The Newcastle ENDOPREM™: a validated patient reported experience measure for gastrointestinal endoscopy.

OBJECTIVES: Measuring patient experience of gastrointestinal (GI) procedures is a key component of evaluation of quality of care. Current measures of patient experience within GI endoscopy are largely clinician derived and measured; however, these do not fully represent the experiences of patients themselves. It is important to measure the entirety of experience and not just experience directly during the procedure. We aimed to develop a patient-reported experience measure (PREM) for GI procedures. DESIGN: Phase 1: semi-structured interviews were conducted in patients who had recently undergone GI endoscopy or CT colonography (CTC) (included as a comparator). Thematic analysis identified the aspects of experience important to patients. Phase 2: a question bank was developed from phase 1 findings, and iteratively refined through rounds of cognitive interviews with patients who had undergone GI procedures, resulting in a pilot PREM. Phase 3: patients who had attended for GI endoscopy or CTC were invited to complete the PREM. Psychometric properties were investigated. Phase 4 involved item reduction and refinement. RESULTS: Phase 1: interviews with 35 patients identified six overarching themes: anxiety, expectations, information & communication, embarrassment & dignity, choice & control and comfort. Phase 2: cognitive interviews refined questionnaire items and response options. Phase 3: the PREM was distributed to 1650 patients with 799 completing (48%). Psychometric properties were found to be robust. Phase 4: final questionnaire refined including 54 questions assessing patient experience across five temporal procedural stages. CONCLUSION: This manuscript gives an overview of the development and validation of the Newcastle ENDOPREM™, which assesses all aspects of the GI procedure experience from the patient perspective. It may be used to measure patient experience in clinical care and, in research, to compare patients' experiences of different endoscopic interventions.

Patient experience of gastrointestinal endoscopy: informing the development of the Newcastle ENDOPREM™.

BACKGROUND: Measuring patient experience is important for evaluating the quality of patient care, identifying aspects requiring improvement and optimising patient outcomes. Patient Reported Experience Measures (PREMs) should, ideally, be patient derived, however no such PREMs for gastrointestinal (GI) endoscopy exist. This study explored the experiences of patients undergoing GI endoscopy and CT colonography (CTC) in order to: identify aspects of care important to them; determine whether the same themes are relevant across investigative modalities; develop the framework for a GI endoscopy PREM. METHODS: Patients aged ≥18 years who had undergone oesophagogastroduodenoscopy (OGD), colonoscopy or CTC for symptoms or surveillance (but not within the national bowel cancer screening programme) in one hospital were invited to participate in semi-structured interviews. Recruitment continued until data saturation. Inductive thematic analysis was undertaken. RESULTS: 35 patients were interviewed (15 OGD, 10 colonoscopy, 10 CTC). Most patients described their experience chronologically, and five 'procedural stages' were evident: before attending for the test; preparing for the test; at the hospital, before the test; during the test; after the test. Six themes were identified: anxiety; expectations; choice & control; communication & information; comfort; embarrassment & dignity. These were present for all three procedures but not all procedure stages. Some themes were inter-related (eg, expectations & anxiety; communication & anxiety). CONCLUSION: We identified six key themes encapsulating patient experience of GI procedures and these themes were evident for all procedures and across multiple procedure stages. These findings will be used to inform the development of the Newcastle ENDOPREM™.

'It's like being conscripted, one volunteer is better than 10 pressed men': A qualitative study into the views of people who plan to opt-out of organ donation.

