{ "id": "AIBD-0067", "title": "An AI eye exam increased screening among young people with diabetes", "summary": "In the ACCESS trial, all 81 young people offered IDx-DR completed an eye exam, compared with 18 of 82 controls referred to an eye-care provider.", "date_observed": "2022-12-06", "date_basis": "event", "date_precision": "day", "benefit_status": "reported", "source_collection": null, "source_entry": null, "account": "The ACCESS trial enrolled young people with diabetes at two Johns Hopkins clinics in Baltimore. Of 164 participants randomized, one control was excluded after entering another screening study. All 81 participants assigned to an IDx-DR eye exam completed screening, compared with 18 of 82 controls referred to an eye-care provider. The AI marked 25 results as positive, and 16 of those participants attended an eye-care visit within six months. A retina specialist reviewed all AI images for safety because the device was not cleared for this age group. The study measured screening and follow-up, not preserved vision.", "category": "general benefit", "unexpected": false, "purpose": "IDx-DR/LumineticsCore is built to autonomously detect more-than-mild diabetic retinopathy from fundus images at the point of care. Increasing screening completion is its intended benefit.", "system": "IDx-DR (now LumineticsCore)", "model_version": null, "developer": "Digital Diagnostics", "deployer": "Johns Hopkins Pediatric Diabetes Center", "location": "Baltimore, United States", "domain": "Healthcare - diabetic retinopathy screening", "segment": "Autonomous AI screening in pediatric diabetes care", "benefit_type": "Improved Physical Health", "taxonomy_note": "The trial reports exam completion and follow-through, process outcomes, rather than vision outcomes.", "registry_ids": { "clinicaltrials_gov": "NCT05131451" }, "ratings": [ { "group": "personal", "depth": 2, "reason": "The trial measured a substantial increase in completed diabetic eye exams. It did not establish improved vision or prevention of blindness." } ], "ai_role": { "status": "assessed", "statement": "IDx-DR assessed retinal photographs and returned a screening result during the diabetes visit. The trial compared this on-site service with referral elsewhere. A retina specialist also reviewed the images for safety. A coauthor had financial interests in the manufacturer, although he did not have access to the underlying data." }, "evidence": [ { "kind": "peer-reviewed study", "citation": "Risa M. Wolf et al., “Autonomous Artificial Intelligence Increases Screening and Follow-up for Diabetic Retinopathy in Youth: The ACCESS Randomized Control Trial,” Nature Communications 15 (2024): 421, doi:10.1038/s41467-023-44676-z. Figures 1–2, Methods, and Supplementary Note 3.", "title": "Autonomous artificial intelligence increases screening and follow-up for diabetic retinopathy in youth: the ACCESS randomized control trial", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/", "date": "2024-01-11", "written_by": "evaluator", "quote": null } ], "replication": { "produced_by": [ "Autonomous AI camera and software located in the diabetes clinic", "Immediate result at the visit with referral only for abnormal findings" ], "must_hold": [ "Gradable images obtainable in the clinic", "A referral route for abnormal results" ], "echoes": [] }, "paired_incident": null, "headline": "An AI eye exam increased screening among young people with diabetes", "metric": "81 of 81 versus 18 of 82 completed screening", "comparator": { "against": "control arm given scripted referral and education with a paper handout", "before": "22%, 95%CI: 14.2%, 32.4%", "after": "100%, 95%CI: 95.5%, 100%", "basis": "measured", "quote": "Diabetic eye exam completion rate was significantly higher (100%, 95%CI: 95.5%, 100%) in the intervention group (n = 81) than the control group (n = 83) (22%, 95%CI: 14.2%, 32.4%)(p < 0.001).", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/" }, "later": { "status": "unknown", "date": null, "note": "The study followed eye-exam completion and referral attendance for six months. It did not report later vision outcomes.", "quote": null, "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/" }, "value": null, "developer_country": "United States", "deployer_country": "United States", "unrated_because": null, "brief_notes": null, "brief": null, "revisions": [ { "date": "2026-10-20", "change": "Record drafted from the cited sources.", "source": null, "editor": "AIBD" }, { "date": "2026-10-20", "change": "Evidence quote restored to the abstract's verbatim sentence including the group sizes (n = 81) and (n = 83), evidence date set to the 11 January 2024 publication date, and the AI-role statement corrected because second author R. Channa is at the University of Wisconsin rather than Johns Hopkins, with the author-contribution statement that Abramoff had no access to the underlying data added.", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Added what the benefit is measured against from the cited sources.", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Benefit type set to Improved Physical Health under Trustible's full taxonomy of 23 types; it was Improved Accessibility among the six first used.", "source": "https://trustible.ai/post/a-framework-for-measuring-the-benefits-of-ai/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Country of the developer and the deployer added from the organization's own site or a registry.", "source": "https://www.digitaldiagnostics.com/contact/; https://en.wikipedia.org/wiki/Johns_Hopkins_Medicine", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Prose pass: account, purpose, the system's part rewritten in shorter sentences with abbreviations expanded; facts, figures and quotations unchanged.", "source": null, "editor": "AIBD" }, { "date": "2026-10-25", "change": "Reviewed the original evidence and supporting material; updated system details, methods, outcomes, limitations, costs, and source lineage.", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/", "editor": "AIBD" } ], "confidence": "claimed", "shade": "low", "claim_status": "The evaluator's account", "claim_basis": "Sources: the