Complex Intervention Research Research Articles

5.A. Scientific session: From theory to action - Applying the Medical Research Council framework on complex interventions

Abstract The reasons for the workshop: Globally, public health problems such as obesity, poor mental health, and social inequality in health are on the rise. Tackling these significant challenges requires well-designed complex interventions. Interventions rarely follow linear sequences from intervention design toward large-scale implementation. Rather, they take non-linear trajectories by constantly adapting the intervention design according to the context. This thinking is outlined in the British Medical Research Council’s (MRC) 2021 framework for developing and evaluating complex interventions. This workshop encompasses four case projects, each corresponding to one of the four phases in the framework: i) development, ii) feasibility, iii) implementation, and iv) evaluation. However, recognising the deliberately generic nature of this framework, our workshop also encompasses co-creation, process evaluation, and implementation theories and methodology. Combining these methodologies presents challenges that necessitate clear argumentation and critical reflection. In this workshop, we will share the challenges encountered when applying the MRC 2021 framework and hopefully inspire future innovative opportunities in intervention research. Specifically, this workshop aims to: i) exchange challenges from intervention research methods and theories drawing on presenters’ experiences across four public health case projects. Presenters will critically reflect on the key concepts from the MRC framework including context, programme theory, engagement of stakeholders, uncertainties, and refinement of interventions. ii) discuss opportunities for future complex intervention research and outline best practices for using the MRC 2021 framework for complex interventions. The added value of organising the workshop: The audience attending this workshop will reflect on multiple on-the-ground experiences of applying methodology and principles from the MRC 2021 framework as well as methods and theories relevant to intervention research: co-creation, qualitative (e.g., ethnography, interviews) and quantitative (e.g. experimental, observational) methods applied to all core phases of complex interventions. At the end of the workshop, the audience will be invited to participate in an open, plenary discussion facilitated by the workshop’s chairs: two international experts on complex interventions, Reader Rhiannon Evans and Prof. Helle Terkildsen Maindal. The experts will encourage the presenters and audience to reflect critically on the case projects and ways forward for complex intervention research. Coherence between the presentations in relation to the workshop topic: The four case projects are guided by the MRC 2021 framework for complex interventions and involve public health interventions at the individual, interpersonal, and structural levels in Denmark and Canada. Key messages • Tackling public health challenges demands innovative and well-designed complex interventions combining research traditions, principles from health promotion, and cutting-edge best-practice frameworks. • The symposium will create a platform for cross-disciplinary knowledge exchange through case projects and expert-led joint discussions on how to apply the MRC 2021 framework for complex interventions.

Designing studies and reviews to produce informative, trustworthy evidence about complex interventions in rehabilitation: a narrative review and commentary.

According to Cochrane Rehabilitation's recently published definition for research purposes, rehabilitation is inherently complex. Rehabilitation teams frequently implement multiple strategies concurrently, draw on input from a range of different health professionals, target multiple outcomes, and personalize therapeutic plans. The success of rehabilitation lies not only in the specific therapies employed, but also in how they are delivered, when they are delivered, and the capability and willingness of patients to engage in them. In 2021, the UK Medical Research Council (MRC) and the National Institute of Health Research (NIHR) released the second major update of its framework for developing and evaluating complex interventions. This framework has direct relevance to the development and implementation of evidence-based practice in the field of rehabilitation. While previous iterations of this framework positioned complex interventions as anything that involved multiple components, multiple people, multiple settings, multiple targets of effect, and behavior change, this latest framework expanded on this concept of complexity to also include the characteristics and influence of the context in which interventions occur. The revised MRC-NIHR framework presents complex intervention research as comprising the following four inter-related and overlapping phases: 1) development or identification of the intervention; 2) feasibility; 3) evaluation; and 4) implementation, with different methods and tools required to address each of these phases. This paper provides an overview of the MRC-NIHR framework and its application to rehabilitation, with examples from past research. Rehabilitation researchers are encouraged to learn about the MRC-NIHR framework and its application. Funders of rehabilitation research are also encouraged to place greater emphasis on supporting studies that involve the right design to address key uncertainties in rehabilitation clinical practice. This will require investment into a broader range of types of research than simply individual-level randomized controlled trials. Rehabilitation research can both learn from and contribute to future iterations of the MRC-NIHR framework as it is an excellent environment for exploring complexity in clinical practice.

