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Background Clinical pathways are tools used to guide evidence-based healthcare that have been implemented internationally since the 1980s. However, there is widespread lack of agreement on the impact of clinical pathways on hospital resources and patient outcomes. This can be partially attributed to the confusion for both researchers and healthcare workers regarding what constitutes a clinical pathway. This paper describes efforts made by a team of Cochrane Review authors to develop criteria to assist in the objective identification of clinical pathway studies from the literature. Methods We undertook a four-stage process aiming to develop criteria to define a clinical pathway: (1) identify publications exploring the definition of a clinical pathway; (2) derive draft criteria; (3) pilot test the criteria; and (4) modify criteria to maximise agreement between review authors. Results Previous literature and liaison with the European Pathways Association resulted in five criteria being used to define a clinical pathway: (1) the intervention was a structured multidisciplinary plan of care; (2) the intervention was used to translate guidelines or evidence into local structures; (3) the intervention detailed the steps in a course of treatment or care in a plan, pathway, algorithm, guideline, protocol or other 'inventory of actions'; (4) the intervention had timeframes or criteria-based progression; and (5) the intervention aimed to standardise care for a specific clinical problem, procedure or episode of healthcare in a specific population. After pilot testing it was decided that if an intervention met the first criteria (a structured multidisciplinary plan of care) plus three out of the other four criteria then it was included as a clinical pathway for the purposes of this review. In all, 27 studies were included in the final review. The authors of the included studies referred to these interventions as 'clinical pathways', 'protocols', 'care model', 'care map', 'multidisciplinary care', evidence-based care' and 'guideline'. Conclusions The criteria used for the identification of relevant studies for this Cochrane Review can be used as a foundation for the development of a standardised, internationally accepted definition of a clinical pathway.

Clinical pathways (CPWs) are a common component in the quest to improve the quality of health. CPWs are used to reduce variation, improve quality of care, and maximize the outcomes for specific groups of patients. An ongoing challenge is the operationalization of a definition of CPW in healthcare. This may be attributable to both the differences in definition and a lack of conceptualization in the field of clinical pathways. This correspondence article describes a process of refinement of an operational definition for CPW research and proposes an operational definition for the future syntheses of CPWs literature. Following the approach proposed by Kinsman et al. (BMC Medicine 8(1):31, 2010) and Wieland et al. (Alternative Therapies in Health and Medicine 17(2):50, 2011), we used a four-stage process to generate a five criteria checklist for the definition of CPWs. We refined the operational definition, through consensus, merging two of the checklist’s criteria, leading to a more inclusive criterion for accommodating CPW studies conducted in various healthcare settings. The following four criteria for CPW operational definition, derived from the refinement process described above, are (1) the intervention was a structured multidisciplinary plan of care; (2) the intervention was used to translate guidelines or evidence into local structures; (3) the intervention detailed the steps in a course of treatment or care in a plan, pathway, algorithm, guideline, protocol or other ‘inventory of actions’ (i.e. the intervention had time-frames or criteria-based progression); and (4) the intervention aimed to standardize care for a specific population. An intervention meeting all four criteria was considered to be a CPW. The development of operational definitions for complex interventions is a useful approach to appraise and synthesize evidence for policy development and quality improvement.

Background In 2012, the Saskatchewan Ministry for Health mandated a system-wide Lean transformation. Research has been conducted on the implementation processes of this system-wide Lean implementation. However, no research has been done on the sustainability of these Lean efforts. We conducted a realist evaluation on the sustainability of Lean in pediatric healthcare. We used the context (C) + mechanism (M) = outcome (O) configurations (CMOcs) heuristic to explain under what contexts, for whom, how and why Lean efforts are sustained or not sustained in pediatric healthcare. Methods We employed a case study research design. Guided by a realist evaluation framework, we conducted qualitative realist interviews with various stakeholder groups across four pediatric hospital units ‘cases’ at one acute hospital. Interview data was analyzed using an integrated approach of CMOc categorization coding, CMOc connecting and pattern matching. Results We conducted thirty-two interviews across the four cases. Five CMOcs emerged from our realist interview data. These configurations illustrated a ‘ripple-effect’ from implementation outcomes to contexts for sustainability. Sense-making and staff engagement were prominent mechanisms to the sustainment of Lean efforts. Failure to trigger these mechanisms resulted in resistance. The implementation approach used influenced mechanisms and outcomes for sustainability, more so than Lean itself. Specifically, the language, messaging and training approaches used triggered mechanisms of innovation fatigue, poor ‘sense-making’ and a lack of engagement for frontline staff. The mandated, top-down, externally led nature of implementation and lack of customization to context served as potential pitfalls. Overall, there was variation between leadership and frontline staff’s perceptions on how embedded Lean was in their contexts, and the degree to which participants supported Lean sustainability. Conclusions This research illuminates important contextual factors and mechanisms to the process of Lean sustainment that can be applicable to those implementing systems changes. Future work is needed to continue to develop the science on the sustainability of interventions for healthcare improvement.

