Health outcomes research in medicine最新文献_第5页

Antidepressant Utilization, Adherence, and Health Care Spending in the United States: The Case of MDD Patients 2000-2007 抗抑郁药的使用、依从性和医疗支出在美国:2000-2007年重度抑郁症患者的案例

Health outcomes research in medicine

Pub Date : 2011-05-01 DOI: 10.1016/j.ehrm.2011.06.003

Hsien-Chang Lin PhD , Steven R. Erickson PharmD , Rajesh Balkrishnan PhD

Objective

Selective serotonin reuptake inhibitors have been widely adopted in the US as the first-line treatment for major depressive disorder (MDD). This study attempted to understand how patient factors and antidepressant choice influenced medication adherence and associated health care expenditures.

Study Design

A retrospective multiple-year cross-sectional study was conducted. This study used the 2004-2007 Medical Expenditure Panel Survey database; MDD patients who filled one or more prescriptions of antidepressants were extracted. Data were analyzed using weighted ordinary least squares regressions to examine MDD patient antidepressant adherence (measured by proportional days covered) and impacts of patient factors on associated health care expenditures.

Results

Sociological factors such as patient ethnicity and health insurance status were associated with differential levels of antidepressant adherence and associated health expenditures. Hispanic ethnicity was associated with the lowest antidepressant adherence among all. Patients covered by insurance were associated with better proportional days covered and spent more on MDD-specific drugs compared with uninsured patients. Use of newer antidepressants such as selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors was associated with an increase in MDD-specific drug expenditure.

Conclusions

Differences in antidepressant adherence and health care spending across patient factors could have important policy implications for health disparity; certain patient populations may be at higher risk for inadequate health care.

目的选择性5 -羟色胺再摄取抑制剂在美国已被广泛应用于重度抑郁症(MDD)的一线治疗。本研究试图了解患者因素和抗抑郁药选择如何影响药物依从性和相关的医疗保健支出。研究设计进行了一项回顾性的多年横断面研究。本研究使用2004-2007年医疗支出小组调查数据库;服用一种或多种抗抑郁药物的重度抑郁症患者被提取出来。使用加权普通最小二乘回归分析数据，以检查重度抑郁症患者抗抑郁药物依从性(按比例覆盖天数衡量)以及患者因素对相关医疗保健支出的影响。结果患者种族和健康保险状况等社会因素与抗抑郁药物依从性和相关医疗支出的差异水平相关。西班牙裔与抗抑郁药物依从性最低相关。与没有保险的患者相比，有保险的患者有更好的比例保险天数，并且在mdd特异性药物上花费更多。使用较新的抗抑郁药，如选择性5 -羟色胺再摄取抑制剂和5 -羟色胺-去甲肾上腺素再摄取抑制剂与mdd特异性药物消耗增加有关。结论不同患者因素在抗抑郁药物依从性和医疗支出方面的差异可能对健康差异具有重要的政策意义;某些患者群体可能面临卫生保健不足的更高风险。

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引用次数: 10

Assessing Coping with Stress Self-Efficacy: English Validation of the CSSES 应对压力自我效能的评估:csss的英语验证

Health outcomes research in medicine

Pub Date : 2011-05-01 DOI: 10.1016/j.ehrm.2011.06.001

Débora Godoy-Izquierdo PhD , Helena Colodro Sola Lyc , Juan F. Godoy García PhD

Background

Specific self-efficacy for coping with stress refers to the judgments regarding the personal resources aimed at effectively facing taxing conditions. Coping self-efficacy is essential in stress-related issues as well as for increasing coping skills.

Objective

To cross-validate the psychometric properties of the Coping with Stress Self-Efficacy Scale (CSSES) among English speakers in order to complement previous findings with the original Spanish version.

Methods

A convenience, population-based sample of adult women and men from the UK answered the CSSES and another questionnaire assessing self-efficacy beliefs for the use of specific strategies for coping with stress.

Results

The CSSES showed adequate reliability and factorial and concurrent validity. Confirmatory factor analysis corroborates those results. A few weaknesses were detected and some solutions are proposed.

Conclusions

Given that the CSSES is brief and easy to use as well as adequate psychometrically, it seems to be an appropriate instrument for evaluating coping with stress self-efficacy in both research and clinical contexts.

