Adapting cleft care protocols in low- and middle-income countries during and after COVID-19: a process-driven review with recommendations

TL;DR: A multidisciplinary international working group met on a videoconferencing platform in a multi-staged process to make consensus recommendations for adaptions to cleft protocols within resource-constrained settings as discussed by the authors.

Abstract: Objective A consortium of global cleft professionals, predominantly from low- and middle-income countries, identified adaptions to cleft care protocols during and after COVID as a priority learning area of need. Design A multidisciplinary international working group met on a videoconferencing platform in a multi-staged process to make consensus recommendations for adaptions to cleft protocols within resource-constrained settings. Feedback was sought from a roundtable discussion forum and global organisations involved in comprehensive cleft care. Results Foundational principles were agreed to enable recommendations to be globally relevant and two areas of focus within the specified topic were identified. First the safety aspects of cleft surgery protocols were scrutinised and COVID adaptions, specifically in the pre and peri-operative periods, were highlighted. Second, surgical operations and access to services were prioritized according to their relationship to functional outcomes and time-sensitivity. The operations assigned the highest priority were emergent interventions for breathing and nutritional requirements and primary palatoplasty. The cleft services assigned the highest priority were new-born assessments, paediatric support for children with syndromes, management of acute dental or auditory infections and speech pathology intervention. Conclusions A collaborative, interdisciplinary and international working group delivered consensus recommendations to assist with the provision of cleft care in low- and middle-income countries. At a time of global cleft care delays due to COVID-19, a united approach amongst global cleft care providers will be advantageous to advocate for children born with cleft lip and palate in resource-constrained settings.

Summary

INTRODUCTION

• Cleft lip and/or palate (CL/P) is the most common craniofacial congenital anomaly, occurring in approximately 1/700 live births worldwide (Mossey et al., 2009).
• It is well established that the best way to treat a child born with CL/P is a multidisciplinary team (MDT) of specialised professionals following a protocol of comprehensive cleft care (Kassam et al., 2020).
• A protocol aims to standardise care and has the potential to streamline multidisciplinary clinical practice by detailing steps of management.
• The need to adapt aspects of the cleft protocol during and following COVID-19 has been identified by global partners and is important in the quest towards re-establishing international comprehensive cleft care services.

Process overview

• The process was centred around the formation of working groups to consider topics highlighted in the CoCP COVID-19 Survey.
• The application to participate in a working group was disseminated widely through the CoCP membership and beyond.
• Applicants were placed in one of six working groups based on research interests, fluency in English or Spanish, and in an attempt to ensure diversity of professional context, discipline, geography and NGO affiliation.
• Working group members were orientated into the process and encouraged to consider their allocated topic area before meeting collectively on three separate occasions over a six-week period in 2021.
• The process culminated with a presentation of recommendations at a round table within an international virtual conference, that had free registration and was widely advertised, entitled ‘Solutions for Comprehensive Cleft Care: Covid and Beyond’ on June 2nd, 2021 (Circle of Cleft Professionals, 2021b).

Composition of the Working Group

• This working group was composed of seven individuals; six healthcare professionals and one non-healthcare professional in an administrative role (see Table 1).
• There was representation from seven countries in four continents and inclusion of three speciality areas from the cleft multidisciplinary team.
• Working group members had a range of experience in the delivery of comprehensive cleft care within their own countries and overseas and were affiliated with a range of global cleft organisations.

Making and testing recommendations

• The working group met virtually on three occasions using a videoconferencing platform.
• The first session entitled ‘exploring’ involved open discussion of the assigned topic and highlighting areas within the assigned topic in which to focus.
• Literature was categorised according to levels of evidence and shared between group members in the interim period to stimulate discussion via email, instant messaging and an online conference platform.
• At the culmination of this process, the working group presented their recommendations at conference round table and attendees were encouraged to comment 9 and provide feedback.
• Further feedback was sought from leading cleft professionals allied to the CoCP NGO network.

RESULTS

• The working group considered the topic area of ‘adapting COVID-19 cleft care protocols in light of evidence-based research’.
• A consensus was reached on foundational principles and recommendations made in two focus areas: first, surgical safety measures within the cleft care protocol and second, prioritisation of surgical procedures and access to cleft care services.

Foundational Principles

• The working group agreed that recommendations for cleft protocol adaptations, supported by a body of identified scientific evidence, could be beneficial to help coordinate and unify the international lobbying of policy makers regarding the need for comprehensive cleft care provision during and after the COVID-19 pandemic in LMICs.
• The aim was to create a document that would be a helpful aid to global lobbying efforts in LMICs, with an appreciation that recommendations could neither be comprehensive nor specific to reflect the needs of each individual healthcare system and setting.
• The extent of pre-operative modifications (such as frequency of COVID-19 testing and the need for isolation strategies) can be adapted in response to regional COVID-19 prevalence, which has been classified as low (<0.5%), medium (0.5-2%) and high (>2%)(Royal College of Paediatrics and Child Health, 2020).
• Post-operative safety protocols exist to ensure that the surgical care episode was successful and that the patient does not develop complications that require treatment.
• There is a need for prioritisation within the cleft protocol despite each element of comprehensive cleft care having equal importance because some elements are timesensitive and linked to functional outcomes, therefore their delay would lead to irreversible harm(Rossell-Perry and Gavino-Gutierrez, 2021).

Prioritisation of surgical procedures

• Surgical emergencies for patients born with CL/P, such as airway or nutritional compromise, require potentially life-saving surgical interventions and are therefore an obvious priority.
• Primary palatoplasty was considered a high priority due to the body of literature identified to demonstrate its relationship with both speech and maxillary growth outcomes (see supplementary table 1 and 2).
• Prioritisation of access to cleft care services.
• New-born babies with CL/P need to be assessed regarding breathing, feeding and hearing and this is a priority, both for the health of the baby and to provide support for parents during this critical neonatal period.
• Innovations in telemedicine during COVID-19 have shown promising signs of the efficacy of delivering speech therapy remotely and this may be a great opportunity in LMICs going forward, especially for patients living in remote rural locations (Camden and Silva, 2021; Law et al., 2021; Pamplona and Ysunza, 2020).

Overview of process

• The condensed 6-week time period, with a pre-established ‘finish-line’, and a platform for the working group to present its recommendations, helped to increase intensity and provide urgency to the process.
• It became apparent that the variety of experience in the management of both CL/P and COVID-19 provided a rich environment for discussion and mutual learning.
• Scheduling meetings on the videoconferencing platform at the same time and day of the week helped to provide consistency and improve attendance, given the working group members’ multiple time zones and working commitments.
• Consensus was achieved via identifying global areas of commonality and recognising areas of diversity and controversy.

Summary of recommendations

• The working group was tasked to make recommendations regarding the adaptation of cleft care protocols during and after COVID-19 to help facilitate the provision of global comprehensive cleft care in LMICs.
• First, recommendations about adaptations to surgical safety protocols were made that were categorised into pre, peri and post-operative phases.
• Adaptations are most likely to be required in the pre and peri-operative phases to identify and manage COVID-19 risk.
• Second, recommendations to prioritise surgical procedures and access to cleft services based on time-sensitivity and functional outcomes.
• Primary palatoplasty was prioritised due its intimate relationship with speech and maxillary growth outcome.

Interpretation and implications:

• The WHO has documented the far-reaching impact of the COVID-19 pandemic in terms of the widespread disruption to essential health services, but elective services are being reestablished (World Health Organisation, 2021a).
• The recommendations in current study focus instead on two important areas of the cleft 18 protocol, and whilst applicable to visiting teams, are aimed at a wider audience of global cleft care providers in LMICs.
• On the other hand, some COVID19 adaptations represent innovations and the advances in telemedicine in particular, which has proven to be successful for pre-operative COVID-19 screening and speech therapy delivery, may be well suited to LMICs (Ramanathan et al., 2021).
• In the United Kingdom, all surgical procedures were prioritised into four categories of urgency by the Federation of Surgical Specialty Associations in July 2020 to expediate the recovery of surgical services during COVID (Federation of Surgical Specialty Associations, 2021).
• Primary palatoplasty and secondary speech surgery were initially categorised as priority 3 but were upgraded to priority 2 in February 2021 (see supplementary table 3) following advice from UK cleft professionals regarding the association with functional speech outcomes (Cleft Development Group, 2021).

