Conflicts of interest affect recommendations in clinical guidelines and disclosure of such conflicts is important. However, not all conflicts of interest are disclosed. Using a public available disclosure list we determined the prevalence and underreporting of conflicts of interest among authors of clinical guidelines on drug treatments.We included up to five guidelines published from July 2010 to March 2012 from each Danish clinical specialty society. Using the disclosure list of the Danish Health and Medicines Authority, we identified author conflicts of interest and compared them with the disclosures in the guidelines. For each guideline we extracted methodological characteristics of guideline development.Forty-five guidelines from 14 specialty societies were included. Of 254 authors, 135 (53%) had conflicts of interest, corresponding to 43 of the 45 guidelines (96%) having one or more authors with a conflict of interest. Only one of the 45 guidelines (2%) disclosed author conflicts of interest. The most common type of conflict of interest (83 of the 135) was being a consultant, an advisory board member or a company employee. Only 10 guidelines (22%) described the methods used for guideline development, 27 (60%) used references in the text and 11 (24%) graded the types of evidence.Conflicts of interest were common, but disclosures were very rare. Most guidelines did not describe how they were developed and many did not describe the evidence behind specific recommendations. Publicly available disclosure lists may assist guideline issuing bodies in ensuring that all conflicts are disclosed. The amount of medical information is overwhelming and it increases rapidly. ClinicaThe potential effects of conflicts of interest might have profound effects on health care because guidelines are written to influence the practice of physicians and can In Denmark, a nation of approximately 5.6 million inhabitants, there are around 22,500 practising physicians, 8.5% of which have a registered affiliation with a drug company. Any phyOur aims were:•to determine the prevalence and types of conflicts of interest among authors of clinical practice guidelines published by Danish specialty societies;•to estimate the proportion of disclosed conflicts of interest;•to describe the methodology used in the guidelines.In Denmark there are 38 Danish specialty societies as defined by the list of the Organization of Danish Medical Societies. CurrentIn March 2012, using the website for each specialty society, one observer included the five most recent drug guidelines published from July 2010. We limited the number to five in order to avoid clustering by specialties with many guidelines. As we focused on conflicts of interest in relation to drugs, we selected guidelines with a focus on drug treatment of medical conditions. For example, for anaesthesia we included a guideline on strategies for sedation, but excluded one on tracheotomy. In case of multiple guidelines of similar publication date, we selected them randomly. Societies without guidelines on their website were contacted by e-mail to determine whether any guidelines had been published. Guidelines referenced on the societies' website that had been developed by other national or international organisations were not considered a guideline for the particular society. Guidelines made in collaboration between different specialties were included in a separate category. Some societies had not produced five guidelines meeting our selection criteria and in those cases we included those that were available. A second observer verified the selection of guidelines according to our criteria. For each society, we obtained information as to whether the society had produced an instruction manual for guideline preparation.For each included guideline, two observers independently extracted information on title, date, number of authors, names of authors, funding of guideline and disclosures of conflicts of interest into a standardised datasheet. Disagreements were resolved through discussion. We contacted the specialty society for missing information on date of publication and funding.We used the publicly available Danish registry of authorization to practise medicine to ensure the identity of authors and that they were physicians. For eacThe type of conflict of interest with drug companies was classified into the following categories, which we defined a priori based on our previous experience with the disclosure list:•Consultant/advisory board member/employee•Speaker/educational activities•Investigator/research collaboration•Equity/stockholderAuthors who have received reimbursement for conference expenses or fees for single activities such as speaking at only one meeting are not listed on the disclosure list.For societies with an instruction manual for guideline preparation, we coded whether the manual contained information on disclosure of conflicts of interest.Our datasheets were developed using a pilot version on one guideline on drug treatments from each of five randomly selected specialty societies.We initially planned to use the AGREE II instrument to assess the reporting of guideline methodology, but dueWe calculated the prevalence of disclosed and undisclosed conflicts of interest overall, at guideline level, and at specialty society level. For authors with conflicts of interest, we calculated the proportions of the individual types of conflicts of interest. Guidelines made in collaboration between different specialties were analysed separately.The estimated overall prevalence of authors with conflicts of interest depends on the number of authors per society and the prevalence of conflicts of interest at society level. We therefore performed a simple sensitivity analysis to test the robustness of our results. We estimated the prevalence as an average of the mean prevalence of conflicts of interest among individual societies, assigning each society the same weight.We also tried to quantify to which extent authors without conflicts of interest according to the disclosure list had such conflicts, in a random sample of 25% of the authors. We searched the authors’ conflicts of interest statements in scientific publications published in the three years prior to the guideline data, searched Google by combining their names with names of companies that authors of the same guideline were affiliated with, and contacted the Danish Health and Medicines Authority for additional information.This study did not require ethical approval as it was based on publicly available information.We included 45 clinical practice guidelines, 40 from 14 Danish specialty societies and 5 collaborative guidelines  included a conflicts of interest statement for three of its four authors; all three were conflicted. We identified conflicts of interest for 132 additional authors, giving a total of 135 out of 254 authors (53%) with conflicts of interest. The true prevalence of conflicts of interest of guideline authors ranged from 0% to 100% among individual guidelines , the Danish Paediatric Society 23%) and the Danish Society of Neurology (25%) . When we searched for additional information about conflicts of interest among the 30 authors without conflicts (25% of 119) we found that 3 (10%) had conflicts that were not disclosed on the Danish Health and Medicines Authority’s list, the reason being that the activities predated our earliest available version of the list. Assuming that the 10% of authors without conflicts, according to the list, actually had conflicts, the prevalence changed from 53% to 58%.A description of the methods used for guideline development was found in 10 guidelines (22%). Nine of those were produced by only two societies, the Danish Society of Gastroenterology and Hepatology and the Danish Society of Obstetrics and Gynaecology, and the tenth guideline was a collaborative one. Twenty-seven guidelines (60%) included references in the text, 10 (22%) used references, but did not include them in the text, and 8 (18%) did not use references at all. Eleven guidelines (24%) graded the types of evidence; 10 of those were produced by the same two societies the Danish Society of Gastroenterology and Hepatology and the Danish Society of Obstetrics and Gynaecology and one by Danish Society of Gastroenterology and Hepatology in collaboration with five other societies.Six out of 14 societies had instruction manuals for guideline preparation and none of those included policies on conflicts of interest.We found that 53% of guideline authors had conflicts of interest, corresponding to 43 out of 45 guidelines being written by one or more authors with conflicts, and that only 2% disclosed them, in just one guideline. Most guidelines did not state how they were developed or graded the evidence, and many did not include references in the text.Our study was based on very comprehensive data from the Danish Health and Medicines Authority, and physicians and drug companies are required by law to report their collaboration to the authority. Our finUsing a publicly available disclosure list made it possible to identify undisclosed conflicts of interest, but one limitation of the list is that drug company affiliations are deleted as soon as the collaboration ends. As judged by our sensitivity analysis, this seemed to have had little impact on our results, but we suggest that such lists include affiliations up to 3 years prior to the current date, similar to the ICMJE criteria.It is therefore likely that previous studies of conflicts of interest among clinical guideline authors have underestimated the prevalence of conflicts of interest, as they have relied on voluntary disclosure. We note, however, that the underreporting of conflicts of interest in our study of Danish guidelines may have been atypical, e.g. US guidelines have more disclosures. We founAlbeit our study was based on Danish guidelines, our sample represents 14 different specialties and we have thereby obtained more comprehensive information on the extent of conflicts of interest among guideline authors than in other studies, which have usually only included guidelines from a few specialties.In a recent systematic review by Norris and colleagues, the prevalence of conflicts of interest ranged widely among the different studies included, from 18% to 100%[Firstly, the sources used for identifying conflicts of interest may have been important. Many studies identified conflicts of interest solely based on authors’ disclosures in guidelines, which will generally underestimate the prevalence,21. OtheSecondly, what constitutes a conflict of interest may also influence its prevalence. We coded a conflict of interest to be present if authors had an affiliation with a company up to 3 years prior to the published guideline. This interval differs among studies as do peThirdly, the overall extent of conflicts of interest among physicians varies between countries. In Denmark, the prevalence is approximately 8.5%, whereasPublic disclosure lists may assist guideline issuing bodies in ensuring that all conflicts of interest are disclosed. In order for guideline end-users to judge fully the possible influence of the conflicts of interest, information on individual authors' income from drug companies is also relevant. This information will be available with the implementation of the US Sunshine act in 2014, which wWhile disclosure improves transparency, it does not remove the potential bias related to conflicts of interest,6,32, anConflicts of interest among guideline authors from Danish specialty societies were common but very rarely disclosed. Most guidelines also lacked transparency as to their development and the evidence in support of the recommendations. Thus, there is a need for better management and disclosure of conflicts of interest, and greater transparency of guideline methodology. Publicly available and law-enforced disclosure lists may assist guideline issuing bodies in ensuring that all conflicts are disclosed.The authors declare that they have no competing interests.AL conceived the idea for the study. The protocol was primarily developed by AL; JBBB, JS and PCG contributed. JBBB identified guidelines and AL verified the selection. AL and JBBB extracted guideline data and JBBB and JS identified conflicts of interest. All authors participated in data analysis and writing of the paper. All authors had full access to all the data in the study. AL and JBBB are guarantors and take responsibility for the integrity of the data and the accuracy of the data analysis. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6939/14/19/prepub


