| |

Received: 26 November 2019    Revised: 3 January 2020    Accepted: 7 January 2020

DOI: 10.1111/pan.13825

SPECIAL INTEREST ARTICLE

Pediatric perioperative outcomes: Protocol for a systematic

literature review and identification of a core outcome set for
infants, children, and young people requiring anesthesia and
surgery

Cyrus Razavi1,2  | Suellen M. Walker3,4  | S. Ramani Moonesinghe1,2  |

Paul A. Stricker5  | on behalf of the Pediatric Perioperative Outcomes Group

1
Health Services Research Centre, Royal
College of Anaesthetists, London, UK Abstract
2
Research Department of Targeted Clinical outcomes are measurable changes in health, function, or quality of life that
Intervention, Centre for Perioperative
are important for evaluating the quality of care and comparing the efficacy of in-
Medicine, University College London,
London, UK terventions. However, clinical outcomes and related measurement tools need to be
3
Clinical Neurosciences (Pain Research), UCL well-defined, relevant, and valid. In adults, Core Outcome Measures in Effectiveness
GOS Institute of Child Health, London, UK
4
Trials (COMET) methodology has been used to develop core outcome sets for perio-
Department of Anaesthesia and Pain
Medicine, Great Ormond St Hospital NHS perative care. Systematic literature reviews identified standardized endpoints (StEP)
Foundation Trust, London, UK and valid measurement tools, and consensus across a broader range of relevant
5
The Children's Hospital of Philadelphia,
stakeholders was achieved via a Delphi process to establish Core Outcome Measures
Perelman School of Medicine at the
University of Pennsylvania, Philadelphia, in Perioperative and Anaesthetic Care (COMPAC). Core outcome sets for pediatric
PA, USA
perioperative care cannot be directly extrapolated from adult data. The type and
Correspondence weighting of endpoints within particular domains can be influenced by age-depend-
Suellen M. Walker, Clinical Neurosciences
ent differences in the indications for and/or nature of surgery and medical comor-
(Pain Research), UCL GOS Institute of Child
Health, 30 Guilford St, London WC1N 1EH, bidities, and the validity and utility of many measurement tools vary significantly
UK
with developmental stage and age. The involvement of parents/carers is essential
Email: [email protected]
as they frequently act as surrogate responders for preverbal and developmentally
Funding information delayed children, parental response may influence child outcome, and parental and/
Author time was funded by departmental
resources. SMW is supported by the Great or child ranking of outcomes may differ from those of health professionals. Here, we
Ormond Street Hospital Charity (Awards describe the formation of the international Pediatric Perioperative Outcomes Group,
W1071H and W1071I). SRM is supported by
career development funding from the Health which aims to identify and create validated, broadly applicable, patient-centered out-
Foundation and University College London come measures for infants, children, and young people. Methodologies parallel that
Hospitals National Institute for Health
Research Biomedical Research Centre where of the StEP and COMPAC projects, and systematic literature searches have been per-
she is a member of the faculty. formed within agreed age-dependent subpopulations to identify reported outcomes
and measurement tools. This represents the first steps for developing core outcome
Section Editor: Laszlo Vutskits
sets for pediatric perioperative care.

KEYWORDS

anesthesia, child, infant, newborn, pain, patient-reported outcomes, postoperative, surgery

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392     © 2020 John Wiley & Sons Ltd wileyonlinelibrary.com/journal/pan Pediatric Anesthesia. 2020;30:392–400.
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1 |  TH E N E E D FO R CO R E O U TCO M E S E T S

FO R PE D I ATR I C PE R I O PE R ATI V E C A R E What is already known about the topic

1.1 | Rationale for consensus in outcome reporting • Determining how best to measure/define a successful
anesthetic in infants, children, and young people is an

Clinical outcomes are measurable changes in health, function, or important unmet need.