Interprofessional follow-up for people at risk of type 2 diabetes in primary healthcare – a randomized controlled trial with embedded qualitative interviews

Objective To examine the effects of an empowerment-based interprofessional lifestyle intervention program among people at risk of type 2 diabetes on knowledge, skills, and confidence in self-management, health, psychological well-being, and lifestyle characteristics, and to explore the participants’ perceptions of participating in the intervention. Design and methods In line with the Medical Research Council complex interventions research methods framework, we conducted a randomized controlled trial with embedded qualitative interviews in primary healthcare clinics in Norway between 2019–2021. Of the patients at risk (The Finnish Diabetes Risk Score Calculator (FINDRISC) ≥15 or Body Mass Index (BMI) ≥30) 142 accepted the invitation, and 14 participants from the intervention group participated in individual interviews after the 12-month follow-up. Our primary outcome was the Patient Activation Measure (PAM-13). Secondary outcomes were EQ-5D-5L, EQ-VAS, WHO-Overall health, WHO-Overall QOL, weight, height, waist circumference, and regularity of physical activity. We used thematic analysis to analyse the qualitative data. Results There was no clinically relevant differences of neither the primary nor the secondary endpoints between intervention and control group. As to the qualitative data, we identified two distinct features: ‘Meaningful perspectives on lifestyle changes’ and ‘Lifestyle change is not a linear process due to challenges faced along the way’ putting ownership of their choices in life into picture. Conclusion The negative results of the RCT stand in contrast to the findings given by the participants voices, perceiving the intervention as a key eye opener placing their health challenges in perspective. How to interpret these seemingly conflicting findings of participants being seen, heard, and understood, helping them to take more conscious ownership of their choices in life, and at the same time demonstrating no improvements in symptoms or measures, is a dilemma that needs further exploration. We should be careful to implement interventions that do not demonstrate any effects on the quantitative outcomes.

Recommendations for successful involvement of patient partners in complex intervention research: a collaborative learning process

BackgroundPatient and public involvement in health-related research is a new discipline in Denmark. In 2021, a national conference titled 'Patient and Public Involvement in Complex Intervention Research' provided a forum for discussion between patient partners, researchers and clinicians on involving patients as partners in complex intervention research.MethodsWe aimed to describe specific challenges to and initiatives for patient partner involvement in order to develop recommendations for creating successful partnerships in complex intervention research. Through a collaborative learning process, 140 researchers identified the most important challenges for them in patient partner involvement and potential initiatives to improve such involvement. At a subsequent workshop, four patient partners identified the challenges and initiatives from their perspective as patient partners. They also gave feedback on the challenges and initiatives suggested by the researchers and helped shape three recommendations for practice. Three of the patient partners were involved in writing this paper.ResultsThe five most important challenges identified by researchers were time, recruitment, ethics, power and inequality. Between four and seven initiatives to overcome these challenges were suggested. The three most important challenges identified by patient partners were communication, when you get information that is hard to handle and recruitment. They suggested three to four initiatives for improvement. Patient partners confirmed the importance of all the researcher identified challenges when presented with them, they also provided additional comments on the researchers’ initiatives. This led to the formation of recommendations for involving patient partners.ConclusionsA collaborative learning process was shown to be a suitable method for patient partner involvement. Consistency was seen between the challenges and initiatives identified by researchers and patient partners. Based on these observations, three recommendations were developed: (1) create specific programmes that aim to involve all kind of patients (including but limited to vulnerable patients) as patient partners, (2) produce ethical guidelines for the involvement of patient partners, and (3) develop a national strategy for patient partner involvement. To build on these recommendations, a joint workshop with both researchers and patient partners is needed.

