Autoantibody measurement is the chosen tool, in addition to clinical observations, for the diagnosis of autoimmune diseases. Hence, it is essential for these measurements to be reliable and in the longer run to be standardised. Due to the intrinsic variability of analytes and reagents, and the heterogeneity of the available techniques, standardisation cannot be taken for granted, and results may vary between laboratories. As a consequence, diagnoses can be missed or wrong and unnecessary costs may burden individuals and healthcare systems. Standardisation of autoantibody testing is a demanding and multi-parameter task, but could be part of the solution. So as to achieve standardisation, the development and availability of suitable certified reference materials for calibration and/or quality control is crucial. In 2011, the American Autoimmune Related Diseases Association (AARDA) and the National Coalition of Autoimmune Patient Groups (NCAPG) reported that more than $100 billion are spent yearly for the diagnosis, treatment and care of ADs in the United States.2 There are more than 100 diseases currently characterised as autoimmune diseases.3 Several groups have used databases and search engines such as Google4 and MEDLINE1 so as to identify incidence and prevalence of various ADs. They are reporting variations in the geographical distribution of ADs as well as between women and men. The observation that many of these reports come to, is that environmental factors seem to be at least as important as genetic factors for the incidence and prevalence of an AD. Figure 1 presents a graph with some ADs and their prevalence in the USA.15 As many of them are rather uncommon, difficult to diagnose, and often not reported, capturing them all in epidemiological studies is rather unreliable. Therefore, the prevalence rates presented in this figure are conservative estimates coming from the studies available. Many ADs are rare, but taken together, they affect large numbers of people. In a workshop held in September 2015 in Brussels,16 it was summarised that there is an overall increase on the prevalence of autoimmune diseases worldwide for several reasons. It is of the outmost importance to understand ADs, their causes and the relation each disease has to one another, so as to improve diagnosis and disease management. According to the same report -agreeing with many others- the amount of data currently available in regard to ADs is insufficient and tend to focus on specific ADs and in industrialised countries only.16 However, a common conclusion is that ADs should not be treated and thought of independently, but rather as a whole. Rarity should not be confused with lack of importance or severity.Autoimmune diseases (AD) are a cause of concern, not only due to their high and increasing overall prevalence,18 Additionally, many of these medicines can be toxic and have serious side effects.18 For these reasons, the scientific society is turning towards the use of biologics and biosimilars. Biologics are complex molecules created in living cells targeting and inhibiting specific immune cells expected to be involved in ADs.19 Biosimilars are biologic products that have demonstrated an action similar to an FDA-approved biologic product. Their only difference to a biologic product is that they may show minor differences is clinically inactive components.19 This new generation of medicine –both biologics and biosimilars- is promising, and has already shown to improve treatment outcomes. However, as they do affect the immune responsiveness, they can as well have negative effect on a patient’s health.17 At the same time, they are very costly, making them inaccessible to a number of people suffering from an AD. In all cases, whether biologics or traditional therapies are being chosen for the treatment of an AD, it is clear that the right treatment has to be chosen: the most straightforward way to assure that is by ensuring that an accurate and correct diagnosis is made.Serological testing is very important for the diagnosis and subsequent treatment choice for a patient. Several ADs, such as small vessel associated vasculitis, consist of subtypes where different markers are responsible for each of them. Therefore, tests able to accurately distinguish and measure those are necessary. ADs are traditionally treated with immunosuppressive medication. Despite their efficiency, when used in long-term treatments, these may cause the patient to be susceptible to infections and malignancies.20 As people are moving from place to place, they demand to have equivalent test results independent from the laboratory where a sample analysis is taking place. This means that different assays are required to give at least comparable analytical results. It is not only a reasonable demand from people that may be unaware of the fact that their test results may vary, but also from legislation and international standards. The International Organization for Standardization has issued several standards describing the requirements for traceability in In-Vitro Diagnostics (ISO/CEN 17511).21 In 1998, the EU Directive on In Vitro Diagnostic Medical Devices (IVD-MD) (Directive 98/79/EC) was published, which requires traceability of calibrants and control materials to reference measurement procedures and/or reference materials of higher order.22 This high-impact directive (98/79/EC) as well as the Commission Decision 2010/227/EU, will be repealed and replaced in May 2022 by Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on IVDs. Because of these legislations, IVD manufacturers must ensure that the systems they market are properly calibrated against certified reference materials (CRMs) and reference measurement procedures.The detection and quantification of autoantibodies is important for clinicians so as to accurately and timely diagnose and treat autoimmune diseases. A variety of ELISA-based immunoassays have been developed throughout the years, which in most cases offer quantitative results. These tests need to be analytically selective and sensitive while at the same time they should preferably show small inter-assay variation. The latter is important for the establishment of common reference ranges and consistent “cut-off” values.24The importance of enzyme-linked immunosorbent assays (ELISA) for specific antibodies is also shown in a proposed revision of the 2012 Chapel Hill Consensus for ANCAs (anti-neutrophil cytoplasmic autoantibodies) in small-vessel vasculitis. In the proposal of 2017, the importance of ELISA techniques for the diagnosis of small-vessel vasculitis is highlighted.25 there are a number of factors contributing to the variability of autoantibody tests. These briefly include, but are not limited to, an increased measurement uncertainty due to high coefficient of variability (CV) of the measurements, variability due to calibration issues, the variability in the units used, as well as the nature of antibodies per se. It is important to understand that a good performance from an individual assay does not ensure that the numerical value will be in agreement with that obtained with another assay performing equally well.28 The lack of result agreement due to the use of different scales by the different assays is shown through several EQAS studies , as for example observed for the ANCA distribution in the year 2013.29 In this study, negative and positive samples were distributed and analysed by several assays. These assays perform perfectly well independently, but occasionally have an overlap in the value range just when a sample would be classified as positive or negative. This overlap could have as a potential consequence the misinterpretation of a sample’s result and subsequent mistreatment of the patient. Another example where, despite best efforts, solid-phase immunoassays such as ELISA have not managed to be established as the most appropriate method of choice, is the detection of antinuclear antibodies (ANA). Immunoassays such as these would be cheaper and easier to perform than the currently and commonly used indirect immunofluorescence (IIF). However, lack of standardisation has resulted in an increased number of unreliable results and thus in IIF remaining the gold standard for ANA testing.26Accurate detection and quantification of autoantibodies is not ensured despite the high number of good quality assays available in the market. As we have described in previous work30 The proper use of a Certified Reference Material -even though not promised to be the absolute solution to the lack of standardisation- could assist in having more comparable and harmonised measurement results; particularly over time. The JRC has produced, until the moment that this paper is being written, 67 CRMs for health related applications.31 These CRMs vary from pure standards and synthetic materials, to matrix materials certified, for example, for their hormone content, their protein content, their total element content and other properties, their catalytic activity, their DNA sequence, and their mass concentration. In addition to the JRC, other organisations like national metrology institutes , companies like Cerilliant (a subdivision of Sigma Aldrich), and the National Institute for Biological Standards and Control (NIBSC) from the UK, are also producing Reference Materials (RM) and/or CRMs. Actually, the first initiative in regard to the stan-dardisation of autoantibody testing began already in the 1980s, through a joint effort from several participants including the US Centre for Control and Disease (CDC), the Arthritis Foundation, the International Union of Immunological Societies, and the World Health Organisation (WHO). The result of this collaboration is the storage at the facilities of CDC of sera with monospecific reactivity to a given autoantigen from patients suffering from a systemic autoimmune rheumatic disease (SARD). These samples are available upon request.32The Joint Research Centre (JRC) of the European Commission is an active participant of the Committee on Harmonisation of Autoantibody Testing (WC-HAT) established by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) in 2009. The main aim of this committee is to evaluate the most important causes of result variability, to identify the autoantibodies for which a common calibrator would reduce inter-assay variation, and eventually to develop and produce materials that could be used for calibration and quality control. These materials should be certified, with well-defined properties and be commutable, i.e., resemble patient samples.33 and the ERM-DA483/IFCC.34 These two CRMs have been developed for the measurement of antibodies related to the diagnosis of small vessel associated vasculitis. The first one is certified for its mass concentration of immunoglobulin G (IgG) selective for myeloperoxidase (MPO) antineutrophil cytoplasmic antibodies (ANCA) in human serum, while the second one is certified for its proteinase 3 (PR3) ANCA IgG concentration. Both antibodies are seen in ANCA associated vasculitis, which include microscopic polyangiitis (MPA), eosinophilic granulomatosis with polyangiitis (EGPA), and granulomatosis with polyangiitis (GPA).36 Each of these materials was prepared from a single patient plasmapheresis sample provided by Serum Staten Institute (DK). The specific patient samples were chosen because of their titre of MPO ANCA and PR3 ANCA autoantibodies as well as for the fact that they were shown to be commutable with most