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1. Artificial intelligence extension of the OSCAR-IB criteria

Author

Petzold, A., Albrecht, P., Balcer, L., Bekkers, E., Brandt, A. U., Calabresi, P. A., Deborah, O. G., Graves, J. S., Green, A., Keane, P. A., Nij Bijvank, J. A., Sander, J. W., Paul, F., Saidha, S., Villoslada, P., Wagner, S. K., Yeh, E. A., Aktas, O., Antel, J., Asgari, N., Audo, I., Avasarala, J., Avril, D., Bagnato, F. R., Banwell, B., Bar-Or, A., Behbehani, R., Manterola, A. B., Bennett, J., Benson, L., Bernard, J., Bremond-Gignac, D., Britze, J., Burton, J., Calkwood, J., Carroll, W., Chandratheva, A., Cohen, J., Comi, G., Cordano, C., Costa, S., Costello, F., Courtney, A., Cruz-Herranz, A., Cutter, G., Crabb, D., Delott, L., De Seze, J., Diem, R., Dollfuss, H., El Ayoubi, N. K., Fasser, C., Finke, C., Fischer, D., Fitzgerald, K., Fonseca, P., Frederiksen, J. L., Frohman, E., Frohman, T., Fujihara, K., Cuellar, I. G., Galetta, S., Garcia-Martin, E., Giovannoni, G., Glebauskiene, B., Suarez, I. G., Jensen, G. P., Hamann, S., Hartung, H. -P., Havla, J., Hemmer, B., Huang, S. -C., Imitola, J., Jasinskas, V., Jiang, H., Kafieh, R., Kappos, L., Kardon, R., Keegan, D., Kildebeck, E., Kim, U. S., Klistorner, S., Knier, B., Kolbe, S., Korn, T., Krupp, L., Lagreze, W., Leocani, L., Levin, N., Liskova, P., Preiningerova, J. L., Lorenz, B., May, E., Miller, D., Mikolajczak, J., Said, S. M., Montalban, X., Morrow, M., Mowry, E., Murta, J., Navas, C., Nolan, R., Nowomiejska, K., Oertel, F. C., Oh, J., Oreja-Guevara, C., Orssaud, C., Osborne, B., Outteryck, O., Paiva, C., Palace, J., Papadopoulou, A., Patsopoulos, N., Pontikos, N., Preising, M., Prince, J., Reich, D., Rejdak, R., Ringelstein, M., Rodriguez de Antonio, L., Sahel, J. -A., Sanchez-Dalmau, B., Sastre-Garriga, J., Schippling, S., Schuman, J., Shindler, K., Shin, R., Shuey, N., Soelberg, K., Specovius, S., Suppiej, A., Thompson, A., Toosy, A., Torres, R., Touitou, V., Trauzettel-Klosinski, S., van der Walt, A., Vermersch, P., Vidal-Jordana, A., Waldman, A. T., Waters, C., Wheeler, R., White, O., Wilhelm, H., Winges, K. M., Wiegerinck, N., Wiehe, L., Wisnewski, T., Wong, S., Wurfel, J., Yaghi, S., You, Y., Yu, Z., Yu-Wai-Man, P., Zemaitien≐, R., Zimmermann, H., Albrecht P., Petzold A., Balcer, L., Bekkers, E., Brandt, A. U., Calabresi, P. A., Deborah, O. G., Graves, J. S., Green, A., Keane, P. A., Nij Bijvank, J. A., Sander, J. W., Paul, F., Saidha, S., Villoslada, P., Wagner, S. K., Yeh, E. A., Aktas, O., Antel, J., Asgari, N., Audo, I., Avasarala, J., Avril, D., Bagnato, F. R., Banwell, B., Bar-Or, A., Behbehani, R., Manterola, A. B., Bennett, J., Benson, L., Bernard, J., Bremond-Gignac, D., Britze, J., Burton, J., Calkwood, J., Carroll, W., Chandratheva, A., Cohen, J., Comi, G., Cordano, C., Costa, S., Costello, F., Courtney, A., Cruz-Herranz, A., Cutter, G., Crabb, D., Delott, L., De Seze, J., Diem, R., Dollfuss, H., El Ayoubi, N. K., Fasser, C., Finke, C., Fischer, D., Fitzgerald, K., Fonseca, P., Frederiksen, J. L., Frohman, E., Frohman, T., Fujihara, K., Cuellar, I. G., Galetta, S., Garcia-Martin, E., Giovannoni, G., Glebauskiene, B., Suarez, I. G., P. , Jensen, G., Hamann, S., Hartung, H. -P., Havla, J., Hemmer, B., Huang, S. -C., Imitola, J., Jasinskas, V., Jiang, H., Kafieh, R., Kappos, L., Kardon, R., Keegan, D., Kildebeck, E., Kim, U. S., Klistorner, S., Knier, B., Kolbe, S., Korn, T., Krupp, L., Lagreze, W., Leocani, L., Levin, N., Liskova, P., Preiningerova, J. L., Lorenz, B., May, E., Miller, D., Mikolajczak, J., Said, S. M., Montalban, X., Morrow, M., Mowry, E., Murta, J., Navas, C., Nolan, R., Nowomiejska, K., Oertel, F. C., Oh, J., Oreja-Guevara, C., Orssaud, C., Osborne, B., Outteryck, O., Paiva, C., Palace, J., Papadopoulou, A., Patsopoulos, N., Pontikos, N., Preising, M., Prince, J., Reich, D., Rejdak, R., Ringelstein, M., Rodriguez de Antonio, L., Sahel, J. -A., Sanchez-Dalmau, B., Sastre-Garriga, J., Schippling, S., Schuman, J., Shindler, K., Shin, R., Shuey, N., Soelberg, K., Specovius, S., Suppiej, A., Thompson, A., Toosy, A., Torres, R., Touitou, V., Trauzettel-Klosinski, S., van der Walt, A., Vermersch, P., Vidal-Jordana, A., Waldman, A. T., Waters, C., Wheeler, R., White, O., Wilhelm, H., Winges, K. M., Wiegerinck, N., Wiehe, L., Wisnewski, T., Wong, S., Wurfel, J., Yaghi, S., You, Y., Yu, Z., Yu-Wai-Man, P., Zemaitien≐, R., and Zimmermann, H.

Subjects
0301 basic medicine, Big Data, medicine.medical_specialty, Neurology, media_common.quotation_subject, Big data, MEDLINE, Reviews, Socio-culturale, Neurosciences. Biological psychiatry. Neuropsychiatry, Review, Public domain, Retina, Cohort Studies, 03 medical and health sciences, Annotation, 0302 clinical medicine, Artificial Intelligence, medicine, Humans, Quality (business), RC346-429, Tomography, media_common, Image pattern recognition, business.industry, General Neuroscience, Nervous System Diseases, Tomography, Optical Coherence, Algorithms, 030104 developmental biology, Optical Coherence, Imaging technology, RC0321, Neurology. Diseases of the nervous system, Neurology (clinical), Artificial intelligence, sense organs, business, 030217 neurology & neurosurgery, RC321-571
Abstract

Artificial intelligence (AI)‐based diagnostic algorithms have achieved ambitious aims through automated image pattern recognition. For neurological disorders, this includes neurodegeneration and inflammation. Scalable imaging technology for big data in neurology is optical coherence tomography (OCT). We highlight that OCT changes observed in the retina, as a window to the brain, are small, requiring rigorous quality control pipelines. There are existing tools for this purpose. Firstly, there are human‐led validated consensus quality control criteria (OSCAR‐IB) for OCT. Secondly, these criteria are embedded into OCT reporting guidelines (APOSTEL). The use of the described annotation of failed OCT scans advances machine learning. This is illustrated through the present review of the advantages and disadvantages of AI‐based applications to OCT data. The neurological conditions reviewed here for the use of big data include Alzheimer disease, stroke, multiple sclerosis (MS), Parkinson disease, and epilepsy. It is noted that while big data is relevant for AI, ownership is complex. For this reason, we also reached out to involve representatives from patient organizations and the public domain in addition to clinical and research centers. The evidence reviewed can be grouped in a five‐point expansion of the OSCAR‐IB criteria to embrace AI (OSCAR‐AI). The review concludes by specific recommendations on how this can be achieved practically and in compliance with existing guidelines.

Published
2021
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2. The need for widely available genomic testing in rare eye diseases: an ERN-EYE position statement

