Cost-effectiveness analysis

成本效益分析
  • 文章类型: Clinical Trial Protocol
    背景:空间驱避剂(SR)已广泛用于预防蚊虫叮咬,初步研究结果表明,对疟疾(1)和伊蚊传播病毒(2)的有效性,但它们在减少实际使用中的蚊子传播疾病的有效性从未得到评估。在典型的媒介控制策略、如杀虫剂处理过的蚊帐(ITN)和室内残留喷洒,例如在流离失所者中或在紧急救济环境中无法进入或利用不足。
    方法:儿童将被纳入3个单独的队列,以建立SRs在不同分销渠道中减少疟疾感染的有效性。一个队列将评估通过参考渠道(研究人员分布)分配的SR的直接影响。剩下的两个队列将估计通过代金券渠道和乡村卫生小组渠道分发的SR的保护。每个月将遵循两次队列(大约每15天):在该月的第一次预定家庭访问中,将采取血液样本进行疟疾快速诊断测试(每月访问#1);和,在第二次预定的家庭访问中,如果参与者最近有发烧史(每月访问#2),则仅采集血液样本。将估计每个队列中的疟疾发病率,并将其与参考队列进行比较,以确定在高,全年传播疟疾。
    结论:这项研究将解决撒哈拉以南非洲地区在人道主义援助和应急环境中SRs是否有效减少人类疟疾疾病的知识差距,这些地区的基本传播率历来很高,并且ITN可能会或可能不会被广泛使用。这项研究将告知政策制定者是否推荐SRs作为进一步减少疟疾传播的手段。
    背景:ClinicalTrials.govNCT06122142。2023年11月8日注册。
    BACKGROUND: Spatial repellents (SRs) have been widely used for the prevention of mosquito bites, and preliminary findings suggest efficacy against both malaria (1) and Aedes-borne viruses (2) but their effectiveness in reducing mosquito-borne diseases under operational use has never been evaluated. SRs have the potential of being critical tools in the prevention of mosquito-borne diseases in contexts where typical vector control strategies, such as insecticide-treated nets (ITNs) and indoor residual spraying, are inaccessible or underutilized such as among displaced persons or in emergency relief settings.
    METHODS: Children will be enrolled in 3 separate cohorts to establish the effectiveness of SRs in reducing malaria infection in different distribution channels. One cohort will estimate the direct effect of the SR distributed through a reference channel (study personnel distribution). The two remaining cohorts will estimate the protection of the SR distributed through a voucher channel and the Village Health Team channel. Cohorts will be followed twice a month (approximately every 15 days): during the first scheduled household visit in the month, a blood sample will be taken for malaria rapid diagnostic test (Monthly Visit #1); and, during the second scheduled household visit, a blood sample will only be taken if the participant has a recent history of fever (Monthly Visit #2). The incidence of malaria in each cohort will be estimated and compared to the reference cohort to determine the benefit of using a SR in an area with high, year-round transmission of malaria.
    CONCLUSIONS: This study will address the knowledge gap of whether or not SRs are effective in reducing human malaria disease in humanitarian assistance and emergency response settings in sub-Saharan Africa where underlying transmission rates are historically high and ITNs may or may not be widely deployed. This research will inform policy makers on whether to recommend SRs as a means to further reduce malaria transmission for such operational programs.
    BACKGROUND: ClinicalTrials.gov NCT06122142. Registered on November 8, 2023.
