Interventional study

介入研究
  • 文章类型: Journal Article
    这项研究检查了出院时日常生活活动(ADLs)差的参与者在6个月的随访后是否体重减轻增加,以及营养治疗是否可以预防这种体重减轻。这项饮食随机对照试验(N=104)检查了社区居住的老年人(66-95岁)出院并有营养不良风险,接受6个月的营养治疗(干预)或仅接受标准治疗(对照)。ADL是根据Katz等人的关于自我护理的七个问题进行评估的。\的方法。出院时,45(43%),36(35%),和23(22%)的高,中等,可怜的ADL,分别,根据卡方检验,对照组和干预组之间没有差异。ADL较差的对照组参与者的体重减轻明显高于ADL较高的参与者(年龄和性别调整的协方差分析:3.6kg;95%置信区间[1.0,6.1]kg,p=.007)。在干预组中没有观察到这种差异。与ADL高的参与者相比,出院时ADL差的参与者在6个月后体重降低约3.5kg。接受营养治疗可以帮助ADL较差的老年人在出院后保持体重。
    This study examined whether participants with poor activities of daily living (ADLs) at hospital discharge had increased weight loss after 6 months of follow-up and whether nutrition therapy can prevent this weight loss. This dietary randomized controlled trial (N = 104) examined community-dwelling older adults (66-95 years) discharged from hospital and at risk for malnutrition, receiving either 6 months of nutrition therapy (intervention) or only standard care (control). ADL was assessed using seven questions on self-care based on the Katz et al.\'s method. At discharge, 45 (43%), 36 (35%), and 23 (22%) had high, medium, and poor ADL, respectively, with no differences between the control and intervention groups according to chi-square test. Participants in the control group with poor ADL had significantly higher weight loss than participants with high ADL (age- and sex-adjusted analysis of covariance: 3.6 kg; 95% confidence interval [1.0, 6.1] kg, p = .007). No such difference was observed in the intervention group. Participants with poor ADL at hospital discharge develop lower body weight by around 3.5 kg 6 months later when compared with participants with high ADL. Receiving nutrition therapy could help older adults with poor ADL to maintain body weight after hospital discharge.
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  • 文章类型: Journal Article
    目的:研究心脏神经节丛(GP)消融治疗慢性心律失常的并发症和有效性,探讨GP消融治疗慢性心律失常的价值。
    方法:本研究是新疆医科大学第一医院和宣城市人民医院(2018/09-2021/08)收治的缓慢性心律失常患者的单臂介入研究。使用Carto3标测系统对左心房进行建模。消融终点是在解剖学定位和高频刺激指导下没有迷走神经反应。术后常规随访。Holter数据在3-,6-,并记录了12个月。
    结果:50名患者(25名男性,平均年龄33.16±7.89岁)是由任一LSGP诱导的迷走神经反应,LIGP,RAGP,或RIGP。心率稳定在76bpm,SNRT1.092s.DC,DR,HR,SDNN,RMSSD值均低于消融前。AC,SSR,TH值高于消融前,平均心率和最慢心率显著增加.术前、术后随访数据差异均有统计学意义(均p<0.05)。所有患者均成功消融,他们的血压明显下降。无血管损伤等并发症,血管栓塞和心包积液。
    结论:左心房GP消融具有良好的长期临床效果,可作为缓慢型心律失常患者的治疗选择。
    To study the complications and effectiveness of the treatment of chronic arrhythmias with cardiac Ganglion Plexus (GP) ablation, and to explore the value of the treatment of chronic arrhythmias with GP ablation.
    This study was a one-arm interventional study of patients from the first hospital of Xinjiang Medical University and the People\'s Hospital of Xuancheng City admitted (09/2018-08/2021) because of bradyarrhythmia. The left atrium was modeled using the Carto3 mapping system. The ablation endpoint was the absence of a vagal response under anatomically localized and high-frequency stimulation guidance. Postoperative routine follow-up was conducted. Holter data at 3-, 6-, and 12-months were recorded.
    Fifty patients (25 male, mean age 33.16 ± 7.89 years) were induced vagal response by either LSGP, LIGP, RAGP, or RIGP. The heart rate was stable at 76 bpm, SNRT 1.092s. DC, DR, HR, SDNN, RMSSD values were lower than that before ablation. AC, SSR, TH values were higher than those before ablation, mean heart rate and the slowest heart rate were significantly increased. There were significant differences in follow-up data between the preoperative and postoperative periods (all p < 0.05). All the patients were successfully ablated, and their blood pressure decreased significantly. No complications such as vascular damage, vascular embolism and pericardial effusion occurred.
    Left Atrial GP ablation has good long-term clinical results and can be used as a treatment option for patients with bradyarrhythmia.
