Follow-up of Abnormal and Inadequate Smear-test Results
Follow-up of Abnormal and Inadequate Test Results in the Danish Cervical Cancer Screening Program.
Denmark has a higher incidence of cervical cancer than other Nordic countries, although all Danish women (aged 23-65) are screened regularly to identify possible cervical dysplasia or asymptomatic invasive cancer.
Annually 40 000 women receives an abnormal or inadequate test result and a follow-up recommendation.
However problems with delayed follow-up may threaten the effectiveness of the Danish Cervical Cancer Screening Program, as 20% of women are delayed and dysplasia potentially can progress into cancer.
Delayed follow-up is found in situations where women either consciously or unconsciously postpone follow-up, or because of organizational aspects of the screening program, where communication regarding test results can fail either in content or with delay.This study will evaluate two interventions designed to increase follow-up:
- A letter with the test result and potential recommendation for follow up will be sent to the women (RCT). The intention is to ensure that all women will be notified about the test result, quickly, homogenously and in layman's written language, still with the opportunity to contact or be contacted by the general practitioner, if there is special needs. Furthermore, it is assumed that general practitioner consultations regarding delivery of normal test results will decrease, so that cost savings is a potential side benefit
- Electronic reminder to the general practitioner if women have not had the recommended follow up, giving the general practioner´s an opportunity to remind the women (retro perspective cohort study).
The results will be of great importance to the future organisation of cervical and colorectal cancer screening programmes in Denmark, but will also have international interest because of their similar challenges.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Central Denmark Region
-
Aarhus、Central Denmark Region、丹麦、8000
- University of Aarhus
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- woman with a pap-smear test
Exclusion Criteria:
- less than 23 years
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Test result sent by letter
The pap-smear test result is sent by letter directly to the women.
Women in need of follow up are in the letter recommended to contact their general practitioner.
|
|
|
有源比较器:Test result conveyed by general practitioners
In Denmark it is a standard procedure that general practitioners convey the pap-smear test results to the women.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of women with timely follow-up
大体时间:1½ year
|
The proportion of women followed up will be calculated as cumulated incidence proportions according to four timeframes (undesirable early, as recommended, late, very late), and be compared by relative risks.
The results will be presented in totals and separately depending on the test result (normal/inadequate/Bethesda classification 2001/HPV).
|
1½ year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Frequency of general practitioner contacts (consultations/telephone calls /e-mails) regarding conveying the smear test result.
大体时间:Three months after the smear test.
|
The two randomisation groups will be compared with respect to contacts with general practitioner after the smear test the first days, weeks, months after the general practitioner is notified of the screening result.
|
Three months after the smear test.
|
合作者和调查者
调查人员
- 研究主任:Peter Vedsted、Center for Research in Cancer Diagnosis in Primary Care - (CaP), Aarhus University
- 研究主任:Flemming Bro、The Research Unit of General Practice in Aarhus, Aarhus University
- 研究主任:Berit S Andersen、The Department of Public Health Programmes at Regional Hospital Randers
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.