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Jinho Ahn

V year, 14 Group

Comparison of changes in quality of life for patients before and

after orthodontic and/or orthognathic treatment using Oral

Health Impact Profile (OHIP-14)

Systematic review

Supervisor Ph.D. Arunas Vasiliauskas

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LITHUANIAN UNIVERSITY OF HEALTH SCIENCES ACADEMY OF MEDICINE

FACULTY of ODONTOLOGY

Comparison of changes in quality of life for patients before and

after orthodontic and/or orthognathic treatment using Oral

Health Impact Profile (OHIP-14)

Systematic review

The thesis was done

by student... Supervisor...

(signature) (signature)

...

(name surname, year, group) (degree, name surname)

... 2018 ... 2018

(day/month) (day/month)

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Kaunas, 5th year

EVALUATION TABLE OF THE MASTER’S THESIS OF THE TYPE OF SYSTEMIC REVIEW OF SCIENTIFIC LITERATURE

Evaluation : ...

Reviewer : ... (scientific degree. name and surname)

Reviewing date: ...

No. MT parts MT evaluation aspects Compliance with MT requirements and evaluation Yes Partially No 1 Summary (0,5 point)

Is summary informative and in compliance with the thesis contentand

requirements?

0,3 0,1 0

2 Are keywords in compliance with the

thesis essence?

0,2 0,1 0

3

Introduction, aim and tasks

(1point)

Are the novelty, relevance and significance of the work justified inthe

introduction of the thesis?

0,4 0,2 0

4 Are the problem, hypothesis, aim and tasks formed clearly and properly?

0,4 0,2 0

5 Are the aim and tasks interrelated? 0,2 0,1 0

6 Selection criteria of the studies, search methods and strategy (3.4 points)

Is the protocol of systemic review present?

0,6 0,3 0

7 Were the eligibility criteria of articles for the selected protocol determined

(e.g., year, language, publication condition, etc.)

0,4 0,2 0

8 Are all the information sources

(databases with dates of coverage, contact with study authors to identify additional studies) described and is the

last search day indicated?

0,2 0,1 0

9 Is the electronic search strategy

described in such a way that it could be repeated (year of search, the last search day; keywords and their combinations; number of found and selected articles

according to the combinations of keywords)?

0,4 0,1 0

10 Is the selection process of studies (screening, eligibility, included in systemic review or, if applicable,

included in the meta-analysis)

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described?

11 Is the data extraction method from the articles (types of investigations, participants, interventions, analysed

factors, indexes) described?

0,4 0,2 0

12 Are all the variables (for which data were sought and any assumptions and

simplifications made) listed and defined?

0,4 0,2 0

13 Are the methods, which were used to

evaluate the risk of bias ofindividual studies and how this information is to

be used in data synthesis,described?

0,2 0,1 0

14 Were the principal summarymeasures

(risk ratio, difference in means)stated?

0,4 0,2 0 15 Systemiza-tion and analysis of data (2.2 points)

Is the number of studies screened: included upon assessment foreligibility

and excluded upon giving thereasons in each stage of exclusionpresented?

0,6 0,3 0

16 Are the characteristics of studies presented in the included articles, according to which the data were extracted (e.g., study size, follow-up period, type of respondents) presented?

0,6 0,3 0

17 Are the evaluations of beneficial or harmful outcomes for each study presented? (a) simple summary datafor

each intervention group; b)effect estimates and confidence intervals)

0,4 0,2 0

18 Are the extracted and systemized data from studies presented in the tables

according to individual tasks?

0,6 0,3 0

19

Discussion (1.5 points)

Are the main findings summarized and is their relevance indicated?

0,4 0,2 0

20 Are the limitations of the performed systemic review discussed?

0,4 0,2 0

21 Does author present the interpretation of the results?

0,4 0,2 0

22

Conclusions (0.5 points)

Do the conclusions reflect thetopic, aim and tasks of the Master’sthesis?

0,2 0,1 0

23 Are the conclusions based on the

analysed material?

0,2 0,1 0

24 Are the conclusions clear and laconic? 0,1 0,1 0

25

References (1 point)

Is the references list formed according to the requirements?

0,4 0,2 0

26 Are the links of the references to the text correct? Are the literature sources

cited correctly and precisely?

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27 Is the scientific level of references

suitable for Master’s thesis? 0,2 0,1 0 28 Do the cited sources not older than 10

years old form at least 70% of sources, and the not older than 5 years – at least

40%?

0,2 0,1 0

Additional sections, which may increase the collected number of points 29

Annexes Do the presented annexes help to understand the analysed topic? +0,2 +0,1 0 30

Practical recommen-dations

Are the practical recommendations suggested and are they related to the

received results?

+0,4 +0,2 0

31 Were additional methods of data

analysis and their results used and described (sensitivity analyses, meta-

regression)?

+1 +0,5 0

32 Was meta-analysis applied? Are the

selected statistical methodsindicated? Are the results of eachmeta-analysis

presented?

+2 +1 0

General requirements, non-compliance with which reduce the number of points 33

General requirements

Is the thesis volume sufficient (excluding annexes)? 15-20 pages(-2 points) <15 pages (- 5 points)

34 Is the thesis volume increased

artificially?

-2

points -1 point 35 Does the thesis structure satisfy the

requirements of Master’s thesis? -1 point

-2 points 36 Is the thesis written in correctlanguage,

scientifically, logically andlaconically? -0.5 point

-1 points 37 Are there any grammatical, styleor

computer literacy-relatedmistakes?

-2

points -1 points 38 Is text consistent, integral, and are the

volumes of its structural parts balanced?

-0.2 point -0.5 points

39 Amount of plagiarism in the thesis. >20%

(not evaluated) 40 Is the content (names of sections and

sub-sections and enumeration of pages) in compliance with the thesis structure

and aims?

-0.2 point -0.5 points 41 Are the names of the thesis parts in

compliance with the text? Are the titles of sections and sub-sections distinguished logically andcorrectly?

-0.2 point -0.5 points

42 Are there explanations of the key terms and abbreviations (if needed)?

-0.2 point -0.5 points

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43 Is the quality of the thesis typography (quality of printing, visual aids,

binding) good?

