Improving the health of school-aged children can yield substantial benefits for cognitive development and educational achievement. However, there is limited experimental evidence on the benefits of school-based malaria prevention or how health interventions interact with other efforts to improve education quality. This study aims to evaluate the impact of school-based malaria prevention and enhanced literacy instruction on the health and educational achievement of school children in Kenya.A factorial, cluster randomised trial is being implemented in 101 government primary schools on the coast of Kenya. The interventions are (i) intermittent screening and treatment of malaria in schools by public health workers and (ii) training workshops and support for teachers to promote explicit and systematic literacy instruction. Schools are randomised to one of four groups: receiving either (i) the malaria intervention alone; (ii) the literacy intervention alone; (iii) both interventions combined; or (iv) control group where neither intervention is implemented. Children from classes 1 and 5 are randomly selected and followed up for 24 months. The primary outcomes are educational achievement and anaemia, the hypothesised mediating variables through which education is affected. Secondary outcomes include malaria parasitaemia, school attendance and school performance. A nested process evaluation, using semi-structured interviews, focus group discussion and a stakeholder analysis will investigate the community acceptability, feasibility and cost-effectiveness of the interventions.Across Africa, governments are committed to improve health and education of school-aged children, but seek clear policy and technical guidance as to the optimal approach to address malaria and improved literacy. This evaluation will be one of the first to simultaneously evaluate the impact of health and education interventions in the improvement of educational achievement. Reflection is made on the practical issues encountered in conducting research in schools in Africa.National Institutes of Health NCT00878007 There is increasing interest in strategies to improve education quality in poorly supported educational environments. Despite recent success in the expansion of educational access in low-income countries , concernThere is less quality evidence on how malaria may affect cognitive abilities and educational achievement or on how schools can tackle the problem of malaria among school children -11. A raEvidence on the effectiveness of interventions to improve educational quality has accumulated in recent years, with randomised trials showing that teacher incentives, student scholarships, providing textbooks, volunteer teacher aids and class size reduction can all boost student performance -22. HoweIn the current study, we aim to evaluate the impact of two interventions, one focused on malaria prevention and another on enhanced literacy instruction, on the educational achievement of school children in Kenya. Based on theories of how health interventions affect children's development and their education ,23, we wTwo interventions are being delivered through schools: (i) a malaria prevention strategy based on intermittent screening and treatment; and (ii) a literacy intervention based on a programme of training and support for class one teachers. Both interventions were developed within the context of current government strategies and guidelines, and were designed to be affordable and replicable on a large scale, within existing government programmes. In the control schools, no malaria or literacy interventions will be implemented, but these schools will receive the interventions at the end of the two year period.Pf device  which is able to detect P. falciparum and other (unspecified) Plasmodium species. Children  found to be RDT-positive are treated with artemether lumefantrine , an artemisinin-based combination therapy. Testing and treatment is administered by district health workers and supported by the Division of Malaria Control, Ministry of Public Health and Sanitation. The first round of screening and treatment was conducted in March 2010, the second round in July 2010 and the third planned in September 2010. Further screening will also occur in 2011.This intervention is based on intermittent screening and treatment (IST) for malaria. Every school term, all children will be tested for malaria using a rapid diagnostic test (RDTs). The RDT used is a ParaCheck-Malaria-free schools initiative [The intervention builds on our previous study evaluating the impact of school-based IPT . In thatitiative .The main components of the literacy intervention include: (i) a teacher manual, which includes 140 lessons for class one teachers develop literacy skills in English and Kiswahili; (ii) an initial three-day training workshop in term 1 and a follow-up one day workshop in term 2; and (iii) ongoing support which includes weekly interactive text messaging, and monthly written communiqués providing information and motivation. This intervention is based on a comprehensive survey of existing literacy instruction practices in the study area region  and an analysis of how these practices can be developed to align more closely with current evidence on how best to promote successful literacy acquisition ,28.The lessons included in the teacher manual are designed to be used daily and are appropriate for developing beginning reading skills in an alphabetic language. They include letter-sound relationships, blending, spelling, connected text, developing a concept of word in text, phonological awareness, vocabulary, and reading comprehension. The 140 sequential lessons are structured to guide the teacher in what to say, what to do , which instructional materials to use, and the estimated time of the lesson. Understandably, there will be school days when the teacher will not instruct. The lesson plans were designed specifically for this study and based on extensive observation and interviews of existing teaching methods in the area over a 12 month period . The plans build from existing teaching methods  and show teachers how these methods can be modified slightly to promote successful beginning reading instruction.The initial training workshops were held in February and March 2010 and sought to provide class one teachers with background information about how children learn to read, to explain how to use the provided teacher manual and to give them the opportunity to customize materials for use in their classroom. Following the workshop, the study teams communicate weekly with teachers using text messages providing brief instructional tips and motivation to implement lesson plans. A response is required in order to receive a small amount of credit for their mobile phones which facilitates and provides an incentive for further communication. Each week teachers are requested to complete a Weekly Summary Sheet that documents which lessons they used, what worked well, and suggestions for improvement. A one-day, follow-up workshop was conducted in June 2010, when teachers learnt additional instructional methods, and received and shared feedback.The impact of the two interventions is being evaluated through a factorial design, cluster randomised trial, in which 101 schools are randomised to one of four groups: receiving either (i) the malaria intervention alone; (ii) the literacy intervention alone; (iii) both interventions combined; or (iv) control group where neither intervention will be implemented. Children from classes 1 and 5 are randomly selected and followed up for 24 months to assess the impact of the two interventions. Both classes receive the malaria intervention, but the literacy intervention is targeted only towards class 1 as this is when children learn to read. This is an unblinded study as, following randomization, schools are aware of whether or not they will receive the malaria or literacy interventions. The timeline and flowchart of the study design is shown in figure The study's primary objective is to evaluate the impact of (i) school-based malaria prevention, using IST, and (ii) enhanced literacy instruction on the educational achievement of school children in Kenya. Secondary objectives are to (i) evaluate the impact of IST on anaemia and malaria parasitiaemia; (ii) evaluate the impact of enhanced literacy instruction in improving literacy rates of schoolchildren; (iii) to determine whether malaria and education interventions work synergistically together, such that learning is improved only when teaching is effective and children are healthy to benefit from it; and (iv) to investigate the cost-effectiveness and feasibility of the interventions.Plasmodium falciparum) transmission, with two seasonal peaks in malaria cases reflecting the bimodal rainfall pattern, with the heaviest rainfall typically occurring between April and June, with a smaller peak in October and November each year [The study is being conducted in rural government primary schools in Kwale and Msambweni districts, situated approximately 50 km south from Mombasa on the Kenyan coast Figure . The stuach year . A 2008 ach year . Around There are 85 schools in Kwale District and 112 schools in Msambweni District. In Kwale District, a separate study is evaluating the impact of an alternative literacy intervention in two of the four zones; therefore only 20 schools in Mkongani and Shimba Hills zones were included in our study allowing the two interventions to proceed without leakage. In Msambweni District, we selected 81 of 112 schools; schools in Lunga Lunga and Mwereni zones about 70 km away from the project office, were excluded because of time and costs involve in travelling to them.Sensitization took place at national, provincial and district levels before visiting the schools. At the national levels, the study was approved by the Division of Malaria Control, Ministry of Public Health and Sanitation and the Director of Basic Education, Ministry of Education. At provincial and district levels, meetings were held with the Provincial Medical Officer and the Provincial Director of Education in Mombasa, as well as district health and education officials in Kwale and Msambweni. Finally, school head teachers and Teachers' Advisory Centres (TAC) tutors were informed of the study.Prior to randomisation, enumeration of children in all schools was carried out through school visits in January and February 2010. Subsequently, school meetings were held with parents and guardians of children to explain all aspects of the study, emphasizing that the participation of their children in the study was voluntary and they had the opportunity to opt out of the study at any time. There was an opportunity to ask questions. We then sought written consent from parents or guardians. If parents failed to attend these meeting, home visits were undertaken to obtain consent - see below. The eligibility criteria for inclusion into the study were as follows: enrolled at participating schools in classes 1 and 5; provision of informed consent from parent or guardian; and willingness of the child to participant. Exclusion criteria include parents or guardians unwilling to provide informed consent; an unwillingness of the child to participant; known allergy or history of adverse reaction to study medications; and known or suspected sickle-cell trait .Randomisation was conducted in two stages, each involving public randomisation ceremonies. These ceremonies were considered important in assuring participating schools and stakeholders of the fairness and transparency of the allocation and represented a simple way of allocating schools to the four different groups Figure .school clusters of