Patient reported outcomes

患者报告的结果
  • 文章类型: Journal Article
    这项研究的目的是评估心理健康属性的影响,例如存在精神病合并症或心理合并症(低弹性),肩袖修复(RCR)和全肩关节置换术(TSA)后的结局。
    PubMed,科克伦,和谷歌学者(结果第1-20页)被搜索到2023年11月。感兴趣的心理健康问题包括精神病合并症的存在(抑郁症,焦虑)或心理功能不良的指标,例如低弹性或存在痛苦。在这项研究中,根据原始研究中的分组,将患者分为不良或良好的心理健康组。
    14项研究纳入荟萃分析。在TSA队列中,心理健康良好的患者在术后美国肩肘外科医师和单肩测试评分方面有较大改善(P=0.003和P=0.01),RCR队列(P<0.001),以及TSA和RCR组合队列(P<0.001)。视觉模拟量表评分无差异,满意,外部旋转,或两个心理健康群体之间的屈曲。接受RCR的心理健康差的患者出现较高的不良事件和输血率(P<0.001)。在TSA队列中,心理健康差的患者的修订率和急诊就诊率也更高(P<0.001),RCR队列(P=0.05和P=0.03),和组合队列(P<0.001)。精神健康差的患者接受TSA的再入院率较高(P<0.001)。
    术前心理健康差的患者显示患者报告的结果评分较差,不良事件发生率增加,修订,和重新录取。
    UNASSIGNED: The aim of this study was to evaluate the impact of mental health attributes, such as the presence of psychiatric comorbidities or psychological comorbidities (low resilience), on outcomes after rotator cuff repair (RCR) and total shoulder arthroplasty (TSA).
    UNASSIGNED: PubMed, Cochrane, and Google Scholar (results pages 1-20) were searched up to November 2023. Mental health problems of interest included the presence of psychiatric comorbidities (depression, anxiety) or indicators of poor psychological functioning, such as low resilience or the presence of distress. Patients were assigned to poor or good mental health groups in this study based on their grouping in the original study.
    UNASSIGNED: Fourteen studies were included in the meta-analysis. Patients with good mental health had greater improvements in postoperative American Shoulder and Elbow Surgeons and Simple Shoulder Test scores in the TSA cohort (P=0.003 and P=0.01), RCR cohort (P<0.001), and the combined TSA and RCR cohort (P<0.001). No difference was found in visual analog scale score, satisfaction, external rotation, or flexion between the two mental health groups. Patients with poor mental health undergoing RCR experienced higher rates of adverse events and transfusions (P<0.001). Patients with poor mental health also had greater rates of revision and emergency department visits in the TSA cohort (P<0.001), RCR cohort (P=0.05 and P=0.03), and combined cohort (P<0.001). Patients with poor mental health undergoing TSA had a higher rate of re-admission (P<0.001).
    UNASSIGNED: Patients with poor preoperative mental health showed inferior patient-reported outcome scores and increased rates of adverse events, revisions, and re-admissions.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    背景:巴西成人急性淋巴细胞白血病治疗方案尚未得到很好的描述。
    方法:1981年至2019年在巴西淋巴瘤和白血病协会(ABRALE)注册的400名诊断为急性淋巴细胞白血病的患者或其护理人员通过电话采访,以评估患者报告的诊断观念。治疗和不良反应。
    结果:总体而言,203名男性,平均年龄15.7岁,中位随访时间6.2年。主要症状为发热(39%),出血/瘀斑(38%),强烈疲劳(30%),肌肉骨骼疼痛(28%)。在公共医疗保健(17.9%)和私人医疗保健(31.1%;p值=0.019)之间,在症状发作后一周内诊断出的患者比例有所不同。此外,公共护理中的诊断困难较高:35%对22.6%(p值=0.034).只有36名患者能够报告他们的治疗方案;从八个报告的方案列表中,最常见的是巴西儿童急性淋巴细胞白血病治疗合作小组(GBTLI-10/27.8%)和柏林-法兰克福-明斯特(BFM-8/22.2%).70名患者(17.5%)需要修改治疗方案,37.1%由于严重的不良反应;21.7%的人接受了短的治疗时间(≤6个月),16%的人进行了异基因造血干细胞移植,17/64(27%)报告在此步骤中存在困难,特征为>3个月的延迟。移植指征与微小残留病和头颅放疗有关;41.7%报告了治疗相关的不良反应(范围:1-6),特别是:情绪障碍(26.3%),神经功能缺损(13.8%),认知/记忆障碍(12%),和肺部疾病(15%)。不良反应的危险因素是年龄,移植和生活在大城市的迹象。在这些患者中,诸如诊断和移植延迟等治疗差异仍然是挑战。
    结论:需要紧急干预措施来优化医疗保健并减少不良反应,尤其是青少年和年轻的成年患者。
    BACKGROUND: The scenario of adult patients with acute lymphoblastic leukemia treated in Brazil has not been well described yet.
