Translating ethical and quality principles for the effective, safe and fair development, deployment and use of artificial intelligence technologies in healthcare.

OBJECTIVE: The complexity and rapid pace of development of algorithmic technologies pose challenges for their regulation and oversight in healthcare settings. We sought to improve our institution's approach to evaluation and governance of algorithmic technologies used in clinical care and operations by creating an Implementation Guide that standardizes evaluation criteria so that local oversight is performed in an objective fashion. MATERIALS AND METHODS: Building on a framework that applies key ethical and quality principles (clinical value and safety, fairness and equity, usability and adoption, transparency and accountability, and regulatory compliance), we created concrete guidelines for evaluating algorithmic technologies at our institution. RESULTS: An Implementation Guide articulates evaluation criteria used during review of algorithmic technologies and details what evidence supports the implementation of ethical and quality principles for trustworthy health AI. Application of the processes described in the Implementation Guide can lead to algorithms that are safer as well as more effective, fair, and equitable upon implementation, as illustrated through 4 examples of technologies at different phases of the algorithmic lifecycle that underwent evaluation at our academic medical center. DISCUSSION: By providing clear descriptions/definitions of evaluation criteria and embedding them within standardized processes, we streamlined oversight processes and educated communities using and developing algorithmic technologies within our institution. CONCLUSIONS: We developed a scalable, adaptable framework for translating principles into evaluation criteria and specific requirements that support trustworthy implementation of algorithmic technologies in patient care and healthcare operations.

Leveraging Artificial Intelligence and Digital Health to Address Health-Related Social Needs and Optimize Risk-Based Value in Orthopaedic Surgery.

As the health care landscape evolves toward value-based care and emphasizes health-related social needs, the importance of developing health policies and digital health solutions that foster health equity and risk-based reimbursement strategies has grown. Orthopaedic surgery, catering to a diverse patient population but challenged by a lack of workforce diversity, encounters distinct opportunities and obstacles in adopting digital health technologies for delivering equitable, high-value care. The integration of health-related social needs into the emerging value-based care model and risk-based reimbursement policies is important. Furthermore, the potential of incorporating robust artificial intelligence governance and big data analytics to enhance patient outcomes and support orthopaedic surgeons in treating their patient populations should be studied. There are crucial considerations for creating comprehensive digital health platforms tailored for orthopaedic surgery, and the significance of specialty-specific advocacy and collaboration among clinicians, policymakers, and MedTech companies cannot be understated.

Mitigating Racial And Ethnic Bias And Advancing Health Equity In Clinical Algorithms: A Scoping Review.

In August 2022 the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking prohibiting covered entities, which include health care providers and health plans, from discriminating against individuals when using clinical algorithms in decision making. However, HHS did not provide specific guidelines on how covered entities should prevent discrimination. We conducted a scoping review of literature published during the period 2011-22 to identify health care applications, frameworks, reviews and perspectives, and assessment tools that identify and mitigate bias in clinical algorithms, with a specific focus on racial and ethnic bias. Our scoping review encompassed 109 articles comprising 45 empirical health care applications that included tools tested in health care settings, 16 frameworks, and 48 reviews and perspectives. We identified a wide range of technical, operational, and systemwide bias mitigation strategies for clinical algorithms, but there was no consensus in the literature on a single best practice that covered entities could employ to meet the HHS requirements. Future research should identify optimal bias mitigation methods for various scenarios, depending on factors such as patient population, clinical setting, algorithm design, and types of bias to be addressed.

An investment case for maternal and neonatal tetanus elimination.

INTRODUCTION: Globally, 13 countries have yet to eliminate maternal and neonatal tetanus. While efforts have improved access to tetanus toxoid containing vaccines (TTCVs) and increased clean delivery practices, reaching elimination targets (<1 case of neonatal tetanus per 1000 live births per district per year) may require significant resources to reach the remaining high risk and hard-to-reach districts. METHODS: We estimated the cost to achieve maternal and neonatal tetanus elimination (MNTE) in three years in the remaining 13 countries: Afghanistan, Angola, Central African Republic, Democratic Republic of the Congo, Guinea, Mali, Nigeria, Pakistan, Papua New Guinea, Somalia, South Sudan, Sudan, and Yemen. Costs were estimated for: (1) vaccination campaigns using standard TTCVs and TT-Uniject™ targeting women of reproductive age in high risk areas, (2) additional vaccinations delivered to pregnant women at antenatal care (ANC) clinics, (3) clean delivery and umbilical cord care promotion, (4) neonatal tetanus surveillance strengthening, and (5) validation activities. We forecasted the averted mortality to assess the cost-effectiveness of achieving MNTE. RESULTS: It will cost an estimated US$197.7 million to realize MNTE over three years. These costs include $161.4 million for vaccination campaigns, $6.1 million for routine vaccination during ANC, $23.3 million for promotion of clean delivery practices, $4 million for surveillance, and $3 million for validation of MNTE. Achieving MNTE will avert approximately 70,000 neonatal deaths over ten years of vaccine protection, resulting in approximately 4.4 million life years gained. It will cost $2,900 per death averted and $45 per life year gained. CONCLUSION: Maternal and neonatal tetanus can be eliminated with significant financial investment, high prioritization, and strong political will. While substantial costs must be incurred to reach hard-to-reach populations, MNTE should be accomplished as a matter of health equity, and will significantly contribute to reaching the United Nations' Sustainable Development Goals.

