Clinical Evaluation of the Benefits of the MiProstate Platform: Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,329
- 试验地点
- 1
- 主要终点
- Pre-operative conference quality
研究概览
简要总结
This is an observational cohort study with a non-concurrent comparison group evaluating the use of a digital decision support tool (MiProstate/ISPM) at pre-prostatectomy, multidisciplinary conferences.
详细描述
In the study cohort, all clinically relevant data on patients undergoing radical prostatectomy at Karolinska University Hospital were registered on the platform and subsequently presented using the platform at the conferences in which a detailed treatment plan was devised for each patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All patients planned for prostatectomy and discussed at pre-operative conference at Karolinska University Hospital
排除标准
- 未提供
结局指标
主要结局
Pre-operative conference quality
时间窗: Recorded at pre-operative conference held <30 days prior to surgery
Quality of pre-operative conference as measured by MDT-MODe (MultiDisciplinary Therapy conference - Metric Of Decision Making) score assigned by an external observer. After prostate cancer diagnosis, work-up, and the decision to offer the patient surgical treatment with curative intent, a conference is held in which surgical strategies are discussed.
Efficiency - time spent in pre-operative conference
时间窗: Recorded at pre-operative conference held <30 days prior to surgery
Time spent per patient in pre-operative, multidisciplinary conference, measured by an external observer. After prostate cancer diagnosis, work-up, and the decision to offer the patient surgical treatment with curative intent, a conference is held in which surgical strategies are discussed.
次要结局
- PROM1 - patient-reported outcome measure on urinary function(At 12 months post surgery (11-18 months is tolerated))
- PLND - pelvic lymph node dissection strategy(Recorded at pre-operative conference (<30 days prior to surgery))
- PSM - positive surgical margin(At surgery. Reported within 30 days after surgery)
- PROM2 -patient-reported outcome measure on erectile function(At 12 months post surgery (11-18 months is tolerated))
- Nerve-sparing strategy(Recorded at pre-operative conference (<30 days prior to surgery))
研究者
Olof Akre
Professor
Karolinska University Hospital