-0.2 point -0.5 points *In total (maximum 10 points):

*Remark: the amount of collected points may exceed 10 points.

Reviewer’scomments:

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TABLE OF CONTENTS

SUMMARY ...1

INTRODUCTION...2

SELECTION CRITERIA OF THE STUDIES SEARCH METHODS ANDSTRATEGY... 5

SYSTEMIZATION AND ANALYSIS OF DATA...10

DISCUSSION...22

CONCLUSIONS ...25

PRACTICAL RECOMMENDATIONS...25

REFERENCES...26

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Comparison of changes in quality of life for patients before

and after orthodontic and/or orthognathic treatment using

Oral Health Impact Profile (OHIP-14)

ABSTRACT

Objective: The aim of this study was to compare the quality of life(QoL) and satisfaction using

Oral Health Impact Profile of patients before and after orthodontic and/or orthognathic treatment

Materials and methods: Search was performed using databases of Pubmed, ScienceDirect,

Pubmed Central and Scopuson September 10, 2017, and updated until December 17, 2017. Different keywords and phrases (OHIP-14, Quality of life, Orthodontic treatment, Orthognathic treatment, Orthognathic surgery) were typed to get general perspective and research articles. Inclusion criteria were that study related to Oral Health Impact Profile (OHIP-14) with orthodontic treatment, orthognathic treatment, orthognathic surgery with comparison before and after treatment, on humans and English language articles not older than 10 years.

Result: The search resulted in 209 articles. The articles were filtered and then reviewed for title,

abstract and the duplicates were sorted out. After following the inclusion/exclusion criteria,11 articles included in the review. `Psychological discomfort` and `Psychological disability` were the two most high scored items using the mean sum OHIP-14 score. Women were more affected by oral health and had lower OHRQoL than men. Patients with malocclusion improved quality of life after the treatment. However, there was a difference in each domain and changing interval

Conclusions: The quality of life was improved after orthodontic and/or orthognathic treatment by

decreasing particularly `Psychological discomfort` and `Psychological disability` domain in OHIP-14

Keywords: OHIP-14, Quality of life, Orthodontic treatment, Orthognathic treatment, Orthognathic

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INTRODUCTION

Malocclusion is not considered as a disease but rather related to an inherited condition which incorrect relation relationship between the upper and lower jaw and/or misalignment of the teeth. Malocclusion is associated not only with oral pathological conditions but has a strong impact on patients’ psychological, social, functional health[1-3] and even intelligence[4,5]. These psychological, social, and functional aspects are referred to as oral health related quality of life(OHRQoL).

The concept of `quality of life(QoL)‘ can be defined as a comprehensive concept, affecting multiple aspects of a person’s physical and mental health, social relations, and environment. `OHRQoL‘ as a related concept to well-being with oral health can be defined as affecting in the physical and psychological effects by oral health status and self-confidence about the maxillofacial region in life.

Many patients with malocclusion seek orthodontic or orthognatic treatment for living a better quality of life. Motivation which physical or psychological reasons related to esteem, self-concept and self-confidence for treatment in the patients is generally associated with a negative effect of malocclusion [6]. Many articles were also reported malocclusions have a significant impact on the patient's emotional and social well-being[7-9].

World Health Organization recommended including quality of life measurements in a medical clinical study.[10] Research on quality of life assessment also has been increased and more importantly, the area of focus has widened with greater emphasis placed on social well-being rather than disease mortality and the importance of these psychological factors in influencing treatment need and outcome has resulted in a paradigm change toward patient-centered care and developing of self-report assessments. For these reasons, many instruments have been developed for the measurement of OHRQoL over the last 30 years[11,12].

One of most internationally and widely used[13,14] perceptive measures in assessing OHRQoL changes in orthodontic treatment [15-17] is The Oral Health Impact Profile (OHIP). There are two OHIP versions OHIP- 49 (by Slade & Spencer 1994)[18] and OHIP-14 (by Slade 1997)[19] base on Locker’s conceptual model of oral health which is derived from the World Health Organization's Categorization of the impacts of disease[20]. The original OHIP-49 contains 49 questions(Annex1) and A shortened adaptive version OHIP-14 contains 14 questions(Annex2). Although, OHIP-49 is a useful and precise instrument and translated into several languages(e.g. German, Swedish, Chinese, Hungarian, Brazilian) [21-25], but was a too long and considered time-consuming to complete.

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Thus, the OHIP-14 is developed and used a more practical instrument in clinical practice.OHIP-14 also has been validated and translated into different languages such as Malaysian, Sinhalese, Japanese, Chinese, Swedish, Croatian, Hebrew, Brazilian and German[26-34]. The OHIP-14 questionnaire that classified into seven different domains and each domain contains two questions 1. functional limitation (hard to sense of taste and/or pronouncing words)

2. physical pain (painful etching and/or uncomfortable to eat) 3.psychological discomfort (self-conscious feeling and/or felt tense) 4. physical disability (unsatisfactory diet and/or had to interrupt meals) 5. psychological disability (difficult to relax and/or being embarrassed 6. social disability (irritability with others and/or difficulty doing usual jobs) 7. handicap (felt life less satisfying and/or totally unable to function)

They are given to patients and self-assessing impact factors on their oral health with using a five-point ordinal Likert scale code: never (score 0), hardly ever (score 1), occasionally (score2), fairly often (score 3) and very often (score 4). Total possible score on the OHIP-14 can range from 0 -56, A lower OHIP-14 scores mean a lower impact on QHRQoL. In other words, it means that patients have less dissatisfaction and disability on their life.

OHIP-14 is good at measuring the psychological impacts, focus on recognizing the importance of the impact of oral health conditions on well-being and the quality of life of individuals, considering multidimensional parts such as physical, psychological and social part[Annex 3]. Its advantages are the possibility of the orthodontist understanding and explaining patients who seeking and treated orthodontic or orthognathic treatment, providing more uniform and useful data.

Due to these specific characters, there have been expanding trend to use combining conventional clinic-based measuring instruments with patient-centered measuring instruments such as OHIP to better treatment and gauge a patient's perception of satisfaction.

