Determining the effectiveness of social and psychological interventions is important for improving individual and population health. Such interventions are complex and, where possible, are best evaluated by randomised controlled trials (RCTs). The use of research findings in policy and practice decision making is hindered by poor reporting of RCTs. Poor reporting limits the ability to replicate interventions, synthesise evidence in systematic reviews, and utilise findings for evidence-based policy and practice. The lack of guidance for reporting the specific methodological features of complex intervention RCTs contributes to poor reporting. We aim to develop an extension of the Consolidated Standards of Reporting Trials Statement for Social and Psychological Interventions (CONSORT-SPI).This research project will be conducted in five phases. The first phase was the project launch, which consisted of the establishment of a Project Executive and International Advisory Group, and recruitment of journal editors and the CONSORT Group. The second phase involves a Delphi process that will generate a list of possible items to include in the CONSORT Extension. Next, there will be a formal consensus meeting to select the reporting items to add to, or modify for, the CONSORT-SPI Extension. Fourth, guideline documents will be written, including an explanation and elaboration (E&E) document that will provide detailed advice for each item and examples of good reporting. The final phase will comprise guideline dissemination, with simultaneous publication and endorsement of the guideline in multiple journals, endorsement by funding agencies, presentations at conferences and other meetings, and a dedicated website that will facilitate feedback about the guideline.http://tinyurl.com/CONSORT-study).As demonstrated by previous CONSORT guidelines, the development of an evidence-based reporting guideline for social and psychological intervention RCTs should improve the accuracy, comprehensiveness, and transparency of study reports. This, in turn, promises to improve the critical appraisal of research and its use in policy and practice decision making. We invite readers to participate in the project by visiting our website ( Social and psychological interventions that aim to improve health and related outcomes are often complex and challenging to evaluate. As outlined in the Medical Research Council  Framework for developing and evaluating complex interventions , they usReporting guidelines do not prescribe research conduct; they suggest those items of information that are necessary to understand how a study was conducted. The most widely-cited reporting guideline is the Consolidated Standards of Reporting Trials (CONSORT) Statement. Its main checklist has 25-items for reporting two-group parallel RCTs , and extDespite improvements in the reporting of RCTs in medical disciplines, several studies indicate that the reporting quality of RCTs in the social and behavioural sciences remains suboptimal -16. We cTo address these issues, many researchers and journal editors have proposed amending the CONSORT Statement to address these important complexities of social and psychological interventions and of their evaluation -23. A neThe methods will follow recommended techniques for developing and disseminating reporting guidelines ,24. AspeTo ensure project success, the following have already been secured for the launch of the project: a project executive; an International Advisory Group (IAG) of key opinion leaders across core fields; participation from high impact-factor journal editors for the consensus process; agreement from and collaboration with the CONSORT Group; and funding to support guideline development and dissemination.e.g., trialists, methodologists, practitioners, policy makers, funders, and recipients of services). The project executive will also run future phases of the project, including the Delphi process, consensus meeting, write-up of the resultant guideline documents, and the implementation strategy.The project executive  has developed the project protocol and secured funding to complete the project, and are assembling the IAG and recruiting various stakeholders . They will help recruit stakeholders to participate in the project and identify topics to discuss at each stage. They will aid dissemination by endorsing and using the guideline, and by presenting it to relevant stakeholders in their respective fields.The most widely used reporting guidelines have enlisted journal editors during development and acquired official journal endorsement upon completion . To begiTo increase successful uptake, new reporting guidelines for RCTs should be officially related to the CONSORT Statement. Previous reviews have found no high impact-factor journal that explicitly recommends an RCT reporting guideline other than the CONSORT statement . MembersThe purpose of phase two is to identify those areas in the reporting of social and psychological intervention trials that are most important for inclusion in the guideline. To involve a wide range of participants at this phase, an online, modified Delphi process will be conducted. The Delphi process will consist of a series of structured questionnaires completed anonymously by expert participants. Summarised responses from each questionnaire will be returned to the participants after each round, along with a new questionnaire to answer, until consensus is reached . This prThe IAG will meet before round one of the Delphi process to nominate items for the initial questionnaire and to suggest credible participants for the process . Prior tTo enhance credibility and ensure widespread acceptance, the project will recruit informed and interested participants representing stakeholders that the guideline is intended to influence . The IAGIdentified stakeholders will be invited to participate in an online Delphi survey to nominate checklist items for the CONSORT-SPI Extension. In each round, participants will be asked to rate  the importance of including proposed checklist items, explain the reasons for their ratings, make suggestions for modifications, and indicate any missing items that should be considered. We expect the IAG to propose 25 to 70 checklist items in round one . Items iThe purpose of phase three is to select the specific reporting items to be included in the new guideline. A consensus development conference will be held to determine guideline content, rather than wording or format . This tiParticipants will be recruited by discipline from the Delphi process by the project executive and the IAG, to include a range of stakeholder perspectives . The sizThe consensus meeting will follow methods  used in The purpose of this phase is to draft the guideline documents so that their wording and content is clear, precise, and suitable for all relevant disciplines.Following the consensus meeting, the proposed checklist will be reviewed by the project executive. The first goal will be to draft a checklist using concise, unambiguous, yet comprehensive wording. Each item will be supported with empirical evidence of previous poor reporting and implications for internal and external validity. In addition to the guideline statement, an Explanation and Elaboration (E&E) Document will explain in-depth the scientific rationale for each recommendation and provide an example of clear reporting for each item. This additional document will help editors and authors understand the importance of these guidelines, students and researchers understand the relevant issues, and authors meet the guideline requirements .Drafts of the checklist will be circulated to consensus group participants to check that the documents accurately represent the decisions made during the meeting, provide examples of good reporting for specific items, and are useful for their intended purpose . FeedbacThe goal of the dissemination plan is to maximise awareness, understanding, and use of the CONSORT Extension when reporting social and psychological intervention trials.The dissemination strategy includes stakeholder involvement in the design and execution of this project, ensuring that the guideline will be acceptable and widely endorsed. Next, simultaneous publications in multiple, high impact-factor journals will begin the process of dissemination and uptake . The IAGe.g., the CONSORT Group, the EQUATOR Network for reporting guidelines). A dedicated webpage will be used to discuss new, relevant evidence related to social and psychological intervention trials, and to ask the wider scientific community to provide feedback on their experiences of using the guideline, in order to allow for the guideline’s continual development [Open-access publications are key to widespread uptake of the reporting guideline . Our intelopment . The proThese methods were chosen to develop the best reporting standards, generate consensus, and promote widespread dissemination and uptake of CONSORT-SPI. They are based on best practice and evidence-based principles. Research-informed purposive sampling by the IAG will provide a less biased selection of participants than the project executive could provide alone ; the invhttp://tinyurl.com/CONSORT-study).If executed successfully, the outputs from this project will help authors write clear reports, create a framework for reviewers to assess publications, expedite funding evaluations, provide a pedagogical tool for training students and researchers in trial methodology, and help research consumers evaluate RCT validity and applicability ,51. In thttp://www.tinyurl.com/CONSORT-study.For more on the CONSORT extension, see The conduct of this research project will conform to the appropriate ethical and legal standards regarding informed consent, confidentiality, and data storage. Ethics approval was obtained from the Department Research Ethics Committee (DREC) for the Department of Social and Intervention, University of Oxford (Ref: 2011-12_83).We commit to the long-term preservation and availability for use by other research teams of the high-quality data produced by this project. The data will be prepared to allow independent usage. The Centre for Evidence Based Intervention (CEBI) at Oxford University is well placed to host this work. It has full University support for this project and the CONSORT Group is close at hand to assist where needed. All data will be safely stored and backed-up at CEBI.The authors declare that they have no competing interest.PM, EMW, and SG conceived of the idea for the project. All authors helped to draft the manuscript, and all have read and approved the final manuscript.


The purpose of this research was to have students rank the significance of the “Evidence-Informed Practice Guidelines” generated at the 2009 NARCCIM workshop to their actual practice.This was a qualitative survey ranking the 10 evidence-informed guidelines. This study was conducted from May 2009 to May 2011 and included 118 students.Of the 10 evidence-informed guidelines list below, “Maintain ethical standards of practice” was rated the highest, with “Access relevant information to find evidence-informed answers to questions that arise in clinical practice” coming in second and “Integrate multiple forms of evidence into clinical practice” ranked third most significant.1. Define EIP and describe its role2. Describe fundamental principles of research3. Generate searchable questions4. Access relevant information to find evidence-informed answers to questions that arise in clinical practice.5. Critically appraise different forms of evidence6. Integrate multiple forms of evidence into clinical practice7. Effectively integrates evidence into professional communications8. Maintain ethical standards of practice9. Engage in reflective practice10. Participate in the culture of researchStudents preparing to graduate and start practice believe that it is most important to “Maintain ethical standards of practice”. The students frequently commented that this guideline does not fit well into what they believe is “evidence-informed practice” and it may need to be removed from the list. The need to “Access relevant information to find evidence-informed answers to questions that arise in clinical practice” was rated consistently high and should be used to inform the teaching and practice of research literacy.


