Invisibilização e preconceitos velados: barreiras para o acesso aos serviços de atenção básica pela população trans / Invisibilization and veiled prejudices: barriers to access to primary care services for the transgender population / Invisibilización y prejuicios velados: barreras para el acceso de la población trans a los servicios de atención primaria

Introdução: No processo de edificação da Política Nacional de Saúde Integral LGBT+, a Atenção Básica ganha importante destaque, pois deveria funcionar como o contato preferencial dos usuários transgênero (trans). Objetivo: Investigar quais as percepções dos profissionais da Atenção Básica quanto às situações de vulnerabilidade enfrentadas pelas pessoas trans, bem como pesquisar os impedimentos que eles consideram existir na busca dessa população por acesso a esses serviços. Métodos: Utilizou-se uma abordagem qualitativa por meio de entrevistas semiestruturadas com 38 profissionais de saúde atuantes das Estratégias Saúde da Família de dois municípios do interior do estado de São Paulo. O material obtido foi submetido à análise de conteúdo de Bardin. Resultados: Os resultados apontaram para o desconhecimento quanto aos reais empecilhos que dificultam o acesso e seguimento de pessoas trans nos serviços de saúde. Observou-se ainda a manutenção de preconceitos e ideias que reforçam estereótipos ligados ao tema e que se estendem ao exercício da profissão. Isso se relaciona diretamente com a falta da abordagem de assuntos relacionados à sexualidade humana na graduação desses profissionais, além da falta de atualização quanto ao tema, o que impacta a qualidade do serviço que é ofertado à população em estudo. Conclusões: As normativas e portarias já existentes precisam ser efetivamente postas em prática, fazendo-se imperativas a ampliação e difusão do conhecimento a respeito da temática trans no contexto dos serviços públicos de saúde, o que pode servir como base para subsidiar a formação dos profissionais que atuam nesse setor, bem como políticas públicas efetivas.

Introduction: In the process of creating the National LGBT+ Comprehensive Health Policy, primary care has important prominence as it must work as the preferential contact of transgender (trans) users. Objective: To investigate the perceptions of primary care professionals about the vulnerability situations faced by trans persons and also hindrances they consider existing in this population's search for access to these services. Methods: A qualitative approach was used through semi-structured interviews with 38 health care professionals working in the Family Health Strategy of two cities in the countryside of the state of São Paulo. The material obtained was submitted to analysis of Bardin content. Results: The results pointed to a lack of knowledge about real hindrances that obstruct the access to and follow-up by health services for trans persons. It was also observed the maintenance of prejudices and ideas that reinforce stereotypes connected to the matter and extend to the practice of professionals. It is directly related to the lack of approach of issues related to human sexuality in the education of those professionals, in addition to lack of update about it, which impacts the quality of service offered to the population under study. Conclusions: The standards and ordinances already existing need to be effectively practiced, being crucial the extension and spread of knowledge about trans matters in the context of public health services. It can be the basis for subsidizing the education of professionals who work in this field, as well as effective public policies.

Introducción: En el proceso de edificación de la Política Nacional de Salud Integral LGBT+, la Atención Básica tiene importante destaque, pues debería funcionar como contacto preferente de los usuarios transgénero (trans). Objetivo: Investigar las percepciones de los profesionales de Atención Básica sobre las situaciones de vulnerabilidad que enfrentan las personas trans, así como investigar los impedimentos que consideran que existe en la búsqueda de esta población por el acceso a estos servicios. Métodos: Se utilizó un abordaje cualitativo por medio de entrevistas semiestructuradas con 38 profesionales de salud actuantes de las Estrategias de Salud de la Familia de dos municipios del interior del estado de São Paulo. El material obtenido fue sometido a análisis de contenido de Bardin. Resultados: Los resultados apuntaron al desconocimiento sobre los reales obstáculos que dificultan el acceso de personas trans a los servicios, además del segmento de los cuidados en las unidades. Se observó además que se mantienen los prejuicios e ideas que refuerzan estereotipos vinculados al tema y que se extienden al ejercicio de la profesión. Esto se relaciona directamente a la falta da abordaje de asuntos relacionados a la sexualidad humana en la graduación de estos profesionales, además de la falta de actualización sobre el tema, lo que impacta en la calidad del servicio que se ofrece a la población en estudio. Conclusiones: Las normas y ordenanzas ya existentes deben ser efectivamente puestas en práctica, por lo que es imperativo ampliar y difundir el conocimiento sobre la temática trans en el contexto de los servicios públicos de salud, que pueda servir de base para apoyar la formación de profesionales que actúan en este sector, así como políticas públicas efectivas.