Aim of the study

To use OHIP-14 to compare change of patients before and after orthodontic and orthognathic treatment.

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Tasks

1. Evaluate the patients change of the quality of life depending on oral health before and after orthodontic and/or orthognathic treatment using OHIP-14

2. Evaluate and compare change of quality of life depending on oral health between male and female patients before and after orthodontic and/or orthognathic treatment using OHIP-14 3. Evaluate and compare change of quality of life depending on oral health in the patients with

different maloclussions before and after orthodontic and/or orthognathic treatment using OHIP-14

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SELECTION CRITERIA OF THE STUDIES & SEARCH METHODS AND STRATEGY

This systematic review conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines.

Selection Criteria

The articles which were included within the study all records had to be determined by the following inclusion criteria

Inclusion criteria:

1. Studies related to Oral Health Impact Profile (OHIP-14). 2. Prospective studies and controlled clinical trials

3. Comparison before and after treatment

4. With orthodontic treatment, orthognathic treatment, orthognathic surgery 5. In-vivo, studies on human

6. Articles not older than 10 years 7. English language articles

Exclusion criteria:

1. Not related to Oral Health Impact Profile 14 (OHIP-14).

2. Other treatments excluded Orthodontic treatment, Orthognathic treatment, Orthognathic surgery

3. Not comparison before and after treatment 4. Articles more than 10 years

5. In vivo, Non-human studies

6. Literature reviews, single case reports, editorials, commentaries 7. Not English articles.

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Search strategy for the identification of studies

An initial literature search was performed on September 10, 2017 and updated until December 17, 2017. Different keywords and phrases were typed on google website to get a general perspective and research articles. Later on more specific words using the electronic databases of Pubmed, ScienceDirect, Pubmed Central, and Scopus. Relevant search terms for "OHIP 14", "Quality of life", "Orthodontic treatment", "Orthognathic treatment", "Orthognathic surgery" (Table 1-4)

Table 1 Keywords used for Pubmed (NCBI) search

Search strategy

The searches in the Pubmed database were based on a combination of keywords "OHIP 14", "Quality of life", "Orthodontic treatment", "Orthognathic treatment", "Orthognathic surgery" and the filters "Humans", "10 years". 45 Results got from searching on December 17, 2017

Search details with MeSH terms

("OHIP14"[All Fields] AND "quality of life"[All Fields]) AND ((orthognathic[All Fields] AND ("therapy"[Subheading] OR "therapy"[All Fields] OR "treatment"[All Fields] OR

"therapeutics"[MeSH Terms] OR "therapeutics"[All Fields])) OR ("orthognathic surgery"[MeSH Terms] OR ("orthognathic"[All Fields] AND "surgery"[All Fields]) OR "orthognathic surgery"[All Fields]) OR (orthodontic[All Fields] AND ("therapy"[Subheading] OR "therapy"[All Fields] OR "treatment"[All Fields] OR "therapeutics"[MeSH Terms] OR "therapeutics"[All Fields]))) AND ("2007/12/17"[PDat] : "2017/12/17"[PDat] AND "humans"[MeSH Terms])

Keywords Filter Results Date of search

(("OHIP 14") AND "quality of life") AND

(orthognathic treatment OR orthognathic surgery OR orthodontic treatment) Humans, 10 years 45 2017.12.17

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Table 2 Keywords used for ScienceDirect search

Search strategy

The searches in the ScienceDirect database were based on a combination of keywords "OHIP 14", "Quality of life", "Orthodontic treatment", "Orthognathic treatment", "Orthognathic surgery", and the filters "10 years".62 Results got from searching on December 17, 2017

Search details with MeSH terms

ScienceDirect database didn‘t provide a searching tool with MeSH term

Table 3 Keywords used for PMC (NCBI) search

Keywords Filter Results Date of search

(("OHIP 14") AND "quality of life") AND

(orthognathic treatment OR orthognathic surgery OR orthodontic treatment) 10 years 62 2017.12.17

Keywords Filter Results Date of search

(("OHIP 14") AND "quality of life") AND

(orthognathic treatment OR orthognathic surgery OR orthodontic treatment) Humans,10 years 89 2017.12.17

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Search strategy

The searches in the PMC database were based on a combination of "OHIP 14", "Quality of life ", "Orthodontic treatment", "Orthognathic treatment", "Orthognathic surgery", and the filters and "humans" "10 years". 89 Results got from searching on December 17, 2017

Search details with MeSH terms

("OHIP14"[All Fields] AND "quality of life"[All Fields]) AND ((orthognathic[All Fields] AND ("therapy"[Subheading] OR "therapy"[All Fields] OR "treatment"[All Fields] OR

"therapeutics"[MeSH Terms] OR "therapeutics"[All Fields])) OR ("orthognathic surgery"[MeSH Terms] OR ("orthognathic"[All Fields] AND "surgery"[All Fields]) OR "orthognathic surgery"[All Fields]) OR (orthodontic[All Fields] AND ("therapy"[Subheading] OR "therapy"[All Fields] OR "treatment"[All Fields] OR "therapeutics"[MeSH Terms] OR "therapeutics"[All Fields]))) AND ("2007/12/17"[PDat] : "2017/12/17"[PDat] AND "humans"[MeSH Terms])

Table 4 Keywords used for Scopus search

Search strategy

The searches in the Scopus database were based on a combination of keywords "OHIP 14",

"Quality of life ", "Orthodontic treatment ", "Orthognathic treatment ", "Orthognathic surgery" and the filters and "dentistry" "humans" "English" "10 years". 13 Results got from searching on

December 17, 2017

Keywords Filter Results Date of search

(("OHIP 14") AND "quality of life") AND

(orthognathic treatment OR orthognathic surgery OR orthodontic treatment) Dentistry, human, English, 10 years 13 2017.12.17

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Search details with MeSH terms

