In Bangladesh, the targets on reduction of maternal mortality and utilization of related obstetric services provided by skilled health personnel in Millennium Development Goals 5 remains unmet, and the progress in reduction of neonatal mortality lag behind that in the reduction of infant and under-five mortalities, remaining as an essential issue towards the achievement of maternal and neonatal health targets in health related Sustainable Development Goals (SDGs). As access to appropriate perinatal care is crucial to reduce maternal and neonatal deaths, recently several mobile platform-based health programs sponsored by donor countries and Non-Governmental Organizations have targeted to reduce maternal and child mortality. On the other hand, good health-care is necessary for the development. Thus, we designed this implementation research to improve maternal and child health care for targeting SDGs.This cluster randomized trial will be conducted in Lohagora of Narail District and Dhamrai of Dhaka District. Participants are pregnant women in the respective areas. The total sample size is 3000 where 500 pregnant women will get Mother and Child Handbook (MCH) and messages using mobile phone on health care during pregnancy and antenatal care about one year in each area. The other 500 in each area will get health education using only MCH book. The rest 1000 participants will be controlled; it means 500 in each area. We randomly assigned the intervention and controlled area based on smallest administrative area (Unions) in Bangladesh. The data collection and health education will be provided through trained research officers starting from February 2017 to August 2018. Each health education session is conducting in their house. The study proposal was reviewed and approved by NCCD, Japan and Bangladesh Medical Research Council (BMRC), Bangladesh. The data will be analyzed using STATA and SPSS software.For the improvement of maternal and neonatal care, this community-based intervention using mobile phone and handbook will do great contribution. Thus, a developing country where resources are limited received the highest benefit. Such intervention will guide to design for prevention of other diseases too.UMIN000025628 Registered June 13, 2016. Every year, approximately 290,000 women die due to pregnancy and childbirth, and 99% of maternal mortality occurring in the developing world. Bangladesh is one of those developing countries with high maternal mortality ratio (MMR), standing at 170 per 100,000 live births .Accessibility to good-quality health care at both community and referral level is crucial to reduce maternal and neonatal deaths. In rural Bangladesh, where the home delivery by traditional birth attendants accounts for approximately 85% of all child birth , antenatIn our proposed community-based intervention, we will test the effectiveness of two essential instruments: mobile phone and home-based maternal records. Mobile phone use is universal in Bangladesh, with the overall coverage of 98% in the population . The cosThis community-based cluster randomized controlled trial (RCT) will be conducted in two Upazilas (sub-districts) in Bangladesh. These two Upazilas are Dhamrai (from Dhaka District in Dhaka division) and Lohagora (from Narail District in Khulna division). Dhamrai has 16 Unions and Lohagora has 12 Unions . Each Union has 20-25 villages with an approximate population of about 15,000 to 30,000. The rural population in Dhamrai and Lohagora is 306,704 and 215,902, respectively, with an annual birth rate of approximately 20 per 1000 . AlthougOur target population is pregnant women at reproductive age (15-49 years old). Eligible criteria include: 1. currently having a good health status, without any maternal complication, 2. living and planning to give a birth in the study settings during the period from February 01, 2017 to August 30, 2018 and 3. willing to participate to the proposed study with agreement to the informed consent. The study population is an open cohort: those target women will be invited to enter the study when they are detected to be pregnant. Our research team is explaining the procedure of the study and participant’s involvement and if the participants are agreed then received the written consent from the participants of this study. Participants also include community health workers (CHWs), skilled birth attendants (SBAs), staffs from community clinic and support committee for community clinic at the community / primary level. To facilitate referral and consultants from those staffs from the primary level, we will include health professionals working at healthcare facilities of the referral level  to cooperate our intervention. Figure sadar Union because of its suburban status and better socio-economic status. There are 16 unions in Dhamrai and 12 unions in Lohagora. To avoid potential contamination, the cluster sampling target will be Unions, rather than the individual. In general, Unions in the targeted study sites have homogeneous socioeconomic characteristics such as income level of household, annual birth rate, accessibility to primary healthcare, literate rate, school attendance, and hygiene conditions in household.We will include all Union in the two Upazilas except the Dhamrai and 6 Unions in Lohagora) are selected randomly and allocated to either the intervention or the control. Project staffs affiliating to the NGO in charge of this study will implement this sampling and allocation process. First, in each Upazila, cluster names will be written on paper and folded and put into an opaque bottle. In the first round, the clusters joining the proposed study will be randomly selected. Then, by the same method, 6 from the 17 clusters in Dhamrai and 6 from the 12 Unions in Lohagora will be randomly selected and assigned to the intervention, and the last cluster will be assigned to the control. In the selected clusters, all eligible pregnant women are subject to the recruitment. We will obtain a full list of pregnant women living in the selected Unions from Upazila health complex collected by their staffs and visit household of those pregnant women by the project staffs. The project staffs are experienced to work in the field and they are trained for this project. Due to the natural characteristic of the intervention, all participants, including pregnant women and their families, staffs at the community / primary level and health professionals at the referral level enrolled the study cannot be masked to their study group allocation. Our field staffs are either involved in the sampling and allocation process or inferred from the recruitment and the field survey during the study. Rather, staffs in charge of data input will be blinded to the allocation.Figure In the intervention settings, we plan to fully apply the platform of mobile short messaging and audio system and to effectively link pregnant women and their family members, CHWs and other involved in maternal and perinatal care at the primary level (village and union), and health professionals at the referral level (Upazila and District). Such a network is used to provide information and health education and to boost communication among various stakeholders. The contents of the existing version of Bangladeshi MCH handbook will be incorporated into the mobile platform, with short message or audio message edited based on the gestational age and individual needs. The mobile platform is expected to strengthen the application of MCH handbook. We also are providing books to the participants for each in the intervention areas.The primary study target is pregnant women. Their families  are also invited to participate to the intervention, as they are often the key person to determine daily health-related behaviors, home-based care during and after pregnancy, and seeking and utilization of healthcare services during pregnancy, childbirth and neonatal period in rural Bangladesh. By using the network, pregnant women and their families are possible to daily consult and seek advices during pregnancy with CHWs and to seek basic childbirth and postnatal services to village doctors and SBAs. Meanwhile, it is also possible to realize communications among health care providers at different levels: for example, CHWs, village doctors and SBAs can consult and seek advices and make referral of maternal complications to health professionals at the upper-level facilities (Upazila and District), and health professionals may contact the primary / community-level staffs for the effective referral and provide necessary advices and training as well. As CHWs play an important role to provide primary healthcare to residents in the village community, our trained field staffs will work together with CHWs to take care of pregnant women in intervention group. By integrating CHWs, SBAs and village doctors at the primary level and health professionals at the referral level, the network will also provide advices on a continuum of care to identify complications or any condition needing referral and to alert and help to seeking ANC, SBAs and facility-based healthcare services including emergency care when necessary to pregnant women and their families. As another effective tool to collect data, the MCH handbook will be recorded by CHWs at the primary level, to boost communication between pregnant women and healthcare providers and to implement health education.This study has been approved by the ethical committee of Bangladesh Medical Research Council, Bangladesh and National Center for Child Health and Development in Japan. We don’t expect the intervention to have adverse effects to the participants and the study sites. The informed content will be implemented targeting all participants, and all paper-based and electronic-based personal information will be anonymous in data analysis.The study period includes one-year recruitment of participants and follow-up during pregnancy and the neonatal period. The study starts from February 01, 2017 when we start to enroll the participants, and is expected to finish on August 30, 2018 when all participants go through the neonatal period, four weeks after giving birth. All eligible pregnant women living in the selected villages for the intervention and the control will be recruited right after the allocation. Our trained staffs will visit each household to collect the baseline and the end-of-point data on the pregnancy by using a structured questionnaire at the enrolment and the end of four weeks after delivery or cessation of pregnancy, the ending point of the participation, respectively. In the survey, variables related to the expected outcomes as describe below as well as demographical and socioeconomic characteristics and indicators on knowledge and practices will be obtained. A code to identify each participant during the study period will be created.In the intervention group, a short message will be sent to the participants to welcome them and the printed version of MCH handbook will be provided to the participants to the intervention. Our trained staffs together with CHWs will build a close linkage with pregnant women and their family members by using mobile short messaging and audio system. To monitor their conditions and make a record, the staffs will send a short message to the participants at the frequency of every two weeks and to alert them to visit for antenatal care in advance, and if necessary, also visit their home to talk with the participants face-to-face. As the coverage of at least four visits of antenatal care recommended by WHO is low in rural Bangladesh, our first target will to improve the number of antenatal care visits. Then, text messages on essential health items including perinatal care, including antenatal care visit, nutrition during pregnancy, intake of iron tablet and folic acid, work, rest and daily activities, husband and families’ support during pregnancy and lactating period, danger signs, list of skilled birth attendants and hospitals, signs of labor, postnatal care, neonatal care, breastfeeding, and family planning, will be edited to be user-friendly and sent accordingly to each participant appropriate to their gestational age and location of the residence. For those cannot read, our staffs will use phone call instead of short messages. For those participants who don’t own a mobile, we will ask the neighbors or the relatives living closely to them to share the mobile where messages could be sent, because of the close liaison in the rural community. Every two month, the enrolled pregnant women and their families and CHWs will be organized to a community meeting by the mobile network, for face-to-face health education, consulting / advices and ANC during pregnancy. Data on health status during pregnancy, childbirth and postpartum, utilization of related healthcare services at community and facility levels, opinions of the participants and maternal and neonatal outcomes will be collected by using the mobile network and home visiting. On the other hand, in the control group, a routine care will be provided usually, but no intervention will be implemented. Related data will be collected by home visiting during the study period and the end-of-point survey.We don’t expect the intervention to have adverse effects at local and individual level. The primary outcome is neonatal mortality (deaths in the first 28 days per 1000 live-births), Secondary outcomes include maternal mortality , stillbirth, miscarriage (cessation of a presumptive pregnancy before 28 weeks of gestation), preterm birth, low birth weight, maternal morbidities such as pregnancy complications or near miss as an alternative, frequency of antenatal care visits, accessibility to skilled birth attendants for delivery, referral for identified complications, utilization of postpartum care, and status of initiating breastfeeding. We will use International Classification of Diseases version 9 definition of stillbirth for the study settings .A local NGO, Bridge of Community Development Foundation will take responsibility to maintain the quality of the implementation and data collection. The local Program coordinators will train the field staffs at the beginning of the project and provide enough education and refreshing training for the standard control as they are doing. The recruited community health workers, birth attendants in the community and field staffs will also receive refresh training from the maternal and child health experts and the health professionals working the referral level facility. They will get idea about their role in the community and necessary knowledge to provide essential care, identify the complications and implement referral to the upper-level facilities. At the end of the field study, we will provide an appropriate incentive to those participants who fully attend without any missing information, in order to reduce the drop-out and missing data and to express our thanks for their cooperation.Data from the field study, including the questionnaire, the MCH handbook and other data collected from the study settings will be double-entered in an electronic database. The local project coordinators, local survey staffs and data managers will work together for the quality control.We assume annual birth cohort of 15 newborns in average in the village, a baseline neonatal mortality of 24.4 per 1000 in Bangladesh, a between-cluster coefficient of variation of 0.3, a 25% loss to follow-up, a type I error of 0.05, and statistical power of 0.80. Our study has a power of 40% to detect a 20% reduction in neonatal mortality at the 95% significance level. Thus, the total sample size is 2700 but we have added other 10% and we targeted the total sample is 3000.First, univariate analysis will be performed to explore the characteristics of variables and the study population. In the comparison of each variable, a stratification by randomization groups will be implemented to examine the equality of covariates of the two groups at baseline. If a difference is found at baseline on one or more covariates, we will further adjust those covariates by using ratio residuals for each cluster obtained from a logistic regression model at the individual level at the cluster-level. Moreover, intention to treat analyses at village and participant levels will be implemented. Risk ratios (RR) for primary outcomes and secondary outcomes will be assessed and compared between the intervention group and the control group by using log-binomial regression. The results of RR will be presented with 95% CI. Additionally, considering a potential correlation in the expected outcomes within villages, a generalized estimating equations will be implemented, in which model village ID will be the subject variable. Options of the suitable working correlation structures such as independent, exchangeable, AR (1), M-dependent, and unstructured will be considered and the QIC statistics (the % QIC macro) will be used to select the final working correlation structure .The intervention incorporating the home-based health records with the mobile health network aims to improve health seeking behaviors of pregnant women living in rural Bangladesh, for better maternal and neonatal health outcomes. The innovative intervention package, the combination of mobile phone network and MCH handbook can be relatively complemented and is expected to maximize both advantages in terms of knowledge dissemination, promotion of communication, preservation of home-based health records, and facilitation of continuum of perinatal care. To our knowledge, our proposed study will be the first one to measure the impact of such a combined approach. The cluster-randomized research design is robust to evaluate the effects of the proposed intervention and to provide insight to maternal and neonatal issues in the field.We recognize that the high proportion of home-based delivery practiced by less skilled personnel in particular in the rural area remains as a bottleneck against achievement of the targets related to maternal and neonatal care in health-related SDGs, which figures are not comparative, but rather absolute. Therefore, as the fundamental step, to improve health seeking behaviors during pregnancy and postnatal period, especially utilization of antenatal care and skilled personnel and timely detection and referral in case of emergency is crucial for the achievement. Although tremendous efforts are necessary in both the demand and the supply side and there is still a long way towards achievement of related targets in SDGs, the project doesn’t have resources to improve service delivery intensively at health facilities, the supply side. Rather, the intervention focus on improving of utilization of antenatal care and skilled personnel, raising of health awareness of pregnant women and their families and strengthening the referral system by the mobile network, and effective link between the primary level and the referral level is expected to contribute to capacity building of CHWs and birth attendants.In Bangladesh, the Ministry of Health and Family Welfare has started a nationwide project to increase health awareness by broadcasting text messages to all mobile phone numbers in 2007 [The study have some limitations due to relying on participants’ report, potentially causing bias of data. First, the pregnancy weeks will be reported by the participants as a precise detection by ultrasound is not available in the study settings. Moreover, cost data also rely on participants’ report. Health seeking behaviors depend on their husband’s decision. Nevertheless, by integrating and empowering the network at the communities, the proposal study is expected to improve health seeking behaviors including utilization of antenatal care and contribute to better maternal and neonatal health outcomes.This will be one of the first implementation study among women to improve the maternal and neonatal care using the mobile messages and home-based health record in Bangladesh, aiming to provide an innovative solution for MCH related SDGs. Know-how on the integration of mobile network and home-based health record would be disseminated and applied in other health program with successful experience.


