Long-term health conditions and UK labour market outcomes during the COVID-19 pandemic.

BACKGROUND: Long-term health conditions can affect labour market outcomes. COVID-19 may have increased labour market inequalities, e.g. due to restricted opportunities for clinically vulnerable people. Evaluating COVID-19's impact could help target support. AIM: To quantify the effect of several long-term conditions on UK labour market outcomes during the COVID-19 pandemic and compare them to pre-pandemic outcomes. METHODS: The Understanding Society COVID-19 survey collected responses from around 20,000 UK residents in nine waves from April 2020-September 2021. Participants employed in January/February 2020 with a variety of long-term conditions were matched with people without the condition but with similar baseline characteristics. Models estimated probability of employment, hours worked and earnings. We compared these results with results from a two-year pre-pandemic period. We also modelled probability of furlough and home-working frequency during COVID-19. RESULTS: Most conditions (asthma, arthritis, emotional/nervous/psychiatric problems, vascular/pulmonary/liver conditions, epilepsy) were associated with reduced employment probability and/or hours worked during COVID-19, but not pre-pandemic. Furlough was more likely for people with pulmonary conditions. People with arthritis and cancer were slower to return to in-person working. Few effects were seen for earnings. CONCLUSION: COVID-19 had a disproportionate impact on people with long-term conditions' labour market outcomes.

EvolvRehab-MoveWell telerehabilitation for stroke survivors: study protocol for a feasibility with embedded initial proof-of-concept study.

INTRODUCTION: Stroke is a leading cause of disability throughout the world. Unilateral upper limb impairment is common in people who have had a stroke. As a result of impaired upper limb function, people who have had a stroke often employ abnormal 'compensatory' movements. In the short term, these compensatory movements allow the individual to complete tasks, though long-term movement in this manner can lead to limitations. Telerehabilitation offers the provision of rehabilitation services to patients at a remote location using information and communication technologies. 'EvolvRehab' is one such telerehabilitation system, which uses activities to assess and correct compensatory upper body movements, although the feasibility of its use is yet to be determined in National Health Service services. Using EvolvRehab, we aim to assess the feasibility of 6 weeks telerehabilitation in people after a stroke. METHODS AND ANALYSIS: A multisite feasibility study with embedded design phase. Normally distributed data will be analysed using paired samples t-tests; non-normally distributed data will be analysed using related samples Wilcoxon signed rank tests. Thematic content analysis of interview transcripts will be used to investigate the usability and perceived usefulness of the EvolvRehab kit. ETHICS AND DISSEMINATION: This study has received ethical approval from Solihull Research Ethics Committee (REC reference: 23/WM/0054). Dissemination will be carried out according to the dissemination plan co-written with stroke survivors, including academic publications and presentations; written reports; articles in publications of stakeholder organisations; presentations to and publications for potential customers. TRIAL REGISTRATION NUMBER: NCT05875792.

Linkage of routinely collected NHS data to evaluate liaison mental health services: challenges and lessons learned.

Background: Liaison mental health services provide mental health care to patients in acute hospital settings. Evaluation of liaison services is challenging due to their heterogeneous organisation and delivery, high case throughput and varied patient case mix. We aimed to link routinely collected National Health Service data from secondary care settings, chosen for their service characteristics, to data from primary care to evaluate hospital-based liaison mental health services in England. Methods: We planned to compare patients referred to hospital-based liaison services with comparable patients in the same hospital not referred to liaison services and comparable patients in hospitals without any liaison services. We designed and enacted a methodology to link data from: (1) Hospital Episode Statistics, a database controlled by the National Health Service Digital and (2) ResearchOne, a primary care database controlled by The Phoenix Partnership. Results: Obtaining approvals for the steps prespecified in the methodological protocol took 907 days. Enactment following approvals took 385 days. Data supplied from Hospital Episode Statistics contained 181,063 patients from 6 hospitals (mean = 30,177, standard deviation = 28,875.86) who matched the inclusion and exclusion criteria. Data supplied from ResearchOne contained 33,666 (18.6%) of these patients from the 6 hospitals (mean = 5611, standard deviation = 5206.59). Discussion: Time required for approvals and enactment was attributable to slowness of data handling processes within each data holder and to resolution of technical and organisational queries between them. Variation in number of patients for which data was supplied between databases and between hospitals was attributable to coding inconsistencies and to the limited intersection of patient populations between databases and variation in recording practices between hospitals. Conclusion: Although it is technically feasible to link primary and secondary care data, the current system is challenging, complicated, unnecessarily bureaucratic, time consuming and costly. This limits the number of studies that could be conducted with these rich data sources. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number 13/58/08.

Liaison mental health services are based in acute general hospitals and provide assessment and treatment for people who have both physical and mental health problems. Our aim was to use routinely collected National Health Service data to find out whether general hospital patients referred to liaison mental health services have improved outcomes, compared with patients not referred to liaison services, and comparable patients in hospitals where there are no liaison services. The main outcomes were less time spent in hospital and fewer re-admissions to hospital following discharge. We tried to link data from routine National Health Service sources for hospital and primary care, to compare patients referred to liaison mental health services with similar people in each hospital who had not been referred, and similar people in hospitals without any liaison services at all. We planned to find out how long these people stayed in hospital, whether they were re-admitted and how much was their healthcare cost was. We experienced significant difficulties in being able to link the National Health Service data from the different organisations we approached. The whole process was extremely complex, and a delay in one part of the process resulted delays in other parts. We eventually had to abandon the research without obtaining any meaningful data, although the lessons we learnt will be useful for other researchers, so they can avoid experiencing similar problems. Routinely collected National Health Service data from primary care and secondary care can be linked using the approaches we tried, but we were unable to complete the process within the time frame of the research programme, even with time extensions. Current processes need to be streamlined and standardised with designated clear response times for the different organisations.

Adapting the EQ-5D-3L for adults with mild to moderate learning disabilities.

BACKGROUND: Approximately 1.5 million adults in the UK have a learning disability. The difference between age at death for this group and the general population is 26 years for females and 22 years for males. The NHS Long Term Plan (January 2019) recognises learning disabilities as a clinical priority area. People with a learning disability are often excluded from research by design or lack of reasonable adjustments, and self-reported health status/health-related quality of life questionnaires such as the EQ-5D are often not appropriate for this population. Here, we systematically examine the EQ-5D-3L (its wording, content, and format) using qualitative methods to inform the adaption of the measure for use with adults with mild to moderate learning disabilities. METHODS: Think-aloud interviews with carers/advocates of learning-disabled adults were undertaken to explore the difficulties with completing the EQ-5D-3L. Alternative wording, language, structure, and images were developed using focus groups, stakeholder reference groups, and an expert panel. Data analysis followed a framework method. RESULTS: The dimensions and levels within the EQ-5D-3L were deemed appropriate for adults with mild to moderate learning disabilities. Consensus on wording, structure, and images was reached through an iterative process, and an adapted version of the EQ-5D-3L was finalised. CONCLUSION: The EQ-5D-3L adapted for adults with mild to moderate intellectual/learning disabilities can facilitate measurement of self-reported health status. Research is underway to assess the potential use of the adaptation for economic evaluation.

Maintaining independence in individuals with dementia at home after a fall: a protocol for the UK pilot cluster randomised controlled trial MAINTAIN.

INTRODUCTION: Individuals with dementia face an increased risk of falls. Falls can cause a decline in the individual's overall functionality. All types of falls, including those that do not result in injury, can lead to psychosocial consequences, such as diminished confidence and a fear of falling. Projections indicate a rising trend in dementia diagnoses, implying an increase in fall incidents. Yet, there is a lack of evidence to support interventions for people living with dementia who have fallen. Our objective is to test the feasibility of a falls intervention trial for people with dementia. METHOD AND ANALYSIS: This is a UK-based two-arm pilot cluster randomised controlled trial. In this study, six collaborating sites, which form the clusters, will be randomly allocated to either the intervention arm or the control arm (receiving treatment as usual) at a 1:1 ratio. During the 6 month recruitment phase, each cluster will enrol 10 dyads, comprising 10 individuals with dementia and their respective carers, leading to a total sample size of 60 dyads. The primary outcomes are the feasibility parameters for a full trial (ie, percentage consented, follow-up rate and cost framework). Secondary outcomes include activities of daily living, quality of life, fall efficacy, mobility, goal attainment, cognitive status, occurrence of falls, carer burden and healthcare service utilisation. Outcome measures will be collected at baseline and 28 weeks, with an additional assessment scheduled at 12 weeks for the healthcare service utilisation questionnaire. An embedded process evaluation, consisting of interviews and observations with participants and healthcare professionals, will explore how the intervention operates and the fidelity of study processes. ETHICS AND DISSEMINATION: The study was approved by the NHS and local authority research governance and research ethics committees (NHS REC reference: 23/WA/0126). The results will be shared at meetings and conferences and will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN16413728.

Cost-Effectiveness of eRAPID eHealth Intervention for Symptom Management During Chemotherapy.

