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Article ; Online: Considerations for addressing bias in artificial intelligence for health equity.

Abràmoff, Michael D / Tarver, Michelle E / Loyo-Berrios, Nilsa / Trujillo, Sylvia / Char, Danton / Obermeyer, Ziad / Eydelman, Malvina B / Maisel, William H

NPJ digital medicine

2023 Volume 6, Issue 1, Page(s) 170

Abstract: Health equity is a primary goal of healthcare stakeholders: patients and their advocacy groups, clinicians, other providers and their professional societies, bioethicists, payors and value based care organizations, regulatory agencies, legislators, and ... ...

Abstract	Health equity is a primary goal of healthcare stakeholders: patients and their advocacy groups, clinicians, other providers and their professional societies, bioethicists, payors and value based care organizations, regulatory agencies, legislators, and creators of artificial intelligence/machine learning (AI/ML)-enabled medical devices. Lack of equitable access to diagnosis and treatment may be improved through new digital health technologies, especially AI/ML, but these may also exacerbate disparities, depending on how bias is addressed. We propose an expanded Total Product Lifecycle (TPLC) framework for healthcare AI/ML, describing the sources and impacts of undesirable bias in AI/ML systems in each phase, how these can be analyzed using appropriate metrics, and how they can be potentially mitigated. The goal of these "Considerations" is to educate stakeholders on how potential AI/ML bias may impact healthcare outcomes and how to identify and mitigate inequities; to initiate a discussion between stakeholders on these issues, in order to ensure health equity along the expanded AI/ML TPLC framework, and ultimately, better health outcomes for all.
Language	English
Publishing date	2023-09-12
Publishing country	England
Document type	Journal Article ; Review
ISSN	2398-6352
ISSN (online)	2398-6352
DOI	10.1038/s41746-023-00913-9
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Article ; Online: Building the foundation for a modern patient-partnered infrastructure to study temporomandibular disorders.

Frontiers in digital health

2023 Volume 5, Page(s) 1132446

Abstract: Background: Conflicting reports from varying stakeholders related to prognosis and outcomes following placement of temporomandibular joint (TMJ) implants gave rise to the development of the TMJ Patient-Led RoundTable initiative. Following an assessment ... ...

Abstract	Background: Conflicting reports from varying stakeholders related to prognosis and outcomes following placement of temporomandibular joint (TMJ) implants gave rise to the development of the TMJ Patient-Led RoundTable initiative. Following an assessment of the current availability of data, the RoundTable concluded that a strategically Coordinated Registry Network (CRN) is needed to collect and generate accessible data on temporomandibular disorder (TMD) and its care. The aim of this study was therefore to advance the clinical understanding, usage, and adoption of a core minimum dataset for TMD patients as the first foundational step toward building the CRN. Methods: Candidate data elements were extracted from existing data sources and included in a Delphi survey administered to 92 participants. Data elements receiving less than 75% consensus were dropped. A purposive multi-stakeholder sub-group triangulated the items across patient and clinician-based experience to remove redundancies or duplicate items and reduce the response burden for both patients and clinicians. To reliably collect the identified data elements, the identified core minimum data elements were defined in the context of technical implementation within High-performance Integrated Virtual Environment (HIVE) web-application framework. HIVE was integrated with CHIOS™, an innovative permissioned blockchain platform, to strengthen the provenance of data captured in the registry and drive metadata to record all registry transaction and create a robust consent network. Results: A total of 59 multi-stakeholder participants responded to the Delphi survey. The completion of the Delphi surveys followed by the application of the required group consensus threshold resulted in the selection of 397 data elements (254 for patient-generated data elements and 143 for clinician generated data elements). The infrastructure development and integration of HIVE and CHIOS™ was completed showing the maintenance of all data transaction information in blockchain, flexible recording of patient consent, data cataloging, and consent validation through smart contracts. Conclusion: The identified data elements and development of the technological platform establishes a data infrastructure that facilitates the standardization and harmonization of data as well as perform high performance analytics needed to fully leverage the captured patient-generated data, clinical evidence, and other healthcare ecosystem data within the TMJ/TMD-CRN.
Language	English
Publishing date	2023-05-15
Publishing country	Switzerland
Document type	Journal Article
ISSN	2673-253X
ISSN (online)	2673-253X
DOI	10.3389/fdgth.2023.1132446
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Article ; Online: Building the foundation for a modern patient-partnered infrastructure to study temporomandibular disorders

Frontiers in Digital Health, Vol

2023 Volume 5

Abstract: BackgroundConflicting reports from varying stakeholders related to prognosis and outcomes following placement of temporomandibular joint (TMJ) implants gave rise to the development of the TMJ Patient-Led RoundTable initiative. Following an assessment of ... ...

