■推荐保守治疗作为男性下尿路症状的初始治疗。然而,缺乏关于交付方法的有效性和不确定性的证据。
■目的是确定在初级保健中实施的标准化和人工护理干预措施是否能在下尿路症状方面取得优于常规护理的症状结果。
■这是一项双臂集群随机对照试验。
■该试验在英格兰的30个NHS一般实践地点进行。
■参与者是成年男性(年龄≥18岁),下尿路症状令人烦恼。
以1:1的比例随机分组,使用非药物和非手术干预试验干预或常规护理,向所有参与者提供初级卫生保健中男性的TReatIng泌尿系统症状。使用非药物和非手术干预措施的初级卫生保健中男性的TReatIng泌尿症状包括英国泌尿外科医师协会为该试验开发的标准化建议手册,与病人和专家的输入。患者在排尿症状评估后,由全科医生或研究护士/医疗助理指导到相关部门。提供手工元素。医疗保健专业人员提供了超过12周的随访联系,以支持对干预的坚持。
■主要结果是同意后12个月经验证的患者报告的国际前列腺症状评分。而不是最小的临床重要差异3.0分的整体国际前列腺症状评分,样本量旨在检测2.0点的差异,由于个别症状的公认临床影响。
■共有1077名男性同意这项研究:524名随机分配到干预组(n=17),553名随机分配到对照组(n=13)。发现12个月时平均国际前列腺症状评分存在差异(调整后的平均差为-1.81分,95%置信区间-2.66至-0.95点),干预手臂得分较低,表明症状不太严重。患者报告的泌尿症状的次要结果,特定于下尿路症状的生活质量和对下尿路症状的感知都显示出有利于干预的两组之间存在差异的证据。两组之间的泌尿科转诊或不良事件比例没有差异。在定性采访中,与会者对干预表示欢迎,描述对他们症状的积极影响,以及他们对保守护理的理解和对下尿路症状经验的态度。访谈强调了结构化,深入的自我管理在全科医生咨询中的嵌入不足。从NHS的角度来看,试验组之间的平均费用和质量调整寿命年相似.干预组的平均成本略低(调整后的平均差为-29.99英镑,95%置信区间-109.84英镑至22.63英镑),质量调整寿命年的小幅增加(调整平均差为0.001,95%置信区间-0.011至0.014)。
■干预显示,在英国初级保健机构的一系列结局指标中,男性下尿路症状和生活质量的持续获益。定性数据显示,男性高度重视干预措施。干预费用略低于常规护理费用。该研究的局限性包括试验参与者被揭露,种族多样性和贫困程度有限。需要进行更多的研究来评估干预措施对更多种族人群的适用性。.
■本试验注册为ISRCTN11669964。
■该奖项由美国国家卫生与护理研究所(NIHR)卫生技术评估计划(NIHR奖参考:16/90/03)资助,并在《卫生技术评估》中全文发表;卷。28号13.有关更多奖项信息,请参阅NIHR资助和奖励网站。
随着年龄的增长,男性的泌尿系统问题变得越来越普遍。所有年龄>65岁的男性中,近三分之一会出现一些泌尿症状,这会对他们的日常生活产生重大影响。症状包括需要更频繁地通过尿液,紧急或在夜间,和排尿困难。男性通常由全科医生诊断和治疗,在尝试药片或手术之前,应提供有关控制症状的建议(例如生活方式的改变和锻炼)。然而,不知道这样的建议有多有用,以及一般实践如何有效地提供它。英格兰西部和威塞克斯的30种一般做法参加了这项研究。实践分为两组,每个实践提供TReatIng男性在初级保健中使用非药物和非手术干预护理包或实践的常规护理的所有患者在试验中。使用非药物和非手术干预护理包的初级医疗保健男性的TReatIng泌尿系统症状包括一本帮助控制泌尿系统症状的建议手册,护士或医疗助理根据男性的症状指导他们到相关部门,并提供后续联系。我们主要使用非药物和非手术干预护理包评估初级保健男性泌尿系统症状的益处。与常规护理相比,通过使用参与者完成的泌尿症状问卷。共有1077名患有泌尿系统症状的男性参与了这项研究。主要结果是,与常规护理相比,使用TRIUMPH护理包对男性的泌尿症状改善更大。加入研究后12个月。我们还发现,接受TRIUMPH护理包的男性在生活质量和泌尿症状方面略有改善。两组转院治疗的患者人数无差异,类型,副作用的数量和严重程度或NHS的费用。总的来说,TRIUMPH护理套餐在治疗有泌尿症状的男性方面比常规治疗更有效.
UNASSIGNED: Conservative therapies are recommended as initial treatment for male lower urinary tract symptoms. However, there is a lack of evidence on effectiveness and uncertainty regarding approaches to delivery.
UNASSIGNED: The objective was to determine whether or not a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for lower urinary tract symptoms to usual care.
UNASSIGNED: This was a two-arm cluster randomised controlled trial.
UNASSIGNED: The trial was set in 30 NHS general practice sites in England.
UNASSIGNED: Participants were adult men (aged ≥ 18 years) with bothersome lower urinary tract symptoms.
UNASSIGNED: Sites were randomised 1 : 1 to deliver the TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions trial intervention or usual care to all participants. The TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions intervention comprised a standardised advice booklet developed for the trial from the British Association of Urological Surgeons\' patient information sheets, with patient and expert input. Patients were directed to relevant sections by general practice or research nurses/healthcare assistants following urinary symptom assessment, providing the manualised element. The healthcare professional provided follow-up contacts over 12 weeks to support adherence to the intervention.
UNASSIGNED: The primary outcome was the validated patient-reported International Prostate Symptom Score 12 months post consent. Rather than the minimal clinically important difference of 3.0 points for overall International Prostate Symptom Score, the sample size aimed to detect a difference of 2.0 points, owing to the recognised clinical impact of individual symptoms.
UNASSIGNED: A total of 1077 men consented to the study: 524 in sites randomised to the intervention arm (n = 17) and 553 in sites randomised to the control arm (n = 13). A difference in mean International Prostate Symptom Score at 12 months was found (adjusted mean difference of -1.81 points, 95% confidence interval -2.66 to -0.95 points), with a lower score in the intervention arm, indicating less severe symptoms. Secondary outcomes of patient-reported urinary symptoms, quality of life specific to lower urinary tract symptoms and perception of lower urinary tract symptoms all showed evidence of a difference between the arms favouring the intervention. No difference was seen between the arms in the proportion of urology referrals or adverse events. In qualitative interviews, participants welcomed the intervention, describing positive effects on their symptoms, as well as on their understanding of conservative care and their attitude towards the experience of lower urinary tract symptoms. The interviews highlighted that structured, in-depth self-management is insufficiently embedded within general practitioner consultations. From an NHS perspective, mean costs and quality-adjusted life-years were similar between trial arms. The intervention arm had slightly lower mean costs (adjusted mean difference of -£29.99, 95% confidence interval -£109.84 to £22.63) than the usual-care arm, and a small gain in quality-adjusted life-years (adjusted mean difference of 0.001, 95% confidence interval -0.011 to 0.014).
UNASSIGNED: The intervention showed a small, sustained benefit for men\'s lower urinary tract symptoms and quality of life across a range of outcome measures in a UK primary care setting. Qualitative data showed that men highly valued the intervention. Intervention costs were marginally lower than usual-care costs. Limitations of the study included that trial participants were unmasked, with limited diversity in ethnicity and deprivation level. Additional research is needed to assess the applicability of the intervention for a more ethnically diverse population..
UNASSIGNED: This trial is registered as ISRCTN11669964.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/90/03) and is published in full in Health Technology Assessment; Vol. 28, No. 13. See the NIHR Funding and Awards website for further award information.
Urinary problems among men become more common with age. Nearly one-third of all men aged > 65 years experience some urinary symptoms, which can have a substantial effect on their daily lives. Symptoms include needing to pass urine more often, urgently or during the night, and difficulties in passing urine. Men are usually diagnosed and treated by their general practitioner, and should be offered advice on controlling their symptoms themselves (e.g. lifestyle changes and exercises) before trying tablets or surgery. However, it is not known how helpful such advice is, and how general practices can effectively provide it. Thirty general practices in the West of England and Wessex took part in the study. Practices were split into two groups, with each practice providing either the TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions care package or the practice’s usual care to all of its patients in the trial. The TReatIng Urinary symptoms in Men in Primary Healthcare using nonpharmacological and non-surgical interventions care package included a booklet of advice to help control urinary symptoms, with a nurse or healthcare assistant directing men to relevant sections according to their symptoms, and providing follow-up contacts. We mainly assessed the benefits of the TReatIng Urinary symptoms in Men in Primary Healthcare using nonpharmacological and non-surgical interventions care package, compared with usual care, by using a questionnaire on urinary symptoms completed by participants. A total of 1077 men with urinary symptoms that bothered them joined the study. The main result was that men reported greater improvement in urinary symptoms with the TRIUMPH care package than with usual care, 12 months after joining the study. We also found that men receiving the TRIUMPH care package had a slight improvement in quality of life and outlook on their urinary symptoms. There was no difference between the two groups in the number of patients referred to hospital for treatment, the type, number and severity of side effects or cost to the NHS. Overall, the TRIUMPH care package was more effective in treating men with urinary symptoms than usual care by their general practice.