Intrahospital Mortality Rate after the Implementation of the Second Phase of the Health Sector Reform in Comparison with Before that in Iran.

Background: The second phase of the health sector reform, called the Health Sector Evolution Plan (HSEP), has been implemented in Iran since 2014, aims to improve the equity and quality of health services. In the present study, we aimed to measure the trend of hospitalization and the crude intrahospital mortality rate from 1 year before the HSEP implementation (2013) to 5 years after the HSEP implementation (2018) in public hospitals compared with profit, nonprofit, and charity hospitals, which are affiliated with the Isfahan University of Medical Sciences (MUI). Methods: In a prospective, cross-sectional study, the data related to the frequency of hospitalized patients and intrahospital mortality during the time of hospitalization were collected through census sampling from 39 public hospitals as the exposed hospitals and 20 profit, nonprofit, and charity hospitals as the control hospitals. Results: After HSEP implementation, the frequency of hospitalization increased in public hospitals by 50.45% compared with the previous period. Although the crude intrahospital mortality rate increased from 12.61 to 12.93 per 1000 hospitalized patients (an increase of 2.54%) in public hospitals, the raise was not significant (P value = 0.348). The frequency of hospitalization increased in Social Security Organization's (SSO) hospitals as well as charity hospitals. However, the percent of decrease in the intrahospital mortality rates were -42.96%, -34.76%, and -18.47% in the private, charity, and SSO hospitals, respectively, but was not significant (P value > 0.05). Conclusions: The crude intrahospital mortality rates in public hospitals affiliated with MUI did not change significantly after the implementation of the HSEP.

"An Act of Complete Care": Provider Perspectives on Linking Maternal Contraceptive Care With Well-Baby Visits in Community Health Centers.

BACKGROUND: Short inter-pregnancy interval (IPI) is associated with adverse health outcomes for women and infants, and low-income women experience disproportionate rates of short IPI. An essential solution is providing postpartum (PP) women with timely contraceptive care. However, patient-centered approaches for facilitating care access are needed. OBJECTIVE: To explore Community Health Center (CHC) staff and provider perspectives on the implementation of a clinical trial offering co-scheduled well-infant/maternal contraceptive care for women with infants 0 to 6 months at the Well-Baby Visit (WBV). METHOD: Eighteen participants (providers, staff, and administrators) representing 7 diverse CHC sites in 2 U.S. states completed semi-structured telephone interviews. Audio-recordings were transcribed and analyzed using hybrid thematic analysis. RESULTS: Offering co-scheduled visits was perceived as beneficial for facilitating timely PP contraception, convenient care access, and encouraging family planning considerations during the PP period. However, provider and staff discomfort with initiating family planning and contraceptive care conversations at the WBV emerged as a salient barrier. CONCLUSION: Paired approaches to well-infant/maternal contraceptive care may promote increased access to timely contraception for PP women, possibly reducing unintended short IPI. Comprehensive training, ongoing support, and patient-centered implementation strategies tailored to context and developed with care team input are needed to ensure competency and comfortability with facilitating contraceptive care conversations at the WBV.

The Role of Family Medicine in Addressing the Maternal Health Crisis in the United States.

