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Generating Items for Measuring Needs-Based Quality of Life and Self-Perceived Health Inequity in Patients with Multimorbidity: Development of the MultiMorbidity Questionnaire (MMQ). 多发病患者基于需求的生活质量和自我感知的健康不平等的测量项目生成:多发病率问卷(MMQ)的开发。
IF 2.1 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-10-10 eCollection Date: 2023-01-01 DOI: 10.2147/PROM.S427183
Kristine Henderson Bissenbakker, Anne Møller, Alexandra Brandt Ryborg Jønsson, John Brandt Brodersen

Purpose: To describe the processes of developing domains and items for the MultiMorbidity Questionnaire (MMQ), a multimorbidity-specific PROM for the assessment of Needs-based QoL.

Patients and methods: We developed items and domains for the MMQ through 17 qualitative content validity questionnaire interviews with adults with multimorbidity by testing items from an item bank (covering items with content inspired by existing Needs-based QoL measures for single diseases). The interviews alternated between an explorative part and more focused cognitive interview techniques.

Results: Testing the 47 items from the first draft of the MMQ items showed that the Needs-based approach as a framework did not cover all the QoL aspects our informants stated as being important. Therefore, the conceptual framework was supplemented by Self-perceived health inequity, and new items were generated. MMQ, measuring Needs-based QoL (MMQ1) and Self-perceived health inequity (MMQ2), was assembled. MMQ1 covers the domains: "Physical ability" (10 items), "Limitations in everyday life" (15 items), "Worries" (11 items), "My social life" (11 items), "Self-image" (12 items), and "Personal finances" (2 items). Self-perceived health inequity proved to be a relevant framework for other aspects of QoL not covered by the Needs-based approach to QoL. MMQ2 covers the domains: "Experiences of being stigmatized" (five items), "Experiences of not being seen and heard" (four items), "Insufficient understanding of the burden of disease" (three items) and "Experiences of feeling powerless" (five items).

Conclusion: We have developed the final MMQ draft, a multimorbidity-specific PROM for the assessment of Needs-based QoL (MMQ1) and Self-perceived health inequity (MMQ2) with high content validity (regarding content relevance and comprehensiveness). The final MMQ draft will be assessed for its psychometric properties using Modern Test Theory.

目的:描述多发病率问卷(MMQ)领域和项目的开发过程,用于评估基于需求的生活质量的多发病特异性PROM。患者和方法:我们通过测试项目库中的项目(包括受现有基于需求的单一疾病生活质量测量启发的内容的项目),对患有多发病的成年人进行了17次定性内容有效性问卷访谈,从而开发了MMQ的项目和领域。访谈在探索性部分和更专注的认知访谈技巧之间交替进行。结果:对MMQ项目初稿中的47个项目进行测试表明,作为一个框架的基于需求的方法并没有涵盖我们的信息提供者所说的所有重要的生活质量方面。因此,概念框架得到了自我感知的健康不平等的补充,并产生了新的项目。MMQ,测量基于需求的生活质量(MMQ1)和自我感知的健康不公平(MMQ2)。MMQ1涵盖了以下领域:“身体能力”(10项)、“日常生活的局限性”(15项)、《担忧》(11项),“我的社交生活”(11条)、“自我形象”(12项)和“个人财务”(2项)。自我感知的健康不公平被证明是生活质量的其他方面的相关框架,而基于需求的生活质量方法没有涵盖这些方面。MMQ2涵盖了以下领域:“被污名化的经历”(五项)、“不被看到和听到的经历”,用于评估基于需求的生活质量(MMQ1)和自我感知健康不公平(MMQ2)的多病特异性PROM,具有高内容有效性(关于内容相关性和全面性)。MMQ最终草案将使用现代测试理论对其心理测量特性进行评估。
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引用次数: 1
Impact of Safinamide on Patient-Reported Outcomes in Parkinson's Disease. 萨芬酰胺对帕金森病患者报告结果的影响。
IF 2.1 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-10-10 eCollection Date: 2023-01-01 DOI: 10.2147/PROM.S369590
Christian Espinoza-Vinces, Rafael Villino-Rodríguez, Ainhoa Atorrasagasti-Villar, Gloria Martí-Andrés, María-Rosario Luquin

Introduction: Parkinson's disease (PD) is a chronic and progressive neurodegenerative condition due to the degeneration of nigral dopaminergic cells. Both motor and non-motor symptoms (NMS) of PD produce a marked impairment in PD patients' quality of life (QoL), but contrary to motor features, NMS do not improve with dopamine replacement. Novel therapeutic interventions for PD have successfully controlled most motor manifestations of PD, but the management of NMS is still challenging. Since NMS have a negative impact on the QoL of PD patients, researchers are currently looking for drugs that can modulate the activity of neurotransmitter systems other than dopamine in the hope that can alleviate NMS in PD. Among the recently approved drugs for patients experiencing fluctuations in motor symptoms, safinamide stands out as an effective add-on therapy to levodopa. Safinamide is a monoamine oxidase type-B inhibitor (MAOB-I), with proven efficacy in reducing motor fluctuations. Its distinctive mechanism of action impacts dopaminergic pathways via MAOB inhibition and glutamatergic pathways by blocking sodium and calcium channels. Findings from Phase III clinical trials, meta-analysis, post-hoc analysis, and real-life experiences indicate that safinamide benefits motor symptoms such as tremor, bradykinesia, rigidity, and gait. Additionally, it shows promise for improving NMS like fatigue, pain, mood, and sleep disturbances in patients with PD.

