Power, policy, and transgender identities: A case study of gatekeeping by mental health professionals in accessing gender affirming surgeries in India.

BACKGROUND: Transgender individuals seeking gender-affirming surgeries (GAS) are often denied or delayed by mental health professionals (MHPs). Studies on the gatekeeping of GAS have been mainly conducted in the Global North and primarily focus on the perspectives of health professionals. This case study from India incorporates health professional, community, advocate, and activist perspectives to contribute new evidence about MHP gatekeeping in GAS. The study aims to examine the role of power and gender in MHP gatekeeping of GAS in India. METHODS: A qualitative multi-method case study including thematic analyses of key informant interviews (n = 9) and policy analysis using the policy triangle framework. RESULTS: Health professionals and transgender persons participate in the construction, performance, and reproduction of gender indicating the persistence of gender normativity in India which enables gatekeeping by MHPs. However, evidence suggests some signs of a change from binormativity to a culturally intelligible and historically familiar "trinormativity". CONCLUSION: To understand MHP gatekeeping, there is a need to contextualise this example of biopower within the larger social construction of gender within which MHPs operate. A transition from binormativity to "trinormativity" enables MHP gatekeeping of transgender persons seeking GAS. This risks creating new forms of gender-related oppression, such as new hierarchies and class differences between the gender binary and the "third gender".

Time is money: general practitioners' reflections on the fee-for-service system.

BACKGROUND: Fee-for-service is a common payment model for remunerating general practitioners (GPs) in OECD countries. In Norway, GPs earn two-thirds of their income through fee-for-service, which is determined by the number of consultations and procedures they register as fees. In general, fee-for-service incentivises many and short consultations and is associated with high service provision. GPs act as gatekeepers for various treatments and interventions, such as addictive drugs, antibiotics, referrals, and sickness certification. This study aims to explore GPs' reflections on and perceptions of the fee-for-service system, with a specific focus on its potential impact on gatekeeping decisions. METHODS: We conducted six focus group interviews with 33 GPs in 2022 in Norway. We analysed the data using thematic analysis. RESULTS: We identified three main themes related to GPs' reflections and perceptions of the fee-for-service system. First, the participants were aware of the profitability of different fees and described potential strategies to increase their income, such as having shorter consultations or performing routine procedures on all patients. Second, the participants acknowledged that the fees might influence GP behaviour. Two perspectives on the fees were present in the discussions: fees as incentives and fees as compensation. The participants reported that financial incentives were not directly decisive in gatekeeping decisions, but that rejecting requests required substantially more time compared to granting them. Consequently, time constraints may contribute to GPs' decisions to grant patient requests even when the requests are deemed unreasonable. Last, the participants reported challenges with remembering and interpreting fees, especially complex fees. CONCLUSIONS: GPs are aware of the profitability within the fee-for-service system, believe that fee-for-service may influence their decision-making, and face challenges with remembering and interpreting certain fees. Furthermore, the fee-for-service system can potentially affect GPs' gatekeeping decisions by incentivising shorter consultations, which may result in increased consultations with inadequate time to reject unnecessary treatments.

The cost of saying no: general practitioners' gatekeeping role in sickness absence certification.

BACKGROUND: General practitioners (GPs) have an important gatekeeping role in the Norwegian sickness insurance system. This role includes limiting access to paid sick leave when this is not justified according to sick leave criteria. 85% of GPs in Norway operate within a fee-for-service system that incentivises short consultations and high service provision. In this qualitative study, we explore how GPs practise the gatekeeping role in sickness absence certification. METHODS: Qualitative data was collected through six focus group interviews with 33 GPs, working in practices with a minimum of four practising GPs, in different geographical regions across Norway, including both urban and rural areas. Data was analysed using Braune and Clarke's thematic analysis approach. RESULTS: Our results indicate that GPs' sick-listing decisions are largely driven by patient demand and preferences for sick leave. GPs reported that they rarely overrule patient requests for sickness absence, including in cases where such requests conflict with the GPs' opinion of whether sick leave is justified or benefits the patient. The degree of effort made to limit unjustified or non-beneficial sick leave seems to depend on the GPs' available time and perceived risk of conflict with the patient. GPs generally expressed dissatisfaction with their role as certifiers of sickness absence. CONCLUSION: Our study suggests that GPs' decisions about sickness certification is largely driven by patient preferences. The GPs' gatekeeping function is limited to negotiations about grade and duration of absence spells.