背景应对压力的特定自我效能是指针对个人资源的判断，目的是有效地面对压力环境。应对自我效能在压力相关问题中以及提高应对技能中都是必不可少的。目的对英语人群应对压力自我效能感量表(cses)的心理测量特征进行交叉验证，以期与西班牙语原版量表相补充。方法为了方便起见，对英国成年男女进行人群抽样，分别回答了cses和另一份评估自我效能感信念的问卷，以评估他们在应对压力时使用的具体策略。结果本量表具有良好的信度、析因效度和并发效度。验证性因子分析证实了这些结果。在此基础上，提出了一些解决方案。结论cses量表具有简洁、易于使用、心理计量学指标完备的特点，在研究和临床中都是一种适合于应激自我效能评价的工具。

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引用次数: 5

Psychometric Evaluation of Brief Patient-reported Outcome Measures of Overactive Bladder: The ICIQ-SF, SAC, SATS, SATT, and TBS 膀胱过度活动患者报告结果的简短心理测量评估:ICIQ-SF、SAC、SATS、SATT和TBS

Health outcomes research in medicine

Pub Date : 2011-05-01 DOI: 10.1016/j.ehrm.2011.07.001

Karin S. Coyne PhD, MPH , Mary Kay Margolis MPH, MHA , Vasudha Vats MPH , Heather Gelhorn PhD , Victor Nitti MD

Objective

Overactive bladder (OAB), a bothersome condition that affects many, is best measured using patient-reported outcomes (PROs). This study was conducted to examine the psychometric properties of 5 brief OAB measures: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Subject's Assessment of Condition (SAC), Subject's Assessment of Treatment Satisfaction (SATS), Subject's Assessment of Treatment Tolerance (SATT), and Treatment Benefit Scale (TBS).

Study Design

These secondary analyses of 2 12-week studies of fesoterodine in OAB patients utilized PRO data from Baseline and Week 12. The concurrent and discriminant validity and responsiveness of each measure were evaluated using Spearman's correlations and general linear models.

Results

There were 798 US patients (Study 1) and 1097 international patients (Study 2) analyzed. Mean age was 58.9 and 56.7 years, with the majority women (75.9% and 80.6%), respectively, in Study 1 and Study 2. The ICIQ-SF and SAC were moderately correlated with most King's Health Questionnaire (KHQ) subscales; the SATT and SATS had weak correlations with the KHQ. Urinary urgency incontinence episodes were highly correlated with the ICIQ-SF, but weak correlations were present with all other PROs and bladder diary variables. The ICIQ-SF significantly discriminated between wet and dry OAB patients. The SAC, SATS, and TBS significantly discriminated between patients who had improved versus not improved in micturition frequency and urinary urgency incontinence episodes. The SATT significantly discriminated among patients reporting adverse events versus no adverse events.

Conclusions

The ICIQ-SF, SAC, TBS, SATT, and SATS are brief, useful measures that can be used in research settings and by health care providers in clinical settings who wish to quickly evaluate patients' treatment.

膀胱过动症(OAB)是一种影响许多人的恼人疾病，最好使用患者报告的结果(PROs)来衡量。本研究旨在检验5种OAB量表的心理测量学特征:国际失禁咨询问卷简表(ICIQ-SF)、受试者状态评估(SAC)、受试者治疗满意度评估(SATS)、受试者治疗耐受性评估(SATT)和治疗获益量表(TBS)。研究设计:对2项为期12周的OAB患者使用fesoterodine的研究进行二次分析，利用基线和第12周的PRO数据。采用Spearman相关和一般线性模型评估各测量的并发效度和判别效度和反应性。结果共分析了798名美国患者(研究1)和1097名国际患者(研究2)。研究1和研究2的平均年龄分别为58.9岁和56.7岁，以女性为主(分别为75.9%和80.6%)。ICIQ-SF和SAC与King’s Health Questionnaire (KHQ)的大部分分量表存在中度相关;sat和SATS与KHQ的相关性较弱。尿急失禁发作与ICIQ-SF高度相关，但与所有其他pro和膀胱日记变量存在弱相关性。ICIQ-SF对湿性和干性OAB患者有显著的区分。SAC、SATS和TBS在排尿频率和尿急性尿失禁发作改善与未改善的患者之间有显著区别。SATT在报告不良事件的患者和没有不良事件的患者之间有明显的区别。结论ICIQ-SF、SAC、TBS、SATT和SATS是简短、有用的测量方法，可用于研究环境和临床环境中希望快速评估患者治疗的卫生保健提供者。