evaluators' peer-reviewed study. The cited evidence includes no independent source and no finding by a regulator or court.", "profile": { "case_id": "AIBD-0067", "catalog_version": "1.0.0", "source_fingerprint": "f6eae30ef3c156d711228cb8bcf5969e1eca2919712de3047d11d854ad4ba314", "collection_refs": [ { "collection_id": "aibd", "version": "snapshot-8bf7cfec9cb185aa" }, { "collection_id": "aibd", "version": "2026-10-25" } ], "source_ids": [ "AIBD-0067-source-0001" ], "families": { "strategic assessments": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] }, "evaluations": { "state": "value_present", "value": { "kind": "identifiers", "identifiers": [ "NCT05131451" ], "role": "evaluations" }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The evaluation described in the cited original sources." }, "record_ids": [ "NCT05131451" ] }, "monetary observations": { "state": "value_present", "value": { "kind": "identifiers", "identifiers": [ "AIBD-0067-study-compensation" ], "role": "monetary observations" }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "A reported payment for study participation, retained as context." }, "record_ids": [ "AIBD-0067-study-compensation" ] }, "institutional decisions": { "state": "value_present", "value": { "kind": "identifiers", "identifiers": [ "Johns Hopkins IRB00288043" ], "role": "institutional decisions" }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Approval of pediatric investigational use." }, "record_ids": [ "Johns Hopkins IRB00288043" ] } }, "fields": { "actors[]": { "state": "value_present", "value": { "kind": "text", "text": "Johns Hopkins conducted the trial at Johns Hopkins Hospital and Mount Washington Pediatric Hospital. Digital Diagnostics supplied the diagnostic product." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Johns Hopkins conducted the trial at Johns Hopkins Hospital and Mount Washington Pediatric Hospital. Digital Diagnostics supplied the diagnostic product." } }, "actors[].ownership_control": { "state": "not_reported", "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "reason": "The reviewed clinical sources identify the organizations involved, but do not establish their complete ownership or control arrangements.", "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The reviewed clinical sources identify the organizations involved, but do not establish their complete ownership or control arrangements." } }, "ai_contribution": { "state": "value_present", "value": { "kind": "text", "text": "IDx-DR made an eye exam available at the diabetes visit. The trial tests this entire on-site service against referral elsewhere." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "IDx-DR made an eye exam available at the diabetes visit. The trial tests this entire on-site service against referral elsewhere." } }, "ai_relationship": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "category": "general benefit", "ai_role": { "status": "assessed", "statement": "IDx-DR assessed retinal photographs and returned a screening result during the diabetes visit. The trial compared this on-site service with referral elsewhere. A retina specialist also reviewed the images for safety. A coauthor had financial interests in the manufacturer, although he did not have access to the underlying data." } } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "ai_role", "category" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "assessments[].alternatives": { "state": "value_present", "value": { "kind": "text", "text": "A null grade would omit the measured improvement. Grades 3–5 would require a lasting capability or health benefit that this trial did not establish." }, "provenance": { "kind": "curatorial", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "A null grade would omit the measured improvement. Grades 3–5 would require a lasting capability or health benefit that this trial did not establish." } }, "assessments[].assessor_date": { "state": "value_present", "value": { "kind": "structured", "data": { "assessor": "AIBD, AI-assisted source review", "date": "2026-10-25" } }, "provenance": { "kind": "curatorial", "basis": "Review of the sources listed in the lineage assessment.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "AIBD, 25 October 2026." } }, "assessments[].depth": { "state": "value_present", "value": { "kind": "structured", "data": { "ratings": [ { "group": "personal", "depth": 2, "reason": "The trial measured a substantial increase in completed diabetic eye exams. It did not establish improved vision or prevention of blindness." } ] } }, "provenance": { "kind": "curatorial", "basis": "Local five-level depth rubric; Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Depth 2 for improved access to completed screening." } }, "assessments[].display_confidence": { "state": "value_present", "value": { "kind": "text", "text": "A randomized academic evaluation with a manufacturer-affiliated coauthor. The outline is retained under the current independence rule." }, "provenance": { "kind": "curatorial", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "A randomized academic evaluation with a manufacturer-affiliated coauthor. The outline is retained under the current independence rule." } }, "assessments[].rationale": { "state": "value_present", "value": { "kind": "text", "text": "Depth 2 for improved access to completed screening." }, "provenance": { "kind": "curatorial", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Depth 2 for improved access to completed screening." } }, "assessments[].rubric_version": { "state": "value_present", "value": { "kind": "text", "text": "AIBD’s five-level depth rubric, reviewed on 25 October 2026." }, "provenance": { "kind": "curatorial", "basis": "Local methodology; no separately numbered rubric version is published.