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  • 文章类型: Journal Article
    背景:尽管一些研究报告说机器人方法比腹腔镜检查更昂贵,机器人远端胰腺切除术(RDP)相对于腹腔镜远端胰腺切除术(LDP)的成本效益仍然是一个问题.这项研究评估了西班牙几个中心的RDP和LDP方法的成本效益。
    方法:这项研究是一项观察性的,多中心,国家前瞻性研究(ROBOCOSTES)。从2022年开始的一年中,所有连续接受微创远端胰腺切除术的患者都包括在内,临床,QALY,和成本数据是前瞻性收集的。主要目的是分析RDP和LDP之间的成本效益。
    结果:在研究期间,分析了来自14个西班牙中心的80例手术。LDP的手术时间比RDP方法短(192.2分钟vs241.3分钟,p=0.004)。RDP的转化率较低(19.5%vs2.5%,p=0.006)和较低的脾切除术率(60%vs26.5%,p=0.004)。据报道,两个研究组之间的综合并发症指数差异具有统计学意义。支持机器人方法(12.7vs6.1,p=0.022)。RDP与1600欧元的手术成本增加相关(p<0.031),而总体费用支出导致比LDP高1070.92欧元,但没有统计学上的显着差异(p=0.064)。RDP手术后90天的平均QALY(0.9534)高于LDP(0.8882)(p=0.030)。在2万和3万欧元的支付意愿门槛下,RDP比LDP更具成本效益的可能性分别为62.64%和71.30%,分别。
    结论:西班牙医疗保健系统中的RDP程序似乎比LDP更具成本效益。
    BACKGROUND: Although several studies report that the robotic approach is more costly than laparoscopy, the cost-effectiveness of robotic distal pancreatectomy (RDP) over laparoscopic distal pancreatectomy (LDP) is still an issue. This study evaluates the cost-effectiveness of the RDP and LDP approaches across several Spanish centres.
    METHODS: This study is an observational, multicenter, national prospective study (ROBOCOSTES). For one year from 2022, all consecutive patients undergoing minimally invasive distal pancreatectomy were included, and clinical, QALY, and cost data were prospectively collected. The primary aim was to analyze the cost-effectiveness between RDP and LDP.
    RESULTS: During the study period, 80 procedures from 14 Spanish centres were analyzed. LDP had a shorter operative time than the RDP approach (192.2 min vs 241.3 min, p = 0.004). RDP showed a lower conversion rate (19.5% vs 2.5%, p = 0.006) and a lower splenectomy rate (60% vs 26.5%, p = 0.004). A statistically significant difference was reported for the Comprehensive Complication Index between the two study groups, favouring the robotic approach (12.7 vs 6.1, p = 0.022). RDP was associated with increased operative costs of 1600 euros (p < 0.031), while overall cost expenses resulted in being 1070.92 Euros higher than the LDP but without a statistically significant difference (p = 0.064). The mean QALYs at 90 days after surgery for RDP (0.9534) were higher than those of LDP (0.8882) (p = 0.030). At a willingness-to-pay threshold of 20,000 and 30,000 euros, there was a 62.64% and 71.30% probability that RDP was more cost-effective than LDP, respectively.
    CONCLUSIONS: The RDP procedure in the Spanish healthcare system appears more cost-effective than the LDP.
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  • 文章类型: Journal Article
    一项多中心非随机对照研究证明了中国多学科联合管理治疗髋部骨折患者的临床有效性。本研究旨在评估共同管理护理的成本效益。
    该研究基于中国的多中心临床试验(n=2071)。我们开发了一种状态过渡微观模拟模型,以从医疗保健系统的角度评估与常规护理相比,共同管理的护理对髋部骨折患者的成本效益。纳入模型的费用包括住院费用,出院后费用,和二次骨折治疗费用。使用质量调整生命年(QALYs)衡量有效性。成本和效果每年折价5%。采用了1年的模拟周期长度和生命周期。成本效益阈值定为37,118美元。为了解决不确定性,进行了单向确定性敏感性分析和概率敏感性分析.
    在基本情况分析中,共同管理的护理小组的终生成本为31,571美元,并实现了3.22QALY的有效性,而常规护理组的费用为27,878美元,获得了2.85QALY。增量成本效益比为每QALY获得9981美元;因此,共同管理的护理模式具有成本效益。干预组的成本效益对髋部骨折的年龄和住院费用敏感。
    髋部骨折患者的共同管理护理物有所值,并应扩大规模并优先考虑在中国的资金。
    该研究得到了Capital的健康改善和研究基金(2022-1-2071,2018-1-2071)的支持。
    UNASSIGNED: The clinical effectiveness of multidisciplinary co-managed care for hip fracture patients in China has been demonstrated in a multicenter non-randomized controlled study. This study aims to estimate the cost-effectiveness of the co-managed care.
    UNASSIGNED: The study is based on a multicenter clinical trial (n = 2071) in China. We developed a state transition microsimulation model to estimate the cost-effectiveness of the co-managed care compared with usual care for hip fracture patients from healthcare system perspective. The costs incorporated into the model included hospitalization costs, post-discharge expenses, and secondary fracture therapy costs. Effectiveness was measured using quality-adjusted life years (QALYs). Costs and effects were discounted at 5% annually. A simulation cycle length of 1-year and a lifetime horizon were employed. The cost-effectiveness threshold was established at USD 37,118. To address uncertainties, one-way deterministic sensitivity analysis and probabilistic sensitivity analysis were conducted.
    UNASSIGNED: In the base case analysis, the co-managed care group had a lifetime cost of USD 31,571 and achieved an effectiveness of 3.22 QALYs, whereas the usual care group incurred a cost of USD 27,878 and gained 2.85 QALYs. The incremental cost-effectiveness ratio was USD 9981 per QALY gained; thus the co-managed care model was cost-effective. The cost-effectiveness was sensitive to the age of having hip fractures and hospitalization costs in the intervention group.
    UNASSIGNED: The co-managed care in hip fracture patients represents value for money, and should be scaled up and prioritized for funding in China.
    UNASSIGNED: The study is supported by Capital\'s Funds for Health Improvement and Research (2022-1-2071, 2018-1-2071).
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  • 文章类型: Journal Article
    目的:内镜套管胃成形术(ESG)是一种微创日间手术,MERIT随机对照试验(RCT)已证明是一种有效且安全的减肥方法,而不是单纯的生活方式改变。基于此RCT,我们试图从美国商业付款人的角度评估ESG的成本效益。
    方法:我们使用马尔可夫建模方法对BMI组健康状况和吸收死亡状态进行建模。基线特征,公用事业,BMI组转移概率,和不良事件(AE)由MERITRCT的患者水平数据告知。死亡率是通过将BMI特异性风险比应用于美国一般人群死亡率来估计的。我们使用基于BMI的健康状态实用程序来反映肥胖合并症的影响,并应用ESGAE引起的功能缺陷。成本包括干预成本,AE成本,和基于BMI的年度直接医疗费用,以计算与肥胖合并症相关的费用。假设每个质量调整生命年(QALY)的支付意愿门槛为10万美元。
    结果:在我们5年时间范围内的基本案例分析中,与单独改变生活方式相比,ESG具有成本效益,增量成本效益比为23,432美元/季度。ESG在我们进行的所有敏感性分析中仍然具有成本效益,并且在时间范围更长的分析中占主导地位。
    结论:ESG对于肥胖患者是一种具有成本效益的治疗选择,应在商业健康计划中考虑作为临床合格患者的额外治疗选择。
    OBJECTIVE: Endoscopic sleeve gastroplasty (ESG) is a minimally invasive day procedure that the MERIT randomized controlled trial (RCT) has demonstrated to be an effective and safe method of weight loss versus lifestyle modification alone. We sought to evaluate the cost-effectiveness of ESG from the perspective of a US commercial payer in a cohort of adults with class II and class I obesity with diabetes based on this RCT.
    METHODS: We used a Markov modelling approach with BMI group health states and an absorbing death state. Baseline characteristics, utilities, BMI group transition probabilities, and adverse events (AEs) were informed by patient-level data from the MERIT RCT. Mortality was estimated by applying BMI-specific hazard ratios to US general population mortality rates. We used BMI-based health state utilities to reflect the impact of obesity comorbidities and applied disutilities due to ESG AEs. Costs included intervention costs, AE costs, and BMI-based annual direct healthcare costs to account for costs associated with obesity comorbidities. A willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY) was assumed.
    RESULTS: In our base-case analysis over a 5-year time horizon, ESG was cost-effective versus lifestyle modification alone with an incremental cost-effectiveness ratio of $23,432/QALY. ESG remained cost-effective in all sensitivity analyses we conducted and was dominant in analyses with longer time horizons.
    CONCLUSIONS: ESG is a cost-effective treatment option for people living with obesity and should be considered in commercial health plans as an additional treatment option for clinically eligible patients.
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  • 文章类型: Journal Article
    危重病人的用药方案复杂而动态,导致毒品相关问题的高发生率。这项研究旨在评估这些患者的药学服务的有效性和经济效率。
    在这项在三级医院进行的前瞻性队列研究中,根据现有的临床分组规则,将成年患者分为临床药学服务组或对照组.收集健康结果和经济指标,其次是成本效益分析。
    临床药师干预的接受率为89.31%。药物护理组显着降低了用药错误率(40.65%vs.61.69%,P<0.001)和药物不良事件(44.52%vs.56.45%,P=0.020)。特殊等级抗生素的使用率(85.16%vs.91.13%,P=0.009)和质子泵抑制剂(77.42%vs.88.71%,P=0.002)在药物护理组中也较低。次要结局在总住院时间上没有显着差异(21天与22天,P=0.092)。然而,ICU住院时间明显缩短(9天vs.11天,药物护理组的P=0.003)。成本-效果分析表明,与ICU药物护理相关的不良药物事件每减少1%,可节省ICU住院费用226.75美元,ICU药物总费用203.42美元。药物错误率降低1%,可节省ICU住院费用128.57美元,ICU总药费115.34美元。
    药学监护显著减少药物不良事件和用药错误,促进合理使用药物,缩短ICU住院时间,降低危重病人的治疗费用,在成本效益方面建立明确的优势。
    UNASSIGNED: The medication regimen for critically ill patients is complex and dynamic, leading to a high incidence of drug-related problems. This study aimed to assess the effectiveness and economic efficiency of pharmaceutical care for these patients.
    UNASSIGNED: In this prospective cohort study conducted in a tertiary hospital, adult patients were assigned either to a clinical pharmaceutical care group or a control group based on existing clinical grouping rules. Health outcomes and economic indicators were collected, followed by a cost-effectiveness analysis.
    UNASSIGNED: The acceptance rate for clinical pharmacist interventions was 89.31%. The pharmaceutical care group exhibited significant reductions in the rate of medication errors (40.65% vs. 61.69%, P < 0.001) and adverse drug events (44.52% vs. 56.45%, P = 0.020). The usage rates for special-grade antibiotics (85.16% vs. 91.13%, P = 0.009) and proton pump inhibitors (77.42% vs. 88.71%, P = 0.002) were also lower in the pharmaceutical care group. Secondary outcomes did not show significant differences in total hospital stay (21 days vs. 22 days, P = 0.092). However, ICU stay was significantly shorter (9 days vs. 11 days, P = 0.003) in the pharmaceutical care group. Cost-effectiveness analysis demonstrated that each 1% reduction in adverse drug events associated with ICU pharmaceutical care saved $226.75 in ICU hospitalization costs and $203.42 in total ICU drug costs. A 1% reduction in the medication error rate saved $128.57 in ICU hospitalization costs and $115.34 in total ICU drug costs.
    UNASSIGNED: Pharmaceutical care significantly reduces adverse drug events and medication errors, promotes rational use of medications, decreases the length of ICU stay, and lowers treatment costs in critically ill patients, establishing a definitive advantage in terms of cost-effectiveness.
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  • 文章类型: Journal Article
    背景:这项研究是对两种实施策略的成本效益研究,旨在培训大学和大学咨询中心的治疗师提供人际心理治疗。估计了实施培训师培训(TTT)战略与专家咨询战略的成本,计算并比较了它们对治疗师结局的相对影响。
    方法:在美国招募了24个咨询中心。这些中心被随机分配到TTT(实验)条件,内部治疗师培训了其他中心治疗师,或专家咨询条件,中心治疗师参加了一个研讨会,并接受了12个月的持续监督。主要结果是治疗师对人际心理治疗的忠诚(依从性和能力),通过治疗会议的录音评估,并使用线性混合模型进行分析。使用时间驱动的基于活动的成本计算方法对每个条件的成本进行量化,并涉及对中心主任进行的成本计算调查,跟进访谈和验证检查,以及专家条件下培训师时间跟踪日志的比较。获得每种情况下产生一名治疗师的平均成本。然后在两种情况下比较了在治疗师水平上产生同等改善的成本。
    结果:咨询中心使用TTT策略培训一名治疗师的平均成本为3,407美元(中位数=3,077美元);在控制条件下生产一名经过培训的治疗师的平均成本为2,055美元(中位数=1,932美元)。处于TTT状态的治疗师,平均而言,与对照条件下的治疗师相比,依从性得分高0.043;然而,这一差异无统计学意义.对于能力结果,在TTT条件下,治疗师的效应大小在很大范围内(1.16;95%CI:0.85-1.46;p<.001),和这种情况下的治疗师,平均而言,与专家咨询条件相比,能力得分高0.073(95%CI,0.008-0.14;p=.03)。使用TTT模型的咨询中心减少了353美元的培训费用,以提高治疗师的能力。
    结论:尽管短期成本较高,与专家咨询相比,TTT实施策略可提高治疗师的能力。扩大资源以支持该服务提供平台可以是增强在大学和大学咨询中心寻求护理的年轻人的精神保健的有效途径。
    背景:ClinicalTrials.gov标识符:NCT02079142。
    BACKGROUND: This study is a cost-effectiveness study of two implementation strategies designed to train therapists in college and university counseling centers to deliver interpersonal psychotherapy. Costs of implementing a train-the-trainer (TTT) strategy versus an expert consultation strategy were estimated, and their relative effects upon therapist outcomes were calculated and compared.