Organisational culture is a key factor in both patient and staff experience of the healthcare services. Patient satisfaction, staff engagement and performance are related to this experience. The department of health in the Western Cape espouses a values-based culture characterised by caring, competence, accountability, integrity, responsiveness and respect. However, transformation of the existing culture is required to achieve this vision.To explore how to transform the organisational culture in line with the desired values.Retreat Community Health Centre, Cape Town, South Africa.Participatory action research with the leadership engaged with action and reflection over a period of 18 months. Change in the organisational culture was measured at baseline and after 18 months by means of a cultural values assessment (CVA) survey. The three key leaders at the health centre also completed a 360-degree leadership values assessment (LVA) and had 6 months of coaching.Cultural entropy was reduced from 33 to 13% indicating significant transformation of organisational culture. The key driver of this transformation was change in the leadership style and functioning. Retreat health centre shifted from a culture that emphasised hierarchy, authority, command and control to one that established a greater sense of cohesion, shared vision, open communication, appreciation, respect, fairness and accountability.Transformation of organisational culture was possible through a participatory process that focused on the leadership style, communication and building relationships by means of CVA and feedback, 360-degree LVA, feedback and coaching and action learning in a co-operative inquiry group. Software refers to the observable skills and competencies as well as the organisational systems and procedures. However, software also refers to the less visible values, norms, relationships, communication and use of power within the health system. These intangible aspects are the hidden drivers of the organisational culture, which is experienced by both patients and staff.South Africa is in a process of strengthening primary healthcare in order to provide universal coverage and improve equity through the introduction of national health insurance.3 Currently, high levels of burnout have been reported, which suggests that healthcare workers, however competent, may not have the emotional and personal resources to form effective patient-centred relationships.4 Healthcare workers are in fact frequently criticised for being abusive and rude.5 Patients may therefore experience an organisational culture that lacks caring, compassion, empathy and support.The healthcare workers are the most important resource in the health system. The effective functioning of an organisation not only depends on the competence and technical expertise of its workers but also on their job satisfaction, motivation, engagement and performance.6At the same time, the staff experience of the organisational culture has been described as strongly hierarchical, with decision making dominated by command and control approaches implemented through organisational silos (of directorates and units), in which management is traditionally seen as an administrative function rather than a proactive process of enabling learning, and in which control is exercised in an authoritarian manner.6Changing organisational culture has been identified as a key goal in improving the resilience and quality of a resource-constrained health system.7 Part of their approach to achieving this is a more values-based approach within the organisation that identified caring, competence, accountability, integrity, responsiveness and respect (C2AIR2) as the core desired values.7 Nevertheless, recent cultural values assessment (CVA) have shown that the top 10 current organisational values in the metropolitan district health services included poor sharing of information, cost reduction, confusion, control, manipulation, blame, power, hierarchy and long hours.8 These results indicated that the current organisational culture was limiting staff performance and engagement.The Western Cape Department of Health has emphasised that improving health outcomes, quality of care and patient experience is central to their vision.9 Despite this, there has been very little research on the challenges of organisational transformation at the facility level in South Africa. Retreat Community Health Centre (CHC) was one of the facilities that participated in the CVA8 and after receiving their feedback expressed interest in a process to change their organisational culture. Therefore, the aim of this study was to explore how to transform the organisational culture in line with the desired values expressed in the baseline assessment and by the Department of Health.The Negotiated Service Delivery Agreement between the President and the Minister of Health acknowledges the need to strengthen management at the facility level.A co-operative inquiry group (CIG) used participatory action research to engage with the question of how to transform organisational culture at Retreat CHC over a period of 18 months. Change in the organisational culture was measured at baseline and after 18 months by means of a CVA survey. The three key leaders at the health centres also completed a 360-degree leadership values assessment (LVA) and had 6 months of coaching based on the feedback.Retreat CHC serves the community of Retreat in the City of Cape Town. People living in Retreat are mostly from a low socio-economic background, usually speak either English or Afrikaans and historically belong to the so-called ‘coloured’ community. The CHC had a facility manager, family physician and nursing managers in charge of operations, trauma unit, HIV unit and maternity unit. There was also a pharmacy manager and an administrative officer in charge of reception. It offered ambulatory primary care services as well as 24-hour emergency care to both adults and children as well as 24-hour maternity services. A multidisciplinary team consisted of a family physician, medical officers, primary care nurses, midwives, pharmacists as well as allied health and dentistry staff. In addition, support services included cleaners, security guards, a porter, a personal assistant and clerks. Total staff complement at the facility totalled 128 people.2AIR2 club process. As the C2AIR2 club initiative also focused on promoting key organisational values, the management felt it made sense for them to join the CIG. The principal researcher, who was not a member of staff at Retreat CHC, facilitated the CIG.The purpose of the study and CIG process was presented to a meeting of senior staff, invited by the facility manager, from all the departments at the CHC. Fourteen people consented to participate in the CIG and included the facility manager, family physician, five senior nursing managers, a medical officer, a post basic pharmacist’s assistant, nurses working in the preparation room, emergency centre and maternity unit, the supervisor of the general assistants and the radiologist. Towards the end of the CIG process, six additional staff members joined the CIG. These included a new pharmacy manager, a new administrative officer and four other staff who were leading the CThe CIG followed a cyclical process of planning, action, observation and reflection over a period of 18 months from June 2014 until November 2015. The meetings of the CIG are summarised in During June and July 2014, the three key leaders at the CHC  also had 360-degree LVAs conducted. The LVA is said to be a 360-degree assessment because feedback is elicited from managers, colleagues and subordinates who work all around the leader. These LVAs give feedback on how these respondents experienced them as leaders in terms of their values and compared this assessment to their own perceptions. An independent personal coach gave them the feedback and then provided them with 6 sessions of individual coaching over a period of 6-months.3 This tool was selected as it was already an accepted approach to measure organisational culture in the Government of the Western Cape and Department of Health. Values could be positive or limiting. Limiting values were ones that usually limit the performance of the organisational system. Each respondent selected their top 10 personal and current and desired organisational values. These were then collated and analysed by the Barrett’s Value Centre who provided a detailed report.All staff at the CHC were invited to complete a CVA survey at baseline (January 2014) and follow-up 18 months later (August 2015). The CVA measured how staff perceived their personal values, the values expressed in the current organisational culture and the values that they would like to see in the future culture. The CVA is a validated tool produced by the Barrett’s Values Centre and offers the respondents a list of personal and organisational values to choose from.3 In this model, whole system change is based on improving the alignment between all four quadrants of the model shown in The CVA was used in two different ways in this study. Firstly, the baseline report on organisational culture was used to stimulate reflection and planning in the CIG as described above. An integral model of the organisation was used for this process of reflection.Secondly, the CVAs performed at baseline and 18 months later were used to compare the extent to which the organisational values had changed over this period. The degree of cultural entropy was also measured, which is the amount of energy in a group consumed in unproductive work and is a measure of the conflict, friction and frustration that exists within a group. It was measured as the percentage of all values selected that were limiting values.3 The top 10 organisational values were plotted according to these seven levels for both the current and desired culture at baseline and follow-up. The pattern that emerged indicated where the organisation was currently investing its energy and what organisational needs were being addressed. Levels without any values could represent a blind spot for the organisation that needed attention, a level that had been fully achieved and did not require attention or an opportunity for future development. A well-functioning organisation should have full-spectrum consciousness with values across all seven levels.Values could also be analysed as belonging to seven different levels of organisational consciousness as shown in The study received ethical approval from the Health Research Ethics Committee at Stellenbosch University (Ref N12/10/059) and permission