( TITLE-ABS-KEY ( ( ( "OHIP 14" ) AND "quality of life" ) AND ( orthognathic AND treatment OR orthognathic AND surgery OR orthodontic AND treatment ) ) ) AND ( OHIP 14 AND quality AND of AND life AND ( orthognathic AND treatment OR orthognathic AND surgery OR

orthodontic AND treatment ) ) AND ( LIMIT-TO ( SUBJAREA , "DENT" ) ) AND ( LIMIT-TO ( EXACTKEYWORD , "Human" ) ) AND ( LIMIT-TO ( LANGUAGE , "English" ) )

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SYSTEMIZATION AND ANALYSIS OF DATA

The article review and data extraction was performed according to the PRISMA flow diagram (Figure 1). The initial search displayed 209 results from an electronic search using four

databases(PubMed 45 studies, ScienceDirect 62 studies, PMC 89 studies, Springer 13 studies).87 articles were excluded due to duplicates. From the remaining 122 articles results, excluded 62 articles from screening titles and abstracts. 60 full-text articles were assessed for eligibility. 21 articles not to use OHIP-14,18 article Not comparison before and after treatment and other 10 articles were excluded. 11 articles fulfilled inclusion criteria.

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Data Extraction.

The studies that met the inclusion criteria and proven eligibility were submitted for data extraction. The systematic review with their methods, results are summarized in(Table 5,6)(Figure 2,3).

Table 5 Characteristics included in the studies on the OHIP-14

Authors / Year Study design Number of individuals (N) Treat-ment method Age of sample Follow up period Statistical analysis Comment of the main finding Zheng et al. 2015 [35] Prospec- tive Clinical trial N = 81 Class I (n=35) Class II (n=32) ClassIII (n=14) Ortho-dontic treatment 15 to 24y - Friedman ANOVA Wilcoxon signed rank tests Investigated changes in OHRQoL among patients with different classifications patients with Class I,

Class II, Class III malocclusion to comprehensive orthodontic treatment. Alzoubi et al. 2017 [36] Prospec- tive Clinical trial N = 98 Fixed treamtent (n=49) Functional treatment (n=49) Ortho-dontic treatment 10 to 16 y 25 month ANOVA Evaluation of oral healthrelated quality of life in orthodontic patients

treated with fixed and twin blocks

appliances Chen et al. 2015 [37] Conse- cutive N = 190 Mal-occlusion (n=190) Ortho-dontic treatment 18 to 25 y - ANOVA

To assess oral health related quality of life (OHRQoL) in young adult patients with malocclusion and to

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association between orthodontic treatment

need and OHRQoL.

Silvola et al. 2014 [38] Longitu-dinal N = 52 Ortho- dontic or orthodontic -surgical treatment (n=52) Ortho-dontic treatment Ortho-gnathic surgery 18 to 61 y 5.1year (66.1m) T-test Investigate the relationship between satisfaction with dental esthetics and oral health related quality of life

in adults who have undergone orthodontic or orthodontic-surgical treatment Huang et al. 2015 [39] Longitu-dinal N = 50 Surgery-first group (n=25) Ortho-dontic -first group (n=25) Ortho-dontic treatment Ortho-gnathic surgery Surgery-first group 24.2y ±5.8 Ortho- dontic first group 25.2y ±4.2 Surgery-firstgrou p 16.6m ±2.4 Ortho- donticfir st group 25.3m ±2.4 ANOVA To evaluate the changes of oral health related quality of life

and satisfaction between surgery-first and orthodontic-first orthognathic surgery Antoun et al. 2016 [40] Conse- cutive N = 83 Standard (n=30) Cleft lip (n=24) Orthognatic Surgery Ortho-dontic treatment Ortho-gnathic surgery - 24 month Chi-square test To investigate the effect of orthodontic treatment on oral health related quality

of life (OHRQoL) in groups of standard

patients with severe malocclusions; cleft lip, cleft palate,

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(n=29) palate patients; and

orthognathic surgery patients Nichols et al. 2017 [41] Longitu-dinal N=57 Standard (n=16) Cleft lip (n=19) Ortho-gnathic surgery (n=22) Ortho-dontic treatment - - Chi-square test To assess long-term changes and describe

the trajectories of oral health- related quality of life

(OHRQoL) in a cohort of cleft, surgery, and standard

patients who received orthodontic treatment Silvola et al. 2016 [42] Prospec- tive Clinical trial N = 64 Ortho-gnathic surgery (n=44) Ortho-dontic treatment (n=20) Ortho-dontic treatment Ortho-gnathic surgery 18 to 64 y 36 month Non para-metric To evaluate the relationships of changes in facial pain, temporomandibular disorders and oral health related

quality-of-life in adults who underwent orthodontic or orthodontic/surgical treatment

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14 | P a g e Feu et al. 2017 [43] Non- randomi zed N = 16 surgery- first group (n=8) orthodontic first group (n=8) Ortho-dontic treatment Ortho-gnathic surgery - 24 month Mann-Whitney test

Compared the effects of the surgery-first

approachwith conventional 2-jaw orthognathic surgery on skeletal Class III patients' oral health-related quality of life Baheri moghad dam et al. 2015 [44] Longitu-dinal N = 58 Class II (n=28) Class III (n=30) Ortho-dontic treatment Ortho-gnathic surgery Class II 25.1y ±3.4 Class III 21.3y ±2.7 Exam-ined period 0.9y Treat-ment period 12month ANOVA To assess and compare the oral health related quality of life (OHRQoL) of patients with class II and III deformities

during and after orthodontic–surgical treatment Goelzer et al. 2014 [45] Prospec- tive Clinical trial N = 74 Class I (n=5) Class II (n=11) ClassIII (n=58) Ortho-gnathic surgery 15 to 53 y 36 month Wilcoxon matched pairs test Assessing change in the qualityof life usingthe OralHealth ImpactProfile(OHIP) in patients with different dentofacial deformities undergoing orthognathic surgery Descriptive results

A total of 823 participants, who were asked to complete the 14-item OHIP-14 questionnaire, were evaluated in the 11 studies of the studies. 11 Study designs consist of 4 Prospective, 2 consecutive,4 longitudinal, and 1 non-randomized studies. 4 studies researched on QoL of participants with

