Socioeconomic differences in expected discomfort from colonoscopy and colon capsule endoscopy.

Individual income and educational level are associated with participation rates in colorectal cancer screening. We aimed to investigate the expected discomfort from the endoscopic diagnostic modalities of colonoscopy and colon capsule endoscopy in different socioeconomic groups as a potential barrier for participation. In a randomized clinical trial within the Danish colorectal cancer screening program, we distributed questionnaires to 2031 individuals between August 2020 and December 2022 to investigate the expected procedural and overall discomfort from investigations using visual analogue scales. Socioeconomic status was determined by household income and educational level. Multivariate continuous ordinal regressions were performed to estimate the odds of higher expected discomfort. The expected procedural and overall discomfort from both modalities were significantly higher with increasing educational levels and income, except for procedural discomfort from colon capsule endoscopy between income quartiles. The odds ratios for higher expected discomfort increased significantly with increasing educational level, whereas the differences between income groups were less substantial. Bowel preparation contributed most to expected discomfort in colon capsule endoscopy, whereas in colonoscopy, the procedure itself was the largest contributor. Individuals with prior experiences of colonoscopy reported significantly lower expected overall but not procedural discomfort from colonoscopy. The threshold for acceptable discomfort between subgroups is unknown, but the expected discomfort in colon capsule endoscopy and colonoscopy was higher in higher socioeconomic subgroups, suggesting that expected discomfort is not a significant contributor to the inequalities in screening uptake.

Socioeconomic inequalities in interval colorectal cancer are explained by differences in faecal haemoglobin concentration and age: a register-based cohort study.

OBJECTIVE: To estimate the risk of interval colorectal cancer (CRC) in faecal immunochemical test (FIT) negative screening participants according to socioeconomic status. DESIGN: In this register-based study, first round FIT negative (<20 µg hb/g faeces) screening participants (biennial FIT, citizens aged 50-74) were followed to estimate interval CRC risk. Multivariate Cox proportional hazard regression models estimated HRs based on socioeconomic status defined by educational level and income. Models were adjusted for age, sex and FIT concentration. RESULTS: We identified 829 (0.7‰) interval CRC in 1 160 902 individuals. Interval CRC was more common in lower socioeconomic strata with 0.7‰ for medium-long higher education compared with 1.0‰ for elementary school and 0.4‰ in the highest income quartile compared with 1.2‰ in the lowest. These differences did not translate into significant differences in HR in the multivariate analysis, as they were explained by FIT concentration and age. HR for interval CRC was 7.09 (95% CI) for FIT concentrations 11.9-19.8 µg hb/g faeces, and 3.37 (95% CI) for FIT between 7.2 and 11.8 compared with those <7.2. The HR rose with increasing age ranging from 2.06 (95% CI 1.45 to 2.93) to 7.60 (95% CI 5.63 to 10.25) compared with those under 55 years. CONCLUSION: Interval CRC risk increased with decreasing income, heavily influenced by lower income individuals more often being older and having increased FIT concentrations. Individualising screening interval based on age and FIT result, may decrease interval CRC rates, reduce the social gradient and thereby increase the screening efficiency.

The Effect of Prucalopride on the Completion Rate and Polyp Detection Rate of Colon Capsule Endoscopies.

Purpose: To investigate whether the prokinetic prucalopride increases the completion rate of colon capsule endoscopy (CCE). Secondary outcomes included demographic distribution, polyp detection rate (PDR), distribution of Leighton-Rex grade, and adverse events. Patients and Methods: In a nested cohort within the CareForColon2015 trial, a subgroup of 406 individuals underwent CCE in 2021. The first half (control) received the standard bowel preparation and the second half (prucalopride) was supplemented with 2 mg of prucalopride. Transit times and bowel preparations were analyzed and completion rates calculated as those having timely transit and acceptable bowel cleanliness. Major adverse events were recorded continuously and minor adverse events were quantified from questionnaires. Results: The group demographics were homogenous. The prevalence ratio for complete CCE was 1.32 (CI 95% 1.15; 1.53) in the prucalopride group compared to the control group. Completion rate was 74.9% in the prucalopride group and 56.7% in the control group. The proportions of acceptable bowel preparation and complete transits were higher in the prucalopride group. The mean CCE transit time was 2 hours and 8 minutes faster in the prucalopride group. The PDR was higher in the intervention group with 55.7% compared to 36.0% in the control group for polyps greater than 9 mm, whereas the groups' PDRs were similar for small and diminutive polyps. In all, 589 polyps (mean 2.9) were found in the prucalopride group compared to 522 polyps (mean 2.6) in the control group. Conclusion: Prucalopride led to an increase in CCE completion rates. The proportions of complete transits and acceptable bowel preparations were higher in the prucalopride group. The PDR was higher in the prucalopride group compared to the control group. No major adverse events were identified. Nausea, diarrhea, headache and fatigue were more commonly reported in the prucalopride group.

Colon capsule endoscopy in colorectal cancer screening: Interim analyses of randomized controlled trial CareForColon2015.

Background and study aims The Danish CareForColon2015 trial, launched in 2020 as part of the Danish Colorectal Cancer Screening program, is the largest randomized controlled trial to date on colon capsule endoscopy (CCE). This paper presents the interim analysis with the objective of ensuring the safety of patients in the intervention group and evaluating the clinical performance of the trial's predefined clinical parameters. Patients and methods We evaluated the initial 234 CCEs according to quality, safety, and completion. The participation rates and preference distribution of all individuals invited were analyzed and sample size calculations were adjusted. Results Fecal immunochemical test and diagnostic participation rates were 62.1 % and 91.1 %, respectively. The completion rate for CCEs was 67.9 % and the rate of conclusive investigations was 80.3 %. The polyp detection rate (PDR) was high (73.5 %), only two (0.85 %) technical failures in 234 videos were observed, and six suspected cancers were identified (2.6 %). No major adverse events were recorded. The required number of invitations had been underestimated due to inaccurate assumptions in sample size calculations. Conclusions The trial was efficient and safe in terms of CCE quality and time to diagnostic investigation. Participation rates and PDRs were high. The proportion of suspected cancers was lower than expected and will be followed. The completion rate for CCEs was acceptable but lower than expected and the CCE procedure was reviewed for potential improvements and Resolor was added to the regime. The number of invitations for the intervention group of the trial has been adjusted from 62,107 to 185,153.

Colon capsule endoscopy in colorectal cancer screening: a randomised controlled trial.

INTRODUCTION: The use of capsule endoscopy has become an approved method in small bowel diagnostics, but the same level of integration is not seen in large bowel diagnostics. We will use colon capsule endoscopy (CCE) as a filter test in colorectal cancer (CRC) screening between the faecal immunochemical test (FIT) and colonoscopy. We aim to investigate the clinical performance, population acceptability, and economic implications of the procedure in a large-scale clinical trial. METHODS AND ANALYSIS: We will randomly allocate 124 214 Danish citizens eligible for participation in the national CRC screening programme within the Region of Southern Denmark to either an intervention group or a control group. Prior to submitting a FIT, citizens randomised to the intervention group will be informed about their opportunity to undergo CCE, instead of colonoscopy, if the FIT is positive. Suspected cancers; >3 adenomas <10 mm in size, 1 adenoma >10 mm in size or >4 adenomas regardless of size, detected during CCE will generate an invitation to colonoscopy as per regular screening guidelines, whereas citizens with suspected low risk polyps will re-enter the biennial screening programme. Citizens with no CCE findings will be excluded from screening for 8 years. In the control group, citizens will follow standard screening procedures. ETHICS AND DISSEMINATION: All participants must consent prior to capsule ingestion. All collected data will be handled and stored in accordance with current data protection legislation. Approvals from the regional ethics committee (ref. S-20190100) and the Danish data protection agency have been obtained (ref. 19/29858). TRIAL REGISTRATION DETAILS: The study has been registered with ClinicalTrials.gov under: NCT04049357.

Screening individuals' experiences of colonoscopy and colon capsule endoscopy; a mixed methods study.

BACKGROUND: The standard investigation in colorectal cancer screening (optical colonoscopy [OC]) has a less invasive alternative with the colon capsule endoscopy (CCE). The experiences of screening individuals are needed to support a decision aid (DA) and to provide a patient view in future health technology assessments (HTA). We aimed to explore the experiences of CCE at home and OC in an outpatient clinic by screening participants who experienced both investigations on the same bowel preparation. METHODS: In a mixed methods study, Danish screening individuals with a positive immunological fecal occult blood test (FIT) were consecutively included and underwent both CCE and OC in the same bowel preparation. They answered questionnaires about discomfort during CCE, delivered at home, and during a following OC in the outpatient clinic. Data were calculated in percentages and Wilcoxon signed rank test was used for comparisons. Among the 253 included patients, 10 participants were selected for a semi-structured interview about their experiences of the two examinations. The analysis and interpretation of the transcribed data were inspired by Ricoeur. RESULTS: Questionnaire data were received from 239 participants and revealed significant less discomfort during the CCE than the OC. Interview data included explained discomfort elements in two categories: 'The examination' and 'The setting'. Compared to OC, the CCE was experienced with less pain, embarrassment and invasiveness, but presented challenges and disadvantages as well, i.e., a large camera capsule to swallow, a longer waiting time for test results after CCE and an additional OC, if pathologies were found. The home setting for CCE delivery made the participants feel less like they were ill or patients less restricted and that they received more personal care, but could induce technical challenges. CONCLUSION: In screening individuals, CCE at home was associated with significantly less discomfort compared to OC at a hospital, and multiple reasons for this was identified.

Early breastfeeding problems: A mixed method study of mothers' experiences.

OBJECTIVES: Breastfeeding problems are common and associated with early cessation. Still length of postpartum hospital stay has been reduced. This leaves new mothers to establish breastfeeding at home with less support from health care professionals. The objective was to explore mothers' perspectives on when breastfeeding problems were the most challenging and prominent early postnatal. The aim was also to identify possible factors associated with the breastfeeding problems. METHODS: In a cross-sectional study, a mixed method approach was used to analyse postal survey data from 1437 mothers with full term singleton infants. Content analysis was used to analyse mothers' open text descriptions of their most challenging breastfeeding problem. Multiple logistic regression was used to calculate odds ratios for early breastfeeding problems according to sociodemographic- and psychosocial factors. RESULTS: Up to 40% of the mothers had experienced early breastfeeding problems. The problems were associated with the mother, the infant and to lack of support from health care professionals. Most prominent problems were infant's inability to latch on (40%) and mothers having sore, wounded and cracked nipples (38%). Pain often occurred when experiencing breastfeeding problems. Factors associated with the problems were primiparity, lower self-efficacy and lower self-perceived knowledge of breastfeeding. Mothers with no or short education reported less frequently breastfeeding problems. CONCLUSIONS: Breastfeeding problems occurred frequently in the early postnatal period and often caused breastfeeding to be painful. Health care professionals should prepare mothers to deal with possible breastfeeding problems. New support options should be reviewed in an early postnatal discharge setting.

Factors affecting patients' ratings of health-care satisfaction.

INTRODUCTION: Surveys that include rating scales are commonly used to collect data about patients' experiences. We studied how patients associated their ratings with their experiences of care. METHODS: A survey and a qualitative study were conducted at a Danish hospital. Initially, 19 female patients completed a questionnaire using the response categories from very good to very bad; and subsequently they participated in a semi-structured interview held within two days after they completed the questionnaire. Additionally, 44 female patients participated in an interview within six weeks of completing a questionnaire. A phenomenological-hermeneutical approach was used in the analysis and interpretation. RESULTS: Two major themes emerged: experienced versus expected clinical quality and health-care professional attitude. Patients responded to each question by combining their experiences of both themes, e.g. a "very good" experience required that clinical service was provided at the expected level, at the very least, and that it was provided with recognition and respect. CONCLUSIONS: The female patients associated their experiences with their ratings, and two types of relation seemed to be at play: a care relation and a human relation. This finding can inform health-care practice, but department-specific examples may be needed to initiate improvements. FUNDING: The study received funding from the Centre for Patient Experience and Evaluation, Copenhagen, Denmark. The Danish Scientific Ethical Committees deemed it unnecessary to be involved in this project. TRIAL REGISTRATION: The Danish Data Protection Agency number of this study is 2008-58-0035.

The self-efficacy in patient-centeredness questionnaire - a new measure of medical student and physician confidence in exhibiting patient-centered behaviors.

BACKGROUND: Patient-centered communication is a core competency in modern health care and associated with higher levels of patient satisfaction, improved patient health outcomes, and lower levels of burnout among physicians. The objective of the present study was to develop a questionnaire assessing medical student and physician self-efficacy in patient-centeredness (SEPCQ) and explore its psychometric properties. METHODS: A preliminary 88-item questionnaire (SEPCQ-88) was developed based on a review of the literature and medical student portfolios and completed by 448 medical students from Aarhus University. Exploratory Principal Component analysis resulted in a 27-item version (SEPCQ-27) with three underlying self-efficacy factors: 1) Exploring the patient perspective, 2) Sharing information and power, and 3) Dealing with communicative challenges. The SEPCQ-27 was completed by an independent sample of 291 medical students from 2 medical schools and 101 hospital physicians. RESULTS: Internal consistencies of total and subscales were acceptable for both students and physicians (Cronbach's alpha (range): 0.74-0.95). There were no overall indications of gender-related differential item function (DIF), and a Confirmatory Factor Analysis (CFA) indicated good fit (CFI = 0.98; NNFI = 0.98; RMSEA = 0.05; SRMR = 0.07). Responsiveness was indicated by increases in SEPCQ scores after a course in communication and peer-supervision (Cohen's d (range): 0.21 to 0.73; p: 0.053 to 0.001). Furthermore, positive associations were found between increases in SEPCQ-scores and course-related motivation to learn (medical students) and between SEPCQ scores and years of clinical experience (physicians). CONCLUSIONS: The final SEPCQ-27 showed satisfactory psychometric properties, and preliminary support was found for its construct validity, indicating that the SEPCQ-27 may be a valuable measure in future patient centered communication training and research.

Video-, Audio-, and Computer-Mediated Education of Patients and Relatives in Gynecologic Cancer Care: A Systematic Review.

BACKGROUND: Cancer patients can often experience emotional distress, and gynecologic cancer patients may be among the most distressed. As hospital stays become shorter, nurses are challenged to educate patients and relatives adequately. The use of computer-based technologies may alleviate the situation. OBJECTIVE: This article aims to review the literature related to the use of audio-, visual-, or computer-based technologies to support healthcare professional training of adult female patients and their close relatives in gynecologic cancer care. We describe to what extent these technologies were found to be effective and evaluate clinical implications. METHODS: PubMed, EMBASE and PsycINFO via Ovid, CINAHL via EBSCO, and the Cochrane Library were searched, and 4177 unique references were examined. All studies evaluating healthcare professional training of women with gynecologic cancer and/or their relatives via audio-, visual-, or computer-based technologies were included. RESULTS: We found scarce and conflicting evidence of benefits to gynecologic patients of healthcare professional use of video- or computer-based patient education. These interventions might be best suited to the highest educated with coping skills beyond the average. No studies were found to include relatives or found to test audio-based patient education. CONCLUSION: More rigorously produced and reported studies of healthcare professional training initiatives for gynecologic cancer patients and their relatives are recommended. Measures used to capture the perceived benefits to patients might be reconsidered. IMPLICATION FOR PRACTICE: Precautions should be taken before recommending technologies that are unevaluated in own context. Attention must be on both what is provided when and to whom.

Gynecological cancer patients' differentiated use of help from a nurse navigator: a qualitative study.

BACKGROUND: Fragmentation in healthcare can present challenges for patients with suspected cancer. It can add to existing anxiety, fear, despair and confusion during disease trajectory. In some circumstances patients are offered help from an extra contact person, a Nurse Navigator (NN). Scientific studies showing who will benefit from the extra help offered are missing. This study aims to explore who could benefit from the help on offer from a nurse appointed as NN in the early part of a cancer trajectory, and what would be meaningful experiences in this context. METHODS: A longitudinal study with a basis in phenomenology and hermeneutics was performed among Danish women with gynecological cancer. Semi-structured interviews provided data for the analysis, and comprehensive understanding was arrived at by first adopting an open-minded approach to the transcripts and by working at three analytical levels. RESULTS: Prior experience of trust, guarded trust or distrust of physicians in advance of encountering the NN was of importance in determining whether or not to accept help from the NN. For those lacking trust in physicians and without a close relationship to a healthcare professional, the NN offered a new trusting relationship and they felt reassured by her help. CONCLUSIONS: Not everyone could use the help offered by the NN. This knowledge is vital both to healthcare practitioners and to administrators, who want to do their best for cancer patients but who are obliged to consider financial consequences. Moreover patients' guarded trust or distrust in physicians established prior to meeting the NN showed possible importance for choosing extra help from the NN. These findings suggest increased focus on patients' trust in healthcare professionals. How to find the most reliable method to identify those who can use the help is still a question for further debate and research.

Benefits and challenges perceived by patients with cancer when offered a nurse navigator.