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "AIBD’s five-level depth rubric, reviewed on 25 October 2026." } }, "assessments[].status_basis": { "state": "value_present", "value": { "kind": "text", "text": "The depth describes the reported result. Evidence strength is assessed separately." }, "provenance": { "kind": "curatorial", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The depth describes the reported result. Evidence strength is assessed separately." } }, "assessments[].target": { "state": "value_present", "value": { "kind": "text", "text": "The benefit described here, for the beneficiary groups shown." }, "provenance": { "kind": "curatorial", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The benefit described here, for the beneficiary groups shown." } }, "availability": { "state": "value_present", "value": { "kind": "text", "text": "LumineticsCore is commercially available. The trial’s pediatric use was investigational because the FDA indication covered adults aged 22 or older." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "LumineticsCore is commercially available. The trial’s pediatric use was investigational because the FDA indication covered adults aged 22 or older." } }, "brief": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "case_kind": { "state": "value_present", "value": { "kind": "text", "text": "A randomized trial of on-site screening versus referral." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "A randomized trial of on-site screening versus referral." } }, "case_links[]": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "claims[].evidence_links": { "state": "value_present", "value": { "kind": "structured", "data": { "screening": { "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/", "locator": "Figure 1; Tables 2–3" }, "oversight": { "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/", "locator": "Methods; Supplementary Note 3" }, "conflicts": { "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/", "locator": "Author contributions; Competing interests" } } }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The trial flow diagram supplies the analyzed counts. Its supplement records specialist safety review." } }, "claims[].evidence_strength": { "state": "value_present", "value": { "kind": "text", "text": "A peer-reviewed randomized trial by academic investigators, with a coauthor who held financial interests in the manufacturer." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "A peer-reviewed randomized trial by academic investigators, with a coauthor who held financial interests in the manufacturer." } }, "claims[].missingness": { "state": "value_present", "value": { "kind": "text", "text": "The paper does not establish later vision outcomes, the device’s exact software release, or a separate causal effect of the algorithm." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The paper does not establish later vision outcomes, the device’s exact software release, or a separate causal effect of the algorithm." } }, "claims[].proposition": { "state": "value_present", "value": { "kind": "text", "text": "An on-site IDx-DR exam increased screening completion from 22% to 100%." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "An on-site IDx-DR exam increased screening completion from 22% to 100%." } }, "cross_border_flows[]": { "state": "not_reported", "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "reason": "The reviewed sources do not document international transfers of patient data or quantify cross-border financial flows.", "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The reviewed sources do not document international transfers of patient data or quantify cross-border financial flows." } }, "decisions[].action_outcome": { "state": "value_present", "value": { "kind": "text", "text": "Staff used the device in the trial and arranged retina-specialist review of every AI image." }, "provenance": { "kind": "source_review", "basis": "Methods: Study design; Supplementary Note 3; NCT05131451, protocol identifier IRB00288043.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Staff used the device in the trial and arranged retina-specialist review of every AI image." } }, "decisions[].grounds": { "state": "value_present", "value": { "kind": "text", "text": "The study received IRB approval, an investigational device exemption, and independent safety monitoring." }, "provenance": { "kind": "source_review", "basis": "Methods: Study design; Supplementary Note 3; NCT05131451, protocol identifier IRB00288043.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The study received IRB approval, an investigational device exemption, and independent safety monitoring." } }, "decisions[].institution_task": { "state": "value_present", "value": { "kind": "text", "text": "Johns Hopkins evaluated AI screening in young people below the device’s FDA-indicated age." }, "provenance": { "kind": "source_review", "basis": "Methods: Study design; Supplementary Note 3; NCT05131451, protocol identifier IRB00288043.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Johns Hopkins evaluated AI screening in young people below the device’s FDA-indicated age." } }, "decisions[].success_criterion": { "state": "value_present", "value": { "kind": "text", "text": "The prespecified primary outcome was completion of an eye exam within six months." }, "provenance": { "kind": "source_review", "basis": "Methods: Study design; Supplementary Note 3; NCT05131451, protocol identifier IRB00288043.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The prespecified primary outcome was completion of an eye exam within six months." } }, "deployment_stage": { "state": "value_present", "value": { "kind": "text", "text": "Investigational use in a pediatric diabetes trial." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Investigational use in a pediatric diabetes trial." } }, "economics[].amount": { "state": "value_present", "value": { "kind": "text", "text": "US$25 per participant, plus a parking pass whose value was not reported." }, "provenance": { "kind": "source_review", "basis": "Methods: Acceptability and satisfaction, last sentence. This payment is study context only.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "US$25 per participant, plus a parking pass whose value was not reported." } }, "economics[].costs[]": { "state": "value_present", "value": { "kind": "text", "text": "The article does not report the full cost of the service, specialist review, staff time, or parking passes." }, "provenance": { "kind": "source_review", "basis": "Methods: Acceptability and satisfaction, last sentence. This payment is study context only.