between 3 and 6 schools, which regularly meet and share information, supported by a Teacher Advisory Centre (TAC) tutor. This randomisation was stratified by (i) cluster size, to ensure equal numbers of schools in the experimental groups; and (ii) average primary school leaving exam scores across the cluster, to balance the two groups for school achievement. District officials and representatives from all 26 school clusters were invited to a meeting, at which the objectives of the evaluation and randomisation procedures were described. Volunteers were chosen to represent the different school clusters and were asked to randomly draw envelopes each containing a cluster name from 10 pre-stratified ballot boxes and to sequentially place the envelopes in group A and group B. Volunteers then opened the envelopes to reveal which clusters were in groups A and B, but were not told which of group A or group B represented the literacy intervention group and which the control group. Subsequently, only intervention schools were informed of their participation in the literacy intervention, starting with the three-day training workshop. This randomisation procedure was designed to minimize contamination across clusters. It is still nonetheless possible that following the training workshop, teachers from the intervention schools will discuss their training with teachers from control schools. This is often unavoidable in studies evaluating education interventions and therefore, we will conduct classroom observations and interviews with teachers to assess the level of contamination in control schools in order to take this into account during analysis. However, it is unlikely that teachers from control schools will obtain the complete set of training materials.In stage one, groups of schools were randomised either to receive the literacy intervention or to serve as a control school. In Kenya, schools are grouped by the District Education Office into so-called In stage two, the malaria intervention was randomly allocated amongst the 51 schools allocated to the literacy intervention and the 50 schools allocated to serve as control schools during the first randomisation. Schools were stratified by average primary school leaving exam scores into 5 quintiles and by literacy intervention group, producing 10 strata overall. Prior the randomization ceremony, computer simulations were conducted to investigate the probability that all schools in a cluster could randomly receive the same malaria group allocation, thereby limiting the potential for independent analysis of the effects of literacy and malaria interventions. In this, 10,000 simulations were run using random numbers generated with Stata version 10  to assign schools to malaria intervention and control groups. The results of these simulations showed that the probability of malaria allocation being the same across 8 or more of the 26 clusters was 0.1%, across 6 or more clusters was 2.1%, 4 or more was 17.2%, and 2 or more was 82.5%. On the basis of these simulations and because further restricting the randomisation process threatened the random nature of group allocation, it was decided to leave the coincidence of malaria and literacy group allocation to chance.During the ceremony, the objectives of the evaluation and randomisation procedures were described to invited representatives from schools and local communities. Volunteers were then chosen to represent each of the 101 schools and asked to write school names on identical pieces of paper and include into identical envelopes. These were placed into ballot boxes based on the above system of restricted randomisation. The volunteers were asked to draw envelopes from each ballot box and sequentially allocate into two groups. Volunteers were not told which group was the intervention and which was the control, only that schools had been allocated to group C and group D. Contamination of the malaria intervention is unlikely since only children in the malaria intervention schools will be visited by district health workers and screened, and treated if found positive. Randomisation resulted in only one cluster where all schools received the same malaria group allocation.The school year in Kenya runs from January to end of November. The study commenced in January 2010 Figure , followiThe school population is dynamic due to transfers, repetitions and drop-outs. We will not attempt to follow-up recruited children who transfer to schools outside the study area, but children who transfer to other study schools will be accounted for in the analysis. Children who repeat or drop-out will be included in the analysis up until the point they repeated or dropped-out, but excluded from the analysis thereafter.The primary outcomes are educational achievement and anaemia, the hypothesised mediating variables through which education is affected Figure . These oIn addition, we will assess secondary outcomes occurring along the hypothesized causal pathway Figure , includiDetailed process indicator data will be collected on the up-take and fidelity of programme implementation and, in the case of the literacy intervention, teacher attendance at professional development seminars, understanding of content, and implementation of lesson plans. Qualitative research on the acceptability, feasibility and cost-effectiveness of the two interventions will be evaluated by a semi-independent team of social scientists. This will seek to identify key assumptions and conditions underlying program sustainability and scaling-up, including organization and technical capacity of the government at national and local levels, based on focus group discussions and semi-structured interviews.Children's competence in three main educational domains will be assessed at baseline, and 12 month and 24 month follow-up. Assessments are administered either as individual or group tasks.Among children in class 1, literacy and numeracy tests are conducted in individualized and small-group settings. The literacy tasks focus on early literacy skills that are highly predictive of later reading acquisition , and incAmong all children in both classes, sustained attention and non verbal reasoning are assessed. Among children in class 5, the sustained attention measure was the 'code transmission' adapted from the TEA-Ch (Tests of everyday attention for children) battery . In the In total, 13 tasks are assessed in class 1: receptive language, spelling, beginning sounds, letter knowledge, word recognition, passage reading with comprehension, non-verbal reasoning, sustained attention, and five math tasks. Five tasks are assessed in class 5: word recognition, sentence reading comprehension, spelling, arithmetic and sustained attention. All of these tasks are included in the baseline and endpoint data collection. A limited number of these tasks will be used as a mid-point assessment.All instruments were adapted to the Kenyan context to ensure face validity and appropriate stimuli over a period of 5 months . The provisional battery of tests was administered in 5 schools to provide pilot data to assess (i) properties of individual test items; (ii) internal reliability of individual tests; (iii) test-retest reliability of individual tests; and (iv) relationships between individual tests assessing related concepts. On the basis of these data, final changes were made to test items and a final battery of tests selected.Among all children, haemoglobin concentration is assessed at baseline and 12 and 24 months follow-up, based on a finger-prick blood sample using a portable photometer . Malaria parasitaemia will only be assessed at follow-up due to the ethical constraints of testing for malaria but not treating children found to be infected in the control schools. A finger-prick blood sample will be used to prepare thin and thick film for confirmation and quantification of malaria parasites on the basis of expert microscopy.Attendance at school will be assessed through unannounced school visits made at three time points in term 2. Reasons for absence  will also be recorded.Authentic Pedagogy classroom observation tool [During the second school term, two unannounced visits to each school will be carried out to conduct teacher interviews and classroom observations. The teacher interview is based on a questionnaire developed in previous work in Western Kenya  and on scenario-based questions adapted from the ion tool .CLASSIC observation schedule designed to assess pedagogy for language instruction [The classroom observation involves an assessor observing class 1 English and Kiswahili lessons on two separate days and involves the integration of two approaches to classroom observation. Every 90 seconds a 'snapshot' of the classroom is taken, based in part on the Stallings snapshot instrument  and our truction . The insDuring consent, parents and guardian were asked to complete a parental questionnaire, which contained questions designed to assess the educational and socio-economic environment of children's households. Thirteen questions asked parents and guardians about the main languages they spoke in the household and to their children, their own reading ability and habits, their schooling, and involvement in their children's school. Nine questions asked parents about the ownership and use of mosquito nets by themselves and their children. Five questions asked parents about household construction and ownership of key assets, in order to provide proxy information on socio-economic status .During school meetings, interviews with the head teacher collected information on the number of boys and girls enrolled in each class; examination results in English, mathematics and Kiswahili for the previous five years; indicators of the quality of infrastructure of the school, such as presence of toilets and hand washing facilities; whether the school had been in school health activities in the last year, such as school feeding, deworming and water and sanitation programmes; and the presence of health education material, including those for malaria. Of the 101 schools, all had recently received deworming and 48 have school feeding programmes, but none had implemented any malaria interventions.The household and school level information will subsequently be used in the analysis to account for potential confounding, but also to explore the differential impact of the interventions.A detailed process evaluation is being undertaken which aims to: (i) examine the implementation of the interventions; (ii) explore the context and fidelity of interventions; (iii) investigate community acceptability of interventions; and (iv) document factors external to the interventions which might impact upon both its implementation and its effectiveness. Such an evaluation will help the interpretation of results and help inform future large-scale implementation of the interventions.First, a modified stakeholder analysis approach will be adopted to identify and assess the importance of key people, or groups of people who are likely to affect the implementation and longer-term sustainability of the programme ,41. Key Second, an analysis will be undertaken of the structural, organisational and management factors that enhance or constrain effective implementation of the programme by staff from the Ministries of Health and Education. In addition to identifying and mapping these stakeholders through the stakeholder analysis, interviews will be conducted with purposefully selected key stakeholders in order to assess the organization and managerial capacities of the government at national and local levels . These dAn economic evaluation will be being undertaken alongside the trial, relating costs to a range of educational