Although evidence-based guidelines are important for improving the quality of patient care, implementation in practice is below expectations. With the recent focus on team care, guidelines are intended to promote the integration of care across multiple disciplines. We conducted an exploratory study to understand oncology nurses' perceptions of guideline implementation and to learn their views on how their experiences affected the implementation.A qualitative study was used with focus group interviews. We collected data from 11 nurses with more than 5 years of oncology nursing experience in Japan. The data were analyzed using grounded theory.Results of the analysis identified "preconditions for successful guideline implementation" as a core category. There were 4 categories  and 11 subcategories related to organizational, multidisciplinary, individual, and guideline levels.Although the guidelines were viewed as important, they were not fully implemented in practice. There are preconditions at the organizational, multidisciplinary, individual, and guideline levels that must be met if an organization is to successfully implement the guideline in clinical settings. Prioritizing strategies by focusing on these preconditions will help to facilitate successful guideline implementation. The search for evidence has been an integral part of nursing since Florence Nightingale . With thAnother important aspect of meeting the diverse needs of cancer patients and their families is the team approach to multidisciplinary care ,10. The Since practice guidelines promote consistency of knowledge and practice among team members  and imprAn increasing number of Japanese professional societies have developed their own practice guidelines in addition to the Japanese versions of the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) guidelines. In nursing, international guidelines such as the Best Practice Guideline of the Registered Nurses' Association of Ontario (RNAO) and Putting Evidence Into Practice: Improving Oncology Patient Outcomes (PEP) of Oncology Nursing Society (ONS) have been or being translated into Japanese. Although it is easy to access these guidelines on the Internet or in publications except the PEP which will be published soon, they are not systematically used by the health care organizations.Not only in Japan bust also globally, the utilization of such guidelines in practice is below expectations ,7. ThereTo understand the complex phenomena involved in the process of guideline implementation, we need a qualitative study. Our focus in the present study was on the perceptions of oncology nurses regarding guideline implementation, as oncology nurses are well positioned to disseminate best practice information, and thus their views are critical for successful guideline implementation ,23.We coOur focus was on oncology nurses' perceptions of guideline implementation within the realities of everyday clinical practice. Symbolic interactionism theory assumes that people create meaning through social interaction . GroundeWe conducted an open sampling in this study, and at a chemotherapy workshop we purposefully selected 30 oncology expert nurses who had basic knowledge of oncology care guidelines to participate in our study. Each nurse had more than 5 years of oncology nursing experience and had attended a training session on the use of guidelines in Japan. The nurses studied chemotherapy for 6 months and held oncology nursing certifications (certified nurse), issued by the Japanese Nursing Association, and differed from master-level clinical nurse specialists. Of the 30 selected oncology nurses, 11 agreed to participate in the study, while 19 elected not to participate, possibly because the focus group interview day was not convenient for them or they lived outside of Tokyo.The study sample included expert nurses with a mean experience of 12 years  from university-affiliated, general or cancer hospitals  and different locations in Japan .First, goal congruence is critical at the organizational level. Guideline implementation was hindered mostly by organizational factors, including resistance to change, brand-loyal organization, weak collaborative network with researchers, lack of disseminators, and cost-conscious organization. The oncology nurses perceived various challenges such as poor consensus building across multiple disciplines and the team dynamics in relation to obedience to physicians and senior staff at the multidisciplinary level, calling for equal partnership. At the individual level, professional self-development is essential. The nurses felt implementation was hampered by a lack of guideline knowledge, judgment and skills, detachment from the guidelines, and workload pressure. User-friendly guidelines are needed, because the oncology nurses expressed that the guidelines were impractical for routine use due to their overwhelming volume and the difficulties inherent in understanding the recommendations. These factors influence guideline use in the clinical setting, and they work as preconditions for successful guideline implementation.Goal congruence means that organizational goals are shared by all with support of the associated operations and activities. This category emerged as an important precondition to achieve the goal of implementing the guideline at the organizational level. The nurses perceived that the value of guideline implementation was not shared throughout the organization, although shared goals would facilitate constructive discussion.When motivated nurses tried to introduce a new procedure based on the guidelines, they faced the emotional resistance of team leader to change and the resistance of team members in daily practice.Even though I presented evidence, the physician showed his emotional resistance to the guidelines, as he has never understood them (Participant D).I presented evidence, but the physician and hospital management said there has been no problem so far (Participant C).Regarding changing of needles, a physician asked why nurses insist on changing them because it's no problem (to re-use a used one). We had such an argument (Participant G).On the other hand, the nurses anticipated constructive discussion and shared-values among multidisciplinary members when following the guidelines:The guidelines have authority; if a certain instruction is described in the guidelines, nobody will completely refuse it in front of their co-workers. Also, the guidelines give us a good opportunity for discussion (Participant I).The nurses indicated that organizations were inclined to "follow a name value rather than the guidelines". Organizational values and culture impede the utilization of guidelines.Even though something is recommended in the guidelines, somebody would say that a certain hospital is doing it like this. In such a case, "me-tooism" occurs, and it is difficult to breakaway from the consensus (Participant F).It is hard to change one's attitude  when following a brand (Participant I).The oncology nurses faced the resistance of organizations, supervisors, and other professionals, and felt that "there are limitations if we try to disseminate information or make changes by ourselves". The participants addressed the need for collaboration with researchers.It doesn't work for me, even if I work hard. I still need the help of other people and various networks (Participant G).We are not able to determine whether the guidelines constitute real evidence, so we need to work together with researchers as they are the ones who acquire the evidence, and then we want to use the guideline in practice (Participant E).We also need companions to work with. We hope that the researcher determines whether or not appropriate evidence exists. We want to present the necessary information together with the researchers (Participant F).The participants who were not comfortable using the guidelines in practice expected a leader to develop a network to disseminate information. They perceived the lack of guideline disseminators as a hindrance. The chemotherapy relevant committees were established in individual institutions, but there were no professionals who have knowledge of manual development and procedures relevant to practice. The participants demanded disseminators to promote the guidelines for appropriate use.We need to inform others of the availability of the guideline...somebody needs to promote it (Participant J).We need a person who can clearly tell why we need to have evidence (Participant I)."we need to foster professionals who disseminate new ideas in our institution" (Participant J), suggesting the development of human resources and the establishment of a worthy role model for other staff to promote the guidelines.The oncology nurses noted "costs will be a barrier when we make a change". "The organization tries to reduce costs when they are high even though evidence in the guidelines recommends otherwise" (Participant K). Relevant to this, "even though the evidence is clear, we cannot use it due to the policies of a certain physician or hospital management", suggesting "the organization lacks interest in evidence-based practices" (Participant I).The participants recognized that As for gloves (for chemotherapy), we presented the guidelines, but because additional cost would have been incurred, the administrator resisted spending by saying "Well...". On the other hand, if something can be reimbursed, the administrators change their attitudes (positively) (Participant H).I think the organization should recognize the meaning and value of the guidelines. There seems to be a fundamental consensus that evidence-based guidelines are important. Without organizational support, both physicians and nurses follow superficial procedures (Participant K).The participants also noted that financial reimbursement for work specified by the guidelines would be an important driving force for the organization.Since financial matters are important for management, administrators will implement the guidelines if costs are reimbursed (Participant I).If for example, extra chemotherapy work specified by the guidelines is reimbursed, we will get serious about the guidelines (as an organization) (Participant H).Equal partnership emerged as a precondition at the multidisciplinary level in which all professionals would have equal rights to participate in decision-making.The oncology nurses addressed the lack of communication and information sharing and the difficulty of reaching a consensus regarding the use of the guidelines across multiple disciplines. For example, extravasation care of chemotherapy drugs and changes of procedures are practiced by not only nurses but also other professionals, including physicians, oncologists, dermatologists, and pharmacists. The interviews revealed that there was no formal system for routine discussion of such matters among multidisciplinary members. Furthermore, there was no established consensus-building process among multidisciplinary members in daily practice.Since nurses are not in the position to effect change, we need physicians' involvement...but we don't know how to get physicians involved (Participant H).The oncology nurses required opportunities to share their goals and discuss decision making among multidisciplinary members. In addition, they believe that the more professionals discuss the guidelines in daily practice, the more utilization of the guidelines will be promoted.If there is a multidisciplinary committee where all the members can share problems, then, we believe we can do it (Participant B).The participants perceived that these challenges were not limited to