Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life
Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life
复制标题
DOI：
10.1111/bju.13582
复制
发表时间：
2016-12-01
影响因子：
4.5
通讯作者：
Donovan, Jenny L.
中科院分区：
文献类型：
--
作者：
Lane, Athene;Metcalfe, Chris;Donovan, Jenny L.
目的：在前列腺癌检测和治疗（ProtecT）随机试验中，比较主动监测、根治性前列腺切除术和外束适形放疗治疗局限性前列腺癌的基线患者报告结果（PROMs），并与其他人群的结果进行比较。材料与方法1999-2009年英国9个城市随机选取1643名年龄在50-69岁、经前列腺特异性抗原（PSA）检测诊断为临床局限性疾病的男性。经验证的PROMs对特定疾病（尿、肠和性功能）和特定疾病对生活质量的影响(扩展前列腺指数综合[EPIC]， 2005年起；国际尿失禁问卷咨询-尿失禁[ICIQ-UI]， 2001年起；国际尿失禁协会简短男性调查[icsmallesf]；在随机分组前，对前列腺活检诊所的焦虑和抑郁（医院焦虑和抑郁量表[HADS]）、一般精神和身体健康（12项简短健康调查[SF-12]； EuroQol生活质量调查，EQ-5D-3L）进行评估。描述性统计数据由治疗分配和男性年龄在活检和PSA测试时间点所选择的措施。结果共有1438名参与者（88%）完成了活检问卷，其中77-88%的人对个体prom进行了分析。少于1%的参与者每天使用卫生巾（5/754）。储物性下尿路症状常见（如夜尿症22%，312/1423）。除稀便外，肠道症状罕见（16%,118/754）。三分之一的参与者报告勃起功能障碍（241/735），16%（118/731）的参与者报告勃起功能障碍是中度或重度问题。抑郁不常见（80/ 1399,6 %），但20%的参与者（278/1403）报告焦虑。年龄较大的男性（6570岁）的性功能和尿障碍明显较年轻男性（49-54岁）差，而尿障碍和身体健康状况略差，P均< 0.001。肠道健康、泌尿功能和抑郁不受年龄的影响，而老年男性的心理健康和焦虑更好（P < 0.001）。PSA检测和活检评估在精神或身体健康、焦虑和抑郁方面仅存在微小差异。结论ProtecT试验的基线PROMs应答率较高。症状频率和一般生活质量与前列腺癌筛查人群和无癌对照人群的观察结果相似。
ObjectivesTo present the baseline patient-reported outcome measures (PROMs) in the Prostate Testing for Cancer and Treatment (ProtecT) randomized trial comparing active monitoring, radical prostatectomy and external-beam conformal radiotherapy for localized prostate cancer and to compare results with other populations.Materials and MethodsA total of 1643 randomized men, aged 50-69 years and diagnosed with clinically localized disease identified by prostate-specific antigen (PSA) testing, in nine UK cities in the period 1999-2009 were included. Validated PROMs for disease-specific (urinary, bowel and sexual function) and condition-specific impact on quality of life (Expanded Prostate Index Composite [EPIC], 2005 onwards; International Consultation on Incontinence Questionnaire-Urinary Incontinence [ICIQ-UI], 2001 onwards; the International Continence Society short-form male survey [ICSmaleSF]; anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), generic mental and physical health (12-item short-form health survey [SF-12]; EuroQol quality-of-life survey, the EQ-5D-3L) were assessed at prostate biopsy clinics before randomization. Descriptive statistics are presented by treatment allocation and by men's age at biopsy and PSA testing time points for selected measures.ResultsA total of 1438 participants completed biopsy questionnaires (88%) and 77-88% of these were analysed for individual PROMs. Fewer than 1% of participants were using pads daily (5/754). Storage lower urinary tract symptoms were frequent (e.g. nocturia 22%, 312/1423). Bowel symptoms were rare, except for loose stools (16%, 118/754). One third of participants reported erectile dysfunction (241/735) and for 16% (118/731) this was a moderate or large problem. Depression was infrequent (80/1399, 6%) but 20% of participants (278/1403) reported anxiety. Sexual function and bother were markedly worse in older men (6570 years), whilst urinary bother and physical health were somewhat worse than in younger men (49-54 years, all P < 0.001). Bowel health, urinary function and depression were unaltered by age, whilst mental health and anxiety were better in older men (P < 0.001). Only minor differences existed in mental or physical health, anxiety and depression between PSA testing and biopsy assessments.ConclusionThe ProtecT trial baseline PROMs response rates were high. Symptom frequencies and generic quality of life were similar to those observed in populations screened for prostate cancer and control subjects without cancer.