Utilization and utility of diagnostic imaging : Quantitative studies and normative considerations

Today the practice of most medical disciplines is almost unrecognisable without modern radiology. Imaging technology is fascinating, is developing rapidly, and is without doubt beneficial, but there are also concerns about over-utilization, the risks of harm and the costs involved. The overall aim of this dissertation is to improve our understanding of utilization of radiological services, by investigating aspects of the actual use and as perceived by the radiologist. Further, the aim is to illuminate utility issues based on empirical research. The utilization of imaging was investigated through two quantitative surveys. We collected activity data from all radiology institutions in Norway in order to estimate the frequency of radiological examinations. A questionnaire was mailed to Norwegian radiologists to obtain information about their perceptions, actions and reasoning regarding utilization of imaging. We found a significant increase in utilization of diagnostic imaging, especially MRI and CT examinations, leading to a relatively high increase in the collective effective dose. We found that geographical variation in examination frequency was highest for these newer technologies. Accessibility is a likely explanation for both the increase in utilization over time and the geographical variation. According to the radiologists, the major causes of increasing utilization were related to ‘supply and demand’ mechanisms, like expanded technological and medical possibilities, availability of services, and the demands of people and referring clinicians for assurance. They consider over-utilization to comfort patients and clinicians to be the main cause of unnecessary examinations, followed by insufficient referral information. Almost all radiologists reported that they frequently took action in response to inadequate referrals, mainly by contacting the clinician and by checking the medical records. Such actions were primarily motivated by patient safety considerations (risk of complications, radiation dose and low patient age), while somewhat hindered by respect for the judgment of the referrer, the wishes of the patient and practical obstacles. The empirical findings indicate benefits of increasing utilization of imaging in the shape of improved health outcome, reduced pain and lower costs, but also lack of such benefits and possible harm. The overall usefulness of increased utilization can be considered to be limited from a utilitarian perspective. Norms and measures to manage utilization of imaging initiated by the professionals are those that should have the highest potential for increasing the utility of services. Key elements of such measures should be clinical guidelines, giving radiologists more discretionary power, and critical assessment of referrals

Q-SEA - a tool for quality assessment of ethics analyses conducted as part of health technology assessments

Introduction: Assessment of ethics issues is an important part of health technology assessments (HTA). However, in terms of existence of quality assessment tools, ethics for HTA is methodologically under-developed in comparison to other areas of HTA, such as clinical or cost effectiveness.Objective: To methodologically advance ethics for HTA by: (1) proposing and elaborating Q-SEA, the first instrument for quality assessment of ethics analyses, and (2) applying Q-SEA to a sample systematic review of ethics for HTA, in order to illustrate and facilitate its use. Methods: To develop a list of items for the Q-SEA instrument, we sys-tematically reviewed the literature on methodology in ethics for HTA, reviewed HTA organizations’ websites, and solicited views from 32 ex-perts in the field of ethics for HTA at two 2-day workshops. We sub-sequently refined Q-SEA through its application to an ethics analysis conducted for HTA.Results: Q-SEA instrument consists of two domains – the process do-main and the output domain. The process domain consists of 5 ele-ments: research question, literature search, inclusion/exclusion criteria, perspective, and ethics framework. The output domain consists of 5 elements: completeness, bias, implications, conceptual clarification, and conflicting values.Conclusion: Q-SEA is the first instrument for quality assessment of ethics analyses in HTA. Further refinements to the instrument to enhance its usability continue

Development and conduction of an active re-implementation of the Norwegian musculoskeletal guidelines

Abstract Objective Significant geographical variations in the use of diagnostic imaging have been demonstrated in Norway and elsewhere. Non-traumatic musculoskeletal conditions is one area where this has been demonstrated. A national musculoskeletal guideline was implemented in response by online publishing and postal dissemination in Norway in 2014 by national policy makers. The objective of our study was to develop and conduct an intervention as an active re-implementation of this guideline in one Norwegian county to investigate and facilitate guideline adherence. The development and implementation process is reported here, to facilitate understanding of the future evaluation results of this study. Results The consolidated framework for implementation research guided the intervention development and implementation. The implementation development was also based on earlier reported success factors in combination with interviews with general practitioners and radiologists regarding facilitators and barriers to guideline adherence. A combined implementation strategy was developed, including educational meetings, shortening of the guideline and easier access. All the aspects of the implementation strategy were adapted towards general practitioners, radiological personnel and the Norwegian Labor and Welfare Administration. Sixteen educational meetings were held, and six educational videos were made for those unable to attend, or where meetings could not be held.publishedVersio

Comprehensive assessment of complex technologies: integrating various aspects in health technology assessment

Objectives: Despite recent development of health technology assessment (HTA) methods, there are still methodological gaps for the assessment of complex health technologies. The INTEGRATE-HTA guidance for effectiveness, economic, ethical, socio-cultural, and legal aspects, deals with challenges when assessing complex technologies, such as heterogeneous study designs, multiple stakeholder perspectives, and unpredictable outcomes. The objective of this article is to outline this guidance and describe the added value of integrating these assessment aspects. Methods: Different methods were used to develop the various parts of the guidance, but all draw on existing, published knowledge and were supported by stakeholder involvement. The guidance was modified after application in a case study and in response to feedback from internal and external reviewers. Results: The guidance consists of five parts, addressing five core aspects of HTA, all presenting stepwise approaches based on the assessment of complexity, context, and stakeholder involvement. The guidance on effectiveness, health economics and ethics aspects focus on helping users choose appropriate, or further develop, existing methods. The recommendations are based on existing methods’ applicability for dealing with problems arising with complex interventions. The guidance offers new frameworks to identify socio-cultural and legal issues, along with overviews of relevant methods and sources. Conclusions: The INTEGRATE-HTA guidance outlines a wide range of methods and facilitates appropriate choices among them. The guidance enables understanding of how complexity matters for HTA and brings together assessments from disciplines, such as epidemiology, economics, ethics, law, and social theory. This indicates relevance for a broad range of technologies

Impact on radiological practice of active guideline implementation of Musculoskeletal guideline, as measured over a 12-month period

Background An ever-increasing technological development in the field of radiology urges a need for guidelines to provide predictable and just health services. A musculoskeletal guideline was developed in Norway in 2014, without active implementation. Purpose To investigate the impact of active guideline implementation on the use of musculoskeletal diagnostic imaging most frequently encountered in general practice (pain in the neck, shoulders, lower back, and knees). Material and Methods The total number of outpatient radiological examinations across modalities registered at the Norwegian Health Economics Administration between January 2013 and February 2019 was assessed using an interrupted time series design. Results A 12% reduction in the total examination of Magnetic Resonance Imaging shoulder and knee, and x-ray lower back and shoulder was found at a significant level (p = 0.05). Stratified analysis (Magnetic Resonance Imaging examination as one group and x-ray examinations as the other) showed that this reduction mainly was due to the reduction in the use of Magnetic Resonance Imaging examinations (shoulder and knee) which was reduced by 24% at a significant level (p = 0.002), while x-ray examinations had no significant level change (p = 0.71). No other statistically significant changes were found. Conclusion The impact of the implementation on the use of imaging of the neck, shoulder, lower back, and knee is uncertain. Significant reductions were demonstrated in the use of some examinations in the intervention county, but similar effects were not seen when including a control group in the analysis. This indicates a diffusion of the implementation, or other interventions or events that affected both counties and occurred in the intervention period.publishedVersio

Ethical analysis in HTA of complex health interventions

Background: In the field of health technology assessment (HTA), there are several approaches that can be used for ethical analysis. However, there is a scarcity of literature that critically evaluates and compares the strength and weaknesses of these approaches when they are applied in practice. In this paper, we analyse the applicability of some selected approaches for addressing ethical issues in HTA in the field of complex health interventions. Complex health interventions have been the focus of methodological attention in HTA. However, the potential methodological challenges for ethical analysis are as yet unknown. Methods: Six of the most frequently described and applied ethical approaches in HTA were critically assessed against a set of five characteristics of complex health interventions: multiple and changing perspectives, indeterminate phenomena, uncertain causality, unpredictable outcomes, and ethical complexity. The assessments are based on literature and the authors’ experiences of developing, applying and assessing the approaches. Results: The Interactive, participatory HTA approach is by its nature and flexibility, applicable across most complexity characteristics. Wide Reflective Equilibrium is also flexible and its openness to different perspectives makes it better suited for complex health interventions than more rigid conventional approaches, such as Principlism and Casuistry. Approaches developed for HTA purposes are fairly applicable for complex health interventions, which one could expect because they include various ethical perspectives, such as the HTA Core Model® and the Socratic approach. Conclusion: This study shows how the applicability for addressing ethical issues in HTA of complex health interventions differs between the selected ethical approaches. Knowledge about these differences may be helpful when choosing and applying an approach for ethical analyses in HTA. We believe that the study contributes to increasing awareness and interest of the ethical aspects of complex health interventions in general

Why is it so difficult to integrate ethics in Health Technology Assessment (HTA)? The epistemological viewpoint

Ethics has been identified as a key element in Health Technology Assessment (HTA) since its conception. However, ethical issues are still not frequently addressed explicitly in HTA. Several valuable reasons have been identified. The basis of the article is the claim that ethics is often not part of HTA for “epistemological reasons”. Hence, the main aim of the contribution is to explore in more details and emphasize them by using the fact/value dichotomy. Our conclusion is that current HTA configuration is dominantly based on the comparison among objective and empirically testable “facts”, whilst ethics is not empirically testable. In this sense, there is a sort of “epistemological gap”, which can explain why it is so difficult to integrate ethics in HTA. We suggest that the epistemological differences among the various domains of HTA are addressed more explicitly

Stakeholder involvement throughout health technology assessment: an example from palliative care

