Overtime is an international phenomenon, especially in some Chinese Internet technology companies, the 996 work regime is a common corporate atmosphere. This paper holds that overtime work is the result of a long-term dynamic game between employees and employers. In such a dynamic evolution process, employers and employees both cooperate and conflict, they will choose a strategy conducive to their own development through long-term learning and improvement.Based on the evolutionary game theory and principal-agent theory, this paper constructs a Through an in-depth study of the model and data simulation, the system has five equilibrium points, an ESS point, and a saddle point in any case. Accordingly, we put forward two theorems and three propositions, which are verified not only theoretically but also by data simulation. Besides, the strategies of the employees and the employers will evolve from the initial state to  or  under different situations. This is closely related to the initial parameters of the evolutionary game model and the payment matrix.By summarizing the influence of each parameter on the evolutionary path, we believe that fairness and information equivalence between employees and employers can effectively promote both parties to reach the Pareto optimal state. In other words, employees and employers need to communicate and share information promptly to ensure the unity of information acquired by each other and achieve a win–win situation. This paper contributes to providing theoretical guidance and practical enlightenment for organizations to manage employees' overtime behavior scientifically and improve their work psychology reasonably. Working hours are getting longer all over the world, and overtime has become very common, especially in China. Nowadays, China not only leads the world in economic growth but also attracts attention from other countries for its long-term and stable development. However, the development of productivity and the improvement of economic level have not freed employees from heavy work. On the contrary, overtime work has gradually become a new normal and a new culture in the workplace. According to the disclosure of the National Bureau of Statistics in April 2021, the average weekly working time of employees in Chinese enterprises is 46.4 h, 2.4 h higher than the legal maximum weekly working hours. At present, China is still a developing country, with an aging population, the advantage of labor resources will gradually weaken, and the phenomenon of overtime work may become increasingly severe.Another noteworthy circumstance in China is the 996 work regime, it derives its name from its requirement that employees work from 9:00 am to 9:00 pm, 6 days per week, i.e. 72 h per week . Some orThis paper holds that the 996 work regime is the result of a long-term interactive game between employers and employees. Whether employees choose to work overtime voluntarily or involuntarily, depending on the work atmosphere and the strategies of employers. In such a dynamic evolution process, employers and employees both cooperate and conflict, and they will choose a strategy conducive to their own development through long-term learning and improvement. In addition, employees are often at a disadvantage in information compared to employers, and the information asymmetry between them will also affect their strategic choices. In this context, we believe evolutionary game theory is an effective method to describe this universal social phenomenon.The evolutionary game theory originated from the research of evolutionary biology and was largely used to study the competition phenomenon in the process of biological evolution, which is based on the assumption of bounded rationality and limited information . The plaAs described above, the formation of the 996 work regime can be regarded as a dynamic evolution process between employers and employees, and evolutionary game theory has good applicability here. First of all, we review the causes of voluntary overtime work as well as the relationship between information asymmetry and overtime work.Voluntary overtime is defined as working overtime for positive reasons . The conFirstly and most crucially, to increase economic income. From the perspective of the economic utility analysis, overtime is a utility maximization decision made by employees based on their ability endowments under a given labor market wage rate, regardless of the group of employees . Under aSecondly, for an organizational culture characterized by overtime. The formation of organizational culture is influenced by the beliefs and values of the leadership , which iThirdly, for a sense of personal achievement. There are also some employees who are enthusiastic about their work and willing to devote a lot of spare time to their work. According to self-determination theory, when the degree of overtime self-determination is high, employees control overtime behavior with their own will, and the satisfaction of their independent needs brings positive emotions, which alleviates the negative psychological effects of overtime . FurtherAmong them, we believe that salary is the key factor affecting whether employees work overtime. A study has shown that low-paid employees have higher levels of burnout when they work overtime, especially when they work involuntary overtime . HoweverInformation asymmetry refers to a relationship in which one party has more or better information than the other . The conTo some extent, the information asymmetry between employers and employees also affects overtime behavior. Studies have pointed out that information asymmetry on employee productivity is the cause of low efficiency and long working hours. Since employers cannot observe the true productivity of employees, they use long working hours as a mechanism to screen out productive employees . In addiExisting researches mainly analyze employees' overtime behavior from the perspectives of management, organizational behavior, and psychology , 41, 42.This paper has made contributions in the following aspects: (a) We use the evolutionary game model to solve problems in organizational behavior, which is a convergence of disciplines. (b) We include information asymmetry into the game model and conduct simulation experiments to quantitatively study the impact of information asymmetry on voluntary overtime work of employees, which is a supplement to existing overtime literature. (c) We use the principal-agent theory to construct the hypothesis and payment matrix, which is an extension of the theory.The most commonly used model in evolutionary game is the two-party game model. In the simplest two-player game, players are given a finite number of strategies, and the game is defined by listing the strategies players use and the benefits they generate . If each dilemma . Evoluti dilemma . RD was  dilemma , it refe dilemma .In a two-party game, let i.ii.if both comparisons in (i) are equalities, then either , 49 \docThe equilibrium condition (i) maintain that Let ation is , 50\docuFrom an organizational point of view, working hour is an important criterion for the game between employees and employers, because the unreasonable working hour and remuneration are important factors for labor conflict. In the labor market, labor supply has exceeded demand for a long time, resulting in serious inequality in labor-capital relations, and employers play a dominant role in the game of labor-capital power.The principal-agent theory is the application of asymmetric information game theory in economics, it studies the optimal transaction contract under the condition of asymmetric information. Specifically speaking, principal-agent refers to a contractual relationship in which a person or some people  entrust others (agents) to engage in certain activities by the interests of principals, and correspondingly grant agents some decision-making rights . In thisAccording to principal-agent theory, the employer can be regarded as the principal and the employee as the agent in our game. Overtime work behavior is the result of a long-term dynamic game between employees and employers. The unequal status of labor and capital causes information asymmetry between employees and employers, and employers play a dominant role. In order to maximize corporate profits, employers have a strong incentive to manipulate employees' working hours and turn it into reality. However, due to information asymmetry, it is difficult for employers to determine whether employees are working overtime effectively, and thus pay employees at all levels equally for overtime. Similarly, employees who choose to volunteer overtime also have a hard time judging the authenticity of positive messages from employers, which tend to avoid negative messages in order to increase employee motivation and loyalty. In principal-agent issues, information asymmetry after a contract is signed can lead to moral hazard , so in oAs have discussed above, we assume that both employers and employees are bounded rational economic individuals. When they are faced with incomplete information, their strategies are not optimal at the beginning. But as time goes by, they gradually find the optimal strategy for themselves through continuous learning and trial. The purpose of employees is to maximize their labor utility, while the purpose of employers is to maximize profits.During the dynamic game between employees and employers, both parties have two choice strategies. Employees can be divided into working overtime voluntarily or involuntarily. Assume that the ratio of employees who choose voluntary overtime strategy is Table Based on the above assumptions, we can construct a payment matrix about the employee-employer relationship of overtime behavior, as shown in Table Case 1 . Employees have to work overtime involuntarily without pay, in which case the benefits of employees and employers are Case 2 . Employees who volunteer to work overtime pay extra costs Case 3 . Employers cannot judge the overtime efficiency of the employees who work overtime involuntarily, but they offer the same remuneration to employees at the same level, so the employees can get extra benefits Case 4 . Due to information asymmetry, both parties have to pay a certain cost of According to Table The expected returns of an employee’s choice of involuntary overtime are:The employee’s average expected returns can be denoted by:The replicated dynamic equation of the employee can be expressed as follows:Similarly, the expected returns of an employer’s choice of pay strategy and not pay strategy are as follows:Accordingly, the employer’s average expected returns can be denoted by:Further, the replicated dynamic equation of the employer can be expressed as follows:Equilibrium points  to Eqs.  and 8),,\documenFive equilibrium points can be acquired, namelyandwhere:Substituting the five equilibrium points into Eqs.  and 8),,8), it iTheorem 1 reveals all equilibrium points according to the replication dynamic equations Eqs.  and 8),,8), but The equilibrium