REVIEW PAPER

The IDEAL Reporting Guidelines

A Delphi Consensus Statement Stage Specific Recommendations
for Reporting the Evaluation of Surgical Innovation
Nicole A. Bilbro, MD, MPH,  y Allison Hirst, MSc,  Arsenio Paez, PT, DPT,z§ Baptiste Vasey, 
Maria Pufulete,ô Art Sedrakyan, MD, PhD,jj and Peter McCulloch, MD  Y, on behalf
Downloaded from [Link] by 01UGrXh3ipqzR4DKqW7bOJtSxsRVOheLV9OzOeHq2POX2t1GrKUD6m1aBQdlm0lX7bZxxCFBpuxAM3exuxdXARVaPXROhrEIELxLuiE5dAoxEXL1EbBXOmtN5qOe2K0cRH9XYihoqJLhl/QMQTWBWg== on 03/16/2021

of the IDEAL Collaboration Reporting Guidelines Working Group

(n ¼ 54 and n ¼ 47, respectively), resulting in a penultimate checklist for each

Objective: The aim of this study was to define reporting standards for IDEAL
stage. Fourteen expert working group members finalized the checklist items
format studies.
and successfully resolved any outstanding areas without agreement on a
Background: The IDEAL Framework and Recommendations establish an
consensus call.
integrated pathway for evaluation of new surgical techniques and complex
Conclusions: Participants familiar with IDEAL called for reporting guide-
therapeutic technologies. However guidance on implementation has been
lines for studies in all IDEAL stages except stage 3. The checklists developed
incomplete, and incorrect use is commonly seen. We describe the consensus
have the potential to improve standards of reporting and thereby advance the
development of reporting guidelines for the IDEAL stages, and plans for their
quality of research on surgery and complex interventions and technologies,
dissemination and evaluation.
but require further evaluation in use.
Methods: Using the EQUATOR Network recommendations, participants with
knowledge of IDEAL were surveyed to determine which IDEAL stages needed Keywords: complex interventions, ethics, IDEAL, registries, reporting
reporting guidelines. Draft checklists for stages 1, 2a, 2b, and 4 were subse- guidelines, research methodology, surgical innovation, surgical research
quently developed by 3 researchers (N.B., A.H., P.M.), and revised through a 2-
(Ann Surg 2021;273:82–85)
round Delphi consensus process. A final consensus teleconference resolved
outstanding disagreements and clarified wording for checklist items.
Results: Sixty-one participants completed the initial survey, a clear majority
indicating that new reporting guidelines were needed for IDEAL Stage 1
(69.5%), Stage 2a (78%), Stage 2b (74.6%), and Stage 4 (66%). A proposed
set of checklists was modified by survey participants in 2 online Delphi rounds S urgical innovation is recognized as having unique methodologi-
cal and practical barriers that make rigorous evaluation and
quality reporting inherently complex.1 The Idea, Development,
Exploration, Assessment, Long Term Study (IDEAL) Framework
From the University of Oxford, Nuffield Department of Surgical Sciences, John
Radcliffe Hospital, Oxford, UK; yMaimonides Medical Center, Department of and Recommendations were introduced in 2009 to clarify and
Surgery, Brooklyn, NY; zNuffield Department of Primary Care Health Sci- address the key challenges presented in surgical innovation.2 The
ences, University of Oxford, Oxford, UK; § Northeastern University, Depart- IDEAL integrated evaluation pathway guides the conduct and report-
ment of Physical Therapy, Movement, and Rehabilitation Sciences, Boston, ing of clinical studies of the outcomes of surgery and complex
