Systematic review
13767
Defining low anterior resection syndrome: a systematic review
of the literature
C. Keane* , C. Wells*, G. O’Grady* and I. P. Bissett*†
*Department of Surgery, University of Auckland, Auckland, New Zealand, and †Department of Surgery, Auckland City Hospital, Auckland, New
Zealand
Received 7 September 2016; accepted 29 March 2017; Accepted Article online 14 June 2017
Abstract
Aim There is increasing awareness of the poor func-
tional outcome suffered by many patients after sphinc-
ter-preserving rectal resection, termed ‘low anterior
resection syndrome’ (LARS). There is no consensus def-
inition of LARS and varying instruments have been
employed to measure functional outcome, complicating
research into prevalence, contributing factors and
potential therapies. We therefore aimed to describe the
instruments and outcome measures used in studies of
bowel dysfunction after low anterior resection and iden-
tify major themes used in the assessment of LARS.
Method A systematic review of the literature was per-
formed for studies published between 1986 and 2016.
The instruments and outcome measures used to report
bowel function after low anterior resection were
extracted and their frequency of use calculated.
Results The search revealed 128 eligible studies. These
employed 18 instruments, over 30 symptoms, and
Introduction
‘Low anterior resection syndrome’ (LARS) has been
reported to occur in up to 80% of patients after low
anterior resection (LAR) [1]. LARS has been used to
encompass a wide array of symptoms after sphincter-
preserving rectal surgery, including difficulty emptying
the bowel, faecal urgency and faecal incontinence [2].
Despite numerous publications measuring functional
outcomes after LAR, a consensus definition of LARS is
lacking. A pragmatic definition proposed by Bryant
et al., ‘disordered bowel function after rectal resection,
leading to a detriment in quality of life’ [2], is appropri-
ate for clinical use, but a specific definition is needed to
Correspondence to: Prof. Ian P. Bissett, The University of Auckland, Private Bag
92019, Auckland Mail Centre, Auckland 1142, New Zealand.
E-mail: i.bissett@auckland.ac.nz
Colorectal Disease ª 2017 The Association of Coloproctology of Great Britain and Ireland. 19, 713–722
doi:10.1111/codi.
follow-up time periods from 4 weeks to 14.6 years. The
most frequent follow-up period was 12 months (48%).
The most frequently reported outcomes were inconti-
nence (97%), stool frequency (80%), urgency (67%),
evacuatory dysfunction (47%), gas–stool discrimination
(34%) and a measure of quality of life (80%). Faecal
incontinence scoring systems were used frequently. The
LARS score and the Bowel Function Instrument (BFI)
were used in only nine studies.
Conclusion LARS is common, but there is substantial
variation in the reporting of functional outcomes after
low anterior resection. Most studies have focused on
incontinence, omitting other symptoms that correlate
with patients’ quality of life. To improve and standard-
ize research into LARS, a consensus definition should
be developed, and these findings should inform this
goal.
Keywords Cancer, functional, surgery, colorectal
standardize research into prevalence, risk factors, patho-
physiology, prevention and therapy of LARS.
Due to the lack of a consensus definition of LARS,
functional outcomes after LAR have been measured
using a wide variety of tools. Functional outcome has
commonly been assessed by evaluating faecal inconti-
nence [3], reflecting the emphasis clinicians place on
this outcome. Two tools, the Memorial Sloan Kettering
Cancer Center (MSKCC) Bowel Function Instrument
(BFI) [4] and the LARS score [5], have been intro-
duced to measure bowel function after LAR. The
authors of the LARS score noted that clinicians lack a
patient-centred understanding of which LARS symp-
toms correlate most closely with quality of life, for
example clustering and urgency [5,6]. The LARS score
is a quick clinically applicable tool while the BFI is a
comprehensive instrument. Neither tool was intended
as a definition of LARS.
713
Defining LARS: a systematic review of the literature
The aim of this systematic review is to describe the
outcome measures (bowel function instruments, symp-
toms and follow-up time periods) being used to assess
bowel dysfunction after LAR for rectal cancer, and to
assess the frequency of use for each measure. The moti-
vation behind this review was to identify key priorities
in the assessment of LARS to help inform the develop-
ment of an accepted consensus definition.
Method
Data sources
A systematic review was conducted according to the
PRISMA guidelines [7]. A systematic search was per-
formed through the Ovid MEDLINE, EMBASE,
CINAHL and Cochrane databases, capturing publica-
tions between 1986 and July 2016. Boolean AND/OR
operators were used to combine keyword (and trunca-
tions) and MeSH search terms. For the MEDLINE and
EMBASE search the keywords and MeSH terms
included faecal incontinence, urgency, evacuatory disor-
ders and obstructive defaecation, as well as operative
techniques in anterior resection surgery. A similar search
strategy was used for the CINAHL and Cochrane data-
bases. The full search string details are given in
Appendix S1. There were no language limits. A manual
search of review article reference lists was undertaken.
Study selection
Studies were eligible for inclusion if they reported
prospectively collected bowel function outcomes, as a
primary or secondary outcome, in adult human subjects
who had undergone anterior resection with tumour-
specific mesorectal excision (TsME) for rectal cancer.
Studies that included patients undergoing intersphinc-
teric resection (ISR) or transanal total mesorectal exci-
sion (TaTME) were included. Reviews, case reports,
editorials, commentaries and retrospective studies were
excluded. Studies reporting solely on operative out-
comes, survival, recurrence, postoperative urinary or
sexual function, or quality of life outcomes were
excluded, as were studies reporting sphincter recon-
struction procedures. Studies reporting duplicated data
were excluded.
Methods of review and data extraction
Two reviewers compiled a list of studies that met the
inclusion criteria by independently screening titles and
abstracts. The list of eligible studies was compared prior
to acquisition of full texts, and data were extracted in a
714 Colorectal Disease ª 2017 The Association of Coloproctology of Great Britain and Ireland. 19, 713–722
C. Keane et al.
proforma, with verification by the second reviewer. Any
discrepancies were resolved by consensus or arbitration
by a third author. The following data were extracted for
each study:
1 study characteristics
2 instrument(s) used to assess bowel function and qual-
ity of life
3 number of participants
4 surgery performed and indication for surgery
5 symptoms of postoperative bowel function reported
(including symptoms contained within a bowel func-
tion instrument but not those incorporated into a
quality of life instrument)
6 follow-up time
7 LARS score (if reported).
Data were analysed according to four themes: instru-
ments used, symptoms reported, follow-up periods and
quality of life evaluation. Descriptive statistics were used
to summarize the major outcomes.
Methodological quality of included studies
Two reviewers independently assessed the quality of the
studies. The Jadad score [8] was applied to assess the
quality of randomized controlled trials (RCTs), although
its application was limited by a lack of blinding in the
included studies. Therefore, a second measure, adapted
from previous reviews was employed (Table 1) [9,10].
Results
Included studies
A total of 4542 articles were identified and 605 full text
articles were screened. From these, 128 eligible prospec-
tive studies were identified including 45 RCTs. Full
search outcomes including reasons for exclusion are
shown in the PRISMA diagram (Fig. 1). A detailed list
of included studies is given in Appendix S2.
Substantial heterogeneity was identified in the surgi-
cal approaches employed in the research papers.
Seventy-nine studies reported outcomes after LAR.
Coloanal anastomosis was included in 47 studies and
ISR in 22 studies. A straight anastomosis was created in
53% of studies, a J pouch in 52% and a coloplasty in
17% (some studies included multiple types of recon-
struction).
Study quality assessment
All studies were assessed for quality using the six criteria
in Table 1. The median score was 3 [interquartile range
C. Keane et al.
Table 1 Quality assessment tool.
Quality assessment criteria
Were consecutive patients enrolled?