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引用次数: 2

Comparative Performance of Comorbidity Indices in Discriminating Health-related Behaviors and Outcomes 共病指数在区分健康相关行为和结果中的比较表现

Health outcomes research in medicine

Pub Date : 2011-05-01 DOI: 10.1016/j.ehrm.2011.06.002

Huang-Tz Ou PhD , Bhramar Mukherjee PhD , Steven R. Erickson PharmD , John D. Piette PhD , Richard P. Bagozzi PhD , Rajesh Balkrishnan PhD

Background and Objective

Although the predictive ability of the Charlson Index, Elixhauser Index (EI), Chronic Disease Score (CDS), and Health-related Quality of Life Comorbidity Index (HRQL-CI) for health care outcomes has been assessed individually, little research has compared the discriminative performance of these indices directly in a single study. The current study compared these indices in discriminating among type 2 diabetes patients varying in demographics and health care outcomes characteristics.

Study Design

There were 9832 Medicaid patients with type 2 diabetes from 8 states evaluated. Endpoints included demographics (age, race), health care behaviors (physician's diabetes care standard adherence, patient's medication adherence), and health care utilization and expenditures. Discriminative power of comorbidity indices was determined by c-statistics from logistic regression, the shape of receiver operator characteristic curve, and area under the curve.

Results

The CDS demonstrated the best ability in discriminating between age subgroups (c = 0.61) and patients who were or were not adherent to their medication (c = 0.56). The CDS and HRQL-CI mental index performed similarly in discriminating based on diabetes care standard adherence (c = 0.60). The EI had the best discrimination for health care utilization and costs, while HRQL-CI physical index performed similarly to EI in predicting hospitalization admission (c = 0.62), and the HRQL-CI mental index performed similarly to the EI in predicting outpatient visits (c = 0.74).

Conclusions

The CDS was found to be the best metric for differentiating among patients varying in demographics, physician's diabetes care standard adherence, and patient's medication adherence, while the EI should be the first choice to identify patients at risk of high medical resource use.

背景与目的虽然Charlson指数、Elixhauser指数(EI)、慢性病评分(CDS)和健康相关生活质量共病指数(HRQL-CI)对卫生保健结果的预测能力已被单独评估，但很少有研究在单一研究中直接比较这些指数的判别性能。目前的研究比较了这些指标在区分不同人口统计学和保健结局特征的2型糖尿病患者中的作用。研究设计对来自8个州的9832名接受医疗补助的2型糖尿病患者进行了评估。终点包括人口统计学(年龄、种族)、医疗保健行为(医生的糖尿病护理标准依从性、患者的药物依从性)和医疗保健利用和支出。共病指数的判别能力由逻辑回归的c统计量、受者算子特征曲线的形状和曲线下面积确定。结果CDS在区分年龄亚组(c = 0.61)和是否坚持用药(c = 0.56)方面表现出最好的能力。CDS和HRQL-CI心理指数在区分糖尿病护理标准依从性方面表现相似(c = 0.60)。EI对医疗保健利用和医疗费用的辨别效果最好，HRQL-CI身体指数与EI在预测住院率方面的表现相似(c = 0.62)， HRQL-CI心理指数与EI在预测门诊次数方面的表现相似(c = 0.74)。结论CDS是区分不同人口统计学、医生糖尿病护理标准依从性和患者药物依从性患者的最佳指标，而EI应是识别高医疗资源使用风险患者的首选。

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引用次数: 6

Predictors of Duloxetine Treatment Persistence for Patients with Major Depressive Disorder 重度抑郁症患者度洛西汀治疗持续性的预测因素

Health outcomes research in medicine

Pub Date : 2011-02-01 DOI: 10.1016/j.ehrm.2010.12.002

Steve Gelwicks MS , Douglas E. Faries PhD , Xianchen Liu MD, PhD

Objectives

Early discontinuation of antidepressant therapy is associated with relapse and increased costs. This exploratory study examined demographical and pretreatment clinical predictors of duloxetine (Eli Lilly and Company, Indianapolis, IN) treatment persistence in patients treated in real-world clinical settings.