    METHODS: Four hundred patients diagnosed with acute lymphoblastic leukemia from 1981 to 2019, registered in the Brazilian lymphoma and leukemia association (ABRALE) or their caregivers were interviewed by telephone to evaluate patient-reported perceptions of diagnosis, treatment and adverse effects.
    RESULTS: Overall, 203 were male with a mean age of 15.7 years and median follow-up of 6.2 years. Main presenting symptoms were fever (39 %), bleeding/ecchymosis (38 %), intense fatigue (30 %), and musculoskeletal pain (28 %). The proportion of patients diagnosed within one week of symptoms onset differed between public (17.9 %) and private healthcare (31.1 %; p-value = 0.019). Additionally, diagnostic difficulties were higher in public care: 35 % versus 22.6 % (p-value = 0.034). Only 36 patients were able to report their treatment protocols; from a list of eight reported protocols, the most common were the Brazilian Childhood Cooperative Group for Treatment of Acute Lymphoblastic Leukemia in Children (GBTLI - 10/27.8 %) and Berlin-Frankfurt-Münster (BFM - 8/22.2 %). Seventy patients (17.5 %) required treatment modification, 37.1 % due to severe adverse effects; 21.7 % received short treatment duration (≤6 months) and 16 % proceeded to allogeneic hematopoietic stem cell transplantation with 17/64 (27 %) reporting difficulties in this step, characterized as >3 months delay. Indication for transplantation was related to minimal residual disease and cranial radiotherapy; 41.7 % reported treatment-related adverse effects (range: 1-6), in particular: mood disorders (26.3 %), neurologic deficit (13.8 %), cognitive/memory impairment (12 %), and lung disease (15 %). Risk factors for adverse effects were age, indication of transplantation and living in a large city. Treatment disparities such as diagnostic and transplantation delays remain challenges in these patients.
    CONCLUSIONS: Urgent interventions are needed to optimize healthcare and reduce adverse effects, especially in adolescent and young adult patients.
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  • 文章类型: Journal Article
    背景:褪黑素是一种抗氧化剂和抗炎剂,通过清除自由基来调节免疫系统,减少促炎细胞因子的上调,减少内皮细胞迁移。因此,褪黑素可能在调节多发性硬化症(MS)疾病活动中起作用。然而,关于补充褪黑激素如何影响MS患者的情况知之甚少。
    目的:确定尿液和血清褪黑素浓度是否存在剂量依赖性升高。确定是否补充褪黑激素对患者报告的结果有影响。
    方法:这是一个随机的,剂量盲探索性研究。使用稳定剂量的口腔疾病改善疗法治疗至少6个月的复发性多发性硬化症(RMS)的成年人(18-65岁)随机分为每天3mg或5mg的褪黑激素。尿和血清褪黑激素水平和改良疲劳影响量表(MFIS),多发性硬化症影响量表(MSIS-29),匹兹堡睡眠质量指数(PSQI)在基线测量患者确定的疾病步骤(PDDS)和表现量表(PS),3、6和12个月。进行尿和血清褪黑素分析以通过重复测量线性混合模型来估计平均浓度及其随时间在治疗组之间的差异。该模型包括治疗,评估时间,和治疗×时间相互作用。
    结果:30名患者,随机1:1,在治疗人群的意图中进行了分析。23人完成了这项研究。所有时间点的重复测量线性混合模型分析显示,对于尿6-SMT(p=0.03)和血清褪黑激素(p=0.04),5mg患者的褪黑激素浓度高于3mg褪黑激素。MFIS,MSIS-29,PSQI,PDSS-PS评分从基线到第12个月无显著变化.在两个剂量之间没有看到这些测量的显著差异。5例患者因不良事件停用褪黑素(3例服用5mg,2例服用3mg),包括一名发生局灶性海绵状皮炎的患者。一名患者经历了三次与补充褪黑激素无关的连续严重不良事件。
    结论:在治疗12个月期间,与3mg组相比,5mg褪黑素补充组的尿6-SMT和血清褪黑素浓度更高。6-SMT与血清褪黑素浓度之间存在相关性。这表明测量血清褪黑素是测量尿6-SMT的可靠替代方法。然而,在患者报告的结局中,两个剂量组之间的临床获益没有差异.
    背景:NCT03498131。
    BACKGROUND: Melatonin is an antioxidant and anti-inflammatory agent that modulates the immune system by scavenging free radicals, reducing the upregulation of pro-inflammatory cytokines, and reducing transendothelial cell migration. Therefore, melatonin may play a role in regulating multiple sclerosis (MS) disease activity. However, little is known about how melatonin supplementation effects individuals with MS.
    OBJECTIVE: Determine if there was a dose-dependent elevation in urine and serum melatonin concentrations. Determine if melatonin supplementation had an impact on patient reported outcomes.
    METHODS: This was a randomized, dose-blinded exploratory study. Adults (age 18-65) with relapsing forms of multiple sclerosis (RMS) treated with a stable dose of oral disease modifying therapy for at least 6 months were randomized into melatonin 3 mg or 5 mg daily. Urinary and serum melatonin levels and modified fatigue impact scale (MFIS), multiple sclerosis impact scale (MSIS-29), and Pittsburgh sleep quality index (PSQI), patient determined disease steps (PDDS) and performance scales (PS) were measured at baseline, 3, 6, and 12 months. Urinary and serum melatonin analyses was performed to estimate mean concentrations and their differences between treatment arms over time by a repeated measures linear mixed model. The model included treatment, assessment time, and treatment × time interaction.
    RESULTS: Thirty patients, randomized 1:1, were analyzed in an intent to treat population. Twenty-three completed the study. The repeated measures linear mixed model analysis of all timepoints revealed higher melatonin concentrations in patients on 5 mg compared to 3 mg melatonin for both urinary 6-SMT (p = 0.03) and serum melatonin (p = 0.04). MFIS, MSIS-29, PSQI, and PDSS-PS scores did not significantly change from baseline to month 12. No significant differences in these measures were seen between the two doses. Five patients stopped melatonin (three on 5 mg and two on 3 mg) due to adverse events, including one patient who developed focal spongiotic dermatitis. One patient experienced three consecutive serious adverse events that were unrelated to melatonin supplementation.
    CONCLUSIONS: The 5 mg melatonin supplementation group had higher concentrations of urinary 6-SMT and serum melatonin compared to the 3 mg group over 12 months of treatment. There was a correlation between 6-SMT and serum melatonin concentrations. This suggests that measuring serum melatonin is a reliable alternative to measuring urinary 6-SMT. However, no differences in clinical benefit between the two dosage groups were demonstrated in the patient reported outcomes.
    BACKGROUND: NCT03498131.
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  • 文章类型: Journal Article
    确定影响功能性听力表现和生活质量(QoL)结果的因素在中国大陆两个大学中心的儿科人工耳蜗植入(CI)接受者。
    中国大陆的两个大学中心,前瞻性纵向儿科植入受体观察性研究(P-IROS)的一部分,贡献的参与者数据。在CI时,参与者的年龄在10岁以下。在设备激活前收集功能性听力表现和QoL测量值。植入后2年,间隔6个月。使用序数混合效应回归模型评估和分析了功能性听力终点,包括听觉表现-II(CAP-II)和QoL类别。
    数据来自288名平均年龄为2.74岁的儿童。1年的总体随访率为59%,2年为51%。植入时年龄较小(p<0.001)和植入前使用助听器(p=0.026)与显着益处相关。在CAP-II上,双侧设备用户(同时使用CI和双峰)的功能听力明显优于单侧CI用户(p<0.001)。与父母期望较高的期望相比,父母期望较低的人的听力功能改善较慢(p<0.001)。QoL随着时间的推移而改善,但在中心之间遵循不同的初始轨迹。
    随着时间的推移,所有参与者都表现出听觉表现和QoL的显着改善。年龄较小的atCI和双侧/双峰装置拟合有助于早期改善。其他可能有助于告知家庭的潜在因素,专业人士,卫生当局关于听力设备的选择和所需的教育支持包括听力损失的病因和母亲教育水平。
    UNASSIGNED: To identify factors affecting functional hearing performance and quality of life (QoL) outcomes in paediatric cochlear implantation (CI) recipients at two University centres in mainland China.
