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Final 240525 235238
Final 240525 235238
LIBRARY DISSERTATION
Submitted by
DR. SELVA AROCKIAM. A
Post graduate student
2018 – 2021
Date :
Place: CHENNAI
ENDORSEMENT BY THE PRINCIPAL / HEAD OF THE
INSTITUTION
This is to certify that the library dissertation entitled
“CAN DIFFERENT FORMS OF SKELETAL
ANCHORAGE SYSTEMS ENHANCE THE SKELETAL
EFFECTS OF FIXED FUNCTIONAL APPLIANCES-A
NETWORK META-ANALYSIS BASED ON A
FREQUENTIST APPPROACH” is done by Dr. SELVA
AROCKIAM. A, under the guidance of Dr.R. DEVAKI
VIJAYALAKSHMI, Professor and Head, Department of
Orthodontics & Dentofacial Orthopaedics, Meenakshi Ammal
Dental College, and Chennai.
1. INTRODUCTION 1
2. REVIEW OF LITERATURE 4
NETWORK META-ANALYSIS VS
4. 36
PAIRED META-ANALYSIS
SEARCH STRATEGY AND STUDY
5. 41
SELECTION
CHARACTERISTICS OF INCLUDED
9. 51
STUDIES
20. BIBLIOGRAPHY 94
Objectives:
To compare the skeletal and dento -alveolar effects of
mini-plate anchored fixed functional appliances, mini -
screw anchored fixed functional appliances and
conventional fixed functional applianc es using
frequentist network meta-analysis.
Search methods:
Unrestricted electronic search of eight databases
(pubmed, CENTRAL, scopus, embase, ovid medline, proquest,
lilacs, web of science) and manual searches were performed up
to September 2019.
Eligibility criteria:
Randomized, prospective non-randomized controlled
trials and retrospective studies comparing the use of fixed
functional appliances with skeletal anchorage (mini -screw,
mini-plates) and conventional fixed functional appliances were
included in the study.
Results:
When we take improvement of mandibular retrognathism,
mini-screw herbst produces more skeletal changes when
compared with other skeletally anchored fixed functional
appliances and conventional fixed functional appliances. But
due to the limited evidence available we were unable to do the
rank probability and SUCRA to confirm the superiority of the
skeletally anchored fixed functional appliances among
themselves.
Introduction
INTRODUCTION
2
Introduction
3
Review Of Literature
REVIEW OF LITERATURE
Etiology and Development of Class II Malocclusion
The development of Class II malocclusion is a complex
process involving many factors and typically arises due to
both skeletal and dental abnormalities (Mossey 1999). These
abnormalities may result due to a genetic predisposition and/or
a wide variety of environmental influences.
5
Review Of Literature
6
Review Of Literature
7
Review Of Literature
8
Review Of Literature
9
Review Of Literature
10
Review Of Literature
11
Review Of Literature
12
Review Of Literature
13
Review Of Literature
14
Review Of Literature
Class II Elastics
Another compliance-‐based modality to correct Class II
malocclusions is using intermaxillary elastics. Class II ela stics
are used in combination with full fixed orthodontic appliances
and are typically worn from maxillary canines to mandibular
first molars. The effects of Class II elastics have been
previously investigated in several studies.
15
Review Of Literature
[11]
Nelson et al. (1999) studied the effects of Class II elastics
(Begg technique) in 18 Class II division 1 patients. The
overall reduction in overjet was 5.8 mm, with 71.1% of the
reduction being due to dental changes. The molar correction of
3.0mm in the total treatment period , was due to 63% dental
changes (1.9 mm) and 37% skeletal changes (1.1 mm). Of the
dental changes, the primary factor was forward movement of
the mandibular molars (2.0 mm). The mandibular plane angle
increased an average of 1.0°, while the lower anterior facial
height increased 5.0 mm. In summary, the Class II correction
occurred primarily through dental changes, while vertical
skeletal measurements increased.
[ 13 ]
Gianelly et al. (1984) investigated the effects of
Class II elastics with both Begg and edgewise appliances.
