| BackgroundThe incidence of neonatal jaundice is high,which seriously threatens the health and life of neonates.Phototherapy is the most commonly used,effective and safe treatment method,but conventional in-hospital phototherapy has many adverse effects.Home phototherapy is an economical and convenient alternative to in-hospital phototherapy.At present,phototherapy devices are designed for hospitals and have a single function,which is not suitable for home environments.Therefore,the development of home phototherapy device in neonatal jaundice is an important problem to be solved.ObjectivesWith the guidance of user’s participation in the medical device technology development process,this study aim to complete the demand analysis,design and usability evaluation of the home phototherapy prototype in neonatal jaundice.Methods1.Demand analysis of home phototherapy device in neonatal jaundice.(1)Medical staffs interviews:Semi-structured interviews were used to understand the current status of neonatal jaundice management and medical staffs’views on home phototherapy device.(2)User investigation:A mixed research method was used to analyze users’needs and preferences of the home phototherapy device.2.Developement of the home phototherapy prototype(1)Literature review:Using the scope review guidelines issued by the Joanna Briggs Institute as the methodological framework to review the related research of home phototherapy,and summary the application conditions and treatment plans.(2)Delphi expert consultation:The members of the research group discussed according to the results of the demand analysis and literature review,formed the design scheme of the home phototherapy device,and conducted the Delphi expert consultation to determine the product design.3.Evaluation usability of the home phototherapy prototypeTaking the home phototherapy prototype formed by the rapid prototyping method as a research tool,after recruiting the research subjects to fully experience and try it out,a mixed research method was conducted to evaluate the usability of the prototype.Results1.Demand analysis of home phototherapy device(1)Medical staff interviews:Qualitative interviews with 8 medical staffs showed that the current situation of neonatal jaundice management is not optimistic,and home phototherapy devices need to be safe,effective,cheap,easy to operate,and temperature monitoring.(2)User investigation:The results of interviews with 23 users showed that the new device should be safe,effective,cheap,reduce the amount of heat production,equipped with hood,and online guidance function.2.Development of the home phototherapy prototype(1)Literature review:A total of 141 literatures were retrieved,and 9 were finally included.According to literature research,it is found that the current application of home phototherapy requires professional support,and most of them application of continuous phototherapy.(2)Delphi Expert Consultation:After expert consultation,it was finally determined that the product features of the device include:reduce the amount of heat production,optimal light,efficient light intensity,adjustable phototherapy mode,adjustable light source distance,simple operation,visual interface,temperature and humidity monitoring,shading,good stability.3.Evaluation usability of the home phototherapy prototype15 users completed the usability evaluation of the prototype,9 uses were caregivers and 6 uses were medical staffs,the average score of system usability scale was 64.16,indicating that the usability of the device is good.Through qualitative interviews,users believe that the product is easy to learn and use,and has a strong willingness to use.ConclusionsTaking user participation in MDTDP as the theoretical framework to develop the home phototherapy device,which enhances the usability of the product.It also provides a tool for the development of clinical research on home phototherapy in the future.It is expected that the successful development of this device will promote the home phototherapy in China. |
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