Application of Safety Protocols for International Cleft Outreach Programs During the COVID-19 Pandemic: Global Smile Foundation Precaution Guidelines and Implications.

BACKGROUND: Since COVID-19 was declared a worldwide pandemic by the World Health Organization (WHO) in March of 2020, foundation-based cleft outreach programs to Low- and Middle-Income Countries (LMICs) were halted considering global public health challenges, scarcity of capacity and resources, and travel restrictions. This led to an increase in the backlog of untreated patients with cleft lip and/or palate, with new challenges to providing comprehensive care in those regions. Resumption of international outreach programs requires an updated course of action to incorporate necessary safety measures in the face of the ongoing pandemic. In this manuscript, the authors outline safety protocols, guidelines, and recommendations implemented in Global Smile Foundation's (GSF) most recent outreach trip to Beirut, Lebanon. METHODS: COVID-19 safety protocols for outreach cleft care and an Action Response Plan were developed by the GSF team based on the published literature and recommendations from leading international organizations. RESULTS: GSF conducted a 1-week surgical outreach program in Beirut, Lebanon, performing 13 primary cleft lip repairs, 7 cleft palate repairs, and 1 alveolar bone grafting procedure. Safety protocols were implemented at all stages of the outreach program, including patient preselection and education, hospital admission and screening, intraoperative care, and postoperative monitoring and follow-up. CONCLUSIONS: Organizing outreach programs in the setting of infectious diseases outbreaks should prioritize the safety and welfare of patients and team members within the program's local community. The COVID-19 protocols and guidelines described may represent a reproducible framework for planning future similar outreach initiatives in high-risk conditions.

Enhanced Recovery After Cleft Lip Repair: Protocol Development and Implementation in Outreach Settings.

INTRODUCTION: Clefts of the lip are of the most common congenital craniofacial anomalies. The development and implementation of an enhanced recovery after surgery (ERAS) protocol among patients undergoing cleft lip repair may decrease postoperative complications, accelerate recovery, and result in earlier postoperative discharge. METHODS: A modified ERAS program was developed and applied through Global Smile Foundation outreach craniofacial programs. The main components of this protocol include: (1) preoperative patient education, (2) nutrition screening, (3) smoking cessation when applicable, (4) use of topical anesthetic adjuncts, (5) facial nerve blocks, (6) postoperative analgesia, (7) preferential use of short-acting narcotics, (8) antibiotic administration, (9) use of elbow restraints, (10) early postoperative oral feeding and hydration, and (11) discharge planning. RESULTS: Between April 2019 and March 2020, GSF operated on 126 patients with cleft lip from different age groups and 58.8% of them were less than 1 year of age. Three patients (2.4%) had delayed wound healing and one (0.8%) had postoperative bleeding. There were no cases of mortality, length of hospital stay did not exceed 1 postoperative day, and patients were able to tolerate fluids intake at discharge. CONCLUSION: The implementation of an ERAS protocol among patients undergoing cleft lip repair has shown to be highly effective in minimizing postoperative discomfort while reducing opioids use, decreasing the length of stay in hospital, and leading to early oral feeding resumption. The ERAS principles described carry increased relevance in the context of the ongoing COVID-19 pandemic and opioid crisis and can be safely applied in resource-constrained settings.

Quality Assurance Standards for Outreach Cleft Lip and Cleft Palate Repair Programs in Low-Resource Settings.

BACKGROUND: Comprehensive cleft care is a multidisciplinary team endeavor. While untreated craniofacial conditions have multiple undue repercussions, cleft care in outreach settings can be fraught with significant perioperative morbidity risks. AIM: Propose updated quality assurance standards addressing logistic and operational considerations essential for the delivery of safe and effective cleft lip and /or palate (CL/P) care in low and middle-income countries (LMICs) settings. METHODS: Based on American Cleft Palate-Craniofacial Association (ACPA) quality standards, published literature, published protocols by Global Smile Foundation (GSF), and the senior author's three-decade experience, updated standards for outreach cleft care were synthesized. RESULTS: Ten axes for safe, effective, and sustainable cleft lip and palate care delivery in underserved settings were generated: 1) site assessment, 2) establishment of community partnerships, 3) team composition and credentialing, 4) team training and mission preparation, 5) implementation of quality assurance guidelines, operative safety checklists, and emergency response protocols, 6) immediate and long-term postoperative care, 7) medical record keeping, 8) outcomes evaluation, 9) education, and 10) capacity building and sustainability. Subsequent analysis further characterized essential components of each of those ten axes to delineate experience derived and evidence-based recommendations. DISCUSSION: Quality assurance guidelines are essential for the safe delivery of comprehensive cleft care to patients with CL/P in any setting. Properly designed surgical outreach programs relying on honest community partnerships can be effectively used as vehicles for local capacity building and the establishment of sustainable cleft care ecosystems.

Emergency Response Protocols for Overseas Outreach Settings: Global Smile Foundation Strategy.

Non-governmental organizations (NGOs) aim to alleviate unmet global disease burden and promote collaboration between visiting and host countries. Well-executed emergency response protocols are foundational to providing safe and quality care in an unpredictable global setting. Global Smile Foundation (GSF) instituted a protocol in 2012 based on over three decades of cleft care experience. Here, we update this protocol and provide information on how to address special circumstances such as humanitarian crises and disease outbreaks. The GSF response protocol was developed in conjunction with surgeons, anesthesiologists, nurses, and administrators to ensure all team members are adequately prepared to respond to emergency situations in global outreach. This protocol provides information on pre-departure preparation, onsite setup, operative precautions, and post-departure debriefings. Emphasis is placed on a standardized, reproducible workflow that accounts for necessary site-specific adjustments. Strategies include emergency simulations, site-specific safety checklists, standardized operating room protocols, and well-defined individual responsibilities. The authors also provide anticipatory guidance in addressing unexpected circumstances, such as disease outbreak and natural disaster, during global outreach. In conclusion, a proactive and systematic approach to emergency response and prevention is vital to minimizing morbidity and mortality during surgical outreach initiatives. The GSF protocol represents a reproducible approach that other organizations can adopt and adapt to their unique needs.

Perceived Barriers to Comprehensive Cleft Care Delivery: Results From A Capacity-Building Educational Initiative and Implications.

INTRODUCTION: We analyzed the perceptions of participants and faculty members in simulation-based comprehensive cleft care workshops regarding comprehensive cleft care delivery in developing countries. METHODS: Data were collected from participants and faculty members in 2 simulation-based comprehensive cleft care workshops organized by Global Smile Foundation. We collected demographic data and surveyed what they believed was the most significant barrier to comprehensive cleft care delivery and the most important intervention to deliver comprehensive cleft care in developing countries. We also compared participant and faculty responses. RESULTS: The total number of participants and faculty members was 313 from 44 countries. The response rate was 57.8%. The majority reported that the most significant barrier facing the delivery of comprehensive cleft care in developing countries was financial (35.0%), followed by the absence of multidisciplinary cleft teams (30.8%). The majority reported that the most important intervention to deliver comprehensive cleft care was creating multidisciplinary cleft teams (32.2%), followed by providing cleft training (22.6%). We found no significant differences in what participants and faculty perceived as the greatest barrier to comprehensive cleft care delivery (P = 0.46), or most important intervention to deliver comprehensive cleft care in developing countries (P = 0.38). CONCLUSIONS: Our study provides an appraisal of barriers facing comprehensive cleft care delivery and interventions required to overcome these barriers in developing countries. Future studies will be critical to validate or refute our findings, as well as determine country-specific roadmaps for delivering comprehensive cleft care to those who need it the most.

Comprehensive Cleft Care Delivery in Developing Countries: Impact of Geographic and Demographic Factors.

