How to Navigate the Pitfalls of AI Hype in Health Care.

In this Medical News article, Arvind Narayanan, PhD, a professor of computer science at Princeton University, discusses the benefits of using artificial intelligence in research and clinical settings while remaining cautious of hype, biases, and data privacy issues.

Effectiveness of RADAR on diabetes processes of care for First Nations communities in Alberta, Canada.

The epidemic of type-2 diabetes in First Nations communities is tragic. Culturally-appropriate approaches addressing multiple components, focusing beyond glycemic control, are urgently needed. Using an intention-to-treat framework, 13 processes of care indicators were assessed to compare proportions of patients who received care at baseline relative to 2-year follow-up. Clinical improvements were demonstrated across major process of care indicators (e.g. screening, education, and vaccination activities). We found RADAR improved reporting for most diabetes processes of care across seven FN communities and was effective in supporting diabetes care for FN communities, in Alberta Canada.

A Nationwide Network of Health AI Assurance Laboratories.

Importance: Given the importance of rigorous development and evaluation standards needed of artificial intelligence (AI) models used in health care, nationwide accepted procedures to provide assurance that the use of AI is fair, appropriate, valid, effective, and safe are urgently needed. Observations: While there are several efforts to develop standards and best practices to evaluate AI, there is a gap between having such guidance and the application of such guidance to both existing and new AI models being developed. As of now, there is no publicly available, nationwide mechanism that enables objective evaluation and ongoing assessment of the consequences of using health AI models in clinical care settings. Conclusion and Relevance: The need to create a public-private partnership to support a nationwide health AI assurance labs network is outlined here. In this network, community best practices could be applied for testing health AI models to produce reports on their performance that can be widely shared for managing the lifecycle of AI models over time and across populations and sites where these models are deployed.

Racial differences in low value care among older adult Medicare patients in US health systems: retrospective cohort study.

OBJECTIVE: To characterize racial differences in receipt of low value care (services that provide little to no benefit yet have potential for harm) among older Medicare beneficiaries overall and within health systems in the United States. DESIGN: Retrospective cohort study SETTING: 100% Medicare fee-for-service administrative data (2016-18). PARTICIPANTS: Black and White Medicare patients aged 65 or older as of 2016 and attributed to 595 health systems in the United States. MAIN OUTCOME MEASURES: Receipt of 40 low value services among Black and White patients, with and without adjustment for patient age, sex, and previous healthcare use. Additional models included health system fixed effects to assess racial differences within health systems and separately, racial composition of the health system's population to assess the relative contributions of individual patient race and health system racial composition to low value care receipt. RESULTS: The cohort included 9 833 304 patients (6.8% Black; 57.9% female). Of 40 low value services examined, Black patients had higher adjusted receipt of nine services and lower receipt of 20 services than White patients. Specifically, Black patients were more likely to receive low value acute diagnostic tests, including imaging for uncomplicated headache (6.9% v 3.2%) and head computed tomography scans for dizziness (3.1% v 1.9%). White patients had higher rates of low value screening tests and treatments, including preoperative laboratory tests (10.3% v 6.5%), prostate specific antigen tests (31.0% v 25.7%), and antibiotics for upper respiratory infections (36.6% v 32.7%; all P<0.001). Secondary analyses showed that these differences persisted within given health systems and were not explained by Black and White patients receiving care from different systems. CONCLUSIONS: Black patients were more likely to receive low value acute diagnostic tests and White patients were more likely to receive low value screening tests and treatments. Differences were generally small and were largely due to differential care within health systems. These patterns suggest potential individual, interpersonal, and structural factors that researchers, policy makers, and health system leaders might investigate and address to improve care quality and equity.

Fraud within the Nigerian health system, a double threat for resilience of a health system and the response to the COVID-19 pandemic: a review.

As Nigeria battles the COVID-19 pandemic, systemic fraud within the health system may undermine the efforts to halt the devastating effect of the disease and the fight against COVID-19. Fraud is a major concern worldwide, especially in developing countries such as Nigeria, where it is widespread within the health system. The vulnerability of the Nigerian health system despite several efforts from relevant stakeholders, has consistently been underscored before the pandemic arose, raising serious concerns. These concerns include fraud, embezzlement, and mismanagement of funds, exploitation, lack of transparency in policymaking, cutting corners in procurement processes, and taking advantage of the healthcare workforce for personal benefits. Also, other involvements in the vulnerability of the Nigerian health system that are worrisome include stakeholders using the pandemic to their advantage to increase their private benefits, a short supply of vital health resources, fraudulent recruitment of the health workforce, and ineffective crisis management. This study explores fraud within the Nigerian health system, its impact and implications for health-system resilience as well as its response to the COVID-19 pandemic. Guided by agency theory, causes and impacts of fraud in the health system and its implications on the response to COVID-19 were explained. Systematic review method was employed; out of 1462 articles identified and screened dated from 1991 to 2021, sixty articles were included in the analysis and interpretation. Specific fraud interventions should focus on a weak and vulnerable health system, service delivery, high-risk institutionalized health workforce, and addressing issues of fraud within and outside the health system in order to curb the dreaded COVID-19 and its variants in Nigeria.

Creating and Implementing a Community Engagement Strategy for the 2022-2027 Illinois Comprehensive Cancer Control Plan Through an Academic-State Public Health Department Partnership.

INTRODUCTION: Comprehensive cancer control (CCC) plans are state-level blueprints that identify regional cancer priorities and health equity strategies. Coalitions are encouraged to engage with community members, advocacy groups, people representing multiple sectors, and working partners throughout the development process. We describe the community and legislative engagement strategy developed and implemented during 2020-2022 for the 2022-2027 Illinois CCC plan. METHODS: The engagement strategies were grounded in theory and evidence-based tools and resources. It was developed and implemented by coalition members representing the state health department and an academic partner, with feedback from the larger coalition. The strategy included a statewide town hall, 8 focus groups, and raising awareness of the plan among state policy makers. RESULTS: A total of 112 people participated in the town hall and focus groups, including 40 (36%) cancer survivors, 31 (28%) cancer caregivers, and 18 (16%) Latino and 26 (23%) African American residents. Fourteen of 53 (26%) focus group participants identified as rural. Participants identified drivers of cancer disparities (eg, lack of a comprehensive health insurance system, discrimination, transportation access) and funding and policy priorities. Illinois House Resolution 0675, the Illinois Cancer Control Plan, was passed in March 2022. CONCLUSION: The expertise and voices of community members affected by cancer can be documented and reflected in CCC plans. CCC plans can be brought to the attention of policy makers. Other coalitions working on state plans may consider replicating our strategy. Ultimately, CCC plans should reflect health equity principles and prioritize eliminating cancer disparities.

Emicizumabe para tratamento profilático de pacientes com hemofilia A, moderada ou grave, e anticorpos inibidores do Fator VIII, sem restrição de faixa etária, conforme Protocolo do Ministério da Saúde / Emicizumab for prophylactic treatment of patients with moderate or severe hemophilia A and Factor VIII inhibitor antibodies, without age group restrictions, according to the Ministry of Health Protocol

INTRODUÇÃO: A hemofilia A é uma condição rara que afeta a habilidade de coagulação do sangue, caracterizada pela disfunção ou diminuição da produção do fator de coagulação VIII (FVIII), uma proteína chave na cascata de coagulação para uma hemostasia efetiva. Tal deficiência está associada com a ocorrência de sangramentos, sendo os principais sintomas da doença a presença de sangramentos prolongados. Os quadros podem ser classificados de acordo com a atividade coagulante endógena do fator seja 0,01 UI/ml ou < 1% (grave), 0,01 a 0,05 UI/mL ou 1% a 5% (moderada) e > 0,05 a < 0,40 IU/ml ou > 5% a < 40% (leve), respectivamente. O tratamento dos sangramentos na hemofilia requer a infusão intravenosa do fator de coagulação deficiente. A reposição deste fator pode ser feita sob demanda (tratamento do episódio hemorrágico) ou de forma profilática (manutenção dos níveis de FVIII suficientemente elevados para prevenir os episódios hemorrágicos). Entretanto, uma complicação grave na hemofilia A é o desenvolvimento de inibidores, anticorpos da classe IgG, contra o FVIII infundido, inibindo assim a atividade coagulante dos concentrados de FVIII. A presença destes inibidores tem como consequência a ausência de resposta ao tratamento ou maior frequência ou gra

Implante biodegradável de dexametasona para o tratamento do edema macular diabético em maiores de 18 anos, conforme Protocolo Clínico do Ministério da Saúde / Biodegradable dexamethasone implant for the treatment of diabetic macular edema in people over 18 years of age, according to the Clinical Protocol of the Ministry of Health