The United States (US) is experiencing a maternal health crisis, with high rates of maternal morbidity and mortality. The US has the highest rates of pregnancy-related mortality among industrialized nations. Maternal mortality has more than quadrupled over the last decades. Rural areas and minoritized populations are disproportionately affected. Increased pregnancy-care workforce with greater participation from family medicine, greater collaborative care, and adequate postpartum care could prevent many maternal deaths. However, more than 40% of birthing people in the US receive no postpartum care. No singular solutions can address the complex contributors to the current situation, and efforts to address the crisis must address workforce shortages and improve care during and after pregnancy. This essay explores the role family medicine (FM) can play in addressing the crisis. We discuss pregnancy care training in FM residencies as well as the threats posed by financial and medico-legal climates to the maternal health workforce. We explore how collaborative care models and comprehensive postpartum care may impact the maternal health workforce. Efforts and resources devoted to high impact solutions for which FM has considerable autonomy, including collaborative and postpartum care, are likely to have greatest impact.

Project GIVE: using a virtual genetics service platform to reduce health inequities and improve access to genomic care in an underserved region of Texas.

BACKGROUND: The utilization of genomic information to improve health outcomes is progressively becoming more common in clinical practice. Nonetheless, disparities persist in accessing genetic services among ethnic minorities, individuals with low socioeconomic status, and other vulnerable populations. The Rio Grande Valley (RGV) at the Texas-Mexico border is predominantly Hispanic/Latino with a high poverty rate and very limited access to genetic services. Funded by the National Center for Advancing Translational Sciences, Project GIVE (Genetic Inclusion by Virtual Evaluation) was launched in 2022 to reduce the time to diagnosis and increase provider knowledge of genomics in this region, with the goal of improving pediatric health outcomes. We describe our experience of establishing a virtual pediatric genomic service in this region to expeditiously identify, recruit, and evaluate pediatric patients with undiagnosed diseases. METHODS: We have utilized an innovative electronic health record (EHR) agnostic virtual telehealth and educational platform called Consultagene to receive referrals from healthcare providers in the RGV. Using this portal, genetic services, including virtual evaluation and genome sequencing (GS), are being delivered to children with rare diseases. The study has also integrated effective methods to involve and educate community providers through in-person meetings and Continuing Professional Education (CPE) events. RESULTS: The recruitment efforts have proven highly successful with the utilization of Consultagene in this medically underserved region. The project's ongoing engagement efforts with local healthcare providers have resulted in progressively more referrals to the study over time, thus improving inclusion and access to genomic care in the RGV. Additionally, the curated CPE content has been well received by healthcare providers in the region. CONCLUSIONS: Project GIVE study has allowed advanced genetic evaluation and delivery of GS through the virtual Consultagene portal, effectively circumventing the recognized socioeconomic and logistical barriers to accessing genetic services within this border community.

Beginning with the End in Mind: Creating a Practice that Centers Equity-Part 1.

The concept of equity recognizes historical and current barriers and promotes thriving for veterinary teams and people and animals in the community. Veterinary medicine lacks sociodemographic diversity; veterinarians and other team members who identify with systemically excluded groups offer valuable contributions but are at risk of workplace discrimination. Client families who face barriers for financial and other reasons are at risk of poor animal health and welfare outcomes, including separation from their animals. This article is part one of 2 articles reviewing how the concept of equity applies and could transform well-being in companion animal veterinary practice in North America.

Parents' use of the Internet and social media as a source of information on health and parenting. / Consulta de los padres a internet y redes sociales como fuente de información sobre salud y crianza infantil.

Introduction. The Internet and social media have revolutionized access to information on health and parenting issues. Virtual consultations are spreading worldwide, are increasing, and represent a challenge for professional practice. Objective. To characterize the use of the Internet and social media by mothers and fathers as a source of information on the health and parenting of their children. Population and methods. A descriptive, cross-sectional study in an outpatient pediatric center in the City of Buenos Aires to determine the online consultation habits of caregivers of healthy children or children with health problems. Results. Two hundred-one surveys were analyzed, and the answers were predominantly from mothers of healthy children; 70.6% search online for health and parenting topics; 80% consult more than once a month. Although 36% of the families use the information to complement the medical consultation, 95% would not replace the pediatric consultation with the online search. The participants are not in the habit of following official pages, nor do they tend to verify the veracity of the contents. The search topics are related to the child's age, and satisfaction with the information results are modified according to whether the child is healthy or has a health problem. Only 4.7% responded that the search always answers their questions. Conclusions. Caregivers frequently seek online parenting and health information, but the sources are not always reliable. Although consultation with pediatricians is not displaced, we need to know the impact of online information on health decision-making. Pediatricians can intervene and guide caregivers to safe sources.

