Modified implementation guide.

Clinical audits are an important intervention that enables health workers to reflect on their practice and identify and act on modifiable gaps in the care provided. To effectively audit the quality of care provided to the small and sick newborns, the clinical audit process must use a structured tool that comprehensively covers the continuum of newborn care from immediately after birth to the period of newborn unit care. The objective of the study was to co-design a newborn clinical audit tool that considered the key principles of a Human Centred Design approach. A three-step Human Centred Design approach was used that began by (1) understanding the context, the users and the available audit tools through literature, focus group discussions and a consensus meeting that was used to develop a prototype audit tool and its implementation guide, (2) the prototype audit tool was taken through several cycles of reviewing with users on real cases in a high volume newborn unit and refining it based on their feedback, and (3) the final prototype tool and the implementation guide were then tested in two high volume newborn units to determine their usability. Several cycles of evaluation and redesigning of the prototype audit tool revealed that the users preferred a comprehensive tool that catered to human factors such as reduced free text for ease of filling, length of the tool, and aesthetics. Identified facilitators and barriers influencing the newborn clinical audit in Kenyan public hospitals informed the design of an implementation guide that builds on the strengths and overcomes the barriers. We adopted a Human Centred Design approach to developing a newborn clinical audit tool and an implementation guide that we believe are comprehensive and consider the characteristics of the context of use and the user requirements.