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.

BACKGROUND: The number of people living in a different place from their place of birth is increasing year by year. Although women have always been involved in migratory movements, today they are increasingly doing so independently. Women are migrating from the Global South to higher-income countries. One of the challenges they face is access to sexual and reproductive health (SRH) services.
OBJECTIVE: To identify the policy-level barriers that limit the access of migrant women to SRH services, their consequences, and strategies implemented to overcome these barriers.
METHODS: A systematic review of the literature was undertaken in accordance with the PRISMA statement. A search was undertaken for articles published between 2018 and 2023 focusing on migrant women\'s experiences of SRH services. In total, 462 articles were retrieved from PubMed (n = 135), Scopus (n = 94) and Web of Science (n = 233); of these, 28 articles were included in this review.
RESULTS: The most common barrier to SRH services identified in the reviewed articles was lack of information (57 %), followed by language issues (43 %), cultural differences (39 %), economic status (25 %), administrative barriers (25 %) and discrimination (14 %). These barriers led to under-utilisation of maternity services and contraceptive methods. Strategies used by migrant women to overcome these barriers were primarily based on seeking help within their own community or family settings.
CONCLUSIONS: Strategies at institutional level to improve the access of migrant women to SRH services need to reduce existing barriers, promote health literacy, and train health workers to be culturally sensitive and responsive to the needs of migrant women.

OBJECTIVE: Healthcare fraud comprises a sizable portion of United States healthcare expenditure and inflicts undue burden on payors, patients, and the healthcare system overall. The genetic testing industry is rapidly growing which propagates opportunities for healthcare fraud. Although federal organizations have highlighted it as an issue, there is limited research exploring genetic testing fraud.
METHODS: A retrospective review of federal websites, news articles, and a legal database resulted in 42 cases of fraud involving outpatient genetic testing published between February 2019 and December 2023. These cases were analyzed for themes via inductive conventional content analysis.
RESULTS: Themes of fraudulent activity included submission of fraudulent claims, kickback or bribe payments, minimal or no contact with patients for which testing was ordered, inappropriate billing and documentation practices, and further actions to conceal fraud. Repercussions imposed on defendants included monetary penalty, imprisonment, business restrictions, and seizure of property.
CONCLUSIONS: High rates of medically inappropriate testing in fraud cases highlight the value of genetics experts in ordering or reviewing claims for genetic testing. Examining fraudulent activity in genetic testing can help providers identify and report fraud, and provide awareness of optimal healthcare allocation in the genetic testing industry.

UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: The crude intrahospital mortality rates in public hospitals affiliated with MUI did not change significantly after the implementation of the HSEP.

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.
UNASSIGNED: RR2-10.3399/BJGPO.2021.0037.

BACKGROUND: Worldwide, the uptake of peritoneal dialysis (PD) compared with hemodialysis remains limited. This study assessed organizational structures, availability, accessibility, affordability and quality of PD worldwide.
METHODS: This cross-sectional study relied on data from kidney registries as well as survey data from stakeholders (clinicians, policymakers and advocates for people living with kidney disease) from countries affiliated with the International Society of Nephrology (ISN) from July to September 2022.
RESULTS: Overall, 167 countries participated in the survey. PD was available in 79% of countries with a median global prevalence of 21.0 [interquartile range (IQR) 1.5-62.4] per million population (pmp). High-income countries (HICs) had an 80-fold higher prevalence of PD than low-income countries (LICs) (56.2 pmp vs 0.7 pmp). In 53% of countries, adults had greater PD access than children. Only 29% of countries used public funding (and free) reimbursement for PD with Oceania and South East Asia (6%), Africa (10%) and South Asia (14%) having the lowest proportions of countries in this category. Overall, the annual median cost of PD was US$18 959.2 (IQR US$10 891.4-US$31 013.8) with full private out-of-pocket payment in 4% of countries and the highest median cost in LICs (US$30 064.4) compared with other country income levels (e.g. HICs US$27 206.0).
CONCLUSIONS: Ongoing large gaps and variability in the availability, access and affordability of PD across countries and world regions were observed. Of note, there is significant inequity in access to PD by children and for people in LICs.

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.
CONCLUSIONS: 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.