Abstract	BackgroundConflicting reports from varying stakeholders related to prognosis and outcomes following placement of temporomandibular joint (TMJ) implants gave rise to the development of the TMJ Patient-Led RoundTable initiative. Following an assessment of the current availability of data, the RoundTable concluded that a strategically Coordinated Registry Network (CRN) is needed to collect and generate accessible data on temporomandibular disorder (TMD) and its care. The aim of this study was therefore to advance the clinical understanding, usage, and adoption of a core minimum dataset for TMD patients as the first foundational step toward building the CRN.MethodsCandidate data elements were extracted from existing data sources and included in a Delphi survey administered to 92 participants. Data elements receiving less than 75% consensus were dropped. A purposive multi-stakeholder sub-group triangulated the items across patient and clinician-based experience to remove redundancies or duplicate items and reduce the response burden for both patients and clinicians. To reliably collect the identified data elements, the identified core minimum data elements were defined in the context of technical implementation within High-performance Integrated Virtual Environment (HIVE) web-application framework. HIVE was integrated with CHIOS™, an innovative permissioned blockchain platform, to strengthen the provenance of data captured in the registry and drive metadata to record all registry transaction and create a robust consent network.ResultsA total of 59 multi-stakeholder participants responded to the Delphi survey. The completion of the Delphi surveys followed by the application of the required group consensus threshold resulted in the selection of 397 data elements (254 for patient-generated data elements and 143 for clinician generated data elements). The infrastructure development and integration of HIVE and CHIOS™ was completed showing the maintenance of all data transaction information in blockchain, flexible ...
Keywords	temporomandibular joint ; temporomandibular joint disorders ; temporomandibular joint dysfunction syndrome ; temporomandibular joint disc ; delphi ; coordinated registry network ; Medicine ; R ; Public aspects of medicine ; RA1-1270 ; Electronic computers. Computer science ; QA75.5-76.95
Subject code	310
Language	English
Publishing date	2023-05-01T00:00:00Z
Publisher	Frontiers Media S.A.
Document type	Article ; Online
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Article ; Online: Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE): Updated Report 2012-2020.

McCarthy, Colleen M / Roberts, John / Mullen, Erin / Loyo-Berrios, Nilsa / Clemens, Mark W / Yoon, Sung W / Levinson, Howard / Sommers, Katie / Hume, Keith / Carr, Logan

Plastic and reconstructive surgery

2023 Volume 152, Issue 4S, Page(s) 16S–24S

Abstract: Background: In January of 2011, the U.S. Food and Drug Administration released a safety communication regarding the potential association between breast implants and anaplastic large-cell lymphoma (ALCL). In 2012, the American Society of Plastic ... ...