pointis the ESS, the equilibrium pointis a saddle point, while the other three equilibrium points need to be discussed on a case-by-case basis.According to Friedman , the staThe expression of the determinant and trace of the Jacobian matrix at five equilibrium points is shown in Table It is obvious that Theorem 2 indicates that there must be an ESS in the system for two parties to establish a stable relationship. Both parties of the game can constantly adjust from the initial state so as to achieve the optimal revenue, and the evolution path is dependent.In order to further determine the evolutionary stability strategy of the system, we substitute the above five equilibrium points into the Jacobian matrix to calculate its determinant and trace for local stability analysis under different constraints. See Table When the benefits gained through moral hazard is greater than the difference between the synergy benefit generated by cooperative trust and the cost of information asymmetry, the game will stabilize at .When mentclass2pt{minimWhen the benefit gained through moral hazard is less than the difference between the synergy benefit generated by cooperative trust and the cost of information asymmetry, there are two sets of equilibrium strategies:  and .When entclass1pt{minimaSpecifically, when the difference between the synergy benefit generated by trust and the cost of information asymmetry is greater than twice the moral hazard benefit, the game will stabilize at .When entclass1pt{minimaThrough the theoretical analysis demonstrated above, two evolutionary game stability strategies have been recognized, which can be acquired when corresponding constraints are satisfied. In order to intuitively reveal the evolutionary trajectories of employees and employers, along with their sensitivity to each parameter, this section intends to simulate the model based on the three constraints and replication dynamics equations by using MATLAB.Scenario 1. We set Here we simulate values In Fig. mentclass2pt{minimScenario 2. We set Then we assign values Obviously, the Proposition Scenario 1. We set Therefore, we set When the value of Under the same conditions of other parameters, the curve in figure (a) can approach the As a whole, the information asymmetry coefficient has a great influence on the evolution time of both parties, and the Proposition Scenario 2. We set In Fig. entclass1pt{minimaOn the left, when The right picture and the left picture have similar patterns. For the top four curves, the smaller the In particular, when By summarizing the curve rules of the two graphs, we can find that the information asymmetry coefficients of the curves in the upper part of the graph are relatively small, and both parties of the game can reach the equilibrium point faster with the decrease of the two parameters. The information asymmetry coefficients of curves in the lower part of the graph are slightly larger, and both parties of the game reach the equilibrium point faster with the increase of the two parameters. The practical significance of scenario 2 is similar to scenario 1, that is, the information asymmetry coefficient gap between employees and employers should not be too large, and only when Scenario 1. We set In scenario 1, the impact of the trust coefficient on the evolution path of employees and employers is basically the same. The evolution curves of both parties all reach the equilibrium point until t = 8. The increase of Scenario 2. We set In scenario 2, the evolution rules of curves in figure (a) and (b) can be summarized as follows: in the lower part of figures, both parties tend to the equilibrium point In either case, the trust coefficient has a consistent effect on both employees and employers. The decrease of Scenario 1. We set whereupon, we set mentclass2pt{minimScenario 2. We set we set entclass1pt{minimaIn summary, as In any case, the system has five equilibrium points, an ESS point, and a saddle point. There are two scenarios depending on the constraints of the four parameters: resource consumption, information asymmetry coefficient, trust coefficient, and moral hazard coefficient. Based on the size of the determinant and trace at five equilibrium points, we put forward two theorems and three propositions, which are verified not only theoretically but also by data simulation.The strategies of the employees and the employers will evolve from the initial state to  or  under different situations. This is closely related to the initial parameters of the evolutionary game model and the payment matrix. However,  is the Pareto optimal state, while  does not conform to social expectations and social morality. Employers' behavior of not providing overtime payment violates social ethics and relevant laws and regulations. Such moral anomie will hinder the normal operation of society and the development of organizations.By summarizing the influence of each parameter on the evolution path, we can notice that fairness and information equivalence between employees and employers can effectively promote both parties to reach the Pareto optimal state. For example, in Fig. In order to facilitate the evolution of employees and employers from a stable state  to an optimal stable state , four parameters should satisfy the following conditions: (a) Employees and employers should devote similar but not equal resources to overtime work. (b) Reduce information asymmetry between employees and employers to ensure that both sides have equal information. (c) Raise the level of trust between employees and employers, and trust can help promote a win–win optimal situation. (d) Reduce moral hazard between employees and employers.Based on the principal-agent theory, this study applies the evolutionary game method to construct a In the practice of working overtime in organizations, if employees choose to work overtime involuntarily, while employers do not provide overtime pay, such a strategy of evolutionary stability is against social morality and relevant laws, which not only damages the physical and mental health of employees but also harms the reputation and honor of the organization. In this case, it is necessary to introduce third-party supervision to strengthen the supervision of unpaid overtime work and reduce a series of moral hazard problems caused by overtime. Therefore, the government should regulate the rights and interests of employees by the law more strictly, improve the trade union system in enterprises more widely, thus establish a reasonable labor supervision system. Meanwhile, organizations must take social responsibility and stop exchanging employees' well-being for surplus value.If employees choose to work overtime voluntarily and employers are willing to provide overtime payment, the system will dynamically converge to the Pareto optimal equilibrium point after the joint efforts of employers and employees in the long run. This is beneficial and sustainable for the development of the organization as well as the growth of employees. The organization's attitude towards overtime should adapt to the increasing needs of the new era, the need for sustainable social development, and the need for economic development to maintain progress. Even if employees choose to work overtime voluntarily, organizations should also minimize unnecessary overtime, which can be reduced by adopting new technologies and optimizing management processes to improve work efficiency.Reduce information asymmetry between employees and the organization. First of all, the organization should help employees to establish a sense of "ownership", and share the success and benefits of the enterprise with them through the implementation of an employee stock ownership plan, which is bound to greatly improve the enthusiasm of employees. Second, pay attention to the compensation effect of overtime pay and further provide a high level of remuneration that can satisfy employees. The form of overtime pay is not limited to material payment, but can also recognize their efforts and achievements through the promotion of positions and awarding of personal honors, so as to realize the sense of accomplishment and life value of employees. Third, the assignment of work tasks should take urgency and task quantity into consideration, maintain the balance of task quantity as well as promote work-family balance among employees.The findings of this paper are helpful to understand the evolutionary logic of overtime behavior in organizations, which has good theoretical significance and practical value.This study innovatively applies the evolutionary game method to solve the problem in organizational behavior, that is, the ubiquitous overtime problem. Previous studies on overtime work mainly use multi-layer linear model and multiple regression model, but these two methods not only fail to show the dynamic evolution process between employees and employers, but also cannot explain the information asymmetry between them. However, we believe that the evolutionary game model is closer to the actual situation, and there is indeed a game between employees and employers about overtime. Moreover, the evolutionary game model can well reflect the information asymmetry between the two sides. Finally, our research complements the literature on overtime and principal-agent theory.There are several limitations. First, this paper uses simulation experiments to verify the model, while actual case data may help to better understand the game between employees and employers. Second, in addition to information asymmetry and overtime pay, there may be other factors that influence whether employees volunteer to work overtime. Third, as we mentioned in the findings, third-party supervision needs to be introduced, so the three-way game between employees, employers, and the government may better interpret the mechanism of overtime.Future research can consider the three-way game among employees, employers, and the government. Besides information asymmetry and overtime payment, other factors need to be taken into account. In addition, if possible, subsequent studies can validate the model with actual case data.This research shows that the strategic choice of employees and employers will eventually be in  or Pareto optimal state , which is closely related to resource consumption, information asymmetry coefficient, trust coefficient, and moral hazard coefficient. By summarizing the influence of each parameter on the evolutionary path of employees and employers, it can be found that fairness and information equivalence between employees and employers can effectively promote both parties to reach Pareto optimal state. In other words, employees and employers need to communicate and share information promptly to ensure that the information obtained by each other is consistent. The findings of this paper are helpful to understand the evolutionary logic of organizational overtime behavior, provide theoretical guidance for scientific management of employees' overtime behavior, and further improve employees' working psychology.


