Getting our ducks in a row: The need for data utility comparisons of healthcare systems data for clinical trials.

BACKGROUND: Better use of healthcare systems data, collected as part of interactions between patients and the healthcare system, could transform planning and conduct of randomised controlled trials. Multiple challenges to widespread use include whether healthcare systems data captures sufficiently well the data traditionally captured on case report forms. "Data Utility Comparison Studies" (DUCkS) assess the utility of healthcare systems data for RCTs by comparison to data collected by the trial. Despite their importance, there are few published UK examples of DUCkS. METHODS-AND-RESULTS: Building from ongoing and selected recent examples of UK-led DUCkS in the literature, we set out experience-based considerations for the conduct of future DUCkS. Developed through informal iterative discussions in many forums, considerations are offered for planning, protocol development, data, analysis and reporting, with comparisons at "patient-level" or "trial-level", depending on the item of interest and trial status. DISCUSSION: DUCkS could be a valuable tool in assessing where healthcare systems data can be used for trials and in which trial teams can play a leading role. There is a pressing need for trials to be more efficient in their delivery and research waste must be reduced. Trials have been making inconsistent use of healthcare systems data, not least because of an absence of evidence of utility. DUCkS can also help to identify challenges in using healthcare systems data, such as linkage (access and timing) and data quality. We encourage trial teams to incorporate and report DUCkS in trials and funders and data providers to support them.

Satisfaction with remote consultations in primary care during COVID-19: a population survey of UK adults.

BACKGROUND: Mode of access to primary care changed during the COVID-19 pandemic; remote consultations became more widespread. With remote consultations likely to continue in UK primary care, it is important to understand people's perceptions of remote consultations and identify potential resulting inequalities. AIM: To assess satisfaction with remote GP consultations in the UK during the COVID-19 pandemic and identify demographic variation in satisfaction levels. DESIGN AND SETTING: A cross-sectional survey from the second phase of a large UK-based study, which was conducted during the COVID-19 pandemic. METHOD: In total, 1426 adults who self-reported having sought help from their doctor in the past 6 months completed an online questionnaire (February to March 2021). Items included satisfaction with remote consultations and demographic variables. Associations were analysed using multivariable regression. RESULTS: A novel six-item scale of satisfaction with remote GP consultations had good psychometric properties. Participants with higher levels of education had significantly greater satisfaction with remote consultations than participants with mid-level qualifications (B = -0.82, 95% confidence interval [CI] = -1.41 to -0.23) or those with low or no qualifications (B = -1.65, 95% CI = -2.29 to -1.02). People living in Wales reported significantly higher satisfaction compared with those living in Scotland (B = -1.94, 95% CI = -3.11 to -0.78), although caution is warranted due to small group numbers. CONCLUSION: These findings can inform the use and adaptation of remote consultations in primary care. Adults with lower educational levels may need additional support to improve their experience and ensure equitable care via remote consultations.

Using healthcare systems data for outcomes in clinical trials: issues to consider at the design stage.

BACKGROUND: Healthcare system data (HSD) are increasingly used in clinical trials, augmenting or replacing traditional methods of collecting outcome data. This study, PRIMORANT, set out to identify, in the UK context, issues to be considered before the decision to use HSD for outcome data in a clinical trial is finalised, a methodological question prioritised by the clinical trials community. METHODS: The PRIMORANT study had three phases. First, an initial workshop was held to scope the issues faced by trialists when considering whether to use HSDs for trial outcomes. Second, a consultation exercise was undertaken with clinical trials unit (CTU) staff, trialists, methodologists, clinicians, funding panels and data providers. Third, a final discussion workshop was held, at which the results of the consultation were fed back, case studies presented, and issues considered in small breakout groups. RESULTS: Key topics included in the consultation process were the validity of outcome data, timeliness of data capture, internal pilots, data-sharing, practical issues, and decision-making. A majority of consultation respondents (n = 78, 95%) considered the development of guidance for trialists to be feasible. Guidance was developed following the discussion workshop, for the five broad areas of terminology, feasibility, internal pilots, onward data sharing, and data archiving. CONCLUSIONS: We provide guidance to inform decisions about whether or not to use HSDs for outcomes, and if so, to assist trialists in working with registries and other HSD providers to improve the design and delivery of trials.