Strengths and limitations:

• The main strength of this piece of work was the collaborative nature of the international working group, which was inclusive of multiple disciplines and affiliation with multiple global cleft organisations.
• The working group was a good size in terms of productivity, but it was not inclusive of all specialties, organisations or regions and deliberations all took place in English.
• The consensus recommendations were based on common principles, but this is not an exhaustive document and therefore not a comprehensive guide to delivering cleft care protocols in LMICs during and after COVID-19.
• It is hoped the efforts of cleft providers in resource-constrained settings will be supported by this work to present a united and coordinated case for the provision of comprehensive cleft care to policy makers and ultimately improve safety and outcomes for patients.
• Ideally, there should be a focus on local protocols and guidance, therefore the relevance of these recommendations in specific environments may be limited (Truche et al., 2020).

Further work

• It is hoped that collaborative efforts such as this will galvanise the global cleft community to perform multi-centre international trials to reach a consensus on cleft care protocols and outcomes.
• Local outcome data collection must be encouraged to drive context-specific 21 guidance.
• Finally, the efficacy of innovations highlighted by this pandemic should be explored so that they can ultimately help with the provision of global cleft care.

CONCLUSION

• The COVID-19 pandemic has had a detrimental impact on the delivery of comprehensive cleft care, which was already stretched in many areas of the world.
• A unified approach amongst global cleft care providers may help to lobby policy makers effectively at this crucial time of scarce resource allocation.

Figures

Table 1: The composition of the working group

Table 3: Recommended time-sensitive prioritisation of surgical procedures and access to comprehensive cleft care

Table 2: Cleft surgery safety measures that were routine before COVID-19 and specific adaptations for consideration during and after COVID-19

Full text

Adapting cleft care protocols in low- and middle-income countries during and
after COVID-19: a process-driven review with recommendations
Authors names:
Matthew Fell MRCS
1
,
2
Michael Goldwasser MD
3
,
4
B.S Jayanth MD
5
Rui Manuel Rodrigues Pereira MD
6
,
7
Christian Tshisuz Nawej MMED
8
Rachel Winer BA
9
Neeti Daftari MA, MSc
9
Hugh Brewster MEd
9
Karen Goldschmied SLT
10
Collaborating authors names:
Fernando Almas MD
11
Mekonen Eshete MD
12
George W. Galiwango MD
13
Larry H. Hollier Jr. MD
14
,
15
Lun-Jou Lo MD
16
,
17
Debbie Sell FRCSLT
18
Amanuel Tafase MD
11
Ronald M. Zucker MD
19
,
20
1
CLEFT Charity, Chelmsford, United Kingdom
2
Cleft Collective, University of Bristol, Bristol, United Kingdom
3
Operation Smile, Virginia Beach, USA
4
Craniofacial and Surgical Care, University of North Carolina School of Dentistry, Chapel Hill, NC, USA
5
ABMSS, Bengaluru, India
6
Faculdade de Medicina da Universidade de Sao Paulo, Sau Paulo, Brazil
7
Instituto de Medicina Integral Prof Fernando Figueira, Recife, Brazil
8
Cliniques Universitaires de Lubumbashi, Democratic Republic of Congo
9
Transforming Faces, Toronto, Canada
10
Hospital Dr Luis Calvo Mackenna, Santiago de Chile, Chile
11
Project Harar Ethiopia, Henfield, United Kingdom
12
Cleft Lip and Palate Program, Yekatit 12 Hospital Medical College, Addis Ababa, Ethiopia
13
CORSU Rehabilitation Hospital, Kisubi, Uganda
14
Smile Train Global Medical Advisory Board, New York, USA
15
Division of Plastic Surgery, Michael E. DeBakey Department of Surgery, Baylor College of Medicine,
Department of Surgery, Texas Children’s Hospital, Houston, Texas, USA
16
Noordhoff Craniofacial Foundation, Taipei, Taiwan
17
Craniofacial Center, Plastic and Reconstructive Surgery, Chang Gung Memorial Hospital, Taoyuan, Taiwan
18
Great Ormond Street Hospital for Children, London, United Kingdom
19
Division of Plastic and Reconstructive Surgery, The Hospital for Sick Children, Toronto Canada
20
The University of Toronto, Toronto, Canada
All rights reserved. No reuse allowed without permission.
perpetuity.
preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in
The copyright holder for thisthis version posted October 19, 2021. ; https://doi.org/10.1101/2021.10.14.21265004doi: medRxiv preprint
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.

