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Introduction: This study characterized the extent to which (1) financial barriers and (2) abortion care-seeking within a person's country of residence were associated with delays in abortion access among those travelling to England and the Netherlands for abortion care from European countries where abortion is legal on broad grounds in the first trimester but where access past the first trimester is limited to specific circumstances. Methodology: We drew on cross-sectional survey data collected at five abortion clinics in England and the Netherlands from 2017 to 2019 (n = 164). We assessed the relationship between difficulty paying for the abortion/travel, acute financial insecurity, and in-country care seeking on delays to abortion using multivariable discrete-time hazards models. Results: Participants who reported facing both difficulty paying for the abortion procedure and/or travel and difficulty covering basic living costs in the last month reported longer delays in accessing care than those who had no financial difficulty (adjusted hazard odds ratio: 0.39 95% CI 0.21–0.74). This group delayed paying other expenses (39%) or sold something of value (13%) to fund their abortion, resulting in ~ 60% of those with financial difficulty reporting it took them over a week to raise the funds needed for their abortion. Having contacted or visited an abortion provider in the country of residence was associated with delays in presenting abroad for an abortion. Discussion: These findings point to inequities in access to timely abortion care based on socioeconomic status. Legal time limits on abortion may intersect with individuals' interactions with the health care system to delay care. Plain Language Summary: This paper explores delays in accessing abortion care associated with financial and medical system barriers. We focus on residents of countries in Europe where abortion is available on broad grounds in the first trimester seeking abortion care outside of their country of residence. This study demonstrates an association between difficulty covering abortion costs for people facing financial insecurity and in-country care seeking and delays in accessing abortion abroad. Policy barriers, medical system barriers, as well as financial barriers may interact to delay access to care for people in European countries with broad grounds for abortion access in the first trimester but restrictions thereafter, especially for people later in pregnancy. [ABSTRACT FROM AUTHOR]

Introduction: Drug reimbursement decisions are often made based on a price set by the manufacturer. In some cases, this price leads to public and scientific debates about whether its level can be justified in relation to its costs, including those related to research and development (R&D) and manufacturing. Such considerations could enter the decision process in collectively financed health care systems. This paper investigates whether manufacturers' costs in relation to drug prices, or profit margins, are explicitly mentioned and considered by health technology assessment (HTA) organisations. Method: An analysis of reimbursement reports for cancer drugs was performed. All relevant Dutch HTA-reports, published between 2017 and 2019, were selected and matched with HTA-reports from three other jurisdictions (England, Canada, Australia). Information was extracted. Additionally, reimbursement reports for three cases of expensive non-oncolytic orphan drugs prominent in pricing debates in the Netherlands were investigated in depth to examine consideration of profit margins. Results: A total of 66 HTA-reports concerning 15 cancer drugs were included. None of these reports contained information on manufacturer's costs or profit margins. Some reports contained general considerations of the HTA organisation which related prices to manufacturers' costs: six contained a statement on the lack of price setting transparency, one mentioned recouping R&D costs as a potential argument to justify a high price. For the case studies, 21 HTA-reports were selected. One contained a cost-based price justification provided by the manufacturer. None of the other reports contained information on manufacturer's costs or profit margins. Six reports contained a discussion about lack of transparency. Reports from two jurisdictions contained invitations to justify high prices by demonstrating high costs. Conclusion: Despite the attention given to manufacturers' costs in relation to price in public debates and in the literature, this issue does not seem to get explicit systematic consideration in the reimbursement reports of expensive drugs. [ABSTRACT FROM AUTHOR]