Medicines and Healthcare products Regulatory Agency's "Consultation on proposals for legislative changes for clinical trials": a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing.

In the UK, the Medicines and Healthcare products Regulatory Agency consulted on proposals "to improve and strengthen the UK clinical trials legislation to help us make the UK the best place to research and develop safe and innovative medicines". The purpose of the consultation was to help finalise the proposals and contribute to the drafting of secondary legislation. We discussed these proposals as members of the Trials Methodology Research Partnership Adaptive Designs Working Group, which is jointly funded by the Medical Research Council and the National Institute for Health and Care Research. Two topics arose frequently in the discussion: the emphasis on legislation, and the absence of questions on data sharing. It is our opinion that the proposals rely heavily on legislation to change practice. However, clinical trials are heterogeneous, and as a result some trials will struggle to comply with all of the proposed legislation. Furthermore, adaptive design clinical trials are even more heterogeneous than their non-adaptive counterparts, and face more challenges. Consequently, it is possible that increased legislation could have a greater negative impact on adaptive designs than non-adaptive designs. Overall, we are sceptical that the introduction of legislation will achieve the desired outcomes, with some exceptions. Meanwhile the topic of data sharing - making anonymised individual-level clinical trial data available to other investigators for further use - is entirely absent from the proposals and the consultation in general. However, as an aspect of the wider concept of open science and reproducible research, data sharing is an increasingly important aspect of clinical trials. The benefits of data sharing include faster innovation, improved surveillance of drug safety and effectiveness and decreasing participant exposure to unnecessary risk. There are already a number of UK-focused documents that discuss and encourage data sharing, for example, the Concordat on Open Research Data and the Medical Research Council's Data Sharing Policy. We strongly suggest that data sharing should be the norm rather than the exception, and hope that the forthcoming proposals on clinical trials invite discussion on this important topic.

Lessons learned from using linked administrative data to evaluate the Family Nurse Partnership in England and Scotland.

Introduction: "Big data" - including linked administrative data - can be exploited to evaluate interventions for maternal and child health, providing time- and cost-effective alternatives to randomised controlled trials. However, using these data to evaluate population-level interventions can be challenging. Objectives: We aimed to inform future evaluations of complex interventions by describing sources of bias, lessons learned, and suggestions for improvements, based on two observational studies using linked administrative data from health, education and social care sectors to evaluate the Family Nurse Partnership (FNP) in England and Scotland. Methods: We first considered how different sources of potential bias within the administrative data could affect results of the evaluations. We explored how each study design addressed these sources of bias using maternal confounders captured in the data. We then determined what additional information could be captured at each step of the complex intervention to enable analysts to minimise bias and maximise comparability between intervention and usual care groups, so that any observed differences can be attributed to the intervention. Results: Lessons learned include the need for i) detailed data on intervention activity (dates/geography) and usual care; ii) improved information on data linkage quality to accurately characterise control groups; iii) more efficient provision of linked data to ensure timeliness of results; iv) better measurement of confounding characteristics affecting who is eligible, approached and enrolled. Conclusions: Linked administrative data are a valuable resource for evaluations of the FNP national programme and other complex population-level interventions. However, information on local programme delivery and usual care are required to account for biases that characterise those who receive the intervention, and to inform understanding of mechanisms of effect. National, ongoing, robust evaluations of complex public health evaluations would be more achievable if programme implementation was integrated with improved national and local data collection, and robust quasi-experimental designs.

Exploring the issues that influence how people with rare neurological conditions engage in physical activity.