SNA decreased in both the Begg (0.4°) and edgewise (1.5°)
groups, while SNB increased 0.3° in both groups. The
mandibular plane angle increased 1.3° in the Begg group and
0.6° in the edgewise group. Overall mandibular size increased
16
Review Of Literature
[14]
Janson et al. (2013) recently completed a systematic
review on the treatment effects of Class II elastics. The review
consisted of 11 studies: 4 that tested the effects of Class II
elastics alone, and another 7 that compared the effects of
Class II elastics to another method of Class II malocclusion
correction. From the 4 studies that solely focused on the effect
of Class II elastics, the following effects were found:
17
Review Of Literature
18
Review Of Literature
19
Review Of Literature
20
Review Of Literature
21
Review Of Literature
[ 1 7]
Pangrazio-Kulbersh et al. (2003) studied the effects
of the MARA in 30 Class II patients (12 boys with aver age age
11.2 years and 18 girls with average age of 11.2 years) treated
22
Review Of Literature
23
Review Of Literature
[18]
Ghislanzoni et al. (2011) investigated the effects of
the MARA in 2011. They cephalometrically compared the
effects of the appliance in 23 growing patients (treated at pre -
‐pubertal or pubertal stages, as assess ed by the cervical
vertebral maturation method) to an untreated control group.
24
Review Of Literature
25
Review Of Literature
Saif Spring
Saif Springs, introduced in the 1960’s, are long nickel -
‐titanium closed coil springs used in combination with full
fixed appliances to produce Class II intermaxillary traction.
They were introduced as a fixed alternative to Class II elastics
and the force vector and location of attachment are like
conventional Class II elastics. The springs are tied in place
with steel ligatures. There have been no longitudinal research
studies on this appliance, so its effects are not well known.
Jasper Jumper TM
The Jasper JumperTM, introduced in 1994, consists of
two vinyl coated auxillary springs fitted to fully bonded fixed
orthodontic appliances. The springs are attached to the upper
first molars posteriorly and the lower archwire anteriorly.
[ 1 9]
Cope et al. (1994) investigated the effects of the
appliance in a group of 31 growing patients (average age of
12.9 years at start of treatment and treated for 0.4 years) and
compared them to an untreated, matched control group. The
maxilla underwent significant posterior displacement as
evidenced by posterior movement of ANS and A -point by
0.91mm per year and 0.60mm per year respectively. There
was no evidence of enhanced mandibular growth in patients
treated with the Jasper JumperTM compared to controls.
26
Review Of Literature
[20]
A similar study was conducted by Covell et al. (1999)
on 36 growing Class II patients (average age of 13 years 2
months at the time of appliance insertion) treated with the
Jasper Jumper TM (for average of 5 months) compared to an
untreated control group. Compared to controls, the treated
group showed significant maxillary skeletal restriction (SNA
angle decreased 1.6°), clockwise rotation of the occlusal plane
(0.6°), and proclination of the lower incisors (5.3°). The
maxillary molars were distalized and intruded, while the
mandibular molars were mesialized (2.6mm) and extruded
(0.9mm). These results are largely in agreement with those
[19]
found by Cope et al. (1994) .
27
Review Of Literature
Eureka SpringTM
The Eureka SpringTM, introduced in 1997, is another
intermaxillary force delivery system. Designed for use with
full fixed edgewise appliances, the Eureka Spring utilizes an
open wound coil spring encased in a telescoping plunger. The
spring attaches to the upper molar headgear tubes and lower
archwire distal to the canines. The telescoping mechanism is
different from other appliances and allows mouth opening of
up to 60 mm.
28
Review Of Literature
[ 2 1]
Franchi et al. (2011) described the effects of the
ForsusTM appliance in 32 consecutively treated, growing
Class II patients (mean age 12.8 years pre -‐
treatment) and compared them to a matched, untreated control
group. The mean duration of ForsusTM treatment was 5.3
months, while comprehensive treatment was 2.4 years.
