Management of Depression in Patients With Cancer: A Clinical Practice Guideline. How useful are systematic reviews for informing palliative care practice? Survey of 25 Cochrane systematic reviews PROBAST: A Tool to Assess the Risk of Bias and Applicability of Prediction Model Studies A Pan-Canadian practice guideline: prevention, screening, assessment, and treatment of sleep disturbances in adults with cancer How has the impact of 'care pathway technologies' on service integration in stroke care been measured and what is the strength of the evidence to support their effectiveness in this respect? How has the impact of 'care pathway technologies' on service integration in stroke care been measured and what is the strength of the evidence to support their effectiveness in this respect? Development and evaluation of the Supportive and Palliative Care Indicators Tool (SPICT): a mixed-methods study The risk of bias in observational studies of exposures (ROBINS-E) tool: concerns arising from application to observational studies of exposures Comparison of tools for assessing the methodological quality of primary and secondary studies in health technology assessment reports in Germany Spine surgery research: on and beyond current strategies. Interventions aimed at increasing research use in nursing: a systematic review Interventions to reduce the incidence of falls in older adult patients in acute care hospitals: a systematic review Key Steps in Conducting Systematic Reviews for Underpinning Clinical Practice Guidelines: Methodology of the European Association of Urology. A systematic review of outcome tools used to measure lower leg conditions. Evidence-Based Interventions to Improve the Palliative Care of Pain, Dyspnea, and Depression at the End of Life: A Clinical Practice Guideline from the American College of Physicians The Evidence Project risk of bias tool: assessing study rigor for both randomized and non-randomized intervention studies Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review Interrater reliability in assessing quality of diagnostic accuracy studies using the QUADAS tool. A preliminary assessment. Effects of music listening on adult patients' pre‐procedural state anxiety in hospital Bias in Systematic Reviews? Rating the strength of scientific evidence: relevance for quality improvement programs. Effects of music listening on adult patients' pre-procedural state anxiety in hospital. INVITED COMMENTARY: Rating the Quality of Trials in Systematic Reviews of Physical Therapy Interventions
PURPOSE This report up date s the Cancer Care Ontario Program in Evidence -Based Care guideline for the management of  depression in adult patients with cancer . This guideline covers pharmacologic , psychological , and collaborative care interventions , with a focus on integrating practical management tools to assist clinicians in delivering appropriate treatments for depression in patients with cancer . METHODS Recommendations were developed by synthesizing information from extant guidelines and review s and search ing for r and omized controlled trials from the date of data base inception ( 1964 for MEDLINE and 1974 for EMBASE ) to January 2015 . Quality assessment of guidelines and systematic review s were conducted by using the Appraisal of Guidelines for Research and Evaluation II ( AGREE II ) , Assessment of Multiple Systematic Review s ( AMSTAR ) , and Cochrane Risk of Bias tools . Final recommendations were developed through a st and ardized Program in Evidence -Based Care multidisciplinary expert and knowledge user review process . RESULTS Two high- quality relevant clinical practice guidelines , eight pharmacologic trials , nine psychological trials , and eight collaborative care intervention trials composed the evidence base upon which the recommendations were developed . Eight specific recommendations were made to establish a st and ard of care for the management of depression in patients with cancer . The recommendations and practical management tools were review ed as being well organized and helpful , although systemic barriers to implementation were identified . CONCLUSION This up date d guideline supports the previous general recommendation that patients with cancer who have depression may benefit from psychological and /or pharmacologic interventions , without evidence for the superiority of any specific treatment over another . New recommendations for a collaborative care model that incorporates a stepped care approach suggest that multidisciplinary mental health care restructuring may be required for optimal management of depression Background In contemporary medical research , r and omised controlled trials are seen as the gold st and ard for establishing treatment effects where it is ethical and practical to conduct them . In palliative care such trials are often impractical , unethical , or extremely difficult , with multiple method ological problems . We review the utility of Cochrane review s in informing palliative care practice . Methods Published review s in palliative care registered with the Cochrane Pain , Palliative and Supportive Care Group as of December 2007 were obtained from the Cochrane Data base of Systematic Review s , issue 1 , 2008 . We review ed the quality and quantity of primary studies available for each review , assessed the quality of the review process , and judged the strength of the evidence presented . There was no prior intention to perform any statistical analyses . Results 25 published systematic review s were identified . Numbers of included trials ranged from none to 54 . Within each review , included trials were heterogeneous with respect to patients , interventions , and outcomes , and the number of patients contributing to any single analysis was generally much lower than the total included in the review . A variety of tools were used to assess trial quality ; seven review s did not use this information to exclude low quality studies , weight analyses , or perform sensitivity analysis for effect of low quality . Authors indicated that there were frequently major problems with the primary studies , individually or in aggregate . Our judgment was that the review ing process was generally good in these review s , and that conclusions were limited by the number , size , quality and validity of the primary studies .We judged the evidence about 23 of the 25 interventions to be weak . Two review s had stronger evidence , but with limitations due to method ological heterogeneity or definition of outcomes . No review provided strong evidence of no effect . Conclusion Cochrane review s in palliative care are well performed , but fail to provide good evidence for clinical practice because the primary studies are few in number , small , clinical ly heterogeneous , and of poor quality and external validity . They are useful in highlighting the weakness of the evidence base and problems in performing trials in palliative care Prediction relates to estimating the probability of something currently unknown . In the context of medical research , prediction typically concerns either diagnosis ( probability of a certain condition being present but not yet detected ) or prognosis ( probability of an outcome developing in the future ) ( 13 ) . Prognosis applies not only to sick persons or those with an established diagnosis but also to , for example , pregnant women at risk for diabetes ( 4 ) . Prediction research includes predictor finding studies , prediction model studies ( development , validation , and extending or updating ) , and prediction model impact studies ( 1 ) . Predictor finding studies ( also known as risk factor or prognostic factor studies ) aim to identify which predictors ( such as age , disease stage , or biomarkers ) independently contribute to the prediction of a diagnostic or prognostic outcome ( 1 , 5 ) . Prediction model studies aim to develop , vali date , or up date ( for example , extend ) a multivariable prediction model . A prediction model uses multiple predictors in combination to estimate probabilities to inform and often guide individual care ( 2 , 6 , 7 ) . These models can predict an individual 's probability of either currently having a particular outcome or disease ( diagnostic prediction model ) or having a particular outcome in the future ( prognostic prediction model ) . Both types of model are widely used in various medical domains and setting s ( 810 ) , as evidence d by the large number of models developed in cancer ( 11 , 12 ) , neurology ( 13 , 14 ) , and cardiovascular disease ( 15 ) . Prediction models are sometimes described as  risk prediction models , predictive models , prediction indices or rules , or risk scores ( 2 , 7 ) . An example is QRISK2 for predicting cardiovascular risk ( 16 ) . Prediction model impact studies evaluate the effect of using a model to guide patient care compared with not using such a model . They use a comparative design , such as a r and omized trial , to study the model 's effect on clinical decision making , patient outcomes , or costs of care ( 1 ) . Systematic review s have a key role in evidence -based medicine and the development of clinical guidelines ( 1719 ) . They are considered to provide the most reliable form of evidence for the effects of an intervention or diagnostic test ( 20 , 21 ) . Systematic review s of prediction models are a relatively new and evolving area but are increasingly undertaken to systematic ally identify , appraise , and summarize evidence on the performance of prediction models ( 1 , 6 , 22 ) . Assessing the quality of included studies is a crucial step in any systematic review ( 20 , 21 ) . The QUIPS ( Quality In Prognosis Studies ) tool has been developed to assess risk of bias ( ROB ) in predictor finding ( prognostic factor ) studies ( 23 ) . Research ers can use the revised Cochrane ROB Tool ( ROB 2.0 ) ( 24 ) to investigate the method ological quality of prediction model impact studies that use a r and omized comparative design , or ROBINS-I ( Risk Of Bias In Nonr and omized Studies of Interventions ) for those that use a nonr and omized comparative design ( 25 ) . As more prediction model studies and systematic review s of such studies are used as evidence for clinical guidance , a tool facilitating quality assessment for individual prediction model studies is urgently needed . We present PROBAST ( Prediction model Risk Of Bias ASsessment Tool ) , a tool to assess the ROB and concerns regarding the applicability of diagnostic and prognostic prediction model studies . PROBAST can be used to assess studies of model development and model validation , including those updating a prediction model ( Box 1 [ 26 ] ) . We refer to the accompanying explanation and elaboration document ( 27 ) , for detailed explanations of how to use PROBAST and how to judge ROB and applicability . Box 1 . Types of diagnostic and prognostic modeling studies or reports addressed by PROBAST . Adopted from the TRIPOD ( Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis ) and CHARMS ( CHecklist for critical Appraisal and data extraction for systematic Review s of prediction Modelling Studies ) guidance ( 7 , 26 ) . PROBAST = Prediction model Risk Of Bias ASsessment Tool . Methods : Development of PROBAST Development of PROBAST was based on a 4-stage