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Exploring the role of health-related quality of life measures in predictive modelling for oncology: a systematic review. 探索与健康相关的生活质量测量在肿瘤学预测模型中的作用:一项系统综述。
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-12-09 DOI: 10.1007/s11136-024-03820-y
T G W van der Heijden, K M de Ligt, N J Hubel, S van der Mierden, B Holzner, L V van de Poll-Franse, B H de Rooij

Health related quality of life (HRQoL) is increasingly assessed in oncology research and routine care, which has led to the inclusion of HRQoL in prediction models. This review aims to describe the current state of oncological prediction models incorporating HRQoL. A systematic literature search for the inclusion of HRQoL in prediction models in oncology was conducted. Selection criteria were a longitudinal study design and inclusion of HRQoL data in prediction models as predictor, outcome, or both. Risk of bias was assessed using the PROBAST tool and quality of reporting was scored with an adapted TRIPOD reporting guideline. From 4747 abstracts, 98 records were included in this review. High risk of bias was found in 71% of the publications. HRQoL was mainly incorporated as predictor (78% (55% predictor only, 23% both predictor and outcome)), with physical functioning and symptom domains selected most frequently as predictor. Few models (23%) predicted HRQoL domains by other or baseline HRQoL domains. HRQoL was used as outcome in 21% of the publications, with a focus on predicting symptoms. There were no difference between AI-based (16%) and classical methods (84%) in model type selection or model performance when using HRQoL data. This review highlights the role of HRQoL as a tool in predicting disease outcomes. Prediction of and with HRQoL is still in its infancy as most of the models are not fully developed. Current models focus mostly on the physical aspects of HRQoL to predict clinical outcomes, and few utilize AI-based methods.

与健康相关的生活质量(HRQoL)在肿瘤学研究和日常护理中得到越来越多的评估,这促使人们将 HRQoL 纳入预测模型中。本综述旨在描述纳入 HRQoL 的肿瘤预测模型的现状。我们对将 HRQoL 纳入肿瘤预测模型的文献进行了系统性检索。选择标准是纵向研究设计以及预测模型中包含作为预测因子、结果或两者的 HRQoL 数据。偏倚风险采用 PROBAST 工具进行评估,报告质量采用改编的 TRIPOD 报告指南进行评分。在 4747 篇摘要中,有 98 条记录被纳入本综述。71%的文献存在高偏倚风险。HRQoL主要作为预测指标(78%(55%仅作为预测指标,23%既作为预测指标又作为结果)),其中身体功能和症状领域最常被选为预测指标。很少有模型(23%)通过其他或基线 HRQoL 领域来预测 HRQoL 领域。21%的出版物将 HRQoL 用作结果,重点是预测症状。在使用 HRQoL 数据时,基于人工智能的方法(16%)与传统方法(84%)在模型类型选择或模型性能方面没有差异。这篇综述强调了 HRQoL 作为疾病结果预测工具的作用。由于大多数模型尚未完全开发出来,因此对 HRQoL 的预测和使用 HRQoL 进行预测仍处于起步阶段。目前的模型主要集中在预测临床结果的 HRQoL 的物理方面,很少有模型采用基于人工智能的方法。
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引用次数: 0
Patients' experience on waiting for spinal arthrodesis: a qualitative study. 腰椎融合术患者等待经验的定性研究。
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-12-08 DOI: 10.1007/s11136-024-03861-3
Paolo Pillastrini, Silvano Ferrari, Angela Albano, Michela Beni, Ilaria Burbello, Laura De Cristofaro, Cristiana Griffoni, Katia Mattarozzi, Giuliana Nervuti, Carla Vanti

Purpose: A number of studies have explored patients' subjective experience of waiting for spinal surgery, however, they did so through an investigation conducted post-operatively. Thus, the aim of this study was to explore the experience of patients while still on the waitlist for lumbar spinal arthrodesis.

Methods: This qualitative study of semi-structured interviews was conducted at an orthopedic research institute in Italy. The interview track was developed by a team of professionals (physiotherapists, orthopedic surgeon, psychologist) and consisted of 40 questions. Fifteen patients, 10 females and 5 males aged between 23 and 80 years, waiting for spinal arthrodesis were interviewed. The interviews were performed, transcribed and analyzed by the multiprofessional team through thematic analysis using a reflexive approach.

Results: Five main themes were generated: (1) Impact of persistent pain on patients' physical and psychological functioning; (2) Fear of the unknown and uncertainties; (3) Hope and regaining normality; (4) The impact of the unpredictability of the waiting time; (5) Need for better communication and information on the care pathway. Two minor themes were also produced.

Conclusions: These findings highlighted that patients on the waiting list for spinal arthrodesis need more certainty about waiting times, better communication with hospital staff, more thorough information about their care pathway. This could help patients feel more confident and may lead to more adequate expectations before surgery.

Trial registration: The study protocol was registered on ClinicalTrials.gov database on 14/03/2022 with ID number NCT06323694.

目的:许多研究探讨了患者等待脊柱手术的主观体验,然而,他们是通过术后调查来进行的。因此,本研究的目的是探讨仍在等待腰椎融合术的患者的经验。方法:在意大利一家骨科研究所进行半结构化访谈的定性研究。访谈跟踪是由一组专业人士(物理治疗师、整形外科医生、心理学家)开发的,包括40个问题。对15例等待腰椎融合术患者进行访谈,其中女性10例,男性5例,年龄在23 ~ 80岁之间。访谈由多专业团队进行,记录和分析,通过主题分析,使用自反性方法。结果:得出以下五个主要主题:(1)持续性疼痛对患者身心功能的影响;(2)对未知和不确定性的恐惧;(3)希望和恢复正常;(4)等待时间不可预测性的影响;(5)需要更好的沟通和信息的护理途径。还制作了两个次要主题。结论:这些研究结果突出表明,等待关节融合术的患者需要更确定的等待时间,更好地与医院工作人员沟通,更全面地了解他们的护理途径。这可以帮助患者感到更自信,并可能导致在手术前更充分的期望。试验注册:研究方案于2022年3月14日在ClinicalTrials.gov数据库注册,ID号NCT06323694。
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引用次数: 0
Health-related quality of life and sexual function among women with overweight or obesity and urinary incontinence: a cross-sectional study. 超重或肥胖和尿失禁妇女的健康相关生活质量和性功能:一项横断面研究
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-12-07 DOI: 10.1007/s11136-024-03868-w
Zhao Tian, Xiuqi Wang, Linru Fu, Zhe Du, Tangdi Lin, Wei Chen, Zhijing Sun

Purpose: To assess the health related quality of life (HRQoL) and sexual function related to urinary incontinence (UI) severity among women with overweight or obesity.

Methods: From September 2023 to January 2024, a cross-sectional was conducted among women seeking weight loss with overweight or obesity focusing on the symptoms and effects of UI. The degree of UI severity, UI-specific HRQoL, sexual function, and generic HRQoL were detected via Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF), Incontinence Impact Questionnaire-Short Form (IIQ-7), Short-form Prolapse Incontinence Sexual Questionnaire (PISQ-12), and European Quality of Life-5 Dimensions 5-Level questionnaire (EQ-5D-5 L) respectively.

Results: Out of 1205 valid responses, 564 (46.8%) reported UI with 354 classified as mild, 179 as moderate, and 31 as severe based on ICIQ-UI-SF scores. The mean age and body mass index of the respondents were 36.65 years and 29.9 kg/m², respectively. Individuals with more severe symptoms of UI exhibited correspondingly lower levels of UI-specific HRQoL, sexual function, and generic HRQoL. Although the correlations were weak, the severity of UI symptoms measured by ICIQ-UI-SF and IIQ-7 were significantly correlated with the mean utility values (r=-0.335, and - 0.351, P<0.001) of EQ-5D-5 L especially in the domains of anxiety/depression symptoms (r = 0.339 and 0.322, P<0.001).

Conclusion: Nearly half of women seeking weight loss with overweight or obesity may experience UI, which significantly affects HRQoL and sexual function. The severity of UI symptoms is significantly correlated with the generic HRQoL measured by EQ-5D-5 L, especially in the domain of anxiety/depression symptoms.

目的:评估超重或肥胖女性尿失禁(UI)严重程度与健康相关生活质量(HRQoL)和性功能的关系。方法:从2023年9月至2024年1月,对超重或肥胖寻求减肥的女性进行横断面调查,重点研究尿失禁的症状和影响。分别采用尿失禁模块问卷-尿失禁短表(ICIQ-UI-SF)、尿失禁影响问卷-短表(IIQ-7)、短表脱出性失禁问卷(PISQ-12)和欧洲生活质量5维度5级问卷(eq - 5d - 5l)检测尿失禁严重程度、尿失禁特异性HRQoL、性功能和一般HRQoL。结果:1205例有效应答中,564例(46.8%)报告尿失禁,其中354例根据ICIQ-UI-SF评分分为轻度,179例为中度,31例为重度。调查对象的平均年龄为36.65岁,体重指数为29.9 kg/m²。UI症状越严重的个体相应地表现出较低的UI特异性HRQoL、性功能和一般HRQoL水平。虽然相关性较弱,但ICIQ-UI-SF和IIQ-7测量的尿失禁症状严重程度与平均效用值显著相关(r=-0.335, - 0.351, p)。结论:超重或肥胖的减肥女性中近一半可能出现尿失禁,显著影响HRQoL和性功能。尿失速症状的严重程度与eq - 5d - 5l测量的通用HRQoL显著相关,特别是在焦虑/抑郁症状领域。
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引用次数: 0
Unmet Needs, Pain, Shame, Regret, and Loss of Identity among Men with Urethral Injuries Resulting from Traffic Accidents; A Qualitative Study. 交通事故尿道损伤患者未满足的需求、痛苦、羞耻、后悔和身份丧失定性研究。
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-12-07 DOI: 10.1007/s11136-024-03862-2
Jalil Hosseini, Roxana Parsapour, Maryam Ganji, Seyed Alimohammad Mirjalili, Arash Baluch

Introduction: Urethral injuries are the most severe injuries caused by high-energy mechanisms such as traffic accidents, which have significant long-term serious consequences on the quality of life of the injured.

Objectives: Exploration of lived experiences of urethral injury in traffic accident victims is the main goal of this study.

Methods: This is a phenomenological qualitative study among men suffering from urethral injuries due to traffic accidents and referred to hospitals for urethroplasty in Iran. Sixteen in-depth interviews were conducted with 15-59-year-old injured men from August 2022 to May 2023 using a semi-structured questionnaire at Shohada Hospital, considering maximum variation and achieving saturation. For data analysis, Colizzi's analysis method was implemented in MaxQDA2020. Lincoln's and Guba's criteria were assessed to achieve the trustworthiness of the study.

Results: Five main themes emerged from the interviews: Urethral Injury resulting from traffic accidents as a Complex, Unknown Problem with a general lack of public awareness, Unpleasant Experience with Permanent Suffering from pain, shame, regret, isolation, Urethral Injury Causes Regret and Loss of Normalcy, Impact on Sexual and Social Identity, and its long-term consequences as neglected health and socio-economic issues are the unmet needs of the injured patients.

Conclusion: The majority of expressions related to low public awareness and poor infrastructure. There are needs neglected by public services, especially health care services. Alongside wresting with these issues, considering policies to support this vulnerable people, and their well-being, quality of life and prevent further damage in terms of physical, social and mental health is an axiom.

导读:尿道损伤是交通事故等高能机制造成的最严重的损伤,对受伤者的生活质量有显著的长期严重后果。目的:探讨交通事故受害者尿道损伤的生活经历。方法:对伊朗因交通事故致尿道损伤并转诊到医院行尿道成形术的男性进行现象学定性研究。采用半结构式问卷,于2022年8月至2023年5月在Shohada医院对15-59岁的受伤男性进行了16次深度访谈,考虑最大变异并达到饱和。对于数据分析,Colizzi的分析方法在MaxQDA2020中实现。对Lincoln和Guba的标准进行了评估,以达到研究的可信度。结果:访谈中出现了五个主要主题:交通事故导致的尿道损伤是一个复杂的未知问题,公众普遍缺乏认识;长期遭受痛苦、羞耻、后悔、孤立的不愉快经历;尿道损伤导致后悔和失去正常状态;对性和社会身份的影响;以及作为被忽视的健康和社会经济问题的长期后果是受伤患者的需求未得到满足。结论:多数表达与公众意识低、基础设施差有关。有些需求被公共服务部门,特别是保健服务部门所忽视。在努力解决这些问题的同时,考虑支持这些弱势群体及其福祉、生活质量和防止在身体、社会和精神健康方面受到进一步损害的政策是一个公理。
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引用次数: 0
Health-related quality of life among extrapulmonary tuberculosis patients and inequalities by disease manifestations: a longitudinal study analysing the impact of TB treatment. 肺外结核患者的健康相关生活质量和疾病表现的不平等:一项分析结核病治疗影响的纵向研究。
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-12-05 DOI: 10.1007/s11136-024-03860-4
Shoaib Hassan, Manju Raj Purohit, Mala Kanthali, Reza Yaesoubi, Swapnil Jain, Tehmina Mustafa

Background: To understand the impact of extrapulmonary tuberculosis (EPTB) and its treatment on quality of life, we analysed patient-reported outcome measures (PROMs) among presumptive ETPB patients.

Methods: EuroQol's five-dimensional three-level (EQ-5D-3L) questionnaire and the Visual Analogue Scale (EQ-VAS) were used to measure PROMs by 274 presumptive EPTB patients at pre- and post-treatment stages. The patients were categorised as TB and non-TB by using a composite reference standard. Following the EuroQol suggested analysis methods, we calculated the health utility summary measure at the pre- and post-treatment stages. The health state density curve and index were used to analyse inequality in reported health profiles. We investigated factors associated with EPTB patients' health utility through multivariable regression at the pre-treatment stage.

Results: The analysis of PROMs showed both physical (mobility, self-care, usual activities) and psychological (pain, discomfort, anxiety & depression) health affected by all EPTB manifestations (lymphadenitis, pleuritis, meningitis and others). Moreover, we found inequality in reported health profiles across disease manifestations at pre- and post-treatment stages. Post-treatment, we found improvement in PROMs and no reports of extreme-level health problems. However, some problems persisted across all dimensions of EPTB manifestations. We found 100% improvement in pleuritis and meningitis manifestations. Socioeconomic status, type of health facility attended, and patients' working capacity were associated with health utility.

Conclusion: Despite post-treatment improvement in health, inequality of reported health states by EPTB manifestations persisted, though decreased. This highlights that holistic patient- and health system-level interventions addressing the impact of illness should consider EPTB by its manifestations, not as a single disease entity.

背景:为了了解肺外结核(EPTB)及其治疗对生活质量的影响,我们分析了疑似ETPB患者报告的预后指标(PROMs)。方法:采用EuroQol五维三级问卷(EQ-5D-3L)和视觉模拟量表(EQ-VAS)对274例EPTB推定患者治疗前后的PROMs进行测量。采用综合参考标准将患者分为结核和非结核。根据EuroQol建议的分析方法,我们计算了治疗前和治疗后阶段的健康效用汇总度量。使用健康状态密度曲线和指数来分析报告健康概况的不平等。我们通过治疗前阶段的多变量回归研究了与EPTB患者健康效用相关的因素。结果:PROMs分析显示EPTB所有表现(淋巴结炎、胸膜炎、脑膜炎等)对身体(活动能力、自我保健、日常活动)和心理(疼痛、不适、焦虑和抑郁)健康的影响。此外,我们发现在治疗前和治疗后的疾病表现中,报告的健康状况不平等。治疗后,我们发现PROMs有所改善,没有极端健康问题的报告。然而,一些问题在EPTB表现的各个方面都存在。我们发现胸膜炎和脑膜炎症状100%改善。社会经济地位、医疗机构类型和患者工作能力与医疗效用相关。结论:尽管治疗后健康状况有所改善,但EPTB表现所报告的健康状况不平等现象虽然有所减少,但仍然存在。这突出表明,针对疾病影响的患者和卫生系统层面的整体干预措施应根据其表现来考虑EPTB,而不是将其视为单一疾病实体。
{"title":"Health-related quality of life among extrapulmonary tuberculosis patients and inequalities by disease manifestations: a longitudinal study analysing the impact of TB treatment.","authors":"Shoaib Hassan, Manju Raj Purohit, Mala Kanthali, Reza Yaesoubi, Swapnil Jain, Tehmina Mustafa","doi":"10.1007/s11136-024-03860-4","DOIUrl":"https://doi.org/10.1007/s11136-024-03860-4","url":null,"abstract":"<p><strong>Background: </strong>To understand the impact of extrapulmonary tuberculosis (EPTB) and its treatment on quality of life, we analysed patient-reported outcome measures (PROMs) among presumptive ETPB patients.</p><p><strong>Methods: </strong>EuroQol's five-dimensional three-level (EQ-5D-3L) questionnaire and the Visual Analogue Scale (EQ-VAS) were used to measure PROMs by 274 presumptive EPTB patients at pre- and post-treatment stages. The patients were categorised as TB and non-TB by using a composite reference standard. Following the EuroQol suggested analysis methods, we calculated the health utility summary measure at the pre- and post-treatment stages. The health state density curve and index were used to analyse inequality in reported health profiles. We investigated factors associated with EPTB patients' health utility through multivariable regression at the pre-treatment stage.</p><p><strong>Results: </strong>The analysis of PROMs showed both physical (mobility, self-care, usual activities) and psychological (pain, discomfort, anxiety & depression) health affected by all EPTB manifestations (lymphadenitis, pleuritis, meningitis and others). Moreover, we found inequality in reported health profiles across disease manifestations at pre- and post-treatment stages. Post-treatment, we found improvement in PROMs and no reports of extreme-level health problems. However, some problems persisted across all dimensions of EPTB manifestations. We found 100% improvement in pleuritis and meningitis manifestations. Socioeconomic status, type of health facility attended, and patients' working capacity were associated with health utility.</p><p><strong>Conclusion: </strong>Despite post-treatment improvement in health, inequality of reported health states by EPTB manifestations persisted, though decreased. This highlights that holistic patient- and health system-level interventions addressing the impact of illness should consider EPTB by its manifestations, not as a single disease entity.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142786736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
PRISMA-COSMIN: response from ISOQOL's ANZ SIG leadership. PRISMA-COSMIN:来自ISOQOL ANZ SIG领导层的回应。
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-12-05 DOI: 10.1007/s11136-024-03744-7
Imogen Ramsey, Nadia Corsini, Jessica Roydhouse