Introducción. La llegada de internet y las redes sociales ha revolucionado el acceso a la información sobre temas de salud y crianza. Las consultas virtuales se extienden en el mundo, van en aumento y representan un desafío para el ejercicio profesional. Objetivo. Caracterizar el uso, por parte de madres y padres, de internet y redes sociales como fuente de información sobre la salud y/o crianza de sus hijos. Población y métodos. Estudio descriptivo, transversal en un centro pediátrico ambulatorio de la Ciudad Autónoma de Buenos Aires para conocer hábitos de consulta en línea de cuidadores de niños sanos o con problemas de salud. Resultados. Se analizaron 201 encuestas, respondidas predominantemente por madres de niños sanos. El 70,6 % realiza búsquedas en línea sobre temas de salud y/o crianza; de ellos, el 80 % consulta más de una vez al mes. Si bien el 36 % de las familias usa la información en forma complementaria a la consulta médica, el 95 % no reemplazaría la consulta pediátrica por la búsqueda en línea. Los participantes no tienen el hábito de seguir páginas oficiales ni suelen verificar la veracidad de los contenidos. Los temas de búsqueda se relacionan con la edad del niño y la satisfacción con los resultados de la información se modifican según el niño sea sano o tenga un problema de salud. Solo el 4,7 % respondió que la búsqueda siempre responde sus dudas. Conclusiones. Los cuidadores buscan información en línea sobre crianza y salud con alta frecuencia, pero las fuentes no siempre son confiables. Aunque la consulta con pediatras no se ve desplazada, desconocemos el impacto de la información en línea en la toma de decisiones sobre la salud. Los pediatras podemos intervenir y orientar hacia fuentes seguras.

Narrowing the Digital Divide: Framework for Creating Telehealth Equity Dashboards.

Telehealth presents both the potential to improve access to care and to widen the digital divide contributing to health care disparities and obliging health care systems to standardize approaches to measure and display telehealth disparities. Based on a literature review and the operational experience of clinicians, informaticists, and researchers in the Supporting Pediatric Research on Outcomes and Utilization of Telehealth (SPROUT)-Clinical and Translational Science Awards (CTSA) Network, we outline a strategic framework for health systems to develop and optimally use a telehealth equity dashboard through a 3-phased approach of (1) defining data sources and key equity-related metrics of interest; (2) designing a dynamic and user-friendly dashboard; and (3) deploying the dashboard to maximize engagement among clinical staff, investigators, and administrators.

A qualitative study of negative sociocultural experiences of accessing primary health care services among Africans from refugee backgrounds in Australia: implications for organisational health literacy.

BACKGROUND: Primary health care is the first point of contact for patients from refugee backgrounds in the Australian health system. Sociocultural factors, including beliefs and value systems, are salient determinants of health literacy and access to primary health care services. Although African refugees in Australia have diverse sociocultural backgrounds, little is known about the influence of sociocultural factors on their experiences of accessing primary health care services. Guided by the theoretical framework of access to health care, this study examined from the perspective of African refugees how culturally and religiously conditioned, constructed and bound health beliefs, knowledge and practices influence their experiences of access to, acceptance and use of primary health care services and information in Australia. METHODS: This exploratory, qualitative study involved 19 African refugees from nine countries living in New South Wales, Australia. Semi-structured interviews were conducted and recorded using Zoom software. The interviews were transcribed verbatim and analysed using a bottom-up thematic analytical approach for theme generation. RESULTS: Four main themes were identified. The themes included: participants' experiences of services as inaccessible and monocultural and providing information in a culturally unsafe and insensitive manner; the impact of the clinical care environment; meeting expectations and needs; and overcoming access challenges and reclaiming power and autonomy through familiar means. The findings generally support four dimensions in the access to health care framework, including approachability, acceptability, availability and accommodation and appropriateness. CONCLUSION: African refugees experience significant social and cultural challenges in accessing primary health care services. These challenges could be due to a lack of literacy on the part of health services and their providers in servicing the needs of African refugees. This is an important finding that needs to be addressed by the Australian health care system and services. Enhancing organisational health literacy through evidence-informed strategies in primary health systems and services can help reduce disparities in health access and outcomes that may be exacerbated by cultural, linguistic and religious differences.