and health outcomes in the form of a cost and cost-effectiveness analysis. Costs will be assessed from both provider (government) and societal perspectives using an ingredient approach , based oCost-effectiveness analysis will consider improvements in test scores and educational achievement, assessed in terms of differences in standard deviation units. Changes in participation, attendance and educational achievement will be assessed in terms of percentage differences, and test scores in terms of differences in standard deviation units. CE will be calculated for each outcome and expressed as incremental cost-effectiveness ratios (ICER) in relation to the status quo, the other health/education intervention packages tested in the present study, and current interventions. Analysis will also incorporate improved cognition and learning into long-term outcomes, e.g. future earning streams , as wellIt is considered that a reduction of at least 25% in anaemia is needed if the intervention is to be considered to have public health value. In our previous study of IPT in western Kenya, we found a 48% reduction in anaemia , whilst Educational achievement and cognitive tests sample size calculations were conducted separately for outcomes measures used in class 1 and class 5 using optimal design software . For eacAn additional concern when calculating the sample size arose from the relatively low prevalence of malaria, estimated from recent school surveys to be around 15% . When a small sample (N = 25) are sampled from a large class, the possibility arises either that the proportion of children with malaria in the sample would be low relative to the overall sample and, for both large and small classes, that the absolute number of children with malaria in the sample would be small. To investigate this issue, we ran 10,000 simulations of such a random sampling exercise, assuming a uniform malaria prevalence of 15%, to determine the sample size required to ensure both of two eventualities with 80% certainty: a) the proportion of children with malaria in the sample is at least 75% of the proportion in the population and b) at least 3 children with malaria would be included in the sample in each class. Simulations suggested that a sample of 25 children would be needed for class up to 50 children in size, and a sample of 30 would be needed for large classes. This sample size was able to be achieved for class 5, but logistical constraints in conducting the battery of educational assessments meant that only 25 children could be sampled in class 1.The primary analysis will follow the intention to treat principle, whereby all children regardless of whether they received the full intervention or not will be included in the analysis. Data will be analysed both at the cluster level, by deriving summarizing summary statistics, and at the individual level (see ). The efWeighted estimates will be provided, with weights proportional to the number of schools per stratum. For binary outcomes, the overall risk for each school will be presented by intervention group and linear regression used to estimate unadjusted relative risk and 95% confidence intervals (CI) associated with each intervention. For continuous outcomes, means for each school will be shown and the arithmetic mean and SD of mean values and scores and associated 95% CI for each intervention group calculated. Again, linear regression will be used to estimate mean difference and 95% CI for each intervention.In addition to estimation of crude intervention effects, adjusted analysis will be performed to account for potential confounding variables measured at baseline. Depending on the outcome, logistic or linear regression will be conducted at the individual level, ignoring the clustering of the data and intervention effect. In each case, the outcome will be regressed on baseline predictors and the resultant residuals will then be used as the summary measure for each school based on a comparison of the observed outcome in that school and predicted outcome in the absence of an intervention effect. Systematic differences in the residuals by intervention groups will provide a measure of intervention effect.As well as cluster-level analysis, individual-level analysis using suitable generalised linear models will be undertaken to adjust for clustering by school . Random-Once the separate effects of each intervention have been analysed, the joint effects of the two interventions will be examined at the cluster level. In its simplest form, these will be evaluated by incorporating interaction terms into the regression model. If a significant interaction is present, then each intervention effect will be reported separately in the presence and absence of the other intervention. If sample size permits, individual-based regression analysis of interaction effects will be examined.The study was approved by the Kenya Medical Research Institute and National Ethics Review Committee (SSC No. 1543), the London School of Hygiene and Tropical Medicine (LSHTM) Ethics Committee (5503), and the Harvard University Committee on the Use of Human Subjects in Research (F17578-101). Sponsorship and insurance is provided by the LSHTM's Clinical Trials Sub-Committee (QA225).Written and verbal information is provided in English and Kiswahili. Documents translated into Kiswahili were checked through back-translation. Prior to the onset of the study, school meetings were held with the parents/guardians of children enrolled in participating classes to describe the purpose of the study, the procedures to be followed, the risks and benefits of participation. Information sheets are provided to the parents/guardians for their review. Individual informed consent is obtained from parents/guardians of selected children, and is recorded by signature or thumb-print. For those parents who not attend these meetings, follow-up was made through community leaders and household visits. Parents/guardians had the chance to ask questions and were asked to provide signed informed consent for their child to participate in the study. They were also informed that participation of their child in the study is completely voluntary and that they may withdraw from the study at any time. At each data collection, verbal assent is sought from children.Ethical and safety aspects of the study are overseen by an independent data safety and monitoring board (DSMB) consisting of experts in clinical medicine, epidemiology, and statistics, who met convened to the start of data collection and will convene at the completion of the study to approve the final data analytical plan. A local clinician based at the KEMRI-Wellcome Trust Research Programme in Kilifi, two hours from the study area, acts as a Local Safety Monitor monitors and reports to the DSMB chair any severe adverse effects arising from the malaria treatment.Community and school mechanisms have been established to facilitate a two-way flow of information between the study team and the schools and communities. These mechanisms include feedback letters to schools, school meetings, community meetings and meetings with local chiefs and leaders, as well as regular reporting to health and education officials at district, provincial and national levels. This system of communication, especially community meeting, is particularly important in control schools in order to prevent attrition or any non-cooperation for outcome assessment.It is well accepted that decisions regarding health, education and social interventions should be based on robust evidence on the benefits of the proposed intervention. Cluster randomised trials, whereby groups of individuals may be randomly allocated to different interventions or a counterfactual , have the potential to provide unbiased estimates of the impact of interventions which are delivered at the community level . More reMalaria-free Schools Initiative [Conducting research in schools, especially in an African context, raises a number of practical issues. First, in order to maximize the policy relevance it is essential to understand the country context of the research, the related policymaking processes and to engage key stakeholders . We sougitiative . TherefoSecond, it is essential to conduct adequate sensitization with local communities and community leaders, and not just with schools and parents. This is because opinion leaders in the community can influence involvement in the study. Gaining community trust is a lengthy process, but essential to the study's success. Third, it is important to obtain a reliable census of children enrolled in school. School populations are very dynamic, with children transferring between schools, dropping out and repeating classes. Because of this fluidity, school registers do not always provide up-to-date information. We therefore undertook a school census prior to consenting, but also found that this needed to be subsequently updated since some children repeated years half way through the school term. Fourth, during data collection, it was important to coordinate activities so as to minimize disruption to teaching and school activities.Fifth, school-level cluster randomized trials require large sample sizes. This is especially the case with educational outcomes which vary from one school to another. It is essential to measure the intra-class correlation coefficient of such outcomes in order to derive precise estimates of required sample size. We found that, although 100 schools may be insufficient to detect very small effect sizes (< 0.2 SD), the marginal utility of increasing the number of schools further was small. Efforts to improve precision of outcome measures could alternatively be invested in expanding the assessment of baseline measures likely to predict final outcomes .Finally, contamination between schools was a concern and transfers of children between schools may also dilute the effect of the interventions. This was a particular concern for the education intervention. To reduce the potential for contamination, we randomised the education intervention by school cluster and are also measuring possible contamination through unannounced classroom observations.Despite these issues, the study is well underway and the interventions appear to be practical feasible and popular with the local communities. A particular strength of our study is the strong policy linkages with both health and education sectors in Kenya. These sectors are seeking clear policy and technical guidance as the optimal approach to malaria control in schools as well as evidence that systematic instruction is essential for progress in early grading reading and educational achievement overall. The current evaluation, the first of its kind in Africa, will address this policy information gap. In addition, the work has the potential to raise awareness of the need to improve both health and instruction quality to enhance education in Kenya, and also other countries where malaria is common and literacy poor.The authors declare that they have no competing interests.SB secured the funding and is responsible for the overall study design and project management, and drafted the manuscript. GO is responsible for coordination and supervision of fieldwork. KN participated in the study design and coordination. MMD designed the education intervention and coordinated the development and implementation of educational assessments. KEH is responsible for coordination of data management and fieldwork. HI contributed to the design of the education intervention and assessments. MCHJ is responsible for the overall study design and the design and implementation of the educational assessments. All authors read and approved the final manuscript.