PURPOSE: People with rare neurological conditions (RNCs) struggle to achieve regular physical activity (PA). This study explored experiences of people with RNC engaging in PA, their carers, and health care professionals (HCPs) working with them. MATERIALS & METHODS: We developed three surveys: for individuals living with RNCs, their carers, and HCPs working with them. Themes from interviews with RNC charity representatives were used to co-design questions, together with people living with RNCs, their representatives, and an expert panel. Surveys were disseminated via charity mailing lists, social media accounts, and professional networks (HCPs). RESULTS: We received 436 responses (225 people with RNC, 94 carers, 117 HCPs). Most respondents with RNC achieved some level of regular PA but needed motivation to maintain it. Many felt they lacked knowledge on starting and staying active, with scarce resources and support. Most HCP respondents worked in specialist services, and overwhelmingly agreed that people with RNC should be physically active, while acknowledging lack of evidence and resources. CONCLUSIONS: We identified key barriers at environmental/organisational, interpersonal, and intrapersonal levels, highlighting a critical lack of support for people with RNC across UK health services. These factors can be targeted to increase engagement in PA.Implications for rehabilitationPeople living with rare neurological conditions experience barriers to engaging in physical activity, with some common to more prevalent neurological diseases, e.g. access and facilities, but some notable differences due to the rarity of the conditionFor people living with rare neurological conditions, and their carers, there is a lack of knowledge on safe and appropriate engagement in physical activityIncreasing the knowledge of health and exercise professionals may improve how they support people with rare neurological disease to engage with physical activity.Evidence based resources and recommendations for people living with rare neurological conditions, and professionals working with them, may facilitate engagement in physical activity.

Interventions targeting the mental health and wellbeing of care-experienced children and young people in higher-income countries: Evidence map and systematic review.

BACKGROUND: The mental health and wellbeing of care-experienced children and young people (i.e. foster care, kinship care, residential care) is poorer than non-care-experienced populations. The Care-experienced cHildren and young people's Interventions to improve Mental health and wEll-being outcomes Systematic review (CHIMES) aimed to synthesise the international evidence base for interventions targeting subjective wellbeing, mental health and suicide amongst care-experienced young people aged ≤ 25 years. METHODS: For the first phase of the review, we constructed an evidence map identifying key clusters and gaps in interventions and evaluations. Studies were identified through 16 electronic databases and 22 health and social care websites, in addition to expert recommendations, citation tracking and screening of relevant systematic reviews. We charted interventions and evaluations with a summary narrative, tables and infographics. RESULTS: In total, 64 interventions with 124 associated study reports were eligible. The majority of study reports were from the USA (n = 77). Interventions primarily targeted children and young people's skills and competencies (n = 9 interventions), the parental functioning and practices of carers (n = 26), or a combination of the two (n = 15). While theoretically under-specified, interventions were largely informed by theories of Attachment, Positive Youth Development, and Social Learning Theory. Current evaluations prioritised outcomes (n = 86) and processes (n = 50), with a paucity of study reports including theoretical descriptions (n = 24) or economic evaluations (n = 1). Interventions most frequently targeted outcomes related to mental, behavioural or neurodevelopmental disorders, notably total social, emotional and behavioural problems (n = 48 interventions) and externalising problem behaviours (n = 26). There were a limited number of interventions targeting subjective wellbeing or suicide-related outcomes. CONCLUSIONS: Future intervention development might focus on structural-level intervention theories and components, and target outcomes related to subjective wellbeing and suicide. In accordance with current methodological guidance for intervention development and evaluation, research needs to integrate theoretical, outcome, process and economic evaluation in order to strengthen the evidence base. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020177478.

Impact of the COVID-19 pandemic on domiciliary care workers in Wales, UK: a data linkage cohort study using the SAIL Databank.

OBJECTIVES: To quantify population health risks for domiciliary care workers (DCWs) in Wales, UK, working during the COVID-19 pandemic. DESIGN: A population-level retrospective study linking occupational registration data to anonymised electronic health records maintained by the Secure Anonymised Information Linkage Databank in a privacy-protecting trusted research environment. SETTING: Registered DCW population in Wales. PARTICIPANTS: Records for all linked DCWs from 1 March 2020 to 30 November 2021. PRIMARY AND SECONDARY OUTCOME MEASURES: Our primary outcome was confirmed COVID-19 infection; secondary outcomes included contacts for suspected COVID-19, mental health including self-harm, fit notes, respiratory infections not necessarily recorded as COVID-19, deaths involving COVID-19 and all-cause mortality. RESULTS: Confirmed and suspected COVID-19 infection rates increased over the study period to 24% by 30 November 2021. Confirmed COVID-19 varied by sex (males: 19% vs females: 24%) and age (>55 years: 19% vs <35 years: 26%) and were higher for care workers employed by local authority social services departments compared with the private sector (27% and 23%, respectively). 34% of DCWs required support for a mental health condition, with mental health-related prescribing increasing in frequency when compared with the prepandemic period. Events for self-harm increased from 0.2% to 0.4% over the study period as did the issuing of fit notes. There was no evidence to suggest a miscoding of COVID-19 infection with non-COVID-19 respiratory conditions. COVID-19-related and all-cause mortality were no greater than for the general population aged 15-64 years in Wales (0.1% and 0.034%, respectively). A comparable DCW workforce in Scotland and England would result in a comparable rate of COVID-19 infection, while the younger workforce in Northern Ireland may result in a greater infection rate. CONCLUSIONS: While initial concerns about excess mortality are alleviated, the substantial pre-existing and increased mental health burden for DCWs will require investment to provide long-term support to the sector's workforce.