In conclusion, the PCS did not influence hospital admission rates. More studies are needed to design health policies that strike a balance between the amount contributed by the taxpayer and hospital admission rates.No studies have evaluated the influence of pharmaceutical copayment on hospital admission rates using time series analysis. Therefore, we aimed to analyze the relationship between hospital admission rates and the influence of the introduction of a pharmaceutical copayment system (PCS). In July 2012, a PCS was implemented in Spain, and we designed a time series analysis (1978–2018) to assess its impact on emergency hospital admissions. Hospital admission rates were estimated between 1978 and 2018 each month using the Hospital Morbidity Survey in Spain . This was conducted for men, women and both and for all-cause, cardiovascular and respiratory hospital discharges. Life expectancy was obtained from the National Institute of Statistics. The copayment variable took a value of 0 before its implementation (pre-PCS: January 1978–June 2012) and 1 after that (post-PCS: July 2012–December 2018). ARIMA (Autoregressive Integrated Moving Average)  models were estimated with two predictors (life expectancy and copayment implementation). Pharmaceutical copayment did not influence hospital admission rates (with  A chronic disease is a physical or mental condition that lasts more than one year and causes functional limitations or requires ongoing monitoring or treatment . ApproxiDifferent studies have evaluated the influence of pharmaceutical copayments on different aspects of health ,16,17,18The scientific literature does not appear to have addressed in detail whether the implementation of a pharmaceutical copayment system (PCS) influences the hospitalization rate, since it has only been evaluated with very specific patients and/or with a brief or cross-sectional follow-up. We need to know whether, at the population level and in the long term, this implementation produces any change in the hospitalization rate, taking into account the seasonality of admissions and the increase in the life expectancy of the population—key factors when analyzing this relevant issue. Patients may not have been able to acquire their medicines and would therefore have failed to adhere to their treatment ,15,19,20In Spain, medical care  and emergency room visits are completely free and universal. Patient contributions to pharmaceutical services until June 2012 were based on the Royal Decrees 945/1978, 1605/1980 and 83/1993 ,25,26. TDefinitions: (1) Unemployment subsidy: economic aid received by unemployed persons who are not entitled to unemployment benefits, aimed at individuals and collectives without economic resources and who find it difficult to integrate; (2) Unemployment benefit: contributory benefit for loss of work, the duration and amount of which is determined by the length of time the worker has paid unemployment contributions into the Social Security system; (3) Noncontributory pensions: economic benefits for citizens who lack sufficient resources for subsistence, even if they have never contributed or contributed for an insufficient length of time to reach contributory benefits; (4) Social Integration Income: social benefit intended to ensure economic subsistence resources for those who lack them, personal, family, social and, if applicable, labor integration actions; (5) Work accident: an accident suffered by a worker during working hours or on the way to work or from work to home; (6) Occupational disease: disease contracted as a result of work for another party; (7) Toxic oil syndrome: mass poisoning suffered in Spain in the spring of 1981. The disease affected more than 20,000 people, causing the death of about 330 people. In 1989, the Supreme Court considered the causal link between the intake of denatured rapeseed oil and disease to be proven; (8) Disability: a condition under which certain people have a physical, mental, intellectual or sensory impairment that, in the long term, affects the way they interact and participate fully in society.The study population included all inhabitants in Spain between 1978 and 2018.This time series study analyzed the evolution of the mean emergency admissions rate per 100,000 inhabitants in each month from January 1978 to December 2018, establishing a cut-off point to determine whether copayment implementation (July 2012) influenced this evolution. The data for constructing the series were obtained from the Hospital Morbidity Survey, which has been carried out in Spain since 1977. The data have been available for download in an anonymized and encrypted form since 1978 ,31, togeAlthough the methodology of the survey has been previously published ,31, we sThe data collected were extracted through the website of the National Institute of Statistics, in a completely anonymized and encrypted form, thus preventing the identification of any individual person . This woThe main study variable was the emergency admissions rate per 100,000 inhabitants for each month and year, starting in January 1978 and ending in December 2018. To calculate this rate, all the weights of patients with a diagnosis of emergency admission and discharge date in the corresponding month and year were summed, dividing this amount by the total population of that year. This was done after separating men and women, changing the population totals accordingly. The mean emergency admissions rate for cardiovascular or respiratory causes was also determined for men, women and both, using the ICD-9-CM and ICD-10-CM codes. The data sources were the Hospital Morbidity Survey ,31 and tThe copayment indicator variable was defined, taking a value of 1 as of July 2012 and 0 before that date, together with the population life expectancy. A distinction was made between men and women, when necessary, with this information also obtained from the National Statistics Institute (INE) .Each time series  was plotted on a time plot, and the Ljung-Box Q test was applied to ascertain whether the data were independently distributed. As a strong dependence between hospital admissions was found, ARIMA  models were estimated for each series , without transforming the data. The justification for the model parameters lies in the seasonality of admissions, both on an annual and seasonal basis . This was directly visible in the time plots. Two predictors were added to all the models: pharmaceutical copayment and life expectancy in that year. We wanted to determine whether the former had an influence on admissions, and the latter was a key adjustment factor, since as the life expectancy of the population increases, annual admissions increases as a result. The stationary R-squared was calculated to determine the goodness of fit of the models. No transformations were applied to obtain simple models, and the coefficient associated with the predictors indicated how they directly affect the rate of admissions per 100,000 inhabitants in the population. A step-by-step procedure of the analysis was as follows (with data for our case in parenthesis): (1) identify the dependent variable ; (2) select the explanatory variables (life expectancy and PCS); (3) determine whether the data were independently distributed; (4) establish the difference order in the ARIMA, depending on the nature of the data ; and (5) consider whether there is seasonality . Although several methods exist for modeling time series, we selected ARIMA as it is easy to understand and perfectly reflects the time relation between the data mentioned, particularly when there is seasonality. In the case of hospital admissions, similar rates were found in the different seasons, with similar results between one year and the previous year. In addition, this enabled predictors to be added to see their impact on the dependent variable. This type of model was, therefore, suitable for our purpose. More details about our models are given in p < 0.001 in all cases, The time graphs are shown in The dotted line indicates when the copayment system was implemented. The top figure corresponds to all-cause admissions, the middle figure to cardiovascular admissions and the bottom figure to respiratory admissions.The dotted line indicates when the copayment system was implemented. The top figure corresponds to all-cause admissions, the middle figure to cardiovascular admissions and the bottom figure to respiratory admissions.The dotted line indicates when the copayment system was implemented. The top figure corresponds to all-cause admissions, the middle figure to cardiovascular admissions and the bottom figure to respiratory admissions.p = 0.857).The coefficients of the models are presented in The results of this study show that the pharmaceutical copayment system had no influence on the hospital admission rate. This lack of association was equally true for cardiovascular and respiratory admissions, regardless of the sex of the patients. An increase in the rate of hospitalization was observed, but it seemed to be due to the increase in the life expectancy of the population.The main strength of this study is its assessment of the influence of a pharmaceutical copayment system on the hospital admission rate through a time series analysis including data from 1978 to 2018. These results are innovative as our literature search found only three papers assessing this association that compared only two time points without a long time series. Clearly, the association between the pharmaceutical copayment system and a change in the hospital admission rate should be evaluated through a randomized intervention study with a control group. However, since the pharmaceutical copayment system was implemented across the country at the same time, the design used was the best option to address our research question. Although we could have selected a shorter time period for the study nearer to the implementation of the PCS, we preferred to study the time series available with 40 years of data with precision. Logically, there are great differences in the early stages, but by considering life expectancy as a covariable, the ARIMA models have a very good fit, showing stationary R-squared values near 1, indicating that the choice of models was very suitable. We could also have used another type of econometric model, such as linear regression. However, we must bear in mind that there exists a temporality and we were not dealing with independent data. Thus, for this and the other reasons mentioned, we preferred to use the ARIMA models, which adjusted very well to our data and helped to answer our research question.Regarding selection bias, we must bear in mind that the National Institute of Statistics selects all public and private hospitals in the national territory for sampling, thus minimizing this bias ,31. ConcWhen comparing our results with those published by other authors, we encountered a difficulty in that two of the three relevant studies found were conducted in public health systems that are very different from the Spanish public health system ,18. FurtAlthough the association between the PCS and hospital admissions was not addressed in depth, we can nevertheless suggest a hypothesis about how it would work for hospital admissions in other types of health care systems, as found for example in developing countries with a lack of free public health care or countries dominated by private health insurance. The former would represent a situation in which most of the population have limited resources and the latter a situation in which citizens without sufficient economic resources would be unable to acquire medical insurance with good cover. We consider that a PCS would have a great impact in the latter case as, if the state is able to subsidize part of the pharmacological costs, the insurance companies could then reduce the individual quotas payable, thereby enabling greater health care cover to be acquired, which in turn could result in fewer hospital admissions. On the other hand, if used in developing countries, it would alleviate expenses, resulting in improved individual health . AnotherTo attempt to understand why the results were not statistically significant, we should analyze Considering that we have found no studies assessing the influence of pharmaceutical copayment on hospital admission rates with time series, it would of interest to conduct studies in other health care systems. This is an important issue because there are health systems with fixed or variable fees according to prescription, drug classification by disease or effectiveness, etc. . This vaIn a country with a free health care system in which a pharmaceutical services copayment system was introduced, the new system did not influence the hospital admission rate, not even for cardiovascular and respiratory diseases or when distinguishing between male and female patients. As a conclusion, in light of these results, we need more studies to be able to propose health policies that strike a balance between the amount contributed by the taxpayer and hospital admission rates. However, this should be without prejudice to the health of the citizens and should attempt to reduce hospital admissions with preventive policies such as encouraging healthy lifestyle habits. This study also shows that, given the great differences between health care systems, it is extremely important to try to examine our research question elsewhere so that we can determine whether this lack of association between PCS and hospital admissions is also found in a system that is unlike the Spanish system .