O.2.1-2 How do social prescribing interventions for physical activity work from a complex intervention research perspective: a narrative review on mechanisms of change

Abstract Purpose Social prescribing (SP) interventions for physical activity (PA) remain to reveal consistent findings on health outcomes, partly because suboptimal research methods have been applied. The purpose of this study was to synthesise the behaviour-related mechanisms and socio-economic considerations of SP interventions for PA based on a narrative literature review. The synthesis was then used to develop a logic model inspired by the methodology from complex intervention research, illustrating how these interventions may improve health outcomes. Methods A narrative review was performed using Medline, Embase and PsycINFO to identify scientific literature on SP interventions for PA. The literature search was executed on February 20-21, 2023. Inclusion criteria were; studies investigating person-centred mechanisms and/or system-based mechanisms. Any population was eligible, and no source restrictions were applied. Findings were synthesised and illustrated in a comprehensive logic model on SP interventions for PA. Results A total of 340 studies were identified from the electronic literature search, and 11 studies met the inclusion criteria. Person-centred mechanisms for successful SP intervention were identified as: (1) Integrating medical and social needs in the referral process; (2) Trusted and informed relationships in the linking process; and (3) Meaningful relationships in a non-stigmatising setting in the engagement process. System-based mechanisms for successful SP intervention were identified as the need to fully integrate the SP interventions in the General Practice and community organisations. In addition, successful SP intervention was, among other findings, explained through emotional buy-in from all SP agents and clients. Conclusion The present study display mechanisms of SP interventions for PA, suggesting that they should include socio-economic considerations and preferably system thinking. We also urge for more complex intervention thinking in developing and evaluating SP interventions for PA to clarify the mechanisms of what works for whom and under which circumstances. Support/Funding Source No funding source was applied for this study.

Person-attuned musical interactions (PAMI) in dementia care. Complex intervention research for constructing a training manual.

Music is of vital importance for cognition, human care, and the formation of social communities throughout life. Dementia is a neurocognitive disorder that affects cognitive domains, and in late-stage dementia, care is needed in all aspects of daily living. Within residential care home contexts, carers play a significant role for the "caring culture" but often lack professional training in verbal and non-verbal communication skills. Thus, there is a need for training carers to respond to the multidimensional needs of persons with dementia. Music therapists use musical interactions but are not trained to train carers. Therefore, our aim was to explore person-attuned musical interactions (PAMI), and additionally, to develop and evaluate a training manual to be used by music therapists when supporting and training carers in non-verbal communication with persons with late-stage dementia in residential care home contexts. With a realist perspective and systems thinking and within the framework for complex intervention research, the research group integrated several overlapping subprojects by applying a non-linear and iterative research process. Core elements related to person-centered dementia care as well as learning objectives were considered through the following four phases; Developing, Feasibility, Evaluation, and Implementation. The result was a training manual for qualified music therapists to use when teaching and collaborating with carers about how to implement PAMI in dementia care. The manual included comprehensive resources, a clear structure for training, defined learning objectives, and integration of theory. With increased knowledge about caring values and non-verbal communication, residential care home cultures may develop carer competencies and provide professional attuned care for persons with dementia. Further piloting and testing to examine the general effect on caring cultures is needed.

Contextual factors influencing complex intervention research processes in care homes: a systematic review and framework synthesis.

BackgroundCare homes are complex settings to undertake intervention research. Barriers to research implementation processes can threaten studies’ validity, reducing the value to residents, staff, researchers and funders. We aimed to (i) identify and categorise contextual factors that may mediate outcomes of complex intervention studies in care homes and (ii) provide recommendations to minimise the risk of expensive research implementation failures.MethodsWe conducted a systematic review using a framework synthesis approach viewed through a complex adaptive systems lens. We searched: MEDLINE, Embase, CINAHL, ASSIA databases and grey literature. We sought process evaluations of care home complex interventions published in English. Narrative data were indexed under 28 context domains. We performed an inductive thematic analysis across the context domains.ResultsWe included 33 process evaluations conducted in high-income countries, published between 2005 and 2019. Framework synthesis identified barriers to implementation that were more common at the task and organisational level. Inductive thematic analysis identified (i) avoiding procedural drift and (ii) participatory action and learning as key priorities for research teams. Research team recommendations include advice for protocol design and care home engagement. Care home team recommendations focus on internal resources and team dynamics. Collaborative recommendations apply to care homes’ individual context and the importance of maintaining positive working relationships.DiscussionResearchers planning and undertaking research with care homes need a sensitive appreciation of the complex care home context. Study implementation is most effective where an intervention is co-produced, with agreed purpose and adequate resources to incorporate within existing routines and care practices.

