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Abstract Background Melanoma is the 5th commonest cancer in the UK and survivors require frequent and thorough skin checks. During the Achieving Self-directed Integrated Cancer Aftercare (ASICA) trial, melanoma survivors used an app to submit images of concerning lesions for assessment by a dermatology nurse. In the past, online courses have been used to train non-specialist primary care practitioners (PCPs) in this skill. Objectives This study aimed to determine whether an online course could increase knowledge, confidence, and attitudes towards skin image triage in PCPs in the Grampian area. Methods Preliminary discussions were held with PCPs to determine the need for an online course. The course was designed at the University of Aberdeen and included an introduction to the skin, case studies and quizzes on a variety of skin conditions based on melanoma survivors’ submissions via the ASICA app. Two pre- and post-course questionnaires were administered to all participants to (1) assess knowledge gained and (2) assess any improvements in confidence and attitudes towards triaging skin lesions that could be indicative of skin cancer. All PCPs in the Grampian area were invited to participate with almost 70 medical practices contacted. Results were analysed using a paired sample T-test. Results The course was advertised to all GP practices in the Grampian area and 38 PCPs completed all its stages. Undertaking the course improved all PCPs’ confidence and attitudes towards triaging (p

Background Gallstone disease is a common gastrointestinal disorder in industrialised societies. The prevalence of gallstones in the adult population is estimated to be approximately 10–15%, and around 80% remain asymptomatic. At present, cholecystectomy is the default option for people with symptomatic gallstone disease. Objectives To assess the clinical and cost-effectiveness of observation/conservative management compared with laparoscopic cholecystectomy for preventing recurrent symptoms and complications in adults presenting with uncomplicated symptomatic gallstones in secondary care. Design Parallel group, multicentre patient randomised superiority pragmatic trial with up to 24 months follow-up and embedded qualitative research. Within-trial cost–utility and 10-year Markov model analyses. Development of a core outcome set for uncomplicated symptomatic gallstone disease. Setting Secondary care elective settings. Participants Adults with symptomatic uncomplicated gallstone disease referred to a secondary care setting were considered for inclusion. Interventions Participants were randomised 1: 1 at clinic to receive either laparoscopic cholecystectomy or observation/conservative management. Main outcome measures The primary outcome was quality of life measured by area under the curve over 18 months using the Short Form-36 bodily pain domain. Secondary outcomes included the Otago gallstones’ condition-specific questionnaire, Short Form-36 domains (excluding bodily pain), area under the curve over 24 months for Short Form-36 bodily pain domain, persistent symptoms, complications and need for further treatment. No outcomes were blinded to allocation. Results Between August 2016 and November 2019, 434 participants were randomised (217 in each group) from 20 United Kingdom centres. By 24 months, 64 (29.5%) in the observation/conservative management group and 153 (70.5%) in the laparoscopic cholecystectomy group had received surgery, median time to surgery of 9.0 months (interquartile range, 5.6–15.0) and 4.7 months (interquartile range 2.6–7.9), respectively. At 18 months, the mean Short Form-36 norm-based bodily pain score was 49.4 (standard deviation 11.7) in the observation/conservative management group and 50.4 (standard deviation 11.6) in the laparoscopic cholecystectomy group. The mean area under the curve over 18 months was 46.8 for both groups with no difference: mean difference –0.0, 95% confidence interval (–1.7 to 1.7); p-value 0.996; n = 203 observation/conservative, n = 205 cholecystectomy. There was no evidence of differences in quality of life, complications or need for further treatment at up to 24 months follow-up. Condition-specific quality of life at 24 months favoured cholecystectomy: mean difference 9.0, 95% confidence interval (4.1 to 14.0), p

Background: While primary care physicians (PCPs) play a key role in cancer detection, they can find cancer diagnosis challenging, and some patients have considerable delays between presentation and onward referral. Aim: To explore European PCPs’ experiences and views on cases where they considered that they had been slow to think of, or act on, a possible cancer diagnosis. Design & setting: A multicentre European qualitative study, based on an online survey with open-ended questions, asking PCPs for their narratives about cases when they had missed a diagnosis of cancer. Method: Using maximum variation sampling, PCPs in 23 European countries were asked to describe what happened in a case where they were slow to think of a cancer diagnosis, and for their views on why it happened. Thematic analysis was used to analyse the data. Results: A total of 158 PCPs completed the questionnaire. The main themes were as follows: patients’ descriptions did not suggest cancer; distracting factors reduced PCPs’ cancer suspicions; patients’ hesitancy delayed the diagnosis; system factors not facilitating timely diagnosis; PCPs felt that they had acted wrongly; and problems with communicating adequately. Conclusion: The study identified six overarching themes that need to be addressed. Doing so should reduce morbidity and mortality in the small proportion of patients who have a significant, avoidable delay in their cancer diagnosis. The ‘Swiss cheese’ model of accident causation showed how the themes related to each other.