The demands in hospitals for safety and quality, combined with limitations in financing health care require effective cooperation between physicians and managers. The complex relationship between both groups has been described in literature. We aim to add a perspective to literature, by developing a questionnaire which provides an opportunity to quantitatively report and elaborate on the size and content of differences between physicians and managers. Insight gained from use of the questionnaire might enable us to reflect on these differences and could provide practical tools to improve cooperation between physicians and managers, with an aim to enhance hospital performance.The CG-Questionnaire was developed by adjusting, pre-testing, and shortening Kralewski's questionnaire, and appeared suitable to measure culture gaps. It was shortened by exploratory factor analysis, using principal-axis factoring extraction with Varimax rotation. The CG-Questionnaire was sent to all physicians and managers within 37 Dutch general hospitals. ANOVA and paired sample T-tests were used to determine significant differences between perceptions of daily work practices based in both professional cultures; culture gaps. The size and content of culture gaps were determined with descriptive statistics.The total response (27%) consisted of 929 physicians and 310 managers. The Cronbachs alpha's were 0.70 - 0.79. Statistical analyses showed many differences; culture gaps were found in the present situation; they were even larger in the preferred situation. Differences between both groups can be classified into three categories: (1) culture gaps in the present situation and not in the preferred, (2) culture gaps in the preferred situation and not in the present, and (3) culture gaps in both situations.With data from the CG-Questionnaire it is now possible to measure the size and content of culture gaps between physicians and managers in hospitals. Results gained with the CG-Questionnaire enables hospitals to reflect on these differences. Combining the results, we distinguished three categories of increasing complexity. We linked these three categories to three methods from intergroup literature  which could help to improve the cooperation between physicians and managers. The history of the development of hospital organizations and the wider scope of quality initiatives shows that cooperation between physicians and managers is becoming of paramount importance to enhance hospital performance . HospitaIn the hospital setting there are well known difficulties in the cooperation between physicians and managers -11. The We based our CG-Questionnaire on Kralewski's work ,27 on thAn extra feature was added to the Kralewski questionnaire by asking about the present and preferred situation. When asking about the way practices are perceived in the present situation, we searched for the negotiated order between physicians and managers. Answers to statements in the present situation represent organizational reality as perceived by physicians and managers. We postulated that differences in answers in the present situation between the two professional groups reveal culture gaps in the way both groups perceive reality. Additionally, answers to statements in the preferred situation represent the desired order . We postThis study adds a perspective to the literature, from a methodological point of view, to improve insight into the complex relationship between physicians and managers. We applied the questionnaire by Kralewski et al.   to the hIn this paper we report the development of the CG-Questionnaire as well as the results from our use of this instrument to assess culture gaps between physicians and managers in a representative sample of Dutch general hospitals. To obtain the national data, we split the research into three separate studies. Firstly we developed a Dutch questionnaire by translating and slightly adapting Kralewski's  questionWe translated and back translated Kralewski's culture questionnaire; then Kralewski's statements had to be aligned with the Dutch system features. No changes were needed in the original statements related to the hospital setting. The only two alterations were related to the differences between American and Dutch health care systems. Most hospitals in the Netherlands are non-profit foundations. It is only recently that market elements have been introduced, such as free negotiations on the price of 20% of the volume of hospital care and facilitating new market entries. The majority of physicians is not employed by the hospital, but is associated with a hospital  and the physicians are partners in their own within-hospital firm. In the within-hospital firms the accumulated fees are divided. Physicians depend on hospital policies for the allocation of staff (for example secretaries and nurses) and equipment. In the Dutch structure physicians have economic autonomy because of the way they are paid, but they are economically dependent on operational and staff support in the hospital. Physicians are organized as the "medical staff", commonly without hierarchy, and they mandate an internal board which has to be consulted on important organizational and medical issues by the executive hospital board. Following from the above we altered two survey statements in the dimension "business emphasis" linked to the financial system, focusing to a lesser degree on commercialization in hospital care. In the Dutch system the degree of market regulation is expected to remain considerably higher than the situation in the United States. The statements which we changed were:• "Maximizing revenue is our highest priority" into: "Reducing costs is our highest priority".• "We won't add a piece of equipment if it won't make money" into: "When purchasing medical equipment financial considerations are an important factor".In order to have six statements per dimension, we added 15 statements concerning work practices which conform to medical protocols, multidisciplinary cooperation, working atmosphere, and the involvement of physicians in the policy and the mission of the organization. Because our goal is different from Kralewski et al., we added a dimension, also consisting of six statements, directly assessing the level of cooperation between physicians and managers and, accordingly, the extent to which there are culture gaps.For our qualitative pretest we selected 15 representative respondents from four Dutch general hospitals, located in both rural and urban settings, and asked physicians in both surgical and internal medical specialties as well as board members and managers in different hierarchical positions. We piloted the questionnaire by asking the respondents to complete it, in our presence. The Dutch pretesting questionnaire contained 60 statements with a double five-point Likert scale, which assessed the respondents' personal perceptions of practices in the hospital in the present and preferred situation. During the interviews we posed a set of 13 questions about the clarity, redundancy, lay out, relevance, and other format-related aspects of the Dutch questionnaire. If a respondent criticized one of the statements, it meant that the questionnaire was not completely clear. After every interview we improved the clarity of the language used in the Dutch questionnaire, until there were no further such remarks.An important criterion for a usable questionnaire is that it needs to be short in order to receive better response rates . We sentIn order to shorten the questionnaire we determined the reliability and the correlation between the list with and without a certain statement with an item-total correlation test. The item-total correlation was the correlation between the item and the sum score calculated without that particular item. If the item-total correlation was below 0.20, the statement was removed from the list. The item with the lowest score was deleted first, and then the item-total correlation was calculated again. This was repeated until all item-total correlations were above 0.20. Subsequently we determined the Cronbach's alpha score. Repeating the factor analysis with the shortened list, the total variance explained was determined. In order to finalize a valid, reliable and relevant version of the CG-Questionnaire, we compared the outcomes of the analyses of all four categories  with the statements found in the item-total correlation test. When a statement scored in at least three categories, it was included in the CG-Questionnaire. To statistically finalize the shortening of our list we combined the statements that had been identified with the factor analysis (with Varimax rotation) with the statements which revealed significant differences (ANOVA). We took at least two statements per initial Kralewski dimension that scored significant culture gaps in at least one of the five hospitals. If only one statement scored in a dimension, based on the factor analysis, we took a second statement based on the culture gaps scores.Table Agreement from the general hospitals was needed for the purpose of obtaining a list of physicians and managers to whom the questionnaire could be sent. Therefore we needed the consent and participation of the boards of the hospitals. In our national study, 37 out of a total 86 Dutch general hospitals agreed to participate. These 37 hospitals were spread throughout the country in terms of size and location; therefore we believe we can generalize our findings to the national level. We e-mailed an invitation to all physicians (N = 3941) and managers (N = 680) within the 37 hospitals, who had agreed to participate, to complete the questionnaire on our website. This led to a total N of 4621. After three months the physicians and managers in 11 hospitals who had not responded were reminded with a hard copy sent by post. The remaining physicians and managers in the other 26 hospitals were reminded by e-mail.The reliability of the total CG-Questionnaire was determined with the Cronbach's alpha. Paired sample T-tests and ANOVA were used to determine significant differences between answers to the statements between physicians and managers. We analyzed differences between physicians and managers, using individual data, pooled over the whole data for the present and the preferred situation and we compared the present and preferred situation. A p-value below 0.05 was considered to be statistically significant. The magnitude and direction of culture gaps were determined with descriptive statistics .In this study we developed a concise, valid questionnaire based on Kralewski et. al. ,27. The The average response rate among physicians was 24% (n = 929) and among managers 46% (n = 310), leading to a total response rate of 27% (n = 1239). This response resembled our qualitative and quantitative pilot study (which had a response rate of 35%). As mentioned before, the responding hospitals reflected the national division of urbanization, size and type of hospital. Moreover, our response