Modeling the Economic Impact of Substandard and Falsified Antimalarials in the Democratic Republic of the Congo.

Substandard and falsified medicines pose significant risks to global health, including increased deaths, prolonged treatments, and growing drug resistance. Antimalarials are one of the most common medications to be of poor quality in low- and middle-income countries. We assessed the health and economic impact of substandard and falsified antimalarials for children less than 5 years of age in the Democratic Republic of the Congo, which has one of the world's highest malaria mortality rates. We developed an agent-based model to simulate patient care-seeking behavior and medicine supply chain processes to examine the impact of antimalarial quality in Kinshasa province and Katanga region. We simulated the impact of potential interventions to improve medicinal quality, reduce stockouts, or educate caregivers. We estimated that substandard and falsified antimalarials are responsible for $20.9 million (35% of $59.6 million; 95% CI: $20.7-$21.2 million) in malaria costs in Kinshasa province and $130 million (43% of $301 million; $129-$131 million) in malaria costs in the Katanga region annually. If drug resistance to artemisinin were to develop, total annual costs of malaria could increase by $17.9 million (30%; $17.7-$18.0 million) and $73 million (24%; $72.2-$72.8 million) in Kinshasa and Katanga, respectively. Replacing substandard and falsified antimalarials with good quality medicines had a larger impact than interventions that prevented stockouts or educated caregivers. The results highlight the importance of improving access to good quality antimalarials to reduce the burden of malaria and mitigate the development of antimalarial resistance.

Engaging United States Black Communities in HIV Pre-exposure Prophylaxis: Analysis of a PrEP Engagement Cascade.

BACKGROUND/PURPOSE: National PrEP utilization analyses show US non-Hispanic Blacks accessing PrEP at disproportionately low rates given the higher HIV prevalence among Blacks, and in comparison to utilization by non-Hispanic Whites. Women also are underrepresented among PrEP utilizers, especially Black women. We examine the process of accessing PrEP for a majority Black population in an urban community health center setting. METHODS: In the Philadelphia city health centers, patients referred for PrEP were followed through six steps of accessing PrEP: referral, patient contact by a PrEP team, maintained interest by patients, scheduling of screening appointments, attending screening appointments, and initiating PrEP. Chi-squared tests were performed at each stage to identify gender differences in drop-off at each step. RESULTS: Between August 2014 and December 2015, 14% of 785 patients referred for PrEP initiated. Women constituted 37.8% of referrals. A smaller majority of Blacks initiated (84.6% of females, 69.5% of males) than were referred (94.5% of females, 88.1% of males). Prior knowledge of PrEP was associated with screening (68% of those with prior knowledge screened, compared with 29.6% of those without prior knowledge,Χ2 p<0.0001). Higher initiation:referral ratios were noted for self-referrals, and for those referred by clinicians, peers and partners. CONCLUSIONS: In a diverse cohort in a community health center setting, myriad barriers resulted in a 14% initiation rate for persons at elevated risk for HIV who were referred for PrEP. These barriers led to disproportionately fewer non-Hispanic Blacks and women initiating PrEP. Efforts to better engage Blacks and women in PrEP care are urgently needed, and may include better dissemination of PrEP-related information in Black communities and to women, and training of clinicians serving Black and female populations to improve competency in provision of PrEP care.

Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis.