INTRODUÇÃO: A retinopatia diabética, a principal causa de cegueira em pessoas em idade laboral, é uma manifestação do diabetes na forma de lesão de órgãos-alvo. Clinicamente, as primeiras lesões são anormalidades vasculares como microaneurismas, hemorragias e exsudatos. O aumento da vasopermeabilidade resulta em espessamento da retina e/ou depósitos lipídicos. Quando esses eventos ocorrem na mácula, instala-se o edema macular diabético (EMD), levando ao risco de perda visual central. Dois mecanismos fundamentais estão envolvidos no EMD: angiogênese e inflamação. A angiogênese é secundária ao aumento da expressão de VEGF, principal molécula envolvida na perda da ruptura da barreira hemato-retiniana, que por sua vez causa a exsudação e espessamento macular. A inflamação pode ser causa ou consequência da angiogênese, atualmente considerada fator interdependente. Citocinas encontram-se elevadas em pacientes com retinopatia diabética e EMD, tendo correlação positiva com a severidade da doença ocular. O PCDT atual de retinopatia diabética, publicado pelo Ministério da Saúde, inclui os antiVEGFs ranibizumabe e aflibercepte para pacientes sem tratamento medicamentoso prévio, associado ou não à fotocoagulação a laser, para o EMD, mas não contempla a corticoterapia para o bloqueio da produção dos mediadores inflamatórios e barreira vascular endotelial. Por este motivo ainda existem necessidades não atendidas no cenário de tratamento das retinopatias diabéticas, especialmente relacionadas ao EMD. De acordo com a literatura, pacientes vitrectomizados, pacientes com eventos tromboembólicos recentes ou que não apresentaram resposta satisfatória ao tratamento com os antiangiogênicos, por exemplo, se encontram desassistidos pelo PCDT, além das dificuldades relacionadas ao regime de aplicações dos anti-VEGFs (injeções frequentes com deslocamentos aos serviços em saúde), complicando o atendimento no SUS. Ainda, relacionado às complicações da retinopatia diabética e qualidade de vida dos pacientes, a falta de tratamento ou tratamento subotimo pode levar à cegueira, além de outras complicações. BREVE HISTÓRICO: Em 2020 a tecnologia foi submetida e teve recomendação desfavorável devido as incertezas frente à ineficácia terapêutica, ausência de evidências robustas e falta de informação sobre delimitação e escopo para uso no SUS. PERGUNTA: O uso do implante intravítreo de dexametasona é seguro e efetivo no tratamento tratamento de adultos com edema macular diabético , como opção terapêutica no SUS? EVIDÊNCIAS CLÍNICAS: As evidências de eficácia e segurança do implante intravítreo de dexametasona são baseadas no estudo pivotal do implante intravítreo de dexametasona e em três estudos de comparação direta com os antiVEGFs, já incorporados ao SUS. O estudo pivotal que comparou o implante de dexametasona ao placebo, utilizando adicionalmente ou não a fotocoagulação a laser, demonstrou melhora da acuidade visual maior ou igual a 15 letras da linha de base do estudo, em ambos os braços de tratamento (DEXi 0,7 e 0,35 mg) em relação ao grupo placebo tratado apenas com fotocoagulação a laser. A melhora significativa no BCVA (do inglês, Best Corrected Visual Acuity) ocorreu independentemente do status do cristalino na linha de base do estudo. Os resultados do primeiro estudo de comparação direta são de não-inferioridade da dexametasona em relação ao ranibizumabe e redução do número de injeções realizadas, com perfil de segurança aceitável. O segundo estudo demonstrou equivalência da dexametasona ao tratamento com aflibercepte, uma vez que a diferença em BCVA não foi clinicamente significativa. O terceiro ECR de comparação direta incluído aponta para a segurança e eficácia em melhorar a BCVA e diminuir a espessura da mácula central, em pacientes com EMD, por ambos os implantes intravítreos (dexametasona vs ranibizumabe). A avaliação da qualidade metodológica dos ECRs foi realizada e os riscos de vieses foram descritos sendo de baixo risco, em sua maioria. AVALIAÇÃO ECONÔMICA: O presente dossiê demonstrou que Ozurdex se configura como uma tecnologia poupadora de recursos para o sistema de saúde, através de apresentação de uma análise de custo-minimização abrangente, que incluiu custos de medicação, custos de administração e custos relativos a potenciais eventos adversos. Através de uma análise de cenários que variou os principais parâmetros tais como horizonte temporal (1 ou 3 anos), e custo de aquisição dos comparadores (anti-VEGFs), valor de APAC (forma de financiamento dos