Study Design

Using a large US managed-care claims database (PharMetrics Integrated Outcomes Database; PharMetrics Inc., Watertown, MA), study subjects were individuals aged 18 to 64 years who initiated duloxetine treatment between April 2005 and March 2006, had ≥1 claim associated with major depressive disorder diagnosis, and had continuous insurance coverage 6 months before and 12 months after initiation of duloxetine therapy. Treatment persistence was defined as continuous duloxetine treatment without a 30-day gap for ≥3 months. Chi-squared tests and logistic regression analysis were used to examine predictors of persistence.

Results

Among 9148 patients (74.1% female; mean age 45.6 years) who initiated duloxetine treatment, 63.5% stayed on the medication for ≥3 months. Logistic regression analysis showed that an initial dose ≥60 mg (odds ratio [OR] 1.43), older age groups (OR ≥1.49), and venlafaxine XR (OR 1.85) or selective serotonin reuptake inhibitor (OR 1.59) use in the prior 6 months were significantly associated with increased odds of treatment persistence, whereas prior benzodiazepine use (OR 0.86), comorbid alcohol dependence (OR 0.75), drug dependence (OR 0.76), and Parkinson disease (OR 0.36) were associated with decreased odds of treatment persistence. Findings were essentially unchanged with classification and regression tree analysis.

Conclusion

The results suggest that multiple demographic and clinical variables are associated with treatment persistence of duloxetine therapy. The findings may have important implications for clinicians to take actions to prevent early therapy discontinuation.

目的早期停止抗抑郁治疗与复发和费用增加有关。本探索性研究考察了在现实世界的临床环境中接受治疗的患者的度洛西汀(礼来公司，印第安纳波利斯，IN)治疗持续性的人口学和预处理临床预测因素。研究设计:使用美国大型管理医疗索赔数据库(PharMetrics Integrated Outcomes database;PharMetrics Inc.， Watertown, MA)，研究对象是在2005年4月至2006年3月期间开始度洛西汀治疗的18至64岁的个体，与重度抑郁症诊断相关的索赔≥1项，并且在开始度洛西汀治疗前6个月和开始治疗后12个月有连续保险覆盖。治疗持续性定义为连续度洛西汀治疗，无30天间隔，持续≥3个月。使用卡方检验和逻辑回归分析来检验持久性的预测因子。结果9148例患者中，女性占74.1%;开始度洛西汀治疗的患者平均年龄45.6岁，63.5%的患者服药时间≥3个月。Logistic回归分析显示，初始剂量≥60 mg(比值比[OR] 1.43)、年龄较大(OR≥1.49)、前6个月使用文拉法辛XR (OR 1.85)或选择性5 -羟色胺再摄取抑制剂(OR 1.59)与持续治疗的几率显著相关，而先前使用苯二氮卓类药物(OR 0.86)、共病酒精依赖(OR 0.75)、药物依赖(OR 0.76)、和帕金森氏病(OR 0.36)与持续治疗的几率降低相关。分类和回归树分析的结果基本不变。结论多种人口统计学和临床变量与度洛西汀治疗的持久性有关。这一发现可能对临床医生采取措施防止早期停药具有重要意义。