Was patient symptomatology recorded at baseline?
Was anastomotic height (not tumour height) reported?
Was the number of patients undergoing radiotherapy reported?
Was a validated bowel function instrument used?
Was loss to follow-up greater than 25%?*
NR, not reported.
*If a study had multiple follow-up time points the initial time point was used to assess loss to follow-up. The criterion for loss to
follow-up was set at 25% as many of the studies had lengthy follow-up periods.
(IQR) 2–4]. Five studies (4%) met all criteria and 63
studies (49%) met at least four quality criteria. One
RCT [11] had a Jadad score of 5, as it was double
blind. All studies were included to provide a compre-
hensive description of the outcome measures used in
the literature to describe bowel function after anterior
resection.
Study quality was not associated with use of a vali-
dated instrument designed to measure LARS. The six
studies that employed the LARS score had a median
quality score of 4 and the two RCTS had a Jadad score
of 2. The three studies that employed the BFI had a
median quality score of 3.
Instruments used to measure bowel function
Eighteen instruments were identified that assessed post-
operative bowel function, and the frequency of use for
each instrument is reported in Fig. 2. The most fre-
quently used instruments evaluated incontinence only:
the Wexner score (23%) [12], the Kirwan classification
(17%) [13] and the Fecal Incontinence Severity Index
(5%) [14]. In 36% of studies no specific instrument was
used and authors instead assessed varying combinations
of symptoms.
Twenty-six studies were published after the LARS
score was introduced. The LARS score was applied in
six studies (23%) and outcomes were reported in five
studies (19%) [15–20]. A pooled analysis of LARS
scores was not possible as the studies were heteroge-
neous in terms of follow-up period(s) and patient popu-
lations (e.g. rates of neoadjuvant therapy, partial vs total
mesorectal excision, straight anastomosis vs reservoir
reconstruction). Major LARS was reported in 38–62%,
minor LARS in 22–28% and no LARS in 10–38% of
patients.
The MSKCC BFI was used in three (5%) of the
studies published after the BFI was introduced [21–23].
Colorectal Disease ª 2017 The Association of Coloproctology of Great Britain and Ireland. 19, 713–722
Defining LARS: a systematic review of the literature
Score
1 0
Yes No/NR
Yes No/NR
Yes No/NR
Yes No/NR
Yes No/NR
No Yes/NR
One study reported the outcome categories of excellent,
good, fair and poor function [21], another reported
mean scores [23] and the third study reported using
the BFI but did not report the outcomes [22], hence a
pooled analysis was not possible. A further study
reported anterior resection syndrome in 6% (two
patients) but did not specify how this was defined [24].
Symptoms reported
More than 30 symptoms of postoperative bowel dys-
function were reported in the 128 studies. These symp-
toms are listed in Fig. 3a with their frequency of
occurrence. Overall, the most frequently reported symp-
toms were faecal incontinence (97% of studies), stool
frequency (80%), flatus incontinence (70%), urgency
(67%) and pad wearing (66%). These symptoms were
reported twice as many times as almost all of the other
symptoms reported. The next most frequently recorded
outcome was lifestyle modification (52%).
Incontinence
Some authors distinguished between soiling and incon-
tinence, and incontinence for liquid/loose stool vs solid
stool incontinence. Nocturnal incontinence was assessed
in 21 studies (16%). Mucus discharge was assessed in
12 studies (9%). Perianal excoriation was assessed in 10
studies (8%); two of these did not ask about pad wear-
ing. All studies that asked about pad wearing and/or
perianal excoriation also assessed faecal incontinence.
Urgency was assessed in 86 studies (67%): 66 studies
assessed urgency outside of a bowel function instru-
ment, 45 studies assessed deferral time (from 5 to
30 min) and nine studies assessed toilet dependence,
‘warning period’, or ‘rush to the toilet’, while the
remaining studies did not define urgency. Despite being
included in only the BFI questionnaire, gas–stool
discrimination was reported in 44 studies (35%).
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Defining LARS: a systematic review of the literature C. Keane et al.