A DELPHI study priority setting the remaining challenges for the use of routinely collected data in trials: COMORANT-UK.

BACKGROUND: Researchers are increasingly seeking to use routinely collected data to support clinical trials. This approach has the potential to transform the way clinical trials are conducted in the future. The availability of routinely collected data for research, whether healthcare or administrative, has increased, and infrastructure funding has enabled much of this. However, challenges remain at all stages of a trial life cycle. This study, COMORANT-UK, aimed to systematically identify, with key stakeholders across the UK, the ongoing challenges related to trials that seek to use routinely collected data. METHODS: This three-step Delphi method consisted of two rounds of anonymous web-based surveys and a virtual consensus meeting. Stakeholders included trialists, data infrastructures, funders of trials, regulators, data providers and the public. Stakeholders identified research questions or challenges that they considered were of particular importance and then selected their top 10 in the second survey. The ranked questions were taken forward to the consensus meeting for discussion with representatives invited from the stakeholder groups. RESULTS: In the first survey, 66 respondents yielded over 260 questions or challenges. These were thematically grouped and merged into a list of 40 unique questions. Eighty-eight stakeholders then ranked their top ten from the 40 questions in the second survey. The most common 14 questions were brought to the virtual consensus meeting in which stakeholders agreed a top list of seven questions. We report these seven questions which are within the following domains: trial design, Patient and Public Involvement, trial set-up, trial open and trial data. These questions address both evidence gaps (requiring further methodological research) and implementation gaps (requiring training and/or service re-organisation). CONCLUSION: This prioritised list of seven questions should inform the direction of future research in this area and should direct efforts to ensure that the benefits in major infrastructure for routinely collected data are achieved and translated. Without this and future work to address these questions, the potential societal benefits of using routinely collected data to help answer important clinical questions will not be realised.

The practicalities of adapting UK maternity clinical information systems for observational research: Experiences of the POOL study.

Background: Using routinely collected clinical data for observational research is an increasingly important method for data collection, especially when rare outcomes are being explored. The POOL study was commissioned to evaluate the safety of waterbirth in the UK using routine maternity and neonatal clinical data. This paper describes the design, rationale, set-up and pilot for this data linkage study using bespoke methods. Methods: Clinical maternity information systems hold many data items of value for research purposes, but often lack specific data items required for individual studies. This study used the novel method of amending an existing clinical maternity database for the purpose of collecting additional research data fields. In combination with the extraction of existing data fields, this maximised the potential use of existing routinely collected clinical data for research purposes, whilst reducing NHS staff data collection burden.Wellbeing Software®, provider of the Euroking® Maternity Information System, added new study specific data fields to their information system, extracted data from participating NHS sites and transferred data for matching with the National Neonatal Research Database to ascertain outcomes for babies admitted to neonatal units. Study set-up processes were put in place for all sites. The data extraction, linkage and cleaning processes were piloted with one pre-selected NHS site. Results: Twenty-six NHS sites were set-up over 27 months (January 2019 - April 2021). Twenty-four thousand maternity records were extracted from the one NHS site, pertaining to the period January 2015 to March 2019. Data field completeness for maternal and neonatal primary outcomes were mostly acceptable. Neonatal identifiers flowed to the National Neonatal Research Database for successful matching and linkage between maternity and neonatal unit records. Discussion: Piloting the data extraction and linkage highlighted the need for additional governance arrangements, training at NHS sites and new processes for the study team to ensure data quality and confidentiality are upheld during the study. Amending existing NHS electronic information systems and accessing clinical data at scale, is possible, but continues to be a time consuming and a technically challenging exercise.