There is an unmet need for review methods to support priority-setting, policy-making and strategic planning when a wide variety of interventions from differing disciplines may have the potential to impact a health outcome of interest. This article describes a Modular Literature Review, a novel systematic search and review method that employs systematic search strategies together with a hierarchy-based appraisal and synthesis of the resulting evidence.We designed the Modular Review to examine the effects of 43 interventions on a health problem of global significance. Using the PICOS  framework, we developed a single four-module search template in which population, comparison and outcome modules were the same for each search and the intervention module was different for each of the 43 interventions. A series of literature searches were performed in five databases, followed by screening, extraction and analysis of data. “ES documents”, source documents for effect size (ES) estimates, were systematically identified based on a hierarchy of evidence. The evidence was categorised according to the likely effect on the outcome and presented in a standardised format with quantitative effect estimates, meta-analyses and narrative reporting. We compared the Modular Review to other review methods in health research for its strengths and limitations.The Modular Review method was used to review the impact of 46 antenatal interventions on four specified birth outcomes within 12 months. A total of 61,279 records were found; 35,244 were screened by title-abstract. Six thousand two hundred seventy-two full articles were reviewed against the inclusion criteria resulting in 365 eligible articles.what works?”. Thus, it is a well-suited literature review method to support prioritisation, decisions and planning to implement an agenda for health improvement.The Modular Review preserves principles that have traditionally been important to systematic reviews but can address multiple research questions simultaneously. The result is an accessible, reliable answer to the question of “The online version contains supplementary material available at 10.1186/s12874-021-01463-y. To advance evidence-informed planning, practitioners need to know what works. In the context of limited resources, they need to decide which interventions to prioritise. Priority setting in health policy is an evidence-informed complex process considered a valuable approach to support achieving national health goals particularly in low- and middle-income countries (LMIC) . It is bThe effectiveness of interventions is a crucial part of priority setting and should be based on best available evidence. However, in most areas of healthcare, there is too much potentially relevant research for those involved in health policy or care provision to integrate in decision making . A singlDuring the last decade, systematic reviews have been accompanied by an increasing number of other review types and methodological approaches . Rapid rExploration of the effectiveness of interventions to inform priority setting represents a typical situation that requires a potentially high number of systematic, concurrent searches in a broad evidence base to find the most reliable and up-to-date data on not one but several interventions. At the same time, there is often a limited timeline to produce a synthesis that facilitates comparative discussion on multiple interventions. Yet, no method for obtaining, reviewing and synthesising data has been proposed for this purpose. In response, this paper introduces the Modular Literature Review (hereafter: Modular Review), a novel systematic search and review method for expanding current methodologies to capture quantitative estimates of effect size where available and to identify gaps and frontiers to inform research and implementation. The method was developed in response to the need to prioritise interventions to reduce the prevalence of an important global health problem.Specifically, the aims of the project were to 1) obtain a set of data in order to consider a wide variety of interventions that potentially reduce unfavourable outcomes of interest, 2) provide estimates of effect on the outcomes of interest for each intervention where possible, 3) systematically obtain an assessment of the quality of evidence of each intervention’s effect on the outcomes of interest, 4) classify the evidence based on a balanced assessment of the strength, quality and quantity of evidence to produce an accessible synthesis and 5) achieve the above aims in 12 months.In this paper, we describe the method developed to meet these aims and assess it in terms of the sensitivity of the searches and the time and resource usage. We compare it to other established review methods in health research that could have been utilised in the project, namely systematic reviews, scoping reviews, overviews of systematic reviews and rapid reviews, to demonstrate its value and unique contribution.In 2019, an international group of 16 experts working in research, clinical and funding roles in broad areas of nutrition, infection control and maternal and child health in LMIC convened a workshop to develop a common framework for action to tackle low birth weight (LBW) and its dual contributors: preterm birth (PTB) and fetal growth restriction (FGR). LBW is an important determinant of child survival and development and a large burden of morbidity and mortality may be prevented by addressing the associated risk factors [The mechanisms leading to LBW via PTB and FGR are complex, with many opportunities to intervene to avert poor outcomes. The expert group agreed on 43 potential interventions and sought evidence of effectiveness for each from randomised controlled trials (RCTs). Each intervention was conceptualised as a combination of a risk factor and a method of eliminating or reducing exposure to the risk factor or mitigating its impact , two information specialists , two statisticians and six research assistants. Three other information specialists supported the core team by occasional assistance in information retrieval. The team was accountable through regular meetings to two senior researchers . The majority of the team members worked on the project on a part-time basis.In the autumn of 2020, a panel of international experts in global maternal and newborn health convened to review the results of the project. The group consisted of 51 experts from Africa, Asia, Europe and North America. They represented academia, governmental and non-governmental organisations, the World Health Organization, the United Nations and research funders.We developed a literature search model using an adaptation of the PICOS framework where I (intervention) was each of the 43 interventions stemming from the expert workshop. For each search, Population, Outcome and Study design modules were the same. The population was pregnant women, the outcome was LBW and related outcomes of preterm birth (PTB), small-for-gestational age (SGA) and stillbirth (SB), and the study design was controlled study designs . Comparison was omitted as it was not possible to define the broad range of relevant control types, for example routine care, different types of counselling, placebo products and alternative nutritional products. The Intervention module was different for each search Fig. . Figure We proceeded to convert the Population, Outcome and Study design parts of the model into a search strategy template for MEDLINE  into equivalent searches for the other databases. The template was prepared for the following databases: MEDLINE (OvidSP), Embase (OvidSP), Cochrane Database of Systematic Reviews (Wiley Cochrane Library), Cochrane Central Register of Controlled Trials (Wiley Cochrane Library), CINAHL Complete (EbscoHOST).Map all possible interventions, including new and emerging (e.g. the search term “depression” finds everything from yoga to antidepressants if they have been researched with controlled methods with respect to LBW).Identify risk factors that we may have not considered with respect to LBW (e.g. the search term “vaccination” found infection risks not considered in the workshop)We then designed the search strategy for the intervention modules following the same method described above. Search terms were related to either known risk factors for LBW  or alternatively, terms related to an intervention (e.g. “lipid-based nutrient supplements”) , were entered into a Microsoft Excel-based repository on a shared work platform (Microsoft OneDrive). Titles and abstracts of the retrieved records were screened for eligibility by six research assistants. Our shared repository included functions to record several data elements such as the decision on eligibility, the rationale for the decision and who has made the decision. Due to the large number of records and time constraints, this screening step was undertaken in a single reviewer manner with the following quality control methods. Firstly, extensive training was given throughout the screening phase. This consisted of practice, feedback and regular meetings. Secondly, regular checks were made by a senior researcher (AK). Finally, occasional second reviews were undertaken in which the same randomly selected data was dual reviewed by two research assistants and possible discrepancies were discussed and solved in training meetings.Relevant in terms of populationRelevant in terms of interventionReports at least one outcome of interest as primary or secondary outcome in a usable formatRelevant in terms of research designFull article available in EnglishThe inclusion criteria were derived from the PICOS framework as followsArticles were excluded if they did not meet the inclusion criteria. The same inclusion and exclusion criteria were broadly applied to all interventions. However, some interventions required additional specifications to the inclusion/exclusion criteria. For example, studies of interventions, such as cervical cerclage, that are known to have different outcomes in twin pregnancies had twin and multiple pregnancies as an additional exclusion criterion. At the title-abstract screening stage, the research assistants were advised to err on the side of caution and include records where some doubts existed regarding eligibility, particularly regarding outcomes as this information may be unclear in abstracts.A second Microsoft Excel-based repository was set up for the records that were deemed eligible at the title-abstract screening stage. Full text articles (approximately 6000) were uploaded into separate files on Microsoft OneDrive for each intervention. Full texts were independently reviewed by two researchers for relevance against the inclusion/exclusion criteria. We also included records of relevant RCTs in the Cochrane Central Register of Controlled Trials. Studies that had started before 2010 but for which no publication of results could be found were presumed to be discontinued and were excluded. The post-2010 RCT records were presumed to be in progress. These records represented novel, emerging interventions for which there may not yet be an established evidence base.The inclusion