Importance: Substandard and falsified medicines burden health systems by diverting resources to ineffective or harmful therapies, causing medical complications and prolonging illnesses. However, the prevalence and economic impact of poor-quality medicines is unclear. Objective: To conduct a systematic review and meta-analysis to assess the prevalence and estimated economic burden of substandard and falsified essential medicines in low- and middle-income countries. Data Sources: Five databases (PubMed, EconLit, Global Health, Embase, and Scopus) were searched from inception until November 3, 2017. Study Selection: Publications were assessed to determine whether they examined medicine quality and the prevalence and/or economic burden of substandard and falsified medicines in low- and middle-income countries. Studies with a sample size of 50 or more were included in the meta-analysis. Data Extraction and Synthesis: The study is registered in PROSPERO and reported via the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines. Study quality was assessed using an adapted Medicine Quality Assessment Reporting Guidelines scoring metric. Multiple reviewers conducted the data extraction and quality assessment independently. Main Outcomes and Measures: Prevalence and/or estimated economic impact of substandard and falsified medicines. Results: Two hundred sixty-five studies that estimated the prevalence of poor-quality essential medicines in low- and middle-income countries were identified. Among 96 studies that tested 50 samples or more (67 839 total drug samples), overall prevalence of poor-quality medicines was 13.6% (95% CI, 11.0%-16.3%), with regional prevalence of 18.7% in Africa (95% CI, 12.9%-24.5%) and 13.7% in Asia (95% CI, 8.2%-19.1%). Of studies included in the meta-analysis, 19.1% (95% CI, 15.0%-23.3%) of antimalarials and 12.4% (95% CI, 7.1%-17.7%) of antibiotics were substandard or falsified. Eight approximations of the economic impact, focused primarily on market size, with poor or undisclosed methods in estimation were identified, ranging from $10 billion to $200 billion. Conclusions and Relevance: Poor-quality essential medicines are a substantial and understudied problem. Methodological standards for prevalence and rigorous economic studies estimating the burden beyond market size are needed to accurately assess the scope of the issue and inform efforts to address it. Global collaborative efforts are needed to improve supply-chain management, surveillance, and regulatory capacity in low- and middle-income countries to reduce the threat of poor-quality medicines. Trial Registration: PROSPERO Identifier: CRD42017080266.

Engaging African and Caribbean Immigrants in HIV Testing and Care in a Large US City: Lessons Learned from the African Diaspora Health Initiative.

The lifting in 2010 of the HIV entry ban eliminated an access point for HIV testing of the foreign-born. The African Diaspora Health Initiative (ADHI) was developed to examine alternative pathways to testing for African and Caribbean persons. The ADHI consists of Clinics Without Walls (CWW) held in community settings. HIV testing is offered to participants along with hypertension and diabetes screening. A survey is administered to participants. Descriptive data were analyzed using SAS 9.2. Between 2011 and 2015, 4152 African and Caribbean individuals participated in 352 CWW. Participants were mostly (67.7 %) African. HIV rates were lowest in Caribbean women (0.4 %) and highest in Caribbean men (8.4 %). Efforts to engage African and Caribbean communities in HIV testing are important given the elimination of the HIV entry ban and continued immigration to the US from areas of higher prevalence. The ADHI offers a successful model of engagement.

Measuring domestic water use: a systematic review of methodologies that measure unmetered water use in low-income settings.

OBJECTIVE: To present a systematic review of methods for measuring domestic water use in settings where water meters cannot be used. METHODS: We systematically searched EMBASE, PubMed, Water Intelligence Online, Water Engineering and Development Center, IEEExplore, Scielo, and Science Direct databases for articles that reported methodologies for measuring water use at the household level where water metering infrastructure was absent or incomplete. A narrative review explored similarities and differences between the included studies and provide recommendations for future research in water use. RESULTS: A total of 21 studies were included in the review. Methods ranged from single-day to 14-consecutive-day visits, and water use recall ranged from 12 h to 7 days. Data were collected using questionnaires, observations or both. Many studies only collected information on water that was carried into the household, and some failed to mention whether water was used outside the home. Water use in the selected studies was found to range from two to 113 l per capita per day. CONCLUSION: No standardised methods for measuring unmetered water use were found, which brings into question the validity and comparability of studies that have measured unmetered water use. In future studies, it will be essential to define all components that make up water use and determine how they will be measured. A pre-study that involves observations and direct measurements during water collection periods (these will have to be determined through questioning) should be used to determine optimal methods for obtaining water use information in a survey. Day-to-day and seasonal variation should be included. A study that investigates water use recall is warranted to further develop standardised methods to measure water use; in the meantime, water use recall should be limited to 24 h or fewer.

Attitudes Toward HIV Pre-Exposure Prophylaxis in a United States Urban Clinic Population.

A majority of US studies on attitudes toward PrEP focus on men who have sex with men with little representation of African Americans. This cross-sectional study seeks to determine openness to PrEP, and examine motivations for openness among Philadelphia residents. Patients undergoing HIV rapid testing between May 2012 and December 2014 in a public setting were administered a survey. Questions included openness to PrEP and reasons for openness to PrEP. Multivariate logistic regression models were used to investigate associations between openness and potential predictors. Analyses were conducted using R version 3.2.4 and the epitools and car packages. Of 5606 respondents, over 90 % were African American. Men were more likely to express openness (61.4 % of men, 54.8 % of women, p < 0.0001). Predictors of openness were younger age, black race, higher perceived risk for HIV by patient or as assessed by Tester, intermittent /no condom use, greater number of partners in 12 months and previous HIV testing. The main reason for openness was fear of HIV, and for disinterest was lack of recognition of risk. Understanding openness to PrEP, and reasons for openness to or disinterest in PrEP are critical to determining the best approaches to facilitate engagement in PrEP care by communities and persons at elevated risk for HIV acquisition. Further study is needed on how best to manage disinterest in PrEP by those at high risk for HIV, and how openness to PrEP translates into concrete steps to take PrEP.