Kristin Bakke Lysdahl

Making sense of complexity in context and implementation: the Context and Implementation of Complex Interventions (CICI) framework

BackgroundThe effectiveness of complex interventions, as well as their success in reaching relevant populations, is critically influenced by their implementation in a given context. Current conceptual frameworks often fail to address context and implementation in an integrated way and, where addressed, they tend to focus on organisational context and are mostly concerned with specific health fields. Our objective was to develop a framework to facilitate the structured and comprehensive conceptualisation and assessment of context and implementation of complex interventions.MethodsThe Context and Implementation of Complex Interventions (CICI) framework was developed in an iterative manner and underwent extensive application. An initial framework based on a scoping review was tested in rapid assessments, revealing inconsistencies with respect to the underlying concepts. Thus, pragmatic utility concept analysis was undertaken to advance the concepts of context and implementation. Based on these findings, the framework was revised and applied in several systematic reviews, one health technology assessment (HTA) and one applicability assessment of very different complex interventions. Lessons learnt from these applications and from peer review were incorporated, resulting in the CICI framework.ResultsThe CICI framework comprises three dimensions—context, implementation and setting—which interact with one another and with the intervention dimension. Context comprises seven domains (i.e., geographical, epidemiological, socio-cultural, socio-economic, ethical, legal, political); implementation consists of five domains (i.e., implementation theory, process, strategies, agents and outcomes); setting refers to the specific physical location, in which the intervention is put into practise. The intervention and the way it is implemented in a given setting and context can occur on a micro, meso and macro level. Tools to operationalise the framework comprise a checklist, data extraction tools for qualitative and quantitative reviews and a consultation guide for applicability assessments.ConclusionsThe CICI framework addresses and graphically presents context, implementation and setting in an integrated way. It aims at simplifying and structuring complexity in order to advance our understanding of whether and how interventions work. The framework can be applied in systematic reviews and HTA as well as primary research and facilitate communication among teams of researchers and with various stakeholders.

Moral principles and medical practice: the role of patient autonomy in the extensive use of radiological services.

There has been a significant increase in the use of radiological services in the past 30 years. There are many reasons for this, but one has received little attention: the increased role of patient autonomy in healthcare. Patients demand x rays, CT scans, MRI, and positron emission tomography scans. The key question in this article is how a moral principle, such as respect for patient autonomy, can influence the extension of radiological services. A literature review reveals how patient autonomy is acknowledged in radiology, and how it is used both to explain and to justify the increase in radiological examinations. Furthermore, it also shows how the premises favouring patients’ exercise of their autonomy are not always present, which makes patient autonomy subject to adverse side effects and even abuse. Patient autonomy can be used to reduce the professionals’ responsibility for radiological examinations (by avoiding complaints and lawsuits), to increase the popularity of the profession (by giving the people what they want), to increase the income of the professionals or their institutions, and to promote professional activity. Patient autonomy intended to reduce paternalism, to legitimise otherwise morally unjustifiable actions (such as exposure to radiation), and to protect patients, can easily be used as a moral means for opposite ends. These adverse effects are not peculiar to radiology. However, they emerge particularly clearly in explanations and justifications of the substantial increase in radiological services, as well as in debates on overuse of radiological services.

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.

Ethical analysis in HTA of complex health interventions

BackgroundIn 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.MethodsSix 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.ResultsThe 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.ConclusionThis 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.

Radiologists’ responses to inadequate referrals

ObjectivesTo investigate radiologists’ responses to inadequate imaging referrals.MethodsA survey was mailed to Norwegian radiologists; 69% responded. They graded the frequencies of actions related to referrals with ambiguous indications or inappropriate examination choices and the contribution of factors preventing and not preventing an examination of doubtful usefulness from being performed as requested.ResultsNinety-five percent (344/361) reported daily or weekly actions related to inadequate referrals. Actions differed among subspecialties. The most frequent were contacting the referrer to clarify the clinical problem and checking test results/information in the medical records. Both actions were more frequent among registrars than specialists and among hospital radiologists than institute radiologists. Institute radiologists were more likely to ask the patient for additional information and to examine the patient clinically. Factors rated as contributing most to prevent doubtful examinations were high risk of serious complications/side effects, high radiation dose and low patient age. Factors facilitating doubtful examinations included respect for the referrer’s judgment, patient/next-of-kin wants the examination, patient has arrived, unreachable referrer, and time pressure.ConclusionsIn summary, radiologists facing inadequate referrals considered patient safety and sought more information. Vetting referrals on arrival, easier access to referring clinicians, and time for radiologists to handle inadequate referrals may contribute to improved use of imaging.