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orthodontic treatment and 1 study researched on QoL of participants with orthognathic surgery. 6 studies researched on QoL of participants with both treatments. Age ranges of participants were from 10 to 62 years old. Mainly, the majority of studies researched on adolescent and young people. The follow-up period was from 16.6 months to 61.1 months. Majority of the follow-up period was from 24 months to 36 months. The studies were analysed by various statistical analysis

tools(Friedman, Anova,Wilcoxon sighed rank, Wilcoxon matched pairs tests,T-test, Chi-square test, Non-para-metric, Mann-Whitney test). A most common finding of the studies was to investigate and evaluate the change of QoL of participants during the treatments.(Table 5)

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Table 6 Comparisonof quality of life scores at before treatment(T0) and after treatment(T1)

Autor / year Charateristics of Treatment group Functional limitation Physical pain Psychological discomfort Physical disability Psychological disability Social

disability Handicap Overall

T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 T0 T1 Zheng et al. 2015 [35] Malooclusion Class 1 1.77 0.54 1.60 1.23 3.94 1.63 2.57 1.43 4.26 1.83 0.63 0.56 1.14 1.29 15.91 9.11 Malocclusion Class 2 1.75 0.50 2.09 0.50 3.56 0.53 3.56 0.56 3.13 0.66 0.66 0.31 0.61 0.54 15.36 3.60 Malocclusion Class 3 1.57 0.50 1.43 0.57 3.93 0.71 4.14 0.36 4.50 0.43 0.93 0.57 0.48 0.32 16.98 3.46 Alzoubi et al. 2017 [36] Treated with fixed treamtent appliances 3.0 2.0 3.8 2.0 4.0 2.0 3.2 2.0 3.6 2.0 3.1 2.0 3.1 2.0 23.80 14.0 Threated with functional treatment appliances 4.5 2.0 4.1 2.0 4.0 2.1 3.4 2.1 3.9 2.2 3.7 2.2 3.3 2.2 26.90 14.8 Chen et al. 2015 [37] Little or no treatment need 0.49 0.10 1.12 0.10 1.80 0.85 0.78 0.07 0.93 0.56 0.41 0.07 0.54 0.02 6.07 1.78 Borderline need 0.84 0.36 1.54 0.22 2.84 1.00 1.01 0.28 1.57 0.59 0.75 0.10 0.50 0.04 9.06 2.60 Treatment required 1.85 0.43 1.64 0.25 3.51 1.34 1.13 0.45 2.21 0.66 12.5 0.36 1.17 0.29 12.75 3.70 Men 1.8 0.4 4.4 2.2 2.9 0.8 1.1 0.3 1.8 0.4 1.5 0.4 1.2 0.4 14.7 4.8 Women 1.8 0.9 4.8 1.6 4.1 1.1 2.0 0.3 3.1 0.6 2.2 0.2 1.9 0.3 19.9 4.7

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17 | P a g e Silvola et al. 2014 [38] Orthodontic treatment 2.4 0.7 4.6 1.9 3.9 1.2 1.7 0.3 2.4 0.7 2.1 0.3 1.6 0.3 18.7 5.5 Orthodontic & surgery treatment 1.7 0.8 4.6 1.8 3.7 0.9 1.8 0.3 2.8 0.5 1.9 0.2 1.7 0.3 18.3 4.4 Huang et al. 2015 [39] Surgery Treatment first 8.42 1.89 5.26 1.34 6.12 0.45 6.29 0.10 6.54 0.15 6.03 0.15 3.24 0.12 38.68 3.89 Orthodontic Treatment First 8.45 1.92 5.46 1.75 6.25 0.92 6.39 1.49 6.72 0.88 6.86 0.98 6.34 0.78 41.67 8.68 Antoun et al. 2016 [40] Orthodontic treatment 1.23 0.77 1.50 0.67 3.00 0.70 0.73 0.23 2.67 0.67 1.27 0.37 1.20 0.23 11.60 3.63 Cleft lip&palatate 1.75 1.37 1.25 1.29 2.54 1.75 0.75 0.33 1.92 1.33 1.17 0.58 1.10 0.58 10.50 7.25 Orthodontic & Surgery treatment 2.03 0.24 3.10 0.86 4.83 0.48 1.59 0.10 3.93 0.24 2.00 0.03 2.03 0.07 19.52 2.03 Nichols et al. 2017 [41] Orthodontic treatment 1.3 1.3 1.4 1.5 3.4 2.5 0.7 1.3 2.6 1.6 1.6 0.8 1.4 0.4 12.4 9.4 Cleft lip&palatate 1.9 2.1 1.4 2.0 2.6 3.4 0.8 2.0 2.1 2.7 1.3 1.9 1.2 1.6 11.2 15.7 Orthodontic & Surgery treatment 2.1 1.2 2.8 1.6 4.7 1.8 1.7 0.8 3.6 1.2 1.9 0.8 1.9 0.5 18.8 8.0 Male - - - 16.2 4.2 Female - - - 18.8 4.6

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18 | P a g e Silvola et al. 2016 [42] Orthodontic treatment - - - 18.3 4.2 Orthognathic treatment - - - 17.6 5.3 Feu et al. 2017 [43] Orthodontic treatment first - - - 25.4 8.1 Orthodontic treatment first - - - 21.5 22.1 Baherimo ghaddzm et al. 2015 [44] Malocclusion Class 2 1.82 0.85 2.86 1.11 3.07 1.18 3.15 0.86 2.75 0.90 3.07 3.00 2.46 2.25 19.18 6.87 Malocclusion Class 3 1.53 0.81 1.47 0.80 5.23 0.93 1.30 0.77 4.33 0.97 3.03 2.50 2.97 2.37 19.86 6.24 Goelzer et al. 2014 [45] Malocclusion Class 1 1.30 0.80 2.46 1.40 3.11 1.02 1.50 1.10 2.48 0.56 1.40 0.65 1.32 0.44 13.57 5.97 Malocclusion Class 2 0.87 0.55 2.06 1.40 2.45 0.50 1.40 0.55 1.96 0.53 1.08 0.27 1.45 0.47 11.27 4.27 Malocclusion Class 3 1.65 0.57 2.08 0.70 2.70 0.39 1.55 0.48 2.14 0.38 1.66 0.21 1.80 0.26 13.58 2.99 Descriptive results

Table 7 was made and filled in the OHIP-14 scores at before treatment(T0) and after treatment(T1). Figure 2 was made a graph for comparison of means of overall between men and women at before treatment and after treatment. Figure 3 was made a graph for comparison of means of overall of 3 malocclusion groups at before treatment and after treatment.

