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.
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
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 .