PURPOSE: A randomized controlled trial of online symptom monitoring during chemotherapy with electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) system found improved symptom control and patient self-efficacy, without increasing hospital admissions and visits. The aim of this study was to evaluate the cost-effectiveness of the eRAPID eHealth intervention compared with usual care for patients receiving systemic treatment for colorectal, breast, or gynecologic cancers in the United Kingdom. METHODS: An embedded economic evaluation was conducted alongside the trial evaluating the effectiveness of eRAPID from health care provider and societal perspectives. Costs and quality-adjusted life-years (QALYs) of patients were compared over 18 weeks of the trial. Incremental cost-effectiveness ratios (ICERs) were estimated and compared with the National Institute for Health and Care Excellence cost-effectiveness threshold. Uncertainty around the ICER was explored using nonparametric bootstrapping and sensitivity analyses. Follow-up data were collected 12-months after random assignment for a subset of the study sample to conduct exploratory analysis of potential longer-term effects. RESULTS: Patients in the eRAPID group had the highest QALY gain and lowest costs over 18 weeks. Although differences were small and not statistically significant, eRAPID had a 55%-58% probability of being more cost-effective than usual care. Patient out-of-pocket costs were lower in the eRAPID group, indicating eRAPID may help patients access support needed within the National Health Service. Exploratory 12-months analysis showed small differences in costs and QALYs, with higher QALY gains in the eRAPID group but also higher costs. Exploratory subgroup analysis by disease status indicated that the eRAPID intervention was cost-effective for patients with early-stage cancers but not for patients with metastatic disease. CONCLUSION: Despite small differences in QALYs and costs, the analyses show potential cost-effectiveness of online symptom monitoring, when added to usual care, particularly during adjuvant systemic treatment for early-stage cancers.

PeRsOnaliSed care Planning for oldER people with frailty (PROSPER): protocol for a randomised controlled trial.

BACKGROUND: Frailty is common in older age and is characterised by loss of biological reserves across multiple organ systems. These changes associated with frailty mean older people can be vulnerable to sudden, dramatic changes in health because of relatively small problems. Older people with frailty are at increased risk of adverse outcomes including disability, hospitalisation, and care home admission, with associated reduction in quality of life and increased NHS and social care costs. Personalised Care Planning offers an anticipatory, preventative approach to supporting older adults to live independently for longer, but it has not been robustly evaluated in a population of older adults with frailty. METHODS: Following an initial feasibility study, this multi-centre, individually randomised controlled trial aims to establish whether personalised care planning for older people improves health-related quality of life. It will recruit 1337 participants from general practices across Yorkshire and Humber and Mid-Mersey in the North of England. Eligible patients will be aged 65 and over with an electronic frailty index score of 0.21 or above, living in their own homes, without severe cognitive impairment and not in receipt of end-of-life care. Following confirmation of eligibility, informed consent and baseline data collection, participants will be individually randomised to the PeRsOnaliSed care Planning for oldER people with frailty (PROSPER) intervention or usual care in a 2.6:1 allocation ratio. Participants will not be blinded to allocation, but data collection and analysis will be blinded. The intervention will be delivered over 12 weeks by a Personal Independence Co-ordinator worker based within a voluntary sector organisation, Age UK. The primary outcomes are health-related quality of life, measured using both the physical and mental components of the Short-Form 12 Item Health Questionnaire at 12 months after randomisation. Secondary outcomes comprise activities of daily living, self-management capabilities and loneliness, admission to care homes, hospitalisations, and health and social care resource use at 12 months post randomisation. Parallel cost-effectiveness and process evaluations will be conducted alongside the trial. DISCUSSION: The PROSPER study will evaluate the effectiveness and cost-effectiveness of a personalised care planning approach for older people with frailty and inform the process of its implementation. TRIAL REGISTRATION: ISRCTN16123291 .  Registered on  28 August 2020.

Recommendations for Emerging Good Practice and Future Research in Relation to Family and Caregiver Health Spillovers in Health Economic Evaluations: A Report of the SHEER Task Force.

BACKGROUND: Omission of family and caregiver health spillovers from the economic evaluation of healthcare interventions remains common practice. When reported, a high degree of methodological inconsistency in incorporating spillovers has been observed. AIM: To promote emerging good practice, this paper from the Spillovers in Health Economic Evaluation and Research (SHEER) task force aims to provide guidance on the incorporation of family and caregiver health spillovers in cost-effectiveness and cost-utility analysis. SHEER also seeks to inform the basis for a spillover research agenda and future practice. METHODS: A modified nominal group technique was used to reach consensus on a set of recommendations, representative of the views of participating subject-matter experts. Through the structured discussions of the group, as well as on the basis of evidence identified during a review process, recommendations were proposed and voted upon, with voting being held over two rounds. RESULTS: This report describes 11 consensus recommendations for emerging good practice. SHEER advocates for the incorporation of health spillovers into analyses conducted from a healthcare/health payer perspective, and more generally inclusive perspectives such as a societal perspective. Where possible, spillovers related to displaced/foregone activities should be considered, as should the distributional consequences of inclusion. Time horizons ought to be sufficient to capture all relevant impacts. Currently, the collection of primary spillover data is preferred and clear justification should be provided when using secondary data. Transparency and consistency when reporting on the incorporation of health spillovers are crucial. In addition, given that the evidence base relating to health spillovers remains limited and requires much development, 12 avenues for future research are proposed. CONCLUSIONS: Consideration of health spillovers in economic evaluations has been called for by researchers and policymakers alike. Accordingly, it is hoped that the consensus recommendations of SHEER will motivate more widespread incorporation of health spillovers into analyses. The developing nature of spillover research necessitates that this guidance be viewed as an initial roadmap, rather than a strict checklist. Moreover, there is a need for balance between consistency in approach, where valuable in a decision making context, and variation in application, to reflect differing decision maker perspectives and to support innovation.