MA; ôClinical Trials and Evaluation Unit, Bristol Medical School, University
of Bristol, Bristol Royal Infirmary, Bristol, UK; and jjWeill Cornell Medical therapeutic interventions. The IDEAL Framework has evolved over
College, New York, NY. time, and now includes a model for medical devices evaluation,
[Link]@[Link]. IDEAL-D, and a modified framework for physical therapy and
N.B., A.H., and A.P. are joint first authors rehabilitation, IDEAL-Physio.3–6
Funding: No specific funding was obtained for this project. The IDEAL Collabo-
ration is supported by the Oxford NIHR Biomedical Research Centre, an Although widely accepted in principle, the use of the IDEAL
unrestricted Educational Grant from Medtronic as well as other educational recommendations in practice to date has been limited and in many
grants and meetings income (A.H. and P.M.). cases suboptimal. Surveys of publications using IDEAL have shown
The authors report no conflicts of interests. that reporting of the stages was often inaccurate and the key features
Delphi Survey Participants: Alfred Adiamah, Augusto Azuara-Blanco, Chris
Bainbridge, Dimitri Barski, Natalie Blencowe, Jan Bosteels, Cristina which define each stage were frequently omitted.7 –9 The IDEAL
Camargo, Wim Ceelen, Alejandro Correa Paris, Neil Corrigan, Joanna Recommendations introduce several novel ideas into clinical study
Crocker, Nathan Curtis, Prita Daliya, Susan Dutton, Thorsten Ecke, Julio F design, and following other published guidelines alone is therefore
Fiore Jr., George Garas, Herney Garcia-Perdomo, Gus Gazzard, Janneke unlikely to enable authors to report them accurately. The lack of clear
Grutters, Emma Hall, Thomas Hamilton, Ted Heise, Daniel Hind, Sorin
Hostiuc, Jarkko Jokihaara, Emma Jones, Lileswar Kaman, Sean Kehoe, and detailed instructions on reporting has been considered to be a
Samuel Lawday, Aaron Lawson McLean, Daniel Liu, Mario Lobao, Robert barrier to wider adoption of IDEAL, and there have been calls for the
Michael Lundin, Karen MacPherson, Guy Maddern, Varaidzo Mapunde, John development of reporting guidelines specific to IDEAL.10,11
Mathews, Jose G Merino, Andrew Metcalfe, Richard Naspro, Ionut Negoi,
Stefano Olgiati, Thomas Pidgeon, Pascal Probst, Sarah Prowse, Wendy
Rogers, Camiel Rosman, Laura Rossi, Suzanne Ryan, Franziska Saxer, Markus Reporting Guidelines
Schafer, Patrick Sequeira-Byron, Neil Smart, Diederik Smeeing, Matthew The EQUATOR Network ([Link]
Smith, Grant Stewart, William Summerskill, Olga Tucker, Emma Upchurch,
Bolivar Alfonso Villacis Bermeo, Gustavo Zanoli. defines a reporting guideline as a simple, structured tool for health
Supplemental digital content is available for this article. Direct URL citations researchers to use while writing manuscripts to guide the authors in
appear in the printed text and are provided in the HTML and PDF versions of reporting a specific type of research.12 Reporting guidelines are
this article on the journal’s Web site ([Link]). developed using an explicit methodology and provide a minimum list
Copyright ß 2020 Wolters Kluwer Health, Inc. All rights reserved.
ISSN: 0003-4932/20/27301-0082 of information needed to ensure a manuscript can be understood and
DOI: 10.1097/SLA.0000000000004180 assessed by a reader, replicated by a researcher, used to make a