Objectives To overcome the shortage of organ donors, Scotland and England are introducing an opt-out organ donor registration system in 2020. This means individuals will be automatically considered to consent for donation unless they actively opt-out of the register. Research has found that emotional barriers play a key role in donor decisions under opt-in legislation, yet little is known about factors that influence donor decisions under opt-out consent. Our objectives were to investigate attitudes towards organ donation and opt-out consent from individuals who plan to opt-out, and to explore the reasons why they plan to opt-out. Design Qualitative interview study. Methods Semi-structured interviews were conducted with 15 individuals from Scotland (n = 14) and England (n = 1) who self-reported the intention to opt-out of the register following the legislative change to opt-out. The interviews were transcribed verbatim and analysed using thematic analysis. Results Three main themes were identified: (1) consent versus coercion, which describes the perception of freedom of choice under an opt-in system and fears of 'government interference' and threatened autonomy under opt-out, (2) self-protection, encompassing fears of medical mistrust, bodily integrity concerns, and apprehension regarding the recipient selection process, and lastly, (3) 'riddled with pitfalls', which includes the notion that opt-out consent may increase susceptibility of stigma and reproach when registering an opt-out decision. Conclusions This study reinforces existing opt-in literature surrounding medical mistrust and bodily integrity concerns. A threat to one's autonomous choice and heightened reactance arising from perceptions of unwarranted government control have emerged as novel barriers. Statement of contribution What is already known about this subject? Although around 90% of individuals in the United Kingdom support organ donation, just 40% are actively registered as donors. As part of measures to improve rates of organ transplantation, Scotland and England are moving to an opt-out organ donation consent system in 2020. Existing research has shown that feelings and emotions are important factors that influence donor relevant decisions under the current opt-in system, but little research has explored potential deterrents under the new plans for opt-out consent. Minimizing the number of people opting out of the donor register is key to ensure sustained rates of transplantation. What does this study add? This study explored why people plan to opt-out of the new system in Scotland and England. Medical mistrust and bodily integrity concerns remain as salient barriers under opt-out laws. Fears of unwarranted government control and a perceived threat to one's freedom of choice emerged as a novel barrier.

Preference for Deliberation and Perceived Usefulness of Standard- and Narrative-Style Leaflet Designs: Implications for Equitable Cancer-Screening Communication.

BACKGROUND: In the UK, cancer-screening invitations are mailed with information styled in a standard, didactic way to allow for informed choice. Information processing theory suggests this "standard style" could be more appealing to people who prefer deliberative thinking. People less likely to engage in deliberative thinking may be disenfranchised by the design of current standard-style information. PURPOSE: To examine the distribution of preference for deliberative thinking across demographic groups (Study 1) and explore associations between preference for deliberative thinking and perceived usefulness of standard- and narrative-style screening information (Study 2). METHODS: In Study 1, adults aged 45-59 (n = 4,241) were mailed a questionnaire via primary care assessing preference for deliberative thinking and demographic characteristics. In Study 2, a separate cohort of adults aged 45-59 (n = 2,058) were mailed standard- and narrative-style leaflets and a questionnaire assessing demographic characteristics, preference for deliberative thinking, and perceived leaflet usefulness. Data were analyzed using multiple regression. RESULTS: In Study 1 (n = 1,783) and Study 2 (n = 650), having lower socioeconomic status, being a women, and being of nonwhite ethnicity was associated with lower preference for deliberative thinking. In Study 2, the standard-style leaflet was perceived as less useful among participants with lower preference for deliberative thinking, while perceived usefulness of the narrative-style leaflet did not differ by preference for deliberative thinking. CONCLUSIONS: Information leaflets using a standard style may disadvantage women and those experiencing greater socioeconomic deprivation. More work is required to identify design styles that have a greater appeal for people with low preference for deliberative thinking.

Predictors of intention translation in flexible sigmoidoscopy screening for colorectal cancer.

OBJECTIVE: This prospective study aimed to identify predictors of intention and subsequent attendance of flexible sigmoidoscopy screening using constructs derived from the Health Belief Model (HBM). METHOD: A total of 4,330 people aged 54 years and registered at 1 of 83 participating English general practices were sent a preinvitation questionnaire to assess sociodemographics, HBM variables including perceived benefits, barriers, seriousness, health motivation, and external cues to action as well a range of other constructs and personal characteristics known to relate to cancer screening. RESULTS: Of the 1,578 respondents (36.4%), 1,555 (98.5%) answered the intention question: 52.9% stated definitely yes, 38.1% probably yes, 6.8% probably not, and 2.2% definitely not. Intentions were positively associated with a higher score on a scale of benefits (odds ratio [OR] = 4.62; 95% confidence intervals [CI; 3.24, 6.59]) and health motivation, that is, interest in other ways of preventing colorectal cancer (OR = 2.61; 95% CI [1.62, 4.22]), while a higher score on perceived barriers (OR = 0.19; 95% CI [0.12, 0.31]) and currently following recommended healthy lifestyle behaviors (OR = 0.31; 95% CI [0.16, 0.59]) were negatively associated. Attendance was verified for 922 intenders (65.2%) of whom 737 (79.9%) attended. Attendance was predicted by health motivation (OR = 1.75; 95% CI [1.07, 2.86]), perceived benefits (OR = 1.82; 95% CI [1.37, 2.43]), perceived barriers (OR = 0.47; 95% CI [0.32, 0.69]), individual-level deprivation (OR = 0.26; 95% CI [0.14, 0.50]), and having diabetes (OR = 0.48; 95% CI [0.25, 0.94]). CONCLUSION: This study supported the usefulness of the HBM in predicting cancer screening and was further enhanced by adding non-HBM variables such as individual socioeconomic deprivation and comorbidities. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

The impact of descriptive norms on motivation to participate in cancer screening - Evidence from online experiments.