Objective To investigate how individuals diagnosed with cancer use out-of-hours (OOH) medical services, describe the behavioural determinants of OOH service use and explore whether there are differences between urban and rural dwellers.Design and setting A cross-sectional questionnaire study conducted in Northeast Scotland.Participants The questionnaire was sent to 2549 individuals diagnosed with cancer in the preceding 12 months identified through the National Health Service Grampian Cancer Care Pathway database. 490 individuals returned the questionnaire (19.2% response rate), 61.8% were urban and 34.9% were rural.Outcomes Outcomes were differences in frequency of medical service use and attitudes towards OOH services between urban and rural participants. Patient experience (qualitative data) was compared.Results Daytime services were used much more frequently than OOH services—83.3% of participants had never contacted an OOH primary care service in the preceding 12 months but 44.2% had used their daytime general practitioner at least four times. There were no significant differences between urban and rural dwellers in the patterns of OOH or daytime service use, the behavioural determinants of service use or the experiences of OOH services. Rural dwellers were significantly less likely to agree that OOH services were close by and more likely to agree that where they lived made it difficult to access these services. Rural dwellers were no more likely to agree or disagree that distance would affect their decision to contact OOH services. Qualitative results highlighted barriers to accessing OOH services exist for all patients but that long travel distances can be offset by service configuration, travel infrastructure and access to a car.Conclusions Urban and rural dwellers have similar beliefs, attitudes towards and patterns of OOH service use. In Northeast Scotland, place of residence is unlikely to be the most important factor in influencing decisions about whether to access OOH medical care.

Abstract Background Various washout policies are widely used in adults living with long-term catheters (LTC). There is currently insufficient evidence on the benefits and potential harms of prophylactic LTC washout policies in the prevention of blockages and other LTC-related adverse events, such as urinary tract infections. CATHETER II tests the hypothesis that weekly prophylactic LTC washouts (normal saline or citric acid) in addition to standard LTC care reduce the incidence of catheter blockage requiring intervention compared to standard LTC care only in adults living with LTC. Methods CATHETER II is a pragmatic three-arm open multi-centre superiority randomised controlled trial with an internal pilot, economic analysis, and embedded qualitative study. Eligible participants are adults aged ≥ 18 years, who have had a LTC in use for ≥ 28 days, have no plans to discontinue the use of the catheter, are able to undertake the catheter washouts, and complete trial documentation or have a carer able to help them. Participants are identified from general practitioner practices, secondary/tertiary care, community healthcare, care homes, and via public advertising strategies. Participants are randomised 1:1:1 to receive a weekly saline (0.9%) washout in addition to standard LTC care, a weekly citric acid (3.23%) washout in addition to standard LTC care or standard LTC care only. Participants and/or carers will receive training to administer the washouts. Patient-reported outcomes are collected at baseline and for 24 months post-randomisation. The primary clinical outcome is catheter blockage requiring intervention up to 24 months post-randomisation expressed per 1000 catheter days. Secondary outcomes include symptomatic catheter-associated urinary tract infection requiring antibiotics, catheter change, adverse events, NHS/ healthcare use, and impact on quality of life. Discussion This study will guide treatment decision-making and clinical practice guidelines regarding the effectiveness of various prophylactic catheter washout policies in men and women living with LTC. This research has received ethical approval from Wales Research Ethics Committee 6 (19/WA/0015). Trial registration ISRCTN ISRCTN17116445 . Registered prospectively on 06 November 2019

