Cost-effectiveness of a Novel Hypoglycaemia Programme: The 'HARPdoc vs BGAT' RCT.

AIMS: To assess the cost-effectiveness of HARPdoc (Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised care), focussed upon cognitions and motivation, versus BGAT (Blood Glucose Awareness Training), focussed on behaviours and education, as adjunctive treatments for treatment-resistant problematic hypoglycaemia in type 1 diabetes, in a randomised controlled trial. METHODS: Eligible adults were randomised to either intervention. Quality of life (QoL, measured using EQ-5D-5L); cost of utilisation of health services (using the adult services utilization schedule, AD-SUS) and of programme implementation and curriculum delivery were measured. A cost-utility analysis was undertaken using quality-adjusted life years (QALYs) as a measure of trial participant outcome and cost-effectiveness was evaluated with reference to the incremental net benefit (INB) of HARPdoc compared to BGAT. RESULTS: Over 24 months mean total cost per participant was £194 lower for HARPdoc compared to BGAT (95% CI: -£2498 to £1942). HARPdoc was associated with a mean incremental gain of 0.067 QALYs/participant over 24 months post-randomisation: an equivalent gain of 24 days in full health. The mean INB of HARPdoc compared to BGAT over 24 months was positive: £1521/participant, indicating comparative cost-effectiveness, with an 85% probability of correctly inferring an INB > 0. CONCLUSIONS: Addressing health cognitions in people with treatment-resistant hypoglycaemia achieved cost-effectiveness compared to an alternative approach through improved QoL and reduced need for medical services, including hospital admissions. Compared to BGAT, HARPdoc offers a cost-effective adjunct to educational and technological solutions for problematic hypoglycaemia.

Case management for integrated care of older people with frailty in community settings.

BACKGROUND: Ageing populations globally have contributed to increasing numbers of people living with frailty, which has significant implications for use of health and care services and costs. The British Geriatrics Society defines frailty as "a distinctive health state related to the ageing process in which multiple body systems gradually lose their inbuilt reserves". This leads to an increased susceptibility to adverse outcomes, such as reduced physical function, poorer quality of life, hospital admissions, and mortality. Case management interventions delivered in community settings are led by a health or social care professional, supported by a multidisciplinary team, and focus on the planning, provision, and co-ordination of care to meet the needs of the individual. Case management is one model of integrated care that has gained traction with policymakers to improve outcomes for populations at high risk of decline in health and well-being. These populations include older people living with frailty, who commonly have complex healthcare and social care needs but can experience poorly co-ordinated care due to fragmented care systems. OBJECTIVES: To assess the effects of case management for integrated care of older people living with frailty compared with usual care. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL, Health Systems Evidence, and PDQ Evidence and databases from inception to 23 September 2022. We also searched clinical registries and relevant grey literature databases, checked references of included trials and relevant systematic reviews, conducted citation searching of included trials, and contacted topic experts. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared case management with standard care in community-dwelling people aged 65 years and older living with frailty. DATA COLLECTION AND ANALYSIS: We followed standard methodological procedures recommended by Cochrane and the Effective Practice and Organisation of Care Group. We used the GRADE approach to assess the certainty of the evidence. MAIN RESULTS: We included 20 trials (11,860 participants), all of which took place in high-income countries. Case management interventions in the included trials varied in terms of organisation, delivery, setting, and care providers involved. Most trials included a variety of healthcare and social care professionals, including nurse practitioners, allied healthcare professionals, social workers, geriatricians, physicians, psychologists, and clinical pharmacists. In nine trials, the case management intervention was delivered by nurses only. Follow-up ranged from three to 36 months. We judged most trials at unclear risk of selection and performance bias; this consideration, together with indirectness, justified downgrading the certainty of the evidence to low or moderate. Case management compared to standard care may result in little or no difference in the following outcomes. • Mortality at 12 months' follow-up (7.0% in the intervention group versus 7.5% in the control group; risk ratio (RR) 0.98, 95% confidence interval (CI) 0.84 to 1.15; I2 = 11%; 14 trials, 9924 participants; low-certainty evidence) • Change in place of residence to a nursing home at 12 months' follow-up (9.9% in the intervention group versus 13.4% in the control group; RR 0.73, 95% CI 0.53 to 1.01; I2 = 0%; 4 trials, 1108 participants; low-certainty evidence) • Quality of life at three to 24 months' follow-up (results not pooled; mean differences (MDs) ranged from -6.32 points (95% CI -11.04 to -1.59) to 6.1 points (95% CI -3.92 to 16.12) when reported; 11 trials, 9284 participants; low-certainty evidence) • Serious adverse effects at 12 to 24 months' follow-up (results not pooled; 2 trials, 592 participants; low-certainty evidence) • Change in physical function at three to 24 months' follow-up (results not pooled; MDs ranged from -0.12 points (95% CI -0.93 to 0.68) to 3.4 points (95% CI -2.35 to 9.15) when reported; 16 trials, 10,652 participants; low-certainty evidence) Case management compared to standard care probably results in little or no difference in the following outcomes. • Healthcare utilisation in terms of hospital admission at 12 months' follow-up (32.7% in the intervention group versus 36.0% in the control group; RR 0.91, 95% CI 0.79 to 1.05; I2 = 43%; 6 trials, 2424 participants; moderate-certainty evidence) • Change in costs at six to 36 months' follow-up (results not pooled; 14 trials, 8486 participants; moderate-certainty evidence), which usually included healthcare service costs, intervention costs, and other costs such as informal care. AUTHORS' CONCLUSIONS: We found uncertain evidence regarding whether case management for integrated care of older people with frailty in community settings, compared to standard care, improved patient and service outcomes or reduced costs. There is a need for further research to develop a clear taxonomy of intervention components, to determine the active ingredients that work in case management interventions, and identify how such interventions benefit some people and not others.