Gender differences in cost-related unmet healthcare needs: a national study in Turkiye.

BACKGROUND: Unmet healthcare needs are a complex and multifaceted issue, influenced by individual, socioeconomic, and healthcare system factors. This study aimed to investigate the determinants influencing cost-related unmet healthcare needs within the Turkish population, emphasizing a comprehensive analysis of gender disparities in accessing healthcare services. METHODS: This secondary analysis scrutinizes the 2019 Turkiye Health Survey data of 16,976 individuals aged 15 and older. The dependent variables included cost-related unmet medical, dental, and prescribed medication, and mental services. The independent variables were considered under a three-domain approach for the determination of health service utilization, developed by Andersen. Logistic regression models with predisposing, enabling, and need factors were run for any self-perceived cost-related unmet need for each sex and overall population. Another six regression models for both sexes were run for each subgroup of indivuals with unmet healthcare needs. RESULTS: The study revealed that 15.4% of individuals cannot access healthcare due to financial constraints, with 16.8% for women and 13.5% for men. The highest level of unmet needs is associated with accessing dental care services for both sexes. According to multivariate analyses, the unmet need for both sexes decreases with older age and higher education level, and it is greater for those who have difficulties communicating in Turkish. By adding enabling and needs factors, the odds ratios of education decreased for men, while education became nonsignificant for women. Having chronic disease impacts unmet needs for both sexes. However, the inability to perform daily activities due to health problems was not a significant factor for men. Poorer household income increases overall unmet needs. Education is a determinant of both medical and mental care needs. CONCLUSIONS: This pioneering study illuminates the multifaceted gender disparities in cost-related unmet healthcare needs across Turkiye, reflecting the intertwined issues of access influenced by a complex interplay of factors. Our findings underscore the significance of adopting an intersectional approach to address health inequalities.

Low Serum Albumin Levels are Associated with Short-Term Recurrence of Arteriovenous Fistula Failure.

BACKGROUND: Vascular access intervention therapy (VAIVT) is widely used as a treatment for arteriovenous fistula (AVF) failure. However, recurrent AVF failure is a major concern for dialysis patients. By prospectively observing patients after an initial VAIVT, we attempted to identify risk factors for developing restenosis of AVF. METHODS: This single-center prospective study evaluated 57 patients who underwent their first VAIVT procedure at our hospital from April 2022 through March 2023. We performed blood and biochemical tests during the first VAIVT to collect data on clinical variables. Ultrasonography was used to measure vessel diameter reduction rate, flow volume (FV) reduction rate, and increase in resistance index (RI) rate over a 3-month period. RESULTS: Within 3 months, 24 patients developed short-term shunt stenosis and 30 did not. Three were not traceable. In a comparison of the two groups, significant differences were observed in albumin (ALB), FV, RI, and elbow shunt. Analysis of change rates in the three ultrasound findings identified five factors (hematocrit, platelet count, activated partial thromboplastin time, ALB, and FV). The results of logistic regression models revealed that ALB was the most significant predictive factor for short-term shunt stenosis (p = 0.031). CONCLUSION: In conclusion, our findings suggest that low serum ALB at the time of initial VAIVT is a significant risk factor for short-term recurrence of AVF failure in hemodialysis patients. These findings emphasize the importance of careful routine monitoring to reduce the risk of AVF failure and associated complications.

Using Text Messaging Surveys in General Practice Research to Engage With People From Low-Income Groups: Multi-Methods Study.