ISOQOL's Australia and New Zealand Special Interest Group (ISOQOL ANZ SIG) connects local researchers and clinicians in a geographically remote region of the world. Members of our ANZ SIG have been conducting a review following COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) guidance, which outlines a comprehensive process to critically evaluate the properties of outcome measurement instruments, including patient-reported outcome measures (PROMs). Our experience has highlighted challenges for undertaking this type of review, notably a lack of consistency in how COSMIN guidance is applied and reported. In this Letter to the Editor, members of the ANZ SIG leadership discuss the PRISMA-COSMIN for Outcome Measurement Instruments; a new guideline developed to support and improve reporting of systematic reviews of outcome measurement instruments. We explore the potential of this guidance to improve how systematic reviews of PROMs are conducted and reported, from the perspective of a regional SIG.

ISOQOL的澳大利亚和新西兰特别兴趣小组(ISOQOL ANZ SIG)将世界上地理偏远地区的当地研究人员和临床医生联系起来。我们的ANZ小组成员一直在按照COSMIN(基于共识的健康测量工具选择标准)指南进行审查,该指南概述了一个全面的过程,以严格评估结果测量工具的特性,包括患者报告的结果测量(PROMs)。我们的经验突出了进行这类审查的挑战,特别是在如何应用和报告COSMIN指南方面缺乏一致性。在这封致编辑的信中,ANZ SIG领导成员讨论了prism - cosmin结果测量仪器;制定了一项新的指南,以支持和改进结果衡量工具的系统审查报告。我们从区域SIG的角度探讨了该指南的潜力,以改进对prom进行系统审查和报告的方式。
{"title":"PRISMA-COSMIN: response from ISOQOL's ANZ SIG leadership.","authors":"Imogen Ramsey, Nadia Corsini, Jessica Roydhouse","doi":"10.1007/s11136-024-03744-7","DOIUrl":"https://doi.org/10.1007/s11136-024-03744-7","url":null,"abstract":"<p><p>ISOQOL's Australia and New Zealand Special Interest Group (ISOQOL ANZ SIG) connects local researchers and clinicians in a geographically remote region of the world. Members of our ANZ SIG have been conducting a review following COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) guidance, which outlines a comprehensive process to critically evaluate the properties of outcome measurement instruments, including patient-reported outcome measures (PROMs). Our experience has highlighted challenges for undertaking this type of review, notably a lack of consistency in how COSMIN guidance is applied and reported. In this Letter to the Editor, members of the ANZ SIG leadership discuss the PRISMA-COSMIN for Outcome Measurement Instruments; a new guideline developed to support and improve reporting of systematic reviews of outcome measurement instruments. We explore the potential of this guidance to improve how systematic reviews of PROMs are conducted and reported, from the perspective of a regional SIG.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142786752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Applicability of the PRISMA-COSMIN guidelines for systematic reviews of outcome measurement instruments to ISOQOL's special interest group for clinical practice. 结果测量仪器系统评价PRISMA-COSMIN指南对ISOQOL临床实践特殊兴趣组的适用性。
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-12-05 DOI: 10.1007/s11136-024-03815-9
Angela C Wolff, Elizabeth J Austin, Amy M Cizik
{"title":"Applicability of the PRISMA-COSMIN guidelines for systematic reviews of outcome measurement instruments to ISOQOL's special interest group for clinical practice.","authors":"Angela C Wolff, Elizabeth J Austin, Amy M Cizik","doi":"10.1007/s11136-024-03815-9","DOIUrl":"https://doi.org/10.1007/s11136-024-03815-9","url":null,"abstract":"","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142786665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Response to letters from the ISOQOL SIGs regarding PRISMA-COSMIN for OMIs 2024. 对国际标准化组织(ISOQOL)关于prism - cosmin用于omis2024的信函的回应。
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-12-05 DOI: 10.1007/s11136-024-03869-9
Ellen B M Elsman, Lidwine B Mokkink, Martin Offringa
{"title":"Response to letters from the ISOQOL SIGs regarding PRISMA-COSMIN for OMIs 2024.","authors":"Ellen B M Elsman, Lidwine B Mokkink, Martin Offringa","doi":"10.1007/s11136-024-03869-9","DOIUrl":"https://doi.org/10.1007/s11136-024-03869-9","url":null,"abstract":"","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142786755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Patient-reported outcomes in non-small cell lung cancer: psychometric evaluation of the PROMIS PF-SF 8c and NSCLC-SAQ in two phase 3 clinical trials. 非小细胞肺癌患者报告的结局:两项3期临床试验中PROMIS PF-SF 8c和NSCLC-SAQ的心理测量评估
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-12-05 DOI: 10.1007/s11136-024-03846-2
Carrie R Houts, Andrea Savord, Molly J Gardner, Maria Mattera, John Devin Peipert, Trishala Agrawal, Mahadi Baig, Praveen Barala, Joshua Bauml, Brooke Diorio, Angela Girvin, Jan Sermon, Sujay Shah, Monica Withelder, Honeylet Wortman-Vayn, Julia Schuchard

Purpose: Physical functioning and symptom severity are important factors in the experience of people with living with non-small cell lung cancer (NSCLC). This study evaluates the reliability, validity, and meaningful within-person change (MWPC) thresholds of 2 patient-reported outcome (PRO) measures in NSCLC: the Patient-Reported Outcomes Measurement Information System (PROMIS®) Physical Function (PF) short form (SF) 8c and the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ).

Methods: Data came from 2 Phase 3 clinical trials among people living with NSCLC. PROMIS PF-SF analyses included data from 300 participants in the PAPILLON trial, and NSCLC-SAQ analyses included 615 participants in the MARIPOSA 2 trial. Prespecified expected relationships between target PRO measures and relevant study variables were used to evaluate validity evidence. Additionally, MWPC thresholds were estimated using anchor- and distribution-based analyses.

Results: Both PRO measures exhibited adequate internal consistency for clinical trial use. All examined correlations with reference variables and score differences between clinically meaningful groups conformed to expectations for both measures. Estimated thresholds for meaningful worsening were a decrease of 6-7 points on the PROMIS PF-SF and an increase of 2-3 points on NSCLC-SAQ.

Conclusions: This study is the first to examine longitudinal measurement properties of PROMIS PF-SF and investigates thresholds for meaningful change on the PROMIS PF-SF and NSCLC-SAQ measures. Results support the validity of these measures in NSCLC and aid the interpretation of clinically meaningful change in scores over time.