quality of life which, in conjunction with the structures (settings, • Core outcome sets (COSs) can improve standardized re-

qualifications of providers, administrative systems for care) and porting to inform evidence-based practice, and support

processes (components of care) surrounding care delivery, are im- evaluation and quality improvement of perioperative

portant in evaluating the quality of health care in adults 1,2

and chil- care.
3,4
dren. However, clinical outcomes and related measurement tools
need to be well-defined, relevant, and valid to contribute to quality What new information this study adds
improvement 5 and to enable comparative trials to assess the clinical • Methodology based on the Core Outcome Measures in
efficacy of different interventions.6 Effectiveness Trials (COMET) initiative and adult periop-
A number of worldwide initiatives have been established to erative standardized endpoint projects can identify cur-
improve the relevance and consistency of selection of clinical out- rently reported pediatric perioperative outcomes.
comes and their measurement. The Core Outcome Measures in • Developing an agreed core outcome set for pediatric
Effectiveness Trials (COMET) initiative7,8 supports the development perioperative care requires consideration of age-spe-
of agreed standardized core outcome sets that can be consistently cific outcomes and clinical endpoints.
reported across all trials to reliably discriminate between beneficial,
ineffective, or harmful interventions9; allow combination of data in
high-quality systematic reviews and meta-analyses10; compare ef-
ficacy of different interventions6; inform evidence-based practice; relevant stakeholders that includes patients and carers is achieved
and drive improvements in care.7,8 In addition, standardized and via a Delphi process. Participants rank the importance of proposed
clearly defined endpoints should be of significance to key stake- endpoints (scale 1-9:1-3 “not that important or invalid,” 4-6 “impor-
holders, relevant to the patient, clinically important, and valid to en- tant but requires revision,” and 7-9 “critical for inclusion”23). Final
11
sure subsequent impact on healthcare delivery or policy. COMET recommendations are based on identifying items critical for inclu-
resources include details of standardized methodology, 8,12 a data- sion, plus rating the face and content validity, reliability, and feasi-
base of current and completed projects,7 and updated reviews.13 bility of the specific endpoints or measurement tools23 to establish
A core outcome set (COS) is defined as a minimum set of out- the Core Outcome Measures in Perioperative and Anaesthetic Care
comes to be measured and reported in clinical trials for a specific (COMPAC). 21,22 Results have been published across several prede-
condition. However, core outcome sets can also be used for research termined domains21 that include clinical indicators, 24 infection and
designs other than randomized controlled trials, and for quality im- sepsis, 25 renal endpoints, 26 postoperative cancer outcomes, 27 pul-
12
provement projects. Quality improvement initiatives related to monary complications, 28 blood loss and transfusion, 29 patient com-
surgical and perioperative care, such as the American College of fort, 23 and patient-centered outcomes.30
Surgeons National Surgical Quality Improvement Program (ACS-
NSQIP)14 and the Perioperative Quality Improvement Programme
in the United Kingdom,15 focus on adult practice, but similar ap- 1.3 | Need for pediatric-specific core outcome sets
proaches are also relevant for pediatric surgery3,16 and perioperative
care.4,17-19 Core outcome sets for pediatric perioperative care cannot be di-
rectly extrapolated from adult data. The type and weighting of
endpoints within particular domains can be influenced by age-
1.2 | Core outcome sets in adult perioperative care dependent differences in the type and/or indications for surgery,
medical comorbidities, and the range of complications. In addition
Determining which outcomes should be used to measure success is to differing from adults, outcomes within pediatric practice may
20
a research priority for anesthesia and perioperative care. COMET require consideration of specific age-based subpopulations. In
methodology8,12 is being utilized to develop core outcome sets for adults, ischemic heart disease and myocardial infarction are impor-
perioperative care in adults (age ≥ 18 years). 21,22 Systematic reviews tant cardiovascular outcomes, 21 whereas congenital heart disease
have extracted reported outcomes, and expert interpretation and influences mortality,31 risk of perioperative cardiac arrest, 32,33 and
consensus identified standardized endpoints (StEP) for periop- potential clinical indicators such as unplanned intensive care admis-
erative medicine, valid measurement tools, and clinically important sion24 in children. Readmission is a core clinical indicator, 24 but rea-
times for assessment. In parallel to this “top-down approach,” a “bot- sons for rehospitalization after discharge also differ between adults
tom-up” approach to achieve consensus across a broader range of and children.34
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394       RAZAVI et al.

