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Methodological Quality of PROMs in Psychosocial Consequences of Colorectal Cancer Screening: A Systematic Review. 在结直肠癌筛查的社会心理后果中PROMs的方法学质量:一项系统综述。
IF 2.1 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-01-01 DOI: 10.2147/PROM.S394247
Emma Grundtvig Gram, Jessica Á Rogvi, Anders Heiberg Agerbeck, Frederik Martiny, Anne Katrine Lykke Bie, John Brandt Brodersen

Objective: This systematic review aimed to assess the adequacy of measurement properties in Patient-Reported Outcome Measures (PROMs) used to quantify psychosocial consequences of colorectal cancer screening among adults at average risk.

Methods: We searched four databases for eligible studies: MEDLINE, CINAHL, PsycINFO, and Embase. Our approach was inclusive and encompassed all empirical studies that quantified aspects of psychosocial consequences of colorectal cancer screening. We assessed the adequacy of PROM development and measurement properties for content validity using The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias checklist.

Results: We included 33 studies that all together used 30 different outcome measures. Two PROMs (6.7%) were developed in a colorectal cancer screening context. COSMIN rating for PROM development was inadequate for 29 out of 30 PROMs (97%). PROMs lacked proper cognitive interviews and pilot studies and therefore had no proven content validity. According to the COSMIN checklist, 27 out of 30 PROMs (90%) had inadequate measurement properties for content validity.

Discussion: The majority of included PROMs had inadequate development and measurement properties. These findings shed light on the trustworthiness of the included studies' findings and call for reevaluation of existing evidence on the psychosocial consequences of colorectal cancer screening. To provide trustworthy evidence about the psychosocial consequences of colorectal cancer screening, editors could require that studies provide evidence of the methodological quality of the PROM. Alternatively, authors should transparently disclose their studies' methodological limitations in measuring psychosocial consequences of screening validly.

目的:本系统综述旨在评估用于量化平均风险成人结直肠癌筛查的心理社会后果的患者报告结果测量(PROMs)测量特性的充分性。方法:我们检索了MEDLINE、CINAHL、PsycINFO和Embase四个符合条件的数据库。我们的方法是包容性的,包含了所有量化结直肠癌筛查的心理社会后果的实证研究。我们使用基于共识的健康测量仪器选择标准(COSMIN)偏倚风险检查表评估了PROM开发的充分性和内容效度的测量特性。结果:我们纳入了33项研究,总共使用了30种不同的结果测量方法。2例PROMs(6.7%)发生在结直肠癌筛查背景下。在30个PROM中,有29个(97%)的PROM开发的COSMIN评级不足。prom缺乏适当的认知访谈和试点研究,因此没有被证明的内容效度。根据COSMIN检查表,30个prom中有27个(90%)对内容效度的测量特性不充分。讨论:大多数包含的prom具有不充分的开发和测量特性。这些发现阐明了纳入研究结果的可信度,并呼吁重新评估结直肠癌筛查的社会心理后果的现有证据。为了提供关于结直肠癌筛查的社会心理后果的可靠证据,编辑可以要求研究提供PROM方法学质量的证据。或者,作者应该透明地披露他们的研究在有效测量筛查的社会心理后果方面的方法学局限性。
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引用次数: 1
Exploring Disease Remission and Bowel Urgency Severity Among Adults with Moderate to Severe Ulcerative Colitis: A Qualitative Study. 探索中度至重度溃疡性结肠炎患者的疾病缓解和肠道紧迫感严重程度:定性研究。
IF 2.1 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2022-12-22 eCollection Date: 2022-01-01 DOI: 10.2147/PROM.S378759
Marla C Dubinsky, Louise Newton, Laure Delbecque, Theresa Hunter, Aiste Guobyte, April N Naegeli, Shehan McFadden, Jill Donaldson, Tara Symonds, James D Lewis

Purpose: Achieving and maintaining symptom control is a key treatment goal in ulcerative colitis (UC). Bowel urgency is an important symptom of UC, thus measurement of urgency is critical. This research explored the patient experience of UC and "remission" in UC, with a focus on urgency, and cognitively debriefed the Urgency Numeric Rating Scale (NRS), including score interpretation and examination of meaningful improvement.

Patients and methods: Semi-structured hybrid concept elicitation and cognitive debriefing interviews with adults with moderately-severely active UC were conducted to explore experiences of UC and urgency, as well as examine meaningful improvement and score interpretation of the Urgency NRS. Purposive sampling was used to identify 20 eligible adult participants with UC. Concept elicitation data were analyzed using thematic analysis, and a deductive approach was used to analyze cognitive debriefing data. Thematic analysis was also applied to meaningful change-related data.