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The article does not report the full cost of the service, specialist review, staff time, or parking passes." } }, "economics[].counterfactual": { "state": "value_present", "value": { "kind": "text", "text": "No comparison of financial outcomes between the randomized groups was reported." }, "provenance": { "kind": "source_review", "basis": "Methods: Acceptability and satisfaction, last sentence. This payment is study context only.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "No comparison of financial outcomes between the randomized groups was reported." } }, "economics[].currency_price_basis": { "state": "value_present", "value": { "kind": "text", "text": "U.S. dollars during the 2021–2022 study. No inflation adjustment was reported." }, "provenance": { "kind": "source_review", "basis": "Methods: Acceptability and satisfaction, last sentence. This payment is study context only.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "U.S. dollars during the 2021–2022 study. No inflation adjustment was reported." } }, "economics[].gross_net": { "state": "value_present", "value": { "kind": "text", "text": "The US$25 is the face value of a gift card. It is not net benefit from screening." }, "provenance": { "kind": "source_review", "basis": "Methods: Acceptability and satisfaction, last sentence. This payment is study context only.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The US$25 is the face value of a gift card. It is not net benefit from screening." } }, "economics[].measure_type": { "state": "value_present", "value": { "kind": "text", "text": "A gift card for study participation. This was a transfer, not value that AI created." }, "provenance": { "kind": "source_review", "basis": "Methods: Acceptability and satisfaction, last sentence. This payment is study context only.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "A gift card for study participation. This was a transfer, not value that AI created." } }, "economics[].period_unit": { "state": "value_present", "value": { "kind": "text", "text": "Per participant for study participation." }, "provenance": { "kind": "source_review", "basis": "Methods: Acceptability and satisfaction, last sentence. This payment is study context only.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Per participant for study participation." } }, "economics[].realization": { "state": "value_present", "value": { "kind": "text", "text": "The authors report that participants received the gift card and parking pass." }, "provenance": { "kind": "source_review", "basis": "Methods: Acceptability and satisfaction, last sentence. This payment is study context only.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The authors report that participants received the gift card and parking pass." } }, "economics[].recipient_payer": { "state": "value_present", "value": { "kind": "text", "text": "Study participants received compensation. The article does not identify the precise paying account." }, "provenance": { "kind": "source_review", "basis": "Methods: Acceptability and satisfaction, last sentence. This payment is study context only.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Study participants received compensation. The article does not identify the precise paying account." } }, "economics[].return_payback": { "state": "value_present", "value": { "kind": "text", "text": "No financial return or payback period was estimated." }, "provenance": { "kind": "source_review", "basis": "Methods: Acceptability and satisfaction, last sentence. This payment is study context only.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "No financial return or payback period was estimated." } }, "economics[].valuation_method": { "state": "value_present", "value": { "kind": "text", "text": "The source states the gift card’s face value. It does not value health outcomes." }, "provenance": { "kind": "source_review", "basis": "Methods: Acceptability and satisfaction, last sentence. This payment is study context only.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The source states the gift card’s face value. It does not value health outcomes." } }, "evaluations[].ai_uplift": { "state": "value_present", "value": { "kind": "text", "text": "Randomization supports the effect of offering an immediate AI exam rather than a referral. It does not separate the algorithm from convenience and access at the clinic." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Randomization supports the effect of offering an immediate AI exam rather than a referral. It does not separate the algorithm from convenience and access at the clinic." } }, "evaluations[].comparator": { "state": "value_present", "value": { "kind": "text", "text": "Scripted education and referral to an eye-care provider, with a printed handout." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Scripted education and referral to an eye-care provider, with a printed handout." } }, "evaluations[].design": { "state": "value_present", "value": { "kind": "text", "text": "An unmasked randomized trial, with allocation concealed until assignment. Randomization used blocks of four or six and was stratified by clinic." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "An unmasked randomized trial, with allocation concealed until assignment. Randomization used blocks of four or six and was stratified by clinic." } }, "evaluations[].effect": { "state": "value_present", "value": { "kind": "structured", "data": { "screening": { "AI": { "numerator": 81, "denominator": 81, "percent": 100 }, "control": { "numerator": 18, "denominator": 82, "percent": 22 } }, "absolute_difference_percentage_points": 78, "absolute_difference_95CI": [ 69, 87 ], "p_less_than": 0.001, "AI_positive_follow_up": { "numerator": 16, "denominator": 25, "percent": 64, "95CI": [ 43, 81 ] } } }, "provenance": { "kind": "source_review", "basis": "Results; Figure 1; Tables 2–3. The abstract gives 83 assigned controls, while the analyzed control denominator is 82.