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.

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.

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).

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.

Factors that influence patient preferences for virtual consultations in an orthopaedic rehabilitation setting: a qualitative study.

OBJECTIVES: To identify, characterise and explain factors that influence patient preferences, from the perspective of patients and clinicians, for virtual consultations in an orthopaedic rehabilitation setting. DESIGN: Qualitative study using semi-structured interviews and abductive analysis. SETTING: A physiotherapy and occupational therapy department situated within a tertiary orthopaedic centre in the UK. PARTICIPANTS: Patients who were receiving orthopaedic rehabilitation for a musculoskeletal problem. Occupational therapists, physiotherapists or therapy technicians involved in the delivery of orthopaedic rehabilitation for patients with a musculoskeletal problem. RESULTS: Twenty-two patients and 22 healthcare professionals were interviewed. The average interview length was 48 minutes. Four major factors were found to influence preference: the situation of care (the ways that patients understand and explain their clinical status, their treatment requirements and the care pathway), the expectations of care (influenced by a patients desire for contact, psychological status, previous care and perceived requirements), the demands on the patient (due to each patients respective social situation and the consequences of choice) and the capacity to allocate resources to care (these include financial, infrastructural, social and healthcare resources). CONCLUSION: This study has identified key factors that appear to influence patient preference for virtual consultations in orthopaedic rehabilitation. A conceptual model of these factors, derived from empirical data, has been developed highlighting how they combine and compete. A series of questions, based on these factors, have been developed to support identification of preferences in a clinical setting.

Exploring maintenance of physical activity behaviour change among people living with and beyond gastrointestinal cancer: a cross-sectional qualitative study and typology.

OBJECTIVES: In the last decade, there has been a rapid expansion of physical activity (PA) promotion programmes and interventions targeting people living with and beyond cancer (LWBC). The impact that these initiatives have on long-term maintenance of PA remains under-researched. This study sought to explore the experiences of participants in order to characterise those who have and have not successfully sustained increases in PA following participation in a PA intervention after a diagnosis of gastrointestinal (GI) cancer, and identify barriers and facilitators of this behaviour. DESIGN: Cross-sectional qualitative study. Semi-structured interviews with participants who had previously taken part in a PA programme in the UK, explored current and past PA behaviour and factors that promoted or inhibited regular PA participation. Interviews were audio-recorded, transcribed verbatim and analysed using thematic analysis. Themes and subthemes were identified. Differences between individuals were recognised and a typology of PA engagement was developed. PARTICIPANTS: Twenty-seven individuals (n=15 male, mean age=66.3 years) with a diagnosis of GI cancer who had participated in one of four interventions designed to encourage PA participation. SETTING: UK. RESULTS: Seven themes were identified: disease processes, the role of ageing, emotion and psychological well-being, incorporating PA into everyday life, social interaction, support and self-monitoring and competing demands. A typology with three types describing long-term PA engagement was generated: (1) maintained PA, (2) intermittent PA, (3) low activity. Findings indicate that identifying an enjoyable activity that is appropriate to an individual's level of physical functioning and is highly valued is key to supporting long-term PA engagement. CONCLUSION: The typology described here can be used to guide stratified and personalised intervention development and support sustained PA engagement by people LWBC.

Use of virtual consultations in an orthopaedic rehabilitation setting: how do changes in the work of being a patient influence patient preferences? A systematic review and qualitative synthesis.

OBJECTIVES: To systematically review qualitative studies reporting the use of virtual consultations within an orthopaedic rehabilitation setting and to understand how its use changes the work required of patients. METHODS: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement, we conducted a systematic review of papers to answer the research question 'How do changes in the work of being a patient when using communication technology influence patient preferences?' Electronic databases were searched for studies meeting the inclusion criteria in April 2020. RESULTS: The search strategy identified 2057 research articles from the database search. A review of titles and abstracts using the inclusion criteria yielded 21 articles for full-text review. Nine studies were included in the final analysis. Six studies explored real-time video conferencing and three explored telephone consultations. The use of communication technology changes the work required of patients. Such changes will impact on expectations for care, resources required of patients, the environment of receiving care and patient-clinician interactions. This adjustment of the work required of patients who access orthopaedic rehabilitation using communication technology will impact on their experience of receiving care. It is proposed that changes in the work of being a patient will influence preferences for or against the use of communication technology consultations for orthopaedic rehabilitation. CONCLUSION: We found that the use of communication technology changes the work of being a patient. The change in work required of patients can be both burdensome (it makes it harder for patients to access their care) and beneficial (it makes it easier for patients to access their care). This change will likely to influence preferences. Keeping the concept of patient work at the heart of pathway redesign is likely to be a key consideration to ensure successful implementation. PROSPERO REGISTRATION NUMBER: CRD42018100896.

Implementing professional behaviour change in teams under pressure: results from phase one of a prospective process evaluation (the Implementing Nutrition Screening in Community Care for Older People (INSCCOPe) project).

OBJECTIVES: To evaluate the implementation of a new procedure for screening and treatment of malnutrition for older people in community settings and to identify factors promoting or inhibiting its implementation as a routine aspect of care. DESIGN: Prospective process evaluation using mixed methods with pre/post-implementation measures. SETTING AND PARTICIPANTS: Community teams (nursing and allied health professionals) within a UK National Health Service Community Trust. 73 participants were recruited, of which 32 completed both pre-implemetation and post-implementation surveys. MAIN OUTCOME MEASURES: NoMAD survey for pre-post-intervention measures; telephone interviews exploring participant experiences and wider organisational/contextual processes. METHODS: Data prior to implementation of training, baseline (T0-survey and telephone interview) and 2 months following training (T1-follow-up survey). Quantitative data described using frequency tables reporting team type, healthcare provider role group and total study sample; analysis using Wilcoxon rank-sum (subgroup comparison) and Wilcoxon signed-rank (within-group observation point comparison) tests. Qualitative interview data (audio and transcription) analysed through directed content analysis using normalisation process theory. RESULTS: High support for nutrition screening and treatment indicated by participants. Concerns expressed around logistical, organisational and specialist dietetic support. Pre-post-training measures indicated a positive impact of training on knowledge of the new procedure; however, most implementation measures saw no significant changes between time points or between subgroups (training participants vs non-participants). Implementation barriers included the following: high levels of training non-completion; vulnerability to attrition of trained staff; lack of monitoring of post-intervention compliance and lack of access to dietetic support. CONCLUSION: Greater support necessary to support implementation in relation to monitoring of training completion, and organisational support for nutrition screening and treatment activity. Recommended changes to implementation design are as follows: appointment of a key person to support and monitor procedure compliance; adoption of training as an e-learning module within the existing organisational platform to increase participation in changeable working conditions.

HORIZONS protocol: a UK prospective cohort study to explore recovery of health and well-being in adults diagnosed with cancer.

INTRODUCTION: Understanding the impact of cancer and its treatment on people's everyday lives will help prepare people for what to expect, enable health professionals to predict likely recovery trajectories and shape care management according to needs. HORIZONS will recruit people awaiting treatment and follow them up at regular intervals to assess recovery of health and well-being. RESEARCH QUESTIONS: What impact does cancer diagnosis and treatment have on people's lives in the short, medium and long term? What are people's health and well-being outcomes, experiences and self-management activities over time across different cancer types and what influences these? How do people connect with and relate to others in mobilising resources that enable them to self-manage the consequences of cancer and treatment? METHODS AND ANALYSIS: HORIZONS is a multicentre, prospective cohort study exploring recovery of health and well-being in 3000 people diagnosed with breast cancer (<50 years), non-Hodgkin's lymphoma or gynaecological cancer. Recruitment will take place across National Health Service (NHS) sites in the UK between September 2016 and March 2019, before primary treatment starts. Participants will be identified through clinical teams and invited to complete questionnaires including assessments of quality of life, symptoms and functioning (Quality of Life in Adult Cancer Survivors; European Organisation for Research and Treatment Consortium Core quality of life questionnaire, EORTC-QLQ-C30), health status (EuroQol-5 dimensions, EQ-5D), self-efficacy, social support, social networks and lifestyle. Clinical data will also be collected. Descriptive statistics will characterise outcomes. Changes over time will be investigated. Factors that may influence recovery and self-management will be included in regression models to determine which influence health and well-being and self-management. ETHICS AND DISSEMINATION: Ethics and Health Research Authority approvals granted (IRAS Project ID: 202342, REC reference number 16/NW/0425). Adopted onto the National Institute for Health Research Clinical Research Network portfolio. We will engage with our Scientific Advisory Board, Tumour Specific Expert Panels, User Reference Group, Macmillan and the University of Southampton to ensure maximum publicity and benefit.

Systematic review and meta-analysis of maintenance of physical activity behaviour change in cancer survivors.

BACKGROUND: Physical activity can improve health and wellbeing after cancer and may reduce cancer recurrence and mortality. To achieve such long-term benefits cancer survivors must be habitually active. This review evaluates the effectiveness of interventions in supporting maintenance of physical activity behaviour change among adults diagnosed with cancer and explores which intervention components and contextual features are associated with effectiveness. METHODS: Relevant randomised controlled trials (RCTs) were identified by a search of Ovid Medline, Ovid Embase and PsychINFO. Trials including adults diagnosed with cancer, assessed an intervention targeting physical activity and reported physical activity behaviour at baseline and ≥ 3 months post-intervention were included. The behaviour change technique (BCT) taxonomy was used to identify intervention components and the Template for Intervention Description and Replication to capture contextual features. Random effect meta-analysis explored between and within group differences in physical activity behaviour. Standardised mean differences (SMD) describe effect size. RESULTS: Twenty seven RCTs were included, 19 were pooled in meta-analyses. Interventions were effective at changing long-term behaviour; SMD in moderate to vigorous physical activity (MVPA) between groups 0.25; 95% CI = 0.16-0.35. Within-group pre-post intervention analysis yielded a mean increase of 27.48 (95% CI = 11.48-43.49) mins/wk. of MVPA in control groups and 65.30 (95% CI = 45.59-85.01) mins/wk. of MVPA in intervention groups. Ineffective interventions tended to include older populations with existing physical limitations, had fewer contacts with participants, were less likely to include a supervised element or the BCTs of 'action planning', 'graded tasks' and 'social support (unspecified)'. Included studies were biased towards inclusion of younger, female, well-educated and white populations who were already engaging in some physical activity. CONCLUSIONS: Existing interventions are effective in achieving modest increases in physical activity at least 3 months post-intervention completion. Small improvements were also evident in control groups suggesting low-intensity interventions may be sufficient in promoting small changes in behaviour that last beyond intervention completion. However, study samples are not representative of typical cancer populations. Interventions should consider a stepped-care approach, providing more intensive support for older people with physical limitations and others less likely to engage in these interventions.

Patients and informal caregivers' experiences of burden of treatment in lung cancer and chronic obstructive pulmonary disease (COPD): a systematic review and synthesis of qualitative research.

OBJECTIVE: To identify, characterise and explain common and specific features of the experience of treatment burden in relation to patients living with lung cancer or chronic obstructive pulmonary disease (COPD) and their informal caregivers. DESIGN: Systematic review and interpretative synthesis of primary qualitative studies. Papers were analysed using constant comparison and directed qualitative content analysis. DATA SOURCES: CINAHL, EMBASE, MEDLINE, PsychINFO, Scopus and Web of Science searched from January 2006 to December 2015. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Primary qualitative studies in English where participants were patients with lung cancer or COPD and/or their informal caregivers, aged >18 years that contain descriptions of experiences of interacting with health or social care in Europe, North America and Australia. RESULTS: We identified 127 articles with 1769 patients and 491 informal caregivers. Patients, informal caregivers and healthcare professionals (HCPs) acknowledged lung cancer's existential threat. Managing treatment workload was a priority in this condition, characterised by a short illness trajectory. Treatment workload was generally well supported by an immediacy of access to healthcare systems and a clear treatment pathway. Conversely, patients, informal caregivers and HCPs typically did not recognise or understand COPD. Treatment workload was balanced with the demands of everyday life throughout a characteristically long illness trajectory. Consequently, treatment workload was complicated by difficulties of access to, and navigation of, healthcare systems, and a fragmented treatment pathway. In both conditions, patients' capacity to manage workload was enhanced by the support of family and friends, peers and HCPs and diminished by illness/smoking-related stigma and social isolation. CONCLUSION: This interpretative synthesis has affirmed significant differences in treatment workload between lung cancer and COPD. It has demonstrated the importance of the capacity patients have to manage their workload in both conditions. This suggests a workload which exceeds capacity may be a primary driver of treatment burden. PROSPERO REGISTRATION NUMBER: CRD42016048191.

What factors promote or inhibit implementation of a new procedure for screening and treatment of malnutrition in community settings? A prospective process evaluation of the Implementing Nutrition Screening in Community Care for Older People (INSCCOPe) project (UK).

INTRODUCTION: Malnutrition remains underdetected, undertreated and often overlooked by those working with older people in primary care in the UK. A new procedure for screening and treatment of malnutrition is currently being implemented by a large National Health Service (NHS) trust in England, incorporating a programme of training for staff working within Integrated Community Teams and Older People's Mental Health teams. Running in parallel, the Implementing Nutrition Screening in Community Care for Older People process evaluation study explores factors that may promote or inhibit its implementation and longer term embedding in routine care, with the aim of optimising sustainability and scalability. METHODS AND ANALYSIS: Implementation will be assessed through observation of staff within a single area of the trust, in addition to the procedure development and delivery group (PDDG). Data collection will occur at three observation points: prior to implementation of training, baseline (T0); 2 months following training (T1); and 8 months following training (T2). Observation points will consist of a survey and follow-up semistructured telephone interview with staff. Investigation of the PDDG will involve: observations of discussions around development of the procedure; semistructured telephone interviews prior to implementation, and at 6 months following implementation. Quantitative data will be described using frequency tables reporting by team type, healthcare provider role group, and total study sample (Wilcoxon rank-sum and Wilcoxon signed-rank tests may also be conducted if appropriate. Audio and transcription data will be analysed using Nomarlization Process Theory as a framework for deductive thematic analysis (using the NVIVO CAQDAS software package). ETHICS AND DISSEMINATION: Ethical approval for the study has been granted through institutional ethical review (Bournemouth University); NHS Research Ethics committee approval was not required. Dissemination will occur through presentations to academic and practitioner audiences and publication results in peer-reviewed academic journals.

Development and validation of the Patient Experience with Treatment and Self-management (PETS): a patient-reported measure of treatment burden.

PURPOSE: The purpose of this study was to develop and validate a new comprehensive patient-reported measure of treatment burden-the Patient Experience with Treatment and Self-management (PETS). METHODS: A conceptual framework was used to derive the PETS with items reviewed and cognitively tested with patients. A survey battery, including a pilot version of the PETS, was mailed to 838 multi-morbid patients from two healthcare institutions for validation. RESULTS: A total of 332 multi-morbid patients returned completed surveys. Diagnostics supported deletion and consolidation of some items and domains. Confirmatory factor analysis supported a domain model for scaling comprised of 9 factors: medical information, medications, medical appointments, monitoring health, interpersonal challenges, medical/healthcare expenses, difficulty with healthcare services, role/social activity limitations, and physical/mental exhaustion. Scales showed good internal consistency (α range 0.79-0.95). Higher PETS scores, indicative of greater treatment burden, were correlated with more distress, less satisfaction with medications, lower self-efficacy, worse physical and mental health, and lower convenience of healthcare (Ps < 0.001). Patients with lower health literacy, less adherence to medications, and more financial difficulties reported higher PETS scores (Ps < 0.01). CONCLUSION: A comprehensive patient-reported measure of treatment burden can help to better characterize the impact of treatment and self-management burden on patient well-being and guide care toward minimally disruptive medicine.

The burden of comorbidity in people with chronic kidney disease stage 3: a cohort study.

BACKGROUND: Multimorbidity is a growing concern for healthcare systems, with many countries experiencing demographic transition to older population profiles. Chronic kidney disease (CKD) is common but often considered in isolation. The extent and prognostic significance of its comorbidities is not well understood. This study aimed to assess the extent and prognostic significance of 11 comorbidities in people with CKD stage 3. METHODS: A prospective cohort of 1741 people with CKD stage 3 was recruited from primary care between August 2008 and March 2010. Participants underwent medical history, clinical assessment, blood and urine sampling. Comorbidity was defined by self-reported doctor-diagnosed condition, disease-specific medication or blood results (hemoglobin), and treatment burden as number of ongoing medications. Logistic regression was used to identify associations with greater treatment burden (taking >5 medications) and greater multimorbidity (3 or more comorbidities). Kaplan Meier plots and multivariate Cox proportional hazards models were used to investigate associations between multimorbidity and all-cause mortality. RESULTS: One thousand seven hundred forty-one people were recruited, mean age 72.9 +/-9 years. Mean baseline eGFR was 52 ml/min/1.73 m(2). Only 78/1741 (4 %) had no comorbidities, 453/1741 (26 %) had one, 508/1741 (29 %) had two and 702/1741 (40 %) had >2. Hypertension was common (88 %), 30 % had 'painful condition', 24 % anemia, 23 %, ischaemic heart disease, 17 % diabetes and 12 % thyroid disorders. Median medication use was 5 medications (interquartile range 3-8) and increased with degree of comorbidity. Greater treatment burden and multimorbidity were independently associated with age, smoking, increasing body mass index and decreasing eGFR. Treatment burden was also independently associated with lower education status. After median 3.6 years follow-up, 175/1741 (10 %) died. Greater multimorbidity was independently associated with mortality (hazard ratio 2.81 (95 % confidence intervals 1.72-4.58), p < 0.001) for 3 or more comorbidities vs 0 or 1). CONCLUSIONS: Isolated CKD was rare and multimorbidity the norm in this cohort of people with moderate CKD. Increasing multimorbidity was associated with greater medication burden and poorer survival. CKD management should include consideration of comorbidities.

RESTORE: an exploratory trial of a web-based intervention to enhance self-management of cancer-related fatigue: findings from a qualitative process evaluation.

BACKGROUND: Cancer-related fatigue is a distressing symptom experienced by many after cancer treatment. An exploratory randomised controlled trial was conducted to test proof of concept of RESTORE: a web-based tool to enhance self-efficacy to manage cancer-related fatigue. This paper reports findings from a qualitative process evaluation to determine feasibility and acceptability of the intervention and trial processes. METHOD: Qualitative process evaluation carried out at the end of the trial to explore participants' experiences using semi-structured telephone interviews with a purposive sample of participants from both trial arms. Normalisation Process Theory informed data collection and analysis. Analysis involved directed content analysis within a Framework Approach. RESULTS: Nineteen participants took part. They understood the purpose and requirements of the trial and identified beneficial outcomes from taking part. For the majority, the work of the trial was easily accommodated into daily routines and did not require new skills. There were mixed views about the value of the information provided by RESTORE, depending on time since diagnosis and treatment. Personal factors, constraints of the intervention, and environmental context inhibited the integration and embedding of RESTORE into everyday life. Access to the intervention at an early stage in the treatment trajectory was important to effective utilisation, as were individual preferences for delivery of information. CONCLUSION: The theoretical foundations of the intervention were sound. Participants derived benefits from the intervention but barriers to implementation and integration suggest that RESTORE and the trial processes require some modification before testing in a full trial. TRIAL REGISTRATION: ISRCTN67521059 (10(th) October 2012).

Stroke, multimorbidity and polypharmacy in a nationally representative sample of 1,424,378 patients in Scotland: implications for treatment burden.

BACKGROUND: The prevalence of multimorbidity (the presence of two or more long-term conditions) is rising internationally. Multimorbidity affects patients by increasing their burden of symptoms, but is also likely to increase the self-care demands, or treatment burden, that they experience. Treatment burden refers to the effort expended in operationalising treatments, navigating healthcare systems and managing relations with healthcare providers. This is an important problem for people with chronic illness such as stroke. Polypharmacy is an important marker of both multimorbidity and burden of treatment. In this study, we examined the prevalence of multimorbidity and polypharmacy in a large, nationally representative population of primary care patients with and without stroke, adjusting for age, sex and deprivation. METHODS: A cross-sectional study of 1,424,378 participants aged 18 years and over, from 314 primary care practices in Scotland that were known to be demographically representative of the Scottish adult population. Data included information on the presence of stroke and another 39 long-term conditions, plus prescriptions for regular medications. RESULTS: In total, 35,690 people (2.5%) had a diagnosis of stroke. Of the 39 comorbidities examined, 35 were significantly more common in people with stroke. Of the people with a stroke, the proportion that had one or more additional morbidities present (94.2%) was almost twice that in the control group (48%) (odds ratio (OR) adjusted for age, sex and socioeconomic deprivation 5.18; 95% confidence interval (CI) 4.95 to 5.43). In the stroke group, 12.6% had a record of 11 or more repeat prescriptions compared with only 1.5% of the control group (OR adjusted for age, sex, deprivation and morbidity count 15.84; 95% CI 14.86 to 16.88). Limitations include the use of data collected for clinical rather than research purposes, a lack of consensus in the literature on the definition of certain long-term conditions, and the absence of statistical weighting in the measurement of multimorbidity, although the latter was deemed suitable for descriptive analyses. CONCLUSIONS: Multimorbidity and polypharmacy were strikingly more common in those with a diagnosis of stroke compared with those without. This has important implications for clinical guidelines and the design of health services.

Chronic diseases and multi-morbidity--a conceptual modification to the WHO ICCC model for countries in health transition.

BACKGROUND: The burden of non-communicable diseases is rising, particularly in low and middle-income countries undergoing rapid epidemiological transition. In sub-Saharan Africa, this is occurring against a background of infectious chronic disease epidemics, particularly HIV and tuberculosis. Consequently, multi-morbidity, the co-existence of more than one chronic condition in one person, is increasing; in particular multimorbidity due to comorbid non-communicable and infectious chronic diseases (CNCICD). Such complex multimorbidity is a major challenge to existing models of healthcare delivery and there is a need to ensure integrated care across disease pathways and across primary and secondary care. DISCUSSION: The Innovative Care for Chronic Conditions (ICCC) Framework developed by the World Health Organization provides a health systems roadmap to meet the increasing needs of chronic disease care. This framework incorporates community, patient, healthcare and policy environment perspectives, and forms the cornerstone of South Africa's primary health care re-engineering and strategic plan for chronic disease management integration. However, it does not significantly incorporate complexity associated with multimorbidity and CNCICD.Using South Africa as a case study for a country in transition, we identify gaps in the ICCC framework at the micro-, meso-, and macro-levels. We apply the lens of CNCICD and propose modification of the ICCC and the South African Integrated Chronic Disease Management plan. Our framework incorporates the increased complexity of treating CNCICD patients, and highlights the importance of biomedicine (biological interaction). We highlight the patient perspective using a patient experience model that proposes that treatment adherence, healthcare utilization, and health outcomes are influenced by the relationship between the workload that is delegated to patients by healthcare providers, and patients' capacity to meet the demands of this workload. We link these issues to provider perspectives that interact with healthcare delivery and utilization. SUMMARY: Our proposed modification to the ICCC Framework makes clear that healthcare systems must work to make sense of the complex collision between biological phenomena, clinical interpretation, beliefs and behaviours that follow from these. We emphasize the integration of these issues with the socio-economic environment to address issues of complexity, access and equity in the integrated management of chronic diseases previously considered in isolation.

Patient, carer and professional perspectives on barriers and facilitators to quality care in advanced heart failure.

BACKGROUND: Those with advanced heart failure (HF) experience high levels of morbidity and mortality, similar to common cancers. However, there remains evidence of inequity of access to palliative care services compared to people with cancer. This study examines patient, carer, and professional perspectives on current management of advanced HF and barriers and facilitators to improved care. METHODS: Qualitative study involving semi-structured interviews and focus groups with advanced HF patients (n = 30), carers (n = 20), and professionals (n = 65). Data analysed using Normalisation Process Theory (NPT) as the underpinning conceptual framework. FINDINGS: Uncertainty is ubiquitous in accounts from advanced HF patients and their caregivers. This uncertainty relates to understanding of the implications of their diagnosis, appropriate treatments, and when and how to seek effective help. Health professionals agree this is a major problem but feel they lack knowledge, opportunities, or adequate support to improve the situation. Fragmented care with lack of coordination and poor communication makes life difficult. Poor understanding of the condition extends to the wider circle of carers and means that requests for help may not be perceived as legitimate, and those with advanced HF are not prioritised for social and financial supports. Patient and caregiver accounts of emergency care are uniformly poor. Managing polypharmacy and enduring concomitant side effects is a major burden, and the potential for rationalisation exists. This study has potential limitations because it was undertaken within a single geographical location within the United Kingdom. CONCLUSIONS: Little progress is being made to improve care experiences for those with advanced HF. Even in the terminal stages, patients and caregivers are heavily and unnecessarily burdened by health care services that are poorly coordinated and offer fragmented care. There is evidence that these poor experiences could be improved to a large extent by simple organisational rather than complex clinical mechanisms.

RESTORE: an exploratory trial of an online intervention to enhance self-efficacy to manage problems associated with cancer-related fatigue following primary cancer treatment: study protocol for a randomized controlled trial.

BACKGROUND: There are over 25 million people worldwide living with or beyond cancer and this number is increasing. Cancer survivors face a range of problems following primary treatment. One of the most frequently reported and distressing symptoms experienced by cancer survivors is fatigue. There is growing support for survivors who are experiencing problems after cancer treatment to engage in supported self-management. To date there is some evidence of effective interventions to manage fatigue in this population; however, to our knowledge there are no online resources that draw on this information to support self-management of fatigue. This paper describes the protocol for an exploratory randomized controlled trial of an online intervention to support self-management of cancer-related fatigue after primary cancer treatment. METHODS/DESIGN: This is a parallel-group two-armed (1:1) exploratory randomized controlled trial including 125 cancer survivors experiencing fatigue (scoring ≥4 on a unidimensional 11-point numeric rating scale for fatigue intensity) within five years of primary treatment completion with curative intent. Participants will be recruited from 13 NHS Trusts across the UK and randomized to either the online intervention (RESTORE), or a leaflet comparator (Macmillan Cancer Backup, Coping with Fatigue). The primary outcome is a change in Perceived Self-Efficacy for Fatigue Self-Management (as measured by the Perceived Self-Efficacy for Fatigue Self-Management Instrument). Secondary outcomes include impact on perception and experience of fatigue (measured by the Brief Fatigue Inventory), and quality of life (measured by the Functional Assessment of Cancer Therapy - General and the Personal Wellbeing Index). Outcome measures will be collected at baseline, 6 weeks (completion of intervention), and 3 months. Process evaluation (including telephone interviews with recruiting staff and participants) will determine acceptability of the intervention and trial processes. DISCUSSION: Data from this trial will be used to refine the intervention and contribute to the design of an effectiveness trial. This intervention will be expanded to address other cancer-related problems important to cancer survivors following primary cancer treatment. TRIAL REGISTRATION: ISRCTN67521059.