The iFightDepression® (iFD) tool is an internet-based self-management program for individuals with milder forms of depression, used alongside support from trained user guides (e.g., family physicians). Despite strong evidence supporting guided internet-based cognitive behavioural therapy (iCBT), adherence to the iFD tool and its uptake across implementing countries remain variable. This implementation mapping study will be conducted in Germany, Poland, and Spain. Guided by the Consolidated Framework for Implementation Research (CFIR), we aim to identify barriers, facilitators, and country-specific implementation strategies. In Phase 1, we will invite 15 trained iFD user guides to complete an online qualitative survey to explore user experiences and perceived influences on patient uptake and adherence. In Phase 2, three country-specific focus groups will be conducted with trained user guides (one in each country). Survey data will be analyzed using Interpretative Phenomenological Analysis (IPA) and focus group data will be analyzed using template analysis. Findings will be used to develop an iFD implementation manual and country-specific implementation blueprints. These outputs are intended to support consistent and sustainable adoption of this internet-based intervention across participating countries and to improve patient uptake and adherence. The study, including the analysis plan, has been preregistered via the Open Science Framework (internet archive link: https://archive.org/details/osf-registrations-wmbhy-v1) following ethical approval.

Background The General Movements Assessment is a non-invasive and cost-effective tool with demonstrated reliability for identifying infants at risk for cerebral palsy. Early detection of cerebral palsy allows for the implementation of early intervention and is associated with better functional outcomes. No review to date has summarized the utility of the General Movements Assessment to predict cerebral palsy in term and late-preterm infants diagnosed with neonatal encephalopathy. Methods We conducted a scoping review involving infants born greater than or equal to 34 weeks gestational age to identify all available evidence and delineate research gaps. We extracted data on sensitivity, specificity, and positive and negative predictive values and described the strengths and limitations of the results. We searched five databases (MEDLINE, Embase, PsychINFO, Scopus, and CINAHL) and the General Movements Trust website. Two reviewers conducted all screening and data extraction independently. The articles were categorized according to key findings, and a critical appraisal was performed. Results Only three studies, a cohort and two case series, met all of the inclusion criteria. The total number of participants was 118. None of the final eligible studies included late-preterm neonates. All three studies reported on sensitivity, specificity, and positive predictive and negative predictive values. An abnormal General Movement Assessment at 3–5 months has a high specificity (84.6–98%) for cerebral palsy with a similarly high negative predictive value (84.6–98%) when it was normal. Absent fidgety movements, in particular, are highly specific (96%) for moderate to severe cerebral palsy and carry a high negative predictive value (98%) when normal. In the time period between term and 4–5 months post-term, any cramped synchronized movements had results of 100% sensitivity and variable results for specificity, positive predictive value, and negative predictive value. Conclusions A normal General Movements Assessment at 3 months in a term high-risk infant is likely associated with a low risk for moderate/severe cerebral palsy. The finding of cramped synchronized General Movements is a strong predictor for the diagnosis of cerebral palsy by 2 years of age in the term population with neonatal encephalopathy. The deficit of high-quality research limits the applicability, and so the General Movements Assessment should not be used in isolation when assessing this population. Systematic review registration Title registration with Joanna Briggs Institute. URL: http://joannabriggswebdev.org/research/registered_titles.aspx .

Background Experimental designs for evaluating knowledge translation (KT) interventions can provide strong estimates of effectiveness but offer limited insight into how the intervention worked. Consequently, process evaluations have been used to explore the causal mechanisms at work; however, there are limited standards to guide this work. This study synthesizes current evidence of KT process evaluations to provide future methodological recommendations. Methods Peer-reviewed search strategies were developed by a health research librarian. Studies had to be in English, published since 1996, and were not excluded based on design. Studies had to (1) be a process evaluation of a KT intervention study in primary health, (2) be a primary research study, and (3) include a licensed healthcare professional delivering or receiving the intervention. A two-step, two-person hybrid screening approach was used for study inclusion with inter-rater reliability ranging from 94 to 95%. Data on study design, data collection, theoretical influences, and approaches used to evaluate the KT intervention, analysis, and outcomes were extracted by two reviewers. Methodological quality was assessed with the Mixed Methods Appraisal Tool (MMAT). Results Of the 20,968 articles screened, 226 studies fit our inclusion criteria. The majority of process evaluations used qualitative forms of data collection (43.4%) and individual interviews as the predominant data collection method. 72.1% of studies evaluated barriers and/or facilitators to implementation. 59.7% of process evaluations were stand-alone evaluations. The timing of data collection varied widely with post-intervention data collection being the most frequent (46.0%). Only 38.1% of the studies were informed by theory. Furthermore, 38.9% of studies had MMAT scores of 50 or less indicating poor methodological quality. Conclusions There is widespread acceptance that the generalizability of quantitative trials of KT interventions would be significantly enhanced through complementary process evaluations. However, this systematic review found that process evaluations are of mixed quality and lack theoretical guidance. Most process evaluation data collection occurred post-intervention undermining the ability to evaluate the process of implementation. Strong science and methodological guidance is needed to underpin and guide the design and execution of process evaluations in KT science. Registration This study is not registered with PROSPERO.