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  • 文章类型: Journal Article
    背景:这项初步研究评估了短信作为预防脊髓损伤(SCI)患者出院后压疮(PrU)的早期干预措施。
    方法:39名轮椅使用者在获得SCI后出院,随机分为有短信的干预组(n=20)和对照组(n=19)。所有参与者都接受了标准的出院后护理,并在出院前和出院后6个月完成了护肤问卷。主要结果包括使用短信进行早期干预的可行性和可接受性,除了性能,和谐,以及对护肤的态度。次要结果测量感知和PrUs的发生率。
    结果:基线人口统计学在干预组和对照组之间具有可比性。在干预组中,20名参与者中有8名完成了为期6个月的随访问卷,对照组有6名参与者完成了为期6个月的问卷,.与会者对短信表示高度满意,对内容的理解,并增强了预防Pru的信心。出院后6个月,干预组表现出改进的预防措施,提高对PrU风险的认识,意识到预防的重要性增加,对照组未观察到。然而,PrU发病率没有显著差异,可能是由于样本量小,随访时间短。
    结论:该研究表明,在SCI患者中使用短信作为预防PrU的早期干预措施是可行且广受好评的。初步结果表明,对参与者的态度和做法有积极影响,表明短信降低PrU发病率的潜力。然而,更大样本的进一步研究和延长随访对于验证这些有希望的初步发现至关重要.
    BACKGROUND: This pilot study assessed text messaging as an early intervention for preventing pressure ulcers (PrUs) in individuals with spinal cord injury (SCI) post-hospital discharge.
    METHODS: Thirty-nine wheelchair-users discharged after acquiring a SCI, underwent randomisation into an intervention group (n = 20) with text messages and a control group (n = 19). All participants received standard post-discharge care and completed a skincare questionnaire before and 6-month after discharge. Primary outcomes included feasibility and acceptability of early intervention using text messaging, alongside performance, concordance, and attitudes toward skincare. Secondary outcomes measured perception and the incidence of PrUs.
    RESULTS: Baseline demographics were comparable between the intervention and control groups. Eight of 20 participants completed 6-month follow-up questionnaires in the intervention group, six participants completed the 6-month questionnaires in the control group,. Participants expressed high satisfaction with text messages, understanding of content, and increased confidence in preventing PrUs. At 6-month post-discharge, the intervention group showed improved prevention practices, heightened awareness of PrU risks, and increased perceived importance of prevention, which were not observed in the control group. However, there were no significant differences in PrU incidence, possibly due to the small sample size and short follow-up.
    CONCLUSIONS: The study demonstrates that using text messaging as an early intervention for PrU prevention in individuals with SCI is feasible and well-received. Preliminary results suggest a positive impact on participants\' attitudes and practices, indicating the potential of text messaging to reduce PrU incidence. However, further research with larger samples and extended follow-up is crucial to validate these promising initial findings.
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  • 文章类型: Journal Article
    背景:迄今为止,目前尚无帕金森病(PD)的疾病修饰疗法。由于PD是第二常见的神经退行性疾病,对这种疗法有很高的需求。环境和遗传危险因素在PD的病因和进展中起重要作用。PD最常见的遗传风险因素是GBA1(GBA)基因的突变,编码溶酶体酶葡糖脑苷脂酶(GCase)。粘液溶解氨溴索是一种再利用的药物,已显示出在体外和体内上调GCase活性的特性。因此,氨溴索具有成为PD疾病修饰疗法的潜力,这就是在PD患者中设计氨溴索随机对照试验的原因。
    方法:本试验是单中心,双盲,随机化,安慰剂对照研究,包括80例GBA突变的PD患者,接受氨溴索1800毫克/天或安慰剂治疗48周。主要结果指标是运动障碍协会(MDS-UPDRSIII)的统一帕金森病评定量表运动子评分(第三部分),在60周(12周冲洗期后)实际定义的关闭状态下。次要结果包括大脑的3,4-二羟基-6-18F-氟-I-苯丙氨酸([18F]FDOPA)PET扫描,磁共振成像(静息状态f-MRI和扩散张量成像),GCase活动,细胞内和细胞外,血浆中的鞘脂分布,蒙特利尔认知评估(MoCA)通过帕金森病问卷(PDQ-39)和非运动症状量表(NMSS)问卷测量生活质量(QoL)。
    结论:氨溴索高达1200毫克/天已显示出对人类脑脊液终点的影响,它至少支持血脑屏障的通过。该试验中的剂量滴定至1800mg/天将揭示该剂量水平是否安全并且还有效地改变疾病的进程。
    背景:NCT05830396。注册日期:2023年3月20日。
    BACKGROUND: To date, no disease modifying therapies are available for Parkinson\'s disease (PD). Since PD is the second most prevalent neurodegenerative disorder, there is a high demand for such therapies. Both environmental and genetic risk factors play an important role in the etiology and progression of PD. The most common genetic risk factor for PD is a mutation in the GBA1(GBA)-gene, encoding the lysosomal enzyme glucocerebrosidase (GCase). The mucolytic ambroxol is a repurposed drug, which has shown the property to upregulate GCase activity in-vitro and in-vivo. Ambroxol therefore has the potency to become a disease modifying therapy in PD, which was the reason to design this randomized controlled trial with ambroxol in PD patients.
    METHODS: This trial is a single-center, double-blind, randomized, placebo-controlled study, including 80 PD patients with a GBA mutation, receiving either ambroxol 1800 mg/day or placebo for 48 weeks. The primary outcome measure is the Unified Parkinson\'s Disease Rating Scale motor subscore (part III) of the Movement Disorder Society (MDS-UPDRSIII) in the practically defined off-state at 60 weeks (after a 12-week washout period). Secondary outcomes include a 3,4-dihydroxy-6-18F-fluoro-I-phenylalanine ([18F]FDOPA) PET-scan of the brain, Magnetic Resonance Imaging (with resting state f-MRI and Diffusion Tensor Imaging), GCase activity, both intra- and extracellularly, sphingolipid profiles in plasma, Montreal Cognitive Assessment (MoCA), quality of life (QoL) measured by the Parkinson\'s Disease Questionnaire (PDQ-39) and the Non-Motor Symptom Scale (NMSS) questionnaire.
    CONCLUSIONS: Ambroxol up to 1200 mg/day has shown effects on human cerebrospinal fluid endpoints, which supports at least passage of the blood-brain-barrier. The dose titration in this trial up to 1800 mg/day will reveal if this dose level is safe and also effective in modifying the course of the disease.
    BACKGROUND: NCT05830396. Registration date: March 20, 2023.
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  • 文章类型: Journal Article
    在一项前瞻性开放研究中,通过干预,由葡萄牙的全科医生(GP)在初级卫生保健单位进行,坎地沙坦/氨氯地平(ARB/氨氯地平)单药的有效性,作为唯一的抗高血压(抗HTN)药物,在HTN不受控制的成年患者中(BP>140/或>90mmHg),无论是以前用抗HTN单一疗法治疗(组I),或与氢氯噻嗪(HCTZ)(II组)的组合,或根本不接受药物治疗(第三组),在实施新的治疗措施后的12周内进行评估。
    共有118名全科医生招募了符合纳入/排除标准的未受控制的HTN患者。参与者被分配,根据严重程度,3(早晨)固定组合坎地沙坦/氨氯地平剂量(8/5或16/5或16/10mg/天)之一,并在3次访问(v0,v6和v12周)中进行纵向评估。每次就诊都测量办公室血压,并且根据指南定义了HTN的控制(BP<140/90mmHg)。
    在接受治疗的1234名患者中,752(年龄61±10岁,52%的女性)参加了研究,并根据以前的治疗情况进行了分组。在接受固定组合坎地沙坦/氨氯地平剂量后,3组显示出统计学上显著的血压控制增加。受控制的HTN参与者的总体比例从v0时的0.8%增加到v12时的82%。平均动脉血压值从基线时的SBP=159.0(±13.0)和DBP=91.1(±9.6)下降到12周时的SBP=132,1(±11.3)和DBP=77,5(±8.8)(p<0.01)。控制年龄和性别时,结果保持一致。
    在HTN不受控制的患者中,根据指导方针采取治疗措施,使用坎地沙坦/氨氯地平的固定组合,在82%的先前未控制的HTN患者中,允许在12周时总体实现HTN控制,加强这些策略在初级临床实践中的优势。
    背景是什么?动脉高血压(HTN)是心血管疾病(CV)死亡的主要危险因素。适当控制高血压可降低CV风险并显著预防CV事件和相关的发病率和死亡率。这需要患者坚持和坚持实施治疗,并实现与降低CV风险相关的紧张目标。最新的国际建议表明,大多数国家的高血压控制不足。在葡萄牙,高血压控制<43%,大量接受治疗的患者不符合建议.什么是新的?在未来,介入,多中心研究,由葡萄牙各地初级卫生保健单位的全科医生(GP)进行,目的是确定(i)不受控制的高血压的存在是否由于不遵守建议的规定和DireçãoGeralerdeSaúde(DGS)的综合护理程序(PAI),即不适当使用单一疗法或低剂量的抗高血压药组合,以及(二)高血压治疗的调整,赞成建议中提供的计划,可以充分控制动脉高血压,在以前不受控制的患者中,在12周的时间内密切监测这些情况。有什么影响?当遵循指南的治疗方案时,为每个确定的患者组建立(单一疗法,氢氯噻嗪,并且没有药物治疗),结果表明,SBP和DBP值及高血压控制在不同时间均有显著且统计学显著的改善.
    UNASSIGNED: In a prospective open study, with intervention, conducted in Primary Health Care Units by General Practitioners (GPs) in Portugal, the effectiveness of a single pill of candesartan/amlodipine (ARB/amlodipine), as the only anti-hypertension (anti-HTN) medication, in adult patients with uncontrolled HTN (BP > 140/or > 90 mm Hg), either previously being treated with anti-HTN monotherapies (Group I), or combinations with hydrochlorothiazide (HCTZ) (Group II), or not receiving medication at all (Group III), was evaluated across 12-weeks after implementation of the new therapeutic measure.
