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.

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.

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.

Co-construction of the family-focused support conversation: a participatory learning and action research study to implement support for family members whose relatives are being discharged for end-of-life care at home or in a nursing home.

BACKGROUND: Many people move in and out of hospital in the last few weeks of life. These care transitions can be distressing for family members because they signify the deterioration and impending death of their ill relative and forthcoming family bereavement. Whilst there is evidence about psychosocial support for family members providing end-of-life care at home, there is limited evidence about how this can be provided in acute hospitals during care transitions. Consequently, family members report a lack of support from hospital-based healthcare professionals. METHODS: The aim of the study was to implement research evidence for family support at the end-of-life in acute hospital care. Informed by Participatory Learning and Action Research and Normalization Process Theory (NPT) we co-designed a context-specific intervention, the Family-Focused Support Conversation, from a detailed review of research evidence. We undertook a pilot implementation in three acute hospital Trusts in England to assess the potential for the intervention to be used in clinical practice. Pilot implementation was undertaken during a three-month period by seven clinical co-researchers - nurses and occupational therapists in hospital specialist palliative care services. Implementation was evaluated through data comprised of reflective records of intervention delivery (n = 22), in-depth records of telephone implementation support meetings between research team members and co-researchers (n = 3), and in-depth evaluation meetings (n = 2). Data were qualitatively analysed using an NPT framework designed for intervention evaluation. RESULTS: Clinical co-researchers readily incorporated the Family-Focused Support Conversation into their everyday work. The intervention changed family support from being solely patient-focused, providing information about patient needs, to family-focused, identifying family concerns about the significance and implications of discharge and facilitating family-focused care. Co-researchers reported an increase in family members' involvement in discharge decisions and end-of-life care planning. CONCLUSION: The Family-Focused Support Conversation is a novel, evidenced-based and context specific intervention. Pilot implementation demonstrated the potential for the intervention to be used in acute hospitals to support family members during end-of-life care transitions. This subsequently informed a larger scale implementation study. TRIAL REGISTRATION: n/a.

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.

Improving the normalization of complex interventions: part 1 - development of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT).

BACKGROUND: Understanding and measuring implementation processes is a key challenge for implementation researchers. This study draws on Normalization Process Theory (NPT) to develop an instrument that can be applied to assess, monitor or measure factors likely to affect normalization from the perspective of implementation participants. METHODS: An iterative process of instrument development was undertaken using the following methods: theoretical elaboration, item generation and item reduction (team workshops); item appraisal (QAS-99); cognitive testing with complex intervention teams; theory re-validation with NPT experts; and pilot testing of instrument. RESULTS: We initially generated 112 potential questionnaire items; these were then reduced to 47 through team workshops and item appraisal. No concerns about item wording and construction were raised through the item appraisal process. We undertook three rounds of cognitive interviews with professionals (n = 30) involved in the development, evaluation, delivery or reception of complex interventions. We identified minor issues around wording of some items; universal issues around how to engage with people at different time points in an intervention; and conceptual issues around the types of people for whom the instrument should be designed. We managed these by adding extra items (n = 6) and including a new set of option responses: 'not relevant at this stage', 'not relevant to my role' and 'not relevant to this intervention' and decided to design an instrument explicitly for those people either delivering or receiving an intervention. This version of the instrument had 53 items. Twenty-three people with a good working knowledge of NPT reviewed the items for theoretical drift. Items that displayed a poor alignment with NPT sub-constructs were removed (n = 8) and others revised or combined (n = 6). The final instrument, with 43 items, was successfully piloted with five people, with a 100% completion rate of items. CONCLUSION: The process of moving through cycles of theoretical translation, item generation, cognitive testing, and theoretical (re)validation was essential for maintaining a balance between the theoretical integrity of the NPT concepts and the ease with which intended respondents could answer the questions. The final instrument could be easily understood and completed, while retaining theoretical validity. NoMAD represents a measure that can be used to understand implementation participants' experiences. It is intended as a measure that can be used alongside instruments that measure other dimensions of implementation activity, such as implementation fidelity, adoption, and readiness.

Improving the normalization of complex interventions: part 2 - validation of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT).

INTRODUCTION: Successful implementation and embedding of new health care practices relies on co-ordinated, collective behaviour of individuals working within the constraints of health care settings. Normalization Process Theory (NPT) provides a theory of implementation that emphasises collective action in explaining, and shaping, the embedding of new practices. To extend the practical utility of NPT for improving implementation success, an instrument (NoMAD) was developed and validated. METHODS: Descriptive analysis and psychometric testing of an instrument developed by the authors, through an iterative process that included item generation, consensus methods, item appraisal, and cognitive testing. A 46 item questionnaire was tested in 6 sites implementing health related interventions, using paper and online completion. Participants were staff directly involved in working with the interventions. Descriptive analysis and consensus methods were used to remove redundancy, reducing the final tool to 23 items. Data were subject to confirmatory factor analysis which sought to confirm the theoretical structure within the sample. RESULTS: We obtained 831 completed questionnaires, an average response rate of 39% (range: 22-77%). Full completion of items was 50% (n = 413). The confirmatory factor analysis showed the model achieved acceptable fit (CFI = 0.95, TLI = 0.93, RMSEA = 0.08, SRMR = 0.03). Construct validity of the four theoretical constructs of NPT was supported, and internal consistency (Cronbach's alpha) were as follows: Coherence (4 items, α = 0.71); Collective Action (7 items, α = 0.78); Cognitive Participation (4 items, α = 0.81); Reflexive Monitoring (5 items, α = 0.65). The normalisation scale overall, was highly reliable (20 items, α = 0.89). CONCLUSIONS: The NoMAD instrument has good face validity, construct validity and internal consistency, for assessing staff perceptions of factors relevant to embedding interventions that change their work practices. Uses in evaluating and guiding implementation are proposed.

Implementation of grip strength measurement in medicine for older people wards as part of routine admission assessment: identifying facilitators and barriers using a theory-led intervention.

BACKGROUND: Low grip strength in older inpatients is associated with poor healthcare outcomes including longer length of stay and mortality. Measuring grip strength is simple and inexpensive. However, it is not routinely used in clinical practice. We aimed to evaluate the implementation of grip strength measurement into routine clinical practice. METHODS: This implementation study was a mixed methods study based in five acute medical wards for older people in one UK hospital. Intervention design and implementation evaluation were based on Normalization Process Theory (NPT). A training program was developed and delivered to enable staff to measure grip strength and use a care plan for patients with low grip strength. Routine implementation and monitoring was assessed using the "implementation outcome variables" proposed by WHO: adoption, coverage, acceptability, fidelity, and costs analysis. Enablers and barriers of implementation were identified. RESULTS: One hundred fifty-five nursing staff were trained, 63% in just 3 weeks. Adoption and monthly coverage of grip strength measurement varied between 25 and 80% patients across wards. 81% of female patients and 75% of male patients assessed had low grip strength (< 27 kg for men and < 16 kg for women). Staff and patients found grip measurement easy, cheap and potentially beneficial in identifying high-risk patients. The total cost of implementation across five wards over 12 months was less than £2302. Using NPT, interviews identified enablers and barriers. Enablers included: highly motivated ward champions, managerial support, engagement strategies, shared commitment, and integration into staff and ward daily routines. Barriers included lack of managerial and staff support, and high turnover of staff, managers and champions. CONCLUSIONS: Training a large number of nurses to routinely implement grip strength measurement of older patients was feasible, acceptable and inexpensive. Champions' motivation, managerial support, and shared staff commitment were important for the uptake and normalisation of grip strength measurement. A high percentage of older patients were identified to be at risk of poor healthcare outcomes and would benefit from nutritional and exercise interventions. Measuring grip strength in these patients could provide an opportunity to identify those with normal grip strength for fast tracking through admission to discharge thereby reducing length of stay. TRIAL REGISTRATION: Clinicaltrials.gov NCTO2447445 . Registered May 18, 2015.

A conceptual model of treatment burden and patient capacity in stroke.

BACKGROUND: Treatment burden is the workload of healthcare experienced by those with long-term conditions and the impact that this has on well-being. Treatment burden can negatively impact on quality of life and adherence to treatments. Individuals are likely to differ in their ability to manage health problems and follow treatments, defined as patient capacity. This has been under investigated in stroke. The aim of this paper is to create a conceptual model of treatment burden and patient capacity for people who have had a stroke through exploration of their experiences of healthcare. METHODS: Interviews were conducted at home with 29 individuals who have had a stroke. These were recorded and transcribed verbatim. Fifteen explored treatment burden and were analysed by framework analysis underpinned by Normalisation Process Theory (NPT). Fourteen explored patient capacity and were analysed by thematic analysis. Taxonomies of treatment burden and patient capacity were created and a conceptual model produced. RESULTS: Mean age was 68 years. Sixteen were men and 13 women. The following broad areas of treatment burden were identified: making sense of stroke management and planning care; interacting with others including health professionals, family and other stroke patients; enacting management strategies; and reflecting on management. Treatment burdens were identified as arising from either: the workload of healthcare; or the endurance of care deficiencies. Six factors were identified that influence patient capacity: personal attributes and skills; physical and cognitive abilities; support network; financial status; life workload, and environment. CONCLUSIONS: Healthcare workload and the presence of care deficiencies can influence and be influenced by patient capacity. The quality and configuration of health and social care services has considerable influence on treatment burden and patient capacity. Findings have important implications for the design of clinical guidelines and healthcare delivery, highlighting issues such as the importance of good care co-ordination.

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.

Managing expectations: cognitive authority and experienced control in complex healthcare processes.

BACKGROUND: Balancing the normative expectations of others (accountabilities) against the personal and distributed resources available to meet them (capacity) is a ubiquitous feature of social relations in many settings. This is an important problem in the management of long-term conditions, because of widespread problems of non-adherence to treatment regimens. Using long-term conditions as an example, we set out middle range theory of this balancing work. METHODS: A middle-range theory was constructed four stages. First, a qualitative elicitation study of men with heart failure was used to develop general propositions about patient and care giver experience, and about the ways that the organisation and delivery of care affected this. Second, these propositions were developed and confirmed through a systematic review of qualitative research literature. Third, theoretical propositions and constructs were built, refined and presented as a logic model associated with two main theoretical propositions. Finally, a construct validation exercise was undertaken, in which construct definitions informed reanalysis of a set of systematic reviews of studies of patient and caregiver experiences of heart failure that had been included in an earlier meta-review. RESULTS: Cognitive Authority Theory identifies, characterises and explains negotiation processes in in which people manage their relations with the expectations of normative systems - like those encountered in the management of long-term conditions. Here, their cognitive authority is the product of an assessment of competence, trustworthiness and credibility made about a person by other participants in a healthcare process; and their experienced control is a function of the degree to which they successfully manage the external process-specific limiting factors that make it difficult to otherwise perform in their role. CONCLUSION: Cognitive Authority Theory assists in explaining how participants in complex social processes manage important relational aspects of inequalities in power and expertise. It can play an important part in understanding the dynamics of participation in healthcare processes. It suggests ways in which these burdens may lead to relationally induced non-adherence to treatment regimens and self-care programmes, and points to targets where intervention may reduce these adverse outcomes.

Integrating acute stroke telemedicine consultations into specialists' usual practice: a qualitative analysis comparing the experience of Australia and the United Kingdom.

BACKGROUND: Stroke telemedicine can reduce healthcare inequities by increasing access to specialists. Successful telemedicine networks require specialists adapting clinical practice to provide remote consultations. Variation in experiences of specialists between different countries is unknown. To support future implementation, we compared perceptions of Australian and United Kingdom specialists providing remote acute stroke consultations. METHODS: Specialist participants were identified using purposive sampling from two new services: Australia's Victorian Stroke Telemedicine Program (n = 6; 2010-13) and the United Kingdom's Cumbria and Lancashire telestroke network (n = 5; 2010-2012). Semi-structured interviews were conducted pre- and post-implementation, recorded and transcribed verbatim. Deductive thematic and content analysis (NVivo) was undertaken by two independent coders using Normalisation Process Theory to explore integration of telemedicine into practice. Agreement between coders was M = 91%, SD = 9 and weighted average κ = 0.70. RESULTS: Cross-cultural similarities and differences were found. In both countries, specialists described old and new consulting practices, the purpose and value of telemedicine systems, and concerns regarding confidence in the assessment and diagnostic skills of unknown colleagues requesting telemedicine support. Australian specialists discussed how remote consultations impacted on usual roles and suggested future improvements, while United Kingdom specialists discussed system governance, policy and procedures. CONCLUSION: Australian and United Kingdom specialists reported telemedicine required changes in work practice and development of new skills. Both groups described potential for improvements in stroke telemedicine systems with Australian specialists more focused on role change and the United Kingdom on system governance issues. Future research should examine if cross-cultural variation reflects different models of care and extends to other networks.

Patient capacity and constraints in the experience of chronic disease: a qualitative systematic review and thematic synthesis.

BACKGROUND: Life and healthcare demand work from patients, more so from patients living with multimorbidity. Patients must respond by mobilizing available abilities and resources, their so-called capacity. We sought to summarize accounts of challenges that reduce patient capacity to access or use healthcare or to enact self-care while carrying out their lives. METHODS: We conducted a systematic review and synthesis of the qualitative literature published since 2000 identifying from MEDLINE, EMBASE, Psychinfo, and CINAHL and retrieving selected abstracts for full text assessment for inclusion. After assessing their methodological rigor, we coded their results using a thematic synthesis approach. RESULTS: The 110 reports selected, when synthesized, showed that patient capacity is an accomplishment of interaction with (1) the process of rewriting their biographies and making meaningful lives in the face of chronic condition(s); (2) the mobilization of resources; (3) healthcare and self-care tasks, particularly, the cognitive, emotional, and experiential results of accomplishing these tasks despite competing priorities; (4) their social networks; and (5) their environment, particularly when they encountered kindness or empathy about their condition and a feasible treatment plan. CONCLUSION: Patient capacity is a complex and dynamic construct that exceeds "resources" alone. Additional work needs to translate this emerging theory into useful practice for which we propose a clinical mnemonic (BREWS) and the ICAN Discussion Aid.

Making sense of technology adoption in healthcare: meso-level considerations.

It has been clear for some time that the development of telecare faces significant problems. Large scale studies and clinical trials seem to suggest that the cost and clinical effectiveness of telecare systems is doubtful, and the claim that these systems empower or enable service users often seems greatly overstated. The question that stems from this is, can these problems be overcome? Greenhalgh et al. have critiqued the construction of telecare as a generalised technological solution to problems of the delivery of care and have offered a new framework for defining quality in telecare and telehealth. They outline a set of principles that focus on user-centredness, co-creation, integration, and evaluation. This is a valuable approach, and is part of a much wider transformation of the way in which policy and practice researchers conceptualise healthcare delivery as a problem of performativity. Recognising that this is an important shift, in this paper I argue that we also need to keep in mind the meso-level factors that structure new technology applications in practice. Please see the related article: http://dx.doi.org/10.1186/s12916-015-0279-6.

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.