Perioperative mortality is a key outcome for adult practice. weighting of individual items and the consistency of clinically signifi-
However, odds of death within 48  hours of surgery are much cant cutoff values should be confirmed in different clinical settings
lower in 1- to 18-year-olds than all older age groups, and risk is and populations (eg, Pediatric Anesthesia Emergence Delirium Scale
greatest for neonates and infants under 1 year of age (US National in Asian children52).
Anesthesia Clinical Outcomes Registry). 35 Similarly, data from a
tertiary pediatric hospital document low overall perioperative
mortality in children and adolescents, but higher rates in neo- 2 | FO R M ATI O N O F PE D I ATR I C
nates. 31 Additional levels of physiological instability 36 or poten- PE R I O PE R ATI V E O U TCO M E S G RO U P
tial long-term effects on neurodevelopmental outcome37 or pain
response38 may also result in core outcome sets for neonates and 2.1 | Development of the PPOG
infants differing from older children.
The validity and utility of many measurement tools vary sig- The Pediatric Perioperative Outcomes Group (PPOG) is an inter-
nificantly with developmental stage and age. While important national collaboration of clinicians and researchers that is pursuing
23
standardized endpoints for patient comfort domains in adults the question “How do we measure/define a successful anesthetic
such as pain, postoperative nausea and vomiting, quality of re- in infants, children and young people?”53 A Steering Committee
covery, time to gastrointestinal recovery, time to mobilization, was formed to decide on foundational work, formalize the PPOG
and sleep quality are also important for children, measurement Charter, and appoint a Project Advisory Group that included lead-
tools are influenced by age and cognitive development (eg, pain ers in pediatric clinical research and quality improvement, as well as
intensity), 39 may require further validation across pediatric age representatives from the StEP-COMPAC Group to guide the process
groups (eg, quality of recovery scores), or are not appropriate of pediatric core outcome set development.
for all ages (eg, reporting nausea or mobilization in neonates and
infants). Parents/carers frequently act as surrogate responders
for preverbal and developmentally delayed children, and play 2.2 | Registration, group charter, definition of
significant roles in reporting outcomes such as pain, analge- scope, and basis for methodology
sic requirements, and behavioral change following discharge. 40
In addition, as parental response may influence child outcome Pediatric Perioperative Outcomes Group methodology aimed to
(eg, parental pain catastrophizing and persistent postsurgical parallel that of the StEP and COMPAC projects for adult periopera-
pain 41) parent-reported measures will be relevant for some do- tive care, and the project was registered with the COMET initiative
mains. Engagement of key stakeholders is an important part of (http://www.comet-initi​ative.org/studi​es/detai​ls/1096). Consensus
the COMET process, and patients' reporting or ranking of dif- was sought for a phased approach, with an initial focus on systematic
ferent outcomes may differ from those of health professionals.42 reviews of the literature to identify reported outcomes and related
There is a clear need to include views of children and adolescents measurement tools. Subsequent phases will include stakeholder
where possible, and to involve parents/carers 43 and include par- consultation to rank candidate outcomes and develop a core out-
ent-reported tools in developing core outcome sets for pediatric come set.
perioperative care. The PPOG Charter was approved and states both the vision
(“To have a set of validated, broadly applicable, patient-centered
perioperative core outcome measures in infants, children and young
1.4 | International collaboration in core outcome set people”) and aim (“To facilitate the identification and creation of val-
(COS) development idated, broadly applicable, patient-centered outcome measures for
infants, children and young people”) of the group. In accordance with
Diverse international involvement in core outcome set development established guidelines,8,12 the PPOG aims to demonstrate transpar-
helps ensure identification of outcomes that are broadly valid and ency with open and detailed reporting.6
applicable for use in pediatric populations in different countries The Steering Committee agreed that the scope of the project
around the globe. Consensus requires an international collabora- covers patients under the age of 18 years undergoing anesthesia and
tion13 as usual practice 44 and limited resources45 may influence surgery, but excluding those having surgery for congenital heart dis-
46,47
clinical indicators and the relative importance of different out- ease. General anesthesia or sedation for nonsurgical indications (for
comes. Ideally, the validity, reliability, and sensitivity to change  of instance to facilitate imaging), that may require variable depths of
measurement tools is confirmed in different populations to ensure anesthesia/sedation and incorporate a wide range of pharmacolog-
accurate translation of instructions for observers (eg, FLACC score ical and/or nonpharmacological techniques, was also excluded. The
48,49
for pain ) and child understanding (eg,  pictorial representations COS would encompass outcomes related to the perioperative care
for self-report of  PONV50 or pain49). Behavioral outcomes follow- of the patient (that is, every aspect of patient care before, during,
ing general anesthesia in children may be influenced by cultural and after surgery other than those relating to the technical aspects
differences, and while the same outcome tools may be used,51 the of surgery and anesthesia itself). 20
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2.3 | Membership TA B L E 1   PPOG membership and committees

