RANOMIZED TRIAL OF THE SDP FOR PATIENTS WITH BPH
RANOMIZED TRIAL OF THE SDP FOR PATIENTS WITH BPH
批准号:
3372229
负责人:
MICHAEL J BARRY
金额:
$35.3万
依托单位国家:
美国
项目类别:
财政年份:
1991
资助国家:
美国
项目状态:
已结题
起止时间:
1991-08-01 至 1994-07-31
中文摘要
在美国,每年约有40万男性接受乳房切除术,
良性前列腺增生:更多的人有BPH症状,
一年内不做手术。 教育男性了解BPH和
提供治疗替代方案,并促进患者参与
在决策过程中,调查人员制定了一个
交互式教育程序,包括计算机和视频光盘,称为
共同决策程序(SDP)。 SDP用作
这是对传统办公室决策的补充。 SDP已经
已经被确定为患者和泌尿科医生都可以接受,
4个研究中心的初步研究。
拟议的项目是一个有效性研究的SDP,将在两个
在普吉特海湾集团健康合作社的泌尿科实践。 后
基线数据收集期,出现症状性
BPH但无迫切手术指征的患者将随机分配至
SDP或对照组;后者患者将接受
最低限度的教育干预(小册子)。
研究结果将确定使用SDP是否会导致:
1.改善健康和福祉;
2.更好地了解BPH及其治疗;
3.患者更愿意参与治疗决策:
4.治疗决定的改变;
5.患者对所做的决定和
决策过程。
6.在决策中更多地考虑患者的偏好。
为了给研究提供足够的把握度,将有200名男性入组研究。
基线期,400名男性随后将被随机分组。 人人都要
入组后至少随访9个月。 到项目周期
将是三年。
虽然SDP方法具有很大的表面有效性,
推广到其他医疗问题,除了BPH,一个正式的测试,
在实际操作中的有效性至关重要。
英文摘要
About 400,000 men undergo prostatectomy annually in the United States for
benign prostatic hyperplasia: a much greater number have BPH symptoms but
do not have surgery in a given year. To educate men about BPH and the
treatment alternatives available, and to facilitate patient participation
in the decision-making process, the investigators have developed an
interactive educational program, both computer and videodisc based, called
the Shared Decision-Making Procedure (SDP). The SDP is used as a
supplement to traditional office-based decision-making. The SDP has
already been determined to be acceptable to both patients and urologists in
a 4 site pilot study.
The proposed project is an efficacy study of the SDP, to take place in two
urologic practices in Group Health Co-operative of Puget Sound. After a
period of baseline data collection, patients presenting with symptomatic
BPH but without pressing indications for surgery will be randomized to
either the SDP or a control group; the latter patients will receive a
minimal educational intervention (a brochure).
Study outcomes will determine whether SDP use leads to:
1. Improved health and well being;
2. Better knowledge about BPH and its treatments;
3. Greater patient willingness to participate in treatment decisions:
4. A change in treatment decisions;
5. Greater patient satisfaction with both the decisions made and the
process of decision-making.
6. More weight in decision-making placed on patient preferences.
To provide adequate power for the study, 200 men will be enrolled in the
baseline period and 400 men will subsequently be randomized. All men will
be followed for at least nine months after enrolling. The project duration
will be three years.
Although the SDP approach has great face validity and is readily
generalized to other medical problems besides BPH, a formal test of its
efficacy in actual practice is essential.
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