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Screening completion was 100% with AI and 22% with referral, a difference of 78 percentage points (95% CI, 69–87)." } }, "evaluations[].exposure": { "state": "value_present", "value": { "kind": "text", "text": "Participants enrolled from 24 November 2021 to 6 June 2022. Follow-up ended on 6 December 2022. An AI exam generally took five to ten minutes." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Participants enrolled from 24 November 2021 to 6 June 2022. Follow-up ended on 6 December 2022. An AI exam generally took five to ten minutes." } }, "evaluations[].id": { "state": "value_present", "value": { "kind": "text", "text": "NCT05131451" }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "NCT05131451" } }, "evaluations[].measurement_method": { "state": "value_present", "value": { "kind": "text", "text": "The primary outcome was documented completion of a diabetic eye exam within six months. Researchers also tracked referral attendance and participant satisfaction." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The primary outcome was documented completion of a diabetic eye exam within six months. Researchers also tracked referral attendance and participant satisfaction." } }, "evaluations[].metric": { "state": "value_present", "value": { "kind": "text", "text": "Completion of a diabetic eye exam within six months, with referral attendance as a secondary outcome." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Completion of a diabetic eye exam within six months, with referral attendance as a secondary outcome." } }, "evaluations[].reproduction_materials": { "state": "value_present", "value": { "kind": "text", "text": "The protocol and supplement describe the procedure. De-identified data require an approved proposal and data-use agreement. The commercial diagnostic code is not published." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The protocol and supplement describe the procedure. De-identified data require an approved proposal and data-use agreement. The commercial diagnostic code is not published." } }, "evaluations[].setting_sample": { "state": "value_present", "value": { "kind": "text", "text": "The trial randomized 164 participants at two Baltimore clinics. After one control was excluded, the analysis included 81 AI participants and 82 controls." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The trial randomized 164 participants at two Baltimore clinics. After one control was excluded, the analysis included 81 AI participants and 82 controls." } }, "evaluations[].uncertainty_limitations": { "state": "value_present", "value": { "kind": "text", "text": "The trial measured access to screening, not later vision. The referral comparison used 25 AI-positive participants versus the entire control group, so those secondary denominators are not equivalent." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The trial measured access to screening, not later vision. The referral comparison used 25 AI-positive participants versus the entire control group, so those secondary denominators are not equivalent." } }, "external_references[]": { "state": "value_present", "value": { "kind": "structured", "data": { "ClinicalTrials.gov": "NCT05131451" } }, "provenance": { "kind": "source_review", "basis": "Original study registration, inspected through the ClinicalTrials.gov API.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "NCT05131451" } }, "follow_up[]": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "later": { "status": "unknown", "note": "The study followed eye-exam completion and referral attendance for six months. It did not report later vision outcomes.", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/" } } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "later" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "human_oversight": { "state": "value_present", "value": { "kind": "text", "text": "A board-certified retina specialist reviewed every AI image for safety. An independent monitoring board oversaw the study." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "A board-certified retina specialist reviewed every AI image for safety. An independent monitoring board oversaw the study." } }, "id": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "id": "AIBD-0067" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "id" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "infrastructure_dependencies[]": { "state": "value_present", "value": { "kind": "text", "text": "The service required a retinal camera, trained clinic staff, IDx-DR, specialist safety review, and a referral route." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The service required a retinal camera, trained clinic staff, IDx-DR, specialist safety review, and a referral route." } }, "outcomes[].beneficiaries": { "state": "value_present", "value": { "kind": "text", "text": "Young people with type 1 or type 2 diabetes who were due for a diabetic eye exam." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Young people with type 1 or type 2 diabetes who were due for a diabetic eye exam." } }, "outcomes[].beneficiary_count": { "state": "value_present", "value": { "kind": "structured", "data": { "eligible": 170, "declined": 6, "randomized": 164, "assigned_AI": 81, "assigned_control": 83, "excluded_control": 1, "analyzed": 163, "screened": { "AI": 81, "control": 18 }, "AI_positive_screens": 25, "AI_positive_follow_up_visits": 16 } }, "provenance": { "kind": "source_review", "basis": "Figure 1; Results: Participant flow and Primary and secondary outcomes.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "All 81 AI participants and 18 of 82 controls completed screening. The 25 positive AI screens were not all confirmed diagnoses." } }, "outcomes[].benefit_type": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "benefit_type": "Improved Physical Health", "taxonomy_note": "The trial reports exam completion and follow-through, process outcomes, rather than vision outcomes." } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "benefit_type", "taxonomy_note" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "outcomes[].claim": { "state": "value_present", "value": { "kind": "text", "text": "More participants completed screening when an AI eye exam was offered during their diabetes visit." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "More participants completed screening when an AI eye exam was offered during their diabetes visit." } }, "outcomes[].distribution": { "state": "value_present", "value": { "kind": "text", "text": "The trial included a racially diverse population, and 47% of participants had Medicaid coverage. It was not large enough to establish equal effects across every subgroup." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The trial included a racially diverse population, and 47% of participants had Medicaid coverage. It was not large enough to establish equal effects across every subgroup." } }, "outcomes[].duration": { "state": "value_present", "value": { "kind": "text", "text": "Screening and referral attendance were followed for six months." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Screening and referral attendance were followed for six months." } }, "outcomes[].id": { "state": "value_present", "value": { "kind": "text", "text": "AIBD-0067-outcome-01" }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "AIBD-0067-outcome-01" } }, "outcomes[].stakeholder_group": { "state": "value_present", "value": { "kind": "structured", "data": { "groups": [ "personal" ] } }, "provenance": { "kind": "curatorial", "basis": "The beneficiary groups correspond to the reviewed depth assessments.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "People." } }, "outcomes[].status": { "state": "value_present", "value": { "kind": "text", "text": "Observed in a randomized trial." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Observed in a randomized trial." } }, "outcomes[].tradeoffs": { "state": "value_present", "value": { "kind": "text", "text": "The AI produced positive screening results that required further assessment. Its reported specificity was 78.9% against specialist review. A positive screen was not a confirmed diagnosis." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The AI produced positive screening results that required further assessment. Its reported specificity was 78.9% against specialist review. A positive screen was not a confirmed diagnosis." } }, "outcomes[].unexpected": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "unexpected": false, "purpose": "IDx-DR/LumineticsCore is built to autonomously detect more-than-mild diabetic retinopathy from fundus images at the point of care. Increasing screening completion is its intended benefit." } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "unexpected", "purpose" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "places[]": { "state": "value_present", "value": { "kind": "text", "text": "Both clinics were in Baltimore, Maryland, United States. The manufacturer was also based in the United States." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Both clinics were in Baltimore, Maryland, United States. The manufacturer was also based in the United States." } }, "purpose": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "purpose": "IDx-DR/LumineticsCore is built to autonomously detect more-than-mild diabetic retinopathy from fundus images at the point of care. Increasing screening completion is its intended benefit." } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "purpose" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "record_dates": { "state": "value_present", "value": { "kind": "structured", "data": { "enrollment_start": "2021-11-24", "enrollment_end": "2022-06-06", "follow_up_end": "2022-12-06", "publication": "2024-01-11" } }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Enrollment began on 24 November 2021, and follow-up ended on 6 December 2022." } }, "replication.attempts[]": { "state": "not_reported", "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "reason": "The reviewed sources do not report an independent repetition of this clinical result.", "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The reviewed sources do not report an independent repetition of this clinical result." } }, "replication.conditions": { "state": "value_present", "value": { "kind": "text", "text": "The tested service combined an immediate eye exam, clinic staff, follow-up referrals, and specialist safety review for young participants." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The tested service combined an immediate eye exam, clinic staff, follow-up referrals, and specialist safety review for young participants." } }, "revision_history[]": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "revisions": [ { "date": "2026-10-20", "change": "Record drafted from the cited sources.", "editor": "AIBD" }, { "date": "2026-10-20", "change": "Evidence quote restored to the abstract's verbatim sentence including the group sizes (n = 81) and (n = 83), evidence date set to the 11 January 2024 publication date, and the AI-role statement corrected because second author R. Channa is at the University of Wisconsin rather than Johns Hopkins, with the author-contribution statement that Abramoff had no access to the underlying data added.", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Added what the benefit is measured against from the cited sources.", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Benefit type set to Improved Physical Health under Trustible's full taxonomy of 23 types; it was Improved Accessibility among the six first used.", "source": "https://trustible.ai/post/a-framework-for-measuring-the-benefits-of-ai/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Country of the developer and the deployer added from the organization's own site or a registry.", "source": "https://www.digitaldiagnostics.com/contact/; https://en.wikipedia.org/wiki/Johns_Hopkins_Medicine", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Prose pass: account, purpose, the system's part rewritten in shorter sentences with abbreviations expanded; facts, figures and quotations unchanged.", "editor": "AIBD" }, { "date": "2026-10-25", "change": "Reviewed the original evidence and supporting material; updated system details, methods, outcomes, limitations, costs, and source lineage.", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/", "editor": "AIBD" } ] } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "revisions" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "sector": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "domain": "Healthcare - diabetic retinopathy screening", "segment": "Autonomous AI screening in pediatric diabetes care" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "domain", "segment" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "sources[].access_version": { "state": "value_present", "value": { "kind": "structured", "data": { "reviewed_on": "2026-10-25", "versions_and_access": [ { "source_ref": "AIBD-0067-source-0001", "source_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/", "access_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/", "locator": "Figure 1; Tables 1–4; Methods; Data and Code availability; Author contributions; Competing interests.", "status": "Original text read.", "reviewed_on": "2026-10-25" }, { "source_ref": "AIBD-0067-source-0001", "source_url": "https://media.springernature.com/original/springer-static/esm/art%3A10.1038%2Fs41467-023-44676-z/MediaObjects/41467_2023_44676_MOESM1_ESM.docx", "access_url": "https://media.springernature.com/original/springer-static/esm/art%3A10.1038%2Fs41467-023-44676-z/MediaObjects/41467_2023_44676_MOESM1_ESM.docx", "locator": "Supplementary Note 3 and supplementary tables.", "status": "Original text read.", "reviewed_on": "2026-10-25" }, { "source_ref": "AIBD-0067-source-0001", "source_url": "https://clinicaltrials.gov/study/NCT05131451", "access_url": "https://clinicaltrials.gov/api/v2/studies/NCT05131451", "locator": "Protocol identification, status, locations, eligibility, and outcomes.", "status": "Original text read.", "reviewed_on": "2026-10-25" } ] } }, "provenance": { "kind": "source_review", "basis": "Access records below distinguish full text, supplements, metadata, and inaccessible material.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Access and version details are listed for each reviewed source." } }, "sources[].citation_locator": { "state": "value_present", "value": { "kind": "structured", "data": { "citations": [ { "source_ref": "AIBD-0067-source-0001", "citation": "Risa M. Wolf et al., “Autonomous Artificial Intelligence Increases Screening and Follow-up for Diabetic Retinopathy in Youth: The ACCESS Randomized Control Trial,” Nature Communications 15 (2024): 421, doi:10.1038/s41467-023-44676-z. Figures 1–2, Methods, and Supplementary Note 3.", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/", "date": "2024-01-11" } ], "locators": [ { "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/", "locator": "Figure 1; Tables 1–4; Methods; Data and Code availability; Author contributions; Competing interests.", "contribution": "Randomized screening results, denominators, age limits, procedures, and conflicts.", "relationship": "Original academic evaluation with a manufacturer-affiliated coauthor.", "source_refs": [ "AIBD-0067-source-0001" ] }, { "url": "https://media.springernature.com/original/springer-static/esm/art%3A10.1038%2Fs41467-023-44676-z/MediaObjects/41467_2023_44676_MOESM1_ESM.docx", "locator": "Supplementary Note 3 and supplementary tables.", "contribution": "Image procedure, investigational use, and specialist safety review.", "relationship": "Supplement to the same trial.", "source_refs": [ "AIBD-0067-source-0001" ] }, { "url": "https://clinicaltrials.gov/study/NCT05131451", "locator": "Protocol identification, status, locations, eligibility, and outcomes.", "contribution": "Study registration and ethics identifier.", "relationship": "Sponsor-supplied trial registration.", "source_refs": [ "AIBD-0067-source-0001" ] } ] } }, "provenance": { "kind": "source_review", "basis": "Reviewed source metadata and contribution-specific locators.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Original citations and the passages that support each finding." } }, "sources[].id": { "state": "value_present", "value": { "kind": "identifiers", "identifiers": [ "AIBD-0067-source-0001" ], "role": "Retained sources" }, "provenance": { "kind": "curatorial", "basis": "Identifiers correspond to the retained source order.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "1 retained sources." } }, "sources[].language": { "state": "value_present", "value": { "kind": "text", "text": "English. No translation was used." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "English. No translation was used." } }, "sources[].relationship": { "state": "value_present", "value": { "kind": "text", "text": "Academic investigators conducted the trial. One coauthor was an investor, director, and consultant of Digital Diagnostics, but had no access to the underlying data." }, "provenance": { "kind": "source_review", "basis": "Author contributions and Competing interests.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Academic investigators conducted the trial. One coauthor was an investor, director, and consultant of Digital Diagnostics, but had no access to the underlying data." } }, "sources[].upstream_sources": { "state": "value_present", "value": { "kind": "structured", "data": { "reviewed_on": "2026-10-25", "lead_source_ref": "AIBD-0067-source-0001", "retained_source_order": [ "AIBD-0067-source-0001" ], "origins": [ { "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10784572/", "locator": "Figure 1; Tables 1–4; Methods; Data and Code availability; Author contributions; Competing interests.", "contribution": "Randomized screening results, denominators, age limits, procedures, and conflicts.", "relationship": "Original academic evaluation with a manufacturer-affiliated coauthor.", "source_refs": [ "AIBD-0067-source-0001" ] }, { "url": "https://media.springernature.com/original/springer-static/esm/art%3A10.1038%2Fs41467-023-44676-z/MediaObjects/41467_2023_44676_MOESM1_ESM.docx", "locator": "Supplementary Note 3 and supplementary tables.", "contribution": "Image procedure, investigational use, and specialist safety review.", "relationship": "Supplement to the same trial.", "source_refs": [ "AIBD-0067-source-0001" ] }, { "url": "https://clinicaltrials.gov/study/NCT05131451", "locator": "Protocol identification, status, locations, eligibility, and outcomes.", "contribution": "Study registration and ethics identifier.", "relationship": "Sponsor-supplied trial registration.", "source_refs": [ "AIBD-0067-source-0001" ] } ], "excluded_or_consolidated_sources": [], "review_scope": "Methods, results, counts, chronology, AI identity and operation, human responsibilities, limitations, and economic evidence." } }, "provenance": { "kind": "source_review", "basis": "The original materials and exact locators are listed in this assessment.