rates do not deviate much from response rates in comparable Dutch studies . The ratTable In the present situation 15 out of 20 statements scored statistically significant differences between physicians and managers . Six of these 15 statements were answered in the opposite direction (agreeing (score >3) vs disagreeing (score <3)). As to statement 6 (autonomy of physicians), statement 16 (about provision of information to improve cost-effectiveness) and statement 18 (about trust in decisions made by the board of directors), physicians do not agree, whereas managers do agree. Statement 7 , statement 9  and statement 14 (about methods to include new technologies) show the opposite: physicians agree and managers disagree. In the preferred situation there are 16 out of 20 statements scoring statistically significant differences between physicians and managers . The only statement that does not score a statistically significant difference between physicians and managers in both the present and preferred situation is statement 12 (about belonging to the group).As shown in Tables The many large gap sizes in the different culture aspects, uncovered by this study confirm that focusing on rational organizational elements  may not be sufficient to improve hospital quality. Moreover, the cultural dimension, when thinking about organizational improvement, can be addressed more specifically. Our results support the literature: a focus on cooperation with an explicit eye for intergroup differences should be added to organizational improvement methods ,30. WithThe results of the qualitative pretest and the subsequent quantitative studies confirm the findings in the literature ,8,11, thIn our results, three statements scored culture gaps in the first category; differences in the present situation and not in the preferred situation Table . ApparenIn the second category, four statements scored culture gaps between physicians and managers in the preferred situation and not in the present situation. For instance, publicizing about and mentioning the innovativeness of plans and relying on computer-based registration is preferred more by managers than by physicians. Physicians, on the other hand, prefer more informal consultations Table . This meThe third category shows 12 statements that score culture gaps in the present and the preferred situation; these statements reveal the most imminent aspects of the culture gaps. Therefore, these are presumably the most difficult aspects to change within a hospital organization. Physicians' values of the professional autonomy and collegiality among physicians are higher than among managers. Consequently, the physicians scored even higher in the preferred situation. Managers value the registration of adverse events and the trust in the decisions made by the Board of Directors was higher in the current situation compared to the physicians. Managers want it to be even higher in the preferred situation. The situation in which both the preferred and the present situation are different, can be seen as a persisting intergroup conflict situation. From intergroup literature, the third approach, meta cognition, facilitates the overcoming of cognitive obstructions, preventing openness towards information about the other group. A training program could provide insight into the way cognition works and therefore the awareness of ones own prejudices towards the other group. This, in turn, provides the opportunity to reflect on the sources of prejudice. Insight into meta cognitive processes can change people's perceptions and behavior .Methodologically, in the process of transforming Kralewski's questionnaire into the CG-Questionnaire, the extra dimension added to the initial nine dimensions was not confirmed to be a one-dimensional construct and, therefore did not add information. Therefore we decided not to include these additional six statements in that dimension into further data analysis, nor in the CG-Questionnaire. Statistically, we could not confirm Kralewski's nine dimensions. We checked whether the scores in the factor analysis with Varimax rotation were caused by the additional statements, when compared to the original Kralewski questionnaire , but thaDespite the differences between the goal of our study and Kralewski's goal, and the different national settings of the researches, the underlying issues in health care  are also relevant in health care elsewhere ,7,8,28. Further research could focus on the relation between different gap sizes between physicians and managers and the effectiveness of the cooperation; it is possible that a small gap could be hypothesized as causing possible productive friction. Either studies covering large numbers in cross sectional designs, or longitudinal studies using interventions, could lead to new and creative insights to significantly enhance the effectiveness of the cooperation.The results of our study confirm the existence of the presumed latent conflict between physicians and managers and show that, below the surface of the daily practices, the relationship between (members of) both groups is tense, leading to suboptimal cooperation. This might decrease hospital performance, and could ultimately harm patients. When implementing change, hospitals could use the CG-Questionnaire to gain data on the content and size of culture gaps between physicians and managers in order to better substantiate the chosen methods used for organizational improvement. Combining results from the present and preferred culture gaps, we arrived at three categories of increasing complexity. We linked these categories to the three methods described in the intergroup literature to help develop the interventions. Interventions based on intergroup literature  could help improve the cooperation between physicians and managers. At the very least, our findings will increase the awareness of the importance of tension, which is kept below the surface, and ultimately hindering effective cooperation. Our results may stimulate research into the relation between the size and content of culture gaps that hinder cooperation and affect the performance of hospitals.The adjusted questionnaire and the full rotated matrix of the factor analysis can be obtained from the authors by email.The authors declare that they have no competing interests.HAHJK contributed to the design, data retrieval, analysis and writing of the paper. SS contributed to the design, analysis and writing of the paper. NM contributed to the analysis and writing of the paper. CPMW contributed to the design and writing of the paper. WHvH contributed to the design, analysis and writing of the paper. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6963/10/86/prepub


The Baby-Friendly Hospital Initiative (BFHI) seeks to support breastfeeding initiation in maternity services. This study uses country-level data to examine the relationship between BFHI programming and trends in exclusive breastfeeding (EBF) in 14 developing countries.Demographic and Health Surveys and UNICEF BFHI Reports provided EBF and BFHI data. Because country programs were initiated in different years, data points were realigned to the year that the first Baby-Friendly hospital was certified in that country. Pre-and post-implementation time periods were analyzed using fixed effects models to account for grouping of data by country, and compared to assess differences in trends.Statistically significant upward trends in EBF under two months and under six months, as assessed by whether fitted trends had slopes significantly different from 0, were observed only during the period following BFHI implementation, and not before. BFHI implementation was associated with average annual increases of 1.54 percentage points in the rate of EBF of infants under two months (p < 0.001) and 1.11-percentage points in the rate of EBF of infants under six months (p < 0.001); however, these rates were not statistically different from pre-BFHI trends.BFHI implementation was associated with a statistically significant annual increase in rates of EBF in the countries under study; however, small sample sizes may have contributed to the fact that results do not demonstrate a significant difference from pre-BFHI trends. Further research is needed to consider trends according to the percentages of Baby-Friendly facilities, percent of all births occurring in these facilities, and continued compliance with the program. Breastfeeding, especially exclusive breastfeeding (EBF), is one of the most effective preventive health measures available to reduce child morbidity and mortality . The intEvidence from developed and developing countries indicates that the BFHI has had a direct impact on breastfeeding rates at the hospital level -11. In aAlthough global trends in breastfeeding initiation, duration and exclusivity have generally increased during the years since the introduction of the UNICEF/WHO BFHI, few studies have examined these trends specifically within the context of BFHI activities -15. The Data were taken from the Demographic and Health Surveys (DHS) from 1986-2006. These nationally representative sample surveys captured population, health and nutrition-related indicators in 72 developing countries (DHS), including prevalence of EBF according to child's age . Use of First, we selected countries with a minimum of two DHS surveys within the given time frame (the minimum number of data points necessary to establish a trend). A total of 45 countries met this criterion, of which all but three were found to have implemented the BFHI. Due to the lack of "non-BFHI" countries in the data set, we elected to compare trends in EBF before and after implementation of the BFHI, rather than comparing trends between "BFHI" and "non-BFHI" countries.To allow countries to serve as their own comparisons, we selected those with a minimum of two surveys prior to their country's year of initial BFHI implementation, and two after. Few countries had data on EBF available from the year of initial implementation (the "zero" year). In order to capture trends immediately before and after program launch in countries with no "zero" year data, any data point available within two years of BFHI implementation  was included in both the before and after data sets for trend. Therefore some countries with only three data points were included in the sample  for the time periods prior to and following program launch. Fixed effects models were chosen to account for the grouping of data points by country and to control for observed and unobserved between-country differences that were fixed over the time period . Linear models were selected based on the positive trends observed in global rates and the relatively small number of data points available.To compare pre-BFHI and post-BFHI trends in the countries under study, we assessed whether trends were statistically significant during either time period, i.e., whether the slopes of the observed trend pre-BFHI, or the observed trend post-BFHI, was