OBJECTIVE: The current study tested in two online experiments whether manipulating normative beliefs about cancer screening uptake increases intention to attend colorectal screening among previously disinclined individuals. METHODS: 2461 men and women from an Internet panel (Experiment 1 N = 1032; Experiment 2, N = 1423) who initially stated that they did not intend to take up screening were asked to guess how many men and women they believe to get screened for colorectal cancer. Across participants, we varied the presence/absence of feedback on the participant's estimate, as well as the stated proportion of men and women doing the screening test. RESULTS: Across the two experiments, we found that receiving one of the experimental messages stating that uptake is higher than estimated significantly increased the proportion of disinclined men and women becoming intenders. While, we found a positive relationship between the communicated uptake and screening intentions, we did not find evidence that providing feedback on the estimate has an added benefit. CONCLUSION: Screening intention can be effectively manipulated through a high uptake message. PRACTICE IMPLICATIONS: Communication of high screening uptake is an easy and effective way to motivate disinclined individuals to engage in colorectal cancer screening.

Using specialist screening practitioners (SSPs) to increase uptake of bowel scope (flexible sigmoidoscopy) screening: results of a feasibility single-stage phase II randomised trial.

OBJECTIVE: To determine the feasibility of specialist screening practitioners (SSPs) offering patient navigation (PN) to facilitate uptake of bowel scope screening (BSS) among patients who do not confirm or attend their appointment. DESIGN: A single-stage phase II trial. SETTING: South Tyneside District Hospital, Tyne and Wear, England, UK. PARTICIPANTS: Individuals invited for BSS at South Tyneside District Hospital during the 6-month recruitment period were invited to participate in the study. INTERVENTION: Consenting individuals were randomly assigned to either the PN intervention or usual care group in a 4:1 ratio. The intervention involved BSS non-attenders receiving a phone call from an SSP to elicit their reasons for non-attendance and offer educational, practical and emotional support as required. If requested by the patient, another BSS appointment was then scheduled. PRIMARY OUTCOME MEASURE: The number of non-attenders in the intervention group who were navigated and then rebooked and attended their new BSS appointment. SECONDARY OUTCOME MEASURES: Barriers to BSS attendance, patient-reported outcomes including informed choice and satisfaction with BSS and the PN intervention, reasons for study non-participation, SSPs' evaluation of the PN process and a cost analysis. RESULTS: Of those invited to take part (n=1050), 152 (14.5%) were randomised into the study: PN intervention=109; usual care=43. Most participants attended their BSS appointment (PN: 79.8%; control: 79.1%) leaving 22 eligible for PN: only two were successfully contacted. SSPs were confident in delivering PN, but were concerned that low BSS awareness and information overload may have deterred patients from taking part in the study. Difficulty contacting patients was reported as a burden to their workload. CONCLUSIONS: PN, as implemented, was not a feasible intervention to increase BSS uptake in South Tyneside. Interventions to increase BSS awareness may be better suited to this population. TRIAL REGISTRATION NUMBER: ISRCTN13314752; Results.

Rapid review of factors associated with flexible sigmoidoscopy screening use.

Flexible sigmoidoscopy (FS) screening has been shown to reduce colorectal cancer (CRC) incidence and mortality among screened adults. The aim of this review was to identify patient-related factors associated with the screening test's use. We searched PubMed for studies that examined the association between FS screening use and one or more factors. To determine the eligibility of studies, we first reviewed titles, then abstracts, and finally the full paper. We started with a narrow search, which we expanded successively (by adding 'OR' terms) until the number of new publications eligible after abstract review was <1% of the total number of publications. We then abstracted factors from eligible papers and reported the number of times each was found to be positively or negatively associated with FS screening use. We identified 42 papers, most of which reported studies conducted in the United States of America (n = 21, 50%) and the United Kingdom (n = 13, 31%). Across studies, a wide range of factors were examined (n = 123), almost half of which were found to be associated with FS screening use at least once (n = 60). Sociodemographic and health and lifestyle factors that were frequently positively associated with FS screening use included: male gender, higher socioeconomic status and a family history of CRC. Frequently positively associated psychosocial factors included low perceived barriers and high perceived benefits. Findings suggest that future research should focus on developing a theoretical framework of cancer screening behaviour to allow a greater level of consistency and specificity in measuring key constructs.

Testing active choice for screening practitioner's gender in endoscopy among disinclined women: An online experiment.

OBJECTIVES: A large proportion of women have a preference for a same-gender endoscopy practitioner. We tested how information about practitioner gender affected intention to have bowel scope screening in a sample of women disinclined to have the test. METHODS: In an online experimental survey, women aged 35-54 living in England who did not intend to participate in bowel scope screening (N = 1060) were randomised to one of four experimental conditions: (1) control (practitioner's gender is unknown), (2) opposite-gender (male practitioner by default), (3) same gender (female practitioner by default), and (4) active choice (the patient could choose the gender of the practitioner). Intention was measured following the interventions. RESULTS: Of 1010 (95.3%) women who completed the survey, most were White-British (83.6%), and working (63.3%). Compared with control, both active choice and same-gender conditions increased intention among disinclined women (9.3% vs. 16.0% and 17.9%; OR: 1.85; 95% CI: 1.07-3.20 and OR: 2.07; 95% CI: 1.23-3.50). There were no differences in intention between the opposite-gender and control conditions (9.8% vs. 9.3%; OR: 1.06; 95% CI: 0.60-1.90) or the active choice and same-gender conditions (16.0% vs. 17.9%: OR: 0.89; 95% CI: 0.55-1.46, using same gender as baseline). CONCLUSIONS: Offering disinclined women a same-gender practitioner, either by choice or default, increased subsequent intention, while an opposite gender default did not negatively affect intention. Reducing uncertainty about gender of practitioner could positively affect uptake in women, and should be tested in a randomised controlled trial.

Barriers to bowel scope (flexible sigmoidoscopy) screening: a comparison of non-responders, active decliners and non-attenders.

BACKGROUND: Participation in bowel scope screening (BSS) is low (43%), limiting its potential to reduce colorectal cancer (CRC) incidence and mortality. This study aimed to quantify the prevalence of barriers to BSS and examine the extent to which these barriers differed according to non-participant profiles: non-responders to the BSS invitation, active decliners of the invitation, and non-attenders of confirmed appointments. METHODS: Individuals invited for BSS between March 2013 and December 2015, across 28 General Practices in England, were sent a questionnaire. Questions measured initial interest in BSS, engagement with the information booklet, BSS participation, and, where applicable, reasons for BSS non-attendance. Chi-square tests of independence were performed to examine the relationship between barriers, non-participant groups and socio-demographic variables. RESULTS: 1478 (45.8%) questionnaires were returned for analysis: 1230 (83.2%) attended screening, 114 (7.7%) were non-responders to the BSS invitation, 100 (6.8%) were active decliners, and 34 (2.3%) were non-attenders. Non-responders were less likely to have read the whole information booklet than active decliners (x2 (2, N = 157) = 7.00, p = 0.008) and non-attenders (x2 (2, N = 101) = 8.07, p = 0.005). Non-responders also had lower initial interest in having BSS than either active decliners (x2 (2, N = 213) = 6.07, p = 0.014) or non-attenders (x2 (2, N = 146) = 32.93, p < 0.001). Overall, anticipated pain (33%) and embarrassment (30%) were the most commonly cited barriers to BSS participation. For non-attenders, however, practical, appointment-related reasons were most common (27%). CONCLUSIONS: Interventions to improve BSS uptake should be more nuanced and use targeted strategies to address the specific needs of each group.

Use of Two Self-referral Reminders and a Theory-Based Leaflet to Increase the Uptake of Flexible Sigmoidoscopy in the English Bowel Scope Screening Program: Results From a Randomized Controlled Trial in London.

Background: We previously initiated a randomized controlled trial to test the effectiveness of two self-referral reminders and a theory-based leaflet (sent 12 and 24 months after the initial invitation) to increase participation within the English Bowel Scope Screening program. Purpose: This study reports the results following the second reminder. Methods: Men and women included in the initial sample (n = 1,383) were re-assessed for eligibility 24 months after their invitation (12 months after the first reminder) and excluded if they had attended screening, moved away, or died. Eligible adults received the same treatment they were allocated 12 months previous, that is, no reminder ("control"), or a self-referral reminder with either the standard information booklet ("Reminder and Standard Information Booklet") or theory-based leaflet designed using the Behavior Change Wheel ("Reminder and Theory-Based Leaflet"). The primary outcome was the proportion screened within each group 12 weeks after the second reminder. Results: In total, 1,218 (88.1%) individuals were eligible. Additional uptake following the second reminder was 0.4% (2/460), 4.8% (19/399), and 7.9% (29/366) in the control, Reminder and Standard Information Booklet, and Reminder and Theory-Based Leaflet groups, respectively. When combined with the first reminder, the overall uptake for each group was 0.7% (3/461), 14.5% (67/461), and 21.5% (99/461). Overall uptake was significantly higher in the Reminder and Standard Information Booklet and Reminder and Theory-Based Leaflet groups than in the control (odds ratio [OR] = 26.1, 95% confidence interval [CI] = 8.1-84.0, p < .001 and OR = 46.9, 95% CI = 14.7-149.9, p < .001, respectively), and significantly higher in the Reminder and Theory-Based Leaflet group than in the Reminder and Standard Information Booklet group (OR = 1.8, 95% CI = 1.3-2.6, p < .001). Conclusion: A second reminder increased uptake among former nonparticipants. The added value of the theory-based leaflet highlights a potential benefit to reviewing the current information booklet. Trials Registry Number: ISRCTN44293755.

Persuasion, Adaptation, and Double Identity: Qualitative Study on the Psychological Impact of a Screen-Detected Colorectal Cancer Diagnosis.

The NHS Bowel Cancer Screening Programme (BCSP) is aimed at reducing colorectal cancer (CRC) mortality through early detection within a healthy population. This study explores how 5 people (three females) experience and make sense of their screen-detected diagnosis and the psychological implications of this diagnostic pathway. A biographical narrative interview method was used, and transcripts were analysed using a thematic analysis with a phenomenological lens. Themes specifically relating to posttreatment experience and reflections are reported here: Do it: being living proof, Resisting the threat of recurrence, Rationalising bodily change, and Continuing life-"carrying on normally." Participants described their gratefulness to the BCSP, motivating a strong desire to persuade others to be screened. Furthermore, participants professed a duality of experience categorised by the normalisation of life after diagnosis and treatment and an identification of strength post cancer, as well as a difficulty adjusting to the new changes in life and a contrasting identity of frailty. Understanding both the long- and short-term impacts of a CRC diagnosis through screening is instrumental to the optimisation of support for patients. The results perhaps highlight a particular target for psychological distress reduction, which could reduce the direct and indirect cost of cancer to the patient.

Using primary care-based paper and telephone interventions to increase uptake of bowel scope screening in Yorkshire: a protocol of a randomised controlled trial.

INTRODUCTION: Evidence suggests bowel scope screening (BSS) can significantly reduce an individual's risk of developing colorectal cancer (CRC). BSS for 55 year olds was therefore introduced to the English Bowel Cancer Screening Programme (BCSP) in 2013. However, the benefits are only gained from test completion and uptake is low (43%). Primary care involvement has consistently shown benefits to cancer screening uptake and so this study aims to build on this knowledge and evaluate general practitioner (GP) practice led interventions designed to increase BSS attendance. METHODS AND ANALYSIS: A three-arm randomised controlled trial will be conducted to evaluate three interventions: one intervention for prospective BSS invitees (primer letter with locally tailored leaflet sent by an individual's GP practice) and two interventions for those who do not attend their BSS appointment (a self-referral letter sent by an individual's GP practice and a patient navigation call made on behalf of an individual's GP practice). The trial will be set in Yorkshire. Individuals soon to receive their invitation to attend BSS at one of the Hull and East Yorkshire Bowel Cancer Screening centre sites, will be randomly assigned to one of three groups: control (usual care; no input from GP practice), Intervention group A (primer letter/leaflet and a self-referral letter), Intervention group B (primer letter/leaflet and a patient navigation call). Attendance data will be obtained from the BCSP database (via National Health Service (NHS) Digital) 3 months after the last intervention. Regression analysis will compare uptake, and additional clinical outcomes, across the three groups. The analysis will be multivariate and adjust for several covariates including gender and area-level deprivation. ETHICS AND DISSEMINATION: NHS ethical approval has been obtained from London-Harrow Research Ethics Committee. The results will be submitted for publication in a peer-reviewed journal and presented at conferences. TRIAL REGISTRATION NUMBER: ISRCTN16252122; Pre-results.

Reducing the socioeconomic gradient in uptake of the NHS bowel cancer screening Programme using a simplified supplementary information leaflet: a cluster-randomised trial.

BACKGROUND: Uptake of colorectal cancer screening is low in the English NHS Bowel Cancer Screening Programme (BCSP). Participation in screening is strongly associated with socioeconomic status. The aim of this study was to determine whether a supplementary leaflet providing the 'gist' of guaiac-based Faecal Occult Blood test (gFOBt) screening for colorectal cancer could reduce the socioeconomic status (SES) gradient in uptake in the English NHS BCSP. METHODS: The trial was integrated within routine BCSP operations in November 2012. Using a cluster randomised controlled design all adults aged 59-74 years who were being routinely invited to complete the gFOBt were randomised based on day of invitation. The Index of Multiple Deprivation was used to create SES quintiles. The control group received the standard information booklet ('SI'). The intervention group received the SI booklet and the Gist leaflet ('SI + Gist') which had been designed to help people with lower literacy engage with the invitation. Blinding of hubs was not possible and invited subjects were not made aware of a comparator condition. The primary outcome was the gradient in uptake across IMD quintiles. RESULTS: In November 2012, 163,525 individuals were allocated to either the 'SI' intervention (n = 79,104) or the 'SI + Gist' group (n = 84,421). Overall uptake was similar between the intervention and control groups (SI: 57.3% and SI + Gist: 57.6%; OR = 1.02, 95% CI: 0.92-1.13, p = 0.77). Uptake was 42.0% (SI) vs. 43.0% (SI + Gist) in the most deprived quintile and 65.6% vs. 65.8% in the least deprived quintile (interaction p = 0.48). The SES gradient in uptake was similar between the study groups within age, gender, hub and screening round sub-groups. CONCLUSIONS: Providing supplementary simplified information in addition to the standard information booklet did not reduce the SES gradient in uptake in the NHS BCSP. The effectiveness of the Gist leaflet when used alone should be explored in future research. TRIAL REGISTRATION: ISRCTN74121020 , registered: 17/20/2012.

What do people fear about cancer? A systematic review and meta-synthesis of cancer fears in the general population.

BACKGROUND: Cancer has long inspired fear, but the effect of fear is not well understood; it seems both to facilitate and to deter early diagnosis behaviours. To elucidate fear's behavioural effects, we systematically reviewed and synthesised qualitative literature to explore what people fear about cancer. METHODS: We searched Medline, Embase, PsycInfo, Web of Science, AnthroSource, and Anthrobase for studies on cancer fear in breast, cervical, and colorectal cancer screening and analysed 102 studies from 26 countries using thematic synthesis. RESULTS: Fears of cancer emanated from a core view of cancer as a vicious, unpredictable, and indestructible enemy, evoking fears about its proximity, the (lack of) strategies to keep it at bay, the personal and social implications of succumbing, and fear of dying from cancer. CONCLUSIONS: This view of cancer as 'an enemy' reprises the media's 'war on cancer' theme and may affect the acceptance of cancer early detection and prevention messages, since cancer's characteristics influenced whether 'fight' or 'flight' was considered appropriate.

Improving uptake of flexible sigmoidoscopy screening: a randomized trial of nonparticipant reminders in the English Screening Programme.