of the assays used. They were produced according to ISO Guide 34:200937 and are certified in accordance with ISO Guide 35:2006.38 Prior to the development of the CRM, an extensive commutability was performed. Through this study, the best format for the CRM was chosen from all those tested . After this preliminary study was completed, and the commutability of both the matrix material and the purified IgG autoantibody was verified, the serum material was aliquoted into glass vials, closed with rubber stoppers and screw caps under a noble gas atmosphere such as Argon, and stored at −70 °C. The materials were then studied for their homogeneity both between and within a selected number of vials , as well as for their stability during transport for a period of up to one month, for three different temperatures and for their long term stability (up to 2 years) at two different temperatures. The next step in the characterisation of CRM such as the ones mentioned, was to define what was the mass concentration of the protein of interest in a unit traceable to the SI . For this purpose, a minimum of six assays was employed, and each participant laboratory was required to use their own methodology and instrumentation so as to negate laboratory bias and reduce the combined uncertainty of the measurements. Measurements of several dilutions and independent replicates took place on four separate days and the results were submitted by the participating laboratories to JRC to perform the necessary calculations. No values were disregarded on statistical grounds, only ensuring that all results -unless technically invalid- were taken into account for the final calculation of the mass concentration of the protein of interest. The actual value assignment was made following a value transfer procedure as described by Blirup-Jensen in 2008.39 In this procedure, the first step was production and characterisation of a preparation of the protein of interest  in a purified form. It was verified that this solution contains only IgG selective for MPO or PR3, respectively. This pure protein preparation was used for preparing calibration solutions for the (immunoassay) measurements for characterisation of the CRMs. The characterisation and value assignment of the pure protein preparation was made by determining the total IgG content, as all the IgG in the solution had the required selectivity. These measurements were performed by laboratories by commonly used clinical assays for IgG, such as turbidimetry and/or nephelometry. They measured both the purified preparation of the protein of interest  and vials of another material which has a known concentration of total IgG (ERM-DA470k/IFCC),40 and values for the specific IgG preparations were derived from the ratio of the results. The detailed protocols for the procedure followed for the development for each material as well as the assays used for the characterisation can be found in the relevant publications.34Figure 2 depicts a republished graphic representation of the steps for the development of the two CRMs .34An example of matrix CRMs produced by the JRC and certified for their specific protein content are ERM-DA476/IFCCTable 1 shows the results reported from the ten assays used in the characterisation study of the ERM-DA483/IFCC material. In this table, all results presented are of the same material (the candidate CRM). It can be clearly seen that results are varying, not only -as expected- when they are reported in different units, but variations do exist between results reported in the same, but arbitrary, unit (Table 1). In 2016, Monogioudi et al. published a paper where results are graphically represented from the recalibration of the measured values for the CRM, ERM-DA476/IFCC using the responses for the purified MPO ANCA IgG preparation for each assay.27 In the published figure, it is shown that result variation was reduced to 13% through the use of a common calibrant, while at the same time, the results were reported in the same SI unit (mg/L) and not in the arbitrary units used by each assay that make direct comparison impossible. A similar figure with the impact of recalibration of results for the ERM-DA483/IFCC material was submitted in October 2018 elsewhere.The main purpose of the CRMs is to be used in the calibration of immunoassay-based in vitro diagnostics devices and/or as calibrators. The JRC of the European Commission is continuing its close collaboration with the IFCC for setting up new standardisation targets and defining new goals. The current approach of using antigen-affinity-purified immunoglobulin fractions or fully characterized monoclonal antibody preparations has so far shown to be a successful approach.At this moment the development of a material certified for its anti-beta 2 glycoprotein IgG content is in progress, while preparation steps for a CRM against anti glomerular basement protein IgG have started. Measurements of autoantibodies by ELISA-type assays are nowadays required for the diagnosis of ADs. However, despite their widespread use, the variability of these assays often causes discrepancies between reported results, which have as consequence a possible misdiagnosis and impact the usefulness of the chosen treatment. Therefore, standardisation of the available assays is important. In order to achieve that, in addition to the guidelines and legislation developed, availability and use of suitable CRMs for calibration and/or quality control is necessary despite being complicated and often difficult. A CRM cannot solve entirely the problem of assay harmonisation; however, an appropriate and well characterised CRM can reduce inter- and intra-assay variability and retain scales stable over time. The standardisation of protein biomarkers is possible provided that everyone involved, whether in standardisation, calibration or simply use of the assays, is aware of potential pitfalls and difficulties, such as the nature of the antigens used in an assay. For example, clarification of the epitopes that are reactive in a particular assay would shed light in regard to what is actually measured. It is without doubt a very demanding task. Unfortunately, due to the nature of protein biomarkers, there are hardly any generally applicable recipes for standardisation and CRM production. However, the efforts taking place worldwide not only for standardisation but also for increasing awareness of the problem, are good steps forward.41Finally it is important to stress that at the moment the funding allocated to autoimmune diseases does not necessarily reflect on the importance of these diseases  was allocated to inflammatory and immune diseases).Often, autoimmune diseases are being considered as single entities, and that partially explains the lack of funding. If they are taken individually, they are rather rare, thus affecting only a small number of the population. However, it is important to understand that ADs share more than enough similarities so as to be considered as one entity especially in regard to the research, funding and efforts put on them. On the whole, ADs affect a very large part of the population worldwide, and as a consequence, entail a great cost for healthcare systems and individuals.


The most common disorders seen after a catastrophe are major depression, post-traumatic stress disorder, and anxiety disorders; increases in alcohol and drug use are also observed. To call this stress catastrophic is not hyperbole. It is catastrophic because the impact of COVID-19 on mental health will be due to at least five different effects of the pandemic, each of which is expected to independently have profound effects on mental health. This suggests that mental health sequelae will be greater than those seen after other disasters. The first impact of COVID-19 on mental health is the sudden – and in some regions, unexpected – arrival of the virus, which left cities deserted, bringing fear and triggering acute stress reactions. The fear of being contaminated or of contaminating others is no different from that seen after traumatic situations such as an earthquake or other disaster.2The second effect impacting mental health is the need for quarantine. While quarantine is necessary for fighting the pandemic, the sudden change in routine and the confinement can lead to feelings of helplessness, boredom, anxiety, anguish, irritability and anger at the loss of freedom. These reactions can be simply a situational adjustment to the new reality and not necessarily pathological. After all, being depressed and anxious is a normal reaction to the existing insecurity. Nonetheless, the mental health effects of quarantine themselves are remarkably similar to those of traumatic events. 3The third effect impacting mental health relates to the alarmingly numerous deaths resulting from COVID-19 – overwhelming hospitals, mortuaries, and funeral homes. Without the usual farewell rituals, such as spending time with the person as they are dying or having funerals, cases of complicated grief with depression and risk of suicide may increase. Yet another COVID-19 effect on mental health relates to the individual perceptions of those admitted to intensive care units, who will experience searing, terrifying phenomena, with some of them developing future episodes of major depression, post-traumatic stress disorder, and other psychiatric conditions.4Finally, the economic losses, unemployment, food insecurity, and increased social inequality are all generating acute stress likely to morph into chronic stress for a large swath of the population, also increasing risk for mental disorders. At the same time, the impact of this new wave of mental disorders on the economy is not to be underestimated. 5The population most severely exposed to stress during COVID-19 are the health professionals on the frontlines. They are subject to significant physical and emotional demands, often with insufficient assistance or personal protective equipment to guarantee safety. Add to this the daily suffering witnessed, and the difficult ethical decisions to be made, and the situation for those on the frontlines is daunting, to say the least. 6 The best indicator of emotional health is maintenance of functionality, despite a routine that is new and unstructured for many. If the anguish or depression is uncontrollable or impacts other aspects of life, such as family or professional function, it is time to seek professional help.To understand mental health symptoms, the National Institute of Mental Health (NIMH) website is a good resource. 7The World Psychiatric Association (WPA) established an Emergency Response Committee to ensure a centralized, coordinated response to COVID-19. Also, WPA is creating a library of resources, including instruction manuals and materials to support healthcare staff working with COVID-19 patients that will be freely available to the public in simple and immediate ways . 8 Mental health care at the global level will have to reinvent itself, and the crisis precipitated by the pandemic presents an opportunity to make mental health care as available as possible.Because these phenomena are occurring at the global level, humanity has never needed mental health professionals as much as it does now. The predictable, multiple psychological issues deriving from COVID-19 will demand a much more organized response than is currently possible due to the lack of psychiatric care in many parts of the globe, especially in low- and middle-income countries.