INTRODUCTION: Lack of communication, care and respect from healthcare professionals can be challenges for patients in trajectories of cancer, possibly accompanied by experienced fragmentation of the care, anxiety and worries. One way to try to improve delivery of care is additional help from nurse navigators (NN) offered in a predefined shorter or longer period, but patients' experiences with this have seldom been investigated. AIMS: To explore experiences of nurse navigation offered in a short period of a longer subsequent part of cancer trajectories by patients who can use the help on offer. METHODS: The NNs worked from one hospital department with patients in the transition between primary care and a university hospital before admission. A phenomenological-hermeneutical longitudinal study was performed from referral and until two months after discharge from the hospital. Semi-structured interviews with five patients who could use the help from an NN provided data for the analysis, which started open-minded. RESULTS: Affectional bonds were made to the NN and patients felt that they benefited from her presence and her help, which they requested until one month after discharge. They were disappointed and felt rejected when the contact to the NN stopped. CONCLUSION: In efforts to increase quality of care for patients with cancer we recommend an increased awareness of cultural areas within the healthcare system, which may be an impediment to good communication. Moreover, we recommend paying special attention to critical periods in cancer patients' trajectories, as well as to the theory of attachment to supplement thoughts of continuity of care and coordination in the care for women. In short, it is fine to offer additional help to those who can use it, but in practice as well as in research we recommend awareness of how and when to stop the help, to prevent patients from feeling hurt.

Case management used to optimize cancer care pathways: a systematic review.

BACKGROUND: Reports of inadequate cancer patient care have given rise to various interventions to support cancer care pathways which, overall, seem poorly studied. Case management (CM) is one method that may support a cost-effective, high-quality patient-centred treatment and care.The purpose of this article was to summarise intervention characteristics, outcomes of interest, results, and validity components of the published randomized controlled trials (RCTs) examining CM as a method for optimizing cancer care pathways. METHODS: PubMed, Embase, Web of Science, CINAHL and The Cochrane Central Register of Controlled Trials were systematically searched for RCTs published all years up to August 2008. Identified papers were included if they passed the following standards. INCLUSION CRITERIA: 1) The intervention should meet the criteria for CM which includes multidisciplinary collaboration, care co-ordination, and it should include in-person meetings between patient and the case manager aimed at supporting, informing and educating the patient. 2) The intervention should focus on cancer patient care. 3) The intervention should aim to improve subjective or objective quality outcomes, and effects should be reported in the paper. EXCLUSION CRITERIA: Studies centred on cancer screening or palliative cancer care.Data extraction was conducted in order to obtain a descriptive overview of intervention characteristics, outcomes of interest and findings. Elements of CONSORT guidelines and checklists were used to assess aspects of study validity. RESULTS: The searches identified 654 unique papers, of which 25 were retrieved for scrutiny. Seven papers were finally included. Intervention characteristics, outcomes studied, findings and methodological aspects were all very diverse. CONCLUSION: Due to the scarcity of papers included (seven), significant heterogeneity in target group, intervention setting, outcomes measured and methodologies applied, no conclusions can be drawn about the effect of CM on cancer patient care.It is a major challenge that CM shrouds in a "black box", which means that it is difficult to determine which aspect(s) of interventions contribute to overall effects. More trials on rigorously developed CM interventions (opening up the "black box") are needed as is the re-testing of interventions and outcomes studied in various settings.

[Development of an Internet search strategy to identify new medical technologies in prostate cancer]. / Udvikling af en internetsøgestrategi til identifikation af ny medicinsk teknologi inden for prostatacancer.

INTRODUCTION: Technological change is rapid in medicine. The Internet is becoming more and more important as a source of keeping abreast of technological change, but tools to aid clinicians in finding relevant information on the Internet are lacking. The objective of this project was to develop an Internet search strategy to identify new technologies for the treatment of localised prostate cancer. MATERIALS AND METHODS: Web sites were found by means of a literature search and by searching specific Internet sources. Inclusion and exclusion criteria were developed based on literature and applied to a variety of potentially relevant sites. An initial strategy was developed, technologies identified, and the novelty and relevance were assessed by urologists in the team. This information was used to adjust the strategy. 6 general urologists assessed the efficiency of the strategy. Their input was used to define a final listing of sites. RESULTS: The strategy consists of 10 sites which should be visited in the following order: YahooHealth, DoctorsGuide, The National Electronic Library for Medicines, CancerPage, Medscape, MedlinePlus, HealthAndAge, CancerConsultants, EurekAlert, Oncolink. Links to the exact sites are provided at www.ugeskriftet.dk. CONCLUSION: This study resulted in an Internet search strategy to identify new medical technologies for a well-defined indication. The methods used may be useful in order to develop similar strategies in other clinical areas in urology or other specialties.