significantly different from zero, and whether the slopes of these observed trends were statistically significantly different from one another.A total of 14 countries were included in the final sample (Table When rates of EBF for children less than two months were examined, statistically significant upward trends were observed post-BFHI implementation. Prior to the initiation of BFHI, there was a slow upward trend in EBF, but the slope did not achieve statistical significance Table . ImplemeResults were similar using EBF for children less than six months as the outcome. Statistically significant upward trends were observed only during the period post-BFHI implementation Table . BFHI imThere is little debate as to the importance of exclusive breastfeeding ; howeverResults suggest that among the countries under study, there were no significant upward trends in EBF rates in the years prior to BFHI implementation, but that BFHI implementation was associated with a statistically significant annual increase in rates of EBF in the first two, as well as during the first six, months. The two month rate of increase was higher than the six month rate, as might be expected with an immediate postpartum intervention.According to the models, a country that implemented the BFHI would experience, on average, a 7.7- and 5.5-percentage point increase in the first two, and first six, months of EBF respectively, over a subsequent period of five years. If improvements in EBF practices are sustained over time, such an increase could provide a significant improvement in child health outcomes. One can estimate the impact of such an increase as follows: based on the accepted estimate that a 51% increase in EBF is needed to reduce child mortality by 13% (i.e., from the 2006 estimate of a 39% prevalence to the 90% prevalence used for calculation of the 13% reduction in child mortality [One strength of our analysis is the use of the "zero" year to re-center all data to the time of country-specific BFHI implementation. This allowed for countries to serve as their own comparisons over time, and for cross-national trends to be considered in relation to the start of BFHI programming, adding strength to the argument that observed trends are derived from BFHI activities. This adds to our understanding of the impact of the BFHI as it was implemented.The limitations of this study include the reality that the 14 countries analyzed represent a small portion of all developing nations that have implemented the BFHI, and exhibit relatively low rates of hospital certification. In addition, we had no measure of the level of ongoing adherence to the Ten Steps or of the general quality of BFHI implementation over time in this sample. Our results, therefore, are not necessarily reflective of the program's potential to improve breastfeeding rates if implemented on a national or global level.A serious limitation of any effort to evaluate the effectiveness of the BFHI on cross-national breastfeeding trends is the lack of data collected specifically for this purpose. In this study, we have had to rely on a relatively small number of data points. As such, our study was not powered to detect small differences in trends between pre- and post-BFHI time periods. The limited number of data points also hindered examination of non-linear models that may have provided more insight into the behavior of these trends over time. Our use of overlapping trend lines to compensate for a lack of "zero" year data points, and incomplete information on Baby-Friendly changes that may have been instituted prior to actual certification, further impaired our ability to detect differences between pre- and post-BFHI time periods. We cannot fully predict how access to additional EBF measurements, data from additional countries or information about possible preexisting Baby-Friendly practices may have changed our results.The use of fixed effects models allowed us to control for the presence of measured and unmeasured confounders that were fixed over the time period studied, but did not control for factors that were variable over the time period, such as demographic changes, shifts in maternal employment patterns, or other breastfeeding promotion programs implemented concurrently with the BFHI. We lacked sufficient information to control for these variables appropriately. With the exception of concurrent public health programming, we would expect most changes over this broad time period, including increased urbanization and women's employment, to have negatively impacted EBF . For thiIf and when sample size and available data permit, additional analyses are needed to consider trends taking into account the percentages of maternity facilities ever-certified as Baby-Friendly, the percent of all births that occur in these facilities, and continued compliance with and investment in the program. Such analyses would help to determine whether a dose-response relationship exists between the level of BFHI programming and trends in EBF over time. Further research is also needed to investigate the existence and impact of other local and national breastfeeding promotion and support programs implemented concurrently with the BFHI.Implementation of the international BFHI was associated with a statistically significant annual increase in rates of EBF among infants 0 to 2 months of age and among infants 0 to 6 months of age in the 14 countries studied. Further research is needed to explore fully the impact of the BFHI on cross-national breastfeeding trends, including studies that could better control for individual country's rates of BFHI certification, for whether the practices were maintained, and for the proportion of all births that occurred in Baby-Friendly facilities.In sum, although the trends following BFHI introduction were not statistically significantly increased from the pre-BFHI trends, and although we were unable to control for all possible confounders, our findings indicate that implementation of the BFHI is associated with positive changes in EBF at a level that would result in improved child health and survival outcomes.SA declares no competing interests. ML has served as a consultant to UNICEF and WHO, the implementing agencies of the international Baby-Friendly Hospital Initiative.SA was responsible for the preparation and analysis of data, wrote the paper with inputs from ML, and contributed to study design. ML was responsible for study concept, and contributed to study design and writing and editing of the final paper.


In July 2001, employees of the U.S. Bureau of Reclamation closed the big steel gates across the intake of a major irrigation canal just outside the town of Klamath Falls, Oregon. Water stopped flowing to about 85% of the farms in the Klamath Basin, a high-elevation bowl ringed by forested mountains on the Oregon–California border. The ostensible purpose of the shutdown was to protect three threatened or endangered fish species living in the lakes and rivers tapped by the irrigation system.That water cutoff, coming in the middle of the irrigation season in a region almost wholly dependent on irrigated agriculture, ignited a legal and political firestorm. Hundreds of outraged farmers and their supporters surrounded the main irrigation canal’s control structure and turned the water back on, retreating only when federal law enforcement agents arrived. Lawsuits were filed. Protesters arrived from as far away as Nevada, Montana, and Malibu. Among their props was a giant metal bucket, a symbolic water delivery to parched Klamath farms. Three years later, although the out-of-town horde drawn by the water shutoff had long since departed, the bucket—with an American flag on top and the words “Klamath Bucket Brigade” painted on the side—still greeted visitors in front of the County Government Center in Klamath Falls.The dramatic standoff and its bitter aftermath drew nationwide media attention. Nearly every story printed or broadcast during that long, drought-parched summer focused on the spectacle of “farms versus fish,” an emotionally resonant but not particularly accurate or useful description of the conflict.Water War in the Klamath Basin: Macho Law, Combat Biology, and Dirty Politics, a new book by a pair of veteran environmental-law experts, delves deep into the tangled legal underpinnings of the conflict, revealing it to have been about much more than farms and fish. Holly Doremus, a law professor at the University of California at Davis, and A. Dan Tarlock, distinguished professor of law at the Chicago-Kent College of Law, have crafted a dense but concise text that describes the assumptions underlying federal and state natural-resource policies and explains how legal contradictions, changing cultural values, and evolving scientific understanding combined to make the clash in the Klamath Basin both inevitable and intractable.The Klamath Basin contains about 1,400 farms encompassing more than 200,000 acres of cropland, most of it served by a large and complex federal irrigation system known as the Klamath Project. It is one of the oldest federal water projects in the nation, and like nearly all the great public works of the Reclamation Era, it was constructed with no concern for the effect its dramatic reworking of natural hydrology would have on the fish and other wildlife occupying the region’s lakes, streams, and wetlands.The 2001 water cutoff, at least superficially, represented a belated effort to mitigate the effect of agricultural irrigation diversions on three fish species: the Lost River and shortnose suckers, inhabitants of the basin’s largest lake and its tributaries; and coho salmon, found in the Klamath River downstream from the project. But as Doremus and Tarlock correctly point out, the Klamath conflict also pitted the interests of farmers and ranchers against those of commercial fishermen on the coast more than 200 miles away. It was about the conflicting cultural values of whites and Native Americans. And finally, it was about two contradictory ways of thinking about the environment: one deriving from the past and viewing natural resources from a purely utilitarian perspective, and one that arose only recently in American history, regarding ecosystems and their living components as having rights and value beyond their economic utility to human beings.Water War in the Klamath Basin is sometimes a tedious read—the authors have an annoying habit, useful in introductory college textbooks but nowhere else, of reminding the reader about what they have already explained and previewing matters they will explain later—and it shortchanges the rich human component of the Klamath saga. But it is a useful and thorough primer on western water law and federal environmental policy. And it serves as a cautionary guide to the conflicts that inevitably will arise in other overallocated watersheds as population growth, a warming climate, and failing ecosystems conspire to reveal profound flaws in the hydraulic foundation of the West.


