Original Title: Detección de complicaciones de la diabetes. Retinopatía diabética. Evaluación económica de la oftalmoscopia por exploración con láser campo ultra-amplio

Authors' objectives: -To evaluate the appropriate moment of beginning of the early diagnosis of RD and its periodicity. -Analyse the cost effectiveness of DR screening programs at different time intervals. -To make an economic evaluation of the early detection of DR by capture of retinal images with ultra-wide field scanning laser technology compared to the usual practice.

Authors' results and conclusions: In people with a new diagnosis of DM1, the first episode of DR screening can begin between 2 and 5 years after the diagnosis of the disease. The decision can be made taking into account the age of the person at the time of diagnosis and the coexistence of risk factors that can accelerate the evolution towards DR that requires treatment, such as poor glycaemic control. In people with a new diagnosis of DM2, the first episode of DR screening can be started at the time of diagnosis or before the first 2 years after diagnosis. In people with DM1 or DM2, the periodicity of the episodes of screening can be extended, generally to two years. Considering the situation of each person, in people with high risk of developing DR, the periodicity between episodes of screening can be less than two years and if it is a question of people with low risk, the periodicity between episodes of screening can be extended to 4 or 5 years. The incorporation of the UWF technology into the DR screening program in the NHS supposes a cost slightly higher than € 55 per patient correctly classified, with respect to the use of the NMR. In the health sectors with a reduced number of inhabitants (50,000 inhabitants) and keeping the remaining variables constant, the cost could rise to € 227.42 per patient correctly classified. UWF technology has the capability to rule out the presence of DR in people with diabetes in all the stages of severity of the DR, only surpassed by the NMR in patients with STDR. However, UWF is not the technology of choice to be part of a detection program whose objective is the identification of diabetic people with DR.

Authors' methods: Specialised databases in systematic reviews are consulted such as Cochrane Library and Centre for Reviews and Dissemination (CRD) and general databases such as ISI Web of Knowledge, Medline, Embase and Lilacs, as well as web pages of clinical trials registers: Clinical Trials, Current Controlled Trials International Standard Randomised Controlled Trial Number Register (ISRCTN) e International Clinical Trials (WHO). Exclusion and inclusion criteria are applied for the selection of studies and the relevant data of the studies are extracted uniformly from the Critical Reading File tool (FLC 2.0). An economic analysis is performed to examine the viability of a nonmydriatic retinograph (NMR) renewal or substitution by ultra-wide field laser image capture equipment. Given that in the National Health System (NHS) there are different DR screening strategies that involve organisational models, different healthcare circuits and professional profiles for taking and interpretation of images, the economic evaluation has been made taking a specific model. The patient’s circuit has been simulated for the two possible strategies to adopt for DR screening in a healthcare area: a) continue using 45º digital photography with a non-mydriatic camera, renewing the current NMR; or b) install UWF retinographs replacing the current NMR. Each screening strategy can have results of absence or presence of RD in different levels of severity (mild NPDR, moderate NPDR, severe NPDR and STDR, this last level includes PDR and ME). The probability that the patient is correctly identified has drawn on the combination of prevalence in the different stages of DR and the diagnostic accuracy parameters (SE and SP). The perspective adopted was the NHS, taking into account only direct health costs. Excel 2010 (Microsoft, Redmond, Washington, United States of America) has been used for the construction of the economic model. Cost per patient has been calculated for every screening strategy, and a 4-year budget impact analysis for NHS has been derived. For the sensitivity analysis, costs of investment in equipment, staff and training, number of inhabitants per health sector and diagnostic reliability values have been taken into account. In addition, a budgetary impact sensitivity analysis was carried out, proposing a staggered technology renewal scheme (replacing NMR with UWF) of 25% per year, up to the total renewal of devices.

Project Status: Completed

Year Published: 2019

URL for published report: http://www.iacs.es/wp-content/uploads/2019/09/07_IACS_2016_RETINOPATIA_DEF_NIPO.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Health Sciences Institute in Aragon (IACS)

Contact Address: Avda, San Juan Bosco, 13, planta 2

Contact Name: María Pilar Calvo Pérez

Contact Email: direccion.iacs@aragon.es