"I don't mean to be rude, but could you put a mask on while I'm here?" A qualitative study of risks experienced by domiciliary care workers in Wales during the COVID-19 pandemic.

Domiciliary care workers (DCWs) continued to provide care to adults in their own homes throughout the COVID-19 pandemic. The evidence of the impact of COVID-19 on health outcomes of DCWs is currently mixed. The OSCAR study will quantify the impact of COVID-19 upon health outcomes of DCWs in Wales, explore causes of variation and extrapolate to the rest of the UK DCW population. An embedded qualitative study aimed to explore DCW experiences during the pandemic, including factors that may have varied risk of exposure to COVID-19 and adverse health and wellbeing outcomes. Registered DCWs working throughout Wales were invited to participate in a semi-structured telephone interview. 24 DCWs were interviewed between February and July 2021. Themes were identified through inductive analysis using thematic coding. Several themes emerged relating to risk of exposure to COVID-19. First, general changes to the role of the DCW during the pandemic were identified. Second, practical challenges for DCWs in the workplace were reported, including staff shortages, clients and families not following safety procedures, initial shortages of personal protective equipment (PPE), DCW criticism of standard use PPE, client difficulty with PPE and management of rapid antigen testing. Third, lack of government/employer preparation for a pandemic was described, including the reorganisation of staff clients and services, inadequate or confusing information for many DCWs, COVID-19 training and the need for improved practical instruction and limited official standard risk assessments for DCWs. Pressure to attend work and perceptions of COVID-19 risk and vaccination was also reported. In summary, this paper describes the risk factors associated with working during the pandemic. We have mapped recommendations for each problem using these qualitative findings including tailored training and better support for isolated team members and identified the required changes at several socio-ecological levels.

Health behaviour change among UK adults during the pandemic: findings from the COVID-19 cancer attitudes and behaviours study.

BACKGROUND: COVID-19 related lockdowns may have affected engagement in health behaviours among the UK adult population. This prospective observational study assessed socio-demographic patterning in attempts to change and maintain a range of health behaviours and changes between two time points during the pandemic. METHODS: Adults aged 18 years and over (n = 4,978) were recruited using Dynata (an online market research platform) and the HealthWise Wales platform, supplemented through social media advertising. Online surveys were conducted in August/September 2020 when lockdown restrictions eased in the UK following the first major UK lockdown (survey phase 1) and in February/March 2021 during a further national lockdown (survey phase 2). Measures derived from the Cancer Awareness Measure included self-reported attempts to reduce alcohol consumption, increase fruit/vegetable consumption, increase physical activity, lose weight and reduce/stop smoking. Multivariable logistic regressions were used to assess individual health behaviour change attempts over time, adjusted for age, sex, ethnicity, employment and education. RESULTS: Around half of participants in survey phase 1 reported trying to increase physical activity (n = 2607, 52.4%), increase fruit/vegetables (n = 2445, 49.1%) and lose weight (n = 2413, 48.5%), with 19.0% (n = 948) trying to reduce alcohol consumption among people who drink. Among the 738 participants who smoked, 51.5% (n = 380) were trying to reduce and 27.4% (n = 202) to stop smoking completely. Most behaviour change attempts were more common among women, younger adults and minority ethnic group participants. Efforts to reduce smoking (aOR: 0.98, 95% CI: 0.82-1.17) and stop smoking (aOR: 0.98, 95% CI: 0.80-1.20) did not differ significantly in phase 2 compared to phase 1. Similarly, changes over time in attempts to improve other health behaviours were not statistically significant: physical activity (aOR: 1.07; 95% CI: 0.99-1.16); weight loss (aOR: 0.95; 95% CI: 0.90-1.00); fruit/vegetable intake (aOR: 0.98, 95% CI: 0.91-1.06) and alcohol use (aOR: 1.32, 95% CI: 0.92-1.91). CONCLUSION: A substantial proportion of participants reported attempts to change health behaviours in the initial survey phase. However, the lack of change observed over time indicated that overall motivation to engage in healthy behaviours was sustained among the UK adult population, from a period shortly after the first lockdown toward the end of the second prolonged lockdown.