How is return on investment from quality improvement programmes conceptualised by mental healthcare leaders and why: a qualitative study.

BACKGROUND: Return on Investment (ROI), whereby the ratio of costs to benefits is assessed, is encouraged in-order to justify the value of Quality Improvement (QI) programmes. We previously performed a literature review to develop a ROI conceptual framework for QI programmes. We concluded that, QI-ROI is conceptualised as any monetary and non-monetary benefit. In the current study, we explored if this finding is shared by mental healthcare leaders. We also investigated the stability of this conceptualisation against influencing factors and potential for disinvestment. METHODS: We performed qualitative interviews with leaders in an NHS mental health organisation. There were 16 participants: nine board members and seven senior leaders. The interviews were held online via Microsoft Teams and lasted an hour on average. We performed deductive-inductive analysis to seek data from our initial ROI framework and any new data. RESULTS: We found that in mental healthcare, QI-ROI is also conceptualised as any valued monetary and non-monetary benefits. There was a strong emphasis on benefits to external partners and a de-emphasis of benefit monetisation. This conceptualisation was influenced by the 1) perceived mandates to improve quality and manage scarce resources, 2) expectations from QI, 3) health and social care values, 4) ambiguity over expectations, and 5) uncertainty over outcomes. Uncertainty, ambiguity, and potential for disinvestment posed a threat to the stability of this conceptualisation but did not ultimately change it. Health and social care values supported maintaining the QI-ROI as any benefit, with a focus on patients and staff outcomes. Socio-political desires to improve quality were strong drivers for QI investment. CONCLUSION: Mental healthcare leaders primarily conceptualise QI-ROI as any valued benefit. The inclusion of externalised outcomes which are hard to attribute may be challenging. However, mental healthcare services do collaborate with external partners. The de-emphases of benefit monetisation may also be controversial due to the need for financial accountability. Mental healthcare leaders recognise the importance of efficiency savings. However, they raised concerns over the legitimacy and utility of traditional ROI as a tool for assessing QI value. Further research is needed to bring more clarity on these aspects of the QI-ROI concept.

A mixed methods systematic review exploring infant feeding experiences and support in women with severe mental illness.