Identification
Records identified through Additional records identified through
database searching (n = 4437) other sources (n = 105)

Records after duplicates

removed (n = 3187)
Screening

Records screened (n = 3187) Records excluded (n = 2582)

Full-text articles excluded, with reasons

Eligibility

Full-text articles assessed (n = 477)

(n = 605) • Retrospective (n = 186)
• No English translation (n = 115)
• Outcomes other than bowel function (n = 46)
• Treatment of ARS (n = 35)
• Pre TsME era (n = 34)
• Review, case study, or editorial (n = 34)
• Procedure other than anterior resection (n = 16)
• Indication other than rectal cancer (n = 6)
Included

Studies included in qualitative • Animal study (n = 4)

synthesis (n = 128) • Other (n = 1)

Figure 1 PRISMA flow diagram (TsME, tumour-specific mesorectal excision).

Bowel habit concept was assessed in a total of 45 studies (35%). One

The LARS score, BFI, COREFO and Hallbook’s ques-
tionnaire include an assessment of stool frequency.
Twenty studies (16%) evaluated nocturnal stool fre-
quency. Twenty-one studies (16%) asked about stool
consistency including diarrhoea and/or constipation.
Use of medication, including antidiarrhoeals and evacu-
atory aids, was assessed in 49 studies (38%).
Changes to evacuatory function
Clustering was assessed in 15 studies (12%) fragmenta-
tion in 33 studies (26%) and, using either term, the
study used these terms interchangeably [25]. Clustering
was assessed within the LARS score in five studies, and
within the BFI in three studies [15–17,19,21–23,26]
The only study to define clustering used ‘incomplete
evacuation that required multiple movements within a
limited time period (3 h)’[27]. Thirty-nine per cent of
studies assessed fragmentation by asking if, within 1 h,
patients returned to the toilet, needed to defaecate
again or had multiple evacuations.
Incomplete emptying was reported in 26% of studies
by asking the following: do you feel that you have

716 Colorectal Disease ª 2017 The Association of Coloproctology of Great Britain and Ireland. 19, 713–722
C. Keane et al.
COREFO
AMS FIS
Figure 2 Instruments used to assess
McDonald & Heald
post-operative bowel function
(COREFO, Colorectal Functional
Outcome questionnaire [39]; AMS FIS,
American Medical System Fecal
Incontinence Severity score [40]; BFI,
Memorial Sloan Kettering Cancer Center
LARS score
(MSKCC) Bowel Function Instrument
[4]; LARS score, Low Anterior Resection
Syndrome score [5]; FISI, Fecal
Incontinence Severity Index [14];
‘Other’ includes the MSKCC sphincter
function criteria [41], Pecatori Anal
Incontinence Score [42], Anal Sphincter
Conserving Treatment questionnaire No instrument used
[43], Rotterdam symptom checklist [44],
Komatsu score [45] and the
Holschneider questionnaire [46]).
totally emptied your bowels after a bowel motion; do
you have a sense of residual stool; do you have incom-
plete evacuation that required multiple movements
within a limited period of time? Despite an overlapping
definition in some studies, incomplete emptying and
clustering and/or fragmentation were assessed sepa-
rately in 13 studies. Patients were also asked about
tenesmus, difficulty emptying, evacuation time, ability
to expel stool/empty pouch, straining, pain on defaeca-
tion and the desire or urge to defaecate. Use of evacua-
tory aids (laxatives, suppositories, enemas, digitation,
catheter) was assessed in 34 studies (27%), including 11
studies that did not report another measure of evacua-
tory dysfunction. The COREFO, BFI and Hallbook
questionnaire all include measures of evacuatory
function.
Impact on quality of life
One hundred and three studies (80%) included a mea-
sure of behaviour change, patient satisfaction or an
assessment of quality of life (Fig. 3b). In 67 studies
(52%) patients were asked about alterations in their life-
style due to their bowel habit. The Wexner, St Mark’s
and American Medical Society incontinence scores, Kir-
wan classification, BFI, COREFO, Hallbook’s and
McDonald’s questionnaires all include lifestyle alter-
ation. Lifestyle alteration included activity restriction,
impact on social life and sexual function, change in gen-
eral behaviour and effect on overall wellbeing. Seventy-
three per cent of studies evaluated some form of beha-
viour change, including pad wearing, medication use,
dietary measures and lifestyle alteration. Dietary changes
Colorectal Disease ª 2017 The Association of Coloproctology of Great Britain and Ireland. 19, 713–722
Defining LARS: a systematic review of the literature
Other
St Marks
Williams
BFI
FISI
Hallbook
Kirwan
Wexner
0 10 20 30 40 50
Number of studies
or restrictions were assessed in 10 studies (8%). Patient
satisfaction was assessed in 14 studies (11%); eight of
these also assessed lifestyle modification. Quality of life
was assessed using a validated questionnaire in an addi-
tional 20 studies (16%). European Organization for
Research and Treatment of Cancer (EORTC) question-
naires were used in 17 studies (13%). The EORTC
QLQ-C30, QLQ-CR38 and QLQ-CR29 measure qual-
ity of life in patients with cancer and colorectal cancer,
respectively.
Follow-up duration
The follow-up period ranged from 4 weeks to
14.6 years (Fig. 3c). Almost half (48%) of the included
studies included an assessment of bowel function at
12 months. Forty-three per cent of studies measured
outcomes at more than one time point.
Discussion
The aim of this review was to determine the outcome
measures used to report bowel dysfunction after LAR
and quantify their use. The search revealed a substantial
volume of literature which contained considerable
heterogeneity with regard to inclusion criteria and out-
come measures. Eighteen bowel function instruments,
over 30 symptoms, and time periods from 4 weeks to
14.6 years were used to assess outcomes after sphincter-
preserving resection between 1986 and 2016.
The majority of instruments used to assess post-LAR
bowel function measure faecal incontinence, omitting
other symptoms that have been shown to have a more
717
Defining LARS: a systematic review of the literature C. Keane et al.

