Quality of Life

生活质量
  • 文章类型: Journal Article
    目的:恶性间皮瘤(MM)患者的心理痛苦与其他癌症患者的心理痛苦不同,原因是其职业或环境病因及其特殊的症状和预后(即,预后不良,降低了治疗的有效性,剩余寿命质量差,和诊断时的高龄)。因此,已经开发了间皮瘤心理困扰工具患者(MPDT-P)来评估该人群的心理痛苦的具体特征。本文介绍了项目选择,因子分析,和修订后的MPDT-P的心理测量评估
    方法:对当前工作的分析旨在确认MPDT-P的第一个版本中发现的阶乘结构。在不适合的情况下,它旨在找到模型中不适合的替代结构和原因。使用贝叶斯方法进行了对阶乘模型拟合的搜索。
    结果:仪器第一版中报告的双因素模型不符合数据。验证性贝叶斯分析显示出适合三因素解决方案。根据项目的内容,我们将这些因素标记为功能失调的情绪,正义的要求,和对未来的焦虑。
    结论:将MPDT-P纳入临床实践可以帮助临床医生了解与MM相关的具体痛苦,并调查与不同职业和环境暴露背景相关的潜在差异。
    OBJECTIVE: Psychological suffering in patients with Malignant Mesothelioma (MM) is different from the one experienced by patients with other cancers due to its occupational or environmental etiology and its peculiar symptomatology and prognosis (i.e., poor prognosis, reduced effectiveness of the therapies, poor quality of residual life, and advanced age at the time of diagnosis). Therefore, the Mesothelioma Psychological Distress Tool-Patients (MPDT-P) has been developed to evaluate the specific profile of psychological suffering in this population. This paper describes the item selection, factor analysis, and psychometric evaluation of the revised MPDT-P.
    METHODS: The analyses of the current work aimed to confirm the factorial structure found in the first version of the MPDT-P. In the case of nonfit, it aimed to find an alternative structure and causes of nonfit in the model. The search for the fit of the factorial model was conducted using a Bayesian approach.
    RESULTS: The two-factor model reported in the first version of the instrument did not fit the data. Confirmatory Bayesian analyses showed adequate fit for the three-factor solution. Based on the content of the items, we labeled the factors as dysfunctional emotions, claims for justice, and anxieties about the future.
    CONCLUSIONS: Integrating the MPDT-P into clinical practice could help clinicians gain insight into the specific suffering related to MM and investigate potential differences related to different occupational and environmental exposure contexts.
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  • 文章类型: Journal Article
    背景:患有囊性纤维化(CF)的成年人每年都要接受CF相关糖尿病的筛查。这些测试代表了负担并且可能导致不期望的效果,导致低粘附性。这项研究的目的是1)比较金标准住院口服葡萄糖耐量测试(OGTT)与家庭选择,和2)评估在家选择的可接受性。
    方法:共有34名患有CF的成年人在两周内在标准化条件下接受了3种类型的OGTT:1)在医院使用75克葡萄糖饮料,2)在家里用同样的葡萄糖饮料,和3)在家里使用标准化数量的糖果。在OGTT之前测量葡萄糖水平,1和2小时后。葡萄糖测量的一致性,评估了三种选择的副作用和总体评价。
    结果:在三个测试中,平均血糖是相当的。葡萄糖耐量分类(正常,糖耐量受损,或糖尿病)在59%的葡萄糖饮料和75%的糖果参与者中与医院参考测试一致。所有类型的OGTT的副作用都很轻微,94%的参与者更喜欢家庭选择。在家庭OGTT中,葡萄糖饮料比糖果更受欢迎。
    结论:基于家庭的OGTT可以替代基于医院的黄金标准OGTT测试,提高对年度测试的依从性并降低成本。然而,各种OGTT检测方法之间的差异可能导致诊断困境.这种方法应该在更大的样本量上进行测试。
    BACKGROUND: Adult people living with Cystic Fibrosis (CF) undergo annual screening for CF-related diabetes. These tests represent a burden and can lead to undesirable effects resulting in low adherence. The objectives of this study were to 1) compare gold-standard in-hospital oral glucose tolerance testing (OGTT) with at-home options, and 2) evaluate acceptability of at-home options.
