EXPERTS II - How are patient and caregiver participation in health and social care shaped by experienced burden of treatment and social inequalities? Protocol for a qualitative synthesis.

Background: The workload health and social care service users and caregivers take on, and their capacity to do this work is important. It may play a key part in shaping the implementation of innovations in health service delivery and organisation; the utilisation and satisfaction with services; and the outcomes of care. Previous research has often focused on experiences of a narrow range of long-term conditions, and on factors that shape adherence to self-care regimes. Aims: With the aim of deriving policy and practice implications for service redesign, this evidence synthesis will extend our understanding of service user and caregiver workload and capacity by comparing how they are revealed in qualitative studies of lived experience of three kinds of illness trajectories: long-term conditions associated with significant disability (Parkinson's disease, schizophrenia); serious relapsing remitting disease (Inflammatory Bowel Disease, bipolar disorder); and rapidly progressing acute disease (brain cancer, early onset dementia). Methods: We will review and synthesise qualitative studies of lived experience of participation in health and social care that are shaped by interactions between experienced treatment burdens, social inequalities and illness trajectories. The review will involve:   1.  Construction of a theory-informed coding manual; systematic search of bibliographic databases to identify, screen and quality assess full-text papers.   2.  Analysis of papers using manual coding techniques, and text mining software; construction of taxonomies of service user and caregiver work and capacity.   3.  Designing a model of core components and identifying common factors across conditions, trajectories, and contexts.   4.  Work with practitioners, and a Patient and Public Involvement (PPI) group, to explore the validity of the models produced; to develop workload reduction strategies; and to consider person-centred service design. Dissemination: We will promote workload reduction models to support service users and caregivers and produce policy briefs and peer-reviewed publications for practitioners, policy-makers, and researchers.

Our experiences of illness are often complex. We may have to work hard too. We may need to monitor and record symptoms: take up different diets and physical activity; use different drugs and medical devices; develop expertise in using websites and information technology; coordinate input from health and care services; sometimes we have to work out how to pay for the services we need. How we get through this work is affected by our capacity to do it, and that is shaped by personal and wider resources, we can draw on. All of this is also affected by the services that are available to us, and by the ways our chances in life are shaped by income, ethnicity, education, gender, and age. The kinds of illnesses we have and how they progress, mean that these factors change over time. We call these changes trajectories. To better understand service user work and capacity, we will review published studies that tell us about people's everyday experiences of living with illnesses. We focus on three rarely studied trajectories. These are long-term conditions associated with significant disability; serious relapsing remitting disease; and rapidly progressing acute disease. We will first use existing research to build a framework in which we can describe and understand relevant aspects of the published studies. We will use this framework to extract relevant information from the studies. This will enable us to make a model of common features of service user work and capacity across different conditions, their trajectories, service organisation and delivery, and patterns of social and economic disadvantage. Finally, we will work with groups of service users and caregivers, and with health and social care professionals to apply the model to the development of strategies to reduce workload and improve service design for people with complex health problems.

Ubuntu as a mediator in coping with multimorbidity treatment burden in a disadvantaged rural and urban setting in South Africa.

BACKGROUND: People living with multimorbidity in economically precarious circumstances in low- and middle-income countries (LMICs) experience a high workload trying to meet self-management demands. However, in countries such as South Africa, the availability of social networks and support structures may improve patient capacity, especially when networks are governed by cultural patterns linked to the Pan-African philosophy of Ubuntu, which promotes solidarity through humanness and human dignity. We explore the mediating role Ubuntu plays in people's ability to self-manage HIV/NCD multimorbidity in underprivileged settings in urban and rural South Africa. METHODS: We conducted semi-structured interviews with 30 patients living with HIV/NCD multimorbidity between February-April 2022. Patients attended public health clinics in Gugulethu, Cape Town and Bulungula, Eastern Cape. We analysed interviews using framework analysis, using the Cumulative Complexity Model (CuCoM) and Burden of Treatment Theory (BoTT) as frameworks through which to conceptualise the data. RESULTS: Despite facing economic hardship, people with multimorbidity in South Africa were able to cope with their workload. They actively used and mobilized family relations and external networks that supported them financially, practically, and emotionally, allowing them to better self-manage their chronic conditions. Embedded in their everyday life, patients, often unconsciously, embraced Ubuntu and its core values, including togetherness, solidarity, and receiving Imbeko (respect) from health workers. This enabled participants to share their treatment workload and increase self-management capacity. CONCLUSION: Ubuntu is an important mediator for people living with multimorbidity in South Africa, as it allows them to navigate their treatment workload and increase their social capital and structural resilience, which is key to self-management capacity. Incorporating Ubuntu and linked African support theories into current treatment burden models will enable better understandings of patients' collective support and can inform the development of context-specific social health interventions that fit the needs of people living with chronic conditions in African settings.

Maintaining long-term physical activity after cancer: a conceptual framework to inform intervention development.

PURPOSE: This paper describes a conceptual framework of maintenance of physical activity (PA) and its application to future intervention design. METHODS: Evidence from systematic literature reviews and in-depth (N = 27) qualitative interviews with individuals with cancer were used to develop a conceptual framework of long-term physical activity behaviour. Determinants of long-term PA were listed and linked with domains of the Theoretical Domains Framework which in turn were linked to associated behaviour change techniques (BCTs) and finally to proposed mechanisms of action (MoA). RESULTS: The conceptual framework is presented within the context of non-modifiable contextual factors (such as demographic and material resources) and in the presence of learnt and adapted behavioural determinants of skills, competence and autonomous motivation that must be established as part of the initiation of physical activity behaviour. An inventory of 8 determinants of engagement in long-term PA after cancer was developed. Clusters of BCTs are presented along with proposed MoA which can be tested using mediation analysis in future trials. CONCLUSION: Understanding the processes of PA maintenance after cancer and presentation of implementable and testable intervention components and mechanisms of action to promote continued PA can inform future intervention development. IMPLICATIONS FOR CANCER SURVIVORS: This resource can act as a starting point for selection of intervention components for those developing future interventions. This will facilitate effective support of individuals affected by cancer to maintain PA for the long term.

Towards an Implementation-STakeholder Engagement Model (I-STEM) for improving health and social care services.

BACKGROUND: The implementation science literature acknowledges a need for engagement of key stakeholders when designing, delivering and evaluating implementation work. To date, the literature reports minimal or focused stakeholder engagement, where stakeholders are engaged in either barrier identification and/or barrier prioritisation. This paper begins to answer calls from the literature for the development of tools and guidance to support comprehensive stakeholder engagement in implementation research and practice. The paper describes the systematic development of the Implementation-STakeholder Engagement Model (I-STEM) in the context of an international, large-scale empirical implementation study (ImpleMentAll) aimed at evaluating the effectiveness of a tailored implementation toolkit. The I-STEM is a sensitising tool that defines key considerations and activities for undertaking stakeholder engagement activities across an implementation process. METHODS: In-depth, semistructured interviews and observations were conducted with implementers who were tailoring implementation strategies to integrate and embed internet-based cognitive behavioural therapy (iCBT) services in 12 routine mental health care organisations in nine countries in Europe and Australia. The analytical process was informed by principles of first- and third-generation Grounded Theory, including constant comparative method. RESULTS: We conducted 55 interviews and observed 19 implementation-related activities (e.g., team meetings and technical support calls). The final outcome of our analysis is expressed in an initial version of the I-STEM, consisting of five interrelated concepts: engagement objectives, stakeholder mapping, engagement approaches, engagement qualities and engagement outcomes. Engagement objectives are goals that implementers plan to achieve by working with stakeholders in the implementation process. Stakeholder mapping involves identifying a range of organisations, groups or people who may be instrumental in achieving the engagement objectives. Engagement approaches define the type of work that is undertaken with stakeholders to achieve the engagement objectives. Engagement qualities define the logistics of the engagement approach. Lastly, every engagement activity may result in a range of engagement outcomes. CONCLUSION: The I-STEM represents potential avenues for substantial stakeholder engagement activity across key phases of an implementation process. It provides a conceptual model for the planning, delivery, evaluation and reporting of stakeholder engagement activities. The I-STEM is nonprescriptive and highlights the importance of a flexible, iterative approach to stakeholder engagement. It is developmental and will require application and validation across a range of implementation activities. PATIENT OR PUBLIC CONTRIBUTION: Patient contribution to ImpleMentAll trial was facilitated by GAMIAN-Europe at all stages-from grant development to dissemination. GAMIAN-Europe brings together a wide variety of patient representation organisations (local, regional and national) from almost all European countries. GAMIAN-Europe was involved in pilot testing the ItFits-toolkit and provided their views on the various aspects, including stakeholder engagement. Patients were also represented in the external advisory board providing support and advice on the design, conduct and interpretation of the wider project, including the development of the ItFits-toolkit. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883. Retrospectively registered on 29 August 2018.

Qualitative interviews results from heart failure survey respondents on the interaction between symptoms and burden of self-care work.

AIMS AND OBJECTIVES: Following a cross-sectional survey, a sub-sample of participants was interviewed to explore the interaction between symptoms and burden of treatment. BACKGROUND: Burden of treatment considers both the work associated with illness and treatment, including self-care work, as well as the individuals' capabilities and resources to engage in that work. The recent survey revealed the existence of a complex interaction. DESIGN: Qualitative abductive analysis of semi-structured interviews. METHODS: Adults with heart failure who participated in the survey were purposely sampled and invited to participate in semi-structured interviews. Location and mode of interview varied by participant choice. Excerpts from the verbatim transcripts were assessed for interactions between symptoms and burden of treatment, and when identified these were characterised and explained. We followed COREQ checklist for reporting. The patient research ambassador group was involved from research design to dissemination. RESULTS: Participants (n = 32) consistently discussed how symptoms altered their capability to engage in self-care work. As symptom intensity increased the difficultly of their self-care work increased. A number of intervening factors appeared to influence the relationship between symptoms and burden of treatment. Intervening factors included illness pathology, illness identity, the value of the tasks attempted and available support structures. These factors may change how symptoms and burden of treatment are perceived; a model was constructed to explain and summarise these interactions. CONCLUSIONS: The interaction between symptoms and burden of treatment is complex. Intervening factors-illness identity and pathology, task value and performance, and available support structures-appear to exert a strong influence on the interaction between symptoms and burden of treatment. RELEVANCE TO CLINICAL PRACTICE: These intervening factors present clinicians and researchers with opportunities to develop interventions that might reduce burden of treatment and improve symptoms and quality of life. CLINICAL TRIAL REGISTRATION: SYMPACT was registered with ISRCTN registry: ISRCTN11011943.

Negotiating treatment and managing expectations in chronic kidney disease: A qualitative study in Argentina.

OBJECTIVES: To describe how patients with CKD negotiated assigned responsibilities in the management of their disease, resulting in potential relational nonadherence. METHODS: Qualitative study performed in two healthcare facilities in Buenos Aires, Argentina, including 50 patients and 14 healthcare providers. We conducted semistructured interviews which were analysed using a frame of reference with concepts of Burden of Treatment and Cognitive Authority theories. FINDINGS: Adherence to treatment defined "good patients". Patients needed to negotiate starting treatment, its modality and dialysis schedule, although most patients felt they did not participate in the decision process and that providers did not acknowledge implications of these decisions on their routine. Some patients skipped dialysis if concerns were not attended. Regularly, patients negotiated frequency of visits, doses, dietary restrictions and redefined relationships with their support networks, sometimes with devasting effects. As a result of overwhelming uncertainty some patients refused enrolling into a transplant program. When the frequency of complications increased, patients considered abandoning dialysis. CONCLUSION: When patients perceived demands were excessive or conflicting, they entered into negotiations. Relationally induced nonadherence may arise when professionals do not or cannot enter into negotiations over patients' beliefs or knowledge about what is possible for them to do.

Implementing a Virtual Emergency Department: Qualitative Study Using the Normalization Process Theory.