Introducing a gatekeeping system for amyloid status assessment in mild cognitive impairment.

BACKGROUND: In patients with mild cognitive impairment (MCI), enhanced cerebral amyloid-ß plaque burden is a high-risk factor to develop dementia with Alzheimer's disease (AD). Not all patients have immediate access to the assessment of amyloid status (A-status) via gold standard methods. It may therefore be of interest to find suitable biomarkers to preselect patients benefitting most from additional workup of the A-status. In this study, we propose a machine learning-based gatekeeping system for the prediction of A-status on the grounds of pre-existing information on APOE-genotype 18F-FDG PET, age, and sex. METHODS: Three hundred and forty-two MCI patients were used to train different machine learning classifiers to predict A-status majority classes among APOE-ε4 non-carriers (APOE4-nc; majority class: amyloid negative (Aß-)) and carriers (APOE4-c; majority class: amyloid positive (Aß +)) from 18F-FDG-PET, age, and sex. Classifiers were tested on two different datasets. Finally, frequencies of progression to dementia were compared between gold standard and predicted A-status. RESULTS: Aß- in APOE4-nc and Aß + in APOE4-c were predicted with a precision of 87% and a recall of 79% and 51%, respectively. Predicted A-status and gold standard A-status were at least equally indicative of risk of progression to dementia. CONCLUSION: We developed an algorithm allowing approximation of A-status in MCI with good reliability using APOE-genotype, 18F-FDG PET, age, and sex information. The algorithm could enable better estimation of individual risk for developing AD based on existing biomarker information, and support efficient selection of patients who would benefit most from further etiological clarification. Further potential utility in clinical routine and clinical trials is discussed.

Barriers and Facilitators to Adolescent and Young Adult Cancer Trial Enrollment: NCORP Site Perspectives.

Background: Although it is well documented that adolescents and young adults (AYAs) with cancer have low participation in cancer clinical trials (CCTs), the underlying reasons are not well understood. We used the National Cancer Institute Community Oncology Research Program (NCORP) network to identify barriers and facilitators to AYA CCT enrollment, and strategies to improve enrollment at community-based and minority and/or underserved sites. Methods: We performed one-on-one semistructured qualitative interviews with stakeholders (NCORP site principle investigators, NCORP administrators, physicians involved in enrollment, lead clinical research associates or clinical research nurses, nurse navigators, regulatory research associates, patient advocates) in the AYA CCT enrollment process. NCORP sites that included high and low AYA-enrolling affiliate sites and were diverse in geography and department representation (eg, pediatrics, medical oncology) were invited to participate. All interviews were recorded and transcribed. Themes related to barriers and facilitators and strategies to improve enrollment were identified. Results: We conducted 43 interviews across 10 NCORP sites. Eleven barriers and 13 facilitators to AYA enrollment were identified. Main barriers included perceived limited trial availability and eligibility, physician gatekeeping, lack of provider and research staff time, and financial constraints. Main facilitators and strategies to improve AYA enrollment included having a patient screening process, physician endorsement of trials, an "AYA champion" on site, and strong communication between medical and pediatric oncology. Conclusions: Stakeholders identified several opportunities to address barriers contributing to low AYA CCT enrollment at community-based and minority and/or underserved sites. Results of this study will inform development and implementation of targeted interventions to increase AYA CCT enrollment.

Phone triage nurses' assessment of respiratory tract infections - the tightrope walk between gatekeeping and service providing. A qualitative study.

