Anne Spencer

Introduction: Approximately 15 million people in the UK live with obesity and at least 5 million of these are people with severe obesity (PWSO). Severe obesity significantly compromises health, well-being and quality of life and reduces life expectancy. These adverse outcomes are prevented or ameliorated by weight loss, for which sustained behavioural change is the cornerstone of treatment. Several studies suggest the potential of group-based intervention in Specialist Weight Management Services (SWMS), but PWSO remain underrepresented in research, and evidence on optimal design and outcomes is limited. The success of the PROGROUP feasibility randomised controlled trial (RCT) ( ISRCTN22088800 ) informed the development of this study and additional adjustments have been made in response to the rollout of obesity management medication in the National Health Service (NHS). This study aims to assess the effectiveness and cost-effectiveness of PROGROUP in SWMS and primary care. Methods and analysis: The RCT will be conducted in SWMS, alongside an implementation study in primary care. The RCT will recruit cohorts of 30 participants to be randomised 1:1 within-cohort to PROGROUP (intervention) or usual care (control). The implementation arm will recruit cohorts of 15 to PROGROUP. The primary objectives for the study are to undertake a process evaluation and economic evaluation of PROGROUP in the RCT and to assess its implementation in primary care. Baseline data and outcome differences at 6 months will be analysed. These will include weight, other clinical measures and patient-reported outcomes, including social and life-satisfaction measures. Ethics and dissemination: This study is approved by an NHS Research Ethics Committee (REC reference: 23/WS/0101). Results will be reported in a manuscript that will be submitted to a peer-reviewed medical journal as open access. A lay summary of the findings will be published online, and participants and sites will be signposted to this. Trial registration number: ISRCTN13721429 .

Objectives To systematically evaluate associations between comorbidities and differences in treatment decisions, outcomes, health-related quality of life (HRQoL), healthcare resource utilisation and costs, in patients with colon or rectal cancer. Design Systematic review. Data sources PubMed (Medline) and Embase databases were searched for studies published from January 2000 until January 2024. Eligibility criteria for selecting studies We included articles that compared the presence and absence of comorbidities, evaluated multiple comorbid conditions or used the Charlson Comorbidity Index, or variations such as the Charlson-Deyo Index. Primary and secondary outcome measures included cancer treatments, outcomes (including complications from treatments, survival and mortality rates), HRQoL, healthcare resource use and costs. Data extraction and synthesis Two independent reviewers used standardised methods to search, screen and code included studies. Risk of bias was assessed using the Joanna Briggs Institute checklists to ensure the quality of data. Findings were summarised narratively. Results After duplicates were removed, 15 394 hits were screened and 31 studies were selected for inclusion in this systematic review. Comorbidities were associated with a lower likelihood of receiving treatment and lower survival rates and HRQoL, alongside a higher likelihood of complications following treatment, higher mortality rates and higher healthcare resource use. There were very limited studies that reported on HRQoL and resource use, and none reporting data directly relating to the impact of comorbidities on costs. These results were consistent across North America, Europe, Australia and New Zealand. Conclusions For patients with colon and rectal cancer, comorbidities are associated with a lower likelihood of receiving treatments and poorer health outcomes. With global populations ageing, there is likely to be an increase in patients with colon and rectal cancer with comorbidities. Therefore, further research is necessary, especially to inform decisions regarding patient management and treatment, and to understand the implications on healthcare resource allocation, costs and HRQoL.