BackgroundMelanoma is a relatively common cancer type with a high survival rate, but survivors risk recurrences or second primaries. Consequently, patients receive regular hospital follow-up, but this can be burdensome to attend and not optimally timed to detect arising problems. Total skin self-examination (TSSE) supports improved clinical outcomes from melanoma via earlier detection of recurrences and second primaries, and digital technology has the potential to support TSSE. Recent research with app-based interventions aimed at improving the well-being of older adults has found that they can use the technology and benefit from it, supporting the use of digital health care in diverse demographic groups. Thus, the Achieving Self-directed Integrated Cancer Aftercare (ASICA) digital health care intervention was developed. The intervention provided melanoma survivors with a monthly prompt to perform a TSSE as well as access to a dermatology nurse who provided them with feedback on photographs and descriptions of their skin. ObjectiveWe aimed to explore participants’ attitudes, beliefs, and experiences regarding TSSE practices. Furthermore, we explored how participants experienced technology and how it influenced their practice of TSSE. Finally, we explored the practical and technical experiences of ASICA users. MethodsThis was a nested qualitative evaluation within a dual-center randomized controlled trial of the ASICA intervention. We conducted semistructured telephone interviews with the participants during a randomized controlled trial. The participants were purposively sampled to achieve a representative sample with representative proportions by age, sex, and residential geography. Interviews were transcribed verbatim and analyzed using a framework analysis approach applied within NVivo 12. ResultsA total of 22 interviews were conducted with participants from both groups. In total, 40% (9/22) of the interviewed participants were from rural areas, and 60% (13/22) were from urban areas; 60% (13/22) were from the intervention group, and 40% (9/22) were from the control group. Themes evolved around skin-checking behavior, other people’s input into skin checking, contribution of health care professionals outside ASICA and its value, ideas around technology, practical experiences, and potential improvements. ASICA appeared to change participants’ perceptions of skin checking. Users were more likely to report routinely performing TSSE thoroughly. There was some variation in beliefs about skin checking and using technology for health care. Overall, ASICA was experienced positively by participants. Several practical suggestions were made for the improvement of ASICA. ConclusionsThe ASICA intervention appeared to have positively influenced the attitudes and TSSE practices of melanoma survivors. This study provides important qualitative information about how a digital health care intervention is an effective means of prompting, recording, and responding to structured TSSE by melanoma survivors. Technical improvements are required, but the app offers promise for technologically enhanced melanoma follow-up in future. Trial RegistrationClinicalTrials.gov NCT03328247; https://clinicaltrials.gov/ct2/show/NCT03328247?term=ASICA&rank=1 International Registered Report Identifier (IRRID)RR2-10.1186/s13063-019-3453-x

Abstract Background Melanoma incidence has quadrupled since 1970 and melanoma is now the second most common cancer in individuals under 50. Targeted immunotherapies for melanoma now potentially enable long-term remission even in advanced melanoma, but these melanoma survivors require ongoing surveillance, with implications for NHS resources and significant social and psychological consequences for patients. Total skin self-examination (TSSE) can detect recurrence earlier and improve clinical outcomes but is underperformed in the UK. To support survivors, the Achieving Self-directed Integrated Cancer Aftercare (ASICA) intervention was developed to prompt and improve TSSE performance, with subsequent reporting of concerns and submission of skin photos to a Dermatology Nurse Practitioner (DNP). ASICA was delivered as a randomized pilot trial. Methods This paper reports on process evaluation. Data on participants’ demographics and the concerns they reported during the trial were tabulated and displayed using Microsoft Excel and SPSS. We explored which participants used ASICA, and how frequently, to report any skin concerns. We also determined how the interactions had worked in terms of quality of skin photographs submitted, clinical assessments made by the DNP, and the assessments and decisions made for each concern. Finally, we explored significant events occurring during the trial. Data on participants’ demographics and the concerns they reported during the trial were tabulated and displayed using SPSS. A semi-structured interview was undertaken with the DNP to gain perspective on the range of concerns presented and how they were resolved. Results Of 121 recruited melanoma patients receiving ASICA for 12 months, 69 participants submitted a total of 123 reports detailing 189 separate skin-related concerns and including 188 skin photographs. Where participants fully complied with follow-up by the DNP, concerns were usually resolved remotely, but 19 (10.1%) were seen at a secondary care clinic and 14 (7.4%) referred to their GP. 49 (25.9%) of concerns were not completely resolved due to partial non-compliance with DNP follow-up. Conclusion Melanoma patients randomized to the ASICA intervention were able to report skin-related concerns that could be resolved remotely through interaction with a DNP. Feasibility issues highlighted by ASICA will support further development and optimization of this digital tool. Trial registration Clinical Trials.gov , NCT03328247 . Registered on 1 November 2017