Evaluation of a COVID-19 fundamental nursing care guideline versus usual care: The COVID-NURSE cluster randomized controlled trial.

AIM: To evaluate the impact of usual care plus a fundamental nursing care guideline compared to usual care only for patients in hospital with COVID-19 on patient experience, care quality, functional ability, treatment outcomes, nurses' moral distress, patient health-related quality of life and cost-effectiveness. DESIGN: Parallel two-arm, cluster-level randomized controlled trial. METHODS: Between 18th January and 20th December 2021, we recruited (i) adults aged 18 years and over with COVID-19, excluding those invasively ventilated, admitted for at least three days or nights in UK Hospital Trusts; (ii) nurses caring for them. We randomly assigned hospitals to use a fundamental nursing care guideline and usual care or usual care only. Our patient-reported co-primary outcomes were the Relational Aspects of Care Questionnaire and four scales from the Quality from the Patient Perspective Questionnaire. We undertook intention-to-treat analyses. RESULTS: We randomized 15 clusters and recruited 581 patient and 418 nurse participants. Primary outcome data were available for 570-572 (98.1%-98.5%) patient participants in 14 clusters. We found no evidence of between-group differences on any patient, nurse or economic outcomes. We found between-group differences over time, in favour of the intervention, for three of our five co-primary outcomes, and a significant interaction on one primary patient outcome for ethnicity (white British vs. other) and allocated group in favour of the intervention for the 'other' ethnicity subgroup. CONCLUSION: We did not detect an overall difference in patient experience for a fundamental nursing care guideline compared to usual care. We have indications the guideline may have aided sustaining good practice over time and had a more positive impact on non-white British patients' experience of care. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: We cannot recommend the wholescale implementation of our guideline into routine nursing practice. Further intervention development, feasibility, pilot and evaluation studies are required. IMPACT: Fundamental nursing care drives patient experience but is severely impacted in pandemics. Our guideline was not superior to usual care, albeit it may sustain good practice and have a positive impact on non-white British patients' experience of care. REPORTING METHOD: CONSORT and CONSERVE. PATIENT OR PUBLIC CONTRIBUTION: Patients with experience of hospitalization with COVID-19 were involved in guideline development and writing, trial management and interpretation of findings.

Feasibility of delivering supervised exercise training following surgical resection and during adjuvant chemotherapy for pancreatic ductal adenocarcinoma (PRECISE): a case series.

INTRODUCTION: Pancreatic ductal adenocarcinoma (PDAC) is an aggressive neoplasm, with surgical resection and adjuvant chemotherapy the only curative treatment. Treatment-related toxicities place a considerable burden on patients although exercise training has shown promise is helping to manage such adversities and facilitate rehabilitation. The feasibility and safety of exercise training as a supportive therapy during adjuvant chemotherapy remains unknown. METHODS: Patients with PDAC were screened post-surgical resection and enrolled in a 16-week, progressive, concurrent exercise programme alongside their chemotherapy regimen. Feasibility was the primary objective detailing recruitment, retention and adherence rates throughout as well as the safety and fidelity of the intervention. Secondarily, the impact on functional fitness and patient-reported outcomes was captured at baseline, post-intervention and 3-month follow up. RESULTS: Eight patients consented to participate in this trial, with five proceeding to enrol in exercise training. Concurrent exercise training is feasible and safe during adjuvant chemotherapy and prevented an expected decline in functional fitness and patient-reported outcomes during this time. DISCUSSION: This case series provides preliminary evidence that concurrent exercise training during adjuvant therapy is safe, feasible and well tolerated, preventing an expected decline in functional fitness, muscular strength and health-related quality of life (HRQoL). Given the adverse effects of treatment, these findings are promising and provide further evidence for the inclusion of exercise training as a standard of care for surgical rehabilitation and managing treatment-related toxicities. Future research should explore the impact of exercise training during neoadjuvant chemotherapy, with prehabilitation now standard practice for borderline resectable disease. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04305067, prospectively registered 12/03/2020, https://classic. CLINICALTRIALS: gov/ct2/show/NCT04305067 .