Lore Zech Figure  was in aIn 1971, during the IVth International Congress of Human Genetics in Paris, she was invited to present her findings, and from there on chromosome bands were widely accepted and an international nomenclature established.C-MYC oncogene into the immunoglobulin heavy chain locus [During the next decades Lore Zech used the Q-banding technique to identify numerous recurrent chromosome aberrations in human leukemias and lymphomas. The most important example is the Burkitt translocation t8;14)q24;q32), still the diagnostic hallmark of Burkitt lymphoma and B-acute lymphoblastic leukemia. She had received tissue of Burkitt lymphomas, which her esteemed collaborator Georg Klein (born 28.07.1925) had obtained from Africa. The description of the Burkitt translocation was the basis to understand that oncogenes are activated by juxtaposition with regulatory sequences, i.e. by translocating the 2, still q24;q32),in locus -15.Born in Gütersloh, Germany, in 1923, Lore Zech lost both parents at the age of 4 years. She grew up with her grandmother in a rural area, the Sauerland, and began to study Human Medicine in 1944 in Marburg (Germany). After the Second World War, it turned out to be impossible to continue her medical studies and therefore she chose biology, chemistry and physics as her topics in Bonn (Germany). For her doctoral thesis, she went to the Max Planck Institute in Tübingen. In 1953 she followed her husband to Sweden and worked in the Institute of Cell Research and Genetics in Stockholm, until 1989. After her “retirement” she joined the Department of Medical Genetics at the University Hospital of Uppsala, where she spent every day involved in chromosome and FISH analyses as well as discussions with many young colleagues.Last year, she was extremely proud that a PhD student had dedicated his work to her stating she was his major inspiration. This characterizes her as empathetic and widely interested and someone who stimulated the research of numerous colleagues. When she visited conferences, she was always surrounded by scientists and students, who sought her advice and her company.One story documents her as a scientist: Lore Zech had detected, but not published, that the Philadelphia chromosome (Ph) was due to the translocation t - she already found that the Ph was a derivative of chromosome 22  - when hth birthday, she was stopped in a traffic control and had a hard time to convince the police officer she was telling the truth when she replied to his question where she was going by: ‘I am going to the institute to work there’.As mentioned above, after her “retirement”, Lore Zech continued to work in and drive every day to the Institute of Medical Genetics, University Hospital of Uppsala, Sweden in her own car. One day, close to her 90Lore Zech was loved by her colleagues and, with her wide range of interests she stimulated discussions on many scientific topics. Particularly for students and young investigators, she served as a mentor inspiring and supporting them by sharing her vast skills and knowledge.Lore Zech died on 13.3.2013 from the progression of chronic lymphocytic leukemia, a disease she had investigated for decades.Lore Zech is deeply missed by all who had the privilege to meet her.


Multimorbidity is now acknowledged as a research priority in primary care. The identification of risk factors and people most at risk is an important step in guiding prevention and intervention strategies. The aim of this study was to examine the relationship between literacy and multimorbidity while controlling for potential confounders.Participants were adult patients attending the family medicine clinic of a regional health centre in Saguenay (Quebec), Canada. Literacy was measured with the Newest Vital Sign (NVS). Multimorbidity was measured with the Disease Burden Morbidity Assessment (DBMA) by self-report. Information on potential confounders  was also collected. The association between literacy (independent variable) and multimorbidity was examined in bivariate and multivariate analyses. Two operational definitions of multimorbidity were used successively as the dependent variable; confounding variables were introduced into the model as potential predictors.One hundred three patients (36 men) 19–83 years old were recruited; 41.8% had completed 12 years of school or less. Forty-seven percent of patients provided fewer than four correct answers on the NVS (possible low literacy) whereas 53% had four correct responses or more. Literacy and multimorbidity were associated in bivariate analyses (p < 0.01) but not in multivariate analyses, including age and family income.This study suggests that there is no relationship between literacy and multimorbidity when controlling for age and family income. Multimorbidity, the coexistence of two or more chronic diseases in the same patient, has received growing interest in the primary care literature over the past few years and is now acknowledged by many as a research priority -6. PatieIn the wake of prevention and intervention strategies to address this issue, the identification of risk factors and of people most at risk is an important aspect. Aging ,9 and loThe Institute of Medicine defines health literacy as “the degree to which individuals have the capacity to obtain, process and understand basic health information and services needed to make appropriate health decisions” . This deNotwithstanding the interest in looking into a potential association between health literacy and different health outcomes such as multimorbidity, health literacy is easier to conceptualize than to measure. Even if valid measures of literacy exist, a measure that accurately depicts the multiple dimensions of health literacy is still needed ,31. MostA low level of literacy has been linked to several negative health outcomes in patients: poorer knowledge of their health problems -35, poorThe aim of this study was to evaluate the relationship between literacy and multimorbidity while controlling for potential confounders.A descriptive study was conducted among patients attending a family medicine clinic of a regional health centre in Saguenay (Québec), Canada. The Saguenay region’s population is approximately 150,000 living in one major city and several smaller boroughs. The Saguenay region has about 130 general practitioners, nearly 80% of whom have a general practice and work in a private office or a public institution. The present study was carried out in an institutional practice (Centre de santé et de services sociaux de Chicoutimi) where 12 family doctors and four nurses provide their services to 9,000 registered patients.The sampling process took place during 10 four-hour sessions over a two-week period. Patients solicited were asked to complete a short questionnaire to determine eligibility. To be included in the study, participants had to be aged 18 years or older and regular patients of the family medicine clinic.Patients were excluded if they presented an unstable acute or psychiatric condition, or if they were pregnant or unable to provide informed consent. Non eligible patients were thanked for completing the short questionnaire for eligibility and no further action was taken with them.Literacy was measured with the Newest Vital Sign (NVS) . The NVSMultimorbidity was measured with a simplified version of the Disease Burden Morbidity Assessment (DBMA) by self-report described by Bayliss and colleagues . The oriTwo operational definitions of multimorbidity were used: 1) the DBMA score while considering all 11 conditions (DBMA 11); 2) the DBMA score while taking into account only six conditions, which were considered to be associated with lifestyle habits or that have been reported as independently associated with inadequate literacy ,45: hypeThe patients were recruited in the waiting room of a family medicine clinic. A research assistant approached each patient to explain the project. All subjects who refused to participate did it at this point, and no data were collected from them. Patients who agreed to participate and met all eligibility criteria were brought to a small separate room where the research assistant obtained their written consent, collected sociodemographic data , and administered both the NVS and the DBMA. The responses to the NVS were collected by the research assistant while the DBMA questionnaire was completed by the patient in the presence of the research assistant who helped them, if needed . Filling out the questionnaires took no more than 10 min. Participants did not receive any payment for participating in the study.The study was approved by the research ethics board of the Centre de santé et de services sociaux de Chicoutimi.The associations between multimorbidity (dependent variable) and the other variables  were first examined in bivariate analyses. In a multivariate general linear modeling analysis, both operational definitions of multimorbidity were used successively as dependent variable, and the variables with a significant relationship with multimorbidity in the bivariate analysis were used as potential predictors in the model. Correlations between predictor variables were examined to determine the presence of collinearity.All analyses were performed with PASW Statistics 18 (SPSS Inc.). The α significance level was set at 0.05.A total of 103 patients (36 men) between 19 and 83 years of age participated in the study; 41.8% had a 12-year or less school education and 30.1% had completed university studies  was an independent predictor of diabetes mellitus and heart failure but not hypertension, arthritis or pulmonary disease, while adjusting for sociodemographic variables , health risk behaviours , and body mass index . AnotherA low level of literacy may be linked to certain health issues and not others. As our measure of multimorbidity evaluated chronic diseases as a whole as well as their severity, we may not have detected a link because of the presence of specific health issues not associated with literacy. An association between literacy and multimorbidity may exist when two or more specific diseases individually related to health literacy coexist in one person. The conceptualization and measure of multimorbidity could therefore have an impact on this association. That is why we conducted analysis using two distinctive conceptualizations and measures, in order to verify if results were different. It was not the case.We found that multimorbidity was associated with age and family income in the multivariate models. The association of multimorbidity with age is well recognized -9,49. ThOur results do not allow us to rule on a potential association between health literacy, a more global concept than literacy ,31, and A limitation of this study is that participants were not randomly selected from the general population. We recruited patients from the waiting room of a single primary care setting. This method may over sample complex patients with several diseases or frequent attendees. However, we were able to recruit a group of patients with a good distribution of multimorbidity and literacy. Another limitation is the lack of statistical power to carry out multivariate analysis by individual disease. Although the study was conducted in one family practice, we expect the same results from similar primary care settings.In conclusion, this study suggests that there is no relationship between literacy and multimorbidity when controlling for age and family income. Patients with multimorbidity may have specific diseases that are associated with low literacy. Further studies are needed to identify individual diseases and combinations of diseases linked to literacy while controlling for potential confounding variables. A possible association between health literacy and multimorbidity still needs to be explored when a comprehensive measure of health literacy is available.The authors declare that they have no competing interests.CH, MF and M-EP conceived and designed the study. MF supervised the data collection, participated in the data analysis and helped draft the manuscript. M-EP participated in the data collection and analysis and critically reviewed the manuscript. JA and CH analyzed the data and drafted the manuscript. All authors read and gave their final approval of the version of the manuscript submitted for publication. CH takes responsibility for the integrity of the work as a whole.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2296/13/33/prepub


