A Retrospective Review of the Secondary-care Colorectal Cancer Pathway Within NHS Lothian: An Evaluation of 3 Years of Pathway Performance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25,000
- 试验地点
- 3
- 主要终点
- Pathway diagnostic accuracy
研究概览
简要总结
Bowel cancer (colorectal cancer) is the 4th most common cancer in Scotland. Approximately 4,000 cases are diagnosed annually. Cancer-related deaths in Scotland are higher than other UK nations. Improving the early detection of bowel cancer, and therefore survival, is important.
The majority of bowel cancers are diagnosed within secondary-care (colorectal surgery unit). Upon GP referral to secondary-care, patients provide stool samples which are analysed for microscopic blood (FIT; faecal immunohistochemical test). Patients with a single positive result are more likely to have bowel cancer (0.2% risk if no blood detected, but 8.4% if detected). A positive test triggers further investigation, either CT scan or colonoscopy depending on the result. Currently, colonoscopy and radiology services throughout Scotland are under significant pressure causing delays.
Only 2% of patients referred to secondary-care are diagnosed with bowel cancer, and most colonoscopies performed do not yield significant findings. We have shown that performing two repeated FITs upon referral improves cancer pickup rate (sensitivity) and reduces missed cancers. We successfully implemented this in NHS Lothian and contributed to national guidelines.
This study will undertake a comprehensive retrospective review of the double-FIT urgent suspicion of bowel cancer pathway within NHS Lothian, from April 2022 (date of pathway inception) to August 2025, including around 25,000 patients that have been managed through the pathway. We will calculate key performance indicators and diagnostic accuracy of the pathway. Health economic analysis will determine cost-per-diagnosis. Risk factors for bowel cancer in this patient cohort will be identified to develop a support tool for primary and secondary-care. These results will be used to develop a future pathway to optimise pathway efficiency and cancer detection.
详细描述
Design:
This is a retrospective observational cohort data-analysis study of patients managed within the NHS Lothian colorectal cancer (CRC) urgent suspicion of cancer (USoC) pathway and patients referred urgently to the Colorectal department from April 2022 to August 2025. April 2022 corresponds to the start of double FIT testing within the pathway. 5-year follow-up will be included (up to August 2030) to include 5-year cancer outcomes.
Methods:
Patients will be identified from our pathway. Estimated ~25,000 patients will be included. Data will be collected on patient characteristics, past medical and prescribing history, hospital presentations and investigation outcomes, cancer outcomes and mortality data. Linkage to relevant patient datasets will be required.
A service review of the USoC/urgent pathway will focus on key performance indicators such as time to diagnosis and treatment, as well as patient journey pathways (Sankey plots) and re-referral rates.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients managed within the NHS Lothian CRC USoC/urgent pathway (including urgent referrals) due to 'red-flag' symptoms concerning of CRC from April 2022 to August 2025.
排除标准
- •Under the age of
- •History of inflammatory bowel disease.
- •Under polyp surveillance.
- •Previous diagnosis of CRC.
研究组 & 干预措施
FIT non-returners
Referred patients who did not return FIT
Single FIT returners
Referred patients who returned a single FIT
干预措施: Faecal Immunohistochemical test (Diagnostic Test)
Double FIT returners
Referred patients who returned two FITs
干预措施: Faecal Immunohistochemical test (Diagnostic Test)
结局指标
主要结局
Pathway diagnostic accuracy
时间窗: 1 year
Sensitivity, specificity, NNI of pathway
次要结局
- Cost per diagnosis(1 year)
研究者
Julian Camilleri-Brennan
Mr
University of Edinburgh
