Predictors of the experience of a Cytosponge test: analysis of patient survey data from the BEST3 trial.

BACKGROUND: The Cytosponge is a cell-collection device, which, coupled with a test for trefoil factor 3 (TFF3), can be used to diagnose Barrett's oesophagus, a precursor condition to oesophageal adenocarcinoma. BEST3, a large pragmatic, randomised, controlled trial, investigated whether offering the Cytosponge-TFF3 test would increase detection of Barrett's. Overall, participants reported mostly positive experiences. This study reports the factors associated with the least positive experience. METHODS: Patient experience was assessed using the Inventory to Assess Patient Satisfaction (IAPS), a 22-item questionnaire, completed 7-14 days after the Cytosponge test. STUDY COHORT: All BEST3 participants who answered ≥ 15 items of the IAPS (N = 1458). STATISTICAL ANALYSIS: A mean IAPS score between 1 and 5 (5 indicates most negative experience) was calculated for each individual. 'Least positive' experience was defined according to the 90th percentile. 167 (11.4%) individuals with a mean IAPS score of ≥ 2.32 were included in the 'least positive' category and compared with the rest of the cohort. Eleven patient characteristics and one procedure-specific factor were assessed as potential predictors of the least positive experience. Multivariable logistic regression analysis using backwards selection was conducted to identify factors independently associated with the least positive experience and with failed swallow at first attempt, one of the strongest predictors of least positive experience. RESULTS: The majority of responders had a positive experience, with an overall median IAPS score of 1.7 (IQR 1.5-2.1). High (OR = 3.01, 95% CI 2.03-4.46, p < 0.001) or very high (OR = 4.56, 95% CI 2.71-7.66, p < 0.001) anxiety (relative to low/normal anxiety) and a failed swallow at the first attempt (OR = 3.37, 95% CI 2.14-5.30, p < 0.001) were highly significant predictors of the least positive patient experience in multivariable analyses. Additionally, sex (p = 0.036), height (p = 0.032), alcohol intake (p = 0.011) and education level (p = 0.036) were identified as statistically significant predictors. CONCLUSION: We have identified factors which predict patient experience. Identifying anxiety ahead of the procedure and discussing particular concerns with patients or giving them tips to help with swallowing the capsule might help improve their experience. Trial registration ISRCTN68382401.

Morbidity and measures of the diagnostic process in primary care for patients subsequently diagnosed with cancer.

BACKGROUND: There is uncertainty regarding how pre-existing conditions (morbidities) may influence the primary care investigation and management of individuals subsequently diagnosed with cancer. METHODS: We identified morbidities using information from both primary and secondary care records among 11,716 patients included in the English National Cancer Diagnosis Audit (NCDA) 2014. We examined variation in 5 measures of the diagnostic process (the primary care interval, diagnostic interval, number of pre-referral consultations, use of primary care-led investigations, and referral type) by both primary care- and hospital records-derived measures of morbidity. RESULTS: Morbidity prevalence recorded before cancer diagnosis was almost threefold greater using the primary care (75%) vs secondary care-derived measure (28%). After adjustment, there was limited variation in the primary care interval and the number of pre-referral consultations by either definition of morbidity. Patients with more severe morbidities were less likely to have had a primary care-led investigation before cancer diagnosis compared with those without any morbidity (adjusted odds ratio, OR [95% confidence interval]: 0.72 [0.60-0.86] for Charlson score 3+ vs 0; joint P < 0.001). Patients with multiple primary care-recorded conditions or a Charlson score of 3+ were more likely to have diagnostic intervals exceeding 60 days (aOR: 1.26 [1.10-1.45] and 1.19 [>1.00-1.41], respectively), and more likely to receive an emergency referral (aOR: 1.60 [1.26-2.02] and 1.61 [1.26-2.06], respectively). CONCLUSION: Among cancer cases with up to 2 morbidities, there was no evidence of differences in diagnostic processes and intervals in primary care but higher morbidity burden was associated with longer time to diagnosis and higher likelihood of emergency referral.

Individuals with pre-existing long-term conditions (morbidities) may have a different pathways leading to their cancer diagnosis compared with those without such conditions but detailed evidence is limited. We aimed to investigate how morbidities were associated with a range of measures of the diagnostic process in primary care. We examined morbidity in 2 ways, using information from a primary care audit and hospital records. We found that three-quarters of patients were living with 1 or more conditions according to primary care-based information, while the prevalence was almost threefold lower when estimated using hospital records. There was little difference in the time from first primary care appointment to specialist referral and the number of appointments before specialist referral by morbidity, particularly when comparing patients with 1 or 2 conditions vs those without. However, patients with multiple conditions or more serious diseases experienced lower likelihood of investigation, greater likelihood of being sent to the hospital as an emergency, and longer time to diagnosis. We did not find evidence of substantial differences in primary care-based diagnostic processes by morbidity. However, once an initial referral has been made, multiple or more severe conditions appear to influence the time taken to reach a diagnosis.

Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial.

BACKGROUND: Treatment of dysplastic Barrett's oesophagus prevents progression to adenocarcinoma; however, the optimal diagnostic strategy for Barrett's oesophagus is unclear. The Cytosponge-trefoil factor 3 (TFF3) is a non-endoscopic test for Barrett's oesophagus. The aim of this study was to investigate whether offering this test to patients on medication for gastro-oesophageal reflux would increase the detection of Barrett's oesophagus compared with standard management. METHODS: This multicentre, pragmatic, randomised controlled trial was done in 109 socio-demographically diverse general practice clinics in England. Randomisation was done both at the general practice clinic level (cluster randomisation) and at the individual patient level, and the results for each type of randomisation were analysed separately before being combined. Patients were eligible if they were aged 50 years or older, had been taking acid-suppressants for symptoms of gastro-oesophageal reflux for more than 6 months, and had not undergone an endoscopy procedure within the past 5 years. General practice clinics were selected by the local clinical research network and invited to participate in the trial. For cluster randomisation, clinics were randomly assigned (1:1) by the trial statistician using a computer-generated randomisation sequence; for individual patient-level randomisation, patients were randomly assigned (1:1) by the general practice clinics using a centrally prepared computer-generated randomisation sequence. After randomisation, participants received either standard management of gastro-oesophageal reflux (usual care group), in which participants only received an endoscopy if required by their general practitioner, or usual care plus an offer of the Cytosponge-TFF3 procedure, with a subsequent endoscopy if the procedure identified TFF3-positive cells (intervention group). The primary outcome was the diagnosis of Barrett's oesophagus at 12 months after enrolment, expressed as a rate per 1000 person-years, in all participants in the intervention group (regardless of whether they had accepted the offer of the Cytosponge-TFF3 procedure) compared with all participants in the usual care group. Analyses were intention-to-treat. The trial is registered with the ISRCTN registry, ISRCTN68382401, and is completed. FINDINGS: Between March 20, 2017, and March 21, 2019, 113 general practice clinics were enrolled, but four clinics dropped out shortly after randomisation. Using an automated search of the electronic prescribing records of the remaining 109 clinics, we identified 13 657 eligible patients who were sent an introductory letter with 14 days to opt out. 13 514 of these patients were randomly assigned (per practice or at the individual patient level) to the usual care group (n=6531) or the intervention group (n=6983). Following randomisation, 149 (2%) of 6983 participants in the intervention group and 143 (2%) of 6531 participants in the usual care group, on further scrutiny, did not meet all eligibility criteria or withdrew from the study. Of the remaining 6834 participants in the intervention group, 2679 (39%) expressed an interest in undergoing the Cytosponge-TFF3 procedure. Of these, 1750 (65%) met all of the eligibility criteria on telephone screening and underwent the procedure. Most of these participants (1654 [95%]; median age 69 years) swallowed the Cytosponge successfully and produced a sample. 231 (3%) of 6834 participants had a positive Cytosponge-TFF3 result and were referred for an endoscopy. Patients who declined the offer of the Cytosponge-TFF3 procedure and all participants in the usual care group only had an endoscopy if deemed necessary by their general practitioner. During an average of 12 months of follow-up, 140 (2%) of 6834 participants in the intervention group and 13 (<1%) of 6388 participants in the usual care group were diagnosed with Barrett's oesophagus (absolute difference 18·3 per 1000 person-years [95% CI 14·8-21·8]; rate ratio adjusted for cluster randomisation 10·6 [95% CI 6·0-18·8], p<0·0001). Nine (<1%) of 6834 participants were diagnosed with dysplastic Barrett's oesophagus (n=4) or stage I oesophago-gastric cancer (n=5) in the intervention group, whereas no participants were diagnosed with dysplastic Barrett's oesophagus or stage I gastro-oesophageal junction cancer in the usual care group. Among 1654 participants in the intervention group who swallowed the Cytosponge device successfully, 221 (13%) underwent endoscopy after testing positive for TFF3 and 131 (8%, corresponding to 59% of those having an endoscopy) were diagnosed with Barrett's oesophagus or cancer. One patient had a detachment of the Cytosponge from the thread requiring endoscopic removal, and the most common side-effect was a sore throat in 63 (4%) of 1654 participants. INTERPRETATION: In patients with gastro-oesophageal reflux, the offer of Cytosponge-TFF3 testing results in improved detection of Barrett's oesophagus. Cytosponge-TFF3 testing could also lead to the diagnosis of treatable dysplasia and early cancer. This strategy will lead to additional endoscopies with some false positive results. FUNDING: Cancer Research UK, National Institute for Health Research, the UK National Health Service, Medtronic, and the Medical Research Council.

Presenting symptoms of cancer and stage at diagnosis: evidence from a cross-sectional, population-based study.

BACKGROUND: Early diagnosis interventions such as symptom awareness campaigns increasingly form part of global cancer control strategies. However, these strategies will have little impact in improving cancer outcomes if the targeted symptoms represent advanced stage of disease. Therefore, we aimed to examine associations between common presenting symptoms of cancer and stage at diagnosis. METHODS: In this cross-sectional study, we analysed population-level data from the English National Cancer Diagnosis Audit 2014 for patients aged 25 years and older with one of 12 types of solid tumours (bladder, breast, colon, endometrial, laryngeal, lung, melanoma, oral or oropharyngeal, ovarian, prostate, rectal, and renal cancer). We considered 20 common presenting symptoms and examined their associations with stage at diagnosis (TNM stage IV vs stage I-III) using logistic regression. For each symptom, we estimated these associations when reported as a single presenting symptom and when reported together with other symptoms. FINDINGS: We analysed data for 7997 patients. The proportion of patients diagnosed with stage IV cancer varied substantially by presenting symptom, from 1% (95% CI 1-3; eight of 584 patients) for abnormal mole to 80% (71-87; 84 of 105 patients) for neck lump. Three of the examined symptoms (neck lump, chest pain, and back pain) were consistently associated with increased odds of stage IV cancer, whether reported alone or with other symptoms, whereas the opposite was true for abnormal mole, breast lump, postmenopausal bleeding, and rectal bleeding. For 13 of the 20 symptoms (abnormal mole, breast lump, post-menopausal bleeding, rectal bleeding, lower urinary tract symptoms, haematuria, change in bowel habit, hoarseness, fatigue, abdominal pain, lower abdominal pain, weight loss, and the "any other symptom" category), more than 50% of patients were diagnosed at stages other than stage IV; for 19 of the 20 studied symptoms (all except for neck lump), more than a third of patients were diagnosed at stages other than stage IV. INTERPRETATION: Despite specific presenting symptoms being more strongly associated with advanced stage at diagnosis than others, for most symptoms, large proportions of patients are diagnosed at stages other than stage IV. These findings provide support for early diagnosis interventions targeting common cancer symptoms, countering concerns that they might be simply expediting the detection of advanced stage disease. FUNDING: UK Department of Health's Policy Research Unit in Cancer Awareness, Screening and Early Diagnosis; and Cancer Research UK.

Evaluating diagnostic strategies for early detection of cancer: the CanTest framework.

BACKGROUND: Novel diagnostic triage and testing strategies to support early detection of cancer could improve clinical outcomes. Most apparently promising diagnostic tests ultimately fail because of inadequate performance in real-world, low prevalence populations such as primary care or general community populations. They should therefore be systematically evaluated before implementation to determine whether they lead to earlier detection, are cost-effective, and improve patient safety and quality of care, while minimising over-investigation and over-diagnosis. METHODS: We performed a systematic scoping review of frameworks for the evaluation of tests and diagnostic approaches. RESULTS: We identified 16 frameworks: none addressed the entire continuum from test development to impact on diagnosis and patient outcomes in the intended population, nor the way in which tests may be used for triage purposes as part of a wider diagnostic strategy. Informed by these findings, we developed a new framework, the 'CanTest Framework', which proposes five iterative research phases forming a clear translational pathway from new test development to health system implementation and evaluation. CONCLUSION: This framework is suitable for testing in low prevalence populations, where tests are often applied for triage testing and incorporated into a wider diagnostic strategy. It has relevance for a wide range of stakeholders including patients, policymakers, purchasers, healthcare providers and industry.

Associations between general practice characteristics with use of urgent referrals for suspected cancer and endoscopies: a cross-sectional ecological study.

BACKGROUND: Large variation in measures of diagnostic activity has been described previously between English general practices, but related predictors remain understudied. OBJECTIVE: To examine associations between general practice population and characteristics, with the use of urgent referrals for suspected cancer, and use of endoscopy. METHODS: Cross-sectional observational study of English general practices. We examined practice-level use (/1000 patients/year) of urgent referrals for suspected cancer, gastroscopy, flexible sigmoidoscopy and colonoscopy. We used mixed-effects Poisson regression to examine associations with the sociodemographic profile of practice populations and other practice attributes, including the average age, sex and country of qualification of practice doctors. RESULTS: The sociodemographic characteristics of registered patients explained much of the between-practice variance in use of urgent referrals (32%) and endoscopic investigations (18-25%), all being higher in practices with older and more socioeconomically deprived patients. Practice-level attributes explained a substantial amount of between-practice variance in urgent referral (19%) but little of the variance in endoscopy (3%-4%). Adjusted urgent referral rates were higher in training practices and those with younger GPs. Practices with mean doctor ages of 41 and 57 years (at the 10th/90th centiles of the national distribution) would have urgent referral rates of 24.1 and 19.1/1000 registered patients, P < 0.001. CONCLUSION: Most between-practice variation in use of urgent referrals and endoscopies seems to reflect health need. Some practice characteristics, such as the mean age of GPs, are associated with appreciable variation in use of urgent referrals, though these associations do not seem strong enough to justify targeted interventions.

The influence of health literacy on the timely diagnosis of symptomatic cancer: A systematic review.

Low health literacy has been associated with poor cancer screening uptake, difficulty in making treatment choices and reduced quality of life following a cancer diagnosis, yet it is unclear whether and how health literacy influences the pathway to diagnosis for patients with cancer symptoms. This systematic review aimed to evaluate the influence of health literacy on the timely diagnosis of symptomatic cancer. Literature was searched between January 1990 and May 2017 using MEDLINE, Embase, Scopus, ASSIA, CINAHL and PsycINFO. Only three papers met the inclusion criteria. These reported two qualitative studies and one quantitative, with adult patients diagnosed with gastrointestinal (colon, rectum and pancreas), cervical and breast cancer. The definition and assessment of health literacy varied between the studies, as did the descriptions of the pathway to diagnosis. Due to the methodological weaknesses identified, the conclusions are limited; however, the studies did highlight important considerations in the definition and measurement of health literacy. Further research is required that clearly defines health literacy and follows the principles of the Aarhus Statement to assess the influence of health literacy on the pathway to cancer diagnosis. The protocol for this review was registered with PROSPERO (CRD42016048917).

Barrett's oESophagus trial 3 (BEST3): study protocol for a randomised controlled trial comparing the Cytosponge-TFF3 test with usual care to facilitate the diagnosis of oesophageal pre-cancer in primary care patients with chronic acid reflux.

BACKGROUND: Early detection of oesophageal cancer improves outcomes; however, the optimal strategy for identifying patients at increased risk from the pre-cancerous lesion Barrett's oesophagus (BE) is not clear. The Cytosponge, a novel non-endoscopic sponge device, combined with the biomarker Trefoil Factor 3 (TFF3) has been tested in four clinical studies. It was found to be safe, accurate and acceptable to patients. The aim of the BEST3 trial is to evaluate if the offer of a Cytosponge-TFF3 test in primary care for patients on long term acid suppressants leads to an increase in the number of patients diagnosed with BE. METHODS: The BEST3 trial is a pragmatic multi-site cluster-randomised controlled trial set in primary care in England. Approximately 120 practices will be randomised 1:1 to either the intervention arm, invitation to a Cytosponge-TFF3 test, or the control arm usual care. Inclusion criteria are men and women aged 50 or over with records of at least 6 months of prescriptions for acid-suppressants in the last year. Patients in the intervention arm will receive an invitation to have a Cytosponge-TFF3 test in their general practice. Patients with a positive TFF3 test will receive an invitation for an upper gastro-intestinal endoscopy at their local hospital-based endoscopy clinic to test for BE. The primary objective is to compare histologically confirmed BE diagnosis between the intervention and control arms to determine whether the offer of the Cytosponge-TFF3 test in primary care results in an increase in BE diagnosis within 12 months of study entry. DISCUSSION: The BEST3 trial is a well-powered pragmatic trial testing the use of the Cytosponge-TFF3 test in the same population that we envisage it being used in clinical practice. The data generated from this trial will enable NICE and other clinical bodies to decide whether this test is suitable for routine clinical use. TRIAL REGISTRATION: This trial was prospectively registered with the ISRCTN Registry on 19/01/2017, trial number ISRCTN68382401 .

The nature and frequency of abdominal symptoms in cancer patients and their associations with time to help-seeking: evidence from a national audit of cancer diagnosis.

Background: Raising awareness of possible cancer symptoms is important for timely help-seeking; recent campaigns have focused on symptom groups (such as abdominal symptoms) rather than individual alarm symptoms associated with particular cancer sites. The evidence base supporting such initiatives is still emerging however; understanding the frequency and nature of presenting abdominal symptoms among cancer patients could inform the design and evaluation of public health awareness campaigns. Methods: We examined eight presenting abdominal symptoms (abdominal pain, change in bowel habit, bloating/distension, dyspepsia, rectal bleeding, dysphagia, reflux and nausea/vomiting) among 15 956 patients subsequently diagnosed with cancer in England. We investigated the cancer site case-mix and variation in the patient interval (symptom-onset-to-presentation) by abdominal symptom. Results: Almost a quarter (23%) of cancer patients presented with abdominal symptoms before being diagnosed with one of 27 common and rarer cancers. The patient interval varied substantially by abdominal symptom: median (IQR) intervals ranged from 7 (0-28) days for abdominal pain to 30 (4-73) days for dysphagia. This variation persisted after adjusting for age, sex and ethnicity (P < 0.001). Conclusions: Abdominal symptoms are common at presentation among cancer patients, while time to presentation varies by symptom. The need for awareness campaigns may be greater for symptoms associated with longer intervals to help-seeking.

The Aarhus statement on cancer diagnostic research: turning recommendations into new survey instruments.

BACKGROUND: Over recent years there has been a growth in cancer early diagnosis (ED) research, which requires valid measurement of routes to diagnosis and diagnostic intervals. The Aarhus Statement, published in 2012, provided methodological guidance to generate valid data on these key pre-diagnostic measures. However, there is still a wide variety of measuring instruments of varying quality in published research. In this paper we test comprehension of self-completion ED questionnaire items, based on Aarhus Statement guidance, and seek input from patients, GPs and ED researchers to refine these questions. METHODS: We used personal interviews and consensus approaches to generate draft ED questionnaire items, then a combination of focus groups and telephone interviews to test comprehension and obtain feedback. A framework analysis approach was used, to identify themes and potential refinements to the items. RESULTS: We found that many of the questionnaire items still prompted uncertainty in respondents, in both routes to diagnosis and diagnostic interval measurement. Uncertainty was greatest in the context of multiple or vague symptoms, and potentially ambiguous time-points (such as 'date of referral'). CONCLUSIONS: There are limits on the validity of self-completion questionnaire responses, and refinements to the wording of questions may not be able to completely overcome these limitations. It's important that ED researchers use the best identifiable measuring instruments, but accommodate inevitable uncertainty in the interpretation of their results. Every effort should be made to increase clarity of questions and responses, and use of two or more data sources should be considered.

Socio-economic inequalities in stage at diagnosis, and in time intervals on the lung cancer pathway from first symptom to treatment: systematic review and meta-analysis.

Cancer diagnosis at an early stage increases the chance of curative treatment and of survival. It has been suggested that delays on the pathway from first symptom to diagnosis and treatment may be socio-economically patterned, and contribute to socio-economic differences in receipt of treatment and in cancer survival. This review aimed to assess the published evidence for socio-economic inequalities in stage at diagnosis of lung cancer, and in the length of time spent on the lung cancer pathway. MEDLINE, EMBASE and CINAHL databases were searched to locate cohort studies of adults with a primary diagnosis of lung cancer, where the outcome was stage at diagnosis or the length of time spent within an interval on the care pathway, or a suitable proxy measure, analysed according to a measure of socio-economic position. Meta-analysis was undertaken when there were studies available with suitable data. Of the 461 records screened, 39 papers were included in the review (20 from the UK) and seven in a final meta-analysis for stage at diagnosis. There was no evidence of socio-economic inequalities in late stage at diagnosis in the most, compared with the least, deprived group (OR=1.04, 95% CI=0.92 to 1.19). No socio-economic inequalities in the patient interval or in time from diagnosis to treatment were found. Socio-economic inequalities in stage at diagnosis are thought to be an important explanatory factor for survival inequalities in cancer. However, socio-economic inequalities in stage at diagnosis were not found in a meta-analysis for lung cancer. PROSPERO PROTOCOL REGISTRATION NUMBER: CRD42014007145.

The researchers' role in knowledge translation: a realist evaluation of the development and implementation of diagnostic pathways for cancer in two United Kingdom localities.

BACKGROUND: In examining an initiative to develop and implement new cancer diagnostic pathways in two English localities, this paper evaluates 'what works' and examines the role of researchers in facilitating knowledge translation amongst teams of local clinicians and policy-makers. METHODS: Using realist evaluation with a mixed methods case study approach, we conducted documentary analysis of meeting minutes and pathway iterations to map pathway development. We interviewed 14 participants to identify the contexts, mechanisms and outcomes (CMOs) that led to successful pathway development and implementation. Interviews were analysed thematically and four CMO configurations were developed. RESULTS: One site produced three fully implemented pathways, while the other produced two that were partly implemented. In explaining the differences, we found that a respected, independent, well-connected leader modelling partnership working and who facilitates a local, stable group that agree about the legitimacy of the data and project (context) can empower local teams to become sufficiently autonomous (mechanism) to develop and implement research-based pathways (outcome). Although both teams designed relevant, research-based cancer pathways, in the site where the pathways were successfully implemented the research team merely assisted, while, in the other, the research team drove the initiative. CONCLUSION: Based on our study findings, local stakeholders can apply local and research knowledge to develop and implement research-based pathways. However, success will depend on how academics empower local teams to create autonomy. Crucially, after re-packaging and translating research for local circumstances, identifying fertile environments with the right elements for implementation and developing collaborative relationships with local leaders, academics must step back.

Symptoms and patient factors associated with longer time to diagnosis for colorectal cancer: results from a prospective cohort study.

BACKGROUND: The objective of this study is to investigate symptoms, clinical factors and socio-demographic factors associated with colorectal cancer (CRC) diagnosis and time to diagnosis. METHODS: Prospective cohort study of participants referred for suspicion of CRC in two English regions. Data were collected using a patient questionnaire, primary care and hospital records. Descriptive and regression analyses examined associations between symptoms and patient factors with total diagnostic interval (TDI), patient interval (PI), health system interval (HSI) and stage. RESULTS: A total of 2677 (22%) participants responded; after exclusions, 2507 remained. Participants were diagnosed with CRC (6.1%, 56% late stage), other cancers (2.0%) or no cancer (91.9%). Half the cohort had a solitary first symptom (1332, 53.1%); multiple first symptoms were common. In this referred population, rectal bleeding was the only initial symptom more frequent among cancer than non-cancer cases (34.2% vs 23.9%, P=0.004). There was no evidence of differences in TDI, PI or HSI for those with cancer vs non-cancer diagnoses (median TDI CRC 124 vs non-cancer 138 days, P=0.142). First symptoms associated with shorter TDIs were rectal bleeding, change in bowel habit, 'feeling different' and fatigue/tiredness. Anxiety, depression and gastro-intestinal co-morbidities were associated with longer HSIs and TDIs. Symptom duration-dependent effects were found for rectal bleeding and change in bowel habit. CONCLUSIONS: Doctors and patients respond less promptly to some symptoms of CRC than others. Healthcare professionals should be vigilant to the possibility of CRC in patients with relevant symptoms and mental health or gastro-intestinal comorbidities.

The expanding role of primary care in cancer control.

The nature of cancer control is changing, with an increasing emphasis, fuelled by public and political demand, on prevention, early diagnosis, and patient experience during and after treatment. At the same time, primary care is increasingly promoted, by governments and health funders worldwide, as the preferred setting for most health care for reasons of increasing need, to stabilise health-care costs, and to accommodate patient preference for care close to home. It is timely, then, to consider how this expanding role for primary care can work for cancer control, which has long been dominated by highly technical interventions centred on treatment, and in which the contribution of primary care has been largely perceived as marginal. In this Commission, expert opinion from primary care and public health professionals with academic and clinical cancer expertise­from epidemiologists, psychologists, policy makers, and cancer specialists­has contributed to a detailed consideration of the evidence for cancer control provided in primary care and community care settings. Ranging from primary prevention to end-of-life care, the scope for new models of care is explored, and the actions needed to effect change are outlined. The strengths of primary care­its continuous, coordinated, and comprehensive care for individuals and families­are particularly evident in prevention and diagnosis, in shared follow-up and survivorship care, and in end-of-life care. A strong theme of integration of care runs throughout, and its elements (clinical, vertical, and functional) and the tools needed for integrated working are described in detail. All of this change, as it evolves, will need to be underpinned by new research and by continuing and shared multiprofessional development.