BACKGROUND: SMS text messages through mobile phones are a common means of interpersonal communication. SMS text message surveys are gaining traction in health care and research due to their feasibility and patient acceptability. However, challenges arise in implementing SMS text message surveys, especially when targeting marginalized populations, because of barriers to accessing phones and data as well as communication difficulties. In primary care, traditional surveys (paper-based and online) often face low response rates that are particularly pronounced among disadvantaged groups due to financial limitations, language barriers, and time constraints. OBJECTIVE: This study aimed to investigate the potential of SMS text message-based patient recruitment and surveys within general practices situated in lower socioeconomic areas. This study was nested within the Reducing Alcohol-Harm in General Practice project that aimed to reduce alcohol-related harm through screening in Australian general practice. METHODS: This study follows a 2-step SMS text message data collection process. An initial SMS text message with an online survey link was sent to patients, followed by subsequent surveys every 3 months for consenting participants. Interviews were conducted with the local primary health network organization staff, the participating practice staff, and the clinicians. The qualitative data were analyzed using constructs from the Consolidated Framework for Implementation Research. RESULTS: Out of 6 general practices, 4 were able to send SMS text messages to their patients. The initial SMS text message was sent to 8333 patients and 702 responses (8.2%) were received, most of which were not from a low-income group. This low initial response was in contrast to the improved response rate to the ongoing 3-month SMS text message surveys (55/107, 51.4% at 3 months; 29/67, 43.3% at 6 months; and 44/102, 43.1% at 9 months). We interviewed 4 general practitioners, 4 nurses, and 4 administrative staff from 5 of the different practices. Qualitative data uncovered barriers to engaging marginalized groups including limited smartphone access, limited financial capacity (telephone, internet, and Wi-Fi credit), language barriers, literacy issues, mental health conditions, and physical limitations such as manual dexterity and vision issues. Practice managers and clinicians suggested strategies to overcome these barriers, including using paper-based surveys in trusted spaces, offering assistance during survey completion, and offering honoraria to support participation. CONCLUSIONS: While SMS text message surveys for primary care research may be useful for the broader population, additional efforts are required to ensure the representation and involvement of marginalized groups. More intensive methods such as in-person data collection may be more appropriate to capture the voice of low-income groups in primary care research. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.3399/BJGPO.2021.0037.

Improving care and survival of newborns with surgical conditions in Tanzania (TINY Tanzania): a focus on gastroschisis.

PURPOSE: Gastroschisis is associated with over 90% mortality in many sub-Saharan African countries. The introduction of the Gastroschisis Care Bundle at Muhimbili National Hospital (MNH) increased survival up to 60%. We aim to explain the impact of using implementation science methods to decentralize the care of babies with gastroschisis to other parts of Tanzania. METHODS: We used a Step-Wedge Implementation Science design to scale up gastroschisis care through training of providers, dissemination and current revision of evidence-based care protocols, advocacy, and engagement with stakeholders. We used mixed methods for data collection. Anonymous patient and provider evaluation data were collected using a nationwide Gastroschisis Database via REDCap. We evaluated the implementation and effectiveness of the care bundle in different hospitals in Tanzania. RESULTS: Decentralizing care nationally was feasible, acceptable, and adaptable. A total of nine trainings have been conducted training 420 providers (14 Master Trainers) reaching seven regions of Tanzania. The three advocacy national campaigns have ensured community reach and patient engagement. A countrywide gastroschisis database was developed to collect data on patients with gastroschisis, hosted locally at MNH with 332 patients' data entered in 1 year. The majority (90.2%) were treated using preformed silo bags with an overall survival of 28.5% in all centers. Late presentation and infection remain to be the main challenge. CONCLUSION: To achieve quality and sustainable surgical care, there is a need to design, implement, evaluate, and continuously improve context-relevant strategies to achieve and sustain the survival of neonates with congenital anomalies. Decentralization enables clear connectedness of hospitals, bringing care closer to patients.

Peritoneal dialysis catheterization with an upward tunnel and exit site: An observational study.