All clinicians of today know that scientific evidence is the base on which clinical practice should rest. However, this is not always easy, in particular in those disciplines, where the evidence is scarce. Although the last decades have brought an impressive production of research that is of interest to chiropractors, there are still many areas such as diagnosis, prognosis, choice of treatment, and management that have not been subjected to extensive scrutiny.“Traffic Light System” can be applied to most clinical processes.In this paper we argue that a simple system consisting of three questions will help clinicians deal with some of the complexities of clinical practice, in particular what to do when clear clinical evidence is lacking. Question 1 asks: are there objectively tested facts to support the concept? Question 2: are the concepts that form the basis for this clinical act or decision based on scientifically acceptable concepts? And question three; is the concept based on long-term and widely accepted experience? This method that we call the We explain how the Traffic Light System can be used as a simple framework to help chiropractors make clinical decisions in a simple and lucid manner. We do this by explaining the roles of biological plausibility and clinical experience and how they should be weighted in relation to scientific evidence in the clinical decision making process, and in particular how to proceed, when evidence is missing. For health care practitioners, the first clinical encounter has several important goals, two of these are: 1) to get an idea of what is wrong with the patient and 2) to detect any cases that should be directed elsewhere. Chiropractors, and other professionals who often provide manual therapies, will also work out a “technical” diagnosis in relation to where and what to treat. Thereafter follows the treatment itself, any follow-up procedure, and the long-term strategy. This is a relatively complex process, as many different pieces of information must be considered, brought into a coherent picture and acted upon. In addition, clinicians are expected to keep updated on that part of dynamic knowledge – research – that concerns their area of practice and to apply this knowledge on each patient.All clinicians of today know that scientific evidence is the base on which clinical practice should rest. However, this is not always easy, in particular in those disciplines, where the evidence is scarce. There is also the issue of the definition of “evidence”. Textbooks have been devoted to this. Throughout this text we shall assume that “evidence” equals the “best evidence” available at the time, when evaluating the value of a clinical procedure.Although the last decades have brought an impressive production of research that is of interest to chiropractors, there are still many areas such as diagnosis, prognosis, choice of treatment, and management that have not been subjected to extensive scrutiny. Therefore, some aspects of health care are accepted on their logic and face value and through their repeated and successful use over time.This lack of specific evidence, however, is not always worrying, as it is considered acceptable to extrapolate from generally acknowledged scientific concepts, and it follows that procedures and concepts will, generally, not be questioned when this happens.If the underlying rationale is plausible, in addition to the procedure or concept being accepted by many clinicians, then it is likely that it will be considered relatively “acceptable”. However, the level of acceptance is lower for only logic and experience than it is for scientific evidence. This means that decisions and actions based solely on logic and experience usually cannot stand on their own. An example is that the plausible and frequently used test for an acutely injured lumbar disc, antalgia on flexion of the lumbar spine, can be used to help diagnose this disc problem , but thaHowever, if the concept, act or procedure is not biologically plausible, as judged by the scientific community in general, then experience is not enough to justify its use. This is not surprising, because if a procedure or decision is based on a biologically implausible rationale, it is unlikely that it will be clinically valid.An example of a non-acceptable procedure is the use of a pendulum in order to define the gender of the unborn baby. This method lacks an acceptable contemporary scientific rationale, so even if some people think that this method is useful, it cannot be introduced in an obstetrics department, unless several well carried out studies have shown, unequivocally, that the vast majority of unborn babies can be correctly classified by gender using a pendulum. Thus a very heavy onus of proof would rest upon any person who would claim that this method can be used for this purpose.On the other hand, if, against all odds, a test or treatment that lacks (contemporary) plausibility is shown to be clinically valid in several well designed and appropriately performed studies, then it will be considered “acceptable”. The reason for this is, that the contemporary knowledge may not be sufficient to explain why this is so. An historical example of how, sadly, “the evidence” won over common sense and repeated observations is how dirty hands were dismissed as a cause of puerperal fever in childbirth, because its pathogens had not been discovered .Sometimes the question on whether a concept is logical or not will be answered differently by different groups of practitioners. It is, however, outside the scope of this article to define further “logical” and “biologically plausible” in relation to various chiropractic concepts; this discussion belongs elsewhere. However, the plausibility here refers to that which would be acknowledged as such by the contemporary general scientific community.Obviously, there are many aspects in clinical practice that lurk in the areas of no specific evidence yet considered to be perfectly acceptable because they are based on sound and generally accepted biological/physiological/anatomical/pathological concepts combined with longstanding and widespread experience.For example within spinal care it would be considered acceptable to advise a patient with a very painful and antalgic lumbar spine against digging up his garden whilst in such a state. The rationale for this advice is that such activity would be likely to aggravate the affected spinal structures. This advice has never been tested in a randomized controlled clinical trial; instead it is based on our present understanding of the pathology of the disc and backed up by our experience of outcome in relation to whether this type of patients avoid aggravating activities or not.However, there are other times when clinicians may become confused. For example, when the above patient asks how many treatments he will need and how frequently these should be administered, the rationale for this is not so clear. Should there be frequent treatments over a short period of time  or does it suffice with few treatments ? Further, the experiences of various clinicians may be difficult to evaluate, as each of them probably predominantly acknowledges their own specific rationale and therefore has limited experiences to draw on. Each is likely to assume that their specific approach and experiences represents the gold standard. We contend that the same uncertainty will arise over and over, as other unstudied cases present themselves in the practice.It can be challenging and confusing to make clinical decisions in situations where clear evidence is lacking. Many people find it uncomfortable and difficult to deal with uncertainty and feel safer if they can follow an algorithm of thought, some sort of recipe on how to proceed. This probably explains the plethora of more or less complicated experience-based recipe-type techniques that are available in the chiropractic profession.On the other hand, attempts have been made since the early 1990s to assist chiropractors to perform in an evidence-based and streamlined manner. Most manual and/or observational tests in many health care fields would probably be classified under this category. Examples are visual inspections of radiographs, orthopedic and neurological tests, and auscultation of the abdomen and heart. Other examples would be those chiropractic tests that have been poorly studied or studied with conflicting results yet based on a seemingly logical patho-anatomical concept.Over the past 25 years, particular since the Mercy Guidelines  substant“Traffic Light System”, can be applied to most clinical processes. We shall explain how the Traffic Light System can be used as a framework to help chiropractors make clinical decisions in a simple and lucid manner. We do this by explaining the roles of biological plausibility and clinical experience and how they should be weighted in relation to scientific evidence in the clinical decision making process.In this paper we argue that a simple system consisting of three questions will help clinicians deal with some of the complexities of clinical practice, in particular what to do when clear clinical evidence is lacking. This method, the According to the Traffic Light System, decision making is based on some simple concepts. First, scientific evidence carries more weight than biological plausibility and experience and, in particular, when there is lack of biological plausibility, there is a much stronger need for evidence. On the other hand, if there is biological plausibility, strong evidence may not always be needed, provided that the concept is also backed up by considerable clinical experience. This concept is illustrated in Figure We shall present two clinical situations in which the Traffic Light approach can be used: 1) when examining a patient, and 2) when choosing an appropriate method of treatment. However, we propose that the same approach can be used throughout the entire clinical decision-making process.evidence, plausibility and clinical experience. We suggest that three questions be asked, whenever facing a clinical task, and that the continued activities should be based on a set method to interpret the answers to these questions. In order to provide a simple and easy-to-remember algorithm, we have incorporated the three traffic light colors into the system, green (go), yellow (go with care), and red (stop). The three questions are presented below together with their traffic light interpretations in three steps:The Traffic Light System is a method of approach that can be used to deal with the triad of: green, and you can go on with your procedure or decision. If the answer is “no”, go to the second question.Step 1: Are there objectively tested facts to support the concept? In other words, is there sufficient sound research (evidence) supporting this? If the answer is “yes”, the light is red and you should stop here.Step 2: Are the concepts that form the basis for this clinical act or decision based on scientifically acceptable concepts? In other words, is it logical and lucid, biologically plausible? If the answer is “yes”, go to question three. If the answer is “no”, the light is yellow and you can proceed with care. If the answer is “no”, then stop for the red light.Step 3: Is the concept based on long-term and widely accepted experience? In other words, is ‘everybody’ doing it? If also this answer is “yes”, the light is The use of these three questions will now be demonstrated for two specific clinical aspects, 1) in the examination of the patient, and 2) in the choice of method of treatment. Depending on the answers to these questions, the case will be categorized with one of the three Traffic Light System colors .Example 1: Examining the patientAll questions, observations, and clinical examination procedures that are performed in order to obtain an answer to a clinical question can be classified as “tests”. Without discussing details, in general, tests should be used only if they are in some way useful, i.e. if they can help obtain a diagnosis, direct the type of treatment or hint to the prognosis. Tests that provide no such messages are a waste of time, and are to be considered meaningless rituals that may even confuse the issue. The only exception to this would be tests that are used to describe status over the course of treatment to see how the case progresses but play no role in the diagnosis, treatment or initial indications of prognosis. For example, information on particular positions (e.g. bending forward) or activities (e.g. turn in bed) which are painful.red light tests:We propose that these are 1) The test has been submitted to scientific study and found not to “work” (step 1). This is regardless of whether it can be considered to be a plausible test (step 2) or if it is frequently used (step 3); we suggest that this is not a test to be used. In other words, if the test has been shown to be useless, it is not relevant to proceed to steps 2 and 3.2) The test is illogical (step 2) and it has not been submitted to scientific study to prove its value (step 1). Because it is an illogical test, it would be necessary to have positive evidence to make this test acceptable. Therefore, it is not relevant to continue to step 3.Some tests that make up the examination procedure of various chiropractic technique “systems” belong to this category.yellow light tests:Using the same approach, we propose that the following cases are considered to be 1) The test has not been submitted to scientific scrutiny (step 1) but it is a logical test (step 2) that is generally found to be useful (step 3).2) The test, which is logical (step 2), has been studied scientifically with differing results or with only moderate success  (step 1).Most manual and/or observational tests in many health care fields would probably be classified under this category of insufficient evidence. Examples are visual inspections of radiographs, orthopedic and neurological tests, and auscultation of the abdomen and heart. Another example would be the reliability and validity of the identification of a vertebral segment requiring manipulation by using, for example, various types of palpation; generally incompletely studied and/or with conflicting research results but for many seemingly logical.green light tests are the following:According to our method of approach, 1) All tests that have been studied scientifically and found to work (step1), regardless of whether they are plausible or not (step 2).2) Several moderately useful tests that, when combined, are found to ‘work’ (step 1).Manual and observation tests in the green category are uncommon.To conclude, illogical tests must be shown to be valid before they can be used, whereas logical and commonly used but ‘untested’ tests are relatively acceptable provided that major decisions are not based entirely on one such single test.Example 2: Selecting the treatmentOnce patients who are unsuitable for treatment have been excluded (because they have either a contra-indication or a non-indication to treatment), and patients who are thought suitable for treatment have been accepted , the next question to be dealt with is: How should this patient be treated?Again, we suggest that the Traffic Light System can be used in relation to the choice of treatment method. We shall assume that the chiropractor wishes to select a particular manual technique, either one that includes an analytic method  or one red light techniques are those that are 1) illogical and untested or 2) logical but tested and found not to “work”. Yellow light techniques are logical and used extensively with seemingly good results but “unproven” or with research findings indicating only moderately good results or with fluctuating study results between studies. Green light techniques are logical , tested and found to “work”.Using the same theoretical approach as previously, “Ordinary” generic manipulation has been used in randomized clinical trials in which the value of spinal manipulation was studied. The results of these studies generally indicate that there is some clinical effect albeit small and not much different to other modalities including sham . So it cIn the case where a treatment technique is encapsulated within a “system” such as the Sacro-Occipital Technique, it would be relevant to separate the analytical (diagnostic) part from the therapeutic part. The reason for this is that it would be possible for the analytical part  to be a “red light” test whilst the therapeutic aspect of the technique (for example pelvic blocking) could be yellow or even potentially green.With these explanations we hope to have shown how the Traffic Light System can be used to guide chiropractors through a simple thought process, in which they should habitually consider three questions: Is there specific sound research evidence in favor of this clinical procedure? If not, is it at least logical/biologically plausible? And if so, has it gained wide clinical acceptance? Positive or negative answers to these questions will then be interpreted as one of the three lights, red, yellow or green. Green light means “go ahead”, yellow means “proceed with care”, whereas red means “stop”.After having applied this method for a while, it will become clear that most clinical procedures in chiropractic practice (diagnostic tests and choice of specific techniques) probably belong under the yellow light.This abundance of yellow lights makes it obvious that, although the “science of chiropractic practice” is very important, what the clinician often has to deal with is the “art of chiropractic”, in the general absence of evidence. This demands an ability to deal with uncertainty. How well this can be handled would depend on patient values and circumstances, but the practitioner’s own clinical experience and his/her own ethical stamina are also very important. These additional issues, therefore, deserve careful consideration.The authors declare that they have no competing interests.CLY presented the concept and all authors discussed this, CLY drafted the manuscript, OL performed a literature review, and all authors reviewed, revised and accepted the final version. The concept has been previously partially presented at professional conferences. All authors read and approved the final manuscript.Professor Charlotte Leboeuf-Yde, DC, MPH, PhD. The Spine Research Centre, Hospital Lillebaelt, and Institute for Regional Health Research, University of Southern Denmark, Middelfart, Denmark, and Visiting Professor, Complexité, Innovation et Activités Motrices et Sportives, Bâtiment 335, UFR STAPS, Université Paris Sud-11, Orsay Cedex 91405, FranceOlivier Lanlo, DC, LLM, Executive President Institut Franco-Européen de Chiropraxie, Paris and Toulouse, FranceAssociate Professor Bruce Walker, School of Health Professions, Discipline of Chiropractic, Murdoch University, Perth, Western Australia, AustraliaCharlotte Leboeuf-Yde’s position in Denmark was until the 31.12.2012 partially funded by’Fonden til fremme for kiropraktisk forskning og postgraduat uddannelse’.


There has been increasing emphasis on evidence-based approaches to improve patient outcomes through rigorous, standardised and well-validated approaches. Clinical guidelines drive this process and are largely developed based on the findings of systematic reviews (SRs). This paper presents a discussion of the SR process in providing decisive information to shape and guide clinical practice, using a purpose-built review database: the Cochrane reviews; and focussing on a highly prevalent medical condition: hypertension.We searched the Cochrane database and identified 25 relevant SRs incorporating 443 clinical trials. Reviews with the terms ‘blood pressure’ or ‘hypertension’ in the title were included. Once selected for inclusion, the abstracts were assessed independently by two authors for their capacity to inform and influence clinical decision-making. The inclusions were independently audited by a third author.Of the 25 SRs that formed the sample, 12 provided conclusive findings to inform a particular treatment pathway. The evidence-based approaches offer the promise of assisting clinical decision-making through clarity, but in the case of management of blood pressure, half of the SRs in our sample highlight gaps in evidence and methodological limitations. Thirteen reviews were inconclusive, and eight, including four of the 12 conclusive SRs, noted the lack of adequate reporting of potential adverse effects or incidence of harm.These findings emphasise the importance of distillation, interpretation and synthesis of information to assist clinicians. This study questions the utility of evidence-based approaches as a uni-dimensional approach to improving clinical care and underscores the importance of standardised approaches to include adverse events, incidence of harm, patient’s needs and preferences and clinician’s expertise and discretion. Much has been written about evidence-based medicine (EBM) and its potential to inform practice. The terminology surrounding the aggregation of evidence in a systematic way implies that there is a practical import to this work, and the terms “evidence-based practice” (EBP) and “evidence-based approaches” (EBA) have arisen from this concept. The EBA are among the most significant contemporary ways of conceptualising health care, both theoretically and practically , and areDespite the appeal of EBA, and the widespread recognition of this approach in driving care, they present a number of challenges, and there has been a steady undercurrent of concern about their pervasive acceptance and promotion. Debate has focussed on several key factors, including the nature of evidence, particularly the privileging of some forms of evidence and the marginalising and devaluing of others -5. ConceNotwithstanding the theoretical critique however, the aim of EBA is to facilitate the integration of the best available research evidence into practice by transparently assimilating information and aggregating data in ways that can help guide clinical decision-making . Indeed,The purpose of this paper is to explore the efficacy of the systematic review (SR) process in providing decisive information to shape and guide clinical practice. To do this we examined SRs on the management of blood pressure. We chose this because hypertension is a well-researched, common and persistent condition with a significant effect on health outcomes . The CocCochrane Database of Systematic Reviews (http://www.cochrane.org/cochrane-reviews) on 1/12/11 were undertaken to search for SRs on interventions to lower blood pressure. Reviews with the terms ‘blood pressure’ or ‘hypertension’ in the title were included. Once selected for inclusion, the abstracts were assessed independently by two authors. SRs were excluded if they pertained to blood pressure targets, pulmonary hypertension, hypertensive emergencies, acute cardiac events, gestational, postpartum, infant, neonatal and child hypertension. Furthermore, SRs were also excluded if the details of the number of clinical trials were not provided, and if the SR did not include any completed studies. Inclusions were independently audited by a third author.Independent manual searches of the reviews published on the Twenty-five SRs representing a combined total of 443 clinical trials were identified . The recognition of complex interventions in clinical care is another important consideration [Systematic reviews are only as good as the sum of the parts. Strategies such as standardised reporting of clinical trials through CONSORT methods offer some promise in increasing the rigour and usefulness of research .This review also emphasises the need for expertise and interpretation when developing clinical practice guidelines, particularly in the absence of robust Level 1 evidence and differences in clinical trial populations and patient groups. Indeed, it is certainly important to identify where the evidence does not support a particular line of practice. We argue that the corollary is not disproven by this approach, that is, practice may be improved by a particular intervention despite the null hypothesis, but the evidence isn’t strong enough in a normative way. There are many possible reasons why the level of evidence to support EBA in practice will not always be strong enough to inform practice. Assessing change in practice is difficult and robust methodologies have yet to be derived; the process is long-term and it will take some time for robust evidence to emerge; and, the evidence provided to support clinical decision-making may no longer be useful in practical settings. Based upon this review, data from SRs are only one part of the picture. Using systematic guideline development processes such as in ADAPTE framework are an important part of this process (http://www.cochrane.org: accessed 16/1/12).Clearly there is a desire for contemporary and rigorous information upon which clinical treatment can be guided and individual clinical decisions made. The demand for this is evidenced in Cochrane’s own usage data, which states that “every day someone, somewhere searches The Cochrane Library every second, reads an abstract every two seconds and downloads a full-text article every three seconds” (Initially, the EBA have been viewed as a way of incorporating research into practice. The EBA does not always have high utility and reference for consistently assisting clinicians, particularly in groups not included in clinical trials. While the use of a single health issue may be viewed as a limitation of this paper; in using this common health issue – blood pressure management - as a lens, we have raised questions about whether SRs as the core of clinical guideline development can reliably influence practice in an interventional way, and about the strength of evidence that is available to inform clinical practice in some key areas.The authors declare that they have no competing interests.DS conceptualized the project, analysed the data, and contributed to literature and internet searches and drafted parts of the manuscript. DJ analysed the data, and contributed to literature and internet searches and drafted parts of the manuscript. PN audited the data analysis, contributed to literature and internet searches and drafted parts of the manuscript. PMD reviewed the data analysis, contributed to literature and internet searches and drafted parts of the manuscript. DS, DJ, PN, PMD critically reviewed and revised many versions of the drafted manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6947/13/25/prepub


While many women and infants have an uneventful course during the postpartum period, others experience significant morbidity. Effective postpartum care in the community can prevent short, medium and long-term consequences of unrecognised and poorly managed problems. The use of rigorously developed, evidence-based guidelines has the potential to improve patient care, impact on policy and ensure consistency of care across health sectors. This study aims to compare the scope and content, and assess the quality of clinical guidelines about routine postpartum care in primary care.PubMed, the National Guideline Clearing House, Google, Google Scholar and relevant college websites were searched for relevant guidelines. All guidelines regarding routine postpartum care published in English between 2002 and 2012 were considered and screened using explicit selection criteria. The scope and recommendations contained in the guidelines were compared and the quality of the guidelines was independently assessed by two authors using the AGREE II instrument.Six guidelines from Australia (2), the United Kingdom (UK) (3) and the United States of America (USA) (1), were included. The scope of the guidelines varied greatly. However, guideline recommendations were generally consistent except for the use of the Edinburgh Postnatal Depression Scale for mood disorder screening and the suggested time of routine visits. Some recommendations lacked evidence to support them, and levels or grades of evidence varied between guidelines. The quality of most guidelines was adequate. Of the six AGREE II domains, applicability and editorial independence scored the lowest, and scope, purpose and clarity of presentation scored the highest.Only one guideline provided comprehensive recommendations for the care of postpartum women and their infants. As well as considering the need for region specific guidelines, further research is needed to strengthen the evidence supporting recommendations made within guidelines. Further improvement in the editorial independence and applicability domains of the AGREE ll criteria would strengthen the quality of the guidelines. Childbirth and the subsequent postpartum period is an exciting and special life experience for many women. However, it is also a time of great change, physically, mentally and socially for mothers, infants and families. While many mothers and infants transition through this time uneventfully, others find it overwhelming or develop significant health issues that may persist for weeks and months after giving birth. For example, up to 50% of women report tiredness -6 and baPostpartum depression is also common -3,6,10 aWomen who rate their health as low are more likely to report symptoms that affect general physical functioning and well-being such as tiredness, headache, musculoskeletal problems, mastitis, perineal pain and dysuria .Overall, nearly 70% of women describe at least one physical problem within the first 12 months postpartum . For 25%Some infants also experience problems with reports of hypernatraemic dehydration , feedingto detect health problems of mother and/or baby at an early stage, to encourage breastfeeding and to give families a good start’ [Although childbirth must be considered a ‘normal’ part of life, considering the significant life changes associated with it and the burden of morbidity in this population, the aim of care in the postpartum period beyond the immediate peripartum phase must be ‘d start’ . As mostd start’ -25.Although there are some concerns about the practicality of clinical practice guidelines , they prThe aim of this study was to identify clinical guidelines that address routine postpartum care in the primary care setting, to compare their scope and content, and assess their quality.PubMed was searched in December 2012 for articles published in the previous 10 years using the terms perinatal, puerperium, postnatal, postpartum and limited by ‘clinical guidelines’. Since guidelines are rarely published in medical journals, a wider search employing guideline specific databases such as the National Guideline Clearinghouse (NGC) and National Institute for Health and Care Excellence (NICE) was undertaken and relevant college websites in English-speaking countries including the Royal College of Obstetricians and Gynaecologists (RCOG), Royal Australian College of General Practitioners (RACGP) and the American Academy of Pediatrics (AAP) were searched for guidelines. Reference lists of identified guidelines were also searched.To be included in this study the guidelines had to: include recommendations on routine postpartum care and complications arising in the postpartum period; target primary health care providers; aim at a state or nation-wide level; outline recommendations for care with directly cited levels or grades of evidence; include a reference list; and be available in English full text on the internet. No other inclusion and exclusion criteria were used.Each guideline was summarized by one author (CH) to identify key points and recommendations. These summaries were checked by other authors for completeness and accuracy. Direct comparisons of the scope of the guidelines within four themes  were tabulated by one author (CH) and then checked by other authors to ensure they were correct. These broad themes were chosen to assist with comparisons between guidelines and to cover the majority of the recommendations within the all guidelines.For comparison of the content of the recommendations and to highlight similarities and differences, five key areas were selected: timing of routine visits; screening for mood disorders; maternal health checks; infant health checks; and promotion of breastfeeding. Where recommendations differed, the quality and strength of evidence cited was examined.To objectively evaluate the quality of each guideline the Appraisal of Guidelines for Research & Evaluation Instrument (AGREE II) was used . AGREE ITwo authors (CH and MVD) independently scored each guideline. Domain scores were calculated by dividing the difference between the obtained score and the maximum possible score by the difference between the maximum and the minimum possible score. In keeping with similar studies, guidelines with scores of less than 50% were deemed to be of low quality -33.A total of 626 references were identified by the search. The titles and abstracts of these articles were reviewed by CH and 607 references were discarded because they were not primarily clinical guidelines or their scope did not include postpartum care in primary care. The full text of a further 19 references were compared against the inclusion criteria and another 13 articles were rejected, leaving six guidelines for inclusion in the review  is summarised in Table The NICE , RACGP  and FacuTwo guidelines   guidelinAll six of the guidelines provided recommendations regarding breastfeeding, although for three guidelines it only related to maternal medications and the effect on breastfed infants. Areas covered included breastfeeding promotion and initiation and common problems mothers’ experience. Some of the recommendations provided by the NICE guideline applied to in-hospital care and are therefore outside the scope of this review.Under its ‘clinical care pathway’ the NICE guideline key recommendations are divided into three time bands - within 24 hours, between two and seven days and between two and eight weeks (from day 8 onwards). This guideline mentions a routine six to eight week postpartum consultation and discusses some of the strengths and weaknesses of the care currently delivered in this consultation. However, this point is not listed in the overall recommendations and is graded as a ‘good practice point’ indicating it is a recommendation based on expert opinion and long-standing practice rather than direct evidence. The ICSI recommends that ‘preventive service’ visits should occur within the first two weeks after birth and at two, four, six to nine, 12 and 15 months of age. It notes, however, that there is insufficient evidence to recommend one visit schedule over another with evidence cited from two earlier guidelines with recommendations based on ‘low quality evidence’. The SIGN, beyondblue, FSRH and RACGP guidelines do not include clinical care pathways and timing of routine visits is implied rather than explicit. For example, the SIGN guideline suggests enquiring about depressive symptoms postpartum at four to six weeks and three to four months postpartum, suggesting a visit at that point in time. Similarly the beyondblue guideline recommends that screening for postpartum depression between six and 12 weeks after birth during an existing routine postpartum visit. The only statement in the RACGP guideline that includes a timeframe is that the first routine immunisation for a newborn should be at six to eight weeks.The two Australian guidelines (beyondblue and RACGP) recommend the use of the Edinburg Postnatal Depression Scale (EDPS) as a component of the assessment for depression and co-occurring depression and anxiety in postpartum women. Following a review of the existing literature (15 articles between 1987 and 2008) which found that the EPDS had a high sensitivity and specificity and therefore could be considered an appropriate screening tool, beyondblue graded their recommendation ‘B’. This means that the body of evidence can be trusted to guide practice in most situations. They recommend that screening be undertaken between six and 12 weeks postpartum.In contrast, the NICE guideline recommends against using the EPDS as a screening tool, although it may serve as part of assessment alongside professional judgement and clinical interview. The SIGN guideline also only recommends using the EPDS or Whooley Questions  to aid clinical monitoring and to facilitate discussion of emotional issues. Both guidelines recommend asking women about their emotional well-being at every visit (NICE) or at least at four to six weeks and three to four months postpartum, more frequently in women at high risk (SIGN). Both guidelines use the evidence provided in the National Institute for Health and Clinical Excellence Antenatal and Postnatal Mental Health Clinical Management and Service Guidance , to refeThree guidelines contained information about maternal health checks. The NICE guideline provides detailed recommendations under subheadings about routine care and specific problems women may encounter. Topics covered range from urine and bowel problems and sexual difficulties to tiredness, contraceptive use and maternal diet. Many of the key recommendations made in the clinical pathways for postpartum care were ‘good practice points’ and were based on expert opinion. The FSRH guideline focused primarily on sexual health  and contraception and included recommendations about opportunistic consultations about pertinent issues and the need to be able to access appropriate information and support for women, and to refer when necessary. The RACGP guideline contained only one recommendation in this content area; that women should be asked about urinary incontinence on a yearly basis.Three guidelines  contained a number of age related health checks for newborns and infants. Many recommendations involved screening for physical conditions and infant development, haemoglobinopathies, metabolic and endocrine conditions (e.g. phenylketonuria and hypothyrodisim) and other congenital problems such as hearing loss. Preventative counselling for issues including SIDS prevention/safe sleeping, non-accidental injury and immunisation is also recommended. In addition, the guidelines discuss the benefits of assessing family functioning and parent-infant interactions and providing information about available community services. The ICSI guideline recommends against the use of routine biochemical tests.Although the recommendations provided were consistent between guidelines, the levels of evidence cited varied for the same recommendation. For example evidence for immunisation is given level A by the RACGP and Level 1 by the ICSI guideline, but only a ‘good practice point’, indicating a lack of good quality evidence supporting the recommendations, in the NICE guideline.Three guidelines  recommend that breastfeeding should be supported and promoted regardless of the location of care. In addition, the NICE guideline provides a number of detailed recommendations including that all health care facilities should have a written breastfeeding policy that is communicated to all staff and parents. It also recommends that breastfeeding should be discussed with women at each contact with additional support being provided if necessary. Breastfeeding progress should then be assessed and documented in the postnatal care plan at each contact. Both the SIGN and beyondblue guidelines only included information on the suitability of using psychotropic drugs during the breastfeeding period while the FSRH guideline made recommendations about contraceptive methods and breastfeeding.Five of the six guidelines were able to be reviewed using the AGREE II criteria. The RACGP guideline did not provide sufficient information for AGREE II assessment.Overall, there was a high degree of agreement between the two independent reviewers’ AGREE II scores. This was reflected in the overall scores, with the average of all six domains for each guideline being greater than 50%. The only guideline with a domain score deemed to be low quality (less than 50%) was the editorial independence domain in the ICSI guideline. Details for the scoring for each guideline can be found in Table All of the guidelines received high scores for describing their scope and purpose, and stakeholder involvement. Generally the guidelines used systematic methods to select evidence and described their criteria for selection in their final documents. Most guidelines also described the methods for formulating their recommendations clearly and generally the recommendations were specific, unambiguous and easily identifiable. In comparison to other domains, most guidelines scored poorly in applicability. They neglected to include information regarding monitoring and auditing, and details regarding the implementation of recommendations into practice was rarely covered. All five guidelines failed to adequately describe how they ensured that the views of the funding body did not influence the content of the guidelines. Despite stating how the ICSI has a transparent policy with regard to disclosing conflicts of interest, actual conflicts of interest were not disclosed. Therefore this guideline was the only one to score less than 50% in any one domain.Only six guidelines from Australia (2), the UK (3) and the USA (1) met the inclusion criteria and were reviewed. There was a significant variation in the scope of the guidelines with only one guideline encompassing routine postpartum care for the mother/infant dyad and providing sufficient detail to enable a practitioner to provide appropriate care to women during this period . The othThe scarcity of comprehensive guidelines for mothers and infants is a concern because of the stress many women experience at this time, the high burden of maternal morbidity postpartum  and the The lack of evidence is especially apparent when considering the recommendations for the timing of routine visits. While two guidelines had explicit timing for visits , the others implied health professional contact at various times throughout the postpartum period. The ISCI guideline explicitly states that there is no evidence that one regime for postpartum visits is better than another . Other aIn addition, although three guidelines discuss performing routine examinations on infants, the ISCI again states that there is no evidence that examining an asymptomatic child is beneficial in identifying occult disease . HoweverThere was also inconsistency across guidelines in regards to the screening of women for postpartum depression with two recommending and two not recommending the use of EPDS. The recommendations in all four guidelines are the result of systematic reviews of the literature. However, the review conducted by beyondblue (on which the RACGP recommendation is based) was conducted at later point in time than that used by NICE and SIGN when additional high quality trials of the use of the tool had been undertaken. These findings stress the need to update guidelines on a regular basis as new evidence is accumulated .insufficient evidence, different interpretations of the evidence, unsystematic guideline development methods, the influence of professional bodies, patient preferences, cultural and socioeconomic factors or characteristics of the health care system’ [Variability between guideline recommendations is not uncommon -48. Matt system’ . A numbe system’ ,50.The AGREE II instrument can assist guideline developers as well as providing a framework for reviewing quality of guidelines, as was undertaken in this review. Despite all six guidelines being published after the release of the AGREE instrument, only one guideline (RACGP), mentioned its use during guideline development. Surprisingly, the RACGP guideline failed to report their methodology sufficiently for reviewers to use the AGREE II criteria to score the guideline. As noted by Greuter et al. , one wouSimilar to prior reviews of guidelines, applicability and editorial independence domains scored the lowest ,32. In tOne limitation of the study was the exclusion of guidelines that were not available to download over the internet. However, guidelines are there to guide clinical practice and need to be readily available to those who need them. Another limitation was the inclusion of English language guidelines only. This may have led to the exclusion of other relevant guidelines, designed for use in areas such as continental Europe and Asia that may have brought a different cultural perspective to the review. Although attempts were made to obtain all guidelines that fitted the inclusion criteria, some may have been missed if they were not retrieved with the search terms used.Clinical practice guidelines provide an avenue for practitioners to access critically-evaluated evidence-based recommendations for the care of their patients. This review found only six guidelines from the international literature that satisfied the selection criteria and addressed out-of-hospital maternal and infant care in the postpartum period. Despite the quality of the guidelines and the similarity of recommendations, only one guideline covers routine postpartum care for the mother and infant. It is important that the mother and infant be seen as a unit, particularly in the first few months of life, because what affects one inevitably affects the other. It is also important not to position normal postpartum care within an illness framework when most women and infants have an uneventful course. Further research into care within the postpartum period is warranted as many recommendations, such as timing of visits and maternal and infant examinations, are not backed up by high levels of evidence, often relying on historical models of care and the status quo. In addition, there needs to be increased rigor into formulating guidelines, or at least in reporting the development of guidelines – especially with regard to editorial independence and mechanisms to up-date the guidelines.AAP: American Academy of Pediatrics; AGREE ll: Appraisal of guidelines for Rrsearch & evaluation instrument; EDPS: Edinburg postnatal depression scale; ICSI: Institute for clinical systems improvement; NGC: National guideline clearinghouse; NICE: National Institute for Health and Care Excellence; RACGP: Royal Australian College of General Practitioners; ROCG: Royal College of Obstetricians and Gynaecologists; SIGN: Scottish Intercollegiate Guidelines Network; UK: United Kingdom; USA: United States of America.The authors have no competing interests.CH participated in the design of the study, undertook the literature search, summarised the guidelines, assessed the guidelines for quality and wrote the majority of first draft of the manuscript. MVD conceived and participated in the design of the study, reviewed the literature search and guideline summaries, assessed the guidelines for quality and reviewed and revised the manuscript. BM conceived and participated in the design of the study, reviewed the literature search, guideline summaries and quality assessment and reviewed and revised the manuscript. WB conceived and participated in the design of the study, reviewed the literature search, guideline summaries and quality assessment, contributed to the first draft of the manuscript and edited subsequent drafts. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2393/14/51/prepub


While the past two decades have seen a shift towards evidence-based obstetrics and midwifery, the process through which a culture of evidence-based practice develops and is sustained within particular fields of clinical practice has not been well documented, particularly in LMICs (low- and middle-income countries). Forming part of a broader qualitative study of evidence-based policy making, this paper describes the development of a culture of evidence-based practice amongst maternal health policy makers and senior academic obstetricians in South AfricaA qualitative case-study approach was used. This included a literature review, a policy document review, a timeline of key events and the collection and analysis of 15 interviews with policy makers and academic clinicians involved in these policy processes and sampled using a purposive approach. The data was analysed thematically.The concept of evidence-based medicine became embedded in South African academic obstetrics at a very early stage in relation to the development of the concept internationally. The diffusion of this concept into local academic obstetrics was facilitated by contact and exchange between local academic obstetricians, opinion leaders in international research and structures promoting evidence-based practice. Furthermore the growing acceptance of the concept was stimulated locally through the use of existing professional networks and meetings to share ideas and the contribution of local researchers to building the evidence base for obstetrics both locally and internationally. As a testimony to the extent of the diffusion of evidence-based medicine, South Africa has strongly evidence-based policies for maternal health.This case study shows that the combined efforts of local and international researchers can create a culture of evidence-based medicine within one country. It also shows that doing so required time and perseverance from international researchers combined with a readiness by local researchers to receive and actively promote the practice. A shift has taken place in obstetrics over the past three decades ,2. This Research on the process of knowledge translation has generated a considerable body of work on both the range of factors influencing the uptake of evidence into policy and practice ,20 and tThe findings reported below tell the story of the development of a culture of evidence-based obstetrics in South Africa. These findings emerged from a broader qualitative case study which focused on policies regarding the management of eclampsia and severe pre-eclampsia, and particularly the use of magnesium sulphate in the management of these conditions . The focprocesses, rather than simply the outcomes, of research utilisation. Throughout we attempted to adopt a reflexive stance by maintaining an awareness of our influence over the research process and outcomes , grasped with both hands. I think a lot of our research is clinical. So trials are our - if you want to do research - is our bread and butter. We are not going to really be able to do much on the biochemical research because of [lack of] resources and so on. So our research and our strengths are in clinical trials.... I don't think there's any institution out there, O & G [obstetric and gynaecological] academic institution, which doesn't use Cochrane extensively." (Resp 7 p. 21)The international trend or shift in consciousness around evidence was replicated within academic obstetric practice in South Africa. South African academics were not only the passive recipients of international evidence. They were also reviewing it in relation to health conditions being treated locally - for example, in 1980 a researcher at the University of Natal published the results of a survey of hypertension in pregnancy as experienced at the hospital in which he worked as well as a review of the management of hypertension in pregnancy ,48. Simi1994 saw the election of the first democratic government in South Africa. This shift brought about changes in the national management of maternal health including new values and a new policy making staff . Amongst"But I mean, in the world we live today, it is the world of evidence-based practice, evidence-based medicine. So one had to be careful about... cognizant of the fact that one had to use the best available evidence. Because I mean, this would be national... it would be a reflection of us as a country." (DoH 3)It was very clear from this set of interviews that respondents' conceptualisation of evidence reflected the same understanding of the term promoted by proponents of evidence-based medicine internationally . The int"No, it [the Perinatal Education Programme manual] was purely evidence-based. We really tried to be as scientific as possible... the Oxford Database [of Perinatal Trials] was used very extensively, and subsequent to that the Cochrane database. So we tried to stick as close as possible to evidence-based medicine and not sort of traditional ways and means of dealing with things, but really to make it, have it scientifically founded." (Resp 1 p. 2)What this data extract reveals is a sense of evidence-based practice and decision making as being more scientific and therefore 'better' or more sound than the traditional practice of medicine. It carries with it a sense of being modern rather than old fashioned. In another data extract, a respondent links evidence-based medicine with best practice, even suggesting that a sense of prestige surrounds the practice of evidence-based medicine:"At that stage [the 1970s], I was a member of [an international obstetrics] society and attended all their congresses, and I was director of [a] perinatal mortality research unit... So of course, you wanted to do the best practice. You wanted to use the best protocols. You wanted to do evidence-based medicine. And our connections with the Cochrane library also started very long ago when it still used to be the Oxford Database of Perinatal Trials, and Iain Chalmers, who once gave a lecture in South Africa. [1989], I once visited him in London. So we became aware of randomised controlled trials very, very early.... He quoted me in his talk and saying that we were one of the first South Africans to do randomised controlled trials" (Resp 6 p. 5)The conceptualisation of 'evidence' as being based on the findings of RCTs and systematic reviews, and as a key element of scientific best practice, was noted from the start of interviewing. We also found that this conceptualisation was present and influential in the writing of national policies and guidelines for maternal care. Following the democratic elections of 1994, the following guidelines for maternal care were produced by the new administration:Guidelines for Maternity Care in South Africa: A manual for clinics, community health centres and district hospitals, (2000 & 2002)[• 0 & 2002)Saving Mothers: Policy and Management Guidelines for Common Causes of Maternal Deaths, (2001) [• , (2001) Saving Mothers: Second Report on Confidential Enquiries into Maternal Deaths in South Africa, 1999-2001, (2002)[• 1, (2002)Review of these policy documents showed very concrete and explicit examples of research utilisation in policy making and guideline development. For example, both of the editions of the Guidelines for Maternity Care carry in their introduction a statement reading: "The guidelines are based on the best available evidence from published research, modified where necessary to suit local conditions". We also observed a strengthening in the use of research evidence in policy documents over time. While the early policies merely informed the readers that evidence was used, the later documents cited which evidence was used for specific recommendations, and also listed the grade or strength of this evidence. Thus for example in its recommendation for eclampsia treatment, the Saving Mothers Policy and Management Guidelines state: "Magnesium sulphate is the best drug to arrest and prevent further convulsions Grade A evidence. ".Despite extensive attempts to identify differing views, our respondents included only one person who was not wholly supportive of evidence-based medicine. This person (Resp 8) felt that the use of evidence was important and to this end he taught the skills of evidence-based medicine to his obstetric registrars (trainees). However, he also felt that there was a lack of critical appraisal in the use of evidence. He felt that sometimes proponents of evidence-based medicine were more interested in the methods than in the relevance of question. This respondent added that patients needed to be treated individually, calling for the use of clinical judgement, not only adherence to the evidence. Furthermore he felt that the conduct of trials had become an industry. This debate regarding the application of research evidence to policy questions and individual clinical cases is long standing. Alongside the growing strength of evidence-based medicine, there is also wide acceptance amongst its proponents that randomised controlled trials need to be combined with other information, such as the values of preferences of service users and other stakeholders, to address complex clinical and health policy questions ,56.The success with which a culture of evidence-based medicine spread within senior obstetrics networks in South Africa stands in sharp contrast to the literature describing a lack of access to and awareness of evidence in many LMICs ,9-18. WhThe first key lesson is that this process, as well as the growth of evidence-based obstetrics internationally, was a consequence of considerable time and effort on the part of a large number of highly motivated and skilled individuals and networks, who acted as champions in advocating this approach. The presence, in the South African context, of a fairly large number of senior, locally trained academic obstetricians who had worked in the field over long periods of time, thereby creating a 'critical mass' of people with shared views, may have further contributed to the development of a culture of evidence-based medicine. This facilitator may not be present in a number of other low- and middle-income countries, where the number of senior obstetricians may be very small.It is also worth noting that the widespread culture of evidence-based medicine amongst our respondents took twenty years to cultivate. Given the length of time that it took for evidence-based medicine to diffuse into obstetric practice internationally, this is hardly surprising. Reflecting on the international process, Murray Enkin eloquently states:"This pioneering approach received academic accolades, but seemed to have little influence on obstetrical practice. It took what seemed to us to be ages before the profession and the public began to appreciate how effective randomized trials could be as a way to choose between alternative forms of care. We should have been more patient; shifts in paradigms do not occur quickly." (p266)A second key lesson is that the idea of 'evidence', and particularly evidence as constituting the findings of RCTs and systematic reviews, seems to have spread through personal contact and advocacy. Recent efforts such as HINARI  and the Reproductive Health Library rely on health professionals coming into contact with the evidence electronically. Unfortunately both of these interventions have met with challenges ,18. HINAThirdly, the idea of evidence was spread despite the academic isolation of South Africa as a consequence of apartheid. This seems to have been due in part to personal determination on the part of both South African researchers and their international counterparts to ensure that evidence-based interventions that could improve maternal health in disadvantaged communities were translated into policy and practice.In summary then, the growth of a culture of evidence-based medicine amongst obstetricians in South Africa took patience, interpersonal contact and personal determination on the part of a number of key champions. Furthermore, adopting an evidence-based approach was associated with being 'modern' or keeping abreast of the times scientifically. This attitude permeated the policymaking process where at least some key policy developers felt that it was important for the country that its policies be seen to be evidence-based. Of course, evidence-informed maternal health policies are only part of the complex package needed to improve maternal health in settings such as South Africa. For example, despite the robustness of evidence for the provision of continuous support for women during labour , researcConstraints such as over extended staff and health resource shortages also need to be addressed  and thesThis paper has two key limitations. Firstly we did not set out in this study to explore the development of a culture of evidence-based medicine. Rather, we discovered its existence in the process of understanding the relationship between evidence and policy. This means that we may not have explored the topic to its full extent. A second limitation is that we only interviewed senior members of the obstetrics and gynaecology fraternity since they were key figures in policy development. Our focus on this 'policy elite' means that we have little direct data on whether this culture of evidence-based medicine permeated through the maternal health domain more broadly. This is a common constraint of policy analysis case studies .This case study from South Africa shows that it is possible to create a culture of evidence-based medicine that facilitates and supports evidence-based practice by obstetricians. Enabling this culture in this setting, however, took time, perseverance and effort, both from local researchers and their colleagues internationally. Importantly, because local researchers were already open to the concept of evidence-based practice and were organising themselves to promote this, they proved to be fertile ground for initiatives brought by international proponents of this approach to health care delivery.The authors declare that they have no competing interests.KD conducted the research and wrote the paper supervised by SL who was the principal investigator for the study in South Africa. They were supported actively in the process by the Practihc Policy Group. All authors read and approved the final manuscript.