There are many benefits of breastfeeding to women and their infants but meeting the recommended 6 months of exclusive breastfeeding is likely to be more challenging for women with severe mental illness (SMI). This is the first systematic review that aims to examine evidence of (a) infant feeding outcomes in women with SMI and the factors associated with this, (b) the experiences of infant feeding and infant feeding support for women with SMI, (c) interventions for supporting infant feeding among these women and (d) health care professionals' attitudes toward supporting infant feeding in women with SMI. Mixed methods systematic review was carried out using the principles of Joanna Briggs Institute's (JBI) 'convergent integrated' methodology. CINAHL, PsycINFO, Medline and MIDIRS were used to search literature between 1994 and 2022. The quality of selected articles was assessed using JBI critical appraisal tools and thematic synthesis was undertaken to obtain findings. Eighteen papers were included in the final review. Women with SMI were less likely to initiate and continue breastfeeding than women without SMI. Several challenges with breastfeeding were highlighted, and while these were often linked to women's mental health difficulties, inconsistent advice from health care professionals and poor support with breastfeeding further compounded these challenges. This review highlights that policy and practice need to take into account the individual challenges women with SMI face when planning, initiating and maintaining breastfeeding. Education and training for health care professionals are needed to enable them to provide tailored infant feeding support to women with SMI, which reflects their individual needs.

Identifying and understanding benefits associated with return-on-investment from large-scale healthcare Quality Improvement programmes: an integrative systematic literature review.

BACKGROUND: We previously developed a Quality Improvement (QI) Return-on-Investment (ROI) conceptual framework for large-scale healthcare QI programmes. We defined ROI as any monetary or non-monetary value or benefit derived from QI. We called the framework the QI-ROI conceptual framework. The current study describes the different categories of benefits covered by this framework and explores the relationships between these benefits. METHODS: We searched Medline, Embase, Global health, PsycInfo, EconLit, NHS EED, Web of Science, Google Scholar, organisational journals, and citations, using ROI or returns-on-investment concepts (e.g., cost-benefit, cost-effectiveness, value) combined with healthcare and QI. Our analysis was informed by Complexity Theory in view of the complexity of large QI programmes. We used Framework analysis to analyse the data using a preliminary ROI conceptual framework that was based on organisational obligations towards its stakeholders. Included articles discussed at least three organisational benefits towards these obligations, with at least one financial or patient benefit. We synthesized the different QI benefits discussed. RESULTS: We retrieved 10 428 articles. One hundred and two (102) articles were selected for full text screening. Of these 34 were excluded and 68 included. Included articles were QI economic, effectiveness, process, and impact evaluations as well as conceptual literature. Based on these literatures, we reviewed and updated our QI-ROI conceptual framework from our first study. Our QI-ROI conceptual framework consists of four categories: 1) organisational performance, 2) organisational development, 3) external outcomes, and 4) unintended outcomes (positive and negative). We found that QI benefits are interlinked, and that ROI in large-scale QI is not merely an end-outcome; there are earlier benefits that matter to organisations that contribute to overall ROI. Organisations also found positive aspects of negative unintended consequences, such as learning from failed QI. DISCUSSION AND CONCLUSION: Our analysis indicated that the QI-ROI conceptual framework is made-up of multi-faceted and interconnected benefits from large-scale QI programmes. One or more of these may be desirable depending on each organisation's goals and objectives, as well as stage of development. As such, it is possible for organisations to deduce incremental benefits or returns-on-investments throughout a programme lifecycle that are relevant and legitimate.

The development of the concept of return-on-investment from large-scale quality improvement programmes in healthcare: an integrative systematic literature review.

BACKGROUND: Return on Investment (ROI) is increasingly being used to evaluate financial benefits from healthcare Quality Improvement (QI). ROI is traditionally used to evaluate investment performance in the commercial field. Little is known about ROI in healthcare. The aim of this systematic review was to analyse and develop ROI as a concept and develop a ROI conceptual framework for large-scale healthcare QI programmes. METHODS: We searched Medline, Embase, Global health, PsycInfo, EconLit, NHS EED, Web of Science, Google Scholar using ROI or returns-on-investment concepts (e.g., cost-benefit, cost-effectiveness, value). We combined this terms with healthcare and QI. Included articles discussed at least three organisational QI benefits, including financial or patient benefits. We synthesised the different ways in which ROI or return-on-investment concepts were used and discussed by the QI literature; first the economically focused, then the non-economically focused QI literature. We then integrated these literatures to summarise their combined views. RESULTS: We retrieved 10 428 articles. One hundred and two (102) articles were selected for full text screening. Of these 34 were excluded and 68 included. The included articles were QI economic, effectiveness, process, and impact evaluations as well as reports and conceptual literature. Fifteen of 68 articles were directly focused on QI programme economic outcomes. Of these, only four focused on ROI. ROI related concepts in this group included cost-effectiveness, cost-benefit, ROI, cost-saving, cost-reduction, and cost-avoidance. The remaining articles mainly mentioned efficiency, productivity, value, or benefits. Financial outcomes were not the main goal of QI programmes. We found that the ROI concept in healthcare QI aligned with the concepts of value and benefit, both monetary and non-monetary. CONCLUSION: Our analysis of the reviewed literature indicates that ROI in QI is conceptualised as value or benefit as demonstrated through a combination of significant outcomes for one or more stakeholders in healthcare organisations. As such, organisations at different developmental stages can deduce benefits that are relevant and legitimate as per their contextual needs. TRIAL REGISTRATION: Review registration: PROSPERO; CRD42021236948.

