RANOMIZED TRIAL OF THE SDP FOR PATIENTS WITH BPH
RANOMIZED TRIAL OF THE SDP FOR PATIENTS WITH BPH
批准号:
3372228
负责人:
MICHAEL J BARRY
金额:
$39.92万
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
点击翻译按钮获取中文摘要
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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