Intended and Actual Participation in the Colorectal Cancer Screening Program­a Prospective Cohort Study With AOK Insurees.

BACKGROUND: The public generally has a positive view of colorectal cancer screening, but there is still room for improvement in participation rates. The aim of this study was to identify factors that are associated with intended and actual participation. METHODS: We conducted a prospective cohort study of a random sample of insurees of the AOK (a statutory health insurance carrier) in the German federal state of Lower Saxony. 50-year-old men and 55-year-old women who were eligible for their first screening colonoscopy received a written questionnaire in June 2020, three weeks after being invited to undergo colorectal cancer screening. For those who intended to do so, we used multivariable logistic regression analysis to determine any statistical associations between sociodemographic and medical characteristics and participation rates within 30 months. RESULTS: 82.7% of the respondents (239/298) intended to participate, and 43.3% (129/298) actually did so within 30 months. The participation rates among persons who had already decided to have a stool test or a colonoscopy were 50.7% (36/71) and 55.2% (58/105), respectively; the participation rate among undecided persons was 33.3% (19/57). The strongest association in the regression model was with an already made appointment (OR = 11.1, 95% confidence interval: [3.9; 31.8]). After exclusion of the existing-appointment variable from the regression model, living in a smaller town (OR = 2.41 [1.08; 5.35]) and a stated preference for colonoscopy (OR = 2.52; [1.20; 5.27]) were positively associated with participation. Insurees with a parent affected by colorectal cancer rarely participated, even after adjustment for prior colonoscopies (OR = 0.31 [0.12; 0.80]). CONCLUSION: The wide gap between intended and actual participation implies that there is potential for improvement in the prevention of colorectal cancer, and that certain groups of people could benefit from targeted support in making their intention to undergo screening a reality. Because of the methodological limitations of this initial investigation, its findings need to be confirmed by further studies.

Is there a place for sigmoidoscopy in colorectal cancer screening? A systematic review and critical appraisal of cost-effectiveness models.

INTRODUCTION: Screening for colorectal cancer (CRC) is effective in reducing both incidence and mortality. Colonoscopy and stool tests are most frequently used for this purpose. Sigmoidoscopy is an alternative screening measure with a strong evidence base. Due to its distinct characteristics, it might be preferred by subgroups. The aim of this systematic review is to analyze the cost-effectiveness of sigmoidoscopy for CRC screening compared to other screening methods and to identify influencing parameters. METHODS: A systematic literature search for the time frame 01/2010-01/2023 was conducted using the databases MEDLINE, Embase, EconLit, Web of Science, NHS EED, as well as the Cost-Effectiveness Registry. Full economic analyses examining sigmoidoscopy as a screening measure for the general population at average risk for CRC were included. Incremental cost-effectiveness ratios were calculated. All included studies were critically assessed based on a questionnaire for modelling studies. RESULTS: Twenty-five studies are included in the review. Compared to no screening, sigmoidoscopy is a cost-effective screening strategy for CRC. When modelled as a single measure strategy, sigmoidoscopy is mostly dominated by colonoscopy or modern stool tests. When combined with annual stool testing, sigmoidoscopy in 5-year intervals is more effective and less costly than the respective strategies alone. The results of the studies are influenced by varying assumptions on adherence, costs, and test characteristics. CONCLUSION: The combination of sigmoidoscopy and stool testing represents a cost-effective screening strategy that has not received much attention in current guidelines. Further research is needed that goes beyond a narrow focus on screening technology and models different, preference-based participation behavior in subgroups.

Heterogeneous Preferences for Colorectal Cancer Screening in Germany: Results of a Discrete Choice Experiment.

