Purpose: The aim of this study was to identify and analyze the characteristics of leadership and management associated with a successful Lean thinking adaptation in healthcare.

Design: A systematic literature review was undertaken using electronic databases: PubMed, PubMed Systematic Review, ABI/INFORM, Business Source Complete, Emerald, JBI, and Cinahl. Inclusion criteria were: (i) a description of Lean management or leadership in health care, (ii) a reference to Lean thinking, (iii) a peer-reviewed original research article or a literature review, and (iv) a full text article available in English. Among the 1,754 peer-reviewed articles identified, nine original articles and three systematic reviews met the inclusion criteria. Data on informants, methods, and settings were extracted and collated. Content analysis was used to conduct a review of the nine original studies describing and analyzing the success factors of Lean adaptation. The characteristics of leadership and management were analyzed by using the concept of a managerial windshield that divides leadership and management into four ontological dimensions: activities, style, focus, and purpose, each with typical developmental stages of skills and capabilities. The current study has some limitations: some papers from the journals not indexed in the searched databases may have been overlooked and the literature searches were carried out only for a 5-year period.

Findings: Considering the results using the windshield concept emphasizes the philosophy, principles, and tools of Lean thinking. Lean leadership and management factors in health care were mainly conceptualized as skills and capabilities such as problem solving, making changes occur, empowering, communicating, coaching, supporting, facilitating, being democratic, organizational learning, and organizational success, all of which represented middle-stage or advanced managerial skills and capabilities.

Practical Implications: A conceptual analysis of systematically reviewed studies of Lean leadership and management point to certain traits as being typical when adapting Lean thinking to health care. The concept of a managerial windshield is useful when categorizing and analyzing essential managerial skills and capabilities for Lean implementation. Findings are beneficial when learning and educating the skills required for Lean transformation in healthcare organizations.

Objectives: The aim of this study is to report on the experiences, benefits, and challenges of patient and public involvement and engagement (PPIE) from a publicly funded early awareness and alert (EAA) system in the United Kingdom.

Methods: Using email, telephone, a Web site portal, Twitter and focus groups, patients and the public were involved and engaged in the recognized stages of an EAA system: identification, filtration, prioritization, early assessment, and dissemination.

Results: Approaches for PPIE were successfully integrated into all aspects of the National Institute for Health Research Horizon Scanning Research and Intelligence Centre's EAA system. Input into identification activities was not as beneficial as involvement in prioritization and early assessment. Patients gave useful insight into the Centre's Web site and engaging patients using Twitter has enabled the Centre to disseminate outputs to a wider audience.

Conclusions: EAA systems should consider involving and engaging with patients and the public in identification, prioritization, and assessment of emerging health technologies where practicable. Further research is required to examine the value and impact of PPIE in EAA activities and in the early development of health technologies.

Background: Non small cell lung cancer (NSCLC) diagnosis and treatment is a highly complex process, requiring managerial skills merged with clinical knowledge and experience. Integrated care pathways (ICPs) might be a good strategy to overview and improve patient's management. The aim of this study was to review the ICPs of NSCLC patients in a University Hospital and to identify areas of quality improvement.

Materials and Methods: The electronic medical records of 169 NSCLC patients visited at the University Hospital were retrospectively reviewed. Quality of care (QoC) has been measured trough fifteen indicators, selected according main international Guidelines and approved by the multi-disciplinary team for thoracic malignancies. Results have been compared with those of a similar retrospective study conducted at the same hospital in 2008.

Results: A total of 146 patients were considered eligible. Eight of fifteen indicators were not in line with the benchmarks. We compared the results obtained in the two separate periods. Moreover, we process some proposal to be discussed with the general management of the hospital, aimed to redesign NSCLC care pathways.

Conclusions: ICPs confirm to be feasible and to be an effective tool in real life. The periodic measurement of QoC indicators is necessary to ensure clinical governance of patients pathways.

Objectives: The health technology assessment (HTA) Core Model® is a tool for defining and standardizing the elements of HTA analyses within several domains for producing structured reports. This study explored the parallels between the Core Model and a national HTA report. Experiences from various European HTA agencies were also investigated to determine the Core Model's adaptability to national reports.

Methods: A comparison between a national report on Genetic Counseling, produced by the Cellule d'expertise médicale Luxembourg, and the Core Model was performed to identify parallels in terms of relevant and comparable assessment elements (AEs). Semi-structured interviews with five representatives from European HTA agencies were performed to assess their user experiences with the Core Model.