Abstract	Background: In January of 2011, the U.S. Food and Drug Administration released a safety communication regarding the potential association between breast implants and anaplastic large-cell lymphoma (ALCL). In 2012, the American Society of Plastic Surgeons, The Plastic Surgery Foundation, and the Food and Drug Administration signed a cooperative research and development agreement to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large-Cell Lymphoma Etiology and Epidemiology (PROFILE) patient registry. Method: This is an updated report of registry findings. From August of 2012 to August of 2020, 330 unique, suspected, or confirmed cases of breast implant-associated (BIA) ALCL in the United States were reported to PROFILE, including 144 cases newly reported since the 2018 publication. Results: Median time from implantation of any device to BIA-ALCL diagnosis was 11 years (range, 2 to 44 years). At the time of presentation, 91% of cases had local symptoms and 9% had concurrent systemic symptoms. The most common local symptom was seroma, seen in 79% of patients. All patients had a history of a textured device; there were no patients who had a confirmed smooth-only device history. Approximately 11% of the reported cases were diagnosed with stage 1A disease (tumor-node-metastasis staging classification). Conclusions: The PROFILE registry continues to be an essential tool in unifying the collection of granular-level data pertaining to BIA-ALCL. These data emphasize the critical importance of detailed tracking of BIA-ALCL cases, and will contribute significantly to our understanding of the relationship between breast implants and ALCL.
MeSH term(s)	Humans ; Female ; Breast Implants/adverse effects ; Lymphoma, Large-Cell, Anaplastic/epidemiology ; Lymphoma, Large-Cell, Anaplastic/etiology ; Lymphoma, Large-Cell, Anaplastic/diagnosis ; Breast Implantation/adverse effects ; Device Removal/adverse effects ; Registries ; Breast Neoplasms/epidemiology ; Breast Neoplasms/etiology ; Breast Neoplasms/surgery
Language	English
Publishing date	2023-09-28
Publishing country	United States
Document type	Journal Article
ZDB-ID	208012-6
ISSN	1529-4242 ; 0032-1052 ; 0096-8501
ISSN (online)	1529-4242
ISSN	0032-1052 ; 0096-8501
DOI	10.1097/PRS.0000000000010475
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Article ; Online: Selection of prosthetic aortic valves in the United States among elderly Medicare patients from 2006 to 2015.

Du, Dongyi Tony / Lu, Xiaoxiao / McKean, Stephen / Warnock, Rob / Laschinger, John / Loyo-Berríos, Nilsa / Marinac-Dabic, Danica

The Journal of thoracic and cardiovascular surgery

2019 Volume 159, Issue 1, Page(s) 62–69

Abstract: Background: Both biological and mechanical prosthetic valves are treatment choices for aortic valve replacement. We aimed to characterize the selection of prosthetic aortic valves among elderly Medicare patients.: Methods: This was a retrospective ... ...

Abstract	Background: Both biological and mechanical prosthetic valves are treatment choices for aortic valve replacement. We aimed to characterize the selection of prosthetic aortic valves among elderly Medicare patients. Methods: This was a retrospective analysis of patients aged 65 years or older who underwent aortic valve replacement alone or in combination with other procedures in the 2006-2015 Medicare databases. Patients were continuously enrolled in Medicare Part A and B. We characterized the trends and regional variation of the selection of prosthetic valves. Multivariable logistic regression was used to evaluate the determinants that influenced the selection of prosthetic valves. Results: During the study period, there were 272,921 Medicare patients aged 65 years or older who underwent aortic valve replacement and met the inclusion and exclusion criteria. The selection of mechanical aortic valves decreased from 32.0% in 2006 to 24.3% in 2015 (P < .01). In comparison with 18.5% from northeastern states, 34.6% of patients from southern states selected mechanical valves (P < .01). Major determinants of the selection of prosthetic valves include age, gender, region, hospital characteristics, and physician experience. Patients being older, male, living in the northeast region, operated on in a high-volume hospital, and by more experienced physicians were more likely to receive biological valves. Conclusions: A 24.1% decrease in the selection of mechanical aortic valves was observed among elderly Medicare patients from 2006 to 2015. A dramatic regional difference was observed in the choice of prosthetic valves across the nation.
Language	English
Publishing date	2019-02-26
Publishing country	United States
Document type	Journal Article
ZDB-ID	3104-5
ISSN	1097-685X ; 0022-5223
ISSN (online)	1097-685X
ISSN	0022-5223
DOI	10.1016/j.jtcvs.2019.02.012
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Article: Primary-open glaucoma and myopia: a narrative review.

Loyo-Berríos, Nilsa I / Blustein, Joseph N

WMJ : official publication of the State Medical Society of Wisconsin

2007 Volume 106, Issue 2, Page(s) 85–9, 95

Abstract: Refractive errors and primary open-angle glaucoma are common eye conditions in the United States. The identification and quantification of risk factors for primary open-angle glaucoma is critical to understanding and managing the disease process from ... ...

