开发用于男性下尿路症状初级保健管理的临床决策支持工具:PriMUS研究

IF 4 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Adrian Edwards, Ridhi Agarwal, Janine Bates, Alison Bray, Sarah Milosevic, Emma Thomas-Jones, Michael Drinnan, Marcus Drake, Peter Michell, Bethan Pell, Haroon Ahmed, Natalie Joseph-Williams, Kerenza Hood, Yemisi Takwoingi, Chris Harding
{"title":"开发用于男性下尿路症状初级保健管理的临床决策支持工具:PriMUS研究","authors":"Adrian Edwards, Ridhi Agarwal, Janine Bates, Alison Bray, Sarah Milosevic, Emma Thomas-Jones, Michael Drinnan, Marcus Drake, Peter Michell, Bethan Pell, Haroon Ahmed, Natalie Joseph-Williams, Kerenza Hood, Yemisi Takwoingi, Chris Harding","doi":"10.3310/RGTW5711","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Lower urinary tract symptoms particularly affect older men and their quality of life. General practitioners currently have no easily available assessment tools to diagnose lower urinary tract symptom causes. Referrals to urology specialists are increasing. General practitioner access to simple, accurate tests and clinical decision tools could facilitate management of lower urinary tract symptoms in primary care.</p><p><strong>Objectives: </strong>To determine which of several index tests in combination, best predicted three diagnoses (detrusor overactivity, bladder outlet obstruction and/or detrusor underactivity) in men presenting with lower urinary tract symptoms in primary care. To develop and validate three diagnostic prediction models, and a prototype primary care clinical decision support tool.</p><p><strong>Design: </strong>Prospective diagnostic accuracy study. Two participant cohorts, for <i>development</i> and <i>validation</i>, underwent simple index tests and a reference standard (invasive urodynamics).</p><p><strong>Setting: </strong>General practices in England and Wales.</p><p><strong>Participants: </strong>Men (16 years and over) consulting their general practitioner with lower urinary tract symptoms.</p><p><strong>Sample size: </strong>Separate calculations for model development and validation cohorts, from literature estimates of detrusor overactivity, bladder outlet obstruction and detrusor underactivity prevalences of 57%, 31% and 16%, respectively.</p><p><strong>Predictors and index tests: </strong>Twelve potential predictors considered for three diagnostic models.</p><p><strong>Main outcome measures: </strong>The primary outcome was diagnostic model sensitivity and specificity for detecting bladder outlet obstruction, detrusor underactivity and detrusor overactivity, with 75.0% considered minimum clinically useful performance.</p><p><strong>Statistical analysis: </strong>Three separate logistic regression models generated with index test variables to predict the presence of bladder outlet obstruction, detrusor overactivity, detrusor underactivity conditions in men with lower urinary tract symptoms.</p><p><strong>Results: </strong>One model each was developed and validated for bladder outlet obstruction and detrusor underactivity, two for detrusor overactivity (detrusor overactivity main, detrusor overactivity sensitivity analysis 2). Age, voiding symptoms subscore, prostate-specific antigen level, median maximum flow rate, median voided volume were predictors for bladder outlet obstruction. Median maximum flow rate and post-void residual volume were predictors for detrusor underactivity. Age, post-void residual volume and median voided volume were included in detrusor overactivity main model, while age and storage symptoms subscore predicted detrusor overactivity sensitivity analysis 2. For all four models, sensitivity of 75.0% could be achieved with a specificity of 74.2%, 47.3%, 45.6% and 46.2% for bladder outlet obstruction, detrusor underactivity, detrusor overactivity main and detrusor overactivity sensitivity analysis 2 models, respectively. Similarly, a specificity of 75.0% could be achieved with a sensitivity of 71.3%, 39.8%, 33.3% and 62.7% for bladder outlet obstruction, detrusor underactivity, detrusor overactivity main and detrusor overactivity sensitivity analysis 2 models, respectively. The prototype tool (not yet intended for use in practice) is available at Primary care Management of lower Urinary tract Symptoms decision aid for lower urinary tract symptoms (shinyapps.io). General practitioner feedback during tool development and small-scale user-testing in simulated consultation scenarios was favourable. Patients supported such management in primary care.</p><p><strong>Strengths/limitations: </strong>This was a prospective, multicentre study in an appropriate primary care population. Most of the index tests are possible routinely in primary care or at home by patients. The diagnostic models were validated in a separate cohort from the same population. Limitations include that target condition prevalences may differ in other populations.</p><p><strong>Conclusion: </strong>We identified sensitivities and specificities of diagnostic models for detrusor overactivity, bladder outlet obstruction and detrusor underactivity in routine United Kingdom practice and developed a prototype clinical decision support tool.</p><p><strong>Future work: </strong>Economic modelling, a feasibility trial and powered randomised controlled trial are needed to evaluate the Primary care Management of lower Urinary tract Symptoms tool in practice.</p><p><strong>Study registration: </strong>Current Controlled Trials ISRCTN10327305.</p><p><strong>Funding: </strong>This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/40/05) and is published in full in <i>Health Technology Assessment</i>; Vol. 29, No. 1. See the NIHR Funding and Awards website for further award information.</p>","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"29 1","pages":"1-140"},"PeriodicalIF":4.0000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11874884/pdf/","citationCount":"0","resultStr":"{\"title\":\"Development of a clinical decision support tool for Primary care Management of lower Urinary tract Symptoms in men: the PriMUS study.\",\"authors\":\"Adrian Edwards, Ridhi Agarwal, Janine Bates, Alison Bray, Sarah Milosevic, Emma Thomas-Jones, Michael Drinnan, Marcus Drake, Peter Michell, Bethan Pell, Haroon Ahmed, Natalie Joseph-Williams, Kerenza Hood, Yemisi Takwoingi, Chris Harding\",\"doi\":\"10.3310/RGTW5711\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Lower urinary tract symptoms particularly affect older men and their quality of life. General practitioners currently have no easily available assessment tools to diagnose lower urinary tract symptom causes. Referrals to urology specialists are increasing. General practitioner access to simple, accurate tests and clinical decision tools could facilitate management of lower urinary tract symptoms in primary care.</p><p><strong>Objectives: </strong>To determine which of several index tests in combination, best predicted three diagnoses (detrusor overactivity, bladder outlet obstruction and/or detrusor underactivity) in men presenting with lower urinary tract symptoms in primary care. To develop and validate three diagnostic prediction models, and a prototype primary care clinical decision support tool.</p><p><strong>Design: </strong>Prospective diagnostic accuracy study. Two participant cohorts, for <i>development</i> and <i>validation</i>, underwent simple index tests and a reference standard (invasive urodynamics).</p><p><strong>Setting: </strong>General practices in England and Wales.</p><p><strong>Participants: </strong>Men (16 years and over) consulting their general practitioner with lower urinary tract symptoms.</p><p><strong>Sample size: </strong>Separate calculations for model development and validation cohorts, from literature estimates of detrusor overactivity, bladder outlet obstruction and detrusor underactivity prevalences of 57%, 31% and 16%, respectively.</p><p><strong>Predictors and index tests: </strong>Twelve potential predictors considered for three diagnostic models.</p><p><strong>Main outcome measures: </strong>The primary outcome was diagnostic model sensitivity and specificity for detecting bladder outlet obstruction, detrusor underactivity and detrusor overactivity, with 75.0% considered minimum clinically useful performance.</p><p><strong>Statistical analysis: </strong>Three separate logistic regression models generated with index test variables to predict the presence of bladder outlet obstruction, detrusor overactivity, detrusor underactivity conditions in men with lower urinary tract symptoms.</p><p><strong>Results: </strong>One model each was developed and validated for bladder outlet obstruction and detrusor underactivity, two for detrusor overactivity (detrusor overactivity main, detrusor overactivity sensitivity analysis 2). Age, voiding symptoms subscore, prostate-specific antigen level, median maximum flow rate, median voided volume were predictors for bladder outlet obstruction. Median maximum flow rate and post-void residual volume were predictors for detrusor underactivity. Age, post-void residual volume and median voided volume were included in detrusor overactivity main model, while age and storage symptoms subscore predicted detrusor overactivity sensitivity analysis 2. For all four models, sensitivity of 75.0% could be achieved with a specificity of 74.2%, 47.3%, 45.6% and 46.2% for bladder outlet obstruction, detrusor underactivity, detrusor overactivity main and detrusor overactivity sensitivity analysis 2 models, respectively. Similarly, a specificity of 75.0% could be achieved with a sensitivity of 71.3%, 39.8%, 33.3% and 62.7% for bladder outlet obstruction, detrusor underactivity, detrusor overactivity main and detrusor overactivity sensitivity analysis 2 models, respectively. The prototype tool (not yet intended for use in practice) is available at Primary care Management of lower Urinary tract Symptoms decision aid for lower urinary tract symptoms (shinyapps.io). General practitioner feedback during tool development and small-scale user-testing in simulated consultation scenarios was favourable. Patients supported such management in primary care.</p><p><strong>Strengths/limitations: </strong>This was a prospective, multicentre study in an appropriate primary care population. Most of the index tests are possible routinely in primary care or at home by patients. The diagnostic models were validated in a separate cohort from the same population. Limitations include that target condition prevalences may differ in other populations.</p><p><strong>Conclusion: </strong>We identified sensitivities and specificities of diagnostic models for detrusor overactivity, bladder outlet obstruction and detrusor underactivity in routine United Kingdom practice and developed a prototype clinical decision support tool.</p><p><strong>Future work: </strong>Economic modelling, a feasibility trial and powered randomised controlled trial are needed to evaluate the Primary care Management of lower Urinary tract Symptoms tool in practice.</p><p><strong>Study registration: </strong>Current Controlled Trials ISRCTN10327305.</p><p><strong>Funding: </strong>This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/40/05) and is published in full in <i>Health Technology Assessment</i>; Vol. 29, No. 1. See the NIHR Funding and Awards website for further award information.</p>\",\"PeriodicalId\":12898,\"journal\":{\"name\":\"Health technology assessment\",\"volume\":\"29 1\",\"pages\":\"1-140\"},\"PeriodicalIF\":4.0000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11874884/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Health technology assessment\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3310/RGTW5711\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Health technology assessment","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3310/RGTW5711","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0

摘要

背景:下尿路症状尤其影响老年男性及其生活质量。全科医生目前没有容易获得的评估工具来诊断下尿路症状的原因。向泌尿科专家的转诊正在增加。全科医生获得简单,准确的测试和临床决策工具可以促进初级保健下尿路症状的管理。目的:确定几种指标试验组合中哪一种最能预测初级保健中出现下尿路症状的男性的三种诊断(逼尿肌过度活动、膀胱出口梗阻和/或逼尿肌活动不足)。开发并验证三个诊断预测模型,以及一个初级保健临床决策支持工具的原型。设计:前瞻性诊断准确性研究。为了开发和验证,两个参与者队列进行了简单的指数测试和参考标准(侵入性尿动力学)。背景:英格兰和威尔士的全科医生。参与者:男性(16岁及以上)咨询他们的全科医生下尿路症状。样本量:分别计算模型开发和验证队列,根据文献估计,逼尿肌过度活动、膀胱出口梗阻和逼尿肌活动不足的患病率分别为57%、31%和16%。预测因子和指数测试:考虑了三种诊断模型的十二个潜在预测因子。主要结局指标:主要结局是诊断模型检测膀胱出口梗阻、逼尿肌活动不足和逼尿肌过度活动的敏感性和特异性,其中75.0%认为最低临床有用性能。统计分析:用指数检验变量生成三个独立的logistic回归模型,预测有下尿路症状的男性是否存在膀胱出口梗阻、逼尿肌过度活动、逼尿肌活动不足的情况。结果:膀胱出口梗阻和逼尿肌活动不足各建立一个模型并验证,逼尿肌过度活动两个模型(主要是逼尿肌过度活动,逼尿肌过度活动敏感性分析2)。年龄、排尿症状亚评分、前列腺特异性抗原水平、中位最大流速、中位排尿量是膀胱出口梗阻的预测因素。中位最大流速和空隙后残留体积是逼尿肌活动不足的预测指标。年龄、空洞后残留体积和中位空洞体积被纳入逼尿肌过度活动主模型,年龄和储存症状分预测逼尿肌过度活动敏感性分析2。4种模型对膀胱出口梗阻、逼尿肌活动不足、主逼尿肌过度活动和逼尿肌过度活动敏感性分析2种模型的特异性分别为74.2%、47.3%、45.6%和46.2%,敏感性分析均可达到75.0%。同样,膀胱出口梗阻、逼尿肌活动不足、主逼尿肌过度活动和逼尿肌过度活动敏感性分析2种模型的特异性为75.0%,敏感性分别为71.3%、39.8%、33.3%和62.7%。原型工具(尚未打算在实践中使用)可在下尿路症状的初级保健管理决策辅助下尿路症状(shinyapps.io)。全科医生在工具开发和模拟会诊场景的小规模用户测试期间的反馈是有利的。患者支持在初级保健中采用这种管理方法。优势/局限性:这是一项在适当的初级保健人群中进行的前瞻性、多中心研究。大多数指数测试都可以在初级保健或患者家中进行常规测试。诊断模型在来自同一人群的单独队列中得到验证。局限性包括目标疾病患病率在其他人群中可能有所不同。结论:我们在英国的常规实践中确定了逼尿肌过度活动、膀胱出口阻塞和逼尿肌活动不足的诊断模型的敏感性和特异性,并开发了一个原型临床决策支持工具。未来的工作:需要经济建模、可行性试验和随机对照试验来评估下尿路症状的初级保健管理工具在实践中的应用。研究注册:当前对照试验ISRCTN10327305。资助:该奖项由美国国立卫生与保健研究所(NIHR)卫生技术评估项目(NIHR奖励编号:15/40/05)资助,全文发表在《卫生技术评估》杂志上;第29卷第1期有关进一步的奖励信息,请参阅美国国立卫生研究院资助和奖励网站。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development of a clinical decision support tool for Primary care Management of lower Urinary tract Symptoms in men: the PriMUS study.

Background: Lower urinary tract symptoms particularly affect older men and their quality of life. General practitioners currently have no easily available assessment tools to diagnose lower urinary tract symptom causes. Referrals to urology specialists are increasing. General practitioner access to simple, accurate tests and clinical decision tools could facilitate management of lower urinary tract symptoms in primary care.

Objectives: To determine which of several index tests in combination, best predicted three diagnoses (detrusor overactivity, bladder outlet obstruction and/or detrusor underactivity) in men presenting with lower urinary tract symptoms in primary care. To develop and validate three diagnostic prediction models, and a prototype primary care clinical decision support tool.

Design: Prospective diagnostic accuracy study. Two participant cohorts, for development and validation, underwent simple index tests and a reference standard (invasive urodynamics).

Setting: General practices in England and Wales.

Participants: Men (16 years and over) consulting their general practitioner with lower urinary tract symptoms.

Sample size: Separate calculations for model development and validation cohorts, from literature estimates of detrusor overactivity, bladder outlet obstruction and detrusor underactivity prevalences of 57%, 31% and 16%, respectively.

Predictors and index tests: Twelve potential predictors considered for three diagnostic models.

Main outcome measures: The primary outcome was diagnostic model sensitivity and specificity for detecting bladder outlet obstruction, detrusor underactivity and detrusor overactivity, with 75.0% considered minimum clinically useful performance.

Statistical analysis: Three separate logistic regression models generated with index test variables to predict the presence of bladder outlet obstruction, detrusor overactivity, detrusor underactivity conditions in men with lower urinary tract symptoms.

Results: One model each was developed and validated for bladder outlet obstruction and detrusor underactivity, two for detrusor overactivity (detrusor overactivity main, detrusor overactivity sensitivity analysis 2). Age, voiding symptoms subscore, prostate-specific antigen level, median maximum flow rate, median voided volume were predictors for bladder outlet obstruction. Median maximum flow rate and post-void residual volume were predictors for detrusor underactivity. Age, post-void residual volume and median voided volume were included in detrusor overactivity main model, while age and storage symptoms subscore predicted detrusor overactivity sensitivity analysis 2. For all four models, sensitivity of 75.0% could be achieved with a specificity of 74.2%, 47.3%, 45.6% and 46.2% for bladder outlet obstruction, detrusor underactivity, detrusor overactivity main and detrusor overactivity sensitivity analysis 2 models, respectively. Similarly, a specificity of 75.0% could be achieved with a sensitivity of 71.3%, 39.8%, 33.3% and 62.7% for bladder outlet obstruction, detrusor underactivity, detrusor overactivity main and detrusor overactivity sensitivity analysis 2 models, respectively. The prototype tool (not yet intended for use in practice) is available at Primary care Management of lower Urinary tract Symptoms decision aid for lower urinary tract symptoms (shinyapps.io). General practitioner feedback during tool development and small-scale user-testing in simulated consultation scenarios was favourable. Patients supported such management in primary care.

Strengths/limitations: This was a prospective, multicentre study in an appropriate primary care population. Most of the index tests are possible routinely in primary care or at home by patients. The diagnostic models were validated in a separate cohort from the same population. Limitations include that target condition prevalences may differ in other populations.

Conclusion: We identified sensitivities and specificities of diagnostic models for detrusor overactivity, bladder outlet obstruction and detrusor underactivity in routine United Kingdom practice and developed a prototype clinical decision support tool.

Future work: Economic modelling, a feasibility trial and powered randomised controlled trial are needed to evaluate the Primary care Management of lower Urinary tract Symptoms tool in practice.

Study registration: Current Controlled Trials ISRCTN10327305.

Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/40/05) and is published in full in Health Technology Assessment; Vol. 29, No. 1. See the NIHR Funding and Awards website for further award information.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Health technology assessment
Health technology assessment 医学-卫生保健
CiteScore
6.90
自引率
0.00%
发文量
94
审稿时长
>12 weeks
期刊介绍: Health Technology Assessment (HTA) publishes research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信