antiangiogênicos) ou custo do frasco-ampola proposto pelos fabricantes em suas solicitações de incorporação, foi possível demonstrar que o tratamento com Ozurdex pode proporcionar economia de recursos que varia de R$ 1.533,21 até R$ 15.651,77 por paciente, em comparação aos anti-VEGFs. ANÁLISE DE IMPACTO ORÇAMENTÁRIO: Na análise de impacto orçamentário, foram avaliados sete cenários com combinações de diferentes valores para os comparadores (APAC e custo frasco-ampola), estimativas populacionais (epidemiológica ou demanda aferida) e dois possíveis comportamentos de market shares. A economia projetada foi de pelo menos R$ 8 milhões, avaliando o cenário mais conservador. Nos demais cenários as economias projetadas foram de R$ 16 e R$ 39 milhões, e entre R$ 148 e R$ 716 milhões em estimativa de usuários consideravelmente maior. Os montantes apresentados podem contribuir para a otimização dos recursos no manejo dos pacientes com RD. MONITORAMENTO DO HORIZONTE TECNOLÓGICO: Foram detectadas 3 tecnologias para compor o esquema terapêutico do edema macular diabético em adultos. São 3 anticorpos monoclonais inibidores do crescimento do endotélio vascular (VEGF): brolucizumabe, faricimabe e tarcocimabe tedromer, sendo que o segundo apresenta também ação anti-angiopoietina 2 (Ang-2). O brolucizumabe e faricimabe estão registrados na FDA e EMA desde 2022. O tarcocimabe está em fase 3 e pode apresentar resultados dos ensaios a partir de 2023. CONSIDERAÇÕES FINAIS: Adicionalmente às evidências clínicas de qualidade, a avaliação de custo-minimização possui e a análise de impacto orçamentário possuem incertezas em relação à definição de custos e cenários de comparação, mas que sugerem dominância do Implante biodegradável de dexametasona para tratamento do edema macular diabético sob a perspectiva do Sistema Único de Saúde. PERSPECTIVA DO PACIENTE: Foi aberta a Chamada Pública nº 09/2022 de 13 a 26 de fevereiro 2022 e duas pessoas se inscreveram, ambas representantes de associações de pacientes. A definição dos representantes titular e suplente foi determinada por decisão consensual entre o grupo de inscritos. A representante leu três relatos de pacientes que possuem edema macular diabético e recorrem ao DEXi. Os três pacientes iniciaram o tratamento com um antiangiogênico e, após o uso do DEXi, apresentaram melhora dos sintomas e o alcance de maior qualidade de vida. Nenhum deles manifestou eventos adversos após o uso do implante. RECOMENDAÇÃO PRELIMINAR: Os membros do plenário, presentes na 118ª Reunião ordinária da Conitec, no dia 03 de maio de 2023, deliberaram por unanimidade encaminhar para a consulta pública com recomendação favorável a incorporação do implante biodegradável de dexametasona para o tratamento do edema macular diabético (EMD) em maiores de 18 anos no SUS. CONSULTA PÚBLICA: Realizada no período de 03 de julho a 24 de julho do presente ano, teve 62 contribuições de caráter técnico-científico e 146 respostas tidas como de experiência ou opinião. As contribuições recebidas na consulta pública sobre o relatório que avalia a proposta de incorporação do Implante biodegradável de dexametasona para o tratamento do edema macular diabético (EMD) em maiores de 18 anos no SUS foram majoritariamente favoráveis a recomendação preliminar da Conitec, de incorporação. Não foram adicionadas na consulta pública, referências que alterassem a análise da evidência apresentada no relatório, apenas atualização pelo demandante. RECOMENDAÇÃO FINAL: Os membros do plenário, presentes na 121ª Reunião ordinária da Conitec, no dia 02 de agosto de 2023, deliberaram por unanimidade recomendar a incorporação do implante biodegradável de dexametasona para o tratamento do edema macular diabético (EMD) em maiores de 18 anos conforme Protocolo Clínico do Ministério da Saúde, sob registro de deliberação 840/2023. Para tal recomendação, levou-se em consideração, entre outros fatores, que há economia de recursos em todos os cenários analisados e que os estudos demostraram que o benefício clínico do implante de dexametasona é maximizado para algumas populações, que atualmente encontram-se desassistidas ou subtratadas devido à ausência de uma opção de corticoterapia no âmbito do SUS. DECISÃO: Incorporar, no âmbito do Sistema Único de Saúde - SUS, o implante biodegradável de dexametasona para o tratamento do edema macular diabético em maiores de 18 anos, conforme Protocolo Clínico do Ministério da Saúde, publicada no Diário Oficial da União nº 193, seção 1, página 143, em 9 de outubro de 2023.

Sound psychometric properties of a short new screening tool for patient safety climate: applying a Rasch model analysis.

BACKGROUND: WHO recommends repeated measurement of patient safety climate in health care and to support monitoring an 11 item questionnaire on sustainable safety engagement (HSE) has been developed by the Swedish Association of Local Authorities and Regions. This study aimed to validate the psychometric properties of the HSE. METHODS: Survey responses (n = 761) from a specialist care provider organization in Sweden was used to evaluate psychometric properties of the HSE 11-item questionnaire. A Rasch model analysis was applied in a stepwise process to evaluate evidence of validity and precision/reliability in relation to rating scale functioning, internal structure, response processes, and precision in estimates. RESULTS: Rating scales met the criteria for monotonical advancement and fit. Local independence was demonstrated for all HSE items. The first latent variable explained 52.2% of the variance. The first ten items demonstrated good fit to the Rasch model and were included in the further analysis and calculation of an index measure based on the raw scores. Less than 5% of the respondents demonstrated low person goodness-of-fit. Person separation index > 2. The flooring effect was negligible and the ceiling effect 5.7%. No differential item functioning was shown regarding gender, time of employment, role within organization or employee net promotor scores. The correlation coefficient between the HSE mean value index and the Rasch-generated unidimensional measures of the HSE 10-item scale was r = .95 (p < .01). CONCLUSIONS: This study shows that an eleven-item questionnaire can be used to measure a common dimension of staff perceptions on patient safety. The responses can be used to calculate an index that enables benchmarking and identification of at least three different levels of patient safety climate. This study explores a single point in time, but further studies may support the use of the instrument to follow development of the patient safety climate over time by repeated measurement.

Clinical outcomes and health care costs of transferring rural Western Australians for invasive coronary angiography, and a cost-effective alternative care model: a retrospective cross-sectional study.

OBJECTIVES: To examine the severity of coronary artery disease (CAD) in people from rural or remote Western Australia referred for invasive coronary angiography (ICA) in Perth and their subsequent management; to estimate the cost savings were computed tomography coronary angiography (CTCA) offered in rural centres as a first line investigation for people with suspected CAD. DESIGN: Retrospective cohort study. SETTING, PARTICIPANTS: Adults with stable symptoms in rural and remote WA referred to Perth public tertiary hospitals for ICA evaluation during the 2019 calendar year. MAIN OUTCOME MEASURES: Severity and management of CAD (medical management or revascularisation); health care costs by care model (standard care or a proposed alternative model with local CTCA assessment). RESULTS: The mean age of the 1017 people from rural and remote WA who underwent ICA in Perth was 62 years (standard deviation, 13 years); 680 were men (66.9%), 245 were Indigenous people (24.1%). Indications for referral were non-ST elevation myocardial infarction (438, 43.1%), chest pain with normal troponin level (394, 38.7%), and other (185, 18.2%). After ICA assessment, 619 people were medically managed (60.9%) and 398 underwent revascularisation (39.1%). None of the 365 patients (35.9%) without obstructed coronaries (< 50% stenosis) underwent revascularisation; nine patients with moderate CAD (50-69% stenosis; 7%) and 389 with severe CAD (≥ 70% stenosis or occluded vessel; 75.5%) underwent revascularisation. Were CTCA used locally to determine the need for referral, 527 referrals could have been averted (53%), the ICA:revascularisation ratio would have improved from 2.6 to 1.6, and 1757 metropolitan hospital bed-days (43% reduction) and $7.3 million in health care costs (36% reduction) would have been saved. CONCLUSION: Many rural and remote Western Australians transferred for ICA in Perth have non-obstructive CAD and are medically managed. Providing CTCA as a first line investigation in rural centres could avert half of these transfers and be a cost-effective strategy for risk stratification of people with suspected CAD.

The Volume and Cost of Quality Metric Reporting.

Importance: US hospitals report data on many health care quality metrics to government and independent health care rating organizations, but the annual cost to acute care hospitals of measuring and reporting quality metric data, independent of resources spent on quality interventions, is not well known. Objective: To evaluate externally reported inpatient quality metrics for adult patients and estimate the cost of data collection and reporting, independent of quality-improvement efforts. Design, Setting, and Participants: Retrospective time-driven activity-based costing study at the Johns Hopkins Hospital (Baltimore, Maryland) with hospital personnel involved in quality metric reporting processes interviewed between January 1, 2019, and June 30, 2019, about quality reporting activities in the 2018 calendar year. Main Outcomes and Measures: Outcomes included the number of metrics, annual person-hours per metric type, and annual personnel cost per metric type. Results: A total of 162 unique metrics were identified, of which 96 (59.3%) were claims-based, 107 (66.0%) were outcome metrics, and 101 (62.3%) were related to patient safety. Preparing and reporting data for these metrics required an estimated 108 478 person-hours, with an estimated personnel cost of $5 038 218.28 (2022 USD) plus an additional $602 730.66 in vendor fees. Claims-based (96 metrics; $37 553.58 per metric per year) and chart-abstracted (26 metrics; $33 871.30 per metric per year) metrics used the most resources per metric, while electronic metrics consumed far less (4 metrics; $1901.58 per metric per year). Conclusions and Relevance: Significant resources are expended exclusively for quality reporting, and some methods of quality assessment are far more expensive than others. Claims-based metrics were unexpectedly found to be the most resource intensive of all metric types. Policy makers should consider reducing the number of metrics and shifting to electronic metrics, when possible, to optimize resources spent in the overall pursuit of higher quality.

Culturally Responsive Care Delivery in Oncology: The Example of Multiple Myeloma.

Multiple myeloma (MM) represents ∼1% of all cancers and is the second most common hematologic malignancy worldwide. The incidence of MM is at least two times higher in Blacks/African Americans compared with their White counterparts, and Hispanics/Latinxs are among the youngest patients diagnosed with the disease. Recent advances in available treatments for MM have demonstrated significant improvement in survival outcomes; however, patients from non-White racial/ethnic groups clinically benefit less due to multiple factors including access to care, socioeconomic status, medical mistrust, underutilization of novel therapies, and exclusion from clinical trials. Health inequities in disease characteristics and risk factors based on race also contribute to inequities in outcomes. In this review, we highlight racial/ethnic factors as well as structural barriers attributed to variations in MM epidemiology and management. We focus on three populations-Black/African American, Hispanic/Latinx, and American Indian/Alaska Native-and review factors that healthcare professionals may consider when treating patients of color. We offer tangible advice for healthcare professionals on how to incorporate cultural humility into their practice by following the five key steps: establishing trust, respecting cultural diversity, undergoing cross-cultural training, counseling patients on appropriate available clinical trial options, and connecting patients to community resources. The outlined recommendations will help the medical community to better understand and apply the important concept of cultural humility into their practice to provide the best care for all their patients, regardless of race/ethnicity.

Expanding Our Methodological Toolbox to Improve Quality: The Role of Mixed-Methods Evaluations.

The care delivered to patients with cardiovascular disease involves coordination among a multitude of clinical team members spanning diverse inpatient and outpatient settings. The majority of quality improvement interventions in cardiovascular care have been developed based on quantitative evidence, which neither fully accounts for multilevel determinants (eg, patient, clinician, and institution) nor contextualization from key informants. The rigor and effectiveness of these interventions would be enhanced by mixed-methods studies whose strengths include (1) the use of qualitative research methodologies (eg, eliciting patient or clinician perspectives on barriers and facilitators of best practices) and (2) integrating qualitative and quantitative data and analyses to understand more fully effective strategies for achieving optimal care and outcomes for these patients across diverse settings. This article illustrates the application of a complex mixed-methods design to advance an evidence-based, customizable infection prevention toolkit for durable left ventricular assist device therapy. The study (1) uses quantitative clinical data merged with Medicare claims to evaluate interhospital variability in the incidence of infection; (2) uses qualitative methods to understand local practice patterns across low- and high-performing centers; and (3) integrates both data sources to gain a comprehensive understanding of the overall findings.

Standards of Care for Transgender and Gender Diverse People.

This article summarizes the recent update of guidelines on health care for transgender and gender diverse people, including primary care, gender-affirming care, mental health care, and education of the clinical workforce.