from the Department of Health in the Western Cape.Twenty-five staff members completed the baseline survey, including 5 nurses, 5 allied health professionals, 11 support staff and 4 unknown. The top 10 personal, current and desired organisational values are shown in These results were presented to both the staff and CIG, and the final interpretation of these organisational values is given in Following the feedback described above, the CIG summarised the key issues as improving communication, building relationships, reducing the perception of cost reduction as a driving force and increasing accountability.The follow-up CVA was completed by 75 staff members, including 5 doctors, 41 nurses, 7 allied health professionals and 22 support staff. The results are shown in At follow-up there were no limiting values in the top 10 values and cultural entropy had dropped from 33 to 13%. Caring had moved to the top value experienced at the health centre, and all three personal values that were previously asked for as part of the desired culture  were now recognised as part of the current culture. Teamwork, making a difference and continuous improvement were also recognised in the current culture and mirrored the values of teamwork, positive attitude and excellence that were also previously asked for in the desired culture. Information sharing was now an unequivocal part of the organisational culture suggesting that communication was improving. Patient orientation had replaced goals orientation in the current culture.The concentration of values in the current culture at level 4 suggested a focus on organisational transformation and an emerging ability to deliver on this. In the desired culture, staff continued to ask for a greater focus on relationships (level 2), shared community and purpose (level 5). There was still a need to make accountability, staff recognition and fulfilment a greater part of the current culture. More open communication, transparency and accessibility were aspired to, even though information was more shared. Staff remained committed to excellence and being the best.The CIG reached a consensus on the activities that were responsible for transforming organisational culture and ranked them as shown in A large number of the strategies involved changing the managers’ leadership style through their willingness to engage with the issue of organisational culture, personal coaching and involvement in the CIG. Managers became more confident, open, vulnerable, approachable, collaborative, appreciative and empathic. Small changes in their approach to leadership led to a large change in the way the organisational culture was perceived. Managers felt that the process illuminated key aspects of the organisation that had not previously been recognised as important. The coaching process also led to greater bonding and teamwork between the managers.2AIR2 club groups were recognised as important parts of the process of change.Communication of information and decisions were improved as well as opportunities for feedback from staff to managers. Relationships between staff members and teamwork were improved by ensuring that different departments understood each other’s functioning, social events, social media and delegation of responsibility within teams. The action research process itself and the CThe study affirmed that despite the many resource constraints and workload challenges in the public sector, organisational transformation is possible at the level of the primary care facility where the majority of patients and health problems are seen.3 The key drivers of this transformation were change in the leadership style and functioning through feedback from the CVA and LVA, personal coaching of the three key leaders and engagement of broader leadership in the CIG process.Cultural entropy decreased dramatically, indicating that the organisation was functioning better, although entropy should still be reduced further to less than 10% for healthy functioning.Retreat CHC moved from a culture that emphasised hierarchy, authority, command and control to one that established a greater sense of cohesion, shared vision, communication, appreciation, respect, fairness and accountability. Trusting the majority of your professional staff to strive for excellence, to innovate and to care for patients instead of fearing that you needed to police, blame or manipulate them into delivering on goals was a fundamental shift. The willingness of leaders to engage with these issues and allow small changes in their approach to leadership led to substantial improvement.3 This study has demonstrated how values can be engaged with practically to drive change. The integral model outlined in the methods section was a key conceptual framework to make sense of the links between personal and collective values as well as individual behaviour and collective processes and procedures. The focus group interviews, which contextualised the meaning of these values, were also a key part of grounding these values in reality.The study took a values-based approach to understanding organisational culture and leadership. Organisations often espouse a set of values, without the ability to actually embody them ‘on the floor’.6 Managers who lead have been characterised as focusing on collaborative actions taken by groups, seeing the possibilities to make things better, taking responsibility and initiative to tackle challenges, focusing on activities that are aligned with results that matter, displaying generosity and concern to serve the common good and inspiring others to do the same.6 The organisational culture is largely created by the type of leadership; therefore, it makes sense that leadership transformation would be a key driver of improving organisational culture.3The study also confirmed that changing the leadership style was the key factor in enabling this transformation. Managers at Retreat CHC came to embody the concept of managers who led rather than just administered.10Developing self-awareness, managing oneself and continuing personal development were key aspects of the coaching process, while improving interpersonal skills was a key aspect of the CIG approach, which focused on relationship building, teamwork, networking and communication. These aspects of emotional and social intelligence may be somewhat missing from the South African competency framework for assessment of managers.6 This study demonstrated the potential of action learning combined with on-the-job coaching and 360-degree feedback to do this successfully. A number of initiatives in South Africa have focused on more formal leadership courses and teaching, whose impact may be more limited.6 Action learning is a less utilised, but potentially more comprehensive approach to developing leadership.6Different approaches to developing leadership have been identified, such as formal training, on-the-job training, action learning and non-formal training.11 Complex adaptive leaders are more comfortable with uncertainty, understand the importance of connectivity and feedback within the system and the inevitability of holding paradoxical principles, for example, the need to set a number of simple rules for the organisation, while allowing people individual freedom to act within their scope of practice.The approach to transforming organisational culture and leadership was congruent with a model of complex adaptive leadership that sees the organisation as a complex living system rather than a machine defined by reporting lines within an organogram.2AIR2 club leaders also created some confusion and meant accommodating new members towards the end of the whole process. Transformation may have been even greater if the personal coaching had continued for longer and been extended to a broader managerial group.Members of the CIG were selected by the management without fully understanding the nature of action research. Lack of understanding their roles resulted in some frustration and participants leaving the process. Those that stayed behind benefitted from the relationships that were built and hierarchical barriers that were broken down. In hindsight, it may have been better to have taken longer to explain the process and allow departments to have more say in choosing the members. This may have led to a CIG in which people were more committed to both action and reflection. People’s sense of freedom to interact and be honest grew over time and became a strength of the group. Combining the CIG with the C8The surveys were completed by different numbers of people in different proportions according to their professional roles. The follow-up survey is likely to be more accurate as the response rate is better . Although the response rate for the baseline survey is low  the results are consistent with those previously obtained for the MDHS as a whole in 2011.Although a substantial improvement in organisational culture was seen, the momentum needs to be maintained and this may require ongoing external facilitation. Consideration should be given as to how to take such a process to scale within an entire sub-district or district.8 Retreat CHC was the only one that was ready to explore change in this way. The principal researcher ensured that the facility manager and key leaders were aware of and committed to the process beforehand. This suggests that managers may be at different stages of change. Some may be pre-contemplative or unconscious of the need to change, while others may be ambivalent about the importance of change or sceptical about how to change. Exploring the current leadership style and readiness to change of managers at different facilities may be an important aspect of going to scale with this approach.It should be noted that out of the five CHCs that participated in the original survey,Further research should try to explore the relationship between improved organisational culture, staff engagement and satisfaction and the quality of care offered to patients. The effect on levels of staff burnout and ability to be patient-centred could also be explored.Organisational culture at Retreat CHC was transformed over a period of 18 months with a substantial decrease in cultural entropy and embodiment of positive values such as caring, sharing information, teamwork, accountability, respect, client orientation, fairness, commitment, continuous improvement and making a difference. This was achieved through transformation of the leadership style and a focus on communication and building relationships by means of CVA and feedback, 360-degree LVA, feedback and coaching and action learning in a CIG.