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The original studies and their supporting materials are linked to the findings that they support." } }, "strategic_assessments[]": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "strategic assessments" }, "summary": { "state": "value_present", "value": { "kind": "text", "text": "In the ACCESS trial, all 81 young people offered IDx-DR completed an eye exam, compared with 18 of 82 controls referred to an eye-care provider." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "In the ACCESS trial, all 81 young people offered IDx-DR completed an eye exam, compared with 18 of 82 controls referred to an eye-care provider." } }, "systems[].autonomy_permissions": { "state": "value_present", "value": { "kind": "text", "text": "The software produced its result without a clinician interpreting the photographs first. The research team nevertheless obtained specialist overreads for safety." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The software produced its result without a clinician interpreting the photographs first. The research team nevertheless obtained specialist overreads for safety." } }, "systems[].component_role": { "state": "value_present", "value": { "kind": "text", "text": "The software checked image quality and assessed photographs for diabetic eye disease." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The software checked image quality and assessed photographs for diabetic eye disease." } }, "systems[].deployment_configuration": { "state": "value_present", "value": { "kind": "structured", "data": { "algorithm": "locked diagnostic device", "image_fields": [ "fovea", "optic disc" ], "maximum_image_acquisition_attempts": 3, "result_latency": "within 60 seconds", "exam_time_minutes": [ 5, 10 ], "human_overread": "all AI images" } }, "provenance": { "kind": "source_review", "basis": "Supplementary Note 3; Methods; Code availability.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The device used two retinal views and allowed up to three attempts to obtain suitable images. The trial does not name the camera model." } }, "systems[].inputs_outputs": { "state": "value_present", "value": { "kind": "text", "text": "Two color retinal photographs centered on the fovea and optic disc were assessed. The output indicated disease, no disease, or insufficient image quality." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Two color retinal photographs centered on the fovea and optic disc were assessed. The output indicated disease, no disease, or insufficient image quality." } }, "systems[].model_name": { "state": "value_present", "value": { "kind": "text", "text": "The locked diagnostic algorithms within IDx-DR. The trial does not name a separate model family or release." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The locked diagnostic algorithms within IDx-DR. The trial does not name a separate model family or release." } }, "systems[].model_version": { "state": "not_reported", "provenance": { "kind": "source_review", "basis": "Methods and Code availability; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "reason": "The paper and supplement do not identify the installed software release.", "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The paper and supplement do not identify the installed software release." } }, "systems[].product_name": { "state": "value_present", "value": { "kind": "text", "text": "IDx-DR, now sold as LumineticsCore." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "IDx-DR, now sold as LumineticsCore." } }, "systems[].provider": { "state": "value_present", "value": { "kind": "text", "text": "Digital Diagnostics, United States." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Digital Diagnostics, United States." } }, "taxonomy_crosswalks[]": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "title": { "state": "value_present", "value": { "kind": "text", "text": "An AI eye exam increased screening among young people with diabetes" }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "An AI eye exam increased screening among young people with diabetes" } }, "version": { "state": "value_present", "value": { "kind": "identifiers", "identifiers": [ "f6eae30ef3c156d711228cb8bcf5969e1eca2919712de3047d11d854ad4ba314" ], "role": "SHA-256 of normalized original case data" }, "provenance": { "kind": "curatorial", "basis": "Content fingerprint refreshed after the October 25, 2026 source review.", "record_fields": [], "source_refs": [], "reviewed_on": "2026-10-25" }, "review_state": "record_mapped", "coverage": "complete" }, "workflow": { "state": "value_present", "value": { "kind": "text", "text": "Clinic staff photographed the retina during the diabetes visit. Participants received the result immediately and were referred for an eye-care visit when indicated." }, "provenance": { "kind": "source_review", "basis": "Wolf et al., Nature Communications (2024), Figure 1; Tables 1–4; Methods; Supplementary Note 3.", "record_fields": [], "source_refs": [ "AIBD-0067-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Clinic staff photographed the retina during the diabetes visit. Participants received the result immediately and were referred for an eye-care visit when indicated." } } }, "summary": { "total": 91, "addressed": 91, "known": 83, "reviewed": 78, "record_mapped": 9, "not_assessed": 4, "complete": false, "by_state": { "value_present": 83, "not_reported": 4, "unresolved": 0, "not_assessed": 4, "not_applicable": 0, "withheld": 0, "source_unavailable": 0 } } } }