BackgroundMelanoma is common with increasing incidence. Guidelines recommend monthly total skin self-examinations (TSSEs) by survivors to detect recurrent and new primary melanomas. TSSE is underperformed despite evidence of benefit. ObjectiveThis study compares the effect on psychological well-being and TSSE practice of a self-directed digital intervention with treatment as usual in patients treated for a first stage 0 to IIC primary cutaneous melanoma within the preceding 60 months. MethodsThis randomized clinical trial was conducted at 2 UK National Health Service hospitals (Aberdeen Royal Infirmary, Grampian, and Addenbrooke’s, Cambridge). Adults (≥18 years) diagnosed with a first 0 to IIC primary cutaneous melanoma were randomized to receive Achieving Self-directed Integrated Cancer Aftercare (ASICA), a tablet-based intervention prompting and supporting TSSE in survivors of melanoma, or to usual care. The hypothesis was that ASICA would increase TSSE practice in users affected by melanoma and compared with controls without affecting psychological well-being. The main primary outcomes were melanoma worry (Melanoma Worry Scale), anxiety and depression (Hospital Anxiety and Depression Scale), and quality of life (EQ-5D-5L) as well as secondary outcomes collected using postal questionnaires 3, 6, and 12 months following randomization. ResultsA total of 240 recruits were randomized (1:1) into the ASICA (n=121, 50.4%) or control (n=119, 49.6%) groups. There were no significant differences between groups for melanoma worry at 12 months (mean difference: 0.12, 95% CI −0.6 to 0.84; P=.74), 3 months (0.23, 95% CI −0.31 to 0.78; P=.40), or 6 months (−0.1, 95% CI −0.7 to 0.51; P=.76). The ASICA group had lower anxiety scores at 12 months (−0.54, 95% CI −1.31 to 0.230; P=.17), 3 months (−0.13, 95% CI −0.79 to 0.54; P=.71), and significantly at 6 months (−1.00, 95% CI −1.74 to −0.26; P=.009). Depression scores were similar, being lower at 12 months (−0.44, 95% CI −1.11 to 0.23; P=.20) and 3 months (−0.24, 95% CI −0.84 to 0.35; P=.42) but only significantly lower at 6 months (−0.77, 95% CI −1.41 to −0.12; P=.02). The ASICA group had significantly higher quality of life scores at 12 months (0.044, 95% CI 0.003-0.085; P=.04) and 6 months (0.070, 95% CI 0.032-0.107; P5) TSSEs during the study year and significantly higher levels of self-efficacy in conducting TSSE. They also reported significantly higher levels of planning and intention to perform TSSE in the future. ConclusionsUsing ASICA for 12 months does not increase melanoma worry, can reduce anxiety and depression, and may improve quality of life. ASICA has the potential to improve the well-being and vigilance of survivors of melanoma and enable the benefits of regular TSSE. Trial RegistrationClinicalTrials.gov NCT03328247; https://clinicaltrials.gov/ct2/show/NCT03328247 International Registered Report Identifier (IRRID)RR2-10.1186/s13063-019-3453-x

Introduction In an era of personalised healthcare, it has become increasingly important to elicit individual-level preferences. While discrete choice experiments (DCEs) are widely used to measure patient preferences in the delivery of healthcare, the focus has been sample-level analysis. Using the DCE methodology, this project has designed a digital decision aid tool (DAT) with the potential to estimate individual preferences in real time to inform clinical consultation decisions in persistent pain management.Methods Using a feasibility randomised control trial, this study aims to assess the feasibility of using this Understanding Persistent Pain (UPP) DAT in a pharmacy-based clinical setting and to test processes for a future definite randomised trial. Community and practice-based pharmacists (up to 10) will be recruited in The National Health Service (NHS) Grampian and trained in the use of the digital UPP DAT. Pharmacists will recruit up to 60 patients who are living with persistent pain. Patients will be randomised to one of two groups: using the UPP DAT or usual care. Pharmacists will follow-up patients as needed according to clinical need and following standard practice. DCE response data collected by the UPP DAT will be analysed using the penalised logit model, allowing estimation of individual preferences in real time. We will follow-up pharmacists and patients who use the UPP DAT to gather feedback on their experiences.Ethics and dissemination This study received ethical approval from the North of Scotland Research Ethics Committee (21/NS/0059) and received Research & Development Management Permission to proceed from NHS Grampian (2021UA003E). The study has been registered in the ClinicalTrials.gov database. Findings will be disseminated in peer-reviewed publications, presentations and newsletters and made available in the University of Aberdeen and Pharmacy Research UK websites. Participants gave informed consent to participate in the study before taking part.Trial registration number NCT05102578; clinicaltrials.gov.

Objectives To describe trajectories in melanoma survivors’ adherence to monthly total skin self-examination (TSSE) over 12 months, and to investigate whether adherence trajectories can be predicted from demographic, cognitive or emotional factors at baseline.Design A longitudinal observational study nested within the intervention arm of the ASICA (Achieving Self-Directed Integrated Cancer Aftercare) randomised controlled trial.Setting Follow-up secondary care in Aberdeen and Cambridge UK.Participants n=104 adults (48 men/56 women; mean age 58.83 years, SD 13.47, range 28–85 years; mean Scottish Index of Multiple Deprivation score 8.03, SD 1.73, range 2–10) who had been treated for stage 0–IIC primary cutaneous melanoma in the preceding 60 months and were actively participating in the intervention arm of the ASICA trial.Interventions All participants were using the ASICA intervention—a tablet-based intervention designed to support monthly TSSE.Primary and secondary outcome measures The primary outcome was adherence to guideline recommended (monthly) TSSE over 12 months. This was determined from time-stamped TSSE data recorded by the ASICA intervention app.Results Latent growth mixture models identified three TSSE adherence trajectories (adherent −41%; drop-off −35%; non-adherent −24%). People who were non-adherent were less likely to intend to perform TSSE as recommended, intending to do it more frequently (OR=0.21, 95% CI 0.06 to 0.81, p=0.023) and were more depressed (OR=1.31, 95% CI 1.06 to 1.61, p=0.011) than people who were adherent. People whose adherence dropped off over time had less well-developed action plans (OR=0.78, 95% CI 0.63 to 0.96, p=0.016) and lower self-efficacy about TSSE (OR=0.92, 95% CI 0.86 to 0.99, p=0.028) than people who were adherent.Conclusions Adherence to monthly TSSE in people treated for melanoma can be differentiated into adherent, drop-off and non-adherent trajectories. Collecting information about intentions to engage in TSSE, depression, self-efficacy and/or action planning at outset may help to identify those who would benefit from additional intervention.Trial registration number ClinicalTrials.gov Registry (NCT03328247).

Abstract Background Most subsequent new primary or recurrent melanomas might be self-detected if patients are trained to systematically self-examine their skin and have access to timely medical review (patient-led surveillance). Routinely scheduled clinic visits (clinician-led surveillance) is resource-intensive and has not been shown to improve health outcomes; fewer visits may be possible if patient-led surveillance is shown to be safe and effective. The MEL-SELF trial is a randomised controlled trial comparing patient-led surveillance with clinician-led surveillance in people who have been previously treated for localised melanoma. Methods Stage 0/I/II melanoma patients (n = 600) from dermatology, surgical, or general practice clinics in NSW Australia, will be randomised (1:1) to the intervention (patient-led surveillance, n = 300) or control (usual care, n = 300). Patients in the intervention will undergo a second randomisation 1:1 to polarised (n = 150) or non-polarised (n = 150) dermatoscope. Patient-led surveillance comprises an educational booklet, skin self-examination (SSE) instructional videos; 3-monthly email/SMS reminders to perform SSE; patient-performed dermoscopy with teledermatologist feedback; clinical review of positive teledermoscopy through fast-tracked unscheduled clinic visits; and routinely scheduled clinic visits following each clinician’s usual practice. Clinician-led surveillance comprises an educational booklet and routinely scheduled clinic visits following each clinician’s usual practice. The primary outcome, measured at 12 months, is the proportion of participants diagnosed with a subsequent new primary or recurrent melanoma at an unscheduled clinic visit. Secondary outcomes include time from randomisation to diagnosis (of a subsequent new primary or recurrent melanoma and of a new keratinocyte cancer), clinicopathological characteristics of subsequent new primary or recurrent melanomas (including AJCC stage), psychological outcomes, and healthcare use. A nested qualitative study will include interviews with patients and clinicians, and a costing study we will compare costs from a societal perspective. We will compare the technical performance of two different models of dermatoscope (polarised vs non-polarised). Discussion The findings from this study may inform guidance on evidence-based follow-up care, that maximises early detection of subsequent new primary or recurrent melanoma and patient wellbeing, while minimising costs to patients, health systems, and society. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000176864 . Registered on 18 February 2021.

Abstract Background Hormone replacement therapy (HRT) is widely used and has proven benefits for women with menopausal symptoms. An increasing number of women with cancer experience menopausal symptoms but the safety of HRT use in women with cancer is unclear. There are particular concerns that HRT could accelerate cancer progression in women with cancer, and also that HRT could increase the risk of cardiovascular disease in such women. Therefore, our primary aim is to determine whether HRT use alters the risk of cancer-specific mortality in women with a range of common cancers. Our secondary objectives are to investigate whether HRT alters the risk of second cancers, cardiovascular disease, venous thromboembolism and all-cause mortality. Methods The study will utilise independent population-based data from Wales using the SAIL databank and Scotland based upon the national Prescribing Information System. The study will include women newly diagnosed with common cancers from 2000 to 2016, identified from cancer registries. Women with breast cancers will be excluded. HRT will be ascertained using electronic prescribing in Wales or dispensing records in Scotland. The primary outcome will be time to cancer-specific mortality from national mortality records. Time-dependent cox regression models will be used to calculate hazard ratios (HR) and 95% confidence intervals (95% CIs) for cancer specific death in HRT users compared with non-users after cancer diagnosis after adjusting for relevant confounders, stratified by cancer site. Analysis will be repeated investigating the impact of HRT use immediately before cancer diagnosis. Secondary analyses will be conducted on the risk of second cancers, cardiovascular disease, venous thromboembolism and all-cause mortality. Analyses will be conducted within each cohort and pooled across cohorts. Discussion Our study will provide evidence to inform guidance given to women diagnosed with cancer on the safety of HRT use and/or guide modifications to clinical practice.

Data from Northeast Scotland for 11,803 cancer patients (diagnosed 2007-13) were linked to UK Censuses to explore relationships between hospital travel-time, timely-treatment and one-year-mortality, adjusting for both area and individual-level socioeconomic status (SES). Adjusting for area-based SES, those living >60 minutes from hospital received timely-treatment more often than those living 60 minutes from hospital died within one year more often than those living

Background Gallstone disease (cholelithiasis) is common. In most people it is asymptomatic and does not require treatment, but in about 20% it can become symptomatic, causing pain and other complications requiring medical attention and/or surgery. A proportion of symptomatic people with uncomplicated gallstone disease do not experience further episodes of pain and, therefore, could be treated conservatively. Moreover, surgery carries risks of perioperative and postoperative complications.Methods and analysis C-Gall is a pragmatic, multicentre, randomised controlled trial and economic evaluation to assess whether cholecystectomy is cost-effective compared with observation/ conservative management (here after referred to as medical management) at 18 months post-randomisation (with internal pilot).Primary outcome measure Patient-reported quality of life (QoL) (36-Item Short Form Survey (SF-36) bodily pain domain) up to 18 months after randomisation.The primary economic outcome is incremental cost per quality-adjusted life year gained at 18 months.Secondary outcome measures Secondary outcome measures include condition-specific QoL, SF-36 domains, complications, further treatment, persistent symptoms, healthcare resource use, and costs assessed at 18 and 24 months after randomisation. The bodily pain domain of the SF-36 will also be assessed at 24 months after randomisation.A sample size of 430 participants was calculated. Computer-generated 1:1 randomisation was used.The C-Gall Study is currently in follow-up in 20 UK research centres. The first patient was randomised on 1 August 2016, with follow-up to be completed by 30 November 2021.Statistical analysis Statistical analysis of the primary outcome will be intention-to-treat and a per-protocol analysis. The primary outcome, area under the curve (AUC) for the SF-36 bodily pain up to 18 months, will be generated using the Trapezium rule and analysed using linear regression with adjustment for the minimisation variables (recruitment site, sex and age). For the secondary outcome, SF-36 bodily pain, AUC up to 24 months will be analysed in a similar way. Other secondary outcomes will be analysed using generalised linear models with adjustment for minimisation and baseline variables, as appropriate. Statistical significance will be at the two-sided 5% level with corresponding CIs.Ethics and dissemination The North of Scotland Research Ethics Committee approved this study (16/NS/0053). The dissemination plans include Health Technology Assessment monograph, international scientific meetings and publications in high-impact, open-access journals.Trial registration number ISRCTN55215960; pre-results.

Introduction COVID-19 has unprecedented consequences on population health, with governments worldwide issuing stringent public health directives. In the absence of a vaccine, a key way to control the pandemic is through behavioural change: people adhering to transmission-reducing behaviours (TRBs), such as physical distancing, hand washing and wearing face covering. Non-adherence may be explained by theories of how people think about the illness (the common-sense model of self-regulation) and/or how they think about the TRBs (social cognition theory and protection motivation theory). In addition, outbreaks of infectious diseases and the measures employed to curb them are likely to have detrimental effects on people’s mental and general health. Therefore, in representative repeated surveys, we will apply behavioural theories to model adherence to TRBs and the effects on mental and general health in the Scottish population from June to November 2020, following the initial outbreak of COVID-19.Methods and analysis Repeated 20 min structured telephone surveys will be conducted with nationally representative random samples of 500 adults in Scotland. The first 6 weeks the survey will be conducted weekly, thereafter fortnightly, for a total of 14 waves (total n=7000). Ipsos MORI will recruit participants through random digit dialling. The core survey will measure the primary outcomes of adherence to TRBs, mental and general health, and explanatory variables from the theories. Further questions will be added, enabling more detailed measurement of constructs in the core survey, additional themes and questions that align with the evolving pandemic.Ethics and dissemination Ethical approval for this study was granted by the Life Sciences and Medicine College Ethics Review Board (CERB) at the University of Aberdeen (CERB/2020/5/1942). Results will be made available to policy makers, funders, interested lay people and other researchers through weekly reports and three bimonthly bulletins placed on the CHARIS website and advertised through social media.

Objectives Cancer survival rates vary widely between European countries, with differences in timeliness of diagnosis thought to be one key reason. There is little evidence on the way in which different healthcare systems influence primary care practitioners’ (PCPs) referral decisions in patients who could have cancer.This study aimed to explore PCPs’ diagnostic actions (whether or not they perform a key diagnostic test and/or refer to a specialist) in patients with symptoms that could be due to cancer and how they vary across European countries.Design A primary care survey. PCPs were given vignettes describing patients with symptoms that could indicate cancer and asked how they would manage these patients. The likelihood of taking immediate diagnostic action (a diagnostic test and/or referral) in the different participating countries was analysed. Comparisons between the likelihood of taking immediate diagnostic action and physician characteristics were calculated.Setting Centres in 20 European countries with widely varying cancer survival rates.Participants A total of 2086 PCPs answered the survey question, with a median of 72 PCPs per country.Results PCPs’ likelihood of immediate diagnostic action at the first consultation varied from 50% to 82% between countries. PCPs who were more experienced were more likely to take immediate diagnostic action than their peers.Conclusion When given vignettes of patients with a low but significant possibility of cancer, more than half of PCPs across Europe would take diagnostic action, most often by ordering diagnostic tests. However, there are substantial between-country variations.