INTRODUCTION: The authors analyzed the insights of participants and faculty members of Global Smile Foundation's Comprehensive Cleft Care Workshops concerning the barriers and interventions to multidisciplinary cleft care delivery, after stratification based on demographic and geographic factors. METHODS: During 2 simulation-based Comprehensive Cleft Care Workshops organized by Global Smile Foundation, participants and faculty members filled a survey. Surveys included demographic and geographic data and investigated the most relevant barrier to multidisciplinary cleft care and the most significant intervention to deliver comprehensive cleft care in outreach settings, as perceived by participants. RESULTS: The total response rate was 57.8%. Respondents reported that the greatest barrier to comprehensive cleft care was financial, and the most relevant intervention to deliver multidisciplinary cleft care was building multidisciplinary teams. Stratification by age, gender, and geographical area showed no statistical difference in reporting that the greatest barrier to cleft care was financial. However, lack of multidisciplinary teams was the most important barrier according to respondents with less than 5 years of experience (P = 0.03). Stratification by gender, years in practice, specialty, and geographical area showed no statistical difference, with building multidisciplinary teams reported as the most significant intervention. However, increased training was reported as the main intervention to cleft care for those aged less than 30 years old (P = 0.04). CONCLUSIONS: Our study delivers an assessment for barriers facing multidisciplinary cleft care delivery and interventions required to improve cleft care delivery. The authors are hoping that stratification by demographic and geographic factors will help them delineate community-specific road maps to refine cleft care delivery.

Sustainable Cleft Care: A Comprehensive Model Based on the Global Smile Foundation Experience.

INTRODUCTION: Clefts of the lip and palate are leading congenital facial anomalies. Underserved patients with these facial differences lack access to medical care, surgical expertise, prenatal care, or psychological support. Moreover, the disease results in significant economic strains on patients and their families. While surgical outreach programs have attempted to fill this void, significant challenges facing international comprehensive cleft care persist. OBJECTIVE: Propose a path toward international sustainable cleft care based on the Global Smile Foundation experience. RESULTS: International sustainable comprehensive cleft care can be achieved by regulating surgical outreach programs. Regulation of these missions would ensure standardized care and encourage stakeholders to cooperate and adequately allocate funding and resources. Capacity building can be achieved through "diagonal" cleft care delivery models, multidisciplinary workshops, fellowship programs, research and quality assurance, as well as leveraging emerging technologies such as Augmented Reality. CONCLUSION: International comprehensive cleft care requires continuous collaborative efforts between visiting and local teams as well as international and national organizations. Standardizing and regulating current practices as well as promoting capacity building initiatives can contribute to sustainable cleft care.

Simulation-Based Comprehensive Cleft Care Workshops: A Reproducible Model for Sustainable Education.

OBJECTIVE: Evaluate simulation-based comprehensive cleft care workshops as a reproducible model for education with sustained impact. DESIGN: Cross-sectional survey-based evaluation. SETTING: Simulation-based comprehensive cleft care workshop. PARTICIPANTS: Total of 180 participants. INTERVENTIONS: Three-day simulation-based comprehensive cleft care workshop. MAIN OUTCOME MEASURES: Number of workshop participants stratified by specialty, satisfaction with the workshop, satisfaction with simulation-based workshops as educational tools, impact on cleft surgery procedural confidence, short-term impact on clinical practice, medium-term impact on clinical practice. RESULTS: The workshop included 180 participants from 5 continents. The response rate was 54.5%, with participants reporting high satisfaction with all aspects of the workshop and with simulation-based workshops as educational tools. Participants reported a significant improvement in cleft lip (33.3 ± 5.7 vs 25.7 ± 7.6; P < .001) and palate (32.4 ± 7.1 vs 23.7 ± 6.6; P < .001) surgery procedural confidence following the simulation sessions. Participants also reported a positive short-term and medium-term impact on their clinical practices. CONCLUSION: Simulation-based comprehensive cleft care workshops are well received by participants, lead to improved cleft surgery procedural confidence, and have a sustained positive impact on participants' clinical practices. Future efforts should focus on evaluating and quantifying this perceived positive impact, as well reproducing these efforts in other areas of need.