Introduction. Botulinum toxin inhibits acetylcholine (ACh) release and probably blocks some nociceptive neurotransmitters. It has been suggested that the development of myofascial trigger points (MTrP) is related to an excess release of ACh to increase the number of sensitized nociceptors. Although the use of botulinum toxin to treat myofascial pain syndrome (MPS) has been investigated in many clinical trials, the results are contradictory. The objective of this paper is to identify sources of variability that could explain these differences in the results. Material and Methods. We performed a content analysis of the clinical trials and systematic reviews of MPS. Results and Discussion. Sources of differences in studies were found in the diagnostic and selection criteria, the muscles injected, the injection technique, the number of trigger points injected, the dosage of botulinum toxin used, treatments for control group, outcome measures, and duration of followup. The contradictory results regarding the efficacy of botulinum toxin A in MPS associated with neck and back pain do not allow this treatment to be recommended or rejected. There is evidence that botulinum toxin could be useful in specific myofascial regions such as piriformis syndrome. It could also be useful in patients with refractory MPS that has not responded to other myofascial injection therapies. Myofascial pain syndrome (MPS) is defined as a regional pain disorder of muscular origin characterised by the existence of trigger points within muscles. The myofascial trigger point (MTrP) is, in turn, defined as a palpable and hyperirritable nodule located in a taut band of muscle. Stimulation of this point produces two characteristic phenomena: referred pain and sudden contractions of the taut band, called the local twitch response (LTR). Active MTrPs produce pain, and sometimes referred pain, spontaneously. Latent MTrPs produce referred pain as a response to pressure, but not spontaneously.A current hypothesis is that the disorder underlying MPS is related to inappropriate activity of acetylcholine (ACh) at the neuromuscular junction, which produces a sustained contraction of the sarcomere. The ACh-related effects are relevant to the development of the taut band. This activity leads to an increase in local energy demand or energy crisis . Local mThe inappropriate activity at the motor endplate has been studied from an electrophysiological perspective. First, the existence of spontaneous electrical activity (SEA), characterised by continuous low-amplitude action potentials and spikes, was demonstrated in the active MTrP. Excessive ACh activity at the TrP (the muscle endplate) is inferred from the electrophysiologic activity (endplate noise and SEA) , 7. In tAnother factor that plays a determining role in MPS is the sensitization phenomenon. Persistent peripheral muscle nociceptor activation is converted into a permanent stimulus that facilitates pain neurotransmission. This is due both to a local increase in the number of nociceptors and to the opening of silent multisegment spinal cord circuits . This cyIn summary, the disorder underlying MPS is considered to be inappropriate ACh activity at the endplate, producing an energy crisis that favours nociceptive neurotransmitter release. The altered ACh produces active phenomena (taut band), and the nociceptive neurotransmitters initiate the cascade of pain neurotransmission or sensory phenomena: local pain and referred pain.Botulinum toxin has been used for decades in the treatment of disorders characterised by muscle hyperactivity, such as spasticity or dystonia . Its anaClostridium botulinum produces seven neurotoxins (designated by the letters A to G). Their best known action is the blockade of exocytosis of the presynaptic vesicles of ACh at the endplate. Two of these neurotoxins, botulinum toxin A (BTA) and botulinum toxin B, are available as biological therapeutic agents and may frequently be used for the treatment of certain conditions involving muscle hyperactivity [activity . BTA is activity .Botulinum toxin blocks neurotransmission at the neuromuscular junction. Several transport proteins participate in the process by which ACh is released; these proteins aggregate to form the SNARE complex  Attachment Protein Receptor , responsA number of possible mechanisms of action that could explain the antinociceptive effects of BTA have been formulated and investigated .In myofascial syndrome it is believed that the excessive ACh production is responsible for the characteristic SEA of MTrPs, detectable on electromyography (EMG). The injection of 10 U of onabotulinumtoxinA (Botox) in the area of the dysfunctional motor endplate was found to reduce SEA in experimental animals .It has been shown that BTA directly inhibits the release of pain mediators such as substance P, bradykinin, CGRP, and glutamate , 22.Nociceptive sensitization involves an increase in the concentration of substances that facilitate nociceptive neurotransmission, such as substance P, CGRP, and glutamate, both at the peripheral nociceptors and in the posterior horn of the spinal cord. Blockade of the release of these substances peripherally interrupts the first step of sensitization: the accumulation of nociceptive neurotransmitters at the free nerve endings. BTA is therefore considered to be more effective when sensitization phenomena exist , 24 thanAs a result, BTA has recognised mechanisms based on experimental studies that would enable it to act on three critical aspects of MPS: excess Ach release, local nociception, and sensitization phenomena. These are the three reasons that have driven research into the analgesic potential of BTA in the myofascial pain syndrome and in other pain syndromes.The first clinical trial on the treatment of MPS with BTA was published in 1994, and the results were promising . Since tGiven this lack of uniformity or, at least, of similarity between the results and conclusions of those articles, the proposal of the present review is to analyse the publications from a clinical perspective to search for clues that could explain the differences. This is not a systematic review, but rather a critical analysis that aims to examine certain factors that could improve our understanding of the data published to date and of the discrepancies between those data.The objective of this paper was therefore to conduct a qualitative analysis of the possible sources of variability between the different trials and reviews of the use of BTA for the treatment of myofascial pain syndrome.Literature searches were performed in the PubMed database using the following key words: “botulinum toxin” “myofascial pain”, and “botulinum toxin” “trigger point”. The results obtained were filtered to select those clinical trials and systematic reviews that referred to MPS associated with neck or back pain.The clinical trials were studied from a qualitative point of view, recording specific data on the following aspects: diagnostic criteria, muscles injected, injection procedure, treatment for control group, and outcome measures. All these categories were studied using content analysis to search for possible sources of variability.The conclusions of the reviews were studied and, after qualitative analysis of each category, a panel of discordant points was drawn up in order to highlight the sources of variability and suggest ways to achieve uniformity.Nineteen clinical trials –44 and 1Below we describe the possible sources of variability according to the established categories.Given that there is no definitive consensus on the diagnostic criteria of MPS, it is not surprising that studies on the use of BTA for the treatment of MTrPs apply different criteria. There are expert recommendations that propose a series of clinical criteria to make the diagnosis , 60: focAlthough efforts are being made to establish diagnostic imaging for MPS, particularly with elastography techniques , we haveHowever, the diagnostic criteria used were not detailed in the majority of studies, and it was simply stated that the patients suffered myofascial pain , 34, 36.There was also very marked variability between the trials with regard to the concept of pain topography. It must be realised that although MPS has traditionally been defined as specific to each muscle, it is actually a form of regional or widespread