BACKGROUND: COVID-19 necessitated the rapid implementation and uptake of virtual health care; however, virtual care's potential role remains unclear in the urgent care setting. In December 2020, the first virtual emergency department (ED) in the Greater Toronto Area was piloted at Sunnybrook Health Sciences Centre by connecting patients to emergency physicians through an online portal. OBJECTIVE: This study aims to understand whether and how ED physicians were able to integrate a virtual ED alongside in-person operations. METHODS: We conducted semistructured interviews with ED physicians guided by the Normalization Process Theory (NPT). The NPT provides a framework to understand how individuals and teams navigate the process of embedding new models of care as part of normal practice. All physicians who had worked within the virtual ED model were invited to participate. Data were analyzed using a combination of inductive and deductive techniques informed by the NPT. RESULTS: A total of 14 physicians were interviewed. Participant experiences were categorized into 1 of 2 groups: 1 group moved to normalize the virtual ED in practice, while the other described barriers to routine adoption. These groups differed in their perception of the patient benefits as well as the perceived role in the virtual ED. The group that normalized the virtual ED model saw value for patients (coherence) and was motivated by patient satisfaction witnessed (reflexive monitoring) at the end of the virtual appointment. By contrast, the other group did not find virtual ED work reflective of the perceived role of urgent care (cognitive participation) and felt their skills as ED physicians were underutilized. The limited ability to examine patients and a sense that patient issues were not fully resolved at the end of the virtual appointment caused frustration among the second group. CONCLUSIONS: As further digital integration within the health care system occurs, it will be essential to support the evolution of staff skill sets to ensure physicians are satisfied with the care they are providing to their patients, while also ensuring the technology and process are efficient.

Translational framework for implementation evaluation and research: Protocol for a qualitative systematic review of studies informed by Normalization Process Theory (NPT) [version 1; peer review: 2 approved].

Background: Normalization Process Theory (NPT) identifies mechanisms that have been demonstrated to play an important role in implementation processes. It is now widely used to inform feasibility, process evaluation, and implementation studies in healthcare and other areas of work. This qualitative synthesis of NPT studies aims to better understand how NPT explains observed and reported implementation processes, and to explore the ways in which its constructs explain the implementability, enacting and sustainment of complex healthcare interventions. Methods: We will systematically search Scopus, PubMed and Web of Science databases and use the Google Scholar search engine for citations of key papers in which NPT was developed. This will identify English language peer-reviewed articles in scientific journals reporting (a) primary qualitative or mixed methods studies; or, (b) qualitative or mixed methods evidence syntheses in which NPT was the primary analytic framework. Studies may be conducted in any healthcare setting, published between June 2006 and 31 December 2021. We will perform a qualitative synthesis of included studies using two parallel methods: (i) directed content analysis based on an already developed coding manual; and (ii) unsupervised textual analysis using Leximancer® topic modelling software. Other: We will disseminate results of the review using peer reviewed publications, conference and seminar presentations, and social media (Facebook and Twitter) channels. The primary source of funding is the National Institute for Health Research ARC North Thames. No human subjects or personal data are involved and no ethical issues are anticipated.

Process evaluations of mental health and psychosocial support interventions for populations affected by humanitarian crises.

BACKGROUND: Randomised controlled trials (RCTs) have been increasingly used to test the effectiveness of mental health and psychosocial support(MHPSS) interventions for populations affected by humanitarian crises. Process evaluations are often integrated within RCTs of psychological interventions to investigate the implementation of the intervention, the impact of context, and possible mechanisms of action. We aimed to explore limitations and strengths of how process evaluations are currently conceptualised and implemented within MHPSS RCTs specifically. METHODS: In April-June 2021 we conducted semi-structured interviews with 24 researchers involved in RCTs of MHPSS interventions in 23 different countries. Participants were selected based on systematic reviews of MHPSS interventions, funders' databases, and personal networks. Data were analysed using codebook thematic analysis. RESULTS: The conduct of process evaluations was characterized by high heterogeneity in perceived function, implementation outcomes assessed, and methods used. While process evaluations were overwhelmingly considered as an important component of an RCT, there were different opinions on their perceived quality. This could be explained by the varying prioritization of effectiveness data over implementation data, confusion around the nature of process evaluations, and challenges in the collection and analysis of process data in humanitarian settings. Various practical recommendations were made by participants to improve future process evaluations in relation to: (i) study design (e.g., embedding process evaluations in study protocol and overall study objectives); (ii) methods (e.g., use of mixed methods); and (iii) increased financial and human resources dedicated to process evaluations. CONCLUSION: The current state of process evaluations in MHPSS RCTs is heterogeneous. The quality of process evaluations should be improved to strengthen implementation science of the growing number of evidence-informed MHPSS interventions.

How do illness identity, patient workload and agentic capacity interact to shape patient and caregiver experience? Comparative analysis of lung cancer and chronic obstructive pulmonary disease.

Some patients have to work hard to manage their illness. When this work outweighs capacity (the resources available to patients to undertake the illness workload and other workloads such as that of daily life), this may result in treatment burden, associated with poor health outcomes for patients. This cross-sectional, comparative qualitative analysis uses an abductive approach to identify, characterise and explain treatment burden in chronic obstructive pulmonary disease (COPD) and lung cancer. It uses complementary qualitative methods (semi-structured interviews with patients receiving specialist care n = 19, specialist clinicians n = 5; non-participant observation of specialist outpatient consultations in two English hospitals [11 h, 52 min] n = 41). The findings underline the importance of the diagnostic process in relation to treatment burden; whether diagnosis is experienced as a biographically disruptive shock (as with lung cancer) or is insidiously biographically erosive (as with COPD).

SYMptoms in chronic heart failure imPACT on burden of treatment (SYMPACT): a cross-sectional survey.

AIMS: This study aimed to describe patient-reported symptoms and burden of treatment (BoT) experienced by patients with chronic heart failure (CHF). BoT describes the illness workload, individual capacity to perform that work, and resultant impact on the individual. Overwhelming BoT is related to poor quality of life and worse clinical outcomes. This research is the first to explore symptoms and BoT in people with CHF, in the UK. METHODS AND RESULTS: This is a cross-sectional questionnaire survey of CHF patients. Participants completed the Heart Failure Symptom Survey (HFSS; max score 10) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ; max scores: physical 40, emotional 25, and total 105), which measured symptoms. BoT was measured with the Patient Experience with Treatment and Self-management (PETS; max score 100) questionnaires. Participant characteristics and questionnaire results were summarized using descriptive statistics. Relationships between symptoms and BoT, summarized by the workload and impact indices, were explored using Spearman's and Pearson's correlation coefficients together with scatter plots. The survey was completed by 333 participants, mean age of 71 (±13) years old. The majority (89%) were recruited from secondary care NHS trusts, and 25% were female. All types of heart failure were represented. Mean symptom scores were as follows: HFSS burden score: 2.4 (±2.1), and MLHFQ scores: physical score 20 (±12.4), emotional score 9.9 (±8.1), and total score 41.3 (±26.3). The highest mean PETS domain scores were exercise [51.3 (±24.7)], diet [40.3 (±22.7)], difficulty with healthcare services [39.9 (±21.3)], and physical and mental fatigue [36.0 (±25.7)]. Pairwise correlations were observed between HFSS scores and MLHFQ physical and emotional sub-scores with PETS workload and impact indices. Positive correlations were weak to moderate (0.326-0.487) between workload index and symptoms, and moderate to strong between impact index and symptoms (0.553-0.725). The P value was 0.006, adjusted by Bonferroni's correction. CONCLUSIONS: Symptoms are associated with BoT in CHF patients. Although symptom burden was low, CHF patients reported higher levels of burden around self-care activities of exercise, diet, healthcare interaction, as well as physical and mental fatigue due to engagement with self-care regimens. Observed higher levels of burden were in key self-care areas for CHF and suggest areas where service delivery and support of CHF patients may be improved to reduce BoT. Clinicians could individualize their consultations by focusing on troublesome symptoms, as well as alleviating illness workload, which may better enable patients to live well with CHF.

Implementing primary care diabetes prevention for women with previous gestational diabetes: a mixed-methods study.

BACKGROUND: The implementation of diabetes prevention for women with previous gestational diabetes (GDM) has been stymied by many barriers that are located within routine general practice (GP). We aimed to unpack the GP factors and understand the mechanisms that explain why a diabetes prevention intervention for this population succeeds or fails. METHODS: We performed a mixed-methods study with a Normalization Process Theory framework that included clinical audits, semistructured interviews, and focus groups within mixed urban and rural primary care practices in Victoria, Australia. Staff of primary care practices and external support staff who provide services to women with previous GDM participated in a 12-month quality improvement collaborative intervention. We compared diabetes screening and prevention activity planning with the strategies and factors identified through a process evaluation of full-, moderate-, and low-active participating practices. RESULTS: The intervention doubled screening rates (26%-61%) and 1-in-10 women received a diabetes prevention planning consultation. Critical improvement factors were: mothers being seen as participants in the quality improvement work; staff collectively building care strategies; staff taking a long-term care of a community perspective rather than episodic service delivery; and feedback processes being provided and acted on across the practice. The observable factors from the external perspective were: leadership by identified practice staff, reminder systems in action and practice staff driving the process collectively. CONCLUSIONS: Successful engagement in diabetes prevention for women with previous GDM requires proactive building of the critical improvement factors and audit feedback into routine GP.

Translational framework for implementation evaluation and research: a normalisation process theory coding manual for qualitative research and instrument development.

BACKGROUND: Normalisation Process Theory (NPT) is frequently used to inform qualitative research that aims to explain and evaluate processes that shape late-stage translation of innovations in the organisation and delivery of healthcare. A coding manual for qualitative researchers using NPT will facilitate transparent data analysis processes and will also reduce the cognitive and practical burden on researchers. OBJECTIVES: (a) To simplify the theory for the user. (b) To describe the purposes, methods of development, and potential application of a coding manual that translates normalisation process theory (NPT) into an easily usable framework for qualitative analysis. (c) To present an NPT coding manual that is ready for use. METHOD: Qualitative content analysis of papers and chapters that developed normalisation process theory, selection and structuring of theory constructs, and testing constructs against interview data and published empirical studies using NPT. RESULTS: A coding manual for NPT was developed. It consists of 12 primary NPT constructs and conforms to the Context-Mechanism-Outcome configuration of realist evaluation studies. Contexts are defined as settings in which implementation work is done, in which strategic intentions, adaptive execution, negotiating capability, and reframing organisational logics are enacted. Mechanisms are defined as the work that people do when they participate in implementation processes and include coherence-building, cognitive participation, collective action, and reflexive monitoring. Outcomes are defined as effects that make visible how things change as implementation processes proceed and include intervention mobilisation, normative restructuring, relational restructuring, and sustainment. CONCLUSION: The coding manual is ready to use and performs three important tasks. It consolidates several iterations of theory development, makes the application of NPT simpler for the user, and links NPT constructs to realist evaluation methods. The coding manual forms the core of a translational framework for implementation research and evaluation.

Patient, clinician and manager experience of the accelerated implementation of virtual consultations following COVID-19: A qualitative study of preferences in a tertiary orthopaedic rehabilitation setting.

AIM: To investigate the experiences of patients, clinicians and managers during the accelerated implementation of virtual consultations (VCs) due to COVID-19. To understand how patient preferences are constructed and organized. METHODS: Semi-structured interviews with patients, clinicians and managerial staff at a single specialist orthopaedic centre in the United Kingdom. The interview schedule and coding frame were based on Normalisation Process Theory. Interviews were conducted over the telephone or by video call. Abductive analysis of interview transcripts extended knowledge from previous research to identify, characterize and explain how patient preferences for VC were formed and arranged. RESULTS: Fifty-five participants were included (20 patients, 20 clinicians, 15 managers). Key mechanisms that contribute to the formation of patient preferences were identified. These were: (a) context for the consultation (normative expectations, relational expectations, congruence and potential); (b) the available alternatives and the implementation process (coherence, cognitive participation, collective action and reflexive monitoring). Patient preferences are mediated by the clinician and organisational preferences through the influence of the consultation context, available alternatives and the implementation process. CONCLUSIONS: This study reports the cumulative analysis of five empirical studies investigating patient preferences for VC before and during the COVID-19 pandemic as VC transitioned from an experimental clinic to a compulsory form of service delivery. This study has identified mechanisms that explain how preferences for VC come about and how these relate to organisational and clinician preferences. Since clinical pathways are shaped by interactions between patient, clinicians and organisational preferences, future service design must strike a balance between patient preferences and the preferences of clinicians and organisations. PATIENT AND PUBLIC CONTRIBUTION: The CONNECT Project Patient and Public Involvement (PPI) group provided guidance on the conduct and design of the research. This took place with remote meetings between the lead researcher and the chair of the PPI group during March and April 2020. Patient information documentation and the interview schedule were developed with the PPI group to ensure that these were accessible.

Making sense of diabetes medication decisions: a mixed methods cluster randomized trial using a conversation aid intervention.

PURPOSE: To determine the effectiveness of a shared decision-making (SDM) tool versus guideline-informed usual care in translating evidence into primary care, and to explore how use of the tool changed patient perspectives about diabetes medication decision making. METHODS: In this mixed methods multicenter cluster randomized trial, we included patients with type 2 diabetes mellitus and their primary care clinicians. We compared usual care with or without a within-encounter SDM conversation aid. We assessed participant-reported decisions made and quality of SDM (knowledge, satisfaction, and decisional conflict), clinical outcomes, adherence, and observer-based patient involvement in decision-making (OPTION12-scale). We used semi-structured interviews with patients to understand their perspectives. RESULTS: We enrolled 350 patients and 99 clinicians from 20 practices and interviewed 26 patients. Use of the conversation aid increased post-encounter patient knowledge (correct answers, 52% vs. 45%, p = 0.02) and clinician involvement of patients (Mean between-arm difference in OPTION12, 7.3 (95% CI 3, 12); p = 0.003). There were no between-arm differences in treatment choice, patient or clinician satisfaction, encounter length, medication adherence, or glycemic control. Qualitative analyses highlighted differences in how clinicians involved patients in decision making, with intervention patients noting how clinicians guided them through conversations using factors important to them. CONCLUSIONS: Using an SDM conversation aid improved patient knowledge and involvement in SDM without impacting treatment choice, encounter length, medication adherence or improved diabetes control in patients with type 2 diabetes. Future interventions may need to focus specifically on patients with signs of poor treatment fit. CLINICAL TRIAL REGISTRATION: ClinicalTrial.gov: NCT01502891.

Patient preferences for use of virtual consultations in an orthopaedic rehabilitation setting: Results from a discrete choice experiment.

OBJECTIVE: Virtual Consultations may reduce the need for face-to-face outpatient appointments, thereby potentially reducing the cost and time involved in delivering health care. This study reports a discrete choice experiment (DCE) that identifies factors that influence patient preferences for virtual consultations in an orthopaedic rehabilitation setting. METHODS: Previous research from the CONNECT (Care in Orthopaedics, burdeN of treatmeNt and the Effect of Communication Technology) Project and best practice guidance informed the development of our DCE. An efficient fractional factorial design with 16 choice scenarios was created that identified all main effects and partial two-way interactions. The design was divided into two blocks of eight scenarios each, to reduce the impact of cognitive fatigue. Data analysis were conducted using binary logit regression models. RESULTS: Sixty-one paired response sets (122 subjects) were available for analysis. DCE factors (whether the therapist is known to the patient, duration of appointment, time of day) and demographic factors (patient qualifications, access to equipment, difficulty with activities, multiple health issues, travel costs) were significant predictors of preference. We estimate that a patient is less than 1% likely to prefer a virtual consultation if the patient has a degree, is without access to the equipment and software to undertake a virtual consultation, does not have difficulties with day-to-day activities, is undergoing rehabilitation for one problem area, has to pay less than £5 to travel, is having a consultation with a therapist not known to them, in 1 weeks' time, lasting 60 minutes, at 2 pm. We have developed a simple conceptual model to explain how these factors interact to inform preference, including patients' access to resources, context for the consultation and the requirements of the consultation. CONCLUSIONS: This conceptual model provides the framework to focus attention towards factors that might influence patient preference for virtual consultations. Our model can inform the development of future technologies, trials, and qualitative work to further explore the mechanisms that influence preference.

Remote shared decision making through telemedicine: A systematic review of the literature.

OBJECTIVES: To assess the extent to which shared decision making (SDM) can take place in telemedicine (remote SDM). METHODS: We searched Medline, Cochrane, and Scopus from 2010 until August 7th, 2020 for articles on remote SDM in the care of any patient using any technology. We also conducted a search for telemedicine articles citing key reports on SDM outcome measures. Two reviewers independently screened titles and abstracts, reviewed full text eligible studies, and synthesized their content using thematic analysis. RESULTS: Of the 12 eligible articles, most were European with patients with chronic disease or mental and behavioral health. 8 articles used synchronous remote SDM and 1 used asynchronous remote SDM. Themes related to interactional workability of both telemedicine technologies and SDM emerged, namely access to broadband, digital literacy, and satisfaction with the convenience of remote visits. CONCLUSIONS: Telemedicine technologies may foster virtual interactions that support remote SDM, which, in turn, may promote productive patient-clinician interactions and patient-centered care. PRACTICE IMPLICATIONS: Digitally-mediated consultations surged amidst the COVID-19 pandemic. The extent to which SDM frameworks developed for in-person use need any adaptation for remote SDM remains unclear. Investment in innovation, design, implementation, and effectiveness research to advance remote SDM are needed.