approach for developing health research reporting guidelines : define the scope , review the evidence base , use a Web-based Delphi procedure , and refine the tool through piloting ( 28 ) . Guidelines explicitly aim ed at the development of quality assessment tools were not available at the time ( 29 ) . Development Stage 1 : Scope and Definitions A steering group of 9 experts in prediction model studies and development of quality assessment tools agreed on key features of the desired scope of PROBAST . A panel of 38 experts with different background s further refined the scope during the Web-based Delphi procedure . PROBAST was design ed mainly to assess primary studies included in a systematic review . The group agreed that PROBAST would assess both risk of bias and concerns regarding applicability of a study evaluating a multivariable prediction model to be used for individualized diagnosis or prognosis . A domain-based structure was adopted , similar to that used in other ROB tools , such as ROB 2.0 ( 24 ) , ROBINS-I ( 25 ) , QUADAS-2 ( Quality Assessment of Diagnostic Accuracy Studies 2 ) ( 30 ) , and ROBIS ( 31 ) . We agreed that PROBAST should cover primary studies that develop , vali date , or up date multivariable prediction models aim ing to make individualized predictions of a diagnostic or prognostic outcome ( Box 1 ) . Studies that use multivariable modeling techniques to identify predictors ( such as risk or prognostic factors ) associated with an outcome but do not attempt to develop , vali date , or up date a model for making individualized predictions are not covered by PROBAST ( 5 ) . Therefore , PROBAST is not intended for predictor finding studies or prediction model impact studies . Studies of diagnostic and prognostic models often use different terms for predictors and outcomes ( Box 2 ) . A multivariable prediction model is defined as any combination or equation of 2 or more predictors for estimating probability or risk for an individual ( 6 , 7 , 3234 ) . Box 2 . Differences between diagnostic and prognostic prediction model studies . PROBAST = Prediction model Risk Of Bias ASsessment Tool . Development Stage 2 : Review of Evidence We used the following 3 approaches to build an evidence base to inform the development of PROBAST : identifying relevant method ological review s in the area of prediction model research ( November 2012 to January 2013 ) , asking members of the steering group to identify relevant method ological studies ( January 2013 to March 2013 ) , and using the Delphi procedure to ask members of the wider group to identify additional evidence ( February 2012 to July 2014 ) . Identified literature was used to guide the scope and produce an initial list of signaling questions to consider for inclusion in PROBAST ( 1 , 2 , 57 , 26 , 3340 ) . We grouped signaling questions into common themes to identify possible domains . Additional literature provided as part of the Web-based surveys informed development of the explanation and elaboration document . Development Stage 3 : Web-Based Delphi Procedure We used a modified Delphi process to gain feedback and agreement on the scope , structure , and content of PROBAST . Web-based surveys were developed to gather structured feedback for each round . The 38-member Delphi group comprised method ological experts in prediction model research and development of quality assessment tools , experienced systematic review ers , commissioners , and representatives of reimbursement agencies . We included various stakeholders to ensure that the views of end users , method ological experts , and decision makers were represented . The Delphi process consisted of 7 rounds . Round 1 asked about the scope of the tool , and participants agreed to focus on prediction model studies and follow a domain-based structure . Round 2 aim ed to identify relevant domains and agree on which to include . The signaling questions for domains were refined in rounds 3 to 5 . Respondents used a 1-to-5 Likert scale to rate each proposed signaling question for inclusion . They could also suggest rephrasing , provide supporting evidence ( such as references to relevant studies ) , and suggest missing signaling questions . Round 6 refined the domains and introduced further optional guidance for using PROBAST . In the last round , participants received the agreed draft version of PROBAST and had the opportunity to provide any final feedback . Development Stage 4 : Piloting and Refining the Tool We held 6 workshops on PROBAST at consecutive annual Cochrane Colloquia ( Quebec , Canada , 2013 ; Hyderabad , India , 2014 ; Vienna , Austria , 2015 ; Seoul , South Korea , 2016 ; Cape Town , South Africa , 2017 ; and Edinburgh , United Kingdom , 2018 ) . We also held numerous consecutive workshops with MSc and PhD students ( for example , the master 's program in epidemiology at Utrecht University [ Utrecht , the Netherl and s ] and the Evidence -Based Health Care program at Oxford University [ Oxford , United Kingdom ] ) . In these workshops , we piloted the then-current version of PROBAST to gather feedback on practical issues associated with using the tool so that we could further refine and subsequently vali date it . Finally , more than 50 review groups have already piloted PROBAST versions , including the final version , in their review s. Topics included cancer , cardiology , endocrinology , pulmonology , and orthopedics . All feedback received from these initiatives was used to further inform the content and structure of PROBAST , wording of the signaling questions , and content of the guidance documents ( 27 ) . Results : The PROBAST Tool What Does PROBAST Assess ? PROBAST assesses both risk of bias and concerns regarding applicability of primary studies that developed or vali date d multivariable prediction models for diagnosis or prognosis ( Boxes 1 and 2 ) Purpose This study aims to provide recommendations on the optimal strategies and interventions for the prevention , screening , assessment , and management of  cancer-related sleep disturbance ( insomnia and insomnia syndrome ) in adult cancer population s. Methods A systematic search of the published health literature was conducted to identify r and omized controlled trials , clinical practice guidelines , systematic review s , and other guidance documents . The Sleep Disturbance Expert Panel [ comprised of nurses , psychologists , primary care physicians , oncologists , physicians specialized in sleep disturbances , research ers , and guideline method ologists ] review ed , discussed , and approved the final version of the guideline . Health care professionals across Canada were asked to provide feedback through an external review process . Results Three clinical practice guidelines and 12 r and omized controlled trials were identified as the evidence base . Overall , despite the paucity of evidence , the evidence and expert consensus suggest that it is important to screen and assess adult cancer patients for sleep disturbances using st and ardized screening tools on a routine basis . While prevention of sleep disturbance is the desired objective , cognitive behavioral therapies are effective in improving sleep outcomes . As part of the external review with 16 health care providers , 81 % indicated that they agreed with the recommendations as written . Conclusions Sleep difficulty is a prevalent problem in cancer population s that needs greater recognition by health professionals . Prevention , screening , assessment , and treatment strategies supported by the best available evidence are critical . Recommendations and care path algorithms for practice are offered Background Across the developed world , we are witnessing an increasing emphasis on the need for more closely coordinated forms of health and social care provision . Integrated care pathways ( ICPs ) have emerged as a response to this aspiration and are believed by many to address the factors which contribute to service integration . ICPs map out a patient 's journey , providing coordination of services for users . They aim to have : ' the right people , doing the right things , in the right order , at the right time , in the right place , with the right outcome ' . The value for ICPs in supporting the delivery of care across organisational boundaries , providing greater consistency in practice , improving service continuity and increasing collaboration has been advocated by many . However , there is little evidence to support their use , and the need for systematic evaluations in order to measure their effectiveness has been widely identified . A recent Cochrane review assessed the effects of ICPs on functional outcome , process of care , quality of life and hospitalisation costs of in patients with acute stroke , but did not specifically focus on service integration or its derivatives . To the best of our knowledge , no such systematic review of the literature exists . Objectives To systematic ally review all high‐ quality studies which have evaluated the impact of care pathway technologies on ' service integration ' and its derivatives in stroke care To examine how elements of service integration are defined in such studies To examine the type of evidence utilised to measure service integration To analyse the weight of evidence used to support cl aims about the effectiveness of ICPs on improving service integration To produce recommendations for ICP developers , users and evaluators . Inclusion criteria Types of participants The review focused on the care of adult patients who had suffered a stroke . It included the full spectrum of services ‐ acute care , rehabilitation and long‐term support ‐ in hospital and community setting s. Types of intervention(s)/phenomena of interest Integrated care pathways were the intervention of interest , defined for the purpose of this review as ' a multidisciplinary tool to improve the quality and efficiency of evidence based care and is used as a communication tool between professionals to manage and st and ardise the outcome orientated care ' . Here ' multidisciplinary ' is taken to refer to the involvement of two or more disciplines . Types of outcomes Service integration ' was the outcome of interest however , this was defined and measured in the selected studies . Types of studies This review was concerned with how ' service integration ' was defined in evaluations of ICPs ; the type of evidence utilised in measuring the impact of the intervention and the weight of evidence to support the effectiveness of care pathway technologies on ' service integration ' . Studies that made an explicit link between ICPs and service integration were included in the review . Evidence generated from r and omised controlled trials , quasi‐experimental , qualitative and health economics research was sought . The search was limited to publications after 1980 , coinciding with the emergence of ICPs in the healthcare context . Assessment for inclusion of foreign papers was based on the English‐ language abstract , where available . These were included only if an English translation was available . Exclusion criteria This review excluded studies that : focused only on a single aspect of stroke care ( e.g. dysphasia ) evaluated ICPs as part of a wider program of service development did not make an explicit link between ICPs and service integration did not meet the definition of ICP utilised for the purpose s of the review focused exclusively on the outcomes of variance analysis Search strategy In order to avoid replication , the Joanna Briggs Institute for Evidence Based Nursing and Midwifery Data base and the Cochrane Library were search ed to establish that no systematic review s existed and none were in progress . A three‐stage search strategy was then used to identify both published and unpublished studies ( see Appendix III ) . Data collection Our search strategy located 2123 papers , of which 39 were retrieved for further evaluation . We critically appraised seven papers , representing five studies . These were all evaluation studies and , as is typical in this field , comprised a range of study design s and data collection methods . Owing to the diversity of the study types included in the review , we developed a single‐ appraisal checklist and data ‐ extraction tool which could be applied to all research design s.32 The tool drew on the Joanna Briggs Institute ( JBI ) appraisal checklists for experimental studies and interpretive and critical research , and also incorporated specific information and issues which were relevant for our purpose s ( see Appendix VI ) . This extends the thinking outlined in Lyne et al.31 in which , drawing on Campbell and Stanley 's classic paper , the case is made for developing an appraisal tool which is applicable to all types of evaluation , irrespective of study design . In assessing the quality of the papers , we were sympathetic to the method ological challenges of evaluating complex interventions such as ICPs . We were also cognisant of the very real constraints in which service evaluations are frequently undertaken in healthcare context s. In accordance with the aims of this particular review , we have included studies , which are method ologically weaker than is typical of many systematic review s because , in our view , in the absence of stronger evidence , they yield useful information . Data synthesis Given the heterogeneity of the included studies , meta‐ analysis and /or qualitative synthesis was not possible . A narrative summary of the study findings is presented . Results ICPs can be effective in ensuring that patients receive relevant clinical interventions and /or assessment s in a timely manner , although these improvements may reflect better documentation rather than actual changes in practice . ICPs can be effective in improving the documentation of rehabilitation goals , documentation of communication with patients , carers ( diagnosis , prognosis and follow‐up arrangements ) and documentation of notification of primary care physicians of discharge . However , this can create additional burdens of work for staff . Early studies of  ICP‐managed care in the acute stroke context have demonstrated reduced length of stay without any associated adverse effects on discharge destination , morbidity or mortality . These effects do not reach statistical significance , however , and may reflect wider changes in service provision and a general trend towards reduced length of hospital stay . While later studies in the acute and rehabilitation context s do not reveal any significant reduction in length of stay , they do report greater documented use of certain clinical interventions and assessment s , suggesting that ICPs can be effective in mobilising hospital re sources around the patient . ICPs implemented in the context of acute stroke care can be effective in reducing the occurrence of urinary tract infections , although we do not know whether this can be attributed to improved service integration . ICP management in stroke rehabilitation may not be flexible enough to meet diverse patient needs and can result in insufficient attention to higher‐level functioning and carer needs influencing perceptions of quality of life . ICP management may assist in clarifying role boundaries and a shared underst and ing of the work , but this can result in some members of the disciplinary team perceiving that their contribution is not appropriately reflected in the documentation . There is some evidence that ICPs may be effective in changing professional behaviours in the desired direction where there is scope for improvement , but in situations in which multidisciplinary working is effective , their positive effects may be limited . Furthermore , it is far from clear what the active ingredients of ICPs actually are . Kwan et al. suggest that it was the process of ICP development that had most impact on behaviours rather than the use of the artefact per se.20 None of the studies assessed the balance of costs and benefits of ICP use . Therefore , we do not know whether the costs of ICP development and implementation are justified by any of the reported benefits . Conclusions Implication s for practice There is some evidence that ICPs may support certain elements of service integration in the context of stroke care . This seems to be as a result of their ability to support the timely implementation of clinical interventions and the mobilisation of re sources around the patient without incurring additional increases in length of stay . ICPs appear to be most successful in improving service coordination in the acute stroke context where patient care trajectories are predictable . Their value in the context of rehabilitation setting s in which recovery pathways are more variable is less clear . There is some evidence that ICPs may be effective in bringing about behavioural changes in context s where deficiencies in service provision have been identified . Their value in context s where inter‐professional working is well established is less clear . While earlier before and after studies show a reduction in length of stay in ICP‐managed care , this may reflect wider healthcare trends , and the failure of later studies to demonstrate further reductions suggests that there may be limits as to how far this can continue to be reduced . There is some evidence to suggest that ICPs bring about improvements in documentation , but we do not know how far documented practice reflects actual practice . It is unclear how ICPs have their effects and the relative importance of the process of development and the artefact in use . As none of the studies review ed included an economic evaluation , moreover , it remains unclear whether the benefits of ICPs UNLABELLED EXECUTIVE SUMMARY : BACKGROUND Across the developed world , we are witnessing an increasing emphasis on the need for more closely coordinated forms of health and social care provision . Integrated care pathways ( ICPs ) have emerged as a response to this aspiration and are believed by many to address the factors which contribute to service integration . ICPs map out a patient 's journey , providing coordination of services for users . They aim to have : ' the right people , doing the right things , in the right order , at the right time , in the right place , with the right outcome ' . The value for ICPs in supporting the delivery of care across organisational boundaries , providing greater consistency in practice , improving service continuity and increasing collaboration has been advocated by many . However , there is little evidence to support their use , and the need for systematic evaluations in order to measure their effectiveness has been widely identified . A recent Cochrane review assessed the effects of ICPs on functional outcome , process of care , quality of life and hospitalisation costs of in patients with acute stroke , but did not specifically focus on service integration or its derivatives . To the best of our knowledge , no such systematic review of the literature exists . OBJECTIVES • To systematic ally review all high- quality studies which have evaluated the impact of care pathway technologies on ' service integration ' and its derivatives in stroke care • To examine how elements of service integration are defined in such studies • To examine the type of evidence utilised to measure service integration • To analyse the weight of evidence used to support cl aims about the effectiveness of ICPs on improving service integration • To produce recommendations for ICP developers , users and evaluators . INCLUSION CRITERIA Types of participants The review focused on the care of adult patients who had suffered a stroke . It included the full spectrum of services - acute care , rehabilitation and long-term support - in hospital and community setting s. Types of intervention(s)/phenomena of interest Integrated care pathways were the intervention of interest , defined for the purpose of this review as ' a multidisciplinary tool to improve the quality and efficiency of evidence based care and is used as a communication tool between professionals to manage and st and ardise the outcome orientated care ' Here ' multidisciplinary ' is taken to refer to the involvement of two or more disciplines . Types of outcomes ' Service integration ' was the outcome of interest however , this was defined and measured in the selected studies . Types of studies This review was concerned with how ' service integration ' was defined in evaluations of ICPs ; the type of evidence utilised in measuring the impact of the intervention and the weight of evidence to support the effectiveness of care pathway technologies on ' service integration ' . Studies that made an explicit link between ICPs and service integration were included in the review . Evidence generated from r and omised controlled trials , quasi-experimental , qualitative and health economics research was sought . The search was limited to publications after 1980 , coinciding with the emergence of ICPs in the healthcare context . Assessment for inclusion of foreign papers was based on the English- language abstract , where available . These were included only if an English translation was available . EXCLUSION CRITERIA This review excluded studies that : • focused only on a single aspect of stroke care ( e.g. dysphasia ) • evaluated ICPs as part of a wider program of service development • did not make an explicit link between ICPs and service integration • did not meet the definition of ICP utilised for the purpose s of the review • focused exclusively on the outcomes of variance analysis SEARCH STRATEGY In order to avoid replication , the Joanna Briggs Institute for Evidence Based Nursing and Midwifery Data base and the Cochrane Library were search ed to establish that no systematic review s existed and none were in progress . A three-stage search strategy was then used to identify both published and unpublished studies ( see Appendix III ) . DATA COLLECTION Our search strategy located 2123 papers , of which 39 were retrieved for further evaluation . We critically appraised seven papers , representing five studies . These were all evaluation studies and , as is typical in this field , comprised a range of study design s and data collection methods . Owing to the diversity of the study types included in the review , we developed a single- appraisal checklist and data - extraction tool which could be applied to all research design s.