Within the last decade there has been a growth in the call-centre industry in the UK, with a growing awareness of the voice as an important tool for successful communication. Occupational voice problems such as occupational dysphonia, in a business which relies on healthy, effective voice as the primary professional communication tool, may threaten working ability and occupational health and safety of workers. While previous studies of telephone call-agents have reported a range of voice symptoms and functional vocal health problems, there have been no studies investigating the use and impact of vocal performance in the communication industry within the UK. This study aims to address a significant gap in the evidence-base of occupational health and safety research. The objectives of the study are: 1. to investigate the work context and vocal communication demands for call-agents; 2. to evaluate call-agents' vocal health, awareness and performance; and 3. to identify key risks and training needs for employees and employers within call-centres.This is an occupational epidemiological study, which plans to recruit call-centres throughout the UK and Ireland. Data collection will consist of three components: 1. interviews with managers from each participating call-centre to assess their communication and training needs; 2. an online biopsychosocial questionnaire will be administered to investigate the work environment and vocal demands of call-agents; and 3. voice acoustic measurements of a random sample of participants using the Multi-dimensional Voice Program (MDVP). Qualitative content analysis from the interviews will identify underlying themes and issues. A multivariate analysis approach will be adopted using Structural Equation Modelling (SEM), to develop voice measurement models in determining the construct validity of potential factors contributing to occupational dysphonia. Quantitative data will be analysed using SPSS version 15. Ethical approval is granted for this study from the School of Communication, University of Ulster.The results from this study will provide the missing element of voice-based evidence, by appraising the interactional dimensions of vocal health and communicative performance. This information will be used to inform training for call-agents and to contribute to health policies within the workplace, in order to enhance vocal health. Research to date has failed to account for the central and most important tool for the communications industry, the human voice. Failure to investigate the use and impact of vocal performance has resulted in a significant gap in the evidence-base of occupational health and safety research. Voice is not simply the tool for communication transmission, it is directly related to the working ability and efficiency of the single most sought after attribute sourced by employers in the industry – effective verbal communication and interaction .There is substantial epidemiological and physiological evidence supporting the view that groups such as teachers, singers, lawyers, and telemarketing workers are at risk of occupational health and safety voice problems ,3, in paVilkman  states tCall-centre workers have prolonged voice use and heavy vocal loading, thus increasing the risk of occupational dysphonia, which is a voice disorder due to work-related overuse or abuse that threatens communicative, interactive and economic efficiency ,5,7,8. VRisks to vocal performance and efficiency are not simply physiological, but in telephone interaction, also demand co-ordination of optimum psychological, behavioural and environmental settings to maintain an efficient balance for the interaction. Clearly, subtle paralinguistic vocal changes may unconsciously affect the call-agent, but also the receiver negatively. Cameron  describeVast resources have already been spent without fully understanding or appreciating the interactional dimensions of telephone communication – physical, environmental, behavioural and psychosocial aspects of vocal communication. However, there have been no studies investigating the use and impact of vocal performance in the communication industry within the UK. This study aims to address this significant gap in the evidence-base of occupational health and safety research. This research will therefore provide the missing element of voice-based evidence, by appraising and ranking the interactional dimensions of vocal health and communicative performance.The objectives of the study are:1. To investigate the work context and vocal communication demands for call-agents;2. To evaluate call-agents' vocal health, awareness and performance;3. To identify key risks and training needs for employees and employers within call-centres.This research will take the form of an occupational epidemiological study. This will be a mixed methods design, comprising a qualitative and large-scale quantitative approach, including acoustic measurement in the naturalistic work environment. There are three stages of this research study: 1. interviews with a senior manager  within the call-centres; 2. online survey; and 3. acoustic measurements.The research participants will be employees from call-centres throughout the UK and Ireland. As this is a relatively new area of research, the main measurement tool, biopsychosocial questionnaire for the online survey will be developed to collect the relevant information to meet the aim and objectives of this study, thus power calculations were not calculated. The sample sizes of the participants in each stage of this study are as follows: 1. interviews with one manager from each participating call-centre ; 2. online survey will be completed by a purposive sample of at least 500 call-agents from the participating call-centres; and 3. acoustic measurements will be conducted from at least 10% of participants from stage 2. It is anticipated that these sample sizes should be sufficient for the measurement tools to collect information on the vocal demands, communication, vocal health and training needs of call-agents in call-centres within the UK and Ireland. The findings from this study will be used to calculate a power calculation for the follow-up randomised controlled trial in call-centres.The Human Resource department of each call-centre in the UK and Ireland will be contacted via e-mail inviting participation in this research study. Interested call-centres will contact the research team and receive full details of this study, and a manager from the participating organisations will provide written informed consent. The management team within the participating call-centres will inform their call-agents of this study and invite them to complete the online survey. The first question on the questionnaire for the online survey will ask the call-agents to indicate consent.A biopsychosocial questionnaire will be developed for the online survey, and based on self-report tools, tested for reliability and validity. This questionnaire will be piloted among a sample of call-agents, different from those participating in the main survey. The questionnaire will include the Voice Symptom Scale (VoiSS) , Voice HFor the first stage of this research, interviews will be conducted with a senior manager  within the call-centres. These interviews will aim to assess the organisation's communication and training needs and will be via telephone or face-to-face, whichever is the most convenient for the manager. Current occupational safety and health roles will be identified and the analysis of this information will further inform the measurement tool. Secondly, a large scale epidemiology study will be conducted consisting of an online biopsychosocial questionnaire, which will be administered to investigate the work environment and vocal demands of call-agents. This will be published on a secured website and accessed at a convenient time, in agreement with the management team in the call-centres. Participants will receive information on the study including the time required for completion and assurance that all responses are anonymous. The third and final stage will involve acoustic measurement from a monitored telephone call-sample of a random sample of participants, who participated in the online survey. A sample of the natural conversation will be selected by a call-centre staff member and given to the research team in digital format for analysis.The data from the interviews will be transcribed and analysed thematically to determine context and process characteristics of each organisation. Qualitative content analysis will identify underlying themes and issues, which will be used to further refine and inform the questionnaire design.Questionnaire analysis will account for the complex interaction of multi-factorial variables and the wide range of theoretical perspectives requiring evaluation with an appropriate range of methodological tools and approaches. Given the complexity of the study and the array of variables impacting on vocal strain, there is a need to employ sophisticated forms of analysis, with the capacity to explore potential directional effects across a wide range of variables. While multiple regression analysis is frequently used to analyse social science data, the main problem is handling measurement error, indirect or mediating effects. Since most multivariate procedures cannot deal with multiple variables, particularly multiple dependent or criterion variables, hypothesis testing is difficult.Therefore, the study will adopt a multivariate analysis approach using Structural Equation Modelling (SEM), to develop voice measurement models in determining the construct validity of potential factors contributing to Occupational Dysphonia . The resAcoustic analysis will be conducted on a random sample of the voice of call-agents from call-samples using the Multi Dimensional Voice Program (MDVP), which is a software programme that provides a robust multi-dimensional analysis of voice with graphic and numerical presentation of analysis . MDVP isAll numerical data will be analysed using SPSS version 15. Descriptive statistics will include means, standard deviations and ranges for each variable from the online survey and acoustic analysis. Inferential statistics such as Pearson Correlations will be used to compare the objective and subjective measures. If the assumptions for the above parametric tests are violated then the appropriate non-parametric tests such as the Mann-Whitney will be used.This study has obtained ethical approval from the School of Communication Risk and Ethics Filter Committee, University of Ulster. The questionnaires and the telephone call recordings will be anonymous. These will only be identified by code and not by individual call-agent's or customers' name. There are no known risks in this study.All data will be stored securely, data including telephone recordings will be stored on password protected computers, and hard copies will be stored in a locked filing cabinet and will only be accessed by the research team. All information will be treated as confidential as per the Data Protection Act .This study will investigate the work context and vocal communication demands for call-agents, and evaluates their vocal health, awareness and performance, and also identifies key risks and training needs for employees and employers within call-centres. Therefore, this study will provide the missing element of voice-based evidence, by appraising and ranking the interactional dimensions of vocal health and communicative performance.The main body of evidence on occupational voice loss has been sourced from USA, Sweden, Poland, Finland and Australia. The definitions of occupational diseases differ from country to country. Dysphonia among teachers is considered as an occupational disease in countries such as France (only if the teacher is a state civil servant not a private teacher) and Russia but not in other countries such as Germany and the UK. In France, a simple dysphonia will not be over 25% of partial or permanent incapacity, and all related care and absenteeism will be 100% covered by the state. In Russia, if occupational dysphonia is confirmed by a medical team the treatment/re-education may be paid for by the Social Insurance Fund, and disability payment will be provided for the duration of the disability. In fact, in the UK, we are unable to assess the scale of the problem in working populations due to the occupational disease recording system, Occupational Physicians Reporting Activity (OPRA), with no cases of voice disorder recorded in any working population. The Industrial Injuries Advisory Council (IIAC)  considerHowever a growing body of occupational voice research, not considered in the IIAC review , has pro1. Benefits for Employees:Increased awareness of the importance of preserving and enhancing the consistency and quality of their voice as the primary tool for communication.2. Benefits for Employers:Employers will not only fulfil their obligations under occupational health and safety legislation, but may also reduce days lost due to illness as a result of occupational dysphonia.3. Benefits to health and OSH policies and practices:Guidelines and recommendations for early detection and support for screening and training needs.The authors declare that they have no competing interests.DH and OD developed the original idea and were applicants on the successful funding application. All authors participated in development of the research protocol, and drafted all versions and approved the final manuscript.The pre-publication history for this paper can be accessed here:


Philosophical Transactions of the Royal Society, we describe current and future trends in usage, together with the many benefits that plastics bring to society. At the same time, we examine the environmental consequences resulting from the accumulation of waste plastic, the effects of plastic debris on wildlife and concerns for human health that arise from the production, usage and disposal of plastics. Finally, we consider some possible solutions to these problems together with the research and policy priorities necessary for their implementation.Within the last few decades, plastics have revolutionized our daily lives. Globally we use in excess of 260 million tonnes of plastic per annum, accounting for approximately 8 per cent of world oil production. In this Theme Issue of  Bakelite, was developed by Belgian chemist Leo Baekeland in 1907, and many other plastics were subsequently developed over the next few decades. It was not until the 1940s and 1950s, however, that mass production of everyday plastic items really commenced. On the opening page of their book ‘Plastics’, the possible applications [of plastics] are almost inexhaustible’. At that time, global production was less than a million tonnes per annum, but plastics were already widely used in products ranging from cups and saucers to components for cars and aeroplanes. The final chapter of their book anticipates the ways that plastics will influence the life of someone born 70 years ago at the start of our ‘plastic age’.  and polybrominated diphenyl ethers (PBDE) could be transferred to humans directly from plastics, for example from flexible toys mouthed by toddlers, or indirectly, for example via food and drink that is packaged or transported via tubing in plastics containing these additives e.g. . Evidencet al. (2009) and Thompson et al. (2009), who describe current trends and examine the limitations to recycling of plastics.Looking to the next few decades, it seems inevitable that humankind will become more reliant on plastics; therefore, the Theme Issue examines potential solutions for waste management of used plastics. For packaging applications, in particular, biodegradable plastics have been advocated as an approach that uses renewable biomass and/or facilitates decomposition at the end of a product's lifetime. Having considered the benefits of plastics, the problems associated with production and the use of plastics past and present and some solutions, the Theme Issue also examines the science–policy interface where appropriate directions will be determined by governments and where policies will be implemented to restrict activities and incentivize change . Finally


BioProspecting is a novel approach that enabled our team to mine data related to genetic markers from the New England Journal of Medicine (NEJM) utilizing SNOMED CT and the Human Gene Onotology (HUGO). The Biomedical Informatics Research Collaborative was able to link genes and disorders using the Multi-threaded Clinical Vocabulary Server (MCVS) and natural language processing engine, whose output creates an ontology-network using the semantic encodings of the literature that is organized by these two terminologies. We identified relationships between (genes or proteins) and (diseases or drugs) as linked by metabolic functions and identified potentially novel functional relationships between, for example, genes and diseases (e.g. Article #1 ([Gene - IL27] = > {Enzyme - Dipeptidyl Carboxypeptidase 1}) and Article #2 ({Enzyme - Dipeptidyl Carboxypeptidase 1} < = [Disorder - Type II DM]) showing a metabolic link between IL27 and Type II DM). In this manuscript we describe our method for developing the database and its content as well as its potential to assist in the discovery of novel markers and drugs. The Bioinformatics and Genomics communities have had great success in the past several years in the discovery of the genetic basis of Mendelian disorders . This suTo advance medical science and healthcare, a broader understanding of genetic markers and their relationships to each other is needed . Our pro"It is the responsibility of those of us involved in today's biomedical research enterprise to translate the remarkable scientific innovations we are witnessing into health gains for the nation. ... What novel approaches can be developed that have the potential to be truly transforming for human health? [ Elias Zerhouni, M.D., 2005 health?  Elias ZeThe New England Journal of Medicine is widely considered one of the most influencial peer-reviewed medical journals in the world . It is tNew England Journal of Medicine "provided the first significant mainstream visibility for a publication that would achieve enormous attention and prestige in the ensuing decades." [The website for the George Polk Award noted in its 1977 award that the ecades." Journal of the American Medical Association, and The Lancet); in 2006, the impact factor was 51 and according to "Journal Citation Reports" was the first research journal to surpass 50.The journal publishes widely cited editorials, papers on original research, review articles, correspondences and case reports. The journal consistently has the highest impact factor of the journals of clinical medicine (including the NEJM provides on-line (electronic) access dating back to 1994. Our study utilized all electronic data for the 27,000 on-line articles published from January 1994 through December 2006.The SNOMED CT (SCT) is a large-scale ontology used for the description of current medical and health community knowledge . We utilOntologies, to be useful for computation for practical tasks, need to be precise in two ways; firstly, they need to match as closely as possible our understanding of the natural world we wish to deal in. Ontologies need to be accurate and closely follow human understanding otherwise they create confusion in their design and their use. This means the ontology needs to be constructed with very close attention to the meanings of the terms used in it. Hence the names used in the ontology need to represent closely the understanding we have of the real world .Secondly the variety of linguistic "usage" of those terms needs to be explored to uncover the diversity of semantic roles of the terms and ensure that only those roles that are useful are included in the ontological modeling, and to remove ambiguity in the use of those roles. Precision of definition is particularly important in establishing the relationships between elements and identifying the fundamental atomic elements and how they combine or "fit together" systematically to form compositional expressions. Ontologies also consist of abstractions with each level of the ontology being more abstract as one moves up the hierarchy. This structure allows us to talk about the world at the different levels of abstraction we would experience outside the realm of the "machine". In using ontology for computation there are two basic forms of abstraction available, aggregation and generalization. Generalization hierarchies are used throughout SCT as the basic mechanisms for relating content. Aggregation hierarchies on the other hand have not been used properly but rather transposed so that they appear like generalization hierarchies.SCT provides coverage for diagnoses, findings, procedures and testing. In one study SCT provided 92.3% coverage of common medical problems seen at the Mayo Clinic . It has Human Genome Organisation (HUGO) is an organization involved in the Human Genome Project, a project about mapping the human genome. HUGO was established in 1989 as an international organization, primarily to foster collaboration between genome scientists around the world. The HUGO Gene Nomenclature Committee (HGNC) is one of HUGO's committees and it aims to assign a unique gene name and symbol to each human gene.The There are 574 metabolic functions that were used to link to Genes, Proteins, Disorders, and Drugs. See Tables 5We identified 468,371,305 relationships within the 27,000 NEJM full text articles available online from the Massachusetts Medical Society. The dates of the articles ranged from 1994 to 2006. Of these over 54 million (11.7%) were potentially novel relationships, having never been mentioned together in any one NEJM article and over 413 million were previously known. Of the over 66 million relationships identified between Genes and Diseases, over 14 million (21.9%) were potentially novel. This degree of novelty represents a powerful opportunity to capitalize on synergies between articles in the medical literature. Additionally, should we "encode" other electronic journals, with different editorial perspectives, and introduce them into the broader universe of medical literature the benefits are expected to be even greater.An example of two articles that "synergized" to link the "Fyn" gene with Myocarditis using their common association with kinase activity were:Predicting Progression – ZAP-70 in CLL                                 Terry J. Hamblin, M.D."In T-cell signaling, collaboration between ZAP-70 and the other Src kinases, Lck and Fyn, leads to the activation of downstream signaling pathways, including nuclear factor ...κB and mitogen-associated protein kinase, leading to cellular proliferation."Which linked with:Novel Role for Integrin-Linked Kinase in Modulation of Coxsackievirus B3 Replication and Virus-Induced Cardiomyocyte Injury                                 Mitra Esfandiarei, Agripina Suarez, Ansel Amaral, Xiaoning Si, Maziar Rahmani, Shoukat Dedhar, Bruce M. McManus'Recently, more consideration has been given to the role of signaling pathways in pathogenesis of enteroviral myocarditis, providing new platform for identifying a new potential therapeutic target for this, so far, incurable disease.".... "Here, we report on regulation of virus-induced Akt activation by the integrin-linked kinasein infected mouse cardiomyocytesand HeLa cells."Figure One could also envision the process as shown in figure The medical literature is a vast repository of biomedical knowledge. Much of the richness of this resource is not in a form that is easily amenable to computational analysis. Add to this the fact that no medical professional can read all of the medical literature and Natural language processing has the potential to unlock the knowledge within the medical literature. In this experiment we used the information from the NEJM, one of the premier medical journals, to determine if novel relationships could be identified between Genes, Proteins, Drugs and Disorders. These relationships are indeed prevalent and hold the potential to increase our understanding of human disease.The validation by example is illustrated in the identification of a gene "FYN" identified in tissue as a marker for Giant Cell Myocarditis, which was identified also in our database and would have been available from previous literature a full two-years in advance of its identification in tissue and publication. The database not only identified the relationship of the "FYN" gene to Giant Cell Myocarditis but also to Viral Myocarditis which would have otherwise been considered "not known". Identification of new relationships that have been validated in tissue is just one form of validation of the content of the database. We are currently looking at all of the genes related to more than three cancers. In this analysis we have identified 10 genes related to thirty or more cancers, 72 genes related to twenty or more cancers and 191 genes related to ten or more cancers. Perhaps the common basis for transformation of cells to malignancies has already been published but remains "hidden" within the vast amounts of biomedical literature.Biomedical Informatics has the potential to help us to discover novel genetic linkage to human disease. This can lead to benefits in patient care with more rapid knowledge discovery and translational research empowering clinical implementation of personalized/individualized medicine.We parsed the full-text content of the New England Journal of Medicine (1994–2006) using our Multi-threaded Clinical Vocabulary Server (MCVS). The output of this technology creates an ontology-network using the semantic encodings of the literature that is organized by section of the article. In this effort we utilized a single Dell 2650 server with 8 GB of main memory and two processors. The configuration took one year to accomplish, but could have been done in 1/2 the time with two server and a quarter of the time with 4. The software is configured so that this scheme could continue indefinitely.The indexing was done utilizing SNOMED-CT and the HUGO Ontologies. This provides robust indexing as SNOMED-CT has >370,000 concepts and >1,000,000 terms  and HUGO has >26,000 human gene names. This concept based indexing represents a broad and consistent data infrastructure across articles from the literature.We identified relationships between genes and functions, proteins and functions, diseases and functions and drugs and functions. Next, we matched these data sets across function, identifying functional relationships between proteins and diseases, for example. Further functional relationships were developed between genes and diseases, proteins and drugs, genes and drugs, and drugs and diseases. Next, we identified the disjoint sets where, for example, a gene and a disease match across function but have not been mentioned together in any previous NEJM journal article. Our goal was to identify synergy between articles within the literature indicating potential relationships between genes or proteins and drugs or diseases that have heretofore not been previously recognized. The database is searchable in all aspects such that a disease-oriented researcher could search the disease they are interested in and find all of the genes, proteins and drugs associated with that disease organized by function. Researchers could either access this information regarding known synergies (where the gene and disease have been mentioned in the same article) that verifies the utility of the algorithm or discontinuities . This may indicate the possibility of a novel relationship that can then be taken back to the bench for further definition, identification and research. Proteins and drugs, for example, that have a functional relationship but that have never been recognized to affect one another, may be substrate for further basic science analysis thereby leading to more rapid marker and treatment discovery. We see this as a potential method for improving the research productivity.This program/exercise aims to support the development of novel clinical and translational methods that can encompass a wide range of techniques including new methods of phenotyping where one could use SNOMED CT to phenotype the patients described in this paper. New biomarkers for research are a potential output of this project (See Figure Should this "bear fruit" using the New England Journal of Medicine, other journals such as Science, Nature and Cell could be added to the corpora. The current collection holds the New England Journal of Medicine full text collection of over 27,000 articles. We did not survey the Science, Nature and Cell collections for an estimate of the addition to the collection, but we expect significant quality increases with the addition of these collections.The authors declare that they have no competing interests.PLE, MST, BET and SHB all contributed to the design study as well as the writing and review of the manuscript. PLE ran the study.


This study set out to achieve three objectives: to test the application of a context assessment tool in an acute hospital in South Australia; to use the tool to compare context in wards that had undergone an evidence implementation process with control wards; and finally to test for relationships between demographic variables (in particular experience) of nurses being studied (n = 422) with the dimensions of context.The Alberta Context Tool (ACT) was administered to all nursing staff on six control and six intervention wards. A total of 217 (62%) were returned (67% from the intervention wards and 56% from control wards). Data were analysed using Stata (v9). The effect of the intervention was analysed using nested  analysis of variance; relationships between nurses' experience and context was examined using canonical correlation analysis.Results confirmed the adaptation and fit of the ACT to one acute care setting in South Australia. There was no difference in context scores between control and intervention wards. However, the tool identified significant variation between wards in many of the dimensions of context. Though significant, the relationship between nurses' experience and context was weak, suggesting that at the level of the individual nurse, few factors are related to context.e.g., leadership, culture) vary at the ward level, whereas others  do not. The ACT also raised a number of interesting speculative hypotheses around the relationship between a measure of context and the capability and capacity of staff to influence it.Variables operating at the level of the individual showed little relationship with context. However, the study indicated that some dimensions of context , ward (meso) or hospital-level (macro) data most appropriate? The preliminary results also raise questions about how best to utilise this instrument in knowledge translation research. Put set al.  and implThe role of context has been defined in the PARIHS framework , which hypothesised that successful implementation (SI) of evidence into clinical practice occurs as a function (f) of the scientific robustness of the evidence (E), the receptiveness of the context (C) of the care setting and the appropriateness of the facilitation (F) of the change process . Consequet al. [Initially, context was considered to be dependent on three sub-elements: leadership, culture, and measurement ,8. The fet al.  summariset al. ,8. A stret al. .et al. [e.g., context, nurse-to-nurse collaboration) or organisational level  factors.Although the study of context and research uptake is relatively new, relationships between stronger context, greater research utilisation, and less staff and patient adverse events in nursing have been documented ,11. Mostet al.  found thDespite the theoretical advancements of the PARIHS framework, few studies have quantified the sub-elements to context  or have considered how external factors--operating at micro, meso or macro levels--determine context.e.g., 'how often do you have 'down time"), structural and electronic processes , and information-sharing activities  [Two tools to measure context--both based on the PARIHS framework--have recently been developed: the Context Assessment Index (CAI) and the Alberta Context Tool (ACT). The CAI, developed by Brendan McCormack and researchers at the Universities of Ulster and Cork in Ireland, is both an evaluative and self-assessment tool . Users a roles') . The too roles') .The Older Person and Improving Care (TOPIC7) project was set up in a tertiary acute hospital in South Australia. The Nursing Department in the hospital had, since 2005, undertaken a cycle of audits of its standards of nursing care. These audits showed that certain elements of care were not improving. The TOPIC7 project was therefore proposed to improve the experience of older people going through the acute hospital sector by using a Knowledge Translation (KT) toolkit. This clinical initiative provided an opportunity to explore the links between patient safety, quality improvement (QI) and evidence-based practice (EBP) approaches along with an exploration of how knowledge translation could be linked with these techniques. In addition, the initiative was seen to operationalise in a very practical way the policy priority of the state around improving older peoples' care .Results of the actual intervention study have been reported elsewhere ,17. The i.e., intervention wards) and control sites. The third aim was to investigate what factors impact on context and to determine the presence or absence of variables that could be targeted to strengthen context and improve the uptake of evidence into practice, as indicated by the PARIHS framework.The ACT had not previously been used outside of Canada. Therefore, the first aim of this project was to test whether the ACT was culturally applicable and suitable for use in an Australian acute care hospital. The second aim was to compare context between hospital wards involved in the evidence implementation . Following a review by a group of five multidisciplinary health researchers, the terminology used in the ACT was slightly modified. For example, we used the term 'enrolled nurse' in place of 'licensed practical nurse,' and added a range of other positions including 'clinical nurse' and 'clinical service coordinator.'The ACT has 73 items, 14 relating to demographics and site issues and 59 relating to the 11 dimensions of context, which are summarised in Table Ward leaders were briefed about the selected tool, and the least disruptive time period for the evaluation was selected. All nursing staff (enrolled nurses and registered nurses) listed on the payroll for each of the 12 wards were sent a copy of the questionnaire and an explanatory document via the hospital's internal mail. After five weeks, non-responders were sent another copy of the questionnaire. Questionnaires could be returned to the research team either by a collection box stationed in the ward, or by the hospital internal mail.Questionnaires were entered into an Excel spreadsheet and imported into Stata  software. Depending on data type and underlying distribution, a range of statistical tests were used to compare the demographics of the two groups, including chi-square, t-test, and Mann-Whitney U-tests. To account for the likely dependence of data collected within wards, hierarchical (nested) ANOVA was used to test for differences in the dimensions of context between control and intervention sites .i.e., as a registered nurse, or enrolled nurse), and time (months) that they have worked on their current ward/unit. Given the relative infrequency of CCA in nursing literature, it is informative to briefly introduce the method and the calculated statistics. CCA involves the derivation of a number of independent canonical functions that maximise the correlation between linear composites , which are sets of dependent and independent variables [c), analogous to the multiple R in regression. Similarly the squared canonical correlation coefficient  to test for relationships between the dimensions of context and staff experience. Staff experience was measured using two self-reported variables: time (months) in their current position  of each canonical function are routinely reported in CCA [s represents the correlation between an observed variable and the calculated canonical function that describes the relationship between the two canonical variates [s of greater than 0.45 or less than -0.45 to be of sufficient size to indicate an important relationship. The square of rs  is the proportion of the variance explained by each variable across all canonical functions, and is calculated as the sum of Standardised canonical function coefficients and structure coefficients . The response rate at the ward level varied from 6% (at a control ward where the collection box was inexplicably lost) to 86% at an intervention ward (median 69%).In the first round, 422 questionnaires were sent out and 165 completed questionnaires were returned. Additionally, 69 questionnaires were 'returned to sender,' indicating that staff were on extended leave or had left the ward. The second round yielded a further 52 completed questionnaires for a final response rate of 61.5% (217/353) appropriately addressed questionnaires. The response rate was significantly greater at intervention sites  than at control sites   and overall, less than half (41%) of participants were aged 40 or more . Registered nurses made up the bulk (56.7%) of the participants, followed by enrolled nurses (21.0%) and associate clinical service coordinators (7.1%). In terms of highest qualification, there was no difference between the control or intervention sites , with most participants (59.7%) having a Bachelor degree. The proportion of staff who had undertaken a specialist course was at borderline significance ; although there was no difference in the proportion currently enrolled in an educational program or between experience as measured by time worked in current position or at the current site . Demographic variables  were tested for potential confounding. Based on comparison of means between treatment groups, plotting residuals and comparison of different ANOVA models, two independent variables in particular (namely length of time in current position and length of time on unit) were considered to be potential confounders for many of the dimensions of context, in particular leadership and culture. However, comparison of models with and without the potential confounders revealed very similar results, hence the simpler models excluding the confounders are presented here.The results indicated that there was no difference in any of the dependent variables between the treatment groups Table ; similarComparison of the dimensions of context is complicated because of their different derivations and scoring ranges. Examination of only those dimensions calculated as means (shaded in Table These findings are supported by the fact that 83% of respondents (180/217) felt that more time would be useful. A total of 276 comments to the open-ended question were collated  were 0.39 and 0.34, equivalent to 20,370 = 2.87, P < 0.0001), however, the variance shared between the variate sets, which is calculated as (1 - Wilks λ) and is equivalent to the overall effect size, is relatively low at 25%. The second canonical function on its own was significant ; however, shared variance was low (11%).The canonical correlations  did not contribute to the variation between experience and context, and thus can be interpreted as being invariant of experience of nursing staff.The redundancy index is a measure that allows calculation of the shared variance explained by each canonical function . For botThe ACT was applicable in a cultural setting  that is somewhat different to that in which it was developed, suggesting that the tool may have wide acceptance across the English-speaking developed world, at least. The tool is currently being used across four European countries  in a proIn contrast, the tool that was not selected for use (the CAI tool) is specifically devised to act as both a self assessment and an evaluative tool. While it is still in the early stages of development and refinement, there are a number of important issues to be discussed around how such a tool can be used as a reliable repeat measure, and whether it can complement the ACT approach. Indeed, the question would still need to be asked as to whether these two tools are measuring the same concepts at all.Despite these questions, both tools operationalise the complex concepts around context, and through further refinement and use may be able to locate key indicators or predictors of successful innovation. There is clear potential for using these tools for diagnostic purposes to identify wards/sites in which context is amenable to change. Alternatively, dimensions of context may be targeted. For example, overall in this hospital it would appear that 'feedback processes' lag behind 'leadership' and 'culture.' Knowledge translation facilitators could address this issue as the first stage of evidence implementation.This study detected significant variation between wards in many of the dimensions of context, suggesting several important issues for future work on this topic. While factors such as patient acuity and specialism, patterns of care, work method, and physical layout of the ward probably exert an influence, we feel that the role of ward leaders in developing culture, maintaining appropriate feedback mechanisms, and influencing organisational slack is more likely to be important . This suOther dimensions of context, chiefly the 'information sharing' dimensions and 'structural and electronic resources' did not vary between wards (P ≥ 0.05). While it is possible that these dimensions are inherently more variable, or the items used to measure the dimensions are less precise, it seems likely that these dimensions of context operate at the level of the hospital. Therefore, measurements across multiple wards are not required to accurately assess these dimensions of context in a hospital. Although Estabrooks' study  found noFinally, the lack of a difference between intervention and control wards is perhaps not surprising, given the exploratory nature of the study and the different approaches of the interdisciplinary teams involved . The assAggregation of data from the present study and the original study of Alberta nurses allows a simple comparison of context between Australian and Canadian hospitals Table . The rati.e., at the unit, or meso-level), whereas other dimensions were consistent across wards and therefore did not vary at the hospital, or macro-level. Our study did not indicate any readily measurable variables at the level of the individual nurse . Therefore, we propose that context be considered to be dependent on ward- and hospital-level factors, and that efforts to improve poor or weak context need to address both meso- and macro-levels.This study raises a series of questions around what is the appropriate unit of measurement for context and how context may be potentially altered. The ACT demonstrated significant variation of key dimensions between wards  should have been undertaken by clinicians rather than researchers with a specialist knowledge of evidence-based practice and knowledge translation. Their assessment of the useability of either tool may not have been the same as cliniciansAdditionally, as previously mentioned, it would be imprudent to ascribe any cause and effect between the intervention and outcome measurements because no baseline measurements were made, and the study was only conducted at a single point in time. Other limitations include the unexplained loss of completed questionnaires from a control site, the very low response rate from one ward and the greater response rate at intervention wards compared to control wards. All of the above limitations can be addressed in subsequent applications of the tool.The study provoked as many questions as it answered, both from a conceptual design perspective and from a methodological perspective. Acknowledging the limitations of the study we conclude with the following recommendations from the study:1. The ACT is acceptable for use in Australian hospitals for nurses with only minor modifications.i.e., the hospital).2. We need a better understanding of dimensions of context that do not apparently differ between wards and that may be more variable at a higher level  rather than continuing to explore individual nurse characteristics in isolation (for example level of experience and training).4. The factors that shape context at the ward level are presumably related to interdependence between context dimensions such as leadership, culture, feedback processes and organisational slack. Interventions seeking to strengthen context in hospitals should consider the benefits of focussing at this level (The authors declare that they have no competing interests.TS conducted the evaluation, its statistics, and drafted the first version of the manuscript. AK designed and oversaw the implementation project, led the comparison of the CAI and ACT tools and analysed the open-ended question. Both authors designed the evaluation, and the study results and key findings were jointly interpreted by both authors. Both authors contributed to subsequent and final drafts of the manuscript, and take responsibility for the study findings.


Concern has been raised about the potential delay in breast cancer diagnosis in the augmented breast. We linked a cohort of 2955 women, who received cosmetic breast implants in Denmark during the period 1973–1997 with the Danish Cancer Registry and the Danish Breast Cancer Cooperative Group register. We identified 23 incident cases of invasive breast cancer diagnosed subsequent to breast implantation. We randomly selected 11 controls for each case from the Danish Breast Cancer Cooperative Group's register, and obtained detailed information on all study subjects about surgery, histopathology and stage of breast cancer at diagnosis, intended adjuvant treatment according to trial protocols and overall survival. We found that women with breast implants on average were diagnosed with breast cancer at the same stage as controls. Significantly more women with breast implants had tumour cells in the surgical margins according to the Danish Breast Cancer Cooperative Group's data. There was no significant difference in overall survival between the two groups after an average of 6.4 years of follow-up. Based on this limited number of women with breast cancer subsequent to breast augmentation, breast implants do not appear to delay the diagnosis of breast cancer, and no evidence of impaired survival after breast cancer diagnosis in augmented women was found. Breast implants are widely used for both reconstructive and cosmetic purposes. There is no evidence that breast implants increase the risk of breast cancer  register using the Personal Identification number to identify women with invasive breast cancer subsequent to breast implantation. The DBCG register is a clinical database, established in 1977 and designed primarily to evaluate the programmes for adjuvant trials among women with primary breast cancer. The register receives detailed information on primary surgical procedure, histopathological examination, adjuvant treatment and clinical follow-up. Based on tumour stage and menopause status, the patients are allocated to groups with high or low risk of recurrence, and are treated in protocols accordingly. Furthermore, the information on patients treated outside protocol programmes is recorded . A compaWomen with breast implants were followed for invasive breast cancer from date of implantation or 1 January 1977, whichever occurred last, until the age of 76 years, date of breast cancer diagnosis, date of death, emigration, or 1 October 2001, whichever occurred first. Computer linkage of the study cohort to the DBCG register identified 21 women with cosmetic breast implants, who subsequently developed breast cancer.We also linked the implant cohort with the Danish Cancer Registry using data available until the end of 1998. We confirmed the 21 cases found in the DBCG and identified additionally two women with cosmetic breast implants who were registered with subsequent breast cancer, but who had not been reported to the DBCG. Their medical files were obtained, and the relevant information for this study was abstracted. Both cases were subsequently reported to the DBCG register.For each of the 23 breast cancer cases with cosmetic breast implants (cases), we randomly selected 11 controls with invasive breast cancer from the DBCG register, matched on age and calendar year of breast cancer diagnosis 11 was the minimal number of available individually matched controls, and consequently this number of controls was chosen for each case, resulting in a total of 253 control subjects from the background population (controls).Information on the following variables was obtained from the DBCG register: date of cancer diagnosis, place of operation, menopausal status, type of surgery and assessment of whether the surgical margins were tumour free (side and deep margins). The histopathological and staging variables were number of lymph nodes removed, number of involved lymph nodes, size of tumour , oestrogen- and/or progesterone-receptor status of tumour, histological diagnosis , malignancy grading of ductal carcinomas  and distant metastases at the time of surgery . The treatment-related variables were the intended adjuvant treatment according to trial protocols .tumour cells in the surgical margins’ four augmented breast cancer women were recategorised based on the medical record information; in two cases, the biopsy specimen had been reported instead of the final specimen, in one case, the parameter was missing in the DBCG, but was found in the medical record, and in the last case, there were free margins, although narrow, and the patient was recategorised as having free margins. None of the 23 control subjects was recategorised regarding this variable, since there was complete agreement between the medical records and the DBCG-data.The medical records for all the augmented breast cancer cases, with the exception of one, which could not be found, and one randomly selected control per case were retrieved to obtain information on how the cancer was diagnosed, and details on the surgical procedure including implant status. We also compared the data reported to the DBCG register with the medical records. Generally, there was a high level of concordance in the reported data, but with regard to the variable ‘χ2 tests, and crude odds ratios (OR) and corresponding 95% confidence intervals (CI) were calculated. The difference in tumour size between the two groups was evaluated by analysis of variance. In order to preserve power in the tests, the matching variables were not included as covariates, because of the small number of breast cancer cases with cosmetic breast implants and the large range of values of these matching variables. All tests were performed with a 5% level of significance. Overall survival rates, including death from all causes, were estimated by the Kaplan–Meier method and a log-rank test was used for comparisons between the groups. Disease-free survival was not evaluated, as information on first recurrence was unavailable for the seven cases and 52 controls who did not participate in a postoperative treatment protocol.Frequencies were calculated for all variables. The differences between the women with breast implants (cases) and women from the background population (controls) in binary variables were evaluated with In total, 23 of 2955 women (0.8%) with cosmetic breast implants developed breast cancer after implantation. The mean age at the time of breast cancer diagnosis among these women as well as controls was 47.2 years, range 35–75. The mean year of cancer diagnosis was 1993, range 1986–2000. The women had undergone breast implantation at an average age of 38 years (range 22–61 years), yielding an average interval from implantation to breast cancer diagnosis of 9.3 years (range 0.3–17.9 years). A total of 21 women had silicone breast implants, while implant type was unknown for the remaining two, but they most likely also had silicone implants, since this was the preferred implant in Denmark during the relevant period. The majority of women in the study were premenopausal at the time of breast cancer diagnosis, which was to be expected in this relatively young study population. Fewer of the cases were premenopausal compared to the controls, although the difference was not significant .P=0.36).As presented in Table 1As shown in Table 2P=0.36). The medical records stated that in 13 (57%) of the 23 breast cancer cases with implants, the implant was removed during the cancer surgery and in eight women (35%) it was left in situ. In one case, the implant had been removed prior to the cancer diagnosis, and in another case the medical records could not be traced. All five of the implant women who, according to the medical records, had tumour cells in the surgical margins were treated with mastectomy, and four of them also had explantation; for the last case this information was not available. The nonradical margins were found in the final mastectomy-specimen, and the women accordingly received postoperative adjuvant radiotherapy. Two of the implant women were treated with skin-sparing mastectomy, one kept her implant and the other was reconstructed with an immediate TRAM flap, but neither of these patients was among those with nonradical margins.In the survival analyses, the follow-up time was on average 6.4 years (range 0.3–15.7 years). Four women with breast implants died (17%), while 66 (26%) of the control subjects died. As illustrated in a Kaplan–Meier plot  of the implant women discovered the tumour themselves. The remaining were diagnosed as follows: two were diagnosed clinically by physicians during diagnostic work-up because of other diseases, one was found by a plastic surgeon in a consultation related to capsular contracture, two were diagnosed after a biopsy performed during an operation for a presumed breast infection, and two were unknown. An equal proportion of the control subjects whose medical records were retrieved had found the tumour themselves. None of the augmented women with breast cancer and a potential maximum of five controls participated in mammography screening for breast cancer, evaluated by knowledge of the mammography screening centres active in the relevant areas and calendar period.The results of our study of breast cancer among women with cosmetic breast implants indicate that the cancer was not diagnosed later or at a more advanced stage than in the normal population. The women with augmented breasts in our study did not differ from controls with regard to relevant tumour characteristics at diagnosis. More of the women with implants had tumour cells in the surgical margins, but we observed no evidence of an unfavourable survival within our rather limited follow-up time.vs 41% in the comparison group). However, in both the above studies, it was not stated how the patients were referred to the clinic, and selection bias may have influenced the results. In another cohort study (Clinical case series have reported a tendency towards a delayed breast cancer diagnosis among women with breast implants (The presence of breast implants, silicone or saline, makes mammography more difficult (Overall, the results of the above mammographic and epidemiological studies point in different directions regarding delayed breast cancer diagnosis among implanted women. Since most of the women in our study found the tumour themselves, a potential impairment of mammography could not be evaluated. It is possible that in a population of women undergoing regular breast cancer screening with mammography, women with breast implants could be diagnosed at a later state than women without implants. None of the studies to date has sufficient data to answer this question. However, the presence of breast implants, especially submuscularly positioned implants, often makes both clinical examination and self-examination of the breast tissue easier, since the glandular tissue can be palpated against a firm background, and this may account for the lack of delay in diagnosis , and to Both cases and controls in our study received on average the same surgical and adjuvant treatment. However, more implant women had residual tumour cells in the surgical margins, even though this excess was not statistically significant when based on information from the medical records. Medical record information is likely to be more complete than the DBCG register data, but was only obtained for a small subset of the controls, and this could introduce selection bias. If we had reviewed the medical records from all the background controls, which was not feasible because of problems with the availability of the records, we may have encountered controls who would qualify for reclassification, and this could have affected our calculations in an unknown direction.a priori expectation that women with implants would be more likely to request breast preservation than other women and speculated that this could account for the excess of women with nonradical margins. However, similar proportions of women in the two groups were treated with mastectomy, including all the women with nonradical margins. Free surgical margins are a strong predictor of both local control of the disease and survival (We had an We found few cases of breast cancer in the cohort of women with cosmetic breast implants. Previous findings based on the same cohort . In a reThe primary limitations of our study are the small number of breast cancer cases among augmented women and the relatively short follow-up time, which suggest that survival estimates be interpreted with caution. Potential bias exists, since more augmented breast cancer cases were treated outside adjuvant protocols, and there may be differences in the quality of information between the two groups, which thus may not be as comparable as intended. However, since information was sampled from the same registries, this potential bias is less of a concern than in other studies in which different data sources were used. The strengths of this study include the ability to have virtually complete follow-up of a well-defined cohort of women with cosmetic breast implants and to obtain highly detailed clinical and staging information for both cases and controls from the DBCG-register, which permitted evaluation of numerous important tumour- and treatment-related parameters. In addition, linkage with the Danish Cancer Register allowed complete ascertainment of all breast cancer cases.In conclusion, the present study suggests, consistent with several other epidemiological studies, that the stage of breast cancer at diagnosis in breast-implanted woman does not appear to be more advanced compared with age- and calendar-matched controls, indicating that the diagnosis is not meaningfully delayed because of the implants, and that overall survival appears not to be influenced by the presence of implants. We suggest that the issue of nonradical surgical margins be investigated in future studies.


With the demise of TKS, I lost a personal friend. In our fruitful association of more than 45 years (1960–2008), we spent many hours together in educational programs, research meetings, selection committees, and professional conferences. We agreed to disagree in many aspects; however, we were in consonance in many more aspects of health care delivery for common orthopedic patients and orthopedic education. To this generation of orthopedic specialists, he frequently reminded that the most important first aid for a spinal cord injured patient is transportation from the site of accident on a simple padded board 6 feet × 2 ½ feet. He would lament loudly that less than 5% of such patients reach a hospital in less than 8 h of the trauma, and that 50% of cervical cord injured patients die within a few weeks because of quadriplegia. He developed, improvised, propagated, and achieved excellent results in the rehabilitation of spinal cord damaged patient with the use of three-pillow technique of nursing of patients. The upper and lower pillows to help log-rolling turning of the paralyzed patient with minimal help and the middle pillow placed at the site of vertebral column fracture as gentle molder while biological process of healing was in progress. He rightly questioned: do all patients benefit by aggressive and expensive surgeries in spinal cord injured patient? He often pleaded: do not increase the anguish of the family by depleting the scant resources of a common spinal cord injured patient. Offering operative treatment for selected patients who have some likelihood of neural recovery, which he rightly insisted, can be judged by repeated careful clinical examination. In nonoperative treatment, the family can share the burden of nursing. The best of medical graduates were attracted to pursue postgraduate courses in orthopedics under him. This gentle molder nurtured a breed of orthopedic surgeons who proved to be enquiring, empathetic, ethical, skillful, and humane doctors for the society. Any person who was trained under him or was associated with him had an experience that influenced their whole career. Throughout his professional and academic career, he had the rare talent of recognizing a good idea or subject for further workup. This resulted in a number of significant publications in the management of spinal cord injuries, tuberculosis of bones, joints and spine, medical education, and health care delivery system. According to the dictates of his conscience, he improvised many endeavors for doing good to the largest number.He was a voracious reader to mold himself, a frequent lecturer to mold the opinion of the audience, and a prolific writer with a hope to sustain the molding of the thought of the next generations.


Daily smokers and hazardous drinkers are high-risk patients, developing 2-4 times more complications after surgery. Preoperative smoking and alcohol cessation for four to eight weeks prior to surgery halves this complication rate. The patients' preoperative contact with the surgical departments might be too brief for the hospital to initiate these programmes. Therefore, it was relevant to evaluate a new clinical practice which combined the general practitioner's (GP) referral to surgery with a referral to a smoking and alcohol intervention in the surgical pathway.The design was an exploratory prospective trial. The outcome measured was the number of patients referred to a preoperative smoking and alcohol cessation programme at the same time as being referred for elective surgery by their GP. The participants consisted of 72 high-risk patients who were referred for elective surgery by 47 local participating GPs.The GPs, nurses, and specialists in internal medicine, prehabilitation and surgery developed new clinical practice guidelines based on the literature and interviews with 11 local GPs about the specific barriers for implementing a smoking and alcohol cessation programme. The role of the GP was to be the gatekeeper: identifying daily smokers and hazardous drinkers when referring them to surgery; handing out information on risk reduction; and referring those patients identified to a preoperative smoking and alcohol cessation programme. The role of the hospital was to contact these patients to initiate smoking and alcohol cessation at the hospital out-patient clinic for life-style intervention.The GPs increased their referral to the smoking and alcohol cessation programme from 0% to 10% (7/72 patients) in the study period.The effect of the study was limited in integrating the efforts of primary care providers and hospital surgical departments in increasing the up-take of preoperative smoking and alcohol cessation programmes aimed at smokers and harmful drinkers referred for surgery. New strategies for cooperation between GPs and surgical departments are urgently needed.J.nr. 2005-54-1781 in Danish Data Protection Agency.J.nr. 07 268136 in Scientific Ethical Committee for Copenhagen and Frederiksberg Municipalities. Daily smoking and harmful alcohol intake increases the development of postoperative complications by two to four times -4. The mIt is well documented that preoperative smoking and drinking cessation programmes of 4-8 weeks duration, significantly reduce the increased risk of complications after surgery -7. Yet, Currently, preoperative smoking and alcohol cessation are recommended as standard operating procedures for both smokers and hazardous drinkers scheduled for elective surgery ,2,14-17.It is well-known that the GP plays an important role in smoking and alcohol intervention programmes. However, several barriers have been identified which prevent GPs' engaging in lifestyle interventions, especially smoking cessation intervention -22 Tabl; furtherOur hypothesis was that GPs engaged under attractive conditions would refer more high-risk patients to lifestyle intervention programmes prior to surgery. Our aim was to evaluate a new integrated clinical practice for daily smokers and hazardous drinkers admitted for elective surgery.The study was an exploratory prospective trial, evaluating "before and after" outcomes in a clinical setting.We defined a high-risk patient as a daily smoker or a hazardous drinker consuming more than 14 drinks per week for women and 21 drinks per week for men; one drink containing 12 g. of ethanol ,13.This study was approved by the Quality Committee of GPs in Copenhagen and the quality management at our hospital. The study was also approved by the Danish Data Protection Agency and reported to the Scientific Ethical Committee System. It was not necessary to seek patient consent, since according to Danish Policy the intervention was aimed at the implementation of guidelines, involving only doctors, nurses, and the organisation.A working group with key representatives from the local GPs, surgeons and nurses; Tobacco Cessation Clinic; Alcohol Unit; and Clinical Unit of Health Promotion was formed to develop the new integrated guideline for lifestyle intervention prior to surgery Figure . This inThe working group decided how they would monitor the high-risk patient's preoperative route to surgery and give feedback  and 27 (9%) drank hazardously, including 12 patients who did both. The history of alcohol intake was unknown in 73 (=24%) patients, and the history of smoking was unknown in 68 (23%), (Figure In this study, we were only able to show a small increase, from zero to ten percent, in the frequency of patients directly referred by GPs to the surgical departments and the hospital's preoperative smoking and alcohol cessation programme. Though a ten percent increase in some situations is of importance, this low referral rate would not be acceptable in case of surgery from a patient safety view. This is because ninety percent of the high-risk patients that could benefit from a timely risk reduction are overlooked.It was surprising that overcoming the barriers known to be related to GPs' assessment and counselling for tobacco cessation -37, did We discovered that in spite of a positive attitude among the GPs, as well as approval and support from their organisation, the referral rate was very low.It might be speculated that this poor referral rate was due to patients refusing to be referred when offered this option by their GPs. However we discovered that this was not the case in the present study. We learnt in interviews with the GPs, that in daily practice, they forgot to play their role in risk reduction before surgery. In view of this the GPS asked for more information and reminders for both the patients and themselves. However, meeting these local wishes and suggestions did not result in an increased number of referred patients.Some of the elements in the integrated preoperative programme that had been identified in interviews or from previous studies as possible barriers have not yet been subjects for specific intervention research. They may therefore, theoretically, be of minor significance, which would reduce the effect of overcoming them. Another theoretical possibility could be that some of the efforts to overcome the barriers might have a negative effect and thereby neutralise a positive effect from other elements in the integrated programme. Furthermore, some barriers may be of greater importance in different countries; e.g. the simple referral model and easy access to smoking cessation experts has been shown to be effective among GPs in England , but notThe tight time schedule imposed by the requirements of the integrated preoperative programme prior to surgery, could pose a significant challenge for GP's. In other situations the "window of intervention" for smoking and hazardous drinking may either be open longer or there is an opportunity to repeat the intervention programmes, for example in patients with COPD, diabetes, liver diseases etc.Furthermore, the legal responsibility for the surgical pathway may play a role. According to the law in most countries the surgeon is the person responsible for having informed the patient sufficiently before surgery regarding the benefits and harms of that surgery. This is necessary to ensure that the patient has the correct basis for giving their informed consent to the operation.From a clinical point of view, integration of a preoperative smoking and alcohol cessation intervention in the surgical pathway is highly desirable. The effective preoperative lifestyle intervention programmes published hitherto either took place in the hospital out-patient clinics or in units in close relation to the surgical pathway and were given by experts -7.In the long-term it would be relevant to establish a better tradition for collaboration between the primary care providers and the surgical departments. In the short-term it is, however, important to evaluate other strategies for risk reduction to offer the programmes in due time before surgery. Otherwise the consequences would be tremendous for the patient and for the healthcare system in general. In Denmark the annual costs related to the increased complications rate and prolonged hospital stay among harmful drinkers without preoperative lifestyle intervention programmes are approximately 30-50 Euros per capita . The corThe implementation of this programme may also arise from a political level, which may decide that all high-risk patients on waiting lists for elective operations should be offered a lifestyle intervention programme prior to surgery .From a patient perspective, patients, relatives and patient organisations need improved information regarding the high-risk of surgery and the effectiveness of risk reduction programmes prior to surgery. Though smokers and hazardous drinkers undergoing surgery may never develop into a strong and demanding patient organisation, they may complain about misinformation or lost opportunities to improve their surgical outcomes in the future.This study gives rise to a hypothesis that overcoming identified barriers table  are insuIn addition, new research could change the emphasis from projects investigating barriers to exploration of fully implemented and integrated procedures in primary and secondary care. This may help to generate new strategies for implementation among surgical drinking and smoking patients.In conclusion, we did not succeed in using a programme integrating the efforts of the primary care providers and the hospital for risk reduction in the preoperative period aimed at smokers and harmful drinkers referred for surgery. Development, and evaluation, of new strategies for cooperation between primary care providers and surgical departments are urgently required in order to offer intervention programmes in a timely fashion before elective operations and to fulfil surgical obligations and responsibilities.HT, PF and HR have received funds for the present research as mentioned below. Bispebjerg Hospital, Copenhagen Health Services, GP Board of Quality Management, and Novartis might in some way, or to some degree, gain financially from the results. None of the funders took part in the design and conduct of the study; collection, management, analysis, interpretation of the data; preparation, review, or approval of the manuscript.HT is a surgeon as well as director of the WHO Collaborating Centre for Evidence-Based Health in Hospitals; is working together with the National Board of Health and Danish Medical Association; is organising pre- and postgraduate education; and acts as peer reviewer on the subject for scientific journals.PF is organising pre- and postgraduate education.HR has no competing interest to be declared.VB is associated professor, respiratory physician and chief of the respiratory research's unit as well as chief physician at the Tobacco Cession Unit.DMN has no competing interest to be declared.HT has made substantial contributions to conception and design, acquisition of data, and analysis and interpretation of data. HT has been involved in revising the manuscript critically for important intellectual content and has given final approval of the version to be published. PF and HR have made substantial contributions to conception and design and analysis and interpretation of data. Both have been involved in revising the manuscript critically for important intellectual content and have given final approval of the version to be published. VB has made substantial contributions to conception and design. VB has been involved in revising the manuscript critically for important intellectual content and has given final approval of the version to be published. DMN and GT have made substantial contributions to acquisition of data. Both have been involved in revising the manuscript critically for important intellectual content and have given final approval of the version to be published.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6963/10/121/prepubFeedback. Example of individual feedback to a GP.Click here for file


Substance use is highly prevalent among Dutch adolescents. The Healthy School and Drugs program is a nationally implemented school-based prevention program aimed at reducing early and excessive substance use among adolescents. Although the program's effectiveness was tested in a quasi-experimental design before, many program changes were made afterwards. The present study, therefore, aims to test the effects of this widely used, renewed universal prevention program.A randomized clustered trial will be conducted among 3,784 adolescents of 23 secondary schools in The Netherlands. The trial has three conditions; two intervention conditions  and a control condition. The e-learning condition consists of three digital learning modules  that are sequentially offered over the course of three school years . The integral condition consists of parental participation in a parental meeting on substance use, regulation of substance use, and monitoring and counseling of students' substance use at school, over and above the three digital modules. The control condition is characterized as business as usual. Participating schools were randomly assigned to either an intervention or control condition.Participants filled out a digital questionnaire at baseline and will fill out the same questionnaire three more times at follow-up measurements . Outcome variables included in the questionnaire are the percentage of binge drinking (more than five drinks per occasion), the average weekly number of drinks, and the percentage of adolescents who ever drunk a glass of alcohol and the percentage of adolescents who ever smoked a cigarette or a joint respectively for tobacco and marijuana.This study protocol describes the design of a randomized clustered trial that evaluates the effectiveness of a school-based prevention program. We expect that significantly fewer adolescents will engage in early or excessive substance use behaviors in the intervention conditions compared to the control condition as a direct result of the intervention. We expect that the integral condition will yield most positive results, compared with the e-learning condition and control condition.The protocol for this study is registered with the Nederlands Trial Register NTR1516 Dutch adolescents are one of the leaders in terms of drinking frequency and binge drinking in Europe and they usually start drinking in early adolescence . Also, tThe implementation of effective prevention programs is a potential powerful tool to lower the prevalence of substance use in early adolescents and to delay the age of onset of substance use. In the past, many school-based prevention programs have been developed and implemented -12. In gOne of the most well-known and widely used universal prevention programs for Dutch early adolescents is 'The Healthy School and Drugs (HSD)' program. The HSD program combines elements of all three types of school-based prevention and is based on the ASE model -18, whicThe HSD program is a multi-component prevention program aimed at reducing early and/or excessive substance use among adolescents. The program consists of four pillars, which are: information lessons , parental participation, regulation of substance use, and monitoring and counseling of students' substance use. Although scholars argue that multi-component approaches, like the HSD program, are more effective than single component approaches  many DuThe primary aim of the 'Healthy School and Drugs' study is to assess the effectiveness of this multi-component universal prevention program by conducting a randomized clustered trial including 23 Dutch secondary schools. Three follow-up assessments  will be carried out to examine the effects of the intervention conditions. Two hypotheses will be tested. First, in line with prior findings, we expect that the program will lead to a lower likelihood of unhealthy substance use behaviors. We expect that adolescents in the intervention conditions, relative to controls, will be less likely to engage in early or excessive substance use behaviors at follow-up. More specifically, we expect that this effect will be more pronounced in the integral condition compared to the control condition than in the e-learning condition compared to the control condition.Second, following the ASE model, we expect that cognitive aspects of behavior will mediate the effects of the program. Specifically, we expect that adolescents included in the intervention conditions (as compared to controls) will (a) have more knowledge about the -harmful aspects of- specific substances, (b) have more negative and less positive attitudes towards substance use, (c) perceive to have less approval for using substances from their social environment, (d) have more confidence in refraining from use when confronted with tempting substance use offers, and (e) have more adequate risk perceptions concerning the consequences of substance use.The HSD effectiveness study is a 3-year randomized clustered trial (RCT) with three arms - two interventions  and a control condition - testing the prevention program effects. Participants are 3,784 early adolescents of 23 secondary schools from seven different regions in The Netherlands: 1,330 are involved in the e-learning condition, 1,195 in the integral condition, and 1,259 in the control condition. After initial recruitment and enrollment in the trial, randomization took place at the school level, to avoid contamination between conditions . DirectThe HSD program will be implemented after the baseline assessment in different phases to prevent overburdening of schools. In the first year - when adolescents are around 12 years old - the focus in the integral condition will be on starting with the information lessons on alcohol and to get parents involved in the program. In the second year, the schools in the integral condition will implement the two remaining pillars besides the information lessons on tobacco. Finally, in the third year the information lessons on marijuana will be implemented  and Municipal Health Services (MHS). Therefore, we contacted all these institutions to ask for corporation in the effectiveness trial. Seven institutions  agreed to take part in the study and secondary schools were recruited from these regions. All secondary schools in these regions were screened for eligibility. Exclusion criteria were recent involvement  in the HSD program and not offering a four-year education program. All eligible schools received an invitation letter and an information brochure and were contacted after two weeks to discuss participation in the study. Participants were thus recruited by school participation and all first grade students of participating secondary schools were included in the study. We visited the participating schools and during these visits further information was provided about the research project. In collaboration with the schools' headmasters, we informed the students' parents annually about the goals of the study by a letter in which parents were also notified that they could refuse participation of their child in the study. Thus, a passive informed consent procedure is followed in which parents (and their children) can refuse study participation by email, telephone or in person during the entire study period. Approval for the design and data collection procedures was obtained beforehand from the ethic committee of the Radboud University Nijmegen.Randomization occurred at the school level to avoid contamination between conditions. Thus, all first grade students from one school were allocated to the same condition . An independent statistician performed the allocation before baseline assessment. Randomization was carried out centrally, using a blocked randomization scheme (block size 6) and stratified by level of education the schools offered.d) of. 15 [We estimated our targeted sample size based on a small effect size  of. 15 . As the ) of. 15 . We usedThe HSD program is a multi-component, school-based prevention program aimed at reducing excessive and early substance use among adolescents. The program for secondary schools consists of four pillars, which are:1) Information lessons (e-learning modules): e-learning modules were developed for the information part of the program. These digital modules connect well to the experience of adolescents. Students work through the modules in their own pace during biology or counselor lessons, or in a special project week. The lessons pay attention to knowledge, attitude, and behavior with regard to substance use. Besides tutoring the students about the risks concerning substance use, students are also prepared for coping with group pressure by training their refusal skills. The modules consist of small films, animations, and several types of interactive tasks and identification is a central part of the modules. Also, adolescents are able to discuss relevant topics or to exchange their opinions through chat rooms and forums. Students receive three modules: alcohol (4 lessons), tobacco (3 lessons), and marijuana (3 lessons) in the first, second, and third grade, respectively. The lessons and modules are designed to gradually increase adolescent's skills in responsibly dealing with substances. Teachers are trained in the content and operation of the digital modules before the lessons are offered to the students.2) Parental participation: Parents of first grade students are invited to attend a parental meeting in which information will be provided about the HSD prevention program and the relevant substances. Also, parents will be informed throughout a parental brochure and the school newsletter. The parental meeting will be held at school in collaboration with the ITCD or MHS. The duration of the parental meeting will be approximately 90 minutes. First, in a brief opening the attention of parents is captured by facts on substance use in adolescence. Then, brief information on the school regulation on substance use is provided. Characteristics and risks of substance use, opinions on substance use, and education in the home setting with respect to substance use will be discussed in the remainder of the meeting.3) Regulation: the idea behind this pillar of the program is that rules set boundaries and create clarity. Therefore, the school needs to set an adequate regulation standard and rules concerning substance use behaviors of students and personnel. If the school lacks such regulation a special team will be instigated, including all relevant parties . This team will create or revise the rules and will plan how to communicate and maintain the rules in and around school. The school team will be assisted by the ITCD or MHS during this process.4) Monitoring and counseling: An operation protocol (if absent) is to be formulated on how to deal with problematic substance use behaviors among students. Also, the ITCD or MHS will provide a training session on signaling and guiding problematic substance use among individual students. This training is meant for teachers, mentors, student speculators, and the care coordinator(s) of the school. During this training session practical information will be provided on how to recognize problematic use in students and on how to efficiently support these students. Further, advice will be given on how to use the operation protocol in daily practice.The information lessons of the HSD program are based on the ASE model -18, whicThe ASE components are imbedded in the e-learning modules and students work through these ASE components via the principles of information theory. First, effects of information lessons are only expected if students are tuned to the message, so the information should capture the attention of the students and should match the information needs of the students. Special triggers to capture students' attention (stories that students can identify with) are incorporated in the materials. Second, a message can only be effectively communicated if students understand the message. Information is therefore provided in a way that corresponds with the realm of adolescent thought by using age appropriate language and tasks. Third, becoming aware of attitudes and to influence these attitudes in the direction of the desired behavior, information is conceptualized as trustworthy and attuned to the student's opinions. Students are asked to think about pros and cons of substance use and are encouraged to make judgements themselves. Fourth, to account for the influence of the social environment, students are trained to resist social pressure. With the help of specific tasks on social norms, students are invited to think about social norms on substance use. Also, example videos are used to display how adolescents are influenced by others. Fifth, self-efficacy will influence actual behavior of students, thus students should be confident in their refusal skills. Students therefore learn how to carry out the desired behavior, and how to maintain and incorporate these behaviors into their daily living environment with the help of special processing tasks. Finally, students should persist in the desired behavior. Feedback on own behavior is important to achieve this goal, because it makes students aware of positive effects of their (changed) behavior. Students are challenged to think about what they will gain if they do not use a specific substance (just yet). All these information principles are processed in the design of the e-learning intervention by the following route: what happened (1), what do you know (2), what would you do (3 to 6). In total, adolescents work through this process three times; first for alcohol, then for tobacco, and finally for marijuana. Although the focus of the substance changes over the years, booster effects for the e-learning modules are expected because the training process is repeated.The HSD prevention program is based on the assumption that more than information lessons are necessary to prevent adolescents from unhealthy substance use behaviors. Adolescents need rules and tutoring, a task for parents, school boards, teachers, and student counselors ,14. The The participating secondary schools were randomly assigned to one of the three following study conditions:1) E-learning: Secondary schools that only carry out the e-learning modules. These schools will provide the information lessons in our target group.2) Integral: Secondary schools that carry out the entire HSD program. These schools will also provide the information lessons in our target group, but also carry out the other three pillars of the HSD program.3) Control: Secondary schools that do not carry out prevention activities. These schools are characterized by 'business as usual'. Many schools in The Netherlands have employed initiatives concerning substance use. The schools can carry on with these initiatives, as long as no HSD activities are carried out in our target group (both students and school personnel).For the duration of our study, all participating schools, including those in the control condition, agreed not to implement or carry out other substance use prevention programs in the target group.An overview of all measurements is given in Table The HSD prevention program targets reduction of substance use among adolescents. Since the program focuses on alcohol, tobacco, and marijuana use, we operationalized attainment targets for all three substances. The primary outcomes for alcohol are defined as the percentage of binge drinking , the avDescriptive analyses will be conducted to check whether randomization has resulted in a balanced distribution of important student characteristics in all three conditions. Possible confounders will then be included in subsequent analyses to control for potential bias. Because the data have a multilevel structure , the possibility exists that the individual respondents are not independent within schools. To correct for the potential non-independence (complexity) of the data, the TYPE = COMPLEX procedure in Mplus will be used. This procedure corrects the standard errors of the parameter estimates for dependency leading to unbiased estimates.For the main analyses, data will be analyzed in accordance with the intention-to-treat principle and in a completers-only framework by using Mplus , while cThe recruitment, inclusion, and randomization of participants  started in the fall of 2008. The final follow-up measurement is planned for the fall of 2011. The baseline data is collected between January and March 2009. The data of the follow-up measurements will be collected at three fixed time points. These assessments will take place between September and November 2009, September and November 2010, September and November 2011 respectively. Short-term results will be reported before the completion of the 32 months follow-up.The present study protocol presents the design of a randomized clustered trial evaluating the effectiveness of the 'Healthy School and Drugs' prevention program. This universal prevention program aims at reducing excessive and early substance use in adolescence. It is hypothesized that adolescents in the intervention conditions will be less likely to engage in early or excessive substance use behaviors at follow-up compared to the control condition.An important first strength of the Healthy School and Drugs program itself is that it is previously suggested that the program is partly effective in The Netherlands . AnotherA strength of the study design is that it does not only assess immediate effects, but also includes follow-up measurements at 8, 20, and 32 months. This allows us to test both the short and mid-term effects of the HSD program. Second, the extra study condition  will give the opportunity to optimally inform regional ITDC, MHS, and schools about the cost and benefits on their current prevention activities. Also, if the HSD program is found to be effective, the program might be (compulsory) implemented in more schools across The Netherlands, since present govern policy strongly encourages the implementation of effective intervention programs.A limitation of the study is that information on the behavior of adolescents and their environment is entirely based on self-reports of the adolescents, which might lead to measurement errors. Two perspectives can explain possible measurement errors in self-reports on substance use, namely a situational and a cognitive perspective . The sitBased on the results of the HSD effectiveness study, the prevention program will be adjusted accordingly. If necessary the content of the program will be renewed, as will the theoretical concepts and the different parts  of the prevention program. In short, the results will drive the (re)development of the HSD program in the next couple of years.This study will evaluate a multi-component school-based prevention program on substance use in adolescence. The results of this study will provide insights into the effectiveness of the Healthy School and Drugs prevention program and the precursors of substance use among Dutch early adolescents.Karin Monshouwer and Jeroen Lammers work for the Trimbos-institute, which is the institution that developed the 'Healthy School and Drugs' project. Also, this institution is principal for the effectiveness study. The other author(s) declare that they have no competing interests.MM is responsible for the data collection, data analysis and for reporting the study results. All others authors are supervisors and grant applicators. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/10/541/prepub


BMC Medicine.Over recent years there has been a substantial body of evidence demonstrating strong associations between transfusion and adverse outcomes, including myocardial, neurological and renal injury, in a range of clinical settings where transfusion is administered for reasons other than life-threatening bleeding. The strength of these associations across a range of clinical settings suggests that confounding and bias, the chief limitations of all observational studies, are unlikely to account for all of these observations. Given the wide range in transfusion rates in cardiac centres, with up to 100% of patients in some centres exposed to allogenic blood components, this evidence, albeit circumstantial, presents a strong argument for prospective randomised trials to attempt to determine, firstly, if transfusion causes adverse outcomes, and secondly, in which patient groups does the benefit of transfusion outweigh these risks? These issues are discussed in the context of an article published this month in  BMC Medicine, is a useful addition to the literature, and is strengthened by the large numbers of patients considered and the quality of the analysis performed [The development of modern blood services that enable large-scale allogenic red cell donation, storage and transfusion represents one of the greatest achievements of modern medicine. It has saved countless lives and is indispensable for the treatment of trauma patients and those with life-threatening haemorrhage. The early success of blood transfusion, occurring as it did during wartime, coupled with advances in storage techniques led to the widespread use of transfusion for indications where there is little, if any, evidence of efficacy. With the advent of evidence-based medicine over recent decades, coupled with the increasing prevalence of electronic prospective clinical databases, we have seen a large number of retrospective observational studies that appear to show an association between transfusion and adverse outcome in a range of clinical scenarios including cardiac surgery , generalerformed . In thiserformed ,7.The question as to whether transfusion causes adverse outcome in cardiac surgery remains unanswered, however. The Rogers study suffers from the limitations of all retrospective studies in that it cannot adjust for unmeasured confounders, in this case the use of aprotinin, or a measure of left ventricular function, or for the likelihood that there will have been bias in the prescribing of allogenic blood, with patients who are more ill being more likely to receive transfusions than those that are less ill. If we look for clinical evidence that transfusion causes adverse outcome, we can refer only to one study in adults; the Transfusion Requirements in Critical Care (TRICC) study . This stThis brings us to the major question raised by the current study by Rogers and colleagues : when isThe strong associations between transfusion and adverse outcome and the variability in transfusion practice are strong arguments for a randomised trail in cardiac surgery. This should attempt to determine whether more transfusion is harmful than less transfusion. The TITRe2 (for 'Transfusion Indication Threshold Reduction on transfusion rates') trial, a multicentre randomised controlled trial of transfusion indication threshold reduction on transfusion rates, morbidity and healthcare resource use following cardiac surgery, is a UK National Institute for Health Research-funded study that will attempt to address this issue. A total of 2,000 patients in 10 UK cardiac centres will be randomised to either a restrictive transfusion threshold of 7.5 g/dL or a liberal threshold of 9 g/dL, with ischaemic and septic complications as a co-primary endpoint. The choice of thresholds is pragmatic, and reflects the range of haemoglobin over which the vast majority of transfusions are administered in clinical practice [GJM receives funding from the British Heart Foundation and the National Institute for Health Research to undertake research into blood conservation and safer blood transfusion practice.The pre-publication history for this paper can be accessed here: