Assessing the long-term impact of cancer on people’s lives is challenging due to confounding issues such as aging and comorbidities. We aimed to investigate this impact by comparing the outcomes of cancer survivors with a matched control cohort. This was a cross-sectional survey of breast, colorectal and ovarian cancer survivors approximately 5 years post-diagnosis and a cohort of age, sex and social deprivation-matched controls who had never had a cancer diagnosis. Eligible participants were invited by post to complete a survey assessing quality of life (QoL), health, identity, healthcare usage and finances. A total of 2075 out of 5734 (36.2

Patient barriers to self-management in cirrhosis are complex.[1] Although several studies have demonstrated improved knowledge or self-care behaviors following education,[1] long-term outcome data are lacking. We previously reported that a multifaceted pharmacist-led intervention for people with decompensated cirrhosis (including patient-oriented education, medication reconciliation, and identification and resolution of "high-risk" medication-related problems) was associated with fewer unplanned admissions at 12 months compared to usual care (adjusted incidence rate ratio [aIRR], 0.52; 95% confidence interval [CI], 0.30–0.92; p = 0.025).[2] Despite the relatively short 6-month intervention delivery period, new outcome data demonstrate unplanned admission rates in the intervention group remained lower than usual care out to 3 years. Participants were followed for a mean of 27.8 (SD, ±11.9) months and censored at death (n = 41; 35.3%), liver transplant (n = 5; 4.3%), or study closeout at 3 years (n = 70; 60.3%). Forty-one patients receiving intervention (41/57, 71.9%) and 50 patients receiving usual care (50/59, 84.7%) had at least one unplanned admission during the follow-up period (unplanned admission rate, 3.72 vs. 4.34; Mann-Whitney U, p = 0.272) (Figure 1). Using a generalized linear model with negative binomial distribution offset by person time to censorship, patients receiving intervention had a significantly lower incidence rate of unplanned admissions at 3 years compared to usual care (aIRR, 0.56; 95% CI, 0.34–0.92; p = 0.023), following adjustment for Child-Pugh score (aIRR, 1.47; 95% CI, 1.28–1.68; p < 0.001), number of medications (aIRR, 1.09; 95% CI, 1.03–1.15; p = 0.005), history of variceal bleeding (aIRR, 2.36; 95% CI, 1.30–4.29; p = 0.005), and alcoholic liver disease (aIRR, 0.63; 95% CI, 0.40–1.00; p = 0.050). We further conducted a subanalysis of unplanned admissions that were considered medication related and potentially preventable.[2] Using a multinomial logistic regression model (due to the large count of zero admissions) adjusted for Child-Pugh score and number of medications, patients receiving usual care were 3.5 times more likely to have three or more "potentially preventable medication-related admissions" compared to zero than patients receiving intervention, although this did not reach statistical significance (adjusted odds ratio, 3.52; 95% CI, 0.69–17.81; p = 0.129). There was no difference in mortality rate (intervention 31.6% vs. usual care 39.0%; p = 0.404) or mean time to censorship (28.5 vs. 27.2 months, respectively; log-rank p = 0.530). These findings suggest that a pharmacist-led intervention, which empowers patients (and their caregivers) with improved knowledge about cirrhosis and medicines,[3] reinforces perceptions of treatment necessity and utility in disease management,[3] provides tools to manage medicines (e.g., a structured list[2]), and builds confidence to actively engage with health care providers, has long-term benefits for patients and the health care system. Despite completion of active pharmacist intervention at 6 months, the benefits persisted over time and translated to fewer hospitalizations independently of liver disease severity. These data support inclusion of a pharmacist in the multidisciplinary team. Nothing to report.

Background The use of linked healthcare data in research has the potential to make major contributions to knowledge generation and service improvement. However, using healthcare data for secondary purposes raises legal and ethical concerns relating to confidentiality, privacy and data protection rights. Using a linkage and anonymisation approach that processes data lawfully and in line with ethical best practice to create an anonymous (non-personal) dataset can address these concerns, yet there is no set approach for defining all of the steps involved in such data flow end-to-end. We aimed to define such an approach with clear steps for dataset creation, and to describe its utilisation in a case study linking healthcare data. Methods We developed a data flow protocol that generates pseudonymous datasets that can be reversibly linked, or irreversibly linked to form an anonymous research dataset. It was designed and implemented by the Comprehensive Patient Records (CPR) study in Leeds, UK. Results We defined a clear approach that received ethico-legal approval for use in creating an anonymous research dataset. Our approach used individual-level linkage through a mechanism that is not computer-intensive and was rendered irreversible to both data providers and processors. We successfully applied it in the CPR study to hospital and general practice and community electronic health record data from two providers, along with patient reported outcomes, for 365,193 patients. The resultant anonymous research dataset is available via DATA-CAN, the Health Data Research Hub for Cancer in the UK. Conclusions Through ethical, legal and academic review, we believe that we contribute a defined approach that represents a framework that exceeds current minimum standards for effective pseudonymisation and anonymisation. This paper describes our methods and provides supporting information to facilitate the use of this approach in research.

Abstract Background Optimal management of cirrhosis is complex, and patients often lack knowledge and skills, which can affect self-management. We assessed patient knowledge about cirrhosis and examined whether knowledge was associated with clinical outcomes, healthcare service use, and healthcare costs. A cross-sectional ‘knowledge survey’ was conducted during 2018–2020. We assessed patient knowledge about cirrhosis and explore whether knowledge was associated with clinical outcomes, healthcare service use, and costs. Methods Patients with cirrhosis (n = 123) completed a ‘knowledge survey’. We calculated the proportion of correct answers to eight questions deemed to be “key knowledge” about cirrhosis by an expert panel, and dichotomized patients as ‘good knowledge’/‘poor knowledge’. Clinical data, healthcare costs, and health-related quality of life (SF-36) were available. Results 58.5% of patients had ‘good knowledge’ about cirrhosis. Higher education level was associated with higher odds of having ‘good knowledge’ about cirrhosis (adjusted-OR = 5.55, 95%CI 2.40–12.84). Compared to patients with ‘poor knowledge’, those with ‘good knowledge’ had a higher health status in the SF-36 physical functioning domain (p = 0.011), fewer cirrhosis-related admissions (adjusted incidence rate ratio [IRR] = 0.59, 95%CI 0.35–0.99) and emergency presentations (adj-IRR = 0.34, 95%CI 0.16–0.72), and more planned 1-day cirrhosis admissions (adj-IRR = 3.96, 95%CI 1.46–10.74). The total cost of cirrhosis admissions was lower for patients with ‘good knowledge’ (adj-IRR = 0.30, 95%CI 0.29–0.30). Conclusion Poor disease knowledge is associated with increased use and total cost of healthcare services. Targeted educational interventions to improve patient knowledge may be an effective strategy to promote a more cost-effective use of healthcare services.

Objectives Standardised reporting of patient and public involvement (PPI) in research studies is needed to facilitate learning about how to achieve effective PPI. The aim of this evaluation was to explore the impact of PPI in a large UK study, the Life After Prostate Cancer Diagnosis (LAPCD) study, and to explore the facilitators and challenges experienced. Design Mixed-methods study using an online survey and semistructured interviews. Survey and topic guide were informed by systematic review evidence of the impact of PPI and by realist evaluation. Descriptive analysis of survey data and thematic analysis of interview data were conducted. Results are reported using the GRIPP2 (Guidance for Reporting Involvement of Patients and the Public, Version 2) reporting guidelines. Setting LAPCD study, a UK-wide patient-reported outcome study. Participants User Advisory Group (UAG) members (n=9) and researchers (n=29) from the LAPCD study. Results Impact was greatest on improving survey design and topic guides for interviews, enhancing clarity of patient-facing materials, informing best practices around data collection and ensuring steering group meetings were grounded in what is important to the patient. Further impacts included ensuring patient-focused dissemination of study findings at conference presentations and in lay summaries. Facilitating context factors included clear aims, time to contribute, confidence to contribute, and feeling valued and supported by researchers and other UAG members. Facilitating mechanisms included embedding the UAG within the study as a separate workstream, allocating time and resources to the UAG reflecting the value of input, and putting in place clear communication channels. Hindering factors included time commitment, geographical distance, and lack of standardised feedback mechanisms. Conclusion Including PPI as an integral component of the LAPCD study and providing the right context and mechanisms for involving the UAG helped maximise the programme’s effectiveness and impact.

Introduction More people are living with and beyond a cancer diagnosis. There is limited understanding of the long-term effects of cancer and cancer treatment on quality of life and personal and household finances when compared to people without cancer. In a separate protocol we have proposed to link de-identified data from electronic primary care and hospital records for a large population of cancer survivors and matched controls. In this current protocol, we propose the linkage of Patient Reported Outcomes Measures data to the above data for a subset of this population. The aim of this study is to investigate the full impact of living with and beyond a cancer diagnosis compared to age and gender matched controls. A secondary aim is to test the feasibility of the collection of Patient Reported Outcomes Measures (PROMS) data and the linkage procedures of the PROMs data to electronic health records data. Materials and methods This is a cross-sectional study, aiming to recruit participants treated at the Leeds Teaching Hospitals National Health Service Trust. Eligible patients will be cancer survivors at around 5 years post-diagnosis (breast, colorectal and ovarian cancer) and non-cancer patient matched controls attending dermatology out-patient clinics. They will be identified by running a query on the Leeds Teaching Hospitals Trust patient records system. Approximately 6000 patients (2000 cases and 4000 controls) will be invited to participate via post. Participants will be invited to complete PROMs assessing factors such as quality of life and finances, which can be completed on paper or online (surveys includes established instruments, and bespoke instruments (demographics, financial costs). This PROMs data will then be linked to routinely collected de-identified data from patient’s electronic primary care and hospital records. Discussion This innovative work aims to create a truly ‘comprehensive patient record’ to provide a broad picture of what happens to cancer patients across their cancer pathway, and the long-term impact of cancer treatment. Comparisons can be made between the cases and controls, to identify the aspects of life that has had the greatest impact following a cancer diagnosis. The feasibility of linking PROMs data to electronic health records can also be assessed. This work can inform future support offered to people living with and beyond a cancer diagnosis, clinical practice, and future research methodologies.

Objective To evaluate the dynamic nature of self-reported health-related quality of life (HRQL) and morbidity burden in men diagnosed with prostate cancer, we performed a follow-up study of the Life After Prostate Cancer Diagnosis (LAPCD) study cohort 12 months after initial survey. Methods The LAPCD study collected information from 35,823 men across the UK who were 18–42 months post-diagnosis of prostate cancer. Men who were still alive 12 months later were resurveyed. Generic HRQL (EQ-5D-5L plus self-assessed health rating) and prostate cancer-specific outcomes (EPIC-26) were assessed. Treatment(s) received was self-reported. Previously defined clinically meaningful differences were used to evaluate changes in outcomes over time. Results A total of 28,450 men across all disease stages completed follow-up surveys (85.8% response). Of the 21,700 included in this study, 89.7% reported no additional treatments since the first survey. This group experienced stable urinary and bowel outcomes, with good function for most men at both time points. On-going poor (but stable) urinary issues were associated with previous surgery. Sexual function scores remained low (mean: 26.8/100). Self-assessed health ratings were stable over time. The largest declines in HRQL and functional outcomes were experienced by men reporting their first active treatment between surveys. Discussion The results suggest stability of HRQL and most specific morbidities by 18–42 months for men who report no further treatment in the subsequent 12 months. This is reassuring for those with good function and HRQL but re-enforces the need for early intervention and support for men who experience poor outcomes.