Abstract	Refractive errors and primary open-angle glaucoma are common eye conditions in the United States. The identification and quantification of risk factors for primary open-angle glaucoma is critical to understanding and managing the disease process from both individual and public health perspectives. This narrative review was conducted to present the epidemiology of primary open-angle glaucoma and to summarize epidemiologic findings on myopia as a risk factor. Epidemiologic evidence suggests an increasing prevalence of primary open-angle glaucoma over the last decade in the United States. It has been documented that primary open-angle glaucoma prevalence increases with age, and that African Americans tend to have the highest estimates. Epidemiologic data, however, are not as clear with respect to gender differences. Other factors that have been identified are increased intraocular pressure and the use of steroids. The evidence for increased risk of primary open-angle glaucoma among myopies is stronger for moderate and severe myopia and not as clear for mild myopia. The association between primary open-angle glaucoma and its multiple risk factors is complex.
MeSH term(s)	Age Factors ; Glaucoma, Open-Angle/epidemiology ; Glaucoma, Open-Angle/etiology ; Humans ; Myopia/complications ; Myopia/epidemiology ; Prevalence ; Risk Factors ; United States/epidemiology
Language	English
Publishing date	2007-04
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	441051-8
ISSN	1098-1861 ; 0043-6542
ISSN	1098-1861 ; 0043-6542
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Article ; Online: Impact of early surveillance on safety signal identification in the CathPCI DELTA study.

Majithia, Arjun / Matheny, Michael E / Dani, Sourbha S / Paulus, Jessica K / Marinac-Dabic, Danica / Robbins, Susan / Ssemaganda, Henry / Hewitt, Kathleen / Ponirakis, Angelo / Loyo-Berrios, Nilsa / Moussa, Issam / Drozda, Joseph / Normand, Sharon-Lise / Resnic, Frederic S

BMJ surgery, interventions, & health technologies

2020 Volume 2, Issue 1, Page(s) e000047

Abstract: Objectives: The CathPCI Data Extraction and Longitudinal Trend Analysis study was designed to determine the feasibility of conducting prospective surveillance of a large national registry to perform comparative safety analyses of medical devices. We ... ...

Abstract	Objectives: The CathPCI Data Extraction and Longitudinal Trend Analysis study was designed to determine the feasibility of conducting prospective surveillance of a large national registry to perform comparative safety analyses of medical devices. We sought to determine whether the complementary use of retrospective case data could improve safety signal detection time. Design: We performed a simulated surveillance study of the comparative safety of the Mynx vascular closure device (VCD) with propensity score matched alternate VCD recipients, using both retrospective and prospective cohort data. Setting: Centers within the USA using the National Cardiovascular Data Registry (NCDR) CathPCI Registry. Participants: Percutaneous coronary intervention cases captured within the NCDR CathPCI Registry from July 1, 2009 to September 30, 2013 were included in the analysis. Interventions: None. Main outcome measures: Absolute and relative risk (RR) of any vascular complication (a composite of bleeding at access site, hematoma at access site, retroperitoneal bleeding, and other vascular complications requiring treatment); time to signal detection. Results: A safety alert was detected for the primary outcome of "any vascular complication" after 15 months of surveillance and was sustained for the study duration (absolute risk of any vascular complication, 1.20% vs 0.73%, RR, 1.63; 95% CI 1.50 to 1.79; p<0.001). The safety signal was identified 12 months earlier with the use of retrospective case data than during the initial study. Conclusions: Prospective, active surveillance of cardiovascular registries is feasible to perform comparative analyses of medical devices. Retrospective data may complement prospective surveillance to improve time to signal detection, indicating the need for earlier prospective application of safety surveillance for devices new to the market.
Language	English
Publishing date	2020-11-11
Publishing country	England
Document type	Journal Article
ISSN	2631-4940
ISSN (online)	2631-4940
DOI	10.1136/bmjsit-2020-000047
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Article ; Online: Comparative Safety of Aspiration Thrombectomy Catheters Utilizing Prospective, Active Surveillance of the NCDR CathPCI Registry.