(32 ) The tool drew on the Joanna Briggs Institute ( JBI ) appraisal checklists for experimental studies and interpretive and critical research , and also incorporated specific information and issues which were relevant for our purpose s ( see Appendix VI ) . This extends the thinking outlined in Lyne et al.(31 ) in which , drawing on Campbell and Stanley 's classic paper , the case is made for developing an appraisal tool which is applicable to all types of evaluation , irrespective of study design . In assessing the quality of the papers , we were sympathetic to the method ological challenges of evaluating complex interventions such as ICPs . We were also cognisant of the very real constraints in which service evaluations are frequently undertaken in healthcare context s. In accordance with the aims of this particular review , we have included studies , which are method ologically weaker than is typical of many systematic review s because , in our view , in the absence of stronger evidence , they yield useful information . DATA SYNTHESIS Given the heterogeneity of the included studies , meta- analysis and /or qualitative synthesis was not possible . A narrative summary of the study findings is presented . RESULTS 1 ICPs can be effective in ensuring that patients receive relevant clinical interventions and /or assessment s in a timely manner , although these improvements may reflect better documentation rather than actual changes in practice . 2 ICPs can be effective in improving the documentation of rehabilitation goals , documentation of communication with patients , carers ( diagnosis , prognosis and follow-up arrangements ) and documentation of notification of primary care physicians of discharge . However , this can create additional burdens of work for staff . 3 Early studies of ICP-managed care in the acute stroke context have demonstrated reduced length of stay without any associated adverse effects on discharge destination , morbidity or mortality . These effects do not reach statistical significance , however , and may reflect wider changes in service provision and a general trend towards reduced length of hospital stay . While later studies in the acute and rehabilitation context s do not reveal any significant reduction in length of stay , they do report greater documented use of certain clinical interventions and assessment s , suggesting that ICPs can be effective in mobilising hospital re sources around the patient . 4 ICPs implemented in the context of acute stroke care can be effective in reducing the occurrence of urinary tract infections , although we do not know whether this can be attributed to improved service integration . 5 ICP management in stroke rehabilitation may not be flexible enough to meet diverse patient needs and can result in insufficient attention to higher-level functioning and carer needs influencing perceptions of quality of life . 6 ICP management may assist in clarifying role boundaries and a shared underst and ing of the work , but this can result in some members of the disciplinary team perceiving that their contribution is not appropriately reflected in the documentation . 7 There is some evidence that ICPs may be effective in changing professional behaviours in the desired direction where there is scope for improvement , but in situations in which multidisciplinary working is effective , their positive effects may be limited . Furthermore , it is far from clear what the active ingredients of ICPs actually are . Kwan et al. suggest that it was the process of ICP development that had most impact on behaviours rather than the use of the artefact per se.(20 ) 8 None of the studies assessed the balance of costs and benefits of ICP  use . Therefore , we do not know whether the costs of ICP development and implementation are justified by any of the reported benefits . CONCLUSIONS Implication s for practice There is some evidence that ICPs may support certain elements of service integration in the context of stroke care . This seems to be as a result of their ability to support the timely implementation of clinical interventions and the mobilisation of re sources around the patient without incurring additional increases in length of stay .  ICPs appear to be most successful in improving service coordination in the acute stroke context where patient care trajectories are predictable . Their value in the context of rehabilitation setting s in which recovery pathways are more variable is less clear . There is some evidence that ICPs may be effective in bringing about behavioural changes in context s where deficiencies in service provision have been identified . Their value in context s where inter-professional working is well established is less clear . While earlier before and after studies show a reduction in length of stay in ICP-managed care , this may reflect wider healthcare trends , and the failure of later studies to demonstrate further reductions suggests that there may be limits as to how far this can continue to be reduced . There is some evidence to suggest that ICPs bring about improvements in documentation , but we do not know how far documented practice reflects actual practice . It is unclear how ICPs have their effects and the relative importance of the process of development and the artefact in use . ( ABSTRACT TRUNCATED Objective To refine and evaluate a practical , clinical tool to help multidisciplinary teams in the UK and internationally , to identify patients at risk of deteriorating and dying in all care setting s. Methods We used a participatory research approach to refine the 2010 Supportive and Palliative Care Indicators Tool ( SPICT ) and evaluate its use in clinical practice . We conducted an ongoing peer review process for 18 months via an open access webpage , and engaged over 30 clinicians from the UK and internationally in developing an effective tool . Secondly , we carried out a prospect i ve case-finding study in an acute hospital in SE Scotl and . Four multidisciplinary teams identified 130 patients with advanced kidney , liver , cardiac or lung disease following an unplanned hospital admission . Results The SPICT was refined and up date d to consist of readily identifiable , general indicators relevant to patients with any advanced illness , and disease-specific indicators for common advanced conditions . Hospital clinicians used the SPICT to identify patients at risk of deteriorating and dying . Patients who died had significantly more unplanned admissions , persistent symptoms and increased care needs . By 12 months , 62 ( 48 % ) of the identified patients had died . 69 % of them died in hospital , having spent 22 % of their last 6 months there . Conclusions The SPICT can support clinical judgment by multidisciplinary teams when identifying patients at risk of deteriorating and dying . It helped identify patients with multiple unmet needs who would benefit from earlier , holistic needs assessment , a review of care goals , and anticipatory care planning Background Systematic review s , which assess the risk of bias in included studies , are increasingly used to develop environmental hazard assessment s and public health guidelines . These research areas typically rely on evidence from human observational studies of exposures , yet there are currently no universally accepted st and ards for assessing risk of bias in such studies . The risk of bias in non-r and omised studies of exposures ( ROBINS-E ) tool has been developed by building upon tools for risk of bias assessment of r and omised trials , diagnostic test accuracy studies and observational studies of interventions . This paper reports our experience with the application of the ROBINS-E tool . Methods We applied ROBINS-E to 74 exposure studies ( 60 cohort studies , 14 case-control studies ) in 3 areas : environmental risk , dietary exposure and drug harm . All investigators provided written feedback , and we documented verbal discussion of the tool . We inductively and iteratively classified the feedback into 7 themes based on commonalities and differences until all the feedback was accounted for in the themes . We present a description of each theme . Results We identified practical concerns with the premise that ROBINS-E is a structured comparison of the observational study being rated to the ‘ ideal ’ r and omised controlled trial . ROBINS-E assesses 7 domains of bias , but relevant questions related to some critical sources of bias , such as exposure and funding source , are not assessed . ROBINS-E fails to discriminate between studies with a single risk of bias or multiple risks of bias .  ROBINS-E is severely limited at determining whether confounders will bias study outcomes . The construct of co-exposures was difficult to distinguish from confounders . Applying ROBINS-E was time-consuming and confusing . Conclusions Our experience suggests that the ROBINS-E tool does not meet the need for an international st and ard for evaluating human observational studies for questions of harm relevant to public and environmental health . We propose that a simpler tool , based on empirical evidence of bias , would provide accurate measures of risk of bias and is more likely to meet the needs of the environmental and public health community 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 BACKGROUND CONTEXT Systematic review s of the literature are powerful tools in evidence -based medicine . However , the design and report of systematic review s in spinal surgery contain many aspects amenable to improvement . PURPOSE To discuss the issues especially relevant for systematic review s in spinal surgery . METHODS From our experience of systematic review s and meta-analyses of clinical trials in  spinal surgery  , we infer guidance for the design and execution of systematic literature review s. RESULTS There are many difficulties associated with the design as well as conduct of clinical trials and consequently appraising evidence in spinal surgery . New treatments should be compared with the gold st and ard before other comparisons are investigated . Studies should present data as thoroughly as possible regarding all subgroups and follow-up moments , possibly in supplementary material . To provide the highest level of evidence , systematic review s should be as rigorously design ed as possible . CONCLUSIONS Gathering information on clinical effectiveness in spinal surgery can be improved both at the clinical study level and at the systematic review level . Alternatives to r and omized controlled trials such as comparative studies can be valuable tools on the clinical effectiveness of treatments in spinal surgery . The experience reflected in this article can support the scientific efforts in this field Background There has been considerable interest recently in developing and evaluating interventions to increase research use by clinicians . However , most work has focused on medical practice s ; and nursing is not well represented in existing systematic review s. The purpose of this article is to report findings from a systematic review of interventions aim ed at increasing research use in nursing . Objective To assess the evidence on interventions aim ed at increasing research use in nursing . Methods A systematic review of research use in nursing was conducted using data bases ( Medline , CINAHL , Healthstar , ERIC , Cochrane Central Register of Controlled Trials , and Psychinfo ) , grey literature , ancestry search ing ( Cochrane Data base of Systematic Review s ) , key informants , and manual search ing of journals . R and omized controlled trials and controlled before- and after- studies were included if they included nurses , if the intervention was explicitly aim ed at increasing research use or evidence -based practice , and if there was an explicit outcome to research use . Method ological quality was assessed using pre-existing tools . Data on interventions and outcomes were extracted and categorized using a pre-established taxonomy . Results Over 8,000 titles were screened . Three r and omized controlled trials and one controlled before- and after- study met the inclusion criteria . The method ological quality of included studies was generally low . Three investigators evaluated single interventions . The most common intervention was education . Investigators measured research use using a combination of surveys ( three studies ) and compliance with guidelines ( one study ) . Research er-led educational meetings were ineffective in two studies . Educational meetings led by a local opinion leader ( one study ) and the formation of multidisciplinary committees ( one study ) were both effective at increasing research use . Conclusion Little is known about how to increase research use in nursing , and the evidence to support or refute specific interventions is inconclusive . To advance the field , we recommend that investigators : ( 1 ) use theoretically informed interventions to increase research use , ( 2 ) measure research use longitudinally using theoretically informed and psychometrically sound measures of research use , as well as , measuring patient outcomes relevant to the intervention , and ( 3 ) use more robust and method ologically sound study design s to evaluate interventions . If investigators aim to establish a link between using research and improved patient outcomes they must first identify those interventions that are effective at increasing research use Background Falls can have a considerable impact on a patients ' well being , they can result in serious physical and emotional injury , poor quality of life and increased length of hospital stay . Most of the current literature recommends a comprehensive approach to fall prevention that addresses a wide variety of risk factors and involves the use of risk assessment . Objective The objective of this review was to present the best available evidence for the effectiveness of interventions design ed to reduce the incidence of falls in older adult patients in acute care hospitals . Inclusion Criteria Types of Studies Only r and omised controlled trials ( RCTs ) assessing the effectiveness of risk assessment or other interventions that aim ed to minimise the number of falls were included . Types of Participants Participants were older adult in patients ( defined as aged 65 years or over ) in acute care hospitals . Types of Interventions This review focused on interventions design ed to assess the risk of falling or those used to minimise the risk of falling in older adult hospital patients . These interventions were compared to either st and ard practice , which included any method or technique already in place at the facility , or no intervention . Types of Outcome measures The primary outcome was the number of patient falls during hospitalisation . Search Strategy A search for published and unpublished literature from 1998 to 2008 published in the English language was conducted using all major electronic data bases . A three‐step search strategy was developed using MeSH terminology and keywords to ensure that all material relevant to the review was captured . Assessment of Quality The method ological quality of included studies was assessed by two review ers , who appraised each study independently , using st and ardised Joanna Briggs Institute ( JBI ) critical appraisal tools Data Collection and Analysis Data was extracted from the studies that were identified as meeting the criteria for method ological quality using the st and ard JBI data extraction tools . Due to the heterogeneity of population s and interventions , meta‐analyses were not possible and results are presented in narrative form . Results and Conclusions Seven studies were included in the review . The evidence on interventions for reducing the number of falls in older adults during their stay in an acute health care facility is sparse . There is some evidence to suggest that certain multifactorial interventions are more effective than others and that increasing patient education or targeting fall risk factors may be of benefit . Further high quality research is needed in order to ascertain effective fall prevention strategies in acute care facilities . Implication s for Practice There are some evidence to suggest that implementing the following interventions in acute hospitals may be effective in reducing the amount of falls of older adult in patients : ˙ a multidisciplinary multifactorial intervention program consisting of a falls risk alert card , an exercise program , an education program and the use of hip protectors after approximately 45 days ˙ a one‐on‐one patient education package entailing information on risk factors and preventative strategies for falls as well as goal setting ˙ a targeted falls risk factor reduction intervention that includes a falls risk factor screen , recommended interventions encompassing local advice and a summary of the evidence There is some evidence to suggest that implementing a multidisciplinary multifactorial intervention that consists of systematic assessment and treatment of fall risk factors , as well as active management of postoperative complications can reduce the amount of falls in patients with femoral neck fracture following surgery . Implication s for Research Better design ed RCTs that distinguish subgroups of population s ( for example people with or without cognitive impairment ) and that targets interventions at specific groups is required . Further research that focuses on individual intervention components that are part of larger multifactorial interventions are also warranted CONTEXT The findings of systematic review s ( SRs ) and meta-analyses ( MAs ) are used for clinical decision making . The European Association of Urology has committed increasing re sources into the development of high quality clinical guidelines based on such SRs and MAs . OBJECTIVE In this paper , we have summarised the process of conducting SRs for underpinning clinical practice guidelines under the auspices of the European Association of Urology Guidelines Office . EVIDENCE ACQUISITION The process involves explicit methods and the findings should be reproducible . When conducting a SR , the essential first step is to formulate a clear and answerable research question . An extensive literature search lays the foundation for evidence synthesis . Data are extracted independently by two review ers and any disagreements are resolved by discussion or arbitration by a third review er . EVIDENCE SYNTHESIS In SRs , data for particular outcomes in individual r and omised controlled trials may be combined statistically in a meta- analysis to increase power when the studies are similar enough . Biases in studies included in a SR/MA can lead to either an over estimation or an under estimation of true intervention effect size , result ing in heterogeneity in outcome between studies . A number of different tools are available such as Cochrane Risk of Bias assessment tool for r and omised controlled trials . In circumstances where there is too much heterogeneity , or when a review has included nonr and omised comparative studies , it is more appropriate to conduct a narrative synthesis . The GRADE tool for assessing quality of evidence strives to be a structured and transparent system , which can be applied to all evidence , regardless of quality . A SR not only identifies , evaluates , and summarises the best available evidence , but also the gaps to be targeted by future studies . CONCLUSIONS SRs and MAs are integral in developing sound clinical practice guidelines and recommendations . PATIENT SUMMARY Clinical practice guidelines should be evidence based , and systematic review s and meta-analyses are essential in their production . We have discussed the key steps of conducting systematic review s and meta-analyses in this paper BACKGROUND CONTEXT A variety of self-report and physical performance-based outcome measures are commonly used to assess progress and recovery in the lower leg , ankle , and foot . A requisite attribute of any outcome measure is its ability to detect change in a condition , a construct known as " responsiveness " . There is a lack of consistency in how responsiveness is defined in all outcome measures . PURPOSE The purpose of this study was to review the currently used recovery outcome measures for lower leg , ankle and foot conditions in order to determine and report recommended responsiveness values . METHODS A systematic literature search that included electronic search es of PubMed , CINAHL and SportD iscus as well extensive cross-referencing was performed in January , 2013 . Studies were included if each involved : 1 ) a prospect i ve , longitudinal study of any design ; 2 ) any condition associated with the lower leg , ankle or foot ; 3 ) a measure of responsiveness ; and 4 ) was an acceptable type of outcome measure ( eg . self-report , physical performance , or clinician report ) . The quality of the included articles was assessed by two independent authors using the responsiveness sub-component of the Consensus-based St and ards for the selection of health Measurement Instruments ( COSMIN ) . RESULTS Sixteen different studies met the inclusion criteria for this systematic review . The most commonly used outcome measures were the Foot and Ankle Ability Measure and the Lower Extremity Functional Scale . Responsiveness was calculated in a variety of methods including effect size , st and ardized response mean , minimal clinical ly important difference/ importance , minimal detectable change , and minimal important change . CONCLUSION Based on the findings of this systematic review there is a lack of consistency for reporting responsiveness among recovery measures used in the lower leg , ankle or foot studies . It is possible that the variability of conditions that involve the lower leg , ankle and foot contribute to the discrepancies found in reporting responsiveness values . Further research must be conducted in order to st and ardize reporting measures for responsiveness . LEVEL OF EVIDENCE 2a Palliative care at the end of life involves meeting the physical , psychological , social , and practical needs of patients and caregivers . End of life is defined as a phase of life when a person is living with an illness that will worsen and eventually cause death . It is not limited to the short period of time when the person is moribund ( 1 ) . Good clinical care can prevent or alleviate suffering for many patients at the end of life by assessing symptoms and providing psychological and social support to the patients and their families . The purpose of this guideline is to present the available evidence to improve palliative care at the end of life . This guideline does not address any other setting s of palliative care at the end of life . The target audience for this guideline is all clinicians caring for patients needing end-of-life care . The target patient population is everyone with seriously disabling or symptomatic chronic conditions at the end of life . These recommendations are based on the systematic evidence review in the background paper in this issue by Lorenz and colleagues ( 1 ) , which is based on an Agency for Healthcare Research and Quality ( AHRQ ) evidence report ( 2 ) . End-of-life care has been identified by the Institute of Medicine as one of the priority areas to improve quality of health care ( 3 ) . The Institute of Medicine report identified specific gaps related to end-of-life care , such as pain control in advanced cancer and care for patients with advanced organ failure . High- quality evidence on end-of-life care is limited , and most of the evidence is derived from the literature that focused on patients with cancer ; therefore , this guideline does not address many important aspects of end-of-life care . For example , nutritional support , complementary and alternative therapies , and spiritual care were not part of the review . If an end-of-life intervention is not addressed in this guideline , it does not mean that no benefit is related to that particular intervention , but it indicates that the intervention has not been sufficiently studied to demonstrate efficacy . Some important topics in end-of-life care , such as interpersonal and social interventions , may be especially difficult to study . The American College of Physicians ' End-of-Life Care Consensus Panel has a series of papers related to ethical issues around end-of-life care that can be accessed from its Web site ( www.acponline.org/ethics/papers.htm ) . Methods The literature search for this guideline included studies from MEDLINE and review s of cancer , congestive heart failure , and dementia from the Data base of Abstract of Review s of Effects from January 1990 to November 2005 . Citations from the non systematic literature were taken from the review by the National Consensus Project for Quality Palliative Care ( 4 ) . The review included only English- language publications from the United States , Canada , Western Europe , Australia , and New Zeal and . Details about the methods used for the systematic evidence review may be found in detail in the background paper in this issue ( 1 ) . The objective for this guideline was to answer the following questions : 1 . What are the critical elements for clinicians to address when caring for persons coming to the end of life ? 2 . What do definitions of the end of life suggest about identifying patients who could benefit from palliative approaches  ? 3 . What treatment strategies work well for pain , dyspnea , and depression ? 4 . What elements are important in advance care planning for patients coming to the end of life ? 5 . What elements of collaboration and consultation are effective in promoting improved end-of-life care ? 6 . What elements of assessment and support are effective for serving caregivers , including family , when patients are coming to the end of life ? This guideline grade s the evidence and recommendations using the American College of Physicians ' clinical practice guidelines grading system , adopted from the classification developed by the Grading of Recommendations , Assessment , Development , and Evaluation ( GRADE ) workgroup ( Table ) . Table . The American College of Physicians ' Guideline Grading System * Critical Elements for End-of-Life Care There is a wide range of critical elements for patients nearing the end of life , as well as for their caregivers . Preventing and treating pain and other symptoms ; supporting families and caregivers ; ensuring the continuity of care ; ensuring respect for persons and informed decision making ; attending to well-being , including existential and spiritual concerns ; and supporting function and survival duration are general issues that are common for most end-of-life care patients ( 411 ) . Identifying Patients Who Could Benefit from  Palliative Approaches The literature review did not identify any evidence -based tools that have been vali date d and shown to predict the optimal timing to initiate palliative care services . Decisions to initiate palliative care at the end of life should be individualized on the basis of patient symptoms and preferences . Treatment Strategies Pain Strong evidence from trials of patients with cancer supports the use of nonsteroidal anti-inflammatory drugs , opioids , bisphosphonates , and radiotherapy or radiopharmaceuticals for pain ( 12 ) . Bisphosphonates are specifically effective for bone pain . However , head-to-head comparisons of specific drugs or reports on delivery strategies are difficult to do because of method ological issues and heterogeneity ( 12 ) . Evidence was insufficient to assess the usefulness of exercise or acupuncture in pain management ( 13 , 14 ) . A meta- analysis that included 43 studies showed that palliative care teams are modestly beneficial in providing care for pain management compared with usual care teams ( effect size , 0.13 SD [ 95 % CI , 0.11 to 0.63 SD ] ) ( 15 ) . Other studies that evaluated quality of life showed no difference ( 16 ) and no effect of palliative care consultation ( in contrast to palliative care teams ) on pain scores ( 17 ) . Dyspnea Evidence from 13 studies shows a valuable effect of morphine for dyspnea in advanced lung disease ( st and ardized mean difference , 0.31 [ CI , 0.50 to 0.13 ] ) ( 18 ) . This is also supported by other studies that show the benefits of morphine for treating dyspnea in advanced lung disease and terminal cancer ( 19 , 20 ) . However , using nebulized opioids compared with oral opioids showed no additional benefit . Also , 1 study showed that dihydrocodeine result ed in a statistically but not clinical ly significant increase in Pco 2 during treatment ( 18 ) . Good- quality evidence shows that long-acting -agonists are beneficial in the treatment of dyspnea in chronic obstructive pulmonary disease ( 21 ) . Twelve studies evaluated various interventions for reducing dyspnea in patients with chronic obstructive pulmonary disease , heart failure , cancer , or all conditions . Evidence was mixed when comparing oxygen therapy with room air . One study showed better oxygen saturation , respiratory effort and rate , and dyspnea with oxygen ( 19 ) . However , Bruera and colleagues ( 20 ) showed no difference in dyspnea and fatigue between oxygen and air after a 6-minute walk test . Studies that evaluated service delivery showed no effect of facilitated patientprovider communication or palliative care consultation for dyspnea treatment ( 16 , 17 , 22 , 23 ) . Depression Good evidence supports the effectiveness of long-term use of tricyclic antidepressants or selective serotonin reuptake inhibitors , as well as psychosocial interventions ( education , cognitive and noncognitive behavioral therapy , informational interventions , and individual and group support ) for treating patients with cancer who have depression ( 12 ) . Gysels and Higginson ( 24 ) identified 15 intervention studies that showed that behavioral interventions were effective in the treatment of depression , whereas 1 complementary medicine intervention was ineffective for depression ( 24 ) . Evidence for using guided imagery and exercise showed mixed results ( 13 , 25 ) . Palliative care for out patients did not have any effect on depression and anxiety , and care coordination showed no effect on  depression  in patients with cancer near the end of life ( 22 , 23 , 26 , 27 ) . Important Elements for Advance Care Planning Research shows that individuals are more likely to use advance directives in the presence of extensive multicomponent interventions than with limited interventions ( 28 , 29 ) . One study showed that hospice use increased when goal -oriented interviews and decisions between palliative care facilitators and patients were communicated to nursing home physicians ( 30 ) . In addition , another study showed an increase in documented treatment limitations and preference-concordant care for patients served by social workers trained in care planning ( 31 ) . Also , proactive communication from skilled discussants , such as an ethics team , can help reduce utilization of unnecessary services without harming patients or family members ( 32 , 33 ) . In summary , various processes , such as consulting caregivers , enhancing clear communication , eliciting values , and addressing the emotional context , are important elements for comprehensive advance care planning . Clinicians should help patients and families plan in advance for likely or important clinical decisions . Collaboration and Consultation to Improve End-of-Life Care Studies have shown that the following factors improve utilization outcomes and patient-centered outcomes : multidisciplinary teams involving nurses and social services , continuity of care and service coordination , and facilitated communication . A meta- analysis of 29 r and omized , controlled trials done by McAlister and colleagues ( 34 ) showed that follow-up by a multidisciplinary team result ed in decreased hospitalizations due to heart failure . In addition , a multidisciplinary approach also improved patients ' quality of life and functional status ( 34 , 35 ) . Another intervention study showed that coordination between primary physician and Background Different tools exist for assessing risk of bias of intervention studies for systematic review s. We present a tool for assessing risk of bias across both r and omized and non-r and omized study design s. The tool was developed by the Evidence Project , which conducts systematic review s and meta-analyses of behavioral interventions for HIV in low- and middle-income countries . Methods We present the eight items of the tool and describe considerations for each and for the tool as a whole . We then evaluate reliability of the tool by presenting inter-rater reliability for 125 selected studies from seven published review s , calculating a kappa for each individual item and a weighted kappa for the total count of items . Results The tool includes eight items , each of which is rated as being present ( yes ) or not present ( no ) and , for some items , not applicable or not reported . The items include ( 1 ) cohort , ( 2 ) control or comparison group , ( 3 ) pre-post intervention data , ( 4 ) r and om assignment of participants to the intervention , ( 5 ) r and om selection of participants for assessment , ( 6 ) follow-up rate of 80 % or more , ( 7 ) comparison groups equivalent on sociodemographics , and ( 8) comparison groups equivalent at baseline on outcome measures . Together , items (1)–(3 ) summarize the study design , while the remaining items consider other common elements of study rigor . Inter-rater reliability was moderate to substantial for all items , ranging from 0.41 to 0.80 ( median κ = 0.66 ) . Agreement between raters on the total count of items endorsed was also substantial ( κw = 0.66 ) . Conclusions Strengths of the tool include its applicability to a range of study design s , from r and omized trials to various types of observational and quasi-experimental studies . It