This systematic review commissioned by the UK Department for the Environment, Food and Rural Affairs (Defra), considers how the evidence base for noise effects on health has changed following the recent reviews undertaken for the WHO Environmental Noise Guidelines. This systematic review assesses the quality of the evidence for environmental noise effects on mental health, wellbeing, and quality of life; birth and reproductive outcomes; and cognition for papers published since the WHO reviews (mid-2015 to March 2019), as well as for cancer and dementia (January 2014 to March 2019). Using the GRADE methodology  most evidence was rated as low quality as opposed to very low quality in the previous reviews. There is now low-quality evidence for a harmful effect of road traffic noise on medication use and interview measures of depression and anxiety and low quality evidence for a harmful effect of road traffic noise, aircraft noise, and railway noise on some cancer outcomes. Many other conclusions from the WHO evidence reviews remain unchanged. The conclusions remain limited by the low number of studies for many outcomes. The quantification of health effects for other noise sources including wind turbine, neighbour, industrial, and combined noise remains a research priority. The publication of the World Health Organization’s (WHO) Environmental Noise Guidelines for the European Region was accompanied by a number of systematic evidence reviews detailing the strength of the evidence for the effects of environmental noise on annoyance , sleep , cardiovIn the United Kingdom (UK), the current guidance for economically valuing the impacts associated with environmental noise is published by Defra  on behalf of the Interdepartmental Group on Costs and Benefits (Noise Subject Group) (IGCB(N)), with the current guidance relying on evidence for noise and health effects published up to 2014 ,8. This Following publication of the WHO Environmental Noise Guidelines for the European Region , the IGCThis paper reports the methodology and findings of systematic reviews that assess the quality of the evidence for the effect of environmental noise  on mental health, wellbeing and quality of life; birth and reproductive outcomes; dementia and other neurodegenerative conditions; and cognition for papers published since the WHO reviews (from mid-2015 up to March 2019). The previous review undertaken for the WHO for mental health, wellbeing, and quality of life concluded that most evidence was very low quality, with effects only being observed for some noise sources and outcomes . The preThe scope also included additional reviews on health outcomes not considered by the WHO. The evidence for cancer was assessed as several papers on environmental noise and cancer have emerged since the cut-off date of the last Defra review 2014) e.g., ,13). Def. Def13]) e.g., ,1The methodology mirrors that used in the recent systematic reviews carried out to inform the World Health Organization’s (WHO) Environmental Noise Guidelines for the European Region , where pThe review sought to identify original research papers of quantitative design, on the effect of environmental noise on mental health, wellbeing, and quality of life; cancer; birth and reproductive outcomes; dementia and other neurodegenerative diseases; and cognition. Papers were sought that used epidemiological methods, including survey, case-control studies and cohort studies. Following the approach taken for the WHO reviews, experimental studies were excluded as the review focused on the long-term effects of chronic environmental noise exposure on these outcomes, as opposed to effects of acute environmental noise exposure in the laboratory. This has particular relevance to the search for cognition where experimental methods are commonly used.The systematic reviews for each of the health outcomes were carried out for the time-periods shown in Search terms covering different sources of environmental noise  including road; rail, aircraft, windfarms/wind turbines, industrial, noise from building services equipment including ground and air source heat pumps; neighbour noise and neighbourhood noise. Papers examining other types of noise exposure, such as occupational noise or hospital noise were excluded, as per the approach taken in the reviews undertaken for the WHO. Papers that did not characterise noise using established methods, i.e., by measurement or modelling were excluded .Quantitative papers in English were sought but due to time constraints, conference proceedings were not additionally systematically searched. The reference lists of identified papers were checked for further relevant citations. Grey literature, already known to the authors was also included in the review. Papers from Internoise 2019 (June 2019) and ICA2019 (September 2019) were added to the review after the searches had been completed, where relevant.Papers were reviewed in two stages. First, all the titles and abstracts of the identified papers were reviewed by two reviewers  separately to assess eligibility for inclusion in the review. Second, the full text of eligible papers was retrieved and two reviewers  read the paper and re-assessed eligibility for inclusion. At both stages, where there was disagreement between the reviewers’ discussion was held until consensus reached.Population: the inclusion criteria were studies of the general population or specific sub-groups of the population in settings .Exposure: the inclusion criteria were exposure to high levels of environmental noise from the sources specified above. Included studies either measure or calculate noise exposure levels expressed in decibel values at an appropriate location for the study participants . Where calculated levels were available for transportation noise, they reflected the use of roads, railways lines and flight routes. Exclusion criteria included studies using distance to source as a proxy for noise exposure and studies using subjective ratings of noise exposure (including noise annoyance) as a proxy for noise exposure.Comparator: the inclusion criteria were that the study has a comparator group with no noise exposure or a lower level of noise exposure.Assessment of outcome: the inclusion criteria were that the outcome data came from medical records or interviews or cognitive testing using a known scale or validated assessment method or that the outcome was self-reported from a questionnaire.The eligibility criteria matched those used by the reviews undertaken for the WHO, covering the aspects listed below. Papers which failed to meet any one of the (PECO) inclusion criteria or which met one of the exclusion criteria were excluded from the review.Papers were identified for inclusion in the systematic review regardless of the study findings, i.e., all papers, regardless of whether they found a significant positive or negative association between environmental noise and the health outcome or whether they found no effect were considered in the review.Noise exposure assessment leading to information bias: evaluating whether the paper used established noise metrics in dB; the timeframe of noise measurements, if applicable; and quality of noise modelling, if applicable.Bias due to confounding: evaluating whether the study used matching or adjustment in the analysis for potential confounding factors, such as socioeconomic status, which can influence both noise exposure and the health outcome.Bias due to selection of participants: whether participants are randomly sampled from a known population and whether the response rate was higher than 60%. Consideration of bias associated with drop out for longitudinal studies.Outcome assessment leading to information bias I: whether the assessment of the outcome is objectively measured using a known scale or validated measure.Outcome assessment leading to information bias II: whether the assessment is blinded for exposure information in cohort.Each paper was subsequently assessed for the following types of bias:Ratings for each type of bias were low bias, unclear, or high bias. Bias was considered present for each aspect noted above, if this information was omitted from the paper. Many studies fail to report a response rate for their study, which results in the study being assigned a rating as ‘unclear’ for bias due to the selection of participants. The previous reviews of these cognitive and health outcomes have struggled to identify enough papers to warrant the use of meta-analysis and have also identified problems of using meta-analysis when the outcome measures vary greatly across the studies—e.g., for cognition, and mental health and wellbeing ,6. The sThe GRADE methodology , recommeThe adapted GRADE methodology assigns the highest quality of evidence available to longitudinal or intervention studies and where only cross-sectional studies are available the evidence is initially judged as being of low quality. The GRADE methodology allows for these initial evidence ratings to be further upgraded or downgraded according to specific criteria. Upgrades can be made based on the availability of evidence for an exposure–response function (ERF) between noise and the health outcome; the magnitude of the relative risk being >2; or there being evidence for an effect in spite of confounding working towards the null. However, in practice, upgrades for confounding are very rarely made and no upgrading of the evidence for this factor has taken place in this review. Downgrades can be made based on most of the studies being of low quality (study design); inconsistent findings between studies (inconsistency); studies not comparing the same outcomes (indirectness); effect estimate confidence interval containing 25% harm or benefit (precision); or publication bias, as assessed by a funnel plot. Unfortunately, it is not possible to assess precision and publication bias when undertaking a narrative review as these assessments require the statistical outcome from meta-analyses.The GRADE methodology is accompanied by a statement as to whether the body of evidence suggests there is an effect of environmental noise on the health outcome or if there is no effect. Drawing on the approach of previous ICGB(N) reports, where individual studies carried weight in terms of establishing whether there is or is not an effect of noise on a health outcome, in this review, taking a precautionary approach an ‘effect’ has been identified even where there is only one study available within the body of evidence. This approach may result in an over-statement of whether there is an effect or not as it ignores consistency across the available evidence.The systematic review identified 29 studies of associations of environmental noise on mental health, wellbeing, and quality of life ,45,46,47The studies were conducted in Belgium, Bulgaria, Canada, Finland, Germany, the Netherlands, New Zealand, Norway, South Korea, Sweden, and the United Kingdom. Most studies examined road traffic noise. The studies of adult mental health and wellbeing examined a range of outcomes including post-partum depression, medical diagnoses of depression and anxiety, medication use, symptom scales of mental health, wellbeing, and quality of life. For children the outcomes included the Strengths and Difficulties questionnaire , as wellThe detailed data extraction for these studies is shown in The review carried out for the WHO on mental health, wellbeing, and quality of life  covered The conclusions from the review undertaken for the WHO for aircraft noise and mental health, wellbeing, and quality of life do not differ greatly in comparison with the conclusions of the current review. The current review was not able to reassess many of the outcomes for aircraft noise and mental health, wellbeing, and quality of life because of a lack of new studies. The current review suggests that the conclusions for the effect of aircraft noise on interview measures of depressive and anxiety disorders could be updated, as the evidence now suggests that there is low quality evidence for a harmful effect. This difference is attributable to the publication of several longitudinal studies since the review undertaken for the WHO, and the conclusion of the current review should be considered to stand.The conclusions from the review undertaken for the WHO for road traffic noise and mental health, wellbeing, and quality of life do differ slightly in comparison with the conclusions of the current review. The review undertaken for the WHO concluded that there was very low-quality evidence for no effect of road traffic noise on interview measures of depressive and anxiety disorders, whereas the current review suggests there is now low quality evidence for a harmful effect. This difference can be attributed to an increase in longitudinal evidence since the review undertaken for the WHO, and the conclusion of the current review should be considered to stand. During the preparation of this paper, a further systematic review of road traffic noise effects on depression and anxiety  was publFor children and adolescents, a systematic review published whilst the current review was conducted  undertooThe review undertaken for the WHO concluded that there was very low quality evidence for no effect of road traffic noise on medication intake for the treatment of anxiety and depression assessing three studies, whereas the current review suggests there is very low quality evidence for an effect assessing two studies. However, the evidence supporting an effect comes only from one study and the three studies in the review undertaken for the WHO did not find an effect (With the exception of one study that found an effect in a sub-sample only.). Taken as a whole, the conclusion of the review undertaken for the WHO should be considered to stand until further evidence is forthcoming. Both reviews concluded that there is very low-quality evidence for no effect of road traffic noise on self-reported depression, anxiety, and psychological symptoms. The review undertaken for the WHO concluded that there was moderate quality evidence for a harmful effect of road traffic noise on emotional and conduct disorders in children and hyperactivity. The current review considers the evidence for these outcomes to be of low quality for a harmful effect, albeit based on far fewer studies. The conclusions of the review undertaken for the WHO should be considered to stand as the conclusion is drawn from a greater number of studies.The conclusions from the review undertaken for the WHO for railway noise and mental health, wellbeing, and quality of life are little changed by the findings of the current review. The current review additionally suggests that there is low quality evidence for a harmful effect of railway noise on interview measures of depressive and anxiety disorders, which the review undertaken for the WHO did not assess due to a lack of evidence. The findings of the WHO assessment for railway noise should be considered to stand, with the addition of the finding for interview measures of depressive and anxiety disorders and for medication intake for the treatment of anxiety and depression.The current review is additionally able to conclude that there is very low-quality evidence for no effect of wind turbine noise on self-reported quality of life or health which was not assessed in the review undertaken for the WHO.The systematic review identified 11 studies of associations of environmental noise on cancer ,64,65,66Seven of these studies were conducted in Denmark, with six out of eight studies being from large Danish Diet, Health, and Cancer longitudinal cohort study. The other studies were of a different Danish sample and a sample from Frankfurt, Germany. The studies consider the effects of noise on the incidence of a number of types of cancer, including breast cancer, colorectal cancer, prostate cancer, and non-Hodgkin’s lymphoma, as well as sub-types for some of the cancers. Some evidence is available assessing cancer at the population level, using established markers such as all-cause mortality from cancer . The studies were longitudinal prospective cohort studies or case control studies. Most studies examined road traffic noise, but some studies also considered railway noise or aircraft noise. The detailed data extraction for these studies is shown in Cancer is an emerging health outcome in the field of noise and health. In future, it may be worth exploring the application of meta-analysis to the evidence for cancer, to estimate the association of noise with cancer across the studies. However, a few more studies per noise source and cancer outcome may be needed before this would be possible.The systematic review identified nine studies of associations of environmental noise on dementia and other neurodegenerative outcomes ,71,72,73The studies were from European countries including Germany, Spain, Sweden, and the United Kingdom, with a mix of evidence from longitudinal cohort studies and longitudinal time-series studies. The studies examined road traffic noise and considered a range of outcomes including medical diagnoses of Parkinson’s disease, dementia, or Alzheimer’s disease, hospitalisations for dementia-related illnesses, as well as cognitive tests of dementia or dementia symptoms or precursors to dementia. Other neurodegenerative outcomes such as multiple sclerosis have been studied in a very limited number of studies. The detailed data extraction for these studies is shown in The systematic review identified ten studies of associations of environmental noise on birth and reproductive outcomes ,80,81,82The studies were of samples from Austria/Italy, Canada, Denmark, Korea, Sweden, and the United Kingdom, with evidence from longitudinal and retrospective cohort studies. Most studies examined road traffic noise, with one study examining wind-turbine noise . The stuThe detailed data extraction for these studies is shown in The current review identified no papers of aircraft noise, therefore, we consider the conclusions of the review undertaken for the WHO  regardinFor road noise and birthweight, the findings of the current review differ from those of the review undertaken for the WHO. The review undertaken for the WHO concluded based on the findings of eight studies that there was ‘low quality evidence for an association of road traffic noise on low birth weight’, whereas the current review concludes that there is high quality evidence for no effect of road traffic noise on birthweight, based on the findings of two longitudinal studies. In examining the findings of the review undertaken for the WHO, despite the conclusion drawn the evidence was quite mixed with only some studies showing an association. The GRADE used in both reviews is precautionary, in that, if some but not all evidence shows an effect then the conclusion will indicate that there is an effect. During the preparation of this paper a further systematic review of road traffic noise effects on birth outcomes  was publThe systematic review identified nine studies of associations of environmental noise on cognition ,88,89,90The studies were from Germany, Greece, Spain, South Africa and the United States, with a mix of evidence from longitudinal cohort studies and cross-sectional studies. The studies considered a range of cognitive outcomes including cognitive testing of reading and mathematics for children, as well as cognitive testing of adults. One study reported on an observational study of student distraction by aircraft noise during class: this is a potentially weaker measure of cognition but is included in the review given the limited studies available. One study examined the effect of road traffic noise at school on developmental trajectories for working memory and attention. The available studies were of road traffic noise and aircraft noise exposure. The detailed data extraction for these studies is shown in The conclusions of the review undertaken for the WHO  differ tFor road traffic noise the conclusion of the review undertaken for the WHO was based on two studies showing no effect on reading comprehension (both of which reported on the RANCH study) and the current review now identifies one additional paper that shows an effect but is not methodologically robust. Taking the precautionary approach, we could recommend the finding of the current review that there is ‘very low-quality evidence for an effect of road traffic noise on reading comprehension’. However, this conclusion has to be tempered by the high risk of bias for the one study on which the conclusion was based which did not clearly report how children were recruited and did not adjust the finding for confounding factors, versus the findings of the large-scale methodologically robust RANCH study which has clear relevance of the UK context (as one of the samples was from around London Heathrow airport). At this stage, until further evidence is available, it would be prudent to rely on the conclusions of the review undertaken for the WHO.The review undertaken for the WHO concluded that there was low quality evidence for no effect of road traffic noise on executive function/working memory based on five cross-sectional studies. The current review concludes that there is low quality evidence for an effect of road traffic noise on working memory in children based on one longitudinal study. Comparing the conclusions therefore involves weighing up a few cross-sectional studies versus one longitudinal study: as a precautionary approach the conclusion of the current review is put forward as an update to the conclusion of the review undertaken for the WHO.The review undertaken for the WHO concluded that there was very low-quality evidence for no effect of road traffic noise on attention based on five cross-sectional studies. The current review concludes that there is low quality evidence for an effect of road traffic noise on attention in children based on one longitudinal study. Comparing the conclusions therefore involves weighing up a few cross-sectional studies versus one longitudinal study: as a precautionary approach the conclusion of the current review is put forward as an update to the conclusion of the review undertaken for the WHO.This systematic review has assessed the quality of the evidence across the available studies for aircraft noise exposure, road traffic noise exposure, and railway noise exposure on a range of health outcomes including mental health, wellbeing, and quality of life; cancer; dementia and other neurodegenerative disorders; birth and reproductive outcomes; and cognition. The scope of this review included a wide-range of environmental noise sources, yet the available evidence predominantly related to road traffic noise, aircraft noise, and railway noise. There were very few studies of the other environmental noise sources including wind turbine noise, building services noise, ventilation noise, neighbour noise, industrial noise, leisure noise or combined noise. The health effects of these noise sources remain unquantified.The review was undertaken to consider the implications of the findings for the IGCB (N) and has used the GRADE assessment methodology to determine the strength of the evidence for the evidence-base published since the publication of the systematic reviews undertaken for the WHO. Given the shorter time-frame for the current systematic reviews than the systematic reviews undertaken for the WHO, an assessment has been made as to whether the findings of the current review would alter or strengthen the conclusions of the WHO reviews. The systematic reviews were undertaken to consider the implications of the findings for the IGCB (N). The systematic reviews have considered whether here is a harmful effect or no effect of the environmental noise exposure on the various health outcomes and these recommendations are provided below. Where no effect was identified, no recommendation is provided, as there is no need to quantify the effect of the exposure on the health outcome. Given the breadth of outcomes available for most of the health and cognitive outcomes examined in the review, recommendations were made on the basis of the strongest epidemiological outcomes, where possible, so for example, the incidence of dementia or depression, rather than assessments of symptoms. As meta-analyses have not been undertaken, recommendations regarding the evidence follow the previous IGCB (N) approaches, in terms of recommending relationships for a particular noise source and outcome. Previous IGCB (N) recommendations have also applied relationships from one noise source, to estimate effects for a different noise source, where evidence for the noise source was not yet available. This approach was also taken here.A large body of evidence was identified relating to environmental noise effects on mental health, but this is an area that is still beset by some poor quality studies for many outcomes . In termHowever, considering the past reviews ,57 alongWhilst wellbeing as a concept has risen in popularity in recent years, the review identified few studies of environmental noise and wellbeing. This review concluded that there was very low-quality evidence for an effect of aircraft noise on wellbeing . As for No recommendation is made for quality of life, as both this review and the review undertaken for the WHO concluded that there was very low-quality evidence for no effect of aircraft noise on self-reported health or quality of life. The WHO review came to the same conclusion for road traffic noise but did find very low quality evidence for a harmful effect for railway noise . This isThis review is one of the first to consider the emerging body of evidence for environmental noise effects on cancer. Overall, given the number of studies available, the evidence is quite convincing for effects of aircraft noise, road traffic noise, and railway noise on some cancer outcomes. However, no evidence is yet available for the UK. For estimating effects at the population level, it would be useful to have evidence or an ERF for a relevant population-level cancer outcome, such as all-cause mortality from cancer. At present, the data only supports an effect for some types of cancer and different sub-types of the same cancer show different associations. At this point, given that most of the evidence currently comes from one Danish birth cohort it is worth keeping a watching brief on this area, as further evidence becomes available which considers wider population measures of cancer.The review has concluded that there is low quality evidence for no effect of road traffic noise on the incidence of vascular dementia. Evidence is available from a large-scale methodologically robust UK study which found that the association between road noise and an incidence diagnosis of dementia became non-significant after adjustment for air pollution . TherefoOverall, evidence for effects on birth and other reproductive outcomes remains equivocal, with most studies showing no association  is compEvidence from the methodologically robust NORAH study  confirmsStrengths of this systematic review include the addition of emerging health outcomes not previously reviewed for the evidence reviews undertaken for the WHO including cancer, and dementia and other neurodegenerative outcomes, as well as narrative updates to the reviews for cognition and mental health, wellbeing, and quality of life. The review was carried out by one of the authors of the reviews undertaken for the WHO on cognition and mental health, wellbeing, and quality of life ensuring consistency in methodological approach across the reviews. The current review has been able to consider the impact of large-scale longitudinal papers published since the reviews undertaken for the WHO including evidence from the NORAH study and other large scale studies ,51,74.Limitations of the reviews include the relatively short-time frame covered by the reviews; restrictions to papers published in English and the use of only two databases for the searches (PubMed and Science Direct) due to time-constraints for this rapid review. The scope of this review was to examine the evidence for an effect for each measure of the health outcome individually, rather than combining across wider categorisations, as undertaken by the recent systematic review and meta-analysis of road traffic noise effects on depression and anxiety . HoweverA further limitation lies in applying the GRADE methodology to studies of environmental epidemiology, per se. When used in studies of environmental noise and health, the GRADE methodology often results in downgrading of the evidence and very rarely in upgrading of the evidence. There are several reasons for this. Firstly, there are often inconsistent findings across the body of evidence, e.g., the evidence is often a mix of studies that do and do not show an association, which will result in downgrading. This is often the case where there are few studies available for a noise source and a health outcome but is also found where there are a larger number of studies, as the likelihood of inconsistency increases the greater the number of studies that are available. If only one study is available for a specific noise source and a health outcome then consistency cannot be assessed and the evidence is downgraded automatically (this matches the approach used in the systematic reviews undertaken for the WHO). Across the review, there are very few instances where the quality of the evidence does not get downgraded for inconsistency, perhaps reflecting a weakness of the GRADE process when applied to epidemiological rather than clinical research studies. Secondly, whilst the assessment of the overall quality of evidence reflects the strengths and weaknesses introduced by inclusion of all the studies identified in the search, the weaknesses can end up carrying a greater weight in the assessment. If methodologically weaker studies are included within the body of evidence, it does not really matter how methodologically robust the ‘best’ study is, as the other studies will result in a downgrading of the evidence. Thirdly, in terms of upgrading the evidence, whilst recent epidemiological studies typically adjust for a wide-range of relevant confounders and covariates, it can be very difficult to conclude with confidence that adjustment for further factors may not alter the effect. It is also worth noting, some study designs adjust for a limited number of covariates and confounders. For example, ecological studies such as a study of hospital admissions for a specific health outcome within an entire population usually cannot adjust for relevant socioeconomic or other health-related covariates at the individual level: instead, they only adjust for area-level socioeconomic and other health-related covariates, which means that confounding cannot be ruled out.The evidence for effects of environmental noise such as road traffic noise and railway noise has increased for some health outcomes since the publication of the WHO evidence reviews. In particular, there is now low-quality evidence for a harmful effect of road traffic noise on medication use and interview measures of depression and anxiety. However, many other conclusions from the WHO evidence reviews remain unchanged. There is low-quality evidence for a harmful effect of road traffic noise on some cancer outcomes. The conclusions of this review are limited by the low number of studies for many health and cognitive outcomes. The low-quality evidence across studies for noise effects for some outcomes does not necessarily mean that there are no effects: rather, that more robust studies and a greater number of studies are required. The quantification of health effects for other noise sources such as wind turbine noise, building services noise, ventilation noise, neighbour noise, industrial noise, leisure noise, or combined noise remains a research priority.


Evidence based practice in health care has become increasingly popular over the last decades. Many guidelines have been developed to improve evidence informed decision making in health care organisations, however it is often overlooked that the actual implementation strategies for these guidelines are as important as the guidelines themselves. The effectiveness of these strategies is rarely ever tested specifically for the allied health therapy group.Cochrane, Medline, Embase and Scopus databases were searched from 2000 to October 2019. Level I and II studies were included if an evidence informed implementation strategy was tested in allied health personnel.The SIGN method was used to evaluate risk of bias. The evidence was synthesised using a narrative synthesis. The National Health and Medical Research Council (NHMRC) model was applied to evaluate the grade for recommendation.A total of 490 unique articles were identified, with 6 primary studies meeting the inclusion criteria. Three different implementation strategies and three multi-faceted components strategies were described. We found moderate evidence for educational meetings, local opinion leaders and patient mediated interventions. We found stronger evidence for multi-faceted components strategies.Few studies describe the effectiveness of implementation strategies for allied healthcare, but evidence was found for multi-faceted components for implementing research in an allied health therapy group population. When considering implementation of evidence informed interventions in allied health a multi-pronged approach appears to be more successful.The online version contains supplementary material available at 10.1186/s12913-021-06190-0. Evidence-based health care practices have been promoted within healthcare systems internationally , as the However, the practices recommended in guidelines are not always implemented in healthcare delivery, and significant variations in health care practice remain . It has In general, there are two types of implementation strategies; passive strategies, which include the use of educational materials, posters, toolkits and visual aids, or active strategies, which include interactive workshops, academic detailing, audit and feedback and reminders . The eviSome authors have suggested that the differentiation between active and passive or single versus multi implementation strategy is too simplistic and fails to recognize the complexity that is inherent in knowledge translation. They advocate for translational strategies that take account of the type of knowledge to be implemented, the context of implementation and the people and processes involved . The PARThe Cochrane EPOC group (Effective Practice and Organisation of Care Review Group) has presented a data collection checklist for scientists undertaking reviews into interventions for improving professional practice and the delivery of effective health services. The aim of the checklist is to provide reviewers with guidance on the relevant information that could be extracted from primary studies. This checklist provides an overview of ten (10) different implementation strategies, including both passive and active strategies .The Expert Recommendations for Implementing Change study (ERIC) clustered 73 implementation strategies identified from an expert panel of stakeholders  into ninSeveral studies have investigated the effectiveness of one or multiple implementation strategies, and several systematic reviews have aimed to synthesise this evidence –14. HoweThree reviews , 15, 16 As all three reviews are at least seven years old, it is necessary to update the reviews in light of more current evidence and to explore the recommendations in terms of the quality of the evidence presented and using standardised evidence to decision framework. Therefore, the current review aimed to update the previous evidence reviews by identifying studies that have evaluated the effectiveness of strategies for disseminating and implementing evidence-based guidelines, specifically in an allied health context. By narrowing the review question to this specific context and focussing on high hierarchy and high-quality evidence, we aim to provide more valid recommendations for practice.The systematic review protocol was registered in PROSPERO with ID number 152512The primary question of this review was to review the effectiveness of implementation strategies for promoting evidence-informed interventions in allied health. A secondary aim was to describe the context in which certain implementation strategies were most effective.’Studies were selected based on the study design, the participants, implementation strategies and outcomes. Only randomized controlled trials (RCTs) and systematic reviews (SRs) were included. Within the SRs, only the primary RCTs were included that would satisfy the inclusion criteria.Data was included if the participants were part of an allied health therapy group. The classification of allied health was based on the definition of Turnbull et. al  where foStudies were included if the implementation strategy was applied to the therapists in the allied health care therapy group (no patient only interventions) and if the implementation strategy was used to implement evidence informed healthcare guidelines. Studies were included if the outcomes addressed the impact on patient outcomes or process/profession outcomes. Studies were excluded if they were not original publications or were not published in the English language or were unable to be accessed in full text.th 2019Keywords were applied in Cochrane, Medline, Embase and Scopus databases on October 4A systematic search was performed to identify literature regarding the effectiveness of research implementation strategies in allied health contexts. The keywords used were: .Allied Health Personnel/ .“Diffusion of Innovation”/ or Evidence-Based Medicine/ or Evidence-Based Practice/ or Information Dissemination/ .A date limited search (from 2000 onwards) was applied as the contextual related factors  have evolved over time. In addition, the use of formalised evidence-based clinical decision making became popular from approximately 1996 when Sackett and colleagues defined evidence-based clinical decision making as a combination of not only research evidence, but also clinical expertise, taking into account the patient’s preferences .Electronic database searches were supplemented by checking the reference list of included articles.Searches were performed by two authors (KG and JD).From the initial search, duplicates were removed. Titles and abstracts were screened for eligibility based on the criteria above and full texts of potentially included studies were retrieved and further assessed for eligibility. Only level I and II studies (SRs and RCTs) were included as they represent the highest level of evidence. Studies were selected independently by two authors (KG and JD).A purpose-built Microsoft Excel© sheet was used to extract relevant data from the selected studies including the authors, study design, setting, participants, type of implementation strategy and the associated outcomes. Data was extracted by one author (KG)Distribution of educational materials—distribution of published or printed recommendations for clinical care, including clinical practice guidelines, audio-visual materials, and electronic publicationsEducational meetings—health care providers who have participated in conferences, lectures, workshops, or traineeshipsLocal consensus processes—inclusion of participating providers in discussion to ensure that they agreed that the chosen clinical problem was important and the approach to managing the problem was appropriateEducational outreach visits—use of a trained person who met with providers in their practice settings to give information with the intent of changing the provider’s practiceLocal opinion leaders—use of providers nominated by their colleagues as “educationally influential.” The investigators must have explicitly stated that their colleagues identified the opinion leadersPatient mediated interventions—new clinical information (not previously available) collected directly from patients and given to the provider, e.g., depression scores from an instrumentAudit and feedback—any summary of clinical performance of health care over a specified period of timeReminders—patient or encounter-specific information, provided verbally, on paper or on a computer screen that is designed or intended to prompt a health professional to recall informationMarketing—use of personal interviewing, group discussion (“focus groups”), or a survey of targeted providers to identify barriers to change and subsequent design of an intervention that addresses identified barriersMass media—(i) varied use of communication that reached great numbers of people including television, radio, newspapers, posters, leaflets, and booklets, alone or in conjunction with other interventions; and (ii) targeted at the population levelFindings were categorised using the taxonomy of professional interventions form , and theTwo reviewers (KG and JD) independently assessed the quality of included publications using a relevant critical appraisal tool from the Scottish Intercollegiate Guidelines Network (SIGN) stable . The relStudies were assessed for relevancy, reliability, validity, and applicability and the level of Evidence was evaluated using the National Health and Medical Research Council (NHMRC) model for additional levels of evidence and grades for recommendations for developers of guidelines. The NHMRC model is a logical and intuitive way to formulate and grade recommendations that has been widely adopted by Australian guideline developers . The graThe initial search yielded 464 original results, however only six studies remained for inclusion after screening see Fig. . We founWe decided to include the primary studies from the SR. A total of six studies were included  but care should be taken in its application.For patient mediated interventions, the review found significant effects on cost effectiveness and a significant increase in patient referral to falls services. However, all patient outcomes  did not significantly differ from the control group. The overall NHMRC grade of recommendation was C.The body of evidence related to multi-faceted intervention strategies provided the highest grade of recommendation (A), suggesting that this recommendation can be trusted to guide practice. The review found that multi-faceted component studies improved guideline adherence significantly in two studies , 27 and When considering the evidence implementation interventions in terms of clusters the most common cluster of implementation strategy utilised involved training and educating stakeholders, when used in isolation this implementation strategy cluster was the least effective. When interventions were used that spanned a range of clusters the effectiveness of the implementation strategies appeared stronger. The strongest evidence of effectiveness came from the implementation of interventions that spanned the clusters of training and educating stakeholders, adapting and tailoring the context and supporting clinicians .The six studies included in this review were of sound methodologic quality with SIGN scores ranging from adequate or high quality (AQ or HQ) . (see adDuring the review process the following items were changed from the study protocol. Due to the nature of the evidence found we decided to include only level I (systematic reviews) and II (RCT) studies in this paper. Only quantitative studies were considered, and implementation strategies were specified using the EPOC framework. The SIGN checklist and NHMRC grading framework was used to categorise the risk of bias and synthesize the results respectively.This is the most recent review exploring the effectiveness of implementation strategies in allied healthcare. Six studies related to allied health were found but only among physiotherapists, speech pathologists and paramedics. Strategies evaluated were educational meetings, use of local opinion leaders, patient mediated interventions and a combination of different strategies forming multi-faceted interventions. Most strategies were evaluated against professional and process outcomes and only half were evaluated against patient or health outcomes. Multi-faceted strategies appear to remain the most effective in improving knowledge and adherence to guidelines and evidence  but none of the strategies were found to improve patient outcomes.Despite over 20 years since the recognition of the importance of evidence-based practice in quality health care this review could only identify six studies that explored the effectiveness of implementation strategies for promoting evidence-informed interventions in allied health. It was important to limit to the search to allied health as profession -related health discipline practice differences make it unlikely that the evidence associated with medicine would automatically transfer across to allied health. Whilst there has been an exponential growth in published evidence-based research across all allied health disciplines this has not been matched by published research into how best to implement this in clinical practice. Without effective strategies for implementation of evidence-based recommendations it is unlikely that evidence-based practice will improve the quality of care, reduce practice variation and/or reduce cost.The importance of the implementation strategy to the effective use of evidence-based practice has been recognised by numerous authors , 8. WithOf the evidence that exists there is relatively stronger support for the use of intervention strategies that are multi-faceted, including a range of active and passive strategies, rather than uni-faceted strategies such as educational meetings, local opinion leaders and patient mediated interventions. This adds support to the findings of Menon et al , who fouAcross the studies found in this review there was inconsistent outcomes explored. Guideline adherence and knowledge were the two most common outcomes that were measured, potentially reflecting the relative ease of data capture of these two measures. Of concern when considering the body of evidence is the lack of focus on patient-centred outcomes. If the aim of evidence-based recommendations is to improve the health care of patients then this should be reflected in the evidence associated with intervention strategies. Patient-reported outcome measures would appear to be an important indicator of the effectiveness of an intervention strategy in improving patient centred care.Whilst multifaceted interventions demonstrated the greatest effect on improving guideline adherence and knowledge the lack of changes in clinical patient outcomes is a concern. It is difficult to demonstrate cost effectiveness of an intervention if there are not measurable changes in patient outcomes. There remains limited evidence, from the findings of this review, that interventions based on training and educating stakeholders, adapting and tailoring the context and supporting clinicians change patient outcomes. This suggests either that the patient-related outcome measures were not sensitive enough or that different intervention strategies are needed to change patient outcomes. More research is needed in this area.Due to the strict inclusion criteria of including only allied health therapy disciplines, only a few studies were found. Whilst this may be perceived as a limitation of the current review it also ensures that the reviews findings are relevant to the allied health discipline and reinforce the continued limited evidence base available in evaluating implementation strategies in allied health. This review is also limited by its focus on publications in the English language only.The current limited evidence base in allied health suggests that multifaceted interventions, including the use of opinion leaders, follow-up education, educational meetings (workshops), audits and feedback and reminders, appear to be the most effective in implementing evidence-based recommendations. Therefore, when considering the use of evidence informed interventions in allied health an implementation strategy that incorporates these should be developed. Whilst evidence for knowledge uptake and guideline adherence and increased referrals exist there remains little consideration for patient or health related outcomes.Additional file 1 Table S1. Critical appraisal scores.


To explore how to integrate the “best” practice into nursing of venous thromboembolism (VTE) based on the integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) framework.A mixed-methods design was used. A steering group for clinical evidence implementation (EI) was established to conduct pre-implementation baseline surveys, a thorough analysis of the evidence, and an analysis of the survey results. The hindering and enabling factors associated with the clinical implementation of the evidence were analysed based on the three core elements of i-PARIHS, to formulate the clinical implementation plan for VTE nursing evidence. On-site expert reviews and focus group interviews were used to evaluate the feasibility of the draft plan, make adjustments, and finalize the evidence-based practice plan, which was then put into practice and evaluated.A new nursing process, a health education manual and a nursing quality checklist on VTE has been established and proved to be appropriate through the implementation. Compliance with evidence related to VTE nursing increased significantly in the two units, with better compliance in unit B than unit A. The knowledge, attitude and behaviour scores for VTE nursing increased substantially in both nurses and patients.The EI programme of incorporating the “best” evidence on VTE nursing into clinical practice using the i-PARIHS framework demonstrated feasibility, appropriateness and effectiveness and could serve as a reference. Venous thromboembolism (VTE), encompassing deep venous thrombosis (DVT) and pulmonary embolus (PE), has been deemed a major threat to the safety of hospitalized patients . Patientn (I+R+C) [The implementation of evidence into practice is a proactive and gradual process that differs from the promotion of certain technologies through visualization tools to persuade the target population to make a purchase. Innovations in the healthcare sector are complex . Before  (I+R+C) . In the  (I+R+C) .This study takes the clinical implementation of VTE nursing evidence in two ICU units of a hospital in Suzhou from May to September 2017 as an example and describes how to integrate the "best" evidence into clinical VTE nursing in the ICU under the guidance of the i-PARIHS framework.An implementation-study design was used in this study because it provides a practical method of understanding multiple perspectives, different types of causal pathways, and multiple types of outcomes as accepted features of implementation research problems ,22. Thisth to 25th May 2017.Based on the i-PARIHS framework, a baseline survey programme was developed to clarify the characteristics of the core elements of this framework, i.e., evidence, context and recipients from 10A clinical feasibility survey for VTE nursing evidence was conducted to clarify whether “innovation” or the “best” evidence to be implemented was ethically and culturally appropriate, operable, and acceptable with respect to economic cost and safety during the clinical implementation process. This survey tool was self-designed using a four-point Likert scale (1–4) to assess the items’ ethical and cultural appropriateness, operability, and acceptability with respect to economic cost and safety, with 1 indicating the lowest degree  and 4 indicating the highest degree . Higher scores signify a higher degree of feasibility . The parSpot inspection and communicating with the nurses were used to understand the characteristics of “context”, including (i) environmental characteristics: the configuration of human, financial and material resources; (ii) the organizational environment: team culture (whether the team is good at accepting “innovation”) and leadership; and (iii) external environment: support from related departments. The clinical readiness for evidence-based nursing assessment (CREBNA) was used to assess the clinical readiness for evidence-based nursing (EBN). The CREBNA scale included 3 dimensions  and 31 items using a five-point scale (1–5): 1, completely unmatched; 2, basically unmatched; 3, partially matched; 4, basically matched; and 5, completely matched. Higher scores signify a greater level of clinical readiness for EBN. The content validity index (CVI) of the scale was 0.976, and the Cronbach’s α coefficient was 0.959 for the total scale and 0.940, 0.933, and 0.915 for the above three subscales, respectively . The tesThe innovation “recipients” included healthcare personnel, patients, and caregivers on the EI site.A survey of nurses’ knowledge, attitudes and behaviours regarding VTE nursing (NKAB-V) as well as medical professionals’ compliance with VTE nursing evidence was conducted to clarify the characteristics of healthcare personnel.NKAB-V was a 22-item scale developed based on the VTE nursing evidence to be implemented . The 3-pThe survey format assessing the compliance of medical professionals with EBP was developed according to the evidence items of VTE nursing and was implemented accordingly. In this format, “YES” (observer’s EBP behaviour conforms to the recommendation of evidence items) and “NO” (observer’s EBP behaviour does not conform to the recommendation of evidence items) were used as the evaluation criteria. The compliance of the medical professionals with EBP regarding VTE nursing was calculated as the number of items rated “YES” divided by total EI numbers of VTE nursing within the EI period .Participants in these surveys included the nurses of the two ICUs who had worked in the pilot units for at least one year and were willing to participate in these surveys. A purposive and accessible sample of doctors who were at least associate chief physicians and had worked in the ICU for at least 10 years was included.Patients’ knowledge, attitudes and behaviors regarding VTE nursing (PKABR-VP) and VTE occurrence rate were obtained to conduct the baseline survey. The development of PKABR-VP was similar to that of NKAB-V, and its CVI was 0.98. Colour Doppler Ultrasound was used to determine whether the patient had VTE when they were admitted to and discharged from the ICU.The questionnaires were handed out and reclaimed on the spot. The compliance of the medical professional with EBP regarding VTE nursing was evaluated by field observation with reference to medical records and interviews with observers. The scaling of each item was ordinal; therefore, in this study, the constituent ratio was used to describe the results instead of the mean and standard deviation. According to the Pareto principle  , when anBased on the results of the baseline survey, the steering group analyzed the enabling factors in the clinical implementation of each piece of evidence and formulated a viable innovation strategy. Additionally, factors enabling EI were analyzed from the perspectives of “innovation,” “recipients” and “context” to provide a reference for pre-implementation targeted training . There was a consensus process for the development of innovation strategies. The strategies were discussed and tailored by the steering group, and were presented in the For example, during the clinical feasibility survey, the constituent ratio of the operability of daily using intermittent pneumatic compression (IPC) was below 80%. When analyzing the causes, we found that there were no sufficient IPC pumps in the two ICUs for implementation. Then the two hospital-level managers and three ward-level managers included in the steering group were responsible for determining whether the facility had the budget to purchase this equipment, the length of the purchasing cycle, and whether the purchasing cycle would affect clinical implementation. All of these were presented in the focus group discussion on the formation of the innovation strategies. In addition, the economic efficiency of IPC was also considered for the consensus process of innovation strategies.The initial EI plan for VTE nursing evidence developed by the steering group. Then one EBN expert, four medical care experts on VTE, two managers, and two patients recruited using purposive sampling were invited to participate in a group interview to discuss the scientific rigor, feasibility, and safety of the plan. After the interview, their opinions were sorted and ranked in descending order according to consensus degree, and the proposal with the greatest consensus was given the highest priority, upon which the clinical EI plan was revised and optimized by the steering group.th July to 20th Sept. 2017, members of the steering group conducted rounds in the units periodically, addressed challenges, and collected feedback and suggestions proposed by the professionals at the research site. The feedback and suggestions were sorted, and common problems were analysed to determine whether specific training was required.During the implementation of the EI plan from 15The systematic change was assessed with regard to a VTE nursing quality checklist, changes in the VTE nursing process, and measurement tools.Changes in nurses were evaluated using NKAB-V.Changes in patients were evaluated using PKABR-VP and VTE occurrence rate.t tests. Additionally, the ratio of VTE was compared between the two ICUs throughout the EI using t tests.Analyses were performed by IBM SPSS Statistics 24. For the pre- and post-EI evaluation, descriptive statistics were used to analyze the quantitative data related to the outcomes regarding the context, nurses and patients. To analyse the scale of knowledge, attitudes and behaviours regarding VTE nursing of the nurses and patients, we calculated the total scores for each domain and compared the difference between the two ICUs pre- and post-implementation using A total of 47 nurses and 5 doctors from the hospital’s comprehensive ICU and neurology ICU participated in the survey of clinical feasibility and CREBNA, and the included nurses also completed the NKAB-V survey. The general participant information is shown in screening of evidence fully takes into account current medical conditions and medical standards,” “the evidence solves problems within the scope of medical/nursing duties, and corresponding interventions can be conducted,” and “evidence has been transformed into forms that are easy to disseminate, understand and apply, such as procedures, practice manuals, programme posters, etc.,” in the dimension of context for “nurse managers can reasonably allocate human resources according to clinical work,” “I have good execution of the tasks assigned by superiors” and “the ward I am in has a multi-disciplinary cooperation culture and workflow,” and in the dimension of facilitation for “I have the opportunity to participate in decision-making on ward-related matters ,” “the ward I am in has the information resources  needed to carry out evidence-based practice” and “there are plans to promote evidence-based practice .” The results of the NKAB-V indicated that the included ICU nurses’ knowledge, attitudes and behaviours regarding VTE nursing were poor. In the compliance survey of the VTE nursing evidence to be implemented, the implementation rates of each item in the two ICUs were all below 50% , and daily use of IPC, specifically, the acceptability of the economic cost of assessing the contraindications of IPC, and the daily use of IPC, and the appropriateness and safety of the IPC. The results of the CREBNA showed that the constituent ratio of scoring 4 or 5 was below 80% in the dimension of evidence for “ 50% see .Systematic change mainly included the following: developing a VTE nursing process, adding the VTE nursing indicator into the nursing record sheet, embedding the Caprini scaling and the corresponding nursing into the hospital information system (HIS), formulating the health education sheet of VTE for patients, and establishing the VTE nursing quality checklist. Compared with the baseline survey, nurses’ compliance with each piece of evidence improved significantly in both units A and B, with greater improvement in the latter than the former see .Thirty nurses from unit A and unit B completed the pre- and post-EI NKAB-V survey. Before EI, standard screening, assessment and intervention of VTE had not been conducted in either unit A or unit B. There was no significant difference in the attitude scores of VTE nursing between the two units. However, the VTE nursing knowledge scoring of unit A was higher than that of unit B, while the behaviour scoring for VTE nursing of unit B was higher than that of unit A. After EI, the knowledge scoring for VTE nursing increased in the two units compared with the baseline; the improvement in unit A was statistically higher than that of unit B. There was no significant difference in the attitude score of VTE nursing between the two units see . RegardiTwenty patients from unit A and eighteen patients from unit B completed the pre- and post-implementation PKABR-VP survey. After the EI, their knowledge, attitude and behaviour scores regarding VTE self-care all improved compared with the baseline see . During In this study, we used evidence implementation (EI) process of the venous thromboembolism (VTE) nursing as an example and described how to make the EI process achievable by developing a clinical EI plan.Differences in the medical technology level and medical environment make it impossible to ensure that the evidence, even if it is the “best” available, can be implemented in all clinical settings . During The implementation of innovation ultimately depends on the individuals in the organization, and the quality of the implementation process ultimately depends on the daily work quality of these individuals. After EI, Nurses’ knowledge, attitudes and behaviours regarding VTE nursing (NKAB-V) in the two ICUs have significantly improved compared with baseline survey. The scoring of the knowledge dimension of NKAB-V in Unit B was higher than that of Unit A, while the scorings of the attitudes and behaviours dimension in Unit B were lower than those of Unit A. However, the compliance with each piece of evidence in Unit B was higher than Unit A except item 1 and item 4. Considering NKAB-V is a self-report scale, which may result in certain bias, and the compliance of the nurses were assessed by the ward managers, there may exist differences between the two evaluations, even though they both promote the professional growth of the nurses in this study to some extent. In addition, some issues should be given more attention to guarantee the successful implementation of evidence. “Opinion leaders” should be identified in the pilot wards . The opiThe ultimate objective of the EI program is to improve the patients’ clinical outcomes. During this study, patients’ knowledge, attitudes and behaviours regarding VTE nursing have been significantly promoted compared with the baseline survey, which may influence the patients’ self-management of VTE to some extent, resulting in better clinical outcomes regarding VTE occurrence.In summary, constructing the clinical implementation plan for the “best” evidence falls under the preparation phase. The method used to screen the “prevalent” or “most needed” “best” evidence is the first decision to be considered by each researcher or EI facilitator; that is, the starting point for EI is based on clinical problems that need to be solved or improved rather than the individual interests of the researcher. It is necessary to correctly understand “to what degree evidence and policies of the EI site, practices and priorities match” . WhetherDue to limitations in time and funding, the EBP was only implemented in two units, and the clinical implementation of evidence continued for only two months, covering a limited number of patients. In future research, a multi-centre evidence implementation with a longer duration and outcome observations should be performed to examine the long-term application effects of the EBP project.The updated i-PARIHS framework is more descriptive of the key concepts that affect EI than PARIHS and may provide more instructive guidance for incorporating evidence into practice. The EI programme of incorporating the “best” evidence on VTE nursing into clinical practice using the i-PARIHS framework has been successfully conducted in the clinical practice, and evidences implemented have been successfully incorporated into the routine care of VTE, so this EI program could be used as a reference for similar clinical utilizations.Three key points were identified with regard to the EI: (i) the need to simplify the innovation strategies as much as possible to promote their operability; (ii) the need for close attention by hospital administrators  to the EI can facilitate the EI process effectively; (iii) after the EI programme, making the well-integrated evidence part of the standards for routine care can promote the sustainability of the EI.S1 File(DOCX)Click here for additional data file.S2 File(DOCX)Click here for additional data file.S3 File(DOCX)Click here for additional data file.S4 File(DOCX)Click here for additional data file.S5 File(DOCX)Click here for additional data file.


Primary dysmenorrhea (PD) is a common gynecological disease characterized by lower abdominal pain. Moxibustion as a traditional Chinese treatment, can effectively treat PD with few adverse reactions. Nowadays, there is still no standard guideline for moxibustion treatment of PD, so related clinical practice guidelines need to be developed.This guideline will be developed in line with the latest guideline definition from Institute of Medicine, and that applies the GRADE system as well as the World Health Organization handbook to appraise the quality of evidence and develop recommendations. We will set up a Guideline working group, put forward the corresponding problems based on the principle of Population, Intervention, Comparison, Outcomes (PICO), and complete the literature retrieval. After achieving consensus through evidence syntheses and 2 to 3 rounds of Delphi process, we will also consider patients values and preferences and implement peer review in the guideline.We will put forward evidence-based best practice recommendations and moxibustion standard to improve the symptoms caused by primary dysmenorrhea in a more efficient way. At present, the research is still in progress, and there is no result to report.This guideline will be helpful to clinical acupuncturists and other professionals to further improve clinical efficacy in treating PD with moxibustion. Moreover, we will also constantly update and evaluate the evidence to both support recommendations and identify gap areas for future research.registration number: IPGRP-2020CN021 Its typical symptoms are characteristic by crampy, colicky spams of pain during menstruation, and regularly coupling with dizziness, sickness, emesis, diarrhoea, and fatigue, even cold limbs, syncope and other severe symptoms.,3 A recent study in Japan has shown that the morbidity of dysmenorrhea varies with age, wherein 12 years old, its ratio was 31.6%, 13 years old was 39.5%, 14 years old was 50.3%. In China, the morbidity of dysmenorrhea accounts for 33.1%, that more than half is primary dysmenorrhea, greatly affecting patients both physically and mentally.PD are common affliction among women, whose prevalence is relatively high among adolescent and young adult females. The previous study has reported that the PD prevalence in global women was 25%, while was 90% in global teenagers and approaching 15% of patients feeling in great pain.,7 Recently years, many studies have defined the over synthesis of prostaglandin in the endometrium as the dominant reason for PD, especially the PGF2α and PGF2 that play a fundamental role in increasing uterine muscle tone and high-intensity contraction, triggering the acid metabolites adding up in the myometrium thus causing pain.–11 Otherwise, some studies suggests that ET and NO are also important factors causing primary dysmenorrhea, those mainly regulates uterine vascular tone and blood flow.The reason for PD is related to many factors, and the pathogenesis not yet fully elucidated. It has been proved that PD was associated with the hypercontractility of uterine smooth muscle and spiral artery of uterine wall, so that inducing ischemia and hypoxia and triggering pain in the hypogastrium.,14 Therefore, seeking complementary and alternative treatment for PD to relieve pain is significant. Traditional Chinese medicine described that primary dysmenorrhea is closely related to “stasis,” “stagnation” and “deficiency,” and should be treated by the principle of warming yang for dispelling cold, activating blood circulation, and unblocking collaterals.For the treatment of PD, the currently recommended pharmacological therapies of PD mainly included nonsteroidal anti-inflammatory drugs, prostaglandin antagonists, oral contraceptives and anti-spasmodic drugs. To some extent, these medications can temporarily alleviate pain, but it is associated with some shortcoming, such as high recurrence rate, drug resistance, particularly when used for the long term, which is easy to produce gastrointestinal discomforts, and long haul renal dysfunction. Another study has shown that moxibustion can significantly reduce the levels of PGF2ɑ and PGF2ɑ/PGE2 in uterine tissues of Dysmenorrhea Rats, and improve the activity of NK cells in the spleen of rats.,18Moxibustion, as an external therapy of traditional Chinese Medicine, has a wide range of applications to prevent and treat diseases with the advantages of simple operation and good economic benefits. As we all know, the warm and hot stimulation of moxibustion can warm the meridians and activate the collaterals and keep the Qi and blood running unobstructed to relieve the pain symptoms. Modern studies have confirmed that moxibustion can redistribute microcirculatory blood flow in the body by affecting the function of microvascular relaxation and contraction.Although plenty of studies have reported the curative effect and safety of moxibustion for PD, there is still a lack of guidelines involving moxibustion for PD, so we need to formulate relevant clinical practice guideline (CPG). Moreover we preliminary found more than 200 RCTs as well as some SRs or meta-analysis using moxibustion to treat PD, all that have been regarded as the basis of drawing up CPG.2The aim of this study is to formulating systematic guidelines and moxibustion standard that can be used by acupuncture practices as well as other specialities to further improve the management of primary dysmenorrhea with moxibustion.33.1 as well as the World Health Organization handbook for guideline. In addition, we also follow 6 domains of the AGREE II instrument and GRADE system.Regarding guideline development, we closely comply with the Institute of Medicine3.2http://www.guidelines-registry.org/guid/875), and the registration number is IPGRP-2020CN021.We have registered the guideline on the International Practice Guidelines Registry Platform , 3 TCM physicians, 3 physiotherapists, 2 medical clinicians, an editor, a health economist physician and a nurse; and they will be in charge of the following mission:(1)to develop the scope of the guideline, the population of the draft, Intervention, Comparison, Outcomes (PICOs);(2)to assess the evidence quality;(3)to make initial proposal;(4)to formulate a draft guideline;(5)to publish and generalize the guideline.The Guideline Steering Group will be composed of 3 acupuncturists, 1 evidence-based medical experts, 1 TCM physician, 2 physiotherapists and 1 health economist physician; and they will be in charge of the following mission:(1)to authorize the guideline's scope and PICOs;(2)to supervise literature search and systematic reviews;(3)to examine the quality of evidence;(4)to develop the final recommendation based on the revised Delphi approach;(5)to ratify the release of the guidelines.Guideline Secretary Group: The member of the Guideline Secretary Group will be composed of 3 evidence-based medical experts, 2 acupuncturists and 1 statistician. and they will be in charge of the following mission:(1)to do a literature research and accomplish systematic reviews;(2)to survey patients’ viewpoint and favor.(3)to assist the development of the guideline.3.6tatement of Interest forms to enhance the transparency and credibility of the CPG.To ascertain their underlying benefit conflict, all individuals engaged in the Guideline Working Group should accomplish the s3.7We will finalize the PICOs after the scope of guideline defined by the Guideline Steering Group and examined by the Guideline Steering Group. The Guideline Development Group will evaluate the importance of the outcomes. The outcomes will be categorized as critical, important, not important by the score of 1 to 9. wherein, 7 to 9 will be regarded as critical to make a decision and develop recommendations, 4–6 as important and 1 to 3 as not important. According to PICOs principle, we will throw out the recommendations from the aspects of safety and effectiveness of moxibustion, moxibustion method, moxibustion doses as follow.Is moxibustion effective and safe for PD?P: Patients diagnosed with PDI: Patients who treat with moxibustionC: Patients who treat with other therapyO: The Primary outcome is the overall response rate for PD treated with moxibustion. The secondary outcomes mainly including Cox Menstrual Symptom Scale, frequency of analgesic use, and visual analog scale scores. The moxibustion-related adverse events are recorded in the case report form, such as scalding, allergy, pregnancy, skin vesicles, skin pain and others, all that is documented throughout the trial.How to implement moxibustion normatively and effectively?P: Patients diagnosed with PDI: Patients who treat by moxibustion with dynamic operationC: Patients who treat by moxibustion in fixed point without dynamic operationO: The total effective rate, rate of adverse events and the level of plasma PGF2a.How to select the optimal amount of moxibustion for each patient?P: Patients diagnosed with PDI: Patients who treat by moxibustion with individualised ‘sensitivity elimination’ doseC: Patients who treat by moxibustion with a standardised 15 min doseO: The total effective rate, the Cox Menstrual Symptom Scale and the visual analog scale scores.3.8We will systematically search the literature until June 30, 2020, including three foreign Databases- Embase, PubMed, Cochrane library, and four Chinese literature databases- CNKI, SinoMed, Wanfang and VIP. Free words and MeSH terms will be searched synchronously with the help of evidence-based experts. Such as primary dysmenorrhea, essential dysmenorrhea, functional dysmenorrhea, moxibustion, indirect moxibustion, suspended moxibustion, direct moxibustion, mild moxibustion, heat-sensitive moxibustion. There will be no restrictions on publication language, and references must have clear diagnostic and inclusion criteria.3.9Firstly, we will eliminate some unqualified studies according to the title and abstract, then bring into relevant literature by reading the whole text, such as systematic review, meta-analysis and original studies. Meanwhile, we plan to conduct a pre-test before the literature selection that could ensure the consistency of literature choice criterion.3.10The high-quality systematic reviews complying with PRISMA guidelines released in recent two years will be adopted directly. If we get low-quality systematic reviews, we will apply the currently available evidence to conduct new systematic reviews.3.11The assessment of evidence quality will be divided into high, moderate, low or very low with the GRADE instrument. Such as the randomised controlled trials are considered as high-quality, and observational studies as low-quality. In addition, three escalation factors  and 5 downgrading factors  will be considered. The guideline methodologists will be in charge of evaluating the evidence quality, drafting the evidence summaries, and then submitting to the Guideline Working Group.3.12We will survey the value and preference of moxibustion treatment for PD, which mainly includes the effectiveness of moxibustion therapy for AR, adverse reactions, burdens, costs, potential benefits, and so on. Meanwhile, the reliability and acceptability of the findings will be evaluated to inform the development of the clinical questions. The finding will be referenced by the experts of the guideline working group when formulating the recommendations. Besides, the patients will be required to receive related training and sign the informed consent before the investigation.3.13 to reach decisions, and the strength of recommendation is divide into strong recommendation, weak recommendation, unclear recommendation, weak no recommendation, strong no recommendation. The recommendation will be adopted on that condition the approval ratio of the experts is more than 50% for any option or more than 70% for one of the two options on same side.According to the evidence quality, the values and favours of patients, the balance between the pros and cons, and the economic analysis, the preliminary recommendation will be drafted by the Guideline Development Group. With 2 to 4 rounds of the Delphi process, the draft recommendations will be submitted to he Guideline Steering Group for final approval. We will vote by GRADE grid3.14The guideline will be reviewed by external peer experts to ensure uniformity. The Guideline Development Group will be responsible for recording the review process, then the feedback will be discussed by experts to make the final decision.3.15It is expected that the full text consistent with the requirements of RIGHT will be published in 2022. The publication will be published in relevant journals and updated it every 3 to 5 years.3.16After releasing the guideline, the dissemination and promotion of the guideline will be implemented by Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine and Guilin Medical University. They will be in charge of the tasks as follow:(1)The guideline will be proposed in relevant seminars and forums;(2)A nationwide study lecture related to the guideline will be held for acupuncturists, physiotherapists, nurses and others related personnel;(3)The experts of the guidelines will write articles regarding the guidelines and publish them in journals, popular medical or official health websites;(4)An extensive investigation relating to the application and dissemination of the guidelines will be produced.(5)To conduct an assessment for the implementation of the guideline.4The study has not been accomplished, and there is a lack of complete data.5In line with the recognized methodology for guideline developments, this would be the first CPG for management of primary dysmenorrhea with moxibustion, which is expected to be implemented more widely and standardly than previously, thus improving the effectiveness, safety of PD therapy. However, the above protocol still has limitation, we should recognise that the differences of moxibustion methods utilised by different country in literature retrieval.6In this guideline, we will strickly follow the Institute of Medicine new guideline definition and the methodology for guideline developments in hopes that achieve better results in treating PD with moxibustion. Important, the guideline will provide a set of implementation standards for moxibustion based on the rich experience of heat-sensitive moxibustion in our hospital.This protocol was drafted by Rongrong Nie. Shouqiang Huang, Rongrong Nie, Jun Xiong were responsible for the conception of the study. And this protocol was revised by Jun Xiong and Shouqiang Huang. Weiye Liao, Zhiming Mao, Xianglin Li played an important role in protocol development. All authors gave final approval for the version to be published.Data curation: Zhiming Mao, Weiye Liao, Xianglin Li.Resources: Zhiming Mao, Weiye Liao, Xianglin Li.Supervision: Shouqiang Huang, Jun Xiong.Writing – original draft: Rongrong Nie.Writing – review & editing: Rongrong Nie, Shouqiang Huang.