Introduction: Routine population-level screening may in the future reduce the high mortality rates associated with late-stage ovarian cancer diagnosis. However, the voluntary nature of screening means that understanding the public’s acceptability of the benefits, harms and likely uptake of any potential screening programme is crucial to implementation.Objective: To measure public preferences towards the benefits and harms of a potential screening programme and to predict uptake.Methods: An online Discrete Choice Experiment was completed by 250 women 40-80 years old in England and Wales. Subjects were asked 12 questions where they were asked to choose between two hypothetical screening tests described in terms of four attributes; ovarian cancer deaths, false-positive, false-negative and overdiagnosis rates, and no screening. Responses were analysed using mixed logit regression.Results: In total, 250 women completed the survey. Ovarian cancer deaths (0.42, [95% CI: 0.40 – 0.44]) was the most important attribute overall, followed by the rate of false positive results (0.30, [95% CI: 0.30-0.30]). However, there were high levels of heterogeneity with individuals exhibiting low levels of worry about ovarian cancer (OR=1.76 [95% CI: 1.17–2.69]), low perceived risk of ovarian cancer (OR=1.44 [95% 1.03–2.03]) or risk-averse individuals (OR=1.46 [95% CI: 1.05–2.04]) significantly more likely to opt for the no screening alternative. Oppositely, individuals who regularly participate in cervical screening (OR=0.63 [0.47–0.90]) were less likely to opt for no screening. Overall, results indicated participants would be willing to accept 2.59 (95% CI: 1.82 – 3.36) false-negative results, 205 (95% CI: 161 – 248) false-positive results and 2.35 (95% CI: 1.76-2.94) per 10,000 people screened to avoid 1 ovarian cancer-related death. Uptake analysis confirmed a high willingness to undergo screening across varying levels of benefits and harms.Conclusions: Currently ovarian cancer screening is not recommended as available screening methods do not offer benefits in terms of mortality reduction. The results of this study demonstrate a high demand for ovarian cancer screening and a willingness to trade between the benefits and risks of a potential test. Results of this study provide a useful resource for assessing the acceptability of future screening modalities which may become available.

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.

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.

Background Evidence from discrete choice experiments can be used to enrich understanding of preferences, inform the (re)design of screening programmes and/or improve communication within public campaigns about the benefits and harms of screening. However, reviews of screening discrete choice experiments highlight significant discrepancies between stated choices and real choices, particularly regarding willingness to undergo cancer screening. The identification and selection of attributes and associated levels is a fundamental component of designing a discrete choice experiment. Misspecification or misinterpretation of attributes may lead to non-compensatory behaviours, attribute non-attendance and responses that lack external validity. Objectives We aimed to synthesise evidence on attribute development, alongside an in-depth review of included attributes and methodological challenges, to provide a resource for researchers undertaking future studies in cancer screening. Methods A systematic review was conducted to identify discrete choice experiments estimating preferences towards cancer screening, dated between 1990 and December 2020. Data were synthesised narratively. In-depth analysis of attributes led to classification into four categories: test specific, service delivery, outcomes and monetary. Attribute significance and relative importance were also analysed. The International Society for Pharmacoeconomics and Outcomes Research conjoint analysis checklist was used to assess the quality of reporting. Results Forty-nine studies were included at full text. They covered a range of cancer sites: over half (26/49) examined colorectal screening. Most studies elicited general public preferences (34/49). In total, 280 attributes were included, 90% (252/280) of which were significant. Overall, test sensitivity and mortality reduction were most frequently found to be the most important to respondents. Conclusions Improvements in reporting the identification, selection and construction of attributes used within cancer screening discrete choice experiments are needed. This review also highlights the importance of considering the complexity of choice tasks when considering risk information or compound attributes. Patient and public involvement and stakeholder engagement are recommended to optimise understanding of unavoidably complex choice tasks throughout the design process. To ensure quality and maximise comparability across studies, further research is needed to develop a risk-of-bias measure for discrete choice experiments.

Objectives Pilot feasibility randomised controlled trial (RCT) for the singing groups for people with aphasia (SPA) intervention to assess: (1) the acceptability and feasibility of participant recruitment, randomisation and allocation concealment; (2) retention rates; (3) variance of continuous outcome measures; (4) outcome measure completion and participant burden; (5) fidelity of intervention delivery; (6) SPA intervention costs; (7) acceptability and feasibility of trial and intervention to participants and others involved. Design A two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation. Setting Three community-based cohorts in the South-West of England. Participants Eligible participants with post-stroke aphasia were randomised 1:1 to SPA or control. Intervention The manualised SPA intervention was delivered over 10 weekly singing group sessions, led by a music facilitator and assisted by an individual with post-stroke aphasia. The intervention was developed using the Information-Motivation-Behavioural skills model of behaviour change and targeted psychosocial outcomes. Control and intervention participants all received an aphasia information resource pack. Outcome measures Collected at baseline, 3 and 6 months post-randomisation, candidate primary outcomes were measured (well-being, quality of life and social participation) as well as additional clinical outcomes. Feasibility, acceptability and process outcomes included recruitment and retention rates, and measurement burden; and trial experiences were explored in qualitative interviews. Results Of 87 individuals screened, 42 participants were recruited and 41 randomised (SPA=20, control=21); 36 participants (SPA=17, control=19) completed 3-month follow-up, 34 (SPA=18, control=16) completed 6-month follow-up. Recruitment and retention (83%) were acceptable for a definitive RCT, and participants did not find the study requirements burdensome. High fidelity of the intervention delivery was shown by high attendance rates and facilitator adherence to the manual, and participants found SPA acceptable. Sample size estimates for a definitive RCT and primary/secondary outcomes were identified. Conclusions The SPA pilot RCT fulfilled its objectives, and demonstrated that a definitive RCT of the intervention would be both feasible and acceptable. Trial registration number NCT03076736.

Background: Tools based on diagnostic prediction models are available to help general practitioners diagnose cancer. It is unclear whether or not tools expedite diagnosis or affect patient quality of life and/or survival.Objectives: The objectives were to evaluate the evidence on the validation, clinical effectiveness, cost-effectiveness, and availability and use of cancer diagnostic tools in primary care.Methods: Two systematic reviews were conducted to examine the clinical effectiveness (review 1) and the development, validation and accuracy (review 2) of diagnostic prediction models for aiding general practitioners in cancer diagnosis. Bibliographic searches were conducted on MEDLINE, MEDLINE In-Process, EMBASE, Cochrane Library and Web of Science) in May 2017, with updated searches conducted in November 2018. A decision-analytic model explored the tools’ clinical effectiveness and cost-effectiveness in colorectal cancer. The model compared patient outcomes and costs between strategies that included the use of the tools and those that did not, using the NHS perspective. We surveyed 4600 general practitioners in randomly selected UK practices to determine the proportions of general practices and general practitioners with access to, and using, cancer decision support tools. Association between access to these tools and practice-level cancer diagnostic indicators was explored.Results: Systematic review 1 – five studies, of different design and quality, reporting on three diagnostic tools, were included. We found no evidence that using the tools was associated with better outcomes. Systematic review 2 – 43 studies were included, reporting on prediction models, in various stages of development, for 14 cancer sites (including multiple cancers). Most studies relate to QCancer^®(ClinRisk Ltd, Leeds, UK) and risk assessment tools.Decision model: In the absence of studies reporting their clinical outcomes, QCancer and risk assessment tools were evaluated against faecal immunochemical testing. A linked data approach was used, which translates diagnostic accuracy into time to diagnosis and treatment, and stage at diagnosis. Given the current lack of evidence, the model showed that the cost-effectiveness of diagnostic tools in colorectal cancer relies on demonstrating patient survival benefits. Sensitivity of faecal immunochemical testing and specificity of QCancer and risk assessment tools in a low-risk population were the key uncertain parameters.Survey: Practitioner- and practice-level response rates were 10.3% (476/4600) and 23.3% (227/975), respectively. Cancer decision support tools were available in 83 out of 227 practices (36.6%, 95% confidence interval 30.3% to 43.1%), and were likely to be used in 38 out of 227 practices (16.7%, 95% confidence interval 12.1% to 22.2%). The mean 2-week-wait referral rate did not differ between practices that do and practices that do not have access to QCancer or risk assessment tools (mean difference of 1.8 referrals per 100,000 referrals, 95% confidence interval –6.7 to 10.3 referrals per 100,000 referrals).Limitations: There is little good-quality evidence on the clinical effectiveness and cost-effectiveness of diagnostic tools. Many diagnostic prediction models are limited by a lack of external validation. There are limited data on current UK practice and clinical outcomes of diagnostic strategies, and there is no evidence on the quality-of-life outcomes of diagnostic results. The survey was limited by low response rates.Conclusion: The evidence base on the tools is limited. Research on how general practitioners interact with the tools may help to identify barriers to implementation and uptake, and the potential for clinical effectiveness.Future work: Continued model validation is recommended, especially for risk assessment tools. Assessment of the tools’ impact on time to diagnosis and treatment, stage at diagnosis, and health outcomes is also recommended, as is further work to understand how tools are used in general practitioner consultations.Study registration: This study is registered as PROSPERO CRD42017068373 and CRD42017068375.Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology programme and will be published in full inHealth Technology Assessment; Vol. 24, No. 66. See the NIHR Journals Library website for further project information.