Introduction to the complex intervention concept and the research perspectives

Abstract Few interventions are truly simple; complexity can arise from various sources, e.g.: Aspects of the intervention itself, such as the number of intervention components, the number of groups targeted, how dynamic the intervention is permitted to be. The context in which the intervention is developed and delivered, such as the social, political, economic, and geographical context. Complex intervention research should be approached with an awareness of these sources of complexity. Systems thinking can be helpful to understanding the dynamic interaction between interventions and their context. This presentation will introduce concepts of complex adaptive systems, e.g. feedback loops, adaptation, emergence, that should be considered when developing and evaluating complex interventions. It will then introduce participants to the research perspectives set out in the new framework: efficacy, effectiveness, theory-based, and systems perspectives. Each perspective is associated with a different type of research question, and therefore appropriate in different circumstances. The presentation will provide information to support participants to consider the research perspective(s) most suited to the research challenge that they are aiming to address. Main messages There are multiple sources of complexity, each of which can affect how the intervention works or contributes to change. Complex intervention research can take an efficacy, effectiveness, theory-based, or systems perspective, the choice of which is based on what is known already and what further evidence would be most useful.

11.A. Skills building seminar: A new framework for developing and evaluating complex interventions

Abstract The new MRC/NIHR Framework for Developing and Evaluating Complex Interventions will be introduced (by the authors) for participants to consider using to support their own complex intervention research. This Framework provides updated recommendations on the key considerations and phases of complex intervention research. Previous versions of the framework have been widely used internationally, but there have been many methodological and theoretical developments since they were published. This workshop will provide an overview of the new framework, with further worked examples. The workshop will include time for questions and discussion and support participants to think about how to approach their own complex intervention research. The workshop will consist of two 20 minute presentations providing information on a different aspect of our new Framework, and this, alongside questions and discussion, will support attendees to: Consider what makes interventions complex and how this complexity could usefully be handled in intervention research. Critically evaluate and contrast the utility and role of different research perspectives. Understand the core elements of complex intervention research. At the end of each presentation, we will pose questions related to our Framework's checklist to the audience for their own consideration. As well as having the chat feature enabled and monitored throughout, we will use interactive software, e.g. mentimeter, to allow engagement beyond the question/answer session. Key messages The workshop will enable participants to apply the new MRC/NIHR framework for developing and evaluating complex interventions to their own research. Interactive sessions will explore the concepts underpinning the new framework and the practicalities of applying it to specific cases.

The new Framework and the Core Elements of complex intervention research

Abstract The new framework will be presented. The main phases of intervention research: development or identification, feasibility, evaluation and implementation are connected to 6 core elements: Context: any feature of the circumstances in which an intervention is conceived, developed, evaluated and implemented Programme theory: how an intervention is expected to lead to its effects and under what conditions. Programme theory should be tested and refined at all stages and used to guide the identification of uncertainties and research questions Stakeholders: those who are targeted by the intervention, involved in its development or delivery, or more broadly those whose personal or professional interests are affected, that is who have a stake in the topic. This includes patients, the public, and professionals Refinement: the process of ‘fine tuning' or making changes to the intervention once a preliminary version has been developed Uncertainties: identifying key uncertainties that exist given what is already known and what the programme theory, researchers and stakeholders identify as being most important to find out. These judgements inform the framing of research questions that, in turn, govern research perspective choice Economic considerations: exploring the comparative resource and outcome consequences of the interventions for those people and organisations affected The presentation will discuss how to use the framework, highlighting that complex intervention research can be an iterative process. Repeating of phases is preferable to automatic progression to the next phase if uncertainties remain unresolved. Main messages Complex intervention research may begin at any phase, depending on what is appropriate for the intervention in question, and does not necessarily move sequentially through the phases. The core elements should be considered early and revisited continually throughout, as this will make it most likely that the intervention will be implementable in practice.

Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update.

The Medical Research Council published the second edition of its framework in 2006 on developing and evaluating complex interventions. Since then, there have been considerable developments in the field of complex intervention research. The objective of this project was to update the framework in the light of these developments. The framework aims to help research teams prioritise research questions and design, and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. There were four stages to the update: (1) gap analysis to identify developments in the methods and practice since the previous framework was published; (2) an expert workshop of 36 participants to discuss the topics identified in the gap analysis; (3) an open consultation process to seek comments on a first draft of the new framework; and (4) findings from the previous stages were used to redraft the framework, and final expert review was obtained. The process was overseen by a Scientific Advisory Group representing the range of relevant National Institute for Health Research and Medical Research Council research investments. Key changes to the previous framework include (1) an updated definition of complex interventions, highlighting the dynamic relationship between the intervention and its context; (2) an emphasis on the use of diverse research perspectives: efficacy, effectiveness, theory-based and systems perspectives; (3) a focus on the usefulness of evidence as the basis for determining research perspective and questions; (4) an increased focus on interventions developed outside research teams, for example changes in policy or health services delivery; and (5) the identification of six 'core elements' that should guide all phases of complex intervention research: consider context; develop, refine and test programme theory; engage stakeholders; identify key uncertainties; refine the intervention; and economic considerations. We divide the research process into four phases: development, feasibility, evaluation and implementation. For each phase we provide a concise summary of recent developments, key points to address and signposts to further reading. We also present case studies to illustrate the points being made throughout. The framework aims to help research teams prioritise research questions and design and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. In many of the areas of innovation that we highlight, such as the use of systems approaches, there are still only a few practical examples. We refer to more specific and detailed guidance where available and note where promising approaches require further development. This new framework incorporates developments in complex intervention research published since the previous edition was written in 2006. As well as taking account of established practice and recent refinements, we draw attention to new approaches and place greater emphasis on economic considerations in complex intervention research. We have introduced a new emphasis on the importance of context and the value of understanding interventions as 'events in systems' that produce effects through interactions with features of the contexts in which they are implemented. The framework adopts a pluralist approach, encouraging researchers and research funders to adopt diverse research perspectives and to select research questions and methods pragmatically, with the aim of providing evidence that is useful to decision-makers. We call for further work to develop relevant methods and provide examples in practice. The use of this framework should be monitored and the move should be made to a more fluid resource in the future, for example a web-based format that can be frequently updated to incorporate new material and links to emerging resources. This project was jointly funded by the Medical Research Council (MRC) and the National Institute for Health Research (Department of Health and Social Care 73514).

What is the Added Value of Social Network Analysis when Developing and Evaluating Complex Interventions

IntroductionMost complex interventions target upon a network of multiple (health care) professionals. Social Network Analysis (SNA) is a powerful technique that aims to characterize and study how social relationships within a network establish and evolve. This study identified the added value of using SNA in the developing and evaluation of complex interventions.Theory/Methods A scoping review was conducted by identifying the research question, identifying relevant studies, selecting studies, charting the data; and collating, summarizing and reporting the results. EMBASE, PsycInfo, CINAHL and PubMed were searched with a timeframe of 15 years. Complex healthcare intervention studies using SNA were included. The study selection and data extraction were conducted by two researches independently. We identified the characteristics, the reported strengths and limitations and reported implications of SNA application in complex intervention studies.ResultsThe search identified, after removal of duplicates, 2466 studies. After abstract screening, 40 full text studies were assessed for eligibility resulting in 25 studies that were included. Fifteen studies used SNA to examine effectiveness, one study in examining acceptability, one in identifying interventionists, five in process evaluation studies, and three in implementation studies.Reported strengths of SNA application were that primary data can be collected through several methods, and the easy feasibility of data collection and visualization of results. A reported limitation in data analysis was the challenge for untrained researchers to use SNA programs.Reported implications of using SNA when developing complex interventions was identifying key individuals who can be harnessed for dissemination of innovations or selected as interventionists. When evaluating complex interventions, SNA can support the conclusions from traditional analysis and generated new information such as revealing important intervention dynamics that would not have been found with classical methods. SNA allows analysis of the network as whole system and on individual level. When implementing, SNA can provide understanding of the barriers and/or facilitators of the diffusion and implementation of the intervention which offers actionable insights. DiscussionThe application of SNA is wide but at the same time very underutilized in complex intervention research. The optimal use of SNA in developing and evaluating complex interventions is therefore currently underexposed.ConclusionSNA is a widely applicable method that can be used in different phases of complex intervention research. Studies reported more strengths than limitation in the application of SNA. The reported implications emphasized the diverse and added value of using SNA in the development and evaluation of complex interventions.Lessons learnedThe potential value of SNA in unravelling and characterizing networks in the development and evaluation of complex interventions needs more attention in health care research.LimitationThere is no sharp boundary between simple and complex health care interventions. Therefore, search terms that widely cover complex interventions in health care were used and a hand search of reviews was performed.Suggestion for future researchRoutine use of SNA in developing and evaluating complex interventions could gain actionable insights which are useful in a transactional context as in complex interventions.