29
Review Of Literature
30
Review Of Literature
31
Review Of Literature
XbowTM (Crossbow)
The XbowTM Appliance, developed by Dr. Duncan
Higgins and introduced in 2006, is another appliance that
utilizes ForsusTM springs in Class II correction. The
Crossbow consists of a maxillary Hyrax expander and
ForsusTM springs mandibular labial and lingual bows are used
for anchorage. The Crossbow does not allow for simultaneous
use of full fixed orthodontic appliances. Instead, the goal of
the appliance is to correct the sagittal and transver se
dimensions in phase I, followed by full fixed orthodontic
appliances in phase II. In theory, phase II should be shorter
since the sagittal and transverse correction has already been
addressed.
32
Review Of Literature
33
Review Of Literature
34
Review Of Literature
35
Network Meta-Anal ysis Versus Paired Meta-Anal ysis
36
Network Meta-Anal ysis Versus Paired Meta-Anal ysis
Relevant assumptions
Meta-analysis is a statistical methodology to
synthesize the results of several studies, and overall effect
size is valid only if various priori assu mptions are satisfied.
Furthermore, NMA requires stricter methodological, logical,
and statistical assumptions about similarity, transitivity and
consistency respectively. In NMA, whether each of these is
satisfied must also be examined.
37
Network Meta-Anal ysis Versus Paired Meta-Anal ysis
Similarity
To compare among the clinical trial studies extracted for
analysis, similarity in the methodology used in the studies
must be assumed. Similarity is qualitatively assessed on each
of the selected articles from a methodological point of view
and is not a hypothesis to be tested statistically. To examine
similarity, the population, intervention, comparison, and
[ 29 , 3 0 ]
outcome (PICO) technique is used .
Transitivity
Transitivity covers the validity of the logical inference,
while similarity relates to the methodological feasibility of
comparing. Suppose if direct comparisons of 3 drugs —A, B,
and C—treating the same illness found that A was more
effective than B, and B was more effective than C, then A can
be expected to be more effective than C, even though the two
were never directly compared. Such transitivity should be
satisfied for all cases in an NMA.
38
Network Meta-Anal ysis Versus Paired Meta-Anal ysis
Consistency
Consistency, an objective measure of transitivity, means
that the comparative effect sizes obtained through direct and
indirect comparisons are consistent. Hence, consistency is
[30,31]
statistically examined transitivity , and some researchers
[32,33]
call it coherence .
39
Network Meta-Anal ysis Versus Paired Meta-Anal ysis
40
Search Strategy And Study Selection
41
Search Strategy And Study Selection
Selection criteria
To be included in the network meta -analysis, original
studies needed to fulfill the following inclusion criteri a:
1) Population: Patients with a Class II malocclusion with
mandibular retrognathism and who are still in the growth
phase (CVMI stage 3-5);
2) Intervention: Skeletal anchored fixed functional
appliance (ie.) it can be either mini -plate anchored, or
mini-screw anchored
3) Comparisons: Studies that compared the outcomes of
different intervention techniques on cephalometric
radiographs values;
4) Outcomes: Studies that evaluated cephalometric
radiograph difference values (T2 -T1) between pre-
treatment (T1) and post-treatment(T2).
5) Study designs: Randomized clinical trials or non -
randomized clinical or retrospective studies without
language restrictions.
42
Prisma Flow Diagram
43
Materials And Methods
44
Materials And Methods
45
Materials And Methods
46
Materials And Methods
47
Materials And Methods
Additional analyses
Sub-group analyses based on study design, anchorage
type and appliance type were planned to be presented along
with the paired meta-analysis. Meta-analyses were undertaken
using the STATA software (IC version 16; (StataCorp, College
Station, Texas).
48
Results Of Study Selection
51
The preliminary study was excluded from the
[41]
quantitative analysis, together with one of the RCTs , which
analysed the overall acceptance of, and pain experienced by,
patients treated with the miniscrew anchored FFRD. It was the
only article reporting this outcome and thus could not b e
included in a meta-analysis.