    METHODS: A total of 34 adults living with CF undertook 3 types of OGTTs in standardized conditions within two weeks: 1) in a hospital using a 75 g glucose beverage, 2) at home with the same glucose beverage, and 3) at home using a standardized quantity of candy. Glucose levels were measured prior to the OGTT, after 1 and 2 hours. Concordance of glucose measurement, side effects and general appreciation were assessed across the three options.
    RESULTS: Mean blood glucose was comparable among the three tests. Glucose tolerance categorization (normal, impaired glucose tolerance, or diabetes) was concordant with the hospital reference test in 59 % of participants for the glucose beverage and 75 % for the candies. Side effects were mild with all types of OGTTs, and 94 % of participants preferred the home options. Among the at-home OGTTs, the glucose beverage was preferred to the candy option.
    CONCLUSIONS: Home-based OGTT could be an alternative to gold standard hospital-based OGTT testing, improving adherence to annual testing and reducing costs. However, the discrepancy between various OGTT testing methods could lead to diagnosis dilemma. This approach should be tested on a larger sample size.
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  • 文章类型: Journal Article
    目的:为了稳定儿童和青少年1型糖尿病(T1D)患者的社会经济状况与血糖控制之间的关系,治疗依从性和糖尿病生活质量(DQoL)。
    横截面,我们进行了连续纳入的观察性研究.参与者年龄在8-18岁,T1D持续时间>1年。有关家庭结构的数据,家庭收入,对父母的教育水平和父母在初级糖尿病护理监督中的作用进行了登记。分析粘附性(DMQ-Sp)和DQoL(PedsQl)。针对人口统计进行调整的线性和逻辑回归模型,应用家庭结构和父母对初级糖尿病护理责任的作用。
    结果:共包括323例患者(T1D持续时间5,3±3,3年;HbA1c7,7±1,0%;年龄13,3±2,8岁;49,8%女性)。生活在核心家庭中的患者和父母双方共同接受主要糖尿病护理监督的患者显示HbA1c较低[根据人口统计学和家庭结构进行调整(7,06;CI95%6,52-7,59);根据人口统计学和对初级糖尿病护理监督的作用进行调整(7,43;CI95%6,57-8,28)]。父母共同接受糖尿病护理监督的患者的DMQ-Sp评分(根据人口统计学和主要监督角色进行调整)较高(84,56;CI95%73,93-95,19)。共享糖尿病护理监督的父母显示出明显更高的PedsQl得分(均为74,63±12,70,而母亲为68,53±14,59;p=0,001)。
    结论:患有T1D的儿童和青少年HbA1c较低,当生活在一个核心家庭中时,更好的治疗依从性和更好的DQoL,具有较高的社会经济地位和监督糖尿病护理的责任由父母双方共同承担.
    OBJECTIVE: To stablish the relationship between socioeconomic status of a cohort of children and adolescents with type 1 diabetes (T1D) with glycemic control, therapeutic adherence and diabetes quality of life (DQoL).
    UNASSIGNED: A cross-sectional, observational study with consecutive inclusion was carried out. Participants aged 8-18 years with T1D duration >1 year. Data on family structure, family income, parents\' educational level and parental role on primary diabetes care supervision were registered. Adherence (DMQ-Sp) and DQoL (PedsQl) were analyzed. Linear and logistic regression models adjusted for demographics, family structure and parental role on primary diabetes care responsibility were applied.
    RESULTS: A total of 323 patients (T1D duration 5,3 ± 3,3 years; HbA1c 7,7 ± 1,0%; age 13,3 ± 2,8 years; 49,8% females) were included. Patients living in a nuclear family and those whose main diabetes care supervision was shared by both parents showed lower HbA1c [adjusted for demographics and family structure (7,06; CI 95% 6,52-7,59); adjusted for demographics and role on primary diabetes care supervision (7,43; CI 95% 6,57-8,28)]. DMQ-Sp score (adjusted for demographics and role on main supervision) was higher in patients whose parents shared the diabetes care supervision (84,56; CI 95% 73,93-95,19). Parents sharing diabetes care supervision showed a significantly higher PedsQl score (both 74,63 ± 12,70 vs mother 68,53 ± 14,59; p = 0,001).
    CONCLUSIONS: Children and adolescents with T1D had lower HbA1c, better therapeutic adherence and better DQoL when lived in a nuclear family, with higher socioeconomic status and the responsibility for supervising diabetes care was shared by both parents.
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  • 文章类型: Journal Article
    小儿风湿性疾病(PRDs)是一组异质性疾病,可能具有慢性不可预测的疾病过程,会对情绪产生负面影响,功能,和生活质量。鉴于管理PRD面临的一系列困难,以及患有这些疾病的年轻人经历的心理社会问题,儿科心理学家可以很好地解决在治疗患有PRD的年轻人中出现的问题,包括依从性,认知评估,疼痛管理,功能性残疾,和心情。描述了儿科心理学家可以解决这些问题并嵌入针对PRD青少年的跨学科治疗计划中的潜在方法。
    Pediatric rheumatic diseases (PRDs) are a heterogeneous group of diseases that can have a chronic unpredictable disease course that can negatively affect mood, functioning, and quality of life. Given the range of difficulties faced in managing PRDs, as well as the psychosocial issues youth with these diseases experience, pediatric psychologists can be well suited to address concerns that arise in care for youth with PRDs including adherence, cognitive assessment, pain management, functional disability, and mood. Potential ways that pediatric psychologists can address these concerns and be embedded within an interdisciplinary treatment plan for youth with PRDs are described.
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  • 文章类型: Journal Article
    目的/背景特质情绪智力与癌症患者的焦虑和抑郁症状以及生活质量相关。然而,关于特质情绪智力与焦虑关系的研究,抑郁症,胃癌患者的生活质量有限。本研究探讨胃癌患者特质情绪智力与抑郁情绪及生活质量的关系,为临床管理提供理论依据。方法选取2020年7月至2023年7月我院收治的270例胃癌患者,其中筛选出31例问卷缺失和漏诊的患者,结果纳入了239名胃癌患者。在这次调查中,自我管理的一般信息问卷,即特质情绪智力简称(TEIQue-SF),欧洲癌症研究和治疗组织的生活质量问卷-核心30(EORTCQLQ-C30),使用医院焦虑和抑郁量表(HADS)。结果TEIQue-SF总分与QLQ-C30得分呈正相关(p<0.001),与HADS-A、HADS-D得分呈负相关(p<0.001)。TEIQue-SF总分是QLQ-C30评分的阳性预测因子(β=0.412,p<0.001)和HADS评分的阴性预测因子(β=-0.740,p<0.001)。TEIQue-SF总分(β=0.141,p=0.006)和HADS评分(β=-0.665,p<0.001)是QLQ-C30评分的良好预测因子。TEIQue-SF总分对QLQ-C30评分的直接影响为0.141,而TEIQQUE-SF总分与QLQ-C30评分之间的HADS评分的介导效应值为0.492。结论特质情绪智力不仅直接影响生活质量,但也通过焦虑和抑郁间接影响生活质量。临床医生应该注意焦虑,抑郁症,提高胃癌患者的生活质量。
    Aims/Background Trait emotional intelligence is associated with anxiety and depression symptoms and quality of life in cancer patients. However, studies on the relationship of trait emotional intelligence with anxiety, depression, and quality of life in gastric cancer patients are limited. This study investigates the relationship of trait emotional intelligence with depression and quality of life in gastric cancer patients to provide a theoretical basis for clinical management. Methods A total of 270 patients with gastric cancer treated in our hospital from July 2020 to July 2023 were selected, of which 31 patients with missing questionnaire entries and missed visits were screened out, resulting in the enrolment of 239 gastric cancer patients in this study. In this survey, self-administered general information questionnaires, namely Trait Emotional Intelligence Short Form (TEIQue-SF), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), and Hospital Anxiety and Depression Scale (HADS) were used. Results TEIQue-SF total scores were positively correlated with QLQ-C30 scores (p < 0.001) and negatively correlated with HADS-A and HADS-D scores (p < 0.001). TEIQue-SF total score was a superior positive predictor of the QLQ-C30 score (β = 0.412, p < 0.001) and a superior negative predictor of the HADS score (β = -0.740, p < 0.001). TEIQue-SF total score (β = 0.141, p = 0.006) and HADS score (β = -0.665, p < 0.001) were good predictors of QLQ-C30 score. The direct effect of TEIQue-SF total score on QLQ-C30 score was 0.141, while HADS score between TEIQue-SF total score and QLQ-C30 score had a mediated effect value of 0.492. Conclusion Trait emotional intelligence not only directly affects the quality of life, but also indirectly affects the quality of life through anxiety and depression. Clinicians should pay attention to the anxiety, depression, and emotional intelligence of patients with gastric cancer to help them improve their quality of life.
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  • 文章类型: Journal Article
    已经确定,癫痫的生活质量与诊断患者的感知残疾密切相关。然而,在医疗保健过程中很少考虑这一措施。本研究的目的是在拉丁美洲背景下被诊断为癫痫的个体中建立感知残疾问卷的心理测量特性。横截面,分析研究涉及325名参与者,12岁及以上(M40.42岁),在哥伦比亚被诊断为癫痫的个体。探索了该工具的主要心理测量特性,以说明其因子效度和可靠性。感知残疾问卷具有很高的可靠性(α=0.878)和包含问卷最终版本的三个子量表(不满意,悲观主义,和自我蔑视)解释了与癫痫诊断相关的残疾信念的总方差的45.393%;问卷与癫痫量表(QOLIE-10)中的生活质量显着相关。找到了仪器的足够的心理测量特性,这允许其提议作为哥伦比亚背景下癫痫护理过程中的工具。
    It has been determined that quality of life in epilepsy is closely related to the perceived disability experienced by individuals with the diagnosis. However, this measure is seldom considered in healthcare processes. The objective of the present study is to establish the psychometric properties of the Perceived Disability Questionnaire in individuals diagnosed with epilepsy within a Latin American context. A cross-sectional, analytical study was conducted involving 325 participants, aged 12 years and older (M 40.42 years), individuals diagnosed with epilepsy in Colombia. The main psychometric properties of the instrument were explored to account for its factorial validity and reliability. The Perceived Disability Questionnaire exhibits high reliability (α = 0.878) and the three subscales comprising the final version of the questionnaire (Dissatisfaction, Pessimism, and Self-Disdain) explain 45.393 % of the total variance in relation to beliefs of disability associated with the diagnosis of epilepsy; the questionnaire significantly correlates with the Quality of Life in Epilepsy Inventory (QOLIE-10). Adequate psychometric properties of the instrument are found, which allows for its proposal as a tool in epilepsy care processes within the Colombian context.
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  • 文章类型: Journal Article
    背景:在乳房重建中,很少有经过验证的美学评估工具使用离散量表来促进与多个评估者的研究。
    目的:这项研究旨在提出一种用于重建乳房的美学评估量表。
    方法:建议使用离散变量,响应范围为1至10,每个类别的响应可以求和以获得平均值,该平均值可用于多个评估者的研究。为了测试本研究中建议的仪器,5名经验丰富的整形外科医生评估了46名患者。对于所有的分析,零假设的拒绝水平为5%(p<0.05)。
    结果:建议量表获得有效的组内相关系数,0.9用于乳房的整体美学评估,最低为0.77用于定义乳房下褶皱。我们在所有比较中观察到良好的诊断准确性,曲线下面积为0.85~0.97。关于收敛有效性,我们观察到乳房体积和体积对称性之间的相关性为0.77(p<0.001),乳房形状和轮廓自然度之间为0.66(p<0.001)。测试-重测可靠性为0.708,这被认为是良好的。
    结论:这项研究的结果支持拟议的新美学评估量表的有效性,揭示不同评估者之间以及随着时间的推移的一致性。收敛验证加强了新量表变量与Garbay量表变量之间的关系。此外,强大的诊断准确性凸显了新量表在评估乳房重建美学结果方面的临床实用性.
    BACKGROUND: Few validated aesthetic assessment instruments in breast reconstruction use discrete scales to facilitate studies with multiple evaluators.
    OBJECTIVE: This research aimed to propose an aesthetic assessment scale for reconstructed breasts.
    METHODS: A scale was suggested using discrete variables, with responses ranging from 1 to 10, and the responses for each category could be summed to obtain an average that could be used in studies with multiple evaluators. To test the instrument suggested in this study, 5 experienced plastic surgeons assessed 46 patients. For all the analyses, a rejection level for the null hypothesis of 5% (p < 0.05) was adopted.
    RESULTS: The suggested scale obtained valid intraclass correlation coefficients, with 0.9 for the overall aesthetic evaluation of the breast and the lowest being 0.77 for defining the inframammary fold. We observed good diagnostic accuracy in all comparisons, with the area under the curve ranging from 0.85 to 0.97. Regarding convergent validity, we observed correlations of 0.77 (p < 0.001) between breast volume and volume symmetry, 0.66 (p < 0.001) between breast shape and contour naturalness. The test-retest reliability was 0.708, which is considered good.
    CONCLUSIONS: The results of this study support the effectiveness of the proposed new aesthetic evaluation scale, revealing consistency among different evaluators and over time. Convergent validation strengthens the relationship between the variables of the new scale and those of the Garbay scale. Furthermore, the robust diagnostic accuracy highlights the clinical utility of the new scale in assessing aesthetic outcomes in breast reconstructions.
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  • 文章类型: Journal Article
    目的:确定具有医学易感性的个体的症状负担是否表明躯体症状障碍(SSD)具有挑战性,鉴于该组中症状的现象学高度重叠。这项研究旨在提高对有心力衰竭风险的个体的认识。
    方法:分析了汉堡市健康研究的横断面数据,包括从汉堡普通人群中随机选择的个体,德国从2016年2月至2018年11月招募。通过应用聚类分析对使用躯体症状量表-8和躯体症状障碍量表-12评估的SSD症状进行分类,包括412名在未来十年内与心力衰竭相关的住院风险至少为5%的个体。使用ANOVA和卡方检验比较了集群的生物医学和心理因素。线性回归,适应社会人口统计学,生物医学,和心理因素,探索集群与全科医生就诊和生活质量之间的关联。
    结果:出现了三个簇:无(n=215;43%为女性),中度(n=151;48%为女性),和严重(n=46;女性54%)SSD症状负担。SSS-8平均总分为3.4(SD=2.7),中度为6.4(SD=3.4),严重SSD症状负担为12.4(SD=3.7)。SSD-12的平均总分为3.1(SD=2.6),12.2(SD=4.2)为中度,严重SSD症状负担为23.5(SD=6.7)。较高的SSD症状负担与生物医学因素相关(患有糖尿病:p=.005,呼吸困难:p≤.001)和心理负担增加(抑郁严重程度:p≤.001;焦虑严重程度:p≤.001),与心力衰竭风险无关(p=.202)。SSD症状增加与更多的全科医生就诊(β=0.172;p=0.002)和身体生活质量下降(β=-0.417;p≤0.001)相关。
    结论:生物医学因素似乎与心力衰竭风险个体的特征有关,心理因素影响SSD症状体验。了解SSD症状多样性和解决子组需求可能是有益的。
    OBJECTIVE: Identifying whether experienced symptom burden in individuals with medical predisposition indicates somatic symptom disorder (SSD) is challenging, given the high overlap in the phenomenology of symptoms within this group. This study aimed to enhance understanding SSD in individuals at risk for heart failure.
    METHODS: Cross-sectional data from the Hamburg City Health Study was analyzed including randomly selected individuals from the general population of Hamburg, Germany recruited from February 2016 to November 2018. SSD symptoms assessed with the Somatic Symptom Scale-8 and the Somatic Symptom Disorder-12 scale were categorized by applying cluster analysis including 412 individuals having at least 5% risk for heart failure-related hospitalization within the next ten years. Clusters were compared for biomedical and psychological factors using ANOVA and chi-square tests. Linear regressions, adjusting for sociodemographic, biomedical, and psychological factors, explored associations between clusters with general practitioner visits and quality of life.
    RESULTS: Three clusters emerged: none (n = 215; 43% female), moderate (n = 151; 48% female), and severe (n = 46; 54% female) SSD symptom burden. The SSS-8 mean sum scores were 3.4 (SD = 2.7) for no, 6.4 (SD = 3.4) for moderate, and 12.4 (SD = 3.7) for severe SSD symptom burden. The SSD-12 mean sum scores were 3.1 (SD = 2.6) for no, 12.2 (SD = 4.2) for moderate, and 23.5 (SD = 6.7) for severe SSD symptom burden. Higher SSD symptom burden correlated with biomedical factors (having diabetes: p = .005 and dyspnea: p ≤ .001) and increased psychological burden (depression severity: p ≤ .001; anxiety severity: p ≤ .001), irrespective of heart failure risk (p = .202). Increased SSD symptoms were associated with more general practitioner visits (β = 0.172; p = .002) and decreased physical quality of life (β = -0.417; p ≤ .001).
    CONCLUSIONS: Biomedical factors appear relevant in characterizing individuals at risk for heart failure, while psychological factors affect SSD symptom experience. Understanding SSD symptom diversity and addressing subgroup needs could prove beneficial.
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  • 文章类型: Journal Article
    背景:补充医学和综合肿瘤学模式(IOM)已被纳入美国胸科医师学会治疗肺癌患者的临床实践指南。本研究检查了患者量身定制的IOM治疗计划对接受积极肿瘤治疗的非小肺癌和小肺癌患者的生活质量(QoL)相关问题的影响。
    方法:这项对照研究是务实的和前瞻性的评估患者的依从性由他们的肿瘤保健提供者转诊到综合医师咨询,其次是6周的IOM治疗,解决QoL相关的问题。高度坚持综合护理(高AIC,vs.低AIC)定义为参加≥4次IOM会议。使用ESAS(埃德蒙顿症状评估量表)评估症状,EORTCQLQ-C30(欧洲癌症研究和治疗组织生活质量问卷)和MYCAW(测量自己的关注和福祉)工具,在基线和6周。
    结果:在153名患者中,74(48%)为高AIC,与基线人口统计,癌症和QoL相关特征与低AIC患者相似。在6周,高AIC患者报告MYCAW幸福感有更大的改善(p=0.036),观察到EORTC疼痛(p=0.021)和情绪功能(p=0.041)的组内改善;以及ESAS抑郁(p=0.005),对EORTC睡眠具有临界意义(p=0.06)。
    结论:在肺癌患者的支持/姑息治疗中,高度坚持6周的IOM计划可以减轻疼痛和情绪问题,提高整体QoL。需要进一步的研究来确认在现实生活中的IOM实践中对肺癌患者的发现。
    BACKGROUND: Complementary medicine and integrative oncology modalities (IOM) have been included in the clinical practice guidelines of the American College of Chest Physicians in the treatments of patients with lung cancer. The present study examined the impact of a patient-tailored IOM treatment program on quality of life (QoL)-related concerns among patients with non-small and small lung cancer undergoing active oncology treatment.
    METHODS: This controlled study was pragmatic and prospective assessing the adherence among patients referred by their oncology healthcare provider to an integrative physician consultation, followed by 6 weekly IOM treatments addressing QoL-related concerns. High adherence to integrative care (high-AIC, vs. low-AIC) was defined as attending ≥4 IOM sessions. Symptoms were assessed using the ESAS (Edmonton Symptom Assessment Scale), EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire), and MYCAW (Measure Yourself Concerns and Wellbeing) tools, at baseline and 6 weeks.
    RESULTS: Of 153 patients, 74 (48 %) were high-AIC, with baseline demographic, cancer-and QoL-related characteristics similar to those of low-AIC patients. At 6 weeks, high-AIC patients reported greater improvement on MYCAW well-being (p = 0.036), with within-group improvement observed for EORTC pain (p = 0.021) and emotional functioning (p = 0.041); and for ESAS depression (p = 0.005), with borderline significance for EORTC sleep (p = 0.06).
    CONCLUSIONS: High adherence to a 6-week IOM program within supportive/palliative care for patients with lung cancer was found to alleviate pain and emotional concerns, improving overall QoL. Further research is needed to confirm the findings in real-life IOM practice for patients with lung cancer.
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  • 文章类型: Journal Article
    背景:骨关节炎(OA)是一种致残疾病,影响65岁以上人群的三分之一以上。目前,这些患者中有80%报告运动受限,20%的人无法进行主要的日常生活活动,大约11%需要个人护理。2014年,欧洲骨质疏松症和骨关节炎临床和经济方面协会(ESCEO)建议,作为膝骨关节炎药物治疗的第一步,使用慢性有症状的缓慢作用的骨关节炎药物如硫酸葡糖胺的背景疗法,硫酸软骨素,和透明质酸。后者已在临床试验中广泛评估为关节内和口服给药。最近的评论表明,对口服透明质酸的研究通常仅使用主观参数来测量症状,如视觉模拟量表或生活质量问卷。因此,缺乏客观措施,数据有效性通常会受到损害。
    目的:这项使用口服透明质酸的初步研究的主要目标是评估使用客观工具作为评估膝关节活动度改善的结果的可行性。我们建议使用测角仪进行超声和运动范围测量,该测角仪可以客观地将关节活动度的变化与疼痛减轻相关联,通过视觉模拟量表评估。次要目标是收集数据以估计主要双盲研究随机试验的时间和预算。这些数据可能是定量的(例如每月的入学率,筛选失败的数量,和新的潜在结果)和定性(如现场后勤问题,患者不愿参加,和调查人员的人际关系困难)。
    方法:这项开放标签的试点和可行性研究是在骨科诊所进行的(Timisoara,罗马尼亚)。这项研究包括男性和女性参与者,50-70岁,已被诊断为有症状的膝关节OA,并经历了至少6个月的轻度关节不适。必须招募八名患者并用Syalox300Plus(RiverPharma)治疗8周。它是一种含有高分子量透明质酸的膳食补充剂,它已经在几个欧洲国家销售。在基线和最终访问时进行评估。
    结果:8名患者的招募和治疗于2018年2月15日开始,并于2018年5月25日完成。数据分析计划于2018年底完成。该研究于2019年2月获得资助。我们预计这些结果将在2024年最后一个季度发表在同行评审的临床期刊上。
    结论:这项初步研究的数据将用于评估未来OA随机临床试验的可行性。特别是,计划的结果(例如,超声和运动范围),安全,并且必须对定量和定性数据进行评估,以提前估算未来主要研究所需的时间和预算。最后,试点研究应提供有关研究产品疗效的初步信息.
    背景:ClinicalTrials.govNCT03421054;https://clinicaltrials.gov/study/NCT03421054。
    RR1-10.2196/13642。
    BACKGROUND: Osteoarthritis (OA) is a disabling condition that affects more than one-third of people older than 65 years. Currently, 80% of these patients report movement limitations, 20% are unable to perform major activities of daily living, and approximately 11% require personal care. In 2014, the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) recommended, as the first step in the pharmacological treatment of knee osteoarthritis, a background therapy with chronic symptomatic slow-acting osteoarthritic drugs such as glucosamine sulfate, chondroitin sulfate, and hyaluronic acid. The latter has been extensively evaluated in clinical trials as intra-articular and oral administration. Recent reviews have shown that studies on oral hyaluronic acid generally measure symptoms using only subjective parameters, such as visual analog scales or quality of life questionnaires. As a result, objective measures are lacking, and data validity is generally impaired.
    OBJECTIVE: The main goal of this pilot study with oral hyaluronic acid is to evaluate the feasibility of using objective tools as outcomes to evaluate improvements in knee mobility. We propose ultrasound and range of motion measurements with a goniometer that could objectively correlate changes in joint mobility with pain reduction, as assessed by the visual analog scale. The secondary objective is to collect data to estimate the time and budget for the main double-blind study randomized trial. These data may be quantitative (such as enrollment rate per month, number of screening failures, and new potential outcomes) and qualitative (such as site logistical issues, patient reluctance to enroll, and interpersonal difficulties for investigators).
    METHODS: This open-label pilot and feasibility study is conducted in an orthopedic clinic (Timisoara, Romania). The study includes male and female participants, aged 50-70 years, who have been diagnosed with symptomatic knee OA and have experienced mild joint discomfort for at least 6 months. Eight patients must be enrolled and treated with Syalox 300 Plus (River Pharma) for 8 weeks. It is a dietary supplement containing high-molecular-weight hyaluronic acid, which has already been marketed in several European countries. Assessments are made at the baseline and final visits.
    RESULTS: Recruitment and treatment of the 8 patients began on February 15, 2018, and was completed on May 25, 2018. Data analysis was planned to be completed by the end of 2018. The study was funded in February 2019. We expect the results to be published in a peer-reviewed clinical journal in the last quarter of 2024.
    CONCLUSIONS: The data from this pilot study will be used to assess the feasibility of a future randomized clinical trial in OA. In particular, the planned outcomes (eg, ultrasound and range of motion), safety, and quantitative and qualitative data must be evaluated to estimate in advance the time and budget required for the future main study. Finally, the pilot study should provide preliminary information on the efficacy of the investigational product.
    BACKGROUND: ClinicalTrials.gov NCT03421054; https://clinicaltrials.gov/study/NCT03421054.
    UNASSIGNED: RR1-10.2196/13642.
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