Discrepancies between the medicines consumed by patients and those documented in the medical record can affect medication safety. We aimed to characterize medication discrepancies and medication regimen complexity over time in a cohort of outpatients with decompensated cirrhosis, and evaluate the impact of pharmacist-led intervention on discrepancies and patient outcomes. In a randomized-controlled trial (n = 57 intervention and n = 57 usual care participants), medication reconciliation and patient-oriented education delivered over a six-month period was associated with a 45% reduction in the incidence rate of ‘high’ risk discrepancies (IRR = 0.55, 95%CI = 0.31–0.96) compared to usual care. For each additional ‘high’ risk discrepancy at baseline, the odds of having ≥ 1 unplanned medication-related admission during a 12-month follow-up period increased by 25% (adj-OR = 1.25, 95%CI = 0.97–1.63) independently of the Child–Pugh score and a history of variceal bleeding. Among participants with complete follow-up, intervention patients were 3-fold less likely to have an unplanned medication-related admission (adj-OR = 0.27, 95%CI = 0.07–0.97) compared to usual care. There was no association between medication discrepancies and mortality. Medication regimen complexity, frequent changes to the regimen and hepatic encephalopathy were associated with discrepancies. Medication reconciliation may improve medication safety by facilitating communication between patients and clinicians about ‘current’ therapies and identifying potentially inappropriate medicines that may lead to harm.

ABSTRACT Background Men with prostate cancer (PCa) often experience sexual dysfunction following diagnosis and treatment, yet little is known about the support they receive to deal with this. Aim To explore men’s experiences of support for sexual dysfunction following PCa diagnosis. Methods This study included a U.K.-wide survey of men 18–42 months post-diagnosis of PCa, identified through cancer registries. The survey measured sexual function and the extent to which men perceived sexual dysfunction to be a problem (Expanded Prostate Cancer Index Composite-26), access to and experience of medications, devices, and specialist services for sexual dysfunction, and included a free-text question for further comments. Analysis focussed on men who reported poor sexual function, which they considered a moderate or big problem. Descriptive statistics explored the characteristics of men offered intervention and those that found this helpful. Free-text responses were analyzed using thematic analysis. Outcome The main outcome of this study was to assess access to and experience of medications, devices, and specialist services for sexual dysfunction. RESULTS 39.0% of all survey respondents (13,978/35,823) reported poor sexual function, which they considered a moderate or big problem. 51.7% of these men were not offered any intervention to aid sexual functioning. 71.9% of those offered an intervention reported trying it, of whom 48.7% found the intervention helpful. Men treated with surgery or brachytherapy were most likely to be offered an intervention. Medication was the most commonly offered intervention and 39.3% of those who tried medication found this helpful. Although offered less often, approximately half of the men who tried devices or attended specialist services found the intervention helpful. Free-text responses indicated that barriers to accessing support included inadequate information and support from healthcare professionals, embarrassment, negative views about treatment options, concerns about side effects and safety, and inconsistencies between secondary and primary care. Barriers to continuing use included limited effectiveness of treatments, inadequate ongoing support, and funding constraints. Drivers of sexual recovery included patient proactivity and persistence with trying different treatment options and ongoing support from health professionals. Clinical Implications There is an urgent need to ensure that all men are offered, and have equal access to, sexual care support, with referral to specialist services when required. Strengths & Limitations This study presents data from a large, U.K.-wide, population-based study of men with PCa and includes quantitative and qualitative findings. The possibility of non-response bias should, however, be considered. CONCLUSION There are significant shortcomings in the support offered to U.K. men with sexual dysfunction following diagnosis and treatment for PCa which need to be addressed.