49
Results Of Study Selection
[ 40 , 4 2 , 4 3 , 4 4 , 4 5 , 4 6 , 47 , 4 8 , 5 2 ,5 4 , 5 5 ]
Eleven studies were therefore
included in the quantitative analysis. The characteristics of the
[44,46]
included studies are presented in Table 1. Two studies
included an untreated control group in addition to the
skeletally anchored FFA and the conventional FFA. The data
from the untreated control groups are not included in this
review.
50
Characteristics Of Included Studies
51
Characteristics Of Included Studies
53
Characteristics Of Included Studies
Test gp 1:
FFRD on
Test gp:
reaching
Easy-Fit
0.016X0.022
Jumper
ss with mini-screws Test
(modified
gp 2:
Herbst appliance)
FFRD on
Interventions with
reaching
mini screws
0.016X0.022
Control gp:
ss
Easy-Fit
Control gp:
Jumper (historical
no treatment
control)
(historical
control)
- Patients with - At least 1/2
only minor unit Class II
crowding or molar relation,
well aligned - horizontal or
arches - normal growth
Bilateral pattern,
Patients and
Class II molar minimum (up
characterisis
occlusion of at to 3 mm) or no
tics
least 1/2 cusp. crowding,
Absence no extracted or
of extractions, missing permanent
excess or teeth
lack of - Active growth
space period.
54
Characteristics Of Included Studies
Treatment Test gp 1:
duration 5.34 ±} 1.29
(months) Test gp 2:
4.86 ±} 1.32
Control gp:
6.25 ±} 1.06
Skeletal MP3 method (MP3 G or H)
maturational
stage
Gender/age Females
(years) Test gp 1:
13.25 ±} 1.12
Test gp 2:
13.07 ±} 1.41
Control:
12.71 ±} 1.44
Means of .019X .025 ss
attachment to wire between
mini- miniscrew
screws/mini- head and
plates bonded to
labial surface
of L3s
Site of mini- Between lower 3& 4
screws/mini-
plates
Torque added to No
the lower wire
No.of subjects 43;
Test gp 1 (15)
Test gp 2 (16)
Control (12)
Interventions Test gp 1: FFRD on reaching
0.019X0.025 ss with mini screws
Test gp 2: FFRD on reaching
0.019X0.025 ss Control gp: no treatment
55
Characteristics Of Included Studies
T2 ---
Lateral cephalograms,
Time of T1
T1, T2 were not reported
Treatment
duration Test gp: 5.08 ±} 1.11 Control gp: 4.96 ±} 1.47
(months)
Skeletal
maturational Not reported
stage
Gender/age Females Test gp 1: 13.45 ±} 1.12
(years) Control gp: 13.07 ±} 1.41
Means of
attachment to
.019X .025 ss wire between
mini-
miniscrew head and bonded to labial surface of L3s
screws/mini-
plates
Site of mini-
screws/mini- Between lower 3 &4
plates
Torque added to
No
the lower wire
56
Characteristics Of Included Studies
57
Characteristics Of Included Studies
Test gp 1: FFRD on
reaching 0.019X0.025 ss with
Interventions miniscrews
Control gp: FFRD on reaching
0.019X0.025 ss
Females 11–14 y of age -
Skeletal
Class II division 1 with a
deficient mandible (SNB <76)
Patients and
- Horizontal or neutral growth
characterisistics
- Minimum
overjet of 5 mm with Class II
canine relationshipMandibular
arch crowding less than 3 mm
Design and
RCT/not reported CCT
setting
Only Lower
Skeletal Pancherz ,
Outcomes incisors inclination
dento-alveolar
and ANB changes
2 failed mini
screws in 2
Failure of mini- No failure of mini-
different
screws/miniplates screws
patients
(2/10)
T2 after fixed
T2 after the herbst
T2 appl. Ttt/
cephalograms
cephalograms
T1
T1 before Herbst before Herbst
Time of T1
cephalograms appliance/
cephalograms
Treatment
Test gp:7.6 Control Herbst phase:
duration
gp : 7.5 9 months
(months)
58
Characteristics Of Included Studies
Skeletal
maturational Not reported Not reported
stage
A metallic or
Connected
Means of elastic ligature
to the hooks
attachment to (1000 g) linked the
on Herbst
mini- mini-screws to
appliance with
screws/mini- metallic buttons
a 0.12-mm ss
plates bonded to the lower
ligature
canines
Site of mini- Between lower 4&5
Between lower 5
screws/mini- or between lower
&6
plates 5&6
Torque added to
No No
the lower wire
10;
50; Test Gp (25)
No.of subjects Test gp (5):
and Control gp (25)
Control gp (5)
Test gp:
Herbst with Test:
reduced mandibular Modified
acrylic splint & Herbst &
Interventions
mini screws) miniscrew Control:
Control gp: (Herbst conventional
with mandibular cast Herbst
acrylic splint).