Racial Disparities in Uterine Fibroid Treatment Among Veterans Using VA Health Care.

INTRODUCTION: Uterine fibroids are common, nonmalignant tumors that disproportionately impact Black patients. We aimed to examine Black and White differences in receipt of any treatment and type of first treatment in the Department of Veterans Affairs, including effect modification by severity as approximated by anemia. METHODS: We used Department of Veterans Affairs administrative data to identify 5,041 Black and 3,206 White veterans with symptomatic uterine fibroids, identified by International Classification of Diseases, 9th edition, Clinical Modification, codes, between fiscal year 2010 and fiscal year 2012 and followed in the administrative data through fiscal year 2018 for outcomes. Outcomes included receipt of any treatment, hysterectomy as first treatment, and fertility-sparing treatment as first treatment. We stratified all analyses by age (<45, ≥45 years old), used generalized linear models with a log link and Poisson error distribution, included an interaction term between race and anemia, and used recycled predictions to estimate adjusted percentages for outcomes. RESULTS: There was evidence of effect modification by anemia for receipt of any treatment but not for any other outcomes. Across age and anemia sub-groups, Black veterans were less likely to receive any treatment than White veterans. Adjusted racial differences were most pronounced among veterans with anemia (<45 years, Black-White difference = -10.3 percentage points; 95% confidence interval, -15.9 to -4.7; ≥45 years, Black-White difference = -20.3 percentage points; 95% confidence interval, -27.8 to -12.7). Across age groups, Black veterans were less likely than White veterans to have hysterectomy and more likely to have a fertility-sparing treatment as their first treatment. CONCLUSIONS: We identified significant Black-White disparities in receipt of treatment for symptomatic uterine fibroids. Additional research that centers the experiences of Black veterans with uterine fibroids is needed to inform strategies to eliminate racial disparities in uterine fibroid care.

Getting our hopes up: How actors perceive network effectiveness and why it matters.

Health care's grand challenges, such as continuously increasing costs, challenge the sustainability of health systems. Purpose-oriented networks are considered a favorable mode of organization to address these grand challenges. Therefore, it is crucial that they are effective. While network effectiveness is a heavily theorized, multi-dimensional concept that is often measured as a perception of actors, little is known about how network actors perceive effectiveness in practice and how this influences their behavior. In this study, we explored how network actors perceive network effectiveness using 32 interviews with representatives from network member organizations and regulatory agencies actor, 28 h of network meeting observations, and 1.272 pages of documents such as meeting minutes and media outlets. Our results show that actors primarily see hard outcomes (e.g. changes in cost or quality of care) as effectiveness but given the temporal nature of these goals and difficulties quantifying them, they resort to the collaborative process as a proxy to assess effectiveness. Actors engage in networks to solve grand challenges. However, conforming to expectations and environmental pressures also play a substantial role for actors to (continue to) participate in networks. In the absence of hard outcomes, actors legitimize their continued participation in networks using the collaborative process of networks. Actors therefore take purpose-oriented networks for granted as a legitimate way of organizing. Besides attempting to solve grand challenges, networks thus also seem to be adopted because of powerful institutional rules that function as rationalized myths, to gain legitimacy. Future research should be aware of and further unravel the institutional pressures in networks.

Is the evidence-based medicine movement counter-productive: are randomised controlled trials the best approach to establish evidence in complex healthcare situations?

In the modern era, evidence-based medicine (EBM) has been embraced as the best approach to practising medicine, providing clinicians with 'objective' evidence from clinical research. However, for presentations with complex pathophysiology or from complex social environments, sometimes there remains no evidence, and no amount of research will obtain it. Yet, health researchers continue to undertake randomised controlled trials (RCT) in complex environments, ignoring the risk that participants' health may be compromised throughout the trial process. This paper examines the role of research that seeks to obtain evidence to support EBM. We provide examples of RCTs on ear disease in Aboriginal populations as a case-in-point. Decades of ear research have failed to yield statistically significant findings, demonstrating that when multiple factors are at play, study designs struggle to balance the known disease process drivers, let alone unknown drivers. This paper asks the reader to consider if the pursuit of research is likely to produce evidence in complex situations; or if perhaps RCTs should not be undertaken in these situations. Instead, clinicians could apply empirical evidence, tailoring treatments to individuals while taking into account the complexities of their life circumstances.