
|
6.5
|
5th day
|
20
|
64.6
|
10
|
32.2
|
1
|
3.2
|
7th day
|
22
|
70.9
|
9
|
29.1
|
0
|
0
|
10th day
|
24
|
77.4
|
7
|
22.6
|
0
|
0
|
State and attention interactive system
|
Intervention group
|
Pretest
|
2
|
6.5
|
14
|
45.2
|
15
|
48.4
|
3rd day
|
10
|
32.3
|
19
|
61.3
|
2
|
6.5
|
5th day
|
23
|
74.2
|
8
|
25.8
|
0
|
0
|
7th day
|
28
|
90.3
|
3
|
9.7
|
0
|
0
|
10th day
|
29
|
93.5
|
2
|
6.5
|
0
|
0
|
Control group
|
Pretest
|
6
|
16.7
|
7
|
23.3
|
18
|
58.1
|
3rd day
|
8
|
25.8
|
14
|
45.2
|
9
|
29.0
|
5th day
|
10
|
32.3
|
13
|
41.9
|
8
|
25.8
|
7th day
|
12
|
38.7
|
14
|
45.2
|
5
|
16.1
|
10th day
|
14
|
45.2
|
14
|
45.2
|
3
|
6.6
|
Table 4
Effectiveness of ATVV stimulation on weight and physiological parameters among the
preterm newborns, n = 31 + 31
Parameter
|
Intervention arm
|
Control arm
|
F-Value
|
p-Value
|
F-Value
|
p-Value
|
Weight
|
0.607
|
0.658
|
1.501
|
0.205
|
Temperature
|
1.684
|
0.097
|
1.112
|
0.361
|
Heart rate
|
3.542
|
0.009[a]
|
2.108
|
0.068
|
Respiratory rate
|
3.741
|
0.007[a]
|
2.112
|
0.062
|
Oxygen saturation
|
22.651
|
0.000b
|
1.894
|
0.078
|
Preterm infant behavior-autonomic/visceral
|
31.674
|
0.000b
|
1.456
|
0.084
|
Preterm infant behavior-state regulation
|
49.073
|
0.000b
|
2.451
|
0.058
|
Abbreviation: ATVV, Auditory, Tactile, Vestibular, and Visual.
a Highly significant; bVery highly significant.
The information in [Table 2] shows that the differences in terms of physiological parameters are not statistically
significant during the initial period. However, on the 7th and 10th day, the t-value for heart rate, respiratory rate, and oxygen saturation (10th day) is statistically
significant (p-value <0.05) indicating that the intervention was effective to lower heart and respiratory
rate and higher levels of blood oxygen in the experimental arm thereby accepting the
research hypothesis at 0.05 level of significance.
The data in [Table 3] shows the frequency and percentage of each category of preterm infant behavior at
different time points for both groups. The intervention group had an increased proportion
of normal behavioral responses and decreased proportion of abnormal behavioral responses
than the control group in the autonomic/visceral system and state/attention interactive
system. The percentage of normal behavioral responses increased over time for the
intervention group, while it remained relatively consistent for the control group.
Similarly, the percentage of abnormal behavioral responses decreased over time for
the intervention group, while it remained relatively consistent for the comparison
group.
The effectiveness of maternal directed ATVV stimulation on weight, various physiological
parameters, and assessment of preterm infant behavior analyzed using one-way ANOVA
is described in [Table 4].
The findings show that neither the intervention group nor the control group's weight
or temperature differed significantly; hence, the null hypothesis was accepted. However,
in the intervention group, there is a very highly significant rise in oxygen saturation
values and a significant lowering of heart rate, respiratory rate, and significant
improvement in the normal preterm infant behavior compared with the control group
indicating that the difference between the groups is not likely to have happened by
chance; hence, the null hypothesis was rejected.
The correlation between the intervention and outcome among the intervention and control
group in the areas of preterm assessment behavior was assessed using Kendall tau-b
symmetric measures as described in [Table 5] and [Fig. 1]
.
Fig. 1 Comparison of Kendall tau-b value among intervention and control group on Preterm
assessment behavior using line graph.
Table 5
Symmetric measures to assess the correlation of the preterm assessment behavior of
newborns using Kendall tau-b among intervention and control group
Variable/Areas
|
Kendall tau-b value
|
Standard error
|
t-Value
|
p-Value
|
Intervention
arm
|
Control arm
|
Intervention
arm
|
Control
arm
|
Intervention
arm
|
Control
arm
|
Intervention
arm
|
Control
arm
|
Autonomic/visceral system
|
Color
|
0.510
|
0.217
|
0.045
|
0.055
|
8.781
|
1.702
|
<0.001a
|
0.078
|
Respiration
|
0.436
|
0.242
|
0.057
|
0.055
|
7.200
|
1.308
|
<0.001a
|
0.125
|
Visceral
|
0.502
|
0.145
|
0.052
|
0.045
|
9.106
|
1.801
|
<0.001a
|
0.144
|
Neuro
|
0.420
|
0.170
|
0.060
|
0.052
|
6.714
|
1.318
|
0.000b
|
0.154
|
State and attention interactive system
|
State regulation
|
0.624
|
0.145
|
0.042
|
0.057
|
12.617
|
1.194
|
0.000b
|
0.126
|
Orientation to auditory stimulus
|
0.578
|
0.104
|
0.050
|
0.051
|
11.111
|
1.456
|
0.000b
|
0.084
|
Alertness
|
0.586
|
0.193
|
0.048
|
0.054
|
11.383
|
1.766
|
0.000b
|
0.062
|
aVery highly significant; bHighly significant.