pain  and MTrPAn example of how the selection criteria can group together apparently similar but in reality profoundly different samples can be seen if we analyse two of the most detailed studies that have been published to date. In the study by Ferrante et al. there were 142 patients with myofascial pain of the neck or shoulder . The triAnother aspect that was not detailed in the studies was whether the syndromes detected in the patients were primary or secondary. Primary MPS is an independent medical entity, whereas secondary MPS develops in association with other diseases, such as vertebral disc disease, nerve root disease, osteoarthritis, facet joint disease, cervical whiplash or after a muscle lesion , 64–66. In summary, the following sources of variability in the diagnosis were detected: lack of uniformity in the criteria used to diagnose MPS, variability in the regional pain topographies included in the studies and in the minimum and maximum numbers of MTrPs in any given patient in order to satisfy the recruitment criteria, and a lack of information about the clinical characteristics of the MPS and possible associated abnormalities.In view of the diagnostic and topographic variability, we cannot expect greater uniformity in the muscles or muscle groups injected. One aspect that makes it difficult to reproduce certain studies is that the specific muscles injected are not identified in the study reports , 34, 37.Such discrepancies in the muscles injected for each pain topography demonstrate either a difference between the different samples or else a difference between authors regarding the muscles considered to be the cause of each patient's pain.Furthermore, it would probably be difficult to compare the results of studies that injected four different muscles with those that injected only one muscle. The lack of detail about the muscles injected does not help in the interpretation of the data obtained.There is also the possibility that the treatments could be useful in a specific muscle but not in another. This idea is based on the fact that the studies performed on piriformis syndrome have reported the superiority of BTA while studies performed on another single muscle, infraspinatus , have noFor physicians familiarised with MPS, the selection of the target muscles for therapy is crucial. Identification of the most important active MTrPs and of other MTrPs in synergic or antagonistic muscles is a determining factor for obtaining satisfactory clinical results .In summary, the marked differences in the selection of the muscle or muscles to be injected constitute another source of variability that could explain the differences in the results between trials.The myofascial injection procedure is different from any other type of injection, as it requires, insofar as is possible, injection into the nucleus of the trigger point. It means that the needle will be inserted in part of the taut band that is the hardest and most tender, and that gives the most prominent twitch response. A number of techniques have been described to confirm that the injection enters the MTrP: the recommendable clinical procedure requires the LTR to be reproduced on piercing the MTrP. Hong demonstrated that the efficacy of the injection is greater when this response is obtained . The useOn this basis, authors have referred to injections “into trigger point” and “nearby trigger point,” that is, into the nucleus of the MTrP or close to the MTrP . A thirdThis is a crucial issue, as the myofascial injection is specific and, as far as possible, must be performed in accordance with the standard procedure described that guarantees closest approximation to the MTrP. However, the majority of studies do not give details of the injection procedure employed and simply state “injection into the MTrP.” Some give details of the depth reached with the needle (between 1 and 3 cm) . Others number of trigger points injected and the dose of toxin used. A very wide range of doses and of numbers of injections is reported. With onabotulinumtoxinA, there are studies performed with a single injection [Two other very important matters are the njection . At the njection . And in njection –31 or finjection  injectionjection  and 10 [njection . There anjection  and 250 njection . With abnjection  and 400 njection . The onlnjection .dilutions used in the preparation of the medication. OnabotulinumtoxinA is usually used at dilutions of 100 U in 1 to 2 mL, although solution volumes between 0.5 mL [There were also differences in the n 0.5 mL  and 10 mn 0.5 mL  have beeThe variability in these three aspects—the injection procedure, the number of trigger points injected, and the dose per injection point or total dose—makes it very difficult to interpret the data in a unified manner. Citing once again the two largest trials, there were marked differences between treatments, one with 5 injection sites and a total dose of 250 U of onabotulinumtoxinA  and the size of the needle used. Although this might appear less relevant, it has been reported that the results of myofascial injection with local anaesthetic may be better with 21- or 23-gauge (G) needles [Another procedure-related factor is the  needles . Not all needles , 36, 37.In summary, very significant variations have been detected in the injection procedure. Only a few studies have reported using a standardised procedure to locate the MTrP. The number of MTrPs injected varied considerably, with between 1 and 10 injection sites. There was a sevenfold variation in the total dose of onabotulinumtoxinA between the studies with the lowest and highest total doses, and studies performed with abobotulinumtoxinA presented a 16-fold difference in this parameter. This dose variability makes it very difficult to compare results between trials. There have also been up to 10-fold differences in the dilutions used in the different studies. Finally, the gauge of the needles could also affect results.The control treatment in the majority of studies has been normal saline injection. Almost all authors considered this treatment to be a placebo , 37. HowThe effect of dry needling (DN) on inactivation of MPTs is now well known. Many authors have demonstrated the usefulness of DN in MPS , 74, 75.This is an important issue, as the treatments with which BTA has been compared were not placebos but active treatments. Normal saline injection, local anaesthetic injection, and dry needling are all effective procedures, and it must therefore be taken into account that comparative studies using these techniques are trials investigating the superiority of one treatment over another, they are not placebo-controlled trials; this has implications for the determination of study sample size and for the calculation of the expected differences in improvement between the experimental group and the control group.In addition, certain biases regarding the control treatment must be taken into account. For example, a cost-benefit study that compared the efficacy of BTA versus bupivacaine demonstrated that the two treatments produced similar improvements in the pain but that treatment with the local anaesthetic was much less expensive than BTA . IgnorinOther important details that could help to explain the variability in the results of the studies are the concomitant treatments used. For example, in one study, patients in the two treatment arms, BTA and normal saline, also received treatment with amitriptyline, ibuprofen and, when necessary, propoxyphene-acetaminophen. Myofascial release techniques were also applied to all patients for the duration of the study. It is possible that the importance of these associated treatments was not taken sufficiently into account in the evaluation of the improvement achieved in the experimental and control groups .In summary, control treatments considered to be placebos have actually been treatments of known efficacy. In some studies, patients who had previously responded to one of the treatments could have been selected. Finally, some trials have included pharmacological and physical treatments administered concomitantly with the experimental and control treatments and these additional treatments could have masked the improvements observed.The principal outcome variable in the majority of the studies was the difference between the pain measurements before treatment