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2013 Annual National Digital Rectal Exam (DRE) Day Study

2015年4月5日 更新者:Michael E. Chua、St. Luke's Medical Center, Philippines

2013 Annual National Digital Rectal Exam (DRE) Day: Impact on Prostate Health Awareness and Disease Detection

We aim to determine the effectiveness of 2013 "Mag paDRE ka" programme in increasing general public awareness on prostate health and promoting prostate health assessment among Filipino males aged 40 or older.

研究概览

详细说明

Convenience sampling method will be applied to collect all completed Philippine Urological Association (PUA) survey forms from the 11 Philippine Board of Urology accredited training institutions. A data collection form for the purpose of this study will be used to extract data from the Philippine Urological Association survey forms. The data collection form for this study will extract data, which include basic demographic characteristics of the patients (such as age and educational attainment), family history of prostate cancer, other medical conditions, history of prior prostate screening/ consultation for Lower urinary tract Symptoms or prostate disease. The International Prostate Symptom scores (IPSS) collected will be stratified according to mild (1-7), moderate (8-19) and severe (20-35) and the Filipino version Quality of Life (QoL) ratings will be stratified according to Grade 1, grade 2 and grade 3. DRE findings including the approximation of prostate size and prostate characteristic findings will be clustered to normal in size (20grams or less) versus enlarged (>20grams or 2 fingerbreadths in width), nodular vs non-nodular, doughy or hard, and tender versus non-tender.

Participants will be classified according to the following :

  1. Target population for screening or not :

    Target population for screening is defined as Filipino males aged 40 years or older, who also had no previous consultation for Lower urinary tract symptoms (LUTS) or prostate cancer screening in the past 12 months

  2. Case Finding for significant LUTS or prostate cancer or not :

Case of LUTS or prostate cancer is defined as Filipino males aged 40 years or older with IPSS > 8, OR, has abnormal Digital rectal exam (DRE) finding, which is defined as nodular OR hard OR tender. However, DRE finding of an enlarged prostate but non-nodular, doughy in character and non-tender will not be considered as a case of LUTS or prostate cancer suspect).

Confidentiality of all data will be assured. The case report forms/ data collection form for this study will not contain any patient identifiers. All patient records will be coded in the electronic database as serial number and PUA-designated Institutional code (i.e. SLMC #0001). Only the investigators of this study and other authorized personnel from PUA will be given access to the study data. The PUA survey forms will be secured, filed and only accessed in PUA secretariat building. The electronic database coded with the data from the data collection from of this study will be set with password, and only the study investigators have access to the password.

研究类型

观察性的

注册 (实际的)

925

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • National Capital Region
      • Quezon City、National Capital Region、菲律宾、1102
        • Philippine Urological Association Inc.

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

男性

取样方法

非概率样本

研究人群

Filipino males ages 40 or older

描述

Inclusion Criteria:

  • Filipino male ages 40 or older consulted on "Pa-DRE ka" prostate health screening program 2013
  • patients presented to the Philippine Board of Urology accredited 11 training institutions
  • Consented for the screening program.
  • Completed the questionnaire of International Prostate symptoms score
  • Has been examined with digital rectal examination

Exclusion Criteria:

  • Patients who have incomplete data and did not consent for the screening program
  • Non-Filipino male patients

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
New patient presented with prostate disease
prostate disease identified
其他名称:
  • Digital rectal examination, International prostate symptoms score quetionnaire

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
Incidence of Prostate disease (benign prostatic hyperplasia, prostatitis, Prostate cancer)
大体时间:1 year
number of new diagnosed prostate disease (target population) for Pa-DRE ka day screening program.
1 year

次要结果测量

结果测量
措施说明
大体时间
Prevalence of Prostate Diseases
大体时间:1 year
total number of patient consulted on Pa-DRE ka day with prostate diseases
1 year
International Prostate Symptom Score
大体时间:1 year
Total score of international Prostate Symptoms Score of each patients consulted for Prostate screening program (Pa-DRE ka day)
1 year
Prostate gland size estimate
大体时间:1 year
Estimated prostate gland size by digital rectal exam for patients presented to the prostate screening program (Pa-DRE ka day)
1 year
Digital rectal examination result
大体时间:1 year
Summary of digital rectal exam findings of patients presented to prostate screening program (Pa-DRE ka day)
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年6月1日

初级完成 (实际的)

2014年10月1日

研究完成 (实际的)

2014年10月1日

研究注册日期

首次提交

2013年6月23日

首先提交符合 QC 标准的

2013年6月23日

首次发布 (估计)

2013年6月26日

研究记录更新

最后更新发布 (估计)

2015年4月7日

上次提交的符合 QC 标准的更新

2015年4月5日

最后验证

2015年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • PURA-2013

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