BACKGROUND: The preferred techniques for peritoneal dialysis catheterization are uncertain. Catheter implantation with formation of an inferiorly-directed tunnel and exit site is widely recommended to reduce the risk of infective complications. We aimed to compare percutaneous peritoneal dialysis catheter insertion using an upwardly-directed tract to catheter insertion using a downwardly-directed tract. METHODS: A retrospective cohort study was performed on consecutive peritoneal dialysis catheterizations over a 10-year period at a single centre. Participants were classified into two groups: catheter insertion with an upward tunnel and exit site versus insertion with a downward tunnel and exit site. The primary outcome was peritoneal dialysis catheter survival. RESULTS: There were 247 peritoneal dialysis catheters inserted during the study period. The median catheter survival was 18 months, with no difference between the two groups (p = 0.23). The 12-month catheter patency rates were 76% for catheters with an upward tract and 79% for catheters with a downward tract (p = 0.15). Multivariate analysis identified no clinical factors predictive of catheter survival. A downward catheter tunnel and exit site was associated with an increased incidence of peritonitis (0.23 vs 0.11 episodes per year; p ⩽ 0.01). CONCLUSION: In this study, percutaneous peritoneal dialysis catheter insertion with an upward tunnel and exit site demonstrated similar catheter survival to insertion with a downward tunnel and exit site and was not associated with increased infections.

The importance of World Health Organization international reference standards in the product life cycle of biosimilars.

Technological advances in analytics, as well as scientific and regulatory knowledge and experience gained from biosimilar development/approvals over the last decade, enabled the World Health Organization (WHO) in 2022 to revise its guidelines on the evaluation of biosimilars. Among the revisions, there is more reliance on analytical and functional aspects to prove similarity (and likely fewer clinical requirements). WHO international reference standards for biosimilars provide additional confidence to regulators looking for evidence- and data-based regulatory convergence in scientific and technical measures of quality attributes. These standards serve as a benchmark for harmonizing the bioactivity or potency of biosimilars, ensuring their future sustainability. This article discusses the availability and role of WHO international reference standards throughout the product life cycle of biosimilars.

Impact of arteriovenous fistula aneurysms on a UK dialysis populations' perception of vascular access.

BACKGROUND: Clinically-oriented outcome measures are increasingly being recognized as lacking in consideration of factors important to patients. There is an emerging move of guideline bodies advocating a more patient-centred approach. Aneurysms in autogenous arteriovenous fistula (AVF) can be considered unsightly and a constant reminder for patients of their dependence on dialysis. However, their impact on patient's perception has not previously been reported. METHODS: Between April 2017-18, the Vascular Access Questionnaire (VAQ) was administered to prevalent haemodialysis patients across ten dialysis units via structured interviews, as part of a quality improvement project. Data for the subgroup of patients with aneurysmal AVF (categorised as per classification by Valenti et al.), were retrospectively evaluated and compared to the wider cohort. RESULTS: Data were collected for 539 patients (median age: 66 years; 59% male), of whom 195 (36%) had aneurysmal AVF, with Type 2 morphology (cannulation site) being the most common (75%). Duration of AVF was found to be significantly associated with aneurysmal development, with estimated likelihoods of 11%, 43% and 61% after one, five and ten years, respectively. Interestingly, patients with diabetes had a significantly lower prevalence of aneurysmal development than those that were non-diabetic (25% vs. 43%, p < 0.001). Overall VAQ scores were not found to differ significantly by aneurysm status (p = 0.816) or across morphology types (p = 0.277). However, patients with aneurysmal AVF were significantly more concerned with the appearance of their AVF (p < 0.001) than the wider cohort. Despite this, patients with aneurysmal AVF gave significantly higher scores for satisfaction and ease of use and lower scores for bruising and clotting (p < 0.05). CONCLUSIONS: Aneurysmal AVF are often cited as an important factor by patients for not proceeding with fistula formation. In this evaluation of patient reported experiences, those with aneurysmal AVF reported high satisfaction levels. This may help clinicians highlight positive patient reported outcomes of aneurysmal AVF during preprocedural consent processes.