Quality improvement for cancer multidisciplinary teams: lessons learned from the Anglian Germ Cell Cancer Collaborative Group.

Shamash and colleagues describe how their supra-regional germ cell tumour multidisciplinary team achieved standardisation of treatment and improved survival. We discuss some of the insights the study provides into prioritising complex patients, streamlining processes, the use of telemedicine, and the centrality of good data collection to continuous quality improvement.

The cancer multidisciplinary team meeting: in need of change? History, challenges and future perspectives.

Two decades since their inception, multidisciplinary teams (MDTs) are widely regarded as the 'gold standard' of cancer care delivery. Benefits of MDT working include improved patient outcomes, adherence to guidelines, and even economic benefits. Benefits to MDT members have also been demonstrated. An increasing body of evidence supports the use of MDTs and provides guidance on best practise. The system of MDTs in cancer care has come under increasing pressure of late, due to the increasing incidence of cancer, the popularity of MDT working, and financial pressures. This pressure has resulted in recommendations by national bodies to implement streamlining to reduce workload and improve efficiency. In the present review we examine the historical evidence for MDT working, and the scientific developments that dictate best practise. We also explore how streamlining can be safely and effectively undertaken. Finally, we discuss the future of MDT working including the integration of artificial intelligence and decision support systems and propose a new model for improving patient centredness.

Quality of leadership in multidisciplinary cancer tumor boards: development and evaluation of a leadership assessment instrument (ATLAS).

BACKGROUND: High-quality leadership and chairing skills are vital for good performance in multidisciplinary tumor boards (MTBs), but no instruments currently exist for assessing and improving these skills. OBJECTIVE: To construct and validate a robust instrument for assessment of MTB leading and chairing skills. DESIGN AND SETTING: We developed an observational MTB leadership assessment instrument (ATLAS). ATLAS includes 12 domains that assess the leadership and chairing skills of the MTB chairperson. ATLAS has gone through a rigorous process of refinement and content validation prior to use to assess the MTB lead by two urological surgeons (blinded to each other) in 7 real-live (n = 286 cases) and 10 video-recorded (n = 131 cases) MTBs. OUTCOME MEASURES AND STATISTICAL ANALYSIS: ATLAS domains were analyzed via descriptive statistics. Instrument content was evaluated for validity using the content validation index (CVI). Intraclass correlation coefficients (ICCs) were used to assess inter-observer reliability. RESULTS: Instrument refining resulted in ATLAS including the following 12 domains: time management, communication, encouraging contribution, ability to summarize, ensuring all patients have treatment plan, case prioritization, keeping meeting focused, facilitate discussion, conflict management, leadership, creating good working atmosphere, and recruitment for clinical trials. CVI was acceptable and inter-rater agreement adequate to high for all domains. Agreement was somewhat higher in real-time MTBs compared to video ratings. Concurrent validation evidence was derived via positive and significant correlations between ATLAS and an established validated brief MTB leadership assessment scale. CONCLUSION: ATLAS is an observational assessment instrument that can be reliably used for assessing leadership and chairing skills in cancer MTBs (both live and video-recorded). The ability to assess and feedback on team leader performance provides the ground for promotion of good practice and continuing professional development of tumor board leaders.

Predictors of Treatment Decisions in Multidisciplinary Oncology Meetings: A Quantitative Observational Study.