Results: Twenty participants were interviewed (average age = 42.6 years old, 50% male); 14 with moderately active (70.0%) and 6 with severely active UC (30.0%). Disease remission was not consistently defined by participants and description varied in terms of definition (absence vs not complete absence of symptoms), duration (months vs days) and key symptoms to consider. Urgency was a prominent symptom for all participants, with 8 (40.0%) identifying it as the most bothersome aspect of UC. No issues were identified with the Urgency NRS. Participants were able to define different levels of urgency severity, describe how they relate to daily life impacts, and score them differently on the Urgency NRS. Participants were also able to reflect urgency improvement on the NRS and discuss how small changes in numeric ratings of urgency can reflect meaningful change in the symptom burden of their UC.

Conclusion: The Urgency NRS is a content valid and interpretable measure to assess bowel urgency severity.

目的:实现并维持症状控制是溃疡性结肠炎(UC)的主要治疗目标。便急是溃疡性结肠炎的一个重要症状,因此对便急的测量至关重要。本研究探讨了患者对溃疡性结肠炎和溃疡性结肠炎 "缓解 "的体验,重点是急迫感,并对急迫感数值评定量表(NRS)进行了认知汇报,包括分数解释和有意义的改善检查:对患有中度-重度活动性尿路感染的成人进行了半结构式混合概念激发和认知汇报访谈,以探讨尿路感染和尿急的经历,并检查有意义的改善和尿急NRS的评分解释。通过有目的的抽样,确定了 20 名符合条件的 UC 成年参与者。采用主题分析法对概念激发数据进行分析,并采用演绎法对认知汇报数据进行分析。此外,还对有意义的变化相关数据进行了主题分析:20 名参与者接受了访谈(平均年龄 = 42.6 岁,50% 为男性);其中 14 人患有中度活动性 UC(70.0%),6 人患有重度活动性 UC(30.0%)。参与者对疾病缓解的定义并不一致,在定义(无症状与非完全无症状)、持续时间(数月与数天)和需要考虑的主要症状方面的描述也各不相同。尿急是所有参与者的主要症状,其中 8 人(40.0%)认为尿急是 UC 最令人烦恼的症状。急迫感 NRS 没有发现问题。参与者能够定义不同程度的尿急严重性,描述它们与日常生活影响的关系,并在尿急 NRS 上对它们进行不同的评分。参与者还能够在 NRS 上反映出急迫感的改善情况,并讨论急迫感数值评级的微小变化如何能够反映出 UC 症状负担的有意义变化:急迫性 NRS 是一种内容有效、可解释的评估肠急迫严重程度的方法。
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引用次数: 0
Assessing the Validity of the Long-Term Conditions Questionnaire (LTCQ) in Women During Pregnancy and the First Year Following Birth 评估长期状况问卷(LTCQ)在妇女怀孕期间和出生后第一年的有效性
IF 2.1 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2022-10-01 DOI: 10.2147/PROM.S376070
L. Kelly, Ray Fitzpatrick, J. Kurinczuk, O. Rivero-Arias, F. Alderdice
Background The aim of this study was to validate a generic patient-reported outcome measure, the Long-Term Conditions Questionnaire (LTCQ), among pregnant and postpartum women living with a pre-existing long-term condition (LTC). Methods Cognitive interviews were conducted with women who were currently pregnant or had given birth within the past year and living with a pre-existing LTC (n=11) and with healthcare professionals working in maternal care (n=11) to explore the acceptability of LTCQ items. An online survey was subsequently administered among women who were pregnant or had given birth within the past year and living with a pre-existing LTC (n=718). Tests of validity were performed including assessing correlations between the LTCQ and reference measures, the Well-being in Pregnancy (WiP) Questionnaire and the EuroQol EQ-5D-5L. Internal consistency was assessed using the Cronbach’s alpha statistic. Results All LTCQ items were considered relevant and appropriate for use with women who were pregnant or had given birth within the past year. The most commonly reported LTC among the online survey sample (n=718) was a mental health condition (n=350, 48.7%) followed by joint, bone and connective tissues (n= 212, 29.5%) and gastrointestinal (n=143, 19.9%) condition. Data indicated LTCQ scores behaved in a