Introduction
The neonatal period (ie, the first 28 days of life) is the most vulnerable time for a child’s survival. As advances in the ability to resuscitate and stabilise premature neonates improve survival rates, diseases and conditions related to being born preterm are becoming more common.1 Unfortunately, the novel technologies and management approaches which lead to good outcomes for premature neonates in high-income countries are often not available in many low-income and middle-income countries (LMICs).2 Much international attention is being brought to bear on improving access to life-saving measures for premature neonates, including a goal of mitigating all newborn deaths by 2030.3–6 Consequently, there is an increasing focus on managing the complications these neonates can develop as they mature.7
One complication of preterm birth is retinopathy of prematurity (ROP), a vasoproliferative disorder of the immature retina. Risk factors include increasing prematurity and exposure to perinatal and postnatal factors.8 9 Global estimates in 2010 indicated that there were 14.9 million premature births, 848 300 of whom survived and were at risk of ROP. An estimated 184 700 of those who survived developed any stage of ROP, with 32 200 babies becoming blind or visually impaired.10 Rates of blindness from ROP can be higher in LMICs where exposure to modifiable risk factors can be higher, and ROP screening and treatment services are under-resourced or nonexistent.11
Screening for ROP, which should include all eligible infants according to local guidelines, starts within weeks of birth.12 Unlike screening for other conditions, which usually entails a one-off procedure, screening for ROP may need to be repeated at frequent intervals depending on the clinical findings. If repeat screening is required, it is vital that the findings of earlier screening are immediately available in order to determine whether the condition is regressing, remaining the same or progressing, as this influences the management decision (ie, screen again or treatment is required, or screening can stop). Records of earlier screening can be paper records of the stage, site, signs of plus disease in each eye or retinal images.
Screening is usually undertaken in the neonatal unit; infants no longer inpatients can be screened in an eye department. Binocular indirect ophthalmoscopy by a skilled ophthalmologist is the most common method of ROP screening, but there are several other approaches, all of which have advantages and disadvantages (table 1). A significant advantage of retinal imaging is the capital-labour trade-off it can entail, where the high initial cost of the imaging devices is offset by the lower salary costs of the screeners who do not need to be medically qualified. The ideal situation would be that each neonatal unit has an imaging device so that trained members of the neonatal team or technicians can capture images at a convenient time, with remote image grading by an ROP expert.13
A recent adjunct to screening using indirect ophthalmoscopy is image capture using a smartphone; the light source of the phone is used with a condensing lens, and a device can be used to hold the phone if necessary. Despite the images having a narrow field with a limited view of the retina, they can be used to educate parents and neonatal team members, shared on social media to obtain second opinions and serve as a reference to document the findings.14
Where the gold standard for ROP screening, indirect ophthalmoscopy, is not readily available, mainly due to a lack of ophthalmologists able or willing to screen, technology must be designed and tested to improve remote screening capabilities. Target product profiles (TPPs) are used to inform manufacturers of ideal targets and product requirements while aligning with the needs of end users to guide product research and development.15 TPPs should include the agreement of many stakeholders on the requirements necessary for a tool to be considered effective for screening.
To address these issues, NEST360 (an international alliance of 17 organisations and 4 governments united to reduce preventable newborn deaths in African hospitals),16 the London School of Hygiene & Tropical Medicine and UNICEF led a Delphi-like survey process and consensus meeting with global experts to define the product requirements for an ROP screening device. In this paper, we describe the processes undertaken to develop the TPP, which entailed eliciting the perspectives and opinions of a diverse set of stakeholders.