Name Country Email

In keeping with COMET recommendations,11,12 and as initially
(A) Steering Committee
planned,53 the PPOG includes international representatives from
Paul Stricker USA [email protected]
multiple countries (Table 1). This facilitates searching non-English
databases and will enhance generalizability of results across coun- Jurgen de Graaff Netherlands [email protected]

tries and different health services. Suellen Walker UK [email protected]

Laszlo Vutskits Switzerland [email protected]
Andrew Davidson Australia [email protected]
2.4 | Identification of pediatric subpopulations and Ellen Rawlinson UK [email protected]
outcome domains Aideen Keaney UK aideen.keaney@belfasttrust.
hscni.net
Whereas the StEP-COMPAC is a broad initiative focusing on Ting Xu China [email protected]
adults having surgery or major surgery, the PPOG Steering Wallis T. Muhly USA [email protected]
Committee recognized that a single core outcome set would not Alex Torborg South Africa [email protected]
be broadly applicable to all pediatric perioperative patients. A Elsa Taylor New Zealand [email protected]
Delphi process was used to determine the key pediatric subpopu-
Yunxia Zuo China [email protected]
lations. In the first step, all members submitted a list of potential
Raj Subramanyam USA [email protected]
candidate subpopulations via a REDCap survey. 54 The responses
Sandhya India sandhya.yaddanapudi@gmail.
were aggregated and ranked in importance in two Delphi survey Yaddanapudi com
rounds which were followed by a face-to-face consensus meet-
Tania Ramos Australia [email protected]
ing in April 2018. The threshold for consensus was set at 75%
Joe Cravero USA joseph.cravero@childrens.
agreement. harvard.edu
Through this process, group members agreed that patient age
(B) Advisory committee
has a significant impact on the type of surgery required, medical
Ramani UK [email protected]
comorbidities, and the validity and utility of different measurement Moonesinghe
tools. Consensus was reached for the following key age-dependent Lee Fleisher USA [email protected]
subpopulations: (a) neonates and former preterm infants (up to
Oliver Boney UK [email protected]
60 weeks postconception age); (b) infants less than 1 year (excluding
Dean Kurth USA [email protected]
neonates); (c) toddlers and school-age children (1-12 years); and (d)
(C) Additional PPOG members
adolescents (defined here as 13-17 years).
Lei Yang China [email protected]
Cyrus Razavi UK [email protected]

3 |  M E TH O D O LO G Y FO R PE D I ATR I C Susan Goobie USA susan.goobie@childrens.