An intervention to support stroke survivors and their carers in the longer term: results of a cluster randomised controlled feasibility trial (LoTS2Care).

BACKGROUND: To address the limited provision of longer-term stroke care, we conducted a programme of research (LoTS2Care) to develop and test an intervention to form part of a replicable longer-term care strategy. New Start, a programme of facilitated self-management, was developed to be delivered at 6 months post-stroke by trained facilitators. Here, we report the findings from the final workstream of this programme, which aimed to evaluate the feasibility and acceptability of implementing a future definitive cluster randomised controlled trial of the developed intervention (New Start) to support stroke survivors and their carers in the longer term. METHODS: A feasibility cluster randomised controlled trial was conducted in English and Welsh NHS stroke services. Stroke services (clusters) were randomised on a 1:1 basis to implement New Start or continue with usual care only. Community-dwelling stroke survivors between 4 and 6 months post-stroke were invited to participate in the trial by post. Outcome measures were collected via post at 3, 6 and 9 months after recruitment. Recruitment and follow-up rates, delivery and uptake of the intervention, data collection feasibility (including postal outcome measures of health and disability, mental well-being at 3, 6, and 9 months post-recruitment) and safety were assessed. RESULTS: Ten stroke services were recruited. A total of 1127 stroke survivors were screened for participation, and 269 were registered (New Start, n = 145; usual care, n = 124). Retention was high with 239 (89%) stroke survivors being available for follow-up at 9 months, and high return rates of postal questionnaires were achieved (80.3% at 9 months). Intervention training was successfully delivered, and New Start was offered to 95.2% of trial participants in the intervention arm. Uptake was variable, however, ranging from 11.8 to 75.0%. There were no safety concerns. CONCLUSIONS: Stroke service recruitment and longer-term stroke survivor postal recruitment and outcome data collection are feasible; however, refinement of intervention targeting and delivery is required prior to undertaking a definitive trial. TRIAL REGISTRATION: ISRCTN38920246. Registered 22 June 2016 ( http://www.isrctn.com/ISRCTN38920246 ).

How does arthritis affect employment? Longitudinal evidence on 18,000 British adults with arthritis compared to matched controls.

INTRODUCTION: One in ten working age people in the UK live with arthritis or a similar condition affecting their joints. This impacts their quality of life, including through their work. But little is known about how arthritis affects labour market outcomes and the types of people most likely to be affected. METHODS: Data from three population-representative household panel surveys (BHPS, ELSA, UKHLS) collected in 2001-2019 was harmonised. Propensity score matching was used to match 18,014 UK adults aged 18-80 who have arthritis with comparable adults without arthritis. The relationship between arthritis and employment, and earnings and work hours conditional on employment, were assessed using multilevel regression modelling. Heterogeneity in these relationships were assessed by age, gender, degree-level education status, NS-SEC job classification and employer type. RESULTS: On average, arthritis was associated with a 3 percentage point reduction in the probability of employment. The effect size varied over people's life course and was larger amongst females, people without a degree, and those in routine or intermediate occupations (when compared to those in professional occupations) or working for small private companies (when compared to large private companies and non-private employers). Our models predict, for instance, that arthritis is associated with an 11 percentage point reduction in the probability of employment among 50-year-old women without a degree. This contrasts with a 5 percentage point reduction among 50-year-old men without a degree. If employed, men with a degree earned less if they had arthritis, whereas others (including women with a degree and men without a degree) had similar earnings regardless of their arthritis status. Those in professional occupations with arthritis also earnt less, especially if they were women aged over 40, with indications that this was driven by reduced work hours. CONCLUSION: Policy interventions to support people with arthritis who wish to remain in work might be designed with people in routine work in mind, and targeted at those working in smaller private firms. More research on the cost-effectiveness of those interventions is needed.

Online Symptom Monitoring During Pelvic Radiation Therapy: Randomized Pilot Trial of the eRAPID Intervention.

