| Literature DB >> 35788102 |
Nicolas Wagneur1, Patrick Callier2,3, Jean-David Zeitoun3,4, Denise Silber3,5, Remi Sabatier3,6, Fabrice Denis1,3.
Abstract
BACKGROUND: In 2020, more than 250 eHealth solutions were added to app stores each day, or 90,000 in the year; however, the vast majority of these solutions have not undergone clinical validation, their quality is unknown, and the user does not know if they are effective and safe. We sought to develop a simple prescreening scoring method that would assess the quality and clinical relevance of each app. We designed this tool with 3 health care stakeholder groups in mind: eHealth solution designers seeking to evaluate a potential competitor or their own tool, investors considering a fundraising candidate, and a hospital clinician or IT department wishing to evaluate a current or potential eHealth solution.Entities:
Keywords: clinical relevance; clinical validation; digital solution; eHealth; eHealth app; health app; information quality; medical digital solution; prescreening; scoring; scoring tool; solution
Mesh:
Year: 2022 PMID: 35788102 PMCID: PMC9297133 DOI: 10.2196/39590
Source DB: PubMed Journal: J Med Internet Res ISSN: 1438-8871 Impact factor: 7.076
Solution characteristics (several items were possible per solution).
| Characteristic | Solution, n (%) | ||
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| Prevention | 12 (12) | |
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| Early detection and flagging | 23 (23) | |
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| Decision support | 16 (16) | |
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| Treatment support, compliance, and toxicity reduction | 31 (31) | |
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| Direct therapeutic solution (eg, virtual reality) | 6 (6) | |
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| Patient triage | 2 (2) | |
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| Emergency department decongestion | 2 (2) | |
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| Others | 6 (6) | |
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| Oncology | 20 (22) | |
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| Cardiology | 5 (6) | |
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| Neurology | 6 (7) | |
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| Psychiatry | 5 (6) | |
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| Pediatrics | 2 (2) | |
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| Diabetology | 7 (8) | |
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| Gynecology | 5 (6) | |
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| Pulmonology | 1 (1) | |
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| Nephrology | 1 (1) | |
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| Urology and andrology | 1 (1) | |
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| Rheumatology | 2 (2) | |
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| Head and neck | 1 (1) | |
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| Gastroenterology | 0 (0) | |
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| Dermatology | 3 (3) | |
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| Autoimmune disease, internal medicine, and infectiology | 1 (1) | |
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| Surgery | 3 (3) | |
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| Imaging | 2 (2) | |
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| Geriatrics | 3 (3) | |
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| Nutrition | 1 (1) | |
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| Ophthalmology | 0 (0) | |
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| Multiple specialties (emergency medicine, general medicine, and biology, etc) | 21 (23) | |
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| Nonmedical device (nonexecutive) | 15 (22) | |
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| Nonmedical device (but theoretically should be) | 10 (15) | |
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| Class I medical device | 29 (43) | |
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| Class II medical device | 12 (18) | |
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| Other CEa markings (eg, Class III medical device) | 2 (3) | |
aCE: Conformitè Europëenne.
Part 1: general information about the solutions.
| Characteristic | Solution (N=68), n (%) | ||
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| No artificial intelligence (Boolean, common rules, and logistic regression, etc) | 28 (41) | |
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| No algorithm | 17 (25) | |
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| Intelligible artificial intelligence | 16 (24) | |
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| Nonintelligible artificial intelligence | 6 (9) | |
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| Algorithm more than 5 years old that were not reassessed with new support standards | 1 (1) | |
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| Yes, with remote monitoring with a health professional | 32 (47) | |
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| Yes, alerts to the patient who then manages themselves | 15 (22) | |
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| Yes, information not personalized according to the answers | 10 (15) | |
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| Yes, patient alert with teleconsultation possible via the solution | 3 (4) | |
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| Solution not affected | 5 (7) | |
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| None, no user information | 3 (4) | |
Part 2: the target populations of the solutions.
| Characteristic | Solution, n (%) | ||
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| <18 (pediatrics) | 10 (9) | |
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| 18-64 | 58 (53) | |
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| >65 | 42 (38) | |
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| >500 | 20 (29) | |
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| 50-499 | 24 (35) | |
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| 1-49 | 15 (22) | |
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| 0 | 9 (13) | |
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| Simplification | 40 (59) | |
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| Complication without associated act or package | 7 (10) | |
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| Complication with associated act or package for financing the organization | 4 (6) | |
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| No impact | 17 (25) | |
Part 3: the clinical relevance of the solutions.
| Characteristic | Solution, n (%) | ||
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| User satisfaction | 29 (17) | |
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| Quality of life | 24 (14) | |
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| Medico-economic benefit | 20 (12) | |
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| Early diagnosis gain | 19 (11) | |
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| Improved access to care | 19 (11) | |
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| Improved treatment compliance | 18 (11) | |
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| Reduction of severity of a condition or symptom | 13 (8) | |
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| Primary, secondary, or tertiary prevention | 11 (7) | |
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| Survival | 9 (5) | |
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| Reduction of emergencies | 4 (2) | |
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| Less toxicity than reference | 3 (2) | |
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| Expert advice | 28 (25) | |
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| Retrospective study of ≥300 evaluable patients | 18 (16) | |
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| Applications of national or international recommendations in the solution | 16 (15) | |
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| Randomized trial of <200 patients | 13 (12) | |
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| Randomized trial of ≥200 patients or a meta-analysis | 10 (9) | |
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| Prospective study of ≥200 patients versus nonrandomized control arm in real-life settings (historical comparison and data, etc) | 11 (10) | |
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| Prospective study of ≥200 patients -) versus nonrandomized control arm not in real-life settings | 6 (5) | |
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| Not based on any studies or expert opinions | 8 (7) | |
Part 4: information on the solution provider and reimbursement ambition and probability.
| Characteristic | Solution, n (%) | ||
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| Medical management by a specialist doctor | 41 (60) | |
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| Medical management by a nonspecialist doctor | 10 (15) | |
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| No medical direction | 17 (25) | |
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| Yes, 3 or more | 11 (16) | |
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| Yes, 2 | 7 (10) | |
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| Yes, 1 | 13 (19) | |
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| No | 37 (54) | |
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| Yes (unless “device for collective hospital use”) | 38 (56) | |
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| No, no need in the business model (sale of data and user subscription, etc) | 23 (34) | |
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| No, device for collective hospital use | 7 (10) | |
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| High | 7 (18) | |
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| Medium | 5 (13) | |
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| Low | 26 (68) | |
Figure 1Overall rating distribution of the solutions according to overall score out of 20.