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Figure 2 Comparison of means of overall between men and women at before treatment and after

treatment

Figure 3 Comparison of means of overall of 3 malocclusion groups at before treatment and after

treatment 4.2 4.6 4.8 4.7 16.2 18.8 14.7 19.9

Male (Silvola et al. 2015) Female (Silvola et al. 2015) Male (Silvola et al. 2013) Female (Silvola et al. 2013)

Comparison of means of overall

between men and women

Before treatment After treatment

9.11 3.6 3.46 6.87 6.24 5.97 4.27 2.99 15.91 15.36 16.98 19.18 19.86 13.57 11.27 13.58

Class 1 (Zheng et al. 2015) Class 2 (Zheng et al. 2015) Class 3 (Zheng et al. 2015) Class 2 (Baherimoghaddam et al. 2015) Class 3 (Baherimoghaddam et al. 2015) Class 1 (Goelzer et al. 2014) Class 2 (Goelzer et al. 2014) Class 3 (Goelzer et al. 2014)

Comparison of means of overall of

3 malocclusions group

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Risk of bias assessment

Risk of bias was included in the extraction procedure with The Cochrane Risk of Bias Tool that include 7 processes: Random Sequence generation, allocation concealment, selective reporting, other sources of bias, blinding of participants, blinding of outcome, incomplete outcome data and each process assessed as low risk, high risk, and unclear according the bias assessment standard(Annex 4)(Table 7).

Table 7 Risk of bias assessment

Authors / Year Random Sequence generation Allocation Concealment Selective reporting Other sources of bias Blinding of participants Blinding of outcome Incomplete outcome data Zheng et al. 2015 [35]

High High Low Low Unclear Unclear Low

Alzoubi et al. 2017 [36]

Unclear High Low High Unclear Unclear Low

Chen et al. 2015 [37]

High High Low Low Unclear Unclear Low

Silvola et al. 2014 [38]

High High Low Low Unclear Unclear Low

Huang et al.

2015 [39]

High High Low Unclear Unclear Unclear Low

Antoun et al. 2016

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21 | P a g e [40] Nichols et al. 2017 [41]

High High Low High Unclear Unclear Low

Silvola et al. 2016 [42]

High High Low Low Unclear Unclear Low

Feu et al. 2017 [43]

High High Low High Unclear Unclear Low

Baheri moghad dam et al. 2015 [44]

High High Low Low Unclear Unclear Low

Goelzer et al. 2014 [45]

High High Low High Unclear Unclear Low

Majority of studies had high risk of bias spcially in random sequence generation and allocation

concealment part, although seletive reporting, other sources of bias, imcomplete outcome data had low risk. Any studies were not mentioned about blinding of participants and outcome not in the least.

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DISCUSSION

According to Chen et al.study[37] the mean OHIP-14 score was 6.07 for little or no treatment required patients group which had less discomfort and disability before orthodontic treatment and 9.06 was for borderline treatment patients group before orthodontic treatment. Treatment required patient group which had higher discomfort and disability than other two groups was 12.75 the mean of the OHIP-14 score before orthodontic treatment (Table 6). Mary et al.[46] also observed that groups that required orthodontic treatment had significantly higher OHIP-14 mean scores than groups that did not require orthodontic treatment. Navabi N et al.[47] mentioned only the domain functional limitation among 7 domains had a significant difference between treatment and no orthodontic treatment required groups. However, Clijmans et al.[48] mentioned there is a significantly weak association found between treatment required group and OHRQoL. Even some other studies showed no clear relationship between oral health and QRHQoL[49,50]. There were several possible causes for such discrepancy. The following reasons may account for the differences such as different age groups, gender, education level, various cultures, traditions, and social norms between countries and different ethnic and racial groups. Generally, people who had more severe mouth conditions had worse ORHQoL and people who had better condition had better OQHQoL in OHIP.

Overall score in a majority of these 11 studies showed that OHRQoL improved by the end of orthodontic and/or orthognathic treatments except the result of patients with cleft lip and palate group (Table 6). In other words, the majority of patients underwent orthodontic and/or orthognathic treatment got satisfaction. However, some cleft patients did not get satisfaction much unlike other patients. There have been few reports that the limited change in OHRQoL of patients with cleft lip after orthodontic treatment. There are some theories, one of them is that facial aesthetics and some other important factors that may also affect the OHRQoL of the patients. According to study done by Nichols et al.[41], patients with cleft had a greater desire for further treatment than other patients after orthodontic treatment and study by Sinko K et al.[51] also found a similar phenomenon that over 60% of the patients requested further treatment to improve the appearance of especially the nose and upper lip. Another theory is that a patient's perception or criteria of OHRQoL may have changed with the passage of time. Such perception changes could make it hard to compare OHRQoL results over time and decrease the ability of these patient-centered instruments to precisely evaluate treatment effects. However, recent studies from a large prospective study suggest that patients who undergo cleft-related surgery experience improved OHRQoL. This phenomenon needs a more detailed and accurate investigation and analysis. A score in detail within 7 domains, most affected oral impact part was psychological discomfort and psychological

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disability domain. They had higher scores than other 5 domains before treatment. In other word, patients who seek orthodontic or orthognathic treatment came to the clinic with a wish of improving psychological parts. According to Lalićet al.[52] mentioned that adult patients who visit the dental clinic, Pancevo, most commonly complained psychological discomfort, psychological disability, and physical pain. Kari Elisabeth et al.[53] also found that the most frequent domain which complained were, psychological discomfort and psychological disability physical pain domains.Couto et al.[54]and Kristinne Tenorio Guimarães Rocha et al.[55] mentioned similarly that most affected domain of life were physical pain, psychological discomfort and psychological disability domains.