82 | [Link] Annals of Surgery  Volume 273, Number 1, January 2021

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Annals of Surgery  Volume 273, Number 1, January 2021 IDEAL Reporting Guidelines Statement

clinical decision, and included in a systematic review. There are now identifying existing relevant reporting guidelines and those in devel-
>400 checklists on the EQUATOR Network’s website, including 42 opment registered on the EQUATOR Network website (http://
that are surgery related ([Link] [Link]), a survey to establish which stages of
guidelines/). Among these existing reporting guidelines applicable to IDEAL, if any, participants considered in need of new reporting
surgery SCARE,13 PROCESS,14 STROCSS,15 and CONSORT guidelines, the development of draft checklists for Stages 1, 2a, 2b,
NPT16 aim to improve the reporting of specific, well-recognized and 4 following establishment of need based on consensus, 2 rounds
study types (case reports, case series, cohort studies, and randomized of a Delphi consensus survey to refine each of the checklists, and a
controlled trials). Additional guidance exists for specific aspects of consensus meeting via teleconference with the working group to
surgical evaluative study designs. For example TIDIER 17 has been finalize the checklists.
developed as an extension of CONSORT to improve reporting of
intervention details, and the COHESIVE18 guidelines are being Participants
developed for a generic core outcome set in studies of early phase Using our MailChimp e-newsletter, we contacted 445 indi-
surgery and medical devices. A CONSORT extension for RCTs using viduals who met at least 1 of 4 criteria: member of the original
cohorts and routinely collected health data is also underway.19 IDEAL steering group; a wider member of the IDEAL Collaboration
Additionally, the National Evaluation System for Health Technology signed up to receive newsletters; author or co-author of any key core
Coordinating Center (NESTcc) Methods Framework has been devel- IDEAL publication; attended 1 of the 2016, 2017, and 2018 IDEAL
oped to define the key components of study design, protocols, and conferences. From this group, 119 expressed interest in participating,
evidence gathering for the evaluation of medical devices20 and those individuals were invited to complete an online survey about
All these guidelines draw upon principles of good research the need for reporting guidelines for any stage of IDEAL, as defined
methodology, as does the IDEAL framework. However the IDEAL by the EQUATOR Network’s suggested criteria.24 The 61 respond-
reporting guidelines have a unique and specific focus on stepwise ents recommended that new reporting guidelines should be devel-
evaluation of surgical innovation through all stages of its develop- oped for Stage 1 (69%), Stage 2a (78%), Stage 2b (75%), and Stage 4
ment, from pre-clinical through first in human evidence, feasibility (66%) (Supplementary Figure 1, [Link]
and randomized trials to long-term follow-up including use of real- IDEAL Stage 3 was considered adequately covered by existing
world data. Throughout these stages, IDEAL prescribes specific guidelines (CONSORT, CONSORT NPT and other relevant CON-
novel study formats, focusing on clarity about key elements of SORT extensions) by 68% of respondents. Characteristics of
surgical innovation, with which many researchers may be unfamiliar. responding participants are shown in Table 1. Fourteen volunteers
This likely explains the inaccuracy in reporting noted in studies from groups (1) and (3) formed a working group to agree the final
attempting to follow the IDEAL recommendations and suggests a checklists during the final consensus call.
pressing need for IDEAL reporting guidelines.
The development of such IDEAL-specific guidelines would Development of Checklists
serve to improve the usability and impact of IDEAL. As Altman and The initial drafts of checklists for the 4 stages were developed
Moher state, ‘‘reporting problems affect journal articles in 2 main using a combination of approaches to identify what key items may be
ways. First, the study methods are frequently not described in adequate needed. These included ongoing monitoring of the literature using or
detail. Second, the study findings are presented ambiguously, incom- commenting on the usability of IDEAL, identified from Google
pletely, or selectively. The cumulative effect of these problems is to Scholar and Web of Science Alerts of articles citing the 2009 and
render many reports of research unusable or even harmful; at the very 2019 IDEAL Statement articles, assessing gaps in existing reporting
least, such articles certainly represent a waste of resources’’.21 Chalm- guidelines, and accumulated refinements of IDEAL principles devel-
ers and Glasziou have highlighted the detrimental effects of waste in oped from issues repeatedly raised in recent years during educational
the production and reporting of research evidence and call for seminars and lectures on IDEAL. These checklists were evaluated in
increased use of reporting guidelines as part of the solution.22 2 rounds of a Delphi consensus survey using a 9-point Likert scale,
This article describes the development of a set of IDEAL (as recommended by GRADE), to rate agreement on the importance
reporting guidelines which aim to improve the quality, transparency, of each element and elicit free-text comments on the wording of each
consistency, and utility of the surgical innovation evidence base. The item.25,26 In the Likert scale, a score of 1 to 3 signified limited
protocol for the project was published in 2018.23 importance of the item, 4 to 6 important but not critical, and 7 to 9
critical. If 70% of respondents scored an item 7 to 9 and >15%
METHODS scored it 1 to 3, then that item was included in the reporting guideline.
Conversely, consensus that an item should not be included was
Research Design defined as 70% scoring it 1 to 3 and 15% scoring it 7 to 9.
We developed the IDEAL reporting guidelines through a 5- Fifty-four participants completed Round 1 of the Delphi. Two
phase process between October 2018 and May 2019. This comprised reviewers (N.B., A.H.) reviewed the responses and modified the

TABLE 1. Characteristics of Survey Participants (% of group—N ¼ 61)

Professional role Clinical Academic Educator Editor/Publisher Industry Othery
66 74 21 17 2 15
No. of years qualified 0–4 5–9 10–14 15–19 20þ
9 17 23 19 32 —
Location UK Rest of Europe N. America Australia S. America Asia
47 34 10 5 3 2
Sex Male Female
75 25 — — — –

(May have multiple roles).
yIncluding: medical ethicist, program manager, scientist, statistician, trial methodologist, private practice.