Complex health care interventions: Characteristics relevant for ethical analysis in health technology assessment

Complexity entails methodological challenges in assessing health care interventions. In order to address these challenges, a series of characteristics of complexity have been identified in the Health Technology Assessment (HTA) literature. These characteristics are primarily identified and developed to facilitate effectiveness, safety, and cost-effectiveness analysis. However, ethics is also a constitutive part of HTA, and it is not given that the conceptions of complexity that appears relevant for effectiveness, safety, and cost-effectiveness analysis are also relevant and directly applicable for ethical analysis in HTA. The objective of this article is therefore to identify and elaborate a set of key characteristics of complex health care interventions relevant for addressing ethical aspects in HTA. We start by investigating the relevance of the characteristics of complex interventions, as defined in the HTA literature. Most aspects of complexity found to be important when assessing effectiveness, safety, and efficiency turn out also to be relevant when assessing ethical issues of a given health technology. However, the importance and relevance of the complexity characteristics may differ when addressing ethical issues rather than effectiveness. Moreover, the moral challenges of a health care intervention may themselves contribute to the complexity. After identifying and analysing existing conceptions of complexity, we synthesise a set of five key characteristics of complexity for addressing ethical aspects in HTA: 1) multiple and changing perspectives, 2) indeterminate phenomena, 3) uncertain causality, 4) unpredictable outcome, and 5) ethical complexity. This may serve as an analytic tool in addressing ethical issues in HTA of complex interventions.

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 underdeveloped 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 systematically reviewed the literature on methodology in ethics for HTA, reviewed HTA organizations’ websites, and solicited views from 32 experts in the field of ethics for HTA at two 2-day workshops. We subsequently refined Q-SEA through its application to an ethics analysis conducted for HTA. Results: Q-SEA instrument consists of two domains – the process domain and the output domain. The process domain consists of 5 elements: 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.

Evaluation of ethical aspects in health technology assessment: more methods than applications?

Health technology assessment (HTA) emerged with the increased need for systematical evaluation of health technologies in the 1970s. From its very beginning, ethics was a constitutive part of HTA, and over the years a wide range of approaches have been suggested to address ethical aspects of health technologies. Despite a vast variety of methodologies in ethics, there is no consensus about the appropriateness of the existing methods. Moreover, while the available methods are many, their applications are few. While methods for addressing ethical issues in HTA have been richly reviewed, their applications are poorly tracked. Hence, a bottom up approach, that is, from practice to theory, may turn out to be as helpful as a top-down review. We need a review of the examples of ethics in HTA so we better can learn how the methods are used in practice, analyze the role of context, and better can assess the merits of the various methods.

Managers' experience of success criteria and barriers to implementing mobile radiography services in nursing homes in Norway: A qualitative study

BackgroundIn order to meet the future challenges posed by ageing populations, new technology, telemedicine and a more personalized healthcare system are needed. Earlier research has shown mobile radiography services to be highly beneficial for nursing home residents in addition to being cost-effective. Despite the benefits, mobile radiography services are uncommon in Europe and Norway. The purpose of this study was to explore success criteria and barriers in the process of implementing mobile radiography services, from the point of view of the hospital and municipal managers.MethodsEleven semi-structured interviews were conducted with managers from five hospitals and six municipalities in Norway where mobile radiography services had been implemented. Core issues in the interview guide were barriers and facilitators in the different phases of implementation. The framework method for thematic analysis was used for analysing the data inductively in a research team.ResultsFive main categories were developed through the success criteria and barriers experienced by the participants: national health policy, regional and municipal policy and conditions, inter-organizational implementation projects, experienced outcome, and professional skills and personal characteristics. The categories were allocated into three higher-order classifications: macro, meso and micro levels. The main barriers experienced by the managers were financial, procedural and structural. In particular, the reimbursement system, lack of management across healthcare levels and the lack of compatible information systems acted as barriers. The main facilitators were external funding, enthusiastic individuals in the organizations and good collaboration between hospitals and municipalities.ConclusionsThe managers experienced financial, structural and procedural barriers. The main success criteria in the process were external funding, and the support and engagement from the individuals in the organizations. This commitment was mainly facilitated by the intuitive appeal of mobile radiography. Changes in healthcare management and in the financial system might facilitate services across healthcare levels. In addition, compatible information systems across healthcare levels are needed in order to facilitate the use of new technology and mobile services.