As public health practitioners from the National Asthma Control Program (NACP) of the Centers for Disease Control and Prevention, we read the essay "From Evidence-Based Medicine to Evidence-Based Health: the Example of Asthma"  with greA recent article  describeMuch work remains to be done to achieve evidence-based health (as defined by Moskowitz and Bodenheimer), particularly among racial/ethnic minorities, who have a disparately high prevalence of and morbidity from asthma. The authors note 3 necessary actions: linking clinical teams with community resources to address asthma triggers in housing, advocating for better housing and cleaner air, and convincing insurers to reimburse for essential educational and community health services. We suggest that these actions, although necessary, are not sufficient to decrease the burden of asthma at a population level.Although sufficient evidence exists to direct the clinical management of asthma, there is an urgent need to expand the evidence for cost-effective ways to implement medical and behavioral interventions on a large scale and among diverse settings and communities. Moskowitz and Bodenheimer cite reports of successful asthma interventions in several communities. These interventions, although key demonstration projects, are the equivalent of clinical case studies. Just as experts would not base clinical guidelines on case studies, program planners and policy makers should not base decisions about community health interventions on a few demonstration projects.No national system exists to direct program implementation questions back to an organized research effort and address them systematically. Both the research to determine the most cost-effective strategies for ensuring that evidence-based treatments reach the populations most in need and the programs charged with implementing those strategies are grossly underfunded. As Steven Woolf argues , the vasThus, we agree with Moskowitz and Bodenheimer that implementing evidence-based health "is essential to reduce the burden of asthma and other chronic diseases and to help control the associated costs to society." We add, however, that implementation is not a matter of "just doing it." Implementation is a science that requires a systematic cycle of hypothesis formation, testing, analysis, feedback, and dissemination. It should be valued and funded at a level that reflects its potential for improving the public's health.


To evaluate the quality of clinical practice guidelines (CPGs) for otorhinolaryngology in China.A systematic search of relevant literature databases  published between 1978 and March 2012 was undertaken to identify and select CPGs related to otorhinolaryngology. Four independent reviewers assessed the eligible guidelines using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. Their degree of agreement was evaluated using the intraclass correlation coefficient (ICC).From 170 citations, 21 relevant guidelines were included. The overall agreement among reviewers was moderate . The scores for each of the AGREE domains were the following: “scope and purpose” , “stakeholder involvement” , “rigor of development” , “clarity of presentation” , “applicability” , and “editorial independence” . Three guidelines (14%) mentioned updates, and the average update frequency was 7 years. None used the GRADE system.The quality of otorhinolaryngology guidelines in China is low. Greater efforts are needed to provide high-quality guidelines that serve as a useful and reliable tool for clinical decision-making in this field. Clinical practice guidelines (CPGs) are defined as “statements that include recommendations intended to optimize patient care that is informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.” The Appraisal of Guidelines for Research and Evaluation (AGREE) instrument is an appraisal tool and validated instrument that has been endorsed by leading producers, raters, and compilers of international CPGs guideline as a subject heading in the CBM abstract database and three terms, guideline or specification or consensus, in the title of the papers in the other three full-text databases. The references retrieved included guidelines that met the definition of a guideline proposed by the Institute of Medicine We performed a computerized search of four major academic databases , WANFANG database (Chinese Medicine Premier), VIP information , China National Knowledge Infrastructure (CNKI)) and the China Guideline Clearinghouse in China for CPGs for otorhinolaryngology published from 1978 to March 2012. We used /. The maximal possible score for each domain is the number of questions multiplied by the number of reviewers multiplied by 7 . The minimal possible score for each domain is the number of questions multiplied by the number of reviewers multiplied by 1 .AGREE II, an update of the original AGREE instrument, is widely used to assess CPGs across various medical specialties Four independent reviewers who did not participate in the development of the guidelines were trained in CPG appraisal using the AGREE instrument. Two of them are clinicians in otorhinolaryngology and the other two are graduates students. Each reviewer independently reviewed the quality of each CPG using the AGREE instrument. Whenever disagreement arose, a third observer, designated by consensus by the working group, issued the final verdict.p<0.05. The software used for the analysis was SPSS 11.0.We performed a descriptive statistics analysis using the calculation of the total score by each reviewer and the score per domain. The data obtained by assessing the guidelines after applying the AGREE II instrument and intraclass correlation coefficients (ICCs) were considered to assess inter-rater reliability within each domain The initial search identified 170 documents. After applying the inclusion and exclusion criteria, 21 guidelines were eventually considered for inclusion . The demA total of 21 Chinese otorhinolaryngology CPGs were evaluated using the AGREE II, with four reviewers per guideline. Scope and purpose: The score for this domain reflects the degree to which the overall objectives of the guidelines, clinical questions covered, and patients to whom the guidelines were meant to apply were specifically described Stakeholder involvement: This domain evaluates the degree to which CPGs represent the views of their intended users. It evaluates whether individuals from all relevant professional groups are represented, whether the views and preferences of the target population  have been sought, and whether the target users of the guidelines were well-defined Rigor of development: This domain is considered the most important. It evaluates the integrity of the development process, including the reporting of the search methodology, evidence selection criteria, methods used to formulate recommendations, risk and benefit assessment, and links between evidence and recommendations, external review, and updating mechanisms Clarity of presentation: This domain assesses the clarity of the guidelines and whether the recommendations are specific and unambiguous, whether different management options are clearly presented, whether key recommendations are easily identifiable, and whether the guidelines are supported by tools for their application Applicability: This domain evaluates issues that are pertinent to guideline implementation. More specifically, it considers whether the guidelines describe facilitators and barriers to their application, whether the potential resource implications of applying the recommendations have been considered, and whether the guidelines present monitoring or auditing criteria Editorial independence: This domain addresses conflicts of interest, specifically whether the guidelines were editorially independent from the funding body and whether potential conflicts of interest were reported for the members of the guideline development group This is the first systematic evaluation of the quality of published guidelines related to otorhinolaryngology in China using a standardized appraisal instrument. Overall, the guidelines for this field had poor quality. The present study showed that the quality domains with acceptable scores were “scope and purpose” and “clarity of presentation.” Most of the guidelines described their specific and focused clinical questions and target populations well. Little improvement in the “scope and purpose” domain was found over time in the most recent 5 year period . This caThe “rigor of development” domain had a low score. First, most of the documents did not report the systematic methods of searching for and selecting evidence or did not describe specific evaluation or recommendation systems. Second, few of the guidelines were externally reviewed prior to publication. Third, none of the guidelines provided evidence of pilot testing, which is an important issue that would ensure that the guideline can be clinical utilized. Fourth, only 14.3% of the guidelines mentioned updates, and the average update frequency was 7 years. Furthermore, none of the guidelines described procedures for updating the guidelines. Guidelines become obsolete within a mean period of 3.6 years, and the validity of all guidelines should be reevaluated every 3 years Similarly, the scores in the “stakeholder involvement” domain were low. These low scores reflect the lack of multidisciplinary teams. Half of the guidelines were developed by only two professional organizations or agencies, and less than 1% of the guidelines had methodologists. Moreover, none involved patients in the development process or was piloted among end-users. Burgers et al. reported that the quality of guidelines developed by government-funded organizations was higher than those developed by professional and specialist societies The lowest scores on “applicability” and “editorial independence” were particularly conspicuous. These findings appear to be fairly widespread among the CPGs. The low scores may be the result of poor reporting and could be avoided if the guideline authors provided a book section or support that addressed the process concerns listed in the documents. In China, conflict of interest statements are a widely accepted policy in medical journals, but such statements are still not widely used in CPG development. The developers of CPGs need to pay more attention to these domains during the development process.Much time and effort have been spent developing evidence-based guidelines to improve clinical practice First, most Chinese guidelines have been historically derived from consensus conferences or expert opinions. Such documents are potentially useful in practice in China, especially for their emphasis on key clinical management questions. We recognize that this was a selective search for all potential guidelines in this field, so we might have included some poor-quality guidelines. Second, we may have missed guidelines published in book, booklet, or government document form, which may understate the quality of Chinese CPGs. Third, the AGREE II instrument only assesses the reporting of the different items and not the content validity of the recommendations. Lastly, another potential limitation is that the guideline developer could include some of the items listed in AGREE in process, but didn't report it.The quality of Chinese otorhinolaryngology guidelines published from January 1, 2002, to March 1, 2012, is low but seems comparable to the world average. The AGREE II instrument is feasible for appraising available guidelines. The AGREE II instrument should be adopted by China as the preferred method of guideline process assessment.Checklist S1PRISMA 2009 Checklist.doc.(DOC)Click here for additional data file.