nurses, but the knowledge, skills, and judgment of physicians and pharmacists should be improved as well.We feel that instruction on how to use the guidelines needs to be taught to not only nurses but also physicians (Participant J).strongly believe that what the physician says is absolutely right". In addition, "it is very difficult to say 'No' to conservative senior staff" (Participant A).A sense of obedience to physicians in hospitals, particularly in rural areas, is deeply rooted in clinical practice insofar that healthcare providers "In our hospital, what the physician says is absolutely right; for example, the regimen the physician orders are always right (Participant K). "First of all, nurses should be aware of evidence (guidelines). Educational programs are necessary for nurses" (Participant B).Individual nurses perceived that they needed professional self-development for knowledge and skills to implement the guideline. Professional self-development is a key precondition at the individual level.Although the oncology nurses attempted to use the guidelines in practice, they recognized their limited abilities when searching for resources and making decisions about applying the guidelines to individual patients.We can't use the guidelines unless we can access them, but we don't know how to access particular resources (Participant A).We are not able to determine whether we could apply the guidelines for individual patients (Participant E).The nurses were aware of the need to improve their skills through educational programs in oncology nursing.We definitely need to acquire the skills for accessing new information and employing it in a clinical setting (Participant E).Implementation of the guidelines was hindered by "not-my-business" attitudes and lack of interest in guidelines and passive and non-independent attitudes.We were not familiar with the guidelines. We felt it was not our business.Even though the guidelines are accessible to the unit, maybe we will not seethem (Participant F)."first of all, it is necessary to raise awareness of guidelines in daily practice". Some participants noted that their role and responsibility could lead to behavioral changes among healthcare providers.The participants addressed the need of a working group because When asked about new chemotherapy knowledge in the guidelines, it reminded me of my role as an oncology nurse (Participant D).The nurses raised concerns over workload pressures in their already over-burdened profession, as they have no time to find new information during busy working time. Furthermore, they had to overcome a complicated organizational system to change routine practices by using the guidelines; therefore, they deferred dealing with guidelines.I can't find time to consult the guidelines after hours (Participant J).Even if I want to check something, I don't have the time to look it up immediately, so I leave it on the back burner (Participant F).The nurses demanded easy access to guideline information:If something is easy to find and apparent just by looking, and can be used immediately (Participant I).I want to access the guideline via the Internet...but I don't know where and what kinds of guidelines are available. If I did know, I would use it, but such information does not seem to be at my fingertips (Participant A).User-friendliness is important for both guideline developers and users. It is a precondition at the guideline level.The guidelines themselves were viewed as a barrier because they were not presented in an accessible and user-friendly format. The nurses perceived that the guidelines were impractical for routine use because of lack of access and the difficulty in understanding recommendations in the guidelines.The guidelines often say that something is very difficult (Participant A).It is not easy to find the information we want (Participant B).I am too busy to read "all the recommendations" (Participant A).It is impractical unless it is handy (Participant H).The nurses addressed the difficulty and complexity of using the guidelines in a clinical setting and stated that they should be modified for clinical practice.I believe it is necessary to modify the guidelines to ensure feasibility in a clinical setting and that even a novice nurse can use them (Participant G).The interviews revealed that the implementation of the guidelines was affected by factors at the organizational, multidisciplinary, individual, and guideline levels. The development of the guidelines was not directly linked to their immediate use in practice due to various factors that were interlinked in complex ways.This study highlights preconditions for successful guideline implementation based on oncology nurses' perceptions. Many factors influence the implementation of the guidelines at multiple levels. Therefore, future implementation strategies will be focused on a specific precondition at each level: goal congruence at the organizational level, equal partnership at the multidisciplinary level, professional self-development at the individual level, and user-friendliness at the guideline level.There were some differences between the results of our studies and the literature. While Gurses et al. reported physician's disbelief of guidelines as a barrier to guideline implementation in their review, lack of agreement with a guideline or skepticism was not found in nurse participants in our study . Also, aIn this study, goal congruence at the organizational level was revealed as an important precondition to implement guidelines. Priorities are often different between the organization and front line staff. Goal congruence is the first vital step to implementing the guidelines. The guidelines were supposed to represent a strategic change towards best practice ; howeverWith ambiguous rationale, health care providers resist changes or easily become captivated by brand names. Funk et al. addressed the responsibility of researchers for scientific aspects, administrators for the institutional environment for research use, and practitioners for guideline implementation . In addiSince organizations are cost-conscious, costs create obstacles for adopting the guidelines. In reality, organizations need financial incentives to change established routines. As the interviewed oncology nurses argued, reimbursement could be a strong incentive for successful guideline implementation . At the Working in equal partnership among multidisciplinary team members is imperative for guideline implementation at the multidisciplinary level. The hierarchy among healthcare providers impedes the use of the guidelines. Nurses as well as other staff are likely to depend on physicians or senior staff. Individual healthcare providers should be independent as professionals.Cancer care requires a multidisciplinary team approach. With multiple disciplines involved, sharing information towards a common goal beyond the boundaries of the profession is essential, and the guidelines can be an efficient tool. Although the guidelines should be incorporated into practice upon consensus among professionals , poor coProfessional self-development is the key at the individual level. Nurses should prepare themselves to respond to changing needs in health care, and they are responsible for their own development. The results of this study suggest that professional development to update knowledge should be incorporated as a strategy for guideline implication. This study targeted only oncology nurses who had specialty education in chemotherapy, yet even these nurses with relatively high levels of education perceived their individual abilities as limited. They are not comfortable using the guidelines or are not able to make decisions about whether the guidelines are applicable to their own patients. Melnyk et al. reported that nurses' knowledge about evidence-based practice was much lower than their beliefs that evidence-based practice improves clinical care and patient outcomes .Commitment is always required to introduce something new. Some nurses, however, feel detached from the guidelines, which represents their passive attitudes and limited interest. Negative staff attitudes and beliefs , lack ofThe oncology nurses expressed their concerns regarding the additional workload due to the adaptation of the guidelines. This hurdle could be overcome by motivation and professional commitment as a nurse as well as by support from a nursing manager and colleagues . InteresLastly, further improvement of the guidelines is needed. The quality of clinical practice guidelines often varies widely . DespiteThe oncology nurses voiced the need for a collaborative network with researchers who need to incorporate the views of practitioners into the development of the guidelines and support practitioners for dissemination, even after implementation. Such collaborative efforts could lead to sustainable guideline utilization.This study has implications for policy and clinical practice. Japan has established the initiatives to improve the quality of cancer care, begun when the Cancer Control Act was approved in 2006. The use of guideline has been encouraged for standardization of treatment. Preconditions derived from practical issues at different levels identified in this study will provide policy makers with a better understanding of practitioners' perceptions, and help practitioners to implement guidelines. Organizations must understand the significance of guideline implementation and its positive consequences, and set up procedures and activities to support the goal. Furthermore, organizations should strengthen their collaborative networks with researchers to facilitate guideline implementation.The results of this study may be biased toward oncology nurses, including nurse managers, who were more educated for performing chemotherapy and evidence-based practices than are general nurses. We did not interview those from other disciplines in the multidisciplinary team, and therefore, generalizability to the wider inter-professions may be limited. However, the inclusion of hospitals offering different levels of care in not only urban but also rural area communities should increase the validity of the findings. We conducted only open sampling. We failed to conduct relational and variational sampling, and discriminate sampling. The limitations of the sampling and questions based on the semi-structured interview guide might influence the deeper exploration and generation of an emerging theory. Because of the nature of the focus group interview, the results may be influenced by group dynamics. The advantage of this approach is the acquisition of constructive data, while the disadvantage is the influence of the opinions of others. To maintain data validity, two investigators ascertained the analysis process, but there may have been limitations to this approach.This study elucidated the perceptions of oncology nurses regarding guideline implementation. Although the guidelines are seen as important, they are not fully used in practice. Development of the guidelines is not directly linked to their utilization, and there are preconditions at the organizational, multidisciplinary, individual, and guideline levels to successful implementation of the guidelines in clinical settings. Prioritizing strategies by focusing on these preconditions will help to facilitate successful guideline implementation. Future research is needed to assess the quality of care and cost effectiveness that can result from implementing the guidelines, and to develop professional self-development programs for clinical nurses.The authors declare that they have no competing interests.KY was responsible for the study conception and design, data analysis, and manuscript drafting. HK was responsible for the study conception and design, and critical revisions of the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6955/10/23/prepub


