Innovative tools for quality assessment: integrated quality criteria for review of multiple study designs (ICROMS). Assessment of study quality for systematic reviews: a comparison of the Cochrane Collaboration Risk of Bias Tool and the Effective Public Health Practice Project Quality Assessment Tool: methodological research. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Examining the theory‐effectiveness hypothesis: A systematic review of systematic reviews What are the most effective behaviour change techniques to promote physical activity and/or reduce sedentary behaviour in inactive adults? A systematic review protocol Comparison of tools for assessing the methodological quality of primary and secondary studies in health technology assessment reports in Germany Risk of bias in randomised controlled trials of health behaviour change interventions: Evidence, practices and challenges Efficacy of postural and neck-stabilization exercises for persons with acute whiplash-associated disorders: a systematic review. Psychosocial determinants of fruit and vegetable intake in adult population: a systematic review Reducing patient delay with symptoms of acute coronary syndrome: a research protocol for a systematic review of previous interventions to investigate which behaviour change techniques are associated with effective interventions Energy balance-related behaviours associated with overweight and obesity in preschool children: a systematic review of prospective studies. Assessing the complexity of interventions within systematic reviews: development, content and use of a new tool (iCAT_SR) Using Guasha to treat musculoskeletal pain: A systematic review of controlled clinical trials Understanding effects in reviews of implementation interventions using the Theoretical Domains Framework [GRADE guidelines: 18. How ROBINS-I and other tools to assess risk of bias in nonrandomized studies should be used to rate the certainty of a body of evidence]. GRADE guidelines: 18. How ROBINS-I and other tools to assess risk of bias in nonrandomized studies should be used to rate the certainty of a body of evidence. [Psychological mechanisms in the transition from acute to chronic pain: over- or underrated?]. Structural brain alterations following adult non-CNS cancers: a systematic review of the neuroimaging literature The clinical effectiveness of different parenting programmes for children with conduct problems: a systematic review of randomised controlled trials Prevalence of spondylosis deformans in the feline spine and correlation with owner-perceived behavioural changes. Systematic review of cognitive behavioural therapy for the management of headaches and migraines in adults [Active music therapy for chronic pain: a prospective study]. Comparison of perioperative racemic methadone, levo-methadone and dextromoramide in cats using indicators of post-operative pain.
OBJECTIVES With the aim to facilitate a more comprehensive review process in public health including patient safety , we established a tool that we have termed ICROMS ( Integrated quality Criteria for the Review Of Multiple Study design s ) , which unifies , integrates and refines current quality criteria for a large range of study design s including qualitative research . STUDY DESIGN Review , pilot testing and expert consensus . METHODS The tool is the result of an iterative four phase process over two years : 1 ) gathering of established criteria for assessing controlled , non-controlled and qualitative study design s ; 2 ) pilot testing of a first version in two systematic review s on behavioural change in infection prevention and control and in antibiotic prescribing ; 3 ) further refinement and adding of additional study design s in the context of the European Centre for Disease Prevention and Control funded project ' Systematic review and evidence -based guidance on organisation of hospital infection control programmes ' ( SIGHT ) ; 4 ) scrutiny by the pan-European expert panel of the SIGHT project , which had the objective of ensuring robustness of the systematic review . RESULTS ICROMS includes established quality criteria for r and omised studies , controlled before- and -after studies and interrupted time series , and incorporates criteria for non-controlled before- and -after studies , cohort studies and qualitative studies . The tool consists of two parts : 1 ) a list of quality criteria specific for each study design , as well as criteria applicable across all study design s by using a scoring system ; 2 ) a ' decision matrix ' , which specifies the robustness of the study by identifying minimum requirements according to the study type and the relevance of the study to the review question . The decision matrix directly determines inclusion or exclusion of a study in the review . ICROMS was applied to a series of systematic review s to test its feasibility and usefulness in the appraisal of multiple study design s. The tool was applicable across a wide range of study design s and outcome measures . CONCLUSION ICROMS is a comprehensive yet feasible appraisal of a large range of study design s to be included in systematic review s addressing behaviour change studies in patient safety and public health . The tool is sufficiently flexible to be applied to a variety of other domains in health-related research . Beyond its application to systematic review s , we envisage that ICROMS can have a positive effect on research ers to be more rigorous in their study design and more diligent in their reporting BACKGROUND The Cochrane Collaboration is strongly encouraging the use of a newly developed tool , the Cochrane Collaboration Risk of Bias Tool ( CCRBT ) , for all review groups . However , the psychometric properties of this tool to date have yet to be described . Thus , the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity , in comparison with the Effective Public Health Practice Project Quality Assessment Tool ( EPHPP ) . METHODS Both tools were used to assess the method ological quality of 20 r and omized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions  to improve the management of cancer pain . Each study assessment was completed independently by two review ers using each tool . We analysed the inter-rater reliability of each tool 's individual domains , as well as final grade assigned to each study . RESULTS The EPHPP had fair inter-rater agreement for individual domains and excellent agreement for the final grade . In contrast , the CCRBT had slight inter-rater agreement for individual domains and fair inter-rater agreement for final grade . Of interest , no agreement between the two tools was evident in their final grade assigned to each study . Although both tools were developed to assess ' quality of the evidence ' , they appear to measure different constructs . CONCLUSIONS Both tools performed quite differently when evaluating the risk of bias or method ological quality of studies in knowledge translation interventions for cancer pain . The newly introduced CCRBT assigned these studies a higher risk of bias . Its psychometric properties need to be more thoroughly vali date d , in a range of research fields , to underst and fully how to interpret results from its application For the current issue of the Journal , we asked Drs Anna Taddio and C Meghan McMurtry to comment on and put into context the Cochrane Review on psychological interventions for needle-related procedural pain and distress in children and adolescents ( 1 ) . Background This review is an up date d version of the original Cochrane review published in Issue 4 , 2006 . Needle-related procedures are a common source of pain and distress for children . Our previous review on this topic indicated that several psychological interventions were efficacious in managing paediatric needle pain including distraction , hypnosis and combined cognitive behavioural interventions . Considerable additional research in the area has been published since that time . Methods Search strategy Search es of the following data bases were conducted for relevant r and omized controlled trials ( RCTs ): Cochrane Central Register of Controlled Trials ( CENTRAL ) ; MEDLINE ; EMBASE ; PsycINFO ; the Cumulative Index to Nursing and Allied Health Literature ( CINAHL ) ; and Web of Science . Requests for relevant studies were also posted on various electronic list servers . An up date d search was conducted in March 2012 and again in March 2013 . Selection criteria Participants included children and adolescents two to 19 years of age undergoing needle-related procedures . Only RCTs with ≥5 participants in each study arm comparing a psychological intervention group with a control or comparison group were eligible for inclusion . Data analysis Two review authors extracted data and assessed trial quality , and a third author helped with data extraction and coding for one non-English study . Included studies were coded for quality using the Cochrane Risk of bias tool . St and ardized mean differences with 95 % CIs were calculated for all analyses using Review Manager version 5.2 . Results Thirty-nine trials with a total of 3394 participants were included . The most commonly studied needle-related procedures were veni-puncture , intravenous line insertion and immunization .  Studies included children two to 19 years of age , with the most evidence available for children < 12 years of age . Consistent with the original review , the most commonly studied psychological interventions for needle procedures were distraction , hypnosis and cognitive behavioural therapy ( CBT ) . The majority of included studies ( 19 of 39 ) examined distraction only . The additional studies from this review up date continued to provide strong evidence for the efficacy  of distraction and hypnosis . No evidence was available to support the efficacy of preparation and information , combined CBT ( ≥2 cognitive or behavioural strategies combined ) , parent coaching plus distraction , suggestion or virtual reality for reducing children ’s pain and distress . No conclusions could be drawn about interventions of memory alteration , parent positioning plus distraction , blowing out air or distraction plus suggestion because evidence was available from single studies only . In addition , the risk of bias scores indicated several domains with high or unclear bias scores ( eg , selection , detection and performance bias ) , suggesting that the method ological rigour and reporting of RCTs of psychological interventions continue to exhibit considerable room for improvement . Conclusions Overall , there is strong evidence supporting the efficacy of distraction and hypnosis for needle-related pain and distress in children and adolescents , with no evidence currently available for preparation and information or both , combined CBT , parent coaching plus distraction , suggestion or virtual reality . Additional research is needed to further assess interventions that have only been investigated in one RCT to date ( ie , memory alteration , parent positioning plus distraction , blowing out air and distraction plus suggestion ) . There are continuing issues with the quality of trials examining psychological interventions for needle-related pain and distress . The full text of the Cochrane Review is available in The Cochrane Library ( 1 ) PURPOSE Health interventions based on theory may be more effective than those that are not . This review of review s synthesizes all published r and omized controlled trial ( RCT ) meta-analytic evidence from the last decade to examine whether theory-based interventions were found to be associated with more effective  adult health behaviour change interventions . METHODS Systematic review s including meta-analyses were identified by search ing Medline , CINAHL , PsycINFO , and CDSR . A narrative synthesis was used to summarize and analyse the evidence . Only review s including RCTs of health behaviour change interventions with adults aged 18 + published from 2007 to 2017 were included . RESULTS Of 8,659 articles , nine systematic review s met inclusion criteria . The majority of review s ( n = 8) suggested no increased effectiveness for theory-based compared to non-theory-based interventions for effectiveness of outcomes relating to health behaviour . Less than half of the RCTs included in the review s reported the use of theory ( 85/183 ) . Two review s suggested interventions based on control theory , motivational interviewing , or self-determination theory were associated with greater effectiveness for physical activity and /or dietary interventions and outcomes . Method ological and reporting issues limit the conclusions . CONCLUSIONS Theory-based interventions as currently operationalized in systematic review s were not found to be more effective than non-theory-based interventions . Method ological and reporting issues at study and review level may not reflect the true utility of theory use within health behaviour interventions . The promotion of theory use may benefit from using a multifaceted argument , rather than a narrow focus of increased effectiveness . Statement of contribution What is already known on this subject ? Theory use is regularly promoted by cl aim ing that it will lead to more effective behaviour change interventions . Theory use has been frequently linked to effectiveness within systematic review s of behaviour change interventions . The theory-effectiveness hypothesis has not been systematic ally examined at the systematic review level . What does this study add ? Theory use as operationalized by systematic review authors was not associated with increased effectiveness within systematic review s examining r and omized controlled trials of behaviour change interventions in adults . Interventions based on control theory , motivational interviewing , or self-determination theory were associated with greater effectiveness for physical activity and /or dietary interventions and outcomes . Theory use should be promoted using a multifaceted argument , and assertions for increased effectiveness of theory-based interventions should only be used in domains where specific evidence exists to support this cl aim Introduction Large proportions of the population are not meeting recommended levels of physical activity and have increasingly sedentary lifestyles . Low levels of physical activity are predictive of poor health outcomes and time spent sedentary is related to a host of risk factors independently of physical activity levels . Building an evidence base of the best approaches to intervene in the lifestyles of inactive individuals is crucial in preventing long-term disease , disability and higher mortality rates . Methods and analysis Systematic search es will be conducted on all relevant data bases ( eg , PubMed , Scopus , CINAHL , PsycINFO ) . Studies will be included if they assess interventions aim ed at changing physical activity or sedentary behaviour levels in adults ( over 18 ) who are inactive and do not suffer from chronic conditions . Studies must also be r and omised controlled trials ( RCTs ) , have a primary outcome of physical activity or sedentary behaviour , and measure outcomes at least 6 months after intervention completion . Studies will be coded using the Behaviour Change Technique ( BCT ) taxonomy v1 and Template for Intervention Description and Replication ( TIDieR ) guidelines . 2 review ers will independently screen full-text articles and extract data on study characteristics , participants , BCTs , intervention features and outcome measures . Study quality will also be assessed independently by 2 review ers using the Cochrane risk of bias tool . A meta- analysis will be considered if there is sufficient homogeneity across outcomes . GRADE criteria will be used to assess quality of evidence . Dissemination This will be the first review to systematic ally appraise interventions aim ed at changing the physical activity or sedentary behaviour of inactive individuals using RCT design s with a 6-month follow-up post-intervention . This review will better inform intervention design ers targeting inactive population s and inform the design of a future complex intervention . Review registration number This protocol was registered with the International Prospect i ve Register of Systematic Review s ( PROSPERO ) on 17 October 2014 ( registration number : CRD42014014321 ) Health care policy background Findings from scientific studies form the basis for evidence -based health policy decisions . Scientific background Quality assessment s to evaluate the credibility of study results are an essential part of health technology assessment reports and systematic review s. Quality assessment tools ( QAT ) for assessing the study quality examine to what extent study results are systematic ally distorted by confounding or bias ( internal validity ) . The tools can be divided into checklists , scales and component ratings . Research questions What QAT are available to assess the quality of interventional studies or studies in the field of health economics , how do they differ from each other and what conclusions can be drawn from these results for quality assessment s ? Methods A systematic search of relevant data bases from 1988 onwards is done , supplemented by screening of the references , of the HTA reports of the German Agency for Health Technology Assessment ( DAHTA ) and an internet search . The selection of relevant literature , the data extraction and the quality assessment are carried out by two independent review ers . The substantive elements of the QAT are extracted using a modified criteria list consisting of items and domains specific to r and omized trials , observational studies , diagnostic studies , systematic review s and health economic studies . Based on the number of covered items and domains , more and less comprehensive QAT are distinguished . In order to exchange experiences regarding problems in the practical application of tools , a workshop is hosted . Results A total of eight systematic method ological review s is identified as well as 147 QAT : 15 for systematic review s , 80 for r and omized trials , 30 for observational studies , 17 for diagnostic studies and 22 for health economic studies . The tools vary considerably with regard to the content , the performance and quality of operationalisation . Some tools do not only include the items of internal validity but also the items of quality of reporting and external validity . No tool covers all elements or domains . Design -specific generic tools are presented , which cover most of the content criteria . Discussion The evaluation of QAT by using content criteria is difficult , because there is no scientific consensus on the necessary elements of internal validity , and not all of the generally accepted elements are based on empirical evidence . Comparing QAT with regard to contents neglects the operationalisation of the respective parameters , for which the quality and precision are important for transparency , replicability , the correct assessment and interrater reliability . QAT , which mix items on the quality of reporting and internal validity , should be avoided . Conclusions There are different , design -specific tools available which can be preferred for quality assessment , because of its wider coverage of substantive elements of internal validity . To minimise the subjectivity of the assessment , tools with a detailed and precise operationalisation of the individual elements should be applied . For health economic studies , tools should be developed and complemented with instructions , which define the appropriateness of the criteria . Further research is needed to identify study characteristics that influence the internal validity of studies The major strength of a r and omised controlled trial ( RCT ) is the degree to which it can establish a causal relationship between an experimental treatment and the outcome ( i.e. internal validity ) , as r and omisation should ensure that potential confounders are equally distributed over the treatment and control arms . Internal validity in RCTs can be threatened , however , by multiple sources of bias . For example , poor r and omisation procedures ( e.g. failure to conceal allocations until treatments have been assigned ) can lead to selection bias because more high-risk individuals are selected to receive the experimental treatment . There is a range of potential sources of bias in RCTs , and several well-known tools for assessing the risk of bias provide useful overviews of these sources and strategies for reducing them ( e.g. Guyatt et al. , 2011 ; Higgins , Altman , & Sterne , 2011 ) . These tools are also influential : trials scoring high on risk-of-bias assessment s should have a smaller chance on publication and – if published – to be included in ‘ best evidence ’ systematic review s ( Johnson , Low , & MacDonald , 2015 ) , and thus for their interventions to influence policy and practice . Systematic review s suggest that many health behaviour change ( HBC ) trials suffer from a moderate to high risk of bias ( e.g. Oberjé , de Kinderen , Evers , van Woerkum , & de Bruin , 2013 ; Poobalan , Aucott , Precious , Crombie , & Smith , 2009 ) ; more so than , for example , drug trials ( Crocetti , Amin , & Scherer , 2010 ) . Moreover , risk-of-bias scores have been found to explain heterogeneity in effect sizes , especially in trials with subjective outcome measures ( Savovic et al. , 2012 ; Wood et al. , 2008 ) . Since replication studies of HBC intervention evaluations are uncommon , invalid inferences due to bias may not be easily discovered and rectified . Despite these concerns , there has been little attention in the behaviour change intervention literature to the sources and consequences of bias in trials , and to strategies that may be effective in reducing the risk of bias . This paucity of research on risk of bias in HBC trial is in turn reflected in widely used instruments for assessing the risk of bias , such as the Cochrane risk-of-bias tool ( Higgins et al. , 2011 ) , which seems to be mostly based on evidence from non-behavioural trials . The objective of this special issue is to reflect on the evidence , practice s and challenges in relation to reducing the risk of bias in HBC trials . We hope that this special issue will both impact scientific practice ( i.e. enhancing the quality of HBC trial design , reporting and synthesis ) and have an agenda- setting effect ( i.e. inspire people to do empirical research into what sources of bias actually do affect HBC trials , what strategies are effective for mitigating these , and thus what criteria should be used for grading the quality of the evidence of HBC trials ) PURPOSE We systematic ally review ed r and omized and quasi-r and omized clinical trials in the literature to assess the efficacy of neck stabilization and postural exercises on pain , neck range of motion , and time off work in adults with acute whiplash-associated disorders . METHODS Electronic data bases , reference lists of relevant Cochrane review s , reference lists of studies selected for inclusion , and tables of contents of relevant journals were systematic ally search ed for r and omized and quasi-r and omized controlled trials . Two independent review ers selected studies for inclusion , assessed method ological quality , and extracted data . Because of the heterogeneity of the interventions , a qualitative synthesis was performed using " levels of evidence " as recommended by van Tulder et al. RESULTS Eight studies representing five clinical trials were selected for inclusion . Two trials were grade d as high quality , two as moderate quality , and one as low quality . Many of these studies had mixed results , demonstrating significant differences on some outcome measures but not on others . CONCLUSIONS There is moderate evidence to support the use of postural exercises for decreasing pain and time off work in the treatment of patients with acute whiplash-associated disorders . However , no evidence exists to support the use of postural exercises for increasing neck range of motion . There is conflicting evidence in support of neck stabilization exercises in the treatment of patients with acute whiplash-associated disorders Background Accumulating evidence suggests that fruit and vegetable intake ( FVI ) plays a protective role against major diseases . Despite this protective role and the obesity p and emic context , population s in Western countries usually eat far less than five servings of fruits and vegetables per day . In order to increase the efficiency of interventions , they should be tailored to the most important determinants or mediators of FVI . The objective was to systematic ally review social cognitive theory-based studies of FVI and to identify its main psychosocial determinants . Methods Published papers were systematic ally sought using Current Contents ( 2007 - 2009 ) and Medline , Embase , PsycINFO , Proquest and Thesis , as well as Cinhal ( 1980 - 2009 ) . Additional studies were identified by a manual search in the bibliographies . Search terms included fruit , vegetable , behaviour , intention , as well as names of specific theories . Only studies predicting FVI or intention to eat fruits and vegetables in the general population and using a social cognitive theory were included . Independent extraction of information was carried out by two persons using predefined data fields , including study quality criteria . Results A total of 23 studies were identified and included , 15 study ing only the determinants of FVI , seven study ing the determinants of FVI and intention and one study ing only the determinants of intention . All pooled analyses were based on r and om-effects models . The r and om-effect R2 observed for the prediction of FVI was 0.23 and it was 0.34 for the prediction of intention . Multicomponent theoretical frameworks and the theory of planned behaviour ( TPB ) were most often used . A number of method ological moderators influenced the efficacy of prediction of FVI . The most consistent variables predicting behaviour were habit , motivation and goals , beliefs about capabilities , knowledge and taste ; those explaining intention were beliefs about capabilities , beliefs about consequences and perceived social influences . Conclusions Our results suggest that the TPB and social cognitive theory ( SCT ) are the preferable social cognitive theories to predict behaviour and TPB to explain intention . Efficacy of prediction was nonetheless negatively affected by method ological factors such as the study design and the quality of psychosocial and behavioural measures Introduction Delay to presentation with symptoms of acute coronary syndrome ( ACS ) is common meaning many fail to achieve optimal benefit from treatments . Interventions have had variable success in reducing delay . Evidence suggests inclusion of behaviour change techniques ( BCTs ) may improve effectiveness of interventions but this has not yet been systematic ally evaluated . Data from other time-critical conditions may be relevant . Methods and analysis A systematic review will be undertaken to identify which BCTs are associated with effective interventions to reduce patient delay ( or prompt rapid help-seeking ) among people with time-critical conditions ( eg , chest pain , ACS , lumps , stroke , cancer and meningitis ) . A systematic search of a wide range of data bases ( including Cochrane Library , MEDLINE , EMBASE , CINAHL , PsycInfo ) and grey literature will be undertaken to identify all relevant intervention studies ( r and omised controlled trials , controlled clinical trials and cohort studies ) . Two independent review ers will screen abstract s to identify relevant studies , apply inclusion criteria to full papers , assess method ological quality and extract data . Primary outcome measure Change in patient decision time BCTs reported in each of the included studies will be categorised and presented according to the latest reliable taxonomy . Results of included studies will be synthesis ed , exploring relationships between inclusion of each BCT and effectiveness of the overall intervention . Where possible , means and SDs for differences in delay time will be calculated and combined within meta-analyses to derive a st and ardised mean difference and 95 % CI . Analysis of ( 1 ) all time-critical and ( 2 ) ACS-only interventions will be undertaken . Ethics and dissemination No ethical issues are anticipated . Results will be su bmi tted for publication in a relevant peer- review ed journal The current review aim ed to systematic ally identify dietary , physical activity and sedentary behaviours in preschool children ( 4 - 6 years of age ) that are prospect ively related to overweight or obesity later in childhood . Prospect i ve studies published between January 1990 and June 2010 were selected from search es in PubMed , EMBASE , PsycINFO , CINAHL and Cochrane Library . Studies examining the prospect i ve association between at least one relevant behaviour measured during preschool period ( children aged 4 - 6 years at baseline ) in relation to at least one anthropometric measurement at follow-up ( age < 18 years ) were included . Harvest plots were used to summarize the results and draw conclusions from the evidence . Of the 8,718 retrieved papers , 23 papers reporting on 15 different study sample s were included in this review . Strong evidence was found for an inverse association between total physical activity and overweight . Moderate evidence was observed for a positive association between television viewing and overweight . Because of the heterogeneity in the assessed dietary behaviours , insufficient evidence was found for an association between  dietary intake or specific dietary behaviours and overweight . These results suggest that interventions aim ing to prevent overweight among preschool children should focus on promotion of total physical activity and limitation of screen time and that further research is needed to establish whether and which dietary behaviours are important for obesity prevention in this age group . However , despite the lack of evidence for dietary behaviours from the present review , future interventions may already target specific dietary behaviours that are highly prevalent and for which there a clear rationale as well as preliminary evidence that these behaviours are associated with overweight Background Health interventions fall along a spectrum from simple to more complex . There is wide interest in methods for review ing ‘ complex interventions ’ , but few transparent approaches for assessing intervention complexity in systematic review s. Such assessment s may assist review authors in , for example , systematic ally describing interventions and developing logic models . This paper describes the development and application of the intervention Complexity Assessment Tool for Systematic Review s ( iCAT_SR ) , a new tool to assess and categorise levels of intervention complexity in systematic review s. Methods We developed the iCAT_SR by adapting and extending an existing complexity assessment tool for r and omized trials . We undertook this adaptation using a consensus approach in which possible complexity dimensions were circulated for feedback to a panel of method ologists with expertise in complex interventions and systematic review s. Based on these inputs , we developed a draft version of the tool . We then invited a second round of feedback from the panel and a wider group of systematic review ers . This informed further refinement of the tool . Results The tool comprises ten dimensions : ( 1 ) the number of active components in the intervention ; ( 2 ) the number of behaviours of recipients to which the intervention is directed ; ( 3 ) the range and number of organizational levels targeted by the intervention ; ( 4 ) the degree of tailoring intended or flexibility permitted across sites or individuals in applying or implementing the intervention ; ( 5 ) the level of skill required by those delivering the intervention ; ( 6 ) the level of skill required by those receiving the intervention ; ( 7 ) the degree of interaction between intervention components ; ( 8) the degree to which the effects of the intervention are context dependent ; ( 9 ) the degree to which the effects of the interventions are changed by recipient or provider factors ; ( 10 ) and the nature of the causal pathway between intervention and outcome . Dimensions 1–6 are considered ‘ core ’ dimensions . Dimensions 7–10 are optional and may not be useful for all interventions . Conclusions The iCAT_SR tool facilitates more in-depth , systematic assessment of the complexity of interventions in systematic review s and can assist in undertaking review s and interpreting review findings . Further testing of the tool is now needed Background Guasha is a therapeutic method for pain management using tools to scrape or rub the surface of the body to relieve blood stagnation . This study aims to systematic ally review the controlled clinical trials on the effectiveness of using Guasha to treat musculoskeletal pain . Methods We search ed 11 data bases ( without language restrictions ) : MEDLINE , Allied and Complementary Medicine ( AMED ) , EMBASE , Cumulative Index to Nursing and Allied Health Literature ( CINAHL ) , Korean Studies Information ( KSI ) , DBPIA , Korea Institute of Science and Technology Information ( KISTI ) , KoreaMed , Research Information Service System ( RISS ) , China National Knowledge Infrastructure ( CNKI ) and the Cochrane Library . The search strategy was Guasha ( OR scraping ) AND pain . Risk of bias was assessed with the Cochrane criteria ( i.e. sequence generation , blinding , incomplete outcome measures and allocation concealment ) . Results Five r and omized controlled trials ( RCTs ) and two controlled clinical trials ( CCTs ) were included in the present study . Two RCTs compared Guasha with acupuncture in terms of effectiveness , while the other trials compared Guasha with no treatment ( 1 trial ) , acupuncture ( 4 trials ) , herbal injection ( 1 trial ) and massage or electric current therapy ( 1 trial ) . While two RCTs suggested favorable effects of Guasha on pain reduction and response rate , the quality of these RCTs was poor . One CCT reported beneficial effects of Guasha on musculoskeletal pain but had low method ological quality . Conclusion Current evidence is insufficient to show that Guasha is effective in pain management . Further RCTs are warranted and method ological quality should be improved Background Behavioural theory can be used to better underst and the effects of behaviour change interventions targeting healthcare professional behaviour to improve quality of care . However , the explicit use of theory is rarely reported despite interventions inevitably involving at least an implicit idea of what factors to target to implement change . There is a quality of care gap in the post-fracture investigation ( bone mineral density ( BMD ) scanning ) and management ( bisphosphonate prescription ) of patients at risk of osteoporosis . We aim ed to use the Theoretical Domains Framework ( TDF ) within a systematic review of interventions to improve quality of care in post-fracture investigation . Our objectives were to explore which theoretical factors the interventions in the review may have been targeting and how this might be related to the size of the effect on rates of BMD scanning and osteoporosis treatment with bisphosphonate medication . Methods A behavioural scientist and a clinician independently coded TDF domains in intervention and control groups . Quantitative analyses explored the relationship between intervention effect size and total number of domains targeted , and as number of different domains targeted . Results Nine r and omised controlled trials ( RCTs ) ( 10 interventions ) were analysed . The five theoretical domains most frequently coded as being targeted by the interventions in the review included “ memory , attention and decision processes ” , “ knowledge ” , “ environmental context and re sources ” , “ social influences ” and “ beliefs about consequences ” . Each intervention targeted a combination of at least four of these five domains . Analyses identified an inverse relationship between both number of times and number of different domains coded and the effect size for BMD scanning but not for bisphosphonate prescription , suggesting that the more domains the intervention targeted , the lower the observed effect size . Conclusions When explicit use of theory to inform interventions is absent , it is possible to retrospectively identify the likely targeted factors using theoretical frameworks such as the TDF . In osteoporosis management , this suggested that several likely determinants of healthcare professional behaviour appear not yet to have been considered in implementation interventions . This approach may serve as a useful basis for using theory-based frameworks such as the TDF to retrospectively identify targeted factors within systematic review s of implementation interventions in other implementation context OBJECTIVE To provide guidance on how systematic review authors , guideline developers , and health technology assessment practitioners should approach the use of the risk of bias in  nonr and omized studies of interventions ( ROBINS-I ) tool as a part of GRADE 's certainty rating process . STUDY DESIGN AND SETTING The study design and setting comprised iterative discussion s , testing in systematic review s , and presentation at GRADE working group meetings with feedback from the GRADE working group . RESULTS We describe where to start the initial assessment of a body of evidence with the use of ROBINS-I and where one would anticipate the final rating would end up . The GRADE accounted for issues that mitigate concerns about confounding and selection bias by introducing the upgrading domains : large effects , dose-effect relations , and when plausible residual confounders or other biases increase certainty . They will need to be considered in an assessment of a body of evidence when using ROBINS-I. CONCLUSION The use of ROBINS-I in GRADE assessment s may allow for a better comparison of evidence from r and omized controlled trials ( RCTs ) and nonr and omized studies ( NRSs ) because they are placed on a common metric for risk of bias . Challenges remain , including appropriate presentation of evidence from RCTs and NRSs for decision-making and how to optimally integrate RCTs and NRSs in an evidence assessment OBJECTIVE To provide guidance on how systematic review authors , guideline developers , and health technology assessment practitioners should approach the use of the risk of bias in  nonr and omized studies of interventions ( ROBINS-I ) tool as a part of GRADE 's certainty rating process . STUDY DESIGN AND SETTING The study design and setting comprised iterative discussion s , testing in systematic review s , and presentation at GRADE working group meetings with feedback from the GRADE working group . RESULTS We describe where to start the initial assessment of a body of evidence with the use of ROBINS-I and where one would anticipate the final rating would end up . The GRADE accounted for issues that mitigate concerns about confounding and selection bias by introducing the upgrading domains : large effects , dose-effect relations , and when plausible residual confounders or other biases increase certainty . They will need to be considered in an assessment of a body of evidence when using ROBINS-I. CONCLUSIONS The use of ROBINS-I in GRADE assessment s may allow for a better comparison of evidence from r and omized controlled trials ( RCTs ) and nonr and omized studies ( NRSs ) because they are placed on a common metric for risk of bias . Challenges remain , including appropriate presentation of evidence from RCTs and NRSs for decision-making and how to optimally integrate RCTs and NRSs in an evidence assessment INTRODUCTION During the last 20 years a great number of studies have emphasized the potential role of psychological factors as relevant predictors for the first onset of back pain as well as for the development of chronic pain . The formulation of a biopsychosocial perspective of the etiology and chronicity of back pain was a natural consequence . Actual questions concern the relative impact of psychological risk factors in the process of chronicity of back pain compared to biomedical , social and occupational factors . METHODS Whereas several review articles regarding the role of psychological risk factors are available up to now , a recently published review conducted by Steven Linton was the first systematic analysis of well controlled prospect i ve studies published since 1967 . Using a grading system similar to that recommended for guidelines the author defined a level A evidence when at least two good- quality prospect i ve studies supported the prospect i ve power of a variable . Level B evidence had support from one prospect i ve study . Level C represented inconclusive data and level D indicated that no studies met the criteria . Based on a literature search of more than 900 studies , 37 good- quality prospect i ve studies were analysed in detail . RESULTS The results indicated level A evidence for the following interrelations : ( 1 ) Psychosocial variables , especially chronic distress in daily life , depression and work dissatisfaction were clearly associated with the onset of back and neck pain ( 2 ) . Psychological variables , especially chronic stress in daily life , work dissatisfaction , depression and pain-related cognitions and coping behaviour were clearly linked to the transition from acute to chronic pain and disability ( 3 ) . Psychological variables generally had more prospect i ve power than biomedical , social or objective occupational variables . Among the pain-related cognitions , catastrophizing and fear-avoidance-beliefs yielded the most empirical support . Among coping behaviour passive coping stretegies such as avoiding behaviour was most important . At least level B evidence has been shown for the counterpart of an extreme suppressive coping behaviour . Patients who tended to suppress or ignore pain in order to finish all activities they started , who were unable to integrate phases of passive relaxation into the daily routine displayed a high risk of chronicity of pain 6 months after an acute phase of pain . One international and two German good- quality prospect i ve studies have shown the predictive power of a maladaptive suppressive behaviour pattern . Based on the avoidance-endurance-model of pain chronification , both extreme and one-sided passive pain coping as well as one-sided suppressive coping modes were conceptualized as maladaptive due to the process of chronicity . We assume that extreme passive behaviour will lead to immobility and muscular atrophy . Neurophysiological processes of sensitization will further lead to the development of chronic pain . On the other h and , extreme suppressive behaviour will lead to an overuse of muscles and joints with a repetitive combination of muscular hyperactivity and pain . These repetitive pain experiences will also elicit neurophysiological processes of sensitization . ( 4 ) Psychosocial variables displayed more predictive power than biomedical or biomechanical factors . ( 5 ) Psychosocial factors may be used as predictors of the risk for developing long-term pain and disability . Mixed empirical evidence has been shown for the role of personality factors ( level C evidence ) and no support has been found for the idea of a " pain prone " personality disorder or for the role of sexual and physical abuse . DISCUSSION 20 years of research , several qualitative review s and a recently published systematic review of 37 good- quality prospect i ve studies regarding the role of psychological , biomedical , social and objective occupational factors in the process of chronicity of back pain revealed that psychological factors are significantly related to the onset of back pain as well as to the development of chronic pain . Furthermore , the psychological factors displayed more predictive power than biomedical or biomechanical variables . As a consequence for clinical practice , these psychological risk factors have to be considered as " yellow flags " if a back pain problem wo n't respond to medical treatment for more than four weeks . As a further consequence , special risk factor - based psychosocial interventions should be offered in addition to the medical treatment to patients with high psychological risk factors for the development of chronic pain . The efficacy of such an interdisciplinary care in the very early phases of back pain in order to prevent chronicity of pain and disability has been published recently by our group Abstract Background : Cancer and cancer treatments may impact the brain through several pathways leading to cognitive impairment . Neuroimaging evidence has begun to eluci date the neurobiological underpinnings of cancer-related cognitive impairment . The aim of this paper was to systematic ally review available literature on structural brain alterations following adult non- central nervous system ( CNS ) cancers and associated treatments . Methods : This review followed PRISMA guidelines and was registered in PROSPERO ( ID#107387 ) . Comprehensive search es were conducted in June 2018 using PubMed and Web of Science . Inclusion criteria were English peer- review ed journal articles of formal , controlled studies that examined structural neuroimaging outcomes in adult non-CNS cancer patients and survivors . Selected articles were assessed for quality and risk of bias using the National Institutes of Health Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies . Results : Thirty-six publications of prospect i ve and cross-sectional studies met inclusion criteria and were included . Structural brain alterations following cancer and its treatment were reported in a majority of the publications as evidence d by reduced global and local gray matter volumes , impaired white matter microstructural integrity , and brain network alterations . Structural alterations were most often evident when cancer-treated groups were compared with healthy controls , and more subtle when compared with cancer controls . Regarding the existence of pretreatment impairments , the evidence was equivocal . There was significant between- study heterogeneity in imaging analytical approaches and use of statistical adjustments . Over half reported associations with cognitive outcomes , though regions and associated cognitive domains were heterogeneous . Conclusions : Structural brain alterations following cancer and cancer treatments were reported in a majority of the review ed studies . However , the extent of observed alterations depended on the choice of comparison groups . Method ological issues exist that will need to be addressed systematic ally to ensure the validity of findings . Large-scale prospect i ve studies with extended assessment points are warranted to replicate and build upon initial findings Background Conduct problems are common , disabling and costly . The prognosis for children with conduct problems is poor , with outcomes in adulthood including criminal behaviour , alcoholism , drug abuse , domestic violence , child abuse and a range of psychiatric disorders . There has been a rapid expansion of group based parent-training programmes for the treatment of children with conduct problems  in a number of countries over the past 10 years . Existing review s of parent training have method ological limitations such as inclusion of non-r and omised studies , the absence of investigation for heterogeneity prior to meta- analysis or failure to report confidence intervals . The objective of the current study was to systematic ally review r and omised controlled trials of parenting programmes for the treatment of children with conduct problems .  Methods St and ard systematic review methods were followed including duplicate inclusion decisions , data extraction and quality assessment . Twenty electronic data bases from the fields of medicine , psychology , social science and education were comprehensively search ed for RCTs and systematic review s to February 2006 . Inclusion criteria were : r and omised controlled trial ; of structured , repeatable parenting programmes ; for parents/carers of children up to the age of 18 with a conduct problem ; and at least one measure of child behaviour . Meta- analysis and qualitative synthesis were used to summarise included studies . Results 57 RCTs were included . Studies were small with an average group size of 21 . Meta-analyses using both parent ( SMD -0.67 ; 95 % CI : -0.91 , -0.42 ) and independent ( SMD -0.44 ; 95 % CI : -0.66 , -0.23 ) reports of outcome showed significant differences favouring the intervention group . There was insufficient evidence to determine the relative effectiveness of different approaches to delivering parenting programmes . Conclusion Parenting programmes are an effective treatment for children with conduct problems . The relative effectiveness of different parenting programmes requires further research OBJECTIVES The primary objective was to determine the prevalence , spinal distribution , and association with the signalment of cats suffering from different grade s of feline spondylosis deformans ( spondylosis ) . The secondary objective was to document behavioural changes associated with spondylosis by owner observation . METHODS A cross-sectional study was performed to determine the prevalence of feline spondylosis ( group 1 ) . A prospect i ve study was performed to determine the association between radiographic abnormalities of the lumbosacral region ( L3-S1 ) and owner perceived behavioural changes based on a completed question naire ( group 2 ) . The radiographs were review ed using a grading system ( 0 - 3 ) for spondylosis . RESULTS The prevalence of spondylosis in group 1 was 39.4 % ( 158/402 ) . Cats with spondylosis were significantly older than cats without spondylosis ( p < 0.001 ) . The thoracic ( T ) vertebrae T4-T10 were most often affected by spondylosis , but spondylosis was most severe in the T10-S1 vertebrae . In group 2 , spondylosis of the lumbosacral region was significantly correlated with owner-reported behavioural changes , such as a decreased willingness to greet people and to being petted , increased aggressiveness , and a poor perceived quality of life ( p = 0.037 ) . CLINICAL SIGNIFICANCE This study found that feline spondylosis is common and that spondylosis of the lumbosacral region may be accompanied by behavioural changes Aim : This systematic review aim ed to establish if cognitive behavioural therapy ( CBT ) can reduce the physical symptoms of chronic headache and migraines in adults . Methods : Evidence from search es of eight data bases was systematic ally sought , appraised and synthesis ed . Screening of title and abstract s was conducted independently by two review ers . Full papers were screened , data extracted and quality assessed by one review er and checked by a second . Data were synthesis ed narratively by intervention due to the heterogeneity of the studies . The inclusion criteria specified r and omised controlled trials with CBT as an intervention in adults suffering from chronic headaches/migraines not associated with an underlying pathology/medication overuse .  CBT was judged on the basis of authors describing the intervention as CBT . The diagnosis of the condition had to be clinician verified . Studies had to include a comparator and employ headache/migraine-specific outcomes such as patient-reported headache days . Results : Out of 1126 screened titles and abstract s and 20 assessed full papers , 10 studies met the inclusion criteria of the review . Some studies combined CBT with another intervention , as well as employing varying numbers of comparators . CBT was statistically significantly more effective in improving some headaches-related outcomes in CBT comparisons with waiting lists ( three studies ) , in combination with relaxation compared with relaxation only ( three studies ) or antidepressant medication ( one study ) , with no statistically significant differences in three studies . Conclusions : The findings of this review were mixed , with some studies providing evidence in support of the suggestion that people experiencing headaches or migraines can benefit from CBT , and that CBT can reduce the physical symptoms of headache and migraines . However , methodology inadequacies in the evidence base make it difficult to draw any meaningful conclusions or to make any recommendations There are only few publications about the effect of music therapy on pain relief . The intention of this prospect i ve study is to demonstrate the influence of the Nordoff/Robbins method of active music therapy in a group of 12 patients with fibromyalgia , myofascial pain syndromes and polyarthritis on  pain reduction , life quality and coping . The clinical parameters of each patient were related to the observations in the audio- and video-documented music therapy setting s and to the self-reported changes in pain intensity and pain behaviour . There was a significant reduction of pain intensity and pain-related disability in the music group compared to a control group , but no change in the depression and anxiety score . The influence of music therapy could be even better demonstrated in the systematic analysis of the single cases by individual profiles . Active music therapy affects especially the communicative and emotional dimension of chronic pain . Psychophysiological and psychodynamic models are presented to explain the effectiveness of music therapy on pain reduction . Clinical studies on music therapy as well as on other " art therapies " should relate the analysis of clinical parameters to the descriptive-phenomenological documentation of the therapeutic process to demonstrate systematic ally the influence of music and art in the individual case OBJECTIVE To compare three opioid agonist drugs for perioperative analgesia in cats . STUDY DESIGN Prospect i ve , blind , controlled , r and omised trial . ANIMALS Ninety client-owned cats , weighing 3.1 ( 2.1 - 4.5 ) kg , aged 14.6 ( 6.0 - 84.0 ) months , were studied . METHODS Seventy-six cats , scheduled for ovariectomy , received either 0.6 mg kg(-1 ) racemic methadone , 0.3 mg kg(-1 ) levo-methadone , 0.05 mg kg(-1 ) dextromoramide or a saline placebo IM . Behaviour and body position were assessed and scored 20 minutes later by a single ' blinded ' observer . Anaesthesia was induced with propofol and maintained with halothane .  Heart rate ( HR ) , respiratory rate ( RR ) , Fe'CO2 and SpO2 were recorded during anaesthesia . Post-operatively , pain was categorised as absent , moderate or severe , on the basis of appearance , behaviour and response to palpation of the surgical wound ( pain score ) . Appearance , pain scores and physiological variables were monitored every 30 minutes , for a duration of 4 hours . Differences between time-dependent continuous variables were analysed using mixed models for repeated measurements . Differences in categorical , time-dependent variables were analysed using chi2-tests . Significance was set at p < or = 0.05 . RESULTS There were no significant changes in appearance after pre-anaesthetic medication . After surgery , there was no association between appearance and pain score with HR or RR . The assessment of pain depended on comparison with the placebo group , by comparing animals ' reactions to wound palpation . Sixteen of the 18 cats in the placebo group and 14 of the 19 cats in the dextromoramide group showed signs of moderate-to-severe pain after surgery . In the levo-methadone group ( n = 20 ) , one animal showed pain after 60 minutes and two after 120 minutes . One cat in the racemic methadone group ( n = 19 ) showed pain signs and behavioural changes at 60 minutes . Compared to the two methadone groups , ' rescue ' analgesia was required more often in cats treated with dextromoramide or saline . CONCLUSION AND CLINICAL RELEVANCE Dextromoramide ( 0.05 mg kg(-1 ) ) was ineffective , while racemic methadone ( 0.6 mg kg(-1 ) ) and levo-methadone ( 0.3 mg kg(-1 ) ) provided effective analgesia in cats following ovariectomy , without behavioural , respiratory or cardiovascular side effects
Studies were primarily related to the assessment of pain in relation to surgical procedures , and no clear distinction was made concerning the onset of acute and chronic pain .
The metrics used within the tools appeared to focus primarily on the sensory aspect of pain , with no study clearly discriminating between the sensory and affective components of pain .
Objectives The objectives were to review systematic ally the range of assessment tools used in cats to detect the behavioural expression of pain and the evidence of their quality ; and to examine behavioural metrics ( considering both the sensory and affective domains ) used to assess pain .