Patient rights are “those rights that are attributed to a person seeking healthcare”. Patient rights have implications for quality of healthcare and acts as a key accountability tool. It can galvanise structural improvements in the health system and reinforces ethical healthcare. States are duty bound to respect, protect and promote patient rights. The rhetoric on patient rights is burgeoning across the globe. With changing modes of governance arrangements, a number of state and non-state actors and institutions at various levels play a role in the design and implementation of (patient rights) policies. However, there is limited understanding on the multilevel institutional mechanisms for patient rights implementation in health facilities. We attempt to fill this gap by analysing the available scholarship on patient rights through a critical interpretive synthesis approach in a systematic scoping review.th April 2020, for empirical and non-empirical literature in English from both lower middle-income countries and high-income countries. Targeted search will be performed in grey literature and through citation and reference tracking of key records. Using the critical interpretive synthesis approach, a multilevel governance framework on the implementation of patient rights in health facilities which is grounded in the data will be developed.The review question is ‘how do the multilevel actors, institutional structures, processes interact and influence the patient rights implementation in healthcare facilities? How do they work at what level and in which contexts?” Three databases PubMed, LexisNexis and Web of Science will be systematically searched until 30The review uses published literature hence ethics approval is not required. The findings of the review will be published in a peer-reviewed journal.PROSPERO 2020 CRD42020176939 The proposed review will deliver an explanatory framework on the patient rights implementation in health facilities from a multilevel governance perspective.The use of literature from multiple disciplines provide a nuanced understanding of the contested concepts such as the patient rights that are complex involving many stakeholders and tradeoffs.The critical interpretive synthesis approach to synthesise the evidence is a perfect fit to understand the nature of complex fuzzy concepts such as patient rights implementation as it enables the use of data emerging from heterogenic disciplines and methodologies.The application of multilevel governance as the analytical lens is useful to study what vertical and horizontal levels and in what roles various state, market and civil society actors and institutions interact for the implementation of patient rights.Considering the time frame available for the review, the following are not within the scope of this review: (1) Patient rights implementation by the informal healthcare providers, (2) Patient rights concerning mental health disorders, disabilities, genetic screening, euthanasia, advance medical directives and health research as they merit specific considerations, (3) Patient responsibilities/obligations and (4) International mechanisms for patient rights protection .Human rights are believed to be the rights and freedoms that are inherent to every person in this world without any bias. Formally in 1948, in the aftermath of the World War II, the ‘UN Declaration of Human Rights’ laid the foundation for defining fundamental rights shared by every human being . These rights proclaimed in the Declaration were adopted by the UN General Assembly and ever since considered as the norm(s) by all nations for all people.3Embedded within the broader perspective of human rights is the notion of ‘patients rights’.5individual rights , (2) consumer-based rights (one who purchases the economic services and commodities), (3) social rights , (4) procedural patient rights and (5) informational patient rights. The last two categories (4 and 5) are cross-cutting and help to enforce the first three categories of patient rights.Townend and his colleaguesHowever, the categories mentioned above are not mutually exclusive. For example, the right to informed consent  is connected to right to information . Likewise, the right to complain depends on the right to access medical files in order to prove that the right to informed consent was violated.8Because of structural inequalities such as power imbalances between the care seeking individuals and providers and other social inequities related to income gap, gender inequality, social class and stigma associated with health conditions, for example, HIV, tuberculosis, mental disorders, and so on, healthcare settings are specifically vulnerable to patient rights violations.16The importance of patient rights could be gleaned from multiple perspectives:In a traditional hierarchical relationship, patients might refrain from having an open communication with healthcare providers or the healthcare providers may not provide in-depth information to people seeking care. This lack of open communication might deter patients from participating in the discussions related to the prevention of healthcare related errors and thus have implications for patient safety. Patient rights provide a language to empower and engage the care seeking individuals in the processes of delivering healthcare.17The six dimensions of quality healthcare are safety, timeliness/accessibility, patient centredness/acceptability, equity, efficiency and effectiveness.Furthermore, patient rights might galvanise improvements at health system level by infusing accountability through oversight mechanisms.24–26Patient rights are deeply interwoven with the four core principles of medical/healthcare ethics, that is, beneficence (do good), non-maleficence (do no harm), justice and autonomy.9Research studies from both high-income contexts 22 28The social, cultural and the policy context shape the design and the implementation of patient rights resulting in variations across the settings.22 40 41Patient rights movements and civil society organisations arguing for improved accountability in healthcare are gathering momentum across the globe and more so in LMICs.power, authority and accountability as the key aspects of governance.We attempt to fill this gap by critically reviewing the existing scholarship on patient rights and come up with a framework on the implementation of patient rights from a multilevel governance perspective. The concept of governance is difficult to define. Most of the definitions emphasise In the field of evidence synthesis, systematic scoping reviews are considered as an appropriate approach to answer complex questions where systematic reviews are not possible, or do not produce the required  information. Unlike the systematic reviews, systematic scoping reviews are applied for investigating broad questions that are interdisciplinary in nature but in a systematic manner and does not involve strict exclusion criteria for the studies.10.1136/bmjopen-2020-038927.supp1Supplementary dataFurther in this systematic scoping review, considering the limited theoretical development in the area of patient rights implementation, the critical interpretive synthesis (CIS)Use diverse body of evidence from varied forms of data sources, disciplines and methodologies.Modify the review question in response to the search results and findings of the previously retrieved items.Use literature from the adjacent fields relevant to the emerging nature of the review question.Use a pragmatic approach to identify potentially relevant and conceptually sound literature that would contribute for theory building or an explanatory framework.Critique the ways of the problematisation of the phenomena under study in the literature and explore the underlying assumptions on which the solution to the social problems are constituted.We have shown the salient features of CIS approachBox 1The review question serves as a compass rather than an anchor and is therefore revised and refined during the review process.The aim is to develop synthesising argument which could take the form of a plausible theoretical framework reflecting the network of constructs grounded in the evidence.The inductive and iterative nature of the CIS approach demands several cycles of searching, sampling, critiquing and analysing the evidence until a theoretical saturation is reached.The subsequent cycles of searching, sampling, critiquing and analysing the evidence is informed by the emerging theoretical framework.The priority for selecting the evidence is ‘signal’  over ‘noise’. However, formal quality appraisal techniques could be applied for individual papers. The aim is to purposively select papers that are most relevant and conceptually rich.Data extraction charts initially may help in the review but not an essential feature of the CIS approach.The review may not be strictly reproducible or auditable. It can be argued that even with primary data in a qualitative study or other evidence synthesising techniques it is most likely that a different set of researchers may interpret the same data/set of evidence and come up with the different theoretical model.The synthesising argument ‘theoretical framework’ is a product of interpretive process and ’authorial voice’. Therefore there is a need for constant reflexivity throughout the review process on the part of the authors.How do the multilevel actors, institutional structures, processes interact and influence the patient rights implementation in healthcare facilities? How do they work at what level and in which contexts?The objectives of this review are twofold:To describe the institutional arrangements, strategies, approaches and instruments at various levels for patient rights implementation in health facilities.To propose a theoretical framework on the implementation of patient rights in health facilities from a multilevel governance perspective.Operational definitions of the key terminologies used in the review:Patient rights - In this review the scope of patient rights covers the patient rights applicable to facility-based preventive, promotive, curative and rehabilitative healthcare services offered in the primary, secondary and tertiary level healthcare settings.Patient rights implementation approach refers to the overall strategy and the plan of action taken by the state and/or the various non-state actors such as communities, non-governmental organisations (NGOs), civil society organisations and professional bodies to respect, protect and fulfil the patient rights.Patient rights implementation instruments refers to the set of procedures, methods and tools available to implement patient rights. Examples include patient grievance redressal committees, patient rights charter, ombudsman, public hearing, parliamentary hearing, strategic litigation by NGO(s), public protests and patient directly filing a petition in the court system.Patient rights implementation