Author

Black G. C., Sergouniotis P., Sodi A., Leroy B. P., Van Cauwenbergh C., Liskova P., Gronskov K., Klett A., Kohl S., Taurina G., Sukys M., Haer-Wigman L., Nowomiejska K., Marques J. P., Leroux D., Cremers F. P. M., De Baere E., Dollfus H., Ashworth J., Audo I., Bacci G., Balciuniene V. J., Bargiacchi S., Bertelsen M., Black G., Boon C., Bremond-Gignac D., Buzzonetti L., Calvas P., Thomsen A. C., Chirita-Emandi A., Chokoshvili D., Cremers F., Daly A., Downes S., Fasolo A., Fasser C., Fischer D., Fortunato P., Gelzinis A., Hall G., Hamann S., Heon E., Iarossi G., Iberg C., Jouanjan G., Kaariainen H., Kahn K., Keegan D., Laengsfeld M., Leon A., Leroux B., Lorenz B., Maggi R., Mauring L., Melico P., Meunier I., Mohand-Said S., Monterosso C., Morandi P., Parmeggiani F., Passerini I., Pelletier V., Peluso F., Perdomo Y., Rapizzi E., Roos L., Roosing S., Rozet J. -M., Simonelli F., Sowden J., Stingl K., Suppiej A., Testa F., Tracewska A., Traficante G., Valeina S., Wheeler-Schilling T., Yu-Wai-Man P., Zeitz C., Zemaitiene R., Leroux, Dorothée [0000-0002-1412-6611], Apollo - University of Cambridge Repository, Ophthalmology, ANS - Complex Trait Genetics, Black, G. C., Sergouniotis, P., Sodi, A., Leroy, B. P., Van Cauwenbergh, C., Liskova, P., Gronskov, K., Klett, A., Kohl, S., Taurina, G., Sukys, M., Haer-Wigman, L., Nowomiejska, K., Marques, J. P., Leroux, D., Cremers, F. P. M., De Baere, E., Dollfus, H., Ashworth, J., Audo, I., Bacci, G., Balciuniene, V. J., Bargiacchi, S., Bertelsen, M., Black, G., Boon, C., Bremond-Gignac, D., Buzzonetti, L., Calvas, P., Thomsen, A. C., Chirita-Emandi, A., Chokoshvili, D., Cremers, F., Daly, A., Downes, S., Fasolo, A., Fasser, C., Fischer, D., Fortunato, P., Gelzinis, A., Hall, G., Hamann, S., Heon, E., Iarossi, G., Iberg, C., Jouanjan, G., Kaariainen, H., Kahn, K., Keegan, D., Laengsfeld, M., Leon, A., Leroux, B., Lorenz, B., Maggi, R., Mauring, L., Melico, P., Meunier, I., Mohand-Said, S., Monterosso, C., Morandi, P., Parmeggiani, F., Passerini, I., Pelletier, V., Peluso, F., Perdomo, Y., Rapizzi, E., Roos, L., Roosing, S., Rozet, J. -M., Simonelli, F., Sowden, J., Stingl, K., Suppiej, A., Testa, F., Tracewska, A., Traficante, G., Valeina, S., Wheeler-Schilling, T., Yu-Wai-Man, P., Zeitz, C., and Zemaitiene, R.

Subjects
0301 basic medicine, Eye Diseases, lcsh:Medicine, CHILDREN, Position statement, Sensory disorders Donders Center for Medical Neuroscience [Radboudumc 12], MOLECULAR-GENETICS, 0302 clinical medicine, HISTORY, Health care, Medicine and Health Sciences, Genetics(clinical), Pharmacology (medical), Child, Genetics (clinical), medicine.diagnostic_test, General Medicine, Genomics, Europe, TRIALS, ERN-EYE, Rare eye diseases, medicine.symptom, Genetic and genomic testing, Human, medicine.medical_specialty, Visual impairment, LEBER CONGENITAL AMAUROSIS, Socio-culturale, DIAGNOSIS, 03 medical and health sciences, Rare Diseases, medicine, Humans, Genetic Testing, Intensive care medicine, Genetic testing, business.industry, CLINICAL-FEATURES, lcsh:R, Rare eye disease, Eye Disease, Human genetics, Clinical trial, 030104 developmental biology, Genomic, 030221 ophthalmology & optometry, Personalized medicine, business, Rare disease
Abstract

Background Rare Eye Diseases (RED) are the leading cause of visual impairment and blindness for children and young adults in Europe. This heterogeneous group of conditions includes over 900 disorders ranging from relatively prevalent disorders such as retinitis pigmentosa to very rare entities such as developmental eye anomalies. A significant number of patients with RED have an underlying genetic etiology. One of the aims of the European Reference Network for Rare Eye Diseases (ERN–EYE) is to facilitate improvement in diagnosis of RED in European member states. Main body Technological advances have allowed genetic and genomic testing for RED. The outcome of genetic testing allows better understanding of the condition and allows reproductive and therapeutic options. The increase of the number of clinical trials for RED has provided urgency for genetic testing in RED. A survey of countries participating in ERN-EYE demonstrated that the majority are able to access some forms of genomic testing. However, there is significant variability, particularly regarding testing as part of clinical service. Some countries have a well-delineated rare disease pathway and have a national plan for rare diseases combined or not with a national plan for genomics in medicine. In other countries, there is a well-established organization of genetic centres that offer reimbursed genomic testing of RED and other rare diseases. Clinicians often rely upon research-funded laboratories or private companies. Notably, some member states rely on cross-border testing by way of an academic research project. Consequently, many clinicians are either unable to access testing or are confronted with long turnaround times. Overall, while the cost of sequencing has dropped, the cumulative cost of a genomic testing service for populations remains considerable. Importantly, the majority of countries reported healthcare budgets that limit testing. Short conclusion Despite technological advances, critical gaps in genomic testing remain in Europe, especially in smaller countries where no formal genomic testing pathways exist. Even within larger countries, the existing arrangements are insufficient to meet the demand and to ensure access. ERN-EYE promotes access to genetic testing in RED and emphasizes the clinical need and relevance of genetic testing in RED.