59
Characteristics Of Included Studies
- Bilateral
Angle Class II
- Class II division
div. 1 ≥ 1/2 unit.
1 - Increased
- Permanent
overjet (5 to 12
or late mixed
Patients and mm). - Absence of
dentition - Absence
characterisistics mild/severe
of tooth agenesis,
crowding of the
second molars,
lower arch requiring
transverse or
extractions
vertical
discrepancies
Turkkahraman
[43]
Study Elkordy 2019 Et.al
2016 [ 5 5 ]
Only Lower
Skeletal , dento- incisors inclination
Outcomes
alveolar and
ANB changes
2 failed mini
screws in 2
Failure of mini- No failure of mini-
different
screws/miniplates screws
patients
(2/10)
T2 after fixed
T2 after the herbst
T2 appl. Ttt/
cephalograms
cephalograms
T1
T1 before Herbst before Herbst
Time of T1
cephalograms appliance/
cephalograms
Treatment Test gp:7.6 Herbst phase:
duration (months) Control gp : 7.5 9 months
Skeletal
maturational Not reported Not reported
stage
Gender/ 27 males and 23 Both genders
age (years) females 11.8±1.7 11 to 15
60
Characteristics Of Included Studies
Connected
A metallic or
Means of to the hooks
elastic ligature
attachment to on Herbst
(1000 g) linked the
mini-screws/mini- appliance with
mini-screws to
plates a 0.12-mm ss
metallic butttons
ligature
Between lower 4&5
Site of mini- Between lower 5
or between lower
screws/mini-plates &6
5&6
Torque added to
No No
the lower wire
50; Test Gp (25) 10;
No.of subjects and Control gp Test gp (5):
(25) Control gp (5)
Test gp:
Herbst with Test:
reduced Modified
mandibular Herbst &
acrylic miniscrew
Interventions
splint & mini Control:
screws) Control conventional
gp: (Herbst with cast
mandibular acrylic Herbst
splint).
- Bilateral
- Class II division
Angle Class II
1 - Increased
div. 1 ≥ 1/2 unit.
overjet (5 to 12
- Permanent or late
mm). - Absence of
Patients and mixed dentition -
mild/severe
characterisistics Absence of tooth
crowding of the
agenesis, second
lower arch
molars, transverse
requiring
or vertical
extractions
discrepancies
61
Characteristics Of Included Studies
Aboulazm et al.
Study
2009 [ 4 5 ]
Skeletal,
Outcomes
dento-alveolar
Failure of mini-
No failures
screws/miniplates
(T2)
T2 3 months after removal of
TFBC/ lateral cephalograms
(T1) Just before TFBC
Time of T1 insertion/ latera;
cephalograms
Treatment duration Test gp: mean 14 months
(months) Control gp: mean 16 months
Skeletal maturational
Not reported
stage
Both Test gp: 14 years
Gender/
2 months Control gp:
age (years)
13 years 10 months
Direct anchorage
Means of attachment to
of TFBC
mini-screws/mini-plates
on miniplates
Site of mini-screws/mini-
Miniplates at lower 3,4 region
plates
62
Characteristics Of Included Studies
63
Risk Of Bias Within Studies
[52]
For the same study , the sample comprised 50
patients, including 27 males and 23 females. The inclusion of
males and females in studies of Class II correction in subjects
with a circumpubertal age (11.8+/ -1.7 years) is considered of
questionable validity due to the already proven variations in
growth timing, pattern, and rate between males and females.