Blockchain for Increased Trust in Virtual Health Care: Proof-of-Concept Study

BackgroundHealth care systems are currently undergoing a digital transformation that has been primarily triggered by emerging technologies, such as artificial intelligence, the Internet of Things, 5G, blockchain, and the digital representation of patients using (mobile) sensor devices. One of the results of this transformation is the gradual virtualization of care. Irrespective of the care environment, trust between caregivers and patients is essential for achieving favorable health outcomes. Given the many breaches of information security and patient safety, today’s health information system portfolios do not suffice as infrastructure for establishing and maintaining trust in virtual care environments.ObjectiveThis study aims to establish a theoretical foundation for a complex health care system intervention that aims to exploit a cryptographically secured infrastructure for establishing and maintaining trust in virtualized care environments and, based on this theoretical foundation, present a proof of concept that fulfills the necessary requirements.MethodsThis work applies the following framework for the design and evaluation of complex intervention research within health care: a review of the literature and expert consultation for technology forecasting. A proof of concept was developed by following the principles of design science and requirements engineering.ResultsThis study determined and defined the crucial functional and nonfunctional requirements and principles for enhancing trust between caregivers and patients within a virtualized health care environment. The cornerstone of our architecture is an approach that uses blockchain technology. The proposed decentralized system offers an innovative governance structure for a novel trust model. The presented theoretical design principles are supported by a concrete implementation of an Ethereum-based platform called VerifyMed.ConclusionsA service for enhancing trust in a virtualized health care environment that is built on a public blockchain has a high fit for purpose in Healthcare 4.0.

Learning to care for the spirit of dying patients: the impact of spiritual care training in a hospice-setting

BackgroundPatients approaching the end of their life do not experience their existential and spiritual needs being sufficiently met by the healthcare professionals responsible for their care. Research suggest that this is partly due to a lack of insight about spiritual care among healthcare professionals. By developing, implementing, and evaluating a research-based educational course on spiritual care targeting hospice staff, we aimed to explore the perceived barriers for providing spiritual care within a hospice setting and to evaluate the post-course impact among staff members.MethodsCourse development and evaluation was based on primary exploratory action research and followed the UK Medical Research Council’s framework for complex intervention research. The course was implemented at two Danish hospices and comprised thematic days that included lectures, reflective exercises and improvised participatory theatre. We investigated the course impact using a questionnaire and focus group interviews. The questionnaire data were summarized in bar charts and analysis of the transcribed interviews was performed based on Interpretative Phenomenological Analysis.Results85 staff members participated in the course. Of these, 57 answered the evaluative questionnaire and 15 participated in 5 focus group interviews.The course elements that the participants reported to be the most relevant were improvised theatre unfolding existential themes and reflexive group activities. 98% of participants found the course relevant, answering either “relevant” or “very relevant”. 73,1% of participants answered “to a considerable extent” or “to a great extent” when asked to what extent they assessed the content of the course to influence their work in hospice.The focus group data resulted in 3 overall themes regarding perceived barriers for providing spiritual care: 1. Diverse approaches is beneficial for spiritual care, but the lack of a shared and adequate spiritual language is a communicative barrier, 2. Existential conversation is complicated by patients’ overlapping physical and existential needs, as well as miscommunication, and 3. Providing spiritual care requires spiritual self-reflection, self-awareness, introspection, and vulnerability.ConclusionsThis study provides insights into the barriers facing spiritual care in a hospice setting. Furthermore, the course evaluations demonstrate the valuable impact of spiritual care training for health care professionals. Further course work development is warranted to enhance the “science” of spiritual care for the dying.