Published
2021

5. An ontological foundation for ocular phenotypes and rare eye diseases

Author

Sergouniotis, Panagiotis I., Maxime, Emmanuel, Leroux, Dorothée, Olry, Annie, Thompson, Rachel, Rath, Ana, Robinson, Peter N., Dollfus, Hélèneashworth, Jl, Audo, I, Balciuniene, Vj, Banin, E, Black, Gc, Böhringer, D, Boon, Cjf, Bremond-Gignac, D, Calvas, P, Castela, G, Dagnelie, G, Dollfus, H, Downes, Sm, Fasolo, A, Fasser, C, Gelzinis, A, Goetz, K, Hamann, S, Héon, E, Iarossi, G, Kawasaki, A, Keegan, D, Kessel, L, Khan, K, Klett, A, Köhler, S, Leroux, D, Leroy, Bp, Lisch, W, Liskova, P, Lorenz, B, Maggi, R, Maxime, E, Meunier, I, Mohand-Said, S, Nowomiejska, K, Perdomo, Y, Petzold, A, Preising, M, Robinson, Pn, Scholl, Hpn, Sergouniotis, Pi, Sodi, A, Stingl, K, Studer, F, Suppiej, A, Thompson, R, Touitou, V, Traboulsi, E, Trumpaitis, J, Tuft, Sj, Vaclavik, V, Valeina, S, Van Cauwenbergh, C, Verloes, A, Vighetto, A, Wheeler, R, Wheeler-Schilling, T, Yu-Wai-Man, P, Zobor, D, Zrenner, E., Sergouniotis, Panagiotis I [0000-0003-0986-4123], Apollo - University of Cambridge Repository, University of Manchester [Manchester], Plateforme d'information et de services pour les maladies rares et les médicaments orphelins (Orphanet), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Broussais-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Référence pour les Affections Rares en Génétique Ophtalmologique (CARGO) et Service de Génétique Médicale, Hôpitaux Universitaires de Strasbourg, Newcastle University [Newcastle], The Jackson Laboratory for Genomic Medicine, Laboratoire de Génétique Médicale (LGM), Université de Strasbourg (UNISTRA)-Institut National de la Santé et de la Recherche Médicale (INSERM), and European Project: 0305444(2003)

Subjects
0301 basic medicine, Eye Diseases, Computer science, Evidence-based precision medicine, Rare eye disease, Human phenotype ontology, Orphanet rare disease ontology, lcsh:Medicine, [SDV.BC]Life Sciences [q-bio]/Cellular Biology, 030105 genetics & heredity, Ontology (information science), Terminology, NO, Open Biomedical Ontologies, MESH: Eye Diseases / classificationHumans Precision Medicine / methods* Rare Diseases / classification, 03 medical and health sciences, 0302 clinical medicine, Rare Diseases, Human Phenotype Ontology, Eye Diseases/classification, Humans, Pharmacology (medical), Precision Medicine, Letter to the Editor, MESH: Humans Precision Medicine / methods, Genetics (clinical), Information exchange, Evidence-Based Medicine, Orphanet rare disease ontology, Rare Diseases/classification, MESH: Computational Biology / methods, lcsh:R, Computational Biology, Human phenotype ontology, Biological Ontologies, Precision Medicine/methods, General Medicine, Evidence-based medicine, Rare eye disease, Computational Biology/methods, Data science, MESH: Rare Diseases / classification, 3. Good health, [SDV.GEN.GH]Life Sciences [q-bio]/Genetics/Human genetics, Evidence-based precision medicine, Eye disorder, MESH: Biological Ontologies, MESH: Evidence-Based Medicine, 030217 neurology & neurosurgery
Abstract