BACKGROUND: In many healthcare systems, treatment recommendations for cancer patients are formulated by multidisciplinary tumor boards (MTBs). Evidence suggests that interdisciplinary contributions to case reviews in the meetings are unequal and information-sharing suboptimal, with biomedical information dominating over information on patient comorbidities and psychosocial factors. This study aimed to evaluate how different elements of the decision process affect the teams' ability to reach a decision on first case review. METHODS: This was an observational quantitative assessment of 1045 case reviews from 2010 to 2014 in cancer MTBs using a validated tool, the Metric for the Observation of Decision-making. This tool allows evaluation of the quality of information presentation (case history, radiological, pathological, and psychosocial information, comorbidities, and patient views), and contribution to discussion by individual core specialties (surgeons, oncologists, radiologists, pathologists, and specialist cancer nurses). The teams' ability to reach a decision was a dichotomous outcome variable (yes/no). RESULTS: Using multiple logistic regression analysis, the significant positive predictors of the teams' ability to reach a decision were patient psychosocial information (odds ratio [OR] 1.35) and the inputs of surgeons (OR 1.62), radiologists (OR 1.48), pathologists (OR 1.23), and oncologists (OR 1.13). The significant negative predictors were patient comorbidity information (OR 0.83) and nursing inputs (OR 0.87). CONCLUSIONS: Multidisciplinary inputs into case reviews and patient psychosocial information stimulate decision making, thereby reinforcing the role of MTBs in cancer care in processing such information. Information on patients' comorbidities, as well as nursing inputs, make decision making harder, possibly indicating that a case is complex and requires more detailed review. Research should further define case complexity and determine ways to better integrate patient psychosocial information into decision making.

Implementation of streamlining measures in selecting and prioritising complex cases for the cancer multidisciplinary team meeting: a mini review of the recent developments.

In January 2020, NHS England and NHS Improvement, in the United Kingdom, issued a permissive framework for streamlining cancer multidisciplinary (MDT) meetings. Streamlining is defined as a process whereby complex cases are prioritized for full discussion by an MDT in an MDT meeting (MDM), while the management of straightforward cases is expedited using Standards of Care (SoC). SoC are points in the pathway of patient management where there are recognized guidelines and clear clinical consensus on the options for management and should be regionally agreed and uniformly applied by regional Cancer Alliances. While this report marks the first major change in cancer MDT management since the Calman-Hine report in 1995, its implementation, nationally, has been slow with now nearly four years since its publication. It is argued however that streamlining is a necessary step in ensuring the viability of MDT processes, and therefore maintaining patient care in the current socioeconomic context of rising workload and cancer incidence, financial pressures, and workforce shortages. In this mini review, we offer a succinct summary of the recent developments around the implementation of the 2020 streamlining framework, including challenges and barriers to its implementation, and the potential future directions in this field, which we propose should increase utilisation of implementation science. We conclude that ensuring successful implementation of the framework and the SOC requires securing a buy-in from key stakeholders, including MDTs and hospital management teams, with clearly defined (a) management approaches that include triage (e.g. through a mini MDT meeting), (b) assessment of case complexity (something that directly feeds into the SOC), and (c) roles of the MDT lead and the members, while acknowledging that the SOC cannot be universally applied without the consideration of individual variations across teams and hospital Trusts.

The PD-Ballet study: study protocol for a randomised controlled single-blind hybrid type 2 clinical trial evaluating the effects of ballet dancing on motor and non-motor symptoms in Parkinson's disease.

BACKGROUND: To date, beneficial effects of multimodal exercise programmes on Parkinson's disease (PD) have focused on motor symptoms and little attention has been paid to the potential effects of such programmes on the non-motor symptoms of PD, which are now universally known as one of the key drivers of quality of life and a key unmet need. We aim to explore clinical effectiveness of a ballet-based dance programme in addressing non-motor and motor symptoms of Parkinson's disease across all stages of progression. METHODS: A randomised, single-blind, controlled trial of 160 people with Parkinson's across all motor stages (Participants will be stratified into three groups of motor advancement: Hoehn and Yahr (HY) stages I and II being Mild Group, HY Stage III being Moderate Group and HY Stages IV and V being Severe Group) will be randomly allocated to either an intervention or a control group using an independent randomisation body. The primary outcome is an improvement in non-motor symptoms as measured by the Movement Disorders Society Non-Motor Scale (MDS-NMS). The intervention protocol consists of 12 one-weekly dance sessions led by English National Ballet. Each session is followed by a 'tea and biscuit' social time. Control group follows standard clinical pathway and joins the 'tea and biscuit' to control for any positive effects of social interactions. All participants are assessed at baseline, immediately after completion of the intervention and 3-6 months later to explore any potential longitudinal effects. DISCUSSION: To our knowledge, no adequately powered study has explored the effects of a dance-based intervention on non-motor symptoms of Parkinson's disease, assessing these on both holistic and granular levels. We also aim to stratify participants in accordance with their motor state as assessed by. HY staging to explore specific effects on the symptoms at the initial, moderate and complex stages of the disease. If successful, this trial provides first evidence on clinical effectiveness of a ballet-based dance intervention for symptoms of Parkinson's disease, assessed in a robust, rigorous manner. TRIAL REGISTRATION: NCT04719468.

