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德国结直肠癌筛查中乙状结肠镜检查的附加建议:SIGMO 研究中决策分析模型方法的基本原理和方案。

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

机构信息

Institute for Epidemiology, Social Medicine and Health Systems Research, Hannover Medical School, Hannover, Niedersachsen, Germany

Institute for Epidemiology, Social Medicine and Health Systems Research, Hannover Medical School, Hannover, Niedersachsen, Germany.

出版信息

BMJ Open. 2022 Jan 6;12(1):e050698. doi: 10.1136/bmjopen-2021-050698.

DOI:10.1136/bmjopen-2021-050698
PMID:34992106
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8739067/
Abstract

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.

摘要

简介

在德国,根据年龄和性别,法定参保人有权选择进行粪便免疫化学测试(FIT)或结肠镜检查进行结直肠癌(CRC)筛查,但参与率相对较低。乙状结肠镜检查是一种目前不可用的筛查措施,其在降低发病率和死亡率方面具有强有力的证据基础。由于其独特的特点,它可能会受到一些人的青睐,这些人现在拒绝接受结肠镜检查。本研究的目的是估计在德国,与目前的筛查实践相比,额外提供乙状结肠镜检查进行 CRC 筛查的经济后果,同时考虑到普通人群的偏好。

方法和分析

将开发一种决策分析模型方法,从社会角度比较德国目前的 CRC 筛查计划(FIT、结肠镜检查)与通过乙状结肠镜检查扩展的计划。将决策树和马尔可夫模型相结合,以评估短期和长期效果,如 CRC 和腺瘤检出率、CRC 病例数、CRC 死亡率以及并发症。将计算每种替代方案的每获得一个质量调整生命年的增量成本。该模型将根据离散选择实验纳入普通人群的偏好。此外,模型将采用来自文献、德国癌症登记处和健康保险索赔数据的输入参数。

伦理与传播

该研究已获得汉诺威医学院伦理委员会的批准(ID:8671_BO_K_2019)。研究结果将发表在同行评议的期刊上,并在国家和/或国际会议上展示。

试验注册号

DRKS00019010。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7097/8739067/f8c8c732aa68/bmjopen-2021-050698f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7097/8739067/0760709755c6/bmjopen-2021-050698f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7097/8739067/90e6767166ef/bmjopen-2021-050698f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7097/8739067/f8c8c732aa68/bmjopen-2021-050698f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7097/8739067/0760709755c6/bmjopen-2021-050698f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7097/8739067/90e6767166ef/bmjopen-2021-050698f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7097/8739067/f8c8c732aa68/bmjopen-2021-050698f03.jpg

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