Areas covered: In this article, the authors explore the impact of safinamide on patient-reported outcomes in PD. A thorough search was conducted on PubMed focusing on studies published between 2018 and 2023 in English. The inclusion criteria encompassed clinical trials, randomized controlled trials, systematic reviews, meta-analyses, and reviews. The search strategy revolved around the implementation of MeSH terms related to safinamide and its impact on the quality of life in PD.

Conclusion: Our data strongly support the improving effect on QoL, reducing the disabling NMS reported in patients with PD.

引言:帕金森病(PD)是一种由黑质多巴胺能细胞变性引起的慢性进行性神经退行性疾病。帕金森病的运动和非运动症状(NMS)都会对帕金森病患者的生活质量(QoL)造成显著损害,但与运动特征相反,多巴胺替代并不能改善NMS。新的帕金森病治疗干预措施已成功控制了帕金森病的大多数运动表现,但NMS的管理仍然具有挑战性。由于NMS对PD患者的生活质量有负面影响,研究人员目前正在寻找能够调节多巴胺以外的神经递质系统活性的药物,希望能够缓解PD患者的NMS。在最近批准的治疗运动症状波动患者的药物中,沙芬酰胺是左旋多巴的有效补充疗法。萨芬酰胺是一种单胺氧化酶B型抑制剂(MAOB-I),已被证明在减少运动波动方面有效。其独特的作用机制通过MAOB抑制影响多巴胺能通路,通过阻断钠和钙通道影响谷氨酸能通路。III期临床试验、荟萃分析、事后分析和现实生活经验的结果表明,沙芬酰胺有益于震颤、运动迟缓、僵硬和步态等运动症状。此外,它有望改善帕金森病患者的NMS样疲劳、疼痛、情绪和睡眠障碍。涵盖的领域:在这篇文章中,作者探讨了沙芬酰胺对患者报告的帕金森病结果的影响。在PubMed上进行了彻底的搜索,重点是2018年至2023年间发表的英文研究。纳入标准包括临床试验、随机对照试验、系统综述、荟萃分析和综述。搜索策略围绕着与沙那酰胺相关的MeSH术语的实施及其对PD患者生活质量的影响。结论:我们的数据有力地支持了对生活质量的改善效果,减少了PD患者报告的致残性NMS。
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引用次数: 0
Disutilities Associated with Intravenous Iron Infusions: Results from a Time Trade-off Survey and Diminishing Marginal Utility Model for Treatment Attributes in China. 与静脉铁输注相关的不良反应:来自中国治疗属性的时间权衡调查和递减边际效用模型的结果。
IF 2.1 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-09-26 eCollection Date: 2023-01-01 DOI: 10.2147/PROM.S400389
Shanlian Hu, Depei Wu, Jing Wu, Yabing Zhang, Mette Bøgelund, Johannes Pöhlmann, Richard F Pollock

Purpose: Treatment process attributes can affect health state utilities associated with therapy. For intravenous iron, used to treat iron deficiency and iron deficiency anemia, research into process attributes is still lacking. This study estimated utilities associated with process attributes for intravenous iron infusions.

Methods: An online survey including seven health state vignettes and time trade-off tasks was administered to participants, who were not patients living with iron deficiency or iron deficiency anemia, from a Chinese online panel. Vignettes used an identical description of iron deficiency and iron deficiency anemia but differed in the annual number of infusions, infusion duration, and infusion-associated risk of hypophosphatemic osteomalacia. Disutilities and their rate of change as the number of infusions increased were examined using a power model.

Results: The survey was completed by 1091 participants. The highest utilities were observed for one annual infusion of 15-30 minutes or 30-60 minutes, without risk of hypophosphatemic osteomalacia (0.754 and 0.746, respectively). In comparison, more infusions and infusions with a risk of hypophosphatemic osteomalacia were associated with lower utilities. Utility continued to decrease, but at a diminishing rate, as the annual number of infusions increased, with utility decrements of 0.006 and 0.002, respectively, when going from zero to one and from four to five infusions per year. All marginal disutilities were small (values <0.01).

Conclusion: This study suggested that treatment attributes of intravenous iron infusions affect health state utilities. Using intravenous iron formulations that allow for fewer and shorter infusions without the risk of hypophosphatemic osteomalacia can reduce the number of visits required and increase patients' quality of life.