Analysis of communication styles underpinning clinical decision-making in cancer multidisciplinary team meetings.

Introduction: In cancer care, multidisciplinary team (MDT) meetings are the gold standard. While they are trying to maximize productivity on the back of the steadily increasing workload, growing cancer incidence, financial constraints, and staff shortages, concerns have been raised with regards to the quality of team output, as reported by Cancer Research UK in 2017: "Sometimes we discuss up to 70 patients. This is after a whole day of clinics, and we do not finish until after 19.00. Would you want to be number 70?". This study aimed to explore systematically some of the dynamics of group interaction and teamwork in MDT meetings. Materials and methods: This was a prospective observational study conducted across three MDTs/university hospitals in the United Kingdom. We video-recorded 30 weekly meetings where 822 patient cases were reviewed. A cross-section of the recordings was transcribed using the Jefferson notation system and analyzed using frequency counts (quantitative) and some principles of conversation analysis (qualitative). Results: We found that, across teams, surgeons were the most frequent initiators and responders of interactional sequences, speaking on average 47% of the time during case discussions. Cancer nurse specialists and coordinators were the least frequent initiators, with the former speaking 4% of the time and the latter speaking 1% of the time. We also found that the meetings had high levels of interactivity, with an initiator-responder ratio of 1:1.63, meaning that for every sequence of interactions initiated, the initiator received more than a single response. Lastly, we found that verbal dysfluencies (laughter, interruptions, and incomplete sentences) were more common in the second half of meetings, where a 45% increase in their frequency was observed. Discussion: Our findings highlight the importance of teamwork in planning MDT meetings, particularly with regard to Cancer Research UK in 2017 cognitive load/fatigue and decision-making, the hierarchy of clinical expertise, and the increased integration of patients' psychosocial information into MDT discussion and their perspectives. Utilizing a micro-level methodology, we highlight identifiable patterns of interaction among participants in MDT meetings and how these can be used to inform the optimization of teamwork.

Evaluation of changes to work patterns in multidisciplinary cancer team meetings due to the COVID-19 pandemic: A national mixed-method survey study.

BACKGROUND: It is not well understood the overall changes that multidisciplinary teams (MDTs) have had to make in response to the COVID-19 pandemic, nor the impact that such changes, in addition to the other challenges faced by MDTs, have had on decision-making, communication, or participation in the context of MDT meetings specifically. METHODS: This was a mixed method, prospective cross-sectional survey study taking place in the United Kingdom between September 2020 and August 2021. RESULTS: The participants were 423 MDT members. Qualitative findings revealed hybrid working and possibility of virtual attendance as the change introduced because of COVID-19 that MDTs would like to maintain. However, IT-related issues, slower meetings, longer lists and delays were identified as common with improving of the IT infrastructure necessary going forward. In contrast, virtual meetings and increased attendance/availability of clinicians were highlighted as the positive outcomes resulting from the change. Quantitative findings showed significant improvement from before COVID-19 for MDT meeting organisation and logistics (M = 45, SD = 20) compared to the access (M = 50, SD = 12, t(390) = 5.028, p = 0.001), case discussions (M = 50, SD = 14, t(373) = -5.104, p = 0.001), and patient representation (M = 50, SD = 12, t(382) = -4.537, p = 0.001) at MDT meetings. DISCUSSION: Our study explored the perception of change since COVID-19 among cancer MDTs using mixed methods. While hybrid working was preferred, challenges exist. Significant improvements in the meeting organisation and logistics were reported. Although we found no significant perceived worsening across the four domains investigated, there was an indication in this direction for the case discussions warranting further 'live' assessments of MDT meetings.

Protocol for a feasibility study and process evaluation of a psychosocially modelled diabetes education programme for young people with type 1 diabetes: the Youth Empowerment Skills (YES) programme.

