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The effect of positive mental well-being on patient reported outcome (PRO): finding from a cross-sectional multi-disease study in China. 积极心理状态对患者报告结果(PRO)的影响:中国一项多疾病横断面研究的发现。
IF 3.2 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-16 DOI: 10.1186/s12955-024-02314-2
Zhihao Yang, Nan Luo, Yanming Hong

Purpose: This study aims to investigate the potential impact of positive mental well-being on responses of patient-reported outcome measures (PROMs), such as EQ-5D-5L.

Methods: This study utilized the data collected in a cross-sectional study in a sample consisted of individuals with different health conditions. Spearman's rank correlations were employed to investigate the relationship between the responses to the dimensions of EQ-5D-5L and the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS). A binary logistic regression analysis and ordered logistic multivariable regression were utilized to examine how SWEMWBS scores could impact the responses to EQ-5D-5L dimensions, while controlling for variables such as age, gender, education level, health conditions, caring experience, and data collection methods. The effects of SWEMWBS on EQ-VAS and utility values were also examined.

Results: One thousand nine individuals participated in the survey. Spearman's rank correlation revealed that all dimensions of EQ-5D-5L, except for the anxiety/depression dimension, exhibited weak correlations with all dimensions of SWEMWBS. Binary logistic regression and ordered logistic multivariable regression indicated that age, SWEMWBS scores, gender, health conditions, data collection methods, and caring experience significantly influenced the likelihood of reporting problems in EQ-5D-5L responses. Notably, better SWEMWBS outcomes increased the likelihood of reporting no or fewer problems across all EQ-5D-5L dimensions. Spearman's rank correlation suggested a moderate or strong positive correlation between SWEMWBS scores and EQ-5D-5L utility values and EQ-VAS. The results of multiple linear regression analysis revealed that SWEMWBS scores, health conditions, caring experience, and data collection methods were significantly associated with EQ-5D utility values and EQ-VAS.

Conclusions: Individuals with better positive mental well-being results are more likely to report better results in PROMs like EQ-5D-5L. Future study is needed to understand the thought process and to explore strategies to cope with the response heterogeneity that led by the status of mental well-being.

目的:本研究旨在探讨积极的心理健康对患者报告结果测量(PROMs)(如 EQ-5D-5L)反应的潜在影响:本研究利用横断面研究中收集的数据,样本包括不同健康状况的个体。采用斯皮尔曼等级相关性来研究 EQ-5D-5L 各维度的反应与华威-爱丁堡心理健康简易量表(SWEMWBS)之间的关系。在控制年龄、性别、教育水平、健康状况、护理经验和数据收集方法等变量的情况下,利用二元逻辑回归分析和有序逻辑多变量回归分析来研究 SWEMWBS 分数如何影响 EQ-5D-5L 各维度的反应。此外,还研究了 SWEMWBS 对 EQ-VAS 和效用值的影响:共有 199 人参与了调查。斯皮尔曼等级相关性表明,除焦虑/抑郁维度外,EQ-5D-5L 的所有维度都与 SWEMWBS 的所有维度呈弱相关性。二元逻辑回归和有序逻辑多元回归表明,年龄、SWEMWBS 分数、性别、健康状况、数据收集方法和护理经验对 EQ-5D-5L 反应中报告问题的可能性有显著影响。值得注意的是,SWEMWBS 结果越好,在所有 EQ-5D-5L 维度上报告无问题或问题较少的可能性就越大。斯皮尔曼等级相关性表明,SWEMWBS 分数与 EQ-5D-5L 效用值和 EQ-VAS 之间存在中等或较强的正相关性。多元线性回归分析结果显示,SWEMWBS 评分、健康状况、护理经验和数据收集方法与 EQ-5D 实用价值和 EQ-VAS 显著相关:结论:心理健康状况较好的人更有可能在 EQ-5D-5L 等 PROMs 中报告较好的结果。未来的研究需要了解其思维过程,并探索应对因精神健康状况而导致的反应异质性的策略。
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引用次数: 0
Effect of ginkgo diterpene lactone meglumine on the quality of life in patients with acute ischemic stroke. 银杏二萜内酯葡甲胺对急性缺血性中风患者生活质量的影响。
IF 3.2 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-15 DOI: 10.1186/s12955-024-02315-1
Xue Tian, Qin Xu, Xue Xia, Yijun Zhang, Xingquan Zhao, Anxin Wang