Majithia, Arjun / Matheny, Michael E / Paulus, Jessica K / Marinac-Dabic, Danica / Robbins, Susan / Ssemaganda, Henry / Hewitt, Kathleen / Ponirakis, Angelo / Loyo-Berrios, Nilsa / Moussa, Issam / Drozda, Joseph / Normand, Sharon-Lise / Resnic, Frederic S

Circulation. Cardiovascular quality and outcomes

2019 Volume 12, Issue 2, Page(s) e004666

Abstract: Background Current strategies for ensuring the postmarket safety of medical devices are limited by small sample size and reliance on voluntary reporting of adverse events. Prospective, active surveillance of clinical registries may provide early warnings ...

Abstract	Background Current strategies for ensuring the postmarket safety of medical devices are limited by small sample size and reliance on voluntary reporting of adverse events. Prospective, active surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety but has not been demonstrated in national clinical data registries. Methods and Results The CathPCI DELTA (Data Extraction and Longitudinal Trend Analysis) study was designed to assess the feasibility of prospective, active safety surveillance of medical devices within a national cardiovascular registry. We sought to assess the ability of our surveillance strategy to avoid false safety alerts by conducting an active safety surveillance study of aspiration thrombectomy catheters using data within the National Cardiovascular Data Registry CathPCI registry, where no difference in safety outcomes were anticipated for the primary in-hospital safety outcome of death and major adverse cardiovascular events (MACE). We performed a propensity-matched analysis of 5 aspiration thrombectomy catheter devices used during percutaneous coronary intervention among 95 925 patients presenting with ST-segment-elevation myocardial infarction between January 1, 2011 and September 30, 2013. After 33 months of surveillance, no safety alerts were triggered for the primary safety endpoints of death or MACE, with no between-catheter differences observed. The absolute risk of death during acute hospitalization ranged from 5.11% to 5.32% among the most commonly used aspiration thrombectomy catheter devices, with relative risks for death ranging from 0.96 to 1.03. The absolute risk of MACE ranged from 9.78% to 10.18%, with relative risks for MACE ranging from 0.99 to 1.02. There were no statistically significant differences in the rates of death or MACE between any of the aspiration thrombectomy catheter devices analyzed. Conclusions The CathPCI DELTA study demonstrates that prospective, active safety surveillance of national clinical registries is feasible to provide near-real-time safety assessments of new medical devices.
MeSH term(s)	Aged ; Cardiac Catheterization/adverse effects ; Cardiac Catheterization/instrumentation ; Cardiac Catheterization/mortality ; Cardiac Catheters ; Equipment Design ; Equipment Failure ; Feasibility Studies ; Female ; Humans ; Male ; Middle Aged ; Patient Safety ; Percutaneous Coronary Intervention/adverse effects ; Percutaneous Coronary Intervention/instrumentation ; Percutaneous Coronary Intervention/mortality ; Product Surveillance, Postmarketing ; Prospective Studies ; Registries ; Risk Assessment ; Thrombectomy/adverse effects ; Thrombectomy/instrumentation ; Thrombectomy/mortality ; Treatment Outcome
Language	English
Publishing date	2019-02-14
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	2483197-9
ISSN	1941-7705 ; 1941-7713
ISSN (online)	1941-7705
ISSN	1941-7713
DOI	10.1161/CIRCOUTCOMES.118.004666
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Article: Childhood asthma prevalence in northern Puerto Rico, the Rio Grande, and Loíza experience.

Loyo-Berríos, Nilsa I / Orengo, Juan C / Serrano-Rodríguez, Ruby A

The Journal of asthma : official journal of the Association for the Care of Asthma

2006 Volume 43, Issue 8, Page(s) 619–624

Abstract: Objective: Childhood asthma is highly prevalent in some areas of Puerto Rico. The objective of this study was to estimate the prevalence of asthma in two municipalities of Northern Puerto Rico.: Methods: Children 6 to 7 and 13 to 14 years of age ... ...