Monitoring variation to Guided Imagery and Music (GIM): Development of the GIM Treatment Fidelity Instrument

ABSTRACT Introduction: The Bonny Method of Guided Imagery and Music (GIM) is a complex music therapy method that practitioners use in varied and individualized ways. To improve validity in a quantitative GIM research study and to build knowledge about clinical uses of GIM, we developed a process to monitor variation within GIM sessions. Method: According to recommendations for complex intervention research, we undertook a process to develop a system to monitor variation to the GIM method that was focused on maintaining consistency of process and function of the GIM method. A team of GIM researchers, practitioners, and primary trainers identified elements of the GIM method and developed an instrument designed to capture variations in a GIM session. The instrument was piloted in 28 individual GIM sessions. Results: The final version of the GIM Treatment Fidelity Instrument contained 17 items organized into four categories, and included a manual to provide additional clarity for each item. Pilot-testing confirmed that the instrument captured adequate detail for monitoring treatment fidelity and was efficient to use. Discussion: The GIM Treatment Fidelity Instrument comprises the central part of a comprehensive process to monitor treatment fidelity in GIM research and has the potential to improve implementation and reporting of GIM research. Utilization of this process may help GIM researchers and therapists generate knowledge about implicit decision-making within GIM practice. This descriptive approach to monitoring treatment fidelity may also provide a model for research related to other complex music therapy approaches.

Value of social network analysis for developing and evaluating complex healthcare interventions: a scoping review

ObjectivesMost complex healthcare interventions target a network of healthcare professionals. Social network analysis (SNA) is a powerful technique to study how social relationships within a network are established and evolve....

Nursing handovers and patient safety: Findings from an umbrella review.

To summarise available reviews on nursing handover (NH) and patient safety (PS), providing a set of evidence-based recommendations for clinical practice and research. Umbrella review. We systematically searched PubMed, CINAHL, and Cochrane Library CENTRAL databases up to October 2018. Retrieved reviews were critically evaluated using the Checklist for Systematic Review and Research Syntheses. Then, an iterative approach and two different frameworks were adopted to categorize the findings in: (a) practice; and (b) research recommendations. A total of 17 reviews were included: among them, 16 reported a range of recommendations for clinical practice to promote PS by reducing adverse events. For what concerns research, 16 reviews recommended specific strategies to improve and strengthen research and its quality in the field of NHs and PS. Changing nursing handover practices to increase PS is complex: it means changing the culture, roles and behaviour of any given clinical nursing setting. To be effective, the change requires a tailored approach, time and implementation strategies including education and support. Future studies should address the flexibility required by handovers in daily practice and the multiple needs with the aim of increasing the robustness of the available evidence on NHs. These should also embrace the Complex Interventions Research Framework. Several reviews have been performed as summaries of research and practice evidence on NHs, but no summary of the established clinical and research recommendations on NHs and PS has been provided to date. Standardized handovers supported by technological solutions, facilitating face-to-face contact between nurses, possibly alongside bedside reports, can improve PS. Well-designed longitudinal studies, on a wide scale, in different settings, based on a strong rationale and focused on measuring the association between handover and patients' safety issues are recommended.