BACKGROUND: Phone nurses triage callers to Norwegian out-of-hours cooperatives to estimate the appropriate urgency and level of care for the caller. Many callers with mild symptoms of respiratory tract infections receive a doctor's consultation, which may lead to busy sessions and in turn impair clinical decisions. OBJECTIVE: This study explores how phone triage nurses assess callers with mild-to-moderate symptoms of respiratory tract infections and their views and experiences on triaging and counselling these callers. METHODS: We conducted four focus groups with 22 nurses (five men and 17 women aged 24-66 years) in three different locations in Norway. The interviews were transcribed verbatim and analysed by systematic text condensation. RESULTS: The informants were reluctant to call themselves gatekeepers. However, their description of their work indicates that they practice such a role. When nurses and callers disagreed about the right level of care, the informants sought consensus through strategies and negotiations. The informants described external factors such as organisational or financial issues as decisive for the population's use of out-of-hours services. They also described callers' characteristics, such as language deficiency and poor ability to describe symptoms, as determining their own clinical assessments. CONCLUSIONS: Nurses perceive assessments of callers with respiratory tract infections as challenging. They need skills and time to reach a consensus with the callers and guide them to the right level of health care. This should be considered when planning nurse training and staffing of out-of-hours cooperatives.KEY-POINTSPhone triage nurses assess callers to the out-of-hours service and estimate the level of urgencyThis study explores how phone triage nurses assess callers with respiratory tract infections and their views and experiences on this taskThe nurses describe their professional role as a tightrope walk between gatekeeping and service providingThe nurses seek consensus with callers through strategies and negotiations.

Delayed healthcare access among victims of sexual abuse, understood through internal and external gatekeeping mechanisms.

BACKGROUND: Sexual abuse is associated with severe health consequences, and the European Union has, through the Istanbul Convention, urged its member countries to provide specialist care for victims of sexual abuse. AIM: This aim of this study was to investigate patient- and abuse-related characteristics among patients seeking help at a specialist clinic in Sweden, with focus on disclosure, mental health and appropriate healthcare access. METHODS: This is a descriptive study where journal data from 100 consecutive patients January 2017 to February 2018 were analyzed. All adult individuals (women n = 80, men n = 8) who had taken part in the standardized semi-structured intake interview at the clinic were included (n = 88). RESULTS: At admission, mean age was 40.3 (SD 11.9), mean number of psychiatric diagnoses 6.3 (2.6), and 93% of the patients scored above cut-off (≥34) on IES-R for PTSD. A majority of the patients (87%) had been exposed to childhood sexual abuse (CSA), and mean time to first disclosure was 15.9 (SD 15.3) years. In total, 82% of the patients had, despite disclosure, experienced difficulties accessing appropriate healthcare before coming to the specialist clinic. CONCLUSION: Adult victims of sexual abuse have difficulties accessing appropriate healthcare. This constitutes a gender-based equality problem. A model of gatekeeping mechanisms with two dimensions (external and internal) and three categories (Competence related, Organizational and Emotional) is proposed to understand these difficulties.

Effectiveness of primary care gatekeeping: difference-in-differences evaluation of a pilot scheme in China.

INTRODUCTION: This paper evaluates the effectiveness of a gatekeeping pilot in shifting resources and patient visits from hospitals to primary care facilities under the Chinese New Rural Cooperative Medical Scheme. METHODS: We applied a difference-in-differences regression analysis using claims data from a pilot district in northern China. The study covered 200 685 enrollees in 17 townships in 2012 and followed-up the townships over 12 year-quarters until the end of 2014. RESULTS: The gatekeeping pilot led to significantly more patients visiting primary care facilities (55.3%, p=0.001), but there was little evidence of increased ambulatory spending on primary care (1.6%, p=0.884). The pilot reduced hospital visits by 23.9% (p=0.048) and ambulatory spending at the hospitals by 22.4% (p=0.011). CONCLUSIONS: This first impact evaluation of gatekeeping outside high-income countries found that gatekeeping policy did not seem to have expanded the care provided by primary care facilities, despite an increased volume of claimed visits. Although claimed patient visits and expenditure at hospitals reduced, we suspect this may have been because patients found it either cumbersome or difficult to obtain reimbursement for their care.