A team-based Learning (TBL) tutor training workshop on research and publication ethics was offered to 8 faculty members and 3 staff at Hallym University in 2009. To investigate the effect of the workshop and any attitude changes, a questionnaire survey was performed after the 8-hr course. Questions in four categories-general course content, change in attitudes toward research and publication ethics, the TBL format, and an open-ended question about the course--were included. Participants responded positively to all items on general course content. There was a positive change in attitude on research and publication ethics. Participants also responded positively to six items on team-based learning. The overall positive response to the workshop on research and publication ethics suggested the effectiveness of this kind of TBL tutor training course for university faculty and staff. Team-based learning (TBL) on research and publication ethics has been required of incoming faculty at the College of Medicine, Hallym University since February 2007 with positive results. For the continuation and expansion of this kind of faculty training, tutor training for TBL on research and publication ethics was suggested for university faculty beyond medical professors. Trained faculty members will be able to participate as tutors in graduate student education as well as resident training in the hospital. This paper introduces the curriculum of the workshop for TBL tutors on research and publication ethics and describes the evaluation of the course by participants.In June 2009, the tutor training course for TBL on research and publication ethics was opened as a one-day 8 hr course. The timetable was as follows:Research ethics on animal experimentsSubmission and review process of the animal experiment proposal		Research and publication ethics TBLFabrication, falsification, and plagiarismDuplicate publication and authorship misconduct		Clinical research ethicsEthical consideration and the Institutional Review Board (IRB)Case discussionExercise on reviewing a research proposal		How to organize and maintain an IRB in the institute    Four faculty members participated as tutors in the course. Participants consisted of 8 faculty members from bioscience, audiology, electrical engineering, nursing, radiology, psychiatry, family medicine, and hemato-oncology and 3 staff from the research support department and the laboratory animal center. The curriculum consisted of a brief lecture, an exercise, an introduction to the TBL training method, and a case discussion. TBL consists of an individual readiness assurance test, group readiness assurance test, and further application. First, individual participants try to answer items. After that, group members discuss the items together and select only one correct answer to each item. The tutor leads the participants to discuss the correct answers and their background reasoning. Further application is suggested through open-ended questions. This is intended to lead to advanced thinking and deep reasoning. Only 2 of the 8 hours were devoted to TBL. The rest of the time was focused on knowledge and skill acquisition on research and publication ethics.To obtain feedback from participants, a 5-point Likert scale questionnaire with 5 being "strongly agree" and 1 being "strongly disagree" was distributed at the end of the workshop. The questionnaire used was derived from that of Kim [To every items of questionnaire, there was a positive response. Out of 7 items on general course content, "the importance of learning materials" was the most positive item. There was a positive change in attitude on research and publication ethics. Out of 6 items on attitude toward research and publication ethics, "knowledge on the research and publication ethics increased"generated the most positive response. TBL format also showed a positive response, except for the item "increase in workload to participate in the class." Out of 5 items on the TBL format, "communication with the tutor" was the most positive response. Open-ended answers are as follows: It was good opportunity to understand research and publication ethics; It was important content; This is a useful program to apply to education; I will apply this program in my institute; It broadens my view of research and publication ethics.The results of this evaluation showed that this kind of workshop on TBL tutor training was meaningful for the faculty and staff to understand the content of research and publication ethics and TBL procedures. A change in attitude on research and publication ethics appeared to occur in this workshop, and TBL tutor training might be another good basis for supporting the value of this workshop. In the future, they will be able to work as volunteer TBL tutors of for graduate students, residents, or peer faculty members not only in a special program but also as part of the classes they already teach. s. All faculty members, graduate students, and residents should be required to participate in a research and publication ethics training program since duplicate publication and other misconduct should be prevented . TBL may


Previous publications indicate that acupuncture is efficient for the treatment of pelvic girdle pain, PGP, in pregnant women. However, the use of acupuncture for PGP is rare due to insufficient documentation of adverse effects of this treatment in this specific condition. The aim of the present work was to assess adverse effects of acupuncture on the pregnancy, mother, delivery and the fetus/neonate in comparison with women that received stabilising exercises as adjunct to standard treatment or standard treatment alone.In all, 386 women with PGP entered this controlled, single-blind trial. They were randomly assigned to standard treatment plus acupuncture (n = 125), standard treatment plus specific stabilising exercises (n = 131) or to standard treatment alone (n = 130) for 6 weeks. Acupuncture that may be considered strong was used and treatment was started as early as in the second trimester of pregnancy. Adverse effects were recorded during treatment and throughout the pregnancy. Influence on the fetus was measured with cardiotocography (CTG) before-during and after 43 acupuncture sessions in 43 women. A standardised computerized method to analyze the CTG reading numerically  was used. After treatment, the women rated their overall experience of the treatment and listed adverse events if any in a questionnaire. Data of analgesia and oxytocin augmentation during labour, duration of labour, frequency of preterm birth, operative delivery, Apgar score, cord-blood gas/acid base balance and birth weight were also recorded.There were no serious adverse events after any of the treatments. Minor adverse events were common in the acupuncture group but women rated acupuncture favourably even despite this. The computerized or visually assessed CTG analyses of antenatal recordings in connection with acupuncture were all normal.This study shows that acupuncture administered with a stimulation that may be considered strong led to minor adverse complaints from the mothers but had no observable severe adverse influences on the pregnancy, mother, delivery or the fetus/neonate. Pelvic girdle pain (PGP) is common complaint in pregnant women all over the world . It has Women affected with PGP typically adopt abnormal patterns of muscle activity, to relieve and avoid pain. The longer this pattern persists, the more pain will arise from the unphysiological burden on muscles and joints and the pain in turn will aggravate the dysfunction of muscles resulting in a vicious circle. As a consequence, the pain often becomes more severe in late pregnancy ,8,9.Randomized controlled trials -14, two Cardiotocography (CTG) is often used in the prenatal period for detection of fetal distress,30. HoweAt present, results from randomised controlled trials indicate that acupuncture and stabilising exercises as adjunct to standard treatment  are effiThis paper is an additional report of further results from a large study earlier presented in 2005 . The delStandard treatment consisted of basic information about PGP and anatomy of the back and pelvis. The purpose of this information was to reduce fear, and to encourage patients to become active in their own treatment. The patients got a pelvic belt and a traditional home training programme including easy performed exercises for global muscles, with aim to increase strength in the abdominal, back, gluteal and shoulder muscles. Patients were told that they were free to call the physiotherapist at any time if they had questions about the home exercises or wanted more help i.e. needed crutches.The same treatment as in the standard group, but in addition acupuncture. The aim with acupuncture was to establish control of PGP to prevent dysfunction of muscles of the spine and pelvis. The aim with the stimulation was to activate both the segmental pain inhibitory system, involving the so-called gate control mechanism  and the The needles  were disposable and made of stainless steel (∅ 0.30) and they were inserted intramuscularly to a depth of 15–70 mm. Needles were manipulated manually to evoke needle sensation (De Qi), a characteristic feeling of tension, local pain, soreness or numbness, and often a radiating feeling from the point of insertion. The needles were manually stimulated every ten minutes and left in situ for 30 minutes. Treatment was given twice a week.The same treatment as in the standard group but, in addition, stabilising exercises and massage . The aimThe women receiving acupuncture and stabilising exercises were asked whether they had identified a side effect at each visit, although they were not presented with a list of possible side effects. However, before the first treatment the women in the acupuncture group were informed of possible side effects connected to acupuncture. I.e. they were informed that bleeding or bruising, pain on needling, and aggravation of symptoms occur in some patients and that they could experience drowsiness, especially after the first treatment. Patients were also advised to avoid strenuous physical activity the same day as the treatment. Immediate adverse events connected to acupuncture as hypotension/fainting and/or nausea were recorded. Fetal heart rate, maternal heart rate and blood pressure were monitored before and after all acupuncture sessions to assess the cardiovascular effect of acupuncture and influence on the fetal heart rate was measured with CTG in 43 women. CTG was recorded prior, during and after 43 treatment . The CTG traces were assessed both by the computer  and visually by an