Abstract	Objective: Childhood asthma is highly prevalent in some areas of Puerto Rico. The objective of this study was to estimate the prevalence of asthma in two municipalities of Northern Puerto Rico. Methods: Children 6 to 7 and 13 to 14 years of age participated in the school-based cross-sectional study. Results: A total of 1,467 elementary school students and 1,334 junior-high school students were included in the survey. A high prevalence of asthma was observed; 46% in elementary schools and 24% in junior-high schools. In elementary schools, family history of asthma (FHA) was associated with ever wheezed (PR = 2.00, 95%CI 1.59, 2.52), wheeze during last year (PR = 2.02, 95%CI 1.54, 2.62), and asthma (PR = 2.33, 95%CI 1.86, 2.92). For junior-high schools FHA was associated with ever wheezed (PR = 2.01, 95%CI 1.56, 2.57), wheeze during previous year (PR = 2.00, 95%CI 1.47, 2.73), and asthma (PR = 2.72, 95%CI 2.06, 3.60). Conclusions: This study showed a high prevalence of asthma and related symptoms in Northern Puerto Rico. FHA was strongly associated with asthma and its symptoms. Further research is recommended to look at genetics, sensitivity levels, indoor and outdoor pollution, and gene-environment interactions.
MeSH term(s)	Adolescent ; Asthma/diagnosis ; Asthma/epidemiology ; Asthma/genetics ; Child ; Cross-Sectional Studies ; Data Collection/statistics & numerical data ; Female ; Genetic Predisposition to Disease/genetics ; Health Surveys ; Humans ; Incidence ; Male ; Puerto Rico/epidemiology ; Respiratory Sounds/diagnosis ; Risk Factors ; Topography, Medical
Language	English
Publishing date	2006-10
Publishing country	England
Document type	Journal Article ; Multicenter Study ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	603816-5
ISSN	0277-0903
ISSN	0277-0903
DOI	10.1080/02770900600878693
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Article ; Online: Building Blocks for the Long-acting and Permanent Contraceptives Coordinated Registry Network.

Baird, Courtney E / Guiahi, Maryam / Chudnoff, Scott / Loyo-Berrios, Nilsa / Garcia, Stephanie / Jung, Mary / Gressler, Laura Elisabeth / Mao, Jialin / Hodshon, Beth / Sedrakyan, Art / Andrews, Sharon / Colden, Kelly / Roberts, Jason / Anderson, Abby / Sewell, Catherine / Marinac-Dabic, Danica

BMJ surgery, interventions, & health technologies

2022 Volume 4, Issue Suppl 1, Page(s) e000075

Abstract: Objectives: A multistakeholder expert group under the Women's Health Technology Coordinated Registry Network (WHT-CRN) was organized to develop the foundation for national infrastructure capturing the performance of long-acting and permanent ... ...

Abstract	Objectives: A multistakeholder expert group under the Women's Health Technology Coordinated Registry Network (WHT-CRN) was organized to develop the foundation for national infrastructure capturing the performance of long-acting and permanent contraceptives. The group, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry and the patient community, was assembled to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess contraceptive medical product technologies. Design: We applied a Delphi survey method approach to achieve consensus on a core minimum data set for the future CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated and analyzed by a study design team from Weill Cornell Medicine. After the first survey, questions for subsequent surveys were based on the analysis process and conference call discussions with group members. This process was repeated two times over a 6-month time period until consensus was achieved. Results: Twenty-three experts participated in the Delphi process. Participation rates in the first and second round of the Delphi survey were 83% and 100%, respectively. The working group reached final consensus on 121 core data elements capturing reproductive/gynecological history, surgical history, general medical history, encounter information, long-acting/permanent contraceptive index procedures and follow-up, procedures performed in conjunction with the index procedure, product removal, medications, complications related to the long-acting and/or permanent contraceptive procedure, pregnancy and evaluation of safety and effectiveness outcomes. Conclusions: The WHT-CRN expert group produced a consensus-based core set of data elements that allow the study of current and future contraceptives. These data elements influence patient and provider decisions about treatments and include important outcomes related to safety and effectiveness of these medical devices, which may benefit other women's health stakeholders.
Language	English
Publishing date	2022-11-11
Publishing country	England
Document type	Journal Article
ISSN	2631-4940
ISSN (online)	2631-4940
DOI	10.1136/bmjsit-2020-000075
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