BACKGROUND:Cancer awareness campaigns aim to increase awareness of the potential seriousness of signs and symptoms of cancer, and encourage their timely presentation to healthcare services. Enhanced understanding of the prevalence of symptoms possibly indicative of cancer in different population subgroups, and associated general practitioner (GP) help-seeking behaviour, will help to target cancer awareness campaigns more effectively. AIM:To determine: i) the prevalence of 21 symptoms possibly indicative of breast, colorectal, lung or upper gastrointestinal cancer in the United Kingdom (UK), including six 'red flag' symptoms; ii) whether the prevalence varies among population subgroups; iii) the proportion of symptoms self-reported as presented to GPs; iv) whether GP help-seeking behaviour varies within population subgroups. METHODS:Self-completed questionnaire about experience of, and response to, 25 symptoms (including 21 possibly indicative of the four cancers of interest) in the previous month and year; sent to 50,000 adults aged 50 years or more and registered with 21 general practices in Staffordshire, England or across Scotland. RESULTS:Completed questionnaires were received from 16,778 respondents (corrected response rate 34.2%). Almost half (45.8%) of respondents had experienced at least one symptom possibly indicative of cancer in the last month, and 58.5% in the last year. The prevalence of individual symptoms varied widely (e.g. in the last year between near zero% (vomiting up blood) and 15.0% (tired all the time). Red flag symptoms were uncommon. Female gender, inability to work because of illness, smoking, a history of a specified medical diagnosis, low social support and lower household income were consistently associated with experiencing at least one symptom possibly indicative of cancer in both the last month and year. The proportion of people who had contacted their GP about a symptom experienced in the last month varied between 8.1% (persistent cough) and 39.9% (unexplained weight loss); in the last year between 32.8% (hoarseness) and 85.4% (lump in breast). Nearly half of respondents experiencing at least one red flag symptom in the last year did not contact their GP about it. Females, those aged 80+ years, those unable to work because of illness, ex-smokers and those previously diagnosed with a specified condition were more likely to report a symptom possibly indicative of cancer to their GP; and those on high household income less likely. CONCLUSION:Symptoms possibly indicative of cancer are common among adults aged 50+ years in the UK, although they are not evenly distributed. Help-seeking responses to different symptoms also vary. Our results suggest important opportunities to provide more nuanced messaging and targeting of symptom-based cancer awareness campaigns.

ABSTRACT Objectives To determine whether cancer diagnostic pathways and survival are affected by access to GP practice, diagnostic centre and cancer treatment centre. Cancer treatment in the UK is generally delivered in large cancer centres within major cities. This could have a detrimental effect on outcomes for people from rural areas who develop cancer. Historical UK studies suggest distance from services affects cancer outcomes. In recent years several developments, such as cancer networks and suspected cancer referral pathways, have occurred within the UK NHS, which may have reduced earlier inequalities. It is currently unknown whether a persons’ geographical location within the UK has implications for the timeliness of their receipt of a diagnosis and treatment for cancer. Approach Routine clinical data from Scottish Morbidity Record (SMR) 01, Scottish Cancer Registry SMR 06, and Geographical Information Systems (GIS) derived measures of road distances and travelling times from key healthcare facilities have been linked to a clinical tracking database, NHS Grampian Cancer Care Pathway to form the Northeast and Aberdeen Scotland Cancer and Residence (NASCAR) database. This linkage provided a retrospective cohort of 13 702 people diagnosed with cancer since 2007. Logistic regression analyses have been conducted to determine the effect of distance from services on provider delays and survival at one year following diagnosis. Results Of the 13 702 patients included in the analysis the mean age was 67.4 ± 13 years and 45% were male. The highest proportion of patients lived within one mile of their GP practice (35.5%), less than five miles from their diagnostic centre (39.6%) and less than five miles from their cancer treatment centre (39.6%). Distance to GP practice or distance to diagnostic centre was not a significant predictor of timely treatment (treatment within 62 days of GP referral) or survival at one year following diagnosis. Increased distance to cancer treatment centre predicted shorter timely treatment intervals (5-9 miles [OR 1.50; CI 1.18-1.90], 10-29 miles [OR 1.09; CI0.90-1.31], 30-59 miles [OR 1.26; CI 1.05-1.52], > 60 miles [OR 1.72; CI 1.41-2.09]. Increased distance to treatment centre > 60 miles was associated with quicker times between diagnosis and receipt of treatment [OR 1.26; CI 1.12-1.42). Conclusions Increased distance to cancer treatment centre is associated with shorter treatment intervals. There was no association between likelihood of metastatic disease at diagnosis or survival at one year. Analysis is on-going into travelling times to services and may provide further insight.