and during followup. In general, a visual analogue scale (VAS) was used , 33, 37,The majority of the studies reported that BTA was not superior to the treatments with which it was compared , 37, 38.In the study by Ferrante et al. , it shouduration of follow-up, which varied between 4 weeks [Another of the differences detected was in the  4 weeks  and 6 mo 4 weeks . On this 4 weeks . The out 4 weeks .In summary, there are contradictory results in the different trials in terms of pain improvement, with some trials that do not demonstrate superiority of BTA over alternative treatments and other trials that do confirm the superiority of BTA. Improvements have also been detected in some quality of life measures; these have been considered to be possible errors, but further explanation is required. In addition, there was considerable variation in the times at which the outcomes were measured and this may not have been ideal based on our knowledge of the duration of action of BTA.The contradictory results in terms of superiority or nonsuperiority of BTA in the different clinical trials are the main source of doubt regarding the true efficacy of BTA in MPS associated with neck and back pain.The use of BT for the treatment of pain of myofascial origin has been analysed in specific systematic reviews and also in joint reviews on the usefulness of BTA in pain –59. As tThe conclusions of the reviewers can be grouped into three types: BTA not recommended, a lack of data to be able to recommend or not recommend the treatment, and recommendation for use in specific conditions.Some reviews concluded that BTA is not superior to other injection therapies, such as saline or local anaesthetic injection, and that current evidence therefore did not support the use of BTA injection into MTrPs for myofascial pain in general , 57 or iAnother group of reviewers concluded that the available data were not sufficiently strong either to recommend or to reject the use of botulinum toxin in MPS , 59. In Finally, another group of reviewers concluded that botulinum toxin can be useful in MPS in certain clinical conditions.The first of these involves pain topography. Based on high-quality clinical trials on the treatment of the lumbar pain using the toxin , severalAnother of the clinical situations is the treatment risk of the patient, for example, when the analgesic regimen carries a high potential for adverse effects .One further important aspect is the difference between chronic pain and refractory pain. Refractory pain refers to pain that does not respond to other treatments. There are clinical trials and reviews that have focused exclusively on refractory pain, that is, on chronic pain that has not responded to other treatments , 76.In summary, the different systematic reviews on the use of botulinum toxin in MPS and in regional axial pain  associated with this diagnosis, vary from no recommendation for use, through the absence of a recommendation in favour or against, or finally, to use only in specific conditions: pain refractory to treatment, and pain at specific sites .The use of botulinum toxin in MPS has a pharmacological and pathophysiological basis. In MTrPs there is excessive Ach release and an increase in the concentration of nociceptive neurotransmitters in the biochemical milieu of the MTrPs. BTA appears to be effective on both targets, reducing ACh release and blocking nociceptive neurotransmission.This rational basis has been the justification for a number of clinical trials, but there are marked discrepancies between the results of those trials. Looking at the most important ones, some do not demonstrate the superiority of BTA over other treatments , 37, 38 Diagnostic selection and criteria: the trials have used different diagnostic criteria for MPS. There is insufficient standardisation of the different topographies of pain, with studies that have focused on a single area of the vertebral column and others that include several areas. In addition, there are very relevant discrepancies in the number of MTrPs treated and a lack of information on clinical characteristics, such as the type of myofascial pain and its associated abnormalities. The selection criteria for some studies would have led to the exclusion of their patients from other studies , 37.Muscles injected: in general, the different studies do not coincide in the target muscles. Even in patients with the same pain topography, different muscles were injected. And in some studies, the muscles treated were not even mentioned.Injection procedure, number of trigger points injected, and dose used: in many studies, it was not stated whether a myofascial type injection procedure was used, with robust criteria for injection into or nearby the MTrP. The number of trigger points treated showed little uniformity, as between 1 and 10 were injected, depending on the study. The doses used varied by up to 16-fold between the trials with the highest and lowest total doses. There was also variability in other factors, such as the dilution and the type of needle used.Control group treatments: the groups treated with placebo received treatments of known efficacy, such as normal saline, local anaesthetics, or dry needling. The investigations were therefore comparative studies between two treatments rather than an experimental group versus placebo. Outcome measures: the results of the trials are contradictory. In some, superiority of BTA over other treatments was not observed whereas others reported the superiority of BTA. Improvements were also detected in some quality of life measurements, and these require further explanation. Finally, the length of followup was often suboptimal if the duration of the effect of botulinum toxin is taken into account.In this paper, content analysis has been used to scrutinise the trials from a clinical perspective in order to identify sources of variability that could explain the differences in the results. The most significant findings were the following.These marked differences have led reviewers to reach contradictory conclusions: BTA not recommended, neither recommended nor rejected or, finally, recommended for use in specific conditions of refractory pain or for pain with a specific topographic diagnosis.The contradictory results in terms of superiority or nonsuperiority of BTA in the different clinical trials are the main source of doubt about the true efficacy of BTA in myofascial pain syndrome associated with neck and back pain.In reality, no study has demonstrated that BTA does not improve a patient's pain. In all of them, the pre- and post-treatment outcome measures showed significant improvements. What has not been possible to demonstrate in some studies is the superiority (or inferiority) of BTA versus other treatments.To resolve these issues, further studies must be performed that take into account these and other sources of variability described in the literature , 46. TheIn addition, in the light of all these findings, it must be concluded that there are insufficient data either to recommend or reject treatment with BTA in MPS. Many reviews close with this statement after an extensive analysis and the use of complex statistical methods, and physicians who study those reviews may therefore be left with an uncomfortable feeling that their reading has not helped to resolve the complex task of clinical decision taking.Although this is a particularly controversial subject, some additional arguments may perhaps be given. At the present time, the treatment of MPS with BTA is an off-label indication. Some trials conclude that BTA is neither superior nor inferior to other treatments injected into the MTrPs, whereas other trials show that BTA is superior to other injection treatments. There is evidence that BTA could be useful in at least some subgroups of patients in which the most relevant characteristic is therapeutic refractoriness . Some sp