harvard.edu
PE R I O PE R ATI V E O U TCO M E S YS TE M ATI C
Heidi Meyer South Africa [email protected]
REVIEW
Peidad Echeverry Colombia [email protected]

3.1 | Bibliographic database search strategy Carolina Perez Colombia [email protected]

Simon Whyte Canada [email protected]
A systematic search of the EMBASE database identified publica- Ruth Graham Canada [email protected]
tions (between 2008 and 2018 inclusive) that reported pediatric Rob Seal Canada [email protected]
perioperative outcomes or outcome measures (Table 2; search
strategy). In accordance with the PPOG scope, studies in children
undergoing surgery for congenital cardiac disease were excluded 3.2 | Abstract screening
with specific search terms. An initial search included all EMBASE-
listed journals, while a second search focused on pre-agreed Pediatric Perioperative Outcomes Group members were randomly al-
journals identified by the Steering Committee as most likely to located a number of abstracts to screen online, and mark as Included,
publish relevant articles. Results of the two searches were com- Excluded, or Unsure. Any uncertainties or conflicts regarding abstract
bined. To identify additional papers for either full-text or ab- inclusion/exclusion were resolved by the principal investigator (PS).
stract-only analysis, searches of the Chinese literature database All PPOG members were engaged in a WhatsApp group, overseen by
and LILACS (Latin America and Caribbean literature) were per- the principal investigator, to answer queries or request clarification.
formed by group members in the relevant countries using similar Abstracts were included if they reported outcomes related to as-
search strategies. pects of anesthetic and perioperative care, but excluded if outcomes
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396       RAZAVI et al.

related only to the surgery itself. For example, a trial evaluating post- into a draft set of domains/categories by the lead investigators for
operative pain following two different surgical procedures for tonsil- each subpopulation. Preliminary outcome domains were initially
lectomy was included, whereas one reporting anastomotic leakage based on COMPAC-StEP groupings (eg, patient comfort, patient-cen-
with two types of bowel surgical technique was excluded. Similarly, tered outcomes, clinical indicators, and healthcare resource utiliza-
anesthesia-specific intraoperative outcomes (such as intraocular tion). 21 Each draft domain set was distributed to all PPOG group
pressure during airway manipulation or supraglottic airway leak members for comment regarding the classification of outcomes and/
pressure) were excluded, while trials including outcomes such as anx- or the need for reorganization to establish thematic outcome do-
iety or postoperative vomiting with different anesthesia techniques mains. Additional details are reported in the related manuscript.
were included. Trials reporting perioperative relevant outcomes such
as length of stay or perioperative complications in addition to anes-
thesia-specific or surgery-specific outcomes were included. Studies 4 | M E TH O D O LO G Y FO R S TA K E H O LD E R
examining sedation in the emergency department, or sedation for E N G AG E M E NT A N D S E LEC TI O N O F CO R E
other indications or nonsurgical procedures, were excluded. O U TCO M E S E T S
Data related to study type, sample size, study population, age
group, perioperative outcome, and method of measurement were 4.1 | Initial stakeholder consultation exercise
extracted based on information provided in the abstract only.
Perioperative outcomes that are prioritized by pediatric patients, their
families, physicians, and other perioperative healthcare providers re-
3.3 | Full-text review main to be identified and may not be represented in recent published
literature. Acknowledging this, the PPOG will employ a bottom-up, co-
With consensus from the Steering Committee, full-text review was production approach21 to identify additional outcomes that were not
limited to pre-agreed anesthesia, pediatric, surgical, and general among those extracted in the systematic literature reviews. To achieve
medical journals (Table 3). For each subpopulation, full-text articles this, the PPOG investigators will engage patients (when feasible or ap-
were distributed across the whole PPOG membership for review. propriate), parents, perioperative nurses, surgeons, and anesthesiolo-
Data were entered into a REDCap database extraction form54 with gists to specify perioperative outcomes that are important to them.
standardized domains: manuscript title; journal; study type (rand-
omized trial, other prospective trials, retrospective or observational
study, other); sample size; and study population (eg, tonsillectomy; 4.2 | Identification and recruitment of participants
orthopedic surgery). Each reported perioperative outcome, and re-
lated measurement tool was recorded. A purposive sampling approach will be used to recruit a target num-
ber of each stakeholder group from each country with representa-
tion in PPOG. Stakeholder groups will include surgeons from various
3.4 | Results of screening and outcome extraction pediatric surgical subspecialties (general surgery, otolaryngology,
urology, plastic/reconstructive surgery, orthopedic surgery, neu-
Primary screening identified 4161 abstracts that initial reviewers rosurgery), patients and parents, anesthesiologists, pre- and post-
marked as “Included” or “Unsure.” Secondary screening for inclusion anesthesia care unit nurses, and surgical ward nurses. The nature of
and removal of duplicates resulted in 774 abstracts being included contact and its wording will be tailored to the stakeholder category.
for analysis. Abstracts were further distributed into full-text review
or abstract-only review, and allocated to each age-dependent sub-
population (Figure 1; PRISMA flow diagram55). Extracted outcome 4.3 | Data collection and identification of outcomes
lists were then forwarded to lead investigators of each subpopula-
tion for further domain-specific grouping. A mixed-methods approach will be employed with the above stake-
holder groups to explore the question of which outcomes are impor-
tant for children and families after anesthesia and surgery. This will
3.5 | Grouping of perioperative be accomplished via one-on-one free-listing methods (where partici-
outcomes and thematic domains pants list everything they consider to be relevant),56 semi-structured
interviews (where researchers use a predetermined interview sched-
It was agreed that key candidate outcome domains would not be de- ule as a basis for broader discussion with respondents), or focus
termined a priori but would instead be defined following the identifi- groups (where one or two researchers mediate an open group dis-
cation of reported outcomes in the systematic reviews, and be open cussion of several respondents). Stakeholder or site preference, and/
to modification following subsequent stakeholder engagement. or practical or cultural factors will also be considered in selecting the
Following data extraction, all outcomes and their measures from specific methodologies employed. Pediatric Perioperative Outcomes
both full-text and abstract-only arms were combined and organized Group investigators conducting these stakeholder engagement
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TA B L E 2   EMBASE search strategy

No. Query 1 Results

#13 #11 AND 'randomized controlled trial'/de AND (2008:py OR 2009:py OR 2010:py OR 2011:py OR 2012:py OR 2013:py 3706
OR 2014:py OR 2015:py OR 2016:py OR 2017:py OR 2018:py) AND ([adolescent]/lim OR [child]/lim OR [infant]/lim
OR [newborn]/lim OR [preschool]/lim OR [school]/lim)
#12 #11 AND ('clinical trial'/de OR 'controlled clinical trial'/de OR 'randomized controlled trial'/de) AND (2008:py OR 7933
2009:py OR 2010:py OR 2011:py OR 2012:py OR 2013:py OR 2014:py OR 2015:py OR 2016:py OR 2017:py OR
2018:py) AND ([adolescent]/lim OR [child]/lim OR [infant]/lim OR [newborn]/lim OR [preschool]/lim OR [school]/lim)
#11 #9 NOT #10 344 000
#10 'heart catheterization'/exp OR 'congenital heart disease'/exp OR 'congenital heart malformation'/exp OR 'history of 1 832 839
medicine'/exp OR 'heart disease'/exp
#9 #6 AND #7 AND #8 405 609
#8 'human'/exp 19 561 684
#7 'pediatric*' OR 'paediatric*' 1 514 888
#6 #1 OR #2 OR #3 OR #4 OR #5 7 420 949
#5 'analgesia'/exp OR 'spinal anesthesia'/exp OR 'postoperative analgesia'/exp OR 'analgesic agent'/exp 925 006
#4 ('(anaesthe*' NEAR/5 'complication*)') OR ('(anesthe*' NEAR/5 'complication*)') OR ('(surger*' NEAR/5 'complication*)') 461 829
OR ('(surgical*' NEAR/5 'complication*)')
#3 'perioperative period'/exp OR 'perioperative complication'/exp OR 'postoperative period'/exp OR 'postoperative 1 034 794
complication'/exp
#2 'surgery'/exp OR 'surgical technique'/exp OR 'surg*' 6 390 798
#1 'an*esth*esia' OR 'an*estheti*' OR 'an*esthesiolog*' OR 'an*esthetic agent' 829 072

No. Query 2 Results

#21 #20 AND ('clinical trial'/de OR 'controlled clinical trial'/de OR 'randomized controlled trial'/de) AND (2008:py OR 455
2009:py OR 2010:py OR 2011:py OR 2012:py OR 2013:py OR 2014:py OR 2015:py OR 2016:py OR 2017:py OR
2018:py) AND ([adolescent]/lim OR [child]/lim OR [infant]/lim OR [newborn]/lim OR [preschool]/lim OR [school]/lim)
#20 #11 AND #19 8095
#19 #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 117 523
#18 '14968975':is OR 'canadian journal of anesthesia'/jt 5415
#17 '13652044':is OR 'anaesthesia'/jt 22 835
#16 '14609592':is OR 'paediatric anaesthesia'/jt 5244
#15 '14716771':is OR 'british journal of anaesthesia'/jt 21 416
#14 '15267598':is OR 'anesthesia and analgesia'/jt 28 550
#13 '13996576':is OR 'acta anaesthesiologica scandinavica'/jt 9047
#12 '15281175':is OR 'anesthesiology'/jt 25 016
#11 #9 NOT #10 345 769
#10 'heart catheterization'/exp OR 'congenital heart disease'/exp OR 'congenital heart malformation'/exp OR 'history of 1 840 440
medicine'/exp OR 'heart disease'/exp
#9 #6 AND #7 AND #8 407 935
#8 'human'/exp 19 644 017
#7 'pediatric*' OR 'paediatric*' 1 521 958
#6 #1 OR #2 OR #3 OR #4 OR #5 7 449 113
#5 'analgesia'/exp OR 'spinal anesthesia'/exp OR 'postoperative analgesia'/exp OR 'analgesic agent'/exp 927 934
#4 ('(anaesthe*' NEAR/5 'complication*)') OR ('(anesthe*' NEAR/5 'complication*)') OR ('(surger*' NEAR/5 'complication*)') 463 227
OR ('(surgical*' NEAR/5 'complication*)')
#3 'perioperative period'/exp OR 'peroperative complication'/exp OR 'postoperative complication'/exp OR 'postoperative 1 038 980
period'/exp
#2 'surgery'/exp OR 'surgical technique'/exp OR 'surg*' 6 416 067
#1 'an*esth*esia' OR 'an*estheti*' OR 'an*esthesiolog*' OR 'an*esthetic agent' 832 186

Bold values represent entries for search.

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398       RAZAVI et al.