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Bilbro et al Annals of Surgery  Volume 273, Number 1, January 2021

checklist drafts based on the participants scoring and feedback, modifications and monitoring of learning curves. Because of this,
editing phrasing and wording of checklist items, and merging the diligent use of other guidelines cannot help investigators to report
redundant items, but ensuring meaning was not significantly IDEAL studies appropriately, and an IDEAL-specific guideline is
changed. Round 2 of the Delphi survey presented the results of required. For example comparing the SCARE guidelines for surgical
round one to participants, addressed clarifications, and served to case reports13 and the IDEAL Stage 1 recommendations, IDEAL
refine the checklist items where consensus was not yet reached. specifies requirements absent from SCARE (Applicability only to
Participants were again asked to score the Round 2 checklist items on first-in-human studies, justify need and refer to pre-clinical devel-
a 1 to 9 Likert Scale. Forty-seven participants completed Round 2 opment, detailed account of patient selection, requirement for fully
and their responses were analyzed by 2 researchers (N.B., A.H.) and informed consent for treatment, requirement for explanation of
presented to the working group during the final teleconference procedure detailed enough to allow reproduction).
consensus meeting. The IDEAL checklists are intended to provide a minimum list
of concepts authors should include in a report of an IDEAL format
Consensus Teleconference study. They have been created for wide-spread adoption across all
A consensus call held in May 2019 was attended by 11 of the interventional specialties, including therapeutic devices, for which
14 members of the working group. Three participants who were IDEAL has published a modified framework, IDEAL-D.5 The
unable to attend submitted written contributions via email. A draft of checklists are equally usable for IDEAL and IDEAL-D studies,
the methods, checklist drafts for each stage, and a provisional list of most items pertaining to both surgical and device innovation.
items where the Delphi process had not yielded a definitive result Although not designed expressly for these purposes, the guidelines
were prepared in advance and sent to the call participants. The items can also be used both prospectively to help plan a study and
that remained controversial were discussed and modifications were retrospectively to assist in appraisal. They can also be used alongside
made once the group reached agreement. All checklist items for each other reporting guidelines to provide additional useful detail (eg,
stage were then reviewed and revised as needed to ensure clarity. The COHESIVE for core outcomes reporting, CONSORT extension for
group also decided on a strategy to disseminate the checklists. The routinely collected health data for Stage 4).18,19
revisions were then sent out to the participants for final comment
and approval. Dissemination and Evaluation of IDEAL Checklists
Checklists are not effective unless used, so dissemination
RESULTS efforts are important. The EQUATOR network27 recommends 10
The citation alerts and search of the EQUATOR Network list specific actions to aid dissemination: making the checklist freely
of reporting guidelines revealed no specific guidelines dealing with accessible in editable format; publishing and presenting editorials,
the IDEAL Recommendations as an entity either as the sole focus of blogs, website pages, conference papers and webinars, co-operating
study or as part of a larger ambit, and no guidelines which specifi- with EQUATOR, seeking journal endorsements and running training
cally described how to report IDEAL format studies. Numerous courses. We intend to follow this guidance utilizing our website and
guidelines contained generic recommendations also included by Twitter accounts ([Link] and @IDEALCol-
IDEAL, for example, use of standard outcome definitions, publica- lab). Some specific elements of our strategy will be the use of social
tion of protocols, and full informed consent, but none referenced media to establish a feedback dialogue with users, presentation of the
IDEAL as a special case.14– 19 guidelines at conferences and scientific meetings, editorials and
Supplementary Tables 1, [Link] and blogs, and translation into Chinese and Spanish to maximize inter-
2, [Link] show the distribution of scores for national readership. In line with EQUATOR guidance, we will pilot
each checklist item in Rounds 1 and 2 respectively of the Delphi the checklist in ongoing IDEAL format studies, for which we will
process. The 4 unresolved issues following Round 2, discussed shortly be introducing an advisory service, and will publish an
during the final consensus call were: Inclusion of IDEAL and the updated version with any modifications resulting from both feedback
stage number in titles; inclusion of ‘‘first-in-human’’ in the title of and piloting. A pre-post guideline publication survey of reporting of
Stage 1 studies; mandatory publication of a previous protocol for all IDEAL format studies to evaluate the effectiveness of these efforts
studies; and how to resolve tensions between commercial confidenti- will be developed at a future date. Endorsement by authoritative
ality and ethical demands for transparency in early-stage studies bodies and efforts by editors to encourage or enforce compliance
involving devices. The solutions to each are incorporated in the final were features of the development and spread of the CONSORT
full checklists presented here. guidelines, which appear to be the best complied with to date, so we
will continue to seek support in these sectors.
IDEAL Checklists Limitations
IDEAL is based on ethical and methodological principles Like all consensus processes, our Delphi study was dependent
which apply to all stages and types of medical research, and many on the representativeness of participants. We invited participants with
of which are held in common with other methodological paradigms a good understanding of IDEAL, as a naı̈ve group would be unlikely
and checklists. Supplementary Table 3, [Link] to be able to appreciate some of the issues or achieve consensus. We
C820 presents the full checklists for IDEAL Stages 1, 2a, 2b, and 4 attempted to include a wide range of stakeholders but were not
and highlights key or unique IDEAL items with an example from the universally successful. The number of journal editors, for example,
literature, which illustrates appropriate use. We have not provided was small. A different group might have come up with different
examples for more familiar items common to other reporting check- recommendations, but no major differences in responses could be
lists. The article quoted does not necessarily demonstrate good detected according to background in our sample. Although consensus
reporting for other IDEAL recommendations. was achieved by GRADE criteria on the need for a guideline in all
stages except Stage 3, the minority which disagreed was substantial
DISCUSSION (around 25%) in each case. Informal feedback indicates that this may
The IDEAL Recommendations include several innovations in have been because participants familiar with IDEAL had come to see
study design for clinical research, such as reporting of iterative reporting of IDEAL stage items as straightforward, and not needing

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Annals of Surgery  Volume 273, Number 1, January 2021 IDEAL Reporting Guidelines Statement

guidance. Some participants also mentioned the proliferation of oesophageal sphincter for gastro-oesophageal reflux disease. Br J Surg.
2020;107:44–55.
reporting guidelines as a reason for caution.
12. EQUATOR Network website. What is a Reporting Guideline? Available at:
[Link]
CONCLUSIONS (Accessed March 30, 2020)
13. Agha RA, Borrelli MR, Farwana R, et al. For the SCARE Group. The SCARE
The consensus-based checklists developed through this Delphi 2018 Statement: Updating Consensus Surgical CAse REport (SCARE) Guide-
process have the potential to improve the standards of reporting of lines. Int J Surg. 2018;60:132–136.
early-stage innovation and surgical trials and thereby advance the 14. Agha RA, Borrelli MR, Farwana R, et al. For the PROCESS Group. The
quality of research on surgery and complex interventions. Surgical PROCESS 2018 Statement: Updating Consensus Preferred Reporting of CasE
innovation and research that follows a transparent, sequential frame- Series in Surgery (PROCESS) Guidelines. Intl J Surg. 2018;60:279–282.
work such as IDEAL and is reported with these guidelines can also 15. Agha R, Abdall-Razak A, Crossley E, et al. STROCSS 2019 Guideline:
strengthening the reporting of cohort studies in surgery. Int J Surg.
aid reproducibility, reduce research waste, and improve evidence- 2019;72:156–165.
based practice for the benefit of patients. 16. Boutron I, Altman DG, Moher D, et al. CONSORT NPT Group. CONSORT
statement for randomized trials of nonpharmacologic treatments: a 2017
Contributors update and a CONSORT extension for nonpharmacologic trial abstracts.
IDEAL Collaboration Reporting Guidelines Working Group: Ann Intern Med. 2017;167:40–47.
Jane Blazeby, Maroeska Rovers, Christopher Pennell, Joel Horovitz, 17. Hoffmann T, Glasziou P, Boutron I, et al. Better reporting of interventions:
template for intervention description and replication (TIDieR) checklist and
Angelos Kolias, Janet Martin, Tom Lewis, Riaz Agha, Josh Feinberg, guide. BMJ. 2014;348:g1687.
in addition to the authors. 18. Avery K, Blazeby J, Wilson N, et al. Development of reporting guidance and
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