Objectives: Internationally, funders require stakeholder involvement throughout health technology assessment (HTA). We report successes, challenges, and lessons learned from extensive stakeholder involvement throughout a palliative care case study that demonstrates new concepts and methods for HTA. Methods: A 5-step “INTEGRATE-HTA Model” developed within the INTEGRATE-HTA project guided the case study. Using convenience or purposive sampling or directly / indirectly identifying and approaching individuals / groups, stakeholders participated in qualitative research or consultation meetings. During scoping, 132 stakeholders, aged ≥ 18 years in seven countries (England, Italy, Germany, The Netherlands, Norway, Lithuania, and Poland), highlighted key issues in palliative care that assisted identification of the intervention and comparator. Subsequently stakeholders in four countries participated in face–face, telephone and / or video Skype meetings to inform evidence collection and / or review assessment results. An applicability assessment to identify contextual and implementation barriers and enablers for the case study findings involved twelve professionals in the three countries. Finally, thirteen stakeholders participated in a mock decision-making meeting in England. Results: Views about the best methods of stakeholder involvement vary internationally. Stakeholders make valuable contributions in all stages of HTA; assisting decision making about interventions, comparators, research questions; providing evidence and insights into findings, gap analyses and applicability assessments. Key challenges exist regarding inclusivity, time, and resource use. Conclusion: Stakeholder involvement is feasible and worthwhile throughout HTA, sometimes providing unique insights. Various methods can be used to include stakeholders, although challenges exist. Recognition of stakeholder expertise and further guidance about stakeholder consultation methods is needed

Lay and professional stakeholder involvement in scoping palliative care issues: Methods used in seven European countries

BACKGROUND: Stakeholders are people with an interest in a topic. Internationally, stakeholder involvement in palliative care research and health technology assessment requires development. Stakeholder involvement adds value throughout research (from prioritising topics to disseminating findings). Philosophies and understandings about the best ways to involve stakeholders in research differ internationally. Stakeholder involvement took place in seven countries (England, Germany, Italy, Lithuania, the Netherlands, Norway and Poland). Findings informed a project that developed concepts and methods for health technology assessment and applied these to evaluate models of palliative care service delivery. AIMS: To report on stakeholder involvement in the INTEGRATE-HTA project and how issues identified informed project development. DESIGN: Using stakeholder consultation or a qualitative research design, as appropriate locally, stakeholders in seven countries acted as 'advisors' to aid researchers' decision making. Thematic analysis was used to identify key issues across countries. SETTING/PARTICIPANTS: A total of 132 stakeholders (82 professionals and 50 'lay' people) aged ⩾18 participated in individual face-to-face or telephone interviews, consultation meetings or focus groups. RESULTS: Different stakeholder involvement methods were used successfully to identify key issues in palliative care. A total of 23 issues common to three or more countries informed decisions about the intervention and comparator of interest, sub questions and specific assessments within the health technology assessment. CONCLUSION: Stakeholders, including patients and families undergoing palliative care, can inform project decision making using various involvement methods according to the local context. Researchers should consider local understandings about stakeholder involvement as views of appropriate and feasible methods vary. Methods for stakeholder involvement, especially consultation, need further development

Integrated assessment of home based palliative care with and without reinforced caregiver support: ‘A demonstration of INTEGRATE-HTA methodological guidances’

About this Executive Summary This comprehensive executive summary reports on a case study designed to demonstrate the application of a number of the key concepts and methods developed in the INTEGRATE-HTA project to the assessment of complex technologies. The case study focuses on models of home based palliative care with and without an additional element of caregiver support, known as reinforced and non-reinforced home based palliative care respectively. What is already known about the topic With changing disease patterns in Europe, increasingly complex health care technologies, such as palliative care, have gained importance. Current HTA methods rarely take account of wider legal, ethical and socio-cultural issues or context and implementation and are not adequately equipped to assess highly complex technologies, despite considerable progress in recent years. As a result, HTA is rarely applied to highly complex health technologies. What this case study report adds The INTEGRATE-HTA project developed concepts and methods for the assessment of complex technologies, taking into account legal, ethical and socio-cultural issues as well as context and implementation. This case study is designed to demonstrate the application of a number of the key concepts and methods developed in the INTEGRATE-HTA project to home based palliative care, with and without an additional element of caregiver support, as an example of a complex technology; known as “reinforced” and “non-reinforced” home based palliative care respectively. The INTEGRATE-HTA model, developed to enable integration of relevant assessment aspects, is used to structure this report. The case study reports on the application of some of the concepts and methods developed within the INTEGRATE-HTA project to the assessment of effectiveness as well as economic, sociocultural, ethical, and legal aspects; patient preferences and patient-specific moderators of treatment and context and implementation issues related to reinforced and non-reinforced home based palliative care. The highly complex nature of reinforced and non-reinforced home based palliative care is illustrated through an assessment of complexity characteristics. | 4 The case study also involved extensive lay and professional stakeholder involvement, using a variety of methods, to inform the HTA process at key stages throughout the project. Key messages are highlighted for both HTA research and for palliative care. The implications for research and practice The concepts and methods developed in the INTEGRATE-HTA project have been shown to be feasible and to have the potential to offer added value, but require further development and application in the assessment of other complex technologies. Reinforced and non-reinforced models palliative care are highly complex. The case study findings offer some insights into their effectiveness as well as economic, sociocultural, ethical, and legal issues; patient preferences and patient-specific moderators of treatment as well as context and implementation issues