choices by the two independent reviewers were made visible in review meetings with at least three members of the team present and disagreements were discussed until consensus was reached. Reference lists of eligible articles were also checked for additional relevant studies.Data was extracted from the 365 selected articles in a manner that provided the foundation for analysing, summarising and interpreting the body of evidence. An Excel-based form was developed and piloted using a sample of selected studies. We systematically extracted data on study design, participants, intervention, comparison and outcome characteristics as well as geographical context. This was done as a single-extraction with the following quality control measures. Firstly, there was a division of labour between the extraction of basic information and estimates of effect size for each record, with the former undertaken by research assistants and the latter undertaken by members of the core research team . Secondly, random checks of approximately 20% of the data for each intervention were undertaken by a member of the core research team. Automated sorting of the data was used to ensure that the population of the forms was complete and accurate.overview of all data reporting a potentially large and diverse body of interventions and risk factors. We considered each of our 43 research questions and additionally identified novel, interesting questions emerging from the data. We then decided on the final, specific 46 research questions that would be answered with this data. The second tier of analysis consisted of a systematic detailed analysis relating to each specific research question. Part of this analysis was to identify studies that could be pooled and subjected to a meta-analysis.When defining the search strategies, we deliberately kept the Intervention modules relatively broad by searching either the risk factor or the intervention. This resulted in a relatively large and transdisciplinary dataset for each research question. We proceeded with a two-tiered analysis. In the first round, we formed an The ability to provide decision-makers with reliable information for priority setting requires that the evidence meets an adequate standard of quality. Systematic reviews often use Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system for rating the quality of evidence . Within In order to synthesise the body of evidence into estimates of effects on the outcomes, we sought to identify reliable, comprehensive and recent sources of data. These source documents for effect size (ES) estimates, or “ES documents”, were identified through a hierarchical ordering of the various types of evidence according to Table Systematic reviews or reviews of reviews are not always up-to-date and the median update time for a systematic review is more than 5 years . TherefoTo complete the synthesis, we combined the estimate of effect size (where available), the appraisal of quality and the overall availability of evidence for each intervention into a single classification system to enable cross-comparison. Colour codes and standardised statements were used to indicate the classification Table .Table 2CWe documented the results for each intervention in a standardized, user-friendly report format  and tetanus, all of which were synthesised as separate questions. Of these, tetanus was not in the original list of risk factors and would have therefore been missed if the search had risk-specific search terms. Thus, when the risk or the intervention was clearly definable with established terminology, the search was equally capable of finding unexpected risks or interventions as finding those that were expected. Moreover, we provided data on 26 ongoing trials and 22 non-randomised studies for 20 of the 46 research questions where the evidence base was limited or less established. In addition, we produced a list of approximately 15 interventions of potential interest for future research.Our searches found 61,279 records Fig. . After rThe 29 additional free-text searches that were conducted to assess the possibility that the search and screening procedures might have missed relevant records produced 25 records. On closer inspection, 15 did not meet the inclusion criteria, two were already in the dataset and four were in reference lists of identified eligible articles. The remaining four records were likely to have been missed without this test. One was mistakenly screened as ineligible in the title/abstract screen, one failed to report the use of a control group, one was a record of an on-going study with no apparent reason for the search to miss it, and one failed to report outcomes of interest in the abstract although they were in the full article. In their review of the reports, the members of the international expert panel were asked to comment on the coverage of the literature and if there were any articles that were missing. Most responded that there were no relevant records missing from the review. All studies suggested in response to this question were found to be included. Taken together, the result of our assessment was that the coverage of the relevant literature by the review method was adequate. The overall search precision of the project was approximately 1% with variation across the searches attributed to availability of established terminology for specific interventions and risks.The time from the inception of the project to when the results were available for use was 12 months. In total, the active time used in the review was 9360 working hours, i.e. approximately six full-time equivalent (FTE) years. Of this, approximately 60% was spent conducting the central research activity by the researchers in the core research group and 5% was expertise by information specialists (Table This report describes a new method for gathering evidence in support of multifaceted, strategic initiatives to address major health challenges. The Modular Review method can be used to address complex research questions where there are multiple possible interventions that may be medicinal, surgical, nutritional, environmental and psychosocial. We utilised the PICOS framework to search for a variety of interventions, including the unanticipated and novel, by using a template where Population, Outcome and Study design modules are constant and the Intervention module varies with intervention or risk of interest. The end-result of the hierarchy-based synthesis is a list of potential interventions with estimates of effect size where this information is available. Where information on effectiveness is lacking, this method allows for narrative reporting and projection of future impact.There are other established review methods in health research that could have been applied in this project including systematic reviews, scoping reviews, overview of systematic reviews and rapid reviews - all with their own strengths and limitations Table . SystemaOther review types, such as rapid reviews, that aim for an adequate level of comprehensiveness whilst simultaneously working under time pressure , 41, empUnlike standard practice with scoping reviews , two infThe number of records retrieved in the search was large due to the number of research questions, the adoption of a comprehensive approach without major shortcuts and the broad design of the searches, many of which specified only the risk factors. The management of such large datasets required special attention. Conducting the title-abstract screening with a single reviewer to remove irrelevant records saved time and resources. We recognize that double-screening is generally recommended . It is pA formal quality appraisal is a key part of the systematic review process whereas scoping reviews and rapid reviews tend to omit this step , 36. TheSystematic reviews typically synthesise all original studies that meet their criteria, often with a meta-analysis. For some of our research questions, there was already an established evidence base with a recent systematic review providing a meta-analysis, thus obviating the need for this undertaking. We could have conducted an overview of reviews however this would have presented other challenges. First, there were research questions with limited data and no reviews available. Second, conducting a meta-analysis of the included reviews in an overview of reviews is challenging if the included reviews themselves already contain meta-analyses. Data from individual studies should not be used more than once as this may result in a misleading, and possibly overly precise estimate . The solSystematic reviews can be resource-intensive and may take several years , 47. ThiWhile we were able to work within a tight timeframe, the tradeoff in terms of resources was the employment and training of a larger team on short term contracts. Future versions of the Modular Review method may benefit from the automation of some of more high-throughput segments of the method. Steps such as the translation of searches to function in different databases may be automated by programs such as the Polyglot Search Translator . Text miThe Modular Review can be used to inform research agendas. The comprehensive and comparative structure of the review provides a multi-disciplinary landscape view identifying gaps and caveats. It reveals needs for updates of systematic reviews and overarching umbrella reviews. It has the capability to identify emerging trends, overlaps and potential synergies. The search results form a dataset that may be developed into a more technologically advanced format, redeployable for further analyses.This new review method is designed to support high-level decisions and policy making by providing evidence on a range of both practised and potential interventions spanning different disciplines and geographical contexts. Because the evidence has been gathered using the same search strategy, there is no need to try to reconcile differences in focus across a collection of individual reviews. The accessible output is ready for the next level of analysis such as cost-effectiveness and implementation planning. The robust but streamlined process enables the production of timely and reliable evidence. It facilitates comparisons, generalisations, and consolidation of strategic options, including holistic programmes to affect improvement in global health.We have devised the Modular Review, a novel systematic search and review method that is capable of providing and organising evidence on a broad range of interventions to tackle a health problem of global importance. Like the systematic review, this method aims to comprehensively search existing records for RCT and reviews of RCT and to gather and synthesize data toward the estimation of an intervention effect size. The modular approach enables the simultaneous synthesis of a diverse collection of interventions. The result is an accessible, reliable answer to the question of “what works?” Thus, it is an ideal method to support prioritisation, decisions and planning to implement an agenda for global health improvement.Additional file 1.Additional file 2.Additional file 3.Additional file 4.