PURPOSE: Radiation therapy (RT) and chemoRT for pelvic cancers increase survival but are associated with serious treatment-related symptoms. Electronic-patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is a secure online system for patients to self-report symptoms, generating immediate advice for hospital contact or self-management. This pilot study aimed to establish feasibility and acceptability of the system. METHODS AND MATERIALS: In a prospective 2-center randomized parallel-group pilot study, patients undergoing radical pelvic RT for prostate cancer (prostateRT) or chemoRT for lower gastrointestinal and gynecological cancers were randomized to usual care (UC) or eRAPID (weekly online symptom reporting for 12, 18, and 24 weeks). Primary outcomes were recruitment/attrition, study completion, and patient adherence. Secondary outcomes were effect on hospital services and performance of patient outcome measures. Missing data, floor/ceiling effects, and mean change scores were examined for Functional Assessment of Cancer Therapy (FACT-G), European Organisation for Research and Treatment of Cancer, Quality of Life (EORTC QLQ C-30), self-efficacy, and EuroQol (EQ5D). RESULTS: From 228 patients approached, 167 (73.2%) were consented and randomized (83, eRAPID; 84, UC; 87, prostateRT; 80, chemoRT); 150 of 167 completed 24 study weeks. Only 16 patients (9.6%) withdrew (10, eRAPID; 6, UC). In the eRAPID arm, completion rates were higher in patients treated with prostateRT compared with chemoRT (week 1, 93% vs 69%; week 2, 93% vs 68%; week 12, 69% vs 55%). Overall, over 50% of online reports triggered self-management advice for milder adverse events. Unscheduled hospital contact was low, with no difference between eRAPID and UC. Return rates for outcome measures were excellent in prostateRT (97%-91%; 6-24 weeks) but lower in chemoRT (95%-55%; 6-24 weeks). Missing data were low (1%-4.1%), ceiling effects were evident in EQ5D-5L, self-efficacy-scale, and FACT-Physical Wellbeing. At 6 weeks, the chemoRT-eRAPID group showed less deterioration in FACT-G, EORTC QLQ-C30, and EQ5D-Visual Analogue Scale than UC, after baseline adjustment. CONCLUSIONS: eRAPID was successfully added to UC at 2 cancer centers in different patient populations. Acceptability and feasibility were confirmed with excellent adherence by prostate patients, but lower by those undergoing chemoRT for gynecological cancers.

Healthcare utilisation, physical activity and mental health during COVID-19 lockdown: an interrupted time-series analysis of older adults in England.

COVID-19 measures which reduce interpersonal contact may be effective in containing the transmission, but their impacts on peoples' well-being and daily lives overtime remain unclear. Older adults are more vulnerable to both the virus and social isolation. It is therefore imperative to understand how they were affected during this period. Major concerns arising from the pandemic cover the aspects of mental health, healthcare utilisation and individual behavioural changes. Complementing the existing before-and-after analyses, we explore the impacts of easing and re-introducing COVID-19 measures by using a time-series data in England. The data was collected between May and November 2020 from the monthly surveys of the Platform for Research Online to Investigate Genetics and Cognition in Aging (PROTECT). Chi-squared analysis and interrupted time-series analysis were conducted to examine impacts of easing and re-introducing COVID-19 measures. Overall, mental health improves overtime but at a decreasing rate. The use of telephone/video consultations with a doctor or health professional presented a decreasing trend during the pandemic, whilst that of in-person consultation was increasing overtime. We observed significant variations in the time trends of mental health measures, healthcare utilisation and physical activity following the ease but not the re-introduction of COVID-19 measures. Future research is required to understand if these asymmetric impacts were driven by adaption of the people or stringency of the measures. Supplementary Information: The online version contains supplementary material available at 10.1007/s10433-022-00741-y.

Implementing personalised care planning for older people with frailty: a process evaluation of the PROSPER feasibility trial.

BACKGROUND: Personalised Care Planning (PCP) is a collaborative approach used in the management of chronic conditions. Core components of PCP are shared decision making to achieve joint goal setting and action planning by the clinician and patient. We undertook a process evaluation within the PROSPER feasibility trial to understand how best to implement PCP for older people with frailty in the community. METHODS: The trial was set in two localities in England. We observed training sessions and intervention delivery at three time points during the 12-week intervention period. We interviewed delivery teams before, during and after the intervention period, as well as primary care staff. We interviewed older people who had received, declined or withdrawn from PCP. We explored training of staff delivering PCP, structures, mechanisms and resources needed for delivery, and influences on uptake. We undertook a framework approach to data analysis. FINDINGS: We observed thirteen training sessions and interviewed seven delivery staff, five primary care staff, and twenty older people, including seven who had declined or withdrawn from the intervention. Delivery teams successfully acquired skills and knowledge, but felt underprepared for working with people with lower levels of frailty. Timing of training was critical and 'top-ups' were needed. Engagement with primary care staff was tenuous. Older people with lower frailty were unclear of the intervention purpose and benefits, goal setting and action planning. CONCLUSIONS: PCP has the potential to address the individualised needs of older people with frailty. However, training requires careful tailoring and is ideally on-going. Considerable efforts are required to integrate statutory and voluntary stakeholders, understanding the expectations and contributions of each agency from the outset. In addition, older people with frailty need time and support to adjust to new ways of thinking about their own health now and in the future so they can participate in shared decision making. These key factors will be essential when developing models of care for delivering PCP to support older people with frailty to sustain their independence and quality of life. TRIAL REGISTRATION: ISRCTN 12,363,970 - 08/11/2018.