    UNASSIGNED: A total of 118 GPs recruited patients with uncontrolled HTN who met inclusion/exclusion criteria. Participants were assigned, according to severity, one of 3 (morning) fixed combination candesartan/amlodipine dosage (8/5 or 16/5 or 16/10 mg/day) and longitudinally evaluated in 3 visits (v0, v6 and v12 weeks). Office blood pressure was measured in each visit, and control of HTN was defined per guidelines (BP< 140/90 mmHg).
    UNASSIGNED: Of the 1234 patients approached, 752 (age 61 ± 10 years, 52% women) participated in the study and were assigned to groups according to previous treatment conditions. The 3 groups exhibited a statistically significant increased control of blood pressure after receiving the fixed combination candesartan/amlodipine dosage. The overall proportion of controlled HTN participants increased from 0,8% at v0 to 82% at v12. The mean arterial blood pressure values decreased from SBP= 159.0 (± 13.0) and DBP= 91.1 (± 9.6) at baseline to SBP= 132,1 (± 11.3) and DBP= 77,5 (± 8.8) at 12 weeks (p < 0.01). Results remained consistent when controlling for age and sex.
    UNASSIGNED: In patients with uncontrolled HTN, therapeutic measures in accordance with guidelines, with a fixed combination candesartan/amlodipine, allowed to overall achieve HTN control at 12 weeks in 82% of previously uncontrolled HTN patients, reinforcing the advantages of these strategies in primary clinical practice.
    What is the context?Arterial hypertension (HTN) represents the main risk factor for cause of death from cardiovascular disease (CV). Adequate control of hypertension reduces CV risk and significantly prevents CV events and associated morbidity and mortality. This requires patients’ adherence and persistence in implemented treatment and the achievement of tension targets that are related to the reduction of CV risk. The latest international recommendations indicate that hypertension control is insufficient in most countries. In Portugal, hypertension control is <43% and a significant number of patients treated do not comply with the recommendations.What is new?In a prospective, interventional, and multicentre study, carried out by General Practitioners (GPs) in Primary Health Care Units across Portugal, the objective was to determine (i) whether the presence of uncontrolled hypertension results from non-compliance with the provisions of the recommendations and the Integrated Care Process (PAI) of the Direção Geral de Saúde (DGS), i.e. inappropriate use of monotherapies or inadequate low doses of combinations of antihypertensives, and (ii) whether the adjustment of hypertension therapies, favouring the schemes provided in the recommendations, allows adequate control of arterial hypertension, in previously uncontrolled patients, when these are closely monitored in a 12-week time period.What is the impact?When the guidelines’ therapeutic protocol is followed, as established for each identified group of patients (monotherapy, hydrochlorothiazide, and no medication), results indicate a marked and statistically significant improvements in both SBP and DBP values and hypertension control across time.
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  • 文章类型: Journal Article
    目的:建议将体力活动(PA)作为1型发作性睡病(NT1)治疗的一部分。这项研究旨在1)使用客观和主观测量来表征接受NT1治疗的儿童和青少年的PA,2)评估PA如何与NT1症状和合并症相关,和3)评估适应性体力活动(APA)计划对PA和临床特征的影响。
    方法:来自国家发作性睡病参考中心的NT1患者(里昂,法国)被连续纳入APA干预方案。使用标准化问卷收集发作性睡病症状和合并症,并在四周的APA干预前后使用Bron-Lyon注意力稳定性测试评估持续注意力。在整个研究中使用活动描记术客观地测量PA。
    结果:纳入27例NT1患者(中位年龄14.7岁[8.3-18.4],猝倒88.9%,肥胖37.0%)。在基线,根据国际推荐,52.4%的患者PA水平令人满意。闲暇时间PA(LTPA)患者的生活质量高于无闲暇时间PA(LTPA)的患者。与基线相比,45%的患者在干预期间PA增加。在基线时,这些有反应的患者比无反应的患者有更多的抑郁情绪,并且有更低的目标PA。干预前和干预期间的PA水平与其他临床数据之间没有发现显着相关性。
    结论:大多数患有NT1的儿童表现出令人满意的PA水平,尽管他们白天嗜睡。LTPA参与与更高的生活质量相关。APA干预对嗜睡症儿童可能有效,尤其是那些有抑郁情绪的人。
    OBJECTIVE: Physical activity (PA) is recommended as part of the management of narcolepsy type 1 (NT1). This study aimed at 1) characterizing PA in children and adolescents treated for NT1 using objective and subjective measurements, 2) evaluating how PA is associated with NT1 symptoms and comorbidities, and 3) evaluating the effects of an Adapted Physical Activity (APA) program on PA and clinical characteristics.
    METHODS: Patients with NT1 from the National Reference Center of Narcolepsy (Lyon, France) were consecutively included in an APA intervention protocol. Narcolepsy symptoms and comorbidities were collected using standardized questionnaires and sustained attention was evaluated using the Bron-Lyon Attention Stability Test before and after the four-week APA intervention. PA was measured objectively using actigraphy throughout the study.
    RESULTS: Twenty-seven NT1 patients were included (median age 14.7 years [8.3-18.4], cataplexy 88.9%, obesity 37.0%). At baseline, 52.4% of the patients had satisfactory PA levels according to international recommendations. Patients with leisure-time PA (LTPA) showed higher quality of life than patients without. 45% of the patients increased PA during the intervention compared to baseline. These responsive patients had more depressive feelings and tended to have lower objective PA than non-responsive patients at baseline. No significant correlation was found between PA levels before and during the intervention and other clinical data.
    CONCLUSIONS: Most children with NT1 showed satisfying PA levels despite their daytime sleepiness. LTPA engagement was associated with higher quality of life. An APA intervention could be effective in children with narcolepsy, especially for those with depressive feelings.
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  • 文章类型: Journal Article
    背景:由于潜在的合并症,骨科患者发生并发症的风险增加,长期药物治疗和住院期间频繁的治疗变化。临床药师(CP)在有关多重用药的透壁沟通中起着关键作用,以改善出院后全科医生(GP)的护理连续性。在这项研究中,药剂师主导的透壁护理计划,为矫形患者量身定制,评估以减少出院后的药物相关问题(DRP)。
    方法:进行了一项介入研究(前期:1/10/2021-31/12/2021;后期:1/01/2022-31/03/2022)。纳入骨科患者(≥65岁)。预先组接受了常规护理,后组接受了药剂师主导的透壁护理计划.计算出院后1个月的DRP降低率。在多元线性回归分析中确定了DRP降低率的相关因素。确定了拟议干预措施的GP接受率,以及它们使用临床的临床影响,经济和组织(CLEO)工具。评估出院后一个月的再入院情况。
    结果:总体而言,纳入127例患者(对照n=61,干预n=66)。干预组DRP降低率明显高于对照组(p<0.001)。药剂师的干预与DRP降低率增加相关(+1.750,95%置信区间1.222-2.278)。总的来说,CP建议了141种干预措施,其中71%在出院后一个月被接受。在这两个时期,4例患者在出院后1个月再次入院.58%的干预措施具有临床影响(使用CLEO工具≥2C水平),根据老年病学家的说法,对于CP,这是45%,表明他们有可能避免病人的伤害。
    结论:药师主导的透壁护理计划在骨科老年患者出院后1个月显著降低了DRPs。与全科医生的透壁交流导致拟议干预措施的接受度很高。
    BACKGROUND: Orthogeriatric patients have an increased risk for complications due to underlying comorbidities, chronic drug therapy and frequent treatment changes during hospitalization. The clinical pharmacist (CP) plays a key role in transmural communication concerning polypharmacy to improve continuity of care by the general practitioner (GP) after discharge. In this study, a pharmacist-led transmural care program, tailored to orthogeriatric patients, was evaluated to reduce drug related problems (DRPs) after discharge.
    METHODS: An interventional study was performed (pre-period: 1/10/2021-31/12/2021; post-period: 1/01/2022-31/03/2022). Patients (≥ 65 years) from the orthopedic department were included. The pre-group received usual care, the post-group received the pharmacist-led transmural care program. The DRP reduction rate one month after discharge was calculated. Associated factors for the DRP reduction rate were determined in a multiple linear regression analysis. The GP acceptance rate was determined for the proposed interventions, as well as their clinical impact using the Clinical, Economic and Organizational (CLEO) tool. Readmissions one month after discharge were evaluated.
    RESULTS: Overall, 127 patients were included (control n = 61, intervention n = 66). The DRP reduction rate was statistically significantly higher in the intervention group compared to the control group (p < 0.001). The pharmacist\'s intervention was associated with an increased DRP reduction rate (+ 1.750, 95% confidence interval 1.222-2.278). In total, 141 interventions were suggested by the CP, of which 71% were accepted one month after discharge. In both periods, four patients were readmitted one month after discharge. 58% of the interventions had a clinical impact (≥ 2 C level using the CLEO-tool) according to the geriatrician and for the CP it was 45%, indicating that they had the potential to avoid patient harm.
    CONCLUSIONS: The pharmacist-led transmural care program significantly reduced DRPs in geriatric patients from the orthopedic department one month after discharge. The transmural communication with GPs resulted in a high acceptance rate of the proposed interventions.
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  • 文章类型: Journal Article
    背景:青少年和年轻人在癌症轨迹中除了副作用外,还经常经历存在的担忧,他们经常独自携带。因此,与其他青少年和患有癌症的年轻人的凝聚力是必不可少的,但由于相对较小,广泛分散的全国人口。在共同创造中,已经开发了一个智能手机应用程序,包括一个信息库,症状追踪器,和一个社交社区平台,旨在改善该患者组的生活质量(QoL)。
    目标:全国范围内,多中心研究旨在调查青少年和年轻人在使用该应用程序6周时经历癌症轨迹的QoL。
    方法:通过青年支持倡议,参与者来自丹麦所有地区的医院.纳入标准是15-29岁的癌症患者,他们在30天内开始任何癌症治疗或在癌症治疗后开始随访。参与者使用青少年和年轻人癌症应用程序6周。在应用使用6周之前和之后,他们完成了欧洲癌症研究和治疗组织的生活质量问卷核心30(EORTCQLQ-C30).将参与者分为治疗组和随访组进行分析。功能量表或全球健康或总体QoL的高分代表高或健康的功能水平或高QoL,分别;然而,症状量表或项目的高分代表高水平的症状。
    结果:总体而言,招募了81名参与者。然而,4名参与者没有回答问卷,6名参与者没有使用该应用程序。在治疗组(n=36)中,在2个领域发现了显着改善:“角色功能”(基线中位数33.33,IQR16.67-83.33vs6周中位数66.67,IQR33.33-83.33;P=.04)和“疼痛”(基线中位数33.33,IQR16.67-50.00vs6周中位数16.67,IQR0.00-33.33;P=.04)。“全球健康/总体生活质量”量表保持稳定(基线中位数58.33,IQR45.83-77.08与6周中位数62.50,IQR41.67-75.00;P=.25)。在随访组(n=35)中,在3个领域发现了显着改善:“身体功能”(基线中位数79.23,IQR73.33-93.33与6周中位数82.86,IQR73.33-0.00;P=.03),“认知功能”(基线中位数62.38,IQR50.00-83.33与6周中位数69.52,IQR50.00-0.00;P=.02),和“社会功能”(基线中位数76.19,IQR50.00-0.00与6周中位数85.71,IQR83.33-0.00;P=0.05),以及“全球健康/总体QoL”量表(基线中位数57.14,IQR83.33-10.0,而6周中位数75.0,IQR62.91-85.73;P<.001)。
    结论:在这项研究中,我们发现,使用该应用6周后,治疗和随访参与者的特定QoL量表均有所改善.随访组的总体健康或总体QoL评分显著改善。在治疗组中,它保持稳定。
    RR2-10.2196/10098。
    BACKGROUND: Adolescents and young adults often experience existential concerns in addition to side effects during a cancer trajectory, which they often carry alone. Thus, cohesion with other adolescents and young adults with cancer is essential but difficult due to the relatively small, widely dispersed nationwide population. In cocreation, a smartphone app has been developed and includes an information bank, a symptom tracker, and a social community platform, aiming to improve the quality of life (QoL) in this patient group.
    OBJECTIVE: This nationwide, multicenter study aimed to investigate the QoL in adolescents and young adults undergoing a cancer trajectory as they used the app for 6 weeks.
    METHODS: Via youth support initiatives, participants were recruited from hospitals in all regions of Denmark. Inclusion criteria were patients with cancer aged 15-29 years who either initiated any cancer treatment or started follow-up after cancer treatment within 30 days. Participants used the adolescents and young adults cancer app for 6 weeks. Before and after the 6 weeks of app use, they completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The participants were divided into a treatment and a follow-up group for analysis. A high score for a functional scale or the global health or overall QoL represents a high or healthy level of functioning or high QoL, respectively; however, a high score for a symptom scale or item represents a high level of symptomatology.
    RESULTS: Overall, 81 participants were recruited. However, 4 participants did not answer the questionnaire and 6 participants did not use the app. In the treatment group (n=36), significant improvement was found in 2 domains: \"Role functioning\" (baseline median 33.33, IQR 16.67-83.33 vs 6 weeks median 66.67, IQR 33.33-83.33; P=.04) and \"Pain\" (baseline median 33.33, IQR 16.67-50.00 vs 6 weeks median 16.67, IQR 0.00-33.33; P=.04). The \"Global health/Overall QoL\" scale remained stable (baseline median 58.33, IQR 45.83-77.08 vs 6 weeks median 62.50, IQR 41.67-75.00; P=.25). In the follow-up group (n=35), significant improvement was found in 3 domains: \"Physical functioning\" (baseline median 79.23, IQR 73.33-93.33 vs 6 weeks median 82.86, IQR 73.33-100.00; P=.03), \"Cognitive functioning\" (baseline median 62.38, IQR 50.00-83.33 vs 6 weeks median 69.52, IQR 50.00-100.00; P=.02), and \"Social functioning\" (baseline median 76.19, IQR 50.00-100.00 vs 6 weeks median 85.71, IQR 83.33-100.00; P=.05), as well as in the \"Global health/Overall QoL\" scale (baseline median 57.14, IQR 83.33-100.00 vs 6 weeks median 75.0, IQR 62.91-85.73; P<.001).
    CONCLUSIONS: In this study, we found an improvement in specific QoL scales for both participants in treatment and follow-up when using the app for 6 weeks. The global health or overall QoL score improved significantly in the follow-up group. In the treatment group, it remained stable.
    UNASSIGNED: RR2-10.2196/10098.
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    背景:尽管研究和努力减轻细菌耐药性,抗生素处方过量的情况继续发生,通常是由于患者的真实或感知期望。目的:本研究的目的是确定:(1)提供者的患者教育努力与患者满意度之间是否存在关联,和(2)研究参与者的后续行为有关抗生素处方,通过对患者进行教育来利用管理(S.T.E.P.)积极规定性变化的过程。S.T.E.P.程序功能简单,简单的教育,通过面对面的咨询,在病人接触,以及提供来自疾病控制和预防中心(CDC)的适用印刷教育手册。在这项研究中,这两种干预措施与来自医疗保健提供者的研究参与者一起使用,教育重点是适当使用抗生素治疗被诊断患有上呼吸道感染(普通感冒)等常见疾病的成年人,急性鼻窦炎,和急性支气管炎,通常是病毒起源。
    方法:这项质量改进(QI)介入研究利用了研究者的直接面对面的患者教育和CDC打印材料作为抗生素处方的主要结果,通过对使用免费医院员工医疗诊所的40名医院员工进行便利抽样,将患者满意度作为次要结果。
    结果:本研究研究者的患者教学,以及来自CDC的补充印刷患者教育材料,这些材料是在初次医疗相遇期间提供给研究参与者的,是减少抗生素处方的有效干预措施,95%的研究参与者的患者满意度正证明了这一点。
    结论:使用抗生素治疗被诊断患有上呼吸道感染(普通感冒)等常见疾病的成年人,急性鼻窦炎,和急性支气管炎,可以通过使用患者教育和临床医生干预的组合来安全地减少。
    BACKGROUND: Despite research and efforts to mitigate bacterial resistance, antibiotic overprescribing continues to occur, often due to real or perceived expectations of patients.  Objective: The purpose of this study was to determine: (1) if there\'s an association between the provider\'s patient education efforts and the patient\'s satisfaction, and (2) the research participant\'s subsequent behavior concerning antibiotic prescriptions, by utilizing the Stewardship Through Educating Patients (S.T.E.P.) process for positive prescriptive change. The S.T.E.P. program features straightforward, simple education via face-to-face counseling at patient encounters, along with presenting applicable printed educational pamphlets from the Centers for Disease Control and Prevention (CDC). These two interventions were utilized in this study with research participants from the healthcare provider, with education focused on appropriate antibiotic use in the treatment of adults diagnosed with common illnesses such as an upper respiratory infection (the common cold), acute sinusitis, and acute bronchitis, which oftentimes are viral in origin.
    METHODS: This Quality Improvement (QI) interventional study utilized the researcher\'s direct face-to-face patient education and CDC printed materials as a measure of antibiotic prescribing as a primary outcome, with patient satisfaction as a secondary outcome via convenience sampling of 40 hospital employees who utilized a free hospital-based employee healthcare clinic.
    RESULTS: Patient-teaching by this study\'s researcher, along with supplemental printed patient education material from the CDC that were given to research participants during an initial medical encounter, were effective interventions used in reducing antibiotic prescribing, as evidenced by a positive patient satisfaction in 95% of research participants.
    CONCLUSIONS: Antibiotic use in the treatment of adults diagnosed with common illnesses such as an upper respiratory infection (the common cold), acute sinusitis, and acute bronchitis, may be safely reduced by using a combination of patient-education and clinician intervention.
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  • 文章类型: Journal Article
    背景:这项对3期类风湿关节炎(RA)filgotinib临床试验项目的事后分析评估了filgotinib对RA患者体重指数(BMI)的影响以及BMI对filgotinib疗效和安全性的影响。
    方法:FINCH1-3是随机的,双盲,菲尔戈替尼100和200mg用于RA患者的活性或安慰剂对照3期试验(N=3452).BMI评估包括BMI从基线的平均变化以及BMI增加阈值的患者比例。功效测量包括美国风湿病学会(ACR)20/50/70反应和根据使用C反应蛋白的疾病活动评分28的低疾病活动/缓解。通过基线BMI评估不良事件(AE)的暴露校正发生率(EAIR),使用来自FINCH1-4和DARWIN1-32期研究的综合数据(菲戈替尼总暴露量=8085患者-年).
    结果:各治疗组BMI随时间从基线的平均变化相似。在大多数患者中,无论治疗组或基线BMI如何,在第12周和第24周,BMI均增加≤1或2kg/m2;少数患者增加≥4kg/m2。对于大多数有效性措施,在所有BMI亚组中,菲尔戈替尼200mg比菲尔戈替尼100mg或主动比较或安慰剂更有效.对于较高的菲尔戈替尼剂量,严重治疗引起的AE的EAIR,静脉血栓和栓塞事件,主要不良心血管事件随BMI的增加而增加。
    结论:Filgotinib并未导致BMI发生实质性变化,BMI似乎不影响菲尔戈替尼的疗效.
    背景:ClinicalTrials.gov标识符:NCT02889796、NCT02873936、NCT02886728、NCT03025308、NCT01888874、NCT01894516、NCT02065700。
    一些类风湿性关节炎治疗导致肥胖患者体重增加或效果低于无肥胖患者。此外,肥胖会使类风湿性关节炎恶化。Filgotinib是一种类风湿性关节炎治疗,在七项随机临床研究(FINCH1-4和DARWIN1-3)中进行了评估。我们调查了filgotinib是否引起体重变化以及体重指数(BMI)是否影响filgotinib的疗效或安全性。我们分析了参加FINCH1、2或3的患者的BMI随时间的变化。大多数患者在使用菲戈替尼治疗24周后,BMI略有增加(约1-2kg/m2)。BMI的这种变化不受基线时患者BMI的影响。基线BMI并不影响filgotinib的疗效,这是使用疾病活动的标准措施进行评估。在所有患者中,Filgotinib比其他类风湿性关节炎治疗和安慰剂更有效,无论BMI亚组。使用来自所有七项临床研究(FINCH1-4和DARWIN1-3)的安全性数据,我们发现,与无肥胖患者相比,肥胖患者(BMI≥30kg/m2)发生一些不良事件的频率更高.增加的不良事件包括静脉血栓和栓塞事件以及主要不良心血管事件。肥胖是已知的危险因素。这些结果表明,filgotinib没有显著改变BMI(在大多数患者中增加约1-2kg/m2),基线BMI并不影响菲戈替尼的疗效.
    BACKGROUND: This post hoc analysis of the phase 3 rheumatoid arthritis (RA) filgotinib clinical trial program assessed the effect of filgotinib on body mass index (BMI) in patients with RA and the impact of BMI on the efficacy and safety of filgotinib.
    METHODS: FINCH 1-3 were randomized, double-blind, active- or placebo-controlled phase 3 trials of filgotinib 100 and 200 mg in patients with RA (N = 3452). BMI assessments included the mean change from baseline in BMI and the proportion of patients whose BMI increased by incremental thresholds. Efficacy measures included American College of Rheumatology (ACR) 20/50/70 response and low disease activity/remission according to Disease Activity Score 28 using C-reactive protein. The exposure-adjusted incident rate (EAIR) of adverse events (AEs) was assessed by baseline BMI, using integrated data from the FINCH 1-4 and the phase 2 DARWIN 1-3 studies (total filgotinib exposure = 8085 patient-years).
    RESULTS: Mean change from baseline in BMI over time was similar across treatment arms. In most patients, BMI increased by ≤ 1 or 2 kg/m2 at both weeks 12 and 24, regardless of treatment group or baseline BMI; few patients had increases of ≥ 4 kg/m2. For most efficacy measures, filgotinib 200 mg was more efficacious than filgotinib 100 mg or active comparators or placebo across BMI subgroups. For the higher filgotinib dose, the EAIR of serious treatment-emergent AEs, venous thrombotic and embolic events, and major adverse cardiovascular events increased with increasing BMI.
    CONCLUSIONS: Filgotinib did not lead to substantial changes in BMI, and BMI did not appear to affect the efficacy of filgotinib.
    BACKGROUND: ClinicalTrials.gov identifiers: NCT02889796, NCT02873936, NCT02886728, NCT03025308, NCT01888874, NCT01894516, NCT02065700.
    Some rheumatoid arthritis treatments cause patients to gain weight or are less effective in patients with obesity than in patients without obesity. Also, obesity can make rheumatoid arthritis worse. Filgotinib is a rheumatoid arthritis treatment that was evaluated in seven randomized clinical studies (FINCH 1–4 and DARWIN 1–3). We investigated whether filgotinib causes changes in weight and whether body mass index (BMI) affects the efficacy or safety of filgotinib. We analyzed how the BMI of patients who participated in FINCH 1, 2, or 3 changed over time. Most patients had a small increase in BMI (around 1–2 kg/m2) after 24 weeks of filgotinib treatment. This change in BMI was not affected by patients’ BMI at baseline. Baseline BMI did not impact the efficacy of filgotinib, which was assessed using standard measures of disease activity. Filgotinib was more effective than other rheumatoid arthritis treatments and placebo in all patients, regardless of BMI subgroup. Using safety data from all seven clinical studies (FINCH 1–4 and DARWIN 1–3), we found that some adverse events occurred more often in patients with obesity (a BMI of ≥ 30 kg/m2) than in those without obesity. The increased adverse events included venous thrombotic and embolic events and major adverse cardiovascular events, for which obesity is a known risk factor. These results show that filgotinib did not substantially change BMI (which increased by around 1–2 kg/m2 in most patients), and that baseline BMI did not affect the efficacy of filgotinib.
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