Results: The comparative study revealed that 50 percent of the total number (n = 144) of AEs in the Core Model were relevant for the national report. Of these 144 AEs from the Core Model, 34 (24 percent) were covered in the national report. Some AEs were covered only partly. The interviewees emphasized flexibility in using the Core Model and stated that the most important aspects to be evaluated include characteristics of the disease and technology, clinical effectiveness, economic aspects, and safety.

Conclusions: In the present study, the national report covered an acceptable number of AEs of the Core Model. These results need to be interpreted with caution because only one comparison was performed. The Core Model can be used in a flexible manner, applying only those elements that are relevant from the perspective of the technology assessment and specific country context.

Objectives: Patient production losses occur when individuals’ capacities to work, whether paid or unpaid, are impaired by illness, treatment, disability, or death. There is controversy about whether and how to include patient production losses in economic evaluations in health care. Patient production losses have not previously been considered when evaluating medications for reimbursement under the U.K. National Health Service. Proposals for value-based assessment of health technologies in the United Kingdom created renewed interest in whether and how to include costs from a wider societal perspective, such as patient production losses, within economic evaluation of healthcare interventions.

Methods: A narrative review was undertaken of theoretical, ethical, and policy issues that might inform decisions that involve the normative question of whether or not to include patient production losses in economic evaluation.

Results: It seems difficult to reconcile the implications of including patient production losses with the objectives of a healthcare system dedicated to providing universal healthcare coverage without regard to patients’ ability to pay.

Conclusions: Tax payer funded healthcare systems may legitimately adopt maximands other than health gain, but these will be at the opportunity cost of less than maximum health gains.

Background: The importance of economic evaluation in decision making is growing with increasing budgetary pressures on health systems. Diverse economic evidence is available for a range of interventions across national contexts within Europe, but little attention has been given to identifying evidence gaps that, if filled, could contribute to more efficient allocation of resources. One objective of the Research Agenda for Health Economic Evaluation project is to determine the most important methodological evidence gaps for the ten highest burden conditions in the European Union (EU), and to suggest ways of filling these gaps.

Methods: The highest burden conditions in the EU by Disability Adjusted Life Years were determined using the Global Burden of Disease study. Clinical interventions were identified for each condition based on published guidelines, and economic evaluations indexed in MEDLINE were mapped to each intervention. A panel of public health and health economics experts discussed the evidence during a workshop and identified evidence gaps.

Results: The literature analysis contributed to identifying cross-cutting methodological and technical issues, which were considered by the expert panel to derive methodological research priorities.

Conclusions: The panel suggests a research agenda for health economics which incorporates the use of real-world evidence in the assessment of new and existing interventions; increased understanding of cost-effectiveness according to patient characteristics beyond the “-omics” approach to inform both investment and disinvestment decisions; methods for assessment of complex interventions; improved cross-talk between economic evaluations from health and other sectors; early health technology assessment; and standardized, transferable approaches to economic modeling.

Objectives: For medical devices, benefits other than direct clinical effects may have a large impact on the patients’ well-being, but a standardized method for measuring these benefits is unavailable. The objective was to explore potential patient benefits provided by medical devices, and to assess the relative preferences of these benefits in the general Swedish population.

Methods: To identify attributes of patient benefit, healthcare personnel within a wide range of disease areas were interviewed. The generalized attributes were then validated among healthcare personnel, patient organizations, and manufacturers; in two pilot studies in the general population; and in two rounds of cognitive interviews. The general population's preferences of the attributes were measured with a usability-tested questionnaire in a final responding sample of 3,802 individuals, representative of the Swedish population.

Results: Twenty attributes were identified, encompassing aspects of integrity, sense of security, social participation, and convenience. When measuring the relative preferences, the response rate was 37.0 percent, and the results showed that the attributes with the highest preferences concerned reliability, reduced need for assistance, and sense of control of the illness/disability.

Conclusions: A set of twenty attributes of patient benefit relevant to users of medical devices was identified and validated. A questionnaire for patient-reported assessment of the benefits provided by a medical device was developed, based on the attributes. The questionnaire, designated MedTech20, provides a generic measurement method for the evaluation of medical devices used in a wide range of diseases/disabilities.

Objectives: This study was designed to assess the sensitivity of three Ovid MEDLINE search filters developed to identify studies reporting health state utility values (HSUVs), to improve the performance of the best performing filter, and to validate resulting search filters.

Methods: Three quasi-gold standard sets (QGS1, QGS2, QGS3) of relevant studies were harvested from reviews of studies reporting HSUVs. The performance of three initial filters was assessed by measuring their relative recall of studies in QGS1. The best performing filter was then developed further using QGS2. This resulted in three final search filters (FSF1, FSF2, and FSF3), which were validated using QGS3.