    METHODS: Twenty four counseling centers were recruited across the United States. These centers were randomized to either a TTT (experimental) condition, in which an in-house therapist trained other center therapists, or an expert consultation condition, in which center therapists participated in a workshop and received 12 months of ongoing supervision. The main outcome was therapist fidelity (adherence and competence) to interpersonal psychotherapy, assessed via audio recordings of therapy sessions, and analyzed using linear mixed models. Costs of each condition were quantified using time-driven activity-based costing methods, and involved a costing survey administered to center directors, follow up interviews and validation checks, and comparison of time tracking logs of trainers in the expert condition. Mean costs to produce one therapist were obtained for each condition. The costs to produce equivalent improvements in therapist-level outcomes were then compared between the two conditions.
    RESULTS: Mean cost incurred by counseling centers to train one therapist using the TTT strategy was $3,407 (median = $3,077); mean cost to produce one trained therapist in the control condition was $2,055 (median = $1,932). Therapists in the TTT condition, on average, demonstrated a 0.043 higher adherence score compared to therapists in the control condition; however, this difference was not statistically significant. For the competence outcome, effect size for therapists in the TTT condition was in the large range (1.16; 95% CI: 0.85-1.46; p < .001), and therapists in this condition, on average, demonstrated a 0.073 higher competence score compared to those in the expert consultation condition (95% CI, 0.008-0.14; p = .03). Counseling centers that used the TTT model incurred $353 less in training costs to produce equivalent improvements in therapist competence.
    CONCLUSIONS: Despite its higher short run costs, the TTT implementation strategy produces greater increases in therapist competence when compared to expert consultation. Expanding resources to support this platform for service delivery can be an effective way to enhance the mental health care of young people seeking care in college and university counseling centers.
    BACKGROUND: ClinicalTrials.gov Identifier: NCT02079142.
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  • 文章类型: Journal Article
    简介:癌症,尤其是肺癌,是一项重大的全球医疗挑战。非小细胞肺癌(NSCLC)占病例的85%。患者经常寻求替代疗法,如中医和西医治疗。这项研究调查了台湾NSCLC患者辅助中药治疗的生存结果和成本效益。方法:我们在2000年至2018年的回顾性队列研究中利用了国家健康保险研究数据库,重点是2007年至2013年诊断的NSCLC患者。在倾向得分匹配1:5比率后,然后比较有和没有辅助中药治疗的患者。生存结果,成本效益,并进行了敏感性分析。结果:本研究共纳入43,122例NSCLC患者,其中5.76%接受中药辅助治疗。死亡风险与中药辅助治疗无显著相关性,中药辅助治疗181-365天可降低死亡风险(HR=0.88,95%CI:0.80-0.98)。成本效益分析表明,增量成本效益比为880,908新台币/年。结论:中医辅助治疗,特别是当服用181-365天时,显著降低IV期NSCLC患者的死亡风险.成本效益与支付意愿门槛一致,说明经济效益。
    Introduction: Cancer, particularly lung cancer, is a significant global healthcare challenge. Non-Small Cell Lung Cancer (NSCLC) constitutes 85% of cases. Patients often seek alternative therapies like Chinese medicine alongside Western treatments. This study investigates the survival outcomes and cost-effectiveness of adjunctive Chinese medicine therapy for NSCLC patients in Taiwan. Methods: We utilized the National Health Insurance Research Database in a retrospective cohort study from 2000 to 2018, focusing on NSCLC patients diagnosed between 2007 and 2013. After propensity score matching 1:5 ratio, then compared patients with and without adjunctive Chinese medicine therapy. Survival outcomes, cost-effectiveness, and sensitivity analyses were conducted. Results: The study involved 43,122 NSCLC patients with 5.76% receiving adjunctive Chinese medicine. There is no significant associated between the risk of death and adjuvant Chinese medicine therapy until 181-365 days of adjuvant treatment could reduce the risk of death (HR = 0.88, 95% CI: 0.80-0.98). Cost-effectiveness analysis showed an incremental cost-effectiveness ratio of 880,908 NT$/year. Conclusion: Adjunctive Chinese medicine therapy, particularly when administered for 181-365 days, significantly reduced the mortality risk among stage IV NSCLC patients. The cost-effectiveness aligns with willingness-to-pay thresholds, indicating economic benefit.
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  • 文章类型: Journal Article
    背景:急性白血病(AL)是危及生命的血液癌症,可以通过涉及骨髓抑制的治疗治愈,多智能体,强化化疗(IC)。然而,这种治疗与严重感染的风险有关,特别是与长期中性粒细胞减少相关的侵袭性真菌感染(IMF)。当前的实践指南建议对高危患者进行初级抗真菌(AF)预防,以降低FI发生率。AFs也用于经验管理持续的中性粒细胞减少性发热。当前的策略导致AF的大量过度使用。半乳甘露聚糖(GM)和β-D-葡聚糖(BG)生物标记物也用于诊断IFI。与单独施用每个测试相比,两种生物标志物的组合可以增强FI的可预测性。目前,没有大规模随机对照试验(RCT)直接比较基于生物标志物的诊断筛查策略,而不进行AF预防与AF预防(不进行系统生物标志物检测).
    方法:BioDriveAFS是一个多中心,平行,来自英国NHS血液科的404名参与者的双臂RCT。参与者将按1:1的比例分配,以接受基于生物标志物的抗真菌管理(AFS)策略。或预防性房颤策略,其中包括现有的护理标准(SoC)。共同的主要结果将是随机化后12个月的AF暴露和在随机化后12个月测量的患者报告的EQ-5D-5L。次要结果将包括总房颤暴露,可能的/已证实的Iv,生存率(全因死亡率和国际金融机构死亡率),FI治疗结果,房颤相关不良反应/事件/并发症,资源使用,需要入院或门诊治疗的中性粒细胞减少性发热发作,真菌中的AF抗性(非侵入性和侵入性)和结果排序的期望性。该试验将在前9个月进行内部试点阶段。混合方法过程评估将与内部试点阶段和全面试验并行整合,旨在有力地评估干预措施是如何实施的。还将进行成本效益分析。
    结论:BioDriveAFS试验旨在通过比较生物标志物主导的诊断策略与预防性AF的临床和成本效益,进一步了解安全地优化AF使用的策略,以预防和管理急性白血病中的IFI。该研究产生的证据将有助于在抗真菌管理中告知全球临床实践和方法。
    背景:ISRCTN11633399。注册24/06/2022。
    BACKGROUND: Acute leukaemias (AL) are life-threatening blood cancers that can be potentially cured with treatment involving myelosuppressive, multiagent, intensive chemotherapy (IC). However, such treatment is associated with a risk of serious infection, in particular invasive fungal infection (IFI) associated with prolonged neutropenia. Current practice guidelines recommend primary antifungal (AF) prophylaxis to be administered to high-risk patients to reduce IFI incidence. AFs are also used empirically to manage prolonged neutropenic fever. Current strategies lead to substantial overuse of AFs. Galactomannan (GM) and β-D-glucan (BG) biomarkers are also used to diagnose IFI. Combining both biomarkers may enhance the predictability of IFI compared to administering each test alone. Currently, no large-scale randomised controlled trial (RCT) has directly compared a biomarker-based diagnostic screening strategy without AF prophylaxis to AF prophylaxis (without systematic biomarker testing).
    METHODS: BioDriveAFS is a multicentre, parallel, two-arm RCT of 404 participants from UK NHS Haematology departments. Participants will be allocated on a 1:1 basis to receive either a biomarker-based antifungal stewardship (AFS) strategy, or a prophylactic AF strategy, which includes existing standard of care (SoC). The co-primary outcomes will be AF exposure in the 12-month post randomisation and the patient-reported EQ-5D-5L measured at 12-month post randomisation. Secondary outcomes will include total AF exposure, probable/proven IFI, survival (all-cause mortality and IFI mortality), IFI treatment outcome, AF-associated adverse effects/events/complications, resource use, episodes of neutropenic fever requiring hospital admission or outpatient management, AF resistance in fungi (non-invasive and invasive) and a Desirability of Outcome Ranking. The trial will have an internal pilot phase during the first 9 months. A mixed methods process evaluation will be integrated in parallel to the internal pilot phase and full trial, aiming to robustly assess how the intervention is delivered. Cost-effectiveness analysis will also be performed.
    CONCLUSIONS: The BioDriveAFS trial aims to further the knowledge of strategies that will safely optimise AF use through comparison of the clinical and cost-effectiveness of a biomarker-led diagnostic strategy versus prophylactic AF to prevent and manage IFI within acute leukaemia. The evidence generated from the study will help inform global clinical practice and approaches within antifungal stewardship.
    BACKGROUND: ISRCTN11633399. Registered 24/06/2022.
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  • 文章类型: Journal Article
    背景:社会处方链接工作者是非健康或社会护理专业人员,他们将有心理社会需求的人与非临床社区支持联系起来。它们正在广泛实施,但对于适当的目标人群或成本效益的证据有限.本研究旨在探讨其可行性,对于生活在贫困城市社区的多病患者,基于实践的链接工人对健康结果和成本效益的潜在影响。
    方法:在COVID19大流行期间(2020年7月至2021年1月)进行了一项务实的探索性随机试验,包括等待列表常规护理控制和盲点分析。参与者有两种或两种以上持续的健康状况,参加了为贫困城市社区提供服务的全科医生(GP),他们认为他们可以从为期一个月的基于实践的社会处方链接工人干预中受益。.可行性措施是招募和留住参与者,实践和联系工人,并完成结果数据。1个月时的主要结果是健康相关的生活质量(EQ-5D-5L)和心理健康(HADS)。使用质量调整生命年(QALYs)评估了卫生服务角度的潜在成本效益,基于EQ-5D-5L和ICACAP-A能力指数转换为效用评分。
    结果:从600的目标中,在13个一般实践中招募了251名患者。基线数据收集后随机分为干预(n=123)和对照组(n=117)。参与者在一个月时的保留率为80%。所有实践和链接工人(n=10)都保留了试用期。主要结局的数据完成率为75%。在EQ-5D-5L(MD0.01,95%CI-0.07至0.09)或HADS(MD0.05,95%CI-0.63至0.73)中,使用混合效应回归分析没有显着差异,没有成本效益优势。敏感性分析,考虑了在非大流行环境下满负荷工作的联系工人,表明,使用ICACAP-A能力指数,爱尔兰在45,000欧元ICER阈值下的有效性概率为0.787。
    结论:虽然试验招募不足的参与者主要是由于COVID-19的限制,这表明稳健的评估和成本效用分析是可能的。需要进一步评估以确定成本效益,并应考虑使用ICE-CAP-A福利措施进行成本效用分析。
    背景:该试验已在ISRCTN上注册。
    背景:在社会贫困地区,使用链接工人为患有复杂多重性疾病的人提供社会处方以及健康和社会护理协调。
    背景:ISRCTN10287737。注册日期2019年10月12日。链接:https://www.isrctn.com/ISRCTN10287737.
    BACKGROUND: Social prescribing link workers are non-health or social care professionals who connect people with psychosocial needs to non-clinical community supports. They are being implemented widely, but there is limited evidence for appropriate target populations or cost effectiveness. This study aimed to explore the feasibility, potential impact on health outcomes and cost effectiveness of practice-based link workers for people with multimorbidity living in deprived urban communities.
    METHODS: A pragmatic exploratory randomised trial with wait-list usual care control and blinding at analysis was conducted during the COVID 19 pandemic (July 2020 to January 2021). Participants had two or more ongoing health conditions, attended a general practitioner (GP) serving a deprived urban community who felt they may benefit from a one-month practice-based social prescribing link worker intervention.. Feasibility measures were recruitment and retention of participants, practices and link workers, and completion of outcome data. Primary outcomes at one month were health-related quality of life (EQ-5D-5L) and mental health (HADS). Potential cost effectiveness from the health service perspective was evaluated using quality adjusted life years (QALYs), based on conversion of the EQ-5D-5L and ICECAP-A capability index to utility scoring.
    RESULTS: From a target of 600, 251 patients were recruited across 13 general practices. Randomisation to intervention (n = 123) and control (n = 117) was after baseline data collection. Participant retention at one month was 80%. All practices and link workers (n = 10) were retained for the trial period. Data completion for primary outcomes was 75%. There were no significant differences identified using mixed effects regression analysis in EQ-5D-5L (MD 0.01, 95% CI -0.07 to 0.09) or HADS (MD 0.05, 95% CI -0.63 to 0.73), and no cost effectiveness advantages. A sensitivity analysis that considered link workers operating at full capacity in a non-pandemic setting, indicated the probability of effectiveness at the €45,000 ICER threshold value for Ireland was 0.787 using the ICECAP-A capability index.
    CONCLUSIONS: While the trial under-recruited participants mainly due to COVID-19 restrictions, it demonstrates that robust evaluations and cost utility analyses are possible. Further evaluations are required to establish cost effectiveness and should consider using the ICE-CAP-A wellbeing measure for cost utility analysis.
    BACKGROUND: This trial is registered on ISRCTN.
    BACKGROUND: Use of link workers to provide social prescribing and health and social care coordination for people with complex multimorbidity in socially deprived areas.
    BACKGROUND: ISRCTN10287737. Date registered 10/12/2019. Link: https://www.isrctn.com/ISRCTN10287737.
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  • 文章类型: Journal Article
    目的:为了确定12周的补贴运动计划对社区居住的老年人的健康相关生活质量(HRQoL)的影响,以及该计划的成本效用。
    方法:准实验,pre-poststudy.
    方法:参与者包括社区居住的老年人,年龄≥65岁,来自澳大利亚的每个州和领土。干预包括12个一小时,每周,中低强度运动班,由认可的运动科学家或生理学家(AESs/AEPs)提供。使用EQ-5D-3L在计划参与之前和之后测量了与健康相关的生活质量,并使用澳大利亚价值关税转换为公用事业指数。参与者,报告了组织和服务提供商的成本。多变量线性混合模型用于评估程序完成后HRQoL的变化。成本效用结果报告为增量成本效益比(ICER),基于方案成本和效用分数的变化。
    结果:3511名年龄中位数(IQR)为72(69-77)岁的老年人(77%为女性)完成了随访测试。计划完成后,EQ-5D-3L效用得分略有改善(0.04,95%CI:0.04,0.05,p<0.001)。每质量调整生命年(QALY)的成本为12,893美元。
    结论:参加积极老龄化运动权利计划的澳大利亚老年人报告说,在计划完成后,HRQoL略有改善。这包括居住在地区/农村地区的老年人。资助资助运动班,可能是改善老年人健康结果和减少地理健康差异的低成本策略。
    背景:该研究已在澳大利亚新西兰临床试验注册中心(ANZCTR)(ACTRN12623000483651)注册。
    OBJECTIVE: To determine the effect of a 12-week subsidised exercise programme on health-related quality of life (HRQoL) in community-dwelling older Australians, and the cost-utility of the programme.
    METHODS: Quasi-experimental, pre-post study.
    METHODS: Participants included community-dwelling older adults, aged ≥65 years, from every state and territory of Australia. The intervention consisted of 12 one-hour, weekly, low-to-moderate-intensity exercise classes, delivered by accredited exercise scientists or physiologists (AESs/AEPs). Health-related quality of life was measured before and after programme participation using the EQ-5D-3L and converted to a utility index using Australian value tariffs. Participant, organisational and service provider costs were reported. Multivariable linear mixed models were used to evaluate the change in HRQoL following programme completion. Cost-utility outcomes were reported as incremental cost-effectiveness ratios (ICERs), based on programme costs and the change in utility scores.
    RESULTS: 3511 older adults (77 % female) with a median (IQR) age of 72 (69-77) years completed follow-up testing. There was a small improvement in EQ-5D-3L utility scores after programme completion (0.04, 95 % CI: 0.04, 0.05, p < 0.001). The cost per quality-adjusted life year (QALY) gained was $12,893.
    CONCLUSIONS: Older Australians who participated in the Exercise Right for Active Ageing programme reported small improvements in HRQoL following programme completion, and this included older adults living in regional/rural areas. Funding subsidised exercise classes, may be a low-cost strategy for improving health outcomes in older adults and reducing geographic health disparities.
    BACKGROUND: The study was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12623000483651).
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