Objective: Ginkgo diterpene lactone meglumine (GDLM) could improve the functional outcome after acute ischemic stroke (AIS). This study aimed to investigate the efficacy of GDLM on the quality of life in patients with AIS in China.

Methods: This is a post hoc analysis of Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke trial. The quality of life was measured using the EuroQoL questionnaire, including EQ-5D and EQ visual analogue scale (EQ-VAS). The primary outcomes were changes in EQ-5D and EQ-VAS from baseline to day 14 and day 90 after randomization.

Results: A total of 3219 patients with completed data on outcomes were enrolled, with median age of 63 years (interquartile range, 55-70) and 2,067 (64.2%) men. GDLM was associated with a significant decrease in scores of ED-5Q components (from 0 [no problem] to 3[extreme problem]), the mean difference between GDLM and placebo group was -0.14 for mobility, -0.11 for usual activities and self-care, -0.09 for pain/discomfort, and -0.34 for anxiety/depression on day 14, respectively. Similar results were observed on day 90. Additionally, there was statistically significant difference of changes in EQ-VAS between the GDLM group and the placebo group from baseline to day 14 (mean difference, 1.70; 95% confidence interval [CI], 0.78-2.62; P = 0.0003) and to day 90 after randomization (mean difference, 3.29; 95% CI, 2.37-4.22; P < 0.001).

Conclusions: In this analysis of Chinese patients with AIS, GDLM could improve the 14-day and 90-day quality of life compared with the placebo.

Trial registration: URL: https://www.

Clinicaltrials: gov . Unique identifier: NCT02526225. Registration Date: 2016-02-01.

目的:银杏二萜内酯葡甲胺(GDLM银杏二萜内酯葡甲胺(GDLM)可改善急性缺血性脑卒中(AIS)后的功能预后。本研究旨在探讨银杏二萜内酯葡甲胺对中国 AIS 患者生活质量的影响:本研究是银杏二萜内酯美格列净对急性缺血性脑卒中疗效和安全性试验的事后分析。生活质量采用欧洲生活质量调查问卷进行测量,包括EQ-5D和EQ视觉模拟量表(EQ-VAS)。主要结果是随机化后从基线到第14天和第90天EQ-5D和EQ-VAS的变化:共有 3219 名患者获得了完整的结果数据,中位年龄为 63 岁(四分位间范围为 55-70),男性患者为 2067 人(64.2%)。第 14 天,GDLM 与安慰剂组之间的平均差异分别为:行动能力-0.14,日常活动和自我护理-0.11,疼痛/不适-0.09,焦虑/抑郁-0.34。第 90 天也观察到了类似的结果。此外,GDLM 组和安慰剂组的 EQ-VAS 从基线到随机化后第 14 天(平均差异为 1.70;95% 置信区间 [CI],0.78-2.62;P = 0.0003)和第 90 天(平均差异为 3.29;95% 置信区间 [CI],2.37-4.22;P 结论:GDLM 组和安慰剂组的 EQ-VAS 变化有显著统计学差异:在这项对中国 AIS 患者的分析中,与安慰剂相比,GDLM 可改善 14 天和 90 天的生活质量:URL: https://www.Clinicaltrials: gov .唯一标识符:NCT02526225.注册日期:2016-02-01.
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引用次数: 0
The psychometric properties of the amharic version of EuroQoL five-dimensions-five level among Ethiopian cervical cancer patients. 埃塞俄比亚宫颈癌患者的阿姆哈拉语版 EuroQoL 五维度-五级的心理计量特性。
IF 3.2 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-14 DOI: 10.1186/s12955-024-02305-3
Girma Tekle Gebremariam, Gebremedhin Beedemariam Gebretekle, Wondemagegnhu Tigneh, Biruck Gashawbeza, Alemu Belayneh, Abdu Mengesha, Abraham G Welie, Eskinder Eshetu Ali

Background: Despite being a widely used generic measure of health-related quality of life worldwide, there is limited evidence on the psychometric properties of the EuroQoL Five-dimensions five level (EQ-5D) among cervical cancer patients in Ethiopia.

Objective: To evaluate psychometric properties of the Amharic version of EQ-5D among Ethiopian cervical cancer patients.

Methods: A longitudinal survey of cervical cancer patients receiving treatment at two Ethiopian tertiary care facilities was conducted from March 2022 to July 2023. Participants completed the EQ-5D and the European Organization for Research and Therapy of Cancer (EORTC QLQ-C30) at baseline and after three months on treatment. Effect size and standardized response mean were used to assess responsiveness. Anchor-based and distribution-based methods were used to calculate the minimal clinically important difference (MCID). Minimal detectable change (MDC) ratios were computed at the individual and group levels. Statistical significance was determined at p < 0.05.

Results: Three hundred seventy-one patients completed the survey at baseline and follow-up with a mean age of 49.72 (10.80) years. The majority (268,73%) of the patients had early-stage cancer. The EQ-5D index and EQ VAS scores respectively improved by 0.04 and 7.0 post-treatment.The physical domains of EORTC QLQ-C30 had showed high correlation with physical dimensions of EQ-5D (r > 0.6) and the instrument showed good discriminate validity between patients with different health states. The effect size ranged between - 0.12 and 0.60 for the EQ-5D index value and - 0.12 to 1.16 for the EQ VAS, indicating small to large responsiveness. The average (range) MCID value of the EQ-5D index was 0.10-0.15. The findings showed that MCID to MDC ratios at the group level were more clinically meaningful than the individual level.

Conclusion: The EQ-5D effectively detected changes and discriminate patients with different levels of health. While group-level MCIDs were established in this study, further studies are recommended to prove its usefulness at the individual-level.

背景:尽管欧洲生活质量五维度五级(EQ-5D)是全球广泛使用的健康相关生活质量通用测量方法,但在埃塞俄比亚的宫颈癌患者中,有关其心理测量特性的证据却很有限:评估阿姆哈拉语版 EQ-5D 在埃塞俄比亚宫颈癌患者中的心理测量特性:从 2022 年 3 月到 2023 年 7 月,对在埃塞俄比亚两家三级医疗机构接受治疗的宫颈癌患者进行了纵向调查。参与者在基线和治疗三个月后填写了 EQ-5D 和欧洲癌症研究与治疗组织(EORTC)QLQ-C30。效应大小和标准化反应平均值用于评估反应性。采用基于锚的方法和基于分布的方法计算最小临床重要差异(MCID)。计算个体和群体层面的最小可检测变化(MDC)比率。统计显著性以 p 为标准:371 名患者完成了基线和随访调查,平均年龄为 49.72 (10.80) 岁。大多数患者(268.73%)患有早期癌症。EQ-5D指数和EQ VAS评分在治疗后分别提高了0.04分和7.0分。EORTC QLQ-C30的身体领域与EQ-5D的身体维度有很高的相关性(r > 0.6),该工具在不同健康状况的患者之间显示出良好的区分度。EQ-5D指数值的效应大小介于-0.12和0.60之间,EQ VAS的效应大小介于-0.12和1.16之间,表明反应性由小到大。EQ-5D 指数的平均 MCID 值(范围)为 0.10-0.15。研究结果表明,与个体水平相比,群体水平的 MCID 与 MDC 比值更具有临床意义:结论:EQ-5D 能有效检测健康状况的变化并区分不同健康水平的患者。本研究确定了群体水平的 MCID,但建议进一步研究以证明其在个体水平的实用性。
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引用次数: 0
A time trade-off study in the UK, Canada and the US to estimate utilities associated with the treatment of haemophilia. 在英国、加拿大和美国开展时间权衡研究,估算与血友病治疗相关的效用。
IF 3.2 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-13 DOI: 10.1186/s12955-024-02311-5
Anna Okkels, Cecilie Yssing, Michael Lyng Wolden, Mohd Nawi Wahid

Introduction: Haemophilia is a rare bleeding disorder caused by a deficient or absent clotting factor, leading to frequent bleeding. Multiple intravenous (IV) infusions have been the standard prophylactic treatment; however, newer treatment options involve less frequent subcutaneous (SC) injections. To inform future health economic evaluations, this study applied the time trade-off (TTO) method for estimation of utilities associated with haemophilia treatment for both people with the disease and potential caregivers.

Methods: Using the TTO method, utilities were estimated through two online surveys distributed in the UK, Canada and the US. In survey 1 (S1), adults from the general population aged 18 years and above evaluated health states as if they were living with haemophilia themselves and were receiving treatment for the condition. In survey 2 (S2), adults from the general population with a child under the age of 15 years evaluated health states as if they were treating their child for haemophilia. The surveys assessed the following treatment aspects: frequency of treatment, treatment device and injection site reactions.

Results: In total, 812, 739 and 703 respondents completed S1 and 712, 594 and 527 completed S2 in the UK, Canada and the US, respectively. In both surveys, the treatment device was associated with the largest impact on utilities for both people with haemophilia and caregivers. Monthly SC injections with a prefilled pen-device were associated with a significant utility gain compared with SC injections with a syringe and IV infusions. In S1, a lower treatment frequency was preferred in all three countries, while in S2, a lower treatment frequency was preferred only in the UK. Avoiding injection site reactions was associated with a significant utility gain in both surveys, but only in the UK and Canada.

Conclusions: The study suggests that the administration of haemophilia treatment in particular has an impact on utilities for both people and caregivers living with the disease. Thus, less complex and time-consuming treatment devices are expected to improve health-related quality of life. This can be further modified additively by less frequent administration. These results can inform future health economic analyses of haemophilia and haemophilia treatment.

导言:血友病是一种罕见的出血性疾病,由凝血因子缺乏或缺失引起,会导致频繁出血。多次静脉注射(IV)一直是标准的预防性治疗方法;然而,新的治疗方案减少了皮下注射(SC)的频率。为了给未来的健康经济评估提供信息,本研究采用时间权衡(TTO)法估算血友病患者和潜在护理者与血友病治疗相关的效用:使用 TTO 方法,通过在英国、加拿大和美国进行的两次在线调查估算了效用。在调查 1(S1)中,来自 18 岁及以上普通人群的成年人对健康状况进行了评估,就像他们自己患有血友病并正在接受治疗一样。在调查 2(S2)中,有一个 15 岁以下子女的普通人群中的成年人对健康状况进行了评估,就好像他们正在为子女治疗血友病一样。调查对以下治疗方面进行了评估:治疗频率、治疗设备和注射部位反应:在英国、加拿大和美国,分别共有 812、739 和 703 名受访者完成了 S1 调查,712、594 和 527 名受访者完成了 S2 调查。在这两项调查中,治疗设备对血友病患者和护理人员的效用影响最大。与使用注射器进行皮下注射和静脉输液相比,每月使用预充笔装置进行皮下注射可显著提高效用。在 S1 阶段,所有三个国家都倾向于较低的治疗频率,而在 S2 阶段,只有英国倾向于较低的治疗频率。在这两项调查中,避免注射部位反应与显著的效用增益相关,但仅英国和加拿大有此倾向:研究表明,血友病的治疗尤其会影响患者和护理人员的效用。因此,不那么复杂和耗时的治疗设备有望改善与健康相关的生活质量。减少用药次数可进一步改善生活质量。这些结果可为今后对血友病和血友病治疗进行健康经济分析提供参考。
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Health and Quality of Life Outcomes
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