Results: FSF1 (sensitivity maximizing) retrieved 132/139 records (sensitivity: 95 percent) in the QGS3 validation set. FSF1 had a number needed to read (NNR) of 842. FSF2 (balancing sensitivity and precision) retrieved 128/139 records (sensitivity: 92 percent) with a NNR of 502. FSF3 (precision maximizing) retrieved 123/139 records (sensitivity: 88 percent) with a NNR of 383.

Conclusions: We have developed and validated a search filter (FSF1) to identify studies reporting HSUVs with high sensitivity (95 percent) and two other search filters (FSF2 and FSF3) with reasonably high sensitivity (92 percent and 88 percent) but greater precision, resulting in a lower NNR. These seem to be the first validated filters available for HSUVs. The availability of filters with a range of sensitivity and precision options enables researchers to choose the filter which is most appropriate to the resources available for their specific research.

Objectives: Our study addresses the important issue of estimating treatment costs from historical data. It is a problem frequently faced by health technology assessment analysts. We compared four approaches used to estimate current costs when good quality contemporary data are not available using liver transplantation as an example.

Methods: First, the total cost estimates extracted for patients from a cohort study, conducted in the 1990s, were inflated using a published inflation multiplier. Second, resource use estimates from the cohort study were extracted for hepatitis C patients and updated using current unit costs. Third, expert elicitation was carried out to identify changes in clinical practice over time and quantify current resource use. Fourth, routine data on resource use were obtained from National Health Service Blood and Transplant (NHSBT).

Results: The first two methods did not account for changes in clinical practice. Also the first was not specific to hepatitis patients. The use of experts confirmed significant changes in clinical practice. However, the quantification of resource use using experts is challenging as clinical specialists may not have a complete overview of clinical pathway. The NHSBT data are the most accurate reflection of transplantation and posttransplantation phase; however, data were not available for the whole pathway of care. The best estimate of total cost, combining NHSBT data and expert elicitation, is £121,211.

Discussion: Observational data from routine care are potentially the most reliable reflection of current resource use. Efforts should be made to make such data readily available and accessible to researchers. Expert elicitation provided reasonable estimates.

Objectives: Multicomponent interventions (MCIs), consisting of at least two interventions, are common in rehabilitation and other healthcare fields. When the effectiveness of the MCI versus that of its single interventions is comparable or unknown, evidence of their expected incremental cost-effectiveness can be helpful in deciding which intervention to recommend. As such evidence often is unavailable this study proposes an approach to estimate what is more cost-effective; the MCI or the single intervention(s).

Methods: We reviewed the literature for potential methods. Of those identified, headroom analysis was selected as the most suitable basis for developing the approach, based on the criteria of being able to estimate the cost-effectiveness of the single interventions versus that of the MCI (a) within a limited time frame, (b) in the absence of full data, and (c) taking into account carry-over and interaction effects. We illustrated the approach with an MCI for cancer survivors.

Results: The approach starts with analyzing the costs of the MCI. Given a specific willingness-to-pay-value, it is analyzed how much effectiveness the MCI would need to generate to be considered cost-effective, and if this is likely to be attained. Finally, the cost-effectiveness of the single interventions relative to the potential of the MCI for being cost-effective can be compared.

Conclusions: A systematic approach using headroom analysis was developed for estimating whether an MCI is likely to be more cost effective than one (or more) of its single interventions.

Objectives: The study aims to develop an understanding of the views of children and adolescents, parents, and professionals on upper limb prosthetic devices to develop and improve device design. Previous research has found that children are dissatisfied with prostheses but has relied heavily on parent proxy reports and quantitative measures (such as questionnaires) to explore their views.

Methods: Thirty-four participants (eight children aged 8–15 years with upper limb difference, nine parents, eight prosthetists, and nine occupational therapists) contributed to the development of new devices through the BRIDGE methodology of participatory design, using focus groups and interviews.

Results: The study identified areas for improving prostheses from the perspective of children and adolescents, developed prototypes based on these and gained feedback on the prototypes from the children and other stakeholders (parents and professionals) of paediatric upper limb prostheses. Future device development needs to focus on ease of use, versatility, appearance, and safety.

Conclusions: This study has demonstrated that children and adolescents can and should be involved as equal partners in the development of daily living equipment and that rapid prototyping (three-dimensional printing or additive manufacturing), used within a participatory design framework, can be a useful tool for facilitating this.