The role of receipt and timeliness of treatment in socioeconomic inequalities in lung cancer survival: population-based, data-linkage study.

BACKGROUND: Lung cancer survival is socioeconomically patterned, and socioeconomic inequalities in receipt of treatment have been demonstrated. In England, there are target waiting times for the referral (14 days) and treatment intervals (31 days from diagnosis, 62 days from GP referral). Socioeconomic inequalities in the time intervals from GP referral have been found. Cancer registry, Hospital Episode Statistics and lung cancer audit data were linked in order to investigate the contribution of these inequalities to socioeconomic inequalities in lung cancer survival. METHODS: Logistic regression was used to examine the likelihood of being alive 2 years after diagnosis, by socioeconomic position, for 22,967 lung cancer patients diagnosed in 2006-2009, and in a subset with stage recorded (n=5233). RESULTS: Socioeconomic inequalities in survival were found in a multivariable analysis adjusted for age, sex, histology, year, timely GP referral, performance status and comorbidity, with those in the most deprived socioeconomic group significantly less likely to be alive after 2 years (OR=0.77, 95% CI 0.66 to 0.88, p<0.001). When receipt of treatment was included in the analysis, the association no longer remained significant (OR=0.87, 95% CI 0.75 to 1.00, p=0.06). Addition of timeliness of treatment did not alter the conclusion. Patients treated within guideline targets had lower likelihood of two-year survival. CONCLUSIONS: Socioeconomic inequalities in survival from lung cancer were statistically explained by socioeconomic inequalities in receipt of treatment, but not by timeliness of referral and treatment. Further research is required to determine the currently unexplained socioeconomic variance in treatment rates.

For which cancers might patients benefit most from expedited symptomatic diagnosis? Construction of a ranking order by a modified Delphi technique.

BACKGROUND: This study aimed to answer the question 'for which cancers, in a symptomatic patient, does expediting the diagnosis provide an improvement in mortality and/or morbidity?' METHODS: An initial ranking was constructed from previous work identifying 'avoidable deaths' for 21 common cancers in the UK. In a two-round modified Delphi exercise, 22 experts, all experienced across multiple cancers, used an evidence pack summarising recent relevant publications and their own experience to adjust this ranking. Participants also answered on a Likert scale whether they anticipated mortality or morbidity benefits for each cancer from expedited diagnosis. RESULTS: Substantial changes in ranking occurred in the Delphi exercise. Finally, expedited diagnosis was judged to provide the greatest mortality benefit in breast cancer, uterine cancer and melanoma, and least in brain and pancreatic cancers. Three cancers, prostate, brain and pancreas, attracted a median answer of 'disagree' to whether they expected mortality benefits from expedited diagnosis of symptomatic cancer. CONCLUSIONS: Our results can guide future research, with emphasis given to studying interventions to improve symptomatic diagnosis of those cancers ranked highly. In contrast, research efforts for cancers with the lowest rankings could be re-directed towards alternative avenues more likely to yield benefit, such as screening or treatment.

Patient-derived measures of GI endoscopy: a meta-narrative review of the literature.

BACKGROUND AND AIMS: GI endoscopy (GIE) is widely performed, with 1 in 3 people requiring an endoscopic procedure at some point. Patient experience of medical procedures is important, but, to date, experience measures of GIE are derived from clinician opinion rather than from patients themselves. In this meta-narrative review, the literature on methods of assessing patient experience in GIE is reported. METHODS: ScienceDirect, MEDLINE, Web of Knowledge, Web of Science, CINAHL, and PsycINFO were searched to November 2013 using meta-narrative standards. Search terms included those related to endoscopic procedures, combined with those related to patient experience. RESULTS: A total of 3688 abstracts were identified and reviewed for relevance. A total of 3549 were excluded, leaving 139 for full-text review. We subsequently included 48 articles. Three sub-groups of studies were identified--those developing original measures of endoscopy-specific patient experience (27 articles), those modifying existing measures (10 articles), and those testing existing measures for reliability or validity (11 articles). Most measures focused on pain, discomfort, anxiety, and embarrassment. Three studies explored wider aspects of experience, including preparation, unit organization, and endoscopist preference. Likert scales, visual analog scale scores, and questionnaires were used most commonly. The Global Rating Scale was validated for use in 2 studies, confirming that those domains cover all aspects of endoscopy experience. Other measures were modified to assess endoscopic experience, such as the modified Group Health Association of America survey (mGHAA-9) (modified by 5 studies). CONCLUSIONS: No patient-derived and validated endoscopy-specific experience measures were found. Patient-derived and validated experience measures should be developed and used to model optimal healthcare delivery.

Implementing a national flexible sigmoidoscopy screening program: results of the English early pilot.

BACKGROUND AND STUDY AIMS: Following the results of a major UK study showing that once-only flexible sigmoidoscopy (FSIG) screening significantly reduced colorectal cancer (CRC) incidence and mortality, an FSIG screening program in England was announced in late 2010. Three "early pilot" sites were selected in 2011 in Derby, South of Tyne, and Tees to assess the practicalities of the delivery of FSIG screening. PARTICIPANTS AND METHODS: Eligible people aged 55 from selected practices in the three early pilot areas received postal invitations to participate. The South of Tyne and Derby sites employed interactive models of screening invitation, while Tees used a simple invitation. Data were collected to assess uptake, process, and outcome. A self-completion participant satisfaction questionnaire was sent to all participants 1 month after attendance. RESULTS: A total of 4023 55-year-olds were invited to participate. Uptake was 29 %, with 1151 people screened over a 3-month period. Screening uptake differed by method of invitation: a simple approach was significantly more successful than an interactive one (32 % vs. 27 %, P = 0.0015). Uptake decreased significantly with increasing deprivation. Adenomas were found in 111 (9.8 %) of those screened and cancer in two. The procedure was rated "very" or "fairly" acceptable by 97 % of participants. Over 90 % of respondents said they would participate in future cancer screening and a similar proportion would recommend doing so to others. CONCLUSION: Delivery of an FSIG screening program to prevent CRC is feasible and should be implemented using a simple invitation system. The national Bowel Scope program subsequently commenced at pilot sites in May 2013, with full implementation planned by 2016.

Exploring GPs' experiences of using diagnostic tools for cancer: a qualitative study in primary care.

BACKGROUND: The UK has an estimated 5-10000 extra cancer deaths each year when compared to other European countries and diagnostic delays are thought to make a significant contribution to this. One of the initiatives in England intended to support primary care professionals has been the development of cancer risk assessment tools (RATs). These tools assist in identifying and quantifying the risk of cancer in symptomatic primary care patients. OBJECTIVE: To explore GPs' experiences of incorporating the RATs for lung and bowel cancers into their clinical practice and in so doing, identify constraints and facilitators to the wider dissemination of the tools in primary care. METHODS: We conducted semi-structured interviews over the telephone with 11 project managers who implemented the study and 23 GPs who used the tool. The interviews were digitally recorded, professionally transcribed verbatim and analysed through the construction of a 'thematic framework'. RESULTS: The training and support package was fundamental to the successful integration of the RATs into GPs' daily routines. Ongoing support from cancer networks alongside acknowledgement of the clinical expertize of the GPs by those implementing the study enhanced GPs' uptake of the tool in practice. CONCLUSION: Findings suggest that the embedding of clinical decision support tools into clinical practice is more likely to be achieved when they are perceived to support but not supersede the clinical judgement of their users. This element of our findings is a focal point of this article.

Attitudes and beliefs of non-participants in a population-based screening programme for colorectal cancer.

BACKGROUND: Uptake of colorectal cancer screening programmes needs to be improved or at least maintained in order to achieve projected reductions in mortality and morbidity. Understanding the origins of non-participation in screening is therefore important. OBJECTIVE: To explore the beliefs and experiences of individuals who had not responded either to their screening invitation or reminder. DESIGN: A qualitative study using in-depth interviews with non-participants from England's population-based colorectal cancer screening programme. Data collection and analysis were carried out using a grounded theory approach, with an emphasis on the constant comparison method, and continued until saturation (27 interviews). FINDINGS: The interviews provided an in-depth understanding of a range of reasons and circumstances surrounding non-participation in screening, including contextual and environmental influences as well as factors specific to the screening test. Non-participation in screening was not necessarily associated with negative attitudes towards screening or a decision to not return a kit. Reasons for non-participation in screening included not feeling that participation is personally necessary, avoiding or delaying decision making, and having some degree of intention to take part but failing to do so because of practicalities, conflicting priorities or external circumstances. Beliefs, awareness and intention change over time. DISCUSSION AND CONCLUSIONS: A range of approaches may be required to improve screening uptake. Some non-participants may already have a degree of intention to take part in screening in the future, and this group may be more responsive to interventions based on professional endorsement, repeat invitations, reminders and aids to making the test more practical.