Given the extensive number of barriers that exist for children from LMICs needing surgical treatment of OFCs, it is critical that we understand how to make surgery as safe and effective as possible when it finally becomes available to them. This means that we must elucidate which interventions effectively optimize patient factors, like nutritional status, prior to receiving surgery. This recognition was the primary driving force behind the study’s aim to determine whether or not RUTF effectively treated children with moderate and severe malnutrition so they became surgically eligible.
Operation Smile (OS), a globally active non-governmental organization providing cleft surgery and comprehensive care, has supplied and tracked the distribution of RUTF supplementation to 677 patients in six LMICs along with the patients’ weight gain to determine their nutrition status and eligibility to receive cleft surgery. The program demonstrated the significant benefits of a short-term preoperative nutritional intervention on nutritional status and surgical eligibility in a large trans-continental group of pediatric patients with OFC in LMICs. While studies have previously established the significant impact of RUTF on improving the nutritional status of children with malnutrition (19, 27, 33), the focus of our study on a large population of potential surgical patients with OFC with malnutrition is unique in the literature. This knowledge is pertinent because patients with OFC are an especially vulnerable population, as systemic conditions in LMICs may exacerbate malnutrition even in patients without OFC, putting patients with disease at a greater disadvantage (34). This impactful program uniquely addresses pediatric malnutrition from a collaborative standpoint through a cost-effective, short-term, and context-appropriate solution for individuals in LMICs.
Based on the global standards of care used by OS, nearly two-thirds of the initially malnourished patients who returned for follow-up visits were eligible for cleft surgery at the end of their RUTF treatment. Overall, 64% of all patients enrolled in the program who came for at least one follow-up visit reached a healthy weight with 35% having successfully received surgery as of March 2020. This corroborates the existing evidence that RUTF packets are very effective in resource-constrained settings where surgical NGOs frequently operate. As patients are often sequenced into care prior to the surgical mission by OS in-country teams, this program will provide a highly effective treatment to ensure that when children present for surgery, they are not unnecessarily delayed by treatable causes since these delays in surgical care often lead to lifelong disability. Short-term programs such as these can be used with minimal contact to patients prior to surgery (for example, 1 visit 6 weeks prior) to ensure that they are adequately nourished when the surgical teams are in-country and available to provide treatment.
It has been demonstrated that patients with OFC are more prone to malnutrition (30%- 50% of all cases) than patients without OFC (7, 8), which translates to a minimum of 30% of all patients with OFC globally requiring nutritional intervention. The baseline prevalence of mild, moderate, and severe malnutrition among patients with OFC in our program were 51%, 21%, and 28%, respectively. Of the 207 patients who returned for follow-up and were eligible for surgery, the majority (70%) had mild malnutrition at baseline, and the remainder were equally split between moderate and severe malnutrition. Despite the high prevalence of malnutrition in OFC patients, the majority of the patients enrolled in this program were mild cases. As a result, they were quickly brought to a healthy weight to receive surgery without intensive or complex nutritional intervention and monitoring. This knowledge can help streamline processes in the future and conserve in-country nutrition resources for patients with more severe needs.
Funding is a critical component of determining sustainability for programs in LMICs. The RUTF program was both designed and proven to be a cost-effective intervention. According to the market value of RUTF, the average cost per patient of RUTF treatment using product-dosing guidelines of two to three sachets per day for a two-month period is approximately $45. When considering the severity of the diagnosis and needs of the patients with OFC to get to the threshold of surgical eligibility, using -2-one-to-two-week treatment periods could be effective for a large portion of patients. This means the cost of RUTF nutritional intervention could be reduced to as low as $10 per patient depending on severity, prior to negotiated supply chain arrangements.
The partnership model used in this program reduced costs even further, which can be utilized as a strategy for similar interventions by non-profits and LMIC groups. The success of the collaboration between local communities, the private sector (Birdsong Peanuts and MANA), and a non-profit organization (OS) counterbalanced costs for added programmatic infrastructure such as medical oversight and patient outreach. Outside of economic benefits, these partnerships have made it possible to establish an extensive nutrition program spanning six countries and three continents with consistent, sustainable standards of care and data collection methods. This improved efficiency has facilitated research, which is often lacking yet critical to the improvement of programmatic interventions in LMICs.
The main limitation of the program, as is true for most research in LMICs, is the difficulty of ensuring long-term follow-up care. In all six countries, a large proportion of patients live far from the OS cleft centers, creating geographical and financial barriers. In many cases, even with travel costs supplemented by OS, patients are faced with the challenges of inadequate or unsafe roads, inconsistent transportation, and extensive travel times making it exceedingly difficult to seek biweekly follow-up care. To further complicate long-term care, communication with families is challenging in these settings. Many families lack access to personal phones, cell service, or electrical power, making it difficult to reach patients to reschedule appointments or to conduct follow-ups by phone. However, the large number of patients who became eligible for surgery after one follow-up visit supports the idea that a single baseline visit to receive the needed supplement could suffice in situations where follow-up is not possible.
A common concern when considering supplementary feeding programs is the possibility that other family members consume the food intended for the patient, also known as leakage (19). In our study, leakage was not tracked, but families were strongly advised to adhere to the prescribed feeding plan for their children to receive surgery, which we believe highly reduced the likelihood of leakage. However, if leakage was an issue, it would cause an underestimation of weight gain per RUTF consumption meaning that the program would be even more effective than calculated. Other significant and recent limitations to providing timely surgical care are the COVID-19 pandemic and related surgical restrictions, which accounts for approximately one third of our study period. The number of surgeries performed would likely have been higher had surgical programs not been halted by the pandemic.
The pilot and initial data collection has led to new developments that will inform the future directions of the program. To improve our ability to consistently provide RUTF supplement to patients and track their progress, we will explore expanding partnerships with local, community healthcare organizations in the field. Strengthening the local healthcare systems and training community health workers to manage the distribution of RUTF and follow-ups will also expand our network and allow us to have a better understanding of what is required for local patients with OFC to achieve surgical eligibility. Additionally, because our study did not include infants younger than 6 months old and did not assess assisted-feeding interventions, a future study using a cohort under 6 months of age will be conducted to assess effective feeding methods in reducing malnutrition during infancy. Further work is also needed to monitor adherence to supplementary feeding plans and track the patients postoperatively to assess any effect that short-term nutrition interventions may have on surgical outcomes.