Although recent reports suggest that service users in West African psychiatric facilities are exposed to poor quality of care and human rights violations, evidence is lacking on the extent and profile of specific deficits in the services provided to persons with mental health conditions.To evaluate the quality of care and respect of human rights in psychiatric facilities in four West African countries, The Gambia, Ghana, Liberia and Sierra Leone, using the World Health Organization QualityRights Toolkit.Trained research workers collected information through observation, review of records and interviews with service users, caregivers and staff. Independent panels of assessors used the information to assign scores to the criteria, standards and themes of the QualityRights Toolkit.The study revealed significant gaps in these facilities. The rights to an adequate standard of living and to enjoyment of the highest attainable standard of health were poorly promoted. Adherence to the right to exercise legal capacity and the right to personal liberty and security was almost absent. Severe shortcomings in the promotion of the right to live independently and be included in the community were reported.Inadequate appreciation of service users’ rights, lack of basic approaches to protect them and the non-promotion of rights-based services in these facilities are major problems that need to be addressed. Although it recognises the resource constraints and need for more human and financial resources, the study also identifies critical areas and challenges that require significant changes at the facility level. An example is the Mental Health Leadership and Advocacy Program (mhLAP), which aims to build leadership and advocacy capacity and address country-specific mental health service development needs.6 Also, community health workers have been trained in some countries to provide mental healthcare14 and, in other countries, local civil society organisations (CSOs) have created mobile outreach teams to provide emergency and preventive mental healthcare to rural and urban populations.15 Furthermore, CSOs have supported the creation of peer support teams, which have become an important component of community mental health programmes.16Despite mental health conditions accounting for a third of the global burden of disability,18 People receiving care in some psychiatric facilities in these countries experience poor physical infrastructure, overcrowding, inadequate food and administration of obsolete medications. Furthermore, chaining, seclusion and restraint are frequently used. In 2012, to address issues such as these, the World Health Organization (WHO) launched the QualityRights initiative,19 which aims to transform psychiatric services and promote the rights of persons with mental health conditions across the globe.20 Among the QualityRights instruments is the QualityRights Toolkit, developed to evaluate the quality of care and respect of human rights in mental health facilities. The QualityRights initiative follows the framework of the United Nations Convention on the Rights of Persons with Disabilities (CRPD),21 which aims to ‘promote, protect and ensure full and equal enjoyment of all human rights by all persons with disabilities’, including those with mental disabilities. When countries ratify the CRPD, they have a legal obligation to abide by its principles. Among the several West African countries that have ratified the CRPD are The Gambia, Ghana, Liberia and Sierra Leone. Thus, it is important to assess how these countries are implementing the CRPD in their public psychiatric services, given the violations that have been reported in this sector. To our knowledge, no previous studies have evaluated the alignment of psychiatric services with the CRPD in sub-Saharan Africa. The main objective of this study was to fill this gap by evaluating the quality of care and respect of human rights in psychiatric facilities in four Anglophone West African countries: The Gambia, Ghana, Liberia and Sierra Leone.Despite these efforts, much work remains to be done to improve the quality of mental healthcare in the region. Recently, psychiatric facilities in a number of West African countries have come under scrutiny for poor quality of care and human rights violations.https://doi.org/10.1192/bjo.2021.1080.The four West African countries were selected based on participation in the mhLAP initiative and willingness of the facilities in these countries to participate in the study. In The Gambia, the study was carried out in the Tanka-Tanka Psychiatric Hospital, located in the West Coast region. Tanka-Tanka is the country`s only psychiatric hospital, with a bed capacity of 100 and a staff strength of 58. In Ghana, the study was conducted in the Pantang Psychiatric Hospital, located in the Greater Accra region. Pantang is one of the three largest psychiatric hospitals in Ghana and serves approximately 8 million people. It is a 500-bed facility with in-patient and out-patient units, and employs 657 mental health workers. In Liberia, the study was carried out in the John F. Kennedy/E.S. Grant Mental Hospital, a national referral mental health hospital with a capacity of 80 beds. The facility has a staff strength of 46 and a small rehabilitation centre. In Sierra Leone, the study was conducted in the Sierra Leone Psychiatric Hospital. This facility is situated at the east end of Freetown in the Kissy community, and it is the only mental hospital in Sierra Leone, with a bed capacity of 150 and a staff strength of 79. All the participating facilities provide pharmacotherapeutic as well as simple psychosocial services. Further details on the facilities evaluated and the staff employed can be found in Supplementary Appendix 1 available at 20 which adopts the human rights framework of the CRPD and includes five themes. Each theme focuses on specific CRPD rights: theme 1, the right to an adequate standard of living (Article 28); theme 2, the right to enjoyment of the highest attainable standard of physical and mental health (Article 25); theme 3, the right to exercise legal capacity and the right to personal liberty and security of person (Articles 12 and 14); theme 4, freedom from torture or cruel, inhuman or degrading treatment or punishment and from exploitation, violence and abuse (Articles 15 and 16); and theme 5, the right to live independently and be included in the community (Article 19). The themes are organised into standards, which consist of different criteria  observation of the facilities and process of service delivery; (b) review of clinical and administrative records, including clinical records and nurses’ ward charts; and (c) interviews of selected service users, caregivers and staff. Research assistants took notes on the dedicated spaces in the WHO QualityRights Toolkit, and shot photos of the wards visited when they deemed it necessary.In the third step, a panel of independent assessors conducted joint ratings, using the reports of the assessments provided by the research assistants. The panel of assessors was selected to ensure a broad range of skills and expertise and consisted of mental health professionals, service users, caregivers, legal practitioners, human rights advocates and representatives of CSOs working in mental health. No assessor worked or was otherwise involved in the provision of services in the facility assessed. Both the research assistants and members of the panel were trained in the use of the QualityRights Tools by country facilitators, who had previously participated in a 5-day training led by the project team and WHO consultants in Ibadan, Nigeria. Assessments by the research assistants were planned in collaboration with the management of each hospital.27 Scores were assigned to the themes/standards/criteria through a process of detailed review of the reports of the assessments, discussions and consensus rating. Each theme, standard and criterion was scored as follows: ‘Not initiated-N/I,’ ‘Achievement initiated-A/I,’ ‘Achieved partially-A/P’ ‘Achieved in full-A/F’ and ‘Not applicable-N/A.’ Criteria were evaluated first. Then, based on the scores of the criteria, a score was assigned to the corresponding standard. Finally, scores of the standards were used to assign a score to each theme. When consensus among assessors could not be reached for a theme, standard or criterion, the lowest score was assigned. However, there was no report of significant disagreement in the scoring in any of the countries involved. Using the ratings provided by the panel, we have calculated the number of standards (with corresponding percentages) that received the different scores for each theme. The percentages were then used to create bar charts to represent the extent to which the specifications of the particular theme were achieved. Finally, we reviewed the qualitative descriptions and justifications provided by the panel in their reports to identify areas for improvement and provide recommendations. The same process has been previously used for analysing the data from assessments conducted in other countries.25The panel of assessors integrated qualitative and quantitative data through a mixed-methods convergent design to assign final ratings for each facility.The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. All procedures involving human participants were approved by the University of Ibadan/University College Hospital Ethics Committee  and the ethics committee of each participating hospital. All participants provided written informed consent.Regarding overall adherence to theme 1, the hospital in Sierra Leone had actively initiated changes to ensure an adequate quality of living for service users, and the hospitals in the other countries had partially met the standards of this theme . Works had been undertaken to make the buildings more accessible ; however, all hospitals presented barriers to access for people with disabilities. Although fire extinguishers were present in the facilities, staff and service users lacked knowledge on fire safety measures. Overall, service users’ sleeping conditions were comfortable, with separate wards for men and women in all hospitals. Clean beds and bedsheets were provided in all countries except for Ghana. However, patients were not allowed to lock their rooms for ‘safety reasons’, and had no individual lockers with locks; thus, their right to privacy was not fully respected. Service users had regular access to bathing and toilet facilities. These were generally clean at the time of the assessment, but, in all countries, they needed repairs . The evaluation teams also found shortcomings in the food served. In Liberia and Sierra Leone, the food was of good quality, but often not sufficient for service users. In The Gambia, the diet was unbalanced, whereas in Ghana, the quality of food varied depending on the ward examined. Sometimes, meals were served at the convenience of staff; for example, in Ghana, dinner was served too early because the kitchen staff wanted to close for the day. The hospitals respected service users’ right to wear clothes of their choice.Service users were allowed to receive visitors during scheduled visiting times. Telephones were the only form of communication potentially accessible to service users. However, they were not always available. Also, sometimes staff were present during the communication, or there were restrictions in using these means of communication, thus limiting service users’ privacy. In Ghana and Sierra Leone, the evaluation teams found that the building