Abstract Background and Objectives A 2008 European consensus on research outcome measures in dementia care concluded that measurement of carer quality of life (QoL) was limited. Three systematic reviews (2012, 2017, and 2018) of dementia carer outcome measures found existing instruments wanting. In 2017, recommendations were published for developing reliable measurement tools of carers’ needs for research and clinical application. The aim of this study was to develop a new instrument to measure the QoL of dementia carers (family/friends). Methods Items were generated directly from carers following an inductive needs-led approach. Carers (n = 566) from 22 English and Welsh locations then completed the items and comparator measures at three time points. Rasch, factor, and psychometric (reliability, validity, responsiveness, and minimally important differences [MIDs]) analyses were undertaken. Results Following factor analysis, the pool of 70 items was refined to three independent scales: primary SIDECAR-D (direct impact of caring upon carer QOL, 18 items), secondary SIDECAR-I (indirect impact, 10 items), and SIDECAR-S (support and information, 11 items). All three scales satisfy Rasch model assumptions. SIDECAR-D, I, S psychometrics: reliability (internal ≥ .70; test–retest ≥ .85); convergent validity (as hypothesized); responsiveness (effect sizes: D: moderate; I and S: small); MIDs (D = 9/100, I = 10/100, S = 11/100). Discussion and Implications SIDECAR scales demonstrate robust measurement properties, meeting COSMIN quality standards for study design and psychometrics. SIDECAR provides a theoretically based needs-led QoL profile specifically for dementia carers. SIDECAR is free for use in public health, social care, and voluntary sector services, and not-for-profit organizations.

Background: Little is known about health-related quality of life (HRQOL) following treatment for bladder cancer (BC). Objective: To determine this, we undertook a cross-sectional survey covering 10% of the English population. Design, setting, and participants: Participants 1?10 yr from diagnosis were identified through national cancer registration data. Intervention: A postal survey was administered containing generic HRQOL and BCspecific outcome measures. Findings were compared with those of the general population and other pelvic cancer patients. Outcome measurements and statistical analysis: Generic HRQOL was measured using five-level EQ-5D (EQ-5D-5L) and European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-C30. BC-specific outcomes were derived from EORTC QLQ-BLM30 and EORTC QLQ-NMIBC24. Results and limitations: A total of 1796 surveys were completed (response rate 55%), including 868 (48%) patients with non?muscle-invasive BC, 893 (50%) patients who received radiotherapy or radical cystectomy, and 35 (1.9%) patients for whom treatment was unknown. Most (69%) of the participants reported at least one problem in any EQ-5D dimension. Age/sex-adjusted generic HRQOL outcomes were similar across all stages and treatment groups, whilst problems increased with age (problems in one or more EQ5D dimensions: <65 yr [67% {95% confidence interval or CI: 61?74}] vs 85+ yr [84% {95% CI: 81?89}], p = 0.016) and long-term conditions (no conditions [53% {95% CI: 48?58}] vs more than four conditions [94% {95% CI: 90?97}], p < 0.001). Sexual problems were reported commonly in men, increasing with younger age and radical treatment. Younger

BACKGROUND:In the UK, inequalities exist in prostate cancer incidence, survival and treatment by area deprivation and rurality. This work aimed to identify variation in patient-reported outcomes of men with prostate cancer by area type.METHODS:A population-based survey of men 18-42 months after prostate cancer diagnosis (N = 35608) measured self-assessed health (SAH) using the EQ-5D and five functional domains using the Expanded Prostate Cancer Index Composite (EPIC-26).RESULTS:Mean SAH was higher for men in least deprived areas compared to most deprived (difference 6.3 (95 %CI 5.6-7.2)). SAH scores were lower for men in most urban areas compared to most rural (difference 2.4 (95 %CI 1.8-3.0)). Equivalent estimates in the general population reported a 13 point difference by deprivation and a 4 point difference by rurality. For each EPIC-26 domain, functional outcomes were better for men in the least deprived areas, with clinically meaningful differences observed for urinary incontinence and hormonal function. There were no clinically meaningful differences in EPIC-26 outcomes by rurality with less than a three point difference in scores for each domain between urban and rural areas.CONCLUSION:In men 18-42 months post diagnosis of prostate cancer in the UK, impacts of area deprivation and rurality on self-assessed health related quality of life were not greater than would be expected in the general population. However, clinically meaningful differences were identified for some prostate functional outcomes (urinary and hormonal function) by deprivation. No impact by rurality of residence was identified.

People with chronic disease often have poor comprehension of their disease and medications, which can negatively affect health outcomes. In a randomised-controlled trial, we found that patients with decompensated cirrhosis who received a pharmacist-led, patient-oriented education and medication management intervention (n = 57) had greater knowledge of cirrhosis and key self-care tasks compared with usual care (n = 59). Intervention patients also experienced improved quality of life. Dedicated resources are needed to support implementation of evidence-based measures at local centres to improve outcomes.