{"title":"Predictors of Duloxetine Treatment Persistence for Patients with Major Depressive Disorder","authors":"Steve Gelwicks MS , Douglas E. Faries PhD , Xianchen Liu MD, PhD","doi":"10.1016/j.ehrm.2010.12.002","DOIUrl":"10.1016/j.ehrm.2010.12.002","url":null,"abstract":"<div><h3>Objectives</h3><p><span><span><span>Early discontinuation of antidepressant therapy is associated with relapse and increased costs. This exploratory study examined demographical and pretreatment clinical predictors of </span>duloxetine (Eli Lilly and Company, Indianapolis, IN) </span>treatment persistence </span>in patients treated in real-world clinical settings.</p></div><div><h3>Study Design</h3><p><span>Using a large US managed-care claims database (PharMetrics Integrated Outcomes Database; PharMetrics Inc., Watertown, MA), study subjects were individuals aged 18 to 64 years who initiated duloxetine treatment between April 2005 and March 2006, had ≥1 claim associated with major depressive disorder diagnosis, and had continuous insurance coverage 6 months before and 12 months after initiation of duloxetine therapy. Treatment persistence was defined as continuous duloxetine treatment without a 30-day gap for ≥3 months. Chi-squared tests and </span>logistic regression analysis were used to examine predictors of persistence.</p></div><div><h3>Results</h3><p>Among 9148 patients (74.1% female; mean age 45.6 years) who initiated duloxetine treatment, 63.5% stayed on the medication for ≥3 months. Logistic regression analysis showed that an initial dose ≥60<!--> <span><span>mg (odds ratio [OR] 1.43), older age groups (OR ≥1.49), and venlafaxine XR<span> (OR 1.85) or selective serotonin reuptake inhibitor (OR 1.59) use in the prior 6 months were significantly associated with increased odds of treatment persistence, whereas prior </span></span>benzodiazepine<span> use (OR 0.86), comorbid alcohol dependence (OR 0.75), drug dependence (OR 0.76), and Parkinson disease (OR 0.36) were associated with decreased odds of treatment persistence. Findings were essentially unchanged with classification and regression tree analysis.</span></span></p></div><div><h3>Conclusion</h3><p>The results suggest that multiple demographic and clinical variables are associated with treatment persistence of duloxetine therapy. The findings may have important implications for clinicians to take actions to prevent early therapy discontinuation.</p></div>","PeriodicalId":88882,"journal":{"name":"Health outcomes research in medicine","volume":"2 1","pages":"Pages e3-e13"},"PeriodicalIF":0.0,"publicationDate":"2011-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ehrm.2010.12.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54245408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Validation and Modification of the Graphical Appraisal Tool for Epidemiology (GATE) for Appraising Systematic Reviews in Evidence-based Guideline Development 基于证据的指南制定中评价系统评价的流行病学图形评价工具(GATE)的验证和修改

Health outcomes research in medicine

Pub Date : 2011-02-01 DOI: 10.1016/j.ehrm.2010.11.001

Anita Fitzgerald MPH, Catherine Coop MPH

Background

There are many checklists and validity scales available to assess the quality of systematic reviews and their content; New Zealand Guidelines Group is a not-for-profit organization that uses the Graphical Appraisal Tool for Epidemiology (GATE), a critical appraisal tool developed by the Effective Practice, Informatics and Quality Improvement collaboration in New Zealand, in guideline development. The objectives of this study were to test the interobserver reliability of individual items on the GATE systematic review checklist and to document reviewers’ experiences of using GATE in order to modify the checklist.

Methods

Two reviewers independently completed a GATE systematic review checklist for each study from a sample of 10 systematic reviews included in clinical practice guidelines. Agreement between reviewers was calculated for each item on the GATE checklist using percentage agreement; kappa, prevalence-adjusted bias-adjusted kappa (PABAK), and reviewers’ experiences of using the tool were documented. The GATE tool was modified based on reviewers’ agreement.

Results

Crude agreement between reviewers on individual GATE items ranged from 55% to 100%, with a median score of 73%. Interrater reliability was variable across individual items, ranging from a PABAK score of 0.09 (poor) to 1 (perfect), with a median score of 0.455 (moderate). Agreement and reliability were both highest for interpretation of subgroup analyses and summary scores of internal validity. Lowest scores related to individual items assessing reproducibility, publication bias, precision of results, and applicability. Agreement on the overall summary score was rated “good,” with 82% agreement and a PABAK score of 0.636. Following the appraisals, 7 question items on the GATE framework were amended and one question was deleted. In the accompanying notes, 12 changes were made.

Conclusions

The amended GATE checklist demonstrates clearer and easier-to-follow notes for appraising systematic reviews. This study demonstrates how the usability of critical appraisal checklists can be adapted through a formal evaluation process that could be undertaken alongside critiquing evidence.