mechanisms refers to the means and the ways through which a particular patient rights enforcement strategy/instrument is expected to work in a given context.Multilevel governance is about the interaction of the vertical  and the horizontal (state society dimension) institutions/actors at various levels for the implementation of patient rights in health facilities.Since the focus of this review is the institutional mechanisms for patient rights implementation, the initial conceptual framework  is develThe implementation approaches to respect, protect and promote patient rights in health facilities could vary across the settings. A number of factors might determine the implementation approaches. To name a few, the political ideology of the state, political framing of the (patient) rights issues, type of health systems and availability of resources for delivering quality healthcare. The failure of the state’s institutional mechanisms to adequately protect the patient rights may result in alternative institutional arrangements steered by the non-state actors such as the professional associations, state independent healthcare quality accrediting bodies, civil society, media, and so on.The key element of the framework is the institutional dimension of patient rights implementation. By institutions we refer to the thick and the thin definitions of institutions. In the thin sense, institutions refer to the formal explicit set of rules and decision-making units, that is, rules in paper. On the contrary the thick sense of institutions encapsulate the ‘social practices’ that emerge out of informal understandings between the actors, that is, rules in use. There are three lines of inquiry in studying the institutions; (1) fit - the degree to which the spatial, functional and temporal institutional arrangements fit the context. Simply put, it is to see whether the institutional arrangements fit the dynamics of policy problem addressed , (2) interplay - concerns the horizontal interaction between the same level and the vertical interaction across the different levels of the institutions and actors. There could be political or functional interdependencies across the institutions and (3) scale is about the density and the degree of diversity of institutions and actors from local to higher levels. The institutions can range from homogeneous to heterogeneous, few to many and individual actor influence to policy communities. In general the scale could be visualised as the shift from simple to complex systems as we move higher up in the levels.63Human resources entail the availability of adequate and competent actors for patient rights implementation. Public engagement in the policy processes concerning patient rights is key. Financial resources refer to the funds that are allocated for facilitating patient rights, policies implementation activities . Managerial resources indicate the availability of tools and monitoring mechanisms within the patient rights’ enforcement system . Technical resources denote the existence of technical capacity and assistance for policy implementation, for example, use of information and communication technology. All of these resources will influence the accessibility and availability of the patient rights’ policies in the manner comprehensible to the stakeholders, including citizens (and the most vulnerable groups).60Political, financial, managerial and technical competencies of the actors/institutions at the national and the subnational levels define the effectiveness of policy instruments used to enforce the patient rights in health facilities. Patient rights are within a contentious policy area. Therefore, implementation of patient rights should not be seen as only a matter of clear policy design and matching resources for implementation. The policy documents related to patient rights , implementation strategies and instruments are a product of a certain context and time and hence have been framed in certain discourses. Understanding how the issues on patient rights are constituted, represented, given shape and meaning within the policies is crucial as it determines the way the implementation is finally panned out within the multiple tiers of the polity.64Strategies and the policies designed to respect, protect and fulfil the patient rights are embedded within a specific social, political, cultural, economic, legal and organisational context. The contextual conditions at the; (1) micro level , for example, nature of the patient provider relationship, (2) meso level (district and subdistrict), for example, organisational culture of the implementation bodies and (3) macro level , for example, economic policies, reforms in health professional education and broader societal and the cultural issues  will influence the implementation processes. Further, it will be an easier task to implement patient rights, when the players supposed to practice them have somehow ‘internalised’ the notion and the importance of patients rights.The complex interaction of the actors/institutions, the implementation approaches, instruments and the policy context at various levels and broader societal context will determine the actual implementation practices.66When the patient rights policies are implemented effectively and conducive context conditions are in place, this should result in enhanced accountability and equity in the health system.23There are three main data sources for this review; (1) select databases, (2) grey literature and (3) reference tracking and citation tracking. To get a comprehensive understanding on patient rights implementation strategies and instruments from a multidisciplinary perspective, three databases PubMed , Web of Science  and LexisNexis (law) will be searched in a systematic manner for all types of evidence  broadly on key concepts such as patient rights, patient rights instruments and person-centred care. The related terms reflecting the key concepts will be used as search terms in the databases see . The sea10.1136/bmjopen-2020-038927.supp2Supplementary datath April 2020.The aim of the literature search is to maximise the possibility of identifying the conceptually rich articles to enable theory building. Hence, in the database searches, no specific start date will be mentioned. However, the end date for the database search will be 30As indicated in the state of the art literature on patient rights, it is clear that the available scholarship is mostly from the European contexts. It is expected that there will be limited empirical work on the patient rights in the LMICs. In order to increase the transferability of the theoretical framework to the LMIC settings it was decided that all types of evidence  in English from both LMICs and high-incomecountries will be included in this review.The review will be conducted between 15 April 2020 and 15 August 2020.Systematic search for the articles on patient rights implementation in the selected three databases.Identifying the relevant articles in grey literature and through citation and reference tracking.Title and abstract review of the articles to identify the relevant articles that are concordant with the initial review question.Creating a sampling frame of all articles.Purposive sampling of the articles from the sampling frame that point towards relevancy and conceptual soundness.Applying the quality appraisal criteria for the individual papers. Perform sensitivity analysis to strike a balance between methodological rigour and conceptual breadth and depth of the study. To give more weightage to the articles that score high on quality.Initial data extraction on the study characteristics.Concept mapping in the retrieved literature and identification of the conceptual gaps.Repeating the search in the selected databases, grey literature, citation tacking and reference tracking to fill the conceptual gaps until a theoretical saturation is reached and refining the synthesising argument, that is, ‘theoretical framework’ on the patient rights implementation.The article selection process is schematically shown in Since the review uses articles emerging from at least three diverse disciplines , finding a common quality assessment framework is challenging. However, it is expected that majority of the empirical work will be of qualitative in nature. Hence, the quality of the studies will be evaluated using the Hannes criteria (2011)10.1136/bmjopen-2020-038927.supp3Supplementary data10.1136/bmjopen-2020-038927.supp4Supplementary dataThe usefulness of the formal data extraction sheet for a complex review topic that uses critical interpretive synthesis technique is questioned.10.1136/bmjopen-2020-038927.supp5Supplementary dataPatient and public involvement is not applicable in this review as the research uses already published literature.The CIS approach used in the evidence synthesis is inductive and iterative in nature. The retrieved items/papers will be critically analysed for patterns and themes that explain the phenomena of patient rights implementation in the literature. By constant comparison of the theoretical constructs with the data in the papers, the relationships between the theoretical constructs will be identified. The conceptual gaps identified will be further filled with subsequent search and analysis of the literature. The aim is to be critical while synthesising the evidence by questioning; (1) the ways in which the patient rights has been problematised or represented to be in the literature and (2) the underlying assumptions behind the policy options or the implementation strategies for patient rights. The synthesis of the evidence retrieved in this review would thus result in a unifying framework  on the implementation of patient rights from a multilevel governance perspective that is grounded in the data.Rights and responsibilities goes together. The review focusses on the rights of the patient and we do not venture into the obligations of the patient in the healthcare processes. Patient rights pertaining to health research context and specific conditions such as mental health disorders, disabilities, genetic screening, euthanasia and advance medical directives merit specific consideration and hence these are out of the scope of this review. In this review we deal with the institutional arrangements for patient rights protection in the healthcare facilities that are formally recognised and considered legitimate by the state. We exclude the healthcare facilities run by the informal healthcare providers. The international institutional mechanisms such as the Office of the United Nations High Commissioner on Human Rights (OHCHR), the Human Rights Council, and so on, are not touched on in this inquiry mainly because of the time constraints.Ethical approval will not be required because this study will retrieve and synthesise data from already published literature. The findings of this review will be published in a peer-reviewed journal.


No previous studies in Mexico have been found that jointly analyze physical and leisure activities as variables related to mental health in police officers. This paper presents research on burnout in Mexican Police officers. The question it answers is: is there any association of burnout with physical and leisure activities and personal profile? A total of 276 police officers (87% men and 13% women) participated. To obtain information, the Spanish Burnout Inventory and the Operational Police Stress questionnaires were used. A cross sectional study design was utilized with tests of validity and reliability, goodness of fit, analysis of variance (ANOVA), and analysis of k-means clusters. Results showed that a high number of policemen had high prevalence of burnout and a high level of mental exhaustion, and that exercise was positively and significantly related to lower burnout risk. Men showed higher risk than women. Results should be considered to improve interventions and occupational health practices in the police force. This paper improves understanding of burnout among policemen and the importance of exercise and leisure activities to alleviate burnout. Burnout has been a topic of interest for academics and professionals for the last five decades ,2,3,4 A Researchers have found that main consequences of burnout include withdrawal from work, overwhelming feelings of exhaustion, ineffectiveness and detachment at the workplace, lack of job involvement and low job accomplishment, physical fatigue, and dehumanization, also known as depersonalization. Impaired work performance as a consequence because of negative attitudes and behaviors is also mentioned. This syndrome develops feelings of exhaustion, cynicism, and a personal lack of accomplishment according to Maslach et al. . To identify and find new evidence relating to burnout is of great importance for organizations to prevent further negative consequences.Nowadays, the interest in this topic has grown all over the world since evidence shows that it is associated with negative job consequences such as absenteeism, presentism, turnover, negative health outcomes such as insomnia and sleep disturbances, depression, anxiety, impaired job performance, fatigue, irritability and frustration, cynical attitudes, professional inefficacy, depersonalization, neglect, withdrawal from work, diminished professional efficacy and poor quality of life ,22,23. IThe literature on burnout and Police officers has been extensive, associating this profession with a high risk of burnout as a negative long-term consequence of the job ,26,27,28One of the most stressful professions is police work  in whichDespite the fact that numerous studies have been conducted on the analysis of burnout in police officers worldwide ,35,36,37Implications can be of high importance in preventing further consequences. Previous studies of police officers have found a strong association between psychosocial risks and job pathologies derived from burnout ,41,42. FThe population of the State Police in Baja California is 3800 officers including administrative employees and preventive police officers. From this figure, 844 active officers belong to the Municipal Police in Ensenada, where the study was performed. From this number, 154 police officers retired and only 30 new officers were recruited in 2018 in Ensenada, this according to information from the Administrative Office of the Municipality. In addition, in the same year, three municipal police officers were killed. Eleven others were released from their positions due to failing the control and trust examinations, another for absenteeism, another for working under the influence of alcohol, and one officer is currently suspended after being arrested in the United States on charges of drug trafficking, according to reports from the public prosecutor’s office.n = 696. Analyzing this number, there should be 300 officers per every 100,000 inhabitants (according to indicators of the Citizens’ Council of Ensenada), and if the population of Ensenada is estimated to be half a million, there should be at least 1500 active police officers.At this date, active police officers in Ensenada is When analyzing the number of active police officers currently available, it is observed that most suffer from addictions and severe post-traumatic stress due to the high criminal rates they are facing and the acute deficit of officers in the municipality. In these conditions, a large number are exposed to psychosocial work issues and emotional exhaustion. Adding to this situation, more than 1280 murders were reported in the state last year and it is considered one of the states with the highest incidence of murders all over the country. Police forces’ precarious budgets, low wages and lack of social security add to this situation . The State Police Force faces high turnover and poor “team spirit” based on poor solidarity and group cohesion, poor social recognition of the value of the professional function and merit, and lack of institutional resources for effective and sufficient protection . A lack finding time to stay in good physical condition”. It is not specific and it does not include minimum time or type of exercise. This is a question that allows the policemen to reply if they feel they are in good shape due to exercise. Other studies using the McCreary questionnaire mention that the different types of physical activity and treatment modalities used in the included studies impede clear conclusions. However, sport or exercise type as long as it is regular does not seem to be decisive for the effectiveness of the exercise-based therapy. For leisure activities, the purpose was to make friends outside the job and to extend their social life. Like physical activity, leisure type does not seem to be decisive for effectiveness as long as the intention of making friends and having a social life is fulfilled [The McCreary questionnaire includes an item that mentions “ulfilled ,49.The relationship between stress, burnout and healthy activities has been a subject of interest for academics and professionals over the years. Important findings have shown consistent association between them; the higher stress and burnout, the poorer physical and mental health will become. Adverse health symptoms related to burnout are affecting the quality of service of Policemen . Strong The aim of this study was to examine the relationship between burnout, physical, leisure activities and personal profile in Mexican police officers. The following hypotheses have been formulated:Hypothesis 1 (H1).Significant differences exist in the prevalence of burnout syndrome between police officers who engage in physical activity and those who do not.Evidence shows that physical activity has a significant negative correlation with burnout. Exercise programs change the cause-effect relationship between burnout and metabolic syndrome components, improving mental health and physical wellbeing . A well-Hypothesis 2 (H2).Significant differences exist in the prevalence of burnout syndrome between police officers who engage in leisure activity and those who do not.Evidence shows that leisure activity has a significant negative correlation with burnout. Organizational encouragement of team members to participate in leisure activity promotes workplace involvement, motivation, provides social opportunities for employees to interact and has a positive impact on mental health ,58,59. Hypothesis 3 (H3).Significant differences exist in the prevalence of burnout syndrome between police officers with stable marriages and single officers.Evidence shows that single individuals present higher emotional exhaustion and depersonalization than married ones and show lower personal achievement . Single Hypothesis 4 (H4).Significant differences exist in the prevalence of burnout syndrome between male police officers and female police officers.Evidence shows that women present higher work related stress and burnout than man due to their double roles . Women aHypothesis 5 (H5).Significant differences exist in the prevalence of burnout syndrome between police officers with daily operational stressors and police officers with occasional operational stressors.Evidence shows that stress and burnout perceived by police officers that work in areas of extreme violence is higher . IndividThis study used primary data collected from police officers from the Municipal Police Force of Ensenada, Mexico. The population of policemen in Ensenada consisted of 720 officers. A census was applied to the total population. Questionnaires were delivered and 276 were completed and returned. This represents 38.33% of the total. The police headquarters were used for the application of the survey, requesting authorization from high-ranking officers. Participation was voluntary for all police officers. The complete workforce was invited to participate. For the purpose of measuring burnout, the (SBI) Spanish Burnout Inventory  was usedThe SBI (Spanish Burnout Inventory) questionnaire was developed by Gil-Monte et al.  and Gil-The McCreary & Thompson’s questionnaire  was also used to measure operational stressors of professional activity in police officers. Only the first nine items of this instrument were used due to their relation to the job elements. The rest of the items such as eating healthy, higher image, stigma, family, etc., were not related to this research and we decided not to include them. Items were evaluated with a Likert scale of 7 options ranging from “never” to “every day”. The questionnaire consists of 20 items that analyze indicators such as favoritism, administrative work, lack of resources, inequality in the workload, obsolete equipment, and their relation to the stress they cause. The lost values were replaced by the mean in cases where the percentage was less than 10% and, if it was higher, that case was eliminated.Extreme values were identified through the standardization of each item. Absolute values higher than four are considered extreme values and were replaced by the mean of the item.The information was entered into a database created in the SPSS software v.24 , where the rows represented each case and the columns represented the items in the questionnaires. For the cleansing of the database, the following was performed:This was a cross sectional design. The study analysis procedure was conducted in two moments. The first was validity analysis of the instrument to identify predictive capacity. In the second moment, a results’ analysis was conducted to evaluate the conditions of prevalence of burnout and the relation with personal profile, recreational activities, and physical exercise, thus validating the hypotheses suggested.A descriptive analysis of the information was conducted in which the sample mean, the standard deviation, and Cronbach’s alpha were obtained for each analyzed dimension. The higher the score obtained in the items (close to five), the higher the prevalence of the syndrome, whereas a lower score lowers the prevalence of the syndrome.For the validity analysis of the instrument, an analysis of the Spearman’s correlations, Cronbach’s alpha and exploratory factor analysis was conducted with the aim of validating the conditions of convergence, divergence, and the reliability of the instrument.Likewise, for the results’ analysis, an analysis of k-means clusters was conducted under the nearest neighbor method with the purpose of identifying the determining attributes that could generate persistence of burnout syndrome. Additionally, an analysis of variance (ANOVA) was conducted with the purpose of identifying how after-work activities , demographic conditions , and work conditions (working hours) can decrease or generate the prevalence of the syndrome. Normality of random errors, homogeneity of variances and compound symmetry tests were performed.This study was performed accordingly to the written informed consent from all policemen participants. The protocol was approved by the Postgraduate Department Committee of the Faculty of Administrative and Social Sciences of Universidad Autonoma de Baja California, according to the NOM-035-STPS-2018, the ethic statement was reviewed and approved.The questionnaire was applied to 276 preventive police officers in Baja California (87% men and 13% women). 82% have a high school education, the remaining 18% have a bachelor’s degree, and their ages fluctuate from 23 to 42 years old. 58.7% have a seniority of 6 to 10 years, 34.8% of 2 to 5 years, and the rest of 11 to 15 years. All were volunteers in the sampling.From the total sample, 3% work in operational areas and the rest in technical areas. Of the total, 60.9% of them are married, 26.1% single, and 13% live in civil union. 