OBJECTIVE: This survey investigates natriuretic peptide (NP) testing in community and hospital settings, assessing awareness, accessibility, and utilization.
RESULTS: This investigator-initiated survey, conceived within the HFA of the European Society of Cardiology, comprised 14 questions. It underwent validation and pilot testing to ensure question readability and online system functionality. The survey was accessible for 87 days, from 5 April 2023 to 1 July 2023 via a web platform. There were 751 healthcare professionals across 99 countries who responded. Of them, 92.5% had access to NPs testing in hospital whereas 34.3% had no access to NTproBNP in community settings. Access to point of care NP testing was uncommon (9.6%). Public insurance fully covered NPs testing in 31.0% of cases, with private insurance providing coverage in 37.9%. The majority (84.0%) of participants believed that the medical evidence supporting NPs testing was strong, and 54.7% considered it cost-effective. Also, 35.8% found access, awareness, and adoption to be in favour of NPs testing both in hospital and community settings. Strategies to optimize NP testing involved regular guideline updates (57.9%), prioritizing NPs testing for dyspnoea assessment (36.4%), and introducing clinician feedback mechanisms (21.2%). Notably, 40% lacked a community-based HF diagnostic pathway for referring high-NP patients for echocardiography and cardiology evaluation.
CONCLUSIONS: This survey reveals NP awareness, access, and adoption across several countries. Highlighting the importance of community-based early heart failure diagnosis and optimizing HF diagnostic pathways remains a crucial, unmet opportunity to improve patient outcomes.

This study undertakes a scoping review of reviews on barriers to accessing mental health care for refugees and asylum seekers in high-income countries. By assessing mental health care access using the Levesque\'s conceptual framework, we identify barriers along the patient care pathway and highlight research gaps. Following PRISMA-ScR guidelines, 10 relevant systematic and scoping reviews were identified and analyzed. Seven common barriers were identified, that could be located across different stages of the conceptual framework. Demand-side barriers included: (1) refugees\' understanding of mental illness, (2) fear of stigma, (3) lack of awareness of services, (4) attitudes towards formal treatment; while supply-side barriers comprised: (5) language barriers, (6) practical and structural issues, and (7) providers\' attitudes and competence. There was a focus on demand-side barriers as key determinants for low service use. We observed a paucity of quantitative studies linking barriers and indicators of access to care. In the context of well-established mental health care systems, previous research has largely explained low access through peculiarities of refugees and asylum seekers, thereby neglecting the role of supply-side factors (including system structures and attitudes of service providers). We discuss how future research can critically question prevailing assumptions and contribute to rigorous evidence.

Despite a growing number of research outputs on the importance of nature contact during the COVID-19 pandemic, we know of no longitudinal research conducted prior to and during the pandemic among low-income and minority ethnicity populations, i.e. those that might be most affected. Furthermore, we have scant information about how and to what degree contact with nature might protect mental health or mitigate worsening of mental health during the pandemic. We filled these gaps using a subset of a longitudinal study of n = 86 individuals in low-income, predominantly African American, neighborhoods in Detroit, MI, USA. The study addressed the following research questions: 1) did self-reported use and perceived value of nature change during, versus prior to, the pandemic; 2) did perceived access to outdoor spaces buffer people against mental health issues such as stress, anxiety and depression symptoms; or 3) did objectively measured quality of nature views from home buffer people against mental health issues, taking into account relevant covariates and pandemic experiences (e.g., loss of employment, death of a friend/relative)? While attitudes to nature improved slightly from pre- to during the pandemic, we also observed significant decreases in most types of outdoor physical activity and passive enjoyment of nature (e.g., smelling plants/rain). We found a positive association between visibility of greenspace and perceived stress and anxiety, which not only contradicts previous research findings, but was especially surprising given that overall there was a decrease in perceived stress from 2019-2020. We did not detect associations between perceived access/use of nature and mental health. However, higher depressive symptoms were associated with exposure to more COVID-19-related stressors (lost employment, death of friends from COVID-19, etc.). Taken together, our results indicate that COVID-19 may serve to prolong or exacerbate mental health issues, rather than create them, in this population and that low quality greenspace may perhaps limit the ability for nature view to buffer mental health during the pandemic.