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ISSN: 03875547
Volume 45, Issue 01, February, 2022
5729
Effect of Montessori on Children Development:
Systematic Review
Noura M. Naguib1*, Maya G. Aly2, Shorouk Elshennawy3, Hoda A. Eltalawy4
Demonstrator of Pediatric Physical Therapy Department, Faculty of Physical Therapy, Deraya University,
Egypt1
Lecturer of Pediatric Physical Therapy Department, Faculty of Physical Therapy, Cairo University, Egypt2
Professor of Pediatric Physical Therapy, Faculty of Physical Therapy, Cairo University- Egypt3
Professor of Pediatric Physical Therapy, Faculty of Physical Therapy, Cairo University- Egypt4
Corresponding author: 1*
Keywords:
ABSTRACT
Montessori, child,
development, autism, attention
deficit hyperactive disorder.
To find the evidence for the effectiveness of Montessori in improving
children development. Systematic search was done on the PubMed,
Cochrane library, Web of science, PEDro, Scopus and Google Scholar
databases till May 2021. Manual search was also done to find relevant
studies. Two authors independently assessed retrieved records and studies
against the eligibility criteria specified for this review, then extracted data
from the included studies and assess studies methodological quality by
using the methodological index for non-randomized studies (MINOR) scale
for the clinical studies and the national institute of health (NIH) tool for
observational designs. Eighteen studies were included; fifteen on normal
children and three on children with communication disorders, autism and
attention deficit hyperactive disorder (ADHD). Quality of 5 clinical studies
rated as moderate and 7 was poor, while the quality of 5 observational
studies was fair and only 1 was poor. These included studies have different
outcomes including gross and fine motor skills, executive function, activity
of daily living and cognitive skills. Meta-analysis was not appropriate
because of the included studies heterogeneity descriptive analysis indicated
that Montessori seems to be effective in improving child development.
Based on this review findings the present evidence promise an effective
role of Montessori for improving child development. More well-designed
primary studies are recommended to find clear evidence.
This work is licensed under a Creative Commons Attribution Non-Commercial 4.0
International License.
1. INTRODUCTION
Early age is considered the "golden age" as it is the ideal time to maximize the development of children. All
children, whether are typically developed or delayed, have the competence of “absorptive mind” [1]. Dr.
Maria Montessori (1869-1952) dealt with children who had mental handicap; she believed that special
education could support child development; her method was based on years of observations of the self-
directed activities from developing children [2]. Montessori approach aims to make children discover
Naguib, et.al, 2022 Teikyo Medical Journal
5730
themselves and achieve their independence and freedom; it depends on carefully and specially designed
materials in a prepared environment that supports the child’s optimal development (physical, mental and
social) [3]. Montessori influences the child’s development positively and focuses on sensory and movement
independent learning [4].
The development motor skills affect other aspects of child's development; it is a very important key for
personal development. Playing with other children and doing daily activities independently make the child
feel happy. If child's motor ability impaired, this will have an impact on her/his development including
concentration skills, school and social activities [5], [6].
Although Montessori has existed for over a hundred years; the evidence of its effectiveness are limited. This
review aims to find the evidence base for the effectiveness of Montessori in improving the development of
normal and disabled children by systematically reviewing the relevant published primary researches.
2. Methods
Registration: The protocol of this review was registered on the international prospective register of systematic
reviews (PROSPERO registration number: CRD42020220356).
Search Strategy: This review is based on the recommendations of the Preferred Reporting Items for
Systematic Reviews and Meta-Analyses (PRISMA) statement [7]. Literature search was conducted by 2
independent reviewers using the following keywords: "Montessori", "practical life materials", "fine motor",
"gross motor", "child development" and "disabled children". Relevant articles were identified from the
following databases: PubMed, Cochrane library, Web of science, PEDro, Scopus and Google scholar.
Manual search was also performed. Electronic databases were searched without time restriction till May 2021.
The eligibility criteria were as the following: Inclusion criteria: Studies: any studies published in English
language at any time till May 2021, Participants: children <18 years (normal/disabled), Intervention:
Montessori, Comparisons: any other classical/ traditional programs, Outcomes: fine or gross motor
development, executive functions, activity of daily living and cognitive skills; Exclusion criteria: thesis,
studies on adults population, studies on other outcomes as educational outcomes and school readiness, and
published abstracts with no full text articles available.
Selection of Studies: Two independent authors used the same selection criteria, at first titles and abstracts
were screened then full paper of the relevant articles. Studies that failed to meet the inclusion criteria were
removed. Any disagreement is resolved through discussion by 2 authors. A third author was consulted if any
disagreement persisted.
Data extraction: A standardized form was used to extract the data from the included studies. The following
data were extracted: study and participant characteristics, description of interventions, outcomes assessed,
measures and authors' conclusion. The data extraction (Table 1) was performed by the same two authors who
selected the studies.
Quality assessment: the included studies were of different designs; quasi-randomized clinical trials, cross
sectional and cohort (ex-post facto) designs; so two different tools were used for assessment of studies'
quality; the first tool was the methodological index for non-randomized studies (MINORS) scale [8], this tool
includes a list of 12 methodological items; the first 8 items are used for assessment of both non-comparative
and comparative studies while the last 4 items for assessment of comparative studies with two or more groups.
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The scoring of MINORS for each item was from 0 to 2; score 0=not reported in the article evaluated, score
1=inadequately reported, and score 2=adequately reported. In this review the MINORS was used for clinical
comparative studies; so the total ideal MINORS score was 24.
The second tool was the quality assessment tool for observational cohort and cross-sectional studies of the
national institute of health (NIH) [9]; it includes 14 criteria with a total score of 14. The rater answered each
question with Yes/No/ Other (CD, cannot determine; NA, not applicable; NR, not reported). NA was not
counted negatively towards the quality rating according to NIH guidance.
The quality assessment of the included studies was done by two authors independently and any disagreement
was resolved by discussion with a third author.
Data analysis: For rating the methodological quality of the studies that were assessed by MINORS tool; for
studies with total MINORS scores of 14 or less were considered to be poor quality, 15-22 moderate quality,
and 23-24 good quality for comparative studies [10].
For quality rating of the studies that were assessed by NIH tool; a percentage of the total score of the study
that was used; poor quality <50%; fair quality= 50-75% and good quality ≥75% [9].
3. Results
Included Studies: A total of 1037 records were found in the initial search, reached 698 records after removing
the duplicate, which were screened from title and abstract; then 680 articles were excluded for different
reasons (e.g. review, not the target population, not in English, not the outcomes of interest or no full-text
available). The PRISMA flow diagram [7] of studies in this review (figure 1) shows that finally 18 studies
[11- 28] were included for analysis; 15 [11- 25] on normal children and 3 [26- 28] on children with
developmental delay. The total number of children included in the 18 reviewed studies was 1212 child (798
normal and 414 children with delay) with age ranged from 2-6 years. An overview of the studies
characteristics are shown in Table (1).
The included studies were from 9 countries (United States of America (USA), Turkey, Spain, Columbia,
Indonesia, Hartford, Chennia, Malaysia and Riga); most of them were from the USA.
3.1 Montessori for Normal Children
This review included 15 studies on the effect of Montessori on normal children development (9 clinical
studies [11- 14], [17], [19], [20], [23], [24] and 6 cross-sectional and cohort studies [15], [16], [18], [21], [22],
[25]. The studies include 15160 children with age ranged from 3 to 12 years (table1). Montessori was
introduced to the experimental groups of children, while the controls received non-Montessori
traditional/classical programs. These 15 studies included different relevant developmental outcomes
including gross and fine motor skills, executive functions, activities of daily living, physical activities and
cognitive skills.
Gross motor skills: measure of gross motor function was reported in one clinical study [11] by using Denver
development screening test II (DDST). Montessori materials as puzzle, picture cards were used in conjunction
with engeklk method to stimulate gross motor skills through drawing squares on the ground and child jump
from one to another. Findings showed significant difference in gross motor development in favor to
Montessori group.
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Fine motor skills: 4 included studies [17], [18], [20], [24] reported measurement of fine motor skills by
different measures; the flag posting test [17] learning accomplishment profile-diagnostic (LAP-D) [18];
lowercase letter formation skill [20] and penny posting test [24]. Students in Montessori posttest demonstrated
high accuracy, speed [17] and improvement in handwriting ability [20].
Executive functions: its measurement was reported in 5 included studies [13- 15], [22], [23] using different
scales; the flanker and the dimensional change card sort tests [13] the head-toe-knee-shoulder (HTKS) task
that involve working memory, planning and attention [14], [23] neuropsychological assessment (NEPSY–II
scale) [14] the neuropsychological assessment of executive functions in children (ENFEN) and
neuropsychological maturity questionnaire for school (CUMANES) [15] and the behavior Rating Inventory
of Executive Function scale (BRIEF) [22]. Montessori was found to enhance memory, perception, attention,
mental flexibility, participation and coordination of children aged 9-12 years [15].
Activities of daily living and physical activity: one study [12] measured daily living skills by the basic skill
inventory scale (BSIS) in 4-5 years Montessori children. Children who received Montessori only and their
mothers were not supported by specific Montessori training program, showed significant positive
improvement in daily activities [12]. Physical activity was measured in two studies [19], [21] by the
developmental skills rating scale [19] and the accelometer [21], Montessori children more active than
traditional schools.
Cognitive skills: 2 studies [16], [19], [25] measured different cognitive functions as memory, level of
temperament and attention through memory task [16]; developmental skill rating scale [19] and subtests of
Colorado childhood temperament inventory (CCTI) [25]. Montessori children perform well in cognitive
development [19]. No significant differences were found between 4-6 years Montessori and traditional school
children on cognitive development [16].
3.2 Montessori for Children with Developmental Delays
The included 3 clinical trials [26-28] in this review about Montessori for children with developmental
disorders included 414 children with communication disorders, autism and attention deficit hyperactive
disorder (ADHD), their age ranged from 2 to 6 years (table1). Montessori was used to improve fine, gross
and cognitive skills through different Montessori activities. Writing skills was assessed in one study [26] on
children with communication disorders, Denver test of psychomotor development was used for fine and gross
motor development in another study on children with autism [27] and frankfurter test for five years
concentration attention test was used for cognitive skills development in children with ADHD [28].
Montessori was found to be effective in improving developmental progress and reducing the developmental
delay in children with autism [27]. Different Montessori materials as tactile boards, color tablets, binominal
cubes and sound boxes were found to be effective in improving attention level of children with ADHD;
Montessori was recommended as a supportive program for those children [28].
3.3 Methodological Quality of Included Studies
Twelve included studies [11- 14], [17], [19], [20], [23], [24], [26- 28] were clinical studies of comparative
design (true and quasi experimental); their quality was assessed using the 12 MINORS items; the total
MINORS scores of them ranged from 12 to 19 out of 24 (table 2). All studies had adequate control group but
none of the studies reported blinding or prospective calculation of the study size, most of studies stated a
clearly stated aim, adequate follow-up period, contemporary groups and statistical analyses. The intention-
to-treat basis not adequately reported in most of studies. Five studies [12- 14], [17], [20] were rated as
moderate quality and seven [11], [19], [23], [24], [26- 28] were poor.
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The quality of the other 6 included observational studies [15], [16], [18], [21], [22], [25] of cross sectional
[15], [21] and cohort (ex-post facto) [16], [18], [22], [25] designs; were assessed by the national institute of
health (NIH) quality assessment tool; their percentage from total scores ranged from 41.6% to 69.2% (table
3); the quality of five studies [15], [18], [21], [22], [25] was rated as fair quality while one study [16] was
rated as poor. All of them clearly stated the study objective; specified the population; defined the outcome
measures and adjusted statistics. Exposure measures were not applicable. Sample size justification and
assessors blinding were not reported in these studies.
4. Discussion
This systematic review included 18 studies [11- 28] about the effect of Montessori on children development;
their findings showed that Montessori can be effective for improving fine and gross motor activities, executive
functions, daily living and physical activities in addition to cognitive skills (attention and memory), in
children with normal and delayed development.
The unique characteristic of Montessori is the child-centred basis that it depends on, focuses on the
importance of early age education in a pre-arranged environment that allows self-learning and independence
[29]. Montessori stresses the importance of pre-school motor and sensory education that directs child's
movements into more meaningful movements and makes the child satisfy and happy [30].
Findings of six reviewed studies on normal children [17], [18], [20], 24], children with communication
disorder [26] and autism [27] showed that Montessori has a good impact on fine motor development through
some activities such as writing, buttoning and generally through using of bilateral hand manipulation. This
improvement was attributed to the main key in Montessori, which are the special materials and the prepared
attractive environment used that facilitate the development of fine motor skills.
Children first specialize in preliminary whole body/hand activities, which teach children all the prerequisite
skills required for more challenging activities. Montessori reported that “Repetition” is a key for enhancing
focused attention and ability to grasp [1]. Montessori practical life activities require using thumb, index and
middle fingers; these activities are designed to develop the digital dexterity required for the manipulation of
writing instrument later on [17].
Montessori activities help enhancing children movement control and coordination, muscles synchronization,
independence, action analysis, and distinguishing-realizing materials contribute to movement development.
A series of practical life and play activities are used using very familiar objects; like plate, button, brush,
glass, water [4]. Children enjoy playing and doing self-care activities (food preparation, dressing and personal
care activities) in Montessori prepared environment with a wide range of materials. The goal of these activities
is to help children to gain physical coordination and achieve complete independence by the age of 4-5. Also,
activities are done independently both indoors and outdoors [1], [24].
The abilities for independence in children come with the maturation of motor-cognitive development.
Montessori included the executive functions in her approach. Five included studies [13- 15], [22], [23]
assessed the effect of Montessori approach on children executive functions development. Executive functions
rely mainly on the dorsolateral prefrontal cortex and its interaction with the cerebellum. During the preschool
age, child's executive functions development support the sensorimotor integration and control that enables
child's discrimination, planning, decision making and action [31].
Montessori focusing on the principle of the “prepared adult” which refers to the guide who is trained to
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support the child’s independent growth; and special learning materials that are designed to learn the child
sensory development and practical life skills. Environmental activities and physical exploration of the unique
Montessori materials support child’s own cognitive-motor growth [12].
Motor and cognitive development are inseparably linked. Neural links are used to regulate motor learning
processes and also cognitive learning. Cognitive activities involve control functions that are associated with
motor development [32]. According to Montessori, movement is a creative process directed by internal drives.
Balanced movements require coordination of mind and body parts. Intelligence guides movement and
movement helps intelligence development [1].
Children with special needs as those with communication disorders, autism and ADHD were included in the
studies on Montessori [26- 28]. Montessori was found to be effective in improving their development through
practical life activities with greater sensorial stimulation by using different attractive materials, colors and
shapes [33].
This review included search on 6 databases in addition to the manual search; because of the difficulty of
randomization in Montessori research; both clinical non-randomized and observational studies were included,
the search revealed 18 included studies [11- 28] of different research designs, their methodological quality
were assessed by two tools; the MINORS and the NIH quality assessment tool. The quality of clinical studies
ranged from moderate to poor, while most observational studies had a fair quality.
The data from the included studies were analyzed only qualitatively as the included studies were
heterogeneous in its characteristics and measured outcomes, this heterogeneity made meta-analysis
inappropriate.
This research systematically reviewed the literature for evidence of the clinical effectiveness of Montessori
on children development. Although no specific quantitative evidence could be identified, the evaluation of
authors’ conclusions from many countries offers professional insight into the use of this approach to improve
children development; whether normal, delayed or disabled.
4.1 Implications into Research and Practice
This review findings support the use of Montessori for children during preschool and school age. It stimulates
future research with better quality and helping therapists in the field of occupational and physical therapy to
better understand whether and why Montessori approach might be effective in facilitating child's
development.
5. References
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Table 1: Children characteristics, interventions, outcomes and main results extracted from the included
studies on normal and disabled children
Authors, year
(Country)
Children
characteristics
Interventions
Outcome of
interest =
measure
Authors' Conclusion
Montessori for Normal Children
[11]
(Indonesia)
Total N= 40
SG=21
CG=19
Age (range)= 3-5
years
Gender= 23 girl &
17 boy
2 Groups:
SG= Montessori/ 20
minutes/ 2 weeks
CG= Non-
Montessori
Gross motor skill
development
= DDST II
Test
Montessori is effective
for improving gross
motor skill development
in children aged 3-5
years
[12]
(Turkey)
Total N=19
SG=8
CG=11
Age (range)= 4-5
years
Gender= not
reported
2 Groups:
SG= Montessori
education + MTPM
program applied to
mothers/2 hours/ 12
weeks
CG= Montessori
education
ADL
= BSSI scale
No difference was found
in pre and post-test
scores in daily living
skills
[13]
(USA)
Total N=23
Age (average)=
3years
Gender= 13 boys &
10 girls
1 Group:
Montessori preschool
education
Executive
functions
= Flanker test &
= Dimensional
card sort test
Montessori is effective in
improving executive
function in children
aged 3 years
[14]
(Hartford)
Total N=141
SG=70
CG=71
Age (average) = 41
months
Gender= 77 boys &
64 girls
2 Groups:
SG= Montessori
CG= Non-Montessori
Executive
function
= HTKS task
= NEPSY–II scale
Montessori is effective in
improving executive
function in age 4 years
[15]
(Spain)
Total N=30
Age (average)= 9-12
years
Gender=15 boys &
15 girls
2 Groups (according
to gender)
Montessori method=
40-minute session/
week
Executive
functions
=ENFEN
& CUMANES
scales
Executive function
improve more when
child spend more time
dealing with Montessori
method but there is no
differences between
males &females
Naguib, et.al, 2022 Teikyo Medical Journal
5738
[16]
(Chennia)
Total N=72
SG =35
CG =37
Age (range)= 4-6
years
Gender=
SG=20 boys & 15
girls
CG=17 boys & 20
girls
2 Groups:
SG=Montessori
education
CG=Traditional
education
Cognitive skill=
memory
(Recognition of
logically related
objects)
= Memory task
No difference was
founded between
Montessori & traditional
methods on cognitive
development
[17]
(USA)
Total N=100
SG=50
CG= 50
Age (range) = 3-6
years
Gender= not
reported
2 Groups:
SG= Montessori
Practical life
activities/ half & full
day program
CG= Traditional KG
program in public
school
*8 months
Fine motor skills
= Flag posting test
(accuracy, speed
& hand
dominance)
Montessori posttest
demonstrated high
accuracy, speed and
hand dominance
[18]
(USA)
Total N= 13745
SG= 770
CG= 12975
Age (average) = 4.6
years
Gender= 7131 boys
& 6614 girls
2 Groups:
SG: Montessori
CG: Conventional
Pre-K programs in
high school
curriculum
Fine motor skills
(writing &
manipulation)
= LAP-D
All children didn’t
benefit equally from
Montessori program
(Latino more than
black)
[19]
(Malaysia)
Total N= 51
SG =24
CG = 27
Age (range)= 5-6
years
Gender= not
reported
2 groups
SG=Montessori
Curriculum
CG=National
Preschool Curriculum
Physical (motor)
& Cognitive
skills=
Developmental
skills rating scale
Montessori preschool
children improve in
cognitive and social
skills
[20]
(USA)
Total N= 66
SG=35
CG=31
Age (range)= 25-72
months (preschool)
Gender=30 boys &
36 girls
2 Groups:
SG= video-based
handwriting program
in Montessori
curriculum
CG= Montessori
curriculum
*Both =16 weeks
Fine motor skills
=Handwriting
skills
Lowercase letter
legibility &
sequence of
strokes
Video-based modeling
for handwriting in
Montessori preschool
effective for enhancing
handwriting
[21]
(Columbia)
Total N= 301
SG=145
CG=156
Age= 4 years old
(preschool children)
Gender= 151 boys
&150 girls
2 Groups:
SG= Montessori
programs
CG= Traditional
programs
5 days /week in
preschool & non-
school days & all day
Physical activity
= Accelerometry
Montessori children
more active than
traditional schools &
Montessori system
important in improving
physical activity
[22]
(USA)
Total N= 112
Montessori =33
Classical =40
Catholic =39
Age (average)=
10.53 years
Gender=60 girls &
52 boys
3 Groups:
Montessori group=
Montessori
Classical group=
Classical education
Catholic group=
Traditional American
Catholic education
Executive
functions
= BRIEF scale
Difference was founded
in rating executive
functions in 3 different
schools by environment
[23]
(USA)
Total N=172
Age & gender=
3 Groups:
Executive
functions
Children in classic
Montessori program
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Volume 45, Issue 01, February, 2022
5739
-Classic=36 child of
55.6 month (22 girls)
-Supplemented = 95
child of 54 month
(47 girls)
-Conventional= 41
child of 59 month
(26 girls)
1-Classic Montessori
group
2-Supplemented
Montessori group
3-Conventional
schools
All program offer:
3hours session for (3-4
years) children & 6-7
hours session for 5
years children
= HTKS task
showed greater gains of
executive functions more
than supplemented and
conventional
[24]
(USA)
Total N=186
SG=101
CG=85
Gender=not
reported
2 Groups:
SG: more than 50
different sets of
activities by
Montessori Practical
life materials
CG: Non-Montessori
(6 months)
Fine motor skill
development =
Penny posting test
Difference was found in
experimental group
posttest indicating the
type of fine motor
activity important in
child development
[25]
(Columbia)
Total N=102
SG= 59
CG= 43
Age (range)= 37-66
month
Gender=
SG= 32 boys, 27
girls
CG= 22 boys, 21
girls
2 Groups:
SG= Montessori
program
CG= Constructivist
program
30-40 h/week at least
2 months
Cognitive
functions
=Temperament
(activity level &
attention-span/
persistence)
= Only 2 subscales
of CCTI
The constructive
program apply more
temperament activity
than Montessori
especially to active boys
Montessori for Disabled Children
[26]
(Spain)
Total N= 352
170 with CD
182 without CD
Age (mean)= 5.4
months
Gender=
Not reported
2 Groups= received
2 educational
activities based on
Montessori method
Children used a
Tablet to perform 2
activities/ 9-12
sessions for 15 min
Fine motor skills
(Writing skills) =
interaction
(variables of time,
interaction &
mistake
No clear difference was
found in the interactions
between both groups so
children with CD need
more strategies
[27]
(Riga)
Total N= 47 with
ASD
26 =Montessori
21 =Special
pedagogue
Age (range)= 2-5
years
Gender= not
reported
2 Groups:
SG: Montessori
particularly fine motor
skills.
CG: Special
pedagogue
Fine & Gross
motor skills
= Denver test of
psychomotor
development
Montessori method is
effective in improving
fine motor skills
[28]
(Turkey)
Total N=15
ADHD=7
AD only=8
SG=8, CG=7
Age (range)= 5-6
years
Gender=6 girls
9boys
2 Groups
SG= Montessori
CG= Non-
Montessori
Cognitive skills
Attention
= FTF-K attention
test.
Difference was found in
posttest children in
attention test
AD=attention disorder, ADHD=attention deficit/hyperactivity disorder, ADL= activity of daily living,
ASD=autistic spectrum disorders, BRIEF=Behavior Rating Inventory of Executive Function scale, BSSI=
Basic skill inventory scale, CCTI= Colorado Childhood Temperament Inventory, CD=communication
Naguib, et.al, 2022 Teikyo Medical Journal
5740
disorder, CG=control group, CUMANES= neuropsychological maturity questionnaire for school,
DDST=Denver development screening test, ENFEN=Neuropsychological Assessment of Executive
Functions in Children, FTF-K= frankfurter test for five years concentration attention test, HTKS= Head-Toes-
Knees-Shoulders task, KG=kindergarten, LAP-D=Learning accomplishment profile diagnosis,
M=Montessori, MTPM=Montessori program for mothers, N=number, NEPSY-II= Neuropsychological
assessment, Pre-k= prekindergarten, SG= study group.
Table 2: Quality assessment of the included clinical studies by MINORS
MI NORS
Ite ms *
[11]
[26]
[24]
[12]
[13]
[27]
[14]
[17]
[28]
[19]
[20]
[23]
1
2
2
2
2
2
2
1
2
2
2
2
2
2
1
1
1
1
2
2
2
1
2
1
1
1
3
0
0
0
0
2
0
2
0
0
0
0
0
4
1
1
1
1
1
0
2
1
1
1
1
1
5
0
0
0
0
0
0
0
0
0
0
0
0
6
0
1
2
2
2
0
2
2
2
0
2
2
7
1
0
0
2
2
0
2
2
1
2
2
0
8
0
0
0
0
0
0
0
0
0
0
0
0
9
2
2
2
2
2
2
2
2
2
2
2
2
10
2
2
2
2
0
2
2
2
2
2
2
2
11
2
1
0
2
1
2
2
1
0
1
2
0
12
1
2
2
1
2
2
2
2
2
2
2
2
Tot al
score
/ 24
12
12
12
15
16
12
19
15
14
13
16
12
Quality
P
P
P
M
M
P
M
M
P
P
M
P
*MINORS items: 1: clearly stated aim; 2: inclusion of consecutive patients; 3: prospective data collection; 4:
endpoints appropriate to study aim; 5: unbiased assessment of study endpoint; 6: appropriate follow-up
period; 7: 5% lost to follow-up; 8: prospective calculation of study size; 9: adequate control group; 10:
contemporary groups; 11: baseline equivalence; 12: adequate statistical analyses. Scoring: 0= not reported,
1= reported but inadequate, 2= reported and adequate. P=poor, M= moderate, G= good. Quality rating: Poor
≤14, Moderate =15-22, Good= 23-24.
Table 3: Quality assessment of the included observational studies by NIH tool
[25]
[22]
[21]
[18]
[16]
[15]
NIH
Items*
Y
Y
Y
Y
Y
Y
1
Y
Y
Y
Y
Y
Y
2
N
N
N
Y
N
N
3
N
N
Y
Y
N
Y
4
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5741
N
N
N
N
N
N
5
Y
Y
N
Y
Y
Y
6
NA
N
N
Y
N
N
7
N
Y
Y
N
N
N
8
NA
NA
NA
NA
NA
NA
9
NA
NA
NA
Y
NA
NA
10
Y
Y
Y
Y
Y
Y
11
N
N
N
N
N
N
12
Y
Y
N
N
N
Y
13
Y
Y
Y
Y
Y
Y
14
6/11
(54.5%)
7/12
(58.3%)
6/12
(50%)
9/13
(69.2%)
5/12
(41.6%)
7/12
(58.3%)
Total
score
Fair
Fair
Fair
Fair
Poor
Fair
Quality
*NIH criteria: 1. objective is clearly stated 2. study population clearly specified 3. participation rate of eligible
persons at least 50% 4. all the subjects selected from the same populations with inclusion and exclusion
criteria prespecified 5. sample size justification 6. exposure(s) of interest measured prior to the outcome(s) 7.
sufficient timeframe 8. study examine different levels of the exposure 9. exposure measures (independent
variables) clearly defined, valid, reliable, 10. Was the exposure(s) assessed more than once over time? 11.
outcome measures (dependent variables) clearly defined, valid, reliable, 12. assessors blinded 13. loss to
follow-up after baseline 20% or less 14. key potential confounding variables measured and adjusted
statistically. NA=not applicable; N= no (not present); Y=yes (present). Total Score= number of yes of
applicable criteria. Quality rating= Poor <50%, Fair 50-75%, Good ≥75%.