50% mentioned working 60 h a week, whereas only 32.6% stated working 48 h a week. All work to a mixed schedule. A total of 43.5% generally experience shift changes, whereas 19.6% only work the night shift. A total of 34.8% mentioned usually working overtime and 26% claimed to always work on their days off. Regarding their safety, 32.4% mentioned usually feeling at risk of being injured in their job and 13% stated feeling that way very often. They also mentioned the lack of protective gear since they are not given bulletproof vests; they must buy them themselves.A total of 43.4% mentioned handling traumatic events such as shootings, clashes, deaths, and wounded people very often. Regarding health, 23% were suffering from gastritis, 21.7% from back pain, 6.5% from insomnia and neck pain, and 2.2% suffer food-related anxiety. A total of 52.2% do not engage in any sport, 73.9% do not practice any recreational activity, and 52% stated that any personal life outside work does not exist.In Regarding the dimension of mental exhaustion, aspects related to personal work over-saturation, the existence of burden-related feelings, physical exhaustion, and emotional exhaustion are conditions observed in 39% of respondents. This condition is similar to attributes of the dimensions of guilt and indolence, in which those aspects related to concern for working with people, to the existence of guilt-related feelings and remorse, to the absence of attention and the indifferent and ironic treatment of those requiring attention, are conditions that are present in the professional work of the studied sample.By comparing the scores in this study with other research that used the same questionnaire, it is possible to notice that the studied sample presents on average lower levels of the prevalence of burnout, considering that, in the case of teachers in the Mexican context, the dimension of mental exhaustion is more frequent  and in tRegarding asymmetry values, their absence is recognized, taking into account that it shows values of less than one in (A ≤ |1|) absolute value; this condition corroborates the normality of the scale, which is necessary for the analyses that are shown in this study. In light of this, it is important to highlight that, in the studies with which the scores of the burnout scale were compared, in most of the items the absence of a scale of normality is shown, which ostensibly affects the expected results.From the analysis of k-means clusters via the criterion of the nearest neighbor, it is possible to identify two sample groups.The first group consists of 45% of police officers and is characterized by regularly presenting the operational processes of their professional activity: shift changes, working night shifts, request to work overtime, risk of being injured at work, working on days off, handling traumatic events, not having time to spend with family and friends, and a lot of paperwork for the performance of their tasks. This cluster was named ‘cluster with daily operational stressors’. Likewise, the second group consists of 47% of police officers and is characterized by occasionally presenting attributes relating to operational processes of their professional activity. This cluster was named ‘cluster with occasional operational stressors’.p value ≤ 0.01) between the two identified clusters. This shows that the changes in the level of stress perceived by operational activities carried out during professional work by the studied subjects are directly due to multidimensional conditions that are not manifested individually, but conversely. For a variation of the stress perceived to occur, adverse operational conditions must be presented jointly . Here, two sample groups are identified. The first consists of 60% of the police officers surveyed, who perceive work as a source of personal realization, gratification and excitement, and as a challenge. In addition, they almost never feel swamped, overwhelmed with physical and emotional exhaustion or with guilt-related feelings, and they rarely assist citizens in an indifferent, ironic, or mean way. For this reason, this group was named ‘cluster with absence of burnout syndrome’. The second group consisted of the remaining 40% of police officers. This was characterized by almost never perceiving work as a source of personal realization, gratification, excitement, or as a challenge. Members of this group feel swamped, overwhelmed, physically and emotionally exhausted with guilt-related feelings, and tend to treat citizens in an indifferent, ironic or mean way. For this reason, it was named ‘cluster with prevalence of burnout syndrome’.Likewise, an analysis of k-means clusters was conducted using Euclidean distance via the criterion of the nearest neighbor with the aim of identifying groups of subjects who present, among the attributes of burnout syndrome, highly significant differences  between the two identified clusters. This shows that the attributes that generate prevalence of burnout syndrome are: not to see work as gratification, not to see work in a positive way, to feel swamped or overwhelmed with physical and emotional exhaustion, to have feelings of guilt and remorse regarding work-related attitudes, not to assist citizens who require service, and to assist them with indifference or in a mean, ironic and disrespectful way  see  was condp value ≥ 0.05); whereas engaging and not engaging in sport activities show significant differences in the dimension of mental exhaustion . There are also significant differences between men and women in the dimension of mental exhaustion ; and there are significant differences between the cluster with occasional operational stressors and the cluster with daily operational stressors in the dimensions of mental exhaustion and guilt .In The above allows us to accept the first hypothesis that there are significant differences in the prevalence of burnout syndrome between professionals who engage in sport activities and those who do not; hypothesis four which states that there are significant differences in the prevalence of burnout syndrome between professional men and women; and hypothesis five which states that there are significant differences between professionals with daily operational stressors and professionals with occasional operational stressors. It is emphasized that these are accepted, considering that the hypotheses were not comparing the totality of the dimensions of the burnout syndrome, only the dimension of mental exhaustion for each of the groups to be contrasted, plus the scale of guilt for the last group. Below, we find The aim of this investigation was to identify the prevalence of burnout in 276 State Police officers in Baja California, and its relationship with personal profile. The percentage of police officers who show warning signs of burnout syndrome was 40%, considering that these have a lower level of work excitement and a higher level of mental exhaustion. This proportion is very similar to what has been found in other professions in Mexico, as in physicians in Guadalajara with a percentage of 42.3% ; in poliThis study has helped to understand the effects of burnout in a sample of police officers. Preventive measures must aim to improve the quality of life of this sector of employees, who are vulnerable not only in their safety but also in the protection of their mental and physical health. Burnout is a silent enemy that affects the whole organization, reduces performance and the quality of service, and prevents staff from performing with efficiency. The practice of sport and recreational activities, as observed, must be a priority for police officers on a daily basis due to the moderating effect of these activities and their feature as a stress and burnout reducer. This should also be considered as an intervention method for police officers that present higher levels of burnout. Prevention must be aimed at addressing the structure of sport and individual leisure activities in order to diminish exposure to stress, promote autonomy and support and increase coping resources and strategies. Taken together, we hope that these findings will enable police head supervisors to better recognize burnout and its risk factors and help prevent its development.In Mexico, although a regulation was recently established in the Federal Labor Law that recognizes burnout as a psychosocial disease, there have yet to be measures put in place to monitor the condition of the policemen who suffer burnout. Likewise, it is recommended that a program is implemented that provides the necessary support to police officers, since it is observed that this phenomenon is increasingly common among these professionals. Also, rehabilitation programs should be implemented for those with problems with addictive substances, and psychological support programs to improve their quality of life in the face of the post-traumatic stress they suffer.The theoretical implications of these findings have similarities with other studies conducted in European countries where the results of Figueiredo-Ferraz et al.  and Gil-We can conclude that organizations and public institutions in Mexico need to pay increasing attention to the organizational behavior of employees. As long as institutions develop a perspective on employee well-being as a means for the institution to improve quality of service and productivity, we will start to see changes such as improved engagement, less exhaustion, and happier employees that use physical activity and leisure activities as part of their daily routine to keep a positive mind set and avoid medication and drug addiction, so common nowadays, to alleviate anguish and depression related to burnout.Police forces in Mexico are facing huge challenges every day in a chaotic situation that endangers their life and puts them in a continuous state of worry which exacerbates their burnout. As shown in this study, policemen who exercise have lower rates of burnout development. Interventions should be applied with the purpose of daily activity as part of the policeman’s routine. Physical activity must become a mandatory requirement in their daily lives to stay healthy and socially involved and to improve their circle of trust and acceptance at the job site. Policemen in Mexico urgently need to be rescued from the daily nightmare in which they live: urgent attention to this topic needs to be paid and studies of this kind must be pushed to call the attention of the authorities and academics to the problem and its implications.The main contributions to this research are the findings that show interventions and occupational health practices in the police force as a means of preventing worst case scenarios of burnout in Police Officers. This paper improves the understanding of burnout among policemen and the importance of exercise and leisure activities to alleviate burnout; therefore, serious attention should be paid to this matter that contributes to alleviate and reduce burnout syndrome and mental ill-health issues in this group of workers that are severely affected by their daily work routine.In regard to gender differences, as shown in this research, there were significant differences between women’s and men’s burnout measurement. Research showed that, due to their double roles, traditional trends and responsibilities, women are at higher risk of burnout ,62,63,64From the results, it is recognized that similar research with larger samples is needed. Additionally, it is emphasized that there is a need to investigate the link between operational and organizational stressors in the prevalence of burnout syndrome in the professional activity of the police in future studies. There is still a need to investigate the relationship between burnout and physical and leisure activity in longitudinal studies. The individual and social impacts of burnout in policemen highlight the need for preventive interventions and early identification of this health condition in this environment. Therefore, future studies should deal with the specific efficacy of different exercise modalities and their combination, with further cognitive behavioral interventions. It would be interesting to study in greater depth the link between sports activity and burnout prevention. Further research is suggested in this regard, considering type and frequency of sports and impact on burnout.The main strength of the study was the evaluation of burnout syndrome occurrence in a population of police officers’ exposed to external extreme violence, as well as findings related to physical activities that were highly significant and positive. This opens opportunities for preventive interventions that can improve the quality of life of police officers and reduce negative impacts.The limitations of this research were the sample size that could not be larger because of the small number of police officers working in the city at the time of the study. The answers to the questionnaire could have been influenced by fear of retaliation from their immediate supervisor, which raises worries about worse scenarios that could not be detected. Follow up of cases where addictions or severe health issues were detected was not possible due to the cross sectional study performed, and intervention was not part of the study.To conclude, we have examined burnout syndrome and its relation with physical and leisure activities. The results showed that physical and leisure activities play an important role in the police officers well-being. These activities showed to have an impact in reducing negative emotions and promoting well-being. These findings should be taken into consideration by police corporations during the evaluation and assessment process to prevent policemen risk factors associated to burnout. Strategies that promote a healthier lifestyle and education programs about the benefits of regular physical exercise and leisure activities should be created. According to Norm 035-STPS-2018, programs that focus con occupational stress and burnout management should be implemented in police forces to allow the emotional discharge of tension build up by their labor activity. This study is expected to bring attention to the benefits of health promotion in the police forces. Interventive actions will help to reduce and alleviate psychological risk factors and disorders that are associated with burnout. New research should be focused on the effect of different types of physical and leisure activities related to burnout reduction.


Introduction: Medical quality indicators (QI) are important tools in the evaluation of medical quality. Their development is subject to specific methodological requirements, which include practical applicability. This is especially true for intensive care medicine with its complex processes and their interactions. This methods paper presents the status quo and shows necessary methodological developments for intensive care QI. For this purpose, a cooperation with the Association of the Scientific Medical Societies’ Institute for Medical Knowledge Management (AWMF-IMWi) was established.Methodology: Review of published German manuals for QI development from guidelines and narrative review of quality indicators with a focus on evidence and consensus-based guideline recommendations. Future methodological adaptations of indicator development for improved operationalization, measurability and pilot testing are presented, and a development process is proposed.Results: The development of intensive care quality indicators in Germany is based on an established process. In the future, additional evaluation criteria (QUALIFY criteria) will be applied to assess the evidence base. In addition, a continuous exchange between the national steering committee of the DIVI responsible for QI development and guideline development groups involved in intensive care medicine is planned.Conclusion: Intensive care quality indicators will have to meet improved methodological requirements in the future by means of an improved development process. Future QI development is intended to improve the structure of the development process, with a focus on scientific evidence and a link to guideline projects. This is intended to achieve the goal of a broad application of QI and to further evaluate its relevance for patient outcome and performance of institutions. The development of intensive care quality indicators (QI) in Germany was initiated by a working group within the German Society for Anaesthesiology and Intensive Care Medicine (DGAI), which aimed to develop evaluation tools for the quality of intensive care. A selection of core processes out of existing Spanish QI seemed to be adequate for this purpose . The selThis contrasts with the development of quality indicators, e.g. from treatment guidelines recommendations, in which the potential for quality improvement has to be determined beforehand (“top-down”) , 5], , , , . In addiIn the following sections, the steps for the development of the next edition of QI, which will be published in 2021, are described and presented for discussion. The evaluation of existing indicators, the development of new indicators including pilot testing, the definition of suitable key figures, and the cooperation in the development process will be addressed.As a first step in the development of the next version of intensive care QI, evaluation criteria were defined, which are based on the QI evaluation instrument QUALIFY . They inimportance for the health care system/potential for improvement,risks of undesirable effects, clarity of definition, evidence- and consensus-based (in guidelines),potential to be influenced by health care providers. These rules differ from the RUMBA system used to date Table 2 . The comAs described in section 2.1, the methodological basis for indicator modification was not rigidly defined. By applying the criteria listed in Table 2 First a review is carried out in the NSPR on the basis of proposals for new indicator topics from the medical societies that are members of the DIVI. Figure 1 Based on the strength of the evidence, the indicator strength will mainly be determined by consensus. This makes sense, since a high level of indicator evidence may still be available if there is an obvious correlation between process fulfilment and outcome (e.g. if no direct studies are possible) .It is desirable that the aspects mentioned in sections 2.3 and 2.4 are pilot tested before a newly developed QI is generally applied. The test focuses on acceptance (by the user) and methodological suitability, including proof of validity, statistical aspects and indicator evidence . The staThe definition of key figures and reference values has so far been based on expert consensus within the NSPR and was based on the existing literature or known indicators. Reference ranges  were determined in a similar way. In the future, determination of indicator key figures and their limits is a central aspect for the development and use of indicators. Two aspects will be essential in this context:collection of valid data to be able to calculate indicators,evaluation of the indicators in relation to the established reference ranges.As mentioned in the previous section, these questions are of particular importance when assessing QI in test phases. As shown in Table 2 In the future, the evaluated indicators should be actively shared with guideline development groups working on intensive care topics Figure 2 . This shThe development and use of quality indicators aims to improve treatment processes and patient outcome. The QI for intensive care medicine of the DIVI meet these requirements. However, as is presented in this paper, there is potential for improvement in the development of the QI in some areas. These relate to the evidence basis of the QI at the patient level and the health care system level and also their definite operationalization to enable broad application. A considerable number of intensive care QI exist worldwide . Their mThe postulated “lack of evidence basis” of QI mentioned in this paper is not intended to discredit the QI developed so far, but to emphasize that the transfer of guideline recommendations into QI is a very complex issue and should therefore be done in a structured and comprehensible way. The following general rule applies: The higher the published evidence for the implementation of a treatment process, the stronger is the evidence for the use of an indicator that evaluates this process. This basically refers to the strength of evidence, especially of guideline recommendations, where this basic principle is based on evaluation criteria from the GRADE system such as inaccuracy, indirectness and inconsistency, as well as others. The evaluation of GL according to the GRADE system cannot be applied directly to QI. However, the described assessment criteria for the transferability of study results into actual treatment recommendations can have an influence on the QI, since GL are the basis of the QI as described, and problems with study safety (=certainty) affect the QI , 29]. I. I29]. IIn Germany, the possibility of standardized data collection, ideally in a digital format, is not available across the country. For this reason, local measurability must currently be considered when developing indicators. The process indicators of the DIVI are well suited for this. However, in order to meet important statistical requirements for a broader application of QI, it is necessary to obtain sufficient data volumes. Here, the opportunities offered by digitalization must be used consistently. In a next step, questions of the statistical evaluability have to be focused on: the question of content validity – that the QI actually measures what it is intended for –, the ability to discriminate between institutions, and the sensitivity to measure change over time, e.g. to detect improvements or failure to improve. Finally, the data have to be consistent enough to evaluate an outcome effect of the indicator in use, since this effect should be as large as possible. The sufficient amount of data can only be collected through the broad implementation of patient data management systems (PDMS) in all ICUs. This would enable low-cost data collection and cross-sectoral data collection on patient-centred outcome parameters , 32]. H. H32]. HWhen a QI is implemented, it is necessary to evaluate whether the chosen indicator is reliable and valid, and whether its measurement can initiate a process of change within an institution or system, and how this is presented. Benefit assessments of QI have to state whether the conclusions drawn from the QI evaluation are reliable enough to prove a change in processes. For the use of QI – at least in intensive care medicine – a positive influence through the use of indicators on patient outcome has not been proven yet. It is also not known if QI can have a negative impact on patient outcome. For example, the application of sedation pauses, as is recommended, might increase the rate of self-extubation, which in itself might pose a risk to the patient. Valid data on this question do not exist. Therefore, a formal risk assessment should be integrated into the QI development process whenever possible. If necessary, an indicator must be withdrawn or amended in such a case.The type of indicator used also plays a role in the benefit assessment. In intensive care, there are some arguments in favor of using process indicators, as they are easy to measure and do not require risk adjustment for disease severity. However, in the literature some indicators are referred to as “process indicators” even if they query a result, e.g. rate of ventilator-associated pneumonia (VAP) as an indicator of appropriate hand hygiene . This woFor the quality dimensions proposed by Donabedian, not only process indicators are considered useful to evaluate a quality problem, but also structure and outcome indicators . In the The following statement by Califf et al. represents an “ideal state” in quality management and quality assurance: “In an ideal clinical world, for every clinical decision there would be an indicator based on a guideline based on evidence from randomized trials” . It is uAWMF: Association of the Scientific Medical SocietiesDIVI: German Interdisciplinary Association for Intensive Care and Emergency MedicineGBA: Federal Joint CommitteeGL: guidelineGRADE: Grading of Recommendations Assessment, Development and EvaluationIQTIG: Institute for Quality Assurance and Transparency in Health CareNSPR: National Steering Committee Peer ReviewNVL: national disease management guidelineQI: quality indicatorQS: quality assuranceVAP: ventilator-associated pneumoniaThe authors declare that they have no competing interests.


Core outcome sets seek to improve the consistency and quality of research by providing agreed-upon recommendations regarding what outcomes should be measured as a minimum for a population and setting. The problems arising from a lack of outcome standardization in population-based cancer survivorship research indicate the need for agreement on a core set of patient-reported outcomes (PROs) to enhance data quality, consistency, and comparability.This study aims to identify a core set of PROs, representing the most important issues impacting on cancer survivors' long-term health, functioning and quality of life, to inform population-based research on cancer survivorship.In Phase I, a list of all potentially important outcomes will be generated through focus group discussions with cancer survivors and a review of measures for assessing quality of life in cancer survivorship. The consolidated list will be advanced to Phase II, where a stakeholder consensus process will be conducted with national experts in cancer survivorship to refine and prioritize the outcomes into a core outcome set. The process will consist of a two-round Delphi survey and a consensus meeting. Cancer survivors, oncology health care professionals, and potential end users of the core outcome set with expertise in cancer survivorship research or policy will be invited to participate. In Phase III, recommended measures for assessment of the core outcome set will be selected with advice from experts on the assessment, analysis, and interpretation of PROs.As of April 2019, data collection for Phase I is complete and data analysis is underway. These data will inform the list of outcomes to be advanced into Phase II. Recruitment for Phase II will commence in June 2019, and it is anticipated that it will take 6 months to complete the three-step consensus process and identify a provisional core outcome set. The study results are expected to be published in early 2020.Expert consensus-driven recommendations on outcome measurement will facilitate the inclusion of survivorship outcomes considered important by cancer survivors and health professionals in future research. Adoption of the core outcome set will enable comparison and synthesis of evidence across studies and enhance the quality of PRO data collected in cancer survivorship research, particularly when applied to address macro-level questions.DERR1-10.2196/14544 Due to the increasing incidence of cancer and advancements in its detection and treatment, the number of people living with cancer as a chronic condition is increasing ,2. With The potential uses of PRO data can be understood using the Lipscomb framework for cancer outcomes research, which proposes three arenas for the application of PROs: micro, meso, and macro . At the A challenge in PRO research is the lack of standardization and comparability of scores from different PROMs. For any given outcome, there may be multiple measures developed for different purposes, populations, and disciplines. Core outcome sets have been proposed as a way of addressing these problems. A core outcome set is a recommended, standardized, and minimum set of outcomes to be measured and reported in research on a specific health condition and which should be agreed upon by relevant stakeholders ,8. By stThis study aims to develop a core outcome set, recommending what PROs should be collected as a minimum for surveillance of cancer survivorship concerns in Australia and how these outcomes should be measured. The need for a set of outcomes applicable to all cancers is underscored by research identifying issues common across cancer sites in the long-term  includinThe core outcome set will be developed using a comprehensive, stepwise approach based on recommendations for core outcome set development  and prevThe research will involve three phases:Phase I: Identifying all possible outcomes relevant to cancer survivorship via focus groups with cancer survivors and a review of available PROMs.Phase II: Reaching expert consensus on the most important outcomes for inclusion in the core outcome set.Phase III: Determining how to best measure the core outcomes. This study has been approved by the University of South Australia Human Research Ethics Committee (application number: 200370)In Phase I, a list of possible outcomes will be generated via two processes: (1) focus groups with cancer survivors and (2) a review of cancer survivorship PROMs.Focus groups will be conducted with adult cancer survivors to explore their experiences of living with cancer and its impacts on physical, functional, social, and psychological health and wellbeing. Five focus groups of 8-10 participants will be held with cancer survivors in Adelaide and Sydney.Adult cancer survivors who are over 18 years of age, English speaking, have been diagnosed with any type of cancer, and are not currently undergoing primary treatment will be eligible to participate. A diverse sample of participants in terms of age, geographical location and cancer type will be sought to ensure that a range of views are considered. Participants will be recruited via the networks of the University of South Australia and state and national cancer organizations. The study will be advertised on social media, the University of South Australia Cancer Research Institute volunteers website, and flyers posted at the University of South AustraliaThe focus group discussions will be guided by open-ended questions about the long-term impacts of cancer and treatment on everyday life.A list of outcomes derived from the transcribed focus group discussions will be generated and organized into a conceptual PRO framework. The outcomes will be periodically reviewed and modified, where necessary, to ensure fit with the data.To determine the outcomes considered relevant in cancer survivorship research, an updated review of PROMs developed to assess quality of life in long-term cancer survivors will be conducted. In concordance with previous studies, long-term cancer survivors will refer to people who have been diagnosed with cancer, are not currently receiving primary treatment, and are likely facing challenges and symptoms unique to those experienced by cancer patients under treatment and the general population .English-language papers describing the characteristics of PROMs developed to assess quality of life in long-term adult cancer survivors will be included. PROMs developed specifically for pediatric cancer survivors will be excluded.Searches for peer-reviewed articles will be performed in Medline, EMBASE, CINAHL, Scopus, the Joanna Briggs Institute Database of Systematic Reviews, and the Cochrane Library. Indexing terms and subject headings for each database will be added.Identified articles will be classified based on the PROMs they refer to. For each measure, the intended population, number of items, included dimensions or constructs, study sample, scoring information, and tested validity and reliability will be extracted. A list of outcome domains will be extracted from the identified instruments and examined for overlap in content and terminology, consistent with the approach taken by Macefield et al  for esopThe list of outcome domains will be used in Round 1 of the consensus process. To consolidate the list, the outcome domains derived from the focus groups and review will be combined and examined by the research team to ensure that there is no duplication and that definitions are clear. The following three criteria adapted from Reeve et al  will be The consensus process will incorporate a three-step modified Delphi method. The Delphi method involves administering sequential surveys anonymously to a group of selected experts. The process traditionally begins with open-ended questions that are subsequently refined through a series of rounds, interspersed with controlled feedback based on the group views, until consensus is reached ,12,20. TTo refine the list of outcomes identified in Phase I into a cancer survivorship core outcome set, key stakeholders will be invited to participate in an online Delphi survey. The list of outcome domains will be formatted into questionnaire items and participants will be asked to rate the importance of each item for inclusion in the core outcome set, with higher scores indicating higher importance.Recent methodological work has demonstrated the importance of receiving feedback from different groups of stakeholders in order to reach consensus on a core outcome set . TherefoAs it is common practice to purposefully select experts to participate in a Delphi process, health and research professionals with cancer survivorship expertise will be identified via professional networks. Focus group participants will be invited to participate and, if necessary, additional cancer survivors will be identified via the same recruitment channels as the focus group participants. All identified stakeholders will receive an email outlining the aims and significance of the research, with a link to register their interest in participating. Online registration will be open for 4 weeks, and two reminder emails will be sent. Written consent will be obtained from the study participants.All registered stakeholders will receive an email detailing the study purpose, a participant information sheet, and a link to the online survey for Round 1. The participant information sheet will explain the study background and objectives, intended end use of the core outcome set, key definitions, and ethical considerations in lay terms. The survey will contain questions about participants’ demographics and expertise in cancer survivorship and the list of outcome domains formatted into items. Participants will be asked to rate the importance of each item for inclusion in a core outcome set for surveillance of the long-term impacts of cancer on quality of life using the 9-point Grading of Recommendations Assessment, Development and Evaluation (GRADE) scale for the quality of evidence of outcomes. The GRADE scale has been previously used in the development of core outcome sets involving the Delphi technique ,24. ScorScore allocations from Round 1, for each panel and overall, will be presented to participants along with the link to the Round 2 survey. A recent trial found that the type of feedback given to participants  did not influence voting . After rItems with a median score ≥7 and an interquartile range no larger than two units, that receive rankings of 7-9 by ≥70% of participants and 1-3 by ≤15% of participants after Round 2 will be eligible for inclusion in a provisional core outcome set and progressed to the consensus meeting. There are no universally agreed-upon consensus criteria in Delphi studies; these thresholds follow published recommendations and previous core outcome set development studies in cancer ,26. To eDescriptive statistics will be used to summarize the results for each round, including the median score for each item and percentage of ratings between 1-3, 4-6, and 7-9. The results will be presented for each panel and overall. A measure of the distribution of scores will be presented for each outcome domain considered in Round 2. This is recommended because major disagreement can be masked by cut-off scores, which do not capture the strength of minority opinion .After Round 2, 10-15 Delphi participants will meet to review, discuss, and agree on a final set of core outcome domains. The participants will be purposively sampled from those who completed both survey rounds to ensure a range of perspectives are represented.After reaching consensus on the core outcome domains, the final step will be to identify and select measures for their assessment. The PROMs identified in the review will be evaluated by applying the OMERACT Filter 2.0, a tool for selecting measures that summarizes three key measurement properties: truth, discrimination, and feasibility . Truth rAs of April 2019, data collection for Phase I is complete and data analysis is underway. These data will inform the list of outcomes to be progressed into Phase II. Recruitment for Phase II will commence in June 2019, and it is anticipated that it will take 6 months to complete the three-step consensus process and identify a provisional core outcome set. The study results are expected to be published in early 2020.Problems arising from the heterogeneity of PROMs have been documented in cancer survivorship research  and otheThis is not the first core set of outcomes to be developed for all cancers, although it is unique in its scope and intended end use. In 2011, the National Cancer Institute’s Symptom Management and Health-Related Quality of Life Steering Committee led an international effort to identify a core set of patient-reported symptoms to be measured in all adult cancer treatment trials  as well In the Netherlands, Geerse et al  developeWe based the study methods on recommendations for evidence-based core outcome set development , guideliAlthough there is little scientific evidence regarding the optimal number of Delphi rounds, two or three rounds have been frequently recommended  and commAnother potential limitation is that we are conducting a review of cancer survivorship PROMs rather than of all outcomes that have been examined in cancer survivorship research, and therefore, we may not identify all possible relevant outcomes. This risk will be mitigated by additionally identifying outcomes in Phase I from focus groups with cancer survivors and providing Delphi participants with the opportunity to suggest additional outcomes in Phase II.This protocol describes the development methods for a core set of PROs to inform our understanding of the long-term impacts of cancer on survivors’ quality of life at a population level. Since the proposed set represents the minimum outcomes that should be collected and reported on, it can be supplemented with other outcomes or measures relevant to a given study setting or population. By providing consensus-driven recommendations from stakeholders with expertise in cancer survivorship research, practice, policy, and lived experience, the study findings will facilitate the inclusion of meaningful survivorship outcomes and enhance the quality and comparability of PRO data collected in survivorship research, particularly when applied to address macro-level questions.