Evaluating the effectiveness of abbreviated breast MRI (abMRI) interpretation training for mammogram readers: a multi-centre study assessing diagnostic performance, using an enriched dataset.

BACKGROUND: Abbreviated breast MRI (abMRI) is being introduced in breast screening trials and clinical practice, particularly for women with dense breasts. Upscaling abMRI provision requires the workforce of mammogram readers to learn to effectively interpret abMRI. The purpose of this study was to examine the diagnostic accuracy of mammogram readers to interpret abMRI after a single day of standardised small-group training and to compare diagnostic performance of mammogram readers experienced in full-protocol breast MRI (fpMRI) interpretation (Group 1) with that of those without fpMRI interpretation experience (Group 2). METHODS: Mammogram readers were recruited from six NHS Breast Screening Programme sites. Small-group hands-on workstation training was provided, with subsequent prospective, independent, blinded interpretation of an enriched dataset with known outcome. A simplified form of abMRI (first post-contrast subtracted images (FAST MRI), displayed as maximum-intensity projection (MIP) and subtracted slice stack) was used. Per-breast and per-lesion diagnostic accuracy analysis was undertaken, with comparison across groups, and double-reading simulation of a consecutive screening subset. RESULTS: 37 readers (Group 1: 17, Group 2: 20) completed the reading task of 125 scans (250 breasts) (total = 9250 reads). Overall sensitivity was 86% (95% confidence interval (CI) 84-87%; 1776/2072) and specificity 86% (95%CI 85-86%; 6140/7178). Group 1 showed significantly higher sensitivity (843/952; 89%; 95%CI 86-91%) and higher specificity (2957/3298; 90%; 95%CI 89-91%) than Group 2 (sensitivity = 83%; 95%CI 81-85% (933/1120) p < 0.0001; specificity = 82%; 95%CI 81-83% (3183/3880) p < 0.0001). Inter-reader agreement was higher for Group 1 (kappa = 0.73; 95%CI 0.68-0.79) than for Group 2 (kappa = 0.51; 95%CI 0.45-0.56). Specificity improved for Group 2, from the first 55 cases (81%) to the remaining 70 (83%) (p = 0.02) but not for Group 1 (90-89% p = 0.44), whereas sensitivity remained consistent for both Group 1 (88-89%) and Group 2 (83-84%). CONCLUSIONS: Single-day abMRI interpretation training for mammogram readers achieved an overall diagnostic performance within benchmarks published for fpMRI but was insufficient for diagnostic accuracy of mammogram readers new to breast MRI to match that of experienced fpMRI readers. Novice MRI reader performance improved during the reading task, suggesting that additional training could further narrow this performance gap.

A Qualitative Investigation of Older Adults' Conceptualization of Quality of Life and a Think-Aloud Content Validation of the EQ-5D-5L, SF-12v2, Warwick Edinburgh Mental Wellbeing Scale, and Office of National Statistics-4.

OBJECTIVES: Old age is characterized by declining health, comorbidities, and increasing health and social care service use. Traditionally, patient-reported outcome measures (PROMs) including the EQ-5D-5L and SF-12v2 have focused on health. Nevertheless, aged care often aims to improve broader elements of quality of life (QoL), captured by well-being measures, such as the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) and Office of National Statistics-4 (ONS-4). This study investigates older adults' conceptualization of QoL and the content validity of the EQ-5D-5L, SF-12v2, WEMWBS, and ONS-4 in measuring their QoL. METHODS: Qualitative cognitive think-aloud interviews were undertaken with older adults aged 75+, exploring their views on what was important to QoL and, for each measure, the relevance, acceptability, and interpretation of items; suitability of response options; and the comprehensiveness of the measure. Conceptualization of QoL was analyzed thematically and content validity using framework analysis. RESULTS: Twenty interviews were undertaken. Older adults' conceptualization of QoL centered on health, ability to perform usual activities, social contact, and emotional functioning. Possible response shift was observed, as older adults assessed their health relative to lower health expectations at their age or to people in worse states. Participants questioned the relevance of negatively phrased mental items and often preferred the functioning-focused EQ-5D-5L to more subjective ONS-4 and WEMWBS items. Domains suggested to improve comprehensiveness included social contact, coping, security, dignity, and control. CONCLUSIONS: These findings are useful to researchers developing new PROMs for older adults or for the developers of included PROMs considering permanently adapting or bolting-on domains to improve content validity in older adults.