Background The optical accessibility of the eye and technological advances in ophthalmic diagnostics have put ophthalmology at the forefront of data-driven medicine. The focus of this study is rare eye disorders, a group of conditions whose clinical heterogeneity and geographic dispersion make data-driven, evidence-based practice particularly challenging. Inter-institutional collaboration and information sharing is crucial but the lack of standardised terminology poses an important barrier. Ontologies are computational tools that include sets of vocabulary terms arranged in hierarchical structures. They can be used to provide robust terminology standards and to enhance data interoperability. Here, we discuss the development of the ophthalmology-related component of two well-established biomedical ontologies, the Human Phenotype Ontology (HPO; includes signs, symptoms and investigation findings) and the Orphanet Rare Disease Ontology (ORDO; includes rare disease nomenclature/nosology). Methods A variety of approaches were used including automated matching to existing resources and extensive manual curation. To achieve the latter, a study group including clinicians, patient representatives and ontology developers from 17 countries was formed. A broad range of terms was discussed and validated during a dedicated workshop attended by 60 members of the group. Results A comprehensive, structured and well-defined set of terms has been agreed on including 1106 terms relating to ocular phenotypes (HPO) and 1202 terms relating to rare eye disease nomenclature (ORDO). These terms and their relevant annotations can be accessed in http://www.human-phenotype-ontology.org/ and http://www.orpha.net/; comments, corrections, suggestions and requests for new terms can be made through these websites. This is an ongoing, community-driven endeavour and both HPO and ORDO are regularly updated. Conclusions To our knowledge, this is the first effort of such scale to provide terminology standards for the rare eye disease community. We hope that this work will not only improve coding and standardise information exchange in clinical care and research, but also it will catalyse the transition to an evidence-based precision ophthalmology paradigm. Electronic supplementary material The online version of this article (10.1186/s13023-018-0980-6) contains supplementary material, which is available to authorized users.

Published
2019
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6. ERN-EYE: the European Reference Network dedicated to European patients with Rare Eye Diseases

Author

Leroux, D., Dollfus, H., Ashworth, J., Black, G., Bohringer, D., Boon, C.J., Cremers, F., Daly, A., Fasser, C., Fischer, D., Keegan, D., Khan, K., Larkin, F., Larsen, M., Leroy, B.P., Liskova, P., Lorenz, B., Martinho, C., Mohand-Said, S., Petzold, A., Preising, M., Reinhart, T., Wheeler-Schilling, T., Wong, S., Zrenner, E., and All ERN-EYE Members

Published
2018

16. Periodontal Disease

Author

Hefley, Donna C., Fasser, C Emil, Smith, Quentin W., and Thomson, William A.

Published
1982

17. A diabetes control program in a public health care setting

Author

Baker, S B, Vallbona, C, Pavlik, V, Fasser, C E, Armbruster, M, McCray, R, and Baker, R L

Subjects
Male, Eye Diseases, Urban Health, Community Health Centers, Middle Aged, Texas, Diabetes Complications, Foot Diseases, Patient Education as Topic, Cardiovascular Diseases, Cost Savings, Risk Factors, Diabetes Mellitus, Humans, Education, Medical, Continuing, Female, Research Article, Aged, Program Evaluation
Abstract

The Houston Diabetes Control Program is part of an effort by the State of Texas and approximately 30 other programs throughout the United States to ensure that persons with diabetes-related complications receive ongoing state-of-the-art preventive care and treatment. For the past 5 years, this program has served an urban, high-risk patient population with special cultural, ethnic, and economic challenges. The intervention has included the development and implementation of protocols for the prevention and care of diabetes-related complications of the eyes, lower extremities, and cardiovascular system, as well as general management of diabetes and patient and professional education. The program is ongoing in nine community health centers located in low-income neighborhoods of a large metropolitan area. The results thus far indicate an increase in sensitive eye examinations from 8 percent to 26 percent of the patient population, a reduction in incidence of legal blindness from 9.5 to 2.7 per 1,000 during a 4-year period, an increase in foot examinations from 18 percent to 44 percent of the patient population, and 77 percent of hypertensive patients in good control of blood pressure at less than 160 over 95 mmHg (millimeters of mercury). On the average, there have not been significant long-term improvements in weight reduction or blood glucose control. The major challenges for this program are (a) improvement in control of glycemia, hypertension, and cholesterol; (b) more effective diet and physical activity interventions; and (c) more effective education approaches that help patients to understand metabolic and cardiovascular functions. These challenges will require collaboration of health care professionals in constructive and imaginative ways through their unselfish commitment toward common goals.

Published
1993

27. Education in Geriatric Medicine:.

Author

Fasser, C. Emil, Roush, Robert E., and Wright, Teresa Lewis

Abstract

The Texas Consortium of Geriatric Education Centers was establisged in 1985. The primary goal of the Consortium is the continued professional development of health professions faculty in gerontology and geriatrics. This article describes a multi-level program of institutional development which has been initiated to accomplish this goal. The components of the program include a strategic planning document (Institutional Action Plan), and a professional development program for faculty (Personal Action Plan). Since October 1985 a total of 63 health professions faculty from 9 academic institutions have enrolled in the two-year program. As designated trainees, these individuals are expected to complete a seven-unit Learning Module in Geriatrics, attend two content-intensive multidisciplinary institutes, and prepare a structured plan for the introduction of aging content within educational experiences provided students in health-related disciplines. The design of the instructional program provided faculty trainees is also described. [ABSTRACT FROM PUBLISHER]