(a)
Straining
Ability to expel stool
Regularity
Pain on defecation
Sensation of need to defecate
Constipation
Diarrhoea
Medication NOS
Tenesmus Symptom reported separately
Stool consistency
Dietary modifications Symptom reported within an
Perianal excoriation instrument
Evacuation time
Difficulty emptying
Mucus discharge
Satisfaction
Clustering
Nocturnal frequency
Nocturnal incontinence
Other
Antidiarrhoeals
Incomplete evacuation
Fragmentation
Evacuatory aids
Gas-stool discrimination
Lifestyle modifications
Pad wearing
Urgency
Flatus incontience
Stool frequency
Faecal incontinence

0 20 40 60 80 100 120
Number of studies
Figure 3 (a) Outcome measures reported (NOS, not otherwise specified; ‘Other’ includes perianal soreness, type of evacuation,
dyschezia, anal pain not during defaecation, flatulence, pelvic pain, anal bleeding, anal mucus loss, mean toilet time per day, need
for care, preference for stoma). (b) Outcome measures used to assess quality of life or behaviour change (QoL, quality of life). (c)
Follow-up time period reported (months, year).

significant correlation with quality of life, such as clus-
tering and urgency [5]. The questionnaires designed
specifically to measure LARS, i.e. the LARS score and
BFI, were used in only 23 and 5%, respectively, of stud-
ies published after they were introduced. Scheer and
colleagues summarized the literature published prior to
the introduction of the LARS score [28]. Their results
are consistent with the current findings, that authors
often used their own measures of outcome rather than
validated instruments, or rely on faecal incontinence
scores to assess functional outcomes [28]. Therefore,
despite the extensive literature on the subject of post-
LAR functional outcome, many studies provide inade-
quate data to compare LARS prevalence or to draw
externally valid conclusions. For example, multiple stud-
ies [17,29–31] have demonstrated that radiotherapy is

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C. Keane et al. Defining LARS: a systematic review of the literature

(b)
Preference for stoma

Patient satisfaction

Validated QoL tool

Lifestyle alteration

Behaviour change

20

40

60

80

0
10
Number of studies
(c)
≥10 years
6-9 years
5 years
4 years
3 years
24 months
18 months
12 months
9 months
8 months
7 months
6 months
5 months
4 months
3 months
2 months
1 month

0 10 20 30 40 50 60 70
Figure 3 Continued. Number of studies

associated with poor function after resection, but
heterogeneity in the outcomes reported has limited
pooled analyses [32,33].
Despite this heterogeneity, several important themes
were revealed. The most common outcomes reported
were: incontinence, stool frequency, urgency, gas–stool
discrimination, multiple evacuations, evacuatory dys-
function and impact on quality of life. Incontinence and
stool frequency were assessed in most studies and are
included in the BFI and LARS score, indicating that
they are consistently considered to be important com-
ponents of LARS. Urgency, gas–stool discrimination
and evacuatory dysfunction were reported frequently
despite being included in few instruments, suggesting
that many researchers consider these to be important
symptoms. The ability to defer defaecation was the most
commonly used definition of urgency, but this differs
from the LARS score (i.e. ‘. . . such a strong urge . . .
that you have to rush to the toilet?’) [5]. The defini-
tions reported for clustering and fragmentation fre-
quently overlapped, and these symptoms may be
appropriately combined. The impact of postoperative
functional outcomes on patients’ lives or wellbeing was
assessed frequently, but variable approaches were also
used.
The symptoms identified as priorities in this review
are consistent with a previous systematic review [28]
conducted prior to the publication of the LARS score.