environment was not stimulating and conducive to interaction. Service users had difficulties in remaining engaged in community life and activities. In The Gambia, some steps to promote interaction and participation were taken (e.g. creating a comfortable area for interactions between service users and visitors). In Liberia, social activities were organised within the facility compound, and service users sometimes participated in activities outside the facility (but only when requested by their families).Adherence to theme 2 was partially achieved in Ghana, initiated in The Gambia and Sierra Leone, and not initiated in Liberia  was insufficient, so the prevalent treatment approach was pharmacological. Sometimes the facilities experienced shortages of medications (e.g. in Sierra Leone and Liberia) or there were not enough psychiatrists or medical doctors to review the prescriptions .Although service users had individual treatment plans in all facilities, these plans were solely based on mental health providers’ inputs from diagnosis and clinical observations. Service users were usually not provided the opportunity to express their preferences on treatment and recovery. Staff had little knowledge of international human rights standards, such as those included in the CRPD . Social support mechanisms and networks to promote living independently in the community were not available in The Gambia, Liberia and Sierra Leone. In Ghana, staff facilitated linkages mostly between service users and other community mental health services. Some general health services were provided only in Ghana. Referral systems were in place in the other facilities. Some form of health education for service users was provided in Ghana , Liberia and Sierra Leone . Reproductive health issues such as family planning and sexually transmitted diseases were not addressed in health education.The psychiatric hospitals in The Gambia, Liberia and Sierra Leone had not initiated changes toward fulfilling service users' right to legal capacity and personal liberty and security. Only the facility in Ghana had taken initial steps toward fulfilling this theme  and neglect were an issue in all facilities. These violations happened in particular when staff had a heavy workload because of the personnel shortage. Bullying among service users was also noted as an issue, and there were no measures in place for staff to address these situations. Seclusion and chemical and physical restraints were used in the facilities as a way of managing crises. Seclusion rooms were still used and were usually uncomfortable . Furthermore, sometimes seclusion and restraint were used as a threat or form of punishment for service users who ‘misbehave’. Alternative methods to seclusion or restraint were rarely in place, and most of the staff had no training nor knowledge about these practices.Electroconvulsive therapy was not practiced in any of the facilities evaluated (none owned the equipment necessary to perform the procedure). Medical and scientific experiments were not carried out in The Gambia, Liberia and Sierra Leone. In Ghana, medical and scientific experiments were conducted, but only upon approval of the ethical committee and with the informed consent of service users.Safeguards were not in place to prevent ill treatment and abuse. In none of the facilities were there structured avenues for service users to lodge complaints, making it difficult to monitor and deal with cases of abuse. Service users could express their complaints informally, but they usually did not do it for fear of retaliation. Only in Ghana was there an independent body created by the government, whose mandate was to monitor the facility. However, the monitoring activities were inadequate.Regarding theme 5 . Particular attention should be given to the provision of good quality food in sufficient quantities for the dietary needs of service users. Another priority is the installation of safety equipment (e.g. fire extinguishers at strategic locations), supported by the provision of training on safety measures for staff and service users.The right to an adequate standard of living  was not fully promoted because of the unsatisfactory state of most buildings and the lack of financial resources to make the necessary renovations and reparations. These findings reflect those of previous studies in West Africa.28 the health workers in these facilities were generally not familiar with international human rights standards. Training on these issues, such as the WHO QualityRights online course, is now freely available and could help fill this gap if promoted within the facilities.The assessments also showed shortcomings in the achievement of the right to the enjoyment of the highest attainable standard of physical and mental health . The treatment provided in psychiatric facilities was mainly pharmacological, and shortages of medications were not uncommon. The number of staff was insufficient to meet service users’ care needs, which led to excessive workload and a decrease in the quality of care provided. Thus, alternatives to pharmacological treatments, such as psychosocial support and occupational therapy, were either not provided or inadequate. More efforts to train and hire a variety of professionals with different skills need to be made at the government and facility levels. In line with what was observed in other countries,29 For instance, a study among Nigerian health professionals showed that providers hold negative attitudes toward people with mental health conditions and endorse paternalistic views.30 In this context, promoting the right to legal capacity and personal liberty and security may be challenging. However, steps in this direction need to be taken. It would be essential to educate service users  on their right to contribute to decisions regarding their recovery process, rehabilitation and reintegration into their communities. Supported decision-making mechanisms should be put in place, and service users should be educated to understand their right to nominate a representative to help them make decisions about treatment and other relevant issues. The introduction of peer support teams (workers or volunteers) in mental health facilities has been shown to have positive outcomes in empowering people with mental health conditions to enjoy their right to legal capacity,22 and could be a valuable resource in West African psychiatric services. Facilities should also develop guidance documents to manage the process and the manner in which informed consent is handled.Adherence to the right to exercise legal capacity and the right to personal liberty and security  was almost absent in all of the countries evaluated. These findings align with data from recent studies that show a strong endorsement of authoritarian and socially restrictive views toward people with mental health conditions in some West African countries.The rights to freedom from torture or cruel, inhuman or degrading treatment or punishment and from exploitation, violence and abuse  were often violated. The assessment teams found evidence of verbal abuse against service users. Neglect was also an issue. Furthermore, seclusion and restraint were frequently used as a means to manage crises and, sometimes, as a threat and form of punishment. Health professionals rarely had training in de-escalation techniques, and service users-preferred intervention methods for crises were not taken into account. The CRPD requires States to implement alternatives to coercion and involuntary practices, and set goals and timelines for this change to happen in psychiatric facilities. Although some of the laws and policies in countries in West Africa are old and may not align with the CRPD on these rights, facilities can still do a lot to promote the rights of service users and stop abuses. For instance, they could provide training on alternatives to coercion and involuntary treatments  for health providers and service users. All of these topics are covered in the WHO QualityRights in-person and online training. They could also develop internal policies setting out goals and deadlines for the implementation of these alternatives. Flyers and informative materials on the legal opportunities and appeal procedures should be made available to service users to enable them to appeal admission and detention effected without consent. It would also be crucial to set up structured complaints reporting mechanism. The reporting mechanisms should be independent of the facility . When this is not possible, staff should be trained to properly handle the process without interfering with service users’ reports. This will provide an avenue for useful feedback on the standard of services delivered in the facility.7 These organisations provide peer support and are engaged in stigma reduction through advocacy, and could be valuable allies in promoting service users’ reintegration into their communities. The mhLAP has played a major role in helping to build the capacity of the members of some of these organisations, and could continue to play a role in the efforts of their leadership to raise community awareness and educate the public on issues around mental health.31 Mental health professionals and their organisations also have an essential role in promoting service users’ rights, including the right to live independently and be included in the community, and ensuring clinical practice is rights-based and dignity is preserved in the hospital setting. Therefore, they should collaborate with people with lived experience and mental health CSOs to achieve these objectives.32The present evaluation revealed shortcomings in the promotion of the right to live independently and be included in the community. There is a strong need for governments to create more community services, for facilities to liaise with the existing ones and for CSOs to create opportunities for service users after discharge. There are growing numbers of mental health CSOs  in The Gambia, Ghana, Liberia and Sierra Leone.The strengths of our study include the rigorously trained assessment teams, the use of a structured and comprehensive evaluation instrument and the inclusion of four countries from a region usually neglected in research. All of these factors contributed to a thorough examination of the psychiatric facilities. However, the study also has some limitations. Different assessment teams were employed in the four countries; thus, although they were supervised by the same central team in Nigeria, we cannot exclude that the differences in the scores were a result of subjectivity and specific cultural values of the local teams.This study offers valuable baseline data on the quality of care and respect of human rights in psychiatric services in these countries. It identifies critical areas and challenges for improvement that facility managers and governments need to address in any effort designed to implement a human rights-based approach to mental health services in these countries, as well as in other low-resource settings. The underlying challenges that need to be addressed for any significant progress to be made include improved policy attention to mental health service, improved funding and staffing, and adequate training and retraining of staff. The latter is particularly important, given that providing care for the complex needs of people with mental health conditions, who are more likely to be discriminated against and exposed to human rights violations, is often more challenging than is commonly the case for many other health conditions.