Objectives: The methodological quality of an economic evaluation performed alongside a clinical trial can be underestimated if the paper does not report key methodological features. This study discusses methodological assessment issues on the example of a systematic review on cost-effectiveness of physiotherapy for knee osteoarthritis.

Methods: Six economic evaluation studies included in the systematic review and related clinical trials were assessed using the 10-question check-list by Drummond and the Physiotherapy Evidence Database (PEDro) scale.

Results: All economic evaluations were performed alongside a clinical trial but the studied interventions were too heterogeneous to be synthesized. Methodological quality of the economic evaluations reported in the papers was not free of drawbacks, and in some cases, it improved when information from the related clinical trial was taken into account.

Conclusions: Economic evaluation papers dedicate little space to methodological features of related clinical trials; therefore, the methodological quality can be underestimated if evaluated separately from the trials. Future economic evaluations should follow more strictly the recommendations about methodology and the authors should pay special attention to the quality of reporting.

Objectives: Exoskeletons are electromechanical devices that are worn by a human operator to increase their physical performance. Several exoskeletons have been developed to restore functional movements, such as walking, for those with paralysis due to neurological impairment. However, existing exoskeletons have limitations with respect to affordability, size, weight, speed, and efficiency, which may reduce their functional application. Therefore, the aim of this scoping review is to collect and narratively synthesize the perspectives of users of exoskeleton technology.

Methods: A systematic literature search was conducted across several healthcare related online databases.

Results: A total of 4,619 articles were identified, of which 51 were selected for full review. Only three studies were identified that met the inclusion criteria. Of these, one showed an incongruence between users’ expectations and experiences of device use; another reported perspectives on potential rather than actual device use, ranking design features in order of perceived importance; and the other reported ratings of ease of device use in training.

Conclusions: The heterogeneity of studies included within this review, leave the authors unable to suggest consensus as to user perspectives of exoskeleton technology. However, it is apparent that users are able to suggest priorities for exoskeleton design and that users’ perspectives of exoskeleton technology might change in response to experience of use. The authors, therefore, suggest that exoskeleton design should be an iterative process, whereby user perspectives are sought, incorporated and refined by tangible experience, to ensure that devices developed are acceptable to and usable by the populations they seek to re-enable.

Objectives: The aim of this study was to evaluate whether ostomy industry patent activity (PA) is associated with patient outcomes and healthcare costs.

Methods: Two groups of ostomy pouch users based on manufacturer PA (low or high) were compared in terms of ostomy-related wear patterns, adverse events, and healthcare expenditure. Using Swedish registry data, all patients with newly formed stomas were divided between each group and were followed during a 2-year period (2011–12). Propensity score matching and parametric duration analysis were used to compare outcomes between patients of similar characteristics such as sex, age, and ostomy surgery type.

Results: In both one- and two-piece systems, the high PA group had significantly lower monthly ostomy-related expenditure than the low PA group (one-piece: 197.47 EUR versus 233.34 EUR; two-piece: 164.00 EUR versus 278.98 EUR). Fewer pouch and skin wafer purchases per month were an important driver of cost differences. Both groups had similar likelihood of purchasing dermatological products for skin complications over time.

Conclusions: PA in the ostomy care industry was associated with reduced healthcare costs, but not necessarily with fewer skin complications. It suggests that there is a health economic benefit from products made by patent intensive companies which may differentiate them from generic comparators, but more research is needed to understand the impact of activities conducive to medical innovation on health outcomes.

Objectives: Coverage decisions are decisions by third party payers about whether and how much to pay for technologies or services, and under what conditions. Given their complexity, a systematic and transparent approach is needed. The DECIDE (Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence) Project, a GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group initiative funded by the European Union, has developed GRADE Evidence to Decision (EtD) framework for different types of decisions, including coverage ones.

Methods: We used an iterative approach, including brainstorming to generate ideas, consultation with stakeholders, user testing, and pilot testing of the framework.

Results: The general structure of the EtD includes formulation of the question, an assessment using twelve criteria, and conclusions. Criteria that are relevant for coverage decisions are similar to those for clinical recommendations from a population perspective. Important differences between the two include the decision-making processes, accountability, and the nature of the judgments that need to be made for some criteria. Although cost-effectiveness is a key consideration when making coverage decisions, it may not be the determining factor. Strength of recommendation is not directly linked to the type of coverage decisions, but when there are important uncertainties, it may be possible to cover an intervention for a subgroup, in the context of research, with price negotiation, or with restrictions.

Conclusions: The EtD provides a systematic and transparent approach for making coverage decisions. It helps ensure consideration of key criteria that determine whether a technology or service should be covered and that judgments are informed by the best available evidence.