64
Risk Of Bias Within Studies
65
Risk Of Bias Assessment For Randomised Clinical Trials
66
Risk Of Bias Assessment Of The Included Non-Randomized Trials
Q1: Aim
clearly Yes Yes Yes Yes yes
described?
Q2:
Outcomes
Yes Yes Yes Yes Yes
clearly
described?
Q3: Patients
characteristi
cs clearly Yes Yes Yes Yes Yes
described?
Q4:
Intervention
s clearly Yes Yes Yes Yes Yes
described?
Q5:
Principal
confounders
Yes Partially Yes No Yes
clearly
described?
67
Risk Of Bias Assessment Of The Included Non-Randomized Trials
Q7: Random
variability for main Yes No No No No
outcome provided?
Q8: Adverse events
Yes Yes Yes Yes Yes
reported?
Q9: Loss-to-follow
Yes Yes Yes No No
up reported?
Q15: Attempt to No
No No No No
blind assessors?
68
Results Of Meta-Analysis, And additional Anal yses
SKELETAL EFFECTS
Skeletal effects were reported in nine of the studies
[ 4 0 , 42 , 4 3 , 4 5 , 4 7 , 49 , 5 0, 5 4 , 5 5 ] .
included in the quantitative analysis A
total of 83 patients were studied (40 were from the
intervention group receiving FFA and skeletal anchors, and 33
received FFA alone). Results of the meta -analysis revealed no
statistically significant difference regarding t he mandibular
length between the skeletal and conventional anchorage
groups, where the overall effect P value = 0.09 [SMD = 1.98
(95% CI −0.11 to 4.07)].
69
Results Of Meta-Analysis, And additional Anal yses
DENTO-ALVEOLAR CHANGES
Dento-alveolar changes that reported inclination changes
[ 4 0 , 4 2 , 4 3 , 44 , 4 5 , 4 7, 4 8 , 4 9 , 5 2 , 5 3 , 5 4 , 5 5]
in the lower incisors were taken
into consideration. As far as the dento -alveolar changes are
concerned, for the lower incisors inclination changes 375
patients were studied (194 for the skeletal anchorage and 181
for conventional FFA).
70
Paired Meta-Anal ysis Summary
71
Paired Meta-Anal ysis Summary
72
Sub-Group Anal ysis
SUB-GROUP ANALYSIS
a) SNB CHANGES
1) BASED ON STUDY DESIGN:
73
Sub-Group Anal ysis
2) BASED ON ANCHORAGE:
74
Sub-Group Anal ysis
1) STUDY DESIGN:
75
Sub-Group Anal ysis
2) TYPE OF ANCHORAGE:
76
Sub-Group Anal ysis
77
Sub-Group Anal ysis
78
Sub-Group Anal ysis
79
Sub-Group Anal ysis
C) TYPE OF APPLIANCE:
80
Publication Bias
PUBLICATION BIAS
81
Publication Bias
82
Publication Bias
83
Publication Bias
PUBLICATION BIAS
84
Publication Bias
85
Results of network meta-Anal ysis
86
Results of network meta-Anal ysis
87
Results of network meta-Anal ysis
88
Results of network meta-Anal ysis
89
Results of network meta-Anal ysis
90
Strengths And Limitations
91
Strengths And Limitations
92
Conclusion Of The Study
CONCLUSIONS
93
Bibliography
BIBLIOGRAPHY
95
Bibliography
96
Bibliography
97
Bibliography
98
Bibliography
99
Bibliography
36. Bucher HC, Guyatt GH, Griffith LE, Walter SD. The
results of direct and indirect treatment comparisons in
meta-analysis of randomized controlled trials. J Clin
Epidemiol 1997; 50:683-691.
100
Bibliography
101
Bibliography
102
Bibliography
103
Bibliography
104
Supplementary Materials
SUPPLEMENTARY MATERIALS
PRISMA CHECKLIST FOR CONDUCTING A
SYSTEMATIC REVIEW INVOLVING A NETWORK
META-ANALYSIS (2015)
ABSTRACT
Structured 2 Provide a structured summary including, as applicable:
summary Background: main objectives
Methods: data sources; study eligibility criteria, participants,
and interventions; study appraisal; and synthesis methods, such
as network meta-analysis.
Results: number of studies and participants identified;
summary estimates with corresponding confidence/credible
intervals; treatment rankings may also be discussed. Authors
may choose to summarize pairwise comparisons against a
chosen treatment included in their analyses for brevity.
Discussion/Conclusions: limitations; conclusions and
implications of findings.
Other: primary source of funding; systematic review
registration number with registry name.
INTRODUCTION
Rationale 3 Describe the rationale for the review in the context of what is
already known, including mention of why a network meta-
analysis has been conducted.
Objectives 4 Provide an explicit statement of questions being addressed, with
reference to participants, interventions, comparisons, outcomes,
and study design (PICOS).
METHODS
Protocol and 5 Indicate whether a review protocol exists and if and where it can
registration be accessed (e.g., Web address); and, if available, provide
registration information, including registration number.
Eligibility criteria 6 Specify study characteristics (e.g., PICOS, length of follow-up)
and report characteristics (e.g., years considered, language,
publication status) used as criteria for eligibility, giving rationale.
Clearly describe eligible treatments included in the treatment
105
Supplementary Materials
106
Supplementary Materials
RESULTS†
Study selection 17 Give numbers of studies screened, assessed for eligibility, and
included in the review, with reasons for exclusions at each stage,
ideally with a flow diagram.
Presentation of S3 Provide a network graph of the included studies to enable
network structure visualization of the geometry of the treatment network.
Summary of S4 Provide a brief overview of characteristics of the treatment
network geometry network. This may include commentary on the abundance of
trials and randomized patients for the different interventions and
pairwise comparisons in the network, gaps of evidence in the
treatment network, and potential biases reflected by the network
structure.
Study 18 For each study, present characteristics for which data were
characteristics extracted (e.g., study size, PICOS, follow-up period) and provide
the citations.
Risk of bias within 19 Present data on risk of bias of each study and, if available, any
studies outcome level assessment.
Results of 20 For all outcomes considered (benefits or harms), present, for
individual studies each study: 1) simple summary data for each intervention group,
and 2) effect estimates and confidence intervals. Modified
approaches may be needed to deal with information from larger
networks.
Synthesis of results 21 Present results of each meta-analysis done, including
confidence/credible intervals. In larger networks, authors may
focus on comparisons versus a particular comparator (e.g.
placebo or standard care), with full findings presented in an
appendix. League tables and forest plots may be considered to
summarize pairwise comparisons. If additional summary
measures were explored (such as treatment rankings), these
should also be presented.
Exploration for S5 Describe results from investigations of inconsistency. This may
inconsistency include such information as measures of model fit to compare
consistency and inconsistency models, P values from statistical
tests, or summary of inconsistency estimates from different parts
of the treatment network.
Risk of bias across 22 Present results of any assessment of risk of bias across studies for
studies the evidence base being studied.
Results of 23 Give results of additional analyses, if done (e.g., sensitivity or
additional analyses subgroup analyses, meta-regression analyses, alternative network
geometries studied, alternative choice of prior distributions for
Bayesian analyses, and so forth).
DISCUSSION
107
Supplementary Materials
FUNDING
Funding 27 Describe sources of funding for the systematic review and other
support (e.g., supply of data); role of funders for the systematic
review. This should also include information regarding whether
funding has been received from manufacturers of treatments in
the network and/or whether some of the authors are content
experts with professional conflicts of interest that could affect
use of treatments in the network.
* Text in italics indicates wording specific to reporting of network meta-analyses that has
been added to guidance from the PRISMA statement.
108