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.

BackgroundLean is a set of operating philosophies and methods that help create a maximum value for patients by reducing waste and waits. It emphasizes the consideration of the customer’s needs, employee involvement and continuous improvement. Research on the application and implementation of lean principles in health care has been limited.MethodsThis is a protocol for a systematic review, following the Cochrane Effective Practice and Organisation of Care (EPOC) methodology. The review aims to document, catalogue and synthesize the existing literature on the effects of lean implementation in health care settings especially the potential effects on professional practice and health care outcomes. We have developed a Medline keyword search strategy, and this focused strategy will be translated into other databases. All search strategies will be provided in the review. The method proposed by the Cochrane EPOC group regarding randomized study designs, non-randomised controlled trials controlled before and after studies and interrupted time series will be followed. In addition, we will also include cohort, case–control studies, and relevant non-comparative publications such as case reports. We will categorize and analyse the review findings according to the study design employed, the study quality (low- versus high-quality studies) and the reported types of implementation in the primary studies. We will present the results of studies in a tabular form.DiscussionOverall, the systematic review aims to identify, assess and synthesize the evidence to underpin the implementation of lean activities in health care settings as defined in this protocol. As a result, the review will provide an evidence base for the effectiveness of lean and implementation methodologies reported in health care.Systematic review registrationPROSPERO CRD42014008853

Industrial improvement approaches such as Lean management are increasingly being adopted in health care. Synthesis is necessary to ensure these approaches are evidence based and requires operationalization of concepts to ensure all relevant studies are included. This article outlines the process utilized to develop an operational definition of Lean in health care. The literature search, screening, data extraction, and data synthesis processes followed the recommendations outlined by the Cochrane Collaboration. Development of the operational definition utilized the methods prescribed by Kinsman et al. and Wieland et al. This involved extracting characteristics of Lean, synthesizing similar components to establish an operational definition, applying this definition, and updating the definition to address shortcomings. We identified two defining characteristics of Lean health-care management: (1) Lean philosophy, consisting of Lean principles and continuous improvement, and (2) Lean activities, which include Lean assessment activities and Lean improvement activities. The resulting operational definition requires that an organization or subunit of an organization had integrated Lean philosophy into the organization’s mandate, guidelines, or policies and utilized at least one Lean assessment activity or Lean improvement activity. This operational definition of Lean management in health care will act as an objective screening criterion for our systematic review. To our knowledge, this is the first evidence-based operational definition of Lean management in health care.

Background Despite the increased utilization of clinical pathways (CPWs) as a strategy to improve patient and system outcomes in hospitals, there remain ongoing challenges with their conceptualization, implementation, and evaluation. Theories that explain how CPWs work in hospitals are lacking, making it difficult to identify important factors for sustaining changes arising from CPWs implemented in hospitals. The objective of this realist review is to develop a program theory for CPWs in hospitals. Methods This is a protocol for a realist review. The review will use a six-step iterative process to develop a program theory for CPWs in hospitals: (1) development of a preliminary program theory; (2) search strategy and literature search; (3) study selection and appraisal; (4) data extraction; (5) data analysis and synthesis; and (6) stakeholder engagement. In addition to searching the gray literature and contacting authors, we will search electronic databases such as MEDLINE, NHSEED, CINAHL EBSCO, HMIC, and PsycINFO. Studies will be included based on their ability to provide data that test some aspect of the program theory. Two independent reviewers will select, screen, and extract data related to the program theory from all relevant sources. A realist logic of analysis will be used to identify all context-mechanism-outcome heuristics that explains how CPWs implemented in hospitals translates to better health system outcomes. Discussion Overall, the review aims to develop a program theory for CPWs in hospitals and to explore how, why, to what extent, and in what contexts does the implementation of CPWs in hospitals contribute to better health system outcomes. As a result, the review will provide a theoretical framework of how CPWs work in hospitals. Systematic review registration PROSPERO CRD42018103220 Electronic supplementary material The online version of this article (10.1186/s13643-019-1046-0) contains supplementary material, which is available to authorized users.

Background. Study examined the determinants of mortality among adult HIV patients in a rural, tertiary hospital in southeastern Nigeria, comparing mortality among various ART regimens. Methods. Retrospective cohort study of 1069 patients on ART between August 2008 and October 2013. Baseline CD4 counts, age, gender, and ART regimen were considered in this study. Kaplan-Meier method was used to estimate survival and Cox proportional hazards models to identify multivariate predictors of mortality. Median follow-up period was 24 months (IQR 6–45). Results. 78 (7.3%) patients died with 15.6% lost to followup. Significant independent predictors of mortality include age (>45), sex (male > female), baseline CD4 stage (<200), and ART combination. Adjusted mortality hazard was 3 times higher among patients with CD4 count <200 cells/μL than those with counts >500 (95% CI 1.69–13.59). Patients on Truvada-based first-line regimens were 88% more likely to die than those on Combivir-based first line (95% CI 1.05–3.36), especially those with CD4 count <200 cells/μL. Conclusion. Study showed lower mortality than most studies in Nigeria and Africa, with mortality higher among males and patients with CD4 count <200. Further studies are recommended to further compare treatment outcomes between Combivir- and Truvada-based regimens in resource-limited settings using clinical indicators.