In a comparison of gender, women had a higher score in overall and some domains before orthodontic or/and orthognathic treatment in these 11 studies(Figure 2). Lina et al.[56]mentioned that women had significantly higher OHIP-14 scores than men indicating that women were more affected by oral health and had lower OHRQoL than men. But Mohd Masood et al.[57] reported that although girls are more often dissatisfied than boys with their oral condition and had been irritable in contact with other people in the young people survey but the difference was not significant. In Cohen-Carneiro et al.[58] study, they found a similar result, that a significantly greater prevalence of impacts on women than in men although the extent of impacts showed no statistical significance between gender. Many studies that were reported by Oliveira et al.[59] in adolescents group and other age groups by Birkeland et al.[60], Hunt et al.[61], and Bernabe et al.[62] reported that women were more likely to get a higher dental impact than men but there was not significant difference.

The data onto relation between malocclusion and QHRQoQ in the study showed that Class I, Class II and Class III patients experienced improvements in the overall score(Figure 3). However, there was a difference in each domain and changing interval. Study of Go ̈elzer et al.[45] found that patients with Class I dentofacial deformities who underwent orthognathic surgery for the correction of vertical or transversal discrepancies obtained significant improvements from the treatment only for the psychological disability domain and questions 10 and 13, not showing any significant changes in the psychological discomfort, social disability, and handicap domains and in questions 5, 6, and 9. Class III patients statistically benefited significantly in all domains assessed and begin to show signs of developmental disorders during childhood and become physically and psychosocially affected by the deformity. These patients benefited especially from oral function and facial aesthetics to interpersonal and psychological factors, such as self-esteem and self-confidence. Although, Class II patients didn‘t show significant benefits regarding the functional limitation domain and questions 1, 2, and 7, but overall oral health in class II patients had a relationship to functional limitation, physical, psychological, social disability, and handicap. They found only two correlations found in all group were those between

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physical pain and physical disability, and between physical disability and overall oral health. According to the study of Zheng et al.[35], patients with Class I malocclusion got significant improvement from orthodontic treatment only after alignment and leveling patients and showed no significant changes in the psychological discomfort, social disability, and handicap domains while Class III patients benefited in all treatment period. Class II patients showed no significant benefits regarding psychological disability and psychological discomfort domains in initial treatment period, the domain scores were changed an apparent decline in the middle of treatment. Patients who are with Class III malocclusion got benefits in every period in, psychological disability, psychological discomfort, and physical disability domains. In addition, there was significant improvement in the functional limitation domain in the middle of a treatment period. They suggested that functional capacity, masticatory function, speech, respiratory function, and bite were positively affected by closing the space and correcting molar relationship. They additionally mentioned about comparing malocclusion patients in OHIP-14 that it would be ideal to classify patients not only by angle’s classification of malocclusion but with such as index of orthodontic treatment need(IOTN)[63] or the index of complexit, outcome, and need(ICON) [64] for accurate assessment and analysis

Although the OHIP-14 is a precise, valid and reliable instrument for assessing oral health related quality of life, the majority of studies analyzed relations or differences between treatment groups but without control groups. There are often a lot of instances when a control group is not included in an experimental design such as prospective cohort studies or pilot studies due to collecting preliminary data without too much expense. However, authors who perform analysis with OHIP-14 may need control a group to establish for more accurate comparison results.

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CONCLUSIONS

1. Majority of patients showed OHRQoL improvement by the end of orthodontic and/or orthognathic treatment.

2. Females were more dissatisfied with their oral condition and had lower OHRQoL than males.

3. All malocclusion patients showed improvements in the all of OHIP-14 domains after orthodontic and/or orthognathic treatment. However, there is a difference in each domain and changing interval during short-term

PRACTICAL RECOMMENDATIONS

Oral health-related quality of life evaluation using (OHIP-14) is helpful especially to understand patient`s dissatisfaction and inconvenience what a patient does not express directly to a dentist during treatment period. Advantage of OHIP-14 is that orthodontist can make diagnosis and evaluate both physical and psychological part of a patient. OHIP-14 should be used in combination with other conventional clinic-based measuring instruments such as IOTN or ICON to get more accurate treatment plan. Furthermore, it can be used as a scale to check how much the patient gets satisfaction after orthodontic and/or orthognathic treatment.

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ANNEX

Annex 1 The 49 items of the Oral Health Impact Profile (OHIP) organized into 7 subscales Functional limitation

1. Have you had difficulty chewing any foods because of problems with your teeth, mouth or dentures?

2. Have you had trouble pronouncing any words because of problems with your teeth, mouth ordentures?

3. Have you noticed a tooth which doesn't look right?

4. Have you felt that your appearance has been affected because of problems with your teeth, mouth or dentures?

5. Have you felt that your breath has been stale because of problems with your teeth, mouth or dentures?

6. Have you felt that your sense of taste has worsened because of problems with your teeth, mouth or dentures?

7. Have you had food catching in your teeth or dentures?

8. Have you felt that your digestion has worsened because of problems with your teeth, mouth or dentures?

9. Have you felt that your dentures have not been fitting properly?

Physical pain

10. Have you had painful aching in your mouth? 11. Have you had a sore jaw?

12. Have you had headaches because of problems with your teeth, mouth or dentures? 13. Have you had sensitive teeth, for example, due to hot or cold foods or drinks? 14. Have you had a toothache?

15. Have you had painful gums?

16. Have you found it uncomfortable to eat any foods because of problems with your teeth, mouth or dentures?

17. Have you had sore spots in your mouth? 18. Have you had uncomfortable dentures? 19. Psychological discomfort

20. Have you been worried by dental problems? 21. Have dental problems made you miserable?

22. Have you felt uncomfortable about the appearance of your teeth, mouth or dentures? 23. Have you felt tense because of problems with your teeth, mouth or dentures?

Physical disability

24. Has your speech been unclear because of problems with your teeth, mouth or dentures?

25. Have people misunderstood some of your words because of problems with your teeth, mouth or dentures?

26. Have you felt that there has been less flavour in your food because of problems with your teeth, mouth or dentures?

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27. Have you been unable to brush your teeth properly because of problems with your teeth, mouth or dentures?

28. Have you had to avoid eating some foods because of problems with your teeth, mouth or dentures?

29. Has your diet been unsatisfactory because of problems with your teeth, mouth or dentures? 30. Have you been unable to eat with your dentures because of problems with them?

31. Have you avoided smiling because of problems with your teeth, mouth or dentures? 32. Have you had to interrupt meals because of problems with your teeth, mouth or dentures?

Psychological disability

33. Has your sleep been interrupted because of problems with your teeth, mouth or dentures? 34. Have you been upset because of problems with your teeth, mouth or dentures?

35. Have you found it difficult to relax because of problems with your teeth, mouth or dentures? 36. Have you felt depressed because of problems with your teeth, mouth or dentures?

37. Has your concentration been affected because of problems with your teeth, mouth or dentures? 38. Have you been a bit embarrassed because of problems with your teeth, mouth or dentures?

Social disability

39. Have you avoided going out because of problems with your teeth, mouth or dentures?

40. Have you been less tolerant of your spouse or family because of problems with your teeth, mouth or dentures?

41. Have you had trouble getting on with other people because of problems with your teeth, mouth or dentures?

42. Have youbeen a bit irritable with other people because of problems with your teeth, mouth or dentures?

43. Have you had difficulty doing your jobs because of problems with your teeth, mouth or denture?

Handicap

44. Have you felt that your general health has worsened because of problems with your teeth, mouth or dentures?

45. Have you suffered any financial loss because of problems with your teeth, mouth or dentures? 46. Have you been unable to enjoy other people's company as much because of problems with

your teeth, mouth or dentures?

47. Have you felt that life in general was less satisfying because of problems with your teeth, mouth or dentures?

48. Have you been totally unable to function because of problems with your teeth, mouth or dentures?

49. Have you been unable to work to your full capacity because of problems with your teeth, mouth or dentures?

(39)

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Annex 2 Questionnaire consisting of OHIP-14 items

OHIP 14-Items

Ex) How often have you had problems with your teeth? Please answer using the following scores:

0 (never) 1 (hardly ever) 2 (occasionally) 3 (very often) 4 (fairly often)

OH-1 Have you had trouble pronouncing any words because of problemswith your teeth or mouth?

OH-2 Have you felt that your sense of taste has worsened because of problems with your teeth or mouth?

OH-3 Have you had painful aching in your mouth?

OH-4 Have you found it uncomfortable to eat any foods because of problems with your teeth or mouth?

OH-5 Have you felt self-conscious because of problems with your teethor mouth?

OH-6 Have you felt tense because of problems with your teeth, Or mouth?

OH-7 Has your diet been unsatisfactory because of problems with teeth or mouth?

OH-8 Have you had to interrupt meals because of problems with teeth or mouth?

OH-9 Have you found it difficult to relax because of problems with your teeth or mouth?

OH-10 Have you been a bit embarrassed because of problems with your teeth or mouth?

OH-11 Have you been a bit irritable with other people because of problems with teeth or mouth?

OH-12 Have you had difficulty doing your usual jobs because of problems with your teeth or mouth?

OH-13 Have you felt that life in general was less satisfying because of problems with your teeth or mouth?

OH-14 Have you been totally unable to function because of problems with your teeth or mouth??

(40)

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(41)

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Annex 4 Criteria for judging risk of bias in the ‘Risk of bias’ assessment tool

RANDOM SEQUENCE GENERATION Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence.

Criteria for a judgment of

‘Low risk’ of

bias

The investigators describe a random component in the sequence generation process such as:

• Referring to a random number table;

• Using a computer random number generator; • Coin tossing;

• Shuffling cards or envelopes; • Throwing dice;

• Drawing of lots; • Minimization*.

*Minimization may be implemented without a random element, and this is considered to be equivalent to being random.

Criteria for the judgment of

‘High risk’ of

bias

The investigators describe a non-random component in the sequence generation process. Usually, the description would involve some systematic, non-random approach, for example:

• Sequence generated by odd or even date of birth;

• Sequence generated by some rule based on date )or day) of admission; • Sequence generated by some rule based on hospital or clinic record number.

Other non-random approaches happen much less frequently than the systematic approaches mentioned above and tend to be obvious. They usually involve judgement or some method of non-random categorization of participants, for example:

• Allocation by judgement of the clinician; • Allocation by preference of the participant;

• Allocation based on the results of a laboratory test or a series of tests; • Allocation by availability of the intervention

Criteria for the judgment of

‘Unclear risk’

of bias

Insufficient information about the sequence generation process to permit judgement of ‘Low risk’ or ‘High risk’.

(42)

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SELECTIVE REPORTING Reporting bias due to selective outcome reporting.

Criteria for a judgment of ‘Low risk’of bias.

Any of the following:

• The study protocol is available and all of the study’s pre-specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre-specified way;

• The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were prespecified (convincing text of this nature may be uncommon).

Criteria for the judgment of ‘High risk’ of

bias.

Any one of the following:

• Not all of the study’s pre-specified primary outcomes have been reported;

• One or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. subscales) that were not pre-specified;

• One or more reported primary outcomes were not pre-specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect); • One or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta-analysis;

• The study report fails to include results for a key outcome that would be expected to have been reported for such a study.

Criteria for the Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. It is likely

ALLOCATION CONCEALMENT Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment.

Criteria for a judgment of

‘Low risk’

of bias

Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: • Central allocation )including telephone, web-based and pharmacycontrolled

randomization);

• Sequentially numbered drug containers of identical appearance; • Sequentially numbered, opaque, sealed envelopes.

Criteria for the judgment of

‘High risk’

of bias.

Participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on:

• Using an open random allocation schedule )e.g. a list of random numbers); • Assignment envelopes were used without appropriate safeguards )e.g. if envelopes were unsealed or non-opaque or not sequentially numbered);

• Alternation or rotation; • Date of birth;

• Case record number;

• Any other explicitly unconcealed procedure. Criteria for the

judgment of

‘Unclear risk’

of bias.

Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. This is usually the case if the method of concealment is not described or not described in sufficient detail to allow a definite judgement – for example if the use of assignment envelopes is described, but it remains unclear whether envelopes were sequentially numbered, opaque and sealed.

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