is relatively easy to use and interpret and can be applied to a range of review topics without adaptation , facilitating comparability across review s. Limitations include the lack of potentially relevant items measured in other tools and potential threats to validity of some items . To date , the tool has been applied in over 30 review s. We believe it is a practical option for assessing risk of bias in systematic review s of interventions that include a range of study design Background Poor recruitment to r and omised controlled trials ( RCTs ) is a widespread problem . Provision of interventions aim ed at supporting or incentivising clinicians may improve recruitment to RCTs . Objectives To quantify the effects of strategies aim ed at improving the recruitment activity of clinicians in RCTs , complemented with a synthesis of qualitative evidence related to clinicians ' attitudes towards recruiting to RCTs . Data sources A systematic review of English and non-English articles identified from : The Cochrane Library , Ovid MEDLINE , Ovid EMBASE , Ovid PsycINFO , Ebsco CINAHL , Index to Theses and Open SIGLE from 2001 to March 2011 . Additional reports were identified through citation search es of included articles . Study eligibility criteria Quantitative studies were included if they evaluated interventions aim ed at improving the recruitment activity of clinicians or compared recruitment by different groups of clinicians . Information about host trial , study design , participants , interventions , outcomes and host RCT was extracted by one research er and checked by another . Studies that met the inclusion criteria were assessed for quality using a st and ardised tool , the Effective Public Health Practice Project tool . Qualitative studies were included if they investigated clinicians ' attitudes to recruiting patients to RCTs . All results / findings were extracted , and content analysis was carried out . Overarching themes were abstract ed , followed by a meta summary analysis . Studies that met the inclusion criteria were assessed for quality using the Critical Appraisal Skills Programme qualitative checklist . Data extraction Data extraction was carried out by one research er using predefined data fields , including study quality indicators , and verified by another . Results Eight quantitative studies were included describing four interventions and a comparison of recruiting clinicians . One study was rated as strong , one as moderate and the remaining six as weak when assessed for quality using the Effective Public Health Practice Project tool . Effective interventions included the use of qualitative research to identify and overcome barriers to recruitment , reduction of the clinical workload associated with participation in RCTs and the provision of extra training and protected research time . Eleven qualitative studies were identified , and eight themes were abstract ed from the data : underst and ing of research , communication , perceived patient barriers , patient – clinician relationship , effect on patients , effect on clinical practice , individual benefits for clinicians and methods associated with successful recruitment . Meta summary analysis identified the most frequently reported subthemes to be : difficulty communicating trial methods , poor underst and ing of research and priority given to patient well-being . Overall , the qualitative studies were found to be of good quality when assessed using the Critical Appraisal Skills Programme checklist . Conclusions There were few high- quality trials that tested interventions to improve  clinicians ' recruitment activity in RCTs . The most promising intervention was the use of qualitative methods to identify and overcome barriers to  clinician recruitment activity . More good quality studies of interventions are needed to add to the evidence base . The meta summary of qualitative findings identified underst and ing and communicating RCT methods as a key target for future interventions to improve recruitment . Reinforcement of the potential benefits , both for clinicians and for their patients , could also be a successful factor in improving recruitment . A bias was found towards investigating barriers to recruitment , so future work should also encompass a focus on successfully recruiting trials RATIONALE AND OBJECTIVES Quality Assessment of Diagnostic Accuracy Studies ( QUADAS ) is a new tool to measure the method ological quality of diagnostic accuracy studies in systematic review s. We used data from a systematic review of magnetic resonance spectroscopy ( MRS ) in the characterization of suspected brain tumors to provide a preliminary evaluation of the inter-rater reliability of QUADAS . MATERIAL S AND METHODS A structured literature search identified 19 diagnostic accuracy studies . These publications were distributed r and omly to primary and secondary review ers for dual independent assessment . Review ers recorded method ological quality by using QUADAS on a custom- design ed spreadsheet . We calculated correlation , percentage of agreement , and kappa statistic to assess inter-rater reliability . RESULTS Most studies in our review were judged to have used an accurate reference st and ard . Conversely , the MRS literature frequently failed to specify the length of time between index and reference tests or that the clinicians were unaware of the index test findings when reporting the reference st and ard . There was good correlation ( rho = 0.78 ) between review ers in assessment of the overall number of quality criteria met . However , mean agreement for individual QUADAS questions was only fair ( kappa = 0.22 ) and ranged from no agreement beyond chance ( kappa < 0 ) to moderate agreement ( kappa = 0.58 ) . CONCLUSION Inter-rater reliability in our study was relatively low . Nevertheless , we believe that QUADAS potentially is a useful tool for highlighting the strengths and weaknesses of existing diagnostic accuracy studies . Low reliability suggests that different review ers will reach different conclusions if QUADAS is used to exclude " low- quality " articles from meta-analyses . We discuss methods for improving the validity and reliability of QUADAS Background Anticipation of an invasive procedure in hospital is likely to provoke feelings of anxiety and stress in patients . An unfamiliar environment , loss of control , perceived or actual physical risk , dependence on strangers and separation from friends and family are all factors that can contribute to the development of such feelings . Recently , there has been considerable interest in the anxiolytic potential of music listening in a variety of clinical setting s , yet thus far , little is known about the impact of music listening on the pre‐procedural patient population . A systematic review of all literature to date was indicated to improve underst and ing of outcomes and impact of music listening on pre‐procedural anxiety , thus helping nurses decide whether or not to incorporate music listening into practice and to highlight a need , or otherwise , for a related primary research agenda . Objective The objective of this review was to determine the best available evidence on the effectiveness of music listening in reducing adult hospital patients ' pre‐procedural state anxiety . Inclusion criteria Types of studies This review included r and omised controlled trials and quasi‐experimental research design s that examined the efficacy of music listening in reducing state anxiety among pre‐procedural hospital patients published between January 1985 and February 2006 . The search was limited to publications after 1985 to coincide with the increasing interest and use of complementary therapies within health care during the 1980s and 1990s . Types of participants Participants of interest to the review were adult day patients , ambulatory patients and in patients who were about to undergo any type of clinical procedure . Types of intervention The review focused on studies that investigated pre‐procedural music listening employed and prescribed as a potentially therapeutic activity . It excluded any other form of music therapy . Types of outcome measures The primary outcome measures examined were alterations in state anxiety and a variety of physiological variables such as blood pressure and respiration and heart rates . Search strategy A search for published and unpublished literature between January 1985 and February 2006 was conducted using all major electronic data bases . A three‐step search strategy was devised which consisted of using high‐precision MeSH terminology and keywords to ensure that all material relevant to the review was captured . Critical appraisal The method ological quality of included studies was assessed by two review ers , who appraised each study independently , using the st and ard Joanna Briggs Institute ( JBI ) critical appraisal tools . Data extraction and synthesis Data were extracted from the studies that were identified as meeting the criteria for method ological quality using a data ‐ extraction tool developed for the review . Studies were grouped by outcome measure and summarised using tabular and narrative formats . Results The review demonstrated that state anxiety is defined and measured using both psychological and physiological parameters . Music listening had a consistently positive and statistically significant effect on reducing psychological parameters of pre‐ procedural state anxiety . However , the results from the measurement of various pre‐ procedural physiological parameters failed to reveal any consistent positive changes in patients who had listened to music . This calls into question the adequacy of the theories in this area which link anxiety and the automated and central nervous systems and the effect that music listening may have on these processes and physiological responses . Conclusions / implication s for practice In order to reduce anxiety , it is likely that patients will benefit psychologically from having the opportunity to listen to music in the immediate pre‐procedural period . Patients do not appear to experience any alteration in physiological status as a result of listening to music . Further research is indicated in order to replicate existing studies , to strengthen the evidence to support such interventions and to establish intervention parameters . Further research is needed analysing the physiological mechanisms by which music listening is believed to reduce state anxiety and the contribution of the automated and other nervous systems to this reduction At an orthodontic meeting in recent years , a colleague recounted to me that when a presenter had finished their presentation on a systematic review , the person beside leaned over and said to my colleague ‘ not another systematic review where it ’s not possible to draw any firm conclusions ’ . So an element of frustration was clear based on the screening of a large volume of evidence to arrive at such a low point for a conclusion . This , however , is now a familiar outcome for many orthodontic systematic review s. In this short editorial , I have attempted to give a brief outline of the proposed benefits of systematic review s but more importantly , to highlight , some issues we all need to bear in mind in their regard . The