[Table 5] and [Fig. 1] show that the values of Kendall tau-b for the study group in all areas indicate
a moderate positive correlation between the intervention and the outcome with a significance
level of 0 to less than 0.001. Hence, the null hypothesis is rejected suggesting that
the intervention had a statistically significant effect on the outcome in all areas
in the intervention arm, whereas the control arm had a weak positive correlation with
no statistically significant outcomes.
Discussion
COVID-19 has restricted the entry of visits in the NICU, causing superimposed stress
among parents, lack of support, and opportunity to engage in parenting, which cause
them to frequently misinterpret their children's behavioral indicators that can influence
the neonatal outcome. Mothers lack knowledge and skill in the care to be provided
to the newborn.[14] Adequate maternal guidance and motivation to provide in utero environment and appropriate
stimulation can benefit the newborn admitted to NICU facing stress related to it.[15] The many components of supportive care for preterm must be actively taken into account
while developing comprehensive developmental support interventions. It is necessary
to perform further study to develop initiatives that directly assist families of premature
infants.[16] This study aimed to guide the mother in ATVV stimulation of their preterm newborn
admitted to NICU and evaluate its effect on their neonatal outcome.
There are professionally directed multisensorial stimulation research studies on preterm
but very few parental-directed intervention studies in India. Mothers in this study
were guided to give multisensory stimulation to their preterm in NICU. Since the brains
of preterm newborns go through a crucial developmental period and maturing during
24 to 40 weeks of gestation, especially during their stay in the intensive care nursery,
they are more presumably to have severe short- and long-term consequences on neurodevelopmental
deficits. Of all infants, those born before 30 weeks of gestation have the lowest
chances for development. These infants stay in the newborn unit of intensive care
for a long period, which is not always conducive to brain development and long-term
developmental requirements.[17] The newborn included in this study included stable preterm ranging between 30 and
36 weeks of gestation admitted in NICU. ATVV stimulation is a multisensory method
of stimulating preterm neonates in the NICU that aims to provide neonates with a range
of sensory experiences that will help to promote developmental outcomes. In stable
preterm newborns, multisensory stimulation (ATVV) has been demonstrated to be safe.[18]
The results in this study indicate that there is no significant difference between
the intervention and control groups in terms of mothers' age (p = 0.73), gestational age (p = 0.73), birth weight (p = 0.218), gender of the newborn (p = 0.2), educational status of the mother (p = 0.35), type of family (p = 0.783), mode of delivery (p = 0.15), and number of delivery (p = 0.6) which indicate that the groups were similar.
This study showed that maternal-directed ATVV stimulation to preterm newborns had
no significant differences between the intervention and control groups for weight,
temperature, heart rate, respiratory rate, and oxygen saturation at the pretest, 3rd
day, and 5th day, However, on the 7th day and 10th day, there were significant differences
(p < 0.05) between the two groups for heart rate, respiratory rate, and oxygen saturation
(on 10th day) when compared with the control group that had a higher heart, respiratory
rate, and lower oxygen saturation. This is thought to be due to the stimulation of
the vagus nerve, which helps to regulate the body's physiological functions in preterm
neonates, which is important for their overall health and development. This was consistent
in study findings where multisensory stimulation led to a decrease in heart rate and
respiratory rate,[19] maintenance of oxygen saturation[20] and an increase in weight considerably among the stimulation-led group when compared
with standard care[21]
[22] Additionally, premature infants' early postnatal exposure to sounds may improve
their ability to process voices.[23] One very relevant stimulation for babies is the mother's voice. In this study mothers
in the intervention group were guided to stimulate their preterm newborns by singing
lullabies in their own language during their interaction in NICU.
In terms of behavior, ATVV stimulation may improve alertness and attention in preterm
neonates. This is thought to be due to the stimulation of the neonate's visual and
auditory systems, which can help to promote the development of their cognitive and
motor abilities. Additionally, ATVV stimulation may also help to improve the neonate's
overall mood and reduce the risk of stress and anxiety. The effectiveness of maternal-directed
ATVV stimulation on preterm behavioral assessment in the present study showed that
the group receiving treatment had increased percentage of normal behavioral responses
and a lower percentage of abnormal behavioral responses compared with the control
group. The New Ballard score was used in one study with 80 individuals (treatment:
40; control: 40) to compare the outcomes of a multimodal intervention to standard
care. Both groups saw considerable progress both before and after the intervention;
however, infants in the experimental group developed their neuromuscular systems more
fully than infants in the comparator group (mean difference (MD): 5.60; 95% confidence
interval: 4.65–6.55; p = 0.00001).[24] Nurses are trained to identify the cues of stress in newborns, but the mother lacks
this knowledge and there is a scarcity of such studies finding the effectiveness of
maternal-directed ATVV stimulation on neonatal outcome.
Conclusion
Maternal-directed ATVV stimulation is a promising method for promoting the developmental
outcomes of preterm neonates in the intensive care nursery. It can have early positive
effects on the physiological parameters and behavior of preterm newborns. However,
more research is needed to fully understand the long-term effects of maternal-directed
ATVV stimulation on preterm neonates and to determine the most effective methods of
implementation.