Using ex-ante economic evaluation to inform research priorities in pesticide self-poisoning prevention: the case of a shop-based gatekeeper training programme in rural Sri Lanka.

OBJECTIVES: Suicide by pesticide self-poisoning is a major public health challenge in low- and middle-income countries. While effectiveness studies are required to test alternative prevention approaches, economic evidence is lacking to inform decision-making in research priority setting. Therefore, this study aimed to estimate the costs of a shop-based gatekeeper training programme for pesticide vendors seeking to prevent pesticide self-poisoning in rural Sri Lanka and assess its potential for cost-effectiveness. METHODS: Ex-ante cost and cost-effectiveness threshold (CET) analyses were performed from a governmental perspective based on a three-year analytic horizon, using 'no programme' as a comparator. A programme model targeting all 535 pesticide shops in the North Central Province and border areas was applied. Total programme costs (TPC) were estimated in 2019 USD using an ingredients approach and 3% annual discounting. The Sri Lankan gross domestic product per capita and life years saved were used as CET and effectiveness measure, respectively. Sensitivity analyses were performed. RESULTS: TPC were estimated at 31 603.03 USD. TPC were sensitive to cost changes of training material and equipment and the programme lifetime. The programme needs to prevent an estimated 0.23 fatal pesticide self-poisoning cases over three years to be considered cost-effective. In the sensitivity analyses, the highest number of fatal cases needed to be prevented to obtain cost-effectiveness was 4.55 over three years. CONCLUSIONS: From an economic perspective, the programme has a very high potential to be cost-effective. Research assessing its effectiveness should therefore be completed, and research analysing its transferability to other settings prioritised.

OBJECTIFS: Le suicide par auto-intoxication par les pesticides est un défi majeur de santé publique dans les pays à revenu faible ou intermédiaire. Bien que des études d'efficacité soient nécessaires pour tester d'autres approches de prévention, les données économiques manquent pour informer la prise de décision dans les priorités de recherche. Par conséquent, cette étude visait à estimer les coûts d'un programme de formation des vendeurs dans les magasins de pesticides visant à prévenir l'auto-intoxication par les pesticides dans les régions rurales du Sri Lanka et à évaluer son potentiel de rentabilité. MÉTHODES: Les analyses ex-ante des coûts et des seuils de rentabilité (SR) ont été réalisées dans une perspective gouvernementale sur la base d'un horizon analytique de trois ans, en utilisant «l'absence de programme¼ comme comparateur. Un modèle de programme ciblant les 535 magasins de pesticides de la province du Centre-Nord et des zones frontalières a été appliqué. Les coûts totaux du programme (CTP) ont été estimés en USD 2019 en utilisant une approche d'ingrédients et une remise annuelle de 3%. Le produit intérieur brut sri-lankais par habitant et les années de vie sauvées ont été utilisés comme SR et mesure d'efficacité, respectivement. Des analyses de sensibilité ont été effectuées. RÉSULTATS: le CTP a été estimé à 31.603,03 USD. Le CTP était sensible aux changements de coût du matériel et de l'équipement de formation et de la durée de vie du programme. Le programme devrait prévenir environ 0,23 cas d'auto-intoxication mortelle par des pesticide sur trois ans pour être considéré comme rentable. Dans les analyses de sensibilité, le plus grand nombre de cas mortels à prévenir pour obtenir une rentabilité était de 4,55 sur trois ans. CONCLUSIONS: D'un point de vue économique, le programme a un potentiel très élevé pour être rentable. La recherche évaluant son efficacité doit donc être complétée et la recherche analysant sa transférabilité à d'autres contextes doit être priorisée.

Regional and patient-related factors influencing the willingness to use general practitioners as coordinators of the treatment in northern Germany - results of a cross-sectional observational study.

BACKGROUND: In most countries, the general practitioner (GP) is the first point of contact in the healthcare system and coordinator of healthcare. However, in Germany it is possible to consult an outpatient specialist even without referral. Coordination by a GP might thus reduce health expenditures and inequalities in the healthcare system. The study describes the patients' willingness/commitment to use the GP as coordinator of healthcare and identifies regional and patient-related factors associated with the aforementioned commitment to the GP. METHODS: Cross-sectional observational study using a standardised telephone patient survey in northern Germany. All counties and independent cities within a radius of 120 km around Hamburg were divided into three regional categories (urban areas, environs, rural areas) and stratified proportionally to the population size. Patients who had consulted the GP within the previous three months, and had been patients of the practice for at least three years were randomly selected from medical records of primary care practices in these districts and recruited for the study. Multivariate linear regression models adjusted for random effects at the level of federal states, administrative districts and practices were used as statistical analysis methods. RESULTS: Eight hundred eleven patients (25.1%) from 186 practices and 34 administrative districts were interviewed. The patient commitment to a GP attained an average of 20 out of 24 possible points. Significant differences were found by sex (male vs. female: + 1.14 points, p < 0.001), morbidity (+ 0.10 per disease, p = 0.043), education (high vs. low: - 1.74, p < 0.001), logarithmised household net adjusted disposable income (- 0.93 per step on the logarithmic scale, p = 0.004), regional category (urban areas: - 0.85, p = 0.022; environs: - 0.80, p = 0.045) and healthcare utilisation (each GP contact: + 0.30, p < 0.001; each contact to a medical specialist: - 0.75, p = 0.018). Professional situation and age were not significantly associated with the GP commitment. CONCLUSION: On average, the patients' commitment to their GP was relatively strong, but there were large differences between patient groups. An increase in the patient commitment to the GP could be achieved through better patient information and targeted interventions, e.g. to women or patients from regions of higher urban density. TRIAL REGISTRATION: The study was registered in ClinicalTrials.gov (NCT02558322).

How does the integration of collaborative care elements in a gatekeeping system affect the costs for mental health care in Germany?

Mental disorders are widespread, debilitating and associated with high costs. In Germany, usual care (UC) for mental disorders is afflicted by poor coordination between providers and long waiting times. Recently, the primary alternative to UC-the gatekeeping-based general practitioners (GP) program-was extended by the collaborative Psychiatry-Neurology-Psychotherapy (PNP) program, which is a selective contract designed to improve mental health care and the allocation of resources. Here, we assess the effects of the GP program and the PNP program on costs for mental health care. We analyzed claims data from 2014 to 2016 of 55,472 adults with a disorder addressed by PNP to compare costs and sick leave days between PNP, the GP program and UC. The individuals were grouped and balanced via entropy balancing to adjust for potentially confounding covariates. We employed a negative binomial model to compare sick leave days and two-part models to compare sick pay, outpatient, inpatient and medication costs over a 12-month period. The PNP program significantly reduced sick pay by 164€, compared to UC, and by 177€, compared to the GP program. Consistently, sick leave days were lower in PNP. We found lower inpatient costs in PNP than in UC (-194€) and in the GP program (-177€), but no reduction in those shares of inpatient costs that accrued in psychiatric or neurological departments. Our results suggest that integrating collaborative care elements in a gatekeeping system can favourably impact costs. In contrast, we found no evidence that the widely implemented GP program reduces costs for mental health care.

Integration vs separation in the provision of health care: 24 OECD countries compared.

This article proposes a classification of the different national health care systems based on the way the network of health care providers is organised. To this end, we present two rivalling models: on the one hand, the integrated model and, on the other, the separated model. These two models are defined based on five dimensions: (1) integration of insurer and provider; (2) integration of primary and secondary care; (3) presence of gatekeeping mechanisms; (4) patient's freedom of choice; and (5) solo or group practice of general practitioners. Each of these dimensions is applied to the health care systems of 24 OECD countries. If we combine the five dimensions, we can arrange the 24 national cases along a continuum that has the integrated model and the separated model at the two opposite poles. Portugal, Spain, New Zealand, the UK, Denmark, Ireland and Israel are to be considered highly integrated, while Italy, Norway, Australia, Greece and Sweden have moderately integrated provision systems. At the opposite end, Austria, Belgium, France, Germany, the Republic of Korea, Japan, Switzerland and Turkey have highly separated provision systems. Canada, The Netherlands and the United States can be categorised as moderately separated.

Perspectives of individuals receiving occupational therapy services through the National Disability Insurance Scheme: Implications for occupational therapy educators.

INTRODUCTION: With the introduction of the National Disability Insurance Scheme (NDIS) in Australia, occupational therapy graduates need to be adequately prepared to support service users in this new policy context. There is, however, limited research informed by service users themselves to inform contemporary occupational therapy curriculum redesign. The aims of this study were: (a) to explore the experience of occupational therapy service provision from the perspective of service users with lived experience of disability; (b) to gain an understanding of the perceptions of people with lived experience of disability regarding the NDIS and whether it will change how they work with occupational therapists; (c) to gain an understanding of the perspectives of people with lived experience of disability regarding the NDIS, and how this influences curriculum content for occupational therapy education. METHODS: A pragmatic qualitative design, underpinned by the constructivist paradigm was utilised. Demographic surveys and semi-structured interviews were completed with 10 participants who were purposively recruited. Peer debriefing and use of an audit trail were undertaken to enhance the rigour of the analysis. RESULTS: Three themes were identified: (a) Occupational therapists as gatekeepers for equipment provision; (b) experience of the NDIS (Knowledge and understanding of the NDIS; Uncertainty regarding the NDIS; Choice and control in the NDIS); (c) curriculum content for occupational therapy. CONCLUSION: The insights provided by the people with lived experience in this study inform key areas of focus for occupational therapy curriculum to adequately prepare graduates to work in the evolving NDIS environment. Involving service users in an authentic manner in curriculum design, content delivery and student assessment is crucial for "real-world" applicability of student education.

Impact of integrated healthcare: Taiwan's Family Doctor Plan.

Integration of health services has been pursued worldwide. Diversity in integration approaches and in the contexts in which integrated programmes operate, however, hinders comparative analysis of care integration in both high-income countries (HICs) and low- and middle-income countries (LMICs). This study evaluates an HIC programme implemented in a delivery system resembling those of LMICs, especially its weak primary care system. The programme, Taiwan's Family Doctor Plan (FDP), targets high-cost and chronic patients, incorporating key elements of integrated care, viz., case management, multidisciplinary teams and care pathways. This study estimates the effects of shifting from usual to integrated care and locates contextual factors that may distort programme implementation. To estimate programme effects, difference-in-differences analysis is applied to a balanced panel comprising >160 000 patients over 2009-13. Because physician participation is voluntary, a propensity score matching method is used to match providers. The research findings reveal that introduction of the FDP has not reoriented the model of care from fragmented towards integrated health services. It reduces continuity of care and has no effect on co-ordination of care. Regarding quality of care, the FDP is shown to have no effect on avoidable admissions and increases drug injections and emergency department visits. Several contextual factors may serve as barriers that impede elements of FDP from generating desirable outcomes. These include absence of registration and gatekeeping systems; limited capacities of clinics; and preponderance of fee-for-service remuneration. These findings suggest that HIC design elements may not be directly transferrable to settings with weak primary care systems, as is typical of LMIC healthcare. Changes at the system level, such as establishing regular sources of care, may be necessary before elements of integrated care are introduced to a weaker primary care system.

The influence of general practitioners on access points to health care in a system without gatekeeping: a cross-sectional study in the context of the QUALICOPC project in Austria.

AIM: To assess the rates of specialist visits and visits to hospital emergency departments (ED) among patients in Austria with and without concurrent general practitioner (GP) consultation and among patients with and without chronic disease. METHODS: The cross-sectional questionnaire study was conducted in the context of the QUALICOPC project in 2012. Fieldworkers recruited 1596 consecutive patients in 184 GP offices across Austria. The 41-question survey addressed patients' experiences with regard to access to, coordination, and continuity of primary care, as well demographics and health status. Descriptive statistics as well as univariate and multivariate regression models were applied. RESULTS: More than 90% of patients identified a GP as a primary source of care. Among all patients, 85.5% reported having visited a specialist and 26.4% the ED at least once in the previous year. Having a usual GP did not change the rate of specialist visits. Additionally, patients with chronic disease had a higher likelihood of presenting to the ED despite having a GP as a usual source of care. CONCLUSION: Visiting specialists in Austria is quite common, and the simple presence of a GP as a usual source of care is insufficient to regulate pathways within the health care system. This can be particularly difficult for chronic care patients who often require care at different levels of the system and show higher frequency of ED presentations.

Shaping access to health care for refugees on the local level in Germany - Mixed-methods analysis of official statistics and perspectives of gatekeepers.

BACKGROUND: Analyses of refugee reception in European countries are increasingly focusing on the local level. We analyzed how gatekeepers can shape access to health care on a local level, taking as an example the federal state of North Rhine-Westphalia (NRW), Germany, where municipalities have implemented different local access models for newly arrived refugees. METHODS: We assessed the details of and the rationale for the implementation of local access models (implementation analysis), and the potential access to health care for refugees in municipalities (local policy analysis). We covered three municipalities with a health care voucher model and three with an electronic health card model. We combined data from official reports and semi-structured interviews (N = 21) with gatekeepers. RESULTS: Larger municipalities are more likely to implement the eHC. Gatekeepers report that costs, workload and control are the major aspects underlying the choice of a model in municipalities. Access plays only a minor role - even though some of the gatekeepers claim that the eHC can facilitate access. Regardless of the implemented model, gatekeepers on the local level can contribute to facilitating the access to health care for refugees. CONCLUSION: Potential access of newly arrived refugees is - among others - determined by the gatekeepers' support and the implementation of the access models. Within the legal framework, municipalities implement the models differently.

Reply to 'Hormone replacement therapy: informed consent without assessment?'

In a previous article, I argued that assessment requirements for transgender hormone replacement therapy (HRT) are unethical and dehumanising. A recent response published by the Journal of Medical Ethics criticises this proposal. In this reply, I advance that their response misunderstood core parts of my argument and fails to provide independent support for assessment requirements. Though transition-related care may have similarities with cosmetic surgeries, this does not suffice to establish a need for assessments, and nor do the high rates of depression and anxiety justify assessments, especially given the protective role HRT plays towards mental well-being.

The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care.

BACKGROUND: Research guidelines generally recognize vulnerable populations to include neonates with the aim of enhancing protections from harm. In practice, such guidance results in limiting participation in randomized clinical trials (RCTs). Yet while medical care of neonates should be based on best research evidence to ensure that safe, efficacious treatment or procedures are used, this seldom happens in contemporary practice. DISCUSSION: The compelling need to generate information on effectiveness and safety of procedures and medications that are already in use during neonatal care has led to increase in calls for pragmatic randomized clinical trials (PCTs). This raises ethical concerns as to whether exclusion of the vulnerable populations from research participations constitutes harm. First, neonates are denied access to both potentially beneficial research outputs and an opportunity to generate data on how interventions or medications perform in diverse clinical settings and inform clinical decision-making. Secondly, risks and harms in PCTs may differ from traditional RCTs, and can be reduced by modifications in study designs. The latter may involve assessment of effectiveness of comparable medication, devices or practices (whose safety data is available), randomization at the group level rather than at the individual level, avoidance of invasive and innovative study procedures, reliance on locally available data on relevant patient outcomes, and employment of procedures that tend to meet the criteria of minimal risk for human subject research. Thirdly, informed consent procedures should be modified from those of traditional RCTs, as neonates in traditional RCTs may be vulnerable to different extents in PCTs. Lastly, regulatory and oversight procedures designed for traditional RCT settings need modification, as they may not be translatable, feasible, appropriate or even ethical to apply in PCTs. CONCLUSION: The principle of justice, commonly interpreted as preventing an inequitable burden of research, should also allow fair access to potential benefits from PCTs for neonates and other vulnerable populations. Under certain conditions, prospective randomized trials involving neonates should be ethically permissible to allow inclusion of neonates in research. This may require modification of the research design, consent procedures or regulations for research oversight.