Corresponding author:
Matthew Fell
The Cleft Collective
Bristol Dental School
University of Bristol
Oakfield House
Oakfield Grove
Bristol
BS8 2BN
United Kingdom
Mobile: 0044 (0)1179505050
Mattfell@doctors.org.uk
Running title: Adapting cleft protocols in LMICs following COVID
Financial support:
MF is supported by the VTCT Foundation for a research fellowship with the Cleft Collective
at the University of Bristol
ACKNOWLEDGEMENTS
The authors would like to thank the Circle of Cleft professionals and the multiple
organisations that support it for facilitating this work.
All rights reserved. No reuse allowed without permission.
perpetuity.
preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in
The copyright holder for thisthis version posted October 19, 2021. ; https://doi.org/10.1101/2021.10.14.21265004doi: medRxiv preprint

Adapting cleft care protocols in low- and middle-income countries during and
after COVID-19: a process-driven review with recommendations
All rights reserved. No reuse allowed without permission.
perpetuity.
preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in
The copyright holder for thisthis version posted October 19, 2021. ; https://doi.org/10.1101/2021.10.14.21265004doi: medRxiv preprint

2
ABSTRACT
Objective: A consortium of global cleft professionals, predominantly from low- and middle-
income countries, identified adaptions to cleft care protocols during and after COVID as a
priority learning area of need.
Design: A multidisciplinary international working group met on a videoconferencing
platform in a multi-staged process to make consensus recommendations for adaptions to
cleft protocols within resource-constrained settings. Feedback was sought from a
roundtable discussion forum and global organisations involved in comprehensive cleft care.
Results: Foundational principles were agreed to enable recommendations to be globally
relevant and two areas of focus within the specified topic were identified. First the safety
aspects of cleft surgery protocols were scrutinised and COVID adaptions, specifically in the
pre and peri-operative periods, were highlighted. Second, surgical operations and access to
services were prioritized according to their relationship to functional outcomes and time-
sensitivity. The operations assigned the highest priority were emergent interventions for
breathing and nutritional requirements and primary palatoplasty. The cleft services assigned
the highest priority were new-born assessments, paediatric support for children with
syndromes, management of acute dental or auditory infections and speech pathology
intervention.
Conclusions: A collaborative, interdisciplinary and international working group delivered
consensus recommendations to assist with the provision of cleft care in low- and middle-
income countries. At a time of global cleft care delays due to COVID-19, a united approach
All rights reserved. No reuse allowed without permission.
perpetuity.
preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in
The copyright holder for thisthis version posted October 19, 2021. ; https://doi.org/10.1101/2021.10.14.21265004doi: medRxiv preprint

3
amongst global cleft care providers will be advantageous to advocate for children born with
cleft lip and palate in resource-constrained settings.
Keywords: comprehensive cleft care, low- and middle-income countries, COVID-19, Circle of
Cleft Professionals
All rights reserved. No reuse allowed without permission.
perpetuity.
preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in
The copyright holder for thisthis version posted October 19, 2021. ; https://doi.org/10.1101/2021.10.14.21265004doi: medRxiv preprint