Healthcare authorities worldwide search for ways to develop integrated care and interprofessional collaboration. In Belgium, Medical-Pharmaceutical Concertation (MPC) was introduced as a format to promote constructive dialogues between GPs and community pharmacists (CPs) with a focus on pharmacotherapy.To evaluate the implementation of MPC from the perspective of healthcare authorities and GPs/CPs.Mixed-methods approach, including semi-structured interviews with stakeholders and service users, observations of MPC meetings and surveys in GPs/CPs. Quantitative data were analyzed using descriptive statistics. Qualitative data were analyzed inductively.The implementation of MPC took a slow start. Parties involved had divergent views on the goals of the MPC: stakeholders focused on measurable results, while service users aimed on improving interprofessional communication. Additionally, service users felt that the lack of local structures hindered consensus building and implementation of agreements in daily practice. Support from professional associations was considered indispensable for the implementation of MPC. In order to organize this efficiently, the establishment of an independent institution, coordinating the MPC initiative, was highly recommended.The study confirms that a thorough context assessment prior to implementation of a complex project is needed and that a step-wise approach should be respected to achieve effective interprofessional relationships. The rising prevalence of chronic diseases and multimorbidity pose a major challenge to modern health care systems 2. For pa3Figure 1). The local projects are meetings that are held between GPs and CPs on a geographical basis. Each meeting must be organized by at least one GP and one CP, henceforth referred to as the project leaders. The programs provide educational support for the local projects, such as materials and moderators. They are developed by the professional associations for GPs and CPs, universities, educational institutions and scientific organizations. Each program covers a topic related to the rational prescribing, rational dispensing and safe use of medication.In Belgium, approximately 16,700 GPs and 21,000 CPs were active in 2019, with an average of 1.5 GPs and 1.8 CPs per 1000 inhabitants [To enhance the implementation of these meetings, the National Institute of Health and Disability Insurance (NIHDI) provides financial support. To receive this funding for the local project, GPs and CPs are required to choose one of the approved supporting programs. In return, the NIHDI expects these meetings to improve quality of care. To capture this, project leaders are asked to evaluate their progress by measuring self-formulated quality indicators (QIs) that reflect the agreements made at the meeting.The current study aimed to assess and evaluate the local implementation of this government-funded MPC project in Belgium from the perspective of stakeholders and service users (GPs and CPs).The study involved two distinct phases. The study population of the first phase consisted of three groups of stakeholders: policy makers, experts and program developers. Policy makers were representatives from the NIHDI. Experts were individuals from health insurance funds or universities. Both groups are involved in the evaluation and approval of submitted programs. Program developers were individuals or representatives of organizations who were qualified to design and submit supporting programs.For the second phase of the study, service users were included. These were the GPs and CPs who participated in the local MPC and the GPs and CPs who organized the MPC (=project leaders).The first phase of the study was performed in 2017. It had a qualitative explorative study design and consisted of semi-structured interviews with policy makers, experts and program developers (‘Study population’). Semi-structured interviews were performed by JF, a social scientist, and SR, a psychologist, both female post-doc researchers, and supported by an interview guide. The interview guide consisted of open-ended questions exploring the role of the stakeholder in MPC, goals, opportunities and threats that could be considered in the further implementation of MPC. Interviews were audio-recorded to facilitate the inductive analysis, supported by the conceptual framework on implementation fidelity (IF), as proposed by Carroll et al. and adapted by Hasson 11. The aThe second phase of the study was performed in 2018 and involved a mixed-method study design, which included the analysis of the approved programs and projects, observations of local projects, surveys of service users (collected immediately after the observations) and semi-structured interviews with project leaders (‘Study population’). All three types of data collection were performed by CH, AD, LV and SF . Observations were supported by an observation template, surveys by an online form and semi-structured interviews by an interview guide. These data collection materials were based on the Theory of Planned Behaviour, as well as the theoretical concepts of ‘community engagement’ and ‘community participation’. Quantitative observation and survey data were analysed descriptively in Excel. The analysis of the interviews was facilitated by audio-recording and verbatim transcriptions and was supported by the aforementioned theoretical frameworks 131415. T1314After the analysis of the separate study phases was finalized, with the purpose of integrating the findings of both phases, an inductive approach was used to generate overarching themes. Using different theoretical approaches in separate phases of the study  provided us with an extensive and in-depth view on the implementation of the MPC in Belgium. In this paper, the focus will be on the major findings that are thought to be relevant for an international audience. For that purpose, the results of both phases will be reported in an integrated manner.Different approaches were applied to ensure trustworthiness of our study findings. Firstly, trustworthiness was supported by the careful documentation of all study procedures and changes therein. Additionally, several forms of triangulation were applied to improve credibility. Both data collection and analysis were performed by a multidisciplinary research team, ensuring investigator triangulation. Method triangulation and data source triangulation were performed by collecting data through interviews, observations and surveys, and by involving the perspectives of all involved parties (e.g. stakeholders and service users), respectively. To further increase trustworthiness, the research teams of both phases regularly held meetings to discuss findings. Likewise, with the purpose of integrating the results of both phases, researchers collaborated closely across teams. Throughout the study, by means of regular multidisciplinary meetings, the potential influence the members of the research team may have had on the study outcomes was limited. Although pharmacists were involved in the study, we believe this had minimal impact on data collection and analysis, since they were 1) not involved in any aspect of the MPC project prior and during the study, and 2) accompanied by other professionals, including psychologists and social scientists, during each step of the way.Since no personal data was collected, but rather the opinion of stakeholders already involved in the MPC project, no approval of the ethics committee was needed for phase one of the study. The second phase of the study was approved by the Ethics Committee for the Social Sciences and Humanities of the University of Antwerp in October 2018.Table 1.A total of 22 interviews was performed with stakeholders in phase one of the study. During phase two, the research team performed 15 interviews and 18 observations, and collected 217 surveys from service users. Characteristics of the study population are given in During both phases of the study, it became clear that the expectations about the MPC were tempered by the reality. Firstly, according to several policy makers, the number of approved programs and local projects remained far below the desired number. Although budget was foreseen to support up to 800 local projects per year, by the end of 2018, only 112 local projects had been approved since the launch of the MPC project in 2015. Furthermore, service users indicated that not all 16 supporting programs approved by NIHDI were relevant for daily practice. Additionally, during the interviews, it became clear they were confronted with many barriers with regard to the organization of local projects (see further). Therefore, it could be concluded that the MPC initiative, funded by the Belgian government, has taken a slow start.One of the issues that arose from the interviews was the interpretation of the goal of MPC, which differed considerably between stakeholders and service users. Although all parties agreed on the long-term goal, i.e., for care to become ‘more efficacious on a regional level’, not everyone agreed on the steps that had to be taken to achieve this goal. Policy makers wanted to see measurable results from the local projects (by means of QIs), while service users preferred to first improve the quality of the collaboration through communication and dialogue.