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

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e050698
Author(s):  
Leonie Diedrich ◽  
Melanie Brinkmann ◽  
Maren Dreier ◽  
Wendelin Schramm ◽  
Christian Krauth

IntroductionIn 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 analysisA 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 disseminationEthical 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 numberDRKS00019010.

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Joaquín Cubiella ◽  
Antía González ◽  
Raquel Almazán ◽  
Elena Rodríguez-Camacho ◽  
Raquel Zubizarreta ◽  
...  

Abstract Background Although colorectal cancer (CRC) screening programs reduce CRC incidence and mortality, they are associated with risks in healthy subjects. However, the risk of overtreatment and overdiagnosis has not been determined yet. The aim of this study was to report the surgery rates in patients with nonmalignant lesions detected within the first round of a fecal immunochemical test (FIT) based CRC screening program and the factors associated with it. Methods We included in this analysis all patients with nonmalignant lesions detected between May 2013 and June 2019 in the Galician (Spain) CRC screening program. We calculated surgery rate according to demographic variables, the risk classification according to the colonoscopy findings (European guidelines for quality assurance), the endoscopist’s adenoma detection rate (ADR) classified into quartiles and the hospital’s complexity level. We determined which variables were independently associated with surgery rate and expressed the association as Odds Ratio and its 95% confidence interval (CI). Results We included 15,707 patients in the analysis with high (19.9%), intermediate (26.9%) low risk (23.3%) adenomas and normal colonoscopy (29.9%) detected in the analyzed period. Colorectal surgery was performed in 162 patients (1.03, 95% CI 0.87–1.19), due to colonoscopy complications (0.02, 95% CI 0.00–0.05) and resection of colorectal benign lesions (1.00, 95% CI 0.85–1.16). Median hospital stay was 6 days with 17.3% patients developing minor complications, 7.4% major complications and one death. After discharge, complications developed in 18.4% patients. In benign lesions, an endoscopic resection was performed in 25.4% and a residual premalignant lesion was detected in 89.9%. The variables independently associated with surgery in the multivariable analysis were age (≥60 years = 1.57, 95% CI 1.11–2.23), sex (female = 2.10, 95% CI 1.52–2.91), the European guidelines classification (high risk = 67.94, 95% CI 24.87–185.59; intermediate risk = 5.63, 95% CI 1.89–16.80; low risk = 1.43; 95% CI 0.36–5.75), the endoscopist’s ADR (Q4 = 0.44, 95% CI 0.28–0.68; Q3 = 0.44, 95% CI 0.27–0.71; Q2 = 0.71, 95% CI 0.44–1.14) and the hospital (tertiary = 0.54, 95% CI 0.38–0.79). Conclusions In a CRC screening program, the surgery rate and the associated complications in patients with nonmalignant lesions are low, and related to age, sex, endoscopic findings, endoscopist’s ADR and the hospital’s complexity.


2020 ◽  
Author(s):  
Joaquin Cubiella ◽  
Antía González ◽  
Raquel Almazán ◽  
Elena Rodríguez-Camacho ◽  
Raquel Zubizarreta ◽  
...  

Abstract Background: Although colorectal cancer (CRC) screening programs reduce CRC incidence and mortality, they are associated with risks in healthy subjects. However, the risk of overtreatment and overdiagnosis has not been determined yet. The aim of this study is to report the surgery rates in patients with nonmalignant lesions detected within the first round of a fecal immunochemical test (FIT) based CRC screening program and the factors associated with it. Methods: We included in this analysis all patients with nonmalignant lesions detected between May 2013 and June 2019. We calculated surgery rate according to demographic variables, the risk classification according to the colonoscopy findings (European guidelines for quality assurance), the endoscopist’s adenoma detection rate (ADR) classified into quartiles and the hospital’s complexity level. We determined which variables were independently associated with surgery rate and expressed the association as Odds Ratio and its 95% confidence interval (CI).Results: We included 15,707 patients in the analysis with high (19.3%), intermediate (25.1%) low risk (21.7%) adenomas and normal colonoscopy (27.8%) detected in the analyzed period. Colorectal surgery was performed in 162 (10.3‰, 95% CI 8.7-11.9), due to colonoscopy complications (0.2‰, 95% CI 0.005-0.5) and resection of colorectal benign lesions (10.0‰, 95% CI 8.5-11.6). Median hospital stay was 6 days with 17.3% patients developing minor complications, 7.4% major complications, one death. After discharge, complications developed in 18.4% patients. In benign lesions, an endoscopic resection was performed in 25.4% and a residual premalignant lesion was detected in 89.9%. The variables independently associated with surgery in the multivariable analysis were age (≥60 years= 1.57, 95% CI 1.11-2.23), sex (female= 2.10, 95% CI 1.52-2.91), the European guidelines classification (high risk= 67.94, 95% CI 24.87-185.59; intermediate risk= 5.63, 95% CI 1.89-16.80; low risk= 1.43; 95% CI 0.36-5.75), the endoscopist’s ADR (Q4= 0.44, 95% CI 0.28-0.68; Q3= 0.44, 95% CI 0.27-0.71; Q2= 0.71, 95% CI 0.44-1.14) and the hospital (third level= 0.54, 95% CI 0.38-0.79). Conclusions: In a CRC screening program, the surgery rate and the associated complications in patients with nonmalignant lesions are acceptable and related to age, sex, endoscopic findings, endoscopist’s ADR and the hospital’s complexity.


2015 ◽  
Vol 24 (2) ◽  
pp. 171-176 ◽  
Author(s):  
Elena Mirela Ionescu ◽  
Tudor Nicolaie ◽  
Serban Ion Gologan ◽  
Ana Mocanu ◽  
Cristina Ditescu ◽  
...  

Background & Aims: Even though Romania has one of the highest incidence and mortality in colorectal cancer (CRC) in Europe, there is currently no organized screening program. We aimed to assess the results of our opportunistic CRC screening using colonoscopy.Methods: A single center retrospective study to include all opportunistic screening colonoscopies performed in two 18 month periods (2007-2008 and 2012-2013) was designed. All asymptomatic individuals without a personal or family history of adenoma or CRC and with complete colonoscopy performed in these two time periods were included.Results: We included 1,807 individuals, 882 in the first period, 925 in the second period. There were 389 individuals aged below 50, 1,351 between 50 and 75 and 67 older than 75 years. There were 956 women (52.9%), with a mean age of 58.5 (median 59, range 23-97). The detection rates were 12.6% for adenomas (6.1% for advanced adenoma) and 3.4% for adenocarcinoma. Adenoma incidence (4.9% in subjects under 50, 14.7% in those aged 50 to 75, and 16.4% in those older than 75, p<0.0001) and size (6.3mm in subjects younger than 50, 9.2mm in those 50 to 75 and 10.8mm in those older than 75, p=0.015) significantly increased with age. Adenoma incidence increased in the second period (14.8% vs. 10.3%, p=0.005), while adenoma size decreased in the second period (8.4mm vs. 10mm, p=0.006). There were no procedure related complications.Conclusions: The neoplasia detection rate was 16% (12.6% adenoma, 3.4% adenocarcinoma). Adenoma incidence and size increased with age in both cohorts. In the second screening period significantly more and smaller adenomas were detected.


2021 ◽  
Vol 09 (07) ◽  
pp. E1070-E1076
Author(s):  
Marco Alburquerque ◽  
Antonella Smarrelli ◽  
Julio Chevarria Montesinos ◽  
Sergi Ortega Carreño ◽  
Ana Zaragoza Fernandez ◽  
...  

Abstract Background and study aims Efficacy and safety of NAAP for gastrointestinal endoscopy have been widely documented, although there is no information about the outcomes of colonoscopy when the endoscopist supervises the sedation. In this context, the aim of this trial was to determine the equivalence of adenoma detection rate (ADR) in colorectal cancer (CRC) screening colonoscopies performed with non-anesthesiologist-administered propofol (NAAP) and performed with monitored anesthesia care (MAC). Patients and methods This was a single-blind, non-randomized controlled equivalence trial that enrolled adults from a national CRC screening program (CRCSP). Patients were blindly assigned to undergo either colonoscopy with NAAP or MAC. The main outcome measure was the ADR in CRCSP colonoscopies performed with NAAP. Results We included 315 patients per group. The median age was 59.76 ± 5.81 years; 40.5 % of patients were women. The cecal intubation rate was 97 %, 81.8 % of patients had adequate bowel preparation, withdrawal time was > 6 minutes in 98.7 %, and the median global exploration time was 24.25 ± 8.86 minutes (range, 8–70 minutes). The ADR was 62.9 % and the complication rate (CR) was 0.6 %. Analysis by intention-to-treat showed an ADR in the NAAP group of 64.13 % compared with 61.59 % in the MAC group, a difference (δADR) of 2.54 %, 95 %CI: −0.10 to 0.05. Analysis by per-protocol showed an ADR in the NAAP group of 62.98 %, compared with 61.94 % in the MAC group, δADR: 1.04 %, 95 %CI: −0.09 to 0.07. There was no difference in CR (NAAP: 0,63 vs. MAC: 0.63); P = 1.0. Conclusions ADR in colorectal cancer screening colonoscopies performed with NAAP was equivalent to that in those performed with MAC. Similarly, there was no difference in complication rates.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ane Sørlie Kværner ◽  
Einar Birkeland ◽  
Cecilie Bucher-Johannessen ◽  
Elina Vinberg ◽  
Jan Inge Nordby ◽  
...  

Abstract Background Colorectal cancer (CRC) screening reduces CRC incidence and mortality. However, current screening methods are either hampered by invasiveness or suboptimal performance, limiting their effectiveness as primary screening methods. To aid in the development of a non-invasive screening test with improved sensitivity and specificity, we have initiated a prospective biomarker study (CRCbiome), nested within a large randomized CRC screening trial in Norway. We aim to develop a microbiome-based classification algorithm to identify advanced colorectal lesions in screening participants testing positive for an immunochemical fecal occult blood test (FIT). We will also examine interactions with host factors, diet, lifestyle and prescription drugs. The prospective nature of the study also enables the analysis of changes in the gut microbiome following the removal of precancerous lesions. Methods The CRCbiome study recruits participants enrolled in the Bowel Cancer Screening in Norway (BCSN) study, a randomized trial initiated in 2012 comparing once-only sigmoidoscopy to repeated biennial FIT, where women and men aged 50–74 years at study entry are invited to participate. Since 2017, participants randomized to FIT screening with a positive test result have been invited to join the CRCbiome study. Self-reported diet, lifestyle and demographic data are collected prior to colonoscopy after the positive FIT-test (baseline). Screening data, including colonoscopy findings are obtained from the BCSN database. Fecal samples for gut microbiome analyses are collected both before and 2 and 12 months after colonoscopy. Samples are analyzed using metagenome sequencing, with taxonomy profiles, and gene and pathway content as primary measures. CRCbiome data will also be linked to national registries to obtain information on prescription histories and cancer relevant outcomes occurring during the 10 year follow-up period. Discussion The CRCbiome study will increase our understanding of how the gut microbiome, in combination with lifestyle and environmental factors, influences the early stages of colorectal carcinogenesis. This knowledge will be crucial to develop microbiome-based screening tools for CRC. By evaluating biomarker performance in a screening setting, using samples from the target population, the generalizability of the findings to future screening cohorts is likely to be high. Trial registration ClinicalTrials.gov Identifier: NCT01538550.


2020 ◽  
Vol 21 (6) ◽  
pp. 877-883
Author(s):  
Florence K. L. Tangka ◽  
Sujha Subramanian ◽  
Sonja Hoover ◽  
Amy DeGroff ◽  
Djenaba Joseph ◽  
...  

The Centers for Disease Control and Prevention (CDC) has a long-standing commitment to increase colorectal cancer (CRC) screening for vulnerable populations. In 2005, the CDC began a demonstration in five states and, with lessons learned, launched a national program, the Colorectal Cancer Control Program (CRCCP), in 2009. The CRCCP continues today and its current emphasis is the implementation of evidence-based interventions to promote CRC screening. The purpose of this article is to provide an overview of four CRCCP awardees and their federally qualified health center partners as an introduction to the accompanying series of research briefs where we present individual findings on impacts of evidence-based interventions on CRC screening uptake for each awardee. We also include in this article the conceptual framework used to guide our research. Our findings contribute to the evidence base and guide future program implementation to improve sustainability, increase CRC screening, and address disparities in screening uptake.


2020 ◽  
Vol 08 (05) ◽  
pp. E673-E683 ◽  
Author(s):  
Prateek Sharma ◽  
Carol A. Burke ◽  
David A. Johnson ◽  
Brooks D. Cash

Abstract Background and study aims Colonoscopy for colorectal cancer (CRC) screening has reduced CRC incidence and mortality and improved prognosis. Optimal bowel preparation and high-quality endoscopic technique facilitate early CRC detection.This review provides a narrative on the clinical importance of bowel preparation for colonoscopy and highlights available bowel preparations. Methods A PubMed search was conducted through June 2019 to identify studies evaluating clinical outcomes, efficacy, safety, and tolerability associated with bowel preparation for CRC screening-related colonoscopy. Results Selecting the optimal bowel preparation regimen is based on considerations of efficacy, safety, and tolerability, in conjunction with individual patient characteristics and preferences. Available bowel preparations include high-volume (4 L) and low-volume (2 L and 1 L), polyethylene glycol (PEG) solutions, sodium sulfate, sodium picosulfate/magnesium oxide plus anhydrous citric acid, sodium phosphate tablets, and the over-the-counter preparations magnesium citrate and PEG-3350. These preparations may be administered as a single dose on the same day or evening before, or as two doses administered the same day or evening before/morning of colonoscopy. Ingesting at least half the bowel preparation on the day of colonoscopy (split-dosing) is associated with higher adequate bowel preparation quality versus evening-before dosing (odds ratio [OR], 2.5; 95 % confidence interval [CI], 1.9−3.4). Conclusions High-quality bowel preparation is integral for optimal CRC screening/surveillance by colonoscopy. Over the last 30 years, patients and providers have gained more options for bowel preparation, including low-volume agents with enhanced tolerability and cleansing quality that are equivalent to 4 L preparations. Split-dosing is preferred for achieving a high-quality preparation.


2019 ◽  
pp. 1-10
Author(s):  
Gregory C. Knapp ◽  
Olusegun I. Alatise ◽  
Olalekan O. Olasehinde ◽  
Ademola Adeyeye ◽  
Omobolaji O. Ayandipo ◽  
...  

PURPOSE The global burden of colorectal cancer (CRC) will continue to increase for the foreseeable future, largely driven by increasing incidence and mortality in low- and middle-income countries (LMICs) such as Nigeria. METHODS We used the Wilson-Jungner framework (1968) to review the literature relevant to CRC screening in Nigeria and propose areas for future research and investment. RESULTS Screening is effective when the condition sought is both important and treatable within the system under evaluation. The incidence of CRC is likely increasing, although the exact burden of disease in Nigeria remains poorly understood and access to definitive diagnosis and treatment has not been systematically quantified. In high-income countries (HICs), CRC screening builds on a well-known natural history. In Nigeria, a higher proportion of CRC seems to demonstrate microsatellite instability, which is dissimilar to the molecular profile in HICs. Prospective trials, tissue banking, and next-generation sequencing should be leveraged to better understand these potential differences and the implications for screening. Fecal immunochemical test for hemoglobin (FIT) is recommended for LMICs that are considering CRC screening. However, FIT has not been validated in Nigeria, and questions about the impact of high ambient temperature, endemic parasitic infection, and feasibility remain unanswered. Prospective trials are needed to validate the efficacy of stool-based screening, and these trials should consider concomitant ova and parasite testing. CONCLUSION Using the Wilson-Jungner framework, additional work is needed before organized CRC screening will be effective in Nigeria. These deficits can be addressed without missing the window to mitigate the increasing burden of CRC in the medium to long term.


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