Identifying researcher learning needs to develop online training for UK researchers working with administrative data: CENTRIC training.

Background: The use of administrative data in health and social science research continues to expand, with increased availability of data and interest from funders. Researchers, however, continue to experience delays in access, storage and sharing of administrative data. Training opportunities are limited and typically specific to individual data providers or focussed on the analytical aspects of working with administrative data. The CENTRIC study was funded by the Information Commissioners Office, with the aim of developing a broader training curriculum for researchers working with administrative data in the UK. Methods: A mixed-methods design informed curriculum content, including surveys with researchers, focus group discussions with data providers and workshops with members of the public. Researchers were identified from relevant administrative data networks and invited to participate in an online survey identifying training needs. Data providers were approached with a request to input to a face-to-face or online meeting with two members of the research team about their experiences of working with researchers. Data were analysed within the broad framework of the interview schedule, free text responses in the survey were analysed thematically. Results: 107 researchers responded to the online survey and four data providers participated in the focus groups. We identified five main themes, relating to research training needs for UK researchers working with administrative data: communication; timelines; changes & amendments; future-proofing applications; and, the availability of training and support. Data providers either provided additional evidence on these learning needs or ways to address identified challenges. Six modules were developed addressing these training needs. Quotes from the survey and focus groups are used anonymously in the online training modules. Conclusion: The CENTRIC online training curriculum was launched in September 2020 and is available, free of charge for UK researchers. CENTRIC specifically addresses commonly identified training needs of researchers working with administrative data.

Nurse-led home-visitation programme for first-time mothers in reducing maltreatment and improving child health and development (BB:2-6): longer-term outcomes from a randomised cohort using data linkage.

OBJECTIVES: Measure effectiveness of family nurse partnership (FNP) home-visiting programme in reducing maltreatment and improving maternal health and child health, developmental and educational outcomes; explore effect moderators, mediators; describe costs. DESIGN: Follow-up of BB:0-2 trial cohort (ISRCTN:23019866) up to age 7 years in England using record linkage. PARTICIPANTS: 1618 mothers aged 19 years or younger and their firstborn child(ren) recruited to BB:0-2 trial at less than 25 weeks gestation and not mandatorily withdrawn from trial or opted out. Intervention families were offered up to a maximum of 64 home visits by specially trained nurses from pregnancy until firstborn child was 2 years old, plus usually provided health and social care support. Comparator was usual care alone. OUTCOME MEASURES: Primary outcome: state-verified child-in-need status recorded at any time during follow-up. SECONDARY OUTCOMES: referral to social services, child protection registration (plan), child-in-need categorisation, looked-after status, recorded injuries and ingestions any time during follow-up, early childcare and educational attendance, school readiness and attainment at key stage 1 (KS1), healthcare costs. RESULTS: Match rates for 1547 eligible children (1517 singletons, 15 sets of twins) were 98.3% (NHS Digital) and 97.4% (National Pupil Database). There was no difference between study arms in the proportion of children being registered as in need (adjusted OR 0.98, 95% CI 0.74 to 1.31), or for any other measure of maltreatment. Children in the FNP arm were more likely to achieve a good level of development at reception age (school readiness) (adjusted OR 1.24, 95% CI 1.01 to 1.52). After adjusting for birth month, children in FNP arm were more likely to reach the expected standard in reading at KS1 (adjusted OR 1.26, 95% CI 1.02 to 1.57). We found no trial arm differences for resource use and costs. CONCLUSIONS: FNP did not improve maltreatment or maternal outcomes. There was evidence of small advantages in school readiness and attainment at KS1. TRIAL REGISTRATION NUMBER: ISRCTN23019866.

Attitudes towards the collection and linkage of maltreatment data for research: A qualitative study.