目的:身体功能和症状严重程度是影响非小细胞肺癌(NSCLC)患者生活体验的重要因素。本研究评估了两种非小细胞肺癌患者报告结果(PRO)测量方法的信度、效度和有意义的人内变化(MWPC)阈值:患者报告结果测量信息系统(PROMIS®)、身体功能(PF)简表(SF) 8c和非小细胞肺癌症状评估问卷(NSCLC- saq)。方法:数据来自2项在非小细胞肺癌患者中进行的3期临床试验。PROMIS PF-SF分析包括PAPILLON试验的300名参与者的数据,NSCLC-SAQ分析包括MARIPOSA 2试验的615名参与者的数据。目标PRO测量值与相关研究变量之间预先指定的预期关系用于评估效度证据。此外,使用基于锚点和分布的分析估计了MWPC阈值。结果:两种PRO测量方法在临床试验中表现出足够的内部一致性。所有与参考变量的相关性和临床意义组之间的评分差异均符合两种测量方法的预期。有意义恶化的估计阈值在PROMIS PF-SF上下降6-7分,在NSCLC-SAQ上增加2-3分。结论:本研究首次考察了PROMIS PF-SF的纵向测量特性,并探讨了PROMIS PF-SF和NSCLC-SAQ测量值有意义变化的阈值。结果支持这些测量在非小细胞肺癌中的有效性,并有助于解释评分随时间的临床意义变化。
{"title":"Patient-reported outcomes in non-small cell lung cancer: psychometric evaluation of the PROMIS PF-SF 8c and NSCLC-SAQ in two phase 3 clinical trials.","authors":"Carrie R Houts, Andrea Savord, Molly J Gardner, Maria Mattera, John Devin Peipert, Trishala Agrawal, Mahadi Baig, Praveen Barala, Joshua Bauml, Brooke Diorio, Angela Girvin, Jan Sermon, Sujay Shah, Monica Withelder, Honeylet Wortman-Vayn, Julia Schuchard","doi":"10.1007/s11136-024-03846-2","DOIUrl":"https://doi.org/10.1007/s11136-024-03846-2","url":null,"abstract":"<p><strong>Purpose: </strong>Physical functioning and symptom severity are important factors in the experience of people with living with non-small cell lung cancer (NSCLC). This study evaluates the reliability, validity, and meaningful within-person change (MWPC) thresholds of 2 patient-reported outcome (PRO) measures in NSCLC: the Patient-Reported Outcomes Measurement Information System (PROMIS®) Physical Function (PF) short form (SF) 8c and the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ).</p><p><strong>Methods: </strong>Data came from 2 Phase 3 clinical trials among people living with NSCLC. PROMIS PF-SF analyses included data from 300 participants in the PAPILLON trial, and NSCLC-SAQ analyses included 615 participants in the MARIPOSA 2 trial. Prespecified expected relationships between target PRO measures and relevant study variables were used to evaluate validity evidence. Additionally, MWPC thresholds were estimated using anchor- and distribution-based analyses.</p><p><strong>Results: </strong>Both PRO measures exhibited adequate internal consistency for clinical trial use. All examined correlations with reference variables and score differences between clinically meaningful groups conformed to expectations for both measures. Estimated thresholds for meaningful worsening were a decrease of 6-7 points on the PROMIS PF-SF and an increase of 2-3 points on NSCLC-SAQ.</p><p><strong>Conclusions: </strong>This study is the first to examine longitudinal measurement properties of PROMIS PF-SF and investigates thresholds for meaningful change on the PROMIS PF-SF and NSCLC-SAQ measures. Results support the validity of these measures in NSCLC and aid the interpretation of clinically meaningful change in scores over time.</p>","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142786740","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
PRISMA-COSMIN for OMIs 2024: response from ISOQOL's child health special interest group. PRISMA-COSMIN for OMIs 2024:来自ISOQOL儿童健康特别兴趣小组的回应。
IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-12-05 DOI: 10.1007/s11136-024-03801-1
Harpreet Chhina, Sumedh Bele, Zephanie Tyack
{"title":"PRISMA-COSMIN for OMIs 2024: response from ISOQOL's child health special interest group.","authors":"Harpreet Chhina, Sumedh Bele, Zephanie Tyack","doi":"10.1007/s11136-024-03801-1","DOIUrl":"https://doi.org/10.1007/s11136-024-03801-1","url":null,"abstract":"","PeriodicalId":20748,"journal":{"name":"Quality of Life Research","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142786749","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Quality of Life Research
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