increasing focus on evidence -based healthcare , including orthodontics , has shunned the narrative review and spawned the systematic review . Aim ing to identify , evaluate and summarize the findings of all relevant studies on a specific topic , its exacting systematic approach should minimize bias and provide conclusions based on reliable findings . Meta-analyses of r and omized clinical trials with low risk of bias are considered the highest level of evidence available for evaluating the effects of an intervention . Systematic review s are also important tools in setting the research agenda via their recommendations for future research and authors can alert research ers to the most pertinent outcomes in clinical practice . But systematic review s like any other study type are not without their variability , both in dentistry in general and specifically in orthodontics . Large differences have also been observed in the quality of reporting of several characteristics between Cochrane and non-Cochrane systematic review s. A key question that must be asked when looking at all Cochrane review s is whether the review has been undertaken in a way to avoid bias and whether the data and results from the included studies are valid . Conclusions may be distorted if bias is introduced to the review process at any stage . For example , incomplete search ing for all relevant studies may lead to publication bias ; there is strong association between publication and studies reporting significant or positive findings in medicine and also within orthodontics . With regard to studies included within the review , these need to be assessed to ensure that they are undertaken and reported in a manner that is free of bias ( systematic error ) . Outcome reporting bias ( ORB ) may also be relevant , e.g. in a study identified as relevant to a review , where data exist on the outcome of interest but only selected findings have been given based on the results . Although systematic review s have emphasized ‘ assessment of method ological quality ’ of included studies , the Cochrane h and book recommends a focus on ‘ risk of bias assessment ’ instead . The justifications are four-fold : it targets whether the results of included studies should be credible ; despite being carried out to the highest st and ards , a study may have risk of bias due to , e.g. impracticality/impossibility of blinding of participants / study personnel ; some quality markers , e.g. a power calculation is unlikely to directly affect risk of bias ; it overcomes ambiguity between quality of reporting and quality of the underlying research OBJECTIVE To summarize an extensive review of systems for grading the quality of research articles and rating the strength of bodies of evidence , and to highlight for health professionals and decision-makers concerned with quality measurement and improvement the available " best practice s " tools by which these steps can be accomplished . DESIGN Drawing on an extensive review of checklists , question naires , and other tools in the field of evidence -based practice , this paper discusses clinical , management , and policy rationale s for rating strength of evidence in a quality improvement context , and documents best practice s methods for these tasks . RESULTS After review of 121 systems for grading the quality of articles , 19 systems , mostly STUDY DESIGN specific , met a priori scientific st and ards for grading systematic review s , r and omized controlled trials , observational studies , and diagnostic tests ; eight systems ( of 40 review ed ) met similar st and ards for rating the overall strength of evidence . All can be used as is or adapted for particular types of evidence reports or systematic review s. CONCLUSIONS Formally grading study quality and rating overall strength of evidence , using sound instruments and procedures , can produce reasonable levels of confidence about the science base for parts of quality improvement programs . With such information , health care professionals and administrators concerned with quality improvement can underst and better the level of science ( versus only clinical consensus or opinion ) that supports practice guidelines , review criteria , and assessment s that feed into quality assurance and improvement programs . New systems are appearing and research is needed to confirm the conceptual and practical underpinnings of these grading and rating systems , but the need for those developing systematic review s , practice guidelines , and quality or audit criteria to underst and and undertake these steps is becoming increasingly clear UNLABELLED EXECUTIVE SUMMARY : BACKGROUND Anticipation of an invasive procedure in hospital is likely to provoke feelings of anxiety and stress in patients . An unfamiliar environment , loss of control , perceived or actual physical risk , dependence on strangers and separation from friends and family are all factors that can contribute to the development of such feelings . Recently , there has been considerable interest in the anxiolytic potential of music listening in a variety of clinical setting s , yet thus far , little is known about the impact of music listening on the pre-procedural patient population . A systematic review of all literature to date was indicated to improve underst and ing of outcomes and impact of music listening on pre-procedural anxiety , thus helping nurses decide whether or not to incorporate music listening into practice and to highlight a need , or otherwise , for a related primary research agenda . OBJECTIVE The objective of this review was to determine the best available evidence on the effectiveness of music listening in reducing adult hospital patients ' pre-procedural state anxiety .  INCLUSION CRITERIA Types of studies This review included r and omised controlled trials and quasi-experimental research design s that examined the efficacy of music listening in reducing state anxiety among pre-procedural hospital patients published between January 1985 and February 2006 . The search was limited to publications after 1985 to coincide with the increasing interest and use of complementary therapies within health care during the 1980s and 1990s . Types of participants Participants of interest to the review were adult day patients , ambulatory patients and in patients who were about to undergo any type of clinical procedure . Types of intervention The review focused on studies that investigated pre-procedural music listening employed and prescribed as a potentially therapeutic activity . It excluded any other form of music therapy . Types of outcome measures The primary outcome measures examined were alterations in state anxiety and a variety of physiological variables such as blood pressure and respiration and heart rates . SEARCH STRATEGY A search for published and unpublished literature between January 1985 and February 2006 was conducted using all major electronic data bases . A three-step search strategy was devised which consisted of using high-precision MeSH terminology and keywords to ensure that all material relevant to the review was captured . CRITICAL APPRAISAL : The method ological quality of included studies was assessed by two review ers , who appraised each study independently , using the st and ard Joanna Briggs Institute ( JBI ) critical appraisal tools . DATA EXTRACTION AND SYNTHESIS Data were extracted from the studies that were identified as meeting the criteria for method ological quality using a data - extraction tool developed for the review . Studies were grouped by outcome measure and summarised using tabular and narrative formats . RESULTS The review demonstrated that state anxiety is defined and measured using both psychological and physiological parameters . Music listening had a consistently positive and statistically significant effect on reducing psychological parameters of pre-procedural state anxiety . However , the results from the measurement of various pre-procedural physiological parameters failed to reveal any consistent positive changes in patients who had listened to music .  This calls into question the adequacy of the theories in this area which link anxiety and the automated and central nervous systems and the effect that music listening may have on these processes and physiological responses . CONCLUSIONS / IMPLICATION S FOR PRACTICE 1 In order to reduce anxiety , it is likely that patients will benefit psychologically from having the opportunity to listen to music in the immediate pre-procedural period . 2 Patients do not appear to experience any alteration in physiological status as a result of listening to music . 3 Further research is indicated in order to replicate existing studies , to strengthen the evidence to support such interventions and to establish intervention parameters . 4 Further research is needed analysing the physiological mechanisms by which music listening is believed to reduce state anxiety and the contribution of the automated and other nervous systems to this reduction & NA ; Physical therapists seeking to use evidence to guide their practice may have limited time to read research reports . One way to reduce the time required to identify and read about the research that is relevant to a particular clinical question is to read a systematic review that summarizes multiple studies . This paper explains the process that is used to conduct systematic review s , which includes the establishment of a protocol , comprehensive search ing , appraisal of the quality of the included studies , data extraction and meta analysis , and consideration of the clinical and research implication s of the findings . We also consider how the reader of a systematic review can determine whether the review is likely to provide an unbiased ( believable ) estimate of the treatment effect . A systematic review of r and omized trials of a  cardiopulmonary physical therapy intervention is used as an example . The issue of appraisal of quality is then discussed further , with a demonstration of how one vali date d tool for quality appraisal ‐‐the PEDro scale‐‐can be used to evaluate a r and omized trial in cardiopulmonary physical therapy
SUMMARY Despite a variety of measurement tools none can be recommended as gold st and ard for the assessment of dyspnoea .
A combination of unidimensional and multidimensional tools seems to be the best for clinical assessment .
PURPOSE OF REVIEW Refractory dyspnoea is a common and difficult to treat symptom in advanced disease .
Accurate assessment helps to guide treatment and prognosis .
RECENT FINDINGS The absence of commonly agreed assessment tools has been a significant barrier to improving care through inhibition of clinical research and limitation of clinicians ' ability to assess the effectiveness of their interventions .
Two recently published systematic review s on measurement tools for breathlessness identified a variety of tools but none could be recommended as gold st and ard .
For clinical purpose s , the combination of a unidimensional tool to assess dyspnoea severity and a multidimensional tool to evaluate the impact on a person 's quality of life seem most appropriate .
This review discusses the present evidence and puts forward a strategy for assessment and measurement of the symptom in clinical practice .