Pain is an enormous problem globally. Estimates suggest that 20% of adults suffer from pain globally and 10% are newly diagnosed with chronic pain each year. Nevertheless, the problem of pain has primarily been regarded as a medical problem, and has been little addressed by the field of public health.Despite the ubiquity of pain, whether acute, chronic or intermittent, public health scholars and practitioners have not addressed this issue as a public health problem. The importance of viewing pain through a public health lens allows one to understand pain as a multifaceted, interdisciplinary problem for which many of the causes are the social determinants of health. Addressing pain as a global public health issue will also aid in priority setting and formulating public health policy to address this problem, which, like most other chronic non-communicable diseases, is growing both in absolute numbers and in its inequitable distribution across the globe.The prevalence, incidence, and vast social and health consequences of global pain requires that the public health community give due attention to this issue. Doing so will mean that health care providers and public health professionals will have a more comprehensive understanding of pain and the appropriate public health and social policy responses to this problem. By any measure, pain is an enormous global health problem. Globally, it has been estimated that 1 in 5 adults suffer from pain and that another 1 in 10 adults are diagnosed with chronic pain each year [In this article, we argue that the paradigmatic view of pain as a symptom of disease, rather than as a disease state itself,  has contRelieving Pain in America[The setting of public health priorities is a complex, controversial and political process. These priorities are determined, it has been argued, by those who have wealth, political power or both . In the n America. What weThere are multiple reasons for regarding pain as a public health priority. The first and foremost is the staggering prevalence of pain. Because pain is a multivalent, dynamic, and ambiguous phenomenon, it is notoriously difficult to quantify, and therefore caution is warranted in issuing broad assessments regarding the epidemiology of chronic pain across the globe. Yet, even with such limitations, there is little question regarding its high prevalence and incidence. 10% of the world's population - approximately 60 million people - endure chronic pain,-7. PrimaMoreover, aside from the prevalence and incidence of chronic pain, both the severity of such pain and the extent of any accompanying disability are also key factors in assessing its burden. The evidence suggests that moderate-to-severe pain is prevalent even in resource-rich settings, ,11 and tUltimately, as one commentator recently concluded, the evidence is strong that "for millions of people across the globe, excruciating pain is an inescapable reality of life."  This is Second, akin to many other chronic non-communicable diseases (NCDs) across the globe, chronic pain is typically accompanied by substantial comorbidities. The roster of chronic NCDs that are positively correlated with chronic pain are myriad,  includinUnderstanding pain as a public health priority helps to explain its tight linkage with social and economic determinants of health. The social epidemiologic evidence suggests strongly that patterns of NCDs from the hyperlocal to the global level are powerfully determined by the conditions in which people and communities live, work, and play . Given tOne of the most promising theories regarding the causal pathways between such social factors and poor NCD and all-cause health outcomes is the allostatic load hypothesis ,33. ThisAn enormous body of literature demonstrates quite strongly that policy action on these social determinants of health cannot be left to the health care sector itself ,39,40. AUnnatural Causes, however useful aspirin may be in the treatment of fever, the cause of fever is not lack of aspirin [Moreover, the primary response to the undertreatment of pain both in the developed world and beyond has closely tracked a medical model, one which analyzes the problem almost exclusively in context of the availability and distribution of opioid analgesics ,41-43. Y aspirin . Moreove aspirin . Thus, tFinally, regarding chronic pain as a global public health priority could have a salutary effect on chronic pain research. Where the medical model dominates research and funding on pain, research allocation is similarly skewed towards basic science (pain at the molecular level) and to clinical medicine, the latter consisting largely of a focus on medical treatments and health care services. Given the likelihood that many of the key determinants of pain across the globe are the social and economic conditions in which people work and live, regarding chronic pain as a global public health priority could shift the emphasis to funding research directed at the root structural, social and cultural factors that shape pain and its inequitable global distribution.The high prevalence and incidence of global chronic pain, its substantial and growing comorbidities, and its linkage with myriad social and economic determinants collectively provide ample justification for regarding pain as a public health priority. Moreover, there are significant public policy consequences for doing so. Thinking about global chronic pain as a public health priority implies immediately that the global focus on access to essential medicines like opioids is insufficient as a primary policy strategy. A public health focus requires stakeholders to heed Rose's insistence that ministering to the health of populations necessitates attention to the causes of the causes ,46. ChroNeither DSG nor SJM has any competing interests to declare.DSG and SJM conceived of the manuscript together and participated in planning the writing, workflow, and timeline. DSG wrote the first draft. SJM reviewed the first draft and offered substantial revisions, which DSG and SJM iteratively incorporated into second and third drafts. All authors read and approved the final manuscript.DSG has been working on the issue of pain and its undertreatment since 2005. The issue was the subject of DSG's 2009 doctoral dissertation, which earned a distinction, and which currently serves as the basis for a book proposal under review at a university press. DSG's general approach to the undertreatment of pain, regarding the error of reducing it to a question of opioid policy, has resulted in a number of publications, commentaries, and presentations in peer-reviewed journals and conferences, as well as invitations to speak at a variety of local, national, and international venues. DSG has also produced multiple publications on global health and public health ethics, and has papers on both subjects forthcoming in major scholarly journals and in an anthology on global health to be published by Oxford University Press. DSG was recently named a 2012 Visiting Fellow with the Birkbeck Pain Project at Birkbeck, University of London.SJM has published over a dozen papers in the area of public health and ethics. The topic of ethics and pain is the focus of the Center for Practical Bioethics' PAINS Project, for which SJM is a consultant. SJM has multiple forthcoming publications in the area of pain, public health, and ethics and is currently developing a book on the ethics of prevention. As the first public health ethicist at the University of Kansas Medical Center, SJM is developing new courses and research programs in public health, pain, and cancer.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/11/770/prepub


In the Netherlands, local authorities are required by law to develop local health memoranda, based on epidemiological analyses. The purpose of this study was to assess the actual use of these epidemiological reports by municipal health officials and associated factors that affect this use.Based on a conceptual framework, we designed a questionnaire in which we operationalized instrumental, conceptual, and symbolic use, the interaction between researchers and local health officials, and four clusters of barriers in this interaction process. We conducted an internet survey among 155 Dutch local health officials representing 35% of all Dutch municipalities. By means of multiple regression analyses, we gained insight into the related factors for each of the three types of research utilization.The results show that local health officials use epidemiological research more often in a conceptual than an instrumental or symbolic way. This can be explained by the complexity of the local policy process which is often linked to policies in other areas, and the various policy actors involved. Conceptual use was statistically associated with a presentation given by the epidemiologist during the policy process, the presence of obstructions regarding the report's accessibility, and the local official's personal belief systems and interests originating from different professional values and responsibilities. Instrumental and symbolic use increased with the involvement of local officials in the research process.The results of this study provide a partial solution to understanding and influencing research utilization. The quantitative approach underpins earlier qualitative findings on this topic. The outcomes suggest that RPHS epidemiologists can use different strategies to improve research utilization. 'Blurring the boundaries', and the enhancement of interfaces between epidemiologists and local health officials, like direct interactions into each other's work processes, is expected to create better possibilities for optimizing research use. In recent years, research utilization has been a growing scientific field. As Nutley et al. 2007) stated: "Research use is a complex and multifaceted process, and the use of research often means different things for different people" . In publ007 stateIn the Netherlands, the Dutch Public Health Act builds on the concept of EBP, stating that local authorities are required to establish a local public health memorandum every four years on the basis of  epidemiological research. The regional or local epidemiological reports that are produced for this purpose are mainly based on health surveys, and have a descriptive nature. For example, the reports describe the frequency of different health measurements such as the occurrence of diseases or quality of life. They also describe the occurrences of determinants of health such as lifestyle and social and environmental factors. The epidemiological research data is provided by 28 Regional Public Health Services (RPHS) serving all 430 Dutch municipalities. However, it is yet not known whether and how the epidemiological reports are used by the local health officials who receive them.The aim of this paper is to determine how and to what extent the RPHS epidemiological research is used by local health officials, and to identify the factors that influence this use. Qualitative studies are valuable for identifying the mechanisms of research use, but to gain insight into the nature of utilization and finding influencing factors, a quantitative approach is more suitable. Earlier municipal case studies  have shoIn this article we start with the explanation of a conceptual framework as a base for this study. In the methodological section we describe how this framework is operationalized into survey questions. In the following result section we will present the descriptive statistics and the linear regression models. We close the article with an extensive discussion concerning the results, methods and the conceptual framework and end with final conclusions.Transfer domain refers to the publication phase of the research cycle, addressing research communication. In another case study conducted in the Netherlands [Acceptance and Interpretation, both contain barriers relating to the individual attributes of the officials. Acceptance barriers refer to the personal perception of the validity of the research outcome, . Interpretation barriers refer to the meaning each person gives to research outcomes. In the conceptual framework all associated factors are described separately however in practice it will be possible that these factors themselves are interrelated [There is an extensive body of international literature on research utilization which is still growing. In an earlier review published in this journal, we developed a conceptual framework on research utilization in this specific Dutch context . This frherlands , it becarrelated .There are various quantitative measurements for research utilization. Many quantitative studies have used the ladder of research utilization of Knott and Wildavsky, a measure of main outcome ,17-19. HIn earlier municipal case studies  it was sIn the absence of a national list of Dutch local health officials, we approached all 28 Dutch RPHSs, asking them to cooperate with our study by providing us with the names and phone numbers of the municipal public health officials in their working area. 20 RPHSs cooperated, covering 339 municipalities. Reasons for the RPHSs not to cooperate were lack of time, other priorities, different timing of the development of the local health memoranda, and participation in other research projects regarding public health policy. Four research assistants approached the 339 local health officials by phone between November 2008 and April 2009, and asked them to participate. Those participating were asked to provide some background information such as the number of years working on this policy issue in this municipality, what other policy issues they have in their portfolio , and their education and research experience. Subsequently we asked for their email addresses, and sent them a protected link to an internet questionnaire. In December 2008, all approached officials received a reminder in the form of a digital Christmas card, and in February 2009 the respondents who had not yet filled in the questionnaire received again a reminder by email.In an earlier study Amara et al. only used one question for each of the concepts of instrumental, conceptual and symbolic use. Given the specific Dutch context we designed multiple questions for each concept, since the concepts can have several meanings . This waThe concept of instrumental use, referring to direct and concrete action due to the specific research results, was measured using two questions that asked whether research results had led to (1) new direct policy actions; and (2) the termination of one or more existing policy activities. Conceptual use was measured using three questions that asked whether the research results had led to (1) a better understanding of the occurrence and causes of health problems within the RPHS region; (2) a better understanding of the causes and occurrence of health problems within the municipality; and (3) new long-term ideas for projects or policies within the municipality or RPHS region. Finally, symbolic use was measured using two questions that asked if, due to the research, the officials were able to (1) question existing policies and decisions; and (2) put personal ideas on the policy agenda. All questions had a 5-point Likert-type response scale ranging from (1) not applicable in my situation; (2) minimally applicable in my situation; (3) moderately applicable in my situation; (4) applicable in my situation; (5) strongly applicable in my situation.All independent variables are shown in Tables For the policy context , we first defined six categories of background variables: the size of the municipality, the urban nature of the municipality, the number of years worked as a local health official in this municipality, whether the local health official had to consider other policy issues in his daily job besides public health (dichotomous), the educational level of the official, and his experience in conducting research. Secondly, we defined two categories of variables relating to the public health memorandum: the composition of the memorandum , and the type of the memorandum . Thirdly, we defined six questions concerning the decision-making process: 1) Who took the initiative to start the memorandum ?; (2) Did they receive support in the decision making process from the municipal Registry office (dichotomous)?; (3-6) four questions asking who took part in the policy preparations . For the content of the epidemiological research information, we asked which geographical area was covered, and, from a list of 22 topics, which public health topics were described, . The frequencies of all these associated factors are shown in Table  Who tookFor the measurement of the actual interaction between the RPHS epidemiologists and the local health officials, we used three questions based on the 'burring the boundaries' model of de Leeuw et al. . In thisFor the measurement of possible barriers to research utilization within the interaction, we operationalized the barriers  Table . QuestioAll barrier questions, except for media and the use of other research sources, had the following 5-point Likert-type response scale: totally agree, agree, neither agree nor disagree, disagree, totally disagree.In social science literature there is an ongoing debate  about whFor each type of research use, the internal reliability coefficient of the corresponding questions was calculated, using Cronbach's Alpha . When thSince the research population is rather small, only a limited number of independent variables can be included in the regression models . For eacIn total, 284 of the 339 eligible local health officials consented to collaborate in the study. Officials who did not want to participate, were either not interested, had no time, or sometimes indicated a poor relationship with their RPHS. After the follow-up email invitation, 224 local health officials started the internet questionnaire, eventually leading to 173 completed questionnaires. This is a response of 51% and covers 39% of all Dutch municipalities.We then excluded 18 respondents who acknowledged that, although they were involved in the policy process and could reproduce information on this, they did not know the epidemiological reports, and therefore were not able to give their opinions on interaction and barriers to research use. Mostly, these officials had been working in their present function for less than three months. As a result of their exclusion, 155 questionnaires were included in our analysis, covering 35% of all Dutch municipalities.Population size is a factor that influences the development of local health policy, and is related to the capacity of civil servants assigned . If we cTables Table For instrumental use, Cronbach's alpha for the two sub questions was too low (α = 0.230) to combine them into one variable. For further regression analysis, we therefore decided to use the first question  as dependent variable, because, in our opinion, it covered the concept of instrumental use sufficiently well, and had enough respondents in each category.The internal reliability of the three sub-questions for conceptual use was high enough (Cronbach's α = 0.841) to sum their scores into one score. The mean sum score for conceptual use was 9.0 (SD = 2.99).Regarding symbolic use, the value of the internal reliability was also sufficient to combine the two sub-questions (Cronbach's α = 0.66). The mean sum score for symbolic use was 4.7 (SD = 2.17).Table instrumental use, as tested with one-way Anova: 1) experience with research , 2) involvement of the local official with the research process , 3) involvement of the RPHS with the policy process , and 4) media attention . Chi-square tests between these associated factors showed that they were not interrelated. Therefore, all four factors were included in a linear regression analysis. Table 2 = 0.17, F = 3.93, p < 0.01). The model shows that the involvement of local officials was significantly related to more instrumental use, whereas unawareness of local officials of a media publication about the epidemiological report was significantly related to less instrumental use.Four independent variables were significantly and unconditionally related to conceptual use: all three actual interaction variables and eleven of the thirteen barrier variables. Only media attention and satisfaction with the local information were not statistically significantly related to conceptual use. The tests for mutual correlation showed that involvement of the RPHS in the policy process was related to an oral presentation on the epidemiological report. Moreover, all barrier variables were interrelated . There was a relation between, on the one hand, the involvement of, and a presentation by, an epidemiologist in the policy process and, on the other hand, a higher sum score for conceptual use of the research. However, as mentioned by the local officials, conceptual use decreased with a higher sum score for barriers to interaction.Fourteen associated factors were significantly related to symbolic use, only one associated factor was significantly related: involvement of the local official during the research process . Table 2 = 0.032, F = 6.071, p = 0.015). It showed that interaction during the research process increased symbolic use, as mentioned by the local health officials.As for The aim of this paper was to quantify the nature and extent of epidemiological research use in the Netherlands during the development of municipal public health policy, and the factors that determine this use. We conducted a survey among local health officials because, in earlier case studies , it was This study provides very specific insight into this specific research population of Dutch local health officials. Conceptual use was more common than instrumental and symbolic use. This means that the knowledge and insights of the epidemiological reports are not translated into concrete actions nor are they used in policy debates. The greater amount of conceptual use was also found by Amara et al., although they conducted their survey among professionals and managers in government agencies in Canada . In our Instrumental use can be explained by preliminary interaction between researcher and policy makers during the research process, in other words, the involvement of local officials during the design of the research and during the publication phase. However, it is harder to understand a lack of awareness by local officials of a media publication on the epidemiological report as a factor for less instrumental use. Because of the cross-sectional design of this study, this association could be the other way round. If a person does not see many possibilities of using an epidemiological report instrumentally ("I do not have to do anything with it"), he might have less interest in media attention.Our results showed that the presentation of the health report was associated with greater conceptual use. This would imply that more value is given to the epidemiological knowledge when presented by an epidemiologist than when presented by another employee of the RPHS. This can probably be explained by the perceived authority of an epidemiologist. In the conceptual framework, we distinguish four domains of barriers to research use. This study shows that most of these barriers are interrelated, so we are not able to assess which barriers are more important.For symbolic use, the only factor was the preliminary interaction, which can explain only limited variance. This means that there must be other factors than those included in our study that explain variance. On the one hand this outcome can be explained by the fact that, during the policy process, local officials do not always take part in the policy discussion but function as process manager. It can be expected that if we had asked administrators, politicians, or client representatives, the symbolic use would have been greater. On the other hand, we may have missed other factors such as the political composition of the municipal council or the political background of the local administrator.The response to the study was 51%, covering 35% of all Dutch municipalities. A study by van Dijk  showed tThere are some methodological limitations of this study that we have to discuss. We recruited the local health official by means of the RPHS. This was because there was no central list of local health officials in the Netherlands, and people regularly change jobs in the policy domain. We believed that the RPHS was the best possible source for the most recent list. However, this use of the RPHS was a potential cause of bias, because those organizations that were willing to cooperate with our study possibly put more emphasis on research utilization. Another form of selection bias could have occurred because officials with a negative attitude towards the RPHS might have been less willing to cooperate in our study. Both types of selection bias can cause an overestimation of research utilization by the group of local health officials. This could have the consequence that the regression models we produced are valid only if there is a neutral or positive relationship between the local health officials and the employees of the RPHS.We chose a specific analysis strategy for the construction of the regression models. This decision was made because of two problems with the data. First is that we had a relatively small research population in comparison with the amount (more than twenty) explaining variables. Second, as shown in Additional file Q5Additional file As we mentioned before in the methodology section we choose for linear multiple regression analyses to determine which independent variables were associated with each type of use of epidemiological research . In the case of conceptual use this can be debatable  and one The ladder of research utilization  is the iAs we described earlier, the regression models developed fit a specific policy context, and do not cover the dynamics of the entire policy network and policy process. However, if certain explanations of research utilization that are found in qualitative studies, for example -33, are There are many conceptual frameworks circulating in the international scientific area of research utilization, of which our conceptual framework is one -12,18. OIn this study it turns out that interaction enhances research use. However we limited ourselves to direct ways of interactions between epidemiologists and local health officials. Taking the literature on nexus theories  and collOne important feature of our framework did not work out well; the classification of the barriers into four domains. The interrelations between these barriers could have multiple reasons. First of all, it is possible that, in the empirical setting, from the perspective of local officials, the meanings of the theoretical notions are hard to distinguish in practice. On the other hand, the way we operationalized the barriers and the sequence in which we questioned the respondents, could have influenced their answers. Because of these methodological shortcomings it is not possible to draw conclusions on the ways interaction between epidemiologists and local health officials are associated to the barriers, for example if the interactions influence the belief systems of officials. It is interesting to explore this clue in future studies because it could provide an explanation what interactions actually do on the interface between research and policy.This study was limited to local health officials. According to our conceptual framework, there are many more stakeholders in the local policy process who could possibly use the epidemiological reports. This study provides no answer to this issue, so it becomes interesting to gain insight into these other groups in order to study research use in a whole policy network. However, to do this in a quantitative way will cost considerable research effort if it is to achieve a sufficient number of respondents.This study shows that conceptual use is more common among Dutch local health officials than other types of use. Probably this is precisely why the concept of evidence based policy, which, on many occasions, suggests instrumental use, should be replaced by evidence informed policy, which is related to conceptual use. Conceptual use itself was associated with a presentation given by the epidemiologist during the policy process, the presence of obstructions regarding the eots accessibility, and the local official's personal belief systems and interests. Furthermore, the results show that instrumental and symbolic use increased with the involvement of local officials in the research process.The outcomes suggest that RPHS epidemiologists can use different strategies to improve research utilization. However, they do have to ask themselves beforehand what type of research utilization they want to achieve - should it be instrumental, conceptual, or symbolic. Either way, 'blurring the boundaries', and the enhancement of interfaces between epidemiologists and local health officials, like direct interactions into each other's work processes, is expected to create better possibilities for optimizing research use.The authors declare that they have no competing interests.JDG has drafted the manuscript and designed the study, acquired, analyzed, and interpreted the data. MVB and JM have been involved in analyzing and interpreting the data, drafting the manuscript, and revising it critically for important intellectual content. KP and HVO have revised the manuscript critically for important intellectual content and all authors have given final approval of the version to be published.The interrelations between the associated variables.Click here for fileThe combination for a new associated interaction variable for the regression analyses of conceptual use.Click here for fileThe additional ordinal regression analyses for instrumental use.Click here for file


Although it has been agreed that complementary and alternative medicine (CAM) should be included in the German medical curriculum, there is no consensus on which methods and how it should be taught. This study aimed to assess needs for CAM education by evaluating current knowledge, attitudes and interests of medical students, general physicians and gynecologists. Two instruments based on established and validated questionnaires were developed. One was given to seventh semester medical students and the other to office-based doctors. Data were analyzed by bivariate correlation and cross-tabulation. Altogether 550 questionnaires were distributed—280 to doctors and 270 to medical students. Completed questionnaires were returned by 80.4% of students and 78.2% of doctors. Although 73.8% (160/219) of doctors and 40% (87/217) of students had already informed themselves about CAM, neither group felt that they knew much about CAM. Doctors believed that CAM was most useful in general medicine, supportive oncology, pediatrics, dermatology and gynecology, while students believed that dermatology, general medicine, psychiatry and rheumatology offered opportunities; both recommended that CAM should be taught in these areas. Both groups believed that CAM should be included in medical education; however, they believed that CAM needed more investigation and should be taught “critically". German doctors and students would like to be better informed about CAM. An approach which teaches fundamental competences to students, chooses specific content based on evidence, demographics and medical conditions and provides students with the skills they need for future learning should be adopted. Alternative and complimentary medicine (CAM) is practiced all over the world. Well-known examples of medical specialties in which CAM therapies are frequently used are oncology and obstetrics , 2. In tGaylord et al.  have desThe prevalence of CAM and the increase in its use.The need to enhance the safety of CAM use and interactions with conventional medical care.CAM education's positive impact on broadening core competencies for conventional healthcare professionals.The need for better communication between practitioners of conventional medicine and CAM therapists.The potential for improving healthcare coordination.The potential impact on increasing the quality and capacity of CAM research.The need for improved communication between providers of conventional medical care and patients using CAM.The potential for enhancing the quality of care through informed use of CAM.The positive impact on enhancing cultural competency.The response to governmental, legislative and other mandates.In Germany, a more conservative approach to CAM has been taken, even though its inclusion in undergraduate training was imposed in 2003 as part of a law on medical education [ducation –8. This ducation .In 2005, Brinkhaus et al.  publisheWe undertook a questionnaire study which aimed to assess current needs for CAM education by analyzing the views, knowledge and experiences of medical students, office-based general physicians and office-based gynecologists in Germany. We believed that these groups could provide valuable judgments and perspectives on educational requirements and could help to identify the areas of conventional medicine in which CAM could be used most effectively and should therefore be taught more intensively. However, we believe that the development of a curriculum for CAM should be based not only on opinions but also on scientific data.Based on experiences with earlier studies, we developed two versions of a questionnaire, one for the doctors and the other for medical students. These questionnaires were based on.The Attitude toward Alternative Cancer Therapy: Questionnaire which has been shown to be reliable and valid –13.A modified version of the questionnaires by Newell and Sanson-Fisher , and FurThe instruments we developed were alike in terms of questions on views on CAM but differed to some extent in the assessment of demographic data. Copies of the questionnaires can be obtained from one of the authors (K.M.).Yellow Pages in the cities of Osnabrück, Münster, Bremen, Lingen (Ems), Meppen (Ems), Papenburg and Dorsten, Germany. Practices were visited between April and November 2007 and the intention of the study was explained briefly to the doctor. Those who agreed to fill in the questionnaire were paid a second visit to pick up the completed form. If it had not yet been filled in, the doctor was reminded to do this. We visited the doctors' practices a third time, and if the form had still not been completed we asked them to return it by mail.All seventh semester medical students attending Giessen University Medical School were given the questionnaire during the summer and winter semesters of 2007. They were asked to complete the questionnaire and were given repeated reminders, if they failed to do so. Questionnaires were also handed out to all office-based general physicians and gynecologist identified from SPSS software for Windows, release version 14.01, was used for data management and statistical analyses . A probability of error <5% was regarded as significant.The project was approved by the ethics committee of the Justus-Liebig-University Giessen on March 15, 2007 (application number 27/07).Between April 2007 and November 2007, we distributed 550 questionnaires—280 to doctors  and 270 to the medical students. The demographic characteristics of the doctors and students are shown in We asked whether doctors and students had already educated themselves about CAM and which methods of acquiring information they considered the most important. The results showed that 73.8% (160/219) of the doctors and 40% (87/217) of the students had already informed themselves about CAM. The doctors believed that practical experience, congresses, talking with colleagues and publications were the most important sources of information; while students thought that practical experience, information from the media and academic publications were more important. Participants were also asked to state subjectively how much they knew about various CAM therapies. Doctors and students were asked whether they disapproved of certain CAM methods. The results, illustrated in r = 0.496–0.782; P < .001)  . We also compared the answers of general physicians and gynecologists and found highly significant correlations between their opinions. Thus, the area of medical practice did not have a major influence on the doctors' opinion on CAM.In The study assessed the experiences and opinions of German doctors and medical students in relation to CAM use in various areas of medicine. We believed that the experience of the doctors with regard to satisfaction or disappointment with conventional medicine or CAM would have influenced their opinions. In general, neither doctors nor students considered themselves to be well informed on CAM and ruled out some CAM methods completely. In some areas of medicine, such as general medicine, use of CAM was considered reasonable, while in others, such as general surgery, they believed that CAM made no sense at all. Thus, doctors and students believed that CAM should be included in the medical education curriculum but that because of the value of CAM varies across medical disciplines and CAM methods, the curriculum should focus on some areas more than others. Unfortunately, it was only possible to analyze the fields of medicine but not various medical situations within each field. This should be done in future studies.The types of CAM considered to be effective by German physicians differed from those viewed as useful by physicians in the United States and Canada , 18. ThiTo the best of our knowledge there have been few investigations into medical practitioners' attitudes to CAM in Germany. One interesting difference between Germany and “the rest of the world" is that in the field of oncology. German physicians are the main promoters of CAM despite the fact that many of them admit that they are not well informed about it , 19–21. Studies on the general topic of CAM have been undertaken in many countries worldwide, including the USA, Canada, Great Britain, New Zealand, Turkey, the Netherlands, Israel and Singapore , 23–31.The main findings of these studies are.Doctors and students are generally interested in CAM methods , 27.Doctors are concerned about the effectiveness and possible harmful effects of CAM , 28.Students admit having little knowledge of CAM .Value and efficacy of CAM methods differ .Some doctors had also referred patients for CAM treatments .The fact that CAM is not taught systematically at present may be the consequence of several aspects.General reluctance regarding CAM—fear that including CAM education at a university could be interpreted as a sign of acceptance of these methods.Lack of knowledge and practical experience.Inexperience regarding the conduct and content of lessons—what should be focused on?Lack of qualified teachers with a balanced and objective viewpoint who can see beyond the prejudices of CAM protagonists and antagonists.The question whether there should be an independent institute for CAM or whether CAM should be taught within the various disciplines.The question in how far patients should be treated in this context.We believe that including CAM methods in the curriculum does not signal the promotion of these methods. Information on the various methods and their potential uses, benefits and risks must be highlighted. After having received the necessary amount of information on CAM and learned how to judge clinical trials, students will be able to make their own judgments on CAM as well as on conventional medicine rather than relying on the judgments of others, including so-called experts. Positive experiences in this field have been reported from Italy [om Italy , 33. It om Italy  and Alpeom Italy . BasicalMaintaining an open mind about all new therapeutic interventions, including CAM.Studying CAM in order to be able to advise patients about these methods. Encouraging carefully performed and approximately controlled studies of these new therapies.Avoiding of hubristic and arrogant attitudes to alternative medicine as it may prove clinically effective.Judging CAM methods and conventional medicine by the same scientific and understandable criteria seems to be the right approach, because there has been some evidence that CAM methods may actually extend the possibilities of conventional medicine. For example, a meta-analysis showed that honey is the best treatment for infected wounds and burns [nd burns . Studentnd burns . This alnd burns .In conclusion, this study underlines the fact that both German doctors and medical students know about some of the benefits of CAM but would like to be better informed so that they can better manage any CAM questions or problems that arise in their daily practice. In this respect, Germany does not differ from other countries as indicated by studies from other parts of the world . As suggTeach fundamental CAM competences to give students a framework for learning about CAM.Choose specific content on the basis of evidence, demographics and conditions (what conditions are most appropriate for CAM therapies).Provide students with skills for future learning, including where to find reliable information about CAM and to search scientific literature.We suggest that alongside the planning of teaching curricula it will be important to develop textbooks on CAM which provide an objective view of the topic. As CAM covers a wide range of diagnostic and therapeutic methods with cover many medical fields, it seems to be important to combine general information on the topic with specific information in the various therapeutic situations. With such a concept physicians will be better prepared for the daily requirements, patients will not be confronted with dangerous and ineffective treatments because of poor knowledge on the topic, and, finally, patients may be able to profit more easily from some benefits of CAM. The results of our study may help to develop educational programs on CAM which are based on the experience of doctors who know about the requirements of day to day practice.