The effectiveness of a primary care-based collaborative care model to improve quality of life in people with severe mental illness: PARTNERS2 cluster randomised controlled trial.

BACKGROUND: Individuals living with severe mental illness can have significant emotional, physical and social challenges. Collaborative care combines clinical and organisational components. AIMS: We tested whether a primary care-based collaborative care model (PARTNERS) would improve quality of life for people with diagnoses of schizophrenia, bipolar disorder or other psychoses, compared with usual care. METHOD: We conducted a general practice-based, cluster randomised controlled superiority trial. Practices were recruited from four English regions and allocated (1:1) to intervention or control. Individuals receiving limited input in secondary care or who were under primary care only were eligible. The 12-month PARTNERS intervention incorporated person-centred coaching support and liaison work. The primary outcome was quality of life as measured by the Manchester Short Assessment of Quality of Life (MANSA). RESULTS: We allocated 39 general practices, with 198 participants, to the PARTNERS intervention (20 practices, 116 participants) or control (19 practices, 82 participants). Primary outcome data were available for 99 (85.3%) intervention and 71 (86.6%) control participants. Mean change in overall MANSA score did not differ between the groups (intervention: 0.25, s.d. 0.73; control: 0.21, s.d. 0.86; estimated fully adjusted between-group difference 0.03, 95% CI -0.25 to 0.31; P = 0.819). Acute mental health episodes (safety outcome) included three crises in the intervention group and four in the control group. CONCLUSIONS: There was no evidence of a difference in quality of life, as measured with the MANSA, between those receiving the PARTNERS intervention and usual care. Shifting care to primary care was not associated with increased adverse outcomes.

Use of Clinical Pathway Simulation and Machine Learning to Identify Key Levers for Maximizing the Benefit of Intravenous Thrombolysis in Acute Stroke.

BACKGROUND: Expert opinion is that about 20% of emergency stroke patients should receive thrombolysis. Currently, 11% to 12% of patients in England and Wales receive thrombolysis, ranging from 2% to 24% between hospitals. The aim of this study was to assess how much variation is due to differences in local patient populations, and how much is due to differences in clinical decision-making and stroke pathway performance, while estimating a realistic target thrombolysis use. METHODS: Anonymised data for 246 676 emergency stroke admissions to 132 acute hospitals in England and Wales between 2016 and 2018 was obtained from the Sentinel Stroke National Audit Programme data. We used machine learning to learn decisions on who to give thrombolysis to at each hospital. We used clinical pathway simulation to model effects of changing pathway performance. Qualitative research was used to assess clinician attitudes to these methods. Three changes were modeled: (1) arrival-to-treatment in 30 minutes, (2) proportion of patients with determined stroke onset times set to at least the national upper quartile, (3) thrombolysis decisions made based on majority vote of a benchmark set of hospitals. RESULTS: Of the modeled changes, any single change was predicted to increase national thrombolysis use from 11.6% to between 12.3% to 14.5% (clinical decision-making having the most effect). Combined, these changes would be expected to increase thrombolysis to 18.3%, but there would still be significant variation between hospitals depending on local patient population. Clinicians engaged well with the modeling, but those from hospitals with lower thrombolysis use were most cautious about the methods. CONCLUSIONS: Machine learning and clinical pathway simulation may be applied at scale to national stroke audit data, allowing extended use and analysis of audit data. Stroke thrombolysis rates of at least 18% look achievable in England and Wales, but each hospital should have its own target.

The value of social practice theory for implementation science: learning from a theory-based mixed methods process evaluation of a randomised controlled trial.

BACKGROUND: Although there is trial evidence that complex interventions are effective for the self-management of heart failure, little evidence supports their effectiveness in routine practice. We used Social Practice Theory to guide a Type 1 Hybrid Trial: a mixed methods process evaluation of a complex intervention for heart failure. The objective of this paper is to explore the value of Social Practice Theory for implementation science. METHODS: Social Practice Theory informed a mixed methods process evaluation of a multi-centre randomised controlled trial of a 12 week home-based intervention to optimise self-care support for people with heart failure and their caregivers - Rehabilitation EnAblement in Chronic Heart Failure (REACH-HF). Interviews were conducted with 19 people with heart failure and 17 caregivers at 4 months and 12 months after recruitment into the trial. Cases were constructed at the level of the individual, couple, facilitator and centre; and included multi-modal process and outcome data. Evaluative coding and subsequent within- and cross-case analyses enabled the development of a typology of relationships linking fidelity of intervention delivery and tailoring of content to individual needs and concerns. Social Practice Theory was used to interrogate the relationships between elements of the intervention and their implementation. RESULTS: Of 216 trial participants, 107 were randomised to the intervention (REACH-HF plus usual care). The intervention was most effective when fidelity was high and delivery was tailored to the individual's needs, but less effective when both tailoring and fidelity were low. Theory-based analysis enabled us to model complex relationships between intervention elements (competencies, materials and meanings) and social context. The findings illustrate how intervention fidelity and tailoring are contextual and how the effectiveness of the REACH-HF intervention depended on both optimal alignment and implementation of these elements. CONCLUSION: The study demonstrates the utility of theory-based analysis which integrates data from multiple sources to highlight contexts and circumstances in which interventions work best. Social Practice Theory provides a framework for guiding and analysing the processes by which a complex intervention is evaluated in a clinical trial, and has the potential to guide context-specific implementation strategies for clinical practice. TRIAL REGISTRATION: ISRCTN, IISRCTN86234930 . Registered 13th November 2014.

Patients' and nurses' experiences of fundamental nursing care: A systematic review and qualitative synthesis.

AIMS AND OBJECTIVES: To systematically identify, appraise and synthesise patients', residents' and nurses' experiences of fundamental nursing care for nutrition, elimination, mobility and hygiene. BACKGROUND: The evidence base for effective nursing behaviours to assist people with their fundamental care needs is sparse, hampering the development of effective interventions. Synthesising data on patients' and nurses' experiences of fundamentals of nursing care could contribute to the development of such an intervention. METHODS: Systematic review and synthesis of qualitative data from qualitative studies on patients' and nurses' experiences of fundamental nursing care behaviours addressing peoples' nutrition, elimination, mobility and hygiene needs. We appraised study quality and relevance and used a narrative approach to data synthesis, fulfilling PRISMA criteria (Appendix S2). RESULTS: We identified 22,374 papers, and 47 met our inclusion criteria. Most papers were of low quality. Sixteen papers met our quality and relevance criteria and were included for synthesis. Papers were about nutrition (2) elimination (2), mobility (5), hygiene (5) and multiple care areas (2). We found nurses and patients report that fundamental nursing care practices involve strong leadership, collaborative partnerships with patients and cohesive organisational practices aligned to nursing care objectives and actions. CONCLUSIONS: To improve fundamental care and interventions suitable for testing may require attention to leadership, patient-nurse relationships and organisational coherence plus the fundamentals of care nursing interventions themselves. RELEVANCE TO CLINICAL PRACTICE: More rigorous mixed methods research about fundamental nursing care is needed to inform nursing practice and improve patient's experience. Nursing interventions should include effective nurse leadership and nurse-patient collaboration and a focus on fundamental care by the host organisation.

Patient involvement in qualitative data analysis in a trial of a patient-centred intervention: Reconciling lay knowledge and scientific method.

BACKGROUND: We conducted a pilot study of an intervention to facilitate patients' agenda setting in clinical consultations. The primary aim of the study was to test the feasibility of running the randomized controlled trial. A secondary objective was to assess the extent to which patient and public involvement (PPI) could contribute to the process of qualitative data analysis (QDA). AIMS: To describe a novel approach to including patient partners in QDA; to illustrate the kinds of contribution that patient partners made to QDA in this context; and to propose a characterization of a process by which patient involvement can contribute to knowledge production. METHODS: Six patient and public representatives were supported to contribute to data analysis via a range of modalities. During a series of QDA workshops, experienced research staff role-played consultations and interviews, and provided vignettes. Workshop data and PPI diaries were analysed using thematic discourse analysis. RESULTS: We characterized a process of thesis, antithesis and synthesis. This PPI group contributed to the rigour and validity of the study findings by challenging their own and the researchers' assumptions, and by testing the emerging hypotheses. By training PPI representatives to undertake qualitative data analysis, we transformed our understanding of doctor-patient consultations. CONCLUSIONS: This research required changes to our usual research practices but was in keeping with the objective of establishing meaningful patient involvement for a future definitive trial. This work was informed by concepts of critical humility, and a process of knowledge production enabled via the construction of a knowledge space.

Amalgamation of Marginal Gains (AMG) as a potential system to deliver high-quality fundamental nursing care: A qualitative analysis of interviews from high-performance AMG sports and healthcare practitioners.

AIMS AND OBJECTIVES: To investigate the components of the Amalgamation of Marginal Gains (AMG) performance system to identify a set of principles that can be built into an innovative fundamental nursing care protocol. BACKGROUND: Nursing is urged to refocus on its fundamental care activities, but little evidence exists to guide practising nurses. Fundamental care is a combination of many small behaviours aimed at meeting a person's care needs. AMG is a successful system of performance management that focusses on small (or marginal) gains, and might provide a new delivery framework for fundamental nursing care. DESIGN: Qualitative interview study. METHODS: We undertook in-depth interviews with healthcare and sports professionals experienced in AMG. We analysed data using open coding in a framework analysis, and then interrogated the data using Normalisation Process Theory (NPT). We triangulated findings with AMG literature to develop an intervention logic model. RESULTS: We interviewed 20 AMG practitioners. AMG processes were as follows: focusing on many details to optimise performance, identification of marginal gains using different sources, understanding current versus optimum performance, monitoring at micro and macro level and strong leadership. Elements of normalisation were as follows: whole team belief in AMG to improve performance, a collective desire for excellence using evidence-based actions, whole team engagement to identify choose and implement changes, and individual and group responsibility for monitoring performance. CONCLUSIONS: We have elicited the processes described by AMG innovators in health care and sport and have mapped the normalisation potential and work required to embed such a system into nursing practice. RELEVANCE TO CLINICAL PRACTICE: The development of our logic model based on AMG and NPT may provide a practical framework for improving fundamental nursing care and is ripe for further development and testing in clinical trials.

Fundamental nursing care: A systematic review of the evidence on the effect of nursing care interventions for nutrition, elimination, mobility and hygiene.

AIMS AND OBJECTIVES: To determine the effects of nursing interventions for people's nutrition, elimination, mobility and hygiene needs. BACKGROUND: Patient experience of health care is sensitive to nursing quality. A refocus on fundamental nursing care is undermined by lack of evidence of effectiveness for interventions in core areas such as elimination, nutrition, mobility and hygiene. DESIGN: Systematic review. METHODS: We searched for and included experimental studies on interventions by professionally qualified and unregistered nurses that addressed participants' nutrition, elimination, mobility and hygiene needs. We extracted data on scope, quality and results of studies followed by descriptive narrative synthesis of included study outcomes using a novel form of harvest plots. RESULTS: We included 149 studies, 35 nutrition, 56 elimination, 16 mobility, 39 hygiene and three addressing two or more areas simultaneously (67 randomised controlled trials, 32 non-randomised controlled trials and 50 uncontrolled trials). Studies into interventions on participant self-management of nutrition (n = 25), oral health (n = 26), catheter care (n = 23) and self-management of elimination (n = 21) were the most prevalent. Most studies focussed their outcomes on observational or physiological measures, with very few collecting patient-reported outcomes, such as quality of life, experience or self-reported symptoms. All but 13 studies were of low quality and at significant risk of bias. The majority of studies did not define primary outcomes, included multiple measures of identical concepts, used inappropriate analyses and did not conform to standard reporting quality criteria. CONCLUSIONS: The current evidence for fundamental nursing care interventions is sparse, of poor quality and unfit to provide evidence-based guidance to practising nurses. RELEVANCE TO CLINICAL PRACTICE: Researchers in nursing internationally should now undertake a programme of work to produce evidence for clinical practice in the fundamentals of care that is reliable, replicable and robust.

Asking More of Qualitative Synthesis: A Response to Sally Thorne.

We continue the conversation initiated by Sally Thorne's observations about "metasynthetic madness." We note that the variety of labels used to describe qualitative syntheses often reflect authors' disciplines and geographical locations. The purpose of systematic literature searching is to redress authors' lack of citation of relevant earlier work and to reassure policy makers that qualitative syntheses are systematic and transparent. There is clearly a need to develop other methods of searching to supplement electronic searches. If searches produce large numbers of articles, sampling strategies may be needed to choose which articles to synthesize. The quality of any synthesis is dependent on the quality of the primary articles; both primary research and qualitative synthesis need to move beyond description and toward theory and explanation. Synthesizers need to pay attention to those articles which do not seem to fit their emerging analysis if they are to avoid stifling new ideas.

Meta-Study as Diagnostic: Toward Content Over Form in Qualitative Synthesis.

Having previously conducted qualitative syntheses of the diabetes literature, we wanted to explore the changes in theoretical approaches, methodological practices, and the construction of substantive knowledge which have recently been presented in the qualitative diabetes literature. The aim of this research was to explore the feasibility of synthesizing existing qualitative syntheses of patient perspectives of diabetes using meta-study methodology. A systematic review of qualitative literature, published between 2000 and 2013, was conducted. Six articles were identified as qualitative syntheses. The meta-study methodology was used to compare the theoretical, methodological, analytic, and synthetic processes across the six studies, exploring the potential for an overarching synthesis. We identified that while research questions have increasingly concentrated on specific aspects of diabetes, the focus on systematic review processes has led to the neglect of qualitative theory and methods. This can inhibit the production of compelling results with meaningful clinical applications. Although unable to produce a synthesis of syntheses, we recommend that researchers who conduct qualitative syntheses pay equal attention to qualitative traditions and systematic review processes, to produce research products that are both credible and applicable.

Context and complexity: the meaning of self-management for older adults with heart disease.

Self-management policies have presented opportunities for patients with long-term conditions to take control and actively improve their health. However, the work of self-management appears to be packaged in the form of essential and desirable skills and attributes required for success. This article presents the findings of a qualitative study, employing longitudinal diary interviews with 21 patients aged between 60 and 85 years diagnosed with coronary heart disease from three contrasting general practice areas. Drawing on concepts of the care of the self and the reflexive self, this article presents the diversity of self-management practices by older patients in the context of their lifeworld. Illustrated through individual case studies, it clearly identifies where patients are engaged self-managers with the agency, knowledge and self-discipline to modify their behaviour for an improved health outcome. This study highlights their life and illness perspectives as well as those of patients who are burdened with emotional insecurity, comorbidities and caring responsibilities. It shows the spectrum of relationships with health professionals that influence engaged self-management. We suggest that policy initiatives that favour behavioural change neglect social context and the individualised practices that are a necessary response to structural and psychosocial constraints.

A qualitative synthesis of diabetes self-management strategies for long term medical outcomes and quality of life in the UK.

BACKGROUND: Qualitative research on self-management for people with Type 2 Diabetes Mellitus (T2DM) has typically reported one-off retrospective accounts of individuals' strategies. The aim of this research was to identify the ways in which self-management strategies are perceived by people with T2DM as being either supportive or unsupportive over time, by using qualitative findings from both longitudinal intervention studies and usual care. METHODS: A systematic review of qualitative literature, published between 2000 and 2013, was conducted using a range of searching techniques. 1374 prospective qualitative papers describing patients' experiences of self-management strategies for T2DM were identified and screened. Of the 98 papers describing qualitative research conducted in the UK, we identified 4 longitudinal studies (3 intervention studies, 1 study of usual care). Key concepts and themes were extracted, reviewed and synthesised using meta-ethnography techniques. RESULTS: Aspects of self-management strategies in clinical trials (e.g. supported exercise regimens) can be perceived as enabling the control of biomarkers and facilitative of quality of life. In contrast, aspects of self-management strategies outwith trial conditions (e.g. self-monitoring) can be perceived of as negative influences on quality of life. For self-management strategies to be sustainable in the long term, patients require a sense of having a stake in their management that is appropriate for their beliefs and perceptions, timely information and support, and an overall sense of empowerment in managing their diabetes in relation to other aspects of their life. This enables participants to develop flexible diabetes management strategies that facilitate quality of life and long term medical outcomes. CONCLUSIONS: This synthesis has explored how patients give meaning to the experiences of interventions for T2DM and subsequent attempts to balance biomarkers with quality of life in the long term. People with T2DM both construct and draw upon causal accounts as a resource, and a means to counter their inability to balance medical outcomes and quality of life. These accounts can be mediated by the provision of timely and tailored information and support over time, which can allow people to develop a flexible regimen that can facilitate both quality of life and medical outcomes.