ABSTRACT Objectives A significant proportion (13.9-21.8%) of cancers are diagnosed during emergency admissions to hospital. Patients who are diagnosed in this way have poorer outcomes. Cancer type, increasing age, and deprivation have shown to be associated with cancer diagnosis as an emergency. The role of primary care consulting behaviour prior to emergency presentation with a new cancer diagnosis is unclear and therefore the principle aim of the present study was to investigate this. Approach All GP practices in the North East of Scotland were invited to participate. 2015 patients with a diagnosis of either colorectal, upper GI, prostate, lung, breast and melanoma were randomly selected from participating practices. A dataset was created that contained routinely collected data from primary care records from these patients. This information was consolidated with information from the NHS Grampian Cancer Care pathway database. Those diagnosed by screening were removed, leaving 1803 patients. The main characteristic examined was whether or not the patient had seen a GP with relevant symptoms in the 2 years before the consultation that resulted in their diagnosis or referral. Chi squared analysis and univariate linear regression analysis was performed on each characteristic to examine the association of independent variables with each outcome. Multivariate linear regression was then carried out across the characteristics. Results 362 (20.1%) of new cancer diagnosis were by emergency. Only 16.2% (n=260) of patients who saw their GP prior to their admission were diagnosed by emergency. 54.5% (n=97) of patients who had not seen their GP prior to diagnosis were emergency diagnoses. 20.7% (n=75) of patients diagnosed by emergency admission had been referred by their GP at the time of diagnosis and were awaiting their appointment with secondary care. Patients who had been seen in primary care before their cancer diagnosis were significantly less likely to have their cancer diagnosed by emergency admission (p

Delayed cancer diagnosis leads to poorer patient outcomes. During short consultations, General Practitioners (GPs) make quick decisions about likelihood of cancer. Patients' facial cues are processed rapidly and may influence diagnosis.To investigate whether patients' facial characteristics influence immediate perception of cancer risk by GPs.Web-based binary forced choice experiment with GPs from Northeast Scotland.GPs were presented with a series of pairs of face prototypes and asked to quickly select the patient more likely to have cancer. Faces were modified with respect to age, gender, and ethnicity. Choices were analysed using Chi-squared goodness-of-fit statistics with Bonferroni corrections.Eighty-two GPs participated. GPs were significantly more likely to suspect cancer in older patients. Gender influenced GP cancer suspicion, but this was modified by age: the male face was chosen as more likely to have cancer than the female face for young (72% of GPs;95% CI 61.0-87.0) and middle-aged faces (65.9%; 95% CI 54.7-75.5); but 63.4% (95% CI 52.2-73.3) decided the older female was more likely to have cancer than the older male (p = 0.015). GPs were significantly more likely to suspect cancer in the young Caucasian male (65.9% (95% CI 54.7, 75.5)) compared to the young Asian male (p = 0.004).GPs' first impressions about cancer risk are influenced by patient age, gender, and ethnicity. Tackling GP cognitive biases could be a promising way of reducing cancer diagnostic delays, particularly for younger patients.

BackgroundInterventions for dietary and physical activity changes in obese adults may be less effective for participants with additional obesity-related risk factors and co-morbidities than for otherwise healthy individuals. This study aimed to test the feasibility and acceptability of the recruitment, allocation, measurement, retention and intervention procedures of a randomised controlled trial of an intervention to improve physical activity and dietary practices amongst obese adults with additional obesity related risk factors.MethodPilot single centre open-labelled outcome assessor-blinded randomised controlled trial of obese (Body Mass Index (BMI)≥30 kg/m2) adults (age≥18 y) with obesity related co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension. Participants were randomly allocated to a manual-based group intervention or a leaflet control condition in accordance to a 2∶1 allocation ratio. Primary outcome was acceptability and feasibility of trial procedures, secondary outcomes included measures of body composition, physical activity, food intake and psychological process measures.ResultsOut of 806 potentially eligible individuals identified through list searches in two primary care general medical practices N = 81 participants (63% female; mean-age = 56.56(11.44); mean-BMI = 36.73(6.06)) with 2.35(1.47) co-morbidities were randomised. Scottish Index of Multiple Deprivation (SIMD) was the only significant predictor of providing consent to take part in the study (higher chances of consent for invitees with lower levels of deprivation). Participant flowcharts, qualitative and quantitative feedback suggested good acceptance and feasibility of intervention procedures but 34.6% of randomised participants were lost to follow-up due to overly high measurement burden and sub-optimal retention procedures. Participants in the intervention group showed positive trends for most psychological, behavioural and body composition outcomes.ConclusionsThe intervention procedures were found to be acceptable and feasible. Attrition rates were unacceptably high and areas for improvements of trial procedures were identified.Trial registrationControlled-Trials.com ISRCTN90101501.