目的:治疗过程属性会影响与治疗相关的健康状态效用。对于静脉注射铁,用于治疗缺铁性和缺铁性贫血,对过程属性的研究仍然缺乏。这项研究估计了与静脉铁输注过程属性相关的效用。方法:对来自中国在线小组的参与者进行了一项在线调查,包括七个健康状态小插曲和时间权衡任务,这些参与者不是缺铁或缺铁性贫血患者。Vignets对缺铁性贫血和缺铁性贫血使用了相同的描述,但在每年输注次数、输注持续时间和输注相关的低磷血症性骨软化风险方面有所不同。使用幂模型检验了效用及其随输注次数增加的变化率。结果:1091名参与者完成了调查。每年输注15-30分钟或30-60分钟的效用最高,没有低磷血症性骨软化的风险(分别为0.754和0.746)。相比之下,更多的输液和有低磷血症骨软化风险的输液与较低的效用有关。效用继续下降,但随着每年输注次数的增加,效用呈下降趋势,从每年0次输注到1次,从每年4次输注至5次,效用分别下降0.006和0.002。所有的边际无效性都很小(值)结论:本研究表明,静脉输注铁的治疗属性会影响健康状态的效用。使用静脉输注更少、更短且没有低磷血症骨软化风险的铁制剂可以减少所需就诊次数,提高患者的生活质量。
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引用次数: 0
NIH Toolbox Emotion Battery Findings Among People with HIV: Normative Comparisons and Clinical Associations. 美国国立卫生研究院工具箱HIV感染者情绪测试结果:规范性比较和临床关联。
IF 1.8 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-02-15 eCollection Date: 2023-01-01 DOI: 10.2147/PROM.S391113
Lilla A Brody, Lily Kamalyan, Kayle Karcher, Lesley A Guarena, Alexis A Bender, Benjamin S McKenna, Anya Umlauf, Donald Franklin, Maria J Marquine, Robert K Heaton

Purpose: Depression and other aspects of emotional health in people with HIV (PWH) can affect functional independence, disease progression, and overall life quality. This study used the NIH Toolbox Emotion Battery (NIHTB-EB), which assesses many features of emotional health, to more comprehensively investigate differences among adults living with and without HIV, and to identify factors associated with emotional health for PWH.

Patients and methods: Participants (n=1451; age: M=50.19, SD=16.84; 47.90% women) included 433 PWH living in southern California seen from 2003 to 2021 (64.72% AIDS, 92.25% on antiretroviral therapy) and 1018 healthy participants from NIHTB-EB national normative cohort. Participants completed the NIHTB-EB and PWH underwent comprehensive HIV disease and psychiatric evaluations. We investigated differences in emotional health by HIV status via independent samples t-tests (continuous scores) and Chi2 tests ("problematic" emotional health scores). Multivariable linear regression models examined correlates of emotional health among PWH.

Results: PWH had significantly worse emotional health than people without HIV across Social Satisfaction (Cohen's d=0.71, p<0.001), Psychological Well-Being (Cohen's d=0.49, p<0.001) and Negative Affect (Cohen's d=0.19, p<0.01) summary T-scores, and most component scales. PWH also had higher rates of "problematic" emotional health, particularly in Social Satisfaction (45% vs 17%, p<0.0001). Poor emotional health among PWH was associated with lifetime Major Depressive and Substance Use Disorders, relationship status (lost relationship versus in relationship), unemployment, and cognitive difficulties and loss of functional independence.

Conclusion: The NIHTB-EB identified that difficulties with multiple aspects of emotional health are common among PWH, and appear to be relatively independent of cognitive impairment as well as HIV disease and treatment history, but are strongly associated with everyday functioning. Given the cross-sectional nature of this study, longitudinal studies should be employed to evaluate causality pertaining to predictors of emotional health in PWH. These findings may inform interventions to promote emotional wellbeing in PWH.

目的:HIV(PWH)患者的抑郁和其他情绪健康方面会影响功能独立性、疾病进展和整体生活质量。这项研究使用了美国国立卫生研究院工具箱情绪电池(NIHTB-EB),该电池评估了情绪健康的许多特征,以更全面地调查感染和未感染HIV的成年人之间的差异,并确定与PWH情绪健康相关的因素。患者和方法:参与者(n=1451;年龄:M=5019,SD=16.84;47.90%为女性)包括2003年至2021年居住在南加州的433名PWH(64.72%为艾滋病,92.25%为抗逆转录病毒治疗)和来自NIHTB-EB国家标准队列的1018名健康参与者。参与者完成了NIHTB-EB,PWH接受了全面的HIV疾病和精神评估。我们通过独立样本t检验(连续得分)和Chi2检验(“有问题的”情绪健康得分)调查了HIV状态下情绪健康的差异。多变量线性回归模型检验了PWH患者情绪健康的相关性。结果:在社会满意度方面,PWH患者的情绪健康明显低于未感染HIV的患者(Cohen’s d=0.71,pppp结论:NIHTB-EB发现,PWH中情绪健康多方面的困难很常见,似乎与认知障碍、HIV疾病和治疗史相对独立,但与日常功能密切相关。鉴于本研究的横断面性质,应采用纵向研究来评估与PWH情绪健康预测因素相关的因果关系。这些发现可能为促进PWH情绪健康的干预措施提供信息。
{"title":"NIH Toolbox Emotion Battery Findings Among People with HIV: Normative Comparisons and Clinical Associations.","authors":"Lilla A Brody, Lily Kamalyan, Kayle Karcher, Lesley A Guarena, Alexis A Bender, Benjamin S McKenna, Anya Umlauf, Donald Franklin, Maria J Marquine, Robert K Heaton","doi":"10.2147/PROM.S391113","DOIUrl":"10.2147/PROM.S391113","url":null,"abstract":"<p><strong>Purpose: </strong>Depression and other aspects of emotional health in people with HIV (PWH) can affect functional independence, disease progression, and overall life quality. This study used the NIH Toolbox Emotion Battery (NIHTB-EB), which assesses many features of emotional health, to more comprehensively investigate differences among adults living with and without HIV, and to identify factors associated with emotional health for PWH.</p><p><strong>Patients and methods: </strong>Participants (n=1451; age: M=50.19, SD=16.84; 47.90% women) included 433 PWH living in southern California seen from 2003 to 2021 (64.72% AIDS, 92.25% on antiretroviral therapy) and 1018 healthy participants from NIHTB-EB national normative cohort. Participants completed the NIHTB-EB and PWH underwent comprehensive HIV disease and psychiatric evaluations. We investigated differences in emotional health by HIV status via independent samples <i>t</i>-tests (continuous scores) and Chi<sup>2</sup> tests (\"problematic\" emotional health scores). Multivariable linear regression models examined correlates of emotional health among PWH.</p><p><strong>Results: </strong>PWH had significantly worse emotional health than people without HIV across Social Satisfaction (Cohen's d=0.71, <i>p</i><0.001), Psychological Well-Being (Cohen's d=0.49, <i>p</i><0.001) and Negative Affect (Cohen's d=0.19, <i>p</i><0.01) summary T-scores, and most component scales. PWH also had higher rates of \"problematic\" emotional health, particularly in Social Satisfaction (45% vs 17%, <i>p</i><0.0001). Poor emotional health among PWH was associated with lifetime Major Depressive and Substance Use Disorders, relationship status (lost relationship versus in relationship), unemployment, and cognitive difficulties and loss of functional independence.</p><p><strong>Conclusion: </strong>The NIHTB-EB identified that difficulties with multiple aspects of emotional health are common among PWH, and appear to be relatively independent of cognitive impairment as well as HIV disease and treatment history, but are strongly associated with everyday functioning. Given the cross-sectional nature of this study, longitudinal studies should be employed to evaluate causality pertaining to predictors of emotional health in PWH. These findings may inform interventions to promote emotional wellbeing in PWH.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"14 ","pages":"15-30"},"PeriodicalIF":1.8,"publicationDate":"2023-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/8b/c6/prom-14-15.PMC9939807.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9867888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of Belimumab on Patient-Reported Outcomes in Systemic Lupus Erythematosus: Insights from Clinical Trials and Real-World Evidence. 贝利木单抗对系统性红斑狼疮患者报告结果的影响:来自临床试验和现实世界证据的启示。
IF 1.8 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-01-19 eCollection Date: 2023-01-01 DOI: 10.2147/PROM.S369584
Alvaro Gomez, Yvonne Enman, Ioannis Parodis

Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease, characterised by a relapsing-remitting pattern of inflammatory activity, with each relapse contributing to irreversible end-organ damage with detrimental effects on patients' course, adding up to morbidity burden and shortening life-length. Along with several other demographic, socioeconomic, and life-style factors, high inflammatory activity and accrued organ damage have been coupled with adverse health-related quality of life (HRQoL) within physical, mental, and psychosocial aspects. The management of SLE has improved substantially during the last decades, owing to a technological explosion that has advanced drug development towards more targeted options. Being the first drug to be approved for SLE in more than half a century and the first in history biological agent for SLE, the introduction in 2011 of the monoclonal antibody belimumab that specifically binds to the soluble counterpart of B cell activating factor (BAFF) was a breakthrough in SLE drug development. The efficacy and favourable safety profile of belimumab has been demonstrated across several clinical trials and observational studies. Herein, we reviewed the literature and provide a summary on the effects of belimumab on SLE patients' HRQoL based on 23 studies. Belimumab has been shown to induce clinically important improvements in physical aspects of HRQoL and in fatigue, the latter being a common and major complaint within the SLE population. People with SLE overall benefit more from belimumab within physical compared with mental aspects of HRQoL. However, despite improvements of clinical and immunological features upon therapy with belimumab, HRQoL perception remains unsatisfactory for a substantial percentage of the patients. Finally, our review made apparent an urgent need for optimisation of the use of patient-reported outcome measures, both in research and clinical practice.

系统性红斑狼疮(SLE)是一种慢性自身免疫性疾病,其特点是炎症活动呈复发-缓解模式,每次复发都会造成不可逆的终末器官损害,对患者的病程产生不利影响,加重发病负担并缩短患者寿命。除了其他一些人口、社会经济和生活方式因素外,高炎症活性和累积的器官损伤还与身体、精神和社会心理方面的健康相关生活质量(HRQoL)有关。在过去的几十年里,系统性红斑狼疮的治疗方法有了很大的改进,这得益于技术的飞速发展,药物的研发也朝着更具针对性的方向迈进。贝利木单抗是半个多世纪以来首个获准用于系统性红斑狼疮的药物,也是历史上首个用于系统性红斑狼疮的生物制剂,它能与B细胞活化因子(BAFF)的可溶性对应物特异性结合,2011年的问世是系统性红斑狼疮药物研发领域的一大突破。贝利木单抗的疗效和良好的安全性已在多项临床试验和观察性研究中得到证实。在此,我们回顾了相关文献,并根据23项研究总结了贝利木单抗对系统性红斑狼疮患者HRQoL的影响。研究表明,贝利木单抗能在临床上显著改善系统性红斑狼疮患者的身体方面的 HRQoL 和疲劳感,而疲劳感是系统性红斑狼疮患者的常见主诉。总体而言,系统性红斑狼疮患者从贝利木单抗中获益更多的是身体方面,而不是精神方面的HRQoL。然而,尽管使用贝利木单抗治疗后,患者的临床和免疫学特征有所改善,但仍有相当一部分患者对自己的生活质量仍不满意。最后,我们的综述表明,无论是在研究还是临床实践中,都迫切需要优化患者报告的结果指标的使用。
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引用次数: 0
Magnitude, Distribution and Contextual Risk Enhancing Predictors of High 10-Year Cardiovascular Risk Among Diabetic Patients in Tanzania. 坦桑尼亚糖尿病患者10年高心血管风险的大小、分布和环境风险增强预测因子
IF 2.1 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-01-01 DOI: 10.2147/PROM.S405392
Nadeem Kassam, Salim Surani, Kamran Hameed, Eric Aghan, Robert Mayenga, Iris Matei, Gijsberta Jengo, Fatma Bakshi, Hanifa Mbithe, James Orwa, George Udeani, Samina Somji

Introduction: Atherosclerotic Cardiovascular Disease (ASCVD) is the leading cause of death worldwide. In Diabetics, ASCVD is associated with poor prognosis and a higher case fatality rate compared with the general population. Sub-Saharan Africa is facing an epidemiological transition with ASCVD being prevalent among young adults. To date, over 20 million people have been living with DM in Africa, Tanzania being one of the five countries in the continent reported to have a higher prevalence. This study aimed to identify an individual's 10-year ASCVD absolute risk among a diabetic cohort in Tanzania and define contextual risk enhancing factors.

Methods: A prospective observational study was conducted at the Aga Khan hospital, Mwanza, for a period of 8 months. The hospital is a 42-bed district-level hospital in Tanzania. Individuals 10-year risk was calculated based on the ASCVD 2013 risk calculator by ACC/AHA. Pearson's chi-square or Fischer's exact test was used to compare categorical and continuous variables. Multivariable analysis was applied to determine contextual factors for those who had a high 10-year risk of developing ASCVD.

Results: The overall cohort included 573 patients. Majority of the individuals were found to be hypertensive (n = 371, 64.7%) and obese (n = 331, 58%) having a high 10-year absolute risk (n = 343, 60%) of suffering ASCVD. The study identified duration of Diabetes Mellitus (>10 years) (OR 8.15, 95% CI 5.25-14.42), concomitant hypertension (OR 1.82 95% CI 1.06-3.06), Diabetic Dyslipidemia (OR 1.44, 95% CI 1.08-1.92) and deranged serum creatinine (OR 1.03, 95% CI 1.02-1.03) to be the risk enhancing factors amongst our population.

Conclusion: The study confirms the majority of diabetic individuals in the lake region of Tanzania to have a high 10-year ASCVD risk. The high prevalence of obesity, hypertension and dyslipidemia augments ASCVD risk but provides interventional targets for health-care workers to decrease these alarming projections.

导读:动脉粥样硬化性心血管疾病(ASCVD)是世界范围内导致死亡的主要原因。在糖尿病患者中,与一般人群相比,ASCVD与预后差和更高的病死率相关。撒哈拉以南非洲正面临流行病学转变,ASCVD在年轻人中流行。迄今为止,非洲有2000多万人患有糖尿病,坦桑尼亚是非洲大陆报告发病率较高的五个国家之一。本研究旨在确定坦桑尼亚糖尿病队列中个体10年ASCVD绝对风险,并确定环境风险增强因素。方法:在姆万扎阿迦汗医院进行为期8个月的前瞻性观察研究。该医院是坦桑尼亚拥有42个床位的区级医院。根据ACC/AHA 2013年ASCVD风险计算器计算个体10年风险。使用Pearson卡方检验或Fischer精确检验来比较分类变量和连续变量。应用多变量分析来确定那些10年发生ASCVD风险高的人的背景因素。结果:整个队列包括573例患者。大多数人患有高血压(n = 371, 64.7%)和肥胖(n = 331, 58%),患ASCVD的10年绝对风险高(n = 343,60%)。研究确定糖尿病病程(>10年)(OR 8.15, 95% CI 5.25-14.42)、合并高血压(OR 1.82, 95% CI 1.06-3.06)、糖尿病性血脂异常(OR 1.44, 95% CI 1.08-1.92)和血清肌酐紊乱(OR 1.03, 95% CI 1.02-1.03)是我们人群中的风险增强因素。结论:该研究证实,坦桑尼亚湖区的大多数糖尿病患者10年ASCVD风险较高。肥胖、高血压和血脂异常的高患病率增加了ASCVD的风险,但为卫生保健工作者提供了减少这些令人担忧的预测的干预目标。
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引用次数: 0
Incidence and Associated Factors of Postoperative Undesirable Anesthetic Outcomes Among Surgical Patients at Referral Hospitals in Amhara Region, Ethiopia: A Multi-Center Study. 埃塞俄比亚阿姆哈拉地区转诊医院手术患者术后不良麻醉结果的发生率及相关因素:一项多中心研究
IF 2.1 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-01-01 DOI: 10.2147/PROM.S403697
Belete Muluadam Admassie, Biruk Adie Admass, Debas Yaregal Melesse

Background: Patients undergoing surgery frequently experience unfavorable anesthetic outcomes. They may have an impact on body systems and result in more serious postoperative morbidities. This study was conducted to determine the incidence of postoperative undesirable anesthetic outcomes among surgical patients at referral hospitals in Amhara region, Ethiopia.

Methods: A total of 412 patients, who underwent surgical procedures between August 1 and October 30 of 2022, were included in this study. The Leiden Perioperative Care Patient Satisfaction Questionnaire's (LPPSq) dimension "discomfort and needs" was used to collect data on the first postoperative day. Data entry and analysis were performed using SPSS version 20. To assess how risk factors affected the outcome variable, logistic regression analysis was utilized. In multivariable logistic regression analysis, a variable with a P-value of less than 0.05 was statistically considered as significant.

Results: The proportion of those who had "at least a little bit" of unfavorable outcomes was calculated to estimate their overall prevalence, and the prevalence of those who had "more than moderate" levels of unfavorable outcomes was determined to appreciate how severe these outcomes were. The percentages of postoperative pain, the most common undesired result, for "at least a little bit" and "more than moderate" were 87.7% and 32.3%, respectively. In this study, postoperative cold was the least prevalent (51.4%) undesirable anesthetic outcome. The remaining undesirable postoperative outcomes were reported less frequently.

Conclusion and recommendation: Undesirable postoperative anesthetic outcomes were still common. The most frequent unfavorable result was postoperative pain. Adequate postoperative patient follow-up and quality service are paramount.

背景:接受手术的患者经常经历不良的麻醉结果。它们可能对身体系统产生影响,并导致更严重的术后并发症。本研究旨在确定埃塞俄比亚阿姆哈拉地区转诊医院手术患者术后不良麻醉结果的发生率。方法:在2022年8月1日至10月30日期间接受手术治疗的412例患者纳入本研究。采用Leiden围手术期护理患者满意度问卷(LPPSq)维度“不适与需求”收集术后第一天的数据。数据录入和分析使用SPSS version 20进行。为了评估危险因素对结果变量的影响,采用了逻辑回归分析。在多变量logistic回归分析中,p值小于0.05的变量被认为具有统计学意义。结果:计算“至少有一点点”不良结果的患者的比例,以估计他们的总体患病率,并确定“中度以上”不良结果水平的患者的患病率,以了解这些结果的严重程度。术后最常见的不期望结果是“至少有一点”和“中度以上”的疼痛百分比分别为87.7%和32.3%。在本研究中,术后感冒是最不常见的不良麻醉结果(51.4%)。其余不良的术后结果较少被报道。结论和建议:术后不良麻醉结果仍然普遍存在。最常见的不良结果是术后疼痛。充分的术后患者随访和优质的服务是至关重要的。
{"title":"Incidence and Associated Factors of Postoperative Undesirable Anesthetic Outcomes Among Surgical Patients at Referral Hospitals in Amhara Region, Ethiopia: A Multi-Center Study.","authors":"Belete Muluadam Admassie,&nbsp;Biruk Adie Admass,&nbsp;Debas Yaregal Melesse","doi":"10.2147/PROM.S403697","DOIUrl":"https://doi.org/10.2147/PROM.S403697","url":null,"abstract":"<p><strong>Background: </strong>Patients undergoing surgery frequently experience unfavorable anesthetic outcomes. They may have an impact on body systems and result in more serious postoperative morbidities. This study was conducted to determine the incidence of postoperative undesirable anesthetic outcomes among surgical patients at referral hospitals in Amhara region, Ethiopia.</p><p><strong>Methods: </strong>A total of 412 patients, who underwent surgical procedures between August 1 and October 30 of 2022, were included in this study. The Leiden Perioperative Care Patient Satisfaction Questionnaire's (LPPSq) dimension \"discomfort and needs\" was used to collect data on the first postoperative day. Data entry and analysis were performed using SPSS version 20. To assess how risk factors affected the outcome variable, logistic regression analysis was utilized. In multivariable logistic regression analysis, a variable with a P-value of less than 0.05 was statistically considered as significant.</p><p><strong>Results: </strong>The proportion of those who had \"at least a little bit\" of unfavorable outcomes was calculated to estimate their overall prevalence, and the prevalence of those who had \"more than moderate\" levels of unfavorable outcomes was determined to appreciate how severe these outcomes were. The percentages of postoperative pain, the most common undesired result, for \"at least a little bit\" and \"more than moderate\" were 87.7% and 32.3%, respectively. In this study, postoperative cold was the least prevalent (51.4%) undesirable anesthetic outcome. The remaining undesirable postoperative outcomes were reported less frequently.</p><p><strong>Conclusion and recommendation: </strong>Undesirable postoperative anesthetic outcomes were still common. The most frequent unfavorable result was postoperative pain. Adequate postoperative patient follow-up and quality service are paramount.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"14 ","pages":"137-152"},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a3/aa/prom-14-137.PMC10199704.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9503852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Assessment of Real-World Patient-Reported Outcomes in Patients Initiating Biologic Agents for the Treatment of Autoimmune Diseases: An Observational Study in Four Patient-Powered Research Networks. 评估患者使用生物制剂治疗自身免疫性疾病的真实世界患者报告的结果:在四个患者支持的研究网络中的观察性研究
IF 2.1 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-01-01 DOI: 10.2147/PROM.S392174
Timothy Beukelman, Millie D Long, Rennie L Rhee, Michael D Kappelman, Peter A Merkel, William Benjamin Nowell, Cassie Clinton, Sarah Ringold, Vincent Del Gaizo, Brian Price, Dianne G Shaw, Shilpa Venkatachalam, David Cuthbertson, Fenglong Xie, Xian Zhang, Jeffrey R Curtis

Background: The most reliable and meaningful approach for inclusion of patient-reported outcomes (PROs) in the evaluation of real-world clinical effectiveness of biologics in the treatment of autoimmune diseases is u ncertain. This study aimed to assess and compare the proportions of patients who had abnormalities in PROs measuring important general health domains at the initiation of treatment with biologics, as well as the effects of baseline abnormalities on subsequent improvement.

Methods: PROs were collected for patient participants with inflammatory arthritis, inflammatory bowel disease, and vasculitis using Patient-Reported Outcomes Measurement Information System instruments. Scores were reported as T-scores normalized to the general population in the United States. Baseline PROs scores were collected near the time of biologic initiation, and follow-up scores were collected 3 to 8 months later. In addition to summary statistics, the proportion of patients with PROs abnormalities (scores ≥5 units worse than the population norm) was determined. Baseline and follow-up scores were compared, and an improvement of ≥5 units was considered significant.

Results: There was wide variation across autoimmune diseases in baseline PROs scores for all domains. For example, the proportion of participants with abnormal baseline pain interference scores ranged from 52% to 93%. When restricted to participants with baseline PROs abnormalities, the proportion of participants experiencing an improvement of ≥5 units was substantially higher.

Conclusion: As expected, many patients experienced improvement in PROs following initiation of treatment with biologics for autoimmune diseases. Nevertheless, a substantial proportion of participants did not exhibit abnormalities in all PROs domains at baseline, and these participants appear less likely to experience improvement. For PROs to be reliably and meaningfully included in the evaluation of real-world medication effectiveness, more knowledge and careful consideration are needed to select the most appropriate patient populations and subgroups for inclusion and evaluation in studies measuring change in PROs.

背景:在评估生物制剂治疗自身免疫性疾病的实际临床有效性时,纳入患者报告的结局(PROs)的最可靠和有意义的方法尚不确定。本研究旨在评估和比较在生物制剂治疗开始时具有重要一般健康领域pro异常的患者比例,以及基线异常对随后改善的影响。方法:使用患者报告结局测量信息系统仪器收集炎症性关节炎、炎症性肠病和血管炎患者的PROs。在美国,分数以标准化的t分数报告。基线PROs评分在生物起始时收集,3 - 8个月后收集随访评分。除汇总统计外,确定PROs异常(评分比人群常模差≥5个单位)的患者比例。基线和随访评分比较,改善≥5个单位被认为是显著的。结果:自身免疫性疾病在所有领域的基线PROs评分存在很大差异。例如,基线疼痛干扰评分异常的参与者比例从52%到93%不等。当局限于基线PROs异常的参与者时,经历≥5个单位改善的参与者比例明显更高。结论:正如预期的那样,许多患者在开始使用生物制剂治疗自身免疫性疾病后,PROs得到了改善。然而,相当比例的参与者在基线时并没有表现出所有pro域的异常,并且这些参与者似乎不太可能经历改善。为了可靠而有意义地将PROs纳入现实世界药物有效性的评估,在测量PROs变化的研究中,需要更多的知识和仔细考虑,以选择最合适的患者群体和亚组进行纳入和评估。
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引用次数: 0
Incidence and Predictors of Mortality Among Patients with Traumatic Brain Injury at University of Gondar Comprehensive Specialized Hospital, Northwest Ethiopia: A Retrospective Follow-Up Study. 埃塞俄比亚西北部贡达尔大学综合专科医院外伤性脑损伤患者的发病率和死亡率预测因素:一项回顾性随访研究
IF 2.1 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-01-01 DOI: 10.2147/PROM.S399603
Nega Getachew Tegegne, Demeke Yilkal Fentie, Biresaw Ayen Tegegne, Belete Muluadam Admassie

Background: Traumatic brain injury is a major list of health and socioeconomic problems especially in low- and middle-income countries which influences productive age groups. Differences in patient characteristics, socioeconomic status, intensive care unit admission thresholds, health-care systems, and the availability of varying numbers of intensive care unit (ICU) beds among hospitals had shown to be the causes for the variation on the incidence in mortality following traumatic brain injury across different continents. The aim of this study was to assess the incidence and predictors of mortality among patients with traumatic brain injury at University of Gondar Comprehensive Specialized Hospital.

Methods: A retrospective follow-up study was conducted based on chart review and selected patient charts admitted from January, 2017 to January, 2022. Participants in the study were chosen using a simple random sample procedure that was computer generated. Data was entered with epi-data version 4.6 and analyzed using SPSS version 26. Both bivariate and multivariate logistic regression analyses were used, and in multivariate logistic regression analysis, P-value <0.05 with 95% CI was considered statistically significant.

Results: The magnitude of mortality was 28.8%. Most of the injuries were caused by assault followed by road traffic accident (RTA). About 30% of the subjects presented with severe head injuries and epidural hematoma (EDH) followed by skull fracture were the most common diagnoses on admission. The independent predictors of mortality were male sex (AOR: 6.12, CI: 1.82, 20.5), severe class injury with Glasco coma scale (GCS <9) (AOR: 5.96, CI: 2.07, 17.12), intraoperative hypoxia episode (AOR: 10.5, CI: 2.6-42.1), hyperthermia (AOR: 25, CI: 5.54, 115.16), lack of pre-hospital care (AOR: 2.64 CI: 1.6-4.2), abnormal appearance on both eyes (AOR: 13.4, CI: 5.1-34.6), in-hospital hypoxia episode and having extra-cranial concomitant injury were positively associated with mortality, while on admission, systolic blood pressure (SBP) of 100-149 (AOR: 0.086, CI: 0.016-0.46) was negatively associated with mortality.

Conclusion: The overall mortality rate was considerably high. As a result, traumatic brain injury management should be focused on modifiable factors that increase patient mortality, such as on-admission hypotension, a lack of pre-hospital care, post-operative complications, an intraoperative hypoxia episode, and hyperthermia.

背景:创伤性脑损伤是健康和社会经济问题的主要清单,特别是在低收入和中等收入国家,影响到生产年龄组。患者特征、社会经济地位、重症监护病房入院门槛、卫生保健系统以及医院间重症监护病房(ICU)床位数量的差异已被证明是造成各大洲创伤性脑损伤后死亡率差异的原因。本研究的目的是评估冈达尔大学综合专科医院外伤性脑损伤患者的发病率和死亡率预测因素。方法:选取2017年1月至2022年1月收治的患者病历,并对病历进行回顾性随访研究。该研究的参与者是通过计算机生成的简单随机抽样程序选择的。数据录入采用epi-data 4.6版本,分析采用SPSS 26版本。采用双变量和多变量logistic回归分析,在多变量logistic回归分析中,p值结果:死亡率幅度为28.8%。伤害以人身攻击为主,其次为道路交通事故。约30%的受试者在入院时以严重头部损伤和硬膜外血肿(EDH)为主,颅骨骨折是最常见的诊断。死亡率的独立预测因素为男性(AOR: 6.12, CI: 1.82, 20.5)、严重程度损伤(Glasco昏迷量表)(GCS)。因此,外伤性脑损伤的管理应侧重于增加患者死亡率的可改变因素,如入院时低血压、院前护理的缺乏、术后并发症、术中缺氧发作和体温过高。
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引用次数: 2
Sensitivity for Change Analyses of the Patient-Reported Outcomes in Obesity (PROS) Questionnaire: A Prospective Cohort Study. 肥胖症(PROS)问卷患者报告结果变化的敏感性分析:一项前瞻性队列研究。
IF 2.1 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-01-01 DOI: 10.2147/PROM.S414144
Pål André Hegland, Ronette L Kolotkin, John Roger Andersen

Purpose: Many patients seeking bariatric surgery experience reduced health-related quality of life (HRQOL). A simple clinical tool, the Patient-Reported Outcomes in Obesity (PROS), was developed to address patients' HRQOL concerns during clinical consultations and facilitate meaningful dialogue. The present study aims to explore its sensitivity to change.

Patients and methods: A prospective study of patients undergoing bariatric surgery was conducted. The patients responded to items on the PROS and the Obesity-related Problems Scale (OP) before surgery and three, 12 and 24 months after surgery. Longitudinal mixed-effects models were applied to estimate the change in PROS and OP scores over time.

Results: Thirty-eight patients were included. A significant change over time was detected for the PROS with the largest effect size at 24 months (effect size -1.34, p ˂ 0.001), while the corresponding effect size for the OP was -1.32 (p ˂ 0.001). In all items of the PROS, the majority of patients responded not bothered at 24 months. The items physical activity, pain, sleep and self-esteem showed the largest change in the percentage of patients reporting not bothered from baseline to 24 months after surgery.

Conclusion: The PROS is sensitive to change over time and may be used as a brief, easy to administer tool to facilitate a conversation about obesity-specific quality of life in clinical consultations.

目的:许多寻求减肥手术的患者经历了健康相关生活质量(HRQOL)的降低。开发了一种简单的临床工具,即患者报告的肥胖结果(PROS),用于在临床咨询中解决患者对HRQOL的担忧,并促进有意义的对话。本研究旨在探讨其对变化的敏感性。患者和方法:对接受减肥手术的患者进行前瞻性研究。患者术前、术后3个月、12个月和24个月分别对PROS和肥胖相关问题量表(OP)进行评分。采用纵向混合效应模型估计PROS和OP分数随时间的变化。结果:纳入38例患者。随着时间的推移,PROS的效应值在24个月时最大(效应值为-1.34,p小于0.001),而OP的相应效应值为-1.32 (p小于0.001)。在所有的PROS项目中,大多数患者在24个月时没有反应。从手术后24个月开始,身体活动、疼痛、睡眠和自尊这些项目显示出最大的变化。结论:PROS随时间变化敏感,可作为一种简短、易于管理的工具,在临床咨询中促进有关肥胖特异性生活质量的对话。
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引用次数: 0
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Patient Related Outcome Measures
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