Patient-centred care in general dental practice--a systematic review of the literature.

BACKGROUND: Delivering improvements in quality is a key objective within most healthcare systems, and a view which has been widely embraced within the NHS in the United Kingdom. Within the NHS, quality is evaluated across three key dimensions: clinical effectiveness, safety and patient experience, with the latter modelled on the Picker Principles of Patient-Centred Care (PCC). Quality improvement is an important feature of the current dental contract reforms in England, with "patient experience" likely to have a central role in the evaluation of quality. An understanding and appreciation of the evidence underpinning PCC within dentistry is highly relevant if we are to use this as a measure of quality in general dental practice. METHODS: A systematic review of the literature was undertaken to identify the features of PCC relevant to dentistry and ascertain the current research evidence base underpinning its use as a measure of quality within general dental practice. RESULTS: Three papers were identified which met the inclusion criteria and demonstrated the use of primary research to provide an understanding of the key features of PCC within dentistry. None of the papers identified were based in general dental practice and none of the three studies sought the views of patients. Some distinct differences were noted between the key features of PCC reported within the dental literature and those developed within the NHS Patient Experience Framework. CONCLUSIONS: This systematic review reveals a lack of understanding of PCC within dentistry, and in particular general dental practice. There is currently a poor evidence base to support the use of the current patient reported outcome measures as indicators of patient-centredness. Further research is necessary to understand the important features of PCC in dentistry and patients' views should be central to this research.

Caregiver presence in a home-based cardiac rehabilitation programme improves the health-related quality of life of patients with heart failure.

Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) is a home-based cardiac rehabilitation intervention designed for patients with heart failure and their caregivers. We present a pooled analysis of patients >18 years with a confirmed diagnosis of HF recruited to two REACH-HF randomized controlled trials. Where identified by patients and consented to participate, caregivers were randomly assigned with patients to receive the REACH-HF intervention plus usual care or usual care alone. Our analysis demonstrated that compared to control group, the REACH-HF group had a greater gain in their disease-specific health-related quality of life at follow-up.

Willingness of people with type 2 diabetes to engage in healthy eating, physical activity and medication taking.

AIM: To assess the willingness of people with type 2 diabetes (T2D) to engage in healthy eating, physical activity and medication taking, and explore associated patient factors. METHODS: Online survey among recently diagnosed T2D patients recruited in the Netherlands and the United Kingdom (UK). Patient factors included general factors and behaviour-specific beliefs. Logistic regression analyses and explorative comparisons were conducted. RESULTS: Overall, 48% of 67 patients were willing to engage in all three management options, whereas 6% were not willing to follow any of them. 73% were willing to manage T2D with healthy eating, 73% with physical activity, and 72% with medication. Country of recruitment was significantly associated with willingness for healthy eating, with higher willingness among Dutch participants. Beliefs surrounding capability, opportunity, and motivation were significantly associated with willingness to engage in physical activity and medication taking. Many beliefs were similar regardless of willingness but those willing to engage in physical activity perceived less barriers and those willing to take medication had more positive and less negative outcome beliefs than those not willing. CONCLUSIONS: Willingness to engage in all management options was limited among recently diagnosed patients, and partly associated with behaviour-specific patient beliefs.

Older Adults' Perspectives of Independence Through Time: Results of a Longitudinal Interview Study.

BACKGROUND AND OBJECTIVES: Understanding how older people experience independence has implications for person-centered care. Existing understanding of older people's experience of independence, generated through methods that provide a "snapshot" view of a person's independence at a given time point, provides little insight into the process of maintaining independence through time. The aim of this study was to explore older participants' perceptions to understand the processes and resources that were most important for maintaining independence. RESEARCH DESIGN AND METHODS: Two semistructured interviews were conducted longitudinally to explore the perspectives of 12 community-dwelling, older people, aged 76-85 years. A social constructivist approach, using dramaturgical and descriptive codes, facilitated the interpretation of the data. Sixteen analytical questions guided the exploration of participants' perceptions of independence through time. RESULTS: Older people suggested that objective representations underestimated, and omitted, important aspects of their independence through time. Some participants perceived "snapshot" judgments of their independence as insensitive to their individual values and context. Change over time required some participants to adapt their methods for maintaining independence. The stability of participants' sense of independence was value dependent and informed by the purpose a participant ascribed to maintaining independence. DISCUSSION AND IMPLICATIONS: This study augments the understanding of independence as a complex and multifaceted construct. The findings challenge the congruence of common interpretations of independence with older people's views, showing areas of commonality, and discrepancy. Exploration of independence in terms of form and function provides an important understanding of how function takes precedence to form in determining the maintenance of independence through time.

How can we improve Comprehensive Geriatric Assessment for older people living with frailty in primary care and community settings? A qualitative study.

OBJECTIVE: With advancing age comes the increasing prevalence of frailty and increased risk of adverse outcomes (eg, hospitalisation). Evidence for comprehensive geriatric assessment (CGA), a multidimensional holistic model of care, is mixed in community settings. Uncertainties remain, such as the key components of CGA, who delivers it, and the use of technology. This study aimed to understand the perspectives, beliefs and experiences, of both older people and health professionals, to improve the current CGA and explore factors that may impact on CGA delivery in community settings. DESIGN: A qualitative interview study was conducted with older people and healthcare professionals (HCPs) identified using a maximum variation strategy. Data were analysed using an abductive analysis approach. The non-adoption, abandonment, scale-up, spread and sustainability framework and the theoretical framework of acceptability guided the categorisation of the codes and identified categories were mapped to the two frameworks. SETTING: England, UK. RESULTS: 27 people were interviewed, constituting 14 older people and 13 HCPs. We identified limitations in the current CGA: a lack of information sharing between different HCPs who deliver CGA; poor communication between older people and their HCPs and a lack of follow-up as part of CGA. When we discussed the potential for CGA to use technology, HCPs and older people varied in their readiness to engage with it. CONCLUSIONS: Viable solutions to address gaps in the current delivery of CGA include the provision of training and support to use digital technology and a designated comprehensive care coordinator. The next stage of this research will use these findings, existing evidence and stakeholder engagement, to develop and refine a model of community-based CGA that can be assessed for feasibility and acceptability.

Processes of change in an asthma self-care intervention.

In this article, we present a qualitative exploration of the psychological and communication processes that occur within an intervention to improve self-care for people with asthma. In the context of a primary-care-based trial of the intervention, we collected data at three time points for 21 patients, comprising 2 audiotaped consultations (nurse and patient together) and individual semistructured interviews 3 months after the second consultation. Using framework analysis, we identified both psychological processes (illness understanding, affective response to asthma, and reasoned motivation) and patient-provider interactions (active patient involvement and individual tailoring). We use these findings to extend and refine the pre-existing theoretical model of behavior change underpinning the intervention, in particular with relation to patient-provider interaction processes. We conclude that it is important for developers and providers of asthma self-care interventions to attend to the style of delivery as well as the behavior change techniques involved.

Using meta-ethnography to understand the emotional impact of caring for people with increasing cognitive impairment.

The majority of people with degenerative neurological conditions are cared for within their own families. Cognitive impairment can be a significant and increasing symptom of these conditions. In this article we report how a team of experienced researchers carried out a meta-ethnography of qualitative research articles focusing on the impact of caring for a loved one with cognitive impairment. We followed the seven-step process outlined by Noblit and Hare. Synthesized findings from 31 papers suggest emotional impact is complex and uncertain and varies from day to day. The benefit of using meta-ethnography is that the results represent a larger sample size and a reinterpretation of multiple studies can hold greater application for practice. The results of this study offer an opportunity for nurses to be aware of both the positive and negative sides of caring and being cared for. This knowledge can be used to discuss with patients and carers how best to prepare for decreasing cognition and still maintain a worthwhile quality of life.

Allied health professionals' views on important outcomes of children's elective lower limb orthopaedic surgery: a qualitative interview study to inform a core outcome set.

PURPOSE: A common methodological limitation of research that guides surgical procedure selection for children's elective lower limb orthopaedic surgeries is inconsistent outcome selection. Improving outcome consistency can be achieved through the development of a core outcome set (COS). The aim of this study is to identify which outcomes are considered important for children's elective lower limb orthopaedic surgeries by allied health professionals (AHPs) and explore why they select these outcomes, to inform a COS development project. METHODS: Online semi-structured interviews were conducted with relevant AHPs. Participants were selected using maximum variation purposive sampling; selection was based on profession and inpatient/outpatient role. The data set was analysed using an inductive and deductive approach to thematic analysis. RESULTS: Four physiotherapists, three orthotists, three prosthetists, and two occupational therapists were interviewed. Most identified outcomes of importance related to "activities and participation". From the data, we conceptualised that AHPs with effective multidisciplinary communication focused on child-centred outcomes, while clinicians with limited multidisciplinary teamwork focused on role-based outcomes. CONCLUSIONS: There is concurrence between outcomes identified as important in this study, and other qualitative studies in similar populations. These important outcomes were seldom measured in previous studies or in routine clinical practice.Implications for rehabilitationAllied health professionals (AHPs) prioritise activity and participation outcomes after children's elective lower limb orthopaedic surgery.It is important to the rehabilitation of children after elective lower limb orthopaedic surgery that all involved AHPs collaborate with the wider multidisciplinary team.Multidisciplinary team communication encourages collaborative outcome identification, and discourages role defined outcome focus.

How do patients and other members of the public engage with the orphan drug development? A narrative qualitative synthesis.

BACKGROUND: The diversity of patient experiences of orphan drug development has until recently been overlooked, with the existing literature reporting the experience of some patients and not others. The current evidence base (the best available current research) is dominated by quantitative surveys and patient reported outcome measures defined by researchers. Where research that uses qualitative methods of data collection and analysis has been conducted, patient experiences have been studied using content analysis and automatic textual analysis, rather than in-depth qualitative analytical methods. Systematic reviews of patient engagement in orphan drug development have also excluded qualitative studies. The aim of this paper is to review qualitative literature about how patients and other members of the public engage with orphan drug development. METHODS: We conducted a systematic search of qualitative papers describing a range of patient engagement practices and experiences were identified and screened. Included papers were appraised using a validated tool (CASP), supplemented by reporting guidance (COREQ), by two independent researchers. RESULTS: 262 papers were identified. Thirteen papers reported a range of methods of qualitative data collection. Many conflated patient and public involvement and engagement (PPIE) with qualitative research. Patients were typically recruited via their physician or patient organisations. We identified an absence of overarching philosophical or methodological frameworks, limited details of informed consent processes, and an absence of recognisable methods of data analysis. Our narrative synthesis suggests that patients and caregivers need to be involved in all aspects of trial design, including the selection of clinical endpoints that capture a wider range of outcomes, the identification of means to widen access to trial participation, the development of patient facing materials to optimise their decision making, and patients included in the dissemination of trial results. CONCLUSIONS: This narrative qualitative synthesis identified the explicit need for methodological rigour in research with patients with rare diseases (e.g. appropriate and innovative use of qualitative methods or PPIE, rather than their conflation); strenuous efforts to capture the perspectives of under-served, under-researched or seldom listened to communities with experience of rare diseases (e.g. creative recruitment and wider adoption of post-colonial practices); and a re-alignment of the research agenda (e.g. the use of co-design to enable patients to set the agenda, rather than respond to what they are being offered).