    UNASSIGNED: Two university centres in mainland China, part of the prospective longitudinal Paediatric Implanted Recipient Observational Study (P-IROS), contributed participant data. Participants were aged under 10 years at time of CI. Functional hearing performance and QoL measures were collected prior to device activation, and at 6-monthly intervals for 2 years post-implantation. Functional hearing endpoints including Categories of Auditory Performance-II (CAP-II) and QoL were evaluated and analysed using ordinal mixed-effects regression models.
    UNASSIGNED: Data were from 288 children with a mean age at implant of 2.74 years. Overall follow-up at 1 year was 59% and 51% at 2 years. Younger age at implantation (p<0.001) and hearing aid use preimplantation (p=0.026) were associated with significant benefit. Bilateral device users (both CI and bimodal) achieved significantly better functional hearing performance on the CAP-II than unilateral CI users (p<0.001). Slower functional hearing improvements were observed in those with lower parental expectations compared to higher expectations (p<0.001). QoL improved over time but followed a different initial trajectory between centres.
    UNASSIGNED: All participants demonstrated significant improvements in auditory performance and QoL over time. Younger age at CI, and bilateral/bimodal device fitting contributed to earlier improvements. Other potential factors that could help inform families, professionals, and health authorities about choice of hearing device and educational supports required included aetiology of hearing loss and level of maternal education.
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  • 文章类型: Journal Article
    虽然全膝关节置换术(TKA)非常成功,15%-20%的患者术后不满意,这可能是由于TKA组件的对齐。开发了无图像计算机导航以提高植入物对准精度和精度,但争议围绕着这项技术的患者利益。股骨矢状面对准的目标及其在使用辅助技术进行TKA后患者报告的结果(PROM)中的作用尚未明确。
    股骨矢状对齐,30天并发症,从2020年7月至2023年2月接受手术的单侧选择性TKA患者中回顾性收集了1年的PROM。两名同样精通常规和无图像导航技术的外科医生参与了患者记录识别。学生t检验和比例卡方检验用于比较结果,30天并发症,和对齐。
    387例患者获得了完整的PROM;计算机导航组181例,常规关节成形术组206例。PROM在组间有统计学上的显著差异,有利于计算机导航(12个月时P=0.014)。接受计算机导航TKA的女性股骨外侧角度测量值更高(P<.001)。值得注意的是,常规技术组14例患者在30天内返回急诊科,导航组中为4个(P=0.033)。
    与传统技术组相比,导航组中的PROM得到了改进。导航组中返回急诊科的患者较少。与传统技术相比,导航似乎提供了一个小的好处,尽管最终股骨外侧角度不能预测结果。可能需要检查其他手术特征,以确定这些技术之间结果差异的原因。
    UNASSIGNED: While total knee arthroplasty (TKA) is highly successful, 15%-20% of patients are not satisfied postoperatively, which may be due to alignment of the TKA components. Imageless computer navigation was developed to increase implant alignment accuracy and precision, but controversy surrounds the patient benefit of this technology. The target of femoral sagittal alignment and its role in patient-reported outcomes (PROMs) after TKA using assistive technology has not been well-defined.
    UNASSIGNED: Femoral sagittal alignment, 30-day complications, and PROMs through 1 year were collected retrospectively from unilateral elective TKA patients who underwent surgery between July 2020 and February 2023. Two surgeons equally versed in conventional and imageless navigation techniques participated in patient record identification. Students t-tests and chi-square tests of proportion were used to compare outcomes, 30-day complications, and alignment.
    UNASSIGNED: Completed PROMs were available for 387 patients; 181 in the computer navigation group and 206 in the conventional arthroplasty group. PROMs were statistically significantly different between groups, favoring computer navigation (P = .014 at 12 months). Lateral femoral angle measurements were greater in females who underwent TKA with computer navigation (P < .001). Of note, 14 patients in the conventional technique group returned to the emergency department within 30 days, as compared to 4 in the navigation group (P = .033).
    UNASSIGNED: PROMs are improved in the navigation group compared to the conventional technique group. Fewer patients in the navigation group returned to the emergency department. Navigation appeared to provide a small benefit compared to conventional techniques, though final lateral femoral angle was not predictive of outcomes. Additional surgical characteristics may need to be examined to determine the reasons for the differences in outcomes between these techniques.
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  • 文章类型: Journal Article
    背景:患者报告的结果测量(PROM)和患者报告的经验测量(PREM)对于理解GD对生活质量和患者对护理的看法的影响至关重要。还可以指导决策过程。然而,GD中没有具体的PREM发布,西班牙GD患者的PROM均未开发。
    方法:两名项目协调员选择了要包含在PROMs/PREMs问卷中的关键点,科学委员会和一组专家患者为初稿做出了贡献。然后,与专家举行了9次会议,讨论有争议的问题。之后,一份关于症状学的103项问卷,日常生活和护理经验的各个方面得到了发展。最后,它是在GD的多学科专家组中进行的Delphi调查。
    结果:在103个项目中达成了85个共识。关于症状学的PROM和PREM的建议,获得了日常生活和护理方面的经验。就考虑疲劳的重要性达成了共识,浓度问题,GD患者使用5步模拟量表的沟通问题。小组成员建议询问GD患者对社会功能和工作/学校表现的影响。最后,在考虑护理经验方面达成了共识,如治疗满意度,治疗中断或过渡以及参与患者管理的医疗保健专业人员感知患者的感知。
    结论:该专家共识可能有助于开发GD特异性PROMs/PREMs,以改善GD管理。正确开发和验证的PROM/PREM可能有助于决策,建立患者量身定制的治疗和后续目标。
    BACKGROUND: Patient-reported outcome measures (PROMs) and patient-reported experiences measures (PREMs) are crucial for understanding the impact of GD on quality of life and patient\'s perceptions on care, but also to guide decision-making processes. Nevertheless, no specific PREMs in GD have been published, neither PROMs for Spanish GD patients have been developed.
    METHODS: Two project coordinators selected key-points to be included in a PROMs/PREMs questionnaire, and the scientific committee and a group of expert patients contributed to the initial draft. Then, 9 meetings with experts were held to discuss controversial points. After, a questionnaire with 103 items regarding symptomatology, aspects of daily life and care experience was developed. Finally, it was conducted a Delphi survey among a multidisciplinary group of experts in GD.
    RESULTS: Consensus was reached on 85 out of the 103 items. Recommendations on PROMs and PREMs regarding symptomatology, aspects of daily life and care experience were obtained. Consensus was reached on the importance of considering fatigue, concentration problems, and communication issues in GD patients using 5-step analog scales. Panelists recommended asking GD patients about the impact on social functioning and work/school performance. Finally, consensus was reached on considering care experiences, such as treatment satisfaction, treatment interruptions or transitions and healthcare professionals involved in patient\'s management to perceive patient\'s perceptions.
    CONCLUSIONS: This expert consensus may help developing GD-specific PROMs/PREMs for improving GD management. Properly developed and validated PROMs/PREMs may help decision-making, establishing patient-tailored therapeutic and follow-up goals.
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  • 文章类型: Journal Article
    目标:许多女性报告骶神经调节(SNM)后症状控制不足,尽管测试刺激后急迫性尿失禁发作(UUIE)减少了50%。
    目的:确定测试刺激后预测24个月成功的理想UUIE减少百分比。
    方法:使用来自多中心SNM试验的数据,我们构建了受试者工作特性曲线,以确定测试刺激后UUIE降低百分比的理想阈值.我们将24个月的成功定义为“非常好”到“更好”的患者整体改善印象。“我们比较了两种预测成功的模型的预测准确性:(1)单独的UUIE减少百分比和(2)与基线特征。
    结果:149名女性(中位数[IQR]基线每日UUIE4.7[3.7,6.0]),24个月成功的理想阈值是72%(95%置信区间64,76%)UUIE减少,准确度为0.54(0.42,0.66),敏感性0.71(0.56,0.86)和特异性0.27(0.05,0.55)。50%降低阈值的准确度为0.60(0.49,0.71),敏感性0.95(0.88,1.0)和特异性0.04(0.0,0.12)。在预测24个月的成功方面,UUIE的减少百分比并不比机会更好(一致性指数[c指数]0.47[0.46,0.62]);加上年龄,身体质量指数,糖尿病和视力或听力障碍的c指数为0.68(0.61,0.78)。
    结论:在测试刺激后由于UUIE降低≥50%而接受内部脉冲发生器(IPG)的女性中,我们没有发现能更好地预测24个月成功的理想阈值.测试刺激后UUIE的减少百分比很难预测有或没有临床因素的24个月成功。鉴于此,需要重新评估我们如何确定谁应该获得IPG。
    OBJECTIVE: Many women report inadequate symptom control after sacral neuromodulation (SNM), despite 50% reduction in urgency incontinence episodes (UUIE) after test stimulation.
    OBJECTIVE: To determine the ideal percent UUIE reduction after test stimulation that predicts 24-month success.
    METHODS: Using data from a multicenter SNM trial, we constructed receiver operating characteristic curves to identify an ideal threshold of percent UUIE reduction after test stimulation. We defined 24-month success as Patient Global Impression of Improvement of \"very much better\" to \"better.\" We compared predictive accuracy of two models predicting success: (1) percent UUIE reduction alone and (2) with baseline characteristics.
    RESULTS: Of 149 women (median [IQR] baseline daily UUIE 4.7 [3.7, 6.0]), the ideal threshold for 24-month success was 72% (95% confidence interval 64,76%) UUIE reduction with accuracy 0.54 (0.42, 0.66), sensitivity 0.71 (0.56, 0.86) and specificity 0.27 (0.05, 0.55). The accuracy of the 50% reduction threshold was 0.60 (0.49, 0.71), sensitivity 0.95 (0.88, 1.0) and specificity 0.04 (0.0, 0.12). Percent reduction in UUIE was not better than chance in predicting 24-month success (concordance index [c-index] 0.47 [0.46, 0.62]); adding age, body mass index, diabetes mellitus and visual or hearing impairment the c-index was 0.68 (0.61, 0.78).
    CONCLUSIONS: Among women who received an internal pulse generator (IPG) due to ≥50% UUIE reduction after test stimulation, we found no ideal threshold that better predicted 24-month success. Percent reduction in UUIE after test stimulation poorly predicts 24-month success with or without clinical factors. Given this, re-evaluating how we determine who should receive an IPG is needed.
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  • 文章类型: Journal Article
    背景:患者报告的结果(PRO)是获得性心脏病的重要指标,但在成人先天性心脏病(ACHD)中尚未明确定义。我们的目的是探索PRO调查工具在Fontan循环衰竭(FCF)中的歧视性能力。方法:从我们的门诊诊所连续招募成年人。纳入标准为年龄≥18岁,Fontan循环或血流动力学上不明显的分流损伤,和足够的认知/语言能力来完成PRO。一套全面的PRO措施,旨在评估感知的健康相关生活质量(HRQOL)(包括堪萨斯城心肌病问卷[KCCQ-12],EuroQol-5维[EQ5D],简式健康状况调查[SF-12],自我报告的纽约心脏协会[NYHA]功能班,和特定活动量表[SAS])。结果:我们比较了54例Fontan患者(35±10年)与25例单纯分流病变患者(34±11年)。Fontan与分流病变患者的KCCQ-12评分较低(87[IQR79,95]对100[IQR97,100],p值<0.001)。与非FCF亚组相比,FCF亚组的KCCQ-12得分较低(82[IQR56,89]对93[IQR81,98],p值=0.002)。尽管KCCQ-12具有确定所有研究的PRO工具的FCF的最佳判别能力(c统计量0.75[CI0.62,0.88]),当KCCQ-12与所有PRO工具结合使用时,获得了较好的FCF判别(c统计量0.82[CI0.71,0.93]).结论:KCCQ-12问卷对FCF的识别具有良好的辨别能力,通过添加互补的PRO工具进一步改进。进一步的研究将确立PRO工具的价值,以指导ACHD的管理策略。
    Background: Patient reported outcomes (PROs) are important measures in acquired heart disease but have not been well defined in Adult Congenital Heart Disease (ACHD). Our aim was to explore the discriminatory capacity of PRO survey tools in Fontan circulatory failure (FCF). Methods: Consecutive adults were enrolled from our ambulatory clinics. Inclusion criteria were age ≥18 years, a Fontan circulation or a hemodynamically insignificant shunt lesion, and sufficient cognitive/language abilities to complete PROs. A comprehensive package of PRO measures, designed to assess perceived health-related quality of life (HRQOL) was administered (including the Kansas City Cardiomyopathy Questionnaire [KCCQ-12], EuroQol-5-dimension [EQ5D], Short Form Health Status Survey [SF-12], self-reported New York Heart Association [NYHA] Functional Class, and Specific Activity Scale [SAS]). Results: We compared 54 Fontan patients (35 ± 10 years) to 25 simple shunt lesion patients (34 ± 11 years). The KCCQ-12 score was lower in Fontan versus shunt lesion patients (87 [IQR 79, 95] versus 100 [IQR 97, 100], p-value < 0.001). The FCF subgroup was associated with lower KCCQ-12 scores as compared with the non-FCF subgroup (82 [IQR 56, 89] versus 93 [IQR 81, 98], p-value = 0.002). Although the KCCQ-12 had the best discriminatory capacity for determination of FCF of all PRO tools studied (c-statistic 0.75 [CI 0.62, 0.88]), superior FCF discrimination was achieved when the KCCQ-12 was combined with all PRO tools (c-statistic 0.82 [CI 0.71, 0.93]). Conclusions: The KCCQ-12 questionnaire demonstrated good discriminatory capacity for the identification of FCF, which was further improved through the addition of complementary PRO tools. Further research will establish the value of PRO tools to guide management strategies in ACHD.
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  • 文章类型: Journal Article
    目的:通常在手术前后收集临床和患者报告的结果,以作为患者的基准和研究结果。这些结果和评分对于跟踪患者手术后的结果很有用,然而,事实上,这些常用的措施通常提供有关患者疼痛程度和功能的信息在一个时间点是一个限制。
    方法:我们从全球范围内的新问卷中介绍了早期功能恢复和初次THA后的工作结果,多中心,前瞻性临床研究。
    结果:术后6周和12周,很大一部分研究对象在完成THA后能够完成功能恢复结果:在没有援助的情况下行走(74%;94%);开车(76%;97%);日常生活的基本活动(94%;99%);执行轻型家庭任务(91%;96%);执行中至重型家庭任务(54%;86%);上下楼梯(92%;99%);从82%的空间进行休闲活动60%的人能够在术后12周恢复工作。这些问题与被遗忘的联合得分有很强的关联。
    结论:优秀患者在该队列中报告了术后6周和12周的早期功能恢复结果和满意度,并且是首次使用新型PRO报告的数据。
    背景:NCT03189303,注册于2017年6月14日。
    OBJECTIVE: Clinical and patient reported outcomes are often collected before and after the procedure to benchmark and study outcomes for patients. These outcomes and scores are useful for tracking patient outcomes after surgery, however, the fact that these commonly used measures typically provide information about a patient\'s level of pain and function at a single point in time is a limitation.
    METHODS: We present early functional recovery and return to work outcomes after primary THA from a novel questionnaire administered in a global, multi-center, prospective clinical study.
    RESULTS: By 6 and 12 weeks post-op, a large proportion of study subjects were able to perform functional recovery outcomes after their THA: walk without an aid (74%; 94%); drive (76%; 97%); basic activities of daily living (94%; 99%); perform light household duties (91%; 96%); perform moderate-to-heavy household duties (54%; 86%); go up and down a flight of stairs (92%; 99%); put on socks/stockings (77%; 93%); bend down to pick up an object from the floor (87%; 97%); stand up from a chair (96%; 99%); perform leisure recreational activities (54%; 84%); perform primary goal identified pre-THA (69%; 86%). 60% were able to return to work by 12 weeks post-op. These questions showed strong association with the Forgotten Joint Score.
    CONCLUSIONS: Excellent patient reported early functional recovery outcomes and satisfaction were observed at 6- and 12-weeks post-op in this cohort and is the first reported data using a novel PRO.
    BACKGROUND: NCT03189303, registered June 14, 2017.
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