Do we understand the intervention? What complex intervention research can teach us for the evaluation of clinical ethics support services (CESS)

BackgroundEvaluating clinical ethics support services (CESS) has been hailed as important research task. At the same time, there is considerable debate about how to evaluate CESS appropriately. The criticism, which has been aired, refers to normative as well as empirical aspects of evaluating CESS.Main bodyIn this paper, we argue that a first necessary step for progress is to better understand the intervention(s) in CESS. Tools of complex intervention research methodology may provide relevant means in this respect. In a first step, we introduce principles of “complex intervention research” and show how CESS fulfil the criteria of “complex interventions”. In a second step, we develop a generic “conceptual framework” for “ethics consultation on request” as standard for many forms of ethics consultation in clinical ethics practice. We apply this conceptual framework to the model of “bioethics mediation” to make explicit the specific structural and procedural elements of this form of ethics consultation on request. In a final step we conduct a comparative analysis of two different types of CESS, which have been subject to evaluation research: “proactive ethics consultation” and “moral case deliberation” and discuss implications for evaluating both types of CESS.ConclusionTo make explicit different premises of implemented CESS interventions by means of conceptual frameworks can inform the search for sound empirical evaluation of CESS. In addition, such work provides a starting point for further reflection about what it means to offer “good” CESS.

Addressing fidelity within complex health behaviour change interventions: A protocol of a scoping review of intervention fidelity frameworks and models.

Intervention fidelity is crucial to facilitate accurate interpretation of research outcomes, but has been inadequately addressed within complex health behaviour change interventions. Recent research has highlighted a need for practical guidance to improve understanding and use of existing fidelity frameworks and models within complex health behaviour change intervention research. The aim of this paper is to present a protocol for a scoping review of existing intervention fidelity frameworks and models. In accordance with scoping review guidelines, the following stages will be conducted: (1) identifying the research question, (2) identifying potentially relevant studies of fidelity frameworks and models, (3) study screening and selection, (4) charting and extracting data from identified frameworks and models, (5) collating, summarising and reporting the results and (6) consultation with stakeholders. Two reviewers will independently conduct the screening and extraction stages. Identified frameworks will be collated, summarized and categorized iteratively by one reviewer in consultation with the review team. The findings of this review will provide a useful resource by identifying and comparing existing fidelity frameworks and models. It is intended that increased clarity and understanding in this area will facilitate the appropriate selection and application of fidelity frameworks for complex health behaviour change interventions, inform areas for future research, and ultimately contribute towards improving how intervention fidelity is addressed in this area.

Developing and evaluating a course programme to enhance existential communication with cancer patients in general practice

Objective: Our objective was to describe the development and evaluation of a course programme in existential communication targeting general practitioners (GPs).Design: The UK Medical Research Council’s (MRC) framework for complex intervention research was used as a guide for course development and evaluation and was furthermore used to structure this paper. The development phase included: identification of existing evidence, description of the theoretical framework of the course, designing the intervention and deciding for types of evaluation. In the evaluation phase we measured self-efficacy before and after course participation. To explore further processes of change we conducted individual, semi-structured telephone interviews with participants.Subjects and setting: Twenty practising GPs and residentials in training to become GPs from one Danish region (mean age 49).Results: The development phase resulted in a one-day vocational training/continuing medical education (VT/CME) course including the main elements of knowledge building, self-reflection and communication training. Twenty GPs participated in the testing of the course, nineteen GPs answered questionnaires measuring self-efficacy, and fifteen GPs were interviewed. The mean scores of self-efficacy increased significantly. The qualitative results pointed to positive post course changes such as an increase in the participants’ existential self-awareness, an increase in awareness of patients in need of existential communication, and an increase in the participants’ confidence in the ability to carry out existential communication.Conclusions: A one-day VT/CME course targeting GPs and including the main elements of knowledge building, self-reflection and communication training showed to make participants more confident about their ability to communicate with patients about existential issues and concerns.Key pointsPatients with cancer often desire to discuss existential concerns as part of clinical care but general practitioners (GPs) lack confidence when discussing existential issues in daily practice.In order to lessen barriers and enhance existential communication in general practice, we developed a one-day course programme.Attending the course resulted in an increase in the participants’ confidence in the ability to carry out existential communication.This study adds knowledge to how confidence in existential communication can be increased among GPs.