“The role of MPC in primary health care is to increase dialogue between pharmacists and GPs. What the policy makers want to achieve with MPC is less clear but seems to focus too much on economic savings . It seems unproductive to regard this as the primary target of MPC. The primary goal is to tackle the communication problem.” “It is not our intention for physicians and pharmacists to just sit together, talk about something and get money for that. We want to standardise MPC and see measurable effects of these efforts.” “The main goal that we have had in mind from the beginning, is to improve the communication between physicians and pharmacists. That is still the main goal.” “I know there are indicators for quality improvement. We discussed that last time, but for us, the concept is very, very unclear. We have absolutely no idea what type of indicator we should use, how we should verify our choice, etc.” Figure 2). During the interviews, project leaders indicated that a better patient care is what they expected to get out of this.According to the survey, almost half of the GPs and CPs  indicated that they were participating for the first time in a local project. Additionally, the objectives mentioned most by both parties during the interviews were to get to know each other, get acquainted with the other professional’s way of working and to improve communication between them. Results from the survey confirmed that by participating in the MPC, service users gained knowledge about the other profession, believed participation increased trust between both professions and believed participation helped them get more acquainted with the other profession .The atmosphere during the MPC was perceived as good and interaction quality was perceived as spontaneous. According to the survey, the majority of service users felt that they were able to express their opinion and felt mutual trust between the different professional groups. Moreover, all participants felt acknowledged by the other professional group(s) and almost everyone felt like the interests of both professional groups were equally represented Only in ten of the observed MPC meetings concrete agreements were made. An example of an agreement was to mention either “CKD” (chronic kidney disease) or the eGFR value on the GP’s prescription to inform the pharmacist about the patient’s decreased renal function . In six of these cases, the agreements would be disseminated and communicated among participants. Only in three cases, plans were made about the follow-up of these new agreements. Additionally, interviewed GPs and CPs indicated that agreements made at the meetings were barely put into practice, which resulted in a feeling of failure. However, they acknowledged that making agreements could have been thwarted by the attendance of health care professionals from different regions of the country. Participants felt that the lack of local structures (e.g. fixed groups of GPs and CPs), made it more difficult to make agreements at the meetings and to implement them in daily practice. Therefore, keeping the meetings local was regularly mentioned as a motivating factor for GPs and CPs to attend.“It’s useless to meet up with a GP from 10 kilometres away, absolutely useless.” Project leaders found the administrative process to organize a local project unclear and too extensive. They considered the support from professional associations indispensable for the organization of the MPC. These organizations mainly helped with practical arrangement, such as assist in the application procedure to receive funding. Although stakeholders from these organizations agreed that this is part of their job, they indicated that this would not be feasible for an increasing number of future local projects. Therefore, it was suggested by several stakeholders to set up an independent institution to carry all responsibilities with regard to the MPC initiative. This institution would be responsible for the dissemination and implementation of MPC, including the evaluation and approval of both supporting programs and local projects, as well as the provision of clear and accessible information for all parties involved.“There really is a need for an online forum where programs are available and requests for financial support can easily be submitted, to make the application for a local MPC more accessible for individual physicians and pharmacists.” Figure 4). Likewise, project leaders indicated that they were willing to organize future local projects. Some of them even had specific plans already.As revealed by the survey, most service users had become more enthusiastic about MPC at the end of the meeting than before. Additionally, GPs and CPs indicated that they would certainly or probably participate in future MPC projects , the idea of MPC was launched with high expectations regarding its dissemination and effectiveness. Our results show that participant responsiveness, one of the indicators to assess implementation fidelity, remained low and that these expectations were not fully met . The upt1617A common understanding of the operational goals of MPC seems to be lacking. According to the IF framework, this may have been caused by a lack of comprehensiveness of the policy description . This isOur results show that the MPC is seen as a means to quality improvement through more efficacious care. However, a step-wise approach for implementation is recommended to ensure the quality of delivery, as expected by NIHDI . GPs and19Project leaders mentioned that by participating in local projects, they gained knowledge about the other profession and communication improved. They also expressed the same objectives: improve trust and communication and subsequently achieve better patient care. These perceived benefits and shared goals, as well as mutual role recognition, have been previously identified as prerequisites for effective CWRs 2324. Non231515It is thought that after creating trust, service users will be able to make more concrete agreements on the prescribing and dispensing of medication. As our results show, agreements were formulated in a minority of meetings and service users indicated that these were seldom put into practice, which resulted in a feeling of failure. This may result in a lack of perceived effectiveness, another prerequisite to achieve successful collaborative practice . A possi23The administrative procedures for the organization of local projects seem to have hindered the implementation of the MPC project. These procedures were unanimously described as too extensive and too complex by project leaders, which meant they had to ask for help of professional associations. Leaving these procedures untouched might result in a decrease of service users’ perceived behavioural control and eventually in them not organizing local projects anymore . AdditioPractice pharmacists, for example, are active within general practices in Australia, USA and UK to perform tasks such as patient education and counselling, as well as medication reviews [prescribing pharmacist in the UK. Pharmacist supplementary prescribing has been on the agenda since 2003, followed by pharmacist independent prescribing in 2006 [The MPC initiative is appreciated by stakeholders and service users and enthusiasm seems to be growing. To further enhance the uptake of MPC, the implementation process should be structured and supported by NIHDI or by an independent institution as suggested. Additionally, aspects that are currently hindering the process should be addressed. With these conditions in mind, the launch of MPC can be seen as the kick-off to the formation of CWRs between GPs and CPs in Belgium. Yet the MPC initiative is only the first step in delivering excellent integrated care. In several countries, more advanced formats of GP-CP collaboration are already in place.  reviews . Another in 2006 . The latThis study is not without its limitations. An important limitation is that no data was collected of GPs and CPs who are currently not participating in local MPC. Including their perspective could have identified additional barriers to participation. Likewise, it should be considered that only motivated stakeholders and service users were included in the study.However, despite these limitations this study has several strengths. It was the first study to assess the implementation of the MPC project in Belgium after the publication of the Royal Decree in 2015. Additionally, the use of a mixed-methods approach involving both quantitative and qualitative data allowed for a more profound understanding of the implementation process.This study confirms that a thorough context assessment should be performed prior to implementation of a complex project. Failing to do so may have been an important reason for the low uptake of the MPC in Belgium so far. Additionally, the results show that a step-wise approach is needed to achieve effective CWRs. In a first step, what might be supported by the creation of fixed groups, a foundation of trust and mutual respect should be obtained between GPs and CPs. Subsequently, these groups need to build up their experience with regard to making concrete agreements with the aim of improving rational prescribing, rational dispensing or safe use of medication. Based on this experience, they can move towards the delivery of interprofessional care of which the impact can be assessed by measuring QIs, either self-developed by these local groups or defined by the program developers. Provided that these different steps of implementation are respected and the identified barriers to implementation are tackled, uptake of the MPC is expected to increase since enthusiasm is growing among all parties involved.


We pose based on a fundamental science examination that events that occur around the time of slaughter have the potential to intensify the pain response, through a process called sensitisation, or an exaggerated response to painful stimuli. Health conditions which result in inflammation, injuries arising from transport and handling and exaggerated fear responses may all be present at the slaughterhouse. Whilst there is limited evidence of a direct effect of these on the processes of sensitisation in animals at slaughter, by analogy with the human neurobiology literature the connection seems plausible. In this review we outline the biology of such a response, and the rationale for suggestion of a possible linkage between events at slaughter and a heightened animal pain response. We pose, based on a neurobiological examination, that events that occur around the time of slaughter have the potential to intensify the pain response, through the processes of sensitisation and enhanced transmission. Sensitisation, or an enhanced response to painful stimuli, is a well-discussed phenomenon in the human medical literature, which can arise from previous injury to an area, inflammatory reactions, or previous overstimulation of the stress axes. A number of events that occur prior to arrival at, or in the slaughterhouse, may lead to presence of these factors. This includes previous on-farm pathology, injuries arising from transport and handling and lack of habituation to humans. Whilst there is limited evidence of a direct effect of these on the processes of sensitisation in animals at slaughter, by analogy with the human neurobiology literature the connection seems plausible. In this review a neurobiological approach is taken to discuss this hypothesis in the light of basic science, and extrapolations from existing literature on the slaughter of ruminants. To confirm the postulated link between events at slaughter, and processes of hypersensitisation, further dedicated study is required.  Recently the International Association for the Study of Pain (IASP) revised the definition of pain to “an unpleasant sensory and emotional experience associated with or resembling that associated with, actual or potential tissue damage” . Pain exIn ruminants the common method of causing death is through sticking. This involves the cutting of the soft tissues of the neck, carotid arteries and jugular veins for bleeding. It is imperative that all major blood vessels are severed to ensure time to death is reduced. The sticking process causes significant nociceptor stimulation , in addiOther factors associated with pain prior to death include the use of electric drivers or prods, hot-iron branding and trauma caused by sticks or tubes that can inflict painful lesions and produce over-stimulation of nociceptors ,6,7. TheAntemortem stunning is designed to minimise pain and distress by rendering animals insensitive prior to sticking. Stunning techniques prevent correct functioning of neurons in the brain leading to a state of unconsciousness which may be reversible or irreversible . HoweverTherefore, the aim of this article is to review the neurobiology of antemortem pain in ruminants, the procedures that cause pain during pre-slaughter handling and those that can mitigate it, and the consequences for the welfare of the animal. A particular focus of the review is on how events occurring at slaughter could impact on hyperalgesia or sensitisation, and the consequences of this for the welfare of the animal. The concerns of an inadequate desensitisation and slaughter without stunning are also discussed.A key consideration in relation to pain at slaughter is the point at which consciousness is lost since this loss prevents the animal experiencing pain and fear . Two eveConsciousness is generally considered to consist of two components; the content, represented by awareness of the environment and oneself, and the level (wakefulness) . The forThe processes of nociception described below are ’pre-conscious’. However, pain perception or the emotional experience of pain is described as a ‘conscious sensation’ since it requires a functioning cerebral cortex . TherefoThe nociceptive pathways and neurophysiological mechanisms associated with pain are similar across mammalian species since the neuronal processes involved in the stages of conduction, modulation and integration develop through a chain of neurons with three pathways ,17,18. T2+, K+ or Na2+ channels follow to produce electrical impulses that transmit the nociceptive signal along the neuronal axons to the spinal cord, brainstem, thalamus and cortex  eEffective stunning, with quick disgorgement prevents pain perception occurring in the higher brain regions, evidenced experimentally by lack of EEG response . StunninDuring sticking the animal experiences prolonged nociceptive stress associated with the time taken to onset of unconsciousness. Moreover, blood may also be aspirated into the airways causing respiratory distress ,10. GregLevel of the transection may play a role in distress caused by fluid entry to the respiratory tract. The laryngeal reflex is regulated through neuronal connections in the C2 cervical vertebra, but in the Halal and Shechita methods the neck is cut between C3 and C5 , so thisThe time to collapse after slaughter is another consideration relevant in comparisons of pre-stun and non-stun methods. Gregory et al. (2010)  reportedThe use of poor transport and handling methods prior to slaughter, as well as the application of unsuitable stunning methods, may result in processes of sensitisation –central or peripheral– which intensify pain perception. In addition, animals destined for slaughter may be suffering from previous pathologies, the sequelae of which could contribute to sensitisation. Even where suitable stunning methods are utilised, deficiencies in handling prior to application of an effective stun, poor equipment maintenance and/or inadequate personnel training could also result in nociceptor stimulation, and trigger processes of peripheral sensitisation and pain perception. Further dedicated study is needed to confirm the hypothesis of a link between events at slaughter and processes of hypersensitisation.


World Environment Day on June 5 and World Oceans Day on June 8 now is the right time to consider some key facts and to share some initiatives with our readers.Since the start of the COVID-19 pandemic, the measures taken in reaction to it presented a mixed environmental impact with both indirect positive and negative effects. Due to global restrictions on travel, there has been a reduction in greenhouse gas emissions. However, the pandemic has also led to an increase in medical waste, including greater use of disposable personal protective equipment and toxic disinfecting chemicals. Early on, prominent environmental activists, such as Nobel laureate economist Joseph Stiglitz in June 2020, suggested to use this unfortunate opportunity to rethink the model of our societies, starting by imagining more sustainable alternatives to our daily activities. Remote working and switching from in-person to virtual conferences are two alternatives that have already been tested in the biomedical community. However, a lot more can be done to align the, currently, negative environmental impact of laboratories and hospitals with their public health mission. With Health care without harm  the footprint of the health-care sector is equivalent to 4 · 4% of global net emissions, meaning that this sector would be the fifth largest emitter on Earth if it were a country. The sources of emissions range from intensive use of energy and water to hazardous chemicals , medical waste, and large amounts of single-use plastic. Similarly, biomedical laboratories with specific equipment  are some of the largest energy and water consuming entities: the non-profit organisation My Green Lab  estimated that research laboratories consume ten times more energy and use four times more water than typical office spaces. Relying heavily on disposable tools, they also generate close to 12 billion pounds of plastic waste per year.According to the international non-governmental organisation Lancet Countdown on health and climate changethe report of the ), the effects of microplastics (that are shed from plastic waste) on human health are still under investigation. However, their ubiquity and increasing volume is worrisome. The endocrine disrupting chemicals that are carried by some microplastics represent an additional source of health concerns. Microplastics were also recently observed for the first time in the placentas of four out of six human participants using Raman microspectroscopy. These studies are an invitation for further investigation and an impetus to take action.While the negative effects on health due to climate change, greenhouse gases, water scarcity, and contaminated water have been widely documented  over 4 weeks. To adjust to each laboratories requirements, managers can tailor their plans of action using the sustainable-lab consumables guide from University College London . Beyond tackling the waste problem, laboratories can also act to reduce their consumption of energy and water. Simple solutions, as described in the comprehensive GoGreen guide written by a team of Technische Universität Dresden  participating in the 2017 international Genetically Engineered Machine competition, are already making a difference. An increasing number of institutions are now offering green certification to promote responsible practices in their laboratories . Following suit, UK Research and Innovation (an organisation that unites the funding bodies) pledged to integrate green certifications into the grant evaluation process by 2025. While waiting for similar change in other countries, applicants should already include sustainability actions into their proposed research programme.One simple way to act is for researchers to reduce, reuse, and recycle. To encourage colleagues to adopt these rules, some have shared valuable experiences and practical tips. For example, Joana Alves and colleagues  reviewed the state of this field. This group of physicians, public health experts, and environmental health experts recommended a wide range of actions, including documenting the life cycle of medical devices and drugs, revising infection control standards (that drive non-evidence-based use of disposable tools), and forming a global commission tracking the progress made. Audits to quantify waste burden and to identify areas for improvement are becoming more common. For example, a Canadian team of orthopaedists led by Marcia Clark  found that, for cases from six orthopaedic subspecialties, an average of 6 · 2kg of waste was collected per case. With 75% of this waste potentially recyclable, the authors recommended implementing appropriate waste segregation and efficient recycling programmes. Such audits might be, by themselves, a tool to reduce cost and waste of procedures as reported by Keon Young Park and colleagues . They observed the positive effects of a monthly surgeon report card detailing the use and cost of disposable and reusable surgical supplies for paediatric laparoscopic procedures: the median cost per case decreased by 43% and the use of disposable tools decreased by 33 to 56% (depending on the type of tools) without a significant change in the clinical outcomes.A growing number of clinicians are also recognising their duty to address this urgent problem and have started analysing the effect of their practices. From these efforts, a new field has been developed: health-care sustainability. In October 2020, the Working Group for Environmental Sustainability in Clinical Care advocated for greener conferencessharing their experience organising the 2018 annual meeting of the International Federation of Medical Students’ Association . All aspects of a conference, including selecting venues located near public transportation, reducing the use of animal products for catering, prohibiting single use utensils, reducing the amount of merchandise per attendee, and recording the amount of waste generated need to be considered to reach the goal of carbon neutral events. As these measures could substantially change the conference experience, the benefits of such actions should be clearly communicated to the audience.The professional life of clinicians and researchers goes beyond the hospital or the laboratory, with conferences representing another major source of greenhouse gas emissions. Olena Zotova and colleagues We can all act to reduce our carbon footprint and we kindly encourage our readers to evaluate the environmental impact of their own activities, in the laboratory, the clinic, and at home. Many small steps can collectively result in large and meaningful change.EBioMedicine