INTRODUCTION: Factors that affect public and professionals' attitudes towards the collection and linkage of health and other data have been explored in the literature. Thus far there has been no study exploring attitudes towards the collection of child maltreatment data. OBJECTIVES: Our aim is to explore attitudes regarding the collection and linkage of maltreatment data for research. METHODS: Participants included younger mothers, older mothers, care-experienced young people, and professionals who were responsible for recording child maltreatment data. Four face-to-face focus groups were conducted, one with younger mothers (n = 6), one with older mothers (n = 10), and two with care-experienced young people (n = 6 and n = 5). An online focus group was conducted with professionals (n = 10), two of whom additionally participated in telephone interviews. Transcribed audio-recorded data were inductively coded, a portion were double-coded by a second researcher, and thematically analysed. RESULTS: Three major themes were identified. The first concerned issues of consent, specifically the conditions for providing consent and factors influencing this. The second concerned trust in data security and validity, the organisations and individuals providing and using the data, and how the information provided shapes attitudes. The third theme explored the benefits of research and the researchers' role in child protection. Participants wanted the choice of providing consent for data collection, especially when consenting on behalf of another, but there were concerns that maltreated children were unidentifiable in anonymised datasets. Care-experienced young people were concerned about data collection from Social Services records due to their sensitivity. There was a general lack of understanding about how research data is viewed and the accuracy of records. CONCLUSIONS: Novel findings in the study were strongly related to the sensitive nature of the topic. The findings may be particularly useful when designing research studies and participant materials and a co-productive approach to this should be taken.

Intentions to participate in cervical and colorectal cancer screening during the COVID-19 pandemic: A mixed-methods study.

Worldwide, cancer screening faced significant disruption in 2020 due to the COVID-19 pandemic. If this has led to changes in public attitudes towards screening and reduced intention to participate, there is a risk of long-term adverse impact on cancer outcomes. In this study, we examined previous participation and future intentions to take part in cervical and colorectal cancer (CRC) screening following the first national lockdown in the UK. Overall, 7543 adults were recruited to a cross-sectional online survey in August-September 2020. Logistic regression analyses were used to identify correlates of strong screening intentions among 2319 participants eligible for cervical screening and 2502 eligible for home-based CRC screening. Qualitative interviews were conducted with a sub-sample of 30 participants. Verbatim transcripts were analysed thematically. Of those eligible, 74% of survey participants intended to attend cervical screening and 84% intended to complete home-based CRC screening when next invited. Thirty percent and 19% of the cervical and CRC samples respectively said they were less likely to attend a cancer screening appointment now than before the pandemic. Previous non-participation was the strongest predictor of low intentions for cervical (aOR 26.31, 95% CI: 17.61-39.30) and CRC (aOR 67.68, 95% CI: 33.91-135.06) screening. Interview participants expressed concerns about visiting healthcare settings but were keen to participate when screening programmes resumed. Intentions to participate in future screening were high and strongly associated with previous engagement in both programmes. As screening services recover, it will be important to monitor participation and to ensure people feel safe to attend.

Cancer symptom experience and help-seeking behaviour during the COVID-19 pandemic in the UK: a cross-sectional population survey.

OBJECTIVES: To understand self-reported potential cancer symptom help-seeking behaviours and attitudes during the first 6 months (March-August 2020) of the UK COVID-19 pandemic. DESIGN: UK population-based survey conducted during August and September 2020. Correlates of help-seeking behaviour were modelled using logistic regression in participants reporting potential cancer symptoms during the previous 6 months. Qualitative telephone interviews with a purposeful subsample of participants, analysed thematically. SETTING: Online UK wide survey. PARTICIPANTS: 7543 adults recruited via Cancer Research UK online panel provider (Dynata) and HealthWise Wales (a national register of 'research ready' participants) supplemented with social media (Facebook and Twitter) recruitment. 30 participants were also interviewed. MAIN OUTCOME MEASURES: Survey measures included experiences of 15 potential cancer symptoms, help-seeking behaviour, barriers and prompts to help-seeking. RESULTS: Of 3025 (40.1%) participants who experienced a potential cancer symptom, 44.8% (1355/3025) had not contacted their general practitioner (GP). Odds of help-seeking were higher among participants with disability (adjusted OR (aOR)=1.38, 95% CI 1.11 to 1.71) and who experienced more symptoms (aOR=1.68, 95% CI 1.56 to 1.82), and lower among those who perceived COVID-19 as the cause of symptom(s) (aOR=0.36, 95% CI 0.25 to 0.52). Barriers included worries about wasting the doctor's time (1158/7543, 15.4%), putting strain on healthcare services (945, 12.6%) and not wanting to make a fuss (907, 12.0%). Interviewees reported reluctance to contact the GP due to concerns about COVID-19 and fear of attending hospitals, and described putting their health concerns on hold. CONCLUSIONS: Many people avoided healthcare services despite experiencing potential cancer symptoms during the COVID-19 pandemic. Alongside current help-seeking campaigns, well-timed and appropriate nationally coordinated campaigns should signal that services are open safely for those with unusual or persistent symptoms. TRIAL REGISTRATION NUMBER: ISRCTN17782018.