Acacia mangium were planted for commercial purposes in savanna areas surrounding indigenous lands in Roraima State, Brazil, at the end of the 1990s. We examined the local ecological knowledge of indigenous Wapichana and Macuxi Amerindians, members of the Arawak and Carib linguistic families, respectively, concerning A. mangium Willdenow (Fabaceae) in a savanna ecosystem (“Lavrado”) to attempt to understand its propagation beyond the limits of the commercial plantations and contribute to mitigating its impacts on socio-ecological systems.Invasive plants can impact biodiversity as well as the lives of native human populations. Natural ecosystems represent sources of natural resources essential for the subsistence and socio-cultural continuity of these social groups. Approximately 30,000 ha of A. mangium and their uses of it.The present study was undertaken in the Moskow, São Domingos, and Malacacheta communities in the Moskow and Malacacheta Indigenous Lands (ILs) in the Serra da Lua region of Roraima State, in the northern Brazilian Amazon region. Interviews were conducted with a total of 94 indigenous individuals of both sexes, with ages between 18 and 76, and low levels of formal schooling, with an average time of permanence in the area of 21 years; some still spoke only their native languages. The interviews focused on their ecological knowledge of the invasive, non-native A. mangium negatively impacted the local fauna and flora, making their subsistence more difficult and altering their daily routines. Among the problems cited were alterations of water quality (71.3%), negative impacts on crops (60.6%), negative impacts on the equilibrium of the local fauna (52.1%), increased farm labor requirements (41.5%), and restriction of access to indigenous lands (23.4%). There were no significant differences between the opinions of men and women, nor between community leaders and nonleaders. Most of the interviewees (89%) felt that A. mangium had no positive importance for the local economy and saw no future prospects of beneficial use.The informants affirmed that A. mangium had caused negative effects on the natural environment and on community subsistence in the indigenous lands due to its rapid and unwanted propagation. The similarity between the opinions of men and women and between community leaders and nonleaders demonstrates the existence of knowledge that is well distributed among these communities and transmitted within their communities through social–cultural interactions.The Wapichana and Macuxi informants felt that the invasion by  It grows on our farm plots soon after they were cleared and burned, and with the coming of the rains. Then the trouble starts. We have to pull out the acacia plants to plant manioc. I can see it growing, the leaves start changing, I used to think that it was a curse.(an indigenous informant from the São Domingos community).Plant invasions of natural ecosystems can seriously threaten native biodiversity and the subsistence of indigenous peoples –4. InvasAcacia mangium of indigenous lands in Roraima, Brazil, and to determine how to contribute to mitigating the environmental damage caused by these trees.Although scientists have investigated the effects of invasive plants in various parts of the world and the phases of the invasion process , there iA. mangium within indigenous lands is considered an injustice imposed on those communities and has been discussed in numerous community meetings. During these discussions, in addition to doubts about how these plants propagated themselves, community members voiced their concerns about future threats to their socio-biodiversity, guarantees of food security, and the physical and cultural continuity of their indigenous lifestyles , or in the houses of interviewees). When an informant spoke only his/her native language, translators were used. Another research technique employed was direct observation during visits to farm plots; these visits were undertaken during the acacia mapping phase of the project and during our participation in events undertaken in the different communities . Open-ended questions were used to investigate the appearance, development, and management of acacia plants, allowing flexibility in the interviewees’ responses and generating opportunities to explore other subjects pertinent to the research project, as suggested by Albuquerque  it wasn’t like that before, after burning for clearing now, only acacia seedlings germinate, and when you’re ready to plant – there she is again, the seedlings germinate before the grasses and grow rapidly; and the rains help, acacias really like water […].There was a positive correlation between age and the numbers of citations contributed by an informant , or by bats (6%). However, 46% of the interviewees stated that they had no explanation for the rapid dissemination of those invasive plants to localities distant from the commercial plots. The following statement expressed their views on dispersal:[…] There is an area in the Malacacheta reserve that has only acacias, they also grow near the neighbor’s house, even 4 or 5 km in from the border of Malacacheta there are acacia plants, so you ask yourself, how did those acacias get there? Their seeds are very light, and the wind and birds will take them, and wherever they fall an acacia will germinate […].roça velha”). During the interviews, many of the interviewees expressed in their answers worries and lamentations about A. mangium:According to the interviewees, burning the vegetation (67%) and rainfall (70%) intensified germination—creating concern among community members in relation to the rapid advance of acacias in secondary vegetation and invading fallow plots , a species that has invaded a wide variety of vegetation types in South Africa, has been shown to use substantially more water than the native vegetation [A. mangium trees in commercial plantations near natural watercourses constitutes a significant drain on groundwater resources, because of the lack of balance between plant transpiration and groundwater replacement through rainfall [In our study of the situations being experienced by the Wapichana and Macuxi people, it became very clear from their statements that environmental changes due to a decade of interactions with the non-native species getation ; equallyrainfall .A. mangium favors subsequent invasions, that is, the growth of new acacia seedlings following the indigenous practice of preparing the land for planting by cutting the cover vegetation and then burning everything. The Soliga ethnic group likewise recognized the influence of fire on stimulating the germination of the invasive species Lantana camara [roça velha). Similar observations, although in forest environments, were described by Sundaram et al. [Lantana camara, as well is the positive influence of fire on its propagation. After invasion by L. camara, it becomes more difficult to harvest tubers in farm plots [Similarly, the indigenous populations of Roraima State have noted the high germination rates of acacia seedlings after burning the cover vegetation (the first step in preparing the land for farming) and at the beginning of the rainy season, as have other authors in studies of invasive plants , 15. Acca camara . It is qm et al. , who reprm plots . These arm plots .A. mangium generates social-environmental impacts due to its wide dissemination in different IL habitats. It must be recognized, however, that this subject has not yet been fully investigated, and a detailed scientific study would be needed to confirm the dispersal capacities of A. mangium propagules [buriti palm stands, near wells, along river banks, and in new and abandoned farm plots.According to the LEK recorded in the social mapping efforts of the New Social Amazonian Cartography Project (2014), opagules . Those aopagules . AccordiNegative impacts on the regional fauna were cited by the indigenous informants as important environmental side effects of economic development and human occupation. The transformation of the natural landscapes near the ILs due to monoculture acacia plantations, the installation of cattle farms, deforestation, and burning have all contributed to upsetting the equilibrium of the fauna near the indigenous communities of Serra da Lua . The marA. mangium resulted in the undesirable ecological consequences mentioned above. Hence, these situations will require direct mitigating actions by the company responsible for the commercial plantations—by working together with the indigenous communities who have intimate ecological knowledge of their lands.The informants in the IL stated that the dissemination of A. mangium seeds. As such, the inclusion of indigenous ecological knowledge concerning the invasive species A. mangium into management projects, together with the participation of these ethnic groups in monitoring invaded areas, will be indispensable for controlling these plants.The LEK of the São Domingos indigenous community is not precise about the dispersal mode of acacia seeds to sites distant from their commercial plots of origin, but birds, bats, and wind are mentioned as probable dispersal agents. These observations are consistent with Kull and Rangan , who detThe experiences of indigenous populations with invasive plants have allowed them to accumulate important information concerning these species that is in agreement with the scientific information available in the literature and has alerted them to some of the multiple facets of its invasive processes, including its manner of dispersal. This local knowledge is important and should be recognized as useful when formulating plans for non-native species management.A. mangium was the target of severe criticisms by local inhabitants, who were discontented with the environmental changes associated with its appearance. In other communities, however, Australian