Selda Ulucanlar and colleagues analyze submissions by two tobacco companies to the UK government consultation on standardized packaging.Please see later in the article for the Editors' Summary Standardised packaging (SP) of tobacco products is an innovative tobacco control measure opposed by transnational tobacco companies (TTCs) whose responses to the UK government's public consultation on SP argued that evidence was inadequate to support implementing the measure. The government's initial decision, announced 11 months after the consultation closed, was to wait for ‘more evidence’, but four months later a second ‘independent review’ was launched. In view of the centrality of evidence to debates over SP and TTCs' history of denying harms and manufacturing uncertainty about scientific evidence, we analysed their submissions to examine how they used evidence to oppose SP.We purposively selected and analysed two TTC submissions using a verification-oriented cross-documentary method to ascertain how published studies were used and interpretive analysis with a constructivist grounded theory approach to examine the conceptual significance of TTC critiques. The companies' overall argument was that the SP evidence base was seriously flawed and did not warrant the introduction of SP. However, this argument was underpinned by three complementary techniques that misrepresented the evidence base. First, published studies were repeatedly misquoted, distorting the main messages. Second, ‘mimicked scientific critique’ was used to undermine evidence; this form of critique insisted on methodological perfection, rejected methodological pluralism, adopted a litigation (not scientific) model, and was not rigorous. Third, TTCs engaged in ‘evidential landscaping’, promoting a parallel evidence base to deflect attention from SP and excluding company-held evidence relevant to SP. The study's sample was limited to sub-sections of two out of four submissions, but leaked industry documents suggest at least one other company used a similar approach.The TTCs' claim that SP will not lead to public health benefits is largely without foundation. The tools of Better Regulation, particularly stakeholder consultation, provide an opportunity for highly resourced corporations to slow, weaken, or prevent public health policies.Please see later in the article for the Editors' Summary Every year, about 6 million people die from tobacco-related diseases and, if current trends continue, annual tobacco-related deaths will increase to more than 8 million by 2030. To reduce this loss of life, national and international bodies have drawn up various conventions and directives designed to implement tobacco control measures such as the adoption of taxation policies aimed at reducing tobacco consumption and bans on tobacco advertising, promotion, and sponsorship. One innovative but largely unused tobacco control measure is standardised packaging of tobacco products. Standardised packaging aims to prevent the use of packaging as a marketing tool by removing all brand imagery and text (other than name) and by introducing packs of a standard shape and colour that include prominent pictorial health warnings. Standardised packaging was first suggested as a tobacco control measure in 1986 but has been consistently opposed by the tobacco industry.The UK is currently considering standardised packaging of tobacco products. In the UK, Better Regulation guidance obliges officials to seek the views of stakeholders, including corporations, on the government's cost and benefit estimates of regulatory measures such as standardised packaging and on the evidence underlying these estimates. In response to a public consultation about standardised packaging in July 2013, which considered submissions from several transnational tobacco companies (TTCs), the UK government announced that it would wait for the results of the standardised packaging legislation that Australia adopted in December 2012 before making its final decision about this tobacco control measure. Parliamentary debates and media statements have suggested that doubt over the adequacy of the evidence was the main reason for this ‘wait and see’ decision. Notably, TTCs have a history of manufacturing uncertainty about the scientific evidence related to the harms of tobacco. Given the centrality of evidence to the debate about standardised packaging, in this study, the researchers analyse submissions made by two TTCs, British American Tobacco (BAT) and Japan Tobacco International (JTI), to the first UK consultation on standardised packaging (a second review is currently underway and will report shortly) to examine how TTCs used evidence to oppose standardised packaging.The researchers analysed sub-sections of two of the four TTC submissions (those submitted by BAT and JTI) made to the public consultation using verification-oriented cross-documentary analysis, which compared references made to published sources with the original sources to ascertain how these sources had been used, and interpretative analysis to examine the conceptual significance of TTC critiques of the evidence on standardised packaging. The researchers report that the companies' overall argument was that the evidence base in support of standardised packaging was seriously flawed and did not warrant the introduction of such packaging. The researchers identified three ways in which the TTC reports misrepresented the evidence base. First, the TTCs misquoted published studies, thereby distorting the main messages of these studies. For example, the TTCs sometimes omitted important qualifying information when quoting from published studies. Second, the TTCs undermined evidence by employing experts to review published studies for methodological rigor and value in ways that did not conform to normal scientific critique approaches (‘mimicked scientific critique’). So, for example, the experts considered each piece of evidence in isolation for its ability to support standardised packaging rather than considering the cumulative weight of the evidence. Finally, the TTCs engaged in ‘evidential landscaping’. That is, they promoted research that deflected attention from standardised packaging  and omitted internal industry research on the role of packaging in marketing.These findings suggest that the TTC critique of the evidence in favour of standardised packaging that was presented to the UK public consultation on this tobacco control measure is highly misleading. However, because the researchers' analysis only considered subsections of the submissions from two TTCs, these findings may not be applicable to the other submissions or to other TTCs. Moreover, their analysis only considered the efforts made by TTCs to influence public health policy and not the effectiveness of these efforts. Nevertheless, these findings suggest that the claim of TTCs that standardised packaging will not lead to public health benefits is largely without foundation. More generally, these findings highlight the possibility that the tools of Better Regulation, particularly stakeholder consultation, provide an opportunity for wealthy corporations to slow, weaken, or prevent the implementation of public health policies.http://dx.doi.org/10.1371/journal.pmed.1001629.Please access these websites via the online version of this summary at tobacco  and an article about first experiences with Australia's tobacco plain packaging law; for information about the tobacco industry's influence on policy, see the 2009 World Health Organization report ‘Tobacco industry interference with tobacco control’The World Health Organization provides information about the dangers of briefing on standardised packaging of tobacco products, a press release about the consultation, and a summary report of the consultation are available; the ideas behind the UK's Better Regulation guidance are described in a leaflet produced by the Better Regulation Task ForceA UK parliamentary web page with information on standardised packaging and includes videosCancer Research UK (CRUK) has a standardised packaging of tobacco products Wikipedia has a page on UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco controlThe TobaccoTactics.org, an online resource managed by the University of Bath, provides up-to-date information on the tobacco industry and the tactics it uses to influence tobacco regulationSmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smokingSmokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking Beginning in the mid-1990s, governments globally have sought to transform policymaking and regulatory activity through a number of reforms collectively known in Europe as Better Regulation The requirements of Better Regulation have significant implications for public health, where major corporations with products damaging to health, including transnational tobacco companies (TTCs) and alcohol The UK experience with standardised packaging (SP) of tobacco products provides a major opportunity to explore the tobacco industry's current approach to and use of evidence. SP aims to prevent the use of packaging as a powerful marketing tool by removing all brand imagery and text (other than name) and instead implementing standard shape/colour packs with prominent pictorial health warnings. First mooted in 1986, SP was consistently opposed by the tobacco industry Prior to the consultation, the Department of Health (DH) commissioned a systematic review of the evidence base on SP , which concluded that there was ‘strong evidence’ that SP would reduce the attractiveness and appeal of tobacco products and increase the effectiveness of health warnings and, therefore, had the potential to ‘contribute to reductions in the harm caused by tobacco smoking’ how the industry critiqued evidence supporting SP. We extend the current literature on TTCs' misuse and misrepresentation of science, summarised above, by building an in-depth conceptual account of industry arguments and practices used to undermine published evidence. We thus provide insights into the complexities of evidence-based policymaking where corporate interests conflict with public policy goals.Here, we build on this initial overview by providing a detailed examination of The four TTCs' submissions to the consultation were published in full on individual company websites. Our initial review of all four TTCs' submissions and coding of the volume, relevance, and quality of all the evidence cited by TTCs highlighted both the large volume of submissions and evidence cited. Submissions from the four TTCs totalled 1521 pages and cited 143 pieces of formal written research evidence We selected for analysis those sections of the BAT and JTI submissions (including expert reports) that focused on whether SP would produce the intended public health objectives . This represented a core topic in three  of the four TCCs' submissions and accounted for the largest volume of cited evidence (88/143) The reports by Keegan Atlas.ti software), constant comparison, discourse sensitivity, attention to divergent data, and conceptual conclusions. One researcher (SU) read and micro-coded selected sections of the documents line-by-line for salient themes. Coding was inductive and emergent, although some themes replicated those identified during the preceding literature review, for example: (ignoring) weight of evidence; diversion ; selective