Colorectal Disease ª 2017 The Association of Coloproctology of Great Britain and Ireland. 19, 713–722 719
Defining LARS: a systematic review of the literature
Scheer et al. also found that incontinence (90%),
urgency (90%), pad usage (75%), clustering (48%), gas–
stool discrimination (48%), incomplete evacuation
(31%) and stool frequency (31%) were frequently
reported [28]. All of these themes are included in the
BFI. The LARS score incorporates all of these themes
except gas–stool discrimination, but it is worth clarify-
ing that the LARS score was designed as an easily appli-
cable clinical tool and was not conceived as a formal
definition of LARS.
There is currently no consensus on when short-lived
postoperative dysfunction should resolve, and therefore
when patients with dysfunction would be categorized as
having LARS. Long-term follow-up studies suggest that
LARS may reflect permanent pathophysiological
changes, as dysfunction can persist beyond 14 years
after surgery. Remodelling or adaptation may occur
beyond 1 year [34]: until 18 months postoperatively a
colonic J pouch gives superior functional results to a
straight anastomosis but after 24 months function is
similar regardless of the type of reconstruction [35,36].
The BFI and the LARS score were developed using
patients who were at least 5 months and 2 years post-
LAR, respectively, but neither instrument specifies a fol-
low-up period for measurement of LARS. In the litera-
ture, outcomes were most frequently assessed
12 months postoperatively (48% of studies). However,
frequency of use may not equate to importance. Inter-
estingly, 30% of studies reported outcomes at 3 months
or earlier, and 5% of studies assessed outcomes at
4 weeks. These short follow-up periods are insufficient
to assess changes in bowel pattern, and the results will
be confounded by temporary postoperative dysfunction.
There is limited evidence to inform discussion about an
adequate follow-up period but we propose a definition
of LARS should incorporate either 6 months of bowel
continuity to align with the Rome III criteria of func-
tional defaecation disorders [37] or 12 months of
bowel continuity, as our results suggest that most
authors think 12 months is acceptable. More research is
needed to examine the prevalence of LARS over time.
Our thematic analysis of the current literature
reporting functional outcomes after LAR has revealed
significant themes that reflect priorities in the assess-
ment of functional outcome. These themes should be
incorporated into a definition of LARS that can be
used to clarify the prevalence and investigate the
pathophysiology and treatment of LARS. We propose
that a preliminary consensus definition of LARS should
incorporate the important themes identified by this
review and include criteria identified as correlating with
quality of life [5,38] – incontinence, stool frequency,
urgency, gas–stool discrimination, clustering,
720 Colorectal Disease ª 2017 The Association of Coloproctology of Great Britain and Ireland. 19, 713–722
C. Keane et al.
evacuatory dysfunction and impact on life – at a
defined follow-up period.
An important limitation of this study is the evalua-
tion of frequency as a marker of importance for each
outcome measure. This approach does not account for
the differential access to various instruments to measure
functional outcome, and may be subject to clinician and
publication bias. Therefore, to advance our consensus
definition of LARS, consultation with experts in the
field will need to be undertaken to supplement this
analysis. The major strength of this review is the
exhaustive search of the literature, with inclusion of
both randomized and nonrandomized studies over a
long time period from multiple colorectal research insti-
tutions.
In conclusion, this review highlights that although
LARS is common, there is significant heterogeneity in
its investigation and reporting, and the majority of stud-
ies have used suboptimal assessment approaches. These
findings should provide motivation and information to
facilitate and inform discussion about a consensus defi-
nition of LARS. A consensus definition should be
achieved through engagement and collaboration
between experts in this field.
Acknowledgements
The AMRF Ruth Spencer Medical Research Fellowship
funds CK.
Author contributions
CK, primary reviewer, responsible for conducting the
search, identifying eligible studies, assessing study qual-
ity, extracting and analysing data, and preparing the
manuscript. CW, second reviewer, responsible for con-
ducting the search, identifying eligible studies, assessing
study quality, verifying accuracy of extracted data.
Involved in preparing and reviewing the manuscript. GO,
third reviewer, responsible for reconciling discrepancies,
preparing and reviewing the manuscript. IB, responsible
for supervision and review of the manuscript.
Disclosures
CK is funded by the Auckland Medical Research Foun-
dation (AMRF) Ruth Spencer Medical Research Fellow-
ship.
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Supporting Information
Additional Supporting Information may be found in the
online version of this article:
Appendix S1. Search strategy.
Appendix S2. Characteristics of included studies.