experienced obstetrician .The women in the stabilising exercise group were informed that PGP could aggravate if they overloaded their pelvis and they were instructed to lower the intensity of the exercises if this happened.At follow-up visit to the physiotherapist, , all women filled out a questionnaire in which they answered a question if they had experienced harm of the treatment they had received (no or yes). If they marked yes, they were asked to list disadvantages and/or adverse events that they had experienced. The women were also asked to indicate their overall experience of the treatments. The options were: no help, some help, good help and very good help.To assess influence of treatments on the pregnancy, delivery and condition of the child at birth, we recorded antenatal, intrapartum, neonatal and infant data that are normally registered in the Medical Birth Register (MBR) in Sweden. Assessment of the condition of the child at birth was based on weight, cord-artery and vein acid-base status  and Apgar score. In Sweden preterm birth is defined as < 37 weeks gestation, metabolic acidosis is defined as cord artery pH ≤ 7.05 and BDef ≥ -12 and neonatal death is defined as death of a live born infant within 28 days of birth.Data analyses were performed by a statistician who was blinded to group and treatment. Continuous data were tested for significance with Kruskal-Wallis test. If a significant difference was found between any of the three groups, Mann Whitney U test was used to compare one group against one another. Dichotomous data were tested for significance with Fischer's exact test. Adjustments (multiplication by three) of the p-values due to multiple comparisons were performed by Bonferroni's method when appropriate. An adjusted p-value < 0.05 was considered statistically significant. Calculation of statistical tests and descriptive evaluations were carried out using SAS software package, version V8.A total of 386 subjects were randomised Fig. , 35 womeThe computerized or visually assessed CTG analyses of antenatal recordings in connection with acupuncture were all normal Table .There were no serious adverse events associated with either of the treatments. Minor adverse events were most common in the group receiving acupuncture Table .The acupuncture group and the stabilising exercise group were significantly more likely to be "very satisfied" with their treatment than the standard treatment group Table .No negative influence on the pregnancy outcomes were found after either of the treatments Table . AcupuncTable Table The main result of this study is acupuncture, which may be considered strong, given during the second and third trimester of pregnancy, does not lead to serious adverse events in women during pregnancy and delivery or in fetuses/neonates. As, expected, no serious adverse events were found after standard treatment and stabilising exercises. All but one of the women in each group that withdraw from treatment are included in the thorough follow-up which guarantees that there were no long-term adverse events in these women.We are not surprised that adverse events were rare in the standard group as the prescribed exercises were of low-force. Experience of slight rubbing connected with use of the semi plastic belt have also been reported by others -42.Our result shows that although minor adverse events were more frequent in the acupuncture group than in the other study groups, they were sparse. Only 64 minor adverse events (5%) out of 1414 acupuncture treatments were reported. These minor adverse events were reported by 43 women showing that some women were more susceptible than others. Also, six out of ten of women who withdrew from acupuncture treatment reported one of these adverse events as reason for not completing their participation. The most frequent adverse events were pain at the site of needling, drowsiness after treatment and headache, which is in line with a postal survey of 9408 prospectively identified acupuncture patients . Our datWe believe that experience of needle pain (n = 27) must be considered unavoidable when treatment involves needling. In addition, the pain may have resulted from the achievement of de qi, a feeling thought to be essential for a successful treatment. Nevertheless, in spite of the minor adverse events, the women rated acupuncture favourably even though this and a majority of them were willing to use the same treatment in the future if needed, suggesting that the pain of the treatment did not negatively impact their overall experience of the treatment.We think that fear of immediate and long-term serious adverse events of acupuncture in pregnant women have resulted in both a restricted use of acupuncture and a delayed start of this treatment in pregnant women. To reduce development of abnormal patterns of muscle activity  we decidIn addition, an adequate dose of acupuncture probably is essential for the outcome of treatment and, as no scientific evidence of harm of acupuncture during pregnancy exists we decided not to reduce the stimulation because of the pregnancy. Therefore we used acupuncture points and the same stimulation that is normally used in a non pregnant population. Fortunately, this strategy resulted in significant pain relieving effects . It is nThere were 22 minor adverse events reported by 22 women in the stabilising exercise group. The most frequent adverse event was pain in the lower back at the beginning of the treatment period (n = 17). Our results of no serious adverse events of physiotherapy are in agreement with earlier research ,11,41-51Our results of no signs of fetal distress in connection with acupuncture is supported by Neri et al.  who founAs described in the method section, we used the same antenatal, intrapartum, neonatal and infant data that has been complied on all births in Sweden by the Swedish MBR since 1973. This register offers a unique possibility to obtain reliable prevalence figures regarding obstetric and neonatal outcome. Unfortunately this register has no data of frequency of acupuncture during the antenatal period. If that had been the case it would have been easy to collect data on safety from all pregnant women in Sweden that had got acupuncture for PGP and/or LBP.The three different treatments were not found to affect the use of pain relief in labour, parturition or neonatal outcome. Effects on labour or parturition or cord blood acid base/gas balance after acupuncture treatment for PGP have not been reported earlier. Analysis showed that four neonates in the acupuncture group and two neonates in the stabilising exercise group had metabolic acidosis in the arterial cord blood. However, only one of the neonates in the standard group, one neonate in the acupuncture group and two of the neonates in the stabilising exercise group had Apgar score ≤ 7 at 5 minutes indicating metabolic acidosis of any importance. One limitation of the study is that cord blood was analysed in only 70% of the neonates. We assume that the generalizability of our results is not biased by selection effects as the frequency of cord blood analysis did not differ from all deliveries at Sahlgrenska University hospital during the same period.The frequency of induction of delivery, oxytocin augmentation, preterm delivery, and postmaternity were similar in the treatment groups. Nor did acupuncture lead to observable negative influences on the neonates in our study, yet, the study was not powered to fully exclude such influences. In Sweden, the frequency of neonatal death is 0.3% and the frequency of preterm delivery is 5.6%, thus a very large number of patients would have been required to fully investigate these issues.Our results are in line with a previous published review  of acupuWhen trying to determine the clinical implications of the present study we have to consider that1. The data emerged from a relatively large randomised trial, although we are aware that an efficacy randomised controlled trial is not an appropriate design to provide evidence of safety. Studies of more than 97 000 participants' have been used in the past .2. A substantial number of women started treatment already during the second trimester of pregnancy.3. The acupuncture may be considered to be strong compared to earlier studies. We used 17 needles, 10 of them were located in the lumbosacral region  . They we4. The investigation of the complications during pregnancy, pregnancy outcomes and the neonates were quite extensive compared to earlier published studies.5. But the study was of insufficient size to exclude negative effects on preterm delivery, perinatal morbidity and mortality as well as on CTG.In conclusion, this is the first large clinical trial of standard treatment, stabilising exercises and acupuncture administered with stimulation that may be considered strong for PGP to report on effects on CTG, labour, parturition and cord blood gas/acid base status. The study result adds support to the view that acupuncture even with stimulation that may be considered as strong is not accompanied by any severe adverse influences on the pregnant women or the fetus/neonate. The data have important clinical implications in eliminating fear of serious adverse effects when treating women with acupuncture during the second and third trimester of pregnancy. Even if more studies are required, the present study provides the most comprehensive data reported to date.ACU: acupuncture plus standard treatment; BL: bladder channel; CTG: cardiotocography: GB: gall bladder channel; KI: kidney channel; LBP: Low back pain; LI: large intestine channel; MBR: medical birth register; PGP: pelvic girdle pain; S: standard treatment; SE: stabilizing exercises plus standard treatment; ST: stomach channel; GV: governor vessel channel.The authors declare that they have no competing interest.All investigators have access to all data in the study. HE initiated and coordinated the study, did most of the data collection, contributed to study design and interpretation of the results. LL advised in data collection and assisted in study design and in the statistical analysis of the data. MF-O assisted in study design and gathered data and assisted in the statistical analysis of the data. HC-O guided the scientific process, assisted in study design, provided advice on the epidemiology of pelvic girdle pain and contributed to funding of the project. HH guided the scientific process, assisted in study design and provided funding. All investigators contributed to data interpretation and preparation of the manuscript. HC-O and HH are guarantors for the study.The pre-publication history for this paper can be accessed here: