Patient-important outcomes

  • 文章类型: Journal Article
    在过去的十年中,钠-葡萄糖协同转运蛋白-2抑制剂(SGLT-2i)和胰高血糖素样肽-1受体激动剂(GLP-1RA)在2型糖尿病(T2D)中的新发现在关键的患者方面具有良好的结果-重要结果,包括发病率,死亡率和健康相关生活质量(HRQoL)。SGLT-2i和GLP-1RA除了降糖作用外,还提供心血管和肾脏保护。减轻体重和低血糖,改善糖尿病相关的痛苦,身体功能和HRQoL。随着基础胰岛素/GLP-1RA的固定比例组合,它们使得大剂量和多次注射胰岛素的方案简化和降级成为可能,从而减轻治疗负担.除了降低心肾风险,SGLT-2i和GLP-1RA降低抑郁症的发生率,认知能力下降,呼吸道疾病,痛风,心律失常和其他共同发生的T2D疾病,即多浊度,这经常使T2D复杂化,并对HRQoL产生不利影响。通过SGLT-2i和GLP-1RA的多效性作用来缓解多重性疾病,可以改善患者的HRQoL。SGLT-2i和GLP-1RA的使用应在共同决策中增加,在共同决策中,它们被重新定义为具有降低血糖潜力的降低心肾风险的药物。通过改善患者可能高度感知和重视的结果,SGLT-2i和GLP-1RA可以促进当代以人为中心的T2D管理.
    The newfound knowledge in type 2 diabetes (T2D) during the past decade for the sodium-glucose cotransporter-2 inhibitors (SGLT-2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA) is wealthy in favorable results for key patient-important outcomes including morbidity, mortality and health-related quality of life (HRQoL). The SGLT-2i and GLP-1RA offer cardiovascular and renal protection beyond their glucose lowering effect, reduce body weight and hypoglycemia and improve diabetes-related distress, physical function and HRQoL. Along with the fixed-ratio combinations of basal insulin/GLP-1RA, they make feasible a regimen simplification and de-escalation from high dose and multiple injections of insulin reducing treatment burden. Besides cardiorenal risk reduction, the SGLT-2i and GLP-1RA reduce the incidence of depression, cognitive decline, respiratory disease, gout, arrhythmias and other co-occurring conditions of T2D, namely multimorbidity, which frequently complicates T2D and adversely affects HRQoL. The alleviation of multimorbidity by the pleiotropic effects of the SGLT-2i and GLP-1RA, could improve patients\' HRQoL. The use of the SGLT-2i and GLP-1RA should be increased within a shared decision-making in which they are reframed as cardiorenal risk-reducing medications with the potential to lower blood glucose. By improving outcomes that patients may highly perceive and value, the SGLT-2i and GLP-1RA may facilitate the contemporary person-centered management of T2D.
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  • 文章类型: Journal Article
    动脉瘤性蛛网膜下腔出血(aSAH)是一种高死亡率和高发病率的破坏性疾病。aSAH临床研究中使用的结果指标各不相同,因此比较和组合不同的研究具有挑战性。此外,患者优先考虑的结果之间可能存在不匹配,看护者,以及医疗保健提供者和研究人员选择的人。我们进行了一次国际会议,在线,多轮Delphi研究,以形成领域的共识(其中一个领域是一个健康概念或方面)由主要利益相关者优先考虑,包括那些生活经验的aSAH,卫生保健提供者,和研究人员,资助者,或行业专业人士。一百七十五人参与调查,59%的人有过aSAH的生活经历。经过三轮,32个领域达到了预定义的共识阈值,即70%的参与者将该领域评为至关重要。在第四轮比赛中,参与者对这32个领域中每个领域的重要性进行了排名.排名最高到最低的前十个领域是(1)认知和执行功能,(2)动脉瘤闭塞,(3)脑梗死,(4)功能结果,包括行走能力,(5)迟发性脑缺血,(6)SAH幸存者报告的总体生活质量,(7)情绪或情绪的变化(包括抑郁),(8)日常生活的基本活动,(9)血管痉挛,(10)ICU并发症。我们的发现证实,利益相关者优先考虑的领域与临床研究中使用的结果之间存在不匹配。我们未来的工作旨在通过开发aSAH研究中的核心结果来解决这种不匹配。
    Aneurysmal subarachnoid haemorrhage (aSAH) is a devastating condition with high mortality and morbidity. The outcome measures used in aSAH clinical research vary making it challenging to compare and combine different studies. Additionally, there may be a mismatch between the outcomes prioritized by patients, caregivers, and health care providers and those selected by researchers. We conducted an international, online, multiple round Delphi study to develop consensus on domains (where a domain is a health concept or aspect) prioritized by key stakeholders including those with lived experience of aSAH, health care providers, and researchers, funders, or industry professionals. One hundred seventy-five people participated in the survey, 59% of whom had lived experience of aSAH. Over three rounds, 32 domains reached the consensus threshold pre-defined as 70% of participants rating the domain as being critically important. During the fourth round, participants ranked the importance of each of these 32 domains. The top ten domains ranked highest to lowest were (1) Cognition and executive function, (2) Aneurysm obliteration, (3) Cerebral infarction, (4) Functional outcomes including ability to walk, (5) Delayed cerebral ischemia, (6) The overall quality of life as reported by the SAH survivor, (7) Changes to emotions or mood (including depression), (8) The basic activities of daily living, (9) Vasospasm, and (10) ICU complications. Our findings confirm that there is a mismatch between domains prioritized by stakeholders and outcomes used in clinical research. Our future work aims to address this mismatch through the development of a core outcome set in aSAH research.
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  • 文章类型: Journal Article
    最近,越来越关注患者对研究和医疗保健改进的投入,促进了以患者为中心的宣传工作的扩大。第一次泛真菌病峰会,MYCology倡导的一部分,Research,&教育努力,把病人聚集在一起,看护者,和真菌学专家更好地记录患者侵袭性真菌病(IFD)的经历,并确定真菌学教育的优先事项,倡导,和研究。
    患有IFD的患者,他们的照顾者,临床医生,行业代表,政府官员,并邀请了耐心的宣传专业人士。患者和护理人员分享了他们的故事和与IFD的斗争。分组会议将真菌学专家与患者和护理人员分开,进行进一步讨论,以确定共同点和感知差距并制定建议。然后,这两个小组再次开会,以制定共识建议。
    IFD患者和他们的照顾者分享的经验反映了通常漫长的预诊断,急性治疗,长期治疗,和IFD的后处理恢复阶段。他们报告了大量的身体,心理,以及与IFD经验相关的财务负担,特别是与延迟诊断有关。他们重申需要协调以病人为中心的教育,同行支持,并倡导记录严重真菌感染的负担。真菌学专家讨论了解决真菌学领域差距的策略,比如训练不足,劳动力支持不足,以及需要与患者群体更多的合作。
    参加IFD患者峰会,家庭照顾者,和真菌学专家确定了与IFD相关的大量非临床疾病负担。患者和真菌学专家优先考虑了几个教育目标,倡导,和研究,以提高对IFD的认识并改善结果。
    UNASSIGNED: Recently, increasing focus on patient input into research and healthcare improvements has fostered expanded patient-centered advocacy efforts. This first pan-fungal disease summit, part of the MYCology Advocacy, Research, & Education effort, brought together patients, caregivers, and mycology experts to better document patient experiences with invasive fungal disease (IFD) and establish priorities for mycology education, advocacy, and research.
    UNASSIGNED: Patients who had suffered from IFD, their caregivers, clinicians, industry representatives, government officials, and patient advocacy professionals were invited. Patients and caregivers shared their stories and struggles with IFD. Breakout sessions separated mycology experts from patients and caregivers for further discussions to identify commonalities and perceived gaps and to formulate recommendations. The 2 groups then reconvened to develop consensus recommendations.
    UNASSIGNED: IFD patients and their caregivers shared experiences reflecting the typically lengthy prediagnosis, acute treatment, long-term treatment, and posttreatment recovery stages of IFD. They reported substantial physical, psychological, and financial burdens associated with the IFD experience, particularly related to delayed diagnoses. They reaffirmed a need for coordinated patient-centered education, peer support, and advocacy to document the burden of serious fungal infections. Mycology experts discussed strategies to address gaps in the mycology field, such as insufficient training, inadequate workforce support, and a need to partner more with patient groups.
    UNASSIGNED: A summit involving patients with IFD, family caregivers, and mycology experts identified a substantial nonclinical burden of disease associated with IFD. Patients and mycology experts prioritized several goals for education, advocacy, and research to raise awareness of IFD and improve outcomes.
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  • 文章类型: Journal Article
    背景:短期辅助全身性皮质类固醇通常用于治疗急性荨麻疹和慢性荨麻疹(伴有或不伴有肥大细胞介导的血管性水肿),但它们的好处和危害尚不清楚。
    目的:评价全身使用糖皮质激素与不使用糖皮质激素治疗急性荨麻疹或慢性荨麻疹的疗效和安全性。
    方法:我们搜索了MEDLINE,EMBASE,中部,CNKI,VIP,万方,和从开始到2023年7月8日的CBM数据库,用于使用和不使用全身性皮质类固醇治疗荨麻疹的随机对照试验。配对的审稿人独立筛选记录,提取的数据,并使用Cochrane2.0工具评估偏差风险。我们做了荨麻疹活动的随机效应荟萃分析,瘙痒严重程度和不良事件。我们使用分级方法评估了证据的确定性。
    结果:我们确定了12项随机试验,纳入944例患者。对于仅使用抗组胺药改善的概率低或中等(17.5%至64%)的患者,附加的全身性皮质类固醇可能使荨麻疹活动改善14%~15%的绝对差异(比值比[OR]2.17,95CI1.43~3.31;治疗所需数量[NNT]7;中度确定性).在仅使用抗组胺药的荨麻疹改善的机会很高(95.8%)的患者中,附加的全身性皮质类固醇可能将荨麻疹活性改善了2.2%的绝对差异(NNT,45;中等确定性)。皮质类固醇可以改善瘙痒严重程度(或,2.44;95CI0.87-6.83;风险差异,9%;NNT,11;低确定性)。全身性皮质类固醇也可能增加不良事件(OR,2.76;95CI1.00-7.62;风险差异,15%;伤害[NNH]所需的数量,9;中等确定性)。
    结论:全身性皮质类固醇治疗急性荨麻疹或慢性荨麻疹加重可能改善荨麻疹,根据抗组胺反应,但也可能增加约15%以上的不良反应。
    BACKGROUND: Short courses of adjunctive systemic corticosteroids are commonly used to treat acute urticaria and chronic urticaria flares (both with and without mast cell-mediated angioedema), but their benefits and harms are unclear.
    OBJECTIVE: To evaluate the efficacy and safety of treating acute urticaria or chronic urticaria flares with versus without systemic corticosteroids.
    METHODS: We searched the MEDLINE, EMBASE, CENTRAL, CNKI, VIP, Wanfang, and CBM databases from inception to July 8, 2023, for randomized controlled trials of treating urticaria with versus without systemic corticosteroids. Paired reviewers independently screened records, extracted data, and appraised risk of bias with the Cochrane 2.0 tool. We performed random-effects meta-analyses of urticaria activity, itch severity, and adverse events. We assessed certainty of the evidence using the Grading of Recommendations Assessment, Development and Evaluations (GRADE) approach.
    RESULTS: We identified 12 randomized trials enrolling 944 patients. For patients with low or moderate probability (17.5%-64%) to improve with antihistamines alone, add-on systemic corticosteroids likely improve urticaria activity by a 14% to 15% absolute difference (odds ratio [OR], 2.17, 95% confidence interval [CI]: 1.43-3.31; number needed to treat [NNT], 7; moderate certainty). Among patients with a high chance (95.8%) for urticaria to improve with antihistamines alone, add-on systemic corticosteroids likely improved urticaria activity by a 2.2% absolute difference (NNT, 45; moderate certainty). Corticosteroids may improve itch severity (OR, 2.44; 95% CI: 0.87-6.83; risk difference, 9%; NNT, 11; low certainty). Systemic corticosteroids also likely increase adverse events (OR, 2.76; 95% CI: 1.00-7.62; risk difference, 15%; number needed to harm, 9; moderate certainty).
    CONCLUSIONS: Systemic corticosteroids for acute urticaria or chronic urticaria exacerbations likely improve urticaria, depending on antihistamine responsiveness, but also likely increase adverse effects in approximately 15% more.
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  • 文章类型: Journal Article
    评估患者重要结局收集的完整性,以及研究中测量的结局与创伤后患者重要问题之间的不匹配。
    到目前为止,严重创伤主要通过院内死亡率进行评估.然而,80%到90%的幸存者出院,评估患者重要的创伤长期结局的收集至关重要.
    混合方法研究结合了对结果的系统评价及其与患者在定性研究中引发的领域的比较。我们搜查了Medline,EMBASE和clinicaltrials.gov从2014年1月1日至2019年9月30日,并从包括严重创伤在内的报告中提取了所有结果。我们将这些结果与先前定性研究中确定的对创伤幸存者重要的97个领域进行了比较。我们将患者重要的结局定义为定性研究中最常见的10个领域。我们评估了每份报告中捕获的领域数量,以说明患者重要结局收集的完整性。我们还评估了收集的结果与对患者重要的结果之间的不匹配。
    在系统审查中包含的116份报告中,我们使用154种独特的测量工具收集了403种结局.除了死亡率,最常用的测量工具是格拉斯哥结果量表(31.0%,n=36),关于患者重返工作岗位的问题(20%,n=24)和EQ-5D(19.0%,n=22)。在系统评价中确定的结果与定性研究领域之间的比较发现,10.3%(n=12)的报告没有收集任何患者重要领域,其中一个收集了所有10个患者重要领域。通过检查10个患者重要领域中的每个领域,超过72%的报告中没有一项被收集到,在研究中10个最常测量的领域中只有5个.
    可以改善创伤后长期患者重要结局的收集的完整性。文献中使用的领域与定性研究中患者认为重要的领域之间存在不匹配。
    To assess the completeness of the collection of patient-important outcomes and the mismatch between outcomes measured in research and patients\' important issues after trauma.
    UNASSIGNED: To date, severe trauma has mainly been assessed using in-hospital mortality. Yet, with 80 to 90% survivors discharged from hospital, it is critical to assess the collection of patient important long-term outcomes of trauma.
    UNASSIGNED: Mixed methods study combining a systematic review of outcomes and their comparison with domains elicited by patients during a qualitative study. We searched Medline, EMBASE and clinicaltrials.gov from January 1, 2014 to September 30, 2019 and extracted all outcomes from reports including severe trauma. We compared these outcomes with 97 domains that matter to trauma survivors identified in a previous qualitative study. We defined as patient-important outcome as the 10 most frequently elicited domains in the qualitative study. We assessed the number of domains captured in each report to illustrate the completeness of the collection of patient-important outcomes. We also assessed the mismatch between outcomes collected and what matters to patients.
    UNASSIGNED: Among the 116 reports included in the systematic review, we identified 403 outcomes collected with 154 unique measurements tools. Beside mortality, measurement tools most frequently used were the Glasgow Outcome Scale (31.0%, n=36), questions on patients\' return to work (20,7%, n=24) and the EQ-5D (19.0%, n=22). The comparison between the outcomes identified in the systematic review and the domains from the qualitative study found that 10.3% (n=12) reports did not collect any patient-important domains and one collected all 10 patient-important domains. By examining each of the 10 patient-important domains, none was collected in more than 72% of reports and only five were among the ten most frequently measured domains in studies.
    UNASSIGNED: The completeness of the collection of the long-term patient-important outcomes after trauma can be improved. There was a mismatch between the domains used in the literature and those considered important by patients during a qualitative study.
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  • 文章类型: Journal Article
    随机临床试验(RCT)是确定给定干预效果的重要工具。研究者应该关注患者感知的结果:患者重要结果(PIOs),患者直接重视并反映他们的感受的临床终点,函数,或生存。然而,更容易考虑替代结果以降低成本并获得更好的结果。这些结果的问题在于它们间接测量了PIO,这可能不线性相关或可靠地转化为正PIO。
    我们系统地搜索了MEDLINE在过去10年中排名前10位的过敏性疾病和普通内科医学杂志中的特应性疾病RCT。两名独立审稿人一式两份,独立地从所有符合条件的文章中收集数据。我们收集了有关研究类型的信息,title,作者信息,journal,干预类型,特应性疾病,以及主要和次要结果。我们评估了研究者在特应性疾病和哮喘的RCT中使用的结果。
    这项定量分析包括n=135项随机临床试验。在所选期间研究最多的特应性疾病是哮喘(n=69),其次是过敏性鼻炎(n=51)。当被特应性疾病分开时,在评估过敏性鼻炎的RCT中,PIOs的主要结局比例最高(76.7),哮喘替代结果(38),和哮喘/过敏性鼻炎实验室结果(42.9)。变应性鼻炎试验中的PIO有最显著比例的PIO有利于干预(81.4),哮喘的替代结局比例最大(33.3),和哮喘/过敏性鼻炎实验室结果(40)。当被特应性疾病分开时,研究特应性皮炎和荨麻疹的试验的PIOs比例(64.7)与其次要结局相同.哮喘的替代结果最高(37.5)。普通/内科学杂志的PIO比例更高,事后分析显示,PIO和实验室结局之间有利于干预的比例和次要结局存在显著差异.
    在一般/内科发表的RCT中,10个主要结局中大约有7.5个是PIO,而在特应性疾病期刊中,10个主要结局中有5个是PIO。研究人员应在临床试验中重点选择患者重要的结局,以建立具有影响患者生活和价值观的高质量建议的临床指南。
    国际系统审查前瞻性注册(PROSPERO,NIHR)ID:CRD42021259256。
    UNASSIGNED: Randomized Clinical Trials (RCTs) are important tools to establish the effects of a given intervention. Investigators should focus on outcomes that patients perceive: patient-important outcomes (PIOs), clinical endpoints that patients value directly and reflect how they feel, function, or survive. However, it is easier to consider surrogated outcomes to reduce costs and achieve better-looking results. The problem with these outcomes is that they indirectly measure PIOs, which might not correlate linearly or translate reliably into a positive PIO.
    UNASSIGNED: We systematically searched MEDLINE for atopic disease RCTs rated among the top 10 allergic diseases and general internal medicine journals from the last 10 years. Two independent reviewers worked in duplicate and independently to collect data from all eligible articles. We gathered information regarding the type of study, title, author information, journal, intervention type, atopic disease, and primary and secondary outcomes. We assessed the outcomes investigators used in RCTs of atopic diseases and asthma.
    UNASSIGNED: This quantitative analysis included n = 135 randomized clinical trials. The most studied atopic disease during the period selected was asthma (n = 69), followed by allergic rhinitis (n = 51). When divided by atopic disease, primary outcomes in RCTs valuing allergic rhinitis had the most significant proportion of PIOs (76.7), asthma surrogated outcomes (38), and asthma/allergic rhinitis laboratory outcomes (42.9). PIOs in allergic rhinitis trials had the most significant proportion of PIOs favoring the intervention (81.4), asthma had the greatest proportion of surrogated outcomes (33.3), and asthma/allergic rhinitis laboratory outcomes (40). When divided by atopic disease, trials studying atopic dermatitis and urticaria had the same proportion of PIOs (64.7) as their secondary outcomes. Asthma had the highest (37.5) surrogate outcomes. Journals of general/internal medicine had a greater proportion of PIOs, and a post hoc analysis showed a significant difference in the proportion and secondary outcomes that favored the intervention between PIOs and laboratory outcomes.
    UNASSIGNED: Approximately 7.5 out of 10 primary outcomes in RCTs published in general/internal medicine are PIOs compared to 5 out of 10 primary outcomes in atopic disease journals. Investigators should focus on selecting patient-important outcomes in their clinical trials to establish clinical guidelines with better-quality recommendations that impact patients\' life and values.
    UNASSIGNED: International Prospective Register of Systematic Reviews (PROSPERO, NIHR) ID: CRD42021259256.
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  • 文章类型: Journal Article
    生存率已被认为是重症监护病房(ICU)重症患者临床结局评估的基石。有证据表明,ICU幸存者通常在长期结局中表现出受损,例如将其视为最相关的生活质量(QoL)。在过去的几年里,在同行评审的出版物中引入了患者重要结局的概念,并越来越多地报道了这一概念.在本系统综述中,我们评估了对危重患者进行的随机对照试验(RCT)的数量,并报告了生存获益情况,还报告了QoL数据.在MEDLINE/PubMed上搜索所有调查非手术干预措施可显着降低危重患者死亡率的RCT,Scopus和Embase从成立到2021年8月。在第二阶段,对于所有纳入的研究,对结果QoL进行了调查。主要结果是评估有多少分析降低死亡率的干预措施的RCT报告了QoL数据。次要终点是调查QoL是否改善,恶化或未改变。在239项研究中,有7项(2.9%)的QoL数据被报告为评估结果。评估QoL和QoL时间点的工具是异质的。四种干预措施对QoL有显著影响:两种干预措施改善了生存率和QoL(普伐他汀在蛛网膜下腔出血,非心脏手术后老年患者的右美托咪定),虽然两项干预措施降低了死亡率,但对QoL(再喂养综合征患者的热量限制和老年患者的系统性ICU入住)产生了负面影响。总之,只有少数RCT显示干预措施会影响危重患者的死亡率,也有QoL数据.除死亡率外,重症监护的未来研究还应包括患者重要的结局,例如QoL。有关该主题的数据应根据专家声明和核心成果集收集,以确保结果的质量和可比性。
    Survival has been considered the cornerstone for clinical outcome evaluation in critically ill patients admitted to intensive care unit (ICU). There is evidence that ICU survivors commonly show impairments in long-term outcomes such as quality of life (QoL) considering them as the most relevant ones. In the last years, the concept of patient-important outcomes has been introduced and increasingly reported in peer-reviewed publications. In the present systematic review, we evaluated how many randomized controlled trials (RCTs) were conducted on critically ill patients and reporting a benefit on survival reported also data on QoL. All RCTs investigating nonsurgical interventions that significantly reduced mortality in critically ill patients were searched on MEDLINE/PubMed, Scopus and Embase from inception until August 2021. In a second stage, for all the included studies, the outcome QoL was investigated. The primary outcome was to evaluate how many RCTs analyzing interventions reducing mortality reported also data on QoL. The secondary endpoint was to investigate if QoL resulted improved, worsened or not modified. Data on QoL were reported as evaluated outcome in 7 of the 239 studies (2.9%). The tools to evaluate QoL and QoL time points were heterogeneous. Four interventions showed a significant impact on QoL: Two interventions improved survival and QoL (pravastatin in subarachnoid hemorrhage, dexmedetomidine in elderly patients after noncardiac surgery), while two interventions reduced mortality but negatively influenced QoL (caloric restriction in patients with refeeding syndrome and systematic ICU admission in elderly patients). In conclusion, only a minority of RCTs in which an intervention demonstrated to affect mortality in critically ill patients reported also data on QoL. Future research in critical care should include patient-important outcomes like QoL besides mortality. Data on this topic should be collected in conformity with PROs statement and core outcome sets to guarantee quality and comparability of results.
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  • 文章类型: Journal Article
    BACKGROUND: In the recent era, antimicrobial resistance has been identified as one of the most important threats to human health worldwide. The rapid emergence of antibiotic-resistant pathogens (ABRP) in the modern intensive care unit (ICU) also represents a \"nightmare scenario\" with unknown clinical consequences. In the Greek ICU, in particular, gram negative ABRPs are now considered endemic. However, the possible longitudinal impact of ABRPs on long-term outcomes of ICU patients has not yet been determined.
    METHODS: In this two-year (January 2014-December 2015) single-centre observational longitudinal study, 351 non-neurocritical ICU patients ≥ 18 year-old were enrolled. Patients\' demographic, clinical and outcome data were prospectively collected. Quality-adjusted life years (QALY) were calculated at 6, 12, 18 and 24 months after ICU admission.
    RESULTS: Fifty-eight patients developed infections due to ABRP (ABRP group), 57 due to non-ABRP (non-ABRP group), and 236 demonstrated no infection (no-infection group) while in ICU. Multiple regression analysis revealed that multiple organ dysfunction syndrome score (OR: 0.676, 95%CI 0.584-0.782; P < 0.001) and continuous renal replacement therapy (OR: 4.453, 95%CI 1.805-10.982; P = 0.001) were the only independent determinants for ABRP infections in ICU. Intra-ICU, 90-day and 2-year mortality was 27.9%, 52.4% and 61.5%, respectively. Compared to the non-ABRP and no-infection group, the ABRP group demonstrated increased intra-ICU, 90-day and 2-year mortality (P ≤ 0.022), worse 2-year survival rates in ICU patients overall and ICU survivor subset (Log-rank test, P ≤ 0.046), and poorer progress over time in 2-year QALY kinetics in ICU population overall, ICU survivor and 2-year survivor subgroups (P ≤ 0.013). ABRP group was further divided into multi-drug and extensively-drug resistant subgroups [MDR (n = 34) / XDR (n = 24), respectively]. Compared to MDR subgroup, the XDR subgroup demonstrated increased ICU, 90-day and 2-year mortality (P ≤ 0.031), but similar 90-day and 2-year QALYs (P ≥ 0.549). ABRP infections overall (HR = 1.778, 95% CI 1.166-2.711; P = 0.008), as well as XDR [HR = 1.889, 95% CI 1.075-3.320; P = 0.027) but not MDR pathogens, were independently associated with 2-year mortality, after adjusting for several covariates of critical illness.
    CONCLUSIONS: The present study may suggest a significant association between ABRP (especially XDR) infections in ICU and increased mortality and inability rates for a prolonged period post-discharge that requires further attention in larger-scale studies.
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  • 文章类型: Journal Article
    The objective of the study was to develop and test feasibility of a framework of patient-important practical issues.
    Guidelines and shared decision-making tools help facilitate discussions about patient-important outcomes of care alternatives, but typically ignore practical issues patients consider when implementing care into their daily routines. Using grounded theory, practical issues in the HealthTalk.org registry and in Option Grids were identified and categorized into a framework. We integrated the framework into the MAGIC authoring and publication platform and digitally structured authoring and publication platform and appraised its use in The BMJ Rapid Recommendations.
    The framework included the following 15 categories: medication routine, tests and visits, procedure and device, recovery and adaptation, coordination of care, adverse effects, interactions and antidote, physical well-being, emotional well-being, pregnancy and nursing, costs and access, food and drinks, exercise and activities, social life and relationships, work and education, travel and driving. Implementation in 15 BMJ Rapid Recommendations added 283 issues to 35 recommendations. The most frequently used category was procedure and device, and the least frequent was social life and relationship.
    Adding practical issues systematically to evidence summaries is feasible and can inform guidelines and tools for shared decision-making. How this inclusion can improve patient-centered care remains to be determined.
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  • 文章类型: Consensus Development Conference
    The omission of outcomes that are of relevance to patients, clinicians, and regulators across trials in autosomal dominant polycystic kidney disease (ADPKD) limits shared decision making. The Standardized Outcomes in Nephrology-Polycystic Kidney Disease (SONG-PKD) Initiative convened an international consensus workshop on October 25, 2018, to discuss the identification and implementation of a potential core outcome set for all ADPKD trials. This article summarizes the discussion from the workshops and the SONG-PKD core outcome set. Key stakeholders including 11 patients/caregivers and 47 health professionals (nephrologists, policy makers, industry, and researchers) attended the workshop. Four themes emerged: \"Relevance of trajectory and impact of kidney function\" included concerns about a patient\'s prognosis and uncertainty of when they may need to commence kidney replacement therapy and the lack of an early prognostic marker to inform long-term decisions; \"Discerning and defining pain specific to ADPKD\" highlighted the challenges in determining the origin of pain, adapting to the chronicity and repeated episodes of pain, the need to place emphasis on pain management, and to have a validated measure for pain; \"Highlighting ADPKD consequences\" encompassed cyst-related complications and reflected patient\'s knowledge because of family history and the hereditary nature of ADPKD; and \"Risk for life-threatening but rare consequences\" such as cerebral aneurysm meant considering both frequency and severity of the outcome. Kidney function, mortality, cardiovascular disease, and pain were established as the core outcomes for ADPKD.
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