Randomised controlled trial and economic evaluation of a targeted cancer awareness intervention for adults living in deprived areas of the UK.

BACKGROUND: Cancer outcomes are poor in socioeconomically deprived communities, with low symptom awareness contributing to prolonged help-seeking and advanced disease. Targeted cancer awareness interventions require evaluation. METHODS: This is a randomised controlled trial involving adults aged 40+ years recruited in community and healthcare settings in deprived areas of South Yorkshire and South-East Wales. INTERVENTION: personalised behavioural advice facilitated by a trained lay advisor. CONTROL: usual care. Follow-up at two weeks and six months post-randomisation. PRIMARY OUTCOME: total cancer symptom recognition score two weeks post-randomisation. RESULTS: Two hundred and thirty-four participants were randomised. The difference in total symptom recognition at two weeks [adjusted mean difference (AMD) 0.6, 95% CI: -0.03, 1.17, p = 0.06] was not statistically significant. Intervention participants reported increased symptom recognition (AMD 0.8, 95% CI: 0.18, 1.37, p = 0.01) and earlier intended presentation (AMD -2.0, 95% CI: -3.02, -0.91, p < 0.001) at six months. "Lesser known" symptom recognition was higher in the intervention arm (2 weeks AMD 0.5, 95% CI: 0.03, 0.97 and six months AMD 0.7, 95% CI: 0.16, 1.17). Implementation cost per participant was £91.34, with no significant between-group differences in healthcare resource use post-intervention. CONCLUSIONS: Improved symptom recognition and earlier anticipated presentation occurred at longer-term follow-up. The ABACus Health Check is a viable low-cost intervention to increase cancer awareness in socioeconomically deprived communities. CLINICAL TRIAL REGISTRATION: ISRCTN16872545.

Cost-effectiveness of home versus hospital management of children at onset of type 1 diabetes: the DECIDE randomised controlled trial.

OBJECTIVE: The aim of this economic evaluation was to assess whether home management could represent a cost-effective strategy in the patient pathway of type 1 diabetes (T1D). This is based on the Delivering Early Care In Diabetes Evaluation trial (ISRCTN78114042), which compared home versus hospital management from diagnosis in childhood diabetes and found no statistically significant difference in glycaemic control at 24 months. DESIGN: Cost-effectiveness analysis alongside a randomised controlled trial. SETTING: Eight paediatric diabetes centres in England, Wales and Northern Ireland. PARTICIPANTS: 203 clinically well children aged under 17 years, with newly diagnosed T1D and their carers. OUTCOME MEASURES: The base-case analysis adopted n National Health Service (NHS) perspective. A scenario analysis assessed costs from a broader societal perspective. The incremental cost-effectiveness ratio (ICER), expressed as cost per mmol/mol reduction in glycated haemoglobin (HbA1c), was based on the mean difference in costs between the home and hospital groups, divided by mean differences in effectiveness (HbA1c). Uncertainty was considered in terms of the probability of cost-effectiveness. RESULTS: At 24 months postintervention, the base-case analysis showed a difference in costs between home and hospital, in favour of home management (mean difference -£2,217; 95% CI -£2825 to -£1,609; p<0.001). Home care dominated, with an ICER of £7434 (saved) per mmol/mol reduction of HbA1c. The results of the scenario analysis also favoured home management. The greatest driver of cost differences was hospitalisation during the initiation period. CONCLUSIONS: Home management from diagnosis of children with T1D who are medically stable represents a less costly approach for the NHS in the UK, without impacting clinical effectiveness. TRIAL REGISTRATION NUMBER: ISRCTN78114042.