Background The costs of investing in health care reform initiatives to improve quality and safety have been underreported and are often underestimated. This paper reports direct and indirect cost estimates for the initial phase of the province-wide implementation of Lean activities in Saskatchewan, Canada. Methods In order to obtain detailed information about each type of Lean event, as well as the total number of corresponding Lean events, we used the Provincial Kaizen Promotion Office (PKPO) Kaizen database. While the indirect cost of Lean implementation has been estimated using the corresponding wage rate for the event participants, the direct cost has been estimated using the fees paid to the consultant and other relevant expenses. Results The total cost for implementation of Lean over two years (2012–2014), including consultants and new hires, ranged from $44 million CAD to $49.6 million CAD, depending upon the assumptions used. Consultant costs accounted for close to 50% of the total. The estimated cost of Lean events alone ranged from $16 million CAD to $19.5 million CAD, with Rapid Process Improvement Workshops requiring the highest input of resources. Conclusions Recognizing the substantial financial and human investments required to undertake reforms designed to improve quality and contain cost, policy makers must carefully consider whether and how these efforts result in the desired transformations. Evaluation of the outcomes of these investments must be part of the accountability framework, even prior to implementation.

Background Lean is a quality improvement management system from the Toyota manufacturing industry. Since the early 2000’s, Lean has been used as an intervention for healthcare improvement. Lean is intended to reduce costs and improve customer value through continuous improvement. Despite its extensive use, the contextual factors and mechanisms that influence the sustainability of Lean in healthcare have not been well studied. Realist synthesis is one approach to “unpack” the causal explanations of how and why Lean is sustained or not in healthcare. We conducted a realist synthesis using the context (C) + mechanim (M) = outcome (O) heuristic, to further develop and refine an initial program theory with seven CMO hypotheses, on the sustainability of Lean efforts across pediatric healthcare. Methods Our search strategy was multi-pronged, iterative, and purposeful in nature, consisting of database, gray literature, and contact with three healthcare organizations known for Lean implementation. We included primary research studies, published and unpublished case studies or reports, if they included Lean implementation with a pediatric focus and sustainability outcome. We used the Normalization Process Theory and the National Health Services Sustainability Model, an operational definition for Lean and a comprehensive definition for sustainability as guidance for data extraction and analysis. Our initial program theory with was refined using a blend of abductive and retroductive analytical processes. Results We identified six published primary research studies, two published quality improvement case studies, and three unpublished quality improvement case reports. Five CMO hypotheses from our initial program theory were substantially supported after synthesis, “sense-making and value congruency,” “staff engagement and empowerment,” and the “ripple effect” or causal pathway between Lean implementation outcomes that served as facilitating or hindering contexts for sustainability. Overall, there was variation with the conceptualization and measurement of sustainability. Conclusions This study is the first to examine Lean sustainability in pediatric healthcare using realist methods. Future research should examine whether the predictors of implementation are the same or different to sustainability and evaluate the underlying mechanisms that influence the sustainability of Lean. There is also a need for research to develop and test conceptual models and frameworks on sustainability. Systematic review registration PROSPERO-CRD42015032252 .

ObjectivesTo map the existing literature and describe interventions aimed at building the capacity of patients to participate in care during hospitalisation by: (1) describing and categorising the aspects of care targeted by these interventions and (2) identifying the behaviour change techniques (BCTs) used in these interventions. A patient representative participated in all aspects of this project.DesignScoping review.Data sourcesMEDLINE, Embase and CINAHL (Inception −2017).Study selectionStudies reporting primary research studies on building the capacity of hospitalised adult patients to participate in care which described or included one or more structured or systematic interventions and described the outcomes for at least the key stakeholder group were included.Data extractionTitle and abstract screening and full text screening were conducted by pairs of trained reviewers. One reviewer extracted data, which were verified by a second reviewer. Interventions were classified according to seven aspects of care relevant to hospital settings. BCTs identified in the articles were assigned through consensus of three reviewers.ResultsDatabase searches yielded a total 9899 articles, resulting in 87 articles that met the inclusion criteria. Interventions directed at building patient capacity to participate in care while hospitalised were categorised as those related to improving: patient safety (20.9%); care coordination (5.7%); effective treatment (5.7%) and/or patient-centred care using: bedside nursing handovers (5.7%); communication (29.1%); care planning (14%) or the care environment (19.8%). The majority of studies reported one or more positive outcomes from the defined intervention. Adding new elements (objects) to the environment and restructuring the social and/or physical environment were the most frequently identified BCTs.ConclusionsThe majority of studies to build capacity for participation in care report one or more positive outcomes, although a more comprehensive analysis is warranted.