A proposed method for identifying Interfacility transfers in Medicare claims data.

OBJECTIVE: To develop a method of consistently identifying interfacility transfers (IFTs) in Medicare Claims using patients with ST-Elevation Myocardial Infarction (STEMI) as an example. DATA SOURCES/STUDY SETTING: 100% Medicare inpatient and outpatient Standard Analytic Files and 5% Carrier Files, 2011-2020. STUDY DESIGN: Observational, cross-sectional comparison of patient characteristics between proposed and existing methods. DATA COLLECTION/EXTRACTION METHODS: We limited to patients aged 65+ with STEMI diagnosis using both proposed and existing methods. PRINCIPAL FINDINGS: We identified 62,668 more IFTs using the proposed method (86,128 versus 23,460). A separately billable interfacility ambulance trip was found for more IFTs using the proposed than existing method (86% vs. 79%). Compared with the existing method, transferred patients under the proposed method were more likely to live in rural (p < 0.001) and lower income (p < 0.001) counties and were located farther away from emergency departments, trauma centers, and intensive care units (p < 0.001). CONCLUSIONS: Identifying transferred patients based on two consecutive inpatient claims results in an undercount of IFTs and under-represents rural and low-income patients.

Internet access during COVID-19 and depressive symptoms in middle-aged and older adults: Evidence from a quasi-experimental study in China.

BACKGROUND: Amid the COVID-19 pandemic, the mental health of middle-aged and older adults has become an increasing concern, and the role of the internet in addressing this public health crisis has drawn the attention of researchers. This study evaluated the impact of internet access during COVID-19 on depressive symptoms among middle-aged and older adults. METHODS: Data were derived from China Health and Retirement Longitudinal Study (CHARLS) 2018 and 2020. Difference-in-differences analysis was performed to compare changes in depressive symptoms between the internet users during COVID-19 and those who didn't have access to the internet before and during the pandemic. RESULTS: We found that internet access during COVID-19 pandemic significantly reduced middle-aged and older adults' depressive symptoms. Further investigation identified the underlying mechanisms through which internet access helps in alleviating depressive symptoms by reducing the likelihood of experiencing negative emotions about COVID-19. Heterogeneity analyses showed that rural residents and middle-aged individuals benefited more from internet access during the pandemic. CONCLUSIONS: Since internet access can alleviate middle-aged and older adults' depressive symptoms amidst public health crisis, policy makers should focus on enhancing their access to the internet.

High-risk rural surgical patients and poor access to elective colorectal cancer surgery: insight for multilevel intervention for rural America.

BACKGROUND: Colorectal cancer (CRC) is a leading cause of death in rural America. Rural populations are large and heterogeneous, yet patient-related drivers of inequities in CRC access are understudied. This study aimed to identify vulnerable rural populations at lower odds of undergoing elective CRC surgery. METHODS: Evaluation of the Policy Map and United States Census Bureau identified factors associated with poor surgical access in the most populous states (by total rural population). To assess whether these identified factors were associated with reduced access to elective CRC surgery, the 2007 to 2020 National Inpatient Sample was used to evaluate 69,212 hospitalizations of rural patients undergoing CRC surgery. Rural was defined as counties with a population of <250,000. Multivariable logistic regression models assessed predictors of elective CRC surgery. Patient- and hospital-level factor interactions were specified a priori. RESULTS: More than 72% of hospitalizations of rural patients were elective. Multivariate regression analysis demonstrated that older age, multimorbidity, Black race, Latino-Hispanic ethnicity, Medicaid insurance, and rural hospitals predicted lower odds of elective CRC surgery. On interaction analyses, high-risk patients were less likely to undergo elective CRC surgery in urban facilities relative to rural. CONCLUSION: In this large study of rural dwellers, ethnoracial minorities, elders, and Medicaid beneficiaries had profoundly less access to elective CRC surgery, especially when care was received in urban settings. Future studies should focus on exploring actionable social drivers of health in these rural populations. Findings underscore the need for multilevel interventions to enhance rural access to equitable and quality surgical cancer care.