QLQ-C30

QLQ - C30
  • 文章类型: Journal Article
    目的:肠外营养(PN)可以成为改善胰腺癌患者营养状况的有效治疗方法。但PN对生活质量(QoL)的影响仍未得到充分研究。因此,我们的目的是调查在接受7周化疗的晚期胰腺癌患者中,与单独使用BSNC相比,家庭最佳支持性营养护理(BSNC)联合PN治疗是否能改变QoL.
    方法:在PANUSCO研究中,n=12例患者仅接受了营养咨询(对照组(CG)),n=9例患者还接受了支持性PN(干预组(IG))。主要终点是7周内组间QoL(EORTC-QLQ-C30和QLQ-PAN26)的变化。
    结果:IG的社会功能显着恶化(p=0.031),两组之间的社会功能变化存在显着差异(p=0.020)。在QoL的所有其他领域中,组间无显著差异。在群体中,IG的域失重有显著改善(p=0.031),这表明患者不太担心自己的体重太低。此外,两组之间的BW随时间的变化存在显着差异(p<0.001),其中IG显示增加(p=0.004),CG显示无变化(p=0.578)。
    结论:PN的管理在五个领域之一对QoL产生负面影响。给予PN的决定应始终与患者一起单独做出,对QoL的影响应包括在管理PN的决定中。
    OBJECTIVE: Parenteral nutrition (PN) can be an effective treatment to improve the nutritional status of patients with pancreatic cancer, but the effects of PN on quality of life (QoL) are still understudied. Therefore, we aimed at investigating whether the best supportive nutritional care (BSNC) in combination with PN at home compared to BSNC alone changed QoL in patients with advanced pancreatic cancer undergoing chemotherapy over a period of 7 weeks.
    METHODS: n = 12 patients in the PANUSCO study received nutritional counseling only (control group (CG)) and n = 9 patients were also given supportive PN (intervention group (IG)). The primary endpoint was the change of QoL (EORTC-QLQ-C30 and QLQ-PAN26) over 7 weeks between the groups.
    RESULTS: There was a significant worsening in social functioning in IG (p = 0.031) and a significant difference between groups in change of social functioning (p = 0.020). In all other domains of QoL, there was no significant difference between groups. Within groups, there was a significant improvement in the domain weight loss in IG (p = 0.031), showing that patients were less worried about their weight being too low. Furthermore, there was a significant difference in the change of BW over time between groups (p < 0.001) with IG showing an increase (p = 0.004) and CG showing no change (p = 0.578).
    CONCLUSIONS: The administration of PN had in one of five domains negative consequences on QoL. The decision to administer PN should always be made individually and together with the patient, and the impact on QoL should be included in the decision to administer PN.
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  • 文章类型: Journal Article
    背景:在KEYNOTE-522(NCT03036488)中,在早期三阴性乳腺癌(TNBC)中,新辅助派姆单抗+化疗,然后辅助派姆单抗显著改善病理完全缓解和无事件生存期,与新辅助化疗相比.我们从KEYNOTE-522报告了患者报告的结果(PRO)。
    方法:患者被随机分为2:1,每3周接受新辅助派姆单抗200mg或安慰剂,加上4个周期的紫杉醇+卡铂,然后4个周期的阿霉素(或表阿霉素)+环磷酰胺。手术后,患者接受pembrolizumab辅助治疗或安慰剂治疗达9个周期.EORTCQLQ-30和QLQ-BR23是预设的次要目标。使用纵向模型(未分配α误差)评估从基线(新辅助和辅助阶段的第1天/第1周期)到预定的最新时间点的最小二乘(LS)平均变化的组间差异。
    结果:第21周(新辅助治疗期)和第24周(辅助治疗期)是完成/依从率≥60%/80%的最新时间点。在新辅助治疗阶段,在QLQ-C30GHS/QoL中,从基线到第21周的LS平均变化的组间差异(派姆单抗+化疗[N=762]与安慰剂+化疗[N=383]),情感功能,身体功能为-1.04(95%CI,-3.46至1.38),-0.69(95%CI,-3.13至1.75),和-2.85(95%CI,-5.11至-0.60),分别。在佐剂阶段,从基线到第24周的LS平均变化的组间差异(pembrolizumab[N=539]与安慰剂[N=308])为-0.41(95%CI,-2.60至1.77),-0.60(95%CI,-2.99至1.79),和-1.57(95%CI,-3.36至0.21)。
    结论:在早期TNBC中,新辅助派姆单抗+化疗后辅助派姆单抗与新辅助安慰剂+化疗之间的PRO评估没有实质性差异。
    背景:ClinicalTrials.gov,NCT03036488。
    BACKGROUND: In KEYNOTE-522 (NCT03036488), neoadjuvant pembrolizumab+chemotherapy then adjuvant pembrolizumab significantly improved pathological complete response and event-free survival vs neoadjuvant chemotherapy in early-stage triple-negative breast cancer (TNBC). We report patient-reported outcomes (PROs) from KEYNOTE-522.
    METHODS: Patients were randomized 2:1 to neoadjuvant pembrolizumab 200 mg or placebo every 3 weeks, plus 4 cycles of paclitaxel+carboplatin then 4 cycles of doxorubicin (or epirubicin)+cyclophosphamide. After surgery, patients received adjuvant pembrolizumab or placebo for up to 9 cycles. EORTC QLQ-30 and QLQ-BR23 were prespecified secondary objectives. Between-group differences in least squares (LS) mean change from baseline (day 1/cycle 1 in both neoadjuvant and adjuvant phases) to the prespecified latest time point with ≥60%/80% completion/compliance were assessed using a longitudinal model (no alpha error assigned).
    RESULTS: Week 21 (neoadjuvant phase) and week 24 (adjuvant phase) were the latest time points at which completion/compliance rates were ≥60%/80%. In the neoadjuvant phase, between-group differences (pembrolizumab+chemotherapy [N = 762] vs placebo+chemotherapy [N = 383]) in LS mean change from baseline to week 21 in QLQ-C30 GHS/QoL, emotional functioning, and physical functioning were -1.04 (95% CI, -3.46 to 1.38), -0.69 (95% CI, -3.13 to 1.75), and -2.85 (95% CI, -5.11 to - 0.60), respectively. In the adjuvant phase, between-group differences (pembrolizumab [N = 539] vs placebo [N = 308]) in LS mean change from baseline to week 24 were -0.41 (95% CI, -2.60 to 1.77), -0.60 (95% CI, -2.99 to 1.79), and -1.57 (95% CI, -3.36 to 0.21).
    CONCLUSIONS: No substantial differences in PRO assessments were observed between neoadjuvant pembrolizumab+chemotherapy followed by adjuvant pembrolizumab vs neoadjuvant placebo+chemotherapy in early-stage TNBC.
    BACKGROUND: ClinicalTrials.gov, NCT03036488.
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  • 文章类型: Journal Article
    目的:本研究旨在开发EORTCQLU-C10D的日语值集,从癌症特异性健康相关生活质量(HRQL)问卷中得出的多属性效用度量,EORTCQLQ-C30.QLU-C10D包含十个HRQL维度:物理、角色,社会和情感功能,疼痛,疲劳,睡眠,食欲,恶心,还有肠道问题.
    方法:使用日本在线小组的配额抽样来实现按性别和年龄(≥18岁)的日本普通人群的代表性。估值方法是在线离散选择实验。每个参与者考虑了16个选择对,从960个选择对中随机分配。每一对包括两个QLU-C10D健康状况和预期寿命。数据采用条件逻辑回归分析,参数化,以符合质量调整生命年框架。偏好权重计算为每个维度级别系数与预期寿命系数的比率。
    结果:总共2809名合格的小组成员同意,2662/2809(95%)完成了至少一个选择对,2435/2662(91%)完成了所有选择对。在维度内,偏好权重通常是单调的。身体功能,角色功能,疼痛与最大的效用权重相关。中等效用权重与社会功能和恶心有关;其余症状和情绪功能与较小的效用减少有关。最差健康状况的值为-0.221,低于大多数其他现有的QLU-C10D特定国家/地区的值集。
    结论:日本特定的QLU-C10D值集适用于评估日本卫生技术评估和决策的肿瘤治疗的成本和效用。
    OBJECTIVE: This study aimed to develop a Japanese value set for the EORTC QLU-C10D, a multi-attribute utility measure derived from the cancer-specific health-related quality-of-life (HRQL) questionnaire, the EORTC QLQ-C30. The QLU-C10D contains ten HRQL dimensions: physical, role, social and emotional functioning, pain, fatigue, sleep, appetite, nausea, and bowel problems.
    METHODS: Quota sampling of a Japanese online panel was used to achieve representativeness of the Japanese general population by sex and age (≥ 18 years). The valuation method was an online discrete choice experiment. Each participant considered 16 choice pairs, randomly assigned from 960 choice pairs. Each pair included two QLU-C10D health states and life expectancy. Data were analyzed using conditional logistic regression, parameterized to fit the quality-adjusted life-year framework. Preference weights were calculated as the ratio of each dimension-level coefficient to the coefficient for life expectancy.
    RESULTS: A total of 2809 eligible panel members consented, 2662/2809 (95%) completed at least one choice pair, and 2435/2662 (91%) completed all choice pairs. Within dimensions, preference weights were generally monotonic. Physical functioning, role functioning, and pain were associated with the largest utility weights. Intermediate utility weights were associated with social functioning and nausea; the remaining symptoms and emotional functioning were associated with smaller utility decrements. The value of the worst health state was - 0.221, lower than that seen in most other existing QLU-C10D country-specific value sets.
    CONCLUSIONS: The Japan-specific QLU-C10D value set is suitable for evaluating the cost and utility of oncology treatments for Japanese health technology assessment and decision-making.
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  • 文章类型: Journal Article
    目的:癌症及其治疗显著影响个体的生活和生活质量(QOL)。对QOL的研究检查了这些影响,包括身体,心理,和社会方面。了解QOL因素对患者和临床医生都至关重要。先前尚未在摩洛哥的BeniMellal-Khenifra地区研究癌症患者的QOL及其相关预测因素的评估。我们的主要目的是评估患者的QOL,同时确定影响其的决定因素和预测因素。
    方法:患者在BeniMelal肿瘤中心进行的横断面研究。每个参与者都需要填写摩洛哥阿拉伯文版本的欧洲癌症研究和治疗组织QLQ-C30问卷,以及收集社会人口统计信息的补充问卷。进行线性回归分析以确定全球健康状况(GHS)和5种功能量表的预测因子。使用社会科学统计软件包(SPSS)v25软件进行统计分析。
    结果:我们的研究包括369名患者,平均年龄为52.89岁。QLQC30GHS量表的平均得分为64.97。值得注意的是,这个分数与情绪呈正相关,社会,和角色功能尺度,虽然与前列腺癌和肺癌呈负相关,以及疼痛的存在。此外,疲劳的存在表现出与所有功能量表的关联,除了社会功能。
    结论:患者表现出良好的GHS。然而,值得注意的是前列腺癌,肺癌,疼痛的存在,情感减弱,社会,角色功能成为与较差的GHS显著相关的独立因素。
    OBJECTIVE: Cancer and its treatments significantly impact individuals\' lives and quality of life (QOL). Research on QOL examines these effects, encompassing physical, psychological, and social aspects. Understanding QOL factors is vital for both patients and clinicians. The evaluation of QOL of patients with cancer and its associated predictive factors has not been previously investigated within the Beni Mellal-Khenifra region of Morocco. Our primary aim was to assess the QOL experienced by patients while simultaneously identifying the determinants and predictors influencing it.
    METHODS: Patients were enrolled in a cross-sectional study conducted at the Beni Mellal Oncology Center. Each participant was required to fill out the Moroccan Arabic version of the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire, along with a supplemental questionnaire gathering sociodemographic information. A linear regression analysis was executed to ascertain predictors of the Global Health Status (GHS) and 5 functional scales. The statistical analysis was carried out using Statistical Package for Social Science (SPSS) v25 software.
    RESULTS: Our study included 369 patients, with an average age of 52.89. The mean score on the QLQC30 GHS Scale was 64.97. Notably, this score exhibited positive correlations with emotional, social, and role functioning scales, while demonstrating negative correlations with prostate and lung cancers, as well as the presence of pain. Furthermore, the presence of fatigue exhibited associations with all functioning scales, except for social functioning.
    CONCLUSIONS: Patients exhibited a favorable GHS. However, it is noteworthy that prostate cancer, lung cancer, the presence of pain, and diminished emotional, social, and role functioning emerged as independent factors significantly associated with poorer GHS.
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  • 文章类型: Journal Article
    这项研究的目的是检查手术类型和激素治疗对接受放疗的乳腺癌患者总体生活质量的影响。
    共109名患者纳入研究。作为研究中的数据收集工具,在第一部分中使用了一种说明人口统计学和临床特征的表格,在第二部分,使用了由欧洲癌症研究和治疗组织开发的“EORTCQLQ-C30”和“EORTCQLQ-BR23”土耳其乳腺癌特有的生活质量形式。要求患者在第一天填写调查表,放疗的最后一天和治疗结束后的三个月。
    本研究的平均年龄为54.8±12.1岁。在第一天的调查问卷中,放疗后的最后一天和三个月,根据EORTCQLQ-C30量表,得分最高的是社会和认知功能,以及在EORTCQLQ-BR23量表上的性生活。根据多重比较测试,比较放疗第一天和放疗后三个月,患者身体功能平均有显著差异(p=0.049),未来预期(p=0.033),性生活(p=0.029),性满意度(p<0.001),和脱发(p=0.011),和手臂相关的问题(p<0.001)。根据重复测量中的方差分析,物理功能,性生活,副作用,脱发,呼吸困难,根据手术类型,未来的期望具有统计学意义,激素治疗,性生活,脱发,便秘和经济困难有统计学意义。
    据观察,除了放疗,激素治疗和手术技术对乳腺癌放疗患者的生活质量也有效.
    UNASSIGNED: The aim of this study was to examine the effect of surgery type and hormone therapy on the general quality of life in breast cancer patients receiving radiotherapy.
    UNASSIGNED: A total of 109 patients were included in the study. As data collection tools in the research, a form stating the demographic and clinical features was used in the first part, and in the second part, \"EORTC QLQ-C30\" developed by the European Organization for Research and Treatment of Cancer and \"EORTC QLQ-BR23\" Turkish quality of life forms specific to breast cancer were used. The patients were asked to fill in the questionnaire forms on the first day, the last day of radiotherapy and three months after the end of the treatment.
    UNASSIGNED: Mean age of this study was 54.8 ± 12.1 years. In the questionnaires made on the first day, last day and three months after radiotherapy, the highest score according to the EORTC QLQ-C30 scale was in social and cognitive function, and in sexual life on the EORTC QLQ-BR23 scale. According to multiple comparison test and comparing the first day of radiotherapy and three months after radiotherapy, there was a significant difference in patients\' physical function average (p= 0.049), future expectation (p= 0.033), sexual life (p= 0.029), sexual satisfaction (p <0.001), and hair loss (p= 0.011), and arm related problems (p <0.001). According to the analysis of variance in repeated measurements, physical function, sexual life, side effects, hair loss, dyspnea, and future expectation were statistically significant according to the type of surgery, and for hormone therapy, sexual life, hair loss, constipation and financial difficulty were found statistically significant.
    UNASSIGNED: It was observed that other than radiotherapy, hormone therapy and surgical techniques were also effective on the quality of life in patients receiving radiotherapy for breast cancer.
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  • 文章类型: Journal Article
    目的:从癌症患者中经常使用的患者报告结果指标(PROMs)中提供身体功能(PF)评分的等百分位数,以促进数据汇总和比较。
    方法:来自五个欧洲国家的成年癌症患者完成了欧洲癌症研究与治疗组织(EORTC)计算机自适应测试(CAT)Core,EORTC生活质量问卷3.0版(QLQ-C30),癌症治疗的功能评估-一般(FACT-G),36项简式健康调查(SF-36),和患者报告的结果测量信息系统(PROMIS)物理功能20a的简短形式。R包“equate”用于建立那些具有至少0.75的双变量等级相关性的度量的PF得分的转换表。
    结果:总计,953例癌症患者(平均年龄58.9岁,54.7%的男性)参加。EORTCCAT核心的PF分数之间的二元等级相关性,EORTCQLQ-C30,SF-36和PROMIS均高于0.85,但FACT-G低于0.69。除FACT-G外,所有措施都建立了转换表。这些表指示来自一个PROM的哪个分数与来自另一个PROM的分数最佳匹配,并提供转换分数的标准误差。
    结论:我们的分析表明,将两种EORTC措施(CAT和QLQ-C30)的PF分数与PROMIS和SF-36联系起来是可能的,而FACT-G的物理域似乎不同。所建立的转换表可用于比较来自使用不同PROM的临床研究的结果或汇集数据。
    OBJECTIVE: To provide equipercentile equating of physical function (PF) scores from frequently used patient-reported outcome measures (PROMs) in cancer patients to facilitate data pooling and comparisons.
    METHODS: Adult cancer patients from five European countries completed the European Organization for Research and Treatment of Cancer (EORTC) computer adaptive test (CAT) Core, EORTC Quality of Life Questionnaire Version 3.0 (QLQ-C30), Functional Assessment of Cancer Therapy - General (FACT-G), 36-item Short Form Health Survey (SF-36), and the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 20a short form. The R package \"equate\" was used to establish conversion tables of PF scores on those measures with a bivariate rank correlation of at least 0.75.
    RESULTS: In total, 953 patients with cancer (mean age 58.9 years, 54.7% men) participated. Bivariate rank correlations between PF scores from the EORTC CAT Core, EORTC QLQ-C30, SF-36, and PROMIS were all above 0.85, but below 0.69 for the FACT-G. Conversion tables were established for all measures but the FACT-G. These tables indicate which score from one PROM best matches the score from another PROM and provide standard errors of converted scores.
    CONCLUSIONS: Our analysis indicates that linking of PF scores from both EORTC measures (CAT and QLQ-C30) with PROMIS and SF-36 is possible, whereas the physical domain of the FACT-G seems to be different. The established conversion tables may be used for comparing results or pooling data from clinical studies using different PROMs.
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  • 文章类型: Journal Article
    背景:接受根治性前列腺切除术的前列腺癌患者生活质量下降,常与性功能障碍和尿失禁有关。了解和测量根治性前列腺切除术对个体社会的影响,情感,和家庭生活质量可以帮助计划和制定适当的,以患者为中心的治疗方法。
    目的:在本研究中,我们旨在评估前列腺癌患者在前列腺癌根治术前后的生活质量变化.
    方法:纵向,采用复试法,对114名参与者进行了观察性研究.通过以下自我管理问卷测量前列腺癌根治术前后的生活质量:(1)西班牙版本的EORTCQLQ-C30用于评估参与者的一般生活质量;(2)西班牙版本的EORTCQLQ-PR25用于评估特定的,前列腺癌患者的健康相关生活质量。
    结果:共有114名男性参加了这项研究。QLQ-C30问卷的结果表明,情感角色和认知功能维度有所改善,以及疲劳的症状,疼痛,恶心和呕吐,失眠,食欲不振,手术后。患者在角色功能方面得分较低,社会功能,前列腺癌根治术后的经济影响。根据QLQ-PR25问卷的结果,61.40%的参与者在手术后出现阳痿,26.31%的参与者在手术后出现尿失禁。保留神经血管束的患者和未保留神经血管束的患者在某些术后结局上存在显着差异。
    结论:深入了解,以及对变化的测量,根治性前列腺切除术后的生活质量应该允许全面,多学科,以患者为中心的护理计划。社会心理评估,手术前后,对前列腺癌患者至关重要。本研究于2012-06-27在CEIC-A进行了前瞻性注册,注册编号为C.P.-C.I.PI12/0088。
    BACKGROUND: Men with prostate cancer who undergo radical prostatectomy experience a decrease in quality of life, often related to sexual disfunction and urinary incontinence. Knowing and measuring the impact of radical prostatectomy on the individual\'s social, emotional, and family quality of life could help to plan and develop an appropriate, patient-centred therapeutic approach.
    OBJECTIVE: In this study, we aimed to evaluate changes in quality of life of patients with prostate cancer before and after radical prostatectomy.
    METHODS: A longitudinal, observational study of 114 participants was conducted using the method of test-retest. Quality of life before and after radical prostatectomy was measured through the following self-administered questionnaires: (1) The EORTC QLQ-C30 in its Spanish version was used to assess the generic quality of life the participants; (2) the EORTC QLQ-PR25 in its Spanish version was used to assess the specific, health-related quality of life of prostate cancer patients.
    RESULTS: A total of 114 men took part in this study. The results from the QLQ-C30 questionnaire indicated an improvement in the dimensions of emotional role and cognitive function, as well as in the symptoms of fatigue, pain, nausea and vomiting, insomnia, and loss of appetite, after surgery. Patients scored lower in the dimensions of role functioning, social function, and economic impact after radical prostatectomy. According to the results from the QLQ-PR25 questionnaire, 61.40% of the participants experienced sexual impotence and 26.31% suffered urinary incontinence after surgery. There were significant differences in some postsurgical outcomes between patients who had neurovascular bundles preserved and those who had not.
    CONCLUSIONS: In-depth knowledge of, and measurement of changes in, quality of life after radical prostatectomy should allow for comprehensive, multidisciplinary, patient-centred care planning. Psychosocial assessment, both before and after surgery, is crucial in patients with prostate cancer. This study was prospectively registered with the CEIC-A on 2012-06-27, with registration number C.P.-C.I. PI12/0088.
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  • 文章类型: Journal Article
    目的:尚未充分考虑疾病状态和治疗阶段对卵巢癌女性生活质量(QoL)的综合影响。因此,这种临床,流行病学研究比较了5个不同治疗阶段的卵巢癌患者的QoL,并通过多变量模型确定了预测其QoL的因素.
    方法:本研究采用横断面调查设计。共有183名参与者来自台湾北部医疗中心的住院和门诊部。使用生活质量量表QLQ-C30和QLQ-OV28以及匹兹堡睡眠质量指数测量QoL。患者的临床特征数据来自台湾妇科癌症网络的数据库,正在接受妇科癌症治疗的活跃患者的注册。
    结论:化疗药物是卵巢癌患者全球健康状况不佳的主要预测因素。然而,良好的睡眠对患者的生活质量有益。研究结果可为调整肿瘤治疗方案以更有效地管理症状和促进患者教育以改善患者生活质量提供参考。
    结论:医生和护士可以考虑预测因素,以调整治疗方案和加强患者教育。
    The combined impact of disease status and treatment phase on the quality of life (QoL) of women with ovarian cancer has not been fully considered. Therefore, this clinical, epidemiologic study compared the QoL of patients with ovarian cancer between five different treatment phases and identified the factors predicting their QoL through multivariate modeling.
    This study had a cross-sectional survey design. The participants total of 183 were recruited from the inpatient and outpatient departments of the medical center in northern Taiwan. QoL was measured using the Quality of Life Scales QLQ-C30 and QLQ-OV28 and the Pittsburgh Sleep Quality Index. The patient\'s clinical characteristics data were obtained from the databank of the Taiwan Gynecologic Cancer Network, a registry of active patients being treated with gynecologic cancer.
    Chemotherapeutic agents were the major predictors of poor global health status in patients with ovarian cancer. However, good sleep was beneficial to patients\' QoL. The study results can be used as a reference to adjust oncological treatment regimens for more effective symptom management and to promote patient education to improve patients\' QoL.
    The predicting factors can be considered by physicians and nurses to adjust treatment regimens and enhance patient education.
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  • 文章类型: Journal Article
    背景和目的:本研究的目的是评估手术和保守治疗的影响,AAOMSI期MRONJ患者的一般健康相关(QoL)和口腔健康相关生活质量(OHRQoL)的非手术治疗。材料和方法:在这项前瞻性临床研究的过程中,使用QLQ-C30和QHIPG14问卷的QoL和OHRQoL在12个月内对174例前瞻性招募的具有MRONJI期治疗指征的患者进行纵向评估。患者接受保守或手术治疗。测量时间点是术前(T0),12周(T1),术后6个月(T2)和1年(T3)。结果:对于OHRQoL,对于所有时间点(T0-T3),两个治疗组之间没有发现显著差异(p>0.05)。在手术治疗组中,T1,T2和T3的OHIP评分显着低于基线测量值(T0)(T0-T1(2.99,p=0.024),T0-T2(5.20,p<0.001),T0-T3(7.44,p<0.001))。保守治疗组OHIP,T2和T3的得分明显低于基线测量值(T0)(T0-T2(9.09,p=0.013),T0-T3(12.79,p<0.001))。两组时间对QLQ-C30评分无统计学意义(手术治疗:F(3,174)=1.542,p<0.205,部分η2=0.026;保守治疗:F(3,30)=0.528,p=0.667,部分η2=0.050)。与手术治疗组相比,非手术组的T1(p=0.036)和T3(p=0.047)的QLQ-C30评分显着降低。结论:MRONJI期的手术和保守治疗显着改善了OHRQoL患者。就一般QoL而言,MRONJI期的手术治疗优于保守治疗。因此,由于QoL原因,不应省略MRONJI期的手术治疗。
    Background and Objectives: The purpose of this study was to evaluate the impact of surgical and conservative, non-surgical treatment on general health-related (QoL) and oral health-related quality of life (OHRQoL) in patients suffering from AAOMS stage I MRONJ. Materials and Methods: In the course of this prospective clinical study, QoL and OHRQoL using QLQ-C30 and QHIP G14 questionnaire were longitudinally assessed in N = 174 prospectively enrolled patients with indication of treatment of MRONJ stage I over a period of 12 months. Patients received conservative or surgical treatment. The measurement time points were preoperatively (T0), 12 weeks (T1), 6 months (T2) and 1 year after operation (T3). Results: For OHRQoL, no significant (p > 0.05) differences were found between both treatment groups for all timepoints (T0-T3). In the surgical treatment group, OHIP scores of T1, T2 and T3 were significantly lower than baseline measures (T0) (T0-T1 (2.99, p = 0.024), T0-T2 (5.20, p < 0.001), T0-T3 (7.44, p < 0.001)). For conservative treatment group OHIP, scores of T2 and T3 were significantly lower than baseline measures (T0) (T0-T2 (9.09, p = 0.013), T0-T3 (12.79, p < 0.001)). There was no statistically significant effect of time on QLQ-C30 scores in both groups (surgical treatment: F(3, 174) = 1.542, p < 0.205, partial η2 = 0.026; conservative treatment: F(3, 30) = 0.528, p = 0.667, partial η2 = 0.050). QLQ-C30 scores turned out to be significantly lower in the non-surgical group at T1 (p = 0.036) and T3 (p = 0.047) compared to the surgical treatment group. Conclusions: Surgical and conservative treatment of MRONJ stage I significantly improves patients\' OHRQoL. Surgical treatment is superior to conservative treatment of MRONJ stage I regarding general QoL. Therefore, surgical treatment of MRONJ stage I should not be omitted for QoL reasons.
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  • 文章类型: Journal Article
    背景:癌症及其治疗可对患者的情绪功能产生重大影响。有几种评估情绪功能的患者报告结果测量(PROM)可用,但是内容的差异限制了结果的可比性。为了更好地理解概念(DIS)相似性,我们对常用的PROM进行了内容比较。
    方法:我们包括情绪功能项目,scales,和EORTCCAT核心的项目银行,EORTCQLQ-C30,FACT-G,医院焦虑和抑郁量表(HADS),SF-36,PRO-CTCAE,和PROMIS(焦虑的项目银行,抑郁症,和愤怒)。项目内容已链接到国际功能分类,残疾,和健康(ICF)以及为PROMIS建立的分层框架。单个项目可以使用多个ICF类别进行编码,但在PROMIS框架中仅分配给一个方面。
    结果:这些措施包括132个独特的项目,涵盖ICF组件“身体功能”(136/153编码,88.9%)和“活动和参与”(15/153,9.8%)。大多数ICF编码(112/153,73.2%)涉及第三级类别\'b1528情绪功能,其他指定的\'。根据PROMIS框架,48.5%的项目评估抑郁(64/132项目),其次是焦虑(41/132,31.1%)和愤怒(26/132,19.7%)。EORTC措施涵盖了抑郁症,焦虑,和愤怒,而PROMIS库存为这些概念提供了单独的物料库。事实G,SF-36,PRO-CTCAE和HADS涵盖了抑郁和焦虑,但不是愤怒。
    结论:我们的结果提供了对所选PROM的深入概念理解和超越心理测量证据的重要定性信息。这样的信息支持对其分数可以与定量方法有意义地联系的PROM的识别。
    Cancer and its treatment can have substantial impact on patients\' emotional functioning. Several patient-reported outcome measures (PROMs) assessing emotional functioning are available, but differences in content limit the comparability of results. To better understand conceptual (dis)similarities, we conducted a content comparison of commonly used PROMs.
    We included emotional functioning items, scales, and item banks from the EORTC CAT Core, EORTC QLQ-C30, FACT-G, Hospital anxiety and depression scale (HADS), SF-36, PRO-CTCAE, and PROMIS (item banks for anxiety, depression, and anger). Item content was linked to the International Classification of Functioning, Disability, and Health (ICF) and a hierarchical framework established for PROMIS. Single items could be coded with more than one ICF category but were solely assigned to one facet within the PROMIS framework.
    The measures comprise 132 unique items covering the ICF components \'Body functions\' (136/153 codings, 88.9%) and \'Activities and participation\' (15/153, 9.8%). Most ICF codings (112/153, 73.2%) referred to the third-level category \'b1528 Emotional functions, other specified\'. According to the PROMIS framework 48.5% of the items assessed depression (64/132 items), followed by anxiety (41/132, 31.1%) and anger (26/132, 19.7%). The EORTC measures covered depression, anxiety, and anger in a single measure, while the PROMIS inventory provides separate item banks for these concepts. The FACT-G, SF-36, PRO-CTCAE and HADS covered depression and anxiety, but not anger.
    Our results provide an in-depth conceptual understanding of selected PROMs and important qualitative information going beyond psychometric evidence. Such information supports the identification of PROMs for which scores can be meaningfully linked with quantitative methods.
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