An Investigation of Age-Related Differential Item Functioning in the EQ-5D-5L Using Item Response Theory and Logistic Regression.

OBJECTIVES: In economic evaluations, quality of life is measured using patient-reported outcome measures (PROMs), such as the EQ-5D-5L. A key assumption for the validity of PROMs data is measurement invariance, which requires that PROM items and response options are interpreted the same across respondents. If measurement invariance is violated, PROMs exhibit differential item functioning (DIF), whereby individuals from different groups with the same underlying health respond differently, potentially biasing scores. One important group of healthcare consumers who have been shown to have different views or priorities over health is older adults. This study investigates age-related DIF in the EQ-5D-5L using item response theory (IRT) and ordinal logistic regression approaches. METHODS: Multiple-group IRT models were used to investigate DIF, by assessing whether older adults aged 65+ years and younger adults aged 18 to 64 years with the same underlying health had different IRT parameter estimates and expected item and EQ-5D-5L level sum scores. Ordinal logistic regression was also used to examine whether DIF resulted in meaningful differences in expected EQ level sum scores. Effect sizes examined whether DIF indicated meaningful score differences. RESULTS: The anxiety/depression item exhibited meaningful DIF in both approaches, with older adults less likely to report problems. Pain/discomfort and mobility exhibited DIF to a lesser extent. CONCLUSIONS: When using the EQ-5D-5L to evaluate interventions and make resource allocation decisions, scoring bias due to DIF should be controlled for to prevent inefficient service provision, where the most cost-effective services are not provided, which could be detrimental to patients and the efficiency of health budgets.

The economic impact of cancer diagnosis to individuals and their families: a systematic review.

BACKGROUND: The effect of a cancer diagnosis is wide-ranging with the potential to affect income, employment and risk of poverty. The aim of this systematic review is to identify the economic impact of a cancer diagnosis for patients and their families/caregivers. METHODS: The search covered peer-reviewed journals using MEDLINE, EMBASE, CINAHL, Cochrane Library, Epistemonikos and PsycINFO databases. Quality appraisal was undertaken using CASP tools. Monetary values were converted to US Dollars/2019 using a purchasing power parities (PPP) conversion factor. The review included articles up to and including January 2020, written in English language, for patients with cancer aged ≥ 18 years and focused on the costs up to 5 years following a cancer diagnosis. RESULTS: The search was run in January 2020 and updated in November 2021. Of the 7973 articles identified, 18 met the inclusion criteria. Studies were undertaken in the USA, Ireland, Canada, Australia, France, UK, Malaysia, Pakistan, China and Sri Lanka. The majority were cohort studies. Twelve reported out-of-pocket costs (range US$16-US$2523/month per patient/caregiver) consisting of medical expenses (e.g. surgery, radiotherapy and chemotherapy) and non-medical expenses (e.g. travel, food and childcare). Fourteen studies reported patient/caregiver loss of income and lost productivity (range 14-57.8%). CONCLUSIONS: A high percentage of cancer patients and their families/caregivers experience out-of-pocket expenditure, loss of income and lost productivity. Future research is needed to observe the effects of continuing changes to healthcare policies and social protections on the economic burden among cancer patients and their families/caregivers.

Social care costs for community-dwelling older people living with frailty.

International evidence indicates that older people with frailty are more likely to access social care services, compared to nonfrail older people. There is, however, no robust evidence on costs of social care provided for community-dwelling older people living with frailty in their own homes. The main objective of this study was to examine the relationship between community-dwelling older people living with frailty, defined using the cumulative deficit model, and annual formal social care costs for the 2012-2018 period. A secondary objective was to estimate formal social care spending for every 1% reduction in the number of older people who develop frailty over 1 year. Secondary analysis of prospective cohort data from two large nationally representative community-based cohort studies in England was performed. Respondents aged ≥75 were used in the main analysis and respondents aged 65-74 in sensitivity testing. We used regression tree modelling for formal social care cost analysis including frailty, age, gender, age at completing education and living with partner as key covariates. We employed a minimum node size stopping criteria to limit tree complexity and overfitting and applied 'bootstrap aggregating' to improve robustness. We assessed the impact of an intervention for every 1% decrease in the number of individuals who become frail over 1 year in England. Results show that frailty is the strongest predictor of formal social care costs. Mean social care costs for people who are not frail are £321, compared with £2,895 for individuals with frailty. For every 1% of nonfrail people not transitioning to frailty savings of £4.4 million in annual expenditures on formal social care in England are expected, not including expenditure on care homes. Given considerably higher costs for individuals classed as frail compared to nonfrail, a successful intervention avoiding or postponing the onset of frailty has the potential to considerably reduce social care costs.