OBJECTIVES: Colorectal cancer (CRC) screening tests differ in benefits, harms, and processes, making individual informed decisions preference based. The objective was to analyze the preferences of insurees in Germany for characteristics of CRC screening modalities. METHODS: A generic discrete choice experiment with 2-alternative choice sets and 6 attributes (CRC mortality, CRC incidence, complications, preparation, need for transportation, and follow-up; 3 levels each) depicting characteristics of fecal testing, sigmoidoscopy, and colonoscopy was generated. Participants completed 8 choice tasks. Internal validity was tested using a within-set dominated pair. Between June and October 2020, written questionnaires were sent to a stratified random sample (n = 5000) of 50-, 55-, and 60-year-old insurees of the AOK (Allgemeine Ortskrankenkasse) Lower Saxony, who had previously received an invitation to participate in the organized screening program including evidence-based information. Preferences were analyzed using conditional logit, mixed logit, and latent-class model. RESULTS: From 1282 questionnaires received (26% [1282 of 4945]), 1142 were included in the analysis. Approximately 42% of the respondents chose the dominated alternative in the internal validity test. Three heterogeneous preference classes were identified. Most important attributes were preparation (class 1; n = 505, 44%), CRC mortality (class 2; n = 347, 30%), and CRC incidence (class 3; n = 290, 25%). Contrary to a priori expectations, a higher effort was preferred for bowel cleansing (class 1) and accompaniment home (classes 1 and 2). CONCLUSION: Internal validity issues of choice data need further research and warrant attention in future discrete choice experiment surveys. The observed preference heterogeneity suggests different informational needs, although the underlying reasons remained unclear.

Attributes in stated preference elicitation studies on colorectal cancer screening and their relative importance for decision-making among screenees: a systematic review.

INTRODUCTION: The SIGMO study (Sigmoidoscopy as an evidence-based colorectal cancer screening test - a possible option?) examines screening eligible populations' preferences for colorectal cancer (CRC) screening in Germany using a discrete choice experiment (DCE). Attribute identification and selection are essential for the construction of choice tasks and should be evidence-based. As a part of the SIGMO study this systematic review provides an overview of attributes included in studies eliciting stated preferences for CRC screening tests and their relative importance for decision-making. METHODS: Systematic search (November 2021) for English-language studies published since January 2000 in PubMed, Embase, Web of Science, Biomedical Reference Collection: Corporate Edition, LIVIVO and PsycINFO. DCEs and conjoint analysis ranking or rating tasks on screening eligible populations' preferences for stool testing, sigmoidoscopy, and/or colonoscopy were included. Attributes were extracted and their relative importance was calculated and ranked. Risk of bias (RoB) of included studies was assessed using a modified GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Study selection and RoB rating were carried out independently by two reviewers. Data were extracted by one reviewer and checked by another one. RESULTS: A total of 23 publications on 22 studies were included. Overall RoB was rated as serious/critical for 21 studies and as moderate for 2 studies. Main reasons for high RoB were non-random sampling, low response rates, lack of non-responder analyses, and, to a lesser extent, weaknesses in the measurement instrument and data analysis. Extracted attributes (n = 120) referred to procedure-related characteristics (n = 42; 35%), structural characteristics of health care (n = 24; 20%), test characteristics (n = 23; 19%), harms (n = 16; 13%), benefits (n = 13; 11%), and level of evidence (n = 2; 2%). Most important attributes were reduction in CRC mortality (and incidence) (n = 7), test sensitivity (n = 7), out-of-pocket costs (n = 4), procedure (n = 3), and frequency (n = 2). CONCLUSIONS: Health preference studies on CRC were found to have a high RoB. The composition of choice tasks revealed a lack of attributes on patient-important outcomes (like incidence reduction), while attributes not considered relevant for individual screening decisions (like sensitivity) were frequently used. Future studies eliciting stated preferences in cancer screening should apply the principles of informed decision-making in attribute identification and selection.

Attributes Characterizing Colorectal Cancer Screening Tests That Influence Preferences of Individuals Eligible for Screening in Germany: A Qualitative Study.

Purpose: This qualitative study is part of the SIGMO study, which evaluates general populations' preferences for colorectal cancer (CRC) screening in Germany using a discrete choice experiment. Attribute identification and selection are essential in the construction of choice tasks and should be evidence-based ensuring that attributes are relevant to potential beneficiaries and contribute to overall utility. Therefore, this qualitative study aims to identify relevant attributes characterizing CRC screening tests from the perspective of those eligible for screening in Germany. Patients and Methods: Individuals aged 50 to 60 were purposively selected. A questioning route was developed and piloted. Four focus groups (FG) (n=20) were conducted (November 2019) with two moderators and one observer each. FGs were audio recorded, transcribed, and analyzed using qualitative content analysis. Attributes were deductively assigned based on a priori identified attribute categories, and inductively derived. Results: Across FGs, 24 attributes (n=293 codes) were discussed, five of which (sedation, inability to work, transportation home, predictive values, waiting time for screening colonoscopy) were inductively derived (n=76 codes). Four attributes identified a priori were not addressed in any FG. The most frequently discussed attribute category was procedural characteristics, followed by measures of screening test validity, benefits, harms, and structural characteristics of health care. The most commonly addressed attributes were preprocedural bowel cleansing, kind of procedure, and predictive values. Conclusion: Newly identified attributes characterizing CRC screening tests from an individual's perspective, and a priori identified attributes not addressed by any FG stress the added value of qualitative research and thereby the importance of applying a mix of methods in identifying and selecting attributes for the construction of choice tasks. This study meets the requirements for a transparent and detailed presentation of the qualitative methods used in this process, which has rarely been the case before.

Additional offer of sigmoidoscopy in colorectal cancer screening in Germany: rationale and protocol of the decision-analytic modelling approach in the SIGMO study.

INTRODUCTION: In Germany, statutory insured persons are entitled to a stool test (faecal immunochemical test (FIT)) or colonoscopy for colorectal cancer (CRC) screening, depending on age and sex, yet participation rates are rather low. Sigmoidoscopy is a currently not available screening measure that has a strong evidence base for incidence and mortality reduction. Due to its distinct characteristics, it might be preferred by some, who now reject colonoscopy. The objective of this study is to estimate the economic consequences of the additional offer of sigmoidoscopy for CRC screening in Germany compared with the present screening practice while considering the preferences of the general population. METHODS AND ANALYSIS: A decision-analytic modelling approach will be developed that compares the present CRC screening programme in Germany (FIT, colonoscopy) with a programme extended by sigmoidoscopy from a societal perspective. A decision tree and Markov model will be combined to assess both short-term and long-term effects, such as CRC and adenoma detection rates, the number of CRC cases, CRC mortality as well as complications. The incremental cost per quality-adjusted life year gained for each alternative will be calculated. The model will incorporate the general population's preferences based on a discrete choice experiment. Further, input parameters will be taken from the literature, the German cancer registry and health insurance claims data. ETHICS AND DISSEMINATION: Ethical approval for the study was obtained from the Ethics Committee of Hannover Medical School (ID: 8671_BO_K_2019). The findings of the study will be published in peer-reviewed journals and presented at national and/or international conferences. TRIAL REGISTRATION NUMBER: DRKS00019010.

General populations' preferences for colorectal cancer screening: rationale and protocol for the discrete choice experiment in the SIGMO study.

INTRODUCTION: In Germany, the organised colorectal cancer (CRC) screening programme includes the immunologic faecal occult blood test and colonoscopy. The sigmoidoscopy is recommended for individuals rejecting colonoscopy but is not included into the screening programme. To examine whether the evidence based sigmoidoscopy should be additionally offered, the first objective of this study is to evaluate the demand for sigmoidoscopy by analysing the German general populations' preferences for CRC screening. METHODS AND ANALYSIS: Preference data will be collected using a discrete choice experiment (DCE). Identification and selection of the attributes and their levels will be supported by evidence resulting from a systematic literature search and focus groups. An efficient, fractional factorial choice design will be generated. In a cross-sectional study, the DCE will be administered as a written questionnaire to a random sample of 4000 members of the statutory health insurance company in Lower Saxony (AOK Lower Saxony). Insured persons 50-60 years of age without CRC or a chronic inflammatory bowel disease will be eligible. The collected choice data will be analysed by conducting a conditional logit regression model and latent class models. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the Ethics Committee of Hannover Medical School (reference number 8671_BO_K_2019). The study results will be disseminated via conference presentations, publications in peer-reviewed journals and, to participants, the membership magazine of the AOK Lower Saxony. TRIAL REGISTRATION NUMBER: DRKS00019010.

Physicians' view on sigmoidoscopy as an additionally offered method for colorectal cancer screening.

BACKGROUND: In Germany, colorectal cancer (CRC) screening includes a fecal blood test or colonoscopy, but not a sigmoidoscopy, which has been shown to reduce CRC incidences and mortality. Our aim was to compile physicians' experiences with sigmoidoscopy and their assessments of this procedure being an additional, possible screening method for early CRC detection. METHODS: At the end of 2015, gastroenterologists and internists in Lower Saxony and North Rhine-Westphalia who regularly perform screening colonoscopies in outpatient care were contacted per mail. Standardized telephone interviews consisting of 17 questions and lasting 10-15 minutes were conducted. RESULTS: Nearly two-thirds (56/87) of the respondents reject sigmoidoscopy as an acceptable early detection method. Compared to colonoscopy, key features of the sigmoidoscopy include more favorable patient-related aspects, while procedural aspects, except sedation, clearly rate in favor of the colonoscopy. In the instance that colonoscopy is rejected, 75 % of the physicians consider a sigmoidoscopy to be a possible alternative. CONCLUSIONS: The survey provides important practical insights into outpatient sigmoidoscopy. A majority of the physicians does not support evidence-based sigmoidoscopy for CRC screening. However, individuals who reject a colonoscopy are, in line with the current guideline, identified as a target group for a screening sigmoidoscopy. The benefit from an additionally offered sigmoidoscopy in CRC screening should be further analyzed with special consideration given to the preferences of insurees within the German healthcare system.

Systematic evaluation of written health information on PSA based screening in Germany.

BACKGROUND: Prostate-specific antigen (PSA) based screening for early detection of prostate cancer is common although it is associated with both benefits and potential harms (e.g., the risk of overdiagnosis). Evidence-based health information could help individuals make informed decisions about whether to undergo PSA testing or not. This evaluation aimed to determine whether the written health information materials available in Germany provide appropriate information for informed decision-making on PSA based screening. METHODS: A list of criteria was developed and used to systematically assess the quality of information on the benefits and harms of prostate cancer screening included in written health information materials. Fourteen information materials identified by information requests and online searches were evaluated independently by two of three reviewers. Consensus was achieved with a third reviewer. RESULTS: Of the 14 information materials evaluated, 10 (71%) list the ability to reduce the absolute risk of death from prostate cancer as a benefit of PSA testing, 9 (64%) point out the risks of follow-up diagnostics, 13 (93%) describe the risks of the available prostate cancer treatments, and all 14 specify the risk of overdiagnosis. The minority provide numerical data on benefits and risks. Partially mismatched framing was identified in four cases: two information materials report only the relative frequencies of benefits, and two report only the absolute frequencies of harms. Half of the materials encouraged participation using downplaying or frightening language. CONCLUSIONS: The majority of health information materials in Germany describe the benefits and harms of PSA based screening, including overdiagnosis, but often lack adequate balance, neutrality and numbers.

Patient-rated importance of key information on screening colonoscopy in Germany: a survey of statutory health insurance members.

BACKGROUND: Primary colonoscopic screening is considered to be of great benefit but also has the potential to cause severe harm. Thus, eligible subjects should be supported in making an informed choice whether to participate. OBJECTIVES: To identify information on screening colonoscopy that colonoscopy-naïve subjects rate as particularly important for decision making. DESIGN: Survey of German statutory health insurance members using a written questionnaire in November 2015. STUDY POPULATION: Colonoscopy-naïve individuals aged 50 to 65 years. MAIN OUTCOME MEASURES: Importance of key information about screening colonoscopy, including potential risks and benefits, baseline risk of colorectal cancer/polyps and practical aspects of the procedure, as well as associations between participants' characteristics and their judgement of information as to being 'very important'. RESULTS: Of 1871 respondents (overall response rate: 31%), a subgroup of 370 colonoscopy-naïve subjects was eligible for inclusion (average age: 55 years, 47% male). Information on the risks was rated as very important by most respondents, unimportant by 6%. Information on the benefits was considered unimportant by 26%. Regression analysis showed that less educated persons regarded most items to be more often relevant than highly educated subjects. A greater proportion of women than men rated details regarding pain and practical aspects as very important. Subjects with a low educational level living alone were identified as the group with the least interest in information on risks. CONCLUSION: Cultivating awareness around the central meaning of the (quantitative) benefits of screening in informed decision making should be focused on more in future information materials. The high requirement of less educated people to become more informed provides a strong motivation for further efforts to develop evidence-based information that adequately informs this group. Tailoring information according to gender-specific needs may be warranted in light of the observed differences in information preferences between women and men.

Independent Pre-Transplant Recipient Cancer Risk Factors after Kidney Transplantation and the Utility of G-Chart Analysis for Clinical Process Control.

BACKGROUND: The aim of this study is to identify independent pre-transplant cancer risk factors after kidney transplantation and to assess the utility of G-chart analysis for clinical process control. This may contribute to the improvement of cancer surveillance processes in individual transplant centers. PATIENTS AND METHODS: 1655 patients after kidney transplantation at our institution with a total of 9,425 person-years of follow-up were compared retrospectively to the general German population using site-specific standardized-incidence-ratios (SIRs) of observed malignancies. Risk-adjusted multivariable Cox regression was used to identify independent pre-transplant cancer risk factors. G-chart analysis was applied to determine relevant differences in the frequency of cancer occurrences. RESULTS: Cancer incidence rates were almost three times higher as compared to the matched general population (SIR = 2.75; 95%-CI: 2.33-3.21). Significantly increased SIRs were observed for renal cell carcinoma (SIR = 22.46), post-transplant lymphoproliferative disorder (SIR = 8.36), prostate cancer (SIR = 2.22), bladder cancer (SIR = 3.24), thyroid cancer (SIR = 10.13) and melanoma (SIR = 3.08). Independent pre-transplant risk factors for cancer-free survival were age <52.3 years (p = 0.007, Hazard ratio (HR): 0.82), age >62.6 years (p = 0.001, HR: 1.29), polycystic kidney disease other than autosomal dominant polycystic kidney disease (ADPKD) (p = 0.001, HR: 0.68), high body mass index in kg/m2 (p<0.001, HR: 1.04), ADPKD (p = 0.008, HR: 1.26) and diabetic nephropathy (p = 0.004, HR = 1.51). G-chart analysis identified relevant changes in the detection rates of cancer during aftercare with no significant relation to identified risk factors for cancer-free survival (p<0.05). CONCLUSIONS: Risk-adapted cancer surveillance combined with prospective G-chart analysis likely improves cancer surveillance schemes by adapting processes to identified risk factors and by using G-chart alarm signals to trigger Kaizen events and audits for root-cause analysis of relevant detection rate changes. Further, comparative G-chart analysis would enable benchmarking of cancer surveillance processes between centers.

Communicating the benefits and harms of colorectal cancer screening needed for an informed choice: a systematic evaluation of leaflets and booklets.

OBJECTIVE: Evidence-based health information (EBHI) can support informed choice regarding whether or not to attend colorectal cancer (CRC) screening. The present study aimed to assess if German leaflets and booklets appropriately inform consumers on the benefits and harms of CRC screening. METHODS: A systematic search for print media on CRC screening was performed via email enquiry and internet search. The identified documents were assessed for the presence and correctness of information on benefits and harms by two reviewers independently using a comprehensive list of criteria. RESULTS: Many of the 28 leaflets and 13 booklets identified presented unbalanced information on the benefits and harms of CRC screening: one-third did not provide any information on harms. Numeracy information was often lacking. Ten cross-language examples of common misinterpretations or basically false and misleading information were identified. DISCUSSION: Most of the CRC screening leaflets and booklets in Germany do not meet current EBHI standards. After the study, the publishers of the information materials were provided feedback, including a discussion of our findings. The results can be used to revise existing information materials or to develop new materials that provide correct, balanced, quantified, understandable and unbiased information on CRC screening.

Development of a comprehensive list of criteria for evaluating consumer education materials on colorectal cancer screening.

BACKGROUND: Appropriate patient information materials may support the consumer's decision to attend or not to attend colorectal cancer (CRC) screening tests (fecal occult blood test and screening colonoscopy). The aim of this study was to develop a list of criteria to assess whether written health information materials on CRC screening provide balanced, unbiased, quantified, understandable, and evidence-based health information (EBHI) about CRC and CRC screening. METHODS: The list of criteria was developed based on recommendations and assessment tools for health information in the following steps: (1) Systematic literature search in 13 electronic databases (search period: 2000-2010) and completed by an Internet search (2) Extraction of identified criteria (3) Grouping of criteria into categories and domains (4) Compilation of a manual of adequate answers derived from systematic reviews and S3 guidelines (5) Review by external experts (6) Modification (7) Final discussion with external experts. RESULTS: Thirty-one publications on health information tools and recommendations were identified. The final list of criteria includes a total of 230 single criteria in three generic domains (formal issues, presentation and understandability, and neutrality and balance) and one CRC-specific domain. A multi-dimensional rating approach was used whenever appropriate (e.g., rating for the presence, correctness, presentation and level of evidence of information). Free text input was allowed to ensure the transparency of assessment. The answer manual proved to be essential to the rating process. Quantitative analyses can be made depending on the level and dimensions of criteria. CONCLUSIONS: This comprehensive list of criteria clearly has a wider range of evaluation than previous assessment tools. It is not intended as a final quality assessment tool, but as a first step toward thorough evaluation of specific information materials for their adherence to EBHI requirements. This criteria list may also be used to revise leaflets and to develop evidence-based health information on CRC screening. After adjustment for different procedure-specific criteria, the list of criteria can also be applied to other cancer screening procedures.