Published
1988
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29. Health Beliefs and Behaviors of Physician Assistants in Texas: Implications for Practice and Education

Author

Fasser, C. Emil, Mullen, Patricia D., and Holcomb, J. David

Abstract

Concern has been expressed over how the volume and effectiveness of physicians’ practices relative to prevention can be increased. While a review of the health care services provided by physician assistants in medical practices indicated an emphasis on health education and patient counseling, there has existed an absence of data regarding their beliefs and practices in the area of health promotion. Based upon an analysis of self-reported data from 256 respondents (89%) of a random sample (n= 289) of the 870 physician assistants in Texas, it appears that physician assistants perceive themselves as having a role in health promotion, are generally satisfied with their preventive health care role, view health promotion activities as being more important in the future, and disagree with the idea that health promotion would not be well received by patients. They routinely gather information on health behaviors and discuss or recommend ways to reduce at-risk behavior. Furthermore, while expressing certainty about their knowledge and skills to educate and influence individuals to change certain risk behaviors, physician assistants indicate less certainty about patient follow-through when it relates to such activities as smoking, drinking, and the use of illicit drugs. Considering the perceived challenge and the view that health promotion will become an even larger component of the physician assistant’s future role, these findings suggest a need for additional skills training to better assist patients to modify their more complex health risk behaviors.

Published
1988
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33. Real-World Safety and Effectiveness of Voretigene Neparvovec: Results up to 2 Years from the Prospective, Registry-Based PERCEIVE Study.

Author

Fischer MD, Simonelli F, Sahni J, Holz FG, Maier R, Fasser C, Suhner A, Stiehl DP, Chen B, Audo I, and Leroy BP

Subjects
Humans, Female, Young Adult, Adult, Male, Prospective Studies, Genetic Therapy, Registries, Retina, Choroid Diseases
Abstract

Voretigene neparvovec (VN) is the first available gene therapy for patients with biallelic RPE65 -mediated inherited retinal dystrophy who have sufficient viable retinal cells. PERCEIVE is an ongoing, post-authorization, prospective, multicenter, registry-based observational study and is the largest study assessing the real-world, long-term safety and effectiveness of VN. Here, we present the outcomes of 103 patients treated with VN according to local prescribing information. The mean (SD) age was 19.5 (10.85) years, 52 (50.5%) were female, and the mean (SD) duration of the follow up was 0.8 (0.64) years (maximum: 2.3 years). Thirty-five patients (34%) experienced ocular treatment-emergent adverse events (TEAEs), most frequently related to chorioretinal atrophy ( n = 13 [12.6%]). Eighteen patients (17.5%; 24 eyes [13.1%]) experienced ocular TEAEs of special interest, including intraocular inflammation and/or infection related to the procedure ( n = 7). The mean (SD) changes from baseline in full-field light-sensitivity threshold testing (white light) at month 1, month 6, year 1, and year 2 were -16.59 (13.48) dB (51 eyes), -18.24 (14.62) dB (42 eyes), -15.84 (14.10) dB (10 eyes), and -13.67 (22.62) dB (13 eyes), respectively. The change in visual acuity from baseline was not clinically significant. Overall, the outcomes of the PERCEIVE study are consistent with the findings of VN pivotal clinical trials.

Published
2024
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35. Patient Preferences in the Management of Wet Age-Related Macular Degeneration: A Conjoint Analysis.

Author

Skelly A, Taylor N, Fasser C, Malkowski JP, Goswami P, and Downey L

Subjects
Aged, Angiogenesis Inhibitors therapeutic use, Cross-Sectional Studies, Female, Humans, Intravitreal Injections, Patient Preference, Vascular Endothelial Growth Factor A therapeutic use, Vascular Endothelial Growth Factors, Ranibizumab therapeutic use, Wet Macular Degeneration drug therapy
Abstract