有许多检查表和效度量表可用于评估系统评价的质量及其内容;新西兰指南小组是一个非营利组织，在指南制定中使用流行病学图形评估工具(GATE)，这是新西兰有效实践，信息和质量改进合作开发的关键评估工具。本研究的目的是测试GATE系统评核表中个别项目的观察者间信度，并记录评核者使用GATE系统评核表的经验，以便修改评核表。方法两名审稿人从临床实践指南中纳入的10项系统评价样本中独立完成了每项研究的GATE系统评价清单。对于GATE检查表上的每个项目，使用百分比协议来计算审稿人之间的协议;kappa，普遍调整偏差调整kappa (PABAK)，以及审稿人使用该工具的经验被记录下来。根据审稿人的同意对GATE工具进行修改。结果审稿人对GATE个别项目的粗略同意度在55%到100%之间，中位数为73%。被测者的信度在个别项目之间是可变的，从0.09分(差)到1分(完美)，中位数为0.455分(中等)。亚组分析的解释和内部效度的总结得分的一致性和信度都是最高的。最低分数与评估再现性、发表偏倚、结果精度和适用性的个别项目有关。总体总结得分的一致性被评为“良好”，一致性为82%，PABAK得分为0.636。评估结束后，对GATE框架的7个题项进行了修改，删除了1个题项。在附注中，作了12处修改。结论修订后的GATE清单为系统评价提供了更清晰、更易于遵循的注释。本研究展示了如何通过一个正式的评估过程来调整关键评估清单的可用性，该过程可以与批评证据一起进行。

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引用次数: 2

Effect of Blood Loss on Physical Function in Arthritis Patients: A Pooled Analysis 失血量对关节炎患者身体功能的影响:一项汇总分析

Health outcomes research in medicine

Pub Date : 2011-02-01 DOI: 10.1016/j.ehrm.2010.12.001

Vibeke Strand MD , Byron Cryer MD , Xuemei Luo PhD , Andrew G. Bushmakin MS , Joseph C. Cappelleri PhD , Brian Cuffel PhD , George Sands MD , Annlouise R. Assaf PhD

Background and Objectives

The clinical consequences of lower gastrointestinal bleeding resulting from nonselective nonsteroidal anti-inflammatory drug (NSAID) use are less well documented than upper gastrointestinal bleeding. The aim of this study was to assess the effect of clinically significant gastrointestinal blood loss on health-related quality of life (HRQoL) using the SF-36 in a large arthritis population.

Study Design

To compare treatment-associated changes in HRQoL, data from 14 multinational randomized controlled trials (2–52 weeks’ duration) involving 14,173 subjects with osteoarthritis/rheumatoid arthritis, treated with celecoxib versus placebo or active comparator NSAIDs or both, were pooled. Clinically significant blood loss was defined as hemoglobin decreases ≥2 g/dL from baseline versus no change (from −1 to +1 g/dL).

Results

Subjects with no change in hemoglobin reported statistically significant and clinically meaningful improvements in all SF-36 domains. In those with clinically significant blood loss, improvements were reported in bodily pain (both females and males), and role physical and vitality domains (females) only. Change scores in SF-36 between subjects with significant blood loss and those with no changes in hemoglobin demonstrated statistically significant and clinically meaningful differences in physical function (both females and males) and role physical (males) domains—more pronounced in women and men with baseline hemoglobin values ≤14 and ≤15 g/dL, respectively.

Conclusions

Treatment-associated improvements in physical function reported by subjects with no blood loss were not evident in those with significant blood loss. Differences between groups were statistically and clinically meaningful, and more pronounced when baseline hemoglobin levels were ≤14 g/dL for females and ≤15 g/dL for males. Use of medications with lower incidence of significant blood loss should be warranted in patients with arthritis.