Background: Lifestyle interventions targeting physical activity, sedentary time and dietary behaviours have the potential to initiate and support behavioural change and result in public health gain. Although men have often been reluctant to engage in such lifestyle programs, many are at high risk of several chronic conditions. We have developed an evidence and theory-based, gender sensitised, health and lifestyle program (European Fans in Training (EuroFIT)), which is designed to attract men through the loyalty they feel to the football club they support. This paper describes the study protocol to evaluate the effectiveness and cost-effectiveness of the EuroFIT program in supporting men to improve their level of physical activity and reduce sedentary behaviour over 12 months.Methods: The EuroFIT study is a pragmatic, two-arm, randomised controlled trial conducted in 15 football clubs in the Netherlands, Norway, Portugal and the UK (England). One-thousand men, aged 30 to 65 years, with a self-reported Body Mass Index (BMI) ≥27 kg/m(2) will be recruited and individually randomised. The primary outcomes are objectively-assessed changes in total physical activity (steps per day) and total sedentary time (minutes per day) at 12 months after baseline assessment. Secondary outcomes are weight, BMI, waist circumference, resting systolic and diastolic blood pressure, cardio-metabolic blood biomarkers, food intake, self-reported physical activity and sedentary time, wellbeing, self-esteem, vitality and quality of life. Cost-effectiveness will be assessed and a process evaluation conducted. The EuroFIT program will be delivered over 12 weekly, 90-minute sessions that combine classroom discussion with graded physical activity in the setting of the football club. Classroom sessions provide participants with a toolbox of behaviour change techniques to initiate and sustain long-term lifestyle changes. The coaches will receive two days of training to enable them to create a positive social environment that supports men in engaging in sustained behaviour change.Discussion: The EuroFIT trial will provide evidence on the effectiveness and cost-effectiveness of the EuroFIT program delivered by football clubs to their male fans, and will offer insight into factors associated with success in making sustained changes to physical activity, sedentary behaviour, and secondary outcomes, such as diet.Trial Registration: Isrctn: 81935608 . Registered 16 June 2015. [ABSTRACT FROM AUTHOR]

Background: To be able to provide high-quality palliative care, there need to be a number of organizational structures available in the nursing homes. It is unclear to what extent such structures are actually present in nursing homes in Europe. We aim to examine structural indicators for quality of palliative care in nursing homes in Europe and to evaluate the differences in terms of availability of and access to palliative care, infrastructure for residents and families, multidisciplinary meetings and quality improvement initiatives. Methods: A PACE cross-sectional study (2015) of nursing homes in Belgium, England, Finland, Italy, the Netherlands and Poland. Nursing homes (N = 322) were selected in each country via proportional stratified random sampling. Nursing home administrators (N = 305) filled in structured questionnaires on nursing home characteristics. Organization of palliative care was measured using 13 of the previously defined IMPACT structural indicators for quality of palliative care covering four domains: availability of and access to palliative care, infrastructure for residents and families, multidisciplinary meetings and quality improvement initiatives. We calculated structural indicator scores for each country and computed differences in indicator scores between the six countries. Pearson's Chi-square test was used to compute the p-value of each difference. Results: The availability of specialist palliative care teams in nursing homes was limited (6.1–48.7%). In Finland, Poland and Italy, specialist advice was also less often available (35.6–46.9%). Up to 49% of the nursing homes did not provide a dedicated contact person who maintained regular contact with the resident and relatives. The 24/7 availability of opioids for all nursing home residents was low in Poland (37.5%). Conclusions: This study found a large heterogeneity between countries in the organization of palliative care in nursing homes, although a common challenge is ensuring sufficient structural access to specialist palliative care services. Policymakers and health and palliative care organizations can use these structural indicators to identify areas for improvement in the organization of palliative care. [ABSTRACT FROM AUTHOR]

Background: In the regulation of healthcare, the subject of patient and family involvement figures increasingly prominently on the agenda. However, the literature on involving patients and families in regulation is still in its infancy. A systematic analysis of how patient and family involvement in regulation is accomplished across different health systems is lacking. We provide such an overview by mapping and classifying methods of patient and family involvement in regulatory practice in four countries; Norway, England, the Netherlands, and Australia. We thus provide a knowledge base that enables discussions about possible types of involvement, and advantages and difficulties of involvement encountered in practice.Methods: The research design was a multiple case study of patient and family involvement in regulation in four countries. The authors collected 1) academic literature if available and 2) documents of regulators that describe user involvement. Based on the data collected, the authors from each country completed a pre-agreed template to describe the involvement methods. The following information was extracted and included where available: 1) Method of involvement, 2) Type of regulatory activity, 3) Purpose of involvement, 4) Who is involved and 5) Lessons learnt.Results: Our mapping of involvement strategies showed a range of methods being used in regulation, which we classified into four categories: individual proactive, individual reactive, collective proactive, and collective reactive methods. Reported advantages included: increased quality of regulation, increased legitimacy, perceived justice for those affected, and empowerment. Difficulties were also reported concerning: how to incorporate the input of users in decisions, the fact that not all users want to be involved, time and costs required, organizational procedures standing in the way of involvement, and dealing with emotions.Conclusions: Our mapping of user involvement strategies establishes a broad variety of ways to involve patients and families. The four categories can serve as inspiration to regulators in healthcare. The paper shows that stimulating involvement in regulation is a challenging and complex task. The fact that regulators are experimenting with different methods can be viewed positively in this regard. [ABSTRACT FROM AUTHOR]

Background: For years, the benefits of septoplasty have been questioned. Due to the scarce and inconclusive literature, several National Health Service (NHS) Clinical Commissioning Groups in England decided to add septal surgery to their list of restricted procedures with low clinical value. Recently, evidence was obtained that septoplasty is actually more effective than non-surgical management for nasal obstruction in adults with a deviated septum. However, the relation between costs and effects of septoplasty remains unknown.Methods: We conducted an economic evaluation alongside an open, multicenter, pragmatic randomized controlled trial in two tertiary and 16 secondary referral hospitals in the Netherlands. Adults with nasal obstruction and a deviated septum were randomized to (1) septoplasty with or without concurrent turbinate surgery or (2) non-surgical management consisting of (a combination of) medical treatment and watchful waiting. Analyses were performed on an intention-to-treat basis. Single imputation nested in the bootstrap percentile method (using 5000 bootstrap replications) was performed to assess the effect of missing data. After 12 and 24 months, we assessed the incremental costs per quality-adjusted life year (QALY) gained from a healthcare and a societal perspective.Results: A total of 203 adults were randomly assigned to septoplasty (N = 102) or non-surgical management (N = 101). After 12 months, the mean cost difference between septoplasty and non-surgical management using a healthcare or societal perspective was €1181 (95%CI €1038 to €1323) or €2192 per patient (95%CI €1714 to €2670), respectively. The mean QALY difference was 0.03 per patient (95%CI - 0.01 to 0.07). Incremental costs per QALY gained from a healthcare or societal perspective were €41,763 or €77,525, respectively. After 24 months, the mean cost difference between the two groups using a healthcare or societal perspective decreased to €936 (95%CI €719 to €1153) or €1671 per patient (95%CI €952 to €2390), respectively. The mean QALY difference increased to 0.05 per patient (95%CI - 0.03 to 0.14). Incremental costs per QALY gained from a healthcare or societal perspective became €17,374 or €31,024, respectively. Analyses of imputed data did not alter our findings.Conclusions: Depending on the selected perspective, cost-effectiveness threshold, and time horizon, septoplasty has the potential to be cost-effective. Despite considerable uncertainty, septoplasty seems to be cost-effective from a healthcare perspective, after 24 months against a threshold of €20,000 per QALY. From a societal perspective, septoplasty is not yet cost-effective after 24 months, but it comes closer to the cost-effectiveness threshold as time passes by.Trial Registration: Nederlands Trial Register, NTR3868 (https://www.trialregister.nl/trial/3698). Prospectively registered on February 21, 2013. [ABSTRACT FROM AUTHOR]

Background: Between 1997 and 2010, the English government pursued an ambitious programme to reduce health inequalities, the explicit and sustained commitment of which was historically and internationally unique. Previous evaluations have produced mixed results. None of these evaluations have, however, compared the trends in health inequalities within England with those in other European countries. We carried out an innovative analysis to assess whether changes in trends in health inequalities observed in England after the implementation of its programme, have been more favourable than those in other countries without such a programme.Methods: Data were obtained from nationally representative surveys carried out in England, Finland, the Netherlands and Italy for years around 1990, 2000 and 2010. A modified difference-in-difference approach was used to assess whether trends in health inequalities in 2000-2010 were more favourable as compared to the period 1990-2000 in England, and the changes in trends in inequalities after 2000 in England were then compared to those in the three comparison countries. Health outcomes were self-assessed health, long-standing health problems, smoking status and obesity. Education was used as indicator of socioeconomic position.Results: After the implementation of the English strategy, more favourable trends in some health indicators were observed among low-educated people, but trends in health inequalities in 2000-2010 in England were not more favourable than those observed in the period 1990-2000. For most health indicators, changes in trends of health inequalities after 2000 in England were also not significantly different from those seen in the other countries.Conclusions: In this rigorous analysis comparing trends in health inequalities in England both over time and between countries, we could not detect a favourable effect of the English strategy. Our analysis illustrates the usefulness of a modified difference-in-difference approach for assessing the impact of policies on population-level health inequalities. [ABSTRACT FROM AUTHOR]

Background: Within implementation research, using theory-based approaches to understanding the behaviours of healthcare professionals and the quality of care that they reflect and designing interventions to change them is being promoted. However, such approaches lead to a new range of methodological and theoretical challenges pre-eminent among which are how to appropriately relate predictors of individual's behaviour to measures of the behaviour of healthcare professionals. The aim of this study was to explore the relationship between the theory of planned behaviour proximal predictors of behaviour (intention and perceived behavioural control, or PBC) and practice level behaviour. This was done in the context of two clinical behaviours - statin prescription and foot examination - in the management of patients with diabetes mellitus in primary care. Scores for the predictor variables were aggregated over healthcare professionals using four methods: simple mean of all primary care team members' intention scores; highest intention score combined with PBC of the highest intender in the team; highest intention score combined with the highest PBC score in the team; the scores (on both constructs) of the team member identified as having primary responsibility for the clinical behaviour. Methods: Scores on theory-based cognitive variables were collected by postal questionnaire survey from a sample of primary care doctors and nurses from northeast England and the Netherlands. Data on two clinical behaviours were patient reported, and collected by postal questionnaire survey. Planned analyses explored the predictive value of various aggregations of intention and PBC in explaining variance in the behavioural data. Results: Across the two countries and two behaviours, responses were received from 37 to 78% of healthcare professionals in 57 to 93% practices; 51% (UK) and 69% (Netherlands) of patients surveyed responded. None of the aggregations of cognitions predicted statin prescription. The highest intention in the team (irrespective of PBC) was a significant predictor of foot examination. Conclusion: These approaches to aggregating individually-administered measures may be a methodological advance of theoretical importance. Using simple means of individual-level measures to explain team-level behaviours is neither theoretically plausible nor empirically supported; the highest intention was both predictive and plausible. In studies aiming to understand the behaviours of teams of healthcare professionals in managing chronic diseases, some sort of aggregation of measures from individuals is necessary. This is not simply a methodological point, but a necessary step in advancing the theoretical and practical understanding of the processes that lead to implementation of clinical behaviours within healthcare teams. [ABSTRACT FROM AUTHOR]

Background: Understanding the resilience of healthcare is critically important. A resilient healthcare system might be expected to consistently deliver high quality care, withstand disruptive events and continually adapt, learn and improve. However, there are many different theories, models and definitions of resilience and most are contested and debated in the literature. Clear and unambiguous conceptual definitions are important for both theoretical and practical considerations of any phenomenon, and resilience is no exception. A large international research programme on Resilience in Healthcare (RiH) is seeking to address these issues in a 5-year study across Norway, England, the Netherlands, Australia, Japan, and Switzerland (2018-2023). The aims of this debate paper are: 1) to identify and select core operational concepts of resilience from the literature in order to consider their contributions, implications, and boundaries for researching resilience in healthcare; and 2) to propose a working definition of healthcare resilience that underpins the international RiH research programme., Main Text: To fulfil these aims, first an overview of three core perspectives or metaphors that underpin theories of resilience are introduced from ecology, engineering and psychology. Second, we present a brief overview of key definitions and approaches to resilience applicable in healthcare. We position our research program with collaborative learning and user involvement as vital prerequisite pillars in our conceptualisation and operationalisation of resilience for maintaining quality of healthcare services. Third, our analysis addresses four core questions that studies of resilience in healthcare need to consider when defining and operationalising resilience. These are: resilience 'for what', 'to what', 'of what', and 'through what'? Finally, we present our operational definition of resilience., Conclusion: The RiH research program is exploring resilience as a multi-level phenomenon and considers adaptive capacity to change as a foundation for high quality care. We, therefore, define healthcare resilience as: the capacity to adapt to challenges and changes at different system levels, to maintain high quality care. This working definition of resilience is intended to be comprehensible and applicable regardless of the level of analysis or type of system component under investigation.