Standardized Collection of Patient Reported Outcomes (PROs) in Everyday Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Change in bladder function/micturition (IPSS: International Prostate Symptom Score)
研究概览
简要总结
All patients undergoing urological surgery or treatment should receive standardized questionnaires on quality of life, satisfaction, pain and physical recovery. Indication-specific, individual pathways are set up, for example, for patients with localized prostate cancer, benign prostate enlargement, bladder dysfunction or erectile dysfunction. In combination with the clinical data, the PROM data should help to improve the quality of the results and, if necessary, adapt treatment pathways to patient needs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated at the Department of Urology
- •≥18 years of age
- •Active Mail-account, use of smartphone/tablet/PC
- •Written informed consent
排除标准
- •Patients who cannot give written consent and/or do not have digital competence (e.g. no active e-mail account)
结局指标
主要结局
Change in bladder function/micturition (IPSS: International Prostate Symptom Score)
时间窗: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years
Electronically recorded Patient Reported Outcomes (PROs) are captured for each patient depending on the condition and surgery/treatment. IPSS: score 0-35; greater values indicates increased symptom severity
Change in functional treatment outcome in patients with prostate cancer, assessed by EPIC-26: (Expanded Prostate cancer Index Composite)
时间窗: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years
Electronically recorded Patient Reported Outcomes (PROs) are captured for each patient depending on the condition and surgery/treatment EPIC-26 score: max 100 points; greater values indicate improved functional outcomes
Change in health-related quality of life (PROMIS-10: Patient-Reported Outcomes Measurement Information System)
时间窗: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years
Electronically recorded Patient Reported Outcomes (PROs) are captured for each patient depending on the condition and surgery/treatment. PROMIS-10 max 50 points; greater values indicate healthier status
Change in erectile function (IIEF: International Index of Erectile Function)
时间窗: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years
Electronically recorded Patient Reported Outcomes (PROs) are captured for each patient depending on the condition and surgery/treatment. IEF: 0-25 points; greater values indicate better ercetile function
Change in bladder function/micturition (OAB-SF: Overactive Bladder Questionnaire, short form)
时间窗: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years
Electronically recorded Patient Reported Outcomes (PROs) are captured for each patient depending on the condition and surgery/treatment. OAB-SF: score 0 - 16; score with greater values indicates increased symptom severity
Change in pelvic pain (NHS-CPSI: Chronic prostatits symptom index)
时间窗: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years
Electronically recorded Patient Reported Outcomes (PROs) are captured for each patient depending on the condition and surgery/treatment. NHS-CSI: 0-43 points; greater values indicate worse outcomes
Change in pain: Brief Pain Inventory (BPI)
时间窗: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years
Electronically recorded Patient Reported Outcomes (PROs) are captured for each patient depending on the condition and surgery/treatment. BPI: max. 11 points; greater values indicate worse outcome
Change in bladder function/micturition (ICIQ-UI: International Consultation on Incontinence Questionnaire-Urinary Incontinence)
时间窗: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years
Electronically recorded Patient Reported Outcomes (PROs) are captured for each patient depending on the condition and surgery/treatment. ICIQ-UI: score 0-21; greater values indicate worse urinary incontinence
次要结局
- patient characteristics: age(Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years)
- patient characteristics: disease-specific data (tumor histology, oncologic status)(Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years)
- patient characteristics:comorbidities(Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years)
- Perioperative data: duration of sugery (minutes)(during surgery, surgery time depending on the disease (30 minutes to 4 hours))
- Perioperative data: blood loss (ml)(during surgery, surgery time depending on the disease (30 minutes to 4 hours))
- Perioperative data: transfusion (ml(during surgery, surgery time depending on the disease (30 minutes to 4 hours))
- patient characteristics: medication (name, type, dose, interval)(Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years)
- Perioperative data: length of hospital stay (days)(depending on the disease and following surgery (1 to 10 days))