INTRODUCTION: Adolescence is a challenging period for young people with type 1 diabetes, associated with worsening glycaemia and care disengagement. Educational interventions in this period tend to focus on diabetes-specific skills, with less emphasis on the psychosocial challenges associated with diabetes experienced by young people. To address this limitation, we codesigned with young people a psychosocially modelled programme of diabetes education, named 'Youth Empowerment Skills' (YES). The programme aims to facilitate a positive adaptation to life with diabetes and engagement with diabetes care through peer-based learning, immersive simulations and support from an outreach youth worker. Here, we present a protocol for a feasibility study of the YES programme. METHODS AND ANALYSIS: The study was designed following the Medical Research Council Complex Intervention Evaluation Framework to: test the feasibility (acceptance, implementability, recruitment and completion) of the YES programme; and estimate its efficacy in relation to metabolic and psychosocial outcomes. The study will take place in diabetes centres serving socioculturally diverse populations. We will conduct a feasibility randomised controlled trial (waiting-list design) with integrated process evaluation. Fifty young people with type 1 diabetes (aged 14-19 years) will be randomly allocated to either the YES intervention or a waiting-list control. Randomisation acceptability will be assessed with provision for a preference allocation. Outcomes will be evaluated at 6 months, at which point the waiting list participants will be exposed to the YES programme with further follow-up to 12 months. A simultaneous process evaluation will use a mixed-methods approach collecting qualitative and quantitative data. Study findings will be used to optimise the intervention components, outcome measures and recruitment methods to inform a subsequent definitive trial. ETHICS AND DISSEMINATION: The protocol has ethical approval from the UK Health Research Authority (approval IRAS project ID: 279877). Findings will be disseminated in multiple formats for lay and professional audiences. PROTOCOL DATE AND VERSION: 7 April 2021, V.1.1. TRIAL REGISTRATION NUMBER: NCT04670198.

Evaluation of a community-based performance arts programme for people who have experienced stroke in the UK: protocol for the SHAPER-Stroke Odysseys study.

INTRODUCTION: Stroke survivors, once in the community, face challenges with their long-term rehabilitation care and present higher levels of loneliness, depression and anxiety than the rest of the population. A community-based performance arts programme, Stroke Odysseys (SO), has been devised to tackle the challenges of living with stroke in the UK. In this study, we aim to evaluate the implementation, impact and experiences of SO for stroke survivors. METHODS AND ANALYSIS: Scaling-up Health Arts Programmes: Implementation and Effectiveness Research (SHAPER)-SO aims to scale-up SO to 75 participants and 47 stakeholders, while simultaneously evaluating the effectiveness and implementation of the programme. The main research aim is to evaluate the implementation, effectiveness, impact and experiences of a community-based performance arts programme (SO for stroke survivors). This mixed-methods study will evaluate the experience and impact of SO on those participating using mixed methods (interviews, observations and surveys) before and after each stage and carry out non-participant observations during a percentage of the workshops, training and tour. Data will be analysed using quantitative and qualitative approaches. This is a study within the SHAPER programme. ETHICS AND DISSEMINATION: Ethical approval has been granted by the King's College London PNM Research Ethics Panel, REC reference: LRS/DP-20/21-21549. Written informed consent will be sought for participants and stakeholders. The results of the study will be reported and disseminated at international conferences and in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT04864470.

Cancer multidisciplinary team meetings: impact of logistical challenges on communication and decision-making.

BACKGROUND: Multidisciplinary teams (MDTs) are widely used in cancer care. Recent research points to logistical challenges impeding MDT decision-making and dissatisfaction among members. This study sought to identify different types of logistical issues and how they impacted team processes. METHODS: This was a secondary analysis of a cross-sectional observational study. Three cancer MDTs (breast, colorectal, and gynaecological) were recruited from UK hospitals. Validated observational instruments were used to measure decision-making (Metrics of Observational Decision-making, MDT-MODe), communication (Bales' Interaction Process Analysis, Bales' IPA), and case complexity (Measure of Case Discussion Complexity, MeDiC), including logistical challenges (Measure of Case Discussion Complexity, MeDiC), across 822 case discussions from 30 videoed meetings. Descriptive analysis and paired samples t tests were used to identify and compare frequency of different types of logistical challenges, along with partial correlations, controlling for clinical complexity of cases, to understand how such issues related to the MDT decision-making and communication. RESULTS: A significantly higher frequency of administrative and process issues (affecting 30 per cent of cases) was seen compared with the frequency of equipment issues (affecting 5 per cent of cases; P < 0.001) and the frequency of the attendance issues (affecting 16 per cent of cases; P < 0.001). The frequency of the attendance issues was significantly higher than the frequency of equipment issues (P < 0.001). Partial correlation analysis revealed that administrative and process issues, including attendance, were negatively correlated with quality of information (r = -0.15, P < 0.001; r = -0.11, P < 0.001), and equipment issues with the quality of contribution to meeting discussion (r = -0.14, P < 0.001). More questioning and answering by MDT members was evident with the administrative and process issues (r = 0.21, P < 0.001; r = 0.19, P < 0.001). Some differences were observed in teams' socioemotional reactions to the administrative and process issues with the gynaecological MDT showing positive correlation with positive socioemotional reactions (r = 0.20, P < 0.001), and the breast cancer MDT with negative socioemotional reactions (r = 0.17, P < 0.001). CONCLUSION: Administrative and process issues were the most frequent logistical challenges for the studied teams. Where diagnostic results were unavailable, and inadequate patient details provided, the quality of decision-making was reduced.

Study protocol: randomised controlled hybrid type 2 trial evaluating the scale-up of two arts interventions for postnatal depression and Parkinson's disease.

INTRODUCTION: Research on the benefits of 'arts' interventions to improve individuals' physical, social and psychological well-being is growing, but evidence on implementation and scale-up into health and social care systems is lacking. This protocol reports the SHAPER-Implement programme (Scale-up of Health-Arts Programmes Effectiveness-Implementation Research), aimed at studying the impact, implementation and scale-up of: Melodies for Mums (M4M), a singing intervention for postnatal depression; and Dance for Parkinson's (PD-Ballet) a dance intervention for Parkinson's disease. We examine how they could be embedded in clinical pathways to ensure their longer-term sustainability. METHODS AND ANALYSIS: A randomised two-arm effectiveness-implementation hybrid type 2 trial design will be used across M4M/PD-Ballet. We will assess the implementation in both study arms (intervention vs control), and the cost-effectiveness of implementation. The design and measures, informed by literature and previous research by the study team, were refined through stakeholder engagement. Participants (400 in M4M; 160 in PD-Ballet) will be recruited to the intervention or control group (2:1 ratio). Further implementation data will be collected from stakeholders involved in referring to, delivering or supporting M4M/PD-Ballet (N=25-30 for each intervention).A mixed-methods approach (surveys and semi-structured interviews) will be employed. 'Acceptability' (measured by the 'Acceptability Intervention Measure') is the primary implementation endpoint for M4M/PD-Ballet. Relationships between clinical and implementation outcomes, implementation strategies (eg, training) and outcomes will be explored using generalised linear mixed models. Qualitative data will assess factors affecting the acceptability, feasibility and appropriateness of M4M/PD-Ballet, implementation strategies and longer-term sustainability. Costs associated with implementation and future scale-up will be estimated. ETHICS AND DISSEMINATION: SHAPER-PND (the M4M trial) and SHAPER-PD (the PD trial) are approved by the West London and GTAC (20/PR/0813) and the HRA and Health and Care Research Wales (REC Reference: 20/WA/0261) Research Ethics Committees. Study findings will be disseminated through scientific peer-reviewed journals and scientific conferences. TRIAL REGISTRATION NUMBERS: Both trials are registered with NIH US National Library of Medicine, ClinicalTrials.gov. The trial registration numbers, URLs of registry records, and dates of registration are: (1) PD-Ballet: URL: NCT04719468 (https://eur03.safelinks.protection. OUTLOOK: com/?url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fct2%2Fshow%2FNCT04719468%3Fterm%3DNCT04719468%26draw%3D2%26rank%3D1&data=04%7C01%7Crachel.davis%40kcl.ac.uk%7C11a7c5142782437919f808d903111449%7C8370cf1416f34c16b83c724071654356%7C0%7C0%7C6375441942616) (date of registration: 22 Jan 2021). (2) Melodies for Mums: NCT04834622 (https://clinicaltrials.gov/ct2/show/NCT04834622?term=shaper-pnd&draw=2&rank=1) (date of registration: 8 Apr 2021).