Implementation challenges from a prospective, interventional biopsy-based study of Environmental Enteropathy in rural Pakistan

Abstract

The Study of Environmental Enteropathy (EE) and Malnutrition in Pakistan (SEEM) is a community intervention trial designed to understand the pathophysiology of EE and its associated clinical phenotypes in children less than two years of age. Undernutrition is the underlying cause of three million deaths worldwide annually, accounting for 45% of all deaths among children under five years of age. Linear growth stunting affects a further 165 million, especially in low- and middle-income countries. In Pakistan,  an estimated one in three children are underweight and nearly half are stunted. This manuscript summarizes the challenges faced by the field team and the solutions employed for achieving our research objectives at the rural Matiari field site. Our study design involved a longitudinal collection of field data and biological samples which required constant engagement of field staff with the participating families. Challenges faced in SEEM included: 1) quality assurance parameters of anthropometry data; 2) 24-hour food recall data collection; 3) clinical management of sick enrolled children; 4) obtaining informed consent for upper gastrointestinal (UGI)endoscopy (an invasive procedure); and 5) biological sample collection (blood, urine, stool) from enrolled children. We enrolled 350 malnourished children(Weight for Height Z (WHZ) score <-2) and 50 well-nourished children(WHZ score ≥ 0 and height-for-age Z (HAZ) score ≥ -1)   with more than 95% success rate of collecting blood, urine and stool specimens. We collected 72% microbiome stool samples within 30 minutes of the child passing stool. We conducted a UGI biopsy in 63 children.   Solutions to these challenges included good project governance, the establishment of credibility, and the development of a longitudinal bidirectional relationship embedded in trust and effective communication with the caretakers of the enrolled children.     Continuous monitoring, regular training of staff, and effective teamwork were key factors that led to the successful execution of our study.