Background: Pediatric tumors can present with vascular extension to the inferior vena cava and right atrium, which impacts the surgical strategy and can be challenging during surgical treatment. Wilms tumor (WT) is the most common retroperitoneal tumor that can present with vascular extension, but also adrenal tumors, clear cell tumors from the kidney, and hepatoblastomas can present with this situation. Surgical aims include obtaining complete tumor resection without risk for patients, to avoid severe bleeding, cardiac arrest, and embolization, and to avoid cardiac bypass if possible.Objective: To describe and discuss the surgical strategies to deal with pediatric tumors with vascular extension and propose a protocol.Method: Retrospectivly review the experience of treating patients with vascular extension in a single institution, describing different scenarios and a decision making fluxogram based on the preoperative evaluation regarding the surgical techniques and the need for cardiac bypass that are adequate for each situation. Image studies are important to guide the surgical strategy. Depending on the quality of image available, computerized tomography (CT) or magnetic resonance imaging (MRI) can be enough to give the information needed for surgical decisions. Ultrasonography (US) with Doppler is helpful to confirm diagnosis and describes factors to guide the adequate surgical strategy, like the upper level extension and presence or absence of blood flow around the thrombus. Neoadjuvant chemotherapy is indicated in most cases, in order to reduce the upper level of extension (and avoid the need for cardiac bypass) and to lower the risk of embolization. The approach is based on the upper level of the thrombus and can include cavotomy or cavectomy, sometimes with cardiac bypass and cardiac arrest with hypothermia, when the thrombus reaches the diaphragmatic level or above. Pathology analysis of the thrombus can guide staging and the need for radiotherapy postoperatively.Results: A decision making fluxogram protocol is presented focusing on the surgical treatment of such condition.Conclusion: Surgery strategy is highly impacted by the presence of vascular extension in pediatric tumors. Surgeons should be aware of potential complications and how to prevent them. Such cases should be treated in reference centers. Vascular extension to the inferior vena cava and right atrium can be challenging for surgical treatment of pediatric tumors. Wilms tumor (WT) is the most common retroperitoneal tumor with vascular extension , but othThe management requires a detailed preoperative evaluation. Neoadjuvant chemotherapy is indicated in most cases, in order to reduce the upper level of extension, to lower the risk of embolization, and mainly to avoid cardiac bypass (CBP) .In cases of WT, despite the differences on the initial approach between the cooperative groups Societé Internationale d'Oncologie Pediatrique (SIOP) in Europe and Children's Oncology Group (COG) in North America, both agree with the use of preoperative chemotherapy in cases with vascular extension, in an attempt to reduce the level of the extension, minimizing the surgical risks and the need for cardiac bypass (CBP) –9. The nTherefore, there are some factors that should be mentioned along with the preoperative evaluation :Tumor histology and stage at presentationResponse to chemotherapyConfirmation of the vascular extension and its levelPresence of blood flow around the thrombusRisk of tumor embolizationThe extension of the thrombus can be classified in 3 levels, according to the hepatic veins:Level 1: infrahepatic thrombusLevel 2: retrohepatic thrombus (subdivided in infradiaphagmatic and diaphragmatic)Level 3: supra hepatic or atrial thrombusImage studies are of the essence to guide the surgical strategy. Depending on the quality of image available, either computerized tomography (CT) or magnetic resonance imaging (MRI) can be enough, but if there is doubt, ultrasonography (US) with Doppler should be performed to confirm the factors previously mentioned, like the upper level extension and blood flow , 6. TranAlthough there is controversy in the literature, preoperative anticoagulation should be indicated only when there is high risk of embolization, symptoms, and clinical impairment.We aim to describe lessons learned from dealing with such cases and suggest a protocol to manage it.In our institution, in the past 24 years, we have registered 40 patients whose tumors presented with vascular extension and were evaluated for surgery. The diagnoses included WT, hepatoblastoma, adrenocortical carcinoma (ACT), and primitive neuroectodermal tumor (PNET) of the kidney.Vascular extension was identified mainly after CT, but also US with Doppler was used in some cases to confirm the upper level and blood flow status. In one case, anticoagulation was performed, in order to prevent embolization, due to a pedicled tumor through the tricuspid valve and clinical symptoms. Anticoagulation was not indicated in other patients of the series.The surgical outcomes will be presented below.The surgical approach is based on the upper level of the thrombus and the presence or absence of blood flow around it. Usually, a midline laparotomy incision is recommended, which can be extended to the chest, if it is necessary, but associated sternotomy and transverse laparotomy provide good exposure as well. Since some patients may need CPB, it would be advisable to minimize muscular section, due to the need of anticoagulation. Most techniques are derived from the liver transplant surgical approach, which allows a good exposure and safe vascular control along the procedure .Based on preoperative information about thrombus level and blood flow around it, the following protocol was designed  Figure .For infradiaphragmatic thrombus, either infra or retro hepatic below the diaphragmatic transition, there is no need for CBP, heparinization, or cardiac arrest. IVC vascular control below the liver and distally, along with renal vein vascular is enough to achieve complete tumor resection, either by cavotomy or cavectomy. In this scenario, blood loss is minimal and the ischemic time to the kidney with this technique is uneventful .If there is blood flow around the thrombus, cavotomy is performed and the thrombus can be easily removed since there is no invasion to the vessel wall.In the case of blood flow absence around the thrombus, it is firmly adherent and invades the vessel wall, thus cavectomy is indicated and no anticoagulation is needed.Contralateral renal vein ligation is justified and safe due to the development of collaterals venous of the azygo's system while the tumor grows, which is responsible to keep adequate venous return to the contralateral kidney or adrenal , 4, 5. FFor tumors with thrombus in the diaphragmatic transition, it is advisable to have a cardiac surgery team backup, for the decision of CBP may be intraoperative. If CBP is not needed, the already described approach for infradiaphragmatic thrombus should be performed. In our initial cases with this scenario, we indicated resection with CBP, but we learned that this can be avoided in many cases.If the vascular control at the upper level is not secure, a small sternotomy should be made in order to achieve IVC control and a “half” CBP without cardiac arrest and without hypothermia is indicated. In this case, the patient receives heparinization (2 mg/Kg), blood is recovered from the surgical field, is filtered and warmed, and cannulation of the aorta or iliac artery is made, in order to provide rapid fluid replacement without CBP.Either cavotomy or cavectomy can be performed, depending on the presence or absence of blood flow around the thrombus, as described above, with or without CBP.Finally, for tumors with intracardiac extension, CPB is always needed, associated with cardiac arrest and hypothermia , 12. ThiThere were 40 patients identified with vascular extension at the initial investigation, six of them were excluded due to lack of data. From 34 patients included, 21 were WT, one hepatoblastoma, 11 adrenocortical carcinomas (ACT), and one PNET of the kidney.Only two patients with ACT were submitted to the surgical approach due to clinical conditions. In both of them, there was a thrombus reaching the atrium and they were submitted to cavotomy with CPB. One of them died due to bypass system obstruction with thrombus. The other one had neurological postoperative complications related to CBP and died 4 years after the procedure of progression of disease .Renal and hepatic tumors were first treated with preoperative chemotherapy. There was complete thrombus regression in six patients, five of them with WT and one of them with renal PNET, with no need for the vascular approach.Partial regression of the thrombus occurred in 17 patients, who needed vascular management. Among them, we performed eight cavotomies and five cavectomies. Four patients still presented atrial thrombus after chemotherapy and needed CPB.We achieved complete remission in 13 patients. Five patients lost follow up after ending adjuvant chemotherapy and radiotherapy, five patients had died due to complications not related to surgery, and one patient is still under treatment.Surgical management changes in the presence of vascular extension and the present paper proposes a fluxogram to guide the surgical treatment, that can be used both for retroperitoneal and intraperitoneal pediatric tumors with vascular extension . Some deIn renal cell carcinoma, vascular extension occurs in 10% of patients  and it iSome authors advise radiotherapy to treat the thrombus instead of surgical resection , but we In ACT, the IVC extension occurs in 20% of the cases. It is more frequent at the right side  and is rIn hepatoblastomas, vascular involvement adds risk to the stratification based on the European based International Childhood Liver Tumors Strategy Group (SIOPEL) Pre Treatment Extent of disease (PRETEXT), as shown in Pediatric Hepatic International Tumor Trial (PHITT). Vascular extension is one of the Annotation Factors and they are considered positive when there is: tumor involvement of all 3 hepatic veins or retrohepatic vena cava and/or tumor thrombus in any 1 or more of the main hepatic veins; tumor involvement of the portal bifurcation, both right and left portal veins; and/or tumor thrombus in either the left or right portal, and others related to the involvement to other organs . The vasPediatric tumors with vascular extension demand careful multidisciplinary discussions and preoperative preparation. They should be referred to high complexity surgical centers.In conclusion, surgery strategy is highly impacted by the presence of vascular extension in pediatric tumors. Despite the protocols, the best approach is determined case by case, considering the preoperative evaluation. The risks are justified because the tumor resection is of essence for treatment. Surgeons should be aware of potential complications and how to prevent them. Such cases should be treated in reference centers, always remembering the importance of a multimodal assistance, including the pediatric oncologist, pediatric radiologists, pathologists, and pediatric and cardiac surgeons.The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author.The studies involving human participants were reviewed and approved by Comitê de ética e Pesquisa UNIFESP - n° 1015/2019. Written informed consent was not required for this study, in accordance with the local legislation and institutional requirements.All authors listed have made a substantial, direct, and intellectual contribution to the work and approved it for publication.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.