quoting; and wholesale discounting (of evidence). A sub-sample of the material (13%) was coded by two other researchers ; there was considerable convergence in the initial analytic themes identified and agreement was reached through discussion on the differences in coding. The micro (first level) themes were grouped under broader categories; for example, the themes ‘misleading quoting’, ‘misleading interpretation’, and ‘selective quoting’ were grouped under ‘misleading quoting of evidence’. Emerging ideas were discussed by the wider team at interim analytic meetings. Finally, we conducted critical appraisal of Devinney's critique We conducted four types of analysis. We examined the presentation of author CVs in all 14 expert reports. We then conducted two types of in-depth analysis on the selected documents (two main submissions and three expert reports): first, a verification-oriented cross-documentary analysis comparing references made to published sources with the original sources to ascertain how they had been used; second, an interpretive analysis to identify conceptual themes. The interpretive analysis was framed by the social constructivist perspectives of social studies of science The 15 pages (of 77) in the main BAT submission and 26 pages (of 116) in the JTI submission (41 of 193 pages (21%) combined) that dealt with the question of whether or not SP would work were analysed. Of the three expert reports we selected, we analysed 4 pages of Klick (BAT) The BAT and JTI documents make the case that the evidence for SP was seriously and fatally flawed, delivering detailed and mostly externally commissioned critiques of the individual published studies and the Moodie review and reiterating that the DH had relied on ‘insufficient and unreliable’ The size of the BAT (77 pages) and JTI (116 pages) submissions was their most immediately noticeable feature; the 12 expert reports that formed part of the JTI submission made up a further 1026 pages and the 2 in the BAT submission made up another 45 pages, bringing the total for the two companies to 1264 pages. In this study, it took one experienced full-time researcher 26 working days to analyse 105 pages, an average of 4 pages per day. If only half the 1521 pages submitted by four TTCs required close analysis, this would take 190 days  to accomplish. Even a straightforward reading with no attempt at analysis would clearly take a very long time. Given that there were many other submissions from organisations and individuals  to devote time to such scrutiny.A frequently employed method of inaccurate reporting was conflating absence of evidence with evidence of absence, i.e., arguing that no connection was found between smoking and packaging when the studies concerned had not explored this relationship. For example, in reporting results of a survey examining reasons for quitting BAT argued that, far from increasing the salience of health warnings, SP ‘may actually reduce smokers’ attention to warnings', citing as evidence a study in the Moodie review ‘The researchers concluded that daily smokers exhibited more eye movements towards health warnings when the pack was branded than when it was plain…’ no effect on daily smokers whose attention to warnings remained the same (and did not decrease as suggested by BAT), while it appeared to increase attention to health warnings among non-smokers and light, non-established smokers.This was not the conclusion of the study by Munafo and colleagues BAT also claimed that the DH had previously concluded that there was not enough evidence to support SP:concluded that: “the research evidence into this [plain packaging] initiative is speculative, relying on asking people what they might do in a certain situation”’ ‘When the Department of Health examined Plain Packaging … in 2008 it conclusion; the DH document listed five ‘positive effects’ and seven ‘potential disadvantages’ of SP, and the extract BAT quoted was one of the disadvantages This statement was not, however, a One of JTI's criticisms of the Moodie review was that it had ‘inappropriately’ included studies ‘which exist only in abstract form’, something that would limit thorough critical assessment systematic review JTI also claimed that the review's authors had ignored reports by two JTI experts, Devinney and Keegan, despite the citation of one by Devinney While not exactly inaccurate reporting, the ‘tweezers method’ misrepresented original studies through selectivity. According to JTI, the Moodie review concluded that studies had failed to show that SP would have a positive impact on smoking behaviours:‘… [the review] finds that the “overall pattern of findings is mixed”’ However, this sentence in the review continues: ‘…. mixed, but tends to be supportive of plain packaging being perceived to have a likely deterrent effect on smoking’ BAT claimed that a US Food and Drug Administration (FDA) document confirmed that graphic warnings  did not impact on smoking cessation:‘… the US FDA Regulatory Impact Assessment estimated that the impact of the graphic warnings on reducing smoking rates was “in general not statistically distinguishable from zero”’ The FDA document in question relates to the introduction of graphic warnings in the US from September 2012 as a result of ‘… substantial evidence indicating that larger … warnings including a graphic component … would offer significant health benefits over the existing warnings’ ‘Although both of the estimation methods… lead to the conclusion that graphic warning labels will reduce smoking rates, FDA has had access to very small data sets, so our effectiveness estimates are in general not statistically distinguishable from zero; we therefore cannot reject, in a statistical sense, the possibility that the rule will not change the U.S. smoking rate. Therefore, the appropriate lower bound on benefits is zero’ (p. 230) The BAT submission quoted part of a report by the US Surgeon General This strategy, central to the JTI submission but also used by BAT, involved the detailed inspection, mainly by commissioned experts, of individual published SP studies and the Moodie review for methodological rigour and value, resulting in the rejection of the entire body of evidence for SP as flawed. This strategy worked at a deeper level because its discovery required broad epistemological understandings of science; specialised expertise in a large number of disciplines, research traditions, and methodologies; and skills in interpretive analysis, unlikely to be common among civil servants. Of the 37 studies in the Moodie review, 23 were subjected to parallel review across five JTI expert reports mechanisms through which SP is likely to reduce smoking rates: reducing the appeal of packs and products; increasing the salience and effectiveness of warnings; and reducing misperceptions of product strength and harm once there was evidence of an actual impact on smoking behaviours, failing to acknowledge that the reverse was just as legitimate a scientific objective. JTI similarly rejected the legitimacy and value of mechanisms research.As SP is not widely implemented, observational evidence of its effects on smoking is not available. Research has therefore focused on three psycho-social Absence of ‘real world evidence’ Because observational evidence cannot be obtained without the introduction of SP (as JTI acknowledged in its submission) ‘… even if [SP legislation in Australia] survives legal challenges … differences between markets may confound comparisons or the transposition of effects’ both groups have access to branded and standardised packages, rendering the results meaningless.It was suggested that the ‘ideal’ SP study, in line with ‘proper research design’, would be a randomised controlled trial that randomised different cities over a ‘long time period’ to having/not having SP no limitations. While acknowledging that ‘no study was perfect’, he declared that ‘a well designed and executed study can avoid and/or correct for such limitations’ Perfectionism was also evident in the industry's representation of research limitations: the presence of limitations  indicated wholesale failure of a study. All studies, including the best designed and conducted, are subject to some limitations, but one industry expert claimed that it was possible to design and conduct research with This view of limitations appeared to be operative in the industry's critique of the Moodie review, along with an apparent failure to understand the logic of synthesis:‘Adding together multiple flawed studies does not make reliable an unreliable study … students who fail one exam do not have their position improved if they fail multiple exams’ ‘Consistent results from studies that uniformly have the same methodological problems provide zero confidence in any conclusion except, perhaps, that the research designs were flawed in consistent ways’ In evidence synthesis, limitations of included studies are dealt with in two ways: studies judged to be below a quality threshold due to severe limitations are excluded; and the limitations of the included studies are taken into account through weighting and interpretation of results Perfectionism also led to suggestions that would breach research governance requirements. Devinney's insistence on studying actual purchasing outcomes or incentive-compatible measures Demanding the perfect study design regardless of real-life and methodological constraints is clearly an unscientific position, at least outside the laboratory, but this was the premise of much industry critique of published SP studies, with the result that the reviewed evidence base for SP was discounted.The industry critiques of SP studies and the Moodie review were all framed by the discipline of market research and associated methodological conventions. The experts' disciplinary backgrounds included law, marketing, psychology, management, economics, and statistics; none declared expertise in tobacco control or public health. Keegan and Devinney reported using a set of assessment criteria for ‘good research’, citing mainly market research or public opinion research organisations as sources. Discrete choice experiments were designated as the best model for experiments involving purchasing decisions Furthermore, the quantitative paradigm was accepted as the only scientifically acceptable one and qualitative methodology was dismissed, based on quantitative criteria, as useless.‘… eight of the studies [in the Moodie review] were little more than small sample focus groups and two other studies were interview based; yet these were considered to be equally valid to other studies in the discussion’ ‘Most of the normal checks that one attributes to good research practice … are violated [in focus groups]. One cannot control for truthfulness or incentive compatibility nor can the focus group questioning be subject to statistical analysis …’ In social science research, focus groups are not conducted to obtain statistical or generalisable findings but to elicit attitudes, beliefs, and experiences in a relatively naturalistic, informal manner systematic review that uses narrative synthesis  with a narrative, non-systematic, review The Moodie review was dismissed as ‘the considered opinion of the author undertaking the review’ and ‘a focus group of researchers giving their opinion’ The industry experts' methodological approach to reviewing the SP evidence base represents a fundamental failure to understand the requirement for methodological pluralism. A key indicator of quality in all research is the fit between the research question and the method(s) because no one paradigm or method can answer all types of research questions.A central tenet of scientific review is diligence, and reviewers take great care to acquire a full and accurate understanding of the original sources they are reviewing; they use a disciplined and methodical approach, applying evaluative criteria consistently across studies to prevent biased judgment. In reviewing the two SP papers by Hammond et al One industry criticism of the Moodie review was that it was ‘inherently biased and self-interested’ The industry reviews appeared to be embedded within a litigation—not scientific—model. Some industry experts referred to parts of their reports that would normally be labelled ‘appendix’ or ‘chapter’ as ‘exhibits’, and their critiques resembled courtroom testimonies aimed at demolishing the adversary's case. In the main TTC submissions, the experts were posited as sources of higher scientific authority, representing ‘the best contemporary scientific thinking’ Another manifestation of the litigation model was the experts' piece-by-piece approach to reviewing. Individual studies were examined in depth to determine whether any—on its own—constituted a warrant for SP and, following systematic deconstruction, none was found to be good enough to justify SP.‘In summary … it is my expert opinion that none of the Studies provide [sic] reliable evidence that plain packaging would be effective in achieving the public policy goals of changing actual smoking behaviour …’ In court, each piece of evidence  is treated as a separate piece of evidence and each needs to be undermined and discredited in turn until no evidence remains that could damage one's client's case. By contrast, in scientific work, it is essential that the extant research is synthesised and greater confidence in the findings established through the cumulative ‘weight of the evidence’ To sum up, the two TTC submissions (by BAT and JTI) and the associated expert reports used different combinations of the techniques of mimicked critique we have documented here to dismiss the entire literature supportive of SP.As well as dismissing research that supported SP, another, more expansive, strategy in the submissions was to change the evidential landscape within which the policy debate was conducted by introducing and promoting research that examined non-packaging issues and, at the same time, excluding relevant industry research on packaging.The industry pointed to the literature on psychological and social explanations of smoking behaviours and individual decision-making to argue that packaging was irrelevant to smoking behaviours and decisions. The DH and the Moodie review were said to ‘ignore’ this parallel evidence base.‘… the real drivers of smoking initiation include factors such as parental influences, risk preferences, peer influences, socioeconomic factors, access and price’ ‘Numerous government funded and independent studies also show that factors other than packaging are the real drivers of decisions relating to quitting and relapse’ JTI submitted two expert reports to support this argument. One was prepared by two marketing professors who drew on the literatures on ‘consumer, cognitive and social psychology, behavioural economics and marketing research’ and concluded that SP would be ineffective because smoking decisions and behaviours were made on the basis of habit, goals and motives, peer influences, the consumer mindset, and self-control The DH consultation brief included a request for respondents to provide ‘any further evidence about tobacco packaging that you believe to be helpful’ We have reported the methods BAT and JTI used in their written submissions to undermine the evidence base for SP. The companies submitted a very large volume of evidence, reported studies in an inaccurate and misleading fashion, and sought to diminish the value and exaggerate the shortcomings of studies by using mimicked scientific critique. This last technique involved judging published studies against unrealistic and perfectionist criteria, dismissing research traditions and methods outside a narrowly defined paradigm , adopting a litigation style that contrasted with the scientific model, and using non-rigorous review practices. In addition, they disregarded the consistency in the evidence for SP and tried to divert attention away from packaging to an alternative, less relevant body of evidence, while excluding a highly relevant body of industry research on packaging. These practices were conducted under the rubric of scientific critique and gave a misleading impression of scientific credibility. Our analysis suggests that they amount instead to an attempt to create a parallel and competing ‘scientific’ discourse. In formulating their response to the stakeholder consultation on SP, the tobacco companies reframed prevailing scientific norms and practices as somehow substandard and corrupt, seeking to impress on policy makers their own—distorted—interpretation of science and the scientific method.It is not possible to ascertain how successful the tobacco industry was in influencing the UK government's stance on SP. Nevertheless, the government's announcement that it was postponing a decision due to concerns about the evidence base, combined with our findings and the industry's record in manipulating evidence to create policy inertia This study had a number of limitations. Our analysis covered just two of the four tobacco company submissions. However, content analysis of how evidence was cited in all four submissions Nevertheless, our work provides crucial insights into how TTCs seek to discredit the evidence for a policy that runs counter to their interests and how regulatory tools associated with the Better Regulation agenda facilitate such efforts. In relation to the former, our findings are consistent with a broad body of literature on industry misuse of science and promotion of ‘sound science’. This literature shows that industries attempt to prevent or delay regulatory action aimed at limiting or removing harms associated with their products by creating doubt about the validity of scientific evidence that documents those harms. This extends from the tobacco industry It is important to understand that the socially constructed nature of scientific work itself While the tobacco industry has a long history of challenging scientific evidence in order to resist public health policies, the Better Regulation agenda, with its emphasis on evidence and requirement for stakeholder consultation, increases the utility of this strategy. This is something the TTCs recognise. Previous work shows that BAT predicted that the implementation of Better Regulation would enhance its ability to prevent public health policies A further problem presented is the question of how such reviews are then handled by civil servants and politicians. Despite calls for transparency This study shows that the TTCs' critique of the evidence in favour of SP is highly misleading. Combined with our earlier work highlighting the very low quality of the TTCs' evidence against SP, it suggests that the TTCs' claim that SP will not lead to public health benefits is largely without foundation. It also highlights that the tools of Better Regulation, particularly stakeholder consultation, just as BAT predicted when pushing for their implementation, provide an opportunity for highly resourced corporations to slow, weaken, or prevent public health policies.


Most textbooks contains messages relating to health. This profuse information requires analysis with regards to the quality of such information. The objective was to identify the scientific evidence on which the health messages in textbooks are based.The degree of evidence on which such messages are based was identified and the messages were subsequently classified into three categories: Messages with high, medium or low levels of evidence; Messages with an unknown level of evidence; and Messages with no known evidence.844 messages were studied. Of this total, 61% were classified as messages with an unknown level of evidence. Less than 15% fell into the category where the level of evidence was known and less than 6% were classified as possessing high levels of evidence. More than 70% of the messages relating to "Balanced Diets and Malnutrition", "Food Hygiene", "Tobacco", "Sexual behaviour and AIDS" and "Rest and ergonomics" are based on an unknown level of evidence. "Oral health" registered the highest percentage of messages based on a high level of evidence (37.5%), followed by "Pregnancy and newly born infants" (35%). Of the total, 24.6% are not based on any known evidence. Two of the messages appeared to contravene known evidence.Many of the messages included in school textbooks are not based on scientific evidence. Standards must be established to facilitate the production of texts that include messages that are based on the best available evidence and which can improve children's health more effectively. Health education forms a part of the compulsory education curriculum in Spain, either as explicit content within a given area of knowledge or as supplementary content in any area or didactic act . In ordeEvidence-based Medicine (EBM) is a process for the critical evaluation and incorporation of scientific discoveries into the decision-making process within the healthcare sector. This process can be applied to any type of health-related action: diagnosis, therapy or preventative measures . From thThe research questions for this study is if the health-related messages in textbooks are based on scientific evidence. The objective was to identify the scientific evidence used as a fundament for health-related messages in textbooks employed within compulsory education in Spain, namely, Primary and Secondary Education. The use of EBM methodology may prove extremely useful when selecting content to be included in school books. Textbooks should only contain the most reliable affirmations in relation to health, that is, statements that are solidly based on scientific evidence. The results of this study may aid the authors and publishers of school books to improve content. In addition, our results may also help teachers to place greater importance on the assimilation of messages that are more firmly based on scientific evidence. Finally, this study may facilitate the adoption of behaviours amongst children and the acquisition of knowledge by children that have more consistently demonstrated a capacity to improve health and prevent illness.This is an observational, descriptive and analytical study that was carried out in the city of Granada.st of March 2006 and the 1st of June 2007, textbooks used in primary and secondary schools in a district of the province of Granada were identified. Books written in languages other than Spanish, "Teacher Guides" and books containing no health related messages were excluded. A representative sample of books was selected: a proportion with a precision of 5% was estimated along with a bilateral confidence interval of 95%.Between the 1health-related messages refer to any statement within a school book that addresses any health-related subject in the form of a recommendation or advice. Messages relating to four areas were excluded: a) Aspects of Anatomy or Physiology that are beyond all scientific doubt were ignored (the heart has four chambers). b) Respect for the environment  as it is currently difficult to evaluate the scientific evidence and effects on health of recommendations in this area; c) Psychological and Social well-being relating to living in a community and mutual respect, as such considerations are not easily transformed into research questions and we were unable to find studies relating to evidence in this regard ; d) Messages relating to personal hygiene and food hygiene that emphasised norms of urbanity or courtesy .Within the framework of the study, The texts selected were reviewed in order to identify any health-related messages. We drew up a table to classify messages, recording information relating to the school year and subject matter of the textbook containing each message. In addition, the focus of the message was defined in accordance with the classification of health priorities for children and adolescents drawn up by the health authorities .Tobacco smoke produces severe diseases of the respiratory system (message) in: Does tobacco smoke produce severe diseases of the respiratory system? (question)Each health-related message in the school books was transformed into a research question. In order to transform the messages into interrogations, where possible, the Patient-Intervention-Comparison-Outcomes (PICO) scheme, drawn up by Richardson et al was employed. However, as these authors drew up their scheme for question construction in a clinical setting, which clearly does not apply to schools, the scheme was slightly modified for the present study. In the present study, the following aspects were considered in each question: (P) the individual or group targeted by the health-related message ; (I) the area of health that the message focuses on, normally in the form of advice or recommendations ; (C) comparison with behaviour that is detrimental to health or with the failure to abide by the advice ; and (O) associated beneficial effects where the advice is followed. An example of transformation of the messages into interrogations is: Trip Database (TD), one of the most important Internet resources for searches relating to evidence-based medicine. In accordance with TD recommendations, searches were carried out using search terms relating to question content in conjunction with Boolean searching, parenthesis and stemming.To this end we employed the url) providing a link to the full text.From the results obtained via the TD, we only considered those documents containing information that was classified in terms of evidence, such as clinical practice guides and systematic reviews. The full texts of the documents were located and thoroughly reviewed, searching for a response to each research question. In each case, we identified the institution that published the document and the uniform resource locator  Messages based evidence without assigned level: messages wherein the research question is answered in at least one of the consulted documents, which nevertheless fail to report on the level of evidence. c) Messages with no known evidence: messages wherein the research question is not addressed in any of the consulted documents.Results relating to the level of evidence were classified into three categories: a) Messages with a level of evidence group, the level of evidence was informed in each case. As different institutions employ a wide variety of systems to classify the degree of evidence, this study employed its own classification system, synthesising the most widely accepted classifications. This study classifies the level of evidence into three groups - high, medium and low - which homogenise and respect the original classification hierarchies that are most widely employed. Table In the case of the The statistically analysis used was only descriptive. Frequencies, percentages and mean were calculated.237 textbooks used in primary and secondary schools were identified. 129 of them met the inclusion criteria. A representative sample of 80 books was randomised via simple aleatory selection. All the books were manually revised and 1135 health-related messages were identified. Subsequent to the elimination of messages that did not meet the criteria for inclusion, 844 were studied.Table rd year of secondary school (37.1) and in the subject Biology and Geology (32.5). The subject Environmental Knowledge (13.5) and the fourth year of primary education (19.1) ranked second in terms of the number of messages. The 18 health-related messages found in the 2 Social Sciences text books were not included as, focusing almost exclusively on respect for the environment, they failed to meet the criteria for inclusion.As Table Table Table "Balanced diets and malnutrition" is the subject matter that is most often addressed in messages and also gives rise to the highest frequency of messages based on a given source of evidence, although the level of evidence is not known. This subject, along with messages concerning "Food and Hygiene", "Tobacco", "Sexual behaviour and AIDS" and "Rest and ergonomics", is based on a source of evidence in more than 70% of cases, although, once again, the level of evidence is not specified."Oral health" registered the highest percentage of messages based on a high level of evidence (37.5%), followed by "Pregnancy and newly born infants" (35%).Almost a quarter of the messages (24.6%) are not based on any known evidence. In the case of "Respiratory illnesses" and "Protection against environmental agents" more than half the messages are not based on any known evidence (57.9% and 53.1% respectively) and in the case of "Oral Health", the number of messages not based on any known evidence accounts for 40% of the total. In two instances, according to the documents consulted, the messages appeared to contravene known evidence.Table Attention should be drawn to the considerable number of health-related messages found in school books. This can be interpreted as a symptom of the high levels of observance of the official recommendation to include health education in all areas of the curriculum. However, a shadow is cast on this optimistic view when we consider the number of messages that are not based on scientific evidence. This raises questions in relation to the criteria that are employed to select messages for inclusion in school books. The fact that almost a quarter of the messages that were studied are not based on any documentary evidence (Guides and Systematic Reviews), suggests a certain degree of arbitrariness and a lack of clearly defined criteria to evaluate the importance of a health-related message. If we assume that the inclusion of a health-related message in the sources of evidence is indicative of their importance and suitability, our results show that far too many health-related messages aimed at school children are not firmly based on scientific evidence.Nevertheless, the presence of health-related messages in guides and systematic reviews can not be used as the only means of justification for their inclusion in school books. This is due to the fact that clinical practice guides and systematic reviews entail a long preparation period that may significantly delay the publication and circulation of health information based on evidence. Moreover, the psychology of learning suggests that directing a health-related message towards children, even where the message is not based on sufficient scientific evidence, may aid the consolidation of healthy habits. For example, consulted documents recommend that children clean their teeth two times a day, a message that is based on a high level of evidence. However, the documents do not state that the cleaning process should be carried out after each meal. Nevertheless, recommending that teeth are cleaned immediately after each meal may help children to consolidate habits and routines that entail health benefits.This paper does not intend to recommend the exclusion, at a general level, of messages that are not clearly based on evidence. However, we do feel that it is advisable to place less emphasis on messages that are not backed up by sources of evidence with a greater degree of frequency. For example, this is the case of messages relating to protection against environmental agents.This study presents a number of shortcomings that bear mention. Considering clinical practice guides and systematic views as the only source of evidence may limit the scope of the study. Nevertheless, the tenets of care practice consider observance of the recommendations of a clinical practice guide or high quality systematic review to represent the most efficient method of ascertaining the best clinical course to follow .Nor can we consider the exclusive use of the Trip Database as an evidence search engine as a shortcoming. Other search engines and other search strategies may produce different results. However, we decided to use this pre-filtered source of evidence and thereby ensure that all documents consulted were based on evidence that has been rigorously verified.As conclusion, almost a quarter of messages included in school textbooks have an unknown scientific evidence. These messages are included in textbooks along with messages that are solidly based on scientific evidence. Children receive all of these messages and are unable to identify the importance or lack of importance of a given message or the extent to which it is based on evidence. The results of our study suggest that there is a need to establish standards that will enable the publishers who draw up the texts and the teachers who employ such texts to select and impart messages with solid scientific evidence.Finally, this study has some practical implications: The results of our study demonstrate that there is a need to establish a mechanism that is capable of selecting messages on the basis of the degree to which they are based on scientific evidence. The publication of books that respect the criterion of a firm basing in scientific evidence with regards to the messages that they contain will facilitate the acquisition of knowledge amongst children that has consistently proved capable of improving health and preventing illnesses.The authors declare that they have no competing interests.IMB was the main researcher; she guided the study and wrote the first manuscript. MLA revised all textbooks and selected the health messages and reviewed the draft. MHG revised all text books and selected the health messages and reviewed the draft. PSL revised the sources of evidence (Guidelines and Systematic Review), analysed the evidence which support the health messages and reviewed the draft. JGG revised the sources of evidence (Guidelines and Systematic Review), analysed the evidence which support the health messages and reviewed the draft. JMT analysed the evidence which support the health messages and reviewed the draft. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/11/54/prepub


Through advances in therapy and technology, the quality of life, morbidity and mortality outcomes in people with type 1 diabetes continue to improve in countries with well-developed health-care systems, but major disparities in diabetes care exist globally. Ideally, an individual with type 1 diabetes should be managed by a multidisciplinary healthcare team delivering integrated clinical care. Essential to the delivery of optimal diabetes care is education of health care teams, individuals, the community and policy makers. Evidence based clinical care guidelines are an important component of such education. However, while guidelines provide guidance for the practice of evidence based care at the organisational level, evidence based medicine requires the integration of research evidence with clinical expertise and patient values. Since many aspects of health care depend on individual factors such as quality of life, guidelines should be used in the context of the health-care needs and circumstance of each individual with diabetes. Globally, the practicality of implementing evidence based recommendations also depends on the health system structure, availability of resources, economic considerations and socio-cultural factors.http://www.apeg.org.au) and the Australian Diabetes Society (http://www.diabetessociety.com.au), the guidelines address key aspects of diabetes care, based on the best available evidence at the time of writing. The guidelines are structured around clinical questions addressed by systematic reviews and meta-analyses. Notably, evidence for rapidly evolving areas such as use of technologies  is constantly changing. Furthermore, there are aspects of care for which there is little or no evidence, so management is based on best practice or consensus. The applicability of these and other contemporary guidelines to the Asia Pacific Region will be reviewed.There are a range of guidelines available for the management of young people with type 1 diabetes, including those produced by NICE, ADA, ISPAD and IDF. In Australia, evidence-based guidelines for management of type 1 diabetes across the lifespan were launched in November 2011 [


Introduction: The temporomandibular disorders (TMDs) have been identified as the most important cause of pain in the facial region. The low level laser therapy (LLLT) has demonstrated to have an analgesic, anti-inflammatory and biostimulating effects. The LLLT is a noninvasive, quick and safe, non-pharmaceutical intervention that may be beneficial for patients with TMDs. However the clinical efficiency of LLLT in the treatment of this kind of disorders is controversial. Objectives: Literature review in reference to the use of LLLT in the treatment of TMDs, considering the scientific evidence level of the published studies. Material and Methods: A MEDLINE and COCHRANE database search was made for articles. The keywords used were “temporomandibular disorders” and “low level laser therapy” or “phototherapy” and by means of the Boolean operator “AND”. The search provided a bank of 35 articles, and 16 relevant articles were selected to this review. These articles were critically analyzed and classified according to their level of scientific evidence. This analysis produced 3 literature review articles and 13 are clinical trials. The SORT criteria (Strength of Recommendation Taxonomy) was used to classify the articles. Results: Only one article presented an evidence level 1, twelve presented an evidence level 2, and three presented an evidence level 3. According to the principle of evidence-based dentistry, currently there is a scientific evidence level B in favor of using LLLT for treatment of TMDs.Discussion and conclusions: Publications on the use of LLLT for treatment of TMDs are limited making difficult to compare the different studies due to the great variability of the studied variables and the selected laser parameters. The great majority of the studies concluded that the results should be taken with caution due to the methodological limitations. Key words:Low level laser therapy; phototherapy; temporomandibular joint disorders. Temporomandibular disorders (TMDs) is a collective term that includes disorders of the temporomandibular joint (TMJ), and of the masticatory muscles and their associated structures; characterized by pain, joint sounds, and restricted mandibular movement ,2. TMD eThere is still a lack of consensus on the classification of TMD, largely because there is unclear etiology and clinical findings can result from different causes, including psychological causes. One commonly used diagnostic scheme intended for research purposes is the Research Diagnostic Criteria for TMD (RDC/TMD) . This stAggressive and irreversible treatments, such as complex occlusal therapies and surgeries should be avoided. Nonsurgical treatment of TMDs generally consists of medication, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and antidepressants, splint therapy or/and physiotherapy. NSAIDs may reduce the inflammation but may also increase the risk of complications, such as gastric ulcer and nephrotoxicity. Other treatments used are physical therapy , treatment of parafunctional activities and alternatives therapies. Physical therapy is used in the treatment of TMD because of its analgesic, myorelaxing, anti-inflammatory and stimulations effects. Low level laser therapy (LLLT) is an option for the treatment of musculoskeletal disorders, it is easy application, limited treatment time and minimum contraindications, due to its analgesic, anti-inflammatory and regenerative effects ,4,8.The clinical efficacy of LLLT for the treatment of TMDs is controversial. Some authors reported best results comparing the LLLT with a placebo control group, while others found no significant differences.According to some authors there is considerable diversity in the results reported, depending on parameters and methodology used.The aim of our study is to make a review of the literature published on the use of LLLT for the treatment of TMDs, considering the level of scientific evidence according to the principals of evidence-based dentistry.A MEDLINE search was made for articles without restriction in year publication. The keywords used were “temporomandibular disorders” and “low level laser therapy” or “phototherapy” and by means of the Boolean operator “AND”. The literature identified was then limited to studies in humans and articles written in English. The same process was used in the COCHRANE database of the Cochrane Oral Health Group. Two authors analyzed the abstracts to verify that the articles obtained were pertinent to the topic under study. The irrelevant articles were discarded. Next, the same two authors independently stratified the scientific articles according to their level of scientific evidence using the SORT criteria (Strength of Recommendation Taxonomy). Subsequently the authors compared their results; in the event of disagreement the results were discussed. If no consensus regarding the level of scientific evidence of a certain article was possible, a third author was included in the discussion. Subsequently, a recommendation was given for or against the use of LLLT in the treatment of TMD according to the level of scientific evidence of the articles analyzed.The MEDLINE search for TMDs and LLLT or photherapy when were cross provided a bank of 35 articles. Next, the abstracts of each article were analyzed to determine if they were pertinent to the topic under study. The search in the COCHRANE database provided no relevant articles that agreed with the search criteria of this study. After this process 16 relevant articles remained. These articles were critically analyzed and classified according to their level of scientific evidence. This analysis produced 3 literature review articles and 13 are clinical trials.Description of studies.1. Bjordal JM, Couppé C, Chow RT, Tunér J, Ljunggren EA. Literature systematic review. Evidence level 2.2. Medlicott MS, Harris SR. Literature systematic review. Evidence level 2.3. McNeely ML, Armijo Olivo S, Magee DJ. Literature systematic review. Evidence level 2.4. De Medeiros JS, Vieira GF, Nishimura PY. Clinical trial. Evidence level 3.5. Carvalho CM, de Lacerda JA, dos Santos Neto FP, Cangussu MC, Marques AM, Pinheiro AL. Clinical trial. Evidence level 3.6. Fikácková H, Dostálová T, Navrátil L, Klaschka J. Clinical trial. Evidence level 2.7. Çetiner S, Kahraman SA, Yücetaş S. Evidence level 2. Clinical trial. Evidence level 2.8. Núñez SC, Garcez AS, Suzuki SS, Ribeiro MS. Clinical trial. Evidence level 3.9. Venancio Rde A, Camparis CM, Lizarelli RF. Clinical trial. Evidence level 1.10. Emshoff R, Bösch R, Pümpel E, Schöning H, Strobl H. Clinical trial. Evidence level 2.11. Kato MT, Kogawa EM, Santos CN, Conti PCR. Clinical trial. Evidence level 2.12. Hotta PT, Hotta TH, Bataglion C, Bataglion SA, Coronatto EAS, Siesseré S, Regalo SCH. Clinical trial. Evidence level 2.13. Katsoulis J, Ausfeld- Hafter B, Windecker-Gétz I, Katsoulis K, Blagojevic N, Mericske-Stern R. clinical trial. Evidence level 2.14. Mazzetto MO, Hotta TH, Pizzo RCA. Clinical trial. Evidence level 2.15. Shirani AM, Gutknecht N, Taghizadeh M, Mir M. Clinical trial. Evidence level 2.16. Kulekcioglu S, Sivrioglu K, Ozcan O, Parlak M. Clinical trial. Evidence level 2.The results of the clinical trials that study the effects of LLLT are summarized in Many clinical applications of laser light can be found in medicine, dentistry, surgery and many types of lasers in different wavelengths have been offered clinicians and researchers . The useLLLT makes use of the electromagnetic radiation of a single wavelength, usually in the red or infrared regions. LLLT provides treatment for several pathologies, including impaired wound healing, pain conditions, and inflammatory situations .Its basic effects are bio-stimulative, regenerative, analgesic and antinflammatory. It also seems to act on the immune, circulatory and haematological systems . The mecThe importance of investigating the actual analgesic efficacy of LLLT lies on the fact that TMD symptoms have been treated by a wide array of methods separately, such as interocclusal splint, medication, physical therapy, and transcutaneous electric nerve stimulation; in most cases, however, better outcome is achieved when the therapies are associated, where lasers can be of great value .LLLT is a noninvasive, quick and safe, non-pharmaceutical intervention that may be beneficial for patients with TMJ pain disorders ,11. LikePublications are scarce on the specific case of using LLLT on TMDs. Our research found only 35 which related the two terms.The relative clinical efficacy of LLLT for treatment of TMD is controversial . For mosLight penetration and absorption in biological tissue are dependent on several variables, and one of the most important is the wavelength of the laser. Different wavelengths have been used for treatment of TMDs: 632.8 nm neon–helium (He–Ne) laser , 670 nm Emshoff et al.  used a 6Concerning the energy density in the different studies reviewed, it is possible to observe a great diversity, since that has still not been any definite consensus about. De Medeiros et al.  recommenFurther studies are required to establish a radiation time and energy dose for significant effects on pathological conditions . Given tKulekcioglu et al.  and ÇetiMost of the reviewed studies evaluated the patients using a VAS ,12,15,19Other or additional way to evaluate the patients is by measuring the different jaw movements ,10,12,15Hotta et al.  and KatsFew clinical studies, systematic reviews and meta-analysis investigated the efficacy of the LLLT in other musculoskeletal disor-ders and pain relief. Chow et al. , in a syJenkins and Carroll , in theiPublications on the use of LLLT for treatment of TMDs are limited. A problem detected in this literature reviewed is the variation in methodology, dosimetry and other parameters between studies, and the inclusion criteria and diagnosis of the patients. The studies are not standardized and consequently the results differ and comparison is difficult.According to the principal of evidence-based dentistry, there is currently a scientific evidence level B in favor of using LLLT for treatment of TMDs. The results published in the literature should be analyzed with caution since none have sufficient scientific basis, either because the sample size is inadequate, or methodological defects are present.We believe that the diagnosis based on the Research Diagnostic Criteria for TMD (RCD/TMD) proposed for Dworkin and LeReserche  and the Furthermore controlled double- blind clinical trials and multicentric studies are necessary to demonstrate the efficacy of LLLT in TMDs.