PMID- 30961576 OWN - NLM STAT- MEDLINE DCOM- 20190410 LR - 20220716 IS - 1471-2415 (Electronic) IS - 1471-2415 (Linking) VI - 19 IP - 1 DP - 2019 Apr 8 TI - Diagnostic test accuracy of diabetic retinopathy screening by physician graders using a hand-held non-mydriatic retinal camera at a tertiary level medical clinic. PG - 89 LID - 10.1186/s12886-019-1092-3 [doi] LID - 89 AB - BACKGROUND: The evidence on diagnostic test accuracy (DTA) of diabetic retinopathy (DR) screening utilising photographic studies by non-ophthalmologist personnel in low and middle-income country (LMIC) settings is scarce. We aimed to assess DTA of DR screening using a nonmydriatic hand-held digital camera by trained general physicians in a non-ophthalmic setting. METHODS: This study is a validation of a screening intervention. We selected 700 people with diabetes (PwDM) > 18 years of age, not previously screened or treated for DR, presenting at a tertiary medical clinic in Sri Lanka. Two-field retinal imaging was used to capture fundus images before and after pupil dilatation, using a hand-held non-mydriatic (Visuscout 100(R)-Germany) digital retinal camera. The images were captured and graded by two trained, masked independent physician graders. The DTA of different levels of DR was assessed comparing physician's grading with a retinologist's clinical examination by mydriatic bio-microscopy, according to a locally adopted guideline. RESULTS: Seven hundred eligible PwDM were screened by physician graders. The mean age of participants was 60.8 years (SD +/-10.08) and mean duration of DM was 9.9 years (SD +/-8.09). Ungradable image proportion in non-mydriatic imaging was 43.4% (either eye-31.3%, both eyes 12.1%). This decreased to 12.8% (either eye-11.6%, both eyes-1.2%) following pupil dilatation. In comparison to detection of any level of DR, a referable level DR (moderate non-proliferative DR and levels above) showed a higher level of DTA. The sensitivity of the defined referable DR was 88.7% (95% CI 81.7-93.8%) for grader 1 (positive predictive value [PPV] 59.1%) and 92.5% (95% CI 86.4-96.5%) for grader 2 (PPV 68%), using mydriatic imaging, after including ungradable images as screen positives. The specificity was 94.9% (95% CI 93.6-96.0%) for grader 1 (negative predictive value [NPV] 99%) and 96.4% (95% CI 95.3-97.3%) for grader 2 (NPV 99.4%). CONCLUSIONS: The Physicians grading of images from a digital hand-held non-mydriatic camera at a medical clinic, with dilatation of pupil of those who have ungradable images, provides a valid modality to identify referable level of DR. This could be a feasible alternative modality to the existing opportunistic screening to improve the access and coverage. TRIAL REGISTRATION: Current Controlled Trials ISRCTN47559703 . Date of Registration 18th March 2019, Retrospectively registered. FAU - Piyasena, Mapa Mudiyanselage Prabhath Nishantha AU - Piyasena MMPN AD - Clinical Research Department, International Centre for Eye Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Prabhath.piyasena@lshtm.ac.uk. FAU - Yip, Jennifer L Y AU - Yip JLY AD - Public Health Ophthalmology, International Centre for Eye Health, Clinical Research Department, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. FAU - MacLeod, David AU - MacLeod D AD - Tropical Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. FAU - Kim, Min AU - Kim M AD - Tropical Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. FAU - Gudlavalleti, Venkata S Murthy AU - Gudlavalleti VSM AD - Public Health for Eye Care and Disability, International Centre for Eye Health, Clinical Research Department, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. LA - eng GR - MR/R010161/1/MRC_/Medical Research Council/United Kingdom GR - ITRCRZC6812/Queen Elizabeth Diamond Jubilee Trust, coordinated through the Commonwealth Eye Health Consortium - United Kingdom./ PT - Journal Article DEP - 20190408 PL - England TA - BMC Ophthalmol JT - BMC ophthalmology JID - 100967802 RN - 0 (Mydriatics) SB - IM MH - Diabetic Retinopathy/*diagnosis MH - Equipment Design MH - Female MH - Humans MH - Image Processing, Computer-Assisted/*methods MH - Male MH - Middle Aged MH - Mydriatics MH - Photography/*instrumentation MH - *Physicians MH - Prospective Studies MH - Reproducibility of Results MH - Retina/*diagnostic imaging MH - *Tertiary Care Centers MH - Vision Screening/*instrumentation PMC - PMC6454614 OTO - NOTNLM OT - Diabetes OT - Diabetic retinopathy OT - Diagnostic accuracy OT - Digital imaging OT - Screening COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: The ethics approval was obtained from the London School of Hygiene and Tropical Medicine - United Kingdom and from the National Eye Hospital of Sri Lanka. Written informed consent was obtained from all the participants recruited in this study. CONSENT FOR PUBLICATION: Not applicable. COMPETING INTERESTS: The authors declare that they have no competing interests. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2019/04/10 06:00 MHDA- 2019/04/11 06:00 PMCR- 2019/04/08 CRDT- 2019/04/10 06:00 PHST- 2018/11/22 00:00 [received] PHST- 2019/03/26 00:00 [accepted] PHST- 2019/04/10 06:00 [entrez] PHST- 2019/04/10 06:00 [pubmed] PHST- 2019/04/11 06:00 [medline] PHST- 2019/04/08 00:00 [pmc-release] AID - 10.1186/s12886-019-1092-3 [pii] AID - 1092 [pii] AID - 10.1186/s12886-019-1092-3 [doi] PST - epublish SO - BMC Ophthalmol. 2019 Apr 8;19(1):89. doi: 10.1186/s12886-019-1092-3.