Introduction: To identify patient preference drivers related to the management of wet age-related macular degeneration (wet AMD)., Methods: In this cross-sectional study, a self-explicated 'conjoint analysis' survey was administered online to eligible patients with wet AMD (receiving anti-vascular endothelial growth factor [VEGF] treatment for at least 12 months) from the USA, Canada, UK, France, Spain, Germany, Italy, Japan, Taiwan, and Australia. The survey consisted of six domains with 21 attributes, which were selected on the basis of a literature review, social media listening, and tele-interviews/discussions with patients, clinical experts, and patient groups. Utility and relative importance scores were generated for each attribute and utility difference significance testing was performed using 'unequal variances t tests'. The Patient Activation Measure (PAM-13) questionnaire was administered to assess patients' knowledge, skill, and confidence in self-management., Results: A total of 466 patients (mean age, 68 years; women, 54%; binocular wet AMD, 28%) with an average anti-VEGF treatment duration of 3.9 years completed the survey. The most important preference domains were 'treatment effects on vision' (non-significant) and 'vision-related symptom burdens' (p < 0.001), followed by 'treatment risk' (p < 0.05), 'impact on daily activities' (p < 0.05), 'burden of clinic/hospital visits' (p < 0.001), and 'impact on psychological well-being'. The five most important attributes in order of importance were clarity of vision, treatment effect on symptoms, quality of vision, time to treatment effect, and time to re-administration. The two most important attributes globally were also in the top three attributes across countries. The majority of participants in the study were level 3 or level 4 of the PAM-13 questionnaire., Conclusions: This study identified the most important disease and treatment attributes to patients using patient-centred methods. The data showed the degree of harmonization of preferences across geographies and that participants actively adopt behaviours required for improved treatment outcomes. The identified preference drivers may inform future clinical development., (© 2022. The Author(s).)

Published
2022
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36. The Economic Impact of Blindness in Europe.

Author

Chakravarthy U, Biundo E, Saka RO, Fasser C, Bourne R, and Little JA

Subjects
Aged, Blindness epidemiology, Europe epidemiology, Female, Humans, Male, Middle Aged, Models, Economic, Prevalence, Blindness economics, Cost of Illness, Health Care Costs, Visually Impaired Persons statistics & numerical data
Abstract

Purpose: To estimate the annual loss of productivity from blindness and moderate to severe visual impairment (MSVI) in the population aged >50 years in the European Union (EU)., Methods: We estimated the cost of lost productivity using three simple models reported in the literature based on (1) minimum wage (MW), (2) gross national income (GNI), and (3) purchasing power parity-adjusted gross domestic product (GDP-PPP) losses. In the first two models, assumptions included that all individuals worked until 65 years of age, and that half of all visual impairment cases in the >50-year age group would be in those aged between 50 and 65 years. Loss of productivity was estimated to be 100% for blind individuals and 30% for those with MSVI. None of these models included direct medical costs related to visual impairment., Results: The estimated number of blind people in the EU population aged >50 years is ~1.28 million, with a further 9.99 million living with MSVI. Based on the three models, the estimated cost of blindness is €7.81 billion, €6.29 billion and €17.29 billion and that of MSVI €18.02 billion, €24.80 billion and €39.23 billion, with their combined costs €25.83 billion, €31.09 billion and €56.52 billion, respectively. The estimates from the MW and adjusted GDP-PPP models were generally comparable, whereas the GNI model estimates were higher, probably reflecting the lack of adjustment for unemployment., Conclusion: The cost of blindness and MSVI in the EU is substantial. Wider use of available cost-effective treatment and prevention strategies may reduce the burden significantly.

Published
2017
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37. Serodiscordance and disclosure among HIV-positive pregnant women in the Southwestern United States.

Author

Nacius LA, Levison J, Minard CG, Fasser C, and Davila JA

Subjects
Adult, Female, HIV Seropositivity epidemiology, Hospitals, County, Humans, Male, Pregnancy, Pregnancy Complications, Infectious epidemiology, Prenatal Care, Prevalence, Retrospective Studies, Social Stigma, Socioeconomic Factors, Southwestern United States, Texas epidemiology, Viral Load, HIV immunology, HIV Seronegativity, HIV Seropositivity psychology, Pregnancy Complications, Infectious psychology, Sexual Partners, Truth Disclosure
Abstract

The prevalence of HIV-positive pregnant women in relationships with HIV-negative men in the United States is unclear. The purpose of this study was to calculate the prevalence of HIV-positive pregnant women with a serodiscordant (HIV-negative) partner within a single clinic population, assess disclosure of their HIV status, and examine factors associated with disclosure. All HIV-positive pregnant women who received prenatal care at the Harris County Hospital District Women's Program at Northwest Health Center in Houston TX between 1/1/2006 and 4/1/2011 were identified. Data were obtained from electronic medical records. Prevalence of serodiscordance and disclosure was calculated, and predictors of disclosure were evaluated. We identified 212 HIV-positive pregnant women. About 40% had a serodiscordant partner, and 34% had a partner with an unknown HIV status. Disclosure occurred in over 90% of women with a serodiscordant partner and in 68% of women with partners whose HIV status was unknown. Among pregnant women who knew their HIV status prior to the current pregnancy and had a serodiscordant partner, 92% reported disclosing their status prior to conception. Our data indicated that serodiscordant relationships are common in our clinic population. Suboptimal disclosure rates were observed, especially among women who have a partner with an unknown HIV status. Further research is needed to evaluate the prevalence of serodiscordance and disclosure in other United States populations.