predictable pattern, demonstrating poorer scores for women reporting a greater number of LTCs; mean (SD) scores, one LTC= 61.86 (17.8), two LTCs= 55.29 (16.0), three LTCs= 49.84 (15.52) and four LTCs= 44.94 (12.2). Poorer scores were also reported for women living with at least one mental health condition compared to those reporting no mental health condition, mean score = 66.18 (SD 16.7) v 48.64 (SD 13.3), p<0.001 respectively. As anticipated, LTCQ scores demonstrated significant correlations in the expected direction with both the EQ-5D-5L and WiP scores. For all LTCQ items, the Cronbach’s alpha statistic was 0.93. Conclusion Data presented here indicate that the LTCQ, which assesses living well with one or more LTC, is suitable for use among pregnant and postpartum women, from both the woman’s perspective and from the perspectives of maternity healthcare professionals. Use of the LTCQ would facilitate the identification of unmet needs within this high-risk cohort and support the exploration of how LTCs may affect women throughout the pregnancy and post-natal period. Understanding unmet needs within this cohort of women provides an opportunity to link up specialist care within maternity services and enhance personalised care.
本研究的目的是验证一种通用的患者报告的结果测量方法——长期状况问卷(LTCQ),该问卷适用于有长期病史(LTC)的孕妇和产后妇女。方法采用认知访谈法,对已有LTC的怀孕或分娩妇女(n=11)和孕产妇保健专业人员(n=11)进行访谈,探讨LTCQ项目的可接受性。随后,对怀孕或在过去一年内分娩并患有LTC的妇女(n=718)进行了一项在线调查。进行效度检验,包括评估LTCQ与参考测量、妊娠幸福感问卷和EuroQol EQ-5D-5L之间的相关性。内部一致性采用Cronbach 's alpha统计量进行评估。结果所有LTCQ项目均被认为适用于过去一年内怀孕或分娩的妇女。在线调查样本(n=718)中最常报告的LTC是精神健康状况(n=350, 48.7%),其次是关节、骨骼和结缔组织(n= 212, 29.5%)和胃肠道(n=143, 19.9%)状况。数据表明,LTCQ得分表现出可预测的模式,表明报告ltc数量较多的妇女得分较低;平均(SD)评分,1个LTC= 61.86(17.8), 2个LTC= 55.29(16.0), 3个LTC= 49.84(15.52), 4个LTC= 44.94(12.2)。与无精神健康状况的女性相比,至少有一种精神健康状况的女性得分也较低,平均得分= 66.18 (SD 16.7) vs 48.64 (SD 13.3), p<0.001。正如预期的那样,LTCQ分数与EQ-5D-5L和WiP分数在预期的方向上表现出显著的相关性。对于所有LTCQ项目,Cronbach 's alpha统计量为0.93。结论:本文提供的数据表明,LTCQ(评估患有一种或多种LTC的生活状况)适用于孕妇和产后妇女,无论是从妇女的角度还是从产科保健专业人员的角度来看。使用LTCQ将有助于确定这一高危人群中未满足的需求,并支持探索ltc如何在整个怀孕和产后期间影响妇女。了解这群妇女未满足的需求提供了一个机会,将产科服务中的专科护理联系起来,加强个性化护理。
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引用次数: 0
The Validity of Clinical Scoring in the Diagnosis of Stroke Subtype: Validation Study 临床评分在脑卒中亚型诊断中的有效性:验证研究
IF 2.1 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2022-10-01 DOI: 10.2147/PROM.S374473
B. Mekonnen, M. Kebede
Background The gold standard for distinguishing stroke subtype is non-contrast CT. However, it’s still prohibitively expensive and out of reach for the majority of recourse-constrained settings. Clinically, not all patients will have a definite diagnosis of hemorrhagic/ischemic stroke. To overcome these challenges and improve clinical bedside diagnosis, clinical stroke scores for stroke subtypes have been developed and recommended to be used in the absence of appropriate imaging modality. Methods We conducted a prospective cross-sectional study among stroke patients to compare the accuracy of level of clinical stroke score methods in differentiating stroke type with CT. it was conducted on 140 people at MTU teaching hospital in Bench-Sheko Zone, South-west Ethiopia. Data were collected using check list. Analysis of the data was done using SPSS version 24. Results Our result revealed an incidence of hemorrhagic stroke were 50%, ischemic stroke were 48.6% by CT evaluation. Specificity, sensitivity, positive predictive value, negative predictive value and the overall accuracy of Siriraj stroke score for differentiation of hemorrhage from ischemic stroke were 68.6%, 83.9%, 74.6%, 79.5%, and 82% respectively, the Guys score were 89.7%, 47.8%, 73.3%, 74.5% and 74.5% respectively and while the Bensson score were 88.6%, 35.3%, 75%, 58.5%, and 62.3% respectively. Conclusion We conclude that Siriraj stroke score showed good sensitivity and fair overall accuracy for hemorrhagic stroke even if it had poor specificity.
背景无对比CT是区分脑卒中亚型的金标准。然而,对于大多数资源受限的设置来说,它仍然非常昂贵,并且遥不可及。临床上,并非所有患者都能明确诊断出出血性/缺血性脑卒中。为了克服这些挑战并改善临床床边诊断,卒中亚型的临床卒中评分已经被开发出来,并建议在缺乏适当成像方式的情况下使用。方法对脑卒中患者进行前瞻性横断面研究,比较临床脑卒中评分方法水平与CT鉴别脑卒中分型的准确性。该研究在埃塞俄比亚西南部Bench-Sheko区的MTU教学医院对140人进行。采用核对表法收集数据。数据分析使用SPSS version 24进行。结果CT显示出血性脑卒中发生率为50%,缺血性脑卒中发生率为48.6%。Siriraj卒中评分鉴别出血与缺血性卒中的特异性、敏感性、阳性预测值、阴性预测值和总体准确率分别为68.6%、83.9%、74.6%、79.5%和82%,Guys评分分别为89.7%、47.8%、73.3%、74.5%和74.5%,Bensson评分分别为88.6%、35.3%、75%、58.5%和62.3%。结论:尽管Siriraj卒中评分的特异性较差,但它对出血性卒中具有良好的敏感性和总体准确性。
{"title":"The Validity of Clinical Scoring in the Diagnosis of Stroke Subtype: Validation Study","authors":"B. Mekonnen, M. Kebede","doi":"10.2147/PROM.S374473","DOIUrl":"https://doi.org/10.2147/PROM.S374473","url":null,"abstract":"Background The gold standard for distinguishing stroke subtype is non-contrast CT. However, it’s still prohibitively expensive and out of reach for the majority of recourse-constrained settings. Clinically, not all patients will have a definite diagnosis of hemorrhagic/ischemic stroke. To overcome these challenges and improve clinical bedside diagnosis, clinical stroke scores for stroke subtypes have been developed and recommended to be used in the absence of appropriate imaging modality. Methods We conducted a prospective cross-sectional study among stroke patients to compare the accuracy of level of clinical stroke score methods in differentiating stroke type with CT. it was conducted on 140 people at MTU teaching hospital in Bench-Sheko Zone, South-west Ethiopia. Data were collected using check list. Analysis of the data was done using SPSS version 24. Results Our result revealed an incidence of hemorrhagic stroke were 50%, ischemic stroke were 48.6% by CT evaluation. Specificity, sensitivity, positive predictive value, negative predictive value and the overall accuracy of Siriraj stroke score for differentiation of hemorrhage from ischemic stroke were 68.6%, 83.9%, 74.6%, 79.5%, and 82% respectively, the Guys score were 89.7%, 47.8%, 73.3%, 74.5% and 74.5% respectively and while the Bensson score were 88.6%, 35.3%, 75%, 58.5%, and 62.3% respectively. Conclusion We conclude that Siriraj stroke score showed good sensitivity and fair overall accuracy for hemorrhagic stroke even if it had poor specificity.","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"13 1","pages":"209 - 219"},"PeriodicalIF":2.1,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48275362","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Potential Role of Dental Patient-Reported Outcomes (dPROs) in Evidence-Based Prosthodontics and Clinical Care: A Narrative Review. 牙科患者报告结果(dPRO)在循证口腔修复和临床护理中的潜在作用:叙述性综述
IF 1.8 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2022-06-03 eCollection Date: 2022-01-01 DOI: 10.2147/PROM.S256724
Cláudio Rodrigues Leles, Jésio Rodrigues Silva, Thalita Fernandes Fleury Curado, Martin Schimmel, Gerald McKenna

Oral health problems are associated with poor quality of life, with the potential to cause functional, aesthetic, nutritional, and psychological difficulties, in addition to pain and suffering. Traditionally, dental treatment outcomes are measured using purely clinical parameters; however, this may be ineffective as these parameters cannot adequately capture the full impact of poor oral health on the patient, or their respective coping strategies. From this perspective, there are significant benefits when the patient's perception of their care is considered, and included in treatment planning and delivery. The impacts perceived by the patient on their treatment outcomes can be measured using patient-reported outcomes (PROS), or more specifically with dPROS, focused on dental patient-reported outcomes. Although there are some instruments available for measuring these outcomes in clinical trials, very little information is available for explaining the context in which these outcomes are considered, and also how to capture this information using appropriate instruments, specially in evidence-based dental practice. This article aims to review the literature, seeking to describe what has been considered about assessing patient's outcomes, as well as how to measure them, and explore the potential benefits of using dPROS in evidence-based prosthodontics and clinical care of partially and fully edentulous patients.

口腔健康问题与生活质量差有关,除了疼痛和折磨外,还可能导致功能、审美、营养和心理方面的困难。传统上,牙科治疗的结果是用纯粹的临床参数来衡量的;然而,这可能是无效的,因为这些参数不能充分捕捉到口腔健康状况不佳对患者的全部影响,或者他们各自的应对策略。从这个角度来看,当考虑到患者对其护理的看法,并将其纳入治疗计划和交付时,会有显著的好处。患者对其治疗结果的感知影响可以使用患者报告结果(PROS)来衡量,或者更具体地使用dPROS来衡量,重点是牙科患者报告的结果。尽管在临床试验中有一些仪器可用于测量这些结果,但很少有信息可用于解释考虑这些结果的背景,以及如何使用适当的仪器获取这些信息,特别是在循证牙科实践中。本文旨在回顾文献,试图描述关于评估患者结果的考虑,以及如何测量它们,并探讨在部分和完全无牙患者的循证修复和临床护理中使用dPROS的潜在益处。
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引用次数: 0
The Inclusion of Patients' Reported Outcomes to Inform Treatment Effectiveness Measures in Opioid Use Disorder. A Systematic Review. 纳入患者报告的结果以告知阿片类药物使用障碍的治疗效果措施。系统综述
IF 1.8 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2022-05-30 eCollection Date: 2022-01-01 DOI: 10.2147/PROM.S297699
Nitika Sanger, Balpreet Panesar, Michael Dennis, Tea Rosic, Myanca Rodrigues, Elizabeth Lovell, Shuling Yang, Mehreen Butt, Lehana Thabane, Zainab Samaan

Introduction: Patient centred care is needed now more than ever in the treatment of opioid use disorder. Trials, policy makers, and service providers have most often used treatment retention and opioid urine screens as measures of treatment effectiveness. However, patients receiving medication for opioid use disorder treatment (MOUD) may prioritise the use of different ways to assess treatment success.

Objective: The aim of this review is to synthesize literature examining the self-reported goals patients would like to achieve in MOUD for opioid use disorder.

Methods: We searched MEDLINE, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Web of Science, Cochrane Library, Cochrane Clinical Trials Registry, the National Institutes for Health Clinical Trials Registry, and the WHO International Clinical Trials Registry Platform from inception until April 30th, 2021. No restrictions were placed on language, age, or type of MOUD. A qualitative synthesis is presented given that a meta-analysis was not possible.

Results: The search yielded a total of 21,082 records from which 8 met criteria for inclusion in the qualitative synthesis. We identified a total of 43 patient-reported treatment goals from the 8 studies. Twelve domains were created from the 43 goals reported. These domains cover a range of important areas for patients' goals related to living a normal life, physical health, mental health, treatment, and substance use specific areas.

Conclusion: This review highlights several patient goals that they would like to achieve during treatment for opioid use disorder that are not commonly considered as markers of treatment effectiveness. Goals related to health, living a normal life, and overall substance use concerns by patients should be taken into consideration by clinical trialists, researchers, policy makers, service providers, patients, and communities engaged in developing and tailoring treatment plans for opioid use disorder.

Systematic review registration: PROSPERO CRD42018095553.

引言在治疗阿片类药物使用障碍方面,现在比以往任何时候都更需要以患者为中心的护理。试验、政策制定者和服务提供者最常使用治疗保留和阿片类药物尿液筛查作为治疗效果的衡量标准。然而,接受阿片类药物使用障碍治疗的患者可能会优先使用不同的方法来评估治疗成功率。目的本综述的目的是综合文献,研究患者在阿片类药物使用障碍的MOUD中希望实现的自我报告目标。方法从成立到2021年4月30日,我们搜索了MEDLINE、EMBASE、PsycINFO、护理和相关健康文献累积指数、Web of Science、Cochrane图书馆、Cochran临床试验注册中心、美国国立卫生研究院临床试验注册处和世界卫生组织国际临床试验注册平台。对语言、年龄或MOUD类型没有任何限制。在不可能进行荟萃分析的情况下,进行了定性综合。结果检索共产生21082份记录,其中8份符合纳入定性综合的标准。我们从8项研究中确定了总共43名患者报告的治疗目标。根据报告的43个目标创建了12个领域。这些领域涵盖了患者目标的一系列重要领域,涉及正常生活、身体健康、心理健康、治疗和药物使用特定领域。结论这篇综述强调了他们在阿片类药物使用障碍治疗期间希望实现的几个患者目标,这些目标通常不被认为是治疗效果的标志。临床试验人员、研究人员、政策制定者、服务提供商、患者和参与制定和定制阿片类药物使用障碍治疗计划的社区应考虑到与健康、正常生活和患者总体药物使用相关的目标。系统审查注册PROSPERO CRD42018095553。
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引用次数: 0
Evaluating the Impact of Therapy on Quality of Life in Type 2 Diabetes: A Literature Review of Utilities Associated with Treatment-Related Attributes 评估治疗对2型糖尿病患者生活质量的影响:与治疗相关属性相关的实用性文献综述
IF 2.1 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2022-05-01 DOI: 10.2147/PROM.S322390
W. Valentine, K. Norrbacka, K. Boye
Introduction Treatment-related attributes and process characteristics such as dosing frequency, timing flexibility, ease of use of injection devices and unpleasant side-effects may have small but measurable effects on quality of life (QoL) in people with type 2 diabetes (T2D). A literature review was performed to identify recently published utility values quantifying the effect of treatment-related attributes on QoL. Methods Literature search strategies were designed using high-level medical subject heading (MeSH) terms supplemented with free-text terms and searches were run in March 2020 in the PubMed, Embase and Cochrane Library databases. For inclusion, studies were required to be published in full-text form, in English, since 2010 and report utility values (elicited using either direct or indirect methods) for treatment-related attributes or process characteristics including side effects, change in weight/body mass index (BMI), dosing frequency and timing flexibility, device attributes (e.g. needle handling, requirement for reconstitution) and convenience (e.g. waiting time). Results A total of 30 studies were included in the review, of which all but three were conducted in people with T2D. The EQ-5D was the most commonly used elicitation method (fourteen studies), followed by time tradeoff (TTO) methodology. Treatment-related adverse events and inconveniences such as needle handling in administration devices and waiting time were consistently associated with lower QoL, whereas lower dosing frequency and increased timing flexibility with dosing were consistently associated with utility benefits. The relationship between change in BMI and QoL was non-linear and influenced by baseline BMI. Conclusion Treatment-related attributes and process characteristics are associated with minor changes in QoL, which should be taken into account in long-term health economic modeling of new treatments and administration devices.
与治疗相关的属性和过程特征,如给药频率、时间灵活性、注射装置的易用性和令人不快的副作用,可能对2型糖尿病(T2D)患者的生活质量(QoL)产生微小但可测量的影响。进行文献回顾,以确定最近发表的效用值,量化治疗相关属性对生活质量的影响。方法采用高水平医学主题词(MeSH)并辅以自由文本词设计文献检索策略,于2020年3月在PubMed、Embase和Cochrane图书馆数据库中进行检索。为纳入研究,自2010年以来,研究要求以英文全文形式发表,并报告治疗相关属性或过程特征的效用值(使用直接或间接方法得出),包括副作用、体重/体重指数(BMI)的变化、给药频率和时间灵活性、设备属性(例如针头处理、重构要求)和便利性(例如等待时间)。结果本综述共纳入30项研究,除3项外,其余均为T2D患者。EQ-5D是最常用的激发方法(14项研究),其次是时间权衡(TTO)方法。治疗相关的不良事件和不便,如给药装置中的针头操作和等待时间始终与较低的生活质量相关,而较低的给药频率和增加的给药时间灵活性始终与效用效益相关。BMI变化与生活质量呈非线性关系,且受基线BMI影响。结论治疗相关属性和工艺特征与生活质量的微小变化相关,在新治疗方法和给药装置的长期健康经济建模中应考虑到这一点。
{"title":"Evaluating the Impact of Therapy on Quality of Life in Type 2 Diabetes: A Literature Review of Utilities Associated with Treatment-Related Attributes","authors":"W. Valentine, K. Norrbacka, K. Boye","doi":"10.2147/PROM.S322390","DOIUrl":"https://doi.org/10.2147/PROM.S322390","url":null,"abstract":"Introduction Treatment-related attributes and process characteristics such as dosing frequency, timing flexibility, ease of use of injection devices and unpleasant side-effects may have small but measurable effects on quality of life (QoL) in people with type 2 diabetes (T2D). A literature review was performed to identify recently published utility values quantifying the effect of treatment-related attributes on QoL. Methods Literature search strategies were designed using high-level medical subject heading (MeSH) terms supplemented with free-text terms and searches were run in March 2020 in the PubMed, Embase and Cochrane Library databases. For inclusion, studies were required to be published in full-text form, in English, since 2010 and report utility values (elicited using either direct or indirect methods) for treatment-related attributes or process characteristics including side effects, change in weight/body mass index (BMI), dosing frequency and timing flexibility, device attributes (e.g. needle handling, requirement for reconstitution) and convenience (e.g. waiting time). Results A total of 30 studies were included in the review, of which all but three were conducted in people with T2D. The EQ-5D was the most commonly used elicitation method (fourteen studies), followed by time tradeoff (TTO) methodology. Treatment-related adverse events and inconveniences such as needle handling in administration devices and waiting time were consistently associated with lower QoL, whereas lower dosing frequency and increased timing flexibility with dosing were consistently associated with utility benefits. The relationship between change in BMI and QoL was non-linear and influenced by baseline BMI. Conclusion Treatment-related attributes and process characteristics are associated with minor changes in QoL, which should be taken into account in long-term health economic modeling of new treatments and administration devices.","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"13 1","pages":"97 - 111"},"PeriodicalIF":2.1,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45521946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Patient-Reported Outcomes in Rheumatoid Arthritis: A Key Consideration for Evaluating Biosimilar Uptake? 类风湿性关节炎患者报告的结果:评估生物类似物摄取的关键考虑因素?
IF 1.8 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2022-03-30 eCollection Date: 2022-01-01 DOI: 10.2147/PROM.S256715
Gabriel Horta-Baas

Purpose: This review aims to provide an overview of the impact of TNFis biosimilars, with marketing authorization, in patient-reported outcome measures (PROMs) scores and explore how PROMs endpoints might add value in biosimilars uptake in RA patients.

Patients and methods: A comprehensive search of Medline, Scopus, Lilacs, and CINAHL databases was performed for papers published between January 2012 and December 2021. For inclusion, studies had to be prospective, published in a peer-reviewed journal, published in English or Spanish language; studies using PROMs as an outcome measure. After screening title and abstracts and assessing the remaining full texts fulfilling the inclusion criteria, 31 papers were used in this narrative review.

Results: PROMs were used as secondary outcomes in included studies. The most frequently employed domains to assess biosimilar efficacy include physical function, patient global assessment (PtGA), health-related quality of life (HRQoL), and fatigue. The results of randomized clinical trials uniformly showed that mean change in PROMs scores is comparable between biosimilar and reference biologic treatment groups. However, open-label and real-world studies revealed high rates of discontinuation of therapy, mainly for subjective worsening of disease activity or non-specific adverse events. Even without objective clinical evidence of inflammation, patients who are considered to have active disease (higher scores on PtGA) have higher discontinuation rates of biosimilars. The available information suggests that the nocebo effect is the most likely cause for the discontinuation of biosimilars.

Conclusion: There is scarce literature surrounding the impact of biosimilars in PROMs, especially in open-label studies. In real-life studies, biosimilars have a higher discontinuation rate than reference products. TNFis biosimilars treatment efficacy in RA depends on disease activity and other factors such as PtGA and fatigue. The nocebo effect is the best explanation for biosimilar's discontinuation.

本综述旨在概述获得上市许可的TNFis生物仿制药对患者报告的预后指标(PROMs)评分的影响,并探讨PROMs终点如何在RA患者的生物仿制药吸收中增加价值。患者和方法综合检索Medline、Scopus、Lilacs和CINAHL数据库,检索2012年1月至2021年12月间发表的论文。纳入的研究必须是前瞻性的,发表在同行评议的期刊上,用英语或西班牙语发表;使用prom作为结果测量的研究。在筛选标题和摘要并评估其余符合纳入标准的全文后,31篇论文被用于本叙述性综述。结果在纳入的研究中,PROMs被作为次要结局。最常用于评估生物类似药疗效的领域包括身体功能、患者总体评估(PtGA)、健康相关生活质量(HRQoL)和疲劳。随机临床试验的结果一致表明,生物仿制药组和参考生物治疗组之间PROMs评分的平均变化具有可比性。然而,开放标签和现实世界的研究显示,主要由于疾病活动的主观恶化或非特异性不良事件,停药率很高。即使没有炎症的客观临床证据,被认为患有活动性疾病的患者(PtGA评分较高)也有较高的生物仿制药停药率。现有的信息表明,反安慰剂效应是最可能导致生物仿制药停止使用的原因。结论关于生物仿制药对PROMs的影响的文献很少,特别是在开放标签研究中。在现实研究中,生物仿制药比参考产品有更高的停药率。TNFis生物仿制药治疗RA的疗效取决于疾病活动性和其他因素,如PtGA和疲劳。反安慰剂效应是生物仿制药停药的最好解释。
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引用次数: 0
How to Improve Interpretability of Patient-Reported Outcome Measures for Clinical Use: A Perspective on Measuring Abilities and Feelings 如何提高临床使用的患者报告结果测量的可解释性:从测量能力和感受的角度
IF 2.1 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2022-03-01 DOI: 10.2147/PROM.S355679
J. Kopec
Abstract Two general classes of concepts measured by patient-reported outcome measures (PROMs) are abilities and feelings. Over the past several decades, there has been a significant progress in measuring both. Nevertheless, current multi-item scales are subject to criticism related to scale length, score dimensionality, interpretability, cultural bias, and insufficient detail in measuring specific domains. To address some of these issues, the author offers an alternative perspective on how questions about abilities and feelings could be formulated. Abilities can be defined in terms of a relationship between the level of performance and the associated perception of difficulty, and represented graphically by an ability curve. For feelings, it may be useful to measure frequency and intensity jointly to determine the proportion of time in each level of intensity. The resultant frequency × intensity matrix can be presented as a bar graph. Empirical data to support the feasibility and validity of these approaches to PROM design are provided, potential advantages and limitations are discussed, and some future research avenues are suggested.
由患者报告的结果测量(PROMs)测量的两大类概念是能力和感觉。在过去的几十年里,在衡量这两方面都取得了重大进展。然而,目前的多项目量表在量表长度、得分维度、可解释性、文化偏见和测量特定领域的细节不足等方面受到批评。为了解决其中的一些问题,作者提供了一个关于能力和情感问题如何形成的另一种观点。能力可以根据表现水平和相关难度感知之间的关系来定义,并通过能力曲线图形化地表示出来。对于感觉,联合测量频率和强度来确定时间在每个强度级别中的比例可能是有用的。得到的频率×强度矩阵可以用柱状图表示。本文提供了实证数据来支持这些方法在PROM设计中的可行性和有效性,讨论了潜在的优势和局限性,并提出了一些未来的研究方向。
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引用次数: 0
CONQUEST: A Quality Improvement Program for Defining and Optimizing Standards of Care for Modifiable High-Risk COPD Patients CONQUEST:定义和优化可修改高危COPD患者护理标准的质量改进计划
IF 2.1 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2022-02-01 DOI: 10.2147/prom.s296506
Luis Alves, R. Pullen, J. Hurst, M. Miravitlles, V. Carter, Rongchang Chen, A. Couper, M. Dransfield, Alexander Evans, A. Hardjojo, David Jones, Rupert C Jones, Margee Kerr, K. Kostikas, J. Marshall, F. Martinez, M. V. van Melle, R. Murray, S. Muro, C. Nordon, M. Pollack, C. Price, Anita Sharma, D. Singh, T. Winders, D. Price
: The COllaboration on QUality improvement initiative for achieving Excellence in STandards of COPD care (CONQUEST) aims to improve the quality of COPD care in primary care. The CONQUEST target population includes patients diagnosed with COPD, and those undiagnosed but with COPD-like exacerbations, who are at high but modifiable risk of COPD exacerbations, increased morbidity, and mortality. Timely diagnosis and optimized management to reduce these risks is vital. There is a need for a quality improvement program (QIP) that enables long-term improvement of patient clinical outcomes via integration of the program into routine clinical care. Core to the CONQUEST program is the adoption of four specifically designed, globally applicable, and expert-agreed quality standards (QS) for modifiable high-risk COPD patients. Translation of the QS into clinical practice, and implementation of the QIP, is guided by the CONQUEST global operational protocol provided to sites meeting the minimum healthcare system requirements. Initial analyses of current practices are conducted to generate baseline assessments of need within healthcare systems and sites looking to implement the QIP. Implementation is supported by the provision of CONQUEST resources and tools, such as clinical decision support, that promote prompt identification and treatment of patients. Utilization of electronic medical record (EMR) and patient-reported data are integral components of the QIP. Regular, automated collection and analysis of data, combined with a cyclical review of the implementation process, will be conducted for long-term, continuous improvement and health impact evaluation. The CONQUEST QIP will be an important resource in the identification and management of patients with modifiable high-risk COPD. Embedding the CONQUEST QS into routine clinical practice with regular evaluation and feedback will result in long-term quality of care improvement.
:旨在实现COPD护理标准卓越的质量改进倡议(CONQUEST)旨在提高初级保健中COPD护理的质量。CONQUEST目标人群包括被诊断为COPD的患者,以及那些未被诊断但患有COPD样加重的患者,他们患有COPD加重、发病率和死亡率增加的高但可改变的风险。及时诊断和优化管理以降低这些风险至关重要。需要一个质量改进计划(QIP),通过将该计划整合到常规临床护理中,能够长期改善患者的临床结果。CONQUEST计划的核心是为可改变的高危COPD患者采用四个专门设计的、全球适用的、专家认可的质量标准(QS)。将QS转化为临床实践,并实施QIP,是由CONQUEST全球运营协议指导的,该协议提供给满足最低医疗系统要求的场所。对当前做法进行初步分析,以生成医疗系统和希望实施QIP的场所内需求的基线评估。CONQUEST资源和工具的提供为实施提供了支持,如临床决策支持,以促进患者的及时识别和治疗。电子病历(EMR)和患者报告数据的使用是QIP的组成部分。将定期自动收集和分析数据,并对执行过程进行周期性审查,以进行长期、持续的改进和健康影响评估。CONQUEST QIP将是识别和管理可改变高危COPD患者的重要资源。将CONQUEST QS纳入常规临床实践,并定期进行评估和反馈,将提高长期护理质量。
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引用次数: 3
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Patient Related Outcome Measures
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