背景和目的与上消化道出血相比，使用非选择性非甾体类抗炎药(NSAID)导致下消化道出血的临床后果文献记载较少。本研究的目的是使用SF-36评估大量关节炎人群中临床显著的胃肠道失血对健康相关生活质量(HRQoL)的影响。研究设计:为了比较治疗相关的HRQoL变化，14项多国随机对照试验(持续时间2-52周)的数据汇总，涉及14173名骨关节炎/类风湿性关节炎患者，接受塞来昔布与安慰剂或活性比较剂非甾体抗炎药或两者同时治疗。临床显著失血定义为血红蛋白较基线降低≥2 g/dL，而无变化(从- 1到+1 g/dL)。结果血红蛋白无变化的受试者报告SF-36各域均有统计学意义和临床意义的改善。在临床上有明显失血的患者中，身体疼痛(男性和女性)和角色身体和活力领域(女性)均有改善。显著失血量受试者与血红蛋白无变化受试者的SF-36评分变化表明，在生理功能(男女)和生理功能(男性)领域(基线血红蛋白值分别≤14和≤15 g/dL的女性和男性中，差异具有统计学意义和临床意义。结论无失血量受试者报告的治疗相关的身体功能改善在失血量显著的受试者中并不明显。组间差异具有统计学意义和临床意义，当基线血红蛋白水平女性≤14 g/dL，男性≤15 g/dL时，差异更为明显。对于关节炎患者，应保证使用显著失血发生率较低的药物。

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引用次数: 4

Basal Supported Oral Therapy with Insulin Glargine Results in Longer Persistence and Lower Costs Compared with Insulin Detemir in Type 2 Diabetics in Germany 在德国，与地特米胰岛素相比，基础支持口服甘精胰岛素治疗2型糖尿病患者的持续时间更长，成本更低

Health outcomes research in medicine

Pub Date : 2011-02-01 DOI: 10.1016/j.ehrm.2011.02.001

Martin Pfohl MD , Franz-Werner Dippel MSc , Karel Kostev MA , Sabine Fuchs MD, MPH , Wioletta Kotowa MD

Objective

To investigate the persistence of basal supported oral therapy (BOT) with either insulin glargine (GLA) or insulin detemir (DET) in type 2 diabetics and to assess long-term costs associated with the initiation of respective treatment regimens.

Study Design

A cost comparison was conducted from the perspective of the German statutory health insurance, applying a Markov model. Two base case scenarios were conducted. Transition probabilities from BOT to intensified conventional therapy (ICT) for scenario 1 were obtained from 5-year persistence data on BOT of the IMS Disease Analyzer (IMS Health Inc. Frankfurt am Main, Germany). Transition probabilities applied for scenario 2 were based on a regression equation of extrapolated persistence data for 10 years. A BOT initiation using GLA and DET at a ratio of 1:1 was assumed. Treatment costs of BOT and ICT with GLA and DET were derived from published sources. Estimation of type 2 diabetics starting a BOT was based on epidemiologic data from the literature. The model was operated over 5 and 10 years for scenarios 1 and 2, respectively. Costs were discounted by 5% per annum in the base case analyses, and varied to 0% and 10%. Multiple one-way sensitivity analyses were conducted varying input cost data.

Results

Based on the persistence data, the cumulative 5-year costs for a cohort of 44,366 type 2 diabetics were 134 million € (GLA) versus 179 million € (DET), resulting in savings of 45 million € in favor of insulin glargine. Total 10-year treatment costs based on the regression equation were 272 million € (GLA) versus 338 million € (DET), resulting in savings of 66 million € in favor of insulin glargine. In sensitivity analyses, cost savings over 10 years for GLA versus DET ranged from € 53 to € 97 million.

Conclusions

Starting an insulin therapy with GLA- rather than DET-based BOT results in a later initiation of ICT in type 2 diabetics. Because treatment costs of an ICT are roughly twice that of a BOT, the longer persistence using GLA shows potential cost savings of € 67 million for the German statutory health insurance within 10 years compared with DET.