Published
2013
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39. A diabetes control program in a public health care setting.

Author

Baker SB, Vallbona C, Pavlik V, Fasser CE, Armbruster M, McCray R, and Baker RL

Subjects
Aged, Cardiovascular Diseases prevention & control, Community Health Centers, Cost Savings, Diabetes Complications, Education, Medical, Continuing, Eye Diseases economics, Eye Diseases etiology, Female, Foot Diseases etiology, Humans, Male, Middle Aged, Program Evaluation, Risk Factors, Texas, Urban Health, Diabetes Mellitus therapy, Eye Diseases prevention & control, Foot Diseases prevention & control, Patient Education as Topic
Abstract

The Houston Diabetes Control Program is part of an effort by the State of Texas and approximately 30 other programs throughout the United States to ensure that persons with diabetes-related complications receive ongoing state-of-the-art preventive care and treatment. For the past 5 years, this program has served an urban, high-risk patient population with special cultural, ethnic, and economic challenges. The intervention has included the development and implementation of protocols for the prevention and care of diabetes-related complications of the eyes, lower extremities, and cardiovascular system, as well as general management of diabetes and patient and professional education. The program is ongoing in nine community health centers located in low-income neighborhoods of a large metropolitan area. The results thus far indicate an increase in sensitive eye examinations from 8 percent to 26 percent of the patient population, a reduction in incidence of legal blindness from 9.5 to 2.7 per 1,000 during a 4-year period, an increase in foot examinations from 18 percent to 44 percent of the patient population, and 77 percent of hypertensive patients in good control of blood pressure at less than 160 over 95 mmHg (millimeters of mercury). On the average, there have not been significant long-term improvements in weight reduction or blood glucose control. The major challenges for this program are (a) improvement in control of glycemia, hypertension, and cholesterol; (b) more effective diet and physical activity interventions; and (c) more effective education approaches that help patients to understand metabolic and cardiovascular functions. These challenges will require collaboration of health care professionals in constructive and imaginative ways through their unselfish commitment toward common goals.

Published
1993

40. Credentialing by legislative fiat: implications for the allied health professions.

Author

Smith QW, Fasser CE, and Holcomb JD

Subjects
Allied Health Personnel supply & distribution, Clinical Competence, Credentialing legislation & jurisprudence, Foreign Medical Graduates standards, Foreign Medical Graduates supply & distribution, Humans, United States, Allied Health Personnel standards, Certification legislation & jurisprudence
Published
1991

42. Physicians' assistants: the new prescribers.

Author

Heller LE and Fasser C

Subjects
Legislation, Drug, Michigan, United States, Drug Prescriptions, Physician Assistants education, Physician Assistants legislation & jurisprudence, Physician Assistants standards
Published
1978
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45. Distribution and utilization of mid-level health care professionals.

Author

Hotvedt MO, Fasser CE, Heller LE, and Middleton JL

Subjects
Nurse Practitioners supply & distribution, Physician Assistants supply & distribution, United States, Nurse Practitioners statistics & numerical data, Physician Assistants statistics & numerical data
Published
1981

46. Selected allied health professionals' self-confidence in health promotion counseling skills and interest in continuing education programs.

Author

Mullen PD, Holcomb JD, and Fasser CE

Subjects
Clinical Competence, Dental Hygienists psychology, Dietetics, Humans, Hypertension, Nurse Midwives psychology, Patient Compliance, Physician Assistants psychology, Smoking, Surveys and Questionnaires, Texas, United States, Allied Health Personnel psychology, Counseling, Education, Continuing, Health Promotion, Self-Assessment
Abstract

Mail surveys of samples of dental hygienists (n = 90, 36% response), registered dietitians (n = 262, 52% response), and physician assistants (n = 289, 89% response) in Texas and certified nurse midwives (n = 143, 57% response) in the US provided data regarding their confidence that they possess skills and knowledge to counsel patients about selected areas of health promotion (self-efficacy). Also, the surveys gathered information regarding respondents' beliefs that patients will follow through on their recommendations (adherence expectation), and their interest in continuing education programs. Overall, respondents displayed highest self-efficacy with regard to counseling patients about blood pressure and smoking. Confidence was lowest in illicit drug abuse and mental health areas. Certified nurse midwives and physician assistants indicated confidence in many more areas than the other two groups. Respondents consistently expressed less certainty about patient adherence than about their own skills and knowledge. They generally indicated a high degree of interest in continuing education across the several health promotion topics. Modest relationships were observed between self-efficacy and interest in continuing education programs for physician assistants and registered dietitians, indicating that those with greater self-efficacy had a greater interest in building their skills. A similar pattern was observed among physician assistant respondents with respect to adherence expectations.

Published
1988

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