TA B L E 3   Journals for full-text review reviewed, duplicate outcomes removed, and similar outcomes may be
Anesthesia Anaesthesia, Anesthesia & Analgesia, grouped together. This process will result in a list of candidate outcomes
and pain Anesthesiology, British Journal of Anaesthesia, and outcome domains for the core outcome set for each subpopulation.
Canadian Journal of Anesthesia, European Journal
of Anaesthesiology, Pain, Pediatric Anesthesia, and
Regional Anesthesia and Pain Medicine
4.5 | Outcome ranking by stakeholders with
Surgery Annals of Surgery, JAMA Surgery, Journal of
Pediatric Surgery Delphi process and selection of core outcome set
Pediatrics Archives of Disease in Childhood, JAMA Pediatrics,
outcome domains
Pediatrics
General British Medical Journal, JAMA, Lancet, Lancet The long list of candidate outcomes will be presented to representa-
medical Respiratory Medicine, New England Journal of tives of stakeholder groups in an international multiround online Delphi
Medicine survey. Stakeholders will be asked to rate the importance of each of
the outcomes presented, using a Likert scale of 1-9 with 1 representing
activities will receive specific training in these techniques by ex- “not important” and 9 representing “very important.” Stakeholders will
perts at the Mixed Methods Research Laboratory (MMRL) at the be engaged in a manner analogous to that used for the initial stake-
University of Pennsylvania. The MMRL will perform interval exami- holder consultation exercise described above, and will include patients,
nations of collected data for methodological quality assurance. parents, perioperative nurses, surgeons, and anesthesiologists. Delphi
survey data will be reviewed by subpopulation lead investigators and
the Steering Committee, with consensus thresholds defined a priori.
4.4 | Long-list outcome creation/merging, grouping
into domains
4.6 | Final consensus meeting
For each age-based subpopulation, the outcomes identified from the
stakeholder consultation exercise will be combined with those identi- Following completion of the Delphi process, a face-to-face con-
fied from the systematic reviews. Subsequently, these long lists will be sensus meeting of experts will be held to review and finalize the

F I G U R E 1   PRISMA flow chart for

systematic literature review. *Some
publications included subjects from more
than one age-specific subpopulation
RAZAVI et al. |
      399

outcome domains in the core outcome set for each subpopula- 3. Cameron DB, Rangel SJ. Quality improvement in pediatric surgery.
Curr Opin Pediatr. 2016;28(3):348-355.
tion. Attendees will be provided with the results of the third Delphi
4. Kurth CD, Tyler D, Heitmiller E, Tosone SR, Martin L, Deshpande
round of outcome ranking, including the scores for each outcome JK. National pediatric anesthesia safety quality improvement pro-
per stakeholder group and status of any consensus. Following dis- gram in the United States. Anesth Analg. 2014;119(1):112-121.
cussion moderated by the meeting chair, each outcome that reaches 5. Khuri SF, Daley J, Henderson W, et al. The Department of
Veterans Affairs' NSQIP: the first national, validated, out-
consensus will be identified, and “what to measure” will be included
come-based, risk-adjusted, and peer-controlled program for the
in the finalized COS. measurement and enhancement of the quality of surgical care.
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The authors wish to thank Dr Sherry Morgan, Clinical and Graduate 14. ACS National Surgical Quality Improvement Program (ACS NSQIP®).
Research Liaison, University of Pennsylvania Biomedical Library, https​://www.facs.org/quali​ty-progr​ams/acs-nsqip​. Accessed January
Philadelphia, PA 19104-6060, for help developing the EMBASE search 10, 2019.
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C O N FL I C T O F I N T E R E S T 16. Rangel SJ. Moving the needle toward high-quality pediatric sur-
The authors report no financial conflict of interest. Paul Stricker is gical care: How can we achieve this goal through prioritization,
measurement and more effective collaboration? J Pediatr Surg.
an associate editor and Suellen Walker is a section editor of Pediatric
2017;52(5):669-676.
Anesthesia. 17. Hagerman NS, Varughese AM, Kurth CD. Quality and safety in pe-
diatric anesthesia: how can guidelines, checklists, and initiatives
ORCID improve the outcome? Curr Opin Anaesthesiol. 2014;27(3):323-329.
18. Polaner DM, Houck CS. Critical elements for the pediatric
Cyrus Razavi  https://orcid.org/0000-0002-4071-5401
perioperative anesthesia environment. Pediatrics. 2015;136(6):​
Suellen M. Walker  https://orcid.org/0000-0002-6086-9459 1200-1205.
Suneetha R. Moonesinghe  https://orcid.org/0000-0002-6730-5824 19. Buck D, Kurth CD, Varughese A. Perspectives on quality and safety
Paul A. Stricker  https://orcid.org/0000-0001-5012-8035 in pediatric anesthesia. Anesthesiol Clin. 2014;32(1):281-294.
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