目的探讨甘精胰岛素(GLA)或地特米胰岛素(DET)基础支持口服治疗(BOT)在2型糖尿病患者中的持续性，并评估各自治疗方案启动的长期成本。研究设计采用马尔可夫模型，从德国法定健康保险的角度进行成本比较。进行了两种基本情况。根据IMS疾病分析仪(IMS Health Inc.)关于BOT的5年持续数据，获得情景1从BOT到强化常规治疗(ICT)的过渡概率。德国美因河畔法兰克福)。应用于情景2的过渡概率基于10年持续数据外推的回归方程。假设使用GLA和DET以1:1的比例启动BOT。GLA和DET治疗BOT和ICT的费用来源于已发表的资料。2型糖尿病患者开始BOT的估计是基于文献中的流行病学数据。模型对情景1和情景2分别进行了5年和10年的运行。在基本案例分析中，成本按每年5%折现，并在0%和10%之间变化。对不同的投入成本数据进行了多重单向敏感性分析。结果基于持续数据，44366例2型糖尿病患者的5年累积成本为1.34亿欧元(GLA)和1.79亿欧元(DET)，结果甘精胰岛素节省了4500万欧元。基于回归方程的10年总治疗费用为2.72亿欧元(GLA)和3.38亿欧元(DET)，因此甘精胰岛素节省了6600万欧元。在敏感性分析中，与DET相比，GLA在10年内节省的成本从5300万欧元到9700万欧元不等。结论:在2型糖尿病患者中，以GLA- BOT开始胰岛素治疗比以det为基础的BOT更晚开始ICT。由于ICT的治疗费用大约是BOT的两倍，因此与DET相比，使用GLA的时间越长，10年内德国法定医疗保险的潜在成本节省就会达到6700万欧元。

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引用次数: 4

New and More Facile Endpoints in Oncology 肿瘤学中新的和更简单的终点

Health outcomes research in medicine

Pub Date : 2011-02-01 DOI: 10.1016/j.ehrm.2011.03.001

John M. Kirkwood

引用次数: 0

A Comparison of Patient and Clinician Assessments of Functional Ability in Predicting Number of Hospitalizations for Older Patients with Left Ventricular Dysfunction 老年左心室功能障碍患者功能能力预测住院次数的比较

Health outcomes research in medicine

Pub Date : 2011-02-01 DOI: 10.1016/j.ehrm.2011.03.002

Donald E. Stull PhD , Karl Kosloski PhD , Kyle Kercher PhD

Objective

To compare the relative ability of patient self-assessments and clinician assessments of functional limitations for predicting hospitalizations for older adults with left ventricular dysfunction.

Study Design

Latent growth model analyses used secondary data from a clinical drug study, the Studies of Left Ventricular Dysfunction. Self-report and clinician-report data of patients' functional limitations were collected at baseline, and 6 weeks, 12 months, and 24 months postbaseline to assess the effects of an angiotensin-converting enzyme inhibitor versus placebo. Latent growth model analyses were used to assess the relative effect of baseline ratings and changes in these 2 ratings of patient functional limitations over the initial 2 years of the study (ie, the drug study component) as potential predictors of the number of hospitalizations occurring over 3 subsequent years.

Results

Data from 1099 patients aged 65+ years were analyzed. Both baseline patient assessments and changes in patient assessments of functional limitations were significant predictors of the number of subsequent hospitalizations (β = 0.119 and 0.273, respectively). This was not the case for clinician assessments. Moreover, baseline patient and clinician assessments of the patient's functional limitations were correlated at 0.42, indicating only a modest relationship between the 2 assessments.

Conclusions

These results demonstrate the greater utility of patient self-report measures for predicting hospitalizations. Incorporating patient-reported outcomes into clinical practice will expand understanding of the effect of diseases. Assessing changes in patient reports yields important insights into those patients more likely to have multiple admissions for heart failure.

目的比较患者自我评估和临床医师功能限制评估在预测老年左心室功能障碍住院治疗中的相对能力。研究设计:潜在生长模型分析使用了一项临床药物研究——左心室功能障碍研究的二次数据。在基线、基线后6周、12个月和24个月收集患者功能限制的自我报告和临床报告数据，以评估血管紧张素转换酶抑制剂与安慰剂的效果。使用潜在增长模型分析来评估基线评分的相对影响，以及这两个评分在研究最初2年(即药物研究部分)中患者功能限制的变化，作为随后3年住院次数的潜在预测因子。结果对1099例65岁以上患者资料进行分析。基线患者评估和患者功能限制评估的变化都是后续住院次数的重要预测因子(β分别= 0.119和0.273)。这不是临床医生评估的情况。此外，基线患者和临床医生对患者功能限制的评估相关性为0.42，表明两种评估之间只有适度的关系。结论:这些结果表明，患者自我报告措施在预测住院治疗方面具有更大的效用。将患者报告的结果纳入临床实践将扩大对疾病影响的理解。评估患者报告的变化对那些更有可能因心力衰竭多次入院的患者有重要的见解。

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