OBJECTIVES:Dementia affects many people, with numbers expected to grow as populations age. Many people with dementia receive informal/family/unpaid care, for example, from a spouse or child, which may affect carer quality of life. Measuring the effectiveness of health/social care interventions for carers requires a value measure of the quality-of-life impact of caring. This motivated development of the Scales Measuring the Impact of Dementia on Carers-D (SIDECAR-D) instrument. This study aimed to obtain general population values for SIDECAR-D to aid incorporating the impact of caring in economic evaluation. METHODS:Members of the UK general public completed a best-worst scaling object case survey, which included the 18 SIDECAR-D items and EQ-5D-3L descriptions. Responses were analyzed using scale-adjusted finite mixture models. Relative importance scores (RISs) for the 18 SIDECAR-D items formed the SIDECAR-D relative scale measuring the relative impact of caring. The SIDECAR-D tariff, on the full health = 1, dead = 0 scale, was derived by rescaling EQ-5D-3L and SIDECAR-D RISs so the EQ-5D-3L RISs equaled anchored valuations of the EQ-5D-3L pits state from a visual analog scale task. RESULTS:Five hundred ten respondents completed the survey. The model had 2 parameter and 3 scale classes. Additive utility decrements of SIDECAR-D items ranged from -0.05 to -0.162. Utility scores range from 0.95 for someone affirming 1 item to -0.297 for someone affirming all 18. CONCLUSION:SIDECAR-D is a needs-based scale of the impact on quality of life of caring for someone with dementia, with a valuation tariff to support its use in economic evaluation.

Objective: Clinical options for managing nonmetastatic prostate cancer (PCa) vary. Each option has side effects associated with it, leading to difficulty in decision-mak-ing. This study aimed to assess the relationship between patient involvement in treatment decision-making and subsequent decision regret (DR), and quantify the impact of health-related quality of life (HRQL) outcomes on DR. Methods: Men living in the United Kingdom, 18 to 42 months after diagnosis of PCa, were identified from cancer registration data and sent extent ” in decision-making (OR = 4.63, 95% CI: 4.27-5.02), compared with men who were “ definitely ” involved. After adjustment, including for involvement, men reporting moderate/big problems with urinary, bowel, or sexual function were more likely to experience regret compared with men with no/small problems. Better HRQL scores were associated with lower levels of DR. Conclusions: This large-scale study demonstrates the benefit of patient involvement in treatment decision-making for nonmetastatic PCa. However, men experiencing side effects and poorer HRQL report greater DR. Promoting engagement in clinical decision-making represents good practice and may reduce the risk of subsequent regret.

Due to recent treatment advances, men are increasingly living longer with advanced prostate cancer (PCa). This study sought to understand men’s experiences of living with and adjusting to advanced hormone-responsive PCa and how this influenced their quality of life (QoL), in order to highlight how support could be optimized. Participants were recruited through a UK wide survey—the ‘Life After Prostate Cancer Diagnosis’ study. In-depth telephone interviews were conducted with 24 men (aged 46–77 years) with advanced (stage IV) hormone-responsive PCa diagnosed 18–42 months previously. Thematic analysis was undertaken using a framework approach. Most participants perceived their QoL to be relatively good, which was influenced by the following factors (enablers to ‘living well’ with PCa): a sense of connectedness to others, engagement in meaningful activities, resources (social, cognitive, financial), ability to manage uncertainty, utilization of adjustment strategies and support, communication and information from health professionals. Barriers to ‘living well’ with PCa were often the converse of these factors. These also included more troublesome PCa-related symptoms and stronger perceptions of loss and restriction. In our study, men living with advanced hormone-responsive PCa often reported a good QoL. Exploring the influences on QoL in men with advanced PCa indicates how future interventions might improve the QoL of men who are struggling. Further research is required to develop and test interventions that enhance QoL for these men.