Background and study aims Uptake of flexible sigmoidoscopy screening in the English Bowel Scope Screening (BSS) Programme is low. The aim of this study was to test the impact of a nonparticipant reminder and theory-based leaflet to promote uptake among former nonresponders (previously did not confirm their appointment) and nonattenders (previously confirmed their appointment but did not attend). Patients and methods Eligible adults were men and women in London who had not attended a BSS appointment within 12 months of their invitation. Individuals were randomized (1:1:1) to receive no reminder (control), a 12-month reminder plus standard information booklet (TMR-SIB), or a 12-month reminder plus bespoke theory-based leaflet (TMR-TBL) designed to address barriers to screening. The primary outcome of the study was the proportion of individuals screened within each group 12 weeks after the delivery of the reminder. Results A total of 1383 men and women were randomized and analyzed as allocated (n = 461 per trial arm). Uptake was 0.2 % (n = 1), 10.4 % (n = 48), and 15.2 % (n = 70) in the control, TMR-SIB, and TMR-TBL groups, respectively. Individuals in the TMR-SIB and TMR-TBL groups were significantly more likely to attend screening than individuals in the control group (adjusted odds ratio [OR] 53.7, 95 % confidence interval [CI] 7.4 - 391.4, P < 0.001 and OR 89.0, 95 %CIs 12.3 - 645.4, P < 0.01, respectively). Individuals in the TMR-TBL group were also significantly more likely to attend screening than individuals in the TMR-SIB group (OR 1.7, 95 %CIs 1.1 - 2.5, P = 0.01). Across all groups, former nonattenders were more likely to participate in screening than former nonresponders (uptake was 14.2 % and 8.0 %, respectively; OR 2.5, 95 %CIs 1.4 - 4.4, P < 0.01). The adenoma detection rate among screened adults was 7.6 %, which is comparable to the rate in initial attenders. Conclusions Reminders targeting former nonparticipants can improve uptake and are effective for both former nonresponders and nonattenders. Theory-based information designed to target barriers to screening added significantly to this strategy.

Using Specialist Screening Practitioners (SSPs) to increase uptake of the Bowel Scope (Flexible Sigmoidoscopy) Screening Programme: a study protocol for a feasibility single-stage phase II trial.

BACKGROUND: The NHS Bowel Scope Screening (BSS) programme offers men and women aged 55 years a once-only flexible sigmoidoscopy (FS), a test that can help reduce colorectal cancer (CRC) incidence and mortality. However, the benefits of BSS are contingent on uptake. This National Institute for Health Research-funded single-stage phase II trial will test the feasibility of using patient navigation (PN), an intervention that offers support to patients to overcome barriers to healthcare, to increase BSS uptake within a socially deprived area of England. METHODS/DESIGN: All individuals invited for BSS at South Tyneside NHS Foundation Trust during the 6-month recruitment period will be invited to take part in the study. Consenting participants will be randomised to receive PN or usual care in a 2:1 ratio. PN involves non-attenders receiving a phone call from a Specialist Screening Practitioner (SSP) who will elicit reasons for non-attendance and offer educational, practical, and emotional support as needed. If requested by the patient, another appointment for BSS will then be arranged. We anticipate 30 % of participants will be non-attenders. Using A'Hern single-stage design, with 20 % significance level and 80 % power, at least 35 participants who receive PN need to subsequently attend for PN to be considered worthy of further investigation in a definitive trial. The primary outcome measure will be the number of participants in the PN group who re-book and attend their BSS appointment. A qualitative analysis of the PN transcripts, and interviews with the SSPs, will also be conducted, alongside a quantitative analysis of completed patient-reported experience questionnaires. An economic analysis will calculate the costs of delivering PN. DISCUSSION: This feasibility study will be instrumental in deciding whether to conduct the first definitive trial of PN in BSS in England. If PN is subsequently shown to be cost-effective at increasing uptake of BSS, NHS policies could be modified to implement PN as a standard service. The results will be disseminated in peer-reviewed journals and at scientific conferences. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number, ISRCTN13314752.

A national cluster-randomised controlled trial to examine the effect of enhanced reminders on the socioeconomic gradient in uptake in bowel cancer screening.

BACKGROUND: The NHS Bowel Cancer Screening Programme in England offers biennial guaiac faecal occult blood testing (gFOBt). There is a socioeconomic gradient in participation and socioeconomically disadvantaged groups have worse colorectal cancer survival than more advantaged groups. We compared the effectiveness and cost of an enhanced reminder letter with the usual reminder letter on overall uptake of gFOBt and the socioeconomic gradient in uptake. METHODS: We enhanced the usual reminder by including a heading 'A reminder to you' and a short paragraph restating the offer of screening in simple language. We undertook a cluster-randomised trial of all 168 480 individuals who were due to receive a reminder over 20 days in 2013. Randomisation was based on the day of invitation. Blinding of individuals was not possible, but the possibility of bias was minimal owing to the lack of direct contact with participants. The enhanced reminder was sent to 78 067 individuals and 90 413 received the usual reminder. The primary outcome was the proportion of people adequately screened and its variation by quintile of Index of Multiple Deprivation. Data were analysed by logistic regression with conservative variance estimates to take account of cluster randomisation. RESULTS: There was a small but statistically significant (P=0.001) increase in participation with the enhanced reminder (25.8% vs 25.1%). There was significant (P=0.005) heterogeneity of the effect by socioeconomic status with an 11% increase in the odds of participation in the most deprived quintile (from 13.3 to 14.1%) and no increase in the least deprived. We estimated that implementing the enhanced reminder nationally could result in up to 80 more people with high or intermediate risk colorectal adenomas and up to 30 more cancers detected each year if it were implemented nationally. The intervention incurred a small one-off cost of £78 000 to modify the reminder letter. CONCLUSIONS: The enhanced reminder increases overall uptake and reduces the socioeconomic gradient in bowel cancer screening participation at little additional cost.

Reducing the Social Gradient in Uptake of the NHS Colorectal Cancer Screening Programme Using a Narrative-Based Information Leaflet: A Cluster-Randomised Trial.

Objective. To test the effectiveness of adding a narrative leaflet to the current information material delivered by the NHS English colorectal cancer (CRC) screening programme on reducing socioeconomic inequalities in uptake. Participants. 150,417 adults (59-74 years) routinely invited to complete the guaiac Faecal Occult Blood test (gFOBt) in March 2013. Design. A cluster randomised controlled trial (ISRCTN74121020) to compare uptake between two arms. The control arm received the standard NHS CRC screening information material (SI) and the intervention arm received the standard information plus a supplementary narrative leaflet, which had previously been shown to increase screening intentions (SI + N). Between group comparisons were made for uptake overall and across socioeconomic status (SES). Results. Uptake was 57.7% and did not differ significantly between the two trial arms (SI: 58.5%; SI + N: 56.7%; odds ratio = 0.93; 95% confidence interval: 0.81-1.06; p = 0.27). There was no interaction between group and SES quintile (p = 0.44). Conclusions. Adding a narrative leaflet to existing information materials does not reduce the SES gradient in uptake. Despite the benefits of using a pragmatic trial design, the need to add to, rather than replace, existing information may have limited the true value of an evidence-based intervention on behaviour.

Use of a 12 months' self-referral reminder to facilitate uptake of bowel scope (flexible sigmoidoscopy) screening in previous non-responders: a London-based feasibility study.

BACKGROUND: In March 2013, NHS England extended its national Bowel Cancer Screening Programme to include 'one-off' Flexible Sigmoidoscopy screening (NHS Bowel Scope Screening, BSS) for men and women aged 55. With less than one in two people currently taking up the screening test offer, there is a strong public health mandate to develop system-friendly interventions to increase uptake while the programme is rolling out. This study aimed to assess the feasibility of sending a reminder to previous BSS non-responders, 12 months after the initial invitation, with consideration for its potential impact on uptake. METHOD: This study was conducted in the ethnically diverse London Boroughs of Brent and Harrow, where uptake is below the national average. Between September and November 2014, 160 previous non-responders were randomly selected to receive a reminder of the opportunity to self-refer 12 months after their initial invitation. The reminder included instructions on how to book an appointment, and provided options for the time and day of the appointment and the gender of the endoscopist performing the test. To address barriers to screening, the reminder was sent with a brief locally tailored information leaflet designed specifically for this study. Participants not responding within 4 weeks were sent a follow-up reminder, after which there was no further intervention. Self-referral rates were measured 8 weeks after the delivery of the follow-up reminder and accepted as final. RESULTS: Of the 155 participants who received the 12 months' reminder (returned to sender, n=5), 30 (19.4%) self-referred for an appointment, of which 24 (15.5%) attended and were successfully screened. Attendance rates differed by gender, with significantly more women attending an appointment than men (20.7% vs 8.8%, respectively; OR=2.73, 95% CI=1.02-7.35, P=0.05), but not by area (Brent vs Harrow) or area-level deprivation. Of the 30 people who self-referred for an appointment, 27 (90%) indicated a preference for a same-sex practitioner, whereas three (10%) gave no preference. Preference for a same-sex practitioner was higher among women than men (χ(2)=7.78, P<0.05), with only 67% of men (six of nine) requesting a same-sex practitioner, compared with 100% of women (n=21). CONCLUSIONS: Sending previous non-responders a 12 months' reminder letter with a brief information leaflet is a feasible and efficacious intervention, which merits further investigation in a randomised controlled trial.