acacias generate income for rural populations in spite of their invasive behavior and some negative effects on traditional lifestyles [Interactions between indigenous groups and acacia plants have been occurring for more than two decades now, as could be confirmed by the immediate recognition of this invasive species in illustrations shown to the interviewees. The plant is thought of as a tree that does not produce any fruits and has very soft wood that renders it essentially useless for constructing traditional residences, etc. Local perceptions of this plant are thus quite negative, and the indigenous populations cannot envision any utility for it, or future benefit from it, in terms of their traditional lifestyles. When this subject was raised during community assemblies, festyles , 8. It ifestyles  and has festyles , attitudIn general, the populations that benefited from introduced acacias were not previously informed about the potential ecological impacts of these invasive plants on natural ecosystems, and when their local natural resources became scarce they were left to deal with these negative effects on their own . NonetheA. mangium, many of which are mentioned in the text above. These problems have contributed to the disinterest of the local indigenous populations in commercially exploiting A. mangium or contemplating any practical use for it—in contrast to populations in other countries that have been able to obtain economic benefits from invasive plants [The statements of the indigenous community members interviewed are dominated by negative comments concerning e plants . Even reA. mangium. Informants that had lived in the indigenous communities for longer periods of time noted that there had been significant changes in local routines due to the uncontrolled propagation of acacia. Different perceptions concerning the effects of invasive plants were observed in terms of informant age and gender [A. mangium, while the women noted the marked disappearance of mushrooms.Most of the statistical tests did not identify significant differences in the perceptions of invasive acacia plants by men or women within the dynamics of their community life. Community leaders, as well as older residents, were aware of larger numbers of problems associated with d gender , with olA. mangium is the result of personal observations and experiences within a new ecological and social environment, combined with personal experiences attempting to minimize the impacts of acacias. In this sense, local knowledge comes from experience with the processes of invasion and can generate insights concerning the restoration of damaged environments. Le Maitre et al. [In terms of the acquisition of local knowledge , it is pe et al.  recognizA. mangium. Their positions reflect, in part, the lack of precise information provided to them when the acacia plantations were first being organized as, according to the informants, the possible negative consequences of the introduction of this non-native species near the IL were not clearly and openly explained [It was noted that indigenous men and women, both young and older, had the same unfavorable opinion concerning the invasive plants as did community leaders and could enumerate large numbers of negative consequences related to the appearance of xplained .The majority of the informants interviewed in the three communities believe that the acacia plants have negative effects on the natural environment and on the subsistence of their communities, because of the many different problems that arose with their uncontrolled propagation. The observed impacts of the acacias (and the lack of any attempts to use them) made any possible utilitarian value seem absolutely insignificant. The similarities between the opinions of men, women, and community leaders show that the knowledge concerning the acacias is well distributed through sociocultural relationships.A. mangium, in management plans designed to contain its dispersal beyond the limits of the commercial plantations, and to mitigate its impacts on local socio-ecological systems. As such, we recommend that all new commercial plantations be established at secure distances from indigenous agricultural plots  to minimize their negative impacts on local ecosystems and to control the species’ invasive propensity.It is important that this indigenous ecological knowledge be included in future evaluations of


An in vitro simulation system for the complete natural hip joint, enabling the acetabulum and femoral head to be positioned with different orientations whilst maintaining the correct joint centre of rotation, was successfully developed for this study. The efficacy of the simulation system was assessed by testing complete, matched natural porcine hip joints and porcine hip hemiarthroplasty joints in a pendulum friction simulator. The results showed evidence of biphasic lubrication, with a non-linear increase in friction being observed in both groups. Lower overall mean friction factor values in the complete natural joint group that increased at a lower rate over time, suggest that the exudation of fluid and transition to solid phase lubrication occurred more slowly in the complete natural hip joint compared to the hip hemiarthroplasty joint. It is envisaged that this methodology will be used to investigate morphological risk factors for developing hip osteoarthritis, as well as the effectiveness of early interventional treatments for degenerative hip disease.The use of hip joint simulators to evaluate the tribological performance of total hip replacements is widely reported in the literature, however,  Despal plugs . This man nature –18. Trib methods –21, albein vitro simulation model, initially using natural porcine hip joints and a pendulum friction simulator, in order to investigate the tribology of the complete natural hip joint. The method was developed to facilitate hips with different morphologies, and to be easily modifiable for use with human tissue and different simulation systems, e.g. a physiological hip joint simulator. The methodology was assessed by conducting in vitro simulations on a group of complete, anatomically matched porcine hip joints and a group of porcine hip hemiarthroplasty joints, and with the intent of testing hip joints positioned with different acetabula and femoral orientations in future studies. The data associated with this paper is available from the University of Leeds Data Repository [The main aim of this study was to develop a complete pository .in vitro simulations in this study , which is a pneumatically loaded single station simulator, was used for the is study . Hip joiFixtures were developed to facilitate the orientation and positioning of natural acetabula with varying angles of version and inclination, and natural femoral heads to be positioned with different combinations of angles in all three planes. The risk of experimental artefact was reduced by enabling natural hips of different sizes to be potted centrally with the centre of rotation (COR) of the head and acetabulum aligned with the pendulum friction simulator. The position of the samples in the simulator was checked using an alignment rod (supplied by the manufacturer), which was designed to pass through holes in the FE rocker and friction measuring carriage, arranged in series corresponding to the COR of the simulator.in vitro simulations to replicate different in vivo morphologies, for example a retroverted acetabulum.A test pot allowing sufficient access and control over the acetabulum during potting and removal of the specimen, whilst also reducing the risk of impingement between the components during testing, was designed and manufactured from stainless steel. A potting methodology using an inclinometer was developed, which provided a consistent and repeatable way of orientating the acetabulum whilst controlling the degree of inclination and version to be applied to the acetabulum . This meThe potting jig was a modular design with interchangeable fixtures enabling femoral heads of different diameters to be correctly positioned. Potting discs of varying depths, designed to be used with femoral heads of different radii, were manufactured and the selected disc was vertically aligned with the centre of the test fixture base, once attached to the top bar of the potting jig . The jig® test pot, offset to accommodate the anatomical offset of the femur whilst maintaining vertical alignment of the head with the direction of axial loading from the simulator. Samples were held in place during positioning and potting using a potting ring and cone point pins  metal head for the hemiarthroplasty studies.Simulations for the complete natural hip and hip hemiarthroplasty studies were conducted with the acetabula positioned with the same orientation so that between-group comparisons of friction factor could be made.Harvested tissue was potted using a three-stage process, and all tissue samples were secured in their respective test pots using polymethyl methacrylate (PMMA) bone cement.Acetabula were positioned and potted with the transverse acetabular ligament uppermost and central region of the articular cartilage inferiorly. Samples were centred and aligned with the COR of the simulator using a potting jig previously developed by Lizhang , that haPorcine femurs were positioned in the potting ring so that the articulating surfaces of the femoral head and acetabulum were congruous, and with the head in anatomical alignment with the potted acetabulum. This was achieved using an alignment mark placed opposite the midpoint of the transverse acetabular ligament and bony reference point on the femoral neck . The bonThe potted acetabulum was replaced with the femoral head test pot fixture and the femur was inverted, whist maintaining its orientation from Stage 2 in the potting ring. The femoral shaft was positioned centrally in the test pot of the head test fixture , and theHemiarthroplasty tests were conducted using natural acetabula and size-matched CoCr femoral heads . Acetabula were potted using the method described above, and the CoCr heads were mounted and tested using an existing fixture. This consisted of a moveable vertical spigot that could be adjusted to set to the correct COR using slip gauges and a Vernier height gauge.In vitro simulations were conducted on porcine hemiarthroplasty specimens (n = 5) and complete, matched natural porcine hip joints (n = 5). Samples were fixed into the simulator with the acetabula pot seated in the friction measuring carriage and the head attached to the FE rocker  was calculated using t) detected by the piezoelectric transducer, where r is the radius of the bearing surfaces (meters) and Wp is the peak load (Newtons):Friction factor (fo) was calculated using data from the constant load tests conducted before (fb) and after (fa) each dynamic profile study The mean friction factor for each one-second cycle of the dynamic load tests, was calculated from the data collected during the peak load (i.e. 800 N) high velocity phase, and friction factor for the constant load tests (example raw data plots shown in fn) by subtracting the frictional offset (fo) from the mean dynamic friction factor (fd) of each logged cycle Friction data was normalised  throughout the two-hour tests was calculated, and a two-way analysis of variance (ANOVA) was carried out on friction factor by bearing couple (i.e. hemiarthroplasty and complete joint), and time (i.e. cycle number) using SPSS predictive analytics software , where p < 0.05. Time was discretised into three levels and analysed at the one-minute , two-hour  and twenty-minute (1200 cycles) time points. The latter was an arbitrary time point enabling data from the initial stages to be compared with data from the start and the end of the tests.In addition to the quantitative analysis of friction, a qualitative macroscopic evaluation of the specimens’ articulating cartilage surfaces was conducted, both before and after the simulation, in order to identify any visible damage or changes in surface appearance following testing.in vitro tribological testing to be conducted in the pendulum friction simulator. During the two-hour test period, an initial rapid increase followed by gradual rise in friction factor was observed for all samples in both groups . A Bonferroni post hoc analysis showed that friction factor at the 60 second time point was significantly different to the friction factor recorded at both the 1200 second and 7200 second time points (both p<0.05), however, there was no significant difference in friction factor when comparing the 1200 and 7200 second time points (p = 0.139).Complete natural porcine hip joints (n = 5) and porcine hip hemiarthroplasties (n = 5) with a diametral range of 35–37 mm were successfully positioned with the required anatomical orientation and joint centre height, enabling h groups . Mean frChanges in the appearance of the lunate surface and small areas of chondral damage were observed during the macroscopic evaluation of the tested acetabula. This was largely discoloration and small superficial scratches, which were evenly dispersed across the lunate surface of complete natural joint specimens, but located more centrally on the hemiarthroplasty specimens. There was also evidence of slightly deeper chondral lesions on the tested hemiarthroplasty specimens, with small fissures being observed on two of the acetabula. Some slight discoloration was observed superiorly on some of the tested natural femoral heads.Osteoarthritis is a common form of degenerative joint disease, and it is generally accepted that the direct and indirect healthcare costs from treating hip OA using THR are expected to rise due to an aging population , 32. InvHistorical pendulum studies of the natural hip joint have been reported in the literature by Unsworth et al. , O'Kellyin vitro simulation system for the complete natural hip joint with potting fixtures enabling the orientation of both the femur and acetabulum to be controlled to simulate different joint morphologies, and with the joint COR aligned with that of the simulator, was successfully developed. The new fixtures and methodology were assessed by conducting in vitro simulations on porcine hip joints in a pendulum friction simulator so that mean friction factor values could be analysed and appraised. The potting methodology that was developed enabled both complete natural hip, and hip hemiarthroplasty joints, to be positioned and tested in the simulator with the joint COR aligned with that of the simulator. Setting the correct COR, together with the normalisation of the data to account for any extra biomechanical torque not due to the application of the loading profile, ensured that as far as possible any experimental artefact arising from the set-up or complex hip geometry was reduced.In this study, an in vitro cartilage-on-cartilage tribological studies, however, the results do fall within the range of values (0.003 to 0.08) for friction between two cartilage surfaces that have been reported in the literature [Friction factor measured during the hemiarthroplasty tests displayed similar trends and values to those reported by Lizhang et al. , in a siterature , 33–35.in vitro friction in the natural knee joint. The natural hip in this study set-up has a spatially varying and time dependent load on the femoral head cartilage compared to the spherical CoCr head of the hemiarthroplasty. This means that exudation of fluid from the cartilage will have been slower, and hence the friction factor was lower and took longer to rise compared to the hemiarthroplasty model. These findings are reinforced by the pin-on-plate work of Forster et al. [The non-linear time response observed in both sample groups is most likely attributed to the viscoelastic response and biphasic nature of the cartilage, where, as the fluid support decreases the load gradually transfers to the solid phase , 37. Frir et al. . Additior et al. . Porciner et al. . It is rr et al. –43.in vivo  could not be reproduced in vitro, which may result in some abnormal stresses being applied to the joint. Additionally, although the friction factor data was normalised to account for any slight misalignment of the joint, this process did not factor in any potential damaging effects that this may have had on the articulating surfaces of the joint. These factors may explain the minor areas of damage that were observed on the lunate surface of the native acetabula after running the complete natural joint simulations for only a relatively small number of cycles (i.e. over two hours).The main limitation of using a pendulum friction simulator for conducting the simulations was that an axial load was applied through the femur, rather than through the acetabulum of the pelvis, and only one axis of motion (flexion-extension) was applied. Consequently, the normal loading and osteokinematics that the hip joint is normally subjected to in vitro simulation system for the natural hip joint with potting fixtures enabling the orientation of both the femur and acetabulum to be controlled in future studies.Bovine calf serum has been used as a lubricant extensively in tribological investigations of the hip joint, however, it has been acknowledged that the viscosity and composition varies from synovial fluid, which is much more complex and contains hyaluronic acid, different proteins, enzymes and lipids . Hyaluroin vitro simulation systems that are able to simulate a more physiological movement, and this will provide a robust system for testing complete natural animal and/or human hip joints. The continuous cyclic loading used throughout the simulation, where the cartilage is unloaded for only relatively short periods during the swing phase, is representative of continuous walking, unlike input profiles that use a stop-dwell-start protocol to facilitate periods of relaxation and re-hydration of the cartilage matrix. If longer duration tests are to be considered in the future, then this type of simulation profile could provide a more realistic in vivo representation of activities of daily living that could be generalised to the wider population [In future work, this methodology will be adapted for use with pulation , 49. Addpulation , will be


Several aetiological models of anorexia nervosa (AN) hold non-eating/weight-gain-related anxiety as a factor relevant to the onset and maintenance of the disorder. Longitudinal studies that allow assessment of this hypothesis have been conducted; however, the evidence has not yet been aggregated in a systematic manner. The proposed study will systematically review articles describing prospective investigations of the relationship between anxiety and AN development or maintenance, with the aim of providing a balanced summary of current understanding and identifying areas for further research.Electronic databases will be searched for articles investigating the longitudinal influence of non-eating/weight-gain-related anxiety (anxiety disorders and trait anxiety) on the development/maintenance of AN. References of eligible articles will be searched to ensure the identification of all relevant studies. Two independent reviewers will complete the title and abstract, and full-text, screening, with a third independent reviewer resolving any conflicts at each stage. A systematic review will be completed, and the quality of the included studies, as well as the strength of the body of evidence generated, will be assessed and reported.Although there are limitations to the present review, understanding the current evidence for the role of non-eating/weight-gain-related anxiety in AN can direct future research that may ensure accurate aetiological models of AN and effective treatments.CRD42017069644The study is registered on PROSPERO under the reference number The online version of this article (10.1186/s13643-018-0685-x) contains supplementary material, which is available to authorized users. Anorexia nervosa (AN) is characterised by the maintenance of a significantly low body weight  that is The high levels of anxiety surrounding eating has caused AN to be compared to anxiety disorders , and anxThe relief of anxiety caused by dietary restriction is suggested to encourage excessive engagement in the behaviour –12. It iAn alternative hypothesis is that anxious traits and anxiety disorders reflect underlying neurobiological abnormalities that predispose individuals to develop pathological fear and avoidant responses , 16, 17.Is anxiety related to the later onset of AN?Is anxiety related to the maintenance of AN?The relationship of trait anxiety and symptoms/diagnoses of anxiety disorders  with both AN onset and maintenance has been probed in a number of longitudinal studies. However, the evidence gathered across these studies has not yet been synthesised in a systematic manner. This prevents a fair evaluation of the longitudinal relationship between anxiety and AN, which is necessary for theoretical accounts of AN, and disorder prevention/treatment interventions, to be appropriately informed. It also means that the need for further investigation in this area may not be fully appreciated. This systematic review will gather and organize evidence from a diverse range of observational studies, to critically evaluate the nature of the relationship between non-eating/weight gain-related anxiety, which we refer to as anxiety in this manuscript, and AN. The current protocol outlines the methods of our investigation, in accordance with the PRISMA-P checklist  and trait anxiety, provided they have been assessed with a validated measure. Studies that have assessed relationships between state anxiety and AN pathology will not be included given we are considering the relevance of more stable forms of anxiety to AN. Further, we are specifically interested in the relationship between non-eating/weight gain-related anxiety and AN, and state anxiety assessments are likely to capture anxiety related to eating and weight gain in individuals with AN. While the range of eligible exposures may seem broad, an initial scoping review of the literature suggests this approach is reasonable and will not result in an unmanageable amount of data to synthesise.Studies may compare individuals with anxiety disorders, or high levels of anxiety disorder symptoms/trait anxiety, with individuals without these disorders/characteristics.For studies investigating the relationship between anxiety and the development of AN, AN diagnosis is the primary outcome. Secondary outcomes are severity of behavioural/psychological symptoms of AN and body mass index (BMI).For studies investigating the relationship between anxiety and AN maintenance, the primary outcome is recovery from AN. Secondary outcomes are severity of behavioural/psychological symptoms of AN/changes in these symptoms and BMI/change in BMI.Outcome data may be collected at different time points; however, AN onset or maintenance must be assessed at least 1 year after the time at which anxiety is measured for the study to be included.We impose no restrictions pertaining to study setting.Only studies reported in English will be included.Literature searches will be conducted on articles held in Medline and PsychInfo using the OVID interface. To identify relevant articles in these databases, a search strategy has been produced and is available in Additional file Following removal of duplicates, the titles and abstracts of studies retrieved using the database searches will be screened by two reviewers. The full text of potentially eligible studies will be retrieved and assessed for inclusion in the review by two reviewers. Should the full text of a study not be accessible through institutional memberships study authors will be contacted in order to retrieve the manuscript. The decision to include studies will be based on criteria outlined in the preceding section, and a third reviewer will resolve any discrepancies between the screeners at both stages. Two reviewers must also approve the inclusion of further studies identified from reference lists of the eligible articles found using database searches. The reason for exclusion of any study will be recorded, and the study selection process presented in a PRISMA flow diagram.Publication details: authors, title, publication date, and country.Study information: study setting and design, details of exposure and outcome, details of comparator (if appropriate), sample size at recruitment and completion, follow-up period, and study measures.Participant characteristics: demographics, illness duration, BMI, number of hospitalisations, length of illness, psychiatric co-morbidities, and use of psychotropic medication.Study results: findings in relation to the primary and secondary outcomes will be reported, as will the statistical methods employed in the investigation.Using a tailored data collection form, the following information will be extracted from each study:Where data are missing, we will attempt to contact study authors to obtain this.The National Institute of Health’s Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies  will be Risk of bias and quality for all studies will be assessed by two reviewers, with discrepancies resolved by a third reviewer, to ensure reliability of the review. If eligible review studies are identified, the outcomes of these review studies will be compared to the outcomes reported by articles included in the present review, to detect systematic reporting biases. The strength of the body of evidence collected in the course of the review will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system .Studies will be categorised according to whether they assess the relationship of anxiety with the development or the maintenance of AN. Within these two categories, studies will be grouped further, according to the type of anxiety considered for its influence on AN (i.e. specific anxiety disorders and trait anxiety). Ideally, meta-analyses would be conducted to determine the pooled effect size pertaining to the longitudinal relationship of each type of anxiety with both AN onset and AN maintenance. However, preliminary investigations suggest that the number of eligible studies within each category, and the heterogeneity of these studies, will mean meta-analyses are not feasible.A systematic narrative review will describe findings of the included studies, and the similarities and differences between studies, for studies grouped by outcome (AN onset or maintenance) and type of anxiety measured. A table outlining findings of each study will also be provided. RevMan version 5.3  will be With the inclusion of anxiety in aetiological models of AN, it is important that the relevance of anxiety to AN development and maintenance is clarified. This study will provide the first, much needed, systematic synthesis of longitudinal studies that investigate the relationship between anxiety and AN. By considering a range of anxiety exposures (i.e. anxiety disorder diagnoses/symptoms and trait anxiety), we hope to be able to evaluate a sufficient number of studies for our research questions to be addressed.The planned quality assessment is extensive, to enable a comprehensive evaluation of the risk of bias within and across included studies, promoting the validity of conclusions arising from the review. The extent of the data extracted from studies will allow for the identification of differences in findings that may arise from participant and study characteristics. Most importantly, our method is transparent and explicitly outlined in detail, allowing its replication, as well as assessment of its quality, by others.Anticipated challenges lie in collecting a sufficient number of studies for firm conclusions regarding the relationship between particular types of anxiety and AN onset/maintenance to be made. Interpreting the body of evidence surrounding AN maintenance may also be problematic given the definitions of recovery are not standardised in the field of eating disorders . We consBecause of their longitudinal nature, studies of the review are likely to be subject to high levels of attrition, which is an issue that has implications on the validity of conclusions that may be drawn from the review. A further limitation is that we will be unable to parse apart the explanatory power of different types of anxiety on AN development/maintenance given studies may have measured only one type of anxiety, focusing on one disorder or trait anxiety for example. Alternatively, studies may not have considered the unique contribution of each type of measured anxiety to AN risk. The review will not be able to determine whether non-eating/weight gain-related anxiety directly causes dietary restriction, or if such reflects an underlying process that promotes concern surrounding eating and weight gain. However, findings can inform the value of continuing to study anxiety that does not surround eating and weight gain in relation to AN.Despite the discussed limitations, it is important for evidence surrounding the longitudinal influence of anxiety on AN to be synthesised so that progress with investigation and understanding may be presented. By highlighting areas that require further study, the review may encourage the development of accurate aetiological models of AN, which may inform effective treatment.Additional file 1:PRISMA-P 2015 Checklist. Checklist of recommended items to address in a systematic review protocol. (DOCX 38 kb)Additional file 2:Systematic Review Search Strategy. Details of the search strategy used to identify relevant articles in the databases Medline and PsychInfo. (DOC 28 kb)