Costs are one of the critical factors for the transferability of the results in health technology assessment and economic evaluation. The objective is to develop a cost database at the European level to facilitate cross-border cost comparisons in different settings and explains the factors that lead to differences in healthcare costs in different countries, taking into account the differences between health systems and other factors.The core of the database is compounded of three main categories  organized into 13 subcategories. A number of elements providing as detailed information of unit cost as possible were identified in order to mitigate the problem of comparability. Consortium partners validated both the database structure and selected costing items.Twenty-seven costing items included in the EU HCSCD resulted in 1450 unit costs when taking into account all item subtypes and countries. Cross-country differences in costs are driven by the type of resources included in the costing items  or by the variety of existing brands and/or models and the type of unit value in most of the primary resources.The EU HCSCD is the only public unit healthcare and social cost database at European level that gather data on unit costs and explains differences in costs across countries. Its maintenance and regular data updating will enable establishing specific systems for generating and recording information that will meet many of its current limitations.The online version contains supplementary material available at 10.1186/s12913-022-07791-z. Economic evaluations (EE) are recognised as a key element of priority setting decisions in Health Technology Assessment. EE should be an unbiased and transparent exercise, and should address issues of generalizability (the degree to which the results of an observation hold true in other settings)  and tranHence accurate unit costs are essential inputs for economic evaluations. Unit cost data are available from multitudinous sources, for example: previous literature, national databases, healthcare provider administrative or billing systems, or expert opinion. This diversity of sources can make interpretation and generalizability of economic evaluations challenging. The unit costs of similar-seeming resource items may vary, for example, due to differences in the definition of the unit of activity, the quantity, quality or mix of resource inputs used in providing a service or activity, average price levels across countries and across time, fluctuations in currency exchange rates, or cost-accounting methodology . HTA evaTo address these issues, the European Healthcare and Social Cost Database (EU HCSCD)  for use Hence the EU HCSCD meets an unmet need among researchers, and it is expected to provide several benefits. First, the EU HCSCD will improve transferability by making it easier to carry out multi-country studies and to adapt economic evaluation studies from country to country, hence saving human resources time and expense in the task of finding appropriate healthcare and social unit costs. Second, the database has information not only on the unit cost, but also describes how that item was constructed or estimated in a common format. This information may help researchers explore and explain variation in unit costs between and within countries. Will improve transparency by presenting unit costs estimated in different countries in a common format, allowing any variation in unit costs to be explored and explained. Third, the availability of this detailed cross-country resource may help national data producers (such as those responsible for Diagnostic Resource Groups) identify strengths and weaknesses in their costing methodology and, over time, may promote the standardization and improvement of these sources .The EU HCSCD includes both healthcare and social  costs. This paper describes the construction and content of the healthcare unit costs module, which was developed in the work package ‘Developing a costing methodology and a core dataset of costs for facilitating cross border comparisons in economic evaluations’ of the IMPACT-HTA project (No 779312) .The unit costs in the database are classified into three main categories: primary resources , composite goods and services , and complex processes and interventions . Table Ensuring comparability consists of collecting as detailed information on costing methodologies used to estimate cost of each item included in the EU HCSCD as possible. This means the knowledge about what resources are included in the cost, how were the resources estimated and how was the unit cost calculated and assigned to the resources. In the long term, the comparability can only be attained if all countries/institutions use the same accounting methodology. However, the unit values applied at present have different origins, not only cost accounting from health care organization, but also market prices, tariffs, public prices, etc. Therefore, all the fields described below have been included in the cost database to mitigate the problems of comparability Table .Table 2ESearches were carried out on the health organizations’ websites , Centre of Health Economics (University of York), etc.) and the most prevalent diseases worldwide were checked in order to decide which costing items  are among the most used in economic evaluations and, therefore, should be included in the beta version of the database. At least one costing item was selected within each costing subcategory. Thus, 27 costing items were included in the EU HCSCD, which resulted in 1450 costs when 9 countries  and all item subtypes were taken into account [The consortium partners , Instituto Superior Técnico (IST) of Portugal, Dental and Pharmaceutical Benefits Agency (TLV) of Sweden, Agency for Health Technology Assessement and Tariff System (AOTMiT) of Poland and University of Bielefeld of Germany) verified this material and provided references to any additional relevant databases and documentation. All documentation was translated to English with the assistance of online tools and consortium partners. An online workshop was organized at the end of October 2019 where one consortium partner from each country explained the functioning of their respective national database and provided any comments on the costing methodology. Consortium partners checked and validated the final selection of data items before inclusion in the EU HCSCD.We updated values to 2019 prices using Gross Domestic Product (GDP) deflator  and ConsThe conversion is based on rates taken from the European Central Bank webpage  and is mhttps://www.easp.es/Impact-Hta/default [The free-access database is available at /default . There aAmplifying the number of costing items and updating the costs in the future years are issues that need to be discussed. Even though all the costs can be updated with GDP deflator or CPI in future years; this would be futile and would quickly make the database irrelevant. The only way the database will remain relevant is if the costs are substitutes by their actual values from the actual source data each time they are updated in the original sources. Even the funding from the European Union’s Horizon 2020 research and innovation program (grant agreement No 779312) expired by the end of June 2021, there is still a need of having such a database. The team members are currently searching for more funding in order to maintain the database. If funding becomes available, all users would propose amendments . Those users that apply for it  will have the power to submit the data to the database. The principal administrator (a person from the IMPACT-HTA project team) will be in charge of revising them and making the updates periodically. All changes will be notified to the users by email. Those users wishing to be in the mail list can send an email to the Principal Investigator Professor Jaime Espín (jaime@easp.es). Each time a new item is proposed, subscribed users will receive a notification on searching for that item in their country and send it to the above contact. Once this new item is introduced into the database, the users will receive a notification. In the absence of financing, the authors propose that a community of volunteers (users) through a model of open collaboration maintains the database.This is a Beta version, which is being released now for testing and feedback from the health economic community to inform further development and maintenance, therefore any comments and suggestions from users are welcomed. Anyone is free to use the data without restriction, but are asked to cite this article.The EU HSCSD has been constructed with the aim of improving transparency, generalizability and transferability of economic evaluations. This resource should help researchers to find unit cost data quickly, cheaply and accurately. It has been developed with a user-friendly design and is relatively simple to manage and update. Where current year data are unavailable, it updates costs using CPI and GDP deflators . Links aUnit cost data have several limitations that need to be borne in mind when comparing values across countries or considering which values are appropriate as inputs to economic evaluations. As described elsewhere , 24, notMany ‘primary resources’ are likely to be defined in a fairly standard way across countries, for example: medicines by name and composition, devices by manufacturer and model. Healthcare professionals may be more complicated. Health professionals of the same grade may have quite different functions, for example, in some countries; a senior doctor has a dedicated percentage of time for administration, travel or research, but not in other countries. In some countries, nurses can take senior roles , in other countries their role is more restricted. Other variation arises in the unit of measurement of the source  or type of expenses included (for example: travel or training). Salaries in the health service may not be “market prices”  but are often determined by other factors, such as labour union negotiations, national legislation, workers’ seniority, and so on –28.Regarding accessibility of cost data, current databases of official prices of medicines were found in each country, though with some heterogeneity in definition. The official “public” price is published in England, France, Poland, Portugal and Sweden. In Germany, Spain and Slovenia, the reference price is published, while in Italy, it is the ex-factory price . Costs o‘Complex processes and interventions’ refers to inpatient and ambulatory surgical procedures. In some countries, costs of ambulatory procedures can be found in the same database as hospital admissions. For example, in England some ambulatory procedures are classified as Diagnosis-Related Groups (DRGs)  or, as in Sweden, there is a close relationship between DRG costs and costs of ambulatory procedures. In some countries, tariffs are published for ambulatory procedures, but not costs . In Italy, tariffs are published at national and provincial levels, while in Spain, there are only provincial tariffs. In France, Germany, Poland and Slovenia, some ambulatory procedures have DRG costs, while others are only attributed a tariff.The methodology of costing DRGs is often reasonably well documented, though there are some gaps and uncertainties, especially around the treatment of overheads . It is uThe EU HCSCD is the only public unit healthcare and social cost database at European level. The project team are actively working towards setting up a stable consortium responsible for improving, updating and ensuring the continuity of the EU HCSCD. National governments or statistical agencies should review their costing methods in healthcare and ensure that they meet best practice , 31. We Additional file 1.


Foreign language proficiency is an unequally distributed form of linguistic capital that is becoming increasingly important in contemporary societies: first, it enables persons to participate transnationally in educational activities and in labor markets beyond the national institutions of their home country. It is also crucial for integrating an increasing share of the population with a migration background into the labor market. Thus, this article focuses on the explanation of language proficiency. Its main aim is to enrich the discussion in this field by deriving hypotheses from the sociological theory of reproduction and the discourse on migrant integration. Variables are included which have not been tested in a broad fashion in previous empirical research. We use data on different groups of migrants and non-migrants in multilingual Switzerland, where we could study the determinants of the unequal distribution of language proficiency in three official languages and foreign language repertoire in general. Our main results show that the hypotheses derived from the two theoretical discussions are empirically supported overall and contribute substantially to the explanation of language proficiency. However, most of these variables indicate the importance of unequally distributed opportunities for learning languages, thus highlighting that language learning may be part of the general process of reproducing social inequality structures. Foreign language proficiency is an unequally distributed and increasingly important resource in contemporary societies: on the one hand, it enables people to participate transnationally in educational activities and labor markets beyond the national institutions of their home country and profit from these boundary crossing engagements. On the other hand, it is crucial for the structural integration of an increasing share of the population with a migration background into both the labor market and the educational system of their country of residence. Up to now, the relevance of language proficiency has been discussed in two more or less completely separate strands of literature. The first is research focusing on the increasing importance of foreign language proficiency of transnationally mobile and active people in the era of globalization  in different disciplines, focusing on psychological, linguistic, social, and biological foundations of language. Our paper concentrates on the social contexts of foreign language proficiency  in order to determine foreign language proficiency's relationship to social and economic inequality and migration experiences. In our contribution we mainly draw on two theoretical discussions which have so far not had much impact in the discussion on language proficiency and its determinants: Pierre Bourdieu's sociological theory of reproduction, which reveals the structural inequalities underlying the unequal distribution of foreign language proficiency. This theory has rarely been tested in quantitative studies of language proficiency . With regard to language integration, there is still the conviction in most cantons of Switzerland that pupils should learn another national language as their first foreign language and English as second foreign language. In some cantons, however, English is the first foreign language and another national language is the obligatory second foreign language EDK, .An analysis of job advertisements in the German-speaking part of Switzerland shows that in 2015 and 2016, 14% of all positions required proficiency in French and 4% in ItalianAccordingly, in our empirical study we do not focus only on proficiency in one language, but due to the specific situation in Switzerland, we study the determinants of linguistic capital in general (number of (foreign) languages spoken) as well as those of Swiss-specific linguistic capital . In both cases, linguistic capital is an unequally distributed resource which is important not only for the higher rungs of the international labor market, but also for successful integration into the Swiss job market. Our empirical study thus contributes to the current state of research by taking a broad theoretical discussion and the hypotheses derived from it into account, focusing on a case in which proficiency in more than one language is relevant, and by studying persons with and without migration experiences. Hence, it goes beyond existing studies on linguistic capital in multilingual countries by first comparing migrants and autochthonous populations and then by studying both proficiency in national languages and (foreign) language competence in general  capital. Traditionally, especially proficiency in the legitimate standard language of a nation-state is a form of cultural capital which may be invested in the education system or the labor market  language repertoire  will be, i.e., the number of foreign languages they speak fluently.H2: The broader the parents' language repertoire, the larger the respondents' (foreign) language repertoire will be.H3: The stronger the person's orientation toward classical highbrow culture, the larger their (foreign) language repertoire will be.H4: The higher the person's education, the larger their (foreign) language repertoire will be.HAn important similarity between the economic approach and Bourdieu's theory is the focus on opportunities to learn and practice a language. In contrast to the economic approach, Bourdieu emphasizes the inequality in opportunities leading to unequally distributed linguistic capital. This is relevant to the following discussion on the relationship between transnational experiences and linguistic capital, which highlights aspects that have received little attention in the literature so far. Derived from Bourdieu's emphasis on the importance of practice and the relevance of learning opportunities in the economic approach, our general assumption is that transnational experiences – enabling individuals to practice a given language – have a positive impact on linguistic capital.The relevance of transnational experiences and relations for the integration of migrants has been intensively discussed in the literature  leads to higher language proficiency Esser, . The conIn general, it must be assumed that the process of reproducing cultural and linguistic capital outlined by Bourdieu is less seamless among migrants than among persons without migration experience, as migration research emphatically shows ” between June and September 2012 in Zurich. The inquiry was addressed to persons in mono-national and binational partnerships . The sample included persons from Switzerland, the EU-27 countries and other European and non-European countries that were living together with their partner. It is thus not a representative survey of the total population of Zurich, but a survey of a nationally and culturally very heterogeneous group that somewhat exaggerates the heterogeneity of Zurich's population. The basic sample was drawn randomly from several predefined strata of people from the population register of the city of ZurichOur dataset contains information on a rather select group of people in the population of Zurich. Due to the national and cultural heterogeneity of the sampled individuals, it is well-suited for analysing the causal mechanisms underlying the accumulation of linguistic capital. The advantage of the data set is the rich coverage of variables relating to social background and transnational experiences. This provides an opportunity to test hypotheses both for persons with and without a migration background. However, in interpreting the results one should take into account that the sample probably contains persons with an above-average endowment with transnational experiences and networks.As a background to our sampling strategy one has to keep in mind that Switzerland's population contains roughly 25% foreigners, the majority of whom (over 80%) come from European countries. Switzerland adopted a treaty of free movement for EU citizens in June 2002, guaranteeing the freedom to move and work in Switzerland but also access for those commuting across the border to Switzerland EDA, . This retransnational linguistic capital), and on the other hand the number of official Swiss languages spoken fluently . Both variables were based on two questions in the survey. First of all, individuals were asked to indicate the language in which they were raised. It was possible to provide up to three answers, but respondents were invited to first list the language they would consider their mother tongue. Additionally, the respondents were asked to note the foreign languages they spoke fluentlytransnational linguistic capital), we added up all languages a respondent spoke minus the mother tongue; in the second case , we added up all national languages a respondent spoke, independent of their monther tongue  German, French, or Italian as their mother tongue).As mentioned above, we studied two different dependent variables. On the one hand, we considered the number of foreign languages spoken fluently (r = 0.5), there is also a considerable chance of measurement error. Nevertheless, it has been shown that the measurement error does not influence the analysis of the determinants of language competencies extensively  foreigners to test hypothesis 6. The differentiation between Swiss and foreigners is merely based on their formal citizenship(s). Swiss with a migration background are defined as Swiss citizens who meet one or more of the following criteria: (a) foreign citizenship(s) in addition to Swiss citizenship, (b) born abroad, (c) at least one parent born abroad. Sixty-three percent of such respondents were born in Switzerland. The vast majority of foreigners are first-generation migrants born abroad (92%) and come from one of the EU27 countries (88%). Sixty percent of the foreigners are citizens of one of the neighboring countries. Thirty-nine percent of all foreigners in the sample have German citizenship, 11% Italian, 7% Spanish, and 5% British. Of the Swiss with a migration background, 63% were born in Switzerland and 43% have an additional citizenship of an EU27 member state. Sixteen percent of all Swiss with a migration background have Italian as their second citizenship, 9% German. For the analysis of Swiss language capital, we further differentiate between foreigners who speak one of the main Swiss languages as their mother tongue and those who do not. We label Swiss citizens as autochthonous if neither of their parents were born abroad. Nevertheless, this group could include third generation migrants.In the next step, we will introduce the independent and control variables. First of all, we differentiate between (1) Swiss persons without and (2) Swiss persons with a intergenerational reproduction of cultural capital, we included the following variables: education of father and mother, the number of foreign languages each parent spoke when the respondent was a child, highbrow cultural orientation, and education of the respondent. As the majority of the respondents were highly educated, we distinguished between secondary education or less, postsecondary education and two levels of tertiary education. Higher tertiary education applied to persons who held a PhD or an equivalent degree. A highbrow cultural orientation was measured as an additive index whereby different regular highbrow cultural activities were summed up .With regard to the transnational relations and experiences were operationalised as follows: for both analyses  we considered regular contact with friends and relatives (including in-laws) (a) within or (b) outside of the European Union. Regular contact meant that the respondent on average visited his/her friends and/or relatives in the respective region at least once a year. Both variables are dichotomous. Another variable concerns the partner's mother tongue. As the survey did not include this variable, it was based on the information of the partner's country of birth. The most frequently spoken language in the country was assumed to be the mother tongue. In the first analysis , we only differentiated between partners speaking the same mother tongue as the respondent and those speaking a different one. In the second analysis of Swiss-specific linguistic capital, we further differentiated between partners with a different mother tongue who spoke a Swiss main language and those who spoke another language. Furthermore, we also took into account whether they were raised bilingually or multilingually. Moreover, we included a variable on trips within Europe as well as longer stays abroad. Trips referred to visits with at least one overnight stay and up to 3 months. Longer stays abroad related to visits that lasted at least 3 months. We only added up the number of visits to (or stays in) different countries. For the analysis of Swiss-specific linguistic capital, we modified both variables in that they only captured travels and stays abroad to countries where one of the main languages of Switzerland is spoken, namely German, French, or Italian. In this analysis, we considered one further variable: the percentage of friends born in Switzerland within the respondent's (max.) five best friends in Switzerland. Regarding hypotheses 7 we also included being an English native speaker and the share of inhabitants in Zurich who speak the same mother tongue. Both variables decreased the necessity to learn one of the Swiss national languages. And regarding hypothesis 8, we took into account whether persons acquired the highest qualification in Switzerland.The migration context as well as economic approach to language learning, we take several empirically established constructs into account as control variables, especially being employed, occupation and the language family of the mother tongue. Being employed is a dichotomous variable discriminating between those currently in paid work and those not. Occupation is based on the major ISCO-08 codes and differentiates among managers, professionals, technicians and associate professionals, clerical support workers, service and sales workers, and a broader category of mainly trades and elementary occupations. People who were not employed at the time were asked to provide information on their last paid job. Individuals who had never worked before were rare in our sample (<3%) and were subsumed under the “missing” category. Our assumption based on the economics of language is that especially those in high-status occupations  will benefit from foreign language skills and accordingly have a higher incentive to invest in learning another language. The language family is relevant insofar as individuals whose mother tongue belongs to the same language family as the Swiss main languages are expected to face lower costs in learning one of the respective languages. We differentiated between the main languages, Indo-Germanic languages and other languages. Age and sex were also included as control variables.In respect to the The language competencies of the respondents in our sample are comparatively high. On average, according to a broad survey of languages in Switzerland, Swiss speak two foreign languages Werlen, . EspeciaWe find that on average, the respondents spoke two of the Swiss national languages cf. . Swiss wIn the following, we show the results of testing the hypotheses for linguistic capital accumulation using Poisson regressions with robust standard errorsAs was also evident descriptively, migrants and non-migrants in our sample did not differ significantly in their endowment with transnational linguistic capital cf. . The tra2 (cf. models 2a and 2b). Parental education has no direct effect on linguistic capital (H1) when controlling for the other variables on the intergenerational reproduction of cultural capital. Only adding parental education to model 1a and 1b would show that especially higher education of the father has a significant positive effect . In contrast, respondents' education has a strong and significant association with linguistic capital (H4), which is assumed to be a result of both increased exposure and increased efficiency coming with higher education. Moreover, our study demonstrates that a highbrow cultural orientation has a consistent positive association with linguistic capital (H3). As assumed by Bourdieu, different forms of cultural capital cohere, and highbrow cultural capital still seems to be an important part of contemporary cultural capital. A comparison of model 1 and 2 indicates, that the variables derived from this theoretical discussion increase the explanatory power of the models. However, the increase is clearly stronger in the case of transnational linguistic capital.Since the results for both forms of linguistic capital are very similar, we first discuss the similarities, followed by expected differences. Turning to the intergenerational reproduction of cultural capital, we find that it is primarily the number of languages a father spoke when the respondent was a child that has a significant positive effect, which partly supports H5) receives strong support for transnational linguistic capital (cf. model 3a). All five indicators have a positive impact on the transnational linguistic repertoire. A particularly important factor is having a partner with a different mother tongue, since having such a partner also shapes the composition of a person's social network. Moreover, we find that the indicators of language and migration context largely correspond to expectations: growing up in a bilingual or multilingual family is significantly associated with greater linguistic capital, as is having acquired their highest educational qualification in Switzerland (H8). However, being an English native speaker is associated with significantly less linguistic capital. This could be explained by the fact that speaking English as a lingua franca is sufficient to get by in an international city like Zurich. The lack of incentives to expand the language repertoire would thus outweigh the effect of exposure. The share of people who speak the same mother tongue as the respondent has a significant negative, but negligibly small effect on linguistic capital, which may be due to the composition of our sample . Both results are consistent with hypothesis 7.Due to the differences in the results, the variables added in model 3 will be discussed separately for transnational and Swiss-specific linguistic capital. For the former, the hypothesis relating to transnational experiences and relations (H6). Obviously, this applies above all to foreigners whose mother tongue differs from one of the Swiss national languages. In line with this result, obtaining the highest qualifications in Switzerland increases this linguistic capital (H8). Exposure to the national languages, as shown by stays abroad in corresponding countries or the partner's mother tongue or social relations within the EU, has the hypothesized positive effect. Travels to and stays in (European) countries where one of the main languages of Switzerland is spoken might differ for the acquisition of Swiss-specific linguistic capital for Swiss and foreigners whose mother tongue is identical to one of those languages. In the case of the foreigners, these trips and stays might concern their home countries, which would not encourage learning of another main Swiss language. In order to take this into account, we also ran a model with interaction effects. While the effects were somewhat stronger for the autochthonous Swiss, the interaction effects were not significant (results available on request). This can be attributed to the particular situation of Switzerland  and the immediate proximity to neighboring countries where the main Swiss languages are spoken, which is used for visits and stays abroad by Swiss and migrants alike. In general, the variables added in model 3 clearly increase the explanatory power of the models in comparison to the models including only the control variables and the variables based on Bourdieu's theory of reproduction. The increase is again stronger for the case of transnational linguistic capital.With respect to the determinants of acquiring Swiss-specific linguistic capital, we will highlight notable results cf. . As hypoWe also ran the Poisson regression models separately for persons with and without migration background see . As expe2 measure underestimates the explanatory power of the model compared to the R2 measure in ordinary regression models. Andress et al.  exhibited a lower proficiency in the Swiss national languages, there was no difference with regard to foreign language repertoire in general. This is an important finding because it shows that while migrants may have a deficit in the national languages of their destination country, they do not necessarily have a deficit in foreign language skills in general, suggesting that a deficit-oriented approach can overlook part of migrants' life situations. Furthermore, the opportunity to speak one's mother tongue was significantly related to speaking fewer national languages.In terms of transnational experiences and relationships, we found quite clear-cut results. They undoubtedly promote foreign language proficiency and increase proficiency in national languages if these experiences or relations are related to countries where the national languages are spoken. Thus, our empirical findings demonstrate that transnational experiences are relevant for linguistic proficiency both for persons with and without migration background and should be included in a social scientific explanation. The empirical results differ somewhat for persons with and without migration background, thus it is very important to include a differentiated set of measuremets of such experiences and relations. However, most transnational activities, like traveling, spending times in foreign countries and meeting friends abroad, are based on the availability of socioenomic resources, thus again indicating that language learning is embedded into the existing social structures of inequality  focus mainly on the opportunities and the efficiency of language learning, seen through the lenses of the economic approach. In contrast to the economic approach with its focus on language learning as an investment, the sociology of reproduction emphasizes that especially the opportunities to learn languages are unequally distributed and thus the constraints for individual choices. Also, transnational relations and opportunities mainly increase the opportunity to learn foreign languages, but they are also based on unequally distributed resources. Hence, a next step in the development of theories of language acquisition should be to integrate these variables into a coherent model that takes the inequality in opportunities and constraints into account. A very promising framework has been developed by Esser . SimilarFinally, we must discuss some limitations of our study. On the one hand, as outlined above, the measurement of linguistic proficiency could be more precise. Future research should focus on testing the robustness of our empirical results concerning the determinants of linguistic capital by including different measurements of language proficiency. Another weakness concerns a possible selection bias, as the questionnaire was only available in German or English and participation was therefore limited to people who were able to understand and read those languages. In addition, our sample included a very specific selection of persons with and without migration background in a very specific country, i.e., Switzerland. Thus, to generalize the empirical results regarding the sociology of reproduction and the transnationalisation literature, further cases need to be studied. Furthermore, our research design completely relies on cross-sectional data. Thus, we cannot interpret most of our results in a causal manner, but have to interpret them as empirical covariations. Yet, to the extent that the empirical correlations support our hypotheses, they suggest that our theoretical approaches lead to correct hypotheses and are therefore not falsified. A stronger interpretation is possible for the role of parental education and parental lingustic capital. Since there is a plausible time ordering involved, these covariations can be interpreted in a causal manner with a higher degree of certainty and thus support the role unequal opportunities play in learning languages. However, in order to present stronger arguments for a causal interpretation, future studies should rely on longitudinal empirical designs.The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.Ethical review and approval was not required for the study on human participants in accordance with the local legislation and institutional requirements. The patients/participants provided their written informed consent to participate in this study.All authors listed have made a substantial, direct and intellectual contribution to the work, and approved it for publication.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


Movement-based mindfulness interventions (MBI) are complex, multi-component interventions for which the design process is rarely reported. For people with stroke, emerging evidence suggests benefits, but mainstream programs are generally unsuitable. We aimed to describe the processes involved and to conduct a formative evaluation of the development of a novel yoga-based MBI designed for survivors of stroke. We used the Medical Research Council complex interventions framework and principles of co-design. We purposefully approached health professionals and consumers to establish an advisory committee for developing the intervention. Members collaborated and iteratively reviewed the design and content of the program, formatted into a training manual. Four external yoga teachers independently reviewed the program. Formative evaluation included review of multiple data sources and documentation . The data were synthesized using inductive thematic analysis. Three broad themes emerged: (a) MBI content and terminology; (b) manual design and readability; and (c) barriers and enablers to deliver the intervention. Various perspectives and feedback on essential components guided finalizing the program. The design phase of a novel yoga-based MBI was strengthened by interdisciplinary, consumer contributions and peer review. The 12-week intervention is ready for testing among survivors of stroke. Stroke is a leading cause of death and disability in Australia, with survivors often experiencing problems with physical, cognitive, and psychological health . There aExtensive planning and formative research are an essential phase in the successful development and implementation of a new intervention that might be tested for its efficacy in a randomized controlled trial (RCT). This is particularly important when the intervention is complex, because it has multiple components or mechanisms of action. A pilot study is an essential preliminary phase of an RCT for testing the effectiveness of a newly developed intervention . HoweverIn this article, we aim to describe the processes involved with co-designing an intervention, and the formative evaluation that was undertaken to inform the final design of this new, contextually appropriate yoga-based MBI for survivors of stroke, which will be tested in a future phase II RCT.This project was undertaken in two main parts as outlined below. The intervention was developed over two years (June 2016–June 2018), with formative evaluation iteratively conducted during the development period. Multiple data sources were used to document the processes involved with designing and developing the intervention .Foundation work including a broad literature review was undertaken. We identified one existing yoga program for stroke that had been used in Australia, which was trialed as a 10-week intervention . The autInvestigators (M.A.I. and S.H.) of the previous yoga for stroke program undertaken in South Australia were invited to collaborate to enhance the design of the current yoga program (yoga intervention working group). We then established an interdisciplinary advisory committee to design the intervention and future clinical trial. T.T. and D.A.C. were tasked with project coordination and collection and synthesis of data as part of the formative evaluation process. To partner in the development process, stakeholders  were invited and their informed consent was obtained.We used the Medical Research Council complex interventions (MRC) framework to develop the intervention ,9,10. WeQualitative data were sourced  to describe the development of the training manual by T.T. and D.A.C. Documentation analysis included: (1) email and phone correspondence between members of the working group and key members of the advisory committee, (2) comments on hard copy drafts of the manual from consumers and yoga teachers, (3) minutes of all advisory committee and working group meetings, and (4) notes from a researcher’s observations (T.T.). Edits to the manual were tracked into a copy of the master document by all the different contributors. The master document was consolidated to ensure all relevant feedback was incorporated from each phase of the development process.Synthesis of the feedback and, where relevant, pragmatic inductive thematic analysis techniques were used. Identified themes were collated and compared. Core intervention and manual content features that were required to be modified were discussed and amended, as required, within the members of the yoga intervention working group. Similarly, if there was mixed or conflicting advice, this was adjudicated by the members of the yoga intervention working group.Across the four phases of yoga program intervention development (as described above in Part B), three broad themes, and related sub-themes, emerged from the thematic analysis: (1) MBI content and terminologies ; (2) manual design and readability ; and (3) barriers and enablers to delivering the intervention . The processes involved, themes, and sub-themes in each phase are presented below.n = 3) and a carer were invited to be members of the advisory committee and to contribute to the design and development process.For Phase 1, an advisory committee was established that included experts from various fields, including a clinical neuropsychologist, epidemiologist, statistician, exercise physiologist, occupational therapists, physiotherapists, yoga experts, basic scientists, and a neuroscientist. Survivors of stroke  via regular emails and telephone calls. This phase also fostered a good working relationship between the stakeholders, researchers, and clinicians. The stakeholders had a critical role in supporting other members of the advisory committee to understand factors that needed consideration for the design of the program. This included the structure of the intervention, accessibility and size of classes, influence of group participation, and involvement of caregivers in classes. The consumers provided information on the various benefits and difficulties of participating in standard (generic) yoga classes from their perspective, i.e., what had and had not helped with their participation in generic yoga programs in the community, and in their recovery. This review process ensured the manual-based program would be practical, achievable, and inclusive for participants of varying abilities.Formative evaluation: In this phase, three major themes and four sub-themes were revealed that led to specific decisions being made in relation to the format of the yoga program. These are detailed below.Following the initial decision to develop a 12-week program, the following three decisions were made related to the development of the intervention. Firstly, the intervention should be comprised of 12 different group classes progressing in intensity and duration over the course of the program. Secondly, the first class would be needed to help participants understand the objectives of the program and to familiarize them with the poses and transitions. Lastly, the final weeks (weeks 11 and 12) would be used to reinforce the various aspects of the program and provide tips to safely practice at home. Adding daily home practices between classes was also discussed. It was also decided that there would be rolling start dates for participants. Therefore, the teachers would offer a range of options for participating in the techniques based on a participant’s class timeline, their movement abilities, and developing competency at directing attention to the movement, breathing, or meditation.Based on the experience of the previous 10-week program ,7, the aA decision was made to include in the manual information on stroke, major risk factors for stroke, and consequences that may occur after stroke. This section would inform those yoga teachers and class assistants who may have limited understanding about stroke and its consequences. This section had not been part of the prior 10-week program, but was considered important if a larger number of yoga teachers were to be trained to deliver the program.There was consensus that the active ingredient of the yoga program for stroke as an intervention was the development and attainment of focused attention through mindfulness mediation, as well as the use of movement via the various poses and concentration on breathing to focus the mind. Consistent with a standard yoga class structure , the last part of each group class would have at least 10 min dedicated to mindfulness meditation only. The focus was to ensure the purposeful allocation of attention so as to have full awareness of experiences in a non-judgmental and accepting manner . It was Survivors of stroke with different levels of impairment were invited for a photo shoot to capture yoga poses that would be included in the manual. The photos were required to provide clear illustrations of how the poses should be completed safely and, as relevant, with stable support furniture .Importantly, the yoga and allied health experts agreed that the manual must highlight the concept “where participants with stroke, particularly those with physical disabilities, are encouraged to use visual imagery of themselves moving the non-functioning limb”. This gives the patient the illusion of moving the non-functioning limb, a process which is proposed to stimulate and reorganize function in damaged neural networks of the adult brain . AnotherThe main aim of Phase 2 was to formulate the draft manual based on the information gathered in Phase 1. Three major themes were identified in this phase.The first step involved development of the terms of the reference document highlighting the roles and responsibilities of the members of the working group. The second step involved the development and execution of a collaborative agreement between members of the working group.The program manual included details of the role of the teacher in ensuring program fidelity. The main headings were agreed upon by the working group, and T.T. wrote the initial draft for many of the subsections. Members of the advisory committee with expertise in stroke contributed feedback. To ensure all yoga teachers would understand the underlying principles of the program, it was agreed to have a section outlining a set of ‘golden rules’  of the main program features that must be adhered to throughout program. Group classes were designed to be delivered by an experienced yoga teacher weekly for one-hour sessions over 12 weeks. A description of the various physical postures, possible variations to the postures, and suggestions on appropriate use of language  were included in the manual.The two survivors of stroke who were part of the advisory committee, and another, were invited to take part as models in a photo shoot. There were two females and one male, with different levels of abilities, who attended the photo shoot. The photos captured were used to illustrate some of the poses included in the manual. At the beginning of the shoot, the models were provided with an information sheet. The shoot was led by M.A.I., while T.T. observed the photo shoot and documented the importance of safe transition from one pose to another. This was important especially for someone with severe physical disability who would require a strong and secure chair for support, or modified means of support in getting up and down from the ground . The models also informed M.A.I. and T.T. that they had been practicing yoga and mindfulness meditation for a long time (>3 years) through generic programs in the community. All models expressed pleasure in being a part of project, and were excited that a tailored intervention was being developed for use in survivors of stroke.n = 3) and people experiencing a stroke and a carer (n = 3) were invited to collaborate and review the content and design of the drafted prototype manual (as described in Phase 2). Members of the advisory committee were also asked to provide their view on the content, design, overall acceptability, and feasibility of the content in the manual. This process lasted seven months (from January 2017 to August 2017). Four major themes were identified in this phase.All members of the working group provided their expert opinion on the content and design of the manual. In addition, through purposeful sampling, allied health professionals ”.Advisor 2: “Are participant able to do this pose with assistance from a caregiver. If so, this needs to be stated and the role of caregiver within the intervention defined”.Advisor 3: “Avoiding injuring, safety is the priority. Imagine both limbs doing it, and encourage participant to use imagery technique”.Through written feedback, the allied health professionals and researchers commented on how particular activities could be better adapted to suit survivors of stroke, whilst maintaining the guiding principles of the program. Examples include:It was also suggested that the content of week 11 and week 12 could largely focus on ‘transition to home techniques’ and include information on how to effectively continue practice at home, rather than traditional group classes. The manual was further modified to incorporate the suggestions provided by the advisory committee and stakeholders. Changes in the class plans were also made to (1) facilitate ease of implementation for teachers, (2) use materials that were available and acceptable for the cohort, and (3) promote implementation fidelity of the program. Practice points were embedded under sections of each posture and class plans to reinforce the major guiding principles of the program. It was also reinforced that an assistant teacher must be present within each class to optimize program delivery and patient safety.Importantly, greater detail was added on how to transition from one pose to another. Photos that provided an illustration of some of the poses were also updated to include more contextually appropriate photographs .The manual was personalized by adding the ‘story’ of the 3 models who had contributed to the photo shoot at the end of the manual. It was believed that, by including these stories, the yoga teachers undergoing training would gain some insights into what it is like to live with stroke and participate in yoga.Through the collaborative network of D.A.C., and via email to the Yoga Australia Association, four yoga teachers  not previously involved in the project were approached to provide independent review of the manual. These yoga teachers had different levels of experience and provided their expert opinion on the content, design and acceptability of the drafted manual over a four-month period (August to December 2017). The yoga teachers also attended a focus group and trial training workshop in December 2017 where they provided additional feedback on the manual. Several aspects of the manual  were deemed feasible and appropriate.Some modifications were identified that needed to be made to the manual to enhance its relevance and feasibility for use in program delivery, for example, including additional instructions to support people with disabilities while sitting on the floor, adding key limitations section in dot points under each pose, and providing alternative seating options or transitions for those unable to move from standing to floor quickly.In this phase, three major themes were identified.The teachers indicated that it would be beneficial to focus on the main concepts of the program and the use of consistent language prior to delivering the first class. Clear terminologies (western or plain English) were suggested to be used instead of Sanskrit words, such as using ‘deep controlled breathing’ instead of ‘pranayama’ for better readability.The teachers suggested including alternative seating options. For example, the use of chairs instead of standing for any ‘standing pose’ could easily be implemented in the group environment. Therefore, this type of practical information was included, where relevant.Teachers also provided information about the suitability of particular resources used in the classes, for example yoga bands for support of shoulder or arm poses. They also advised that the manual should include how to address any concerns about safety and adverse events during class times. Finally, the teachers suggested adding information on the different etiology of stroke to the background section on stroke.In response to the independent review outlined above, we modified the yoga teacher training manual. Overall, positive feedback was received from the allied health professionals, yoga teachers, and consumers about the program and its potential utility. This manual has been designed to train and then be used by yoga teachers to teach groups of survivors of stroke across a broad range of age groups and disabilities in a Phase II trial. .In this study, we provide a description of a systematic, sequential approach to integrating scientific evidence from systematic reviews, qualitative research, and expert knowledge, as well as knowledge and experience with stakeholders to develop an evidence-based complex intervention. We have described in detail how co-design and formative evaluation strategies helped inform the recommendations and refinement of the yoga-based MBI for survivors of stroke with varying abilities who live in the community.This study, to the best of our knowledge, is the first one to document the development of a complex yoga-based MBI for stroke using methodology prescribed by the MRC framework. Before a complex intervention is piloted in a large clinical trial and tested for its effectiveness, it is important that it is designed well to ensure relevance and the ability to be standardized and replicated ,15. As aFormative evaluation is an essential feature of the development and design phase of a new multiple-component intervention or program. The focus of formative evaluation is to uncover the advantages and disadvantages of the intervention during its development process with the purpose of generating evidence to improving the intervention features so that it is implemented as intended, and will produce the hypothesized benefits for the patient group to which it will be applied . ResultsThe involvement of people who had experienced a stroke and a carer in the development stage and other stages of clinical trials is encouraged ,19. In pA major strength of our study is the ‘co-design’ approach whereby a team of allied health professionals, researchers, yoga experts and teachers, survivors of stroke, and a carer worked together . The mulThis study provides a model for other researchers and clinicians who aim to develop and implement complex interventions for survivors of stroke in the community. Illustrating how the yoga-based MBI for stroke was adapted and successfully integrated into a training manual for pilot testing through the processes of co-design provides insights into how this may be accomplished in similar contexts and other populations with chronic disabilities. A number of lessons learned throughout the evaluation process helped further improve the intervention.Ensuring that the intervention is clearly detailed will allow it to be replicated if found to be effective. Effective implementation and trialing of this program is essential for delivering robust evidence about the efficacy of a yoga-based MBI in survivors of stroke. The finalized intervention is to be tested for effectiveness in a future